Operators Manual Canada English THERAKOS CELLEX ...€¦ · y1460451_CV_EN-CA.pdf generic 60322...

Therakos SpecificationIssued Strictly Confidential

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1460451 Label Specification

Revision 4.1 Title Operators Manual Canada English THERAKOS CELLEX Photopheresis System

Issued Date 4/26/2011 2:05:52 PM Owner sbeales

Originated Apr 14, 2011 Expiration Date 12/31/9999 12:00:00 PM

Specification Category

Standard Review Interval 24

Related ECOs ECO-0002571 DescriptionTherakos Cellex Operator's Manual v4.0 - EN-CAUpdate to cover page, changed footer from December 2010 to 2010-12-31

Approvals

State Name Signer Status Description Date/Time

FormalApproval 0000003411 Garro, Joe Approve Accepted Apr 14, 2011

FormalApproval 0000003411 Rosen, Edward Approve approved Apr 14, 2011

FormalApproval 0000003411 Lorenz, Brian Approve approve Apr 14, 2011

FormalApproval 0000003411 Zunic, Eleanore Approve N/A. Legal signature not required per 0850057. Apr 15, 2011

FormalApproval 0000003411 Watters, Tom Approve OK Apr 15, 2011

FormalApproval 0000003411 BARCLAY, PAMELA Approve Approved Apr 19, 2011

FormalApproval 0000003411 Mehrotra, Jyoti Approve Approved Apr 22, 2011

FormalApproval 0000003411 Zunic, Eleanore Approve Assigned disposition of use up per B. Lorenz. Approve. Apr 26, 2011

Suppliers

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1460451-Rev4.1 Strictly Confidential.Please verify that most recently issued document is used Page: 1 of 301

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z1460451_CELLEX_4-0_EN-CA.pdf generic 24825374

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1460451 2 Label Specification Obsolete ezunic 9/17/2008 8:48:46 AM 9/22/2009 10:36:07 AM

1460451 3.2 Label Specification Obsolete bpurcell1 9/22/2009 10:35:43 AM 2/3/2011 12:08:34 PM

1460451 4.0 Label Specification Obsolete ezunic 2/3/2011 12:07:57 PM 4/26/2011 2:07:03 PM

1460451 4.1 Label Specification Issued sbeales 4/26/2011 2:05:52 PM 12/31/9999 12:00:00 PM

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1.0 DESCRIPTION

1.1 Operator's Manual for THERAKOS CELLEX Photopheresis System (EN-CA)

2.0 PROPERTIES AND REQUIREMENTS

2.1 Material

2.1.1 Paper stock A4, 4-hole punched

2.1.2 Cover page on 90 lb paper

2.1.3 Content pages on 32 lb paper

2.1.4 Back cover page on 90 lb paper

2.2 Configuration

2.2.1 Style: Flat

2.2.2 Dimensions: Overall size A4

2.2.3 Cover Dimensions: A4

2.3 Printing

2.3.1 Text

2.3.1.1 Colors – full color for all pages2.3.1.2 Two sided copy2.3.1.3 No print back page

NOTE: An 8 ½ x 11 comb bound copy of the Operator’s Manual (for internal use only) is available and can be ordered from the Publishing Technologies ordering form.

2.4 Artwork/Layout/Text

2.4.1 Copy and layout per artwork supplied by Therakos (Attachment I)

3.0 PACKAGING/SHIPPING

3.1 Cover page to include:3.1.1 Document title3.1.2 Part number3.1.3 Revision level or date issued

3.2 Shrink-wrap manual.

3.3 To be packaged in corrugated boxes – box weight not to exceed 50 lbs.

3.4 Affix a distribution label to the upper right corner (of the side facing out) of each box containing the following information:3.4.1 Therakos logo image3.4.2 Document title 3.4.3 Part number3.4.4 Revision level or date issued3.4.5 Print date


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QUALITY ASSURANCE PAGE

1.0 QUALITY ASSURANCE

1.1 Sampling

1.1.1 Each lot shall be sampled upon receipt and inspected for the characteristics as outlined in this specification.

1.2 Handling Precautions

1.2.1 NA

1.3 Vendor Certification

1.3.1 Vendor shall certify that each lot was manufactured in accordance with this specification. Print vendor to follow Ortho-Clinical Diagnostics SOP 26211 “Publishing Documents for Print, CD, and Web”.

1.4 Inspection Characteristics

1.4.1 Dimensional characteristics shall be inspected per ANSI/ASQ Z1.4 - 2008, Table 1, Level S-3.

1.4.2 Each lot shall be inspected for the following:

Para. Ref.

Char. Ref.

Unit of Measure

Characteristic / RequirementsTest

MethodAQL%

NA NA Each Verify Part Number Visual 6.5

NA NA Each Verify Revision Number Visual 6.5

NA NA Each Verify Date Visual 6.5

1.5 Retain Program

1.5.1 One (1) manual or proofread copy shall be retained as per the requirements of 2050003.

1.6 Approved Vendor(s)/Distributors

1.6.1 Only material from approved sources shall be submitted for evaluation.

1.6.2 GMP Level II

1.6.3 OCD


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2010-12-31

THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual: Rev. 4.0 - 1460451 — EN-CA

(Canadian English)

Please insert these pages into the binder provided by Therakos. IS

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THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual

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Copyright © 2010 by Therakos, Inc. All rights reserved.

Information and descriptions contained in this manual are the property of Therakos. Written permission from Therakos must be obtained before any information or descriptions from this manual are copied or reproduced.

Please direct any written inquiry as follows:

In the USA and Canada, In Europe,Therakos, Inc. Therakos Europe1001 US Highway 202 Johnson & Johnson Medical Ltd., Pinewood CampusRaritan, NJ 08869-0606 Nine Mile RideUSA Wokingham, Berkshire RG40 3EW United Kingdom

All additional contact information for Therakos may be found on the last page of this manual.

Disclaimer: Photographs and schematic diagrams in this operator’s manual may vary slightly from the actual products in use. Operators will be informed in writing of any manufacturing variances that result in instructional changes and / or performance changes to the instrument or procedural kit.

!CAUTION: All automatic sensor functions, pump rates, anticoagulant delivery ratios and fluid balance estimates are limited to the accuracies of the component parts listed in SECTION 8: SPECIFICATIONS. Failure of the instrument to meet these performance specifications may lead to less than optimal Buffy Coat collections, blood loss due to clotting or leakage, increased risk of infection, hypovolemia or hypervolemia and / or a failed treatment.

THERAKOS™ CELLEX™ Photopheresis Procedural Kit Expiration Date is European format: Day / Month / Year

8-MOP™ is a registered trademark of Valeant Pharmaceutical International, formally ICN Pharmaceuticals.IrDA™ is a registered trademark of The Infrared Data Association.Tyvek™ is a registered trademark of DuPont Corporation.THERAKOS™ UVAR XTS™ is a registered trademark of Johnson & Johnson, Inc.

The devices and methods described in this manual are covered by one or more of the following US patents and their foreign counterparts: 5,569,928; 5,459,322; 5,921,951; 6,069,687; 6,219,584; 6,491,656; 6,495,366; 6,793,643; 7,211,037; 7,186,230

Rev. 4.0-1460451

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Contents, Figures, and Tables

™Trademark of Therakos, Inc. THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual

Table of Contents

SECTION 1: ABOUT THIS MANUAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1How to Obtain Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

SECTION 2: WHAT IS PHOTOPHERESIS? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Administering THERAKOS™ Photopheresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Important Safety Information for the THERAKOS™ Photopheresis Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Medications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3Important Safety Information for Methoxsalen Used in Conjunction with THERAKOS™ Photopheresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3Administering Liquid Medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5Oral Medication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

UVA Light Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7Treatment Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Normal Treatment Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8Accelerated Treatment Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Maintenance Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10Anticoagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10Relevant Fluids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11Venous Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Peripheral Venipuncture: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11Central Venous Catheters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12Implanted Venous Access Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12AV Fistulas or Shunts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

SECTION 3: SYSTEM DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1Description of the THERAKOS™ CELLEX™ Photopheresis System Components . . . . . . . . . . . . . . 3-6

Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6Operator Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6THERAKOS™ CELLEX™ Fluid Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12Fluid Management System and Pump Tubing Organizer. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13Hematocrit Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14Air Detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15Placement of Saline and Anticoagulant Bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17Centrifuge Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18Bowl Optic Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19Centrifuge Leak Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20Centrifuge Chamber Door / Manual Release Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20Photoactivation Chamber / THERAKOS™ CELLEX™ Light Assembly. . . . . . . . . . . . . . . . . . . 3-21THERAKOS™ CELLEX™ Photopheresis Procedural Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23Pump Tubing Organizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29Peristaltic Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29Treatment Bag / Return Bag. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30

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Rev. 4.0-1460451

Hematocrit Cuvette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31Tubing Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32Pressure Sensors: Pressure Domes + Pressure Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33Smart Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34

SECTION 4: LOADING THE THERAKOS™ CELLEX™ PHOTOPHERESIS PROCEDURAL KIT 4-1Preparing the Instrument for Procedural Kit Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Engaging the Wheel Locks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1Powering On The Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1Opening the Photoactivation Chamber Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2Preparing the Centrifuge Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2Preparing the Pump Deck . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Installing the THERAKOS™ CELLEX™ Photopheresis Procedural Kit . . . . . . . . . . . . . . . . . . . . . . . 4-3Opening the Procedural Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3Removing the Photoactivation Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4Installing the Photoactivation Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5Removing the Remaining Procedural Kit Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6Hanging the Treatment and Return Bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7Installing The Pump Tubing Organizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8Installing the Centrifuge Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9Manually Loading Each Pump Tubing Segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14Installing the Smart Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15Installing the Three Pressure Domes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16Installing the Lines into the Air Detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18Installing the Hematocrit Cuvette. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19Installing Lines Into the Tubing Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19Preparing and Hanging Saline and Anticoagulant Solutions . . . . . . . . . . . . . . . . . . . . . . . . . 4-20Preparing Patient Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21Final Inspection Before Prime . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

SECTION 5: OPERATING THE THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM . . . . . . 5-1Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1Treatment Phases of THERAKOS™ Photopheresis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

COLLECT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1PURGING AIR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1DRAWING / RETURNING (Double Needle Mode). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1DRAWING / RETURNING (Single Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2EMPTYING BOWL / RECIRCULATING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2RETURNING / READY TO PHOTOACTIVATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3PHOTOACTIVATE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3REINFUSE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4Sterile Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6Cycling Power OFF / ON: After PRIME / During a Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Initiating PRIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8PRIME ACCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Changing Default SETUP Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11Accessing the SETUP Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12Changing Limits and Treatment Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

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Changing the Clock Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13Changing the Language Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

Calculating and Setting Fluid Balance Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14Rationale for Changing Default SETUP Parameter Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Changing COLLECT, RETURN, and REINFUSE Flow Rate Limits . . . . . . . . . . . . . . . . . . . . . . . 5-15Changing COLLECT and RETURN Pressure Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16Changing the A/C Ratio. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16Changing the Saline Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16Changing the Return Bag Threshold Value (Single Needle Mode Only) . . . . . . . . . . . . . . . . . 5-17Changing the Number of Cycles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17Changing the Whole Blood Processed Target . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18Changing the A/C or Saline Volume Thresholds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18Changing the Bowl Optic Threshold Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19

Configuring the THERAKOS™ CELLEX™ Photopheresis Procedural Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20

Determine Single Needle or Double Needle Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20Configuring Collect And Return Lines For Single Needle Mode . . . . . . . . . . . . . . . . . . . . . . 5-21Configuring Collect and Return Lines for Double Needle Mode . . . . . . . . . . . . . . . . . . . . . . 5-22

Single Needle Mode Treatment Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23ESTABLISH ACCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23PURGING AIR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24DRAWING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26RETURNING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28BUFFY COAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30EMPTYING BOWL / RECIRCULATING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31RETURNING / READY TO PHOTOACTIVATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32PHOTOACTIVATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34REINFUSE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35PAUSED. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36PROCEED IMMEDIATELY TO BUFFY COAT / PHOTOACTIVATE / REINFUSE . . . . . . . . . . . . . . . 5-37COLLECT: USING MORE THAN ONE CYCLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38STOPPED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-39TREATMENT COMPLETE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42

Double Needle Mode Treatment Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-45ESTABLISH ACCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-45PURGING AIR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-46DRAWING / RETURNING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-48BUFFY COAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49EMPTYING BOWL / RECIRCULATING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50RETURNING / READY TO PHOTOACTIVATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-51PHOTOACTIVATE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53REINFUSE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-54PAUSED. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-55PROCEED IMMEDIATELY TO BUFFY COAT / PHOTOACTIVATE / REINFUSE . . . . . . . . . . . . . . . 5-56COLLECT: USING MORE THAN ONE CYCLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-57STOPPED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-58TREATMENT COMPLETE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-61

Interrupting a Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-64

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Delivering a Saline Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-65EARLY PHOTOACTIVATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-66END TREATMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-67ABORT TREATMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-68

MANUAL BLOOD RETURN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-69MANUAL BLOOD RETURN (With Power ON and Access to Release Kit Button). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-70MANUAL BLOOD RETURN (With Power OFF and / or No Access to Release Kit Button). . . . . 5-73

SECTION 6: CORRECTING ALARMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Alarm: Power Failure During Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1System Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2Correcting Alarms—Process Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Alarm #1: Air Detected! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6Alarm #2: Temperature! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7Alarm #3: Light Assembly Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8Alarm #4: Centrifuge Chamber Door! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9Alarm #5: Lamp Life Expired!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10Alarm #6: Smart Card Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11Alarm #7: Blood Leak? (Centrifuge Chamber) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12Alarm #8: Blood Leak? (Photoactivation Chamber) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13Alarm #9: Blood Pump Error!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14Alarm #10: Buffy Volume Exceeded! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15Alarm #11: Fluid Routing Valve Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16Alarm #12: Kit Used!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17Alarm #13: Photoactivation Chamber Door! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18Alarm #14: A/C VOLUME THRESHOLD Limit!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19Alarm #15: SALINE VOLUME THRESHOLD Limit! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20Alarm #16: Collect Pressure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21Alarm #17: Return Pressure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22Alarm #18: System Pressure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23Alarm #19: FLUID BALANCE Limit! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24Alarm #20: Low Airflow! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25Alarm #21: Air Detector Test Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26Alarm #22: Collect Pressure Test Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27Alarm #23: Return Pressure Test Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28Alarm #24: System Pressure Test Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29Alarm #25: PRIME 1! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30Alarm #26: PRIME 2! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31Alarm #27: PRIME 3! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32Alarm #28: PRIME 4! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33Alarm #29: PRIME 5! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34Alarm #30: PRIME 6! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35Alarm #31: PRIME 7! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36Alarm #32: PRIME 8! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37Alarm #33: PAUSE Timeout! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38Alarm #34: Return Bag Air Detector! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39

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Alarm #35: Treatment Bag Air Detector! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-40Alarm #36: The Return Bag is Not Empty! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-41Alarm #37: The Treatment Bag is Not Empty! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42Alarm #39: The Treatment Bag is Empty! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-43Alarm #40: Is the Anticoagulant Bag Empty? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44Alarm #41: Is the Saline Bag Empty? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45Alarm #42: PRIME 9! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-46Alarm #43: PRIME 10! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-47Alarm #44: PRIME 11! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-48Alarm #45: Red Blood Cell Pump Alarm! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-49Alarm #46: Accelerometer System Alarm! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-51Alarm #47: Drive Tube Alarm! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-52Alarm #48: Treatment Bag - Air Detected! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-53Alarm #49: Return Bag - Air Detected! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54Alarm #50: PRIME 12! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-55

Popup Messages and Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-56

SECTION 7: MAINTAINING THE THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM . . . . 7-1Recommended Cleaning and Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2Air Detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3Bowl Optic Lens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3Centrifuge Leak Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3Centrifuge Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4External Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4Hematocrit Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5Pressure Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5Operator Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Cleaning a Fluid Spill in the Centrifuge Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6Detachable Parts and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Disposal of the Instrument and Its Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7Power Failure Alarm Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7Replacing the THERAKOS™ CELLEX™ Light Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

SECTION 8: SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1Instrument Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

SECTION 9: WARNINGS AND CAUTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

SECTION 10: FLUID BALANCE MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1Extracorporeal Blood Volume (ECV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2Predicting Actual Procedural Kit Extracorporeal Blood Volume . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

Estimated Extracorporeal Volume (ECV) - Single Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4Estimated Extracorporeal Volume (ECV) - Double Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Estimating the Patient’s Total Blood Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6Example Calculations of TBV and Safe ECV: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

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Rate of Fluid Shifts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8Fluid Balance Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9

Double Needle Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9Single Needle Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10COLLECT: Using More Than One Cycle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10

Fluid Balance Management When Re-purging the Centrifuge Bowl . . . . . . . . . . . . . . . . . . . . . 10-12Re-purging the Centrifuge Bowl in Double Needle Mode. . . . . . . . . . . . . . . . . . . . . . . . . . 10-12Re-purging the Centrifuge Bowl in Single Needle Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13Re-purging the Centrifuge Bowl during a BLOOD PRIMED Procedure . . . . . . . . . . . . . . . . . 10-13

Blood Prime . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14Additional Supplies Needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14Pre-treatment Parameter Setting Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14Priming the Collect Line, Centrifuge Bowl and Return Line with packed Red Blood Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15Cell Collection from the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15Initiating BUFFY COAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17RETURNING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17PHOTOACTIVATE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17REINFUSION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18Completing the Treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18

SECTION 11: GLOSSARY and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10

SECTION 12: Revision history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1Revision Table: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1

Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .IN-IIndex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IN-i

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List of Figures

Figure 1: READY TO PHOTOACTIVATE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5Figure 2: Correct Liquid Medication Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6Figure 3: Incorrect Liquid Medication Administration Relevant Fluids . . . . . . . . . . . . . . . . . . . . . .2-6Figure 4: THERAKOS™ CELLEX™ Photopheresis System – Front View . . . . . . . . . . . . . . . . . . . . .3-2Figure 5: THERAKOS™ CELLEX™ Photopheresis System – Left Side View . . . . . . . . . . . . . . . . . .3-3Figure 6: THERAKOS™ CELLEX™ Photopheresis System – Right Side View . . . . . . . . . . . . . . . . .3-4Figure 7: THERAKOS™ CELLEX™ Photopheresis System – Rear View. . . . . . . . . . . . . . . . . . . . . .3-5Figure 8: Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6Figure 8a: Power Switch Close-Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6Figure 9: Operator Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6Figure 10: Operator Interface in Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7Figure 11a: Graphical Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7Figure 11b: Text Screen 1: Treatment Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7Figure 11c: Text Screen 2: Buffy Coat Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7Figure 12a: Operator Interface Display Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8Figure 12b: Operator Interface Display Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9Figure 12c: Operator Interface Display Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9Figure 12d: % Hematocrit Plot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9Figure 12e: Operator Interface Display Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10Figure 12f: Operator Interface Display Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10Figure 13a: Text Screen 1: Treatment Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11Figure 13b: Text Screen 2: Buffy Coat Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11Figure 14: THERAKOS™ CELLEX™ Fluid Management System . . . . . . . . . . . . . . . . . . . . . . . . . .3-12Figure 15: Pump Tubing Organizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13Figure 16: Pump Tubing Organizer on Pump Deck. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13Figure 17: Automatic Hematocrit Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14Figure 18: Buffy Coat Leaving the Centrifuge Bowl via the Automatic Hematocrit Sensor . . . . . .3-14Figure 19: Change in Light Transmittance during BUFFY COAT Phase . . . . . . . . . . . . . . . . . . . . .3-15Figure 20: Air Detected by Ultrasonic Pulses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15Figure 21a: Location of Air Detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16Figure 21b: Identification of Air Detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16Figure 22: Correct Placement of Saline and Anticoagulant (A/C) Bags . . . . . . . . . . . . . . . . . . . . .3-17Figure 23a: Centrifuge Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18Figure 23b: Centrifuge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18Figure 23c: Centrifuge: Viewing Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18Figure 23d: Centrifuge: Bowl Optic Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18Figure 24a: Plasma / Red Blood Cell Interface (Schematic) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-19Figure 24b: Plasma / Red Blood Cell Interface (Actual) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-19Figure 25: Centrifuge Leak Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-20Figure 26: Centrifuge Chamber Door: Manual Release Access . . . . . . . . . . . . . . . . . . . . . . . . . . .3-20Figure 27: Centrifuge Chamber Door: CLOSED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-20Figure 28: Photoactivation Chamber / THERAKOS™ CELLEX™ Light Assembly . . . . . . . . . . . . . .3-21Figure 29: THERAKOS™ CELLEX™ Photopheresis Procedural Kit . . . . . . . . . . . . . . . . . . . . . . . . .3-23Figure 30: THERAKOS™ CELLEX™ Photopheresis Procedural Kit Components . . . . . . . . . . . . . .3-25Figure 31: Photoactivation Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26

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Figure 32: Continuous Flow Centrifuge Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27Figure 32a: Centrifuge Bowl: Empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27Figure 32b: Centrifuge Bowl: Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-27Figure 33: Specific Gravity Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28Figure 34: Peristaltic Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-29Figure 35: Pump Tubing Organizer Schematic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-29Figure 36: Treatment Bag and Return Bag Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30Figure 37: Treatment Bag / Return Bag Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30Figure 38a: Treatment Bag: Needle-free Port, Spike Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30Figure 38b: Return Bag: Spike Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30Figure 39: Correct: Hematocrit Cuvette Handling and Placement . . . . . . . . . . . . . . . . . . . . . . . . .3-31Figure 40: Patient Collect and Return Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-32Figure 41: Pressure Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33Figure 42: Smart Card Front / Back. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-34Figure 43a: Wheel Locks: OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1Figure 43b: Wheel Locks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1Figure 43c: Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1Figure 43d: Power Switch–Close-up View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1Figure 44a: Photoactivation Chamber Door–CLOSED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2Figure 44b: Photoactivation Chamber Door–OPEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2Figure 45a: Centrifuge Chamber Door–CLOSED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2Figure 45b: Centrifuge Chamber Door–OPEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2Figure 46: Starting Position of Centrifuge Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2Figure 47: Starting Position of Pump Handles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3Figure 48a: THERAKOS™ CELLEX™ Photopheresis Procedural Kit on Instrument. . . . . . . . . . . . . . .4-4Figure 48b: Peel Back Tyvek™ Lid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4Figure 49a: Removing the Photoactivation Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4Figure 49b: Correct handling of Photoactivation Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4Figure 50a: Inserting the Photoactivation Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5Figure 50b: Closing the Photoactivation Chamber Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5Figure 51a: Loosening the Centrifuge Bowl. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6Figure 51b: Removing the Remaining Kit Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6Figure 52a: Treatment Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7Figure 52b: Treatment and Return Bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7Figure 52c: Return Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7Figure 53a: Installing the Pump Tubing Organizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8Figure 53b: Align Mold Indents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8Figure 53c: Gently Push Down to Latch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8Figure 54a: Drive Tube Clamp Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9Figure 54b: Grasping Reinforced Lower Drive Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10Figure 54c: Keyed Drive Tube and Clamp Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10Figure 54d: Closing the Drive Tube Latch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11Figure 55a: Centrifuge Assembly–Starting Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11Figure 55b: Installing Centrifuge Bowl–Align Bowl Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11Figure 55c: Installing Bowl–Rotate Bowl Clockwise to Lock Clip . . . . . . . . . . . . . . . . . . . . . . . . . .4-11Figure 56a: Loading the Drive Tube Lower Bearing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12Figure 56b: Loading the Drive Tube Upper Bearing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

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Figure 57: Verifying Proper Bowl Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13Figure 58a: Stretching Pump Tubing Segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14Figure 58b: Rotating Pump Handle: Clockwise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14Figure 58c: Rotating Pump Handle: Counterclockwise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14Figure 59a: Removing the Smart Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15Figure 59b: Correct Smart Card Insertion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15Figure 59c: Incorrect Smart Card Insertion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15Figure 60a: Location of Pressure Domes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16Figure 60b: Correct Pressure Dome Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16Figure 60c: Incorrect Pressure Dome Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16Figure 61: Installing Lines into Air Detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18Figure 62a: Correct Handling of the Hematocrit Cuvette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19Figure 62b: Incorrect Handling of the Hematocrit Cuvette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19Figure 62c: Correct Placement of the Hematocrit Cuvette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19Figure 62d: Incorrect Placement of the Hematocrit Cuvette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19Figure 63: Placement of Saline and Anticoagulant (A/C) Bags . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20Figure 64a: Close Collect Line (RED) Clamp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21Figure 64b: Clean Needle-free Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21Figure 64c: Connect Return Line (BLUE Striped) Open (BLUE) Clamp . . . . . . . . . . . . . . . . . . . . . . .4-21Figure 64d: Hang Lines on IV Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22Figure 65: Close Centrifuge Chamber Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23Figure 66: Initiating PRIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8Figure 67: PRIME ACCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10Figure 68a: Changing Default SETUP Parameters–SETUP Screen 1 . . . . . . . . . . . . . . . . . . . . . . . . .5-12Figure 68b: Changing Default SETUP Parameters–SETUP Screen 2 . . . . . . . . . . . . . . . . . . . . . . . . .5-12Figure 69a: Changing the Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-13Figure 69b: Changing Language Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-13Figure 70: Position(s) of Plasma / Red Blood Cell Interface in Bowl . . . . . . . . . . . . . . . . . . . . . . . .5-19Figure 71: Select Single Needle Mode or Double Needle Mode . . . . . . . . . . . . . . . . . . . . . . . . . .5-20Figure 72a: Single Needle Mode Line Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21Figure 72b: SELECT SINGLE NEEDLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21Figure 72c: Confirm Screen Display: Single Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21Figure 73a: Double Needle Mode Line Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-22Figure 73b: SELECT DOUBLE NEEDLE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-22Figure 73c: Confirm Screen Display–Double Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-22Figure 74: ESTABLISH ACCESS (Single Needle Mode). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-23Figure 75a: Purging Air (Single Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-24Figure 75b: PURGING AIR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-24Figure 75c: COLLECT Flow Rate and Pressure Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-25Figure 76: DRAWING (Single Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-26Figure 77: RETURNING (Single Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-29Figure 78: BUFFY COAT (Single Needle Mode). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-30Figure 79: EMPTYING BOWL. / RECIRCULATING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-31Figure 80a: Correct Liquid Medication Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-32Figure 80b: Incorrect Liquid Medication Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-32Figure 81: RETURNING / READY TO PHOTOACTIVATE (Single Needle Mode) . . . . . . . . . . . . . . . .5-33Figure 82: PHOTOACTIVATE (Single Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-34Figure 83: REINFUSE (Single Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-35

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Figure 84: PAUSED (Single Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-36Figure 84a: Operator Initiated STOP vs. Automatic STOP in Alarm States (Single Needle Mode) . .5-41Figure 85: TREATMENT COMPLETE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-42Figure 86: Record Treatment Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-42Figure 87: Removing the Pump Tubing Segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-43Figure 88: Removing the Pump Tubing Organizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-43Figure 89: Removing the Centrifuge Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-44Figure 90: ESTABLISH Access (Double Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-45Figure 91: PURGING BOWL (Double Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-46Figure 92: PURGING AIR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-46Figure 93: COLLECT AND RETURN Flow Rates and Pressure Displays . . . . . . . . . . . . . . . . . . . . . .5-47Figure 94: DRAWING / RETURNING (Double Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-48Figure 95: BUFFY COAT (Double Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-50Figure 96: EMPTYING BOWL / RECIRCULATING (Double Needle Mode) . . . . . . . . . . . . . . . . . . . .5-50Figure 97a: Correct Liquid Medication Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-51Figure 97b: Incorrect Liquid Medication Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-51Figure 98: RETURNING / READY TO PHOTOACTIVATE (Double Needle Mode) . . . . . . . . . . . . . . .5-52Figure 99: PHOTOACTIVATE (Double Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-53Figure 100: REINFUSE (Double Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-54Figure 100a: PAUSED (Double Needle Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-55Figure 101: TREATMENT COMPLETE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-61Figure 102: Record Treatment Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-61Figure 102a: Removing the Pump Tubing Segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-62Figure 102b: Removing the Pump Tubing Organizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-62Figure 103: Removing the Centrifuge Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-63Figure 104: Deciding when to PAUSE or STOP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-64Figure 105: Delivering a Saline Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-65Figure 106: Early PHOTOACTIVATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-66Figure 107: END TREATMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-67Figure 108: ABORT TREATMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-68Figure 109: Manually Draining the Photoactivation Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-70Figure 110: Manually Draining the Centrifuge Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-71Figure 111: Manually Draining the Return Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-71Figure 112a: Open Centrifuge Chamber Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-73Figure 112b: Turn Power OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-73Figure 113: Centrifuge Chamber Door Manual Release Access . . . . . . . . . . . . . . . . . . . . . . . . . . .5-74Figure 114: Manually Draining the Photoactivation Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-74Figure 115: Manually Draining the Centrifuge Bowl (With Power OFF and / or No Access to Release Kit Button) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-75Figure 116a: Removing the Pump Tubing Segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-76Figure 116b: Removing the Pump Tubing Organizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-76Figure 117: Draining the Return Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-76Figure 118: Example Alarm text Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2Figure 119a: 9-Volt Battery Low Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-7Figure 119b: Changing the 9-Volt DC Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-7Figure 120a: Light Assembly Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8Figure 120b: Light Assembly Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8Figure 120c: Light Assembly Front: Close-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8

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Figure 121: Changing the THERAKOS™ CELLEX™ Light Assembly . . . . . . . . . . . . . . . . . . . . . . . .7-10Figure 122: Helpful Fluid Balance Management Screen Displays . . . . . . . . . . . . . . . . . . . . . . . . .10-11Figure 123: Normal and Abnormal Red Blood Cell Morphology . . . . . . . . . . . . . . . . . . . . . . . . . . .11-1

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List of Tables

Table 1: Normal / Accelerated Treatment Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8Table 2: Default SETUP Parameter Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-11Table 3: Body Build Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-14Table 4: Cycle Volume Targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-17Table 5: SETUP Changes Required to COLLECT: USING MORE THAN ONE CYCLE . . . . . . . . . . . . .5-37Table 6: SETUP Changes Required to COLLECT: USING MORE THAN ONE CYCLE . . . . . . . . . . . . .5-56Table 7: Manual Blood Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-68Table 8: Cleaning and Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2Table 9: THERAKOS CELLEX Photopheresis System Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2Table 10: Pump Fault Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10Table 11: Pressure Sensor Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-12Table 12: Estimated Extracorporeal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3Table 13: Body Build Factors and Safe Extracorporeal Blood Volume (ECV) Limits . . . . . . . . . . . . .10-8Table 14: Double Needle Mode Fluid Balance Goals and Flow Rates. . . . . . . . . . . . . . . . . . . . . . . .10-9Table 15: Phases of THERAKOS Photopheresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6

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Introduction 1-1

THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual™Trademark of Therakos, Inc.

SECTION 1: ABOUT THIS MANUAL

Introduction

This manual describes the process of THERAKOS™ Photopheresis and contains information about how to use the THERAKOS™ CELLEX™ Photopheresis System.

✎NOTE:

• Therakos provides training for operating the THERAKOS™ CELLEX™ Photopheresis System. Use this manual as a reference after you have been trained.

• Follow the procedures exactly as they are described in this manual. Any deviation or departures from the instructions in this manual are not in accordance with the approved labeling.

How to Obtain Service

Qualified Therakos service personnel will perform the installation of each THERAKOS™ CELLEX™ Instrument. Following installation, each instrument will be inspected to ensure that it is fully operational and set for the proper voltage supply and that the safety alarm systems are tested prior to use.

Therakos assumes responsibility for the reliability and performance of the THERAKOS™ CELLEX™ Photopheresis System only when installation and service to the system are performed by authorized personnel and only when used in accordance with this THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual.

✎NOTE:

• Only personnel trained in THERAKOS™ CELLEX™ Photopheresis Procedural Kit service procedures should perform maintenance procedures. The THERAKOS™ CELLEX™ Photopheresis System does not contain any components that can be repaired by the user.

• For information about service and repair, contact Therakos at the phone numbers listed on the last page of this manual.

!CAUTION:

Follow all operating and maintenance procedures. Failure to do so can result in patient or operator harm.

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SECTION 2: WHAT IS PHOTOPHERESIS?

Introduction

Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where white blood cells are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultra violet A (UVA) light. All blood components, including the treated white blood cells are returned to the patient.

THERAKOS™ Photopheresis utilizes the THERAKOS™ CELLEX™ Photopheresis System to combine state-of-the-art cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS™ CELLEX™ Photopheresis System collects the Buffy Coat (leukocyte-enriched blood) from the patient in a continuous flow process and simultaneously (Double Needle Mode) or intermittently (Single Needle Mode) returns the remaining cells to the patient. The Buffy Coat is passed through the Photoactivation Module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient’s Buffy Coat. After photoactivation, the Buffy Coat is promptly returned to the patient bloodstream.

Administering THERAKOS™ Photopheresis

Only physicians with competency in the diagnosis and treatment of Cutaneous T-Cell Lymphoma (CTCL) should prescribe THERAKOS™ Photopheresis.

Only health care professionals with training in THERAKOS™ Photopheresis should administer this therapy.

When prescribing and administering THERAKOS™ Photopheresis for patients receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy.

Consult the 8-methoxypsoralen (Methoxsalen (20 micrograms / mL)) professional leaflet or the oral 8-methoxypsoralen formulation package insert before prescribing or dispensing any medication.

Carefully read and follow all labeling instructions for the anticoagulant in use. If clinically necessary, adjust the dose of anticoagulant prior to priming the instrument. Monitor the patient’s platelet count before and after exposure to heparin as recommended by the heparin manufacturer.

American Association of Blood Banks (AABB) guidelines recommend that the temporary extracorporeal blood volume be limited to 15% of the patient’s estimated total blood volume. The patient’s clinical condition at the time of THERAKOS™ Photopheresis may warrant even tighter guidelines to maintain haemodynamic stability. Complete assessment of the patient prior to every treatment is necessary to determine the appropriate extracorporeal blood volume and fluid balance during each treatment.

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Important Safety Information for the THERAKOS™ Photopheresis Procedure

✎NOTE:

Please refer to the appropriate product labeling for a complete list of warnings and precautions.

Indications

The THERAKOS™ UVAR XTS™ and THERAKOS™ CELLEX™ Photopheresis Systems are used for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) and systemic sclerosis.

Contraindications

The THERAKOS™UVAR XTS™ or THERAKOS™ CELLEX™ Photopheresis Systems are not designated, sold, or intended for use except as indicated. Certain underlying medical conditions contraindicate THERAKOS™ Photopheresis, including patients who cannot tolerate extracorporeal volume loss during the leukocyte-enrichment phase, patients exhibiting idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen/psoralen compounds, and patients with coagulation disorders.

Warnings and Precautions

THERAKOS™ Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure.

Adverse Events

Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension.

Transient pyretic reactions, 37.7-38.9°C (100-102°F), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.

Treatment frequency exceeding labeling recommendations may result in anemia.

Venous access carries a small risk of infection and pain.

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Medications

Important Safety Information for Methoxsalen Used in Conjunction with THERAKOS™ Photopheresis

!CAUTION:

READ THE THERAKOS™ UVAR XTS™ or THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEMS’ OPERATOR’S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.

Methoxsalen should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience with the THERAKOS™ UVAR XTS™ or THERAKOS™ CELLEX™ Photopheresis Systems.

Contraindications

Methoxsalen is contraindicated in patients exhibiting idiosyncratic reactions to psoralen compounds. Patients possessing a specific history of a light sensitive disease state should not initiate methoxsalen therapy.

Methoxsalen is contraindicated in patients with aphakia because of the significantly increased risk of retinal damage due to the absence of a lens.

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Warnings and Precautions

Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.

Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. Because the dose with liquid methoxsalen is about 200 times less than with PUVA therapy and the skin is not exposed to high cumulative doses of UVA light, the risk of developing skin cancer following this therapy may be lower.

Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinoma should be diligently observed and treated.

Methoxsalen may cause fetal harm when given to a pregnant woman. Women undergoing photopheresis should be advised to avoid becoming pregnant.

Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.

Safety in children has not been established.

Adverse Events

Side effects of photopheresis were primarily related to hypotension secondary to changes in extracorporeal volume (>1%).

Liquid Medication

During a THERAKOS™ Photopheresis procedure, whole blood is withdrawn from the patient and separated by centrifugation to yield a leukocyte-enriched blood fraction. Liquid 8-methoxypsoralen (Methoxsalen (20 micrograms / mL)) is injected directly to this leukocyte-enriched fraction (Buffy Coat) in the Treatment Bag. Then the medicated leukocyte-enriched blood fraction is exposed to a prescribed amount of UVA light. Red blood cells and plasma are returned to the patient without being treated. Once photoactivation is completed, the treated cells are reinfused to the patient.

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Administering Liquid Medication

!CAUTION:

READ THE THERAKOS™ UVAR XTS™ or THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEMS’ OPERATOR’S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.

✎NOTE:

Carefully read the Methoxsalen (20 micrograms / mL) package insert for side effects prior to dispensing this medication.

Methoxsalen (20 micrograms / mL) is supplied in 10mL vials. Each vial contains 200 micrograms (mcg) of methoxsalen with a concentration of 20mcg / mL. There are no preservatives or bacteriostatic agents in the vial, therefore the vial is intended for SINGLE USE ONLY.

Keep Methoxsalen (20 micrograms / mL) stored in the brown glass bottle until use. Do not allow Methoxsalen (20 micrograms / mL) to stand in a syringe or be exposed to UVA light prior to photoactivation.

The instrument calculates the proper dose of Methoxsalen (20 micrograms / mL) using the formula:

TREATMENT VOLUME (mL) multiplied by 0.017 = dose of Methoxsalen (20 micrograms / mL)

Example: TREATMENT VOLUME = 170mL

170 X 0.017 = 2.8mL

Dispense the proper dose of Methoxsalen (20 micrograms / mL) into the Treatment Bag only when you are READY TO PHOTOACTIVATE.

Figure 1: READY TO PHOTOACTIVATE

1. Aseptically attach the luer of the syringe directly to the needle-free port of the Treatment Bag and inject the medication.

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2. Rinse the syringe 3 times with a portion of the Treatment Volume to ensure a complete transfer of the medication from the syringe to the Treatment Bag.

• Measure the medication.

• Remove the needle and attach the syringe luer.

• Dispense the medication and rinse the syringe 3 times.

Figure 2: Correct Liquid Medication Administration

!CAUTION:• Do not puncture the needle-free ports with a needle. Damage to these ports will

result in leaks.• Do not remove the Treatment Bag from the Load Cell Hook. Removal may result in

inaccurate FLUID BALANCE readings.

Figure 3: Incorrect Liquid Medication Administration

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Oral Medication

Oral 8-MOP™ must be administered 2 hours prior to the collection of the plasma and Buffy Coat to allow sufficient time to achieve a minimal blood level of 50 ng / mL at the time of treatment.

!CAUTION:

• Follow all medication dosing instructions carefully.

• Protect the patient’s skin and eyes from sunlight and emphasize this need to the patient to continue protection for 24 hours post treatment. Refer to the Methoxsalen (20 micrograms / mL) labeling or the oral 8-methoxypsoralen dosage formulation package insert for more information on protecting the patient from light and for all warnings and precautions.

UVA Light Dose

The THERAKOS™ CELLEX™ Photopheresis System automatically calculates and sets the photoactivation time—the period during which the blood is exposed to UVA light—and bases the time on remaining lamp life, percentage of hematocrit of the leukocyte-enriched fraction, and treatment volume. This parameter will be automatically calculated and adjusted for each patient treatment. Approximately 1.5 Joules/cm2 is delivered to the leukocyte-enriched blood fraction.

!WARNING:

• The calculated dose of UVA light energy will not be delivered if the THERAKOS™ CELLEX™ Light Assembly is changed after the calculation of photoactivation MINUTES REMAINING is displayed.

• The calculated dose of UVA light energy will not be delivered if PHOTOACTIVATE is ended or aborted before the MINUTES REMAINING is equal to 0.0.

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Treatment Frequency

Normal Treatment Frequency

The PSS patient should receive treatment on two successive days each month for six months. Response in the PSS patient is assessed by measuring changes in the percentage of body surface involved with disease as well as the severity of the areas involved. An “adequate response” is considered to be at least a 15% reduction in their skin severity score. Continued treatments may or may not lead to improvements of greater than 15%. The percent of patients who attain the outcome of at least 15% improvement from baseline may not increase over time or with continued therapy.

The CTCL patient should receive treatment on two successive days each month for six months. An “adequate response” is considered to be a 25% improvement in the skin score obtained within the first eight treatments and maintained for at least 4 weeks. Continued treatments may or may not lead to improvements of greater than 25%.

Accelerated Treatment Frequency

CTCL patients who fail to show an “adequate response” to treatment after eight treatments may have their treatment schedules increased to two successive days every two weeks for the next three months.

FIRST MONTH SECOND MONTH THIRD MONTH

S M T W T F S S M T W T F S S M T W T F S

#1 #2 #3 #4 #5 #6

FOURTH MONTH FIFTH MONTH SIXTH MONTH


#7 #8 #11 #12 #15 #16

#9 #10 #13 #14 #17 #18

SEVENTH MONTH EIGHT MONTH NINTH MONTH


#19 #20

Table 1: Normal / Accelerated Treatment Frequency(Treatments #1-#8) / (Treatments #9-#20)

If no response, or less than an “adequate response” is achieved after 20 treatments, use clinical judgment to decide if Photopheresis should be continued. In the clinical trial of Methoxsalen (20

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Treatment Frequency 2-9


micrograms / mL), fifteen of seventeen responses were seen within six months of treatment. Two patients did respond to treatment after six months.

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Maintenance Frequency

In clinical studies, PSS patients who responded (determined by stoppage or reversal of disease progression) received a maintenance dose of two treatments every four weeks. When maximum response is achieved, physicians can gradually decrease frequency of treatment. However, the physician should continue to follow the patient on a regular basis. CTCL patients who attained a positive response in the clinical studies were maintained at a schedule of two consecutive days of treatment every five weeks for at least three months. When initial response is maintained at this schedule, photopheresis frequency may be gradually decreased, and in some cases may be discontinued entirely. However, the physician should continue to follow the patient on a regular basis.

Anticoagulation

The THERAKOS™ CELLEX™ Photopheresis System uses a heparinized saline concentration of 10,000 - 15,000 Units of heparin per 500mL of 0.9% Normal saline. This concentration is used for priming the system and throughout the patient treatment.

Carefully read and follow all labeling instructions for the anticoagulant in use. Monitor the patient’s platelet count before and after exposure to heparin as recommended by the heparin manufacturer.

!CAUTION:

Individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment. The physician should review the patient’s medical condition, medications and platelet count at the time of treatment and use clinical judgment to establish the optimal heparin dosage for each patient.

If clinically necessary, adjust the dose of heparin prior to priming the instrument and / or by changing the default SETUP parameter setting to alter the A/C ratio. When advised by the physician, adjust the delivery rate of anticoagulant at any time during the treatment by entering the SETUP screen and changing the Anticoagulant (A/C) Ratio. The default A/C Ratio is 10 drops of whole blood to 1 drop of anticoagulant, or 10:1.

The default A/C Volume Threshold is set at 450mL to alert the operator that the 500mL bag is almost empty. If this limit is reached and the physician agrees that additional anticoagulant may be given to the patient, enter the SETUP screen to adjust the A/C Volume Threshold and hang a new bag of heparinized saline.

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Relevant Fluids 2-11


Relevant Fluids

!CAUTION:

It is essential for the THERAKOS™ CELLEX™ Photopheresis System to be installed and used in compliance with all center-specific and local regulations / recommendations on the quality of all relevant fluids used during a therapy.

Some examples of relevant fluids are:

• Saline

• Anticoagulant

• Liquid Psoralen

• Optional Fluid Expanders such as albumin

• Skin Disinfectants

Venous Access

To minimize the risk of infection, Therakos recommends peripheral venous access. Overall Total Treatment Time is dependant on the performance of the access selected. In Single Needle Mode, the access device must be capable of withstanding the negative pressures required to collect whole blood and the positive pressure used to return blood components. In Double Needle Mode, it may be possible to use a large gauge device for DRAWING and a smaller gauge device for RETURNING. Therakos strongly recommends that more than one type of venous access device be available. Choose the one most suitable for the patient undergoing treatment. The following devices are suitable for venous access during a THERAKOS™ Photopheresis treatment:

Peripheral Venipuncture:• 16G, 17G Fistula Needles DRAWING or RETURNING• 17G, 18G IV Catheter (High durometer angiocatheter) DRAWING or RETURNING• 20G IV Catheter (High durometer angiocatheter) RETURNING

When peripheral venipuncture is not possible, alternative devices such as long-term indwelling catheters, temporary catheters, or subcutaneous ports may be used providing they meet the requirements below. Careful planning to ensure the appropriate device is implanted will prevent failed or shortened therapies due to access failure.

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Central Venous Catheters

Any catheter intended to be used with the THERAKOS™ CELLEX™ Photopheresis System must be able to withstand the negative pressure of the peristaltic pressure pumps without collapsing and they must provide a flow rate of at least 15 mL / min. Overall requirements are:

• Minimal internal diameter of 2.3mm or 7FR. (1mm = 3 French)

• Maximum length of 36 cm

• High durometer or stiffness of catheter (generally designed for hemodialysis or apheresis procedures to provide high flow output.)

Implanted Venous Access Devices

Subcutaneous ports designed specifically for high speed infusions will not provide adequate output for DRAWING. Implant only ports designed for both high-speed input and output.

AV Fistulas or Shunts

The THERAKOS™ CELLEX™ Photopheresis System is capable of both DRAWING from and RETURNING to an AV Fistula or shunt. Carefully follow all center-specific guidelines for accessing and maintaining the graft.

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Introduction 3-1


SECTION 3: SYSTEM DESCRIPTION

Introduction

The THERAKOS™ CELLEX™ Photopheresis Procedural Kit offers the option of configuring the THERAKOS™ CELLEX™ Photopheresis Procedural Kit for Single Needle Mode or Double Needle Mode use. The Double Needle Mode configuration provides continuous flow to and from the patient. As whole blood is drawn from the patient, red blood cells and plasma are simultaneously returned to the patient. Single Needle Mode configuration results in discontinuous flow to and from the patient. As whole blood is drawn from the patient, red blood cells and plasma are pooled in a reservoir bag and intermittently returned to the patient.

• Both Double Needle Mode and Single Needle Mode therapies utilize the new, custom-designed continuously spinning Centrifuge Bowl. This Centrifuge Bowl design paired with automatic sensitive Centrifuge Bowl optic monitoring and innovative software-directed pumping mechanisms allows for a single harvest of the Buffy Coat. Extending the dwell time of the leukocyte fraction in the Centrifuge Bowl and harvesting cells only once leads to greater cell collection efficiency and a more consistent Buffy Coat cut. Overall leukocyte collection time is also reduced.

• Only the THERAKOS™ CELLEX™ Photopheresis Procedural Kit (Order Number CLXECP) should be used with the THERAKOS™ CELLEX™ Photopheresis System. This procedural kit is a sterile, single-use closed system. It is pre-connected, latex-free and may be configured for either a single needle or double needle therapy.

• The THERAKOS™ CELLEX™ Photopheresis System is designed for needle-free use and has incorporated needle-free sampling access sites in the patient Collect and Return Lines and at the base of the Treatment Bag.

• Methoxsalen (20 micrograms / mL) may be removed from the vial with the use of a commercially available needle-free vial adapter. If this adapter is not available, withdraw the medication from the bottle using a needle. Discard the needle using center-specific guidelines for disposal of sharp items. Use only the luer of the syringe to inject the Methoxsalen (20 micrograms / mL) into the Treatment Bag (See Figure 2: Correct Liquid Medication Administration on page 2-6 for the correct technique).

!CAUTION:

Do not puncture the needle-free ports with a needle. Damage to these ports will result in leaks.

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Section 3: SYSTEM DESCRIPTION

Rev. 4.0-1460451

Item 7Load Cell Hooks

Item 6Power Failure Battery Alarm Cover

Figure 4: THERAKOS™ CELLEX™ Photopheresis System – Front View

1. Operator Interface and Smart Card Port

2. Centrifuge Chamber3. Pump Deck4. Photoactivation Chamber

5. Wheel Locks6. Power Failure Alarm Battery Cover7. Load Cell Hooks8. Handles

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Introduction 3-3


Figure 5: THERAKOS™ CELLEX™ Photopheresis System – Left Side View

1. Operator Interface2. Pump Deck3. Front Wheel4. Rear Wheel

5. Centrifuge Door-Manual Release6. Rear Handle7. IV Pole

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Figure 6: THERAKOS™ CELLEX™ Photopheresis System – Right Side View

1. IV Pole2. Rear Handle3. Rear Wheel4. Front Wheel

5. Saline & Anticoagulant (A/C) Bag Hanging Hooks6. Centrifuge Chamber Door Handle7. Power Switch

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Introduction 3-5


Figure 7: THERAKOS™ CELLEX™ Photopheresis System – Rear View

1. Rear Handle2. Instrument ID Tag3. Power Cord Socket

4. Power Cord Wrap Cleats5. Rear Cooling Vent6. IV Pole

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Description of the THERAKOS™ CELLEX™ Photopheresis System Components

Power Switch

The Instrument must be plugged into an electrical outlet for the ON / OFF power switch to function. A 9-Volt battery will sound an audible alarm if the power switch is turned on before the Instrument is plugged in.

Figure 8: Power Switch Figure 8a: Power Switch Close-Up

!CAUTION:

Avoid potential electrical hazards by using only properly grounded receptacles and circuits designed to accommodate equipment. Using extension cords is not recommended.

Operator Interface

The operator interface consists of a display monitor with an integrated touch screen. The Interface displays the treatment status, treatment data, and any alarm information. You can perform all treatment operations, including PRIME, COLLECT, PHOTOACTIVATE, REINFUSE, and alarm handling by using the integrated touch screen. Visual and audible alarms are used to alert all special operating conditions. The treatment state number is displayed at the top left of the screen in a faded watermark and may be useful if technical assistance is required.

Figure 9: Operator Interface

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Description Of The Therakos™ Cellex™ Photopheresis System Components 3-7


1

2

3

4

Figure 10: Operator Interface in Detail

1. Color LCD Screen / Touch Sensitive Keypad2. IrDA™ Compliant Data Port and USB port (for service troubleshooting only)3. Smart Card Interface Port4. Adjustable Display Mount

Treatment data is presented on the user interface in one of three screens.

Figure 11a: Graphical Screen Figure 11b: Text Screen 1: Treatment Summary

Figure 11c: Text Screen 2: Buffy Coat Summary

The main screen displays graphical and textual information whereas the other two screens only display textual information. You may switch between these screens by pressing the Next Page Button located in the lower right corner of the screen (See Figure 11a: Graphical Screen).

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The top center section will display the current phase of the treatment while the subtitle line below will display current status information.

The current Cycle Number, Priming Status, or Photoactivation Time Remaining is shown in the right corner of the middle section of the main screen.

Phase Titles and Subtitles

Operator Input Buttons

Cycle Number, Priming Status, Photoactivation MINUTES REMAINING

Next Page Button

Patient Line Return Rate and Pressure

Patient Line Collect Rate and Pressure

Patient Fluid Balance

Patient Whole Blood Processed

Figure 12a: Operator Interface Display Detail

Most input is entered using the oval buttons on the bottom of each screen.

The center section of the main screen includes analog bar graphs and numerical indications for COLLECT and RETURN flow rates and line pressures as well as FLUID BALANCE. The screen also displays the current volume of whole blood processed as the treatment proceeds.

The Buffy Coat Hematocrit is represented as a bar graph and may be useful if manual intervention is required. The graphic display includes an active schematic representation of the treatment procedural kit

and fluid flow paths. Whenever a flow path is active, the path is highlighted in pink. Idle pathways are

shown in blue. Pumps ( idle, active) and fluid routing valves ( closed, open ) are also displayed and indicate direction or status real time.

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Hematocrit Bar Graph % Hematocrit Plot

Figure 12b: Operator Interface Display Detail

Figure 12c: Operator Interface Display Detail

During the BUFFY COAT phase, you may tap on the Hematocrit Bar Graph to expand a hidden graph that will plot Hematocrit %. Over time, the Hematocrit graph will:

1. Go from 0 - 4%. After reaching approximately 4%, the instrument will automatically PAUSE for 2 minutes to repack the BUFFY COAT and perform a brief ELUTRIATION.

2. The plot will rise as the red blood cells in the tubing line pass through the Hematocrit Cuvette and then fall again as plasma re-enters the cuvette.

3. The plot will then display the slope of the curve as the hematocrit percent increases. The target cut-off is a 24% hematocrit.

✎NOTE:

• Hematocrit values displayed on the Hematocrit Bar Graph and % Hematocrit Plot pertain to the hematocrit of the Treatment Volume (Buffy Coat product) and not the patient. Sample results obtained via laboratory analyzers may vary. Laboratory analyzers are calibrated to detect only levels within expected clinical low to high ranges.

Figure 12d: % Hematocrit Plot

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• The treatment is PAUSED. In this state the only active pathway is the Keep Vein Open anticoagulant pathway to the patient access.

• The green arrow shows the direction of the flow.

• All idle pathways are in blue and their fluid routing valves are closed.

• The START SALINE button is now available.

Figure 12e: Operator Interface Display Detail

• In BUFFY COAT, whole blood enters the Centrifuge Bowl and displaces the Buffy Coat.

• The routing valve to the Return Bag is closed (RED) and the routing valve to the Treatment Bag is open (GREEN).

• Anticoagulant is also active in this phase as shown in pink.

• The Collect Flow Rate is automatically slowed during Buffy Coat.

• The Treatment Volume (displayed below the Photoactivation Module) increases.

Figure 12f: Operator Interface Display Detail

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• The System Information Button will display the Instrument Serial Number, Instrument Hours and Software Version Information.

Figure 13a: Text Screen 1: Treatment Summary

• The Buffy Coat Volume per Cycle does not include 80mL of prime solution.

• Treatment Volume = Total Buffy Coat Volume + 80mL prime solution.

Figure 13b: Text Screen 2: Buffy Coat Summary

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THERAKOS™ CELLEX™ Fluid Management System

The THERAKOS™ CELLEX™ Photopheresis System is equipped with a multi microprocessor-controlled Fluid Management System. This system controls all pump and valve functions. It directs fluid routing through the Pump Tubing Organizer and maintains flow rates during all phases of the THERAKOS™ Photopheresis treatment. The Collect and Return Rate Limits are set and controlled by the operator. Collect Line and Return Line pressure is monitored and is a function of the Collect / Return Rate Limit settings and the patient’s access. The Collect Rate, Return Rate, and Reinfusion Rates may be changed as needed by entering the SETUP screen. They may also be changed (within the setup limits) directly at the main screen. Pressure limits may also be set by the operator and will stop fluid flow when limits are exceeded. See Changing Default SETUP Parameters on page 5-11.

8

1

2

3

4

5

6

7

9

10

11

12

Figure 14: THERAKOS™ CELLEX™ Fluid Management System

1. Centrifuge System Pressure Sensor 2. Red Blood Cell Pump (#2)3. Return Pump (#3)4. Air Detectors5. Return Pressure Sensor6. Collect Pressure Sensor

7. Tubing Guides8. Hematocrit Sensor9. Recirculation Pump (#4) 10. A/C Pump (#5)11. Fluid Routing Valves 12. Collect Pump (#1)

✎NOTE:

A number code is assigned to each pump. The pump tubing segments attached to the Pump Tubing Organizer are numbered accordingly.

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Fluid Management System and Pump Tubing Organizer

Whole blood, saline, and anticoagulant are all routed through the Pump Tubing Organizer. Access performance is continually assessed using Pressure Sensors and any fluids that return to the patient are monitored for air and filtered before leaving the Pump Tubing Organizer. In some alarm, states all Fluid Routing Valves will be closed to prevent fluid movement within the extracorporeal circuit until the alarm state is cleared.

Figure 15: Pump Tubing Organizer

Figure 16: Pump Tubing Organizer on Pump Deck

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Hematocrit Sensor

The automatic detection of hematocrit is based on a change in light transmittance as the effluent from the Centrifuge Bowl passes through the hematocrit cuvette seated in the hematocrit sensor housing during BUFFY COAT. (See Figure 19: Change in Light Transmittance during BUFFY COAT Phase on page 3-15.) The Hematocrit Sensor also determines the hematocrit of the Treatment Volume. This value is required to calculate the duration of UVA light exposure or the photoactivation time (displayed in MINUTES REMAINING) during PHOTOACTIVATE.

Figure 17: Automatic Hematocrit Sensor

Figure 18: Buffy Coat Leaving the Centrifuge Bowl via the Automatic Hematocrit Sensor

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No change Slight Change (↓) Target Change (↓ ↓)

Figure 19: Change in Light Transmittance during BUFFY COAT Phase

Air Detectors

Digital ultrasonic pulses are used to detect air bubbles in the patient Collect and Return Lines as well as the Anticoagulant Line. An alarm condition occurs any time air is detected in these lines during a treatment. Additional Air Detectors are used to monitor the level of fluid in the Return Bag and Treatment Bag. All Air Detectors are tested as part of the instrument Power-ON self-test.

Ultra sonic pulses pass readily through fluid but are blocked by air.

Figure 20: Air Detected by Ultrasonic Pulses

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51 2 3 4

Figure 21a: Location of Air Detectors

Figure 21b: Identification of Air Detectors

1. Treatment Bag Line2. Return Bag Line3. Patient A/C Line4. Patient Collect Line5. Patient Return Line

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Placement of Saline and Anticoagulant Bags

Saline and Anticoagulant Bags hang on the two hooks provided below the pump deck on the lower-right side of the instrument (as you face it) and must be connected to the proper spike port of the Pump Tubing Organizer.

SALINE A/C

Figure 22: Correct Placement of Saline and Anticoagulant (A/C) Bags

!CAUTION:

• The correct placement of the Saline and Anticoagulant Bags is essential. (See Figure 22: Correct Placement of Saline and Anticoagulant (A/C) Bags). Incorrect placement may lead to clotting in the procedural kit, patient blood loss, and a failed treatment.

• Always confirm the contents, lot number, and expiration date of any solution prior to its use.

• Saline and Anticoagulant Spike Lines do not have slide clamps. Instead, Fluid Routing Valves—activated when the base of the Drive Tube is inserted into the Drive Tube Clamp Assembly and the Drive Tube Latch is closed—prevent gravity flow of fluid from entering the Pump Tubing Organizer prior to PRIME.

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Centrifuge Assembly

The Centrifuge Assembly of the THERAKOS™ CELLEX™ Photopheresis System is located at eye level for easy monitoring. The motor to the Centrifuge is mounted above the Centrifuge Assembly. The Centrifuge Frame and Centrifuge Bowl Drive Tube rotate at 2400 revolutions per minute. The Centrifuge Bowl and Bowl Holder rotate at 4800 revolutions per minute.

1

2

3

5

4

6

7

1. Centrifuge Frame2. Upper Bearing Retainer Clip3. Centrifuge Leak Detector 4. Centrifuge Bowl Holder5. Lower Bearing Retainer Clip6. Drive Tube Latch7. Tubing Exit Slot

Figure 23a: Centrifuge Assembly

1

2

Figure 23b: Centrifuge1. Centrifuge Chamber Door -

CLOSED2. Viewing Window

Figure 23c: Centrifuge: Viewing Window

Figure 23d: Centrifuge: Bowl Optic Sensor

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Bowl Optic Sensor

The Centrifuge Assembly is equipped with a Bowl Optic Sensor that automatically identifies the red blood cell layer. It is used by the system computer in establishing the Red Blood Cell Pump speed in an effort to maintain the Buffy Coat within the spinning Centrifuge Bowl.

The Bowl Optic Sensor is automatically calibrated to its default setting and checked during PRIME. You can adjust the Bowl Optic setting if necessary. For more information, see Changing Default SETUP Parameters on page 5-11.

Figure 24a: Plasma / Red Blood Cell Interface (Schematic)

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Centrifuge Leak Detector

A Leak Detector located in the Centrifuge Chamber will stop the Centrifuge and sound an alarm if fluid or humidity comes in contact with the sensor due to a Centrifuge Bowl or Drive Tube leak.

Figure 25: Centrifuge Leak Detector

Centrifuge Chamber Door / Manual Release Access

The Centrifuge Chamber Door must be closed before the instrument is primed. An interlocking safety latch will prevent the Centrifuge Chamber Door from opening while the Centrifuge is in use. The door will open freely whenever the Centrifuge is not in use. If the Centrifuge stops due to loss of power during the treatment, you may open the door may manually overriding the safety-interlocking latch. The Centrifuge Chamber Door Manual Release Access is located on the left side of the instrument.

Figure 26: Centrifuge Chamber Door: Manual Release Access

Figure 27: Centrifuge Chamber Door: CLOSED

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Photoactivation Chamber / THERAKOS™ CELLEX™ Light Assembly

The THERAKOS™ CELLEX™ Photopheresis System controls the power source for the THERAKOS™ CELLEX™ Light Assembly. The light assembly is a single assembly incorporating 18 lamps which deliver the optimum UVA light energy for effective photoactivation of the collected leukocytes.

2

3 4

5

6

8

71

Figure 28: Photoactivation Chamber / THERAKOS™ CELLEX™ Light Assembly

1. Photoactivation Chamber Door2. Receptacle for Photoactivation Module3. Photoactivation Chamber Leak Detector4. Photoactivation Chamber Leak Catch Bin

5. THERAKOS™ CELLEX™ Light Assembly Back6. Lamp Data Chip7. UVA Lamps8. THERAKOS™ CELLEX™ Light Assembly Front

The light assembly has a programmed life of 150 photoactivation hours. Lamp life is electronically monitored and displayed by the THERAKOS™ CELLEX™ Photopheresis System. During treatment, the system delivers the full UVA light energy level throughout the entire exposure period. Each light assembly has several reserve hours available to be used if the photoactivation MINUTES REMAINING exceeds remaining hours displayed. When the total lamp life has been depleted, an alarm and message will prompt for replacement prior to the next treatment. See Replacing the Light Assembly on page 7-8 for complete instructions on how to change the light assembly.IS

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During PHOTOACTIVATE the THERAKOS™ CELLEX™ Photopheresis System continuously pumps and recirculates the leukocyte-enriched blood fraction through the Photoactivation Module (at a rate of 100mL/min) for uniform penetration of UVA light to all collected leukocytes. A leak detector continuously monitors the Photoactivation Chamber for fluid leaks.

!WARNING:



!CAUTION:

• Always change an aged THERAKOS™ CELLEX™ Light Assembly prior to starting a treatment.

• Turn the power OFF and unplug the instrument prior to changing the light assembly.

• Never change the light assembly during a treatment if the photoactivation MINUTES REMAINING has already been calculated.

• Do not attempt to modify the THERAKOS™ CELLEX™ Photopheresis System or the THERAKOS™ CELLEX™ Light Assembly in any way.

For more information about replacing the THERAKOS™ CELLEX™ Light Assembly, see Replacing the Light Assembly on page 7-8. IS

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THERAKOS™ CELLEX™ Photopheresis Procedural Kit

The THERAKOS™ CELLEX™ Photopheresis Procedural Kit is a single-use, latex-free, disposable, closed system with sterile fluid pathways. All components are pre-connected for easy setup. The components are contained in a disposable plastic tray. The tray has an easy-to-remove Tyvek™ lid.

Figure 29: THERAKOS™ CELLEX™ Photopheresis Procedural Kit

The THERAKOS™ CELLEX™ Photopheresis Procedural Kit contains the following components:

• Pump Tubing Organizer and Blood Filter• Photoactivation Module• Centrifuge Bowl and Drive Tube• Hematocrit Cuvette• Treatment Bag

• Return Bag• Saline and Anticoagulant Spikes• Patient Collect and Return Lines• Collect, Return, and System Pressure Sensor Domes• Smart Card

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THERAKOS™ CELLEX™ Photopheresis Procedural Kit Storage and Handling

✎NOTE:

• If the package is opened or items appear damaged, do not use the THERAKOS™ CELLEX™ Photopheresis Procedural Kit. Notify Therakos of the damage at one of the phone numbers on the back page of this manual and save the damaged item for inspection by Therakos.

• Do not use a THERAKOS™ CELLEX™ Photopheresis Procedural Kit after its expiration date.

• Do not use the THERAKOS™ CELLEX™ Photopheresis Procedural Kit if any of the protective caps on the patient lines or fluid spikes are missing or off when the kit is opened. Sterility of the kit may be compromised if these caps are removed prior to use.

• Do not allow the packaging tub to become wet.

• Store in a dry place and avoid exposure to vapors of lacquer, paint thinners, and other solvents.

• Avoid exposure to temperatures above 50°C (122°F) and below -20ºC (-4°F).

• Make sure that hands and gloves are clean and dry before handling the THERAKOS™ CELLEX™ Photopheresis Procedural Kit to prevent contamination.

• Use special care when handling the Photoactivation Module. Hold the Photoactivation Module by the edges and avoid the fluid pathways.

• The THERAKOS™ CELLEX™ Photopheresis Procedural Kit contains the phthalate DEHP.

• The THERAKOS™ CELLEX™ Photopheresis Procedural Kit is intended for Single Use Only! Any attempt to re-use this kit may lead to:

• A biohazard risk to both patient and operator

• Risk of infection to the patient

• Risk of blood incompatibility to the patient

Inspecting the THERAKOS™ CELLEX™ Photopheresis Procedural Kit

Inspect each component of the THERAKOS™ CELLEX™ Photopheresis Procedural Kit at the time of setup. Check tubing for kinks that would obstruct flow. Check plastics, such as the Photoactivation Module, Centrifuge Bowl, and Pressure Domes for any defects. Any defective material should not be used for a patient treatment and the defective procedural kit should be returned to Therakos. For information about returning the procedural kit, please contact Therakos at one of the phone numbers listed on the last page of this manual.

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THERAKOS™ CELLEX™ Photopheresis Procedural Kit Components

Figure 30: THERAKOS™ CELLEX™ Photopheresis Procedural Kit Components

1. Photoactivation Module 2. Hematocrit Cuvette 3. Pump Tubing Organizer 4. Centrifuge Bowl4a. Drive Tube5. Smart Card

6. Pressure Domes7. Saline and Anticoagulant Spike Chambers8. Patient Return Line9. Patient Collect Line10. Return Bag11. Treatment Bag

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Photoactivation Module

The Photoactivation Module is a thin, sterile fluid pathway constructed of UVA-transparent acrylic. It is inserted into the slot on the front of the instrument behind the Photoactivation Chamber Door. When installed, it will be situated between the two banks of UVA lamps.

• The Buffy Coat recirculates through the serpentine pathway of the module during PHOTOACTIVATE.

• The vertical orientation of the Photoactivation Module allows it to be drained without the need of a saline rinse.

Figure 31: Photoactivation Module

!CAUTION:

Do not clean the Photoactivation Module. Cleaning agents could leave a film that may adversely affect the transmission of UVA light energy and the photoactivation process.

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Centrifuge Bowl

The THERAKOS™ CELLEX™ Photopheresis System incorporates a custom continuous flow Centrifuge Bowl which is designed to separate the components of anticoagulated whole blood as the blood enters the spinning Centrifuge Bowl. Separation within the Centrifuge Bowl is from the lowest density component near the center of the Centrifuge Bowl to the highest density component near the outer wall (See Figure 33: Specific Gravity Chart on page 3-28). The order of separation from lowest to highest density is: plasma, platelets, white blood cells, and red blood cells. When the default settings are in use, the entire Buffy Coat from 1500mL of Whole Blood Processed will be continuously harvested in the Centrifuge Bowl. Flow of whole blood to and from the patient may be either continuous (Double Needle Mode) or discontinuous (Single Needle Mode).

Figure 32: Continuous Flow Centrifuge Bowl

1. Red Blood Cells: OUT2. Whole Blood: IN3. Plasma: OUT4. Drive Tube5. Continuous Flow Centrifuge Bowl

Figure 32a: Centrifuge Bowl: Empty Figure 32b: Centrifuge Bowl: Full

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White Blood Cells

Red Blood Cells

Figure 33: Specific Gravity Chart

Reticulocytes (1.078)

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Pump Tubing Organizer

The Pump Tubing Organizer integrates the fluid tubing segments and routing manifolds to facilitate easier loading of the pump tubing segments and provides the backstop for tubing clamps. The organizer also includes a drip chamber and 200-micron blood filter for fluids returning to the patient. Tubing segments for all five peristaltic pumps are all routed through the Pump Tubing Organizer.

Peristaltic Pumps

Five pumps (identified in Figure 34) move fluids by the action of multiple equally spaced rollers, which rotate and compress a flexible tube. See SECTION 8: SPECIFICATIONS for pump accuracy and limitation details.

1

2 2

Figure 34: Peristaltic Pumps

1. Pump Tubing Organizer2. Peristaltic Pumps

Circle = Fluid Routing Valve depressed during Manual Return

Square = Fluid Routing Valve depressed if venting required during Manual Return

Figure 35: Pump Tubing Organizer Schematic

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Treatment Bag / Return Bag

The THERAKOS™ CELLEX™ Photopheresis Procedural Kit includes both Treatment and Return bags that are labeled “T” and “R”, respectively.

• The Treatment Bag contains Buffy Coat and is a part of the recirculation loop during PHOTOACTIVATE.

• The Return Bag is used for storage of plasma and / or red blood cells before they are returned to the patient.

Figure 36: Treatment Bag and Return Bag Labels

• The Treatment Bag injection port is used for injecting the prescribed amount of medication prior to photoactivation. It may also be used as a sample site.

• Both the Treatment Bag and Return Bag have spike ports that may be used in the event that manual blood return is required.

Figure 37: Treatment Bag / Return Bag Placement

Buffy Coat in Treatment Bag (on left)Red Blood Cells / Plasma in Return Bag (on right)

Figure 38a: Treatment Bag: Needle-free Port, Spike Port

Figure 38b: Return Bag: Spike Port

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Hematocrit Cuvette

The Hematocrit Cuvette provides the disposable viewing window through which the Hematocrit Sensor measures the hematocrit of the leukocyte-enriched blood fraction as it leaves the Centrifuge Bowl and enters the Treatment Bag. The Hematocrit Sensor determines when Buffy Coat collection should end. During BUFFY COAT the hematocrit is constantly measured and displayed by the system. The Hematocrit Sensor also measures the hematocrit of the product and the THERAKOS™ CELLEX™ Instrument uses this value to calculate the proper photoactivation time.

Avoid putting fingers on the viewing window and be certain the Hematocrit Cuvette is seated properly in the Hematocrit Sensor.

Figure 39: Correct: Hematocrit Cuvette Handling and Placement

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Tubing Lines

The THERAKOS™ CELLEX™ Photopheresis Procedural Kit contains all tubing necessary to complete a treatment. The tubing includes the following lines:

Patient Collect Line

The Patient Collect Line is used to connect to patient blood access. The Patient Collect Line must be placed into the Collect Air Detector slot and is identified with a (RED) stripe and a (RED) clamp.

Patient Return Line

The Patient Return Line is used to connect to patient blood return in Double-Needle configuration or to the Patient Collect Line needle-free sampling site in Single-Needle configuration. The Patient Return Line must be placed into the Return Air Detector slot and is identified with a (BLUE) stripe and a (BLUE) clamp.

1

2

Figure 40: Patient Collect and Return Lines

1. Collect Line2. Return Line

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Patient Anticoagulant Line

The Anticoagulant Pump delivers anticoagulant solution to the Patient Collect Line via the Anticoagulant Line during the treatment at a default ratio of 10 drops of blood to 1 drop of anticoagulant or 10:1. The operator may select an alternative rate of delivery for individual patients if directed by the physician. This line must be placed into the Anticoagulant Air Detector and is identified with a (GREEN) stripe.

Saline Source Line & Spike Chamber

This Saline Source Line connects the Saline Solution Bag and the Pump Tubing Organizer. It has a spike chamber and clear tubing.

Anticoagulant (A/C) Source Line & Spike Chamber

The A/C Source Line connects the Anticoagulant Solution Bag and the Pump Tubing Organizer. It has a spike chamber and is identified with a (GREEN) stripe on the tubing.

Pressure Sensors: Pressure Domes + Pressure Transducers

The procedural kit contains three Pressure Domes that interface with three Pressure Transducers on the Pump Deck. These connections allow for continuous pressure monitoring of the Patient Collect Line, the Patient Return Line, and the Centrifuge Bowl throughout the therapy.

2

1

Figure 41: Pressure Sensors

1. Pressure Dome2. Pressure Transducers

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Smart Card

Each THERAKOS™ CELLEX™ Photopheresis Procedural Kit is equipped with a custom Smart Card that logs many functions and the data from each treatment for diagnostic use. When the START button is pressed during PRIME, data logging begins. Each Smart Card has been programmed at the factory with a unique number. You may be asked to return the Smart Card after a treatment should you require service or technical assistance.

Figure 42: Smart Card Front / Back

*Graphics are representative only.

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Preparing The Instrument For Procedural Kit Installation 4-1


SECTION 4: LOADING THE THERAKOS™ CELLEX™ PHOTOPHERESIS PROCEDURAL KIT

Preparing the Instrument for Procedural Kit Installation

Engaging the Wheel Locks

1. Begin by selecting a clean workspace with proper lighting and access to all necessary supplies.

2. Position the instrument within reach of a properly grounded electrical outlet.

3. Ensure that there is no obstruction of airflow on any side of the instrument.

Do not operate the instrument in the presence of external radio or electromagnetic disturbances that may interfere with proper performance of the device. This could result in treatment interruptions and the possibility of a failed treatment.

4. Engage the wheel locks.

Figure 43a: Wheel Locks: OFF

Figure 43b: Wheel Locks

Figure 43c: Power Switch Figure 43d: Power Switch–Close-up View

Powering On The Instrument

1. Plug the Power Cord into the electrical outlet.

2. Remove the protective pressure domes from the transducers before turning the instrument power ON.

3. Turn the power ON. The Power Switch is located on the right side of the instrument behind the Operator Interface.

Once the power is turned ON, the system beeps and performs a self-check. The Operator Interface Screen remains blank for about 30 seconds before the logo appears.

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Section 4: LOADING THE THERAKOS™ CELLEX™ PHOTOPHERESIS PROCEDURAL KIT

Rev. 4.0-1460451

Opening the Photoactivation Chamber Door

Place your finger in the notch at the top of the door and pull gently. The door is held closed by a magnet.

Figure 44a: Photoactivation Chamber Door–CLOSED

Figure 44b: Photoactivation Chamber Door–OPEN

Preparing the Centrifuge Assembly

1. Open the Centrifuge Chamber Door.

2. Position the Centrifuge Frame so that the two Bearing Holders are on the right side as shown.

3. Rotate the Centrifuge Bowl Holder so the Retainer Clip is facing front.

1

2

3

Figure 45a: Centrifuge Chamber Door–CLOSED

Figure 45b: Centrifuge Chamber Door–OPEN

Figure 46: Starting Position of Centrifuge Components

1. Centrifuge Frame2. Retainer Clip3. Drive Tube Latch

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Installing The Therakos™ Cellex™ Photopheresis Procedural Kit 4-3


Preparing the Pump Deck

Turn all Pump Handles so that the tapered (narrow) ends face the center of the Pump Deck.

Narrow end

Figure 47: Starting Position of Pump Handles

Installing the THERAKOS™ CELLEX™ Photopheresis Procedural Kit

Opening the Procedural Kit

1. Inspect the procedural kit for any damage to the package that could compromise the sterility of the procedural kit. Do not use a damaged procedural kit or a procedural kit that is expired.

!CAUTION:

DO NOT USE the THERAKOS™ CELLEX™ Photopheresis Procedural Kit if:

• the package is already opened or damaged.• the fluid pathway guards (caps on ends of tubing lines) are loose in packaging or

missing. • the Date of Use is beyond the Expiration Date.

2. Place the procedural kit on top of the instrument with the labeling text facing you.

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3. Peel back the Tyvek™ lid.

Figure 48a: THERAKOS™ CELLEX™ Photo-pheresis Procedural Kit on Instrument

Figure 48b: Peel Back Tyvek™ Lid

Removing the Photoactivation Module

1. To release the Photoactivation Module from the protective packing tray, grasp and elevate the top right corner where the tubing lines attach while pushing the back wall of the packing tray away from the plate. Handle the Photoactivation Module by the frosted edges.

2. Discard the protective packing tray.

Figure 49a: Removing the Photoactivation Module

Figure 49b: Correct handling of Photoactiva-tion Module

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Installing the Photoactivation Module

1. Insert the Photoactivation Module into the Photoactivation Chamber with the tubing lines at the top.

2. Close the Photoactivation Chamber Door.

3. Confirm that the lines are not pinched.

Figure 50a: Inserting the Photoactivation Module

Figure 50b: Closing the Photoactivation Cham-ber Door

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Removing the Remaining Procedural Kit Components

1. Loosen the Centrifuge Bowl from the packing tray.

2. Place the Centrifuge Bowl into the left side of the Centrifuge Chamber.

3. Carefully loosen the Pump Tubing Organizer from the packing tray.

4. Remove all remaining procedural kit components and carefully place them on the center of the pump deck surface.

5. Discard the packing tray.

Figure 51a: Loosening the Centrifuge Bowl Figure 51b: Removing the Remaining Kit Com-ponents

!CAUTION:

Do not use the THERAKOS™ CELLEX™ Photopheresis Procedural Kit if any of the protective caps on the patient lines or fluid spikes are missing or off when the procedural kit is opened. Sterility of the procedural kit may be compromised if these caps are removed prior to use.

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Hanging the Treatment and Return Bags

1. The Return Bag hangs on the right front Load Cell Hook below the Pump Deck and is imprinted with the letter “R”.

2. The Treatment Bag hangs on the left front Load Cell Hook below the Pump Deck and is imprinted with the letter “T”.

Figure 52a: Treatment Bag Figure 52b: Treatment and Return Bags

Figure 52c: Return Bag

!WARNING:

Prior to initiating PRIME, ensure the Treatment Bag and Return Bag are properly positioned on their respective Load Cell Hooks. Removal of these bags at any time after PRIME is initiated may result in priming alarms and / or inaccurate FLUID BALANCE readings during the treatment.

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Installing The Pump Tubing Organizer

1. Set aside the bundled tubing lines.

2. Hold the Pump Tubing Organizer at an angle with all tubing free, and then align mold indents on the front edge of Pump Tubing Organizer with the three tabs protruding from the surface of the Pump Deck.

3. Gently press down on the rear edge of the Pump Tubing Organizer to latch it into place against the rear locking tabs.

Figure 53a: Installing the Pump Tubing Organizer

Figure 53b: Align Mold Indents

Figure 53c: Gently Push Down to Latch

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Installing the Centrifuge Bowl

Before proceeding, use Figure 54a to learn the parts of the Drive Tube Clamp Assembly.

1

2

3

1. Drive Tube Latch2. Groove for Drive Tube Notch3. Drive Tube Clamp

Figure 54a: Drive Tube Clamp Assembly

!CAUTION:

• Damage to the Centrifuge Bowl or Drive Tube could result in further damage to the instrument, loss of treatment, and extracorporeal blood loss.

• During installation, do not excessively bend, kink, or damage the Drive Tube, Bearings, or Centrifuge Bowl.

• The instrument must be properly maintained to function safely and properly.

• Warranty does not cover damage caused by improper procedural kit loading or improper instrument setup, operation, or maintenance.

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1. Confirm that the Centrifuge Frame is positioned with the Bearing Holders on the right and the Bowl Holder is positioned with the Retainer Clip facing front.

2. Confirm that the tubing from the Pump Tubing Organizer to the Drive Tube is not twisted.

3. Grasp only the reinforced area of the Lower Drive Tube.

Figure 54b: Grasping Reinforced Lower Drive Tube

CORRECT Notch Position4. Position the Drive Tube so the

(BLACK) stripe faces the rear of the Drive Tube Clamp Assembly. The keyed features (notches) of the Drive Tube will mate with the clamp to ensure proper loading.

Figure 54c: Keyed Drive Tube and Clamp Assembly

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5. With the Drive Tube in the correct position, close the Drive Tube Latch. An audible beep will indicate the activation of two Fluid Routing Valves used to clamp the saline and anticoagulant spike lines.

Figure 54d: Closing the Drive Tube Latch

6. Load the Centrifuge Bowl onto the Centrifuge Bowl Holder by grasping the Bowl Holder as you align the tabs at the bottom of the Centrifuge Bowl with the slots in the Bowl Holder.

7. Hold the Centrifuge Bowl Holder firmly as you press the Centrifuge Bowl downward and rotate it clockwise until all tabs lock into place.

8. Verify the Tab Retainer Clip is in the fully locked position.

Figure 55a: Centri-fuge Assembly–Starting Position

Figure 55b: Installing Centrifuge Bowl–Align Bowl Tabs

Figure 55c: Install-ing Bowl–Rotate Bowl Clockwise to Lock Clip

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9. Load the Lower Drive Tube Bearing.

a. Slide Drive Tube through the Lower Bearing Retainer Clip.

b. Position the Lower Bearing just below the Lower Clip.

c. Gently bend the Drive Tube to match the shape of the Centrifuge Frame.

d. Push up on the Drive Tube to snap the bearing into the Retainer Clip.

Figure 56a: Loading the Drive Tube Lower BearingGently Bend the Tube and Push Up

10. Load the Upper Drive Tube Bearing

a. Position it just above the Upper Bearing Retainer Clip.

b. Slide the Drive Tube through the Clip.

c. Gently bend the Drive Tube to match the curve of the Centrifuge Frame.

d. Pull down on the Drive Tube to snap the bearing into the Retainer Clip.

Figure 56b: Loading the Drive Tube Upper BearingGently Bend the Tube and Pull Down

!CAUTION:

Verify that the Upper and Lower Drive Tube Bearings are fully seated in their Retainer Clips.

Verify that the Bearings and Drive Tube are not damaged in any way.

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11. Carefully insert the Centrifuge Bowl Tubing Lines through the Tubing Exit Slot.

12. Insert the Centrifuge Bowl Tubing Lines into the Tubing Guides in front of the Drive Tube Clamp Assembly.

13. Spin the Centrifuge Frame clockwise to confirm proper Centrifuge Bowl installation.

Figure 57: Verifying Proper Bowl Installation

!CAUTION:

Do Not Proceed with procedural kit installation until you confirm:

✔ The Drive Tube Latch is closed securely.

✔ The Drive Tube does not touch the Centrifuge Frame at any point.

✔ The tubing lines exiting the front of the Drive Tube Clamp Assembly are in their respective tubing guides and are not pinched in the clamp.

✔ All tubing lines pass through the Tubing Exit Slot and are free of kinks or pinch points.

✔ The upper and lower bearings are fully seated in the Bearing Retainer Clips.

✔ The Centrifuge Bowl and Frame spin freely in a clockwise direction.

Exit Slot

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Manually Loading Each Pump Tubing Segment

1. Rotate the tapered edge of each Pump Handle to face the Pump Tubing Organizer.

2. Stretch each Pump Tubing Segment to reach over the Pump Handle.

3. Rotate each Pump Handle clockwise two full rotations.

4. Rotate each Pump Handle counterclockwise one rotation to confirm the tubing is loaded and the Pump Handle turns freely.

Figure 58a: Stretching Pump Tubing Segment

Figure 58b: Rotating Pump Handle: Clockwise

Figure 58c: Rotating Pump Handle: Counterclockwise

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Installing the Smart Card

1. Remove the Smart Card from the Pump Tubing Organizer.

2. Face the gold connector surface of the Smart Card away from you and insert it into the Smart Card slot as shown.

3. An audible beep will confirm correct insertion.

Figure 59a: Removing the Smart Card

Figure 59b: Correct Smart Card Insertion Figure 59c: Incorrect Smart Card Insertion

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Installing the Three Pressure Domes

!CAUTION:

• Handle the Pressure Domes only by the clips to avoid damage to the internal membrane.

• The integrity of pressure monitoring will be compromised if the Pressure Domes are removed after PRIME. Damaged or misplaced pressure domes may leave lines unmonitored which could lead to undetected trauma at the patient access site, Centrifuge Bowl breakage with subsequent blood loss, and a failed treatment.

• Partial pressure dome attachment may provide pressure readings, but as pressures increase, the internal membrane may separate from the pressure dome. Fluid leaks may occur resulting in loss of sterility, blood leaks, and possible blood loss to the patient.

• DO NOT REMOVE ANY PRESSURE DOME DURING A TREATMENT.

1. Two Pressure Domes are located on the Patient Collect and Return Lines near the front right hand corner of the pump deck. The third Pressure Dome is attached to one of the lines that exits the Centrifuge Bowl Drive Tube between the Centrifuge Bowl and the Pump Tubing Organizer. Locate each Pressure Dome.

Figure 60a: Location of Pressure Domes Figure 60b: Correct Pressure Dome Installa-tion

Figure 60c: Incorrect Pressure Dome Installa-tion

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2. Pinch each Pressure Dome Clip to remove the protective covers. Discard covers.

3. With each Pressure Dome Clip pinched, seat the Pressure Dome onto the Pressure Transducer and release the clip.

4. Without pinching the clip, gently rock the Pressure Dome from top to bottom to verify it is secure. Install all three Pressure Domes.

✎NOTE:

Improper loading of Pressure Domes can lead to PRIME Test Failures and longer setup time. Be certain that all three Pressure Domes are in place and secure.

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Installing the Lines into the Air Detectors

✎NOTE:

Five lines will be monitored for air during the treatment. During treatment, air will be present at various times in the lines leading to the Treatment Bag and Return Bag.

1. Set the bundled fluid spike lines aside. These lines are not monitored for air.

2. Begin at the right side of the Air Detector Block and insert the lines from the Pump Tubing Organizer as follows:

2 1345 1. Patient Return Line (BLUE Striped)2. Patient Collect Line (RED Striped)3. Patient Anticoagulant Line (GREEN

Striped)4. Return Bag Line (BLUE Striped)5. Treatment Bag Line (GREEN Striped)

Figure 61: Installing Lines into Air Detectors

✎NOTE:

• The (RED Striped) line to the Return Bag and the fluid spike lines, shown in Figure 61 above without numbers, do not need to be monitored for air and are not inserted into the air detectors.

• Missing or improperly installed lines will result in priming alarms.

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Installing the Hematocrit Cuvette

1. Avoid fingerprints on the window of the Hematocrit Cuvette.

2. Verify that the Hematocrit Cuvette is fully seated in the Hematocrit Sensor Housing.

Figure 62a: Correct Handling of the Hematocrit Cuvette

Figure 62b: Incorrect Handling of the Hemato-crit Cuvette

Figure 62c: Correct Placement of the Hemato-crit Cuvette

Figure 62d: Incorrect Placement of the Hemato-crit Cuvette

!CAUTION:

Avoid fingerprints on the window of the Hematocrit Cuvette. Natural oils may adversely affect the light transmittance through the lens.

Installing Lines Into the Tubing Guide

Align the Treatment Bag, the Return Bag, and the Photoactivation Module tubing lines into the Tubing Guide at the front edge of the Pump Deck.

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Preparing and Hanging Saline and Anticoagulant Solutions

!CAUTION:

• Correct placement of the Saline and Anticoagulant Bags is essential. Incorrect placement may lead to clotting in the procedural kit, patient blood loss and a failed treatment.

• Always confirm the contents, lot number, and expiration date of any solution prior to its use.

• Saline and Anticoagulant Spike Lines do not have slide clamps. Instead, Fluid Routing Valves, activated when the Drive Tube Latch is closed, prevent fluid from entering the Pump Tubing Organizer prior to PRIME.

!CAUTION:

Individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment. The physician should review the patient’s medical condition, medications, and platelet count at the time of treatment and use clinical judgment to establish the optimal heparin dosage for each patient.

1. Add 10,000 - 15,000 Units of heparin to a 500mL bag of 0.9% Normal saline and label the bag per your institution’s labeling procedures.

✎NOTE:

Add 20,000 - 30,000 Units of heparin to a 1000mL bag of 0.9% Normal saline if the smaller bags are not available.

2. Undo the packing tapes of the Solution Spike Lines and inspect for kinks.

3. Spike the Anticoagulant Solution with the spike attached to the (GREEN Striped) line. Hang the Anticoagulant Bag on the lower right side of the instrument (as you face it) using the back hook.

4. Spike a 500mL bag of 0.9% Normal saline with the spike attached to the clear line. Hang the Saline Bag on the lower right side of the instrument (as you face it) using the front hook.

5. Squeeze and fill both drip chambers.

SALINE A/C

Figure 63: Placement of Saline and Anticoagulant (A/C) Bags

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Preparing Patient Lines

1. Undo the Patient Line packing tapes. Inspect for kinks.

2. CLOSE Patient Collect Line (RED) Clamp.

Figure 64a: Close Collect Line (RED) Clamp

3. Clean the needle-free injection port of the Patient Collect Line (RED Striped) with an alcohol swab.

Figure 64b: Clean Needle-free Port

4. Remove the cap from the Patient Return Line (BLUE Striped) and aseptically connect it to the needle-free injection port of the Patient Collect Line (RED Striped).

5. Verify that the Patient Return Line (BLUE) Clamp is OPEN.

Figure 64c: Connect Return Line (BLUE Striped) Open (BLUE) Clamp

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6. Hang the Patient Lines on the IV Pole during PRIME.

Figure 64d: Hang Lines on IV PoleIS

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Final Inspection Before Prime

!CAUTION:

• Check that the Centrifuge Chamber Door is closed properly. An alarm alerts you if the door is not closed properly or if the Centrifuge Chamber Door Manual Release is in the unlocked position.

• Do not unlatch or attempt to open the Centrifuge Chamber Door while the Centrifuge is in operation.

Figure 65: Close Centrifuge Chamber Door

1. Lower the Centrifuge Chamber Door verifying that the Bowl Outlet Tubing is not pinched.

2. Visually inspect Pressure Domes and Air Detectors.

3. Check to be sure that the Hematocrit Cuvette is seated in the Hematocrit Sensor.

4. Visually inspect all Pumps and Pump Tubing.

5. Inspect Solution Bags for content, Anticoagulant Concentration, and primed Drip Chambers.

6. Verify that the Patient Collect Line (RED) Clamp is CLOSED and Patient Return Line (BLUE) Clamp is OPEN.

7. Check all tubing lines for kinks.

✎NOTE:

You are now ready to begin PRIME. Please refer to SECTION 5: OPERATING THE THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM to continue.

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Introduction 5-1


SECTION 5: OPERATING THE THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM

Introduction

The THERAKOS™ CELLEX™ Photopheresis System operator should be adequately trained in all procedures described in the instructions for use. Carefully read all warnings, cautions, and instructions before use. Follow all operating and maintenance procedures. Failure to do so can result in patient or operator harm or system damage. See SECTION 3: SYSTEM DESCRIPTION and SECTION 4: LOADING THE THERAKOS™ CELLEX™ PHOTOPHERESIS PROCEDURAL KIT for more information.

Treatment Phases of THERAKOS™ Photopheresis

The phases of a treatment with the THERAKOS™ CELLEX™ Photopheresis System are COLLECT, PHOTOACTIVATE, and REINFUSE. COLLECT includes DRAWING, BUFFY COAT, ELUTRIATION, EMPTYING BOWL / RETURNING. COLLECT is the phase that concentrates and harvests the leukocyte-enriched fraction from whole blood.

COLLECT

In the default COLLECT phase, 1500mL of whole blood is processed to continuously harvest the Buffy Coat using only one Collection Cycle.

PURGING AIR

The initial goal of DRAWING in both Single Needle and Double Needle modes is to purge the air from the Centrifuge Bowl. For more information, see PURGING AIR on page 5-24 or PURGING AIR on page 5-46.

DRAWING / RETURNING (Double Needle Mode)

The Collect Pump (#1) draws whole blood from the patient into the Centrifuge Bowl via the Collect Line. Leukocytes concentrate in the spinning Centrifuge Bowl. Red blood cells and plasma are simultaneously returned to the patient via the Return Line using the Return Pump (#3). Blood flow from and to the patient is continuous. The Centrifuge is not stopped.

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Section 5: OPERATING THE THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM

Rev. 4.0-1460451

DRAWING / RETURNING (Single Needle Mode)

The Collect Pump (#1) draws whole blood from the patient into the Centrifuge Bowl via the Collect / Return Line using the Return Pump (#3). Leukocytes concentrate in the spinning Centrifuge Bowl. Red blood cells and plasma are first pooled in the Return Bag and then intermittently returned to the patient via the Collect / Return Line. Blood flow from and to the patient is discontinuous and extracorporeal volume is significantly higher in Single Needle Mode (See Table 12: Estimated Extracorporeal Volume on page 10-3.)

The Return Bag Threshold Value (mL) determines the frequency of RETURNING as well as the ultimate extracorporeal volume after PURGING AIR is complete. (See Table 12: Estimated Extracorporeal Volume on page 10-3). Red blood cells and plasma are pooled in the Return Bag until the Return Bag Volume Threshold has been reached. When the threshold has been reached, the Collect Pump is stopped and the Collect / Return Line is used to return the red blood cells and plasma. DRAWING will resume once the Return Bag volume is reduced to about 50mL.

BUFFY COAT

The Bowl Optic Sensor in the Centrifuge Chamber detects the plasma / red blood cell interface and signals the Red Blood Cell Pump (#2) to maintain this interface at the ideal place for optimal cell separation. The Collection Software Algorithm determines the initiation of the BUFFY COAT phase based on the Number of Collection Cycles desired and the Whole Blood Processed Target. Both of these values are selectable via the SETUP screen. The Bowl Optic Sensor, the Collection and Control Software, and the Hematocrit Sensor together select the optimal Buffy Coat and yield the targeted hematocrit of the leukocyte-enriched fraction. The THERAKOS™ CELLEX™ Instrument is designed to continuously harvest one concentrated Buffy Coat using either continuous blood flow or discontinuous blood flow.

EMPTYING BOWL / RECIRCULATING

The Centrifuge is stopped and the Recirculation Pump will speed up to aid in thoroughly mixing the collected Buffy Coat. The red blood cells in the Centrifuge Bowl are pumped out of the Centrifuge Bowl into the Return Bag. The Centrifuge Bowl is rinsed with saline and emptied again into the Return Bag.IS

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Treatment Phases Of Therakos™ Photopheresis 5-3


RETURNING / READY TO PHOTOACTIVATE

The calculated Photoactivation Time will be displayed as MINUTES REMAINING and the red blood cells and plasma in the Return Bag will be returned. The amount of Photoactivation Time will depend on:

• The Total Treatment Volume (mL)

• The Hematocrit of the Treatment Volume (Buffy Coat)

• The Remaining Lamp Life (hours)

You may begin PHOTOACTIVATE while RETURNING.

PHOTOACTIVATE

After adding the required amount of Methoxsalen (20 micrograms / mL), the Buffy Coat is photoactivated. The leukocyte-enriched blood fraction is pumped in a constant circuit through the Photoactivation Module into the Treatment Bag, back through the Pump and again into the Photoactivation Module.

REINFUSE

Following PHOTOACTIVATE, the UVA / psoralen-treated leukocyte-enriched blood is pumped back to the patient through the Blood Filter in the Pump Tubing Organizer. After REINFUSE is complete, any remaining fluid in the Return Bag is returned along with a small saline flush to ensure the patient receives all the treated cells.

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Before You Begin

!CAUTION:

• Review all warnings and cautions summarized in Section 9 of this manual before treating a patient.

• You must be present to supervise the treatment at all times. Your primary responsibility during COLLECT, PHOTOACTIVATE and REINFUSE is the patient’s safety. Carefully monitor the patient for tolerance to the extracorporeal fluid shifts, access performance and potential allergic reactions.

• Follow your center-specific guidelines for Universal Precautions whenever possible exposure to blood is anticipated. Failure to do so may expose you to harmful blood-borne contaminants.

• Follow all operating and maintenance procedures. Failure to do so can result in patient / operator harm or system damage.

• Avoid potential electrical hazards by using only properly grounded receptacles and circuits designed to accommodate equipment. The use of extension cords is not recommended.

• Ensure that the room temperature does not exceed 30° C (86° F) during the treatment.

• Allow a minimum of 18 inches of ventilation space around the air vents in front and back of the instrument while in use.

• Do not use the THERAKOS™ CELLEX™ Photopheresis System in the presence of flammable anesthetic gases.

• Do not operate the instrument in the presence of external radio or electromagnetic disturbances that may interfere with proper performance of the device. This could result in treatment interruptions, and the possibility of a failed treatment.

• Do not clean the Photoactivation Module. Cleaning agents could leave a film that may adversely affect the transmission of UVA light energy and the photoactivation process.

• Complete FINAL INSPECTION BEFORE PRIME (found in Section 4) before beginning PRIME.

• In consultation with the physician, assess the patient’s overall health status immediately before beginning a treatment to determine if the patient is able to tolerate the anticipated fluid shifts during the treatment. Do not proceed if the patient is unstable.

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Before You Begin 5-5


!CAUTION:

• American Association of Blood Banks guidelines recommend the positive and negative fluid balance of the patient during treatment should not exceed 15% of his / her total blood volume. Refer to SECTION 10: FLUID BALANCE MANAGEMENT for additional information on selecting and maintaining Fluid Balance Limits.

• Estimate the patient’s total blood volume and calculate 10-15% of that volume. Refer to Changing Default SETUP Parameters on page 5-11 to determine how to set the +/- Fluid Balance Limit before starting COLLECT.

• When instructed, establish or disconnect patient access utilizing your institution’s standards of practice for this procedure. Failure to do so may lead to patient harm such as increased risk of infection, trauma to the access site, possible air embolus or post treatment blood loss.

• After a treatment has been completed, the used THERAKOS™ CELLEX™ Photopheresis Procedural Kit should be considered a biological hazard. Follow the policies and procedures of your institution’s Infection Control Plan for the handling and disposal of blood-contaminated materials.

• Protect the patient’s skin and eyes from sunlight and emphasize the need to the patient to continue protection for 24 hours post treatment. Refer to the Methoxsalen (20 micrograms / mL) labeling or the oral 8-methoxypsoralen dosage information package insert for more information on protecting the patient from light and for all medication warnings and precautions.

• Therakos recommends that you do not change the THERAKOS™ CELLEX™ Light Assembly during a treatment. Refer to Replacing the Light Assembly on page 7-8 for all warnings, cautions, and instructions when lamp replacement is required.

• Do not attempt to modify the THERAKOS™ CELLEX™ Instrument, THERAKOS™ CELLEX™ Photopheresis Procedural Kit, or THERAKOS™ CELLEX™ Light Assembly in any way.

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Rev. 4.0-1460451

Sterile Air

All fluid pathways are sterile; therefore, the air contained in these pathways is also sterile. The sterile air from the Centrifuge Bowl is saved in the Return Bag during PRIME. As the anticoagulant solution enters, the air is displaced into the Return Bag. This sterile air is used later in the procedure to empty the contents of the Centrifuge Bowl back to the patient through the pump. If you lose this sterile air, you will not be able to empty the Centrifuge Bowl.

Sterile air from the Photoactivation Module is displaced during PRIME into the Treatment Bag. This sterile air is used to empty the Photoactivation Module before reinfusing the treated cells after PHOTOACTIVATE. If you lose this sterile air, you will not be able to automatically reinfuse the treated cells to the patient.

Cycling Power OFF / ON: After PRIME / During a Treatment

Numerous internal safety checks are performed during boot-up each time the THERAKOS™ CELLEX™ Instrument is turned on. Cycling the power OFF and then ON at the end of a patient treatment, after the RELEASE KIT button is pressed, allows the instrument to erase the individual patient treatment data and to repeat these safety checks before beginning a new patient treatment.

✎NOTE:

• The power must be on to properly load a THERAKOS™ CELLEX™ Photopheresis Procedural Kit.

• After a treatment is complete and all data is recorded, you must turn the power OFF and then ON to begin a new treatment. Re-booting the system returns the screen display to READY TO PRIME.

• You may turn OFF the power after PRIME to relocate the instrument. While there is no time limit for power OFF, Therakos recommends that the pending treatment be initiated within four hours.

• If the power is turned OFF or there is a power failure after PRIME begins, the treatment screen will display the following message when the power is restored: “Do you wish to end this treatment and install a new procedural kit?” (YES) (NO)

• To end the treatment, indicate “YES” and confirm your response. The instrument will respond by going to READY TO PRIME.

• To allow the treatment to resume, indicate “NO”.

• If you do not respond to this screen prompt within 5 seconds, the instrument will automatically resume treatment at the place where power was interrupted.

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Initiating Prime 5-7


!WARNING:

If the power is turned OFF for any reason during COLLECT, the Centrifuge Bowl must be re-purged before treatment resumes. This will result in a partial loss of Buffy Coat and higher extracorporeal volume. Refer to SECTION 10: FLUID BALANCE MANAGEMENT when re-purging the Centrifuge Bowl before resuming the treatment.

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Rev. 4.0-1460451

Initiating PRIME

!WARNING:

• The THERAKOS™ CELLEX™ Photopheresis Procedural Kit must be used within four hours after PRIME has been completed.

• Prior to initiating PRIME, ensure the Treatment and Return Bags are properly positioned on their respective Load Cells Hooks. Removal of these bags at any time after PRIME is initiated may result in priming alarms and / or inaccurate FLUID BALANCE readings during a treatment.

Just prior to PRIME, all pathways are illustrated in blue indicating there is no fluid movement within the procedural kit.

Figure 66: Initiating PRIME

1. Confirm proper procedural kit installation.

2. Press START.

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Initiating Prime 5-9


✎NOTE:

• The system is primed automatically.

• During PRIME, the system initially performs a series of tests to ensure proper setup of the procedural kit and calibration of sensors as well as proper operation of pumps, lamps and fluid routing valves. All of these tests occur automatically and will generate an alarm message should a problem be found. Refer to SECTION 6: CORRECTING ALARMS, for alarm troubleshooting.

• The system then pumps anticoagulant solution and saline throughout the procedural kit, eventually filling the Photoactivation Module and the patient Collect and Return Lines fully. The Return and Treatment Bags and the Centrifuge Bowl will only be partially filled during PRIME. Some areas of the procedural kit are simply wetted with anticoagulant solution.

3. When prompted, open the Centrifuge Chamber Door and check the Drive Tube installation.

4. Close the Centrifuge Chamber Door.

5. Inspect entire procedural kit for leaks before proceeding.

6. Press CLOSE.

!CAUTION:

To avoid risk of infection and / or potential patient blood loss do not use a THERAKOS™ CELLEX™ Photopheresis Procedural Kit that:

• has been damaged during installation.• has leaked during PRIME.

Any damaged procedural kit should be returned to Therakos. Please contact Therakos at one of the phone numbers on the last page of this manual.

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Rev. 4.0-1460451

PRIME ACCESSAfter initial priming is complete, a small space remains between the patient Collect Line (RED) Clamp and the patient connection port that needs to be primed. To maintain procedural kit sterility, do not remove the vented cap from the patient Collect Line.

1. Open the patient Collect Line (RED) Clamp and press START.

The remaining portion of the patient line will be primed.

• Approximately 4mL of anticoagulant solution will be delivered.

• It is not necessary to press STOP.

2. Close the patient Collect Line (RED) Clamp. Proceed to Changing Default SETUP Parameters.

• All seven stages of PRIME are complete indicated by the 7 yellow bars in the upper right hand corner of the screen.

• The mL volume of anticoagulant and saline used to PRIME are displayed.

Figure 67: PRIME ACCESS ISSU

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Changing Default Setup Parameters 5-11


Changing Default SETUP ParametersThe THERAKOS™ CELLEX™ Photopheresis System default SETUP parameters are listed in the table below. Individual patients may require a change from these preset parameters. The physician must use clinical judgment when changing these parameters for each patient.

1. Calculate and enter the Fluid Balance Limits for the patient about to be treated. See instructions that follow.

2. Enter and save any other parameter setting changes required.

3. Proceed to Configuring the THERAKOS™ CELLEX™ Photopheresis Procedural Kit for Double Needle or Single Needle Mode.

Setting [Units] Default Parameter Range of Settings

COLLECT LimitsFlow Rate [mL/min] 50 5 to 100

(May be limited in some modes of operation)

Pressure Alarm [mmHg] -100 -200 to 0

!WARNING:A COLLECT Flow Rate higher than 50mL/min may result in decreased cell collection efficiency.

RETURN Limits

Flow Rate [mL/min] 50 5 to 100

Upper Limit Pressure Alarm [mmHg] 250 0 to 300

Lower Limit Pressure Alarm [mmHg] -50 -100 to +50

Treatment Settings

A/C Ratio(Drops Blood: Drops Anticoagulant)

10:1 8:1, 10:1, 12:1, 14:1, 16:1, 25:1, 50:1

Saline Bolus [mL] 100 10 to 100

Number of Collection Cycles 1 1 to 3

Reinfusion Rate [mL/min] 50 1 to 100(1-5, increments of 1)

(5-100, increments of 5)

Whole Blood Processed Target [mL] 1500 500 to 2000

Fluid Balance Alarm Lower Limit [mL] -500 -1000 to –50

Fluid Balance Alarm Upper Limit [mL] 500 50 to 1000

Return Bag Threshold [mL] 200 100 to 500

A/C Volume Threshold [mL] 450 200 to 2000

Saline Volume Threshold [mL] 450 200 to 2000

Bowl Optic Threshold Value 150 50 to 250

Table 2: Default SETUP Parameter Settings

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Rev. 4.0-1460451

Accessing the SETUP ScreenEnter SETUP at any time during the treatment to make changes to any parameter setting. Changes may be made:

• Prior to PRIME or PRIME ACCESS

• During COLLECT (DRAWING / BUFFY COAT / RETURNING)

• Prior to or during PHOTOACTIVATE

• During REINFUSE

1. Press SETUP if SETUP is displayed.

2. If SETUP is not displayed, press PAUSE and then press SETUP.

Changing Limits and Treatment SettingsThere are two pages of SETUP parameter settings. Press the arrow tab on the bottom right corner of the screen to access the second page of setup information. Pressing the tab again will return you to the previous page. To adjust the values on the SETUP Screen:

1. Press the to increase or decrease a value.

2. Press SAVE. This button initiates the changes that you have entered and returns you to the previous screen.

Or

3. Press CANCEL to return to the previous screen and to cancel any changes you made.

Figure 68a: Changing Default SETUP Parameters–SETUP Screen 1

Figure 68b: Changing Default SETUP Parameters–SETUP Screen 2

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Changing Default Setup Parameters 5-13


Changing the Clock Settings

1. Enter SETUP Screen Page 2 then press .

2. Press to change the time and date of the system.

3. Press SAVE. This button initiates the changes that you have entered and returns you to the previous screen.

Or4. Press CANCEL to return to the previous screen and

to cancel any changes you made.

Figure 69a: Changing the Date and Time

Changing the Language Settings

1. Enter SETUP Screen Page 2 then press .

2. Select the language button desired.

Example:

Once you select a language, the text on the screen automatically appears in the selected language.

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Rev. 4.0-1460451

Calculating and Setting Fluid Balance Limits

The THERAKOS™ CELLEX™ Photopheresis System continuously monitors and displays the volume of fluid movement to and from the patient during a THERAKOS™ Photopheresis treatment. These fluids may be whole blood, anticoagulant, or saline. A negative fluid balance indicates that the patient is undergoing a temporary fluid deficit. A positive fluid balance indicates that the patient has received additional fluids. Generally, a patient will be approximately 350-450mL fluid positive at the completion of a routine treatment.

The American Association of Blood Banks recommends that fluid balance be maintained within +/- 10-15% of the patient’s Total Blood Volume during any extracorporeal procedure. To calculate each patient’s Fluid Balance Limit, use the following process:

1. Weigh the patient. Convert to kilograms if necessary.

2. Select the patient’s Body Build Factor.

Body Build Male FemaleAdult Muscular 80mL/kg 75mL/kg

Adult Normal 75mL/kg 70mL/kg

Adult Thin 70mL/kg 65mL/kg

Adult Obese 65mL/kg 60mL/kg

Adolescent 75-70mL/kg 75-70mL/kg

Neonate 100-80mL/kg 100-80mL/kg

Table 3: Body Build Factors

3. Multiply: Weight (kg) X Body Build Factor (mL/kg) = Estimated Total Blood Volume (mL).

4. Calculate 10-15% of Total Blood Volume.

5. Enter +/- 15% of Total Blood Volume as Fluid Balance Limit if patient is stable and able to withstand moderate fluid shifts.

6. Enter +/- 10% of Total Blood Volume as Fluid Balance Limit if patient’s condition warrants minimal fluid shifts.

For additional information about selecting and managing the proper fluid balance limits for each patient, please refer to SECTION 10: FLUID BALANCE MANAGEMENT.

✎NOTE: Conversion Factors:• pounds ÷ 2.2 = kilograms• stones x 6.35 = kilograms

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Rationale For Changing Default Setup Parameter Settings 5-15


Rationale for Changing Default SETUP Parameter Settings

Changing COLLECT, RETURN, and REINFUSE Flow Rate Limits

The instrument gradually reaches a default flow rate of 50mL/minute in each of these phases if access allows. Raise or lower each rate directly at the main operator interface screen within the range of 0-100mL/min. Fluctuating line pressures displayed directly below each flow rate will indicate when flow rate adjustments are necessary. The instrument will automatically decrease the COLLECT Flow Rate to 25mL/min during BUFFY COAT.

You may choose to set lower COLLECT, RETURN and / or REINFUSION Rate Limits for an individual patient. If so, these limits may be entered and saved via the SETUP screen at any time during the treatment. Medical conditions that warrant lower flow rate limits include, but may not be limited to:

• Cardiac insufficiency

• Pulmonary insufficiency

• Renal insufficiency

• Diabetes

• Hypertension

• Hypotension

• Edema

• Fragile veins

• Low or high body weights

!WARNING:

A COLLECT Flow Rate higher than 50mL/minute may result in decreased cell collection efficiency.

Refer to SECTION 10: FLUID BALANCE MANAGEMENT for more information about adjusting flow rates.

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Rev. 4.0-1460451

Changing COLLECT and RETURN Pressure Alarm Settings

The default COLLECT Pressure Alarm is set at –100mmHg. The need to control this pressure will depend on the type of access in use and the condition of the patient’s veins if venipuncture is used. Setting the alarm limit to –200mmHg allows for a stronger pull by the roller pumps before reaching an occlusion alarm. Setting the pressure below –100mmHg increases the sensitivity of an occlusion alarm and may be desired when very fragile veins are accessed.

The RETURN Pressure Alarms have an upper limit of 250mmHg and a lower limit of –50mmHg as default settings. Again, the type of access in use will help to determine if these settings need to be changed. You may need to raise the upper limit from 250 to 300mmHg if returning against arterial pressure into an AV Fistula or graft. Lower Pressure Alarm limits may be used with very fragile veins.

Changing the A/C Ratio

The default A/C Ratio is 10:1 (Drops of blood: Drops of anticoagulant). The standard anticoagulant solution is prepared by adding 10,000 - 15,000 Units of heparin to 500mL of 0.9% Normal saline. Clinical judgment and physician directive may lead to changing the A/C ratio setting. For example:

• Consider using 8:1 if the patient’s platelet count is elevated.

• 12:1, 14:1 and 16:1 may be used with lower platelet counts or if the patient is taking blood thinner medications.

• 25:1 or 50:1 may be considered if the patient is already heparinized.

✎NOTE:

The Keep Vein Open (KVO) rate of anticoagulant, anticoagulated plasma, or saline is 10 mL/hour. KVO is utilized during PAUSE, STOP or PHOTOACTIVATE.

In Double Needle Mode, KVO dispensed to the COLLECT line comes from the anticoagulant bag. KVO dispensed to the RETURN line comes from the patient’s heparinized plasma pooled in the Return Bag. KVO dispensed during PHOTOACTIVATE comes from the saline bag.

Changing the Saline Bolus

The default Saline Bolus volume is 100mL. It may be lowered in increments of 10mL down to 10mL via the SETUP screen. Or you may request a bolus using the default value of 100mL and simply press STOP SALINE to interrupt the flow of saline at any point before the full 100mL is delivered.

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Changing the Return Bag Threshold Value (Single Needle Mode Only)

This value determines how often the instrument will automatically alternate between DRAWING and RETURNING when operating in Single Needle Mode. The default setting is 200mL. As the volume of plasma and red blood cells pooling in the Return Bag reaches the threshold value, DRAWING is interrupted and RETURNING begins. An audible beep signals each time the phase changes from DRAWING to RETURNING.

To minimize extracorporeal volume (ECV), set the Return Bag Threshold Value to 100mL. If the patient is able to tolerate a higher ECV, raise the Return Bag Threshold Value to decrease the frequency of phase changes. See Table 12: Estimated Extracorporeal Volume on page 10-3 for extracorporeal volume estimates at various Return Bag Threshold Values.

Changing the Number of Cycles

The THERAKOS™ CELLEX™ Photopheresis System is designed to process 1500mL of whole blood using only one single collection cycle. Adding additional cycles should only be reserved for troubleshooting scenarios. Refer to COLLECT: USING MORE THAN ONE CYCLE on page 5-38 for more information.

DRAWING changes to BUFFY COAT when the Cycle Volume Target is reached. In the default setting of 1 Cycle, the instrument will process whole blood until it reaches the Cycle Volume Target of 1460mL (which is set to be 40mL less than the Whole Blood Processed Target). The instrument will automatically reset the Cycle Volume Target values if you choose to use more than one collection cycle. Table 3 below shows how the Cycle Volume Target value changes when either the Whole Blood Processed Target or the Number of Cycles is changed.

Number of Cycles Whole Blood Processed Target Cycle Volume Target(s)

1 1500mL 1460mL

2 1500mL 710mL and 1460mL

3 1500mL 460mL, 960mL, 1460mL

1 2000mL 1960mL

2 2000mL 960mL and 1960mL

3 2000mL 627ml, 1293mL, 1960mL

1 1000mL 960mL

2 1000mL 460mL and 960mL

Table 4: Cycle Volume Targets

✎NOTE:

The above Cycle Volume Targets will vary slightly if the hematocrit of the patient is low. Low hematocrits may require more whole blood to be processed to bring the plasma / red blood cell interface to the level of the Bowl Optic laser prior to the onset of BUFFY COAT.

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Rev. 4.0-1460451

Changing the Whole Blood Processed Target

A standard THERAKOS™ Photopheresis therapy will process 1500mL of whole blood. You may raise this target volume to 2000mL or lower it to 500mL. The instrument will automatically reset the Cycle Volume Target value.

Reasons to raise the Whole Blood Processed Target:

• Increase the total number of cells collected.

• Process additional volume if the Centrifuge Bowl requires re-purging.

Reasons to lower the Whole Blood Processed Target:

• Poor access will not allow full treatment.

• Troubleshooting (Prompted by alarm messages).

Changing the A/C or Saline Volume Thresholds

The default delivery limit value for both A/C and saline are set at 450mL. This setting is used to warn that the bags are almost empty and will need to be replenished prior to completing the treatment.

Reasons to lower the A/C or Saline Volume Thresholds:

• The patient’s condition limits the Units of heparin that may be received.

• The patient’s condition limits the volume of saline that may be received.

Reasons to raise the A/C or Saline Volume Thresholds:

• The Whole Blood Processed Target has been increased to 2000mL.

• The A/C Ratio has been set to 8:1.

!CAUTION:

Do not allow the anticoagulant or saline bags to become empty prior to completing a treatment. Loss of prime in the spike lines will interrupt the treatment and prevent successful completion of the therapy.

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Changing the Bowl Optic Threshold Value

The THERAKOS™ CELLEX™ Photopheresis System has an adjustable Bowl Optic Sensor. The Bowl Optic Threshold Value determines the position of the plasma / red blood cell interface in the spinning Centrifuge Bowl. You may need to adjust this setting whenever abnormal plasma conditions occur. The default setting is 150. The range is 50 to 250.

Reasons to lower the Bowl Optic Threshold Value:

• The clarity of the plasma is abnormal (instrument mistakes lipids for red blood cells).

• The color of the plasma is abnormal (instrument mistakes dark plasma for red blood cells).

You may visually recognize that the plasma / red blood cell interface is too low in the Centrifuge Bowl or the instrument may activate the Red Blood Cell Pump alarm. Adjustments to the Bowl Optic Threshold Value are entered via the SETUP screen.

a. Correct b. Too Low c. Too High

Figure 70: Position(s) of Plasma / Red Blood Cell Interface in Bowl

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Rev. 4.0-1460451

Configuring the THERAKOS™ CELLEX™ Photopheresis Procedural Kit

Determine Single Needle or Double Needle Mode

!CAUTION:

The Collect and Return Lines must be configured to match the access mode selected. Failure to do so may lead to clotting at one access site, treatment interruption and a possible failed treatment.

✎NOTE:

• The same procedural kit is used for either a Single Needle Mode or Double Needle Mode treatment. To ensure that the established access matches the software mode instruction, you should first establish your access sites by connecting the patient lines and then select SINGLE NEEDLE or DOUBLE NEEDLE on the Operator Interface Screen.

• The mode of access may be changed anytime during the treatment.

Figure 71: Select Single Needle Mode or Double Needle Mode After you select SINGLE NEEDLE or DOUBLE NEEDLE, a pop-up message will display the access mode selected and the screen schematic will be set to match the mode selected.

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Configuring The Therakos™ Cellex™ Photopheresis Procedural Kit 5-21


Configuring Collect And Return Lines For Single Needle Mode

✎NOTE:

PRIME and PRIME ACCESS are already configured for Single Needle Mode.

1. Following PRIME ACCESS, confirm that the male luer of the Return Line (BLUE Striped) is connected to the Collect Line (RED Striped) needle-free injection port.

Figure 72a: Single Needle Mode Line Configuration

2. Attach the patient Collect / Return Line to the patient’s access site.

3. Select SINGLE NEEDLE button and confirm.

4. Verify that the screen display shows Single Needle configuration.

Figure 72b: SELECT SINGLE NEEDLE Figure 72c: Confirm Screen Display: Single Needle

5. Follow operating instructions in Single Needle Mode Treatment Procedure on page 5-23 to continue.

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Rev. 4.0-1460451

Configuring Collect and Return Lines for Double Needle Mode

1. Following PRIME ACCESS close the Return Line (BLUE) Clamp.

2. Remove Return Line (BLUE Striped) from the patient Collect Line (RED Striped) needle-free access port and connect to patient’s Return access site.

3. Connect the Collect Line (RED Striped) to the patient’s Collect access site.

Figure 73a: Double Needle Mode Line Configuration

4. Select DOUBLE NEEDLE on the display screen and confirm.

5. Verify that the screen display has changed to DOUBLE NEEDLE.

Figure 73b: SELECT DOUBLE NEEDLE Figure 73c: Confirm Screen Display–Double Needle

6. Follow operating instructions in Double Needle Mode Treatment Procedure on page 5-45 to continue.

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Single Needle Mode Treatment Procedure 5-23


Single Needle Mode Treatment Procedure

!WARNING:

The procedural kit must be used within four hours after PRIME has been completed.

ESTABLISH ACCESS

• Subtitle display line alternates between ESTABLISH ACCESS and READY TO COLLECT.

• Only one access line is connected to the patient access site for both Collect and Return.

Figure 74: ESTABLISH ACCESS (Single Needle Mode)

1. Verify the patient’s access configuration correlates with the treatment mode selected and verify the following clamps are OPEN:

• Patient Access Clamp

• Collect Line (RED) Clamp

• Return Line (BLUE) Clamp

2. Press START.

• The START button is always located in the lower left corner of the operator screen.

• The system automatically collects and returns through each cycle(s) without interruption.

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PURGING AIR

• Whole blood is drawn from the patient at the default rate of 50mL/min if access allows.

• Anticoagulant is added at the preset delivery ratio to the speed of the Collect Pump.

• Anticoagulated blood fills the Centrifuge Bowl and the lines to the Return Bag.

• The Centrifuge Bowl does not spin at full speed until it is filled. Once filled, the Centrifuge will start and stop several times allowing air to be purged from the inside of the Centrifuge Bowl.

• The active pathways are illustrated in pink.

• The inactive pathways are blue.

Figure 75a: Purging Air (Single Needle Mode)

Figure 75b: PURGING AIR

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✎NOTE: The Collection Rate Limit Range is 5–100mL/min. DRAWING will automatically use a flow rate of 50mL/min if access allows. Pressing the Collect Increase or Collect Decrease rate arrows on the graphic screen will change the flow rate within the Collection Rate Limit Range. You may change the Collect Rate Limit Range by entering a new value via the SETUP screen. Refer to Changing Default SETUP Parameters on page 5-11 for more information.

Figure 75c: COLLECT Flow Rate and Pressure Display

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DRAWING

In Single Needle Mode DRAWING and RETURNING alternate automatically as the Whole Blood Processed Volume target is reached. You should monitor the patient throughout the treatment.

!WARNING:

• The COLLECT Rate Limit Range is 5-100mL/min. DRAWING will automatically use a flow rate of 50mL/min if access allows. Careful fluid balance management may require a slower COLLECT Flow Rate. Please refer to SECTION 5: OPERATING THE THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM and SECTION 10: FLUID BALANCE MANAGEMENT for additional information.

• Venipuncture access may require a COLLECT Flow Rate of less than 50mL/min.

• A COLLECT Flow Rate higher than 50mL/min may result in decreased cell collection efficiency.

The screen display will show changes in:

• FLUID BALANCE• WHOLE BLOOD PROCESSED• COLLECT Flow Rate and Pressure• RETURN Flow Rate and Pressure• ANTICOAGULANT DELIVERED• SALINE DELIVERED• TREATMENT VOLUME

Figure 76: DRAWING (Single Needle Mode)

• Blood is drawn from the patient and pumped into the Centrifuge Bowl. Anticoagulant is delivered to the Collect Line at a preset ratio to the speed of the Collect Pump.

• The Centrifuge will run at full speed. Red blood cell volume within the Centrifuge Bowl will be maintained at the Bowl Optic Sensor Line. The Buffy Coat layer will form just inside the red blood cell line. Excess red blood cells, plasma and processed anticoagulant will exit the Centrifuge Bowl and are pooled in the Return Bag.

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• DRAWING will continue until the Return Bag Threshold Value is reached.

• DRAWING will be temporarily interrupted to return plasma and red blood cells to the patient and then resume until the collection Cycle Volume Target is reached.

✎NOTE: The THERAKOS™ CELLEX™ Photopheresis System is designed to process 1500mL in one Collection Cycle. The instrument tracks the Whole Blood Processed volume and is programmed to begin BUFFY COAT when the Cycle Volume Target is reached. The Cycle Volume Target is 40mL less than the Whole Blood Processed Target, or 1460mL, when the default setting of 1500mL is used. The Cycle Volume Target will automatically be reset if you change the Whole Blood Processed Target, and / or the Number of Collection Cycles. See Changing Default SETUP Parameters on page 5-11 for more information.

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RETURNING

Once the volume in the Return Bag reaches a preset threshold, the Collect and Anticoagulant Pumps stop and the Return Pump will pump the red blood cells, plasma, and processed anticoagulant from the Return Bag to the patient via the Return Line.

• If RETURNING requires more than 5 minutes:

• The Centrifuge will temporarily stop.

• The Centrifuge will automatically resume.

• Once the interface is re-established DRAWING will begin automatically.

• If RETURNING requires less than 5 minutes:

• The Centrifuge will remain spinning.

• The Collect and Red Cell Pumps will rotate gradually to maintain movement of fluids within the Centrifuge Bowl.

• DRAWING will begin automatically.

• An audible beep signals when blood flow changes from DRAWING to RETURNING.

!WARNING:

• The RETURN Rate Limit Range is 5-100mL/min. RETURNING will automatically use a Flow Rate of 50mL/min if access allows. Careful fluid management may require raising or lowering this flow rate.

• Venipuncture access may require a RETURN Flow Rate of less than 50mL/min.

• The default setting for the Return Bag Threshold is 200mL/min. The operator may change this setting at any time during the treatment via the SETUP screen. In Single Needle Mode, this setting determines how often the instrument alternates between DRAWING and RETURNING and also determines the patient’s extracorporeal blood volume during COLLECT.

• Refer to Changing Default SETUP Parameters on page 5-11 and SECTION 10: FLUID BALANCE MANAGEMENT for additional information.

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• The pathway from the A/C Bag is idle and illustrated in blue during RETURNING.

• RETURNING begins automatically each time the Return Bag Threshold is reached and continues until the volume in the Return Bag is approximately 50mL.

Figure 77: RETURNING (Single Needle Mode)

✎NOTE: The DRAWING and RETURNING phases immediately before Buffy Coat may be shortened to ensure that Buffy Coat begins when the cycle volume target is reached.

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BUFFY COAT

DRAWING automatically changes to BUFFY COAT when the Cycle Volume Target is reached. The Collect Flow Rate is reduced. The Red Blood Cell Pump is stopped, allowing red blood cells to pool in the Centrifuge Bowl. The additional volume of red blood cells forces the Buffy Coat to leave the Centrifuge Bowl. The software changes the position of the Fluid Routing Valves and directs the effluent from the Centrifuge Bowl to the Treatment Bag via the Hematocrit Sensor. Initially, the effluent from the Centrifuge Bowl is plasma, followed by leukocytes and, finally, red blood cells. When the Hematocrit Sensor detects the onset of red blood cells, blood flow from the patient to the Centrifuge Bowl will PAUSE for 2 minutes allowing the Buffy Coat layer to reform at the top of the Centrifuge Bowl. After the PAUSE, the Red Blood Cells Pump will reverse pumping packed red blood cells from the Drive Tube back into the Centrifuge Bowl, forcing additional Buffy Coat to leave the Centrifuge Bowl. It may be necessary to resume blood collection from the patient to reach the hematocrit sensor cutoff point.

• The BUFFY COAT collection is completed when the Hematocrit Sensor detects sufficient red blood cells in the Centrifuge Bowl effluent or when the operator manually activates the END BUFFY COAT Button.

• The screen subtitles will change from BUFFY COAT to PAUSED to ELUTRIATING and finally back to BUFFY COAT.

• The Fluid Routing Valve to the Return Bag is closed (red valve and blue pathway).

• The Fluid Routing Valve to the Treatment Bag is open (green valve and pink pathway).

Figure 78: BUFFY COAT (Single Needle Mode)

✎NOTE: DRAWING will resume if more than one collection cycle is required. If this collection cycle is the last, the Centrifuge will be stopped and the Centrifuge Bowl emptied.

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Following the final BUFFY COAT phase, the Centrifuge is stopped and its contents are emptied into the Return Bag. The Recirculation Pump will speed up to aid in mixing the collected Buffy Coat. After the Centrifuge Bowl is emptied, it is rinsed with saline and partially emptied again into the Return Bag.

• EMPTYING BOWL only occurs after the final BUFFY COAT.

• A small volume of saline rinse will remain in the Centrifuge Bowl to flush the treated cells out of the line after REINFUSE.

• The Centrifuge Bowl will be completely empty at the end of the treatment.

Figure 79: EMPTYING BOWL. / RECIRCULATING(Single Needle Mode)

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✎NOTE: Disregard Steps 1 and 2 and proceed to Step 3 if oral 8-methoxypsoralen has already been administered.

1. The instrument calculates and displays the proper dose of Methoxsalen (20 micrograms / mL) using the formula: TREATMENT VOLUME (mL) multiplied by 0.017 = dose of Methoxsalen (20 micrograms / mL) Example:

TREATMENT VOLUME = 170mL170 X 0.017 = 2.8mL

2. Dispense the proper dose of Methoxsalen (20 micrograms / mL) into the Treatment Bag when you are READY TO PHOTOACTIVATE and rinse the syringe three times.

a. Measure medication.

b. Remove needle and attach syringe luer.

c. Dispense medication and rinse syringe 3 times.

Figure 80a: Correct Liquid Medication Administration !

CAUTION:

Do not remove the Treatment Bag from the Load Cell Hook. Removal may result in inaccurate FLUID BALANCE readings.

!CAUTION:

Do not puncture any needle-free port with a needle. Damage to these ports will result in leaks.

Figure 80b: Incorrect Liquid Medication Administration

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3. Press to begin PHOTOACTIVATE.

Figure 81: RETURNING / READY TO PHOTOACTIVATE (Single Needle Mode)

• The subtitle line will alternate between RETURNING and READY TO PHOTOACTIVATE.

• RETURNING will begin automatically as soon as the Centrifuge Bowl is emptied and rinsed.

• The instrument will calculate the amount of Methoxsalen (20 micrograms / mL) to be injected.

• The operator may initiate PHOTOACTIVATE by pressing while RETURNING is in progress.

• The photoactivation time in MINUTES REMAINING will be displayed.

TEMPERATURE ICON:

Ambient air is used to cool the Photoactivation Chamber during PHOTOACTIVATE. Ensure that the room temperature does not exceed 30° C (86° F) during the treatment. “Alarm: TEMPERATURE” occurs when the temperature sensor in the Photoactivation Chamber reaches 43° C (109.4° F). Before reaching alarm conditions, a flashing temperature icon will appear in the title line of the Operator Interface. In addition, an intermittent audible beep will sound. The appearance of the temperature icon indicates that the Photoactivation Chamber temperature has increased to 39° C (102.2° F). If the temperature icon appears, take measures to lower the room temperature to prevent reaching temperature alarm conditions during PHOTOACTIVATE.

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PHOTOACTIVATE

Once Methoxsalen (20 micrograms / mL) has been injected into the Treatment Bag and has been pressed, the Buffy Coat will be circulated through the Photoactivation Module for the calculated photoactivation time.

• The Return pathway and Recirculation Loop are both active at the same time, illustrated in pink.

• If the return bag volume reaches 50 mLs before the minutes remaining equal zero, saline KVO will be activated to the return line.

Figure 82: PHOTOACTIVATE (Single Needle Mode)

✎NOTE:

If either PHOTOACTIVATE or RETURN are interrupted for any reason, press START to resume RETURNING and press to resume PHOTOACTIVATE.

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REINFUSE

!WARNING:

• The system automatically returns the treated cells to the patient following PHOTOACTIVATE. Therefore, it is recommended that the patient not be disconnected from the system at any time during the treatment.

• The Reinfusion Rate Limit Range is 1-100mL/min (1-5mL, adjustable in increments of 1; 5-100mL, adjustable in increments of 5). REINFUSE will automatically use a flow rate of 50mL/min if access allows. Careful fluid balance management may require a slower Reinfusion Rate. Refer to Changing Default SETUP Parameters on page 5-11 and SECTION 10: FLUID BALANCE MANAGEMENT for additional information.

• Venipuncture access may require a Reinfusion Rate of less than 50mL/min.

After PHOTOACTIVATE is complete, the treated cells are automatically reinfused to the patient. After the Treatment Bag is emptied, the remaining fluid in the Return Bag is also returned to the patient.

The Reinfusion Rate may be adjusted within the Reinfusion Rate Limit range by using the RETURN increase or decrease arrows on the main display screen.

Figure 83: REINFUSE (Single Needle Mode)

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PAUSED

!CAUTION:

• Maximum PAUSE time is 10 minutes. An audible beep signals when 8 minutes have expired. Press START to resume, or select STOP before 10 minutes expires to avoid generating a PAUSED Timeout Alarm.

• A portion of the leukocyte-enriched fraction in the Centrifuge Bowl will be lost when alarm conditions automatically stop the Centrifuge from spinning during COLLECT.

• Refer to instructions in STOPPED on page 5-39 for more information.

• Anticoagulant is dripped at a Keep Vein Open (KVO) rate of 10mL/hour when the system is PAUSED.

• The SETUP screen may be accessed in the PAUSED mode.

• Additional Treatment options are accessed by pressing .

• Refer to Interrupting a Treatment on page 5-64 for more information.

• The spinning Centrifuge Bowl is shown in pink.

Figure 84: PAUSED (Single Needle Mode)

1. Press if you need to temporarily stop blood flow or pumping activity. Pressing the PAUSE button keeps the Centrifuge spinning and the blood components separated.

2. Select SETUP, START SALINE, or additional treatment option buttons while PAUSED.

3. To resume, press START.

4. If a delay of greater than 10 minutes is required, select STOP.

• Do not allow the PAUSE 10-minute limit to expire.

• PAUSE Timeout will automatically stop the Centrifuge.

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PROCEED IMMEDIATELY TO BUFFY COAT / PHOTOACTIVATE / REINFUSE

Occasionally, poor access or other clinical concerns may not allow processing 1500mL of whole blood. To proceed immediately to BUFFY COAT, you must process at least 500mL.

1. PAUSE. Do not press STOP.

2. Enter SETUP screen.

3. Lower WHOLE BLOOD PROCESSED TARGET as much as possible. SAVE.

✎NOTE:

Lowering the Whole Blood Processed Target as far as possible will automatically change the Cycle Volume Target and direct the system to proceed immediately to BUFFY COAT. Because the Number of Cycles remains at ONE as soon as BUFFY COAT phase is complete, the instrument will proceed to the EMPTYING BOWL / RECIRCULATING. At this point, it is not possible to continue COLLECT, to raise the Number of Cycles or to change the WHOLE BLOOD PROCESSED TARGET. However, you will be able to PHOTOACTIVATE all cells in the Treatment Bag and REINFUSE them to the patient.

4. Press START to resume treatment and follow instructions beginning with BUFFY COAT on page 5-30 to complete the treatment.

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Rev. 4.0-1460451

COLLECT: USING MORE THAN ONE CYCLE

✎NOTE: • The THERAKOS™ CELLEX™ Photopheresis System is designed to process 1500mL

of whole blood in one collection cycle. On occasion, it may be necessary to collect the leukocyte-enriched fraction using more than one cycle. Collecting multiple Buffy Coats will yield a higher hematocrit in the final Treatment Volume resulting in a longer photoactivation time.

• Increasing the Number of Cycles allows you to move the Buffy Coat layer in the Centrifuge Bowl to the Treatment Bag and then resume processing more whole blood until the desired Whole Blood Processed Target is reached.

• The instrument automatically determines the Cycle Volume Target for each cycle and will not proceed to EMPTYING BOWL until the BUFFY COAT phase of all collection cycles is complete.

• If at least one BUFFY COAT has been collected, but additional cycles cannot be completed due to access problems, you may proceed to EARLY PHOTOACTIVATE to treat any cells currently in the Treatment Bag. See Interrupting a Treatment on page 5-64 for more information.


2. Enter the SETUP screen.

3. INCREASE the NUMBER OF CYCLES. Refer to Table 5 to verify the Cycle Volume Target for each cycle.

Number of Cycles Whole Blood Processed Target

Cycle Volume Target(s)

1 1500mL 1460mL

2 1500mL 710mL and 1460mL

3 1500mL 460mL, 960mL, 1460mL

1 2000mL 1960mL

2 2000mL 960mL and 1960mL

3 2000mL 627mL, 1293mL, 1960mL

1 1000mL 960mL

2 1000mL 460mL and 960mL

Table 5: SETUP Changes Required to COLLECT: USING MORE THAN ONE CYCLE

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!CAUTION: The patient’s extracorporeal volume will increase between 100mL - 280mL for each additional cycle collected. See Table 12: Estimated Extracorporeal Volume on page 10-3. Confirm ECV using 1 cycle. Before you COLLECT using more than one cycle, confirm the patient is able to tolerate a higher ECV.

4. SAVE the new SETUP entries.

5. Press START. The instrument will proceed to BUFFY COAT as each Cycle Volume Target is reached (Targets may vary with low hematocrits). EMPTYING BOWL / RECIRCULATING will begin only after the last cycle is completed.

STOPPED

The button is always located in the right side upper portion of the screen away from all other

buttons. The plasma / red blood cell interface will be lost whenever STOP is activated. Upon selecting

START to resume the treatment, the interface must be re-established before additional whole blood

volume is processed. When you initiate STOP, a Fluid Routing Valve is activated to prevent fluid

movement through the Plasma Out Line of the Centrifuge Bowl. This valve does not close in alarm

conditions that automatically stop the Centrifuge from spinning. See Figure 84a: Operator Initiated STOP vs. Automatic STOP in Alarm States (Single Needle Mode) on page 5-41.

!CAUTION:

A portion of the leukocyte-enriched fraction in the Centrifuge Bowl will be lost when alarm conditions automatically stop the Centrifuge from spinning during COLLECT.

The Centrifuge Bowl must be re-purged as treatment is resumed after the following alarms:

• Accelerometer System Alarm• Blood Leak (Centrifuge)• Drive Tube Alarm

• Alarm: PAUSE Timeout• Power Failure• Alarm: System Pressure

!WARNING:

Re-purging the Centrifuge Bowl with whole blood will result in a higher extracorporeal blood volume than anticipated. Refer to SECTION 10: FLUID BALANCE MANAGEMENT for additional information before resuming the treatment.

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✎NOTE:

Use to:

• STOP the Centrifuge immediately! • PAUSE for more than 10 minutes. • STOP and END TREATMENT. • STOP and ABORT TREATMENT.

Instrument Automatically STOPS for:• Accelerometer System Alarm• Blood Leak (Centrifuge)• Drive Tube Alarm• Alarm: PAUSE Timeout• Power Failure• Alarm: System Pressure

RESULTS:• Lose plasma / red blood cell interface• Resume without re-purging the

Centrifuge Bowl • No change in ECV• No loss of Buffy Coat

• Lose plasma / red blood cell interface

• Re-purge of Centrifuge Bowl required

• Higher ECV (approximately 50mL)• Loss of some Buffy Coat

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Figure 84a: Operator Initiated STOP vs. Automatic STOP in Alarm States (Single Needle Mode)

COLLECT: DRAWING / RETURNING

(Single Needle Mode)

COLLECT: Operator Initiated

STOP

COLLECT: Automatic STOP

CENTRIFUGE BOWL SPEED

4800 rpm 0 rpm 0 rpm

Collect/Return Line DRAWING: Whole Blood In

RETURNING: Plasma / Red Blood Cells Out

KVO anticoagulant from A/C Bag


Plasma / Red Blood Cell Interface

Established (at Bowl Optic Laser)

Lost Lost

Plasma Line OUT Fluid Routing Valve

During Normal COLLECT: DRAWING and During Re-start of Treatment After

STOP

Plasma Line OUT UNCLAMPED

Plasma Line OUT CLAMPED during RE-ESTABLISHING

INTERFACE

Plasma Line OUT UNCLAMPED during

PURGING AIR (re-purging)

Plasma Line OUT Fluid Contents and

Pathway

Plasma flows from top of Centrifuge Bowl to Return Bag as whole

blood enters

No flow from top of Centrifuge Bowl to Return Bag until

interface re-established

Some Centrifuge Bowl contents flows from top of Centrifuge Bowl to Return

Bag during re-purge

RETURNING Begins when Return Bag Threshold Reached

Volume in Return Bag reduced to 50mL prior to resuming treatment

Volume in Return Bag reduced to 50mL prior to

resuming treatment

Red Blood Cell Line OUT Fluid Pathway

and Activity

Red blood cells gradually pumped from bottom of Centrifuge Bowl to

Return Bag to maintain position of interface

Approximately 15mL red

blood cells pumped from

Drive Tube to Return

Bag as Centrifuge Bowl

re-starts

Approximately 15mL red blood cells pumped from

Drive Tube to Return Bag as Centrifuge Bowl re-starts

Status of Buffy Coat Leukocyte-enriched layer expands in Centrifuge

Bowl

Leukocyte-enriched layer mixes together with plasma and red

blood cells, but remains in Centrifuge Bowl

Partial loss of leucocyte-enriched layer as

Centrifuge Bowl re-purges, (raise WHOLE BLOOD PROCESSED TARGET)

Patient ECV (Based on % Hematocrit of

Patient)

See Table 12: Estimated

Extracorporeal Volume on page 10-3

No change Add approximately 50mL

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TREATMENT COMPLETE

The Treatment Complete screen appears when all treated cells have been returned to the patient.

Figure 85: TREATMENT COMPLETE(Single Needle mode)

Figure 86: Record Treatment Data

!CAUTION:

The used THERAKOS™ CELLEX™ Photopheresis Procedural Kit and any spills should be considered biologically contaminated. In handling any spills, follow the policies and procedures of your institution’s Infection Control Plan.

1. Clamp the patient’s access line, Collect Line, and Return Line.

2. Press Release Kit to release all valves and allow the procedural kit to be removed. DO NOT PRESS RELEASE KIT UNTIL ALL PATIENT LINES HAVE BEEN CLAMPED as blood may flow back into the kit.

3. Disconnect the patient.

a. Use your institution’s standards to provide proper care of the access site.

b. If venous access or a subcutaneous port was used, apply a pressure dressing.

c. Use caution to ensure that the patient’s fluid shifts have stabilized before allowing the patient to stand and ambulate.

d. Communicate all center-specific discharge instructions to the patient not limited to, but including:

• 24-hour increased sun sensitivity to eyes and skin

• Possible slight elevation in temperature

• Possible urticaria

• Possible hypertension

• Risk of bleeding post treatment

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✎NOTE:

To release all internal pressure before removing the kit, always remove all Pump Tubing Segments before removing any Pressure Domes. Check the screen display to confirm that the pressure has been released.

4. Remove each Pump Tubing Segment by placing a finger beneath the Pump Tubing and gently rotating the Pump counter-clockwise 1-2 turns.

5. Release the Pressure Domes by pinching the tabs together while pulling upward.

6. Remove all lines from the Air Detectors.

7. Remove the Hematocrit Cuvette from the Hematocrit Sensor.

8. Remove the Pump Tubing Organizer by pulling backward on both Release Clips and lifting the Organizer upward.

Figure 87: Removing the Pump Tubing Segment


Figure 88: Removing the Pump Tubing Organizer

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10. Open the Centrifuge Chamber Door and remove the Centrifuge Bowl.

a. Open the Drive Tube Latch.

b. Release the top and bottom Drive Tube Bearings.

c. Secure the Centrifuge Bowl Holder and rotate the Centrifuge Bowl counterclockwise to release it.

Figure 89: Removing the Centrifuge Bowl

11. Remove the remaining procedural kit components and fluid bags.

12. Discard the used procedural kit using biohazard precautions.


✎NOTE:

• Record Treatment Data as required by your institution. Data will be erased when the power is turned OFF.

• The power must be cycled OFF and then ON before beginning another treatment.

14. Turn the power OFF.

15. Clean the instrument using your institution’s Infection Control Guidelines prior to storing or next use.

16. If this is the last treatment of the day, clean the inside of the Centrifuge Chamber to remove bearing grease. Refer to SECTION 7: MAINTAINING THE THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM for complete instructions.

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Double Needle Mode Treatment Procedure 5-45


Double Needle Mode Treatment Procedure

!WARNING:

The THERAKOS™ CELLEX™ Photopheresis Procedural Kit must be used within four hours after PRIME has been completed.

ESTABLISH ACCESS

Subtitle display line alternates between ESTABLISH ACCESS and READY TO COLLECT.

Two separate patient access sites must be established. One for the Collect Line and one for Return Line.

Figure 90: ESTABLISH Access (Double Needle Mode)

1. Verify the patient’s access configuration correlates with the treatment mode selected and verify the following clamps are open:

• Patient’s Collect Access Clamp

• Patient’s Return Access Clamp

• Collect Line (RED) Clamp

• Return Line (BLUE) Clamp

2. Press START.

• The START button is always in the lower left corner of the operator screen.

• The system automatically collects and returns through each cycle without interruption.

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PURGING AIR

• Whole blood is drawn from the patient at the default rate of 50mL/min if access allows.

• Anticoagulant is added at the preset delivery ratio to the speed of the Collect Pump.

• Anticoagulated blood fills the Centrifuge Bowl and the lines to the Return Bag.

• Double Needle Mode is designed to be a continuous flow system to manage fluid balance. During PURGING AIR, saline is returned to the patient at the default Return Rate of 25mL/min. This saline return will automatically pause at times while the air is being purged via the Centrifuge Bowl Red Blood Cells Line.

• You may decrease the Return Rate to slow the return delivery to the patient and minimize additional fluids given. However, to ensure patency in the Return Life; do not decrease the return rate to 0mL/min.

• A minimal fluid deficit will develop during PURGING AIR.

• Active pathways are illustrated in pink.

• Inactive pathways are shown in blue.

• The Centrifuge Bowl does not spin at full speed until it is filled. Once filled, the Centrifuge will start and stop several times allowing trapped air to be purged from the inside of the Centrifuge Bowl.

Figure 91: PURGING BOWL (Double Needle Mode)

Figure 92: PURGING AIR

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✎NOTE: The Collection Rate Limit Range and Return Rate Limit Range are both 5-100mL/min. DRAWING and RETURNING will automatically use a flow rate of 50mL/min if access allows. Pressing the Collect Increase or Collect Decrease rate arrows on the graphic screen will change the flow rate within the Collection Rate Limit Range. The Return Rate may also be adjusted from the main screen within the preset Return Rate Limit Range. You may change the Collect or Return Rate Limit Ranges by entering a new value via the SETUP screen. Refer to Changing Default SETUP Parameters on page 5-11 for more information. Figure 93: COLLECT AND

RETURN Flow Rates and Pressure Displays

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DRAWING / RETURNING

In Double Needle Mode, DRAWING and RETURNING occur simultaneously in continuous flow as the Whole Blood Processed Volume target is reached. You should monitor the patient throughout the treatment.

!WARNING:

• The COLLECT and RETURN Rate Limit Ranges are 5-100mL/min. DRAWING and RETURNING automatically use a flow rate of 50mL/min if access allows. Careful fluid management may require adjustments of these flow rates. Refer to Changing Default SETUP Parameters on page 5-11 and SECTION 10: FLUID BALANCE MANAGEMENT for additional information.

• Venipuncture access may require a COLLECT and / or RETURN Flow Rate of less than 50mL/min.


The screen display will show changes in:

• FLUID BALANCE• WHOLE BLOOD PROCESSED• COLLECT Flow Rate and Pressure• RETURN Flow Rate and Pressure• ANTICOAGULANT DELIVERED• SALINE DELIVERED• TREATMENT VOLUME

Figure 94: DRAWING / RETURNING (Double Needle Mode)

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Blood is drawn from the patient and pumped into the Centrifuge Bowl. Anticoagulant is delivered to the Collect Line at the preset ratio to the speed of the Collect Pump.

The Centrifuge will run at full speed. Red cell volume within the Centrifuge Bowl will be maintained at the Bowl Optic Sensor Line. The Buffy Coat layer will form just inside the red blood cells line. Excess red blood cells, plasma and processed anticoagulant will exit the Centrifuge Bowl.

The Return Pump will return the red blood cells, plasma and processed anticoagulant to the patient via the Return Line. DRAWING / RETURNING will continue until the collection Cycle Volume Target is reached.

✎NOTE:

The THERAKOS™ CELLEX™ Photopheresis System is designed to process 1500mL in one Collection Cycle. The instrument tracks the Whole Blood Processed Target and is programmed to begin BUFFY COAT when the Cycle Volume Target is reached. The Cycle Volume Target is 40mL less than the Whole Blood Processed Target, or 1460mL, when the default settings are used. The Cycle Volume Target will automatically be reset if the you change the Whole Blood Processed Target and / or the Number of Collection Cycles. Refer to Changing Default SETUP Parameters on page 5-11 for additional information.

BUFFY COAT

DRAWING automatically changes to BUFFY COAT when the Cycle Volume Target is reached. The Collect Flow Rate is reduced. The Red Blood Cells Pump is stopped, allowing red blood cells to pool in the Centrifuge Bowl. The additional volume of red blood cells forces the Buffy Coat to leave the Centrifuge Bowl. The software changes the position of the Fluid Routing Valves and directs the effluent from the Centrifuge Bowl to the Treatment Bag via the Hematocrit Sensor. Initially, the effluent from the Centrifuge Bowl is plasma, followed by leukocytes and, finally, red blood cells. When the Hematocrit Sensor detects the onset of red blood cells, blood flow from the patient to the Centrifuge Bowl will PAUSE for 2 minutes allowing the Buffy Coat layer to reform at the top of the Centrifuge Bowl. After the PAUSE, the Red Blood Cells Pump will reverse, pumping packed red blood cells from the Centrifuge Bowl Drive Tube back into the Centrifuge Bowl, forcing additional Buffy Coat to leave the Centrifuge Bowl. It may be necessary to resume blood collection from the patient to reach the Hematocrit Sensor cutoff point.

The BUFFY COAT collection is completed when the Hematocrit Sensor detects sufficient red blood cells in the Centrifuge Bowl effluent or when you manually activate the END BUFFY button.

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Rev. 4.0-1460451

• The subtitle line changes from BUFFY COAT to PAUSED to ELUTRIATING and back to BUFFY COAT.

• Collect and Return pathways are both active during BUFFY COAT as illustrated in pink.

• Fluid Routing Valves are now open to allow the leukocyte-enriched fraction leaving the Centrifuge Bowl to flow to the Treatment Bag.

Figure 95: BUFFY COAT (Double Needle Mode)

✎NOTE:

DRAWING / RETURNING will resume if more than one collection cycle is required. If this collection cycle is the last, the Centrifuge will be stopped and the Centrifuge Bowl emptied.


Following the final BUFFY COAT phase, the Centrifuge is stopped and its contents are emptied into the Return Bag. The Recirculation Pump will speed up to aid in mixing the collected Buffy Coat. After the Centrifuge Bowl is emptied, it is rinsed with saline and partially emptied again into the Return Bag.

• EMPTYING BOWL only occurs after the final BUFFY COAT.

• A small volume of saline rinse will remain in the Centrifuge Bowl to flush the treated cells out of the line after REINFUSE.

• The Centrifuge Bowl will be completely empty at the end of the treatment.

Figure 96: EMPTYING BOWL / RECIRCULATING (Double Needle Mode)

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✎NOTE: Disregard Steps 1 and 2 and proceed to Step 3 if oral 8-methoxypsoralen has already been administered.

1. The instrument calculates and displays the proper dose of Methoxsalen (20 micrograms / mL) using the formula: TREATMENT VOLUME (mL) multiplied by 0.017 = dose of Methoxsalen (20 micrograms / mL) Example:

TREATMENT VOLUME = 170mL170 X 0.017 = 2.89 = 2.8mL

2. Dispense the proper dose of Methoxsalen (20 micrograms / mL) into the Treatment Bag when you are READY TO PHOTOACTIVATE and rinse the syringe three times.

a. Measure medication.

b. Remove needle and attach syringe luer.

c. Dispense medication and rinse syringe 3 times.

Figure 97a: Correct Liquid Medication Administration !

CAUTION: Do not remove the Treatment Bag from the Load Cell Hook. Removal may result in inaccurate FLUID BALANCE readings.

!CAUTION: Do not puncture any needle-free port with a needle. Damage to these ports will result in leaks.

Figure 97b: Incorrect Liquid Medication Administration

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Rev. 4.0-1460451

3. Press to begin PHOTOACTIVATE.

Figure 98: RETURNING / READY TO PHOTOACTIVATE (Double Needle Mode)

• The subtitle line will alternate between RETURNING and READY TO PHOTOACTIVATE.

• RETURNING will begin automatically as soon as the Centrifuge Bowl is emptied and rinsed.

• Initiate PHOTOACTIVATE by pressing

while RETURNING is in progress.

• The photoactivation time in MINUTES REMAINING will be displayed.

TEMPERATURE ICON:

Ambient air is used to cool the Photoactivation Chamber during PHOTOACTIVATE. Ensure that the room temperature does not exceed 30° C (86° F) during the treatment. “Alarm: TEMPERATURE” occurs when the temperature sensor in the Photoactivation Chamber reaches 43° C (109.4° F). Before reaching alarm conditions, a flashing temperature icon will appear in the title line of the Operator Interface. In addition, an intermittent audible beep will sound. The appearance of the temperature icon indicates that the Photoactivation Chamber temperature has increased to 39° C (102.2° F). When the temperature icon appears, take measures to lower the room temperature to prevent reaching temperature alarm conditions during PHOTOACTIVATE.

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PHOTOACTIVATE

Once Methoxsalen (20 micrograms / mL) has been injected into the Treatment Bag and has been pressed, the Buffy Coat will be circulated through the Photoactivation Module for the calculated photoactivation time.

• The Return pathway and Recirculation Loop are both active at the same time, illustrated in pink.

• If the return bag volume reaches 50 mLs before the minutes remaining equal zero, saline KVO will be activated to the return line.

Figure 99: PHOTOACTIVATE (Double Needle Mode)

✎NOTE:

If either PHOTOACTIVATE or RETURN are interrupted for any reason, press START to resume RETURNING and press to resume PHOTOACTIVATE.

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Rev. 4.0-1460451

REINFUSE

!WARNING:

• The system automatically returns the treated cells to the patient following PHOTOACTIVATE. Therefore, it is recommended that the patient not be disconnected from the system at any time during the treatment.

• The Reinfusion Rate Limit Range is 1-100mL/min (1-5mL, adjustable in increments of 1; 5-100mL, adjustable in increments of 5). REINFUSE will automatically use a flow rate of 50mL/min if access allows. Careful fluid balance management may require a slower reinfusion rate. Refer to Changing Default SETUP Parameters on page 5-11 and SECTION 10: FLUID BALANCE MANAGEMENT for additional information.


After PHOTOACTIVATE is complete, the treated cells are automatically reinfused to the patient at the Reinfusion Rate established in SETUP. After the Treatment Bag is emptied, the remaining fluid in the Return Bag is also returned to the patient.

The Reinfusion Rate may be adjusted within the Reinfusion Rate Limit range by using the RETURN increase or decrease arrows on the main display screen.

Figure 100: REINFUSE (Double Needle Mode)

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PAUSED

!CAUTION:

• Maximum PAUSE time is 10 minutes. An audible beep signals when 8 minutes have expired. Either press START to resume, or select STOP before 10 minutes expires to avoid generating a PAUSED Timeout Alarm.

• A portion of the leukocyte-enriched fraction in the Centrifuge Bowl will be lost when alarm conditions automatically stop the Centrifuge from spinning during COLLECT.

• Refer to instructions in STOPPED on page 5-58 for more information.

• Anticoagulant is dripped at a Keep Vein Open (KVO) rate of 10mL/hour when the system is PAUSED.

• The SETUP screen may be accessed in the PAUSED mode.

• Additional Treatment options are accessed by pressing .

• Refer to Interrupting a Treatment on page 5-64 for more information.

• The spinning Centrifuge Bowl is shown in pink.

Figure 100a: PAUSED (Double Needle Mode)

1. Press if you need to temporarily stop blood flow or pumping activity. Pressing the PAUSE button keeps the Centrifuge spinning and the blood components separated.

2. Select SETUP, START SALINE, or additional treatment option buttons while PAUSED.

3. To resume, press START.

4. If a delay of greater than 10 minutes is required, you must select STOP.

• Do not allow the PAUSE 10-minute limit to expire.

• PAUSE Timeout will automatically stop the Centrifuge.

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Rev. 4.0-1460451

PROCEED IMMEDIATELY TO BUFFY COAT / PHOTOACTIVATE / REINFUSE

Occasionally, poor access or other clinical concerns may not allow processing 1500mL of whole blood. To proceed immediately to BUFFY COAT, you must process at least 500mL.

✎NOTE:

When access issues occur in Double Needle Mode to avoid lowering the WHOLE BLOOD PROCESSED Target it may be possible to:

• PAUSE• Convert the Collect and Return Lines to Single Needle Mode• Select SINGLE NEEDLE and confirm to convert the software to Single Needle Mode



3. Lower the WHOLE BLOOD PROCESSED TARGET as much as possible. SAVE.

✎NOTE:

Lowering the Whole Blood Processed Target as far as possible will automatically change the Cycle Volume Target and direct the system to proceed immediately to BUFFY COAT. Because the Number of Cycles remains at ONE as soon as BUFFY COAT phase is complete, the instrument will proceed to the EMPTYING BOWL / RECIRCULATING. At this point, it is not possible to continue COLLECT, to raise the Number of Cycles or to change the WHOLE BLOOD PROCESSED TARGET. However, you will be able to PHOTOACTIVATE all cells in the Treatment Bag and REINFUSE them to the patient.

4. Press START to resume treatment and follow the instructions beginning with BUFFY COAT (Double Needle Mode) in Section 5 to complete the treatment.

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COLLECT: USING MORE THAN ONE CYCLE

✎NOTE:

• The THERAKOS™ CELLEX™ Photopheresis System is designed to process 1500mL of whole blood in one collection cycle. On occasion, it may be necessary to collect the leukocyte-enriched fraction using more than one cycle. Collecting multiple Buffy Coats will yield a higher hematocrit in the final Treatment Volume resulting in a longer photoactivation time.

• Increasing the Number of Cycles allows the operator to move the Buffy Coat layer in the Centrifuge Bowl to the Treatment Bag and then resume processing more whole blood until the desired Whole Blood Processed Target is reached.

• The instrument automatically determines the Cycle Volume Target for each cycle and will not proceed to EMPTYING BOWL until the BUFFY COAT phase of all collection cycles is complete.

• If at least one BUFFY COAT has been collected, but additional cycles cannot be completed due to access problems, the operator may proceed to EARLY PHOTOACTIVATE to treat any cells currently in the Treatment Bag. See Interrupting a Treatment on page 5-64 for more information.



Number of Cycles Whole Blood Processed Target

Cycle Volume Target(s)

1 1500mL 1460mL

2 1500mL 710mL and 1460mL

3 1500mL 460mL, 960mL, 1460mL

1 2000mL 1960mL

2 2000mL 960mL and 1960mL

3 2000mL 627ml, 1293mL, 1960mL

1 1000mL 960mL

2 1000mL 460mL and 960mL

Table 6: SETUP Changes Required to COLLECT: USING MORE THAN ONE CYCLE

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!CAUTION: The patient’s extracorporeal volume will increase between 100mL - 280mL for each additional cycle collected. Refer to Table 12: Estimated Extracorporeal Volume on page 10-3. Confirm ECV using 1 cycle. Before you COLLECT using more than one cycle, confirm the patient is able to tolerate a higher ECV.

3. SAVE new SETUP entries.

4. Press START. The instrument will proceed to BUFFY COAT as each Cycle Volume Target is reached. EMPTYING BOWL / RECIRCULATING will begin only after the last cycle is completed.

STOPPED

The button is always located in the right side upper portion of the screen away from all other

buttons. The plasma / red blood cell interface will be lost whenever STOP is activated. Upon selecting

START to resume the treatment, the interface must be re-established before additional whole blood

volume is processed. When the operator initiates STOP, a Fluid Routing Valve is activated to prevent

fluid movement through the Plasma Out Line of the Centrifuge Bowl. This valve does not close in alarm

conditions that automatically stop the Centrifuge from spinning.

!CAUTION: A portion of the leukocyte-enriched fraction in the Centrifuge Bowl will be lost when alarm conditions automatically stop the Centrifuge from spinning during COLLECT. The Centrifuge Bowl must be re-purged as treatment is resumed after the following alarms:

• Accelerometer System Alarm• Blood Leak (Centrifuge)• Drive Tube Alarm

• Alarm: PAUSE Timeout• Power Failure• Alarm: System Pressure

!WARNING:


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✎NOTE:

Use to:

• STOP the Centrifuge immediately! • PAUSE for more than 10 minutes. • STOP and END TREATMENT. • STOP and ABORT TREATMENT.

Instrument Automatically STOPS for:• Accelerometer System Alarm• Blood Leak (Centrifuge)• Drive Tube Alarm• Alarm: PAUSE Timeout• Power Failure• Alarm: System Pressure

RESULTS:• Lose plasma / red blood cell interface• Resume without re-purging the

Centrifuge Bowl • No change in ECV• No loss of Buffy Coat

• Lose plasma / red blood cell interface

• Re-purge of Centrifuge Bowl required

• Higher ECV (approximately 50mL)• Loss of some Buffy Coat

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Figure 101a Operator Initiated

STOP vs. Automatic STOP in Alarm States

(Double Needle Mode)

COLLECT: DRAWING / RETURNING

(Double Needle Mode)

COLLECT: Operator Initiated

STOP

COLLECT: Automatic STOP

CENTRIFUGE BOWL SPEED

4800 rpm 0 rpm 0 rpm

Collect Line

Return Line

DRAWING: Whole Blood In

RETURNING: Plasma / Red Blood Cells Out


KVO anticoagulated blood from Return Bag


KVO anticoagulated blood from Return Bag

Plasma / Red Blood Cell Interface

Established (at Bowl Optic Laser)

Lost Lost

Plasma Line OUT Fluid Routing Valve

During Normal COLLECT: DRAWING and During Re-start of Treatment After

STOP

Plasma Line OUT UNCLAMPED

Plasma Line OUT CLAMPED during RE-ESTABLISHING

INTERFACE

Plasma Line OUT UNCLAMPED during

PURGING AIR (re-purging)

Plasma Line OUT Fluid Contents and

Pathway

Plasma flows from top of Centrifuge Bowl to Return Bag as whole

blood enters

No flow from top of Centrifuge Bowl to Return Bag until

interface re-established

Some Centrifuge Bowl contents flows from top of Centrifuge Bowl to Return

Bag during re-purge

RETURNING Simultaneous with DRAWING (min of 50mL

in Return Bag)

Volume in Return Bag reduced to 50mL prior to resuming treatment

Volume in Return Bag reduced to 50mL prior to

resuming treatment

Red Blood Cell Line OUT Fluid Pathway

and Activity

Red blood cells gradually pumped from bottom of Centrifuge Bowl to patient to maintain position of interface


Drive Tube to Return Bag as Centrifuge Bowl

re-starts


Drive Tube to Return Bag as Centrifuge Bowl re-starts

Status of Buffy Coat Leukocyte-enriched layer expands in Centrifuge

Bowl

Leukocyte-enriched layer mixes together with plasma and red

blood cells, but remains in Centrifuge Bowl

Partial loss of leukocyte-enriched layer as

Centrifuge Bowl re-purges, (raise WHOLE BLOOD PROCESSED TARGET)

Patient ECV (Based on % Hematocrit of

Patient)

See Table 12: Estimated

Extracorporeal Volume on page 10-3

No change Add approximately 50mL

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TREATMENT COMPLETE

The Treatment Complete screen appears when all treated cells have been returned to the patient.

Figure 101: TREATMENT COMPLETE(Double Needle mode)

Figure 102: Record Treatment Data

!CAUTION:

The used THERAKOS™ CELLEX™ Photopheresis Procedural Kit and any spills should be considered biologically contaminated. In handling any spills, follow the policies and procedures of your institution’s Infection Control Plan.

1. Clamp the patient’s access lines, Collect Line, and Return Line.

2. Press RELEASE KIT to release all valves and allow the THERAKOS™ CELLEX™ Photopheresis Procedural Kit to be removed. DO NOT PRESS ‘RELEASE KIT’ UNTIL ALL PATIENT LINES HAVE BEEN CLAMPED as blood may flow back into the THERAKOS™ CELLEX™ Photopheresis Procedural Kit.

3. Disconnect the patient.

a. Use your institution’s standards to provide proper care of the access site.

b. If venous access or a subcutaneous port was used, apply a pressure dressing.

c. Use caution to ensure that the patient’s fluid shifts have stabilized before allowing the patient to stand and ambulate.

d. Communicate all center-specific discharge instructions to the patient not limited to, but including:

• 24-hour increased sun sensitivity to eyes and skin

• Possible slight elevation in temperature

• Possible urticaria

• Possible hypertension

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• Risk of bleeding post treatment

✎NOTE:

To release all internal pressure before removing the kit, always remove all Pump Tubing Segments before removing any Pressure Domes. Check the screen display to confirm that the pressure has been released.

4. Remove each Pump Tubing Segment by placing a finger beneath the Pump Tubing and gently rotating the Pump counter clockwise 1-2 turns.

5. Release the Pressure Domes by pinching the tabs together while pulling upward.

6. Remove all lines from the Air Detectors.

7. Remove the Hematocrit Cuvette from the Hematocrit Sensor.

Figure 102a: Removing the Pump Tubing Segment


Figure 102b: Removing the Pump Tubing Organizer

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9. Open the Centrifuge Chamber Door and remove the Centrifuge Bowl.

a. Open the Drive Tube Latch.

b. Release the top and bottom Drive Tube Bearings.

c. Secure the Centrifuge Bowl Holder and rotate the Centrifuge Bowl counter clockwise to release it.

Figure 103: Removing the Centrifuge Bowl

10. Remove remaining procedural kit components and fluid bags.

11. Discard the used procedural kit using biohazard precautions.


✎NOTE:

• Record Treatment Data as required by your institution. Data will be erased when the power is turned OFF.

• The power must be cycled OFF and ON before beginning another treatment.

13. Turn the power OFF.

14. Clean the instrument using your institution’s Infection Control Guidelines prior to storing or next use.

15. If this is the last treatment of the day, clean the inside of the Centrifuge Chamber to remove bearing grease. Refer to SECTION 7: MAINTAINING THE THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM for complete instructions.

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Interrupting a Treatment

To temporarily interrupt a treatment and then resume use the PAUSE button. PAUSE allows the operator the following options:

• Up to 10 minutes time to adjust or flush the patient’s access site

• Time to deliver a saline bolus

• Time to enter the SETUP screen to modify any Treatment Parameter Setting

For complete instructions on how to use the PAUSE button refer to PAUSED on page 5-36 or PAUSED on page 5-55.

If you need to interrupt the treatment for longer than 10 minutes or if you intend to stop COLLECT to change the course of the treatment, then pressing STOP in any* phase of the treatment enables you to choose from the following options:

• END TREATMENT

• ABORT TREATMENT

• EARLY PHOTOACTIVATE (*Only if at least one Buffy Coat is already in the Treatment Bag)

For complete instructions on how to use the STOP button refer to STOPPED on page 5-39 or STOPPED on page 5-58.

Use to:

• Flush access.• Give saline bolus.• Go to SETUP.• COLLECT >1 Cycle • Go to BUFFY COAT

Use to:

• END TREATMENT• ABORT TREATMENT• PROCEED TO EARLY

PHOTOACTIVATE (See * above).

Figure 104: Deciding when to PAUSE or STOP

!CAUTION:

• A portion of the leukocyte-enriched fraction in the Centrifuge Bowl will be lost when alarm conditions automatically stop the Centrifuge during COLLECT. Refer to instructions in STOPPED on page 5-39 for more information.

• END TREATMENT and ABORT TREATMENT are both selections that will not allow the operator to proceed to PHOTOACTIVATE. Selection and confirmation of these selections will result in immediate termination of the treatment.

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Interrupting A Treatment 5-65


Delivering a Saline Bolus

!CAUTION:

Do not select during the COLLECT phase to deliver a saline bolus. STOP will stop the Centrifuge and cell separation will be lost.

If the patient requires fluids during the procedure, you may administer a saline bolus during the COLLECT or PHOTOACTIVATE phases.

1. Press PAUSE during COLLECT or press STOP during PHOTOACTIVATE.

2. Press then START SALINE. A confirmation message appears.

3. Select YES or NO.

• Pressing the YES button automatically begins the delivery of the preset volume of saline. After the saline is delivered, the previous screen appears.

• Pressing the NO button returns you to the previous screen without delivering saline.

To stop the saline bolus before the entire bolus volume has been delivered, press STOP SALINE.

4. When the bolus is complete press START to resume treatment.

✎NOTE:

• The default Saline Bolus volume is 100mL. Enter the SETUP menu to increase or decrease this setting as required.

• To stop the saline bolus before the entire bolus volume has been delivered, press STOP SALINE.

• If a saline bolus is interrupted by an alarm, clear the alarm state and select START SALINE again.

Figure 105: Delivering a Saline Bolus

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EARLY PHOTOACTIVATE

!CAUTION:

Do not select to EARLY PHOTOACTIVATE unless at least one BUFFY COAT phase

has been completed.

Pressing STOP followed by stops the current collection and directs the system to enter the EMPTYING BOWL / RECIRCULATING phase allowing EARLY PHOTOACTIVATE prior to completion of additional collection cycles. This option should only be used if more than one collection cycle has been entered into the SETUP screen and at least one Collection Cycle has been completed.

If COLLECT must be interrupted and there is no Buffy Coat in the Treatment Bag refer to PROCEED IMMEDIATELY TO BUFFY COAT / PHOTOACTIVATE / REINFUSE on page 5-37.

If COLLECT must be interrupted and there is at least one Buffy Coat in the Treatment Bag proceed as follows:

1. Press .

2. Press .

3. Press . A confirmation message appears.

4. Press YES to proceed to PHOTOACTIVATE. The system empties Centrifuge Bowl, and mixes the Buffy Coat collected then enters the RETURNING / READY TO PHOTOACTIVATE phase. If you choose to cancel this request, press NO.

Do not proceed to PHOTOACTIVATE unless the BUFFY COAT phase of Cycle 1 is complete.

Figure 106: Early PHOTOACTIVATE

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Interrupting A Treatment 5-67


END TREATMENT

!CAUTION:

END TREATMENT and ABORT TREATMENT are both selections that will not allow the operator to proceed to PHOTOACTIVATE. Selection and confirmation of these selections will result in immediate termination of the treatment.

If for any reason you want to interrupt the treatment, stop collection and have the instrument return all blood to the patient immediately:

1. Press STOP.

2. Press .

3. Press END TX. The button selected will flash and the screen will display a prompt to confirm.

4. Confirm by pressing the END TX box in the display box. Press CANCEL if you do not want to END TREATMENT.

5. Refer to TREATMENT COMPLETE on page 5-42 or TREATMENT COMPLETE on page 5-61 for instructions on how to complete the treatment.

Figure 107: END TREATMENT

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ABORT TREATMENT

If for any reason you want to interrupt the treatment, stop all functions and not have the instrument return any blood to the patient:

1. Press STOP.

2. Press .

3. Press ABORT. The button selected will flash and the screen will display a prompt to confirm.

4. Confirm by pressing the ABORT box in the display box. Press CANCEL if you do not want to ABORT TREATMENT.

5. Refer to TREATMENT COMPLETE on page 5-42 or TREATMENT COMPLETE on page 5-61 for instructions on how to complete the treatment.

Figure 108: ABORT TREATMENT

✎NOTE:

Reasons to ABORT TREATMENT:

• Clotting in the procedural kit.• Possible blood contamination due to a leak.• Possible allergic reaction.• Prevent return of packed red blood cells if blood prime has been used.

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Manual Blood Return 5-69


MANUAL BLOOD RETURN

In the event of an instrument malfunction, prolonged power failure, or procedural kit failure, it may be necessary to manually return blood from the procedural kit to the patient. Two sets of instructions are available. Follow Manual Return (With Power ON) if you are able to activate the Release Kit button. Follow Manual Return (With Power OFF) if you are unable to activate the Release Kit button.

!CAUTION:

• Before you begin Manual Blood Return, consult the physician in charge to determine if there is any reason that the blood in the procedural kit should not be returned to the patient.

• In the event of a brief power failure during treatment that does not require Manual Blood Return, turn the power switch OFF, open the door to the Photoactivation Chamber and pull the Photoactivation Module out half way. When power is restored, put the Photoactivation Module back in position, close the Photoactivation Chamber Door and turn the power ON. If the power failure is prolonged, follow instructions for Manual Blood Return (With Power and / or No Access to Release Kit Button) below.

• To release all internal pressure before removing the kit, always remove all Pump Tubing Segments before removing any Pressure Domes. Check the screen display to confirm that pressure has been released.

MANUAL BLOOD RETURNSupplies Required (with Power ON) (with Power OFF)

Access to Release Kit button No access to Release Kit button

Filtered Blood Administration Set 1 1

Slide Clamps or Hemostats 4 9

Centrifuge Chamber Door Opening Tool

N/A 1

Table 7: Manual Blood Return

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MANUAL BLOOD RETURN (With Power ON and Access to Release Kit Button)

1. Clamp all patient line clamps.

2. Use a Slide Clamp or Hemostat to clamp the Anticoagulant and Saline Lines.

3. Press .

4. Press ABORT and Confirm.

5. Press the Release Kit Button. If you are unable to release the kit, proceed to MANUAL BLOOD RETURN (With Power OFF and No Access to Release Kit Button).

6. Keep the Power ON!

7. Drain the Photoactivation Module.

a. Open door of the Photoactivation Chamber and slide Photoactivation Module out half way.

b. Manually rotate the Recirculation Pump (#4) counterclockwise until all the Buffy Coat in the Photoactivation Module is transferred to the Treatment Bag.

#4

Figure 109: Manually Draining the Photoactivation Module

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8. Drain the Centrifuge Bowl.

Manually rotate the Red Blood Cell Pump (#2) clockwise to empty the contents of the Centrifuge Bowl. The blood will flow to either the Treatment Bag and / or to the Return Bag.

#2

Figure 110: Manually Draining the Centrifuge Bowl

9. Drain the Return Bag.

a. Raise and invert the Return Bag to allow the contents to drain into the Treatment Bag. All blood should now be in the Treatment Bag.

b. Use a Slide Clamp or Hemostat to clamp both lines of the Treatment Bag.

Figure 111: Manually Draining the Return Bag

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10. Prepare the Treatment Bag for reinfusion to the patient.

a. Remove the remaining portion of the procedural kit from the instrument.

b. Spike the blood transfusion filter to the Treatment Bag and prime the filter.

!CAUTION:

Do not manually return any blood products without proper filtration. Refer to your institution’s blood transfusion guidelines.

11. Manually return blood from Treatment Bag to patient.

a. Hang the Treatment Bag on an IV pole.

b. Connect the filtered blood administration line to the patient’s access.

c. Return blood through the filter to the patient using center specific guidelines for rate and method of reinfusion.

d. Discard the procedural kit using biohazard precautions when Manual Return is complete.

e. Record all treatment data from the instrument and turn the power OFF.

✎NOTE:

• Data will be erased when the power is turned OFF.

• Power must be cycled OFF and then ON before beginning a new treatment.

• Contact Therakos if instrument service is required.

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MANUAL BLOOD RETURN (With Power OFF and / or No Access to Release Kit Button)

✎NOTE:

Due to an instrument malfunction or prolonged power failure the operator is not able to access the ABORT Treatment button or Release Kit button. Consequently, the Fluid Routing Valves are all in the raised position and will block the flow of fluids as you attempt to drain the procedural kit.

Call Therakos Technical Support at any of the numbers on the last page of this manual to report the problem and to obtain guidance as you proceed.

1. Clamp all patient lines.

2. Clamp the Anticoagulant and Saline lines.

3. If possible, Record Treatment Data from Text Screen 1 and Text Screen 2.

If data is not visible you may send the SMART Card to Therakos to retrieve missing information.

4. If possible, open the Centrifuge Chamber Door and then turn the power OFF.

Figure 112a: Open Centrifuge Chamber Door

Figure 112b: Turn Power OFF

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5. If necessary, manually release the Centrifuge Chamber Door.

a. Turn power OFF.

b. Insert a flat head screwdriver into the Centrifuge Chamber Door Manual Release and turn the latchkey one half turn clockwise.

c. Raise the Centrifuge Chamber Door.

d. Return the latchkey to its original position by turning it one half turn counterclockwise.

Figure 113: Centrifuge Chamber Door Manual Release Access

6. Drain the Photoactivation Module.

a. Open door of the Photoactivation Chamber and slide Photoactivation Module out half way.

b. Manually rotate the Recirculation Pump (#4) counterclockwise until all the Buffy Coat in the Photoactivation Module is transferred to the Treatment Bag.

c. Clamp the lines of the Photoactivation Module close to the Pump Tubing Organizer.

#4

Figure 114: Manually Draining the Photoactivation Module

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7. Drain the Centrifuge Bowl.

a. Use extreme care to avoid puncturing the tubing line as you insert the Fluid Routing Valve Release Tool. Depress and hold the valve down to open the pathway for blood to flow from the Centrifuge Bowl to the Treatment Bag. Locate this valve by following the (GREEN Striped) line of the Treatment Bag back to the bottom of the Tubing Organizer. See Figure 35: Pump Tubing Organizer Schematic on page 3-29.

b. Keeping the valve depressed, manually rotate the RBC Pump (#2) clockwise until the Centrifuge Bowl is completely empty. Additional venting may be required if Centrifuge Bowl does not readily drain. Call Therakos Technical Support for assistance.

c. Clamp all three lines that exit from the Centrifuge Bowl.

!

CAUTION:

Do not puncture

tubing line!

Figure 115: Manually Draining the Centrifuge Bowl (With Power OFF and / or No Access to Release Kit Button)

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8. Remove the Pump Tubing Organizer.

a. Remove all Pump Tubing Segments and Pressure Domes.

b. Pull tabs and lift to remove Pump Tubing Organizer.

Figure 116a: Removing the Pump Tubing Segments Figure 116b: Removing the Pump Tubing Organizer

9. Drain the Return Bag.

a. Raise and invert the Return Bag to allow the contents to drain into the Treatment Bag. All blood should now be in the Treatment Bag.

b. Clamp both lines of the Treatment Bag.

Figure 117: Draining the Return Bag

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10. Prepare the Treatment Bag for reinfusion to the patient.

a. Remove the remaining portion of the procedural kit from the instrument.

b. Spike the blood transfusion filter to the Treatment Bag and prime the filter.

!CAUTION:

Do not manually return any blood products without proper filtration. Refer to your institution’s guidelines for blood transfusions.

11. Manually return blood from Treatment Bag to patient.

a. Hang the Treatment Bag on an IV pole.

b. Connect the filtered blood administration line to the patient’s access.

c. Return blood through the filter to the patient using center specific guidelines for rate and method of reinfusion.

d. Discard the procedural kit using biohazard precautions when Manual Return is complete.

e. Record all treatment data from the instrument and turn the power OFF.

✎NOTE:

• Power must be cycled OFF and ON before beginning a new treatment.

• Data will be erased when the power is turned OFF.

• Contact Therakos if instrument service is required.

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Introduction 6-1


SECTION 6: CORRECTING ALARMS

Introduction

Whenever an alarm condition occurs, the THERAKOS™ CELLEX™ Photopheresis System sounds an audible alarm and displays a message on the screen. The probable cause of the alarm and recommended action are displayed on the operator interface screen.

✎NOTE:

• The power failure alarm will not display a message. Only an audible alarm is sounded.

• The 9-volt battery is responsible for the alarm whenever there is a power failure.

• General guidelines suggest that blood removed from the body should not be extracorporeal for longer than four hours. Use clinical judgment to determine the length of delay each patient may be able to tolerate.

• Airflow is not monitored during a power outage. Verify that the door to the Photoactivation Chamber is open and the Photoactivation Module is halfway out to prevent the product from overheating.

• In the event that power is not restored, the patient’s blood may be manually reinfused as described in Section 5: Manual Blood Return With Power OFF and / or No Access to Release Kit Button.

Alarm: Power Failure During Treatment

In the event of a power failure:

1. Turn the power switch to the OFF position to silence the alarm.

2. Check the power cord at the wall outlet and at the back of the instrument. If re-securing the power cord resolves the power failure, turn the power ON. Press START to resume the treatment. The instrument will begin re-purging the Centrifuge Bowl. See WARNING below.

3. If the power failure is not related to the power cord, open the Photoactivation Chamber Door and pull the Photoactivation Module out halfway.

4. When the power is restored, the treatment may be continued.

5. Reinstall the Photoactivation Module.


7. Turn the power switch to the ON position. The instrument will re-boot and return to the step that was interrupted when power was lost. If the power loss occurred during COLLECT, before resuming the treatment the instrument will re-purge the Centrifuge Bowl (see WARNING below) and re-separate the plasma / red blood cell interface.

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Section 6: CORRECTING ALARMS

Rev. 4.0-1460451

!WARNING:


System Error Messages

System Error Messages are not generally operator correctable alarms. If a System Error Message appears:

1. Note the error code number.

2. Turn OFF the power.

3. Turn the power back ON.

4. Call Therakos at one of the phone numbers listed on the back page of this manual if the alarm continues.

5. If the alarm clears, complete the treatment. Call Therakos at one of the phone numbers listed on the back page of this manual to report the system error number.

Correcting Alarms—Process Overview

The following steps outline the general procedure for correcting an alarm. Instructions for correcting specific alarms are provided later in the chapter.

1. Press MUTE to silence the alarm for a maximum of 60 seconds.

2. Resolve the problem according to the instructions posted on the screen and this section of the Operator’s Manual.

3. Press RESET.

4. Press START to continue the treatment.

Figure 118: Example Alarm text Screens

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Alarm Messages 6-3


✎NOTE:

Be sure to read the screen and resolve the alarm before pressing RESET. Pressing the RESET button will clear the alarm text message from the operator interface.

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Rev. 4.0-1460451

Alarm Messages

The following section lists alarms, popup messages, and alerts, along with the recommended actions.

Alarm #1: Air Detected! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6Alarm #2: Temperature! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7Alarm #3: Light Assembly Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8Alarm #4: Centrifuge Chamber Door! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-9Alarm #5: Lamp Life Expired! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-10Alarm #6: Smart Card Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11Alarm #7: Blood Leak? (Centrifuge Chamber) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-12Alarm #8: Blood Leak? (Photoactivation Chamber) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13Alarm #9: Blood Pump Error! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-14Alarm #10: Buffy Volume Exceeded! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-15Alarm #11: Fluid Routing Valve Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-16Alarm #12: Kit Used!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-17Alarm #13: Photoactivation Chamber Door! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-18Alarm #14: A/C VOLUME THRESHOLD Limit!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-19Alarm #15: SALINE VOLUME THRESHOLD Limit! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-20Alarm #16: Collect Pressure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-21Alarm #17: Return Pressure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-22Alarm #18: System Pressure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-23Alarm #19: FLUID BALANCE Limit! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-24Alarm #20: Low Airflow! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-25Alarm #21: Air Detector Test Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-26Alarm #22: Collect Pressure Test Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-27Alarm #23: Return Pressure Test Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-28Alarm #24: System Pressure Test Failure! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-29Alarm #25: PRIME 1!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-30Alarm #26: PRIME 2!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-31Alarm #27: PRIME 3!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-32Alarm #28: PRIME 4!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-33Alarm #29: PRIME 5!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-34Alarm #30: PRIME 6!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-35Alarm #31: PRIME 7!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-36Alarm #32: PRIME 8!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-37Alarm #33: PAUSE Timeout! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-38Alarm #34: Return Bag Air Detector!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-39Alarm #35: Treatment Bag Air Detector! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-40Alarm #36: The Return Bag is Not Empty! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-41Alarm #37: The Treatment Bag is Not Empty! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-42Alarm #39: The Treatment Bag is Empty! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-43Alarm #40: Is the Anticoagulant Bag Empty?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-44Alarm #41: Is the Saline Bag Empty? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-45Alarm #42: PRIME 9!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-46Alarm #43: PRIME 10!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-47Alarm #44: PRIME 11!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-48Alarm #45: Red Blood Cell Pump Alarm! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-49Alarm #46: Accelerometer System Alarm! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-51

ISSU

ED


Alarm Messages 6-5


Alarm #47: Drive Tube Alarm! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-52Alarm #48: Treatment Bag - Air Detected!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-53Alarm #49: Return Bag - Air Detected! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-54Alarm #50: PRIME 12!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-55Popup Messages and Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-56

ISSU

ED


6-6



Rev. 4.0-1460451

Alarm #1: Air Detected!

CAUSE:

Air has been detected in the patient Collect, Return, or Anticoagulant Line.

CORRECTIVE ACTION:

1. Press MUTE to silence the alarm.

2. Remove air from the patient Collect, Return, or Anticoagulant Line.

3. Check the connections to determine the possible source of air.

4. Press RESET.


6. If the alarm continues, contact Therakos for further assistance.

✎NOTE:

• A small aliquot of air at the onset of COLLECT will be purged out of the Centrifuge Bowl as it is initially filled.

• If access problems occur during COLLECT, avoid allowing air to enter the Centrifuge Bowl if it is already full and spinning at full speed.

• First disconnect your patient and then use a Saline Bolus to flush any air detected in the patient Return Line. Do not continue Returning until the source of the air has been documented and removed.

ISSU

ED


Alarm Messages 6-7


Alarm #2: Temperature!

CAUSE:

The Photoactivation Chamber’s air temperature is greater than 43 °C (109.4 °F).

CORRECTIVE ACTION:

1. Press MUTE to silence the alarm. (The alarm cannot be reset.)

2. Turn the instrument’s power OFF, wait 5 seconds, and then turn the power back ON.

3. Inspect the blood in the Treatment Bag and Photoactivation Module for hemolysis and determine its acceptability for reinfusion or further therapy.

4. Refer to Section 5 in the Operator’s Manual for instructions to interrupt the treatment.



✎NOTE:

If the alarm does not clear and you are unable to select END TX or ABORT and unable to activate the RELEASE KIT button, refer to Section 5: Manual Return (With Power OFF and No Access to RELEASE KIT Button) for instructions on how to manually return blood to the patient. Confirm that the blood is acceptable for reinfusion before you proceed.

ISSU

ED


6-8



Rev. 4.0-1460451

Alarm #3: Light Assembly Failure!

CAUSE:

A Photoactivation Light Assembly failure has been detected.

CORRECTIVE ACTION:

1. Press MUTE to silence the alarm. Read all instructions before proceeding.

2. Turn the instrument power OFF. Unplug the power cord.

3. Remove and reinstall the light assembly to re-seat the lamp connector. Refer to Section 7 in the Operator’s Manual for the light assembly removal / replacement procedure.

4. Plug in the power cord. Turn the instrument power back ON.


6. If the alarm continues, install a new light assembly. Then, contact Therakos for further assistance.

!WARNING:


• The calculated dose of UVA light energy will not be delivered if PHOTOACTIVATE is stopped for any reason before the photoactivation MINUTES REMAINING is equal to 00.00 minutes.

!CAUTION:


• Turn the power OFF and unplug the instrument prior to changing the Light Assembly.

• Never change the THERAKOS™ CELLEX™ Light Assembly during a treatment if the photoactivation MINUTES REMAINING has already been calculated.


ISSU

ED


Alarm Messages 6-9


Alarm #4: Centrifuge Chamber Door!

CAUSE:

• The Centrifuge Chamber Door is open.

• The Centrifuge Chamber Door Manual Release is not in the correct position.

CORRECTIVE ACTION:


2. Close the Centrifuge Chamber Door and / or confirm correct position.

3. Press RESET.

4. Press START to continue.


ISSU

ED


6-10



Rev. 4.0-1460451

Alarm #5: Lamp Life Expired!

CAUSE:

The Photoactivation Light Assembly lamp life expired.

CORRECTIVE ACTION:

1. Turn the instrument power OFF. Unplug the power cord.

2. Replace the Photoactivation Light Assembly. Refer to Section 7 in the Operator’s Manual for the light assembly removal / replacement procedure.

3. Plug in the power cord. Turn the instrument power back ON.


!WARNING:



!CAUTION:


• Turn the power OFF and unplug the instrument prior to changing the Light Assembly.



ISSU

ED


Alarm Messages 6-11


Alarm #6: Smart Card Failure!

CAUSE:

The Smart Card is not installed or is installed incorrectly.

CORRECTIVE ACTION:


2. Remove the Smart Card.

3. Hold the Smart Card so that the gold connector faces away from you and insert it into the Smart Card Holder.

4. Press RESET.



ISSU

ED


6-12



Rev. 4.0-1460451

Alarm #7: Blood Leak? (Centrifuge Chamber)

CAUSE:

The Centrifuge Fluid Leak Detector has detected a fluid leak.

CORRECTIVE ACTION:


2. If a leak is confirmed, ABORT TREATMENT. Due to possible contamination, blood product in the Procedural Kit should not be returned to the patient.

3. Contact Therakos for further assistance.

✎NOTE:

• A leak in the Centrifuge Bowl should be detected during PRIME. Pressing the Abort Treatment option will allow you to dislodge the THERAKOS™ CELLEX™ Photopheresis Procedural Kit and clear the memory so that a new treatment may be started. Note the lot number of the defective THERAKOS™ CELLEX™ Photopheresis Procedural Kit. Save the defective procedural kit. Call Therakos to report the problem. A Return Goods Authorization Number will be issued. Use this number to track the credit for the defective THERAKOS™ CELLEX™ Photopheresis Procedural Kit and to identify the product that is returned to Therakos for evaluation.

• A false positive alarm may be caused by failure to routinely clean the inside of the Centrifuge Chamber to remove bearing grease. Refer to Section 7: MAINTAINING THE THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM for more information.

ISSU

ED


Alarm Messages 6-13


Alarm #8: Blood Leak? (Photoactivation Chamber)

CAUSE:

The Photoactivation Chamber Fluid Leak Detector has detected a fluid leak.

CORRECTIVE ACTION:


2. If a leak is confirmed, ABORT TREATMENT. Due to possible contamination, blood product in the Procedural Kit should not be returned to the patient.


✎NOTE:

A leak in the Photoactivation Module should be detected during PRIME. Pressing the Abort Treatment option will allow you to dislodge the THERAKOS™ CELLEX™ Photopheresis Procedural Kit and clear the memory so that a new treatment may be started. Note the lot number of the defective THERAKOS™ CELLEX™ Photopheresis Procedural Kit. Save the defective procedural kit. Call Therakos to report the problem. A Return Goods Authorization Number will be issued. Use this number to track the credit for the defective THERAKOS™ CELLEX™ Photopheresis Procedural Kit and to identify any product that is returned to Therakos for evaluation.

ISSU

ED


6-14



Rev. 4.0-1460451

Alarm #9: Blood Pump Error!

CAUSE:

• The blood pump is rotating too slowly or the pump head is jammed.

• The blood pump is rotating too fast.

• The blood pump sensor has detected multiple pump rotations while the pump is OFF.

CORRECTIVE ACTION:


2. Remove the obstruction from the pump head or stop the manual movement of the pump.

3. Inspect pump tubing segment for possible damage.

4. Press RESET.



ISSU

ED


Alarm Messages 6-15


Alarm #10: Buffy Volume Exceeded!

CAUSE:

• The Hematocrit Sensor Cuvette is not installed.

• The Buffy Coat volume in this cycle has exceeded the volume limit.

NOTE: The initial volume limit is set at 180mL. When this alarm is reset, the alarm limit is adjusted upwards by 25mL to a maximum of 280mL per collection cycle.

CORRECTIVE ACTION:


2. Verify that the Hematocrit Sensor Cuvette is fully seated into its housing.

3. Press RESET.

4. Press START to continue the treatment. Additional Buffy Coat will be collected.

NOTE: The initial volume limit is set at 180mL. When this alarm is reset, the alarm limit is adjusted upwards by 25mL to a maximum of 280mL per collection cycle.


✎NOTE:

The Buffy Coat Volume per Cycle is displayed on the Operator Interface Text Screen 2 (See Figure 11c: Text Screen 2: Buffy Coat Summary on page 3-7). This volume pertains to the amount of plasma, leukocytes, and erythrocytes collected from the patient each time the BUFFY COAT phase of the treatment is performed. The Buffy Coat Volume per Cycle does not include the 80mL of prime solution that is in the Photoactivation Module when PRIME is complete. Therefore, the displayed Treatment Volume will be approximately 260mL (180 + 80) when the first alarm is generated.IS

SUED


6-16



Rev. 4.0-1460451

Alarm #11: Fluid Routing Valve Failure!

CAUSE:

The Fluid Routing Valves beneath the Pump Tubing Organizer are not in the correct position.

CORRECTIVE ACTION:


2. Verify that the Pump Tubing Organizer is properly loaded.

3. Press RESET.



ISSU

ED


Alarm Messages 6-17


Alarm #12: Kit Used!

CAUSE:

The Procedural Kit or Smart Card has been already used.

CORRECTIVE ACTION:


2. Remove the used Procedural Kit and / or Smart Card.

3. Install a new Procedural Kit and / or Smart Card.

4. Press RESET.


✎NOTE:

• Check to see that the Smart Card from the previous treatment has been removed.

• Each new THERAKOS™ CELLEX™ Photopheresis Procedural Kit has a Smart Card attached to the Pump Tubing Organizer.

ISSU

ED


6-18



Rev. 4.0-1460451

Alarm #13: Photoactivation Chamber Door!

CAUSE:

The Photoactivation Chamber Door is open.

CORRECTIVE ACTION:



3. Press RESET.



ISSU

ED


Alarm Messages 6-19


Alarm #14: A/C VOLUME THRESHOLD Limit!

CAUSE:

The Anticoagulant (A/C) Volume has reached its default or preset Volume Threshold limit.

CORRECTIVE ACTION:


2. Exercise clinical judgment to verify that the patient can tolerate further anticipated delivery of anticoagulant if treatment continues.

3. If the patient can tolerate additional anticoagulant, enter the SETUP screen to increase the A/C VOLUME THRESHOLD limit.

4. Press RESET.


6. If the patient is unable to tolerate additional anticoagulant, enter the SETUP screen and lower the Whole Blood Processed Target to allow for earlier photoactivation of the product already processed.

7. Press RESET.



✎NOTE:

• Approximately 10 additional milliliters of anticoagulant solution will be delivered during BUFFY COAT and PHOTOACTIVATE. Therefore, the A/C Alarm Limit must be raised 50mL to complete the treatment.

• Check the volume of the Anticoagulant Bag. Replenish if necessary.

ISSU

ED


6-20



Rev. 4.0-1460451

Alarm #15: SALINE VOLUME THRESHOLD Limit!

CAUSE:

The Saline Volume has reached its default or preset Volume Threshold limit.

CORRECTIVE ACTION:


2. Use clinical judgment to determine if the patient can tolerate the additional fluids delivered if the treatment continues.

3. Enter the SETUP screen to increase the Saline Volume Threshold limit.

4. To minimize additional fluids given, lower the Whole Blood Processed Target to allow you to immediately proceed to BUFFY COAT collection and photoactivation.

5. Press RESET.



✎NOTE:

• The default Saline Delivery Limit is 450mL.

• If the default limit was reached, add a new bag of saline before proceeding.

• Do not allow the Saline Bag to empty completely. It may be difficult to re-prime the line, and the treatment may be interrupted unnecessarily.

ISSU

ED


Alarm Messages 6-21


Alarm #16: Collect Pressure!

CAUSE:

The Collect Line pressure has exceeded the preset limit.

CORRECTIVE ACTION:


2. DO NOT remove the Collect Line Pressure Dome.

3. Check the Collect Line for occlusions, pinch points, or closed clamps.

4. Verify that the patient’s venous access line is acceptable for the flow rate selected.

5. Select a slower Collection Rate Limit if required.

6. Press RESET.



✎NOTE:

• The default COLLECT Rate Limit is 100mL/min. The instrument will automatically collect at a Flow rate of 50mL/min if access allows. You may raise or lower the actual flow rate within the range of the limit from the main display screen any time collection is in progress.

• To lower the COLLECT Rate Limit range, enter the SETUP screen.

• To maintain isovolemic conditions in Double Needle Mode, lower the RETURN Flow Rate to match the adjusted COLLECT Flow Rate.IS

SUED


6-22



Rev. 4.0-1460451

Alarm #17: Return Pressure!

CAUSE:

The Return Line pressure exceeded the preset limit.

CORRECTIVE ACTION:


2. DO NOT remove the Return Line Pressure Dome.

3. Check the Return Line for occlusions, pinch points, or closed clamps.

4. Verify that the patient RETURN access is acceptable for the flow rate selected.

5. Select a slower RETURN Flow Rate Limit, if required.

6. Press RESET.



✎NOTE:

If the Return Pressure Alarm occurs during DRAWING (Single Needle Mode), enter SETUP and adjust the Lower Return Pressure Limit to -100mmHg.

ISSU

ED


Alarm Messages 6-23


Alarm #18: System Pressure!

CAUSE:

• The system pressure has exceeded the preset limit.

• Allowing air to get into the spinning Centrifuge Bowl may form an air trap.

CORRECTIVE ACTION:


2. DO NOT remove the System Pressure Dome.

3. Refer to Technical Bulletin CLX #05 for corrective action.


✎NOTE:

The Centrifuge Bowl will need to be re-purged, causing displacement of leukocytes already in the Centrifuge Bowl. To compensate, the Whole Blood Processed Target may be increased (via the SETUP screen) prior to pressing START to resume COLLECT.

!WARNING:

Re-purging the Centrifuge Bowl with whole blood will result in a higher extracorporeal blood volume than anticipated. Refer to Section 10: Fluid Balance Management for additional information before resuming the treatment.

ISSU

ED


6-24



Rev. 4.0-1460451

Alarm #19: FLUID BALANCE Limit!

CAUSE:

The FLUID BALANCE has exceeded the preset or default limits.

CORRECTIVE ACTION:


2. Verify that the patient can tolerate further anticipated shifts in fluid balance during the remainder of the treatment.

3. Exercise clinical judgment and deliver a saline bolus if the patient needs additional fluids.

4. Continue to monitor the patient closely.

5. If required, enter SETUP and adjust the fluid balance limits.

6. Press RESET.



✎NOTE:

• FLUID BALANCE is the tool that allows the operator to track the fluid shifts in and out of the patient during a treatment. When the fluid balance is negative the patient has fluid deficit approximating the amount displayed on the screen. A positive fluid balance indicates that the patient has received additional fluids such as anticoagulant and / or saline. Generally, most patients will be approximately 450mL fluid positive at the end of a treatment that has processed 1500mL of whole blood.

• The default Fluid Balance Alarm Limits are set at –500mL and +500mL.

• It is recommended that positive or negative fluid shifts do not exceed 15% of the patient’s Total Blood Volume. Please refer to Section 10: Fluid Balance Management and Section 5: Calculating and Setting Fluid Balance Limits to determine and set the proper range limits for each patient.

ISSU

ED


Alarm Messages 6-25


Alarm #20: Low Airflow!

CAUSE:

The system has detected low airflow in the Photoactivation Chamber.

CORRECTIVE ACTION:


2. Remove any obstructions from the rear of the instrument that would impede air exhaust.

3. Press RESET.



ISSU

ED


6-26



Rev. 4.0-1460451

Alarm #21: Air Detector Test Failure!

CAUSE:

Air was not detected in the air detector lines at the beginning of a new treatment.

CORRECTIVE ACTION:


2. Verify that the new kit is installed.

3. Press RESET.

4. Press START to resume PRIME.


✎NOTE:

• The Air Detectors are tested each time the instrument is powered ON.

• At the start of a new treatment the instrument expects to see air (no fluid in the lines).

• If the power is turned OFF and ON during a treatment, the instrument expects to see no air (fluid in the lines).

ISSU

ED


Alarm Messages 6-27


Alarm #22: Collect Pressure Test Failure!

CAUSE:

• The Collect Line Pressure Dome is not installed properly.

• The operator resumed PRIME without following the complete instructions.

• There was a Collect Pressure Sensor calibration failure.

CORRECTIVE ACTION:


2. Unload all Pump Tubing Segments from the Pumps.

3. Check the position of the Collect Line Pressure Dome.

4. Reload all Pump Tubing Segments.

5. Press RESET.



ISSU

ED


6-28



Rev. 4.0-1460451

Alarm #23: Return Pressure Test Failure!

CAUSE:

• The Return Line Pressure Dome is not installed properly.


• A Pressure Sensor Calibration failure occurred.

CORRECTIVE ACTION:



3. Check the position of the Return Line Pressure Dome.


5. Press RESET.



ISSU

ED


Alarm Messages 6-29


Alarm #24: System Pressure Test Failure!

CAUSE:


• A Pressure Sensor Calibration failure occurred.

CORRECTIVE ACTION:



3. Check the position of the System Pressure Dome.


5. Press RESET.



ISSU

ED


6-30



Rev. 4.0-1460451

Alarm #25: PRIME 1!

CAUSE:

• The Collect Line Clamp was not closed properly.

• The Return Pressure Dome is not installed properly.

• The Return Line was not connected to the Collect Line at the needle-free injection port.

• The Pump Tubing Segment is not installed properly.

• The Return Line Clamp was not open during PRIME.

CORRECTIVE ACTION:



3. Check the position of the Return Pressure Dome.

4. Connect the Return Line to the Collect Line at the needle-free injection port.

5. Close the Collect Line Clamp.

6. Open the Return Line Clamp.


8. Verify that all lines are free of kinks and obstructions.

9. Press RESET.



ISSU

ED


Alarm Messages 6-31


Alarm #26: PRIME 2!

CAUSE:

• The Return Line Clamp was not open during PRIME.

• The Collect Line Pressure Dome is not installed properly.

• The Return Line was not connected to the Collect Line at the needle-free injection port.


CORRECTIVE ACTION:



3. Check the position of the Collect Line Pressure Dome.






9. Press RESET.


11. If the alarm continues, contact Therakos for further assistance.ISSU

ED


6-32



Rev. 4.0-1460451

Alarm #27: PRIME 3!

CAUSE:

• The Saline Line is not connected or is obstructed.

• The Anticoagulant Line is not connected or is obstructed.

• The Return Line is not properly installed into the Air Detector.

• The Anticoagulant Line is not properly installed into the Air Detector.

• The Centrifuge Bowl Lines are obstructed or are pinched in the door.

• The System Pressure Dome is not installed properly.


CORRECTIVE ACTION:









9. Press RESET.



ISSU

ED


Alarm Messages 6-33


Alarm #28: PRIME 4!

CAUSE:

• The System Pressure Dome is not installed properly.


CORRECTIVE ACTION:









9. Press RESET.



ISSU

ED


6-34



Rev. 4.0-1460451

Alarm #29: PRIME 5!

CAUSE:


• The Return Bag Line is obstructed.

CORRECTIVE ACTION:








8. Press RESET.



ISSU

ED


Alarm Messages 6-35


Alarm #30: PRIME 6!

CAUSE:


• The Treatment Bag Line is obstructed.

CORRECTIVE ACTION:








8. Press RESET.



ISSU

ED


6-36



Rev. 4.0-1460451

Alarm #31: PRIME 7!

CAUSE:

• The Bowl Optic Lens needs to be cleaned.

• The Centrifuge Bowl is not installed properly.

• The Hematocrit Sensor optical path is obstructed or needs to be cleaned.

CORRECTIVE ACTION:







7. Clean the Bowl Optic Lens.

8. Verify that the Centrifuge Bowl is installed properly.

9. Clean the Hematocrit Sensor optical path. Re-seat the Hematocrit Cuvette.


11. Press RESET.


13. If the alarm continues, contact Therakos for further assistance.ISSU

ED


Alarm Messages 6-37


Alarm #32: PRIME 8!

CAUSE:

The Collect Line is not installed properly into the Air Detector.

CORRECTIVE ACTION:


2. Reinstall the Collect Line into the Air Detector.

3. Press RESET.



ISSU

ED


6-38



Rev. 4.0-1460451

Alarm #33: PAUSE Timeout!

CAUSE:

The system PAUSED with the Centrifuge spinning for longer than 10 minutes.

CORRECTIVE ACTION:


2. Press RESET.


4. The system will re-prime the Centrifuge Bowl and then re-establish separation of the plasma / red blood cell interface before resuming operation.


✎NOTE:

• The Centrifuge Bowl will need to be re-purged causing displacement of leukocytes already in the Centrifuge Bowl. To compensate, the Whole Blood Processed Volume may be increased (via the SETUP screen) prior to pressing START to resume COLLECT.

• In the future, to avoid losing Buffy Coat as a result of re-purging the Centrifuge Bowl, please refer to Section 5: PAUSED (Single Needle Mode) and STOPPED (Single Needle Mode) or Section 5: PAUSED (Double Needle Mode) and STOPPED (Double Needle Mode).

!WARNING:


ISSU

ED


Alarm Messages 6-39


Alarm #34: Return Bag Air Detector!

CAUSE:

The system detected an invalid Return Bag Air Detector condition.

CORRECTIVE ACTION:


2. Remove and reinstall the Return Bag Line into the Air Detector.

3. Press RESET.



ISSU

ED


6-40



Rev. 4.0-1460451

Alarm #35: Treatment Bag Air Detector!

CAUSE:

The system detected an invalid Treatment Bag Air Detector condition.

CORRECTIVE ACTION:


2. Remove and reinstall the Treatment Bag Line into the Air Detector.

3. Press RESET.



ISSU

ED


Alarm Messages 6-41


Alarm #36: The Return Bag is Not Empty!

CAUSE:

• The Return Bag Air Detector is detecting fluid when the bag should be empty.

• The Return Bag is not empty.

• The Return Bag Air Detector had a failure.

CORRECTIVE ACTION:


2. Remove and reinstall the Return Bag Line into the Air Detector.

3. Press RESET.



ISSU

ED


6-42



Rev. 4.0-1460451

Alarm #37: The Treatment Bag is Not Empty!

CAUSE:

• The Treatment Bag Air Detector is detecting fluid when the Treatment Bag should be empty.

• The Treatment Bag is not empty.

• There was a Treatment Bag Air Detector failure.

CORRECTIVE ACTION:



3. Press RESET.


ISSU

ED


Alarm Messages 6-43


Alarm #39: The Treatment Bag is Empty!

CAUSE:

• The Treatment Bag Air Detector is detecting air when the Treatment Bag should have fluid in it.

• The Treatment Bag is empty.

• There was a Treatment Bag Air Detector failure.

• A Sample was removed from the bag.

CORRECTIVE ACTION:



3. Press RESET.



✎NOTE:

If a sample of more than 5mL is removed from the Treatment Bag, the sample volume must be replaced with sterile saline to avoid creating this alarm.

ISSU

ED


6-44



Rev. 4.0-1460451

Alarm #40: Is the Anticoagulant Bag Empty?

CAUSE:

• Anticoagulant delivery has not been detected during PRIME.

• Prior to starting PRIME, the anticoagulant drip chamber was not primed.

• The Anticoagulant Line is not installed properly into the Air Detector.

CORRECTIVE ACTION:


2. Verify that the anticoagulant is properly connected to the anticoagulant spike port.

3. Reinstall the Anticoagulant Line into the Air Detector.

4. Press RESET.



ISSU

ED


Alarm Messages 6-45


Alarm #41: Is the Saline Bag Empty?

CAUSE:

• The Saline delivery has not been detected during PRIME.

• Prior to starting PRIME, the saline drip chamber was not primed.

• The Saline Line is not installed properly into the Air Detector.

CORRECTIVE ACTION:


2. Verify that the saline is properly connected to the saline spike port.

3. Reinstall the Saline Line into the Air Detector.

4. Press RESET.



ISSU

ED


6-46



Rev. 4.0-1460451

Alarm #42: PRIME 9!

CAUSE:

• The Treatment Bag is not installed properly.

• The Treatment Bag Load Cell Sensor Calibration failed.

• Load Cell Sensor failure.

• The Treatment Bag is hung on the wrong side.

CORRECTIVE ACTION:


2. Reinstall the Treatment Bag.

3. Press RESET.



ISSU

ED


Alarm Messages 6-47


Alarm #43: PRIME 10!

CAUSE:

• The Return Bag is not installed properly.

• The Return Bag Load Cell Sensor Calibration failed.

• Load Cell Sensor failure.

CORRECTIVE ACTION:


2. Reinstall the Return Bag.

3. Press RESET.



ISSU

ED


6-48



Rev. 4.0-1460451


CAUSE:

• An occlusion in the Photoactivation Module, Treatment Bag, or tubing.

• Leakage in the Photoactivation Module, Treatment Bag, or tubing.

CORRECTIVE ACTION:


2. Check the Photoactivation Module, tubing, and bags to determine the possible source of occlusion or leakage.

3. Press RESET.



✎NOTE:

All THERAKOS™ CELLEX™ Photopheresis Procedural Kits are leak tested prior to sterilization. If a leak is detected during PRIME, do not attempt to re-prime the procedural kit. Note the lot number and expiration date of the procedural kit and contact Therakos using the phone numbers on the last page of this manual to report the damaged procedural kit. A Return Goods Authorization Number will be issued if the procedural kit is to be returned to Therakos and to assign a credit for the unused procedural kit.

ISSU

ED


Alarm Messages 6-49


Alarm #45: Red Blood Cell Pump Alarm!

CAUSE:

• The Red Blood Cell Pump is not modulating correctly due to abnormal plasma conditions. The plasma / red blood cell interface is too low in the Centrifuge Bowl.

CORRECTIVE ACTION:


2. Check the Centrifuge Bowl to determine the position of the plasma / red blood cell interface.

If the interface is too low:

a. Press SETUP.

b. Lower (decrease) the Bowl Optic Threshold Value by 10.

c. Press SAVE.

d. Press START.

e. Check the position of the plasma / red blood cell interface.

If necessary, repeat steps a through e.

f. If the alarm continues, contact Therakos for further assistance.

If the interface is too high:

a. Press RESET.

b. Press START.

c. Decrease the Collect Flow Rate to 25mL/min or less.ISSU

ED


6-50



Rev. 4.0-1460451

If the alarm continues, choose one of the following options:

• Proceed directly to BUFFY COAT:

a. Press SETUP.

b. Decrease the WHOLE BLOOD PROCESSED TARGET volume as much as possible.

c. Press SAVE.

d. Press START to proceed to BUFFY COAT.

• Process additional whole blood:

a. Press RESET.

b. Press PAUSE to allow Centrifuge Bowl pressure to stabilize.

c. Press STOP.

d. Press START.

e. Decrease the Collect Flow Rate to 25mL/min or less.

f. If the alarm continues, contact Therakos for further assistance.

ISSU

ED


Alarm Messages 6-51


Alarm #46: Accelerometer System Alarm!

CAUSE:

There is too much vibration in / on the Centrifuge Chamber.

CORRECTIVE ACTION:



3. If there is a leak, ABORT the treatment.

4. If there is no leak, check and verify that the Centrifuge Bowl and the Drive Tube are intact / undamaged.

5. Properly reinstall the Centrifuge Bowl and the Drive Tube.


7. Press RESET.



✎NOTE:

The Centrifuge Bowl will need to be re-purged causing displacement of leukocytes already in the Centrifuge Bowl. To compensate, the Whole Blood Processed Target may be increased (via the SETUP screen) prior to pressing START to resume COLLECT.

!WARNING:


ISSU

ED


6-52



Rev. 4.0-1460451

Alarm #47: Drive Tube Alarm!

CAUSE:

• The Drive Tube is not installed correctly into the Drive Tube Clamp.

• The Drive Tube Latch is not closed properly.

CORRECTIVE ACTION:



3. Reinstall the Centrifuge Bowl and the Drive Tube. Close the Drive Tube Latch.


5. Press RESET.



✎NOTE:

Refer to Section 4: Loading the THERAKOS™ CELLEX™ Photopheresis Procedural Kit for complete instructions on installing the Centrifuge Bowl.

ISSU

ED


Alarm Messages 6-53


Alarm #48: Treatment Bag - Air Detected!

CAUSE:

Air has been detected in the Treatment Bag Line.

CORRECTIVE ACTION:


2. Reinstall the Treatment Bag Line into the Air Detector.

3. Press RESET.

4. Press START.

5. If the alarm continues, contact Therakos for assistance.

ISSU

ED


6-54



Rev. 4.0-1460451

Alarm #49: Return Bag - Air Detected!

CAUSE:

Air has been detected in the Return Bag Line.

CORRECTIVE ACTION:


2. Reinstall the Return Bag Line into the Air Detector.

3. Press RESET.


5. If the alarm continues, contact Therakos for assistance.

ISSU

ED


Alarm Messages 6-55



CAUSE:

The Return Line is not installed properly in the Air Detector.

CORRECTIVE ACTION:


2. Reinstall the Return Line into the Air Detector.

3. Press RESET.


5. If the alarm continues, contact Therakos for assistance.IS

SUED


6-56



Rev. 4.0-1460451

Popup Messages and Alerts

Warning!9-Volt battery is low

CLOSE

The 9-Volt battery voltage is below an acceptable value and should be replaced. Operator must acknowledge message by pressing CLOSE button.

Information! New Treatment SETUP Entered

The system has stored the new treatment settings.

Information! New Date & Time Entered

The system has stored the new date and time settings.

Information! Water Treatment

The smart card inserted has been coded as a training card. This procedure should be reserved only for training!

Warning! Lamp Output Reduced

CLOSE

The system has detected a failure of some of the UVA lamps during the treatment. At least 2/3 of the lamps must work or a Lamp Failure Alarm will be generated. This message indicates that the energy delivered to the cells may be reduced by up to 1/3. The Lamps should be replaced prior to the next treatment. Operator must acknowledge message by pressing CLOSE button.

Warning! Please Set Clock

CLOSE

This message indicates that the current clock setting is invalid and should be reset. Operator must acknowledge message by pressing CLOSE button.

Warning! Lamp Life Low

CLOSE

The Lamp Life Remaining is below 10 hours. Please reorder a new lamp and install it as soon as possible. Operator must acknowledge message by pressing CLOSE button.

Do you wish to end this treatment and install a new kit?

YES NO

Allows the user to initiate a new treatment regardless of whether the last treatment was completed. If the user selects “YES” a confirmation message will appear. Confirming this message will terminate the existing treatment process and initiate a new treatment at the READY TO PRIME screen. This message will only be displayed for 5 seconds upon power up.

Warning! Smart Card is Full

CLOSE

The smart card event log is full. This message indicates that event logging is no longer possible.

CANCEL

Do you want to Save the Changes you Made?

YES NO

User has selected cancel after making changes while in setup mode. This message asks to confirm the loss of these changes.

Information! Single Needle Configuration

User has selected 1-needle configuration.

Information! Double Needle Configuration

User has selected 2-needle configuration.

ISSU

ED


Popup Messages And Alerts 6-57


CONFIRM Are you sure?

YES NO

This message is displayed whenever a button confirmation from the user is required.

Warning! SETUP Lost

This message indicates that the new setup limits are not registered and saved.

CONFIRM

ABORT TREATMENT

Without Blood Return

To Patient

ABORT CANCEL

Confirm message for ABORT button. Pressing the ABORT button will end the treatment without returning the patient’s blood. Press CANCEL to return to the previous screen.

CONFIRM

END TREATMENT

And Return Blood

To Patient

END TX CANCEL

Confirm message for End TX button. Pressing “END TX” will end the treatment and return the patient’s blood. Press “CANCEL” to return to previous screen.

Information!

Watchdog Time-out!

This message indicates that there is no communication between the display and the main controller.

Information!

Inject X.Xml of Methoxsalen

(20 micrograms / mL)

into Treatment Bag

CLOSE

This message displays the calculated dose of Methoxsalen (20 micrograms / mL). The operator must select CLOSE to continue.

TEMPERATURE ICON: Ambient air is used to cool the Photoactivation Chamber during PHOTOACTIVATE. Ensure that the room temperature does not exceed 30° C (86° F) during the treatment. “Alarm: TEMPERATURE” occurs when the temperature sensor in the Photoactivation Chamber reaches 43° C (109.4° F). Before reaching alarm conditions, a flashing temperature icon will appear in the title line of the Operator Interface. In addition, an intermittent audio beep will sound. The appearance of the temperature icon indicates that the Photoactivation Chamber temperature has increased to 39° C (102.2° F). When the temperature icon appears take measures to lower the room temperature to prevent reaching temperature alarm conditions during PHOTOACTIVATE.

ISSU

ED


6-58



Rev. 4.0-1460451

Information!

Open Centrifuge Chamber Door.

Check the Drive Tube Installation.

Inspect the kit for leaks.

CLOSE

This message indicates that the operator should inspect the drive tube installation before proceeding. The operator should confirm that the drive tube bearings are secure in the bearing clips and that the kit has no leaks.

ISSU

ED


7-1


SECTION 7: MAINTAINING THE THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM

General maintenance procedures described below are to be performed only by fully trained personnel. Contact Therakos once a year to schedule complete Preventative Maintenance servicing. Please refer to the last page of this manual for phone numbers.

!WARNING:

Electric Shock Hazard. Turn OFF and unplug the THERAKOS™ CELLEX™ Photopheresis System before servicing. Never perform maintenance on the THERAKOS™ CELLEX™ Photopheresis System during a treatment.

!CAUTION:

Do not allow cleaning solutions to come into contact with any of the automatic sensors. Gently clean all sensors with warm water only.

✎NOTE:

To retain valid warranty coverage Preventative Maintenance Service on the Hematocrit Sensor, Load Cells, Centrifuge Bowl Optic Sensor (Laser) and Power Supply must be performed only by Therakos trained personnel.

ISSU

ED


7-2


Section 7: MAINTAINING THE THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM

Rev. 4.0-1460451

Recommended Cleaning and Maintenance Schedule

Therakos recommends that you keep a schedule of maintenance and cleaning for your THERAKOS™ CELLEX™ Photopheresis System.

Procedure

After Each Use

As Needed

Weekly

Quarterly

Every 13 Months

Cleaning

System Exterior • •

Photoactivation Chamber Door •

Centrifuge Chamber Daily •

Air Detectors • •

Pressure Sensors • •

Hematocrit Sensor • •

Bowl Optic Lens • •

Leak Detector (Centrifuge) (with White Vinegar)

• •

Therakos Service •

Table 8: Cleaning and Maintenance Schedule

Cleaning

Supplies

The following supplies are needed for cleaning:

• Mild soap and water solution

• Warm water

• Lint-free cloths for cleaning and drying

• Cotton swabs

• Center approved biohazard wipes

• White vinegar

• 1:10 dilution of household bleach or a disinfectant wipe suitable for blood decontamination approved for use by your institution’s Infection Control Plan

ISSU

ED


Cleaning 7-3


✎NOTE:

Household bleach is a 5% solution of sodium hypochlorite such as Clorox™ or Eau de Javel. A 1:10 dilution equals 1 part bleach added to 9 parts water.

!CAUTION:

Do not allow cleaning solutions to come in contact with the air detectors.

Air Detectors

1. Gently wash the pathways of the detector with warm water and a moist cotton swab or a lint-free cloth.

2. Dry thoroughly.

3. Clean the outside of the detector with a mild soap and water solution. A 1:10 bleach solution or an approved disinfectant wipe may be used if necessary.

Bowl Optic Lens

!CAUTION:

For optimal performance, the Bowl Optic Sensor Lens must be clean and clear. A dirty or clouded lens on the Bowl Optic Sensor could interfere with its proper function.

1. Clean the Bowl Optic Lens and the Leak Detector in the Centrifuge Chamber with a lint-free cloth and water only. Do not use abrasive pads.

2. Dry with another lint-free cloth.

Centrifuge Leak Detector

1. As needed, or quarterly, dampen a non-abrasive towel with white vinegar and gently clean the Centrifuge Leak Detector.

2. Air dry before using.

ISSU

ED


7-4



Rev. 4.0-1460451

Centrifuge Chamber

!CAUTION:

Do not allow cleaning solutions to come in contact with the Bowl Optic Lens.

Daily, to prevent the build up of bearing grease that may lead to a false positive Alarm: Leak Detected (Centrifuge), clean the inside wall of the Centrifuge Chamber.

1. Turn the Power Switch ON. Open the Centrifuge Chamber Door.

2. Turn the Power Switch OFF and disconnect the power cord from the wall outlet.

3. Spray cleaning solution against the wall of the Centrifuge Chamber avoiding the Bowl Optic Lens. Or, use a center approved biohazard wipe. Wipe the inside chamber including the Leak Detector and viewing window. Use a clear water moisten non-abrasive towel to rinse the Leak Detector and viewing window. Allow Leak Detector to dry overnight.

4. Inspect the Bowl Optic Lens. If necessary, carefully wipe the Bowl Optic Lens.

External Instrument

Clean the THERAKOS™ CELLEX™ Photopheresis System after each treatment and as needed with warm soapy water and a clean damp cloth. A 1:10 bleach solution or an approved disinfectant wipe may be used to disinfect the instrument when needed.

!CAUTION:

The used THERAKOS™ CELLEX™ Photopheresis Procedural Kit and any spills that may occur should be considered biologically contaminated. In handling any spills, follow the policies and procedures of your institution’s infection Control Plan.

ISSU

ED


Cleaning A Fluid Spill In The Centrifuge Chamber 7-5


Hematocrit Sensor

!CAUTION:

Do not allow cleaning solutions to come in contact with the Hematocrit Sensor.

1. Gently wash the pathways of the sensor with warm water and a moist cotton swab or a lint-free cloth.

2. Dry thoroughly.

3. Clean the outside of the sensor with a mild soap and water solution. A 1:10 bleach solution or an approved disinfectant wipe may be used if necessary.

Pressure Transducers

!CAUTION:

Never poke or puncture the center pinhole opening of any pressure transducer.

1. Gently wash only the surface of all pressure transducers with warm water and a moist lint-free cloth. See Figure 14: Fluid Management System on page 3-12 for the location of the COLLECT, RETURN, and Centrifuge System Pressure Transducers.

2. Dry thoroughly.

Operator Interface

1. Clean the Operator Interface screen as needed using a mild soap and warm water solution on a dampened lint-free cloth. Avoid large amounts of water.

2. Dry with a lint-free cloth.

✎NOTE:

Avoid glass cleaning agents. These products tend to smear the screen and decrease visual clarity.

Disinfect with a 1:10 bleach solution or an approved disinfectant wipe only if a blood splash has occurred. Allow disinfectant to dry and then re-wash the screen with clear water to remove any residue. Dry with a lint-free cloth.

ISSU

ED


7-6



Rev. 4.0-1460451

Cleaning a Fluid Spill in the Centrifuge Chamber

!CAUTION:

When cleaning the Centrifuge Chamber, ensure that the cleaning solution does not come in contact with the Bowl Optic Lens. If this should occur, rinse the lens with clear water and dry it so that the lens does not cloud.

1. Turn the power ON. Open the Centrifuge Chamber Door.

2. Turn the Power OFF and disconnect the power cord from the wall outlet.

3. Wipe away as much blood as possible with gauze pads.

4. Spray cleaning solution against the wall of the Centrifuge Chamber avoiding the Bowl Optic Lens. Wipe the chamber. Follow with a clear water rinse.

5. Wash inside the Centrifuge Chamber Door with a cloth moistened with cleaning solution.

6. Wash the Centrifuge Frame with a cloth moistened with cleaning solution.

7. Dry all surfaces with a lint-free cloth.

Detachable Parts and Accessories

Accessories

See the last page of this manual for part numbers.

Power Cord

Should the Power Cord be lost or damaged please refer to the last page of this manual for a list of replacement part numbers and contact Therakos service to report the suspected cause of damage.

ISSU

ED


Disposal Of The Instrument And Its Components 7-7


Disposal of the Instrument and Its Components

In the event that the THERAKOS™ CELLEX™ Photopheresis System or its components including batteries require disposal, please contact the Therakos Service Manager for instructions. Refer to phone numbers listed on the last page of this manual.

Power Failure Alarm Battery

The power failure alarm battery is continuously monitored when the system is powered ON. A Low Battery warning message is displayed at power ON if the battery voltage is too low. During treatment, a flashing battery icon and an alarm chirp will be displayed / heard if the voltage is too low.

Figure 119a: 9-Volt Battery Low Warning Figure 119b: Changing the 9-Volt DC Battery

✎NOTE:

• Only trained personnel should replace the 9-Volt DC Battery.

• Use only a heavy-duty 9-Volt DC Battery.

• Turn power OFF before changing the battery.

• Replace annually or as needed.

• The battery is located on the front lower left of the instrument as you face it, behind a small door.

• Use a flat head screwdriver to remove the battery cover.

• Remove battery if instrument is idle for three months or longer; replace prior to use.

ISSU

ED


7-8



Rev. 4.0-1460451

Replacing the THERAKOS™ CELLEX™ Light Assembly

The light assembly is packaged as a single set of 18 lamps. The light assembly is designed for 150 hours of use. The THERAKOS™ CELLEX™ Photopheresis System automatically records the number of hours of use. The remaining lamp life is displayed throughout the treatment on the Treatment Summary text screen.

It is recommended that the THERAKOS™ CELLEX™ Light Assembly be replaced when the hours remaining are less than or equal to 10.

Figure 120a: Light Assembly Back

Figure 120b: Light Assembly Front

Figure 120c: Light Assembly Front: Close-up

!WARNING:

• The calculated dose of UVA light energy will not be delivered if the light assembly is changed after the calculation of photoactivation MINUTES REMAINING is displayed.


ISSU

ED


Replacing The Therakos™ Cellex™ Light Assembly 7-9


!CAUTION:


• Turn the power OFF and unplug the instrument prior to changing the THERAKOS™ CELLEX™ Light Assembly.



• Changing the THERAKOS™ CELLEX™ THERAKOS™ CELLEX™ Light Assembly with the power ON is UNSAFE and WILL NOT reset the number of lamp hours remaining to 150 hours.

1. Turn the power OFF and unplug the instrument.

2. Using the T-handle hex tool provided (or a 1/8” Allen wrench) loosen the three screws from the Photoactivation Chamber Cover Assembly and then remove the cover.

✎NOTE:

• Two screws are at the top of the assembly (shown in Figure 121) and one is just below the opening for the Photoactivation Module.

• Turn screws left to loosen and right to tighten.

3. Using two hands, pull the light assembly out.

4. Install the new assembly by aligning the lamp set channel with the slot on the instrument and pushing the lamp set all the way into the instrument as shown.

ISSU

ED


7-10



Rev. 4.0-1460451

5. Replace the cover and reinstall the three cover screws.

6. Plug power cord back in and turn instrument power ON.

Figure 121: Changing the THERAKOS™ CELLEX™ Light Assembly

ISSU

ED


Instrument Specifications 8-1


SECTION 8: SPECIFICATIONS

!CAUTION:

An IrDA™ Port and / or a USB Port are located on the monitor. Only authorized and approved devices should be used or connected to this port.

Instrument Specifications

CENTRIFUGE Motor

Brushless DC, with hall effect feedback

Control System

Closed loop with continuous speed / safety monitor

Safety Interlock

Mechanical / electrical door latch interlock

Humidity / Fluid Leak Detector to detect fluid on the sensor surface

Accuracy - Greater than 0.5mL of blood in contact with sensor.

Speed

Frame: 2400 Revolutions per Minute ± 5%

Centrifuge Bowl: 4800 Revolutions per Minute ± 5%

DEGREE OF PROTECTION AGAINST INGRESS OF WATER AND OTHER FLUIDS

Classification IPX0

ISSU

ED


8-2


Section 8: SPECIFICATIONS

Rev. 4.0-1460451

ELECTRICAL Nominal Voltages:

115, 230, 240 VAC (+/- 10% respectively)

Input voltage greater than 264 VAC will damage the device.

Installation technician will set the proper voltage.

Frequency:

50/60 Hz

Current:

6.3, 3.9, 3.8 Amps respectively

Maximum Power Input:

700 VA

Fuses:

All fuses are 5mm x 20mm. Replacing fuses is a service procedure and should only be performed by personnel trained in the THERAKOS™ CELLEX™ instrument service procedures. Always replace blown fuses with the correct size and international certification stamp.

Fuse ID Rating Circuit Location

F1 and F2 T6.3A, 250V Main Power Power Entry

Module

F1 T3.5A, 250V +5, +12, -12VDC Power Supply

F1 T3.5A, 250V +24VDC Power Supply

F3 T1A, 250V System Fans CELLEX™ Fuse PCB

F4 T5A, 250V Lamps CELLEX™ Fuse PCB

F5 T5A, 250V Centrifuge & Air

Pump

CELLEX™ Fuse PCB

Table 9: THERAKOS CELLEX Photopheresis System Fuses

ISSU

ED




Electromagnetic Emissions

The THERAKOS™ CELLEX™ Photopheresis System is intended for use in the electromagnetic environment specified below. The customer or the user of the THERAKOS™ CELLEX™ Photopheresis System should assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic environment- guidance

RF emissions CISPR 11

Group 1 The THERAKOS™ CELLEX™ Photopheresis System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / Flicker emissions IEC 61000-3-3

Complies The THERAKOS™ CELLEX™ Photopheresis System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

ISSU

ED


8-4



Rev. 4.0-1460451

Electromagnetic Immunity

The THERAKOS™ CELLEX™ Photopheresis System is intended for use in the electromagnetic environment specified below. The customer or user of the THERAKOS™ CELLEX™ Photopheresis System should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 6 kV contact ± 8 kV air

Complies Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient / burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input / output lines

Complies Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± kV differential mode ±2 kV common mode

Complies Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 %dip in UT) for 5 sec

Complies Mains power quality should be that of a typical commercial or hospital environment. If the user of the THERAKOS™ CELLEX™ Photopheresis System requires continued operation during power interruptions, it is recommended that the THERAKOS™ CELLEX™ Photopheresis System be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m Complies Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

ISSU

ED




Guidance and manufacture’s declaration-electromagnetic immunity

The THERAKOS™ CELLEX™ Photopheresis System is intended for use in the electromagnetic environment specified below. The customer or the user of the THERAKOS™ CELLEX™ Photopheresis System should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic environment-guidance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2,5 GHz

[ V1 ] V

[ E1 ] V/m

Portable and mobile RF communications equipment should be used no closer to any part of the THERAKOS™ CELLEX™ Photopheresis System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = [3, 5]√ P V1

d = [3, 5]√ P 80 MHz to 800 MHz E1

d = [ 7 ]√ P 800 MHz to 2, 5 GHz E1

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations fro radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the THERAKOS™ CELLEX™ Photopheresis System is used exceeds the applicable RF compliance level above, the THERAKOS™ CELLEX™ Photopheresis System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting the THERAKOS™ CELLEX™ Photopheresis System.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

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8-6



Rev. 4.0-1460451

Recommended separation distances between portable and mobile RF communications equipment and the THERAKOS™ CELLEX™ Photopheresis System

The THERAKOS™ CELLEX™ Photopheresis System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the THERAKOS™ CELLEX™ Photopheresis System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the THERAKOS™ CELLEX™ Photopheresis System as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter W

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz

d = [3, 5]√ P V1

80 MHz to 800 MHz

d = [3, 5]√ P E1

800 MHz to 2,5 GHz

d = [ 7 ]√ P E1

0.01

0.1

1

10

100

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. IS

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FLOW RATES AND TREATMENT SETTINGS

Collect and Return Pumps

5mL to 100mL (adjustable in 5mL increments)

Return Bag Threshold

100mL to 500mL

Saline Volume Delivered


A/C Volume Delivered


Whole Blood Processed


Fluid Balance Limits

-1000mL to 1000mL (adjustable in 50mL increments)

Reinfusion Rate

1mL to 100mL (1-5mL, adjustable in increments of 1; 5-100mL, adjustable in increments of 5)

Collection Cycles

1 to 3

Saline Bolus


A/C Ratio

8/1, 10/1, 12/1, 14/1, 16/1, 25/1, 50/1

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8-8



Rev. 4.0-1460451

GENERAL OPERATING CONDITIONS

Operating Temperature:

15˚C to 30˚C (59˚F to 86˚F)

Operating Humidity:

30% to 75% RH, non-condensing

BTU / Hour:

2390

Time Measurements

Accuracy

Range

Start Time ± < 1% 0-8 hours

Elapsed Time ± < 1% 0-8 hours

Elapsed UVA Time ± < 1% 0-99 minutes

Remaining Lamp Life ± < 1% 0-150 hours

Volume Measurements Range

Fluid Balance -1000 to 1000 mL

Whole Blood Processed 0 to 2000 mL

Treatment Volume 0 to 1000 mL

Buffy Coat Volume 0 to 1000 mL

Saline Delivered 0 to 2000 mL

Anticoagulant Delivered 0 to 2000 mL

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PHYSICAL INSTRUMENT

Dimensions (Height x Width x Depth): 163 cm x 58.4 cm x 79 cm (64 in x 23 in x 31 in)

Working Height: 84 cm (33 in) height from floor to pump deck surface

Shipping Height: 147.3 cm (58 in) with monitor and IV pole down

IV Pole Height: 142 cm (56 in) retracted 183 cm (72 in) extended

Weight: 155 kg (341 lb)

Shipping Weight: 246 kg (542 lb); instrument plus shipping crate

Shipping Container Dimensions (Height x Width x Length): 173 cm (68 in) x 81.3 cm (32 in) x 117 cm (46 in)

Recommended Operating Space: 25.4 cm (10 in) clearing on all sides

Required Floor Space: 4614 cm2 (713 in2)

Power Cord Length: 3.05 m (10 ft)

Display Adjustment: Tilt up: 3˚ Tilt down: 5˚ Rotate: 0˚ to 90˚ with 0˚ being the normal operating position; 90˚ used during transport to enable better visibility

Finish: All exposed plastic surfaces are coated with a polyurethane

enamel finish: purple, gray, or white. All metal surfaces have either a clear or black anodized finish.

Mobility: Front Wheels: 2 swivel and lock casters Rear Wheels: 2 large non-swivel / non-locking wheels

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Rev. 4.0-1460451

PUMPS Type Peristaltic type tubing with pressure sensor monitor on patient and centrifuge lines Stepper motor drive with 3 channel rotary encoder

Control System Closed loop continuous monitor of speed / direction

Pump Pressure Greater than 500 mmHg

At < 40 PSI: Flow Rate Accuracy +/- 10% Range: 0 to 100mL / min Volume Accuracy Fluid Balance Reading — +/- 5% of volume processed or 25mL (whichever is greater) All Other Volume Readings — +/- 10% or 25mL (whichever is greater) A/C Ratio exceeded or not met will yield an alarm state

PumpTask

MonitoringFrequency

MonitoringCondition

Interrupt / loss communication between main controller and pump controller.

Every 200 milliseconds Pump ON or OFF

Pump is spinning faster than its command speed.

Every 50 milliseconds Pump ON

Pump is spinning lower than its command speed.


Pump is spinning in opposite direction from command direction.


Pump is running when is it not commanded to run.

Pump is rotated > 5mL manually

Pump is OFF

Any other alarm or warning puts all pumps in stop or KVO mode.

Continual Pumps ON or OFF

Table 10: Pump Fault Monitoring

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SAFETY CE Marking per EC Declaration of Conformity to MDD 93/42EEC Annex II; June 14, 1993 for Class IIb products

Electromagnetic Compatibility

IEC60601-1-2, with radiated and conducted emissions per CISPR 11, Class B Limits, Group 1

Functional Safety

IEC60601-1:1988, EN60601-1:1990 and BS EN 60601-2-16:1998

Relevant clauses

SYSTEM SENSORS Audible Alarms

Tested to be greater than 70 decibels at 1 meter.

There are no adjustable audible alarms

Volume of audible alarms is 65 – 75 db

Air Detection

Type

5 channel pulsed digital ultrasonic

Sensitivity and Alarm Set Point

Intact air bubble

125 microliters at all flow rates

Test Interval

Two seconds

Sensitivity During Testing: 375 microliters

Pump Tubing Organizer Includes

Internal air trap provided by drip / blood filter

Greater than 12 cc

Leak Detection

0.5mL droplet onto detection strip for both Centrifuge and Photoactivation Chamber

Bowl Optic Sensor

Type

Laser red (670 nm), Class II

Sensing Range

1% < HCT < 90%

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Rev. 4.0-1460451

SYSTEM SENSORS (continued)

Pressure

Accuracy of pressure sensors (MEMSCAP) = ± 2.5% of full scale.

Full scale = 700 mmHg.

Accuracy = ± 17.5 mmHg.

SYSTEM -465 mmHg to 465 mmHg (-9 psi to 9 psi)

RETURN LINE -100 mmHg to 300 mmHg (-1.9 psi to 5.8 psi)

COLLECT LINE -300 mmHg to 100 mmHg (-5.8 psi to 1.9 psi)

Table 11: Pressure Sensor Ranges

Hematocrit (HCT)

LED and Photodiode Assembly,

Sensing Range

0.4% < HCT < 25.5%

Accuracy

± 0.2%

Temperature

Type

Dual digital silicon type non-blood contact chamber air

temperature exit measurement

Range

15 oC to 45 oC

Accuracy

± 1 oC

Safety Interlock

Both temperature sensors must be within 3 oC of each other

System reacts to all alarms within 250 msec.

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TRANSPORTATION Do not:

• Lay instrument on its side

• Lift off the ground via rear and pump deck handles

• Store on an inclined surface greater than 10 degrees

• Operate on an inclined surface

• Push or pull on any of the plastic covers

• Push or pull the instrument by the load cell covers

• Stand, push, or pull on the wheel covers

• Push or pull the instrument by the monitor

Do:

• Lock front casters while in use

• Transport in an upright position

• Use caution when moving up and down inclined surfaces

• Push or pull the instrument via the rear handle or the pump deck handles

TRANSPORT AND STORAGE CONDITIONS

Storage Temperature:

0 ˚C to 57 ˚C (32 ˚F to 135 ˚F)

Storage Humidity:

10% to 95% RH, non-condensing

Atmospheric Pressure Range: 86 kPa to 106 kPa

TUBING PINCH VALVES Type

Normally closed, spring actuated

Pneumatically retracted

Occluding Pressure

Greater than 350 mm/Hg after priming

Operation

All closed if air or system error detected or power off

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Rev. 4.0-1460451

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9-1


Warnings and Cautions 9-1


SECTION 9: WARNINGS AND CAUTIONS

!CAUTION:

Review all warnings and cautions summarized in this section before treating a patient!

!WARNING:

• Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for any signs of hypotension.



• The Procedural Kit must be used within four hours after PRIME has been completed.

• It is essential for the THERAKOS™ CELLEX™ Photopheresis System to be installed and used in compliance with all center specific and local regulations / recommendations on the quality of all relevant fluids used during a therapy.

• Prior to initiating PRIME, ensure the Treatment Bag and Return Bag are properly positioned on their respective Load Cell Hooks. Removal of these bags at any time after PRIME is initiated may result in priming alarms and / or inaccurate FLUID BALANCE readings during the treatment.

• The COLLECT Rate Limit Range is 5-100mL/min. DRAWING will automatically use a flow rate of 50mL/min if access allows. Careful fluid balance management may require a slower COLLECT Flow Rate. Please refer to Section 5: Changing SETUP Default Parameter Settings and Section 10: Fluid Balance Management for additional information.

• Venipuncture access may require a COLLECT Flow Rate of less than 50mL/min.


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9-2


Section 9: WARNINGS AND CAUTIONS

Rev. 4.0-1460451

9-2

Rev. 4.0- THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual


!WARNING:

• The RETURN Rate Limit Range is 5-100mL/min. RETURNING will automatically use a Flow Rate of 50mL/min if access allows. Careful fluid management may require raising or lowering this flow rate. Please refer to Section 5: Changing Default SETUP Parameter Settings and Section 10: Fluid Balance Management for additional information.

• Venipuncture access may require a RETURN Flow Rate of less than 50mL/min.

• The default setting for the Return Bag Threshold is 200mL. You may change this setting at any time during the treatment via the SETUP screen. In Single Needle Mode, this setting determines how often the instrument alternates between DRAWING and RETURNING and also determines the patient’s extracorporeal blood volume during COLLECT. Please refer to Section 5: Changing Default SETUP Parameter Settings and Section 10: Fluid Balance Management for additional information.

• The system automatically returns the treated cells to the patient following PHOTOACTIVATE. Therefore, it is recommended that the patient should not be disconnected from the system at any time during the treatment.

• The Reinfusion Rate Limit Range is 1-100mL/min (1-5mL, adjustable in increments of 1; 5-100mL, adjustable in increments of 5). REINFUSE will automatically use a flow rate of 50mL/min if access allows. Careful fluid balance management may require a slower Reinfusion Rate. Please refer to Section 5: Changing Default SETUP Parameter Settings and Section 10: Fluid Balance Management for additional information.


• Re-purging the Centrifuge Bowl with whole blood will result in a higher extracorporeal blood volume than anticipated. Refer to Section 10: Fluid Balance Management for additional information before resuming the treatment.

• Electric Shock Hazard. Turn OFF and unplug the THERAKOS™ CELLEX™ Photopheresis System before servicing. Never perform maintenance on the THERAKOS™ CELLEX™ Photopheresis System during a treatment.

• If the power is turned off for any reason during COLLECT the Centrifuge Bowl must be re-purged before treatment resumes. This will result in a partial loss of Buffy Coat and higher extracorporeal volume. Refer to Section 10: Fluid Balance Management when re-purging the Centrifuge Bowl before resuming the treatment.

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9-3




!CAUTION:

• You must be present to supervise the treatment at all times. Your primary responsibility during COLLECT, PHOTOACTIVATE and REINFUSE is the patient’s safety. Carefully monitor the patient for tolerance to the extracorporeal fluid shifts, access performance and potential allergic reactions.

• Follow your center-specific guidelines for Universal Precautions whenever you anticipate possible exposure to blood. Failure to do so may expose you to harmful blood-borne contaminates.

• Do not operate the instrument in the presence of external radio or electromagnetic disturbances that may interfere with proper performance of the device. This could result in treatment interruptions, and the possibility of a failed treatment.

• Follow all operating and maintenance procedures. Failure to do so can result in patient or operator harm.

• Ensure that the room temperature does not exceed 30° C (86° F) during the treatment.

• Allow a minimum of 18 inches of ventilation space in front and back of the instrument while in use.

• Do not use the THERAKOS™ CELLEX™ Photopheresis System in the presence of flammable anesthetic gases.

• Avoid potential electrical hazards by using only properly grounded receptacles and circuits designed to accommodate equipment. The use of extension cords is not recommended.

• In consultation with the physician, assess the patient’s overall health status immediately before beginning a treatment to determine if the patient is able to tolerate the anticipated fluid shifts during the treatment. Do not proceed if the patient is unstable.

• American Association of Blood Banks guidelines recommend the positive and negative fluid balance of the patient during a treatment should not exceed 15% of his / her total blood volume. Refer to Section 10: Fluid Balance Management for additional information on selecting and maintaining Fluid Balance Limits.

• Estimate the patient’s total blood volume and calculate 10-15% of that volume. Refer to Section 5: Changing Default SETUP Parameters to determine how to set the +/- Fluid Balance Limit before starting COLLECT.

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9-4



Rev. 4.0-1460451

9-4



!CAUTION:

• Individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment. The physician should review the patient’s medical condition, medications and platelet count at the time of treatment and use clinical judgment to establish the optimal heparin dosage for each patient.

• When instructed, establish or disconnect patient access utilizing your institution’s standards of practice for this procedure. Failure to do so may lead to patient harm such as increased risk of infection, trauma to the access site, possible air embolus or post treatment blood loss.

• Follow all medication dosing instructions carefully.

• In some medical conditions, the patient’s hematocrit may change from day to day. Use a hematocrit measured within 48 hours of photopheresis to estimate the THERAKOS™ CELLEX™ Photopheresis Procedural Kit extracorporeal volume during a treatment.

• It is essential for the THERAKOS™ CELLEX™ Photopheresis System to be installed and used in compliance with all center specific and local regulations / recommendations on the quality of all relevant fluids used during a therapy.

• Protect the patient’s skin and eyes from sunlight and emphasize this need to the patient to continue protection for 24 hours post treatment. Refer to the oral 8-methoxypsoralen dosage formulation package insert for more information on protecting the patient from light and for all medication warnings and precautions.

• DO NOT USE the THERAKOS™ CELLEX™ Photopheresis Procedural Kit if the:

• Package is already opened or damaged.

• Fluid pathway guards (caps on ends of tubing lines are loose in packaging or missing.

• Date of Use is beyond the Expiration Date.

• Do not puncture the needle-free ports with a needle. Damage to these ports will result in leaks.

• Do not remove the Treatment Bag from the Load Cell Hook. Removal may result in inaccurate FLUID BALANCE readings.

• The correct placement of the Saline and Anticoagulant Bags are essential. Incorrect placement may lead to clotting in the procedural kit, patient blood loss and a failed treatment.

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9-5




!CAUTION:

• Always confirm the contents, lot number and expiration date of any solution prior to its use.

• Saline and Anticoagulant Spike Lines do not have slide clamps. Instead, Fluid Routing Valves, activated when the base of the Drive Tube is inserted into the Drive Tube Latch Assembly and the Drive Tube Latch is closed, prevent fluid from entering the Pump Tubing Organizer prior to PRIME.

• Do not allow the anticoagulant or saline bags to become empty prior to completing a treatment. Loss of prime in the spike lines will interrupt the treatment and prevent successful completion of the therapy.


• Turn the power OFF and unplug the instrument prior to changing the THERAKOS™ CELLEX™ Light Assembly.


• Do not attempt to modify the THERAKOS™ CELLEX™ Instrument, Procedural Kit or Light Assembly in any way.

• Changing the THERAKOS™ CELLEX™ Light Assembly with the power ON is UNSAFE and WILL NOT reset the number of Lamp Hours Remaining to 150 hours.

• Do not clean the Photoactivation Module. Cleaning agents could leave a film that may adversely affect the transmission of UVA light energy and the photoactivation process.

• Do not use the THERAKOS™ CELLEX™ Photopheresis Procedural Kit if any of the protective caps on the patient lines or fluid spikes are missing or off when the Procedural Kit is opened. Sterility of the procedural kit may be compromised if these caps are removed prior to use.

• Damage to the Centrifuge Bowl or Drive Tube could result in further damage to the instrument, loss of treatment and extracorporeal blood loss.

• During installation, do not excessively bend, kink or damage the Drive Tube, Bearings, or Centrifuge Bowl.

• Instrument must be properly maintained to function safely and properly.

• Warranty does not cover damage caused by improper loading, setup, operation, or improper maintenance.

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9-6



Rev. 4.0-1460451

9-6



!CAUTION:

• Do Not Proceed (with the THERAKOS™ CELLEX™ Photopheresis Procedural Kit Installation) until you confirm:

✓ The Drive Tube Latch is closed securely.

✓ The Drive Tube does not touch the Centrifuge Frame at any point.

✓ The tubing lines exiting the front of the Drive Tube Clamp Assembly are in their respective tubing guides and are not pinched in the clamp.

✓ All tubing lines pass through the Tubing Exit Slot and are free of kinks or pinch points.

✓ The Upper and Lower Bearings are fully seated in the Bearing Retainer Clips.

✓ The Centrifuge Bowl and Frame spin freely in a clockwise direction.

• Complete FINAL INSPECTION BEFORE PRIME (found in Section 4) before initiating PRIME.

• Handle the Pressure Domes only by clips to avoid damage to the internal membrane.

• The integrity of pressure monitoring will be compromised if the Pressure Domes are removed after PRIME. Damaged or misplaced pressure domes may leave lines unmonitored which could lead to undetected trauma at the patient access site, Centrifuge Bowl breakage with subsequent blood loss and a failed treatment.

• Avoid fingerprints on the window of the Hematocrit Cuvette. Natural oils may adversely affect the light transmittance through the lens.

• Individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment. The physician should review the patient’s medical condition, medications and platelet count at the time of treatment and use clinical judgment to establish the optimal heparin dosage for each patient.

• Check that the Centrifuge Chamber Door is closed properly. An alarm alerts you if the door is not closed properly.

• Do not unlatch or attempt to open the Centrifuge Chamber Door while the Centrifuge is in operation.

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9-7




!CAUTION:

• To avoid risk of infection and / or potential patient blood loss do not use a THERAKOS™ CELLEX™ Photopheresis Procedural Kit that:

• Has been damaged during setup.• Has leaked during PRIME.

Any damaged procedural kits should be returned to Therakos. Please contact Therakos at one of the phone numbers on the last page of this manual.

• The Collect and Return Lines must be configured to match the access mode selected. Failure to do so may lead to clotting at one access site, treatment interruption and a possible failed treatment.

• Maximum PAUSE time is 10 minutes. An audible beep signals when 8 minutes has expired. Either press START to resume, or select STOP before 10 minutes expires, to avoid generating a PAUSE Timeout Alarm.

• A portion of the leukocyte-enriched fraction in the Centrifuge Bowl will be lost when alarm conditions automatically stop the Centrifuge from spinning during COLLECT. Refer to instructions in STOPPED on page 5-39 or STOPPED on page 5-58 for more information.

• The patient’s extracorporeal volume will increase between 100mL - 280mL for each additional cycle collected. Refer to Table 12: Estimated Extracorporeal Volume on page 10-3. Confirm ECV using 1 cycle. Before you COLLECT using more than one cycle, confirm the patient is able to tolerate a higher ECV.

• The used THERAKOS™ CELLEX™ Photopheresis Procedural Kit and any spills should be considered biologically contaminated. In handling any spills, follow the policies and procedures of your institution’s Infection Control Plan.

• END TREATMENT and ABORT TREATMENT are both selections that will not allow you to proceed to PHOTOACTIVE. Selection and confirmation of these selections will result in immediate termination of the treatment.

• Do not select to EARLY PHOTOACTIVATE unless at least one BUFFY COAT phase has been completed.

• Do not select during the COLLECT phase to deliver a saline bolus. STOP will stop the Centrifuge and cell separation will be lost. Instead, select PAUSE.

• Before you begin Manual Blood Return consult the physician in charge to determine if there is any reason that the blood in the procedural kit should not be returned to the patient.

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9-8



Rev. 4.0-1460451

9-8



!CAUTION:

• In the event of a brief power failure during treatment that does not require Manual Blood Return, turn the power switch OFF, open the door to the Photoactivation Chamber and pull the Photoactivation Module out half way. When power is restored, put the Photoactivation Module back in position, close the Photoactivation Chamber Door and turn the power ON. If the power failure is prolonged, follow instructions for Manual Blood Return (With Power OFF and / or No Access to Release Kit Button).

• Do not manually return any blood products without proper filtration. Refer to your institution’s blood transfusion guidelines.

• Do not puncture tubing lines (when inserting Fluid Routing Valve Release Tool during Manual Return with power off and no access to RELEASE KIT button)!

• Do not allow cleaning solution to come into contact with any of the automatic sensors. Gently clean all sensors with warm water only.

• Never poke or puncture the center pinhole opening of any pressure transducer.

• Do not allow cleaning solution to come in contact with the Hematocrit Sensor.

• Do not allow cleaning solution to come in contact with the Air Detectors.

• Do not allow cleaning solution to come in contact with the Bowl Optic Lens.

• For optimal performance, the Bowl Optic Sensor Lens must be clean and clear. A dirty or clouded lens on the Bowl Optic Sensor could interfere with its proper function.

• When cleaning the Centrifuge Chamber, ensure that the cleaning solution does not come in contact with the Bowl Optic Lens. If this should occur, rinse the lens with clear water and dry it so that the lens does not cloud.

• An IrDA™ Port is located on the user interface. Only authorized and approved devices should be used or connected to this port.

• All automatic sensor functions, pump rates, anticoagulant delivery ratios and fluid balance estimates are limited to the accuracies of the component parts listed in Section 8: Specifications. Failure of the instrument to meet these performance specifications may lead to less than optimal Buffy Coat collections, blood loss due to clotting or leakage, increased risk of infection, hypovolemia or hypervolemia and / or a failed treatment.

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9-9




!CAUTION:

• Partial pressure dome attachment may provide pressure readings, but as pressures increase, the internal membrane may separate from the pressure dome. Fluid leaks may occur resulting in loss of sterility, blood leaks and possible blood loss to the patient.

• If priming alarms occur, do not remove the pressure domes until after you remove the pump tubing segments. Check the screen display to confirm that all pressure has been released from the sensors.

• DO NOT REMOVE ANY PRESSURE DOMES DURING A TREATMENT. Please call the Therakos HOTLINE for assistance as needed during troubleshooting events.

• If a manual return must be performed, follow all instructions in this manual. To release all internal pressure before removing the kit, always remove all pump tubing segments before removing any pressure domes. Check the screen display to confirm that pressure has been released.

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9-10



Rev. 4.0-1460451

9-10



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Introduction 10-1


SECTION 10: FLUID BALANCE MANAGEMENT

Introduction

Fluid Balance Management of any patient undergoing a therapeutic photopheresis treatment is critically important. Key factors to estimate and control are:

a. Total Blood Volume and anticipated Extracorporeal Blood Volume (ECV)

b. Rate of Fluid Shifts

c. Negative and Positive Fluid Balance during and immediately post treatment

d. Delivery Rate and Concentration of Anticoagulant

At the time of treatment, the operator and physician must know the patient’s health history, age and current condition to predict how well he / she will tolerate fluid shifts during the procedure. In addition, the patient’s sex, body build, current hematocrit and current weight will be required to perform the calculations necessary to manage fluid balance safely.

The THERAKOS™ CELLEX™ Photopheresis System incorporates numerous software features to assist in maintaining proper fluid balance during a treatment. The following variables are displayed in real time as the treatment proceeds:

1. FLUID BALANCE

2. WHOLE BLOOD PROCESSED

3. SALINE DELIVERED

4. ANTICOAGULANT DELIVERED

5. COLLECT AND RETURN FLOW RATES

✎NOTE:

Instructions on how to alter the above variables will vary depending on whether the instrument is run in Double Needle Mode (Continuous flow) or Single Needle Mode (Discontinuous flow).

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10-2


Section 10: FLUID BALANCE MANAGEMENT

Rev. 4.0-1460451

Extracorporeal Blood Volume (ECV)

American Association of Blood Banks’ guidelines set a maximum extracorporeal blood volume to be less than or equal to 15% of the patient’s Total Blood Volume. A new calculation of Total Blood Volume is necessary prior to each treatment to estimate the safe extracorporeal blood volume that may be allowed for the patient undergoing treatment. These calculations should be performed using the current weight and current hematocrit (the latter drawn after the last photopheresis treatment and within 48 hours prior to the next photopheresis treatment). Certain medical conditions may warrant an extracorporeal blood volume of less than 15% of Total Blood Volume.

Predicting Actual Procedural Kit Extracorporeal Blood Volume

!CAUTION:

In some medical conditions, the patient’s hematocrit may change from day to day. Use a hematocrit measured within 48 hours of photopheresis to estimate the THERAKOS™ CELLEX™ Photopheresis Procedural Kit extracorporeal volume during a treatment.

In both DOUBLE NEEDLE and SINGLE NEEDLE modes a minimum amount of whole blood must be processed to prime the Centrifuge Bowl and establish the proper plasma / red blood cell interface. This extracorporeal blood volume increases as the patient’s hematocrit decreases. A blood prime of the Centrifuge Bowl using crossmatched compatible packed red blood cells may be required if the patient’s current weight and hematocrit exceed the safe 10-15% extracorporeal blood volume. Table 11 estimates the average Procedural Kit ECV for each of the following % hematocrits:

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Predicting Actual Procedural Kit Extracorporeal Blood Volume 10-3


% HCT Estimated ECV

DOUBLE NEEDLE

Estimated SINGLE NEEDLE Mode Extracorporeal Volume (ECV) When Return Bag Threshold Value (RBTV) is Set at (XmL): Return Bag Threshold Value =

100 150 200 250 300 350 400 450 500

27% 415 465 515 565 615 665 715 765 815 865

28% 400 450 500 550 600 650 700 750 800 850

29% 386 436 486 536 586 636 686 736 786 836

30% 373 423 473 523 573 623 673 723 773 823

31% 361 411 461 511 561 611 661 711 761 811

32% 350 400 450 500 550 600 650 700 750 800

33% 339 389 439 489 539 589 639 689 739 789

34% 329 379 429 479 529 579 629 679 729 779

35% 320 370 420 470 520 570 620 670 720 770

36% 311 361 411 461 511 561 611 661 711 761

37% 303 353 403 453 503 553 603 653 703 753

38% 295 345 395 445 495 545 595 645 695 745

39% 287 337 387 437 487 537 587 637 687 737

40% 280 330 380 430 480 530 580 630 680 730

41% 273 323 373 423 473 523 573 623 673 723

42% 267 317 367 417 467 517 567 617 667 717

43% 260 310 360 410 460 510 560 610 660 710

44% 255 305 355 405 455 505 555 605 655 705

Table 12: Estimated Extracorporeal VolumeRelative to % Hematocrit, Access Mode and Return Bag Threshold Value

✎NOTE:

All values in Table 12: Estimated Extracorporeal Volume are estimates only! Some values have been extrapolated from data point generated curves.

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10-4



Rev. 4.0-1460451

Estimated Extracorporeal Volume (ECV) - Single Needle

Double Needle Single Needle (Return Bag Threshold Value = 200mL = Default)

!CAUTION:

The patient’s extracorporeal volume will increase between 100mL - 280mL for each additional cycle collected. Refer to Table 11 in Section 10: Fluid Balance Management. Confirm ECV using 1 cycle. Before you COLLECT using more than one cycle, confirm the patient is able to tolerate a higher ECV.

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Predicting Actual Procedural Kit Extracorporeal Blood Volume 10-5


Estimated Extracorporeal Volume (ECV) - Double Needle

Double Needle Single Needle Return Bag Threshold Value @ 100 mL Single Needle Return Bag Threshold Value @ 150 mL

Single Needle Return Bag Threshold Value @ 200 mL (Default)

Single Needle Return Bag Threshold Value @ 250 mL






!CAUTION:


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Rev. 4.0-1460451

Estimating the Patient’s Total Blood Volume

Total Blood Volume (TBV) in milliliters (mL) can be estimated by multiplying the patient’s weight in kilograms (kg) by the appropriate body build factor predicting blood volume in mL/kg. Ten to fifteen percent of the patient’s TBV represents the volume of blood that may safely become extracorporeal (ECV) during a treatment.

✎NOTE:

• Formula to calculate TBV: Weight (kg) X Body Build Factor (mL/kg) = TBV (mL)

• Conversion Factors: pounds ÷ 2.2 = kilograms stones x 6.35 = kilograms

• Body Build Factors follow in Table 12.

Example Calculations of TBV and Safe ECV:

Example 1. Patient: Adult male, normal body build, weight = 154 pounds

Estimated Total Blood Volume: (154 pounds ÷ 2.2 pounds/kg) x (75mL/kg) = 5250mL TBV

Estimated Safe Extracorporeal Blood Volume Range (10-15% of TBV): Minimal ECV (10% of TBV) = (5250 x 0.1) = 525mL Maximum ECV (15% of TBV) = (5250 x 0.15) = 787mL Safe ECV Range = 525mL – 787mL

Example 2. Patient: Adult female, thin body build, weight = 7 stones

Estimated Total Blood Volume:(7 stones x 6.35 kilogram/stone) x (65mL/kg) = 2889mL TBV

Estimated Safe Extracorporeal Blood Volume Range (10-15% of TBV):Minimal ECV (10% of TBV) = (2889 x 0.1) = 289mL Maximum ECV (15% of TBV) = (2889 x 0.15) = 433mL Safe ECV Range = 289mL – 433mL

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Example Calculations Of Tbv And Safe Ecv 10-7


✎NOTE:

• In DOUBLE NEEDLE mode, the temporary fluid deficit that is generated as the patient’s ECV primes the Centrifuge Bowl may be eliminated by simultaneously returning saline to the patient until the Return Line fills with plasma and red blood cells.

• In SINGLE NEEDLE mode the Return Bag Threshold may be set to minimize the ECV once PURGING AIR is completed.

• ECV ≠ FLUID BALANCE. A patient may lose a significant ECV but still be in an isovolemic condition due to simultaneous fluid replacement.

BODY BUILD MALE FEMALE

Adult Muscular 80mL/kg 75mL/kg

Adult Normal 75mL/kg 70mL/kg

Adult Thin 70mL/kg 65mL/kg

Adult Obese 65mL/kg 60mL/kg

Adolescent 75-70mL/kg 75-70mL/kg

Neonate 100-80mL/kg 100-80mL/kg

Patient Estimated Total Blood Volume

(mL)

SAFE Minimal ECV (mL)

(10% of TBV)

SAFE Maximum ECV (mL)

(15% of TBV)500 50 75

750 75 112

1000 100 150

1250 125 187

1500 150 225

1750 175 262

2000 200 300

2250 225 337

2500 250 375

2750 275 412

3000 300 450

3250 325 487

3500 350 525

3750 375 562

4000 400 600

4250 425 637

4500 450 675

4750 475 712

5000 500 750

5250 525 787

5500 550 825

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Rev. 4.0-1460451

5750 575 862

6000 600 900

6250 625 937

6500 650 975

6750 675 1012

7000 700 1050

7250 725 1087

Table 13: Body Build Factors and Safe Extracorporeal Blood Volume (ECV) Limits Total Blood Volume = (Weight in kg) x (Body Build Factor mL/kg) = TBV mL

Rate of Fluid Shifts

The COLLECT and RETURN Rate Limit range is 5 – 100mL/minute. The default flow rate is 50mL/minute. Factors that determine the most appropriate speed of DRAWING whole blood, RETURNING plasma and red blood cells, and REINFUSING treated white blood cells are the following:

• Weight: Low body weight and obese patients will require slower flow rates to allow time for the physiological adjustments necessary to adapt to the fluid shifts of the procedure.

• Medical Condition at time of treatment: Any condition that includes pulmonary, cardiac or renal insufficiencies will require moderate to slow flow rates. Careful monitoring of the patient’s vital signs during the procedure will guide you in selecting the most appropriate flow rates.

• Access: Venipuncture may require flow rates of less than 50mL/minute. Carefully monitor the COLLECT Line Pressure display and the RETURN Line Pressure display and lower the flow rates as needed to maintain stable line pressures and to avoid occlusion alarms.

• Fluid Balance: In DOUBLE NEEDLE mode (Continuous flow) COLLECT and RETURN flow rates may be adjusted to achieve the desired positive or negative fluid balance for a given patient. Specific examples follow in the Fluid Balance section below. Flow rates do not influence fluid balance in SINGLE NEEDLE mode.

• Cell Yield: All cell yield efficiency testing during the development of the THERAKOS™ CELLEX™ Instrument were performed using the default COLLECT flow rate of 50mL/minute and 25mL/min during BUFFY COAT. Cell yield efficiency may diminish with higher flow rates during DRAWING.

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Fluid Balance Management 10-9


Fluid Balance Management

Double Needle Mode

Careful Fluid Balance Management is the combination of knowing and controlling extracorporeal volume and the rate of fluid shifts as well as any fluid deficits or fluid positive states that occur during the photopheresis treatment and immediately post treatment. In general, all patients will be approximately 450mL fluid positive at the end a typical THERAKOS™ Photopheresis therapy. Appropriate medical follow up and intervention must be given to any patient whose medical condition at the time of treatment warrants assistance in eliminating these extra fluids.

In Double Needle mode (Continuous Flow), simultaneous flow of approximately equal amounts of fluids to and from the patient creates a state of isovolemia. These fluids will be various volumes of whole blood, plasma, red blood cells, saline and anticoagulant. You may adjust COLLECT and RETURN flow rates to manage overall fluid balance as follows:

FLUID BALANCE GOAL

COLLECT Flow Rate

RETURN Flow Rate

MINIMAL FLUID DEFICIT: (Approximately -125mL during PURGING AIR then adjusts isovolemic conditions)

45mL/min*

50mL/min*

MINIMAL ADDITIONAL FLUIDS: (Divert Return of saline during PURGING AIR creating an intentional ECV deficit approximating the values listed in Table 11 for each hematocrit listed under DOUBLE NEEDLE.)

50mL/min* during

PURGING AIR 45mL/min* during

DRAWING

0mL/min during PURGING AIR

50mL/min* during RETURNING

BLOOD PRIME: (Procedural kit ECV will exceed 10-15% TBV or red blood cell loss will be greater than desired during PURGING AIR)

50mL/min during

PURGING AIR 25mL/min** during

DRAWING

N/A (SINGLE NEEDLE mode used to prime

Centrifuge Bowl)

25mL/min** during RETURNING

* The patient’s medical condition at the time of treatment and the Line Pressure displays indicate that access is capable of these flow rates. If necessary, lower COLLECT and RETURN rates by the same increment to achieve the above listed goals. **Patients requiring a blood prime may also require slower flow rates. Set both COLLECT and RETURN to the same rate to maintain isovolemic conditions.

Table 14: Double Needle Mode Fluid Balance Goals and Flow Rates

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Rev. 4.0-1460451

!WARNING:

• Single Needle Mode is a discontinuous flow process, even though the harvesting of white blood cells in the Centrifuge Bowl is continuous. It is not possible to maintain isovolemic conditions in Single Needle Mode. The patient must be able to tolerate the predicted procedural kit extracorporeal volume without simultaneous fluid replacement.

• Double Needle Mode is required when:

• Isovolemic FLUID BALANCE is required.• Minimum fluid deficit is required.• Minimum ECV is allowed.• BLOOD PRIME is required.

Single Needle Mode

Once PURGING AIR is completed in Single Needle Mode the Return Bag Threshold Volume will determine how often the instrument alternates between DRAWING and RETURNING. The default setting is 200mL. The range is 100-500mL. Each time the threshold volume is reached an audio beep will sound, DRAWING will be interrupted and RETURNING will resume until the volume in the Return Bag is approximately 50mL.

Prior to a treatment, calculate the patient’s Total Blood Volume and determine if 10% or 15% of this total will be input as the +/- FLUID BALANCE LIMITS. If during the treatment the negative fluid balance limit is reached:

1. Select PAUSE and then SETUP.

2. Lower the Return Bag Threshold Limit from 200mL to 150 or 100.

3. Save the new entry and press START to resume the treatment. RETURNING will begin and the negative fluid balance will diminish.

COLLECT: Using More Than One Cycle

!WARNING:


The THERAKOS™ CELLEX™ THERAKOS™ CELLEX™ THERAKOS™ CELLEX™ Photophereis System is designed to process up to 2000mL of whole blood using only one collection cycle. Additional cycles should be reserved only for troubleshooting scenarios. If the patient is unable to tolerate a higher ECV refer to Section 5: PAUSE Proceed Immediately to BUFFY COAT for further instructions.

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Fluid Balance Management 10-11


Screen displays that are helpful are for fluid balance management in both Double Needle Mode and Single Needle mode are:

• COLLECT and RETURN Rates and Pressures

• FLUID BALANCE

• RETURN BAG VOLUME (Tap on screen icon to see mL volume displayed)

Figure 122: Helpful Fluid Balance Management Screen Displays

✎NOTE:

• FLUID BALANCE is estimating the volume of fluid taken from and given to the patient during the treatment. Accuracy (+/- 5% or 25mL, which ever is greater) is dependant on the correct placement of the Treatment Bag and Return Bag during PRIME. These bags should not be removed from the Load Cell Hooks once PRIME is complete.

• FLUID BALANCE does not represent red blood cell loss. Refer to Table 11 for estimates of extracorporeal volume at a given hematocrit.

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Rev. 4.0-1460451

Fluid Balance Management When Re-purging the Centrifuge Bowl

!CAUTION:

• Re-purging the Centrifuge Bowl with whole blood during a treatment will result in a higher (approximately 50mL) extracorporeal blood volume than anticipated.

• If necessary, deliver a saline bolus to the patient prior to resuming treatment to prevent hypovolemia.

The THERAKOS™ CELLEX™ Photopheresis System is designed to process 1500mL of whole blood in one continuous collection cycle. Once the buffy coat has been harvested and 8-methoxypsoralen has been injected, the instrument will proceed to PHOTOACTIVATE and REINFUSE. Examples of rare events that may lead to stopping the Centrifuge before BUFFY COAT is complete are:

• System Pressure Alarm, indicating a possible obstruction to or from or within the Centrifuge Bowl.

• Patient access problems that require a delay longer than 10 minutes if you allow the 10-minute PAUSE limit to expire.

• A power interruption.

• Accelerometer System Alarm

• Drive Tube Alarm

• Blood Leak (Centrifuge)

In all of these events, you must determine the root cause of the problem and resolve it and then, if possible, resume the treatment. As treatment resumes the Centrifuge Bowl must be re-purged and then the plasma / red blood cell interface must be re-established. Please review the sequence of events below before resuming the treatment.

Re-purging the Centrifuge Bowl in Double Needle Mode

• To minimize extracorporeal blood volume the instrument will proceed to RETURNING to lower the Return Bag volume to approximately 50mL before it begins to re-purge the Centrifuge Bowl.

• Plasma will be returned to the patient simultaneously except during brief pauses as air is purged from the Centrifuge Bowl.

• The negative fluid deficit will increase slightly during this brief period, however, a saline bolus should not be necessary.

• Once the Centrifuge Bowl is in full speed, you may adjust the COLLECT Flow Rate and the RETURN Flow Rate until the desired fluid balance is achieved.

• If desired, raise the Whole Blood Processed Target to compensate for buffy coat that may have been displaced, as the Centrifuge Bowl is re-purged.

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Fluid Balance Management When Re-purging The Centrifuge Bowl 10-13


Re-purging the Centrifuge Bowl in Single Needle Mode

• You may choose to deliver a saline bolus to the patient prior to resuming treatment.

• To minimize extracorporeal blood volume the instrument will proceed to RETURNING to lower the Return Bag volume to approximately 50mL before it begins to re-purge the Centrifuge Bowl.

• Once the Centrifuge Bowl is re-purged COLLECT and RETURNING will alternate as directed by the Return Bag Threshold Value.

• If desired, raise the Whole Blood Processed Target to compensate for buffy coat that may have been displaced, as the Centrifuge Bowl is re-purged.

Re-purging the Centrifuge Bowl during a BLOOD PRIMED Procedure

• Decide if the extra ECV will be drawn from the patient or the unit of packed cells used for the initial blood prime. Make the proper connections or clamp settings to draw from either the patient or the packed red blood cell unit. Make the necessary adjustments to determine what the new FLUID BALANCE “zero” is depending on which method you used.

• To keep the patient in isovolemic conditions keep the COLLECT and RETURN rates the same during the re-purging. A slight volume (approximately 75mL) deficit will develop as air is purged from the Centrifuge Bowl and interrupts RETURNING. Once the Centrifuge Bowl is spinning at full speed the deficit may be depleted by setting the COLLECT Flow Rate to be less than the RETURN Flow Rate until the desired fluid balance is achieved.

• If fluid overload is of concern, and the patient can tolerate a brief fluid deficit of approximately 100mL you may choose to drop the RETURN Flow Rate to zero to avoid giving the patients additional fluids as the Centrifuge Bowl is re-purged. Once the Centrifuge Bowl is spinning and DRAWING resumes, set the COLLECT and RETURN Flow Rates to be equal and change connections to ensure that the instrument draws from the patient and no longer from the packed red blood

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Rev. 4.0-1460451

Blood Prime

Some medical conditions require not only maintaining intravascular fluid volumes during a procedure, but also, carefully controlling the circulating red blood cell volume. If in preparation for a treatment, calculations show that the estimated extracorporeal blood volume exceeds 10-15% of the patient’s Total Blood Volume (TBV) or the resulting circulating red blood cell volume will become too low due to fluid replacement it will be necessary to prime the procedural kit with packed red blood cells. In these patients careful attention to both negative and positive fluid balance is mandatory.

Additional Supplies Needed

1. One unit of cross-matched compatible packed red blood cells (pRBC). If necessary, add saline to ensure that a minimum of 300mL is available.

2. One Transfer Set with spike and female luer connection.

3. One Large gauge Y-connector tubing adapter. (Y-arms with male luer connectors, stem with female luer connector)

✎NOTE:

Use Male-to-female adapters or 3-way stopcocks to make connections if necessary.

Pre-treatment Parameter Setting Changes

1. INSTALL and PRIME the THERAKOS™ CELLEX™ Photopheresis Procedural Kit according to the instructions in the THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual.

a. Check for leaks before proceeding.

b. Via SETUP, set the Return Bag Threshold Value to 100mL.

c. Use the default Fluid Balance settings of +/- 500mL.

d. Enter additional parameter setting changes as desired. Save all entries.

2. PRIME ACCESS

a. Close both Y-Connector clamps. Attach Y-Connector to patient Collect Line.

b. Open one Y-Connector clamp and the Collect Line (RED) Clamp and press START to prime access. Repeat by pressing PRIME, if necessary, until fluid reaches the tip. Close the Y-Connector clamp.

c. Open the second Y-Connector clamp and press PRIME to complete PRIME ACCESS. Close all clamps.

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Blood Prime 10-15


3. ESTABLISH ACCESS

a. Use Transfer Set to connect pRBC unit to one arm of Y-Connector.

b. Establish and connect patient COLLECT access to other arm of the Y-Connector. Flush to maintain patency until Centrifuge Bowl blood prime is complete.

c. Establish and flush patient RETURN access site. Do not connect the second patient access site to the RETURN Line. Keep the Return Line attached to the Collect Line needle-free injection port and leave the (BLUE) Clamp open.

Priming the Collect Line, Centrifuge Bowl and Return Line with packed Red Blood Cells

✎NOTE:

Single Needle Mode software and line configuration is used to prime the Centrifuge Bowl and Return Line with packed red blood cells. In this mode, prime solution is diverted to the packed red blood cell bag to minimize fluid return to the patient.

4. Select and confirm SINGLE NEEDLE mode.

5. Open clamp to pRBCs and Collect Line (RED) Clamp. Press START to begin DRAWING / PURGING AIR. Continue this process until an audible cadence indicates that RETURNING has begun.

6. RETURNING will prime the blood filter and the patient Return Line and divert prime solution to the packed red blood cell bag. Allow RETURNING to continue until the next audible cadence when DRAWING begins again. Repeat DRAWING / RETURNING once again to raise the plasma / red blood cell interface to the level of the laser in the Centrifuge Bowl.

7. Select PAUSE.

Cell Collection from the Patient

✎NOTE:

REMINDER: There is a ten-minute limit for PAUSE. Press STOP if more than 10 minutes is required to connect the patient.

8. Record the FLUID BALANCE reading. This is the value you will use as “zero” for the duration of the treatment.

9. Record the Whole Blood Processed Volume on the Operator Interface Screen. This represents the volume of packed red blood cells used for priming the Centrifuge Bowl.

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Rev. 4.0-1460451

✎NOTE:

• The operator interface displays FLUID BALANCE as fluid enters and leaves the COLLECT and RETURN Lines. It is not currently possible to reset this value at the end of a blood prime. Note the value at the time that the patient is connected and use this value as the FLUID BALANCE “zero”.

• Approximately 230mL of a packed red blood cell unit with a hematocrit of 57% will be required to prime the Collect Line, Centrifuge Bowl and the Patient RETURN Line.

• An additional 100mL of volume from the packed red blood cell bag must be available if it is to be used during BUFFY COAT to push out the buffy coat or to re-purge the Centrifuge Bowl in a troubleshooting scenario. Diverting the prime solution to this bag will provide that volume.

10. Close the (BLUE) Clamp and separate the Return Line from the Collect Line. Connect the Return Line to the patient’s RETURN access and open all RETURN access clamps.

11. Select DOUBLE NEEDLE and confirm. The screen display icon should now represent Double Needle.

12. Close clamp to pRBC unit.

13. Open patient COLLECT access clamps.

14. Press START to begin processing whole blood from the patient.

15. Set the COLLECT and RETURN Flow Rates to match. At this point, for every red blood cells that is drawn from the patient a red blood cells will be returned to the patient, keeping both the intravascular fluid volume and circulating red blood cells volume constant.

16. Carefully monitor the patient, the line pressures, flow rates and fluid balance. Continue until you have processed the desired amount of whole blood from the patient.

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Blood Prime 10-17


Initiating BUFFY COAT

✎NOTE:

If there is insufficient volume remaining in the packed red blood cell bag and if the patient is able to tolerate a temporary fluid deficit you may draw from the patient during BUFFY COAT.

• The whole blood volume required to displace the buffy coat is hematocrit dependant.

• The average volume required to displace a buffy coat is 100-150mL.

• Low hematocrits may require whole blood volumes as high as 280mL to displace the complete buffy coat.

17. Press PAUSE. Close the patient COLLECT access clamp and open the pRBC unit clamp.

18. Press SETUP. Lower the Whole Blood Processed Target as far as possible. SAVE.

19. Press START to begin BUFFY COAT.

20. Lower the RETURN Flow Rate to 0mL/min.

Once BUFFY COAT collection is completed the COLLECT Line access is no longer needed and may be disconnected. The contents of the Centrifuge Bowl (approximately equal to the volume of packed red blood cells used for PRIMING BOWL) will be emptied into the Return Bag during EMPTYING BOWL / RECIRCULATING.

RETURNING

21. RETURNING will begin automatically once EMPTYING BOWL is complete. Lower the Return Flow Rate to zero to prevent returning the packed red blood cells volume to the patient.

✎NOTE:

KVO to the Return Line is not active. Flush the Return Access to maintain patency during PHOTOACTIVATE.

PHOTOACTIVATE

22. Dose and inject the 8-methoxypsoralen as directed and press to begin PHOTOACTIVATE.

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Rev. 4.0-1460451

REINFUSION

The normal sequence of events is to return most of the fluids from the Return Bag and then proceed to reinfusing the treated cells. In the Blood Prime process, you may change the sequence of events and reinfuse the treated cells first.

✎NOTE:

• Watch for the MINUTES REMAINING to go to 00.00

• Watch for the UVA lights to go off

• Listen for the fans to turn off

23. At the completion of PHOTOACTIVATE press END TREATMENT and confirm.

24. Adjust the RETURN Flow Rate on the Operator Interface from 0mL to whatever rate is appropriate for the patient between 5mL and 100mL. The instrument will reinfuse the treated cells from the Treatment Bag and then proceed automatically to return fluids from the Return Bag.

✎NOTE:

Listen for the audible cadence indicating REINFUSION is complete. Press .

Completing the Treatment

25. Note the volume in the Return Bag. Gently mix the contents of the Return Bag. Press START and return approximately 20mL to flush the treated cells from the Return Line to the patient.

26. Use clinical judgement to determine if any additional volume should be returned to the patient.

✎NOTE:

The estimated hematocrit in the Return Bag following Emptying Bowl is approximately 55% (140mL red blood cells from Centrifuge Bowl in approximately 250mL total fluids).

27. Press ABORT TREATMENT and confirm.

28. Clamp all lines. Press RELEASE KIT.

29. Record treatment data and remove procedural kit before turning the power off.

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SECTION 11: GLOSSARY AND SYMBOLS

8-methoxypsoralen (8-MOP™): A light-sensitive medication that is biologically inert until it is activated by specific wavelengths of UVA energy.

Abnormal plasma: Plasma is visually examined for color. Normal plasma should be clear or pale yellow in color. The pale yellow color is due to the presence of carotenes which are yellow pigments found in a variety of plant materials, including some seeds. Some abnormal plasma conditions may warrant an adjustment of the Bowl Optic Sensor, such as:

• Dark yellow colored plasma is icteric plasma. In mammals, icterus or jaundice is due to increased amounts of bilirubin pigments in plasma as a result of liver disease.

• White or milky colored plasma is lipemic, which is due to the presence of fat. Lipemic plasma is most commonly seen if blood is drawn shortly after a meal high in fat. Sometimes the plasma will always appear mildly lipemic. Medication, liver or pancreatic disorders can cause lipemia.

• Pink color in the plasma is due to hemolysis, which is the breaking apart of RBC’s and the subsequent release of red hemoglobin molecules into the plasma. Hemolysis is most commonly caused by improper handling of blood, such as forcibly expelling blood through the needle, over-centrifugation or mechanical trauma from the peristaltic pumps. If hemolysis is observed during a photopheresis treatment the therapy must be aborted and blood should not be returned to the patient.

Abnormal Red Blood Cell Morphology: Any variation from normal in size, shape or color of erythrocytes as indicated in high or low values of red blood cell indicies such as MCV, MCHC, MCH or RDW in a complete blood cell count laboratory analysis.

Figure 123: Normal and Abnormal Red Blood Cell Morphology

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Section 11: GLOSSARY AND SYMBOLS

Rev. 4.0-1460451

Abort Treatment: Interruption of a photopheresis treatment that results in termination of the treatment without any further fluid return to the patient.

A/C Ratio: The relationship of peristaltic pump flow rates between anticoagulant delivery and whole blood as it is drawn into the instrument.

Air Detector: An ultrasonic pulse sensor that detects air bubbles in Patient COLLECT and RETURN, Anticoagulant, Treatment Bag and Return Bag Lines. The Air Detector may also be referred to as the Air Sensor.

Alarm: Mechanical monitoring device that serves to warn of a technical problem by means of an audio signal. Safety precautions to prevent fluid movement are activated in some alarm states.

Anemia: A condition characterized by abnormally low levels of healthy red blood cells or hemoglobin (the component of red blood cells that delivers oxygen to tissues throughout the body).

Anticoagulant Line, Spike and Drip Chamber:

• Line: Tubing line that delivers anticoagulant solution during the procedure.

• Spike: Sharp hollow adapter used to access to the port of the anticoagulant solution bag.

• Drip Chamber: Hollow cylinder with inlet and outlet to monitor anticoagulant fluid levels.

Bearing: A structural part that supports, guides, and reduces the friction of motion between fixed and moving machine parts.

Bowl Optic Sensor: Red laser sensor located in the Centrifuge Chamber, used to detect and maintain the position of the plasma / red blood cell interface in the spinning Centrifuge Bowl.

Buffy Coat: A leukocyte-enriched blood fraction containing plasma, leukocytes and erythrocytes.

BUFFY COAT: A THERAKOS™ Photopheresis phase in which the leukocyte-enriched blood fraction is displaced from the Centrifuge Bowl by the addition of more whole blood and routed to the Treatment Bag.

Buffy Coat Volume per Cycle: The volume of plasma, leukocytes and red blood cells added to the Treatment Bag during a single BUFFY COAT phase. This volume does not include prime solution that is already in the Treatment Bag and Photoactivation Module at the end of PRIME.

CAUTION: Use careful forethought to minimize risk of mistakes that may lead to a failed treatment or cause physical harm to the patient or photopheresis operator.

Centrifuge: Machine used to separate blood components by their density using centrifugal force.

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Centrifuge Assembly: Includes the following component parts: 1) Centrifuge Frame 2) Upper and Lower Bearing Retainer Clips 3) Fluid Leak Detector 4) Centrifuge Bowl Holder 5) Drive Tube Clamp Assembly and 6) Tubing Guide and Tubing Exit Slot.

Centrifuge Bowl: Sterile, disposable chamber used in the Centrifuge to hold the blood.

Centrifuge Bowl Holder: Free spinning platform used to hold the Centrifuge Bowl. It spins at a rate of 4800 revolutions per minute.

Centrifuge Bowl Drive Tube: A triple lumen tube that provides whole blood entry and simultaneous plasma and red blood cell exit from the spinning Centrifuge Bowl. Because the tube is secured to the spinning Centrifuge Frame and attached to the free rotational Centrifuge Bowl it is responsible for driving the rotation of the Centrifuge Bowl.

Centrifuge Chamber Door Manual Release Access: Rotational latchkey that allows manual opening of a locked Centrifuge Chamber Door in the event of an instrument malfunction or power outage. A flat head screwdriver is required to turn the latchkey.

Centrifuge Frame: Central axis of the Centrifuge spun at a rate of 2400 revolutions per minute by the Centrifuge motor. The Centrifuge Bowl Drive Tube is secured to this frame and spins at the same rate.

Clamp Release Tool: a Tool required to disengage a Fluid Routing Valve in the event of a power failure or instrument malfunction. Used in Manual Blood Return w/o Power or Access to the Release Kit Button.

COLLECT: Phase of operation used to harvest the leukocyte-enriched fraction of the processed whole blood. Includes as sub-phases: DRAWING, RETURNING, BUFFY COAT and EMPTYING BOWL. Designed to be accomplished with only one cycle, but may be divided into as many as three cycles.

Cutaneous T-Cell Lymphoma: A papulosquamous disorder in which collections of atypical lymphocytes are found in the epidermis or dermis.

Cycle Volume Target: The volume at which the instrument automatically proceeds from DRAWING to BUFFY COAT. This volume is calculated by the instrument and is dependant on the number of collection cycles selected by the operator.

Default Parameter(s): A particular setting(s) or value for a variable that is assigned automatically by an operating system and remains in effect unless canceled or overridden by the operator.

Double Needle Mode: Software program written to manage the continuous flow process of drawing and simultaneously returning fluids to and from the patient during a photopheresis therapy.

DRAWING: Sub-phase of COLLECT where whole blood is drawn from the patient using the negative pressure of roller pump #1. The whole blood is routed to the Centrifuge, plasma is expressed from the top of the Centrifuge Bowl and red blood cells are removed from the bottom of the Centrifuge Bowl allowing the leukocyte fraction to expand within the Centrifuge Bowl. The DRAWING phase continues until the cycle volume target is reached, at which time the software advances to BUFFY COAT.

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Rev. 4.0-1460451

Drive Tube Clamp Assembly: Groove, latch and clamp that secures the base of the Centrifuge Bowl Drive Tube and routes the three internal tubing lines to the Pump Tubing Organizer.

Early Photoactivation: A treatment interruption that directs the instrument to proceed immediately to PHOTOACTIVATE without processing any additional whole blood.

ELUTRIATING: “To wash out”. Plasma is used “to wash out” additional leukocytes from the packed red blood cells layer in the Centrifuge Bowl during BUFFY COAT. This sub-phase is automatic.

EMPTYING BOWL: The sub-phase that follows BUFFY COAT, used to transfer the packed red blood cells from the Centrifuge Bowl to the Return Bag, just prior to PHOTOACTIVATE.

END TREATMENT: Treatment interruption that results in stopping the therapy and returning all blood and fluids to the patient immediately. Cells may not have been photoactivated.

Erythrocyte: Red Blood Cell.

Erythroderma: Abnormal redness of the skin. A phase of exfoliative dermatitis.

Filtered Blood Administration Set: A commercially available sterile tubing system that includes a 200-micron filter suitable for blood transfusion, a spike port adapter and luer connection.

FLUID BALANCE: Operator Interface screen display that estimates the fluid volumes taken from and given to the patient during a treatment. Fluids included in the estimation are whole blood, saline and anticoagulant. Pump Head rotation as well as Load Cell data are combined to estimate volumes.

Fluid Leak Detector: A sensor located on the wall and floor of the Centrifuge Chamber and floor of the Photoactivation Chamber that detects blood or fluid leaks and alerts the operator with an alarm when unexpected fluid or humidity is present.

Fluid Routing Valves: Mechanical devices controlled by the instrument software to direct the flow of fluid through the tubing lines of the Pump Tubing Organizer.

Hematocrit Cuvette: A cuvette located on the Treatment Bag collect line. It works in conjunction with the Hematocrit Sensor to determine the hematocrit of the blood and Buffy Coat.

Hematocrit Sensor: Sensor that detects the hematocrit of the blood as it enters the Treatment Bag and detects the hematocrit of the Buffy Coat (or Final Treatment Volume) to help determine the duration of UVA exposure necessary for photoactivation.

Hemostats: A clamp like instrument used to compress a blood vessel in order to reduce or arrest the flow of blood during surgery. Used to clamp Procedural Kit tubing lines during the Manual Blood Return process.

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Heparin: A complex organic acid found especially in lung and liver tissue, which has a mucopolysaccharide as its active constituent, prevents platelet agglutination and blood clotting, and is used in the form of its sodium salt in the treatment of thrombosis.

Instrument ID Tag: Label found on the back of the THERAKOS™ CELLEX™ Photopheresis System that contains the Model Number, Serial Number, Date of Manufacture, voltage, weight and fuse information, as well as patent numbers. Cautions to: order by physician only, use hospital grade receptacles, check grounding periodically, risk of explosion if used in the presence of anesthesia.

KVO: Keep Vein Open. An automatic flow of anticoagulant solution to the COLLECT Line or heparinized plasma to the RETURN line that begins any time the instrument is PAUSED or STOPPED during a treatment. The KVO flow rate is 10mL/hour and is independent of the A/C ratio.

Lamp Failure: Automatic detection of a single lamp malfunction or of light emission below an acceptable treatment intensity.

Lamp Life Remaining: Hours of lamp usage available on the installed light assembly that remain within the therapeutic light intensity required.

Leukocyte: White blood cell.

Light Assembly: Collection of lamps, validated and quality controlled for even distribution, energy decay and performance, used to deliver the UVA energy during PHOTOACTIVATE.

Line Configuration: The position of the connections of the Patient COLLECT and RETURN Lines to the patient access sites and to each other in either SINGLE NEEDLE or DOUBLE NEEDLE modes of operation.

Load Cell Hook: An electronic device (transducer) that is used to convert a force into an electrical signal. Used to estimate the volume of fluid in the Treatment Bag and Return Bag to in turn estimate FLUID BALANCE during a photopheresis treatment.

Manual Blood Return: A process that aseptically drains all blood and fluids from the Procedural Kit and allows return to the patient through a filtered blood administration kit. It is used only in the event of an instrument malfunction or prolonged power outage.

Methoxsalen (20 micrograms / mL): Sterile liquid formulation of 8-methoxypsoralen (8-MOP™).

MUTE: An operator-initiated command to silence an audible alarm signal.

NOTE: A comment, explanation or tip to aid in memory or successful execution of the photopheresis therapy.

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Rev. 4.0-1460451

Operator Interface: Instrument display monitor with integrated touch screen.

Operator Interface Display Detail:

Main screen provides visual and numeric tracking of treatment progress.

Text Screen 1: Summarizes the Treatment

Text Screen 2: Summarizes the Buffy Coat Collection(s)

Patient Lines: Tubing lines that are used to collect whole blood from and return blood components, anticoagulant and / or saline to the patient.

PAUSE: A brief (limited to 10 minutes) intentional interruption of the treatment that allows the operator to change setup parameters, administer a saline bolus, flush access site(s) while maintaining cell separation in the spinning Centrifuge Bowl. The instrument automatically initiates KVO maintenance of the COLLECT and RETURN Lines during PAUSE.

Peristaltic Pump: A device for moving fluids by the action of multiple, equally spaced rollers, which rotate and compress a flexible tube.

Phases: Titled steps of the THERAKOS™ Photopheresis therapy including:

(Sub-phases are listed below each phase)

PRIME SELECT COLLECT PHOTOACTIVATE REINFUSE TREATMENT

COMPLETE

PRIMING SINGLE

NEEDLE

ESTABLISH ACCESS UVA ON REINFUSING CLAMP PATIENT

LINES

PRIME ACCESS

DOUBLE NEEDLE

PURGING AIR RECIRCULATING RINSING RELEASE KIT

DRAWING

BUFFY COAT

ELUTRIATING

EMPTYING BOWL /

RECIRCULATING

RETURNING

Table 15: Phases of THERAKOS Photopheresis

Photoactivation Chamber: Instrument compartment that houses the THERAKOS™ CELLEX™ Light Assembly and the Photoactivation Module.

Photoactivation Module: A molded, validated and quality-controlled for UVA-transparency and sterility, acrylic module containing sterile fluid serpentine pathways through which the Buffy Coat is exposed to the UVA light. Module may also be referred to as “plate”.

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PHOTOACTIVATE: The THERAKOS™ Photopheresis phase in which the Buffy Coat is exposed to an automatically calculated, controlled dose of UVA energy and an operator-injected specific dose of medication, both of which have been validated with post-treatment cell viability testing.

Photopheresis: THERAKOS™ Photopheresis is a leukopheresis-based, immunomodulatory therapy that integrates the use of a medical device, one sterile disposable procedural kit and a psoralen medication. All components are regulated and quality controlled to be used as a complete closed system providing ultimate safety of the patient and maximum efficacy to the patient.

Popup Message: Informational or confirmatory statements that appear on the main screen of the Operator Interface Display at various times throughout the treatment and require acknowledgement by the operator to clear.

Power Cord Wrap Cleats: Projecting arms on which the power cord can be wound and secured.

Pressure Sensors (Domes and Transducers): Instrument components that detect a fluid pressure and produce an electrical signal related to the pressure. Also known as electrical pressure transducers. Used to monitor procedural kit line pressures and the internal pressure of the spinning Centrifuge Bowl.

Procedural Kit: (Part #: CLXECP) A custom made, regulated, patented, sterile, single use only, disposable tubing set made specifically to aseptically contain the patient’s whole blood while undergoing a THERAKOS™ Photopheresis therapy.

Pump Deck: Working surface of the THERAKOS™ CELLEX™ Photopheresis System that supports the Pump Tubing Organizer and contains the Fluid Routing Valves, Hematocrit Sensor, Air Detectors and Tubing Guides.

Pump Tubing Organizer: A cassette designed to integrate all of the peristaltic pump tubing for easy loading and fluid management during the treatment.

Pump Tubing Organizer Mold Indents: Fabricated notches that allow proper alignment and installation of the Pump Tubing Organizer on the Pump Deck.

Pump Tubing Segment: The length of procedural kit tubing that wraps around each peristaltic pump to provide fluid movement.

RESET: An operator-initiated command to return instrument to the ready state required to resume a treatment following an alarm interruption.

Retainer clip: A device or groove designed to restrain or guide. Used to guide the Centrifuge Bowl Drive Tube to maintain the shape of the Centrifuge Frame and to secure it to the frame to ensure that it spins at the same speed as the frame. Also used to secure the Centrifuge Bowl to the Centrifuge Bowl Holder.

Return Bag: Disposable procedural kit bag used to pool the untreated blood components to be returned to the patient.

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Rev. 4.0-1460451

RETURNING: The THERAKOS™ Photopheresis phase that routes all blood components, excluding the leukocyte enriched fraction, back to the patient using pump #3.

Saline: A 0.9% Normal salt solution that is isotonic with blood.

Saline Bolus: Direct infusion of 100mL (default volume) of 0.9% Normal saline.

Saline Line, Spike and Drip Chamber:

Line: Tubing line that delivers 0.9% Normal saline solution during the procedure.

Spike: Sharp hollow adapter used to access the port of the saline solution bag.

Drip Chamber: Hollow cylinder with inlet and outlet to monitor saline fluid levels.

Single Needle Mode: Software programs designed to manage the discontinuous flow process of intermittently drawing, pooling and then returning fluids to and from the patient during a photopheresis therapy using a single access device.

Specific Gravity (SG): A unitless quantity that gives the scientist or engineer an idea of how dense a substance is compared to water. The density of water, which is one kilogram per liter (at 4 degrees C), is assigned a SG of 1.000. If a substance is denser than water, it will have a SG greater than 1.000; if it is less dense than water, its SG will be a value less than 1.000 (but greater than zero).

Smart Card: An integral part of the disposable procedural kit. Data pertaining to the instrument function and the patient treatment is recorded on the Smart Card as the START button is pressed to initiate PRIME.

Smart Card Port: Receptacle in the Operator Interface Screen into which the Smart Card is placed.

Sterility: As it pertains to the procedural kit refers to the microenvironment made free of infectious agents by exposure to ethylene oxide. “Sterilized with Ethylene Oxide” labeling requires meeting all testing requirements for no viable organisms, endotoxins, biocompatibility and residual levels of ethylene oxide following sterilization and required quarantine time prior to shipping.

STOP: An operator initiated treatment interruption that halts the spinning of the Centrifuge as well as all other functions until directed to resume. The instrument activates KVO maintenance of the COLLECT and RETURN Lines while stopped. Cell separation is lost and the plasma / red blood cells interface must be re-established before the treatment may be resumed.

STOP (Automatically): An instrument initiated response to alarm conditions that require stopping the Centrifuge. Once the alarm condition is resolved the Centrifuge Bowl must be re-purged before treatment may resume. A partial loss of the concentrated leukocyte-enriched blood fraction will occur.

System Error: A coded alarm message indicating a technical problem that may be resolved by re-booting the computer, but most often requires technical support and / or service to be resolved.

Treatment Bag: Disposable procedural kit bag which contains the Buffy Coat and is part of the recirculation loop during PHOTOACTIVATE.

Treatment Volume: The total volume of Buffy Coat plus prime solution that will undergo photoactivation. The number is displayed on Text Screen 1 and directly below the Photoactivation Module icon on the main display screen. This volume is used to determine the proper dose of 8-methoxypsoralen and the proper dose of UVA irradiation.

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Tubing Guides: Tracks designed to organize and stabilize tubing of the procedural kit during a treatment. Tracks are found at the base of the Centrifuge Chamber to stabilize the three tubing lines from the Centrifuge Drive Tube to the Pump Tubing Organizer and also at the front of the Pump Deck to stabilize Patient Lines, Treatment Bag Line, Return Bag Line and Anticoagulant Line.

Tyvek™ Lid: Tyvek is a brand of spunbonded olefin, a synthetic material made of high-density polyethylene fibers; the name is a registered trademark of the DuPont Company. Water vapor and ethylene oxide can pass through Tyvek, but not liquid water.

UVA: Ultra Violet-A radiation.

WARNING: Advice to beware of impending danger that may lead to a failed treatment or cause physical harm to the patient or photopheresis operator.

Wetted: A form of priming that uses anticoagulant solution to prepare various components of the Procedural Kit prior to performing a treatment.

Wheel Locks: Clamps that prevent movement of the instrument wheels when engaged.

Whole Blood Processed Target: The desired amount of whole blood to be drawn from the patient during a photopheresis treatment and Centrifuged to extract the leukocyte-enriched fraction. The default setting is 1500mL. The possible target range is 500-2000mL.

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Rev. 4.0-1460451

SYMBOLS

Attention, See Instructions for Use

Authorized Representative in the European Community

Contents Fragile

Date of Manufacture

For Single Use Only (Do not reuse)

Lot Number

Manufacturer

Reorder Number

Serial Number

Sterilized by Ethylene Oxide

(-20 °C to 50 °C) THERAKOS™ CELLEX™ Photopheresis Procedural Kit Temperature Limitations

(0 °C to 57 °C) THERAKOS™ CELLEX™ Instrument Temperature Limitations

Use by Date

Do Not Dispose of Instrument without following local directives as prescribed by CENELEC standard EN50419, dated December 7th, 2004

UV Light symbol warning: Do Not Operate with Cover Removed!

The procedural kit contains the phthalate DEHP

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Revision Table 12-1


SECTION 12: REVISION HISTORY

2010-12-31 Software Version: CLX 3.0…………………………….12-1

This section provides a place for you to store CELLEX revision histories released by Therakos™.

Revision Table:

2010-12-31 Software Version: CLX 3.0

Revision to

Chapter/Section/Topic/Appendix

Pages Description

Front Matter ii • Updated for this revision of the gude.

Table of Contents All • Generated for this version of the guide.

Section 5. Operating the Therakos™ CELLEX™ Photopheresis System

5-28 to 5-29 • Added information about the centrifuge bowl during the RETURN phase.

Section 6. Correcting Alarms 6-3 • Added information regarding the RESET button.

6-9 • Added additional information to Centrifuge Chamber Door alarm.

6-14 • Added information to Blood Pump Error alarm.

6-23 • Added information to System Pressure alarm.

6-29 • Updated information about the System Pressure Test Failure alarm.

Revision History 12-1 • First entry in revision history. Includes all updates for software version 3.0 and documentation version 4.0.

Index All • Generated for this version of the guide.

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Section 12: REVISION HISTORY

Rev. 4.0-1460451

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IN-i


IN-iIndex

INDEX IndexSymbols

8-MOP (8-methoxypsoralen) 2-10, 11-1

A

abnormal plasma 5-19Abnormal Plasma 6-49

adjusting Bowl Optic Threshold for 6-49defined 11-1

Abnormal Red Blood Cells Morphology 5-19defined 11-1

Abort Treatment 5-40, 5-59, 5-64, 5-67, 6-12, 6-13, 9-7

defined 11-2how to 5-68reasons to 5-68

A/C Ratio 5-11, 5-16, 5-10, 5-15, 8-7, 2-13, 2-13changing the 5-16

Air Detector 3-15, 5-43, 5-62, 6-26, 6-32, 6-37, 6-39, 6-40, 6-41, 6-42, 6-43, 6-44, 6-45, 6-53, 6-54, 6-55, 7-2, 7-3, 9-8

defined 11-2described 3-15

alarm 1-1, 3-6, 3-13, 3-15, 3-20, 3-21, 4-23, 5-9, 5-16, 5-18, 5-19, 5-33, 5-36, 5-39, 5-52, 5-55, 5-58, 5-64, 5-65, 6-1, 6-2, 6-6, 6-7, 6-8, 6-9, 6-10, 6-11, 6-12, 6-13, 6-14, 6-15, 6-16, 6-17, 6-18, 6-19, 6-20, 6-21, 6-22, 6-23, 6-24, 6-25, 6-26, 6-27, 6-28, 6-29, 6-30, 6-31, 6-32, 6-33, 6-34, 6-35, 6-36, 6-37, 6-38, 6-39, 6-40, 6-41, 6-42, 6-43, 6-44, 6-45, 6-46, 6-47, 6-48, 6-49, 6-50, 6-51, 6-52, 6-53, 6-54, 6-55, 7-7, 8-10, 9-6, 9-7, 11-2, 11-4, 11-5, 11-7, 11-8

Alarm 1-1, 3-2, 3-6, 3-13, 3-15, 3-20, 3-21, 4-7, 4-18

defined 11-2Alerts 6-56Anemia 11-2Anticoagulant Line 3-15, 3-33, 4-18, 6-6, 6-32,

6-44, 11-2, 11-9defined 11-2

B

Bearing 3-18, 4-2, 4-10, 4-12, 4-13, 9-6, 11-2, 11-3Bowl Optic Sensor 3-18, 3-19, 5-2, 5-19, 5-26,

5-49, 7-1, 7-3, 8-11, 9-8, 11-1, 11-2defined 11-2

Buffy Coat 2-1, 2-6, 2-10, 3-1, 3-7, 3-8, 3-9, 3-10, 3-11, 3-14, 3-19, 3-26, 3-27, 3-30, 3-31, 5-1,

5-2, 5-3, 5-7, 5-26, 5-30, 5-31, 5-34, 5-38, 5-40, 5-41, 5-49, 5-50, 5-53, 5-57, 5-59, 5-60, 5-64, 5-66, 5-70, 5-74, 6-15, 6-38, 8-8, 9-2, 9-8, 11-2, 11-4, 11-6, 11-7, 11-8

BUFFY COAT 3-9, 3-10, 3-14, 3-15, 3-31, 5-1, 5-2, 5-12, 5-15, 5-17, 5-27, 5-30, 5-31, 5-37, 5-38, 5-39, 5-49, 5-50, 5-56, 5-57, 5-58, 5-64, 5-66, 6-15, 6-19, 6-20, 6-50, 9-7, 10-8, 10-10, 10-12, 10-16, 10-17

defined 11-2Buffy Coat Volume per Cycle 3-11, 6-15, 11-2

defined 11-2

C

CAUTIONdefined 11-2summary of 6-15

Centrifuge 3-1, 3-2, 3-4, 3-10, 3-12, 3-14, 3-18, 3-19, 3-20, 3-23, 3-24, 3-25, 3-27, 3-31, 3-33, 5-2, 4-2, 4-6, 4-9, 4-10, 4-11, 4-12, 4-13, 4-16, 4-23, 5-1, 5-2, 5-6, 5-7, 5-9, 5-18, 5-19, 5-24, 5-26, 5-30, 5-31, 5-33, 5-36, 5-37, 5-38, 5-39, 5-40, 5-41, 5-44, 5-46, 5-49, 5-50, 5-52, 5-55, 5-56, 5-57, 5-58, 5-59, 5-60, 5-63, 5-64, 5-65, 5-66, 5-69, 5-71, 5-73, 5-74, 5-75, 5-76, 6-1, 6-4, 6-6, 6-9, 6-12, 6-23, 6-32, 6-34, 6-35, 6-36, 6-38, 6-49, 6-50, 6-51, 6-52, 7-1, 7-2, 7-3, 7-4, 7-5, 7-6, 8-1, 8-2, 8-11, 9-2, 9-5, 9-6, 9-7, 9-8, 10-2, 4-2, 11-2, 11-3, 10-7, 10-9, 10-10, 10-12, 10-13, 10-15, 10-16, 10-17, 10-18

Assembly 3-18, 3-19, 4-2, 4-11, 11-3defined 11-2Frame 3-18, 4-2, 4-10, 4-12, 4-13, 7-6, 9-6, 11-3,

11-7Centrifuge Bowl 3-1, 3-10, 3-14, 3-18, 3-19, 3-20,

3-23, 3-24, 3-25, 3-27, 3-31, 3-33, 4-2, 4-6, 4-9, 4-11, 4-13, 4-16, 5-1, 5-2, 5-6, 5-7, 5-9, 5-18, 5-19, 5-24, 5-26, 5-30, 5-31, 5-33, 5-36, 5-38, 5-39, 5-40, 5-41, 5-44, 5-46, 5-49, 5-50, 5-52, 5-55, 5-57, 5-58, 5-59, 5-60, 5-63, 5-64, 5-66, 5-71, 5-75, 5-76, 6-1, 6-2, 6-6, 6-12, 6-23, 6-32, 6-34, 6-35, 6-36, 6-38, 6-49, 6-50, 6-51, 6-52, 7-1, 8-1, 9-2, 9-5, 9-6, 9-7, 10-2, 10-7, 10-9, 10-10, 10-12, 10-12, 10-13, 10-15, 10-16, 10-17, 10-18

defined 11-2described 3-27drive tube 3-18, 4-16, 5-49, 11-3, 11-4, 11-7holder 3-18, 4-2, 4-11, 5-44, 5-63, 11-3, 11-7installing 4-9removing 5-44, 5-63

Centrifuge Chamber 3-2, 3-4, 3-18, 3-20, 4-2, 4-6,

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1460451-Rev4.1 Strictly Confidential.Please verify that most recently issued document is used Page: 294 of 301THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual

THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual IN-ii

Rev. 4.0-1460451

4-23, 6-4, 5-9, 5-44, 5-63, 5-69, 5-73, 5-74, 6-4, 6-9, 6-12, 6-51, 6-52, 7-2, 7-3, 7-4, 7-6, 9-6, 9-8, 4-2, 11-2, 11-3, 11-4

Centrifuge Chamber DoorManual Release Access 3-20, 5-74, 11-3

Changing Default SETUP Parameters 5-11Clamp Release Tool

defined 11-3Cleaning 3-26, 5-4, 7-1, 7-2

Bowl Optic Lens 7-3Centrifuge Chamber 7-4Hematocrit Sensor 7-5Operator Interface 7-5outside of instrument 7-4pressure transducers 7-5supplies 7-2

Clock Setting 5-13setting 6-56

COLLECT 3-6, 3-8, 5-1, 5-4, 5-5, 5-7, 5-11, 5-12, 5-15, 5-16, 5-23, 5-25, 5-26, 5-28, 5-36, 5-37, 5-38, 5-39, 5-41, 5-45, 5-47, 5-48, 5-55, 5-56, 5-57, 5-58, 5-60, 5-64, 5-65, 5-66, 6-1, 6-6, 6-21, 6-23, 6-38, 6-51, 7-5, 8-12, 9-1, 9-2, 9-3, 9-7, 10-1, 10-4, 10-5, 10-8, 10-9, 10-10, 10-11, 10-12, 10-13, 10-13, 10-15, 10-16, 10-17

described 5-1Double Needle Mode 5-22Limits 5-11Single Needle Mode 5-21

Cutaneous T-cell lymphoma 2-1, 11-3defined 11-3

Cycle Volume Target 5-17, 5-18, 5-27, 5-30, 5-37, 5-38, 5-39, 5-49, 5-56, 5-57, 5-58, 11-3

defined 11-3

D

Default SETUP Parameter Settings 5-11, 5-15, 9-2changing 5-11defined 11-3

Dose 2-1, 2-8, 5-32, 5-32, 5-51, 5-51, 6-8, 6-10, 5-51, 6-7, 6-9, 6-56, 7-8, 9-1, 9-4, 2-13, 9-1, 2-10, 3-22

heparin 2-1, 5-16, 5-18, 4-20, 2-13, 2-13liquid medication 2-6, 2-8, 2-9, 5-32, 5-51oral medication 2-10UVA 2-1, 2-6, 2-8, 5-3, 5-4, 6-8, 3-14, 3-21, 3-22,

6-10, 6-7, 6-9, 6-55, 6-56, 7-8, 8-8, 9-1, 9-5, 9-1, 11-1, 11-4, 11-5, 2-10, 10-18, 3-22

Double Needle Mode 2-1, 3-1, 3-27, 5-16, 5-20, 6-21, 5-22, 6-38, 5-45, 5-46, 5-48, 5-50, 5-52, 5-53, 5-54, 5-55, 5-56, 2-14, 6-37, 6-38, 10-1, 10-9, 10-10, 10-11, 5-46, 10-12

defined 11-3fluid balance management 10-9

line configuration 5-22DRAWING 5-2, 5-12, 5-17, 6-22, 5-25, 5-26, 5-27,

5-28, 5-30, 5-41, 5-47, 5-48, 5-49, 5-50, 5-59, 5-60, 6-21, 2-15, 10-8, 10-9, 10-10, 2-14, 5-28, 5-29, 10-10, 10-13, 10-15

defined 11-3described 5-1double needle mode 5-48single needle mode 5-26

Drive Tube Clamp Assembly 3-17, 4-9, 4-10, 4-13, 9-6, 11-3, 11-4


E

Early Photoactivationdefined 11-4

ELUTRIATING 5-50, 11-6defined 11-4

EMPTYING BOWL 5-1, 5-2, 5-29, 5-31, 5-37, 5-38, 5-39, 5-50, 5-56, 5-57, 5-58, 5-66, 11-3, 11-4, 10-17

defined 11-4described 5-31, 5-50

END TREATMENT 5-40, 5-59, 5-64, 5-67, 9-7, 10-18defined 11-4

Erythrocyte 11-4Erythroderma

defined 11-4ESTABLISH ACCESS 5-23, 5-45, 10-15

F

Filtered Blood Administration Set 5-69, 5-72, 11-4, 11-5FLUID BALANCE 6-23, 6-38, 6-51, 9-1, 9-2, 9-3, 10-1,

10-4, 10-5, 10-9, 10-10, 10-11, 10-12Fluid Management System 3-12Fluid Routing Valves 3-12, 3-17, 4-11, 4-20, 5-30, 5-49,

5-50, 5-73, 6-16, 9-5, 11-4, 11-7defined 11-4

H

Hematocrit Cuvette 3-9, 3-14, 3-23, 3-25, 3-31, 4-19, 4-23, 5-43, 5-62, 6-36, 9-6, 11-4

defined 11-4installation of 4-19

Hematocrit Sensor 3-12, 3-14, 3-31, 4-19, 4-23, 5-2, 5-30, 5-43, 5-49, 5-62, 6-15, 6-36, 7-1, 7-2, 7-5, 9-8, 11-4, 11-7

cleaning 7-5defined 11-4described 3-14

Hemostats 5-69, 11-4

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IN-iiiIndex

defined 11-4Heparin 2-1, 5-16, 5-18, 4-20, 2-13, 2-13

defined 11-5dose 5-69, 11-4setup instructions 4-20

I

Installingcentrifuge bowl 4-9hematocrit cuvette 4-19lines into air detector 4-16photoactivation module 4-5pump tubing organizer 4-8smart card 4-15the procedural kit 4-3three pressure domes 4-16

Instrument ID 11-5Interrupting a Treatment 5-64IrDa 11-5

K

KVO 5-16, 5-36, 5-41, 5-55, 5-60, 8-10, 11-5, 11-6, 10-17

defined 11-5

L

Lamp Failure 6-56, 11-5alarm identifying 6-56defined 11-5

Lamp Life Remaining 3-21, 6-10defined 11-5popup message 6-56, 11-5

Language Settings 6-56Leukocyte 2-1, 2-6, 3-1, 3-22, 3-31, 5-3, 5-36, 5-38,

5-39, 5-50, 5-55, 5-57, 5-58, 5-63, 5-64, 9-7, 11-2, 11-3, 11-8, 2-10

defined 11-5Light Assembly 5-5, 3-21, 3-22, 6-4, 6-8, 6-9, 6-10,

7-8, 7-9, 7-10, 9-1, 9-5, 11-5, 2-10defined 11-5described 3-21lamp life 3-21

Line configurationdefined 11-5Double Needle Mode 5-22during PRIME 5-21Single Needle Mode 5-21

Load Cell Hook 2-9, 4-7, 5-32, 5-51, 9-4, 11-5defined 11-5described 4-7

M

Maintenance 1-1, 4-9, 5-1, 5-4, 7-1, 7-2, 9-2, 9-3,

9-5, 11-6, 11-8importance of 7-1schedule 7-2

Manual Blood Return 5-68, 5-69, 5-70, 5-73defined 11-5described 5-68

Methoxsalen 2-1, 2-6, 2-8, 2-10, 3-1, 5-3, 5-5, 3-1, 2-12, 5-32, 5-33, 5-34, 5-51, 5-53, 5-51, 5-53

Methoxsalen (20 micrograms / mL)defined 11-5

MUTE 6-2, 6-6, 6-7, 6-8, 6-9, 6-11, 6-12, 6-13, 6-14, 6-15, 6-16, 6-17, 6-18, 6-19, 6-20, 6-21, 6-22, 6-23, 6-24, 6-25, 6-26, 6-27, 6-28, 6-29, 6-30, 6-31, 6-32, 6-33, 6-34, 6-35, 6-36, 6-37, 6-38, 6-39, 6-40, 6-41, 6-42, 6-43, 6-44, 6-45, 6-46, 6-47, 6-48, 6-49, 6-51, 6-52, 6-53, 6-54, 6-55, 11-5

N

NOTE 11-5

O

Operating ProceduresBUFFY COAT 3-9, 3-10, 3-14, 3-15, 3-31, 5-1,

5-2, 5-12, 5-15, 5-17, 5-27, 5-30, 5-31, 5-37, 5-38, 5-39, 5-49, 5-50, 5-56, 5-57, 5-58, 5-64, 5-66, 6-15, 6-19, 6-20, 6-50, 9-7, 10-8, 10-10, 10-12, 10-16, 10-17

changing default parameters 5-10, 5-11, 5-12, 5-15, 9-1, 9-2, 9-3, 10-4, 10-5

COLLECT 3-6, 3-8, 5-1, 5-4, 5-5, 5-7, 5-11, 5-12, 5-15, 5-16, 5-23, 5-25, 5-26, 5-28, 5-36, 5-37, 5-38, 5-39, 5-41, 5-45, 5-47, 5-48, 5-55, 5-56, 5-57, 5-58, 5-60, 5-64, 5-65, 5-66, 6-1, 6-6, 6-21, 6-23, 6-38, 6-51, 7-5, 8-12, 9-1, 9-2, 9-3, 9-7, 10-1, 10-4, 10-5, 10-8, 10-9, 10-10, 10-11, 10-12, 10-13, 10-13, 10-15, 10-16, 10-17

DRAWING 5-2, 5-12, 5-17, 6-22, 5-25, 5-26, 5-27, 5-28, 5-30, 5-41, 5-47, 5-48, 5-49, 5-50, 5-59, 5-60, 6-21, 2-15, 10-8, 10-9, 10-10, 2-14, 5-28, 5-29, 10-10, 10-13, 10-15

EMPTYING BOWL 5-1, 5-2, 5-31, 5-37, 5-38, 5-39, 5-50, 5-56, 5-57, 5-58, 5-66, 11-3, 10-17

ESTABLISH ACCESS 5-23, 5-45, 10-15interrupting a treatment 5-64PHOTOACTIVATE 2-8, 5-3, 3-6, 3-14, 3-22, 3-26,

3-30, 5-3, 5-4, 5-6, 6-8, 6-10, 5-12, 5-16, 5-32, 5-33, 5-34, 5-35, 5-37, 5-38, 5-51, 5-52, 5-53, 5-54, 5-56, 5-57, 5-64, 5-65, 5-66, 5-67, 6-19, 6-56, 7-8, 9-2, 9-3, 9-7, 2-10, 3-22, 9-1, 10-12, 10-17, 10-18

PRIME 3-6, 3-17, 3-19, 3-34, 4-7, 4-16, 4-17,

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Rev. 4.0-1460451

4-20, 4-22, 4-23, 6-4, 5-4, 5-6, 5-8, 5-9, 5-10, 5-12, 5-21, 5-22, 5-23, 5-45, 6-4, 6-5, 6-12, 6-13, 6-15, 6-26, 6-27, 6-28, 6-29, 6-30, 6-31, 6-32, 6-33, 6-34, 6-35, 6-36, 6-37, 6-39, 6-40, 6-44, 6-45, 6-46, 6-47, 6-48, 6-55, 6-56, 9-1, 9-5, 9-6, 9-7, 10-9, 5-9, 10-10, 10-11, 10-14

REINFUSE 3-6, 5-1, 5-3, 5-4, 5-12, 5-15, 5-31, 5-35, 5-37, 5-50, 5-54, 5-56, 9-2, 9-3, 10-12

RETURNING 5-2, 5-3, 5-1, 5-12, 2-15, 5-17, 5-26, 5-27, 5-28, 5-32, 5-33, 5-41, 5-47, 5-48, 5-49, 5-50, 5-51, 5-52, 5-59, 5-60, 5-65, 5-66, 2-14, 10-8, 10-9, 10-10, 10-12, 10-13, 2-14, 10-15, 5-29, 10-15, 10-17

SELECT 5-21, 5-22, 11-6TREATMENT COMPLETE 5-42, 5-61, 11-6

Operator Interface 3-2, 3-3, 3-6, 3-7, 3-8, 3-9, 3-10, 4-1, 5-20, 5-33, 5-52, 6-15, 7-5, 11-4, 11-6, 10-15, 10-18

cleaning 7-5defined 11-6described 3-2, 3-3, 3-6display detail 3-6, 3-7, 11-6

Oral Medication 2-10

P

Patient Lines 4-21, 4-22, 11-6, 11-9defined 11-6described 4-21

PAUSEdefined 11-6described 3-9, 5-12, 5-16, 5-30, 5-36, 5-37, 5-38,

5-39, 5-40, 5-49, 5-55, 5-56, 5-57, 5-58, 5-59, 5-64, 5-65, 6-4, 6-38, 6-50, 9-7, 10-10, 10-12, 10-15, 10-15, 10-17

Peristaltic Pump 11-6defined 11-6described 3-29

Phases 3-12, 5-1, 5-14, 5-15, 5-65, 11-3, 11-6described 5-1

PHOTOACTIVATE 2-8, 5-3, 3-6, 3-14, 3-22, 3-26, 3-30, 5-3, 5-4, 5-6, 6-8, 6-10, 5-12, 5-16, 5-32, 5-33, 5-34, 5-35, 5-37, 5-38, 5-51, 5-52, 5-53, 5-54, 5-56, 5-57, 5-64, 5-65, 5-66, 5-67, 6-19, 6-56, 7-8, 9-2, 9-3, 9-7, 2-10, 3-22, 9-1, 10-12, 10-17, 10-18

defined 11-6, 11-7double needle mode 5-51single needle mode 5-32

Photoactivation Chamber 3-2, 3-21, 3-22, 3-26, 4-2, 4-5, 5-33, 5-33, 5-52, 5-69, 5-70, 5-74, 6-1, 6-4, 6-7, 6-13, 6-18, 6-25, 6-56, 7-2, 7-9, 8-11, 9-8, 4-2, 11-4

defined 11-6

described 3-21Photoactivation Module 2-1, 3-10, 3-21, 3-22, 3-23,

3-24, 3-25, 3-26, 4-4, 4-5, 4-19, 5-3, 5-4, 5-6, 5-9, 5-34, 5-53, 5-69, 5-70, 5-74, 6-1, 6-7, 6-13, 6-15, 6-48, 7-9, 9-5, 9-8, 11-2, 11-6, 11-8

defined 11-6described 3-25removing 4-4

Photopheresis THERAKOS 1-1, 2-1, 2-6, 3-12, 3-23, 3-25, 4-4, 5-1, 6-8, 5-14, 5-18, 5-20, 6-10, 6-12, 6-13, 6-48, 6-51, 6-52, 8-3, 8-4, 8-2, 11-2, 10-9, 2-14

changing treatment schedules 2-1, 2-14defined 11-7

Popup Messages 6-5, 6-56defined 11-7table of 6-56

Power Cord Wrap Cleats 3-5, 11-7defined 11-7described 3-5

Pressure Sensors (Domes / Transducers) 3-13, 3-33, 7-2, 11-7

defined 11-7PRIME 3-6, 3-17, 3-19, 3-34, 4-7, 4-16, 4-17, 4-20,

4-22, 4-23, 6-4, 5-4, 5-6, 5-8, 5-9, 5-10, 5-12, 5-21, 5-22, 5-23, 5-45, 6-4, 6-5, 6-12, 6-13, 6-15, 6-26, 6-27, 6-28, 6-29, 6-30, 6-31, 6-32, 6-33, 6-34, 6-35, 6-36, 6-37, 6-39, 6-40, 6-44, 6-45, 6-46, 6-47, 6-48, 6-55, 6-56, 9-1, 9-5, 9-6, 9-7, 10-9, 5-9, 10-10, 10-11, 10-14

Procedural Kit 3-23, 3-25, 4-1, 4-3, 4-4, 4-6, 5-5, 5-6, 5-20, 6-12, 6-13, 6-17, 6-52, 9-1, 9-5, 10-2, 11-4, 11-5, 11-7

components 3-23, 3-25Centrifuge Bowl 3-27Hematocrit Cuvette 3-31Photoactivation Module 3-25Pump Tubing Organizer 3-29Smart Card 3-34Treatment Bag 3-30Tubing Lines 3-32

configuring 5-20defined 11-7described 3-23, 3-25inspection 3-24storing 3-24

Pump Deckdefined 11-7

Pump Tubing Organizer 3-12, 3-13, 3-17, 3-23, 3-25, 3-29, 3-33, 4-6, 4-8, 4-10, 4-14, 4-15, 4-16, 4-18, 4-20, 5-3, 5-43, 5-62, 5-74, 5-76, 6-16, 6-17, 8-11, 9-5, 11-4, 11-7, 11-9

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IN-vIndex

defined 11-7installing 4-8mold indents 4-8, 11-7pump tubing segments 11-7removing 5-43schematic 3-13

R

REINFUSE 3-6, 5-2, 5-3, 5-4, 5-12, 5-15, 5-31, 5-35, 5-37, 5-50, 5-54, 5-56, 9-2, 9-3, 10-12

RESET 6-2, 6-6, 6-9, 6-11, 6-14, 6-15, 6-16, 6-17, 6-18, 6-19, 6-20, 6-21, 6-22, 6-24, 6-25, 6-26, 6-27, 6-28, 6-29, 6-30, 6-31, 6-32, 6-33, 6-34, 6-35, 6-36, 6-37, 6-38, 6-39, 6-40, 6-41, 6-42, 6-43, 6-44, 6-45, 6-46, 6-47, 6-48, 6-50, 6-51, 6-52, 6-53, 6-54, 6-55, 11-7

defined 11-7Retainer Clip 3-18, 4-2, 4-10, 4-11, 4-12

defined 11-7Return Bag 3-10, 3-15, 3-16, 3-23, 3-25, 3-30, 4-7,

4-18, 4-19, 5-2, 5-3, 5-5, 5-6, 5-10, 5-11, 5-16, 5-17, 5-24, 5-26, 5-27, 5-28, 5-30, 5-31, 5-35, 5-41, 5-46, 5-50, 5-54, 5-60, 5-70, 5-71, 5-76, 6-4, 6-5, 6-33, 6-34, 6-38, 6-39, 6-41, 6-47, 6-54, 8-7, 9-1, 9-2, 10-3, 10-4, 10-5, 10-7, 10-10, 10-11, 10-12, 10-13, 10-14, 10-17, 10-18, 10-12, 10-13, 10-14, 10-17, 10-18


RETURNING , 5-2, 5-3, 5-1, 5-3, 5-12, 2-15, 5-17, 5-26, 5-27, 5-28, 5-32, 5-33, 5-41, 5-47, 5-48, 5-49, 5-50, 5-51, 5-52, 5-59, 5-60, 5-65, 5-66, 2-14, 10-8, 10-9, 10-10, 10-12, 10-13, 2-14, 10-15, 10-17, 5-29, 10-15, 10-17

defined 11-8double needle mode 5-48

S

Saline 2-14, 3-4, 3-17, 3-23, 3-25, 3-33, 4-20, 5-11, 5-16, 5-18, 5-65, 5-73, 6-4, 6-6, 6-20, 6-32, 6-45, 8-7, 8-8, 9-4, 9-5, 11-8

defined 11-8installing 3-17

Saline Bolus 5-11, 5-16, 5-65, 6-6, 8-7, 11-8default volume setting 5-16defined 11-8how to deliver 5-65

Saline Line, Spike and Drive Chamber 3-17, 3-23, 3-25, 4-20, 5-73, 6-45, 9-5

defined 11-8Single Needle Mode 2-1, 3-1, 5-2, 5-2, 5-11, 5-17,

5-20, 5-21, 6-22, 5-23, 5-24, 5-26, 5-28, 5-30, 5-31, 5-33, 5-34, 5-35, 5-36, 5-41, 5-56, 5-60, 6-37, 6-38, 9-2, 10-1, 10-10, 10-13, 2-14,

10-15defined 11-8line configuration 5-21

Smart Card 3-34defined 11-8described 3-34

Smart Card Port 3-2, 11-8defined 11-8

Specific Gravity 11-8Sterility 3-24, 4-6, 9-5, 11-8STOP 5-10, 5-16, 5-36, 5-37, 5-38, 5-39, 5-40, 5-41,

5-55, 5-56, 5-57, 5-58, 5-59, 5-60, 5-64, 5-65, 5-66, 5-67, 5-68, 6-50, 9-7, 11-8, 10-15

defined 11-8System Error 6-2, 11-8

defined 11-8

T

Treatment Bag 2-6, 2-8, 2-9, 3-1, 3-10, 3-15, 3-16, 3-23, 3-25, 3-30, 3-31, 4-7, 4-18, 4-19, 5-3, 5-6, 5-30, 5-32, 5-34, 5-35, 5-37, 5-38, 5-49, 5-50, 5-51, 5-53, 5-54, 5-56, 5-57, 5-64, 5-66, 5-70, 5-71, 5-72, 5-74, 5-75, 5-76, 6-4, 6-5, 6-7, 6-35, 6-40, 6-42, 6-43, 6-46, 6-48, 6-53, 9-1, 9-4, 11-2, 11-4, 11-5, 10-11, 10-18

defined 11-8described 2-6, 2-8, 2-9, 3-1, 3-10, 3-15, 3-16,

3-23, 3-25, 3-30, 3-31, 4-7, 4-18, 4-19, 5-3, 5-6, 5-30, 5-32, 5-34, 5-35, 5-37, 5-38, 5-49, 5-50, 5-51, 5-53, 5-54, 5-56, 5-57, 5-64, 5-66, 5-70, 5-71, 5-72, 5-74, 5-75, 5-76, 6-4, 6-5, 6-7, 6-35, 6-40, 6-42, 6-43, 6-46, 6-48, 6-53, 9-1, 9-4, 11-2, 11-4, 11-5, 10-11, 10-18

installing 4-7TREATMENT COMPLETE 5-42, 5-61, 11-6Treatment Volume 2-9, 3-9, 3-10, 3-11, 3-14, 5-3,

5-38, 5-57, 6-15, 8-8, 11-4, 11-8defined 11-8

Tubing Guides 3-12, 4-13, 11-7, 11-9defined 11-8described 3-12

Tyvek Lid 11-9

U

UVA 2-1, 2-6, 2-8, 5-3, 5-4, 6-8, 3-14, 3-21, 3-22, 6-10, 6-7, 6-9, 6-55, 6-56, 7-8, 8-8, 9-1, 9-5, 9-1, 11-1, 11-4, 11-5, 2-10, 10-18, 3-22

defined 11-9

W

WARNING 3-22, 5-7, 5-8, 5-11, 5-15, 5-23, 5-26, 5-28, 5-35, 5-39, 5-45, 5-48, 5-54, 5-57, 5-58, 6-1, 6-8, 6-10, 6-23, 6-38, 6-50, 6-51, 7-1, 7-8, 9-1, 9-2, 10-10, 2-10, 10-10

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THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual IN-vi

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WARNING, defined 11-9Wetted

defined 11-9Wheel Locks 3-2, 4-1, 11-9

defined 11-9Whole Blood Processed Target 5-2, 5-11, 5-17, 5-18,

5-27, 5-37, 5-38, 5-49, 5-56, 5-57, 6-19, 6-20, 6-23, 6-51, 10-12, 10-13, 10-17

changing parameter 5-18defined 11-9

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WI-1


WI-1Warranty and Contact Information

LIMITED WARRANTY

Limited Warranty

Therakos warrants its photopheresis equipment to conform to the specifications contained herein and in literature relating to the equipment and against defects in the workmanship or material under normal use and service for a period of one (1) year from the date of start-up. The sole obligation of Therakos under this warranty is to repair or replace, at its option, defective components sold under this warranty. Replacement components may be new or refurbished at the discretion of Therakos.

Therakos personnel perform equipment start-up (including installation and training). The warranty activation date will be that date indicated on the installation / warranty verification form.

This warranty does not apply to electrical fuses, light bulbs, filters, or other consumable items. Therakos will not warrant any parts found to be defective due to shipping damage, misuse, use of unauthorized parts, or lack of maintenance as specified within the THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual.

This warranty extends to the original purchaser of the equipment from Therakos and is not transferred upon re-sale.

Buyer’s sole remedy for the breach of the Therakos warranty obligation shall be limited to the cost of the equipment and in no event include consequential damages or liability for personal injury or property damages. The foregoing warranty is in lieu of all other warranties, expressed or implied, and no other warranties exist including, without limitation, any warranty of merchantability or fitness for a particular purpose.

If a defect develops with your photopheresis equipment, contact Therakos to be advised as to the disposition of the defective part.

Questions relating to the warranty should be directed to:

National Service Manager

Therakos, Inc. Therakos Europe

1001 US Highway 202 Johnson & Johnson Medical Ltd., Pinewood Campus

Raritan, NJ 08869-0606 Nine Mile Ride

USA Wokingham, Berkshire RG40 3EW

United Kingdom

Telephone: +1 800-823-6316 Telephone: +44 1344 864 000

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THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual WI-2

Rev. 4.0-1460451

All general inquiries should be directed to:

In USA and Canada: In Europe:Therakos, Inc. Therakos Europe1001 US Highway 202 Johnson & Johnson Medical Ltd., Pinewood CampusRaritan, NJ 08869-0606 Nine Mile Road USA Wokingham, Berkshire RG40 3EW United KingdomTelephone: +1 800-828-6316 Telephone: +44 1344 864 000Fax: +1 908-595-2405 Fax: +44 1344 864 111Or: +1 908-595-2409

For Technical Support, Spare Parts and Return Good Authorization:

In US and Canada: In Europe: Toll Free: +1 877-865-6850 Austria, France, Italy, UK, Ireland Freephone: 00800 THERAKOS (00800 843 725 67) Germany Freephone: 00800 181 1715

Language Support: French: +33 3 88 65 49 36 German: +33 3 88 65 49 37 Italian: +33 3 88 65 49 38 English: +33 3 88 65 49 39

THERAKOS™ CELLEX™ Power Cord:

Continental Europe Power Cord / IEC 320 10A CON-9000-007U.K. and Ireland Power Cord / IEC 320 10A CON-9000-009Italy Power Cord / IEC 320 10A CON-9000-013North America Power Cord / IEC 320 10A CON-9000-006

To Reorder Disposable Products:In USA: In Europe:Telephone: +1 800 828-6316 Telephone: +44 1344 864 353Fax: +1 585 453-3344 Fax: +44 1344 864 386 In Canada: In Germany:Telephone: +1 585 453-3504 Fax: +49 4 0529 724 792Fax: +1 585 453-3344

ITEM ORDER CODETHERAKOS™ CELLEX™ Instrument CELLEXTHERAKOS™ CELLEX™ Photopheresis Procedural Kit CLXECP (Shipped 3 per case)THERAKOS™ CELLEX™ Light Assembly CLXLGT

THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual:UK English 1460436 USA English 1460415 Canadian English 1460451 Dutch 1460517French 1460437 German 1460438 Canadian French 1460452 Danish 1460526Spanish 1460439 Italian 1460440 Portuguese 1460454

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State: IssuedThis document is generated by an electronic system.

END OF DOCUMENT


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Signature Manifest

Document Number: LBL-0014 Revision: 4

Title: Operators Manual Canada English THERAKOS CELLEX Photopheresis System

All dates and times are in Eastern Standard Time.

Review: LBL-0014 4

Review

Name/Signature Title Date Meaning/Reason

Jim Handzo (HANDZOJ) Sr Mgr Quality Systems 27 Sep 2016, 10:15:32 AM Reviewed

Page 1 of 1

9/27/2016

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