Alaris™ Gateway Workstation Directions For Use v1€¦ · Alaris GP Guardrails Volumetric Pump...

Alaris™ Gateway Workstation v1.5

Directions For Useen

1000DF00721 Issue 1 1/26


ContentsPage

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Conventions used in this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Workstation Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Available Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Labelling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Features of the Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Modular Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Infusion Line Tidies (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10Alaris Trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11Adjustable Height Bag Hangers (where fitted) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11Power Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11Battery Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12AC Power Output to Infusion Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12System Fault Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Pump Alarm Location Beacon (where fitted) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Nurse Call Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

Operating Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Electromagnetic Compatibility and Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Workstation Mounting Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Operation of Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Switching On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17Switching Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17Resetting the Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17Mounting a Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18Removing a Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Data Communication Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Ethernet Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19Data Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Data Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19CQI Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Data Communications Interface Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Nurse Call Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20Ethernet Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Product Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

1000DF00721 Issue 1 2/26


Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Potential Equalisation Conductor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22Trolley Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

Routine Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23Replacing the AC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23Cleaning and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

Products and Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

Alaris Infusion System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25Associated Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

Service Contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

1000DF00721 Issue 1 3/26

Alaris™ Gateway Workstation v1.5Introduction

IntroductionThe Alaris™ Gateway Workstation v1 .5 (hereinafter referred to as Workstation) has been designed as a modular system providing a communications gateway between an Alaris Infusion Pump (hereinafter referred to as Pump) and the Alaris Communication Engine . The version of Workstation can be identified by the labelling on the front, ensure the correct Workstation Directions For Use is used . Please contact local CareFusion representative for further information about Workstation versions, upgrade options and product availability .

Alaris Gateway Workstation v1 .5 Alaris Gateway Workstation v1 .2 Alaris Gateway Workstation

(software versions 1 .1 .6 and below)

Alaris®

Gateway Workstation

Note: It is possible to identify the Alaris Gateway Workstation v1 .5 from other Workstation versions by observing the Status indicators . On version 1 .5 the A and B Status Indicators have been replaced by b and c Status indicators, respectively .

AThe Alaris DS Docking Station, although similar in appearance to the Workstation, does not have any connectivity features and does not work with the Alaris Communication Engine. The Alaris DS Docking Station can be identified by the number of vertical MDI tiles, as it has an even number compared to the Workstation which has an odd number and that the AC power cable socket is at the front.

Features:

• Central management system for multiple Pumps• Medical Device Interface (MDI) – a unique mounting mechanism providing data communications and AC power to the Pump• Reduced cable clutter with the use of a single AC power inlet• Simple to set up with adaptable modular design• Efficient organisation of multiple infusion lines and configurations• Battery back-up in the event of power supply interruption• High visibility Pump Alarm Location Beacon assists with the location of Pumps in an alarm state, where fitted• Nurse call interface provides for remote Alarm monitoring of Pumps attached to the Workstation MDI Tiles .

1000DF00721 Issue 1 4/26


Intended UseThe Alaris Gateway Workstation v1 .5 is intended to be used to provide mounting, power and communications support to the Alaris Infusion Pumps range, within the operating environment specified in this Directions For Use (DFU) . In such environments, the Workstation may be exposed to the following range of therapies:

Fluid therapy, blood transfusions, parenteral feeding, drug therapy, chemotherapy, dialysis and anaesthesia . The Alaris Gateway Workstation is designed not to directly impact or affect the infusion delivery process .

The Alaris Gateway Workstation v1 .5 is designed to work with the following Alaris Infusion Pumps:

Infusion Pump Model Code Supported Software Version

Beacon Nurse CallHigh (red)

Medium (amber)

High Medium

Alaris GH Syringe Pump 80023UN01 v2 .3 .6 Yes Yes Yes Yes

Alaris CC Syringe Pump 80033UND1 v2 .3 .6 Yes Yes Yes YesAlaris TIVA Syringe Pump 80043UN01 v2 .3 .6 Yes Yes Yes YesAlaris PK Syringe Pump 80053UN01 v3 .2 .16 Yes Yes Yes YesAlaris Enteral Syringe Pump 8002ENT01 v4 .1 .6

v4 .2 .1

Yes Yes Yes Yes

Alaris GH Guardrails™ Syringe Pump 80023UN01-G v3 .1 .4 Yes Yes Yes YesAlaris CC Guardrails Syringe Pump 80033UND1-G v3 .1 .4 Yes Yes Yes YesAlaris GH Syringe Pump (with Plus Software) MK3 8002MED01 v4 .1 .4 Yes Yes Yes YesAlaris CC Syringe Pump (with Plus Software) MK3 8003MED01 v4 .1 .4 Yes Yes Yes YesAlaris GH Guardrails Syringe Pump (with Plus Software) MK3 8002MED01-G v4 .1 .4 Yes Yes Yes YesAlaris CC Guardrails Syringe Pump (with Plus Software) MK3 8003MED01-G v4 .1 .4 Yes Yes Yes YesAlaris GH Syringe Pump (with Plus Software) MK4 8002MED01

8002TIG01

v4 .1 .8 Yes Yes Yes Yes

Alaris CC Syringe Pump (with Plus Software) MK4 8003MED01

8003TIG01


Alaris GH Guardrails Syringe Pump (with Plus Software) MK4 8002MED01-G

8002TIG01-G


Alaris CC Guardrails Syringe Pump (with Plus Software) MK4 8003MED01-G

8003TIG01-G


Alaris GW Volumetric Pump 2504xxxx1* v5r1F (v51F) **

v5r2A (v52A) **

Yes No Yes No

Alaris GP Guardrails Volumetric Pump 80263UN01-G v1 .9 .2 Yes Yes Yes YesAlaris GP Volumetric Pump (with Plus Software) 9002MED01

9002TIG01

v2 .1 .14

v2 .1 .15

Yes Yes Yes Yes

Alaris GP Guardrails Volumetric Pump (with Plus Software) 9002MED01-G

9002TIG01-G

v2 .1 .14

v2 .1 .15

Yes Yes Yes Yes

Alaris VP Plus Guardrails Volumetric Pump 9003MED01-G

9003TIG01-G


* xxxx denotes the language and country specific model codes

** The display on the Alaris GW Volumetric Pump can only show four characters so software version will be shown without the letter r

AThe pumps listed above, except the Alaris GW Volumetric Pump, will activate the alarm beacon and nurse call for high and medium priority alarms. The Alaris GW Volumetric Pump will not activate the alarm beacon and nurse call for medium priority alarms, however will activate the alarm beacon and nurse call for high priority alarms.

Note: The alarm beacon is selectively populated for all Workstation configurations . Nurse call is always populated and the pump has its own means to alarm . If nurse call and a beacon are not equipped, it is the hospital’s responsibility to monitor pump alarm .

1000DF00721 Issue 1 5/26


The Alaris Gateway Workstation v1 .5 is designed to integrate with the Alaris Communication Engine (ACE), refer to the ACE Directions For Use for further details, which can be used to:

• Remotely import and automatically deploy data sets to compatible Alaris Guardrails Infusion Pumps with Plus software based on hospital practices

• Automatically collect CQI data from compatible Alaris Guardrails Plus Infusion Pumps for later analysis via the Alaris CQI Event reporter v4 .2 .2

• View infusion status for supported Alaris Infusion Pumps• Locate connected Workstations and connected Alaris Infusion Pumps within the hospital infrastructure

The Alaris Gateway Workstation v1 .5 does not support the following Pumps, features and accessories:

• Barcode reader• Alaris GS Syringe Pump• Alaris GP Volumetric Pump, Model code 80263UN01 or 80063UN01, software version v1 .7 .18• Alaris SE Pumps• Auxiliary Alaris Gateway Workstation power and communication• Patient Data Management System (PDMS)

About This ManualThe user must be thoroughly familiar with the Workstation described in this manual prior to use .

Please refer to the relevant Directions For Use for correct operation of the Pumps .

All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the Workstation . These settings and values are for illustrative use only . The complete range of settings and values are shown in the Specifications section .

The illustrations in this DFU show example configurations and equipment that might not be available to all markets and regions . Please contact the local affiliate office for further information .

AIt is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service Manual for your CareFusion products. These documents are referenced on www.carefusion.com. Copies can be obtained by contacting your local CareFusion representative.

Conventions used in this manual

BOLD Used for Display names, software commands, controls and indicators referenced in this manual, for example, Battery Indicator, PURGE, ON/OFF button .

'Single quotes' Used to indicate cross-references made to another section of this manual .

Italics Used to refer to other documents or manuals and also used for emphasis .

Warning A warning is an alert to a potential hazard which could result in serious personal injury and/or product damage if proper procedures are not followed .

Caution A caution is an alert to a potential hazard which could result in minor personal injury and/or product damage if proper procedures are not followed .

Note Notes contain supplementary information or emphasize a point or procedure .

AImportant Information: Wherever this symbol is shown an Important note is found . These notes highlight an aspect of use that is important for the user to be aware of when operating the Pump .

User Accesses the product at the patient to administer treatment and monitors the products use .

Qualified Service Personnel Service and repair the product . Upload and download data to product .

1000DF00721 Issue 1 6/26

Alaris™ Gateway Workstation v1.5Workstation Identification

Workstation IdentificationThe Workstation can be confirmed by viewing the serial number label on the rear of the Workstation and checking the SKU is 80153UNS02 or 80153UNS03 . The two or three numbers at the end of the SKU identifies the Workstation configuration, see below for all available configurations .

Available Configurations

80153UNS02-30 80153UNS02-32 80153UNS02-33 80153UNS02-34 80153UNS02-035



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Alaris™ Gateway Workstation v1.5Controls and Indicators

Controls and Indicators

Controls

Symbol Description

a a

ON/OFF Button - Press once to switch the Workstation on . Press and hold for two seconds to switch the Workstation off . In the event that the Workstation needs to be reset, press and hold for at least four seconds, then press again to switch the Workstation on .

Indicators

Symbol Description

j

j

Battery Indicator - When illuminated the Workstation is operating from internal battery; when flashing the battery power is low and auto power down is imminent .

k

k

AC Power Indicator - When illuminated the Workstation is connected to the AC power supply and the battery is being charged .

b ACE Status Indicator - When illuminated the Workstation is connected to ACE .

c AUX Status Indicator - Not in use

d ON Status Indicator - When illuminated the Workstation is powered on .

wSystem Fault Indicator - The Workstation will illuminate this indicator when an internal fault is present and detected .

1000DF00721 Issue 1 8/26

Alaris™ Gateway Workstation v1.5Symbol Definitions

Symbol Definitions

Labelling Symbols

Symbol Description

n Nurse call Connector

RS232 Connector

e Workstation Configuration Connector

Interface Device, General (Barcode Reader Connector)

i Ethernet Network Connector

g AC Inlet

AC Outlet

h This equipment contains an RF transmitter (where fitted)

W Fuse Rating

E F Consult accompanying documents

x Potential Equalisation (PE) Connector

IPX1 Protected against vertically falling drops of water

r Alternating Current

u Workstation complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC .

T Date of Manufacture

t Manufacturer

U Not for Municipal Waste

EC REP Authorised representative in the European Community

Pushing Prohibited - see ‘Operating Precautions’ section for details .

C Warning electrical shock hazard do not tamper .

V Electrostatic discharge (ESD) precautions

m Wired Workstation

1000DF00721 Issue 1 9/26

Alaris™ Gateway Workstation v1.5Features of the Workstation

Features of the Workstation

Modular DesignThe Workstation is a modular design . The Base Module comprises 3 MDI tiles which can have additional vertical modules of 2 MDI tiles to expand the vertical configuration, as required . Horizontal T-pieces of 2, 3 or 4 MDI tiles may be added to accommodate Pumps and fluid bag hangers, as required . See ‘Workstation Identification’ section for all configurations available . The Workstation can only be assembled by Qualified Service Personnel .

Configuration 80153UNS02-73:

Pump Mounting Rail

AC supply outlet

Infrared communications port

Warning Light Emitting Diode (LED)

Adjustable Height Pole

Slip Catch

Pump Alarm Location Beacon (Not fitted on 4 MDI Tile Horizontal Module)

Bag Supports

CareFusion Switzerland 317 Sàrl, A-One Business Centre,

Z.A Vers -La-Pièce n° 10,CH-1180, RolleM

AX30V/1A

CareFusion Switzerland 317 Sàrl, A-One Business Centre,

Z.A Vers -La-Pièce n° 10,CH-1180, Rolle

Made in U.K.

Covered under Patents: U.S. Pat. 6,593,528; EP 1502612 (DE, CH, FR, GB, ES & IT), CA 2614658. Design Patents: AU144124; DE 49910883; FR 997137; and JP 1117998

Rear View

Not Used

Ethernet Interface

Potential Equalisation (PE) Connector

Nurse Call Interface

Not Used

Not Used

Not Used

Not Used

Not Used

AC Power Input

Not Used

Base Module (3 MDI Tile Base) Front View

ACE/AUX Status IndicatorsBattery

Indicator

AC Power Indicator

ON/OFF

ON Status Indicator

System Fault Indicator

Infusion Line Tidies

Alaris® Gateway Workstation 1.5

MDI Tile

Pole Clamp

1000DF00721 Issue 1 10/26


Configuration 80153UNS02-235, shown mounted on an Alaris Trolley:

Infusion Line Tidies

Bag Supports

Trolley

Bag Support Rail

Mounting Rail

Mounting Rail

Mounting Rail

Note: Qualified Service Personnel are required to assemble the Trolley and mounting the Workstation to the Trolley .

Infusion Line Tidies (optional)To assist in the routing of infusion sets and syringe extension sets from the Pumps to the patient, infusion line tidies can be attached to the rear of the Workstation . The infusion line tidies are height adjustable allowing positioning adjacent to both syringe and volumetric pumps, and may be mounted on the left or right hand side of the Workstation . To use the infusion line tidies:

1 . Loosen the hand wheel and adjust to the desired position .2 . Hand tighten the hand wheel to secure the device .3 . Refit rubber strip .

Note: It is recommended that line tidies be used to organize the infusion lines, this could reduce the risk of tangled infusion lines and tripping the user or patient .

1000DF00721 Issue 1 11/26


Alaris TrolleyWhen the Workstation is mounted to the Alaris Trolley and is not being transported, the brakes should be engaged .

To operate the Alaris Trolley brakes:

1 . Locate brake mechanism at the end of the wheels .

2 . Press down to engage the brakes . 3 . Pull up to disengage the brakes .Warning: All wheels that have brakes should be set to the same engaged or disengaged state.

APrior to moving the Alaris Trolley all brakes should be disengaged.

Adjustable Height Bag Hangers (where fitted)The 18 mm diameter adjustable height pole has been designed as a convenient means of securing the fluid bags onto the Workstation . The pole supports a maximum load to 3 kg . The pole is held securely by a clamp and a slip catch . This gives additional flexibility when selecting the required height of the fluid bags . To operate the clamp:

1 . Grip the handle at the lower end of the pole and carefully loosen the hand wheel .

3b

1

2

4

3

2 . Apply an upward pressure to the pole handle, this will release the locking lever and allow the pole to move freely .

3 . Changing the bag hanger height:

a) To increase the bag hanger height: Continue pushing the pole upward to the required height . Once set, release the upward pressure on the pole, re-engaging the locking lever .

b) To reduce the bag hanger height: Hold the locking lever in the released position and adjust the pole downward to the required height . Release the locking lever and release the upward pressure on the pole, re-engaging the locking lever .

4 . Tighten the hand wheel to securely lock the pole into position .

Caution: To reduce the risk of excess pressure and siphoning the fluid bag should be placed a minimum height of 300mm above the Pump.

AWhen bag hanger poles are available they should be adjusted to the height recommended in the specific PumpDirections For Use.For Workstation configurations 80203UNSxx-235 and 80203UNSxx-035, use the bag hanger assembly PN 1000SP01414to secure fluid bags onto the Workstation.

Power InputThe Workstation is powered from the AC supply through a standard IEC AC connector . When connected to the AC supply the AC Power indicator is illuminated . Both the Live and Neutral lines of the main supply are protected using fuses carried in a double fuse holder located on the AC inlet connector .

If the AC Power is lost the AC Power Indicator will extinguish, the Battery Indicator will illuminate and the Workstation will emit a beep . Any pumps configured for detection of power loss will alarm .

Warning: When connected to the AC supply, a three wire (Live, Neutral, Earth) supply must be used. If the integrity of the external protective conductor in the installation or its arrangement is in doubt, then the Workstation must not be used.

ATo isolate the Workstation from AC supply remove the AC connector from the source socket. The Workstation should be positioned to allow access for disconnecting the AC connector.

1000DF00721 Issue 1 12/26


Battery SupplyThe Workstation should normally be operated from the AC power supply . However, in the event of temporary loss of AC power, an internal power supply will provide approximately 20 minutes of communications only . AC power to the Pumps will be discontinued .

Warning: AC Power should be re-applied as soon as possible as there will be no AC power supplied to the Pumps while the Workstation is running on the battery.

The Battery indicator illuminates whenever the Workstation is running from the internal battery . When illuminated the Workstation is operating from internal battery; when flashing the battery power is low and auto power down is imminent . The battery is automatically charged whenever the Workstation is connected to the AC supply . Verify that a Workstation mounted pump is charging by checking the pump AC Power indicator light is illuminated and the pump audio and visual low battery alerts are not observed . As the Workstation is designed to operate from the AC power supply it will only power up when connected to the AC supply .

AIf transfer of the Workstation is required, then prior to disconnecting from AC power supply the User must ensure there is sufficient battery power on each of the Pumps.

AC Power Output to Infusion PumpsThe Workstation has its own power distribution circuit to supply AC power to the attached Pumps . For safety, power is not applied to the Pump until it is fully attached to the MDI tile . The AC power indicator on the infusion Pump will illuminate when Pump is powered and charging .

Warning: The MDI tile AC outlet connection is intended only for connection to a Pump. Never attach any other equipment to the outlet connector.

The Workstation minimises the potential for peak in-rush currents when AC power is applied . When the Workstation is initially switched on, or when re-connected to the AC whilst operating from the internal battery, a small delay in the application of AC power will occur between each MDI tile . This staggers the distribution of AC power to all Pumps and therefore, reduces the peak in-rush current .

Safe use of the Workstation requires management of the number of Pumps installed so that the system earth leakage current does not exceed 500uA . For this reason a warning label is placed blocking access to the auxiliary AC outlet . This warning label should not be removed and a leakage current be performed on the intended configuration to verify compliance with the 500uA limit .

The Workstation power cord provides the return path for earth leakage currents from the Workstation’s internal power supply as well as Pumps that are powered from the tile IEC power connector . When the AC outlet is used, the earth leakage current from the Workstation and attached Pumps also pass through the single power cord . In the unlikely event the power cord losses ground connection, these currents can pass instead through persons touching the metal portion of the Workstation . The maximum permissible system earth leakage current, which includes the contribution of both Workstation and fitted Pumps, is 500uA .

Warning: When fitting Pumps on the Workstations do not exceed the maximum permissible system earth leakage current of 500uA. The system earth leakage current can be calculated by summing up the leakage current of fitted Pumps and the Workstation. Leakage current values for product is given in the following table. Note that only Pumps that are powered from the MDI tile AC outlet connector need to be included in the calculation. Example: Alaris SE Pumps do not need to be included.

Product Leakage Current per productAlaris GS Syringe Pump 30µAAlaris GH Syringe Pump - all models 30µA

Alaris CC Syringe Pump - all models 30µAAlaris TIVA Syringe Pump 30µAAlaris PK Syringe Pump 30µAAlaris Enteral Syringe Pump 30µAAlaris GW Volumetric Pump 15µAAlaris GP Volumetric Pump - all models 52µAAlaris VP Plus Guardrails Volumetric Pump 52µAAlaris Gateway Workstation 90µA

1000DF00721 Issue 1 13/26


System Fault IndicationContinuous monitoring of the power distribution and communications system integrity is performed by the Workstation . In the event that a system fault occurs whilst in use, the System Fault Indicator will be illuminated accompanied by an audible alarm . To avoid any possible interruption to the infusion, AC power to the Pumps will be maintained on the MDI tile should a system fault be detected . The Workstation briefly illuminates the System Fault Indicator and activates the audible alarm each time the Workstation is switched on .

Caution: If the System Fault Indicator fails to illuminate when the Workstation is switched on, remove the Workstation from service and contact Qualified Service Personnel.

Caution: Should a System Fault occur during use, remove the Workstation from service as soon as practical and contact Qualified Service Personnel.

The System Fault Indicator can be triggered by any of the following conditions:

• Workstation configuration error• Communication timeout• Mismatch of software version• No battery detected• Watchdog fails to reboot

Pump Alarm Location Beacon (where fitted)The Pump Alarm Location Beacon is mounted on the upper face of the Workstation to assist with identifying the location of any Pumps that have entered an alarm or warning state . When lit, the Pump Alarm Location Beacon colour matches that of the visual status indicator on the Pumps; red for alarms and amber for warnings . Alarms of high priority, such as when an infusion is terminated are reflected as Red . Alarms or warnings of lower priority, such as Near-end-of-Infusion, are reflected as Amber . The Pump Alarm Location Beacon will indicate the highest level of alarm if there are multiple pumps in alarm . The Pump Alarm Location Beacon flashes automatically whenever any Pump located on an MDI Tile of the Workstation enters the alarm or warning condition, and stops when the condition is cleared on the Pump . The Pump Alarm Location Beacon automatically illuminates red then amber each time the Workstation is switched on .

The Pump Alarm Location Beacon is provided in order to allow Pumps with active alarms or warnings to be easily located; it does not replace the alarm or warning on the Pump which remains the principle indicator that the attention of User is required .

Caution: If the Pump Alarm Location Beacon fails to illuminate when the Workstation is switched on, suspect a fault with the Pump Alarm Location Beacon . Remove the Workstation from service and contact Qualified Service Personnel.

AThe Pump Alarm Location Beacon is selectively populated and cannot be fitted to a 4 MDI Tile Horizontal Module. However the Pumps have their own means to alarm and it is the hospital’s responsibility to monitor.

AFor the Alaris GW Volumetric Pump, which does not have a visual status indicator: • Alarm State - will activate the Pump Alarm Location Beacon of the Workstation • Warning State - will not activate the Pump Alarm Location Beacon of the Workstation

Note: See the ‘Introduction’ section for lists of the Pump Alarm Location Beacon and Nurse Call compatibility between the Pumps and Workstation .

Nurse Call InterfaceA nurse call interface is provided which is activated whenever any Pump attached to the Workstation enters an alarm or warning state, and stops when the condition is cleared on the Pump . The Nurse Call Interface may be connected to operate in a normally open or normally closed contact position . Verify the Nurse Call is automatically activated each time the Workstation is switched on .

The Nurse Call interface on the Workstation allows a single connection point to a hospital Nurse Call system . This Nurse Call activates when a Pump communicates an alarm or warning condition to the Workstation via the IrDA interface . The communication of such an alarm or warning condition could be interrupted if, for example, the Pump was not correctly attached to the Workstation .

Caution: If the Nurse Call Interface fails to operate when the Workstation is switched on, suspect a fault with the interface. Remove the Workstation from service and contact Qualified Service Personnel.

Caution: There will be a delay, of up to 5 seconds, between the Pump going into alarm and the Nurse Call Interface activating via the Workstation.

Caution: Where reliability of the nurse call interface is paramount, then connection has to be made from the nurse call system directly to the nurse call interface on the Pump.

1000DF00721 Issue 1 14/26

Alaris™ Gateway Workstation v1.5Operating Precautions

Operating PrecautionsOperating Environment• Users of the Workstation should read all instructions in this manual before use .

• The user of the Workstation is responsible for verifying the start-up completes correctly and is ready for use prior to starting any Pumps, see ‘Operation of Workstation’ for further details . Should the start-up sequence not complete correctly then remove the Workstation from service for inspection by Qualified Service Personnel .

• The Workstation is suitable for all establishments, including those directly connected to the public low-voltage power supply network . The Workstation is designed for use in the hospital environment, not a road ambulance or home health care environments .

• When setting up a Workstation, an assessment of any potential hazards associated with the routing of electrical leads and infusion lines should be made . Where appropriate, mitigations identified and implemented .

• The Workstation should only be used with compatible CareFusion products, accessories, infusion bags and disposables .

• Use of the Workstation creates a Medical Electrical System, the operational limits of which are impacted by attached Pumps . For example, the operating temperature limit is 40°C for the Workstation, but may be lower for specific Pumps . Please ensure all connected Pumps are compatible with the intended environment .

• While being used for patient therapy, each Workstation should be dedicated to the care of a single patient .

• The Workstation does not support antivirus software . It is the Hospital’s responsibility to ensure that the network is secure .

• Special instructions for isolation room: – Use with the nurse-call feature in order to make alarms visible outside of the room – Exclude use of Alaris GW Volumetric Pumps, which is not fully compatible with the Workstation nurse

call .

Electromagnetic Compatibility and Interference

M• This Workstation is protected against the effects of external interference, including high energy

radio frequency emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and cauterising equipment, large motors, portable radios, cellular telephones etc .) and has been tested to IEC/EN60601-1-2 .

• The Workstation is a CISPR II Group 1 Class A device . When Alaris Infusion Pumps are attached and operational, the system becomes a CISPR II Group 1 Class A system .

• This Workstation is a CISPR II Group 1 Class A equipment and uses RF energy only for its internal function in the normal product offering . Therefore, its RF emissions are very low and are not likely to cause any interference with the nearby electronic equipment . However, this Workstation emits a certain level of electromagnetic radiation which is within the levels specified by IEC/EN60601-2-24 and IEC/EN60601-1-2 . If however the Workstation interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation .

• Therapeutic Radiation Equipment: Do not use the Workstation in the vicinity of any Therapeutic Radiation Equipment . Levels of radiation generated by the radiation therapy equipment such as a Linear Accelerator, may severely affect functioning of the Workstation . Please consult manufacturer’s recommendations for safe distance and other precautionary requirements . For further information, please contact your local CareFusion representative .

MR• Magnetic Resonance Imaging (MRI): The Workstation contains ferromagnetic materials which are

susceptible to interference with magnetic field generated by the MRI devices . Therefore, the Workstation is considered not to be MRI compatible . If use of the Workstation within an MRI environment is unavoidable, then CareFusion highly recommends securing the Workstation at a safe distance from the magnetic field outside the identified ‘Controlled Access Area’ in order to evade any magnetic interference to the Workstation; or MRI image distortion . This safe distance should be established in accordance with the manufacturers’ recommendations regarding electromagnetic interference (EMI) . For further information, please refer to the product technical service manual (TSM) . Alternatively, contact your local CareFusion representative for further guidance .

• Accessories: Do not use any non-recommended accessory with the Workstation . The Workstation is tested and compliant with the relevant EMC claims only with the recommended accessories . Use of any accessory, transducer or cable other than those specified by CareFusion may result in increased emissions or decreased Workstation immunity .

• In some circumstances the Workstation may be affected by an electrostatic discharge through air at levels above 15kV; or by radio frequency radiation above 10V/m . If the Workstation is affected by this external interference, it will remain in a safe mode and alerts the user by generating a combination of visual indicators and audible tones . Should any encountered alarm condition persist, even after user intervention, it is recommended to replace that particular Workstation and quarantine for the attention of Qualified Service Personnel .

1000DF00721 Issue 1 15/26


Hazards• The Workstation is heavy and poses a potential lifting hazard . Use caution when unpacking and installing

the Workstation .

B• An explosion hazard exists if the Workstation is used in the presence of flammable anaesthetics . Exercise

care to locate the Workstation away from any such hazardous sources .

• The Workstation is not intended to be used in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide .

C• Dangerous Voltage: An electrical shock hazard exists if the Workstation’s casing is opened or removed . Refer

all servicing to Qualified Service Personnel .

• When connected to an external power source, a three-wire (Live, Neutral, Earth) supply must be used . If the integrity of the external protective conductor in the installation or its arrangement is in doubt, the Workstation should not be used .

• When using volumetric pumps with the Workstation, it is recommended that, where possible infusion bags be located on a hanger directly above the Pump with which they are being used . A risk of mixing infusion sets from bag hangers exists, it is recommended to organize gravity fed pumps horizontally . This minimises the potential for confusion of lines when multiple volumetric pumps are used . Before starting an infusion with a volumetric pump check that the infusion set in the Pump is connected to the correct bag .

V• Do not remove the RS232 protective covering when the connector is not in use . Electrostatic discharge

(ESD) precautions are required when connecting RS232/Nurse Call . Touching the pins of the connectors may result in ESD protection failure . In order to prevent any potential failure generated by ESD close to or above 15kV, it is recommended that all actions must be taken by appropriately trained personnel and the Pumps should not be connected to the patient when attaching cables .

• If any of the following conditions occur with the Workstation remove it from service for inspection by Qualified Service Personnel:

– dropped – excessive moisture – fluid spillage – high humidity – high temperature – suspicion of damage

• When transporting or storing the Workstation, use original packaging where possible, and adhere to temperature, humidity and pressure ranges stated in the Specifications section and as well as on the outer packaging .

• The black rubber trim strips on the back of the Workstation are designed to prevent the ingress of liquids and other contamination . The Workstation should not be installed or operated without the strips being in place .

• Warning: Alaris Gateway Workstations should not be modified or altered in any way, except where explicitly directed or authorised by CareFusion . Any use of Alaris Gateway Workstations which have been altered or modified otherwise than in strict application of directions provided by CareFusion, is at your sole risk, and CareFusion does not provide any warranty for or endorsement on any Alaris Gateway Workstation that has been so modified or altered . CareFusion product warranty shall not apply in the event the Alaris Gateway Workstation has suffered damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of unauthorised modification or alteration of the Alaris Gateway Workstation .

1000DF00721 Issue 1 16/26


Workstation Mounting Precautions• When mounting the Workstation to a mounting option other than pole or equipment rail, the following

warnings must be observed: – Warning: Ensure the mounting option is capable of supporting a fully laden Workstation (see

Product Specifications) prior to mounting . – Warning: The Workstation should not be fitted to any other mobile mounting option unless the

stability and strength of the whole assembly has been evaluated to IEC/EN60601-1 . – Warning: Do not overload the mounting option . To ensure stability follow the guidelines given in the

Product Specification section . – Warning: Do not orientate the Workstation with the AC inlet or outlets exposed in the event of a

fluid spill .• Pole Mounting

– Warning: Ensure the pole is capable of supporting a fully laden Workstation (see Product Specifications) prior to mounting .

– Warning: Check that the pole clamp handle is in full working order before use .

– Warning: The pole clamp should be used to mount the Workstation on fixed poles / overhead swing arm poles only .

– Warning: People of a weak disposition should not attempt to use / tighten the pole clamp system .

• Equipment Rail/Mobile Trolley Mounting

– Warning: Do not overload the trolley . To ensure stability follow the guidelines given in the Product Specification section .

– Warning: The Workstation should not be fitted to any other mobile pole or drip stand unless the stability and strength of the whole assembly has been evaluated to IEC/EN60601-1 .

– Warning: A mobile trolley mounted Workstation is recommended to be transported by two persons when moving over an uneven surface or when the Workstation is fully loaded .

– Warning: Any rail system for supporting medical devices must comply with BSEN 12218:1999 . Ensure the rail is capable of supporting a fully laden Workstation (see Product Specifications) prior to mounting .

– Warning: Do not orientate the Workstation with the AC inlet or outlets exposed in the event of a spill .

– Warning: When mounted to the Alaris Trolley and not in transport the Trolley brakes should be engaged .

1000DF00721 Issue 1 17/26

Alaris™ Gateway Workstation v1.5Operation of Workstation

Operation of Workstation

Switching OnAfter initially switching on the Workstation, any services and applications running on the Workstation may take up to 90 seconds to become fully operational .

1 . Connect the AC power cord from the AC supply to the IEC inlet socket on the Workstation .2 . Verify the AC Power indicator is illuminated .3 . Verify the network cable is attached to the port denoted by the i symbol .

4 . Press the a key once to switch the Workstation on .Start-up sequence step behaviour User Verification

5 . Start of Workstation power on . ON Status Indicator is illuminated6 . Pump Alarm Location Beacon , where fitted, test . Pump Alarm Location Beacon illuminates red then amber

and is then extinguished7 . Nurse Call, where connected, test . Nurse Call automatically activated8 . Initialisation of each tile . Each tile will blink the System Fault Indicator accompanied

by a beep .9 . Initialisation of the network . The b and c Status Indicators flash alternately .10 . System initiates the Power On Self Test . The following indicators will blink in order: Battery, b

Status, c Status and System Fault accompanied by a secondary speaker beep .

11 . Test of the internal systems . Beep emitted from the secondary speaker .12 . Power on of Workstation complete . Caution: If the System Fault Indicator is illuminated then the

Workstation is not operational, remove the Workstation from service and contact Qualified Service Personnel.

The primary speaker will emit a melody from the primary speaker, click Workstation image to listen . This confirms successful power up .

13 . When the Workstation is connected to ACE . The b Status Indicator is illuminated .

Caution: Do not switch off the Workstation during this initial 90 second period.Caution: If any of the verification checks fails when the Workstation is switched on, suspect a fault. Remove the Workstation

from service and contact Qualified Service Personnel.

ANote: Not all steps may complete prior to the start of the subsequent step.

Switching OffPress the a key and hold for two seconds to switch the Workstation off .

Resetting the WorkstationIn the unlikely event that the Workstation needs to be reset, press and hold the a key for at least four seconds until the On Status Indicator is extinguished, release the key then press again to switch the Workstation back on .

Caution: If the Workstation still fails to operate correctly after resetting, remove the Workstation from service and contact Qualified Service Personnel.

AResetting the Workstation is also required to clear any System Fault Indicator.

1000DF00721 Issue 1 18/26

Alaris™ Gateway Workstation v1.5Operation of Workstation

Mounting a Pump1 . Ensure the Workstation is connected to the AC power and power up sequence has completed successfully .2 . Holding the Pump horizontally, push the Pump into the MDI tile . If correctly positioned, the rotating cam will click into position on

the rectangular bar and the AC outlet will slot into the inlet on the Pump . Ensure that the cam lever is in the return position .3 . Check that the AC power indicator on the Pump is illuminated . Neither AC power nor data communications will be available until the

Pump is correctly located on the MDI tile .When using volumetric pumps with the Workstation, it is recommended that, where possible infusion bags be located on a hanger directly above the Pump with which they are being used . This minimises the potential for confusion of lines when multiple volumetric pumps are used .

AIf a Pump is removed and replaced while the Workstation is operational, it may take up to 60 seconds for the Pump to establish AC power and data communications once correctly located on the MDI tile.

Caution: The location of the Pumps fitted to the Workstation, above or below the patient, may pose a risk of siphoning or over pressure. Please refer to the appropriate Pump DFU for further details.

Caution: Before starting an infusion with a volumetric pump check that the infusion set in the Pump is connected to the correct bag.

Removing a Pump1 . Holding the Pump with both hands, push the release lever on the right hand side of the Pump backwards .2 . Keeping the lever pushed back, pull the Pump horizontally towards you .3 . Check that the red LED indicator on the MDI tile is extinguished after removal of the Pump .Caution: If the indicator in the MDI tile is illuminated when no infusion Pump is attached to the MDI tile, suspect a fault with

the MDI tile. Remove the Workstation from service and contact Qualified Service Personnel.

1000DF00721 Issue 1 19/26

Alaris™ Gateway Workstation v1.5Data Communication Interfaces

Data Communication InterfacesThe user should be familiar with the data communications interfaces available on the Workstation before attempting to connect the Workstation to client / server systems . Erroneous connection of data communication cables will not damage the Workstation, but may cause the Workstation to operate incorrectly until the error is fixed .

Caution: Electrostatic Discharge (ESD) precautions are required when connecting the data communications cables to the Workstation. Avoid touching the pins of the connectors as this may result in an ESD protection failure.

Ethernet InterfacesThe Workstation may be used on a 10 Base-T/100 Base-Tx switched LAN . A DHCP client service allows the use of either fixed or dynamic network addressing of the Workstation . Similarly, a DNS client is provided . The ethernet connection to the Workstation is electrically isolated . The Workstation and Pumps connected to the Workstation can be monitored and have data transferred via the Alaris Communication Engine, see Alaris Communication Engine Directions For Use for full details .

Data Transfer

ARefer to the Alaris Communication Engine and relevant Pump Directions For Use for more information about deploying a data set and downloading CQI data.

Data SetThe workflow for deploying a data set to the Workstation requires the Alaris Plus Editor and the Alaris Communication Engine .

• The data set is deployed by the Alaris Communication Engine to the Pump . • The data set must be activated on the Pump prior to the use of the Pump .

AWhen creating a data set for Pumps to be used on a Workstation it is recommended to enable the Pump AC power failure feature.

CQI DataLocal CQI data can be exported and transferred to the Guardrails CQI database dependent on pump model . See ACE user manual for further details .

1000DF00721 Issue 1 20/26

Alaris™ Gateway Workstation v1.5Data Communications Interface Specifications

Data Communications Interface Specifications

Nurse Call InterfaceWorkstation Connector Plug Type: Binder 09 0978 00 03

Mating Connector Socket Type: Binder ‘710’ series 99 0975 100 03

Cable Type: Max . cable sheath diameter 4mm .

Isolation: 1 .5kV

Rating: 30V/1A

DescriptionPin 1: NC_COM

1

2

3

Pin 2: NC_NCPin 3: NC_NO

Ethernet InterfaceConnector Type: RJ45

Cable Type: CAT5e Ethernet Cable: Length >1 .5m 1

Isolation: 1 .5kV

Data Rate: 10/100Mbps

DescriptionPin 1: TxD+Pin 2: TxD–Pin 3: RxD+Pin 4: N/CPin 5: N/CPin 6: RxD–Pin 7: N/CPin 8: N/C

1000DF00721 Issue 1 21/26

Alaris™ Gateway Workstation v1.5Product Specifications

Product Specifications

ElectricalProtection Against Electrical Shock:Class I

Supply Voltage:115-230V, ~50-60Hz

Rating:460VA (Maximum)

Fuses:2 x 4AH Time-Lag T

Consult Qualified Service Personnel for replacement of fuses .

AC Outlets:MDI Tile: 115-230V, ~50-60Hz, 60VA

Protection against fluid ingress:IPX1 - Protected against vertically falling drops of water .

BatteryType:Nickel Metal Hydride

Charge time:With no pumps attached: Up to 8 hours to 95% charge time based on battery life cycle .

With pumps attached: Up to 16 hours to 95% charge time based on battery life cycle and an 11 pump load .

Operating time:20 minutes

Environmental

Operating Transport and StorageTemperature: +5°C - +40°C -20°C - +50°CHumidity: 20% - 90% 15% - 95%Atmospheric Pressure: 700 - 1060hPa 500 - 1060hPa

AEnviromental ranges for any attached Pumps should be reviewed to ensure the system is within specifications prior to operating, transport or storage.

ClassificationContinuous Operation

Regulatory ComplianceComplies with IEC/EN60601-1, IEC/EN60601-1-2 .

Potential Equalisation ConductorThe function of the Potential Equalisation Connector (Conductor) is to provide a direct connection between the Workstation, its internal and external earth, and the potential equalisation busbar of the electrical installation . To use the Potential Equalisation Connector, connect the Potential Equalisation Connector on the Workstation to the potential equalisation busbar of the electrical installation .

PatentsCovered under the following Patents: U .S . Pat . 6,593,528; EP 1502612 (DE, CH, FR, GB, ES & IT), CA 2614658 . Design Patents: AU144124; DE 49910883; FR 997137; and JP 1117998

1000DF00721 Issue 1 22/26

Alaris™ Gateway Workstation v1.5Product Specifications

Physical

Configuration Bag Supports

Height (mm)1

Width (mm)

Depth (mm)

Maximum Weight (kg approx .)

VA Rating Beacon

Unladen Laden2

80153UNS02-30 - 536 170 155 5 .1 14 100 Yes

80153UNS02-32 2 780 348 155 8 .7 25 .5 220 Yes

80153UNS02-33 3 780 514 155 11 .8 30 .5 280 Yes

80153UNS02-34 2/2 780 710 155 14 .1 36 .5 300 No

80153UNS02-50 - 771 170 155 6 .2 21 .5 180 Yes

80153UNS02-52 2 1015 348 155 10 .8 32 .5 260 Yes

80153UNS02-53 3 1015 514 155 12 .9 38 320 Yes

80153UNS02-54 2/2 1015 710 155 15 .2 43 .5 380 No

80153UNS02-70 - 1016 170 155 9 .8 28 .5 240 Yes

80153UNS02-72 2 1260 348 155 14 .4 40 300 Yes

80153UNS02-73 3 1260 514 155 16 .5 45 360 Yes

80153UNS02-74 2/2 1260 710 155 18 .8 51 400 No

80153UNS02-92 2 1500 348 155 13 .3 45 .8 440 Yes

80153UNS02-035 - 1064 485 155 13 39 320 Yes

80153UNS02-235 - 1240 485 155 14 .5 45 .5 360 Yes

Trolley Compatibility

Configuration Trolley Compatible

(80083UN00-00)3

Alaris Trolley Compatible

(80203UNS00-00)4

80153UNS02-30

80153UNS02-32

80153UNS02-33

80153UNS02-34

80153UNS02-50

80153UNS02-52

80153UNS02-53

80153UNS02-54

80153UNS02-70

80153UNS02-72

80153UNS02-73

80153UNS02-74

80153UNS02-92

80153UNS02-035

80153UNS02-235

1 Height of the Workstation with bag supports in the lowered position where appropriate . Bag supports can extend by a further 500mm above the Workstation .

2 Includes Pumps and 1 litre fluid bags on each bag support .3 Installation should be as low as possible . The mounting height should not exceed 160cm from the ground to the top of the

Workstation .4 Installation should be as low as possible . Refer to 1000PB01717 latest issue for maximum mounting heights .

1000DF00721 Issue 1 23/26

Alaris™ Gateway Workstation v1.5Maintenance

Maintenance

Routine Maintenance ProceduresTo ensure that this Workstation remains in good operating condition, it is important to keep it clean and carry out the routine maintenance procedures described below . All servicing should only be performed by Qualified Service Personnel with reference to the Technical Service Manual (TSM 1000SM00015) .

Circuit diagrams, components parts lists and all other servicing information which will assist the Qualified Service Personnel in performing repair of the parts designated as repairable are available upon request from CareFusion .

AIf the Workstation is dropped, damaged, subjected to excessive moisture or high temperature, immediately take it out of service for examination by Qualified Service Personnel.All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in accordance with the information supplied. CareFusion will not be responsible should any of these actions be performed outside the instructions or information supplied by CareFusion.

Interval Routine Maintenance Procedure

When loading Pumps Check that each Pump is properly located on the MDI and is mechanically locked into position .

When removing Pumps Check that the MDI Warning LED turns off when the Pump is removed . If the LED stays on, the Workstation should be serviced by Qualified Service Personnel .

As per Hospital Policy Thoroughly clean external surfaces of the equipment before and after prolonged periods of storage .

At least once per year

(Refer to TSM for identification of parts)

•InspectACoutlets,communicationconnectorsandtheACinletfordamage.

•Performelectricalsafetychecks.Thecompleteunitleakagecurrentmustbemeasured.Ifmorethan500µAthe equipment should not be used, but should be serviced by Qualified Service Personnel .

BatteryIt is recommended that only Qualified Service Personnel replace the battery, using only a CareFusion recommended battery . For further information regarding the replacement of batteries refer to the Technical Service Manual .

The battery pack used in this Alaris Gateway Workstation is manufactured by CareFusion and includes a proprietary PCB (printed circuit board) designed specifically for the Alaris Gateway Workstation, and in conjunction with Alaris Gateway Workstation software, controls battery use, charge and temperature . Any use of battery packs that are not manufactured by CareFusion in the Alaris Gateway Workstation is at your sole risk, and CareFusion does not provide any warranty for or endorsement on any battery packs that are not manufactured by CareFusion . CareFusion product warranty shall not apply in the event the Alaris Gateway Workstation has suffered damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of use with a battery pack that is not manufactured by CareFusion .

Replacing the AC FusesIf the AC power indicator does not illuminate when the Workstation is connected to the AC power supply, either the power supply fuse in the AC plug or, the AC fuses of the Workstation have blown .

First check the power supply fuse in the plug, if the AC power indication light does not illuminate proceed to check the Workstation AC fuses . Switch the power off and disconnect the Workstation from the AC power supply .

It is recommended that only Qualified Service Personnel replaces the AC fuses . For further information regarding the replacement of internal AC fuses refer to the Technical Service Manual .

AIf the fuses continue to blow, suspect an electrical fault and have the Workstation and power supply checked out by Qualified Service Personnel.

1000DF00721 Issue 1 24/26

Alaris™ Gateway Workstation v1.5Maintenance

Cleaning and StorageBefore the transfer of the Workstation to a new patient and periodically during the use, clean the Workstation by wiping over with a lint-free cloth lightly dampened with warm water and a standard disinfectant / detergent solution .

Do not use the following disinfectant types:

• Disinfectants which are known to be corrosive to metals must not be used, these include:• NaDcc (such as Presept), • Hypochlorites (such as Chlorasol), • Aldehydes (such as Cidex), • Cationic Surfactants (such as Benzalkonium Chloride) .

• Use of Iodine (such as Betadine) will cause surface discoloration . • Concentrated Isopropyl alcohol based cleaners will degrade plastic parts .

Recommended cleaners are:

Brand Concentration

Hibiscrub 20% (v/v)

Virkon 1% (w/v)

The following products were tested and are acceptable for use on the Workstation if used in accordance with the specified manufacturer’s guidelines .

• Warm soapy water• Mild detergent in water (e .g . Young’s Hospec)• 70% Isopropyl Alcohol in water• Chlor-Clean• Clinell Sporicidal wipes• Hibiscrub• TriGene Advance• Tristel Fuse sachets• Tristel Trio wipes system• Tuffie 5 wipe• Virkon Disinfectant• Virusolve+ (Ready To Use)• Virusolve+ (Wipes)

ABefore cleaning the Workstation always switch it off and disconnect it from the AC power supply. Never allow liquid to enter the casing and avoid excess fluid build up on the Workstation. Do not use aggressive cleaning agents as these may damage the exterior surface of the Workstation. Do not steam autoclave, ethylene oxide sterilise or immerse this Workstation in any fluid.If the Workstation has visible cracks or damage to the case do not clean and immediately take out of service for examination by Qualified Service Personnel.Do not clean the AC connector and socket. Please contact local CareFusion Qualified Service Personnel for further guidance.

DisposalDisposal of Waste Electrical & Electronic Equipment This U symbol on the product and/or accompanying documents means that used electrical and electronic products should not be mixed with household waste .

To discard electrical and electronic equipment, please contact local CareFusion affiliate office or distributor for further information .

Disposing of this product correctly will help to save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling .

Disposal in Countries outside the European Union This U symbol is only valid in the European Union . The product should be disposed of taking environmental factors into consideration . To ensure no risk or hazard, remove the internal rechargeable battery and the Nickel Metal Hydride battery from the control board and dispose of as outlined by the local country regulations . All other components can be safely disposed of as per local regulations .

1000DF00721 Issue 1 25/26

Alaris™ Gateway Workstation v1.5Products and Spare Parts

Products and Spare Parts

Alaris Infusion SystemRange of products in the Alaris Infusion System product family are:

Part Number Description8002MED01

8002TIG01Alaris GH Syringe Pump (with Plus software)

8002MED01-G

8002TIG01-GAlaris GH Guardrails Syringe Pump (with Plus software)

8003MED01

8003TIG01Alaris CC Syringe Pump (with Plus software)

8003MED01-G

8003TIG01-GAlaris CC Guardrails Syringe Pump (with Plus software)

80043UN01 Alaris TIVA Syringe Pump80053UN01 Alaris PK Syringe Pump9002MED01

9002TIG01Alaris GP Volumetric Pump (with Plus software)

9002MED01-G

9002TIG01-GAlaris GP Guardrails Volumetric Pump (with Plus software)

9003MED01-G

9003TIG01-GAlaris VP Plus Guardrails Volumetric Pump

8002ENT01 Alaris Enteral Syringe Pump

2504xxxx11 Alaris GW Volumetric Pump7131xxxxxx2 Alaris SE Pump - single channel7231xxxxxx2 Alaris SE Pump - dual channel80203UNS01-xxx3 Auxiliary Alaris Gateway Workstation (option 1)80203UNS02-xxx3 Alaris Gateway Workstation (option 2)80203UNS03-xxx3 Alaris Gateway Workstation wireless option kit (option 3)80203UNS00-00 Alaris Trolley

1 Contact local customer services representative to obtain language specific part number .2 Contact local customer services representative to obtain language specific part number .3 Contact local customer services representative to obtain configurations availability and part numbers .

Associated Documentation

Part Number Description Language Code

1000SM00015 Alaris Gateway Workstation Technical Service Manual en

1000CH00010 Alaris CQI Event Reporter v4 .2 .2 Directions For Use en

1000CH00169 Alaris Communication Engine User Manual en

Spare PartsA comprehensive list of spare parts for this Workstation is included within the Technical Service Manual .

The Technical Service Manual (1000SM00015) is now available in electronic format on the World Wide Web at :

www.carefusion.co.uk/alaris-technical/

A username and password are required to access our manuals . Please contact a local customer services representative to obtain login details .

Part Number Description

0000EL00889 AC Power Lead - UK

0000EL00938 AC Power Lead - European

1000SP00655 Rail Mounting Kit

1000SP00169 Pole Mounting Kit

1000DF00721 Issue 1 26/26

Alaris™ Gateway Workstation v1.5Service Contacts

Service Contacts For service contact your local Affiliate Office or Distributor .

AE DE HU PT

CareFusion,PO Box 5527,Dubai, United Arab Emirates .

CareFusion,Pascalstr . 2, 52499 Baesweiler,Deutschland .

CareFusion, Döbrentei tér 1,H-1013 Budapest,Magyarország .

CareFusion,Avda . São Miguel, 296 Atelier 142775-751 Carcavelos, LisboaPortugal

Tel: (971) 4 28 22 842 Tel: (49) 931 4972 837 Tel: (36) 1 488 0232Tel: (36) 1 488 0233

Tel: +351 219 152 593

Fax: (971) 4 28 22 914 Fax: (49) 931 4972 318 Fax: (36) 1 201 5987 Fax: +351 219 152 598

AU DK IT SE

CareFusion, 3/167 Prospect Highway,PO Box 355Seven Hills, NSW 2147, Australia .

CareFusion, Firskovvej 25 B,2800 Lyngby,Danmark .

CareFusion,Via Ticino 4, 50019 Sesto Fiorentino,Firenze, Italia .

CareFusion,Hammarbacken 4B, 191 46 Sollentuna,Sverige .

Tel: (61) 1800 833 372 Tlf . (45)70 20 30 74 Tél: (39) 055 30 33 93 00 Tel: (46) 8 544 43 200

Fax: (61) 1800 833 518 Fax . (45)70 20 30 98 Fax: (39) 055 34 00 24 Fax: (46) 8 544 43 225

BE ES NL US

CareFusion,Leuvensesteenweg 248 D,1800 Vilvoorde,Belgium .

CareFusion,Edificio Veganova,Avenida de La Vega, nº1,Bloque 1 - Planta 1,28108 Alcobendas, Madrid,España .

CareFusion,De Molen 8-10,3994 DB Houten,Nederland .

CareFusion,10020 Pacific Mesa Blvd .,San Diego, CA 92121,USA .

Tel: +32 (0) 2 267 38 99 Tel: (34) 902 555 660 Tel: +31 (0)30 2289 711 Tel: (1) 800 854 7128

Fax: +32 (0) 2 267 99 21 Fax: (34) 902 555 661 Fax: +31 (0)30 2289 713 Fax: (1) 858 458 6179

CA FR NO ZA

CareFusion,235 Shields Court,Markham, Ontario L3R 8V2,Canada .

CareFusion,Parc d’affaire le Val Saint Quentin2, rue René Caudron78960 Voisins le BretonneuxFrance

CareFusion,Fjordveien 31363 HØVIKNorge .

CareFusion,Unit 2 Oude Molen Business Park,Oude Molen Road, Ndabeni, Cape Town 7405, South Africa .

Tel: (1) 905-752-3333 Tél: (33) 01 30 02 81 41 Tel: (47) 64 00 99 00 Tel: (27) (0) 860 597 572Tel: (27) 21 510 7562

Fax: (1) 905-752-3343 Fax: (33) 01 30 02 81 31 Fax: (27) 21 5107567

CH FI NZ

CareFusion,A-One Business CentreZone d’activitiés Vers-la-Pièce n° 101180 Rolle / Switzerland

CareFusion,Kuortaneenkatu 2,00510 Helsinki

CareFusion,14B George Bourke Drive,Mt Wellington 1060, PO Box 14-518,Panmure 1741, Auckland, New Zealand

Ph .: 0848 244 433 Tel: +358 207871 090 Tel: 09 270 2420 Freephone: 0508 422734

Fax: 0848 244 100 Fax: 09 270 6285

CN GB PLCareFusion, 上海代表机构，中国上海市张杨路 500 号，上海时代广场办事处大楼，A 座，24 层，邮编：200122。

CareFusion,The Crescent, Jays Close,Basingstoke, Hampshire, RG22 4BS,United Kingdom .

CareFusion, ul . Rzymowskiego 53, 02-697 Warszawa, Polska .

电话：(86) 21 58368018 Tel: (44) 0800 917 8776 Tel: (48) 225480069

传真：(86) 21 58368017 Fax: (44) 1256 330860 Fax: (48) 225480001 Rev . J

carefusion.com

CareFusion, Alaris, Guardrails and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries. All rights reserved. All other trademarks are property of their respective owners.

© 2015 CareFusion Corporation or one of its subsidiaries. All rights reserved.

This document contains proprietary information of CareFusion Corporation or one of its subsidiaries, and its receipt or possession does not convey any rights to reproduce its contents, or to manufacture or sell any product described. Reproduction, disclosure, or use other than for the intended purpose without specific written authorization of CareFusion Corporation or one of its subsidiaries is strictly forbidden.

t CareFusion Switzerland 317 Sarl, A-One Business Centre, Z.A Vers –La-Pièce n° 10, CH-1180, Rolle

EC REP CareFusion UK 305 Ltd., The Crescent, Jays Close, Basingstoke, Hampshire, RG22 4BS, UK

1000DF00721 Issue 1

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