Event Medical - Evolution (Service Manual)

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Service Manual

eVolutionVentilatorSystem
http://www.event-medical.com/http://www.event-medical.com/http://www.event-medical.com/http://www.event-medical.com/http://www.event-medical.com/http://www.event-medical.com/http://www.event-medical.com/http://www.event-medical.com/http://www.event-medical.com/http://www.event-medical.com/http://www.event-medical.com/


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Page 2 of 232 eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010


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eVolution Ventilator Service Manual EVL510001 Rev. C v.0 Feb 2010 Page 3 of 232

eVolution Ventilator

Service Manual This manual applies to:

The eVolution ventilator PN: EVL100500

Illustrations in this manual apply to the eVolution ventilator.Installed software / firmware versions are displayed upon power up on the initial screen.

United States Europe

eVent Medical, Inc.971 Calle Amanecer, Suite 101San Clemente, CA 92673United States

eVent Medical Limited 0120 Unit 29 Glenrock Business Park Ballybane, Galway Ireland

Tel:

Fax:

+1 949 360 8368

+1 949 360 1924

www.event-medical.com

For technical assistance please contact eVent Medical at:

[email protected]
http://www.event-medical.com/mailto:[email protected]:[email protected]://www.event-medical.com/


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eVolution Ventilator Service Manual EVL510001 Rev. C v.0 May 2010 Page 5 of 232

TABLE OF CONTENTSPREFACE... ............................................................................................................................................... 15

INTRODUCTION ...........................................................................................................................................................15 COPYRIGHT INFORMATION .........................................................................................................................................15

GENERAL INFORMATION ... ............................................................................................................... 17 PRODUCT DESCRIPTION AND INTENDED USE .........................................................................................................17 S AFETY INFORMATION ................................................................................................................................................18 DEVICE L ABELS AND S YMBOLS..................................................................................................................................19 THE E V OLUTION PRODUCT LABELS :.........................................................................................................................21 R ESPONSIBILITIES AND GUARANTEES ........................................................................................................................22

PRODUCT SPECIFICATIONS ... ........................................................................................................... 23

ELECTROMAGNETIC COMPATIBILITY DECLARATION ..............................................................................................33 TOOLS , TEST EQUIPMENT AND M ATERIALS ( RECOMMENDED ) ..............................................................................38

THEORY OF OPERATION... ................................................................................................................ 39

O VERVIEW OF OPERATION .........................................................................................................................................39 Pneumatic Theory of Operation ... ..........................................................................................................................40 Gas supply systems...................................................................................................................................................40 High and Low Pressure Oxygen Inlets ...................................................................................................................40 Inlet Filters (F1, F2) .................................................................................................................................................41 Inlet O2 Check Valves (CV1 and CV2)..................................................................................................................41 Oxygen Regulator (Reg1) ........................................................................................................................................42 Blower.......................................................................................................................................................................43 Gas Delivery System ................................................................................................................................................43 Proportional Valves (PV1 / PV2)... .........................................................................................................................44 Flow Sensor (FS1 / FS2)... ......................................................................................................................................44 Check Valve (CV3)...................................................................................................................................................45 Oxygen Sensor (FIO 2 sensor)..................................................................................................................................46 Safety Valve (SV) .....................................................................................................................................................47 Safety Valve Solenoid (Sol 2) ...................................................................................................................................47 Check Valve (CV4)...................................................................................................................................................48 Crossover Valve (Sol1).............................................................................................................................................48 Check Valves (CV5 and CV6) .................................................................................................................................49 Exhalation System ...................................................................................................................................................49 Bacteria Filter (F3)...................................................................................................................................................50 Heat Exchanger (H1) ...............................................................................................................................................50 Exhalation Flow Sensor (FS3).................................................................................................................................51 Exhalation Valve (EV).............................................................................................................................................51 Low Flow Regulator (LFR)......................................................................................................................................52 Nebulizer System.....................................................................................................................................................52 Nebulizer Valve (SV4) .............................................................................................................................................52 Electronic System ....................................................................................................................................................55

Power Input Components ..........................................................................................................................................55 Power On/Off Switch...............................................................................................................................................55 Power Supply...........................................................................................................................................................56 Internal Battery Pack ...............................................................................................................................................56

External D.C. Power Socket.....................................................................................................................................57 Power Management Board ........................................................................................................................................58

Power Management..................................................................................................................................................58


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Blower Motor Board ......................................................................................................................................................59 Interface Board...............................................................................................................................................................60 Control Board................................................................................................................................................................61 Backlight Inverter ..........................................................................................................................................................62 LCD Panel...................................................................................................................................................................63 Front Panel Membrane Switch.......................................................................................................................................63

Encoder switch...............................................................................................................................................................64

Touch Screen..................................................................................................................................................................64 Alarm Light Board.......................................................................................................................................................65

SELF TESTS AND USER CONFIGURATION SCREENS... ............................................................... 67

POWER ON SELF TEST (POST).......................................................................................................................................67 USER C ALIBRATION ...........................................................................................................................................................68

Zero Flow Sensor ..........................................................................................................................................................71 Calibrate Exhalation F - S Zero Offset... ...................................................................................................................72 System Leak Test and Compliance Calculation ........................................................................................................73

System Leak Test..........................................................................................................................................................74 Perform Tubing Compliance Test ...................................................................................................................................74 O2 Sensor Calibration...................................................................................................................................................74

Exhalation Flow Sensor................................................................................................................................................76 User Configuration Screens .........................................................................................................................................78

System Pneumatic ..........................................................................................................................................................83 Power Status..................................................................................................................................................................85 System Logs...................................................................................................................................................................86 System Miscellaneous .....................................................................................................................................................88

ENGINEERING SCREENS... ................................................................................................................. 91

S YSTEMPNEUMATIC .........................................................................................................................................................92 POWER S TATUS....................................................................................................................................................................94 S YSTEMLOGS .....................................................................................................................................................................95

Alarm Log .......................................................................................................................................................................96 Calibration Log...............................................................................................................................................................96 Settings Log ....................................................................................................................................................................97

S YSTEMMISCELLANEOUS ................................................................................................................................................97 C ALIBRATION .....................................................................................................................................................................99

Air Valve calibration......................................................................................................................................................99 Calibration Process: .....................................................................................................................................................100

Oxygen Valve calibration ...........................................................................................................................................101 Calibration Process: .....................................................................................................................................................101

Exhalation Valve calibration......................................................................................................................................102 Calibration Process: .....................................................................................................................................................103

O2 Sensor Calibration.................................................................................................................................................104 Exhalation Flow Sensor..............................................................................................................................................105 Touch Screen Calibration...........................................................................................................................................107

System Test...................................................................................................................................................................108 System Leak Test........................................................................................................................................................108 Perform Tubing Compliance Test .................................................................................................................................109 System Leak Test........................................................................................................................................................110

Exhalation F-S Zero Offset ........................................................................................................................................111 Calibrate Exhalation F - S Zero Offset.... ................................................................................................................111

PERFORMANCE VERIFICATION.... .................................................................................................. 113

W HEN TO R UN TESTS .....................................................................................................................................................114 TEST EQUIPMENT AND SERVICE M ATERIALS............................................................................................................115


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CLEANING AND INSPECTION ......................................................................................................................................115 TEST EQUIPMENT SET UP...........................................................................................................................................116 TESTING ORDER ..........................................................................................................................................................116

1. Set-Up..............................................................................................................................................................117 FPGA...................................................................................................................................................................117 POST ....................................................................................................................................................................117 Speaker ..................................................................................................................................................................117

Alarm LED...........................................................................................................................................................117 Fan ........................................................................................................................................................................117 Software..................................................................................................................................................................117 Hours.....................................................................................................................................................................117 Pre-Patient System Tests...........................................................................................................................................117 Calibrate Oxygen Sensor ...........................................................................................................................................117

2. Electrical Safety Testing ..................................................................................................................................118 3. Functional Tests.... ...........................................................................................................................................118

Pneumatic Analyzer .................................................................................................................................................118 Oxygen Inlet regulator...............................................................................................................................................119 Inhalation Air Valve ...............................................................................................................................................119 High Pressure Inhalation Oxygen Valve.....................................................................................................................119 Low Flow Oxygen Inlet............................................................................................................................................120 Flow, Air and Exhalation........................................................................................................................................120 Flow, Oxygen and Exhalation ..................................................................................................................................120 Safety valve ..............................................................................................................................................................121

Exhalation valve .....................................................................................................................................................121 Nebulizer Solenoid ...................................................................................................................................................121 Crossover Valve.......................................................................................................................................................122 Internal battery ........................................................................................................................................................122 Heater....................................................................................................................................................................122 Buzzer....................................................................................................................................................................122

Manual Key.............................................................................................................................................................124 O2 (100% O2) Key...............................................................................................................................................124

Nurse Call .................................................................................................................................................................124 4. Performance Verification Tests.... ...................................................................................................................124

Oxygen Concentration Accuracy..................................................................................................................................124 5. Volume Accuracy (Vti/Vte/RR).... .................................................................................................................125 Pressure Accuracy (Pcontrol/PEEP).... ..................................................................................................................128 Alarm Operation Tests ............................................................................................................................................131 Troubleshooting Performance Verification ............................................................................................................134

ALARM MESSAGES AND DIAGONSTIC ERROR MESSAGES.... .................................................... 137

ALARM SIGNALS ...........................................................................................................................................................137 ALARM LEVELS .............................................................................................................................................................137 ALARM SILENCE K EY ...................................................................................................................................................138 ALARM LOG ..................................................................................................................................................................138

ALARM DEFINITIONS ...................................................................................................................................................138 High Priority Alarms................................................................................................................................................138 Medium Priority Alarms ..........................................................................................................................................140 Information Messages..............................................................................................................................................141 About Diagnostic Messages.....................................................................................................................................141

Startup Mode: .........................................................................................................................................................141 Standby Mode:.........................................................................................................................................................142

PREVENTATIVE MAINTENANCE.... ................................................................................................ 145

Every Year or as required: Clean or Replace Cooling Fan Filter.........................................................................145


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Every Year or as required: Clean or Replace Air Inlet Filter................................................................................146 Every Year or as required: Replace oxygen sensor ................................................................................................146 Every Two Years or as required: Replace the Internal Battery.... ........................................................................147 As Required: Replace Fuses.......................................................................................................................................148

SERVICE AND REPAIR.... .................................................................................................................... 149

R EPAIR S AFETY ................................................................................................................................................................149

R EPAIR GUIDELINES .......................................................................................................................................................149 CLEANING .........................................................................................................................................................................150 ELECTRICAL C ABLES AND PNEUMATIC CONNECTION ...........................................................................................150 ESD CONTROL .................................................................................................................................................................150

General Information .... ...............................................................................................................................................150 Procedures and Precautions.... ...................................................................................................................................150

R EPAINTING .....................................................................................................................................................................151 NONCONFORMING P ARTS AND R ETURN AUTHORIZATION NUMBERS (RGA) ..................................................151 R EPLACEMENT P ARTS.....................................................................................................................................................151 POST R EPAIR AND TESTING ..........................................................................................................................................151 R EPAIR DOCUMENTATION AND R ECORDS ................................................................................................................151 P ATIENT S YSTEM AND ACCESSORIES ..........................................................................................................................151 SERVICING PROCEDURES - R EMOVAL /I NSTALLATION ...........................................................................................152

Ventilator Stand ...........................................................................................................................................................152 AC power ......................................................................................................................................................................152 Air Inlet Filter, Main ...................................................................................................................................................152 Fan Air Inlet Filter.......................................................................................................................................................152 Internal Batteries..........................................................................................................................................................152 Oxygen Sensor .............................................................................................................................................................152 Top Enclosure..............................................................................................................................................................152 Front enclosure Removal.... ....................................................................................................................................153 Rotary Control Knob.... ..............................................................................................................................................153 Front Panel Membrane Switch..................................................................................................................................153 Display Assembley.......................................................................................................................................................153 Control Board...............................................................................................................................................................154 Interface ........................................................................................................................................................................154 Backlight Inverter ........................................................................................................................................................154 LCD Panel ....................................................................................................................................................................154 AlarM Light Board ......................................................................................................................................................154 Rear Panel .....................................................................................................................................................................154 Battery Tray assembly.................................................................................................................................................155 Power Manifold Assembly .........................................................................................................................................155 Blower Motor Board...................................................................................................................................................155 Power Management Board.........................................................................................................................................155 Power Supply................................................................................................................................................................156 Exhalation Valve module ...........................................................................................................................................156 Heat Exchanger.... ........................................................................................................................................................156

Exhalation Flow Sensor..............................................................................................................................................157 Exhalation Valve Assembly .......................................................................................................................................157 Exhalation Valve Diaphagm ......................................................................................................................................157 Nebulizer Manifold .....................................................................................................................................................157 Exhalation Low Flow Regulator (LFR)....................................................................................................................157 Safety Valve Module....................................................................................................................................................158 Safety Valve Diaphram ...............................................................................................................................................158 Safety Valve Check valve............................................................................................................................................158 Inhalation Module Assembley...................................................................................................................................158 Flow Sensor FS1 & FS2..............................................................................................................................................159


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Air Valve (PV2)........................................................................................................................................................159 High pressure inhalation module (PV1)..................................................................................................................159 Oxygen Filter............................................................................................................................................................159 Oxygen Regulator ....................................................................................................................................................160 Crossover solenoid SOL 1 .......................................................................................................................................160 Safety valve solenoid SOL 2 ....................................................................................................................................160 Blower Assembly .....................................................................................................................................................160

PARTS LIST.... ........................................................................................................................................ 161 V ENTILATOR ASSEMBLY , MODEL EVL 100000.........................................................................................................163 SERVICE P ARTSLIST....................................................................................................................................................203 CONSUMABLE P ARTSLIST...........................................................................................................................................208

COMMUNICATION INTERFACE.... ................................................................................................. 209

E THERNET CONNECTION (RJ45 CONNECTOR ).........................................................................................................209 NURSE C ALLPORT CONFIGURATION ........................................................................................................................209

SOFTWARE INSTALLATION INSTRUCTION.... ............................................................................. 211

USING THE DOWNLOAD TOOL ..................................................................................................................................211 Introduction.... ..........................................................................................................................................................211 Environment Compatibility .....................................................................................................................................211 Required Equipment and Files .... ............................................................................................................................212 Download Procedure: Upgrading Existing Application.... ....................................................................................213 Troubleshooting Download Failure ........................................................................................................................217

FORMS.... ................................................................................................................................................ 221

E V OLUTION V ENTILATOR PERFORMANCE VERIFICATION RECORD.... ..............................................222 INDEX .... ................................................................................................................................................................231


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TABLE OF FIGURESFigure 1: eVolution Serial Number Label.......................................................................................................21

Figure 2: eVolution Manufactured For Label .................................................................................................21

Figure 3: eVolution Caution Label..................................................................................................................21

Figure 4: eVolution Date of Manufacture Label... ..........................................................................................21 Figure 5: Pneumatic Diagram.........................................................................................................................40

Figure 6: Pneumatic/Mechanical Tubing Diagram........................................................................................53

Figure 7: eVolution System Wiring Diagram .................................................................................................54

Figure 8: eVolution Electrical Block Diagram................................................................................................66

Figure 9: User Calibration Screen New Patient...........................................................................................69

Figure 10: Pre-Patient System Test Screen.....................................................................................................69

Figure 11: Pre-Patient Calibrations Screen New patient.............................................................................70

Figure 12: User Calibration Screen Previous Patient...................................................................................70

Figure 13: Pre-Patient Calibrations Screen Previous ...................................................................................71

Figure 14: Calibrate Exhalation F - S Zero Offset .........................................................................................72

Figure 15: Calibrate Oxygen Sensor Test Screen............................................................................................75

Figure 16: Settings ..........................................................................................................................................78

Figure 17: Config Screen ................................................................................................................................78

Figure 18: Technical Settings Screen ..............................................................................................................80

Figure 19: Language Setting Screen................................................................................................................81

Figure 20: Time and Date Setting Screen .......................................................................................................81

Figure 21: Technical Settings - Engineering Password ..................................................................................82

Figure 22: Engineering Screen........................................................................................................................83

Figure 23: System Pneumatic Screen..............................................................................................................84

Figure 24: Power Status Screen......................................................................................................................85

Figure 25: System Logs Screen.......................................................................................................................86

Figure 26: Alarm Log Screen..........................................................................................................................87

Figure 27: Calibration Log ..............................................................................................................................87

Figure 28: Settings Log Screen .......................................................................................................................88

Figure 29: System Miscellaneous Screen.........................................................................................................88

Figure 30: Engineering Screen........................................................................................................................91

Figure 31: System Pneumatic Screen..............................................................................................................92

Figure 32: Power Status Screen......................................................................................................................94


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Figure 33: System Logs Screen ...........................................................................................................................95

Figure 34: Alarm Log Screen ..............................................................................................................................96

Figure 35: Calibration Log Screen......................................................................................................................96

Figure 36: Setting Log Screen .............................................................................................................................97

Figure 37: System Miscellaneous Screen ...........................................................................................................97

Figure 38: Calibration Screen..............................................................................................................................99

Figure 39: Calibrate Air Valve Screen................................................................................................................99

Figure 40: Calibrate Oxygen Valve Screen......................................................................................................101

Figure 41: Calibrate Exhalation Valve Screen ................................................................................................102

Figure 42: Calibrate Oxygen Sensor Screen....................................................................................................104

Figure 43: Calibrate Exhalation Flow Sensor Screen ....................................................................................105

Figure 44: Touch Screen Calibration Screen ..................................................................................................107

Figure 45: System Test Screen ..........................................................................................................................108

Figure 46: System Leak Test Screen.................................................................................................................109

Figure 47: Calibrate Exhalation F - S Zero Offset Screen............................................................................111

Figure 48: Electrical Safety Test Set-Up..........................................................................................................118

Figure 49: Pneumatic Analyzer Set-Up............................................................................................................119

Figure 50: Adult Patient Circuit Set-Up ..........................................................................................................122

Figure 51 - Fan Filter and Cover......................................................................................................................145

Figure 52: O2 Sensor..........................................................................................................................................146

Figure 53: O2 Sensor..........................................................................................................................................146

Figure 54: Internal Battery.................................................................................................................................147

Figure 55: Fuse....................................................................................................................................................148

Figure 56: Communication ports, Ethernet and Nurse Call .... ....................................................................209

Figure 57: Back Panel, RJ12 Nurse Call Connector ......................................................................................209

Figure 58: Firmware Version Screen................................................................................................................212


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LIST OF TABLES Table 1: Configurable Attributes .................................................................................................................79

Table 2: System Pneumatic Screen Parameters/Ranges ...............................................................................93

Table 3: System Miscellaneous Screen Paramaters/Ranges .........................................................................98

Table 4: Calibration/Performance Testing Schedule ....................................................................................114

Table 5: Test Equipment & Service Materials Table....................................................................................115

Table 6: Initial settings ................................................................................................................................123

Table 7: Volume Accuracy Test Settings - 1.................................................................................................125



Table 10: Volume Accuracy Test Settings - 4 ..............................................................................................127

Table 11: Pressure Accuracy Test Settings ..................................................................................................128

Table 12: Alarm Operation Test Settings ....................................................................................................131

Table 13: Apnea Backup Test Settings .........................................................................................................133

Table 14: Alarm Signals ..............................................................................................................................137

Table 15: Preventive Maintenance Schedule ...............................................................................................145


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PREFACEINTRODUCTION This manual is intended to provide the necessary information required to service and maintain the eVentMedical eVolution ventilator system. It is intended for use by certified biomedical engineers or engineers with equivalent experience in the maintenance of respiratory life support equipment. It is highlyrecommended that engineers wishing to undertake the maintenance of the eVolution ventilator system attenda technical training seminar with eVent Medical or authorized local agents.

COPYRIGHT INFORMATIONFirst edition (Rev. A1 v.01) of this Service manual: Part Number EVL510001 eVolution Ventilator ServiceManual, English International Feb/2010.

2010 eVent Medical, Inc. All rights reserved.

No part of this Service Manual may be reproduced or stored in a database or retrieval system nor transmitted,in any form or by any means - electronic, photocopying, recording, or otherwise--without the prior writtenpermission of eVent Medical.

Intended for use with the eVolution ventilator, this manual is subject to technical modification and may berevised or replaced by eVent Medical at any time without prior notice. We recommend you have the mostcurrent version of this manual.

The ventilator should be operated, serviced and calibrated by trained professionals. US Federal Law restrictsthis device to sale by or on the order of a physician.

Smart Sigh and Smart Nebulizer are trademarks of eVent Medical. eVolution is a registered trademark ofeVent Medical. Other acronyms and products referenced in this manual may be trademarked by separatecompanies.

Upon request, eVent Medical may provide certain technical, operation, sales and marketing information thatassists clinicians and trained service professionals.

Nothing in this manual shall limit or restrict in any way eVent Medicals right to revise or otherwise change ormodify, without notice, the equipment (including its software) described herein. In the absence of anexpress, written agreement to the contrary, eVent Medical has no obligation to furnish any such revisions,changes, or modifications to the owner or user of the equipment (including its software) described herein.

Section

1
http://www.event-medical.com/http://www.event-medical.com/


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GENERAL INFORMATION This section of the manual is intended to provide introductory information concerning the eVolution ventilator system; along with a brief product description, specifications, a tooling and maintenance summaryand an introduction to the ventilators controls and indicators.

The information within is not intended as a sole source of reference and is intended for use in conjunction with the eVolution User Manual. Both manuals must be referenced when performing any maintenance to the

system.PRODUCT DESCRIPTION AND INTENDED USE The eVolution Ventilator is intended for and suitable for use in the ICU, sub acute, long-term acutecare, rehabilitation, and emergency room, as well as, in hospital transport venues. Specifically, theeVolution Ventilator is designed for adult and pediatric patients needing ventilatory support, asprescribed by an attending physician. This device is intended for and designed to provide continuousand or intermittent mechanical ventilation to patients requiring ventilatory support through invasive ornon-invasive interfaces. The ventilator is a class IIb medical device intended for use by qualified,trained personnel under the direction of a physician.

The eVolution includes these features: User-selected oxygen concentration Volume, volume targeted pressure or pressure-based breaths delivered in controlled,

synchronized intermittent mandatory or spontaneous modes Flow and or pressure breath triggering Apnea monitoring and Apnea backup ventilation system Numeric and waveform display of user-defined ventilator data Respiratory mechanics monitoring Smart Sigh breaths delivered at user-defined frequency and breath amplitude User-defined Smart Nebulizer functions

Prioritized alarm system Spontaneous Positive Airway Pressure (SPAP) Non Invasive Ventilation (NIV) available in all modes Auto Control Integrated Air source User configurable GUI

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Only qualified and properly trained personnel should attempt to use, service, ormaintain the eVolution ventilator: Read this User Manual carefully and keepavailable for reference.

The device is not to be used in the presence of flammable anesthetics. Before operating the eVolution, check the ventilator for proper operation by

performing the System Test, Alarms Test and Calibration procedures describedin this manual.

SAFETY INFORMATION The symbols below draw your attention specifically to the remaining dangers associated with proper useand to emphasize important technical requirements.

Information or directions/warnings intended to prevent potentialdamage to the patient, caregiver or device.

Explanatory notes and comments relevant to the eVolution ventilator.

The eVolution should only be operated and maintained by personnel withappropriate technical and clinical training. All patients requiring ventilationmust be monitored appropriately by competent medical personnel.

US Federal Law restricts this device to sale by or on the order of a physician. Only medically pure oxygen should be used for ventilation. Do not use

anesthetics and potentially explosive gases. Ensure that oxygen supplies arecompletely oil-free.

To avoid any potential fire hazard, keep all matches, lighted cigarettes, andother sources of ignition away from the device.

Ensure that an alternate source of ventilation is always available when usingthe eVolution ventilator .

When the eVolution ventilator is connected to an external device, the powercord should be in use to ensure proper grounding.

Check the remote alarm system (nurse call) is activated before leaving thepatient unattended.

Do not replace any accessories or other parts of the eVolution while apatient is being ventilated.

Do not use the eVolution ventilator unless an internal battery with at least aminimal charge is installed.

If the eVolution has been stored for an extended period, recharge the batterybefore use.

Maintenance must be conducted in compliance with all relevant safetyregulations. Repairs, assembly and use must be conducted by trained personnel; and the

ventilator must be checked by trained personnel annually. A bacteria filter can be placed between the ventilators To Patient outlet and

the patient breathing circuit to prevent cross contamination. Do not sterilize the eVolution ventilator. If any damage to the ventilator is apparent, its life-supporting function can


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no longer be guaranteed. Stop using the ventilator immediately and use analternate form of ventilation.

Do not operate the ventilator positioned next to a curtain that could blockthe flow of cooling air, thereby causing the equipment to overheat.

Adding attachments or other components or subassemblies to the ventilatorbreathing system may cause the pressure gradient to increase across the ventilator breathing system, measured with respect to the patient connection.

To avoid electrical shock while servicing the ventilator, be sure to disconnectthe ventilator from all power sources.

The eVolution ventilator complies with the requirements of IEC 60601-1-2(EMC Collateral Standard), which include E-field immunity and ESDrequirements. However, even though the device is compliant at the levels ofimmunity specified in the standard, certain transmitting devices (cellularphones, walkie-talkies, cordless phones, paging transmitters etc.) emit radiofrequencies that could potentially interrupt ventilator operation if locatedclose to the ventilator. Practitioners must be aware that radio frequencyemissions are additive, and the ventilator must be located a sufficient distancefrom transmitting devices to avoid interruption.

Do not operate the ventilator in a magnetic resonance imaging (MRI)environment.

Consult with your institutions biomedical engineering department in case ofinterrupted ventilator operation, and before relocating any life supportequipment.

Preventive Maintenance, cleaning and sterilization activities must beconducted in accordance with the procedures and recommended intervalsdetailed in this manual to ensure prolonged operation of the eVolution ventilator.

DEVICE LABELS AND SYMBOLS These device labels and symbols appear on the eVolution ventilator.

On/Off switch

Alarm Silence key

An illuminated LED at the top of the deviceindicates there is an active alarm. This is inaddition to the audible and on screen visualalarm.

Running on external power source

Internal battery charge status


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On battery backup

Indicates the settings and screen are not locked

Indicates the settings and screen are locked

Nebulizer nipple connector

Front Panel: A green LED indicates device isconnected to mains

Ethernet Ethernet connection port

RS232 RS232 connection port

Nurse call connection port

Refer to manual for Information, directions andor warnings intended to prevent potential harmor damage to the patient, caregiver and device.

Earth Ground

Designates type B equipment per IEC 601-1

IPX1 Indicates the degree of protection (drip-proof) bythe enclosure.

O 2 2-6 bar (30-90 psi) High pressure Oxygen inlet port label

O 2 .3 2 bar (5 30psi) Low pressure Oxygen inlet port label

DC Input:12VDC168W14A

DC input connector

AC Input:90 -240VAC47/63 Hz120VA100V: 2.4A240V: 1.2AFuse: 250V 3.15AT

AC input connector

O 2 Sensor Oxygen sensor location

SN: Device serial number


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THEEV OLUTION PRODUCT LABELS:

Figure 1: eVolution Serial Number Label

Figure 2: eVolution Manufactured For Label

Figure 3: eVolution Caution Label

Figure 4: eVolution Date of Manufacture Label

Gas flow to patient from ventilator

Gas flow from patient to ventilator

Do not obstruct! Do not obstruct port or outlet

Indicates WEEE (Waste Electrical and ElectronicEquipment) Registration per EU WEEE Reg. No. IE00761, Directive, 2002/96/EC


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RESPONSIBILITIES AND GUARANTEES The manufacturer assumes no responsibility and exonerates itself accordingly from liability claims where the operator or any third party has:

Used the device improperly. Failed to follow the operating instructions. Disregarded any warnings, cautions or other technical data. Modified the device in any way. Operated the device using accessories that are not listed in the associated product

documentation, or do not meet applicable international standards.


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PRODUCT SPECIFICATIONS This section provides specifications for the eVolution ventilator.Pressures are shown on the eVolution in cmH 2O, mbar and Hectopascals (hPa). Mbar and hPa are usedby some institutions instead of cmH 2O. Since 1 mbar equals 1 hPa, which equals 1.016 cmH2O, theunits may be used interchangeably.

Ventilation Modes Assisted Control Mandatory

Ventilation

CMV

Synchronized IntermittentMandatory Ventilation

SIMV

Spontaneous Ventilation SPONT Auto-control Auto-control)Noninvasive Ventilation NIV

Breath Types Volume-controlled breaths VCMV, V SIMV

Pressure-controlled breaths PCMV, P SIMV, PS

Volume Targeted Pressure-

controlled breaths(Pressure Regulated VolumeControl) & (Volume Support)

PRVC-CMV,

PRVC-SIMV, VS

Dual Level PEEP breaths(Spontaneous Positive AirwayPressure)

SPAP

Patient Types Adult and Pediatric Apnea Backup User selected Breath type and

settings, OFFP-CMV; V-CMV; PRVC-CMVPressure triggering (-0.5) (-20)

cmH2O

Breath Triggering

Flow triggering 0.5 20 l/min Additional Settings Respiratory Rate 1 120 b/min

Accuracy: 0 to 100 b/min ( 1 b/min), > 100b/min + 2%

Tidal Volume 50 2000 ml Accuracy: 50 to 2000 ml: (10 ml + 5%)

(compliance &BTPScompensated)

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PEEP / CPAP 0 40 cmH 2O Accuracy: (2 cmH2O + 4%)Pcontrol 0 80 cmH 2O Accuracy: (2 cmH2O +4%)

Psupport 0 60 cmH 2O Accuracy: (2 cmH2O + 4%)Peak Flow Mandatory

5 - 120 l/min Accuracy: 10%Peak Flow Spontaneous

1 180 l/min Accuracy: 10%Leak Comp Automatic LeakCompensation

On or Off

Base Flow 2.5 25 l/minSettable at this range only when automatic leakcomp is set to Off and NIV is set to Off.Base Flow 2.5 60 l/minSettable at this range only when NIV is set to Onand automatic leak comp is set to Off.ITime (Ti) 0.02 4 secI : E Ratio 1 : 99.9 99.9 : 1 Ti, Tp and Te Accuracy: < 10.0 seconds 0.01 s 10.0 seconds 0.1 sNIV On or Off

Non-Invasive ventilation can be enabled in allmodes.Pause (insp plateau) 0 2 secOxygen (FiO2 ) 21 100 %

Blender or Lowflow

Accuracy (Delivery): (3 %) full scaleRise time settings 10 (Fast), 5

(Med) or 1 (Slow)Flow pattern Decelerating,

Decelerating50%, or Square.

Exhalation sensitivity(Esens %)

10 80 % ofpeak flow

Auto Control On or Off Time (s)(used in Auto Control)

3 60 sec

Apnea Backup Settings Apnea backup modes Adult or Apnea backup modes: V-CMV; P-CMV;


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Pediatric PRVC-CMV, OFF+O2% This setting establishes the

percentage increase to FiO2 to beadded to the main oxygen settingduring Backup Ventilation.

Configuration Screen Settings Humidity type None, HME,

Warm HumidifiedSmart Nebulizer On or Off;User selectedduration (1-480minutes,increments of 1minute)User selectedinterval (1-480minutes,increments of 1minute)

Smart Sigh On or Off; 0 50%of volume orpressure settingSigh Interval; 20-200 breathsNumber of sighsper time; 1-6

Graph Settings Waveforms; 1, 2, or3 displayedLoops; 1 or 2displayed

Trend Data Settings 1, 2 or 3 trendsdisplayed

Monitors 5, 8 or 10 displayedCompliance Comp. Compliance

Compensation Onor OffBlower 100% Onor Off


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Low Flow O2 Low Flow O2; Onor OffO2 Sensor; On orOff

Audio/LCD Level Audio Level; 35-

100%Screen Clicks On orScreen Clicks OffLCD Brightness;20-100%

Phigh 5 to 50 orPlow to 50 or5 to (80-Psup high)

Plow 0 to 50 AND0 to Phigh AND0 to (80-Psup low)

SPAP Mode Settings

Psup High 0 to (80 Phighsetting) cmH20

Phigh + Psup High will not exceed 80 cmH 2OPsup Low 0 to (80 Plow

setting) cmH20Plow + Psup Low will not exceed 80 cmH 2O Thigh 0.1 to (60 - Tlow

setting) s Tlow 0.2 to 59.9 s (max

60 Thigh setting)Cycles/min 1 120 c/min

H : L (see time values) 1:59 to 59:1Pressure Values Monitored / Displayed Patient Values Ppeak

(peak pressure during abreath)

0 100 cmH 20 Accuracy: 2cmH20 + 4%

PEEP(pressure at endexhalation)


Pmean(averaged mean pressure)


Volume / Flow Values Vte(exhaled tidal volume)

0 3000 ml Accuracy: 0 40ml (2ml + 5%);41 3000 ml (10 ml + 5%)


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Volume / Flow Values Vti(tidal volume delivered)

0 3000 ml Accuracy: 0 40ml (2ml + 5%);41 3000 ml (10 ml + 5%)

Ve(exhaled minute volume)

0 99 l/min Accuracy: (0.01l/min + 5%)

Leak 20 100% Time Values Resp Rate(measured mandatory andspontaneous breaths perminute)

0 150 b/min Accuracy: 0 100 b/min ( 1b/min), > 100b/min + 2%

ITime (Ti)(inspiration time)

0.1 99.9 sec Accuracy: 0.01sec

Expiratory Time (Te) 0.1 99.9 sec Accuracy: 0.01sec

I : E, calculated only 1 : 99.9 99.9 : 1 Ti/Ttot 1 99.9%H:L 1 : 599 299 : 1

Ratio of time athigh and lowPEEP levels when SPAP isactive

Spont% 1h 0 100 %Percentage ofspontaneousbreaths for thelast 1 hour

Spont% 8h 0 100 %Percentage ofspontaneousbreaths for thelast 8 hours

Respiratory Mechanics Cstat(static compliance, lungstiffness)

0-300 ml/cmH 20 Accuracy: 10%

Rinsp(inspiratory resistance ofairways and tubes)

0 1000cmH20/l/sec


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Rexp(expiratory resistance ofairways and tubes)

0 1000cmH20/l/sec

Auto PEEP(Actual PEEP set PEEP)


Pplateau 0 100 cmH 20 Accuracy: 2cmH20 + 4%

RSBI(Measured breathing ratedivided by Insp tidal volume)(RR/Vt = RSBI)

0 3000 b/min/l

Real Time Curves Pressure + Time Pressure over

time: measuredinternally incmH20

Flow + Time Flow over time:measuredinternally inl/min

Volume + Time Volume overtime: measuredinternally in ml

P V Loop Pressure-volumeloop: measuredinternally incmH20 and ml.Pressuredisplayed on x-axis and volumeon the y-axis

F V Loop Flow-volumeloop: measuredinternally inl/min and ml.Flow is displayedon the y-axis and volume on the x-axis

One, two or three curves OR one to two loopscan be selected to display. The eVolution ventilator provides a user configurable autoscaleor manual scale feature for each graphicdisplayed.


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Delivered FiO 2inspiratory oxygenconcentration

Oxygen 15 - 103% Accuracy: 3%of full scale

Pressure Alarms Alarm Limit SettingsPpeak High 5 or 1 > Ppeak

Low to 85cmH2OPpeak Low 1 84 cmH 2O or

1 < Ppeak HighPEEP High 3 or 1 > PEEP

Low to 50cmH2O

PEEP Low 2 to 49 cmH 2Oor 1 < PEEPHigh, or Off

Volume Alarms

Ve High 0.1 or 0.1 > VeLow to 99.0l/min

Ve Low 0.1 to 98.9 l/minor 0.1 < VeHigh, or Off

Vte High 10 or 2 > VteLow to 2500 ml

Vte Low 2 to 2495 ml or 2< Vte High, orOff

Vti Limit 50 to 2500 ml, orOff

Respiratory Rate Alarms Resp rate High 2 or 1 > Rate

Low to 120b/min

Resp rate Low 1 to 119 b/minor 1 < Rate High

Oxygen Delivery Alarm AutomaticSetting

High FiO 2 Ventilatorsoftwareautomatically setsalarm limit to 7%above oxygen %setting.


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Low FiO 2 Ventilatorsoftwareautomatically setsalarm limit to 7%below oxygen %setting.

Apnea (interval) 3 60 secLeak rate(minimum leak allowed)

20 100 %

AUTO SET(Auto sets alarm values)

See the Section Alarm LimitSettings in theeVolution ServiceManual fordetailed Auto Setalarm keyfunction and Auto alarmsettingadjustments.

Alarm Priority High Priority Alarms Apnea Battery FlatDisconnection OcclusionHigh Pressure Low PressureHigh Minute Volume Low Minute

VolumeHigh Oxygen Low OxygenHigh Oxygen Inlet Pressure Low Oxygen

Inlet PressureHigh Tidal Volume Low Tidal

VolumeMedium Priority Alarms Battery Low Vti Limit

Reached Volume Not Delivered High Leak RateHigh frequency Low frequencyPEEP Low PEEP HighCheck Pcontrol / Pmax Check Psupport

/ PmaxHigh Temperature High external

voltageInformation Messages Alarms Battery Not Available Battery In UseFlow Sensor Error Inverse Ratio SetNebulizer Not AvailableNebulizer Not Available


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Power and Gas Supply AC input 90 to 240 VAC(47 63 Hz)

DC input VDC 12Battery Backup (with fullycharged battery)

> 120 min

High pressure oxygen inletsupply 30 90 psi clean,dry, and oil-freemedical grade

Low pressure oxygen inletsupply

5 30 psi clean,dry, and oil-freemedical grade

Environmental Data Operating temperature 5 40 CStorage temperature -10 60 COperating Humidity 15% - 95% non-

condensingStorage Humidity 5% - 95% RH

non-condensingOperating altitude 11,600 ft (3,536m) above sealevel

Physical Data Width x depth x height(ventilator)

14 x 14 x 12 in or35.5 x 35.5 x 30.5cm

Weight 35 lbs or 15.9 kg

Noise Level 55 dBa Technical Data Maximum limited pressure 90 cmH20 via a

dedicatedpressure relief valve

Maximum operating pressure 80 cmH20controlled byhigh pressurealarm setting

Measuring and displaydevices

Pressuremeasurementsare made bysolid-statepressuretransducerspositioned tomonitor internaloperating,inspiratory, andexpiratory circuitpressures


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Flow and volumemeasurement

Flowmeasurementsare made by oneof three hot wireflow sensors, andare integrated with time tocalculateinspiratory andexpiratory volumes. Flowand volumemeasurementranges areaccording tomonitored dataspecifications

Oxygen measurement A galvanic cell ispositioned inparallel to theinspiratorymanifold tomeasure thedelivered oxygenconcentrationsfrom 0 to 103%.

Display Touch Screen

All data appearson a touchscreen enabledcolor liquidcrystal display(LCD)

Compliance and Approvals IEC 60601-1:1988 + A1:1991+A2:1995

Classified asprotection class I, Type B, internallypowered, drip-proof equipmentfor continuousoperation

Meets International

Standards

IEC 601-1/

EN60601-1, IEC601-1-2,EN60601-1-2,EN794-1, ASTMF1100-90,IEC 60601-2-12:1988, ASTMF1054-87, ISO5356-1


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ELECTROMAGNETIC COMPATIBILITY DECLARATION

Guidance and Manufacturer's Declaration - Electromagnetic Emissions The ventilator is intended for use in the electromagnetic environment specified below. The user ofthe ventilator should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Enforcement - Guidance

RF Emissions CISPR 11 Group 1

The ventilator uses RF energy only for its internalfunction. Therefore, its RF emissions are very lowand are not likely to cause any interference in nearbyelectronic equipment

RF Emissions CISPR 11 Class A

Harmonic emissionsIEC 61000-3-2 Class A

Voltagefluctuations/flicker

emissions IEC 61000-3-3Complies

The system is suitable for use in all establishments,including domestic establishments and those directly

connected to the public low voltage supply networkthat supplies buildings used for domestic purposes


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Guidance and Manufacturer's Declaration - Immunity

The ventilator is intended for use in the electromagnetic environment specified below. The user ofthe ventilator should assure that it is used in such an environment.

Immunity Test IEC 60601 Test LevelComplianceLevel Electromagnetic Environment - Guidance

ElectrostaticDischarge (ESD)

IEC 61000-4-2

+/- 6kVcontact

+/- 8kV air

+/- 6kVcontact

+/- 8kV air

Floors should be wood, concrete or ceramictile. If floors are covered with syntheticmaterial, the relative humidity should be atleast 30%.

Electrical Fast Transient/burst

IEC 61000-4-4

+/- 2kV forpower supplylines.

+/- 1 kV forInput/outputlines

+/- 2kV forpower supplylines.

+/- 1 kV forInput/outputlines

Mains power quality should be that of atypical hospital environment

Surge

IEC 61000-4-5

+/- 1kVdifferentialmode

+/- 2 kVcommon mode

+/- 1kVdifferentialmode

+/- 2 kVcommon mode

Mains power quality should be that of atypical hospital environment

Voltage dips,shortinterruptions and

voltage variationson power supplyinput lines.

IEC 61000-4-11

95% dip inUt ) for a 0.5

cycle40% U t

(60% dip in U t )for 5 cycles

70% Ut (30% dip in Ut )for 25 cycles

5% Ut (>95% dip in

Ut ) for 5 sec

95% dip inUt ) for a 0.5

cycle40% U t

(60% dip in U t )for 5 cycles

70% Ut (30% dip in Ut )for 25 cycles

5% Ut (>95% dip in

Ut ) for 5 sec

Mains power quality should be that of atypical hospital environment. If the user ofthe ventilator requires continued operation

during power mains interruptions, it isrecommended that the ventilator be poweredfrom an external battery.

Power Frequency(50/60 Hz)magnetic field.

IEC 61000-4-8

3 A/m 3 A/mPower frequency magnetic fields should be atlevels characteristic of a typical location in atypical hospital environment.

* Note U t is the a.c. mains voltage prior to application of the test level.


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Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The ventilator is intended for use in the electromagnetic environment specified below. The user ofthe ventilator should assure that it is used in such an electromagnetic environment.

Immunity Test

IEC 60601 Test Level

ComplianceLevel Electromagnetic Environment-Guidance

ConductedRF

IEC61000-4-6

3 Vrms 150kHz to 80MHz outsideISM bands(a)

3 Vrms

Portable and mobile RF communications equipmentshould be used no closer to any part of the ventilator,including cables, than the recommended separationdistance calculated from the equation applicable to thefrequency of the transmitter.

Recommended separation distance:

RadiatedRF

IEC 61000-4-3

10 Vrms

150 kHz to80 kHz in

10 V/m

80 MHz to2.5 GHz

10 Vrms

10 V/m

where P is the maximum output power rating of thetransmitter in watts (W) according to the transmittermanufacturer and d is the recommended separationdistance in meters (m) (b)

Field strengths from fixed RF transmitters, asdetermined by an electromagnetic site survey.(c) should be less than the compliance level in eachfrequency range (d)

Interference may occur in the vicinity of equipmentmarked with the following symbol.


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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) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHzto 40.70 MHz.(b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in thefrequency range of 80 MHz to 2.5 GHz are intended to decrease the likelihood thatmobile/portable communication equipment could cause interference if it is inadvertently broughtin to the patient areas. For this reason, an additional factor of 10/3 is used in calculating therecommended separation distances for transmitters in these ranges.(c ) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcastcannot be predicted theoretically with accuracy. To assess the electromagnetic environment dueto fixed RF transmitters, an electromagnetic site survey should be considered. If the measuredfield strength in the location in which the ventilator is used exceeds the applicable RF compliancelevel above, the ventilator should be observed to verify normal operation. If abnormalperformance is observed, additional measures may be necessary, such as re-orienting or relocatingthe ventilator.(d) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 1V/m.


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Recommended Separation distances Between Portable and Mobile RF CommunicationsEquipment and the eVolution Ventilator

The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbancesare controlled. The use of the ventilator can help to prevent electro-magnetic disturbances bymaintaining the minimum distance between portable and mobile RF communications equipment prior

(transmitters) and the ventilator as recommended below, according to the maximum output of power ofthe communications equipment.

Separation Distance According to Frequency of Transmitter (meters)

RatedMaximumOutput ofPower of

Transmitter(watts)

150 kHz to 80MHz Outside ISM

Bands

150 kHz to 80MHz in ISM Bands

80 MHz to 800MHz

800 MHz to 2.5 GHz

0.01 0.12 0.12 0.12 0.23

0.1 0.38 0.38 0.38 0.741 1.2 1.2 1.2 2.310 3.8 3.8 3.79 7.4100 12 12 12 12For transmitters rated at a maximum output power not listed above, the recommended separationdistance d in meters (m) can be determined using the equation applicable to the frequency of thetransmitter, where P is the maximum output power rating of the transmitter in watts (W) according tothe transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency rangeapplies.

NOTE 2: The ISM (industrial, scientific and medical) bands between 150 Hz and 80 MHz are6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26..957MHz to 27.283 MHz;and 40.66 MHz to 40.70 MHz

NOTE 3: An additional factor of 10/3 is used in calculating the recommended separation distancefor transmitters in the ISM frequency bands between 150 KHz and 80 MHz and in thefrequency range 80MHz to 2.5 GHz to decrease the likelihood that mobile/portablecommunications equipment could cause interference if it is advertently brought intopatient areas.

NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagations affectedby absorption and reflection from structures, objects and people.


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TOOLS, TEST EQUIPMENT AND MATERIALS (RECOMMENDED)

Description Manufacturer / Part No. Test Equipment: Pneumatic Analyzer TSI Certifier FA Plus or equivalentElectrical Safety Tester Local SupplyDesktop / Laptop PC Local SupplyCategory 6 Crossover Cable eVent Medical, EVL370018-SPE or equivalent Adult Tubing System Local supplyPediatric Tubing System Local Supply Test Lung, Kit Local supplyHigh Pressure Oxygen Source Local Supply (medical grade)External Power source Local supplyIsopropyl Alcohol Cleaner Local Supply

Description Manufacturer / Part No.Hand Tools: Flat Bladed Screwdriver Local SupplyPhilips Screwdriver No 1, 2, Local Supply1.5 mm Allen Wrench Local Supply4 mm Open End Wrench Local Supply11 mm Socket Wrench Local SupplyStatic Dissipative Service Kit Local Supply


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THEORY OF OPERATION This section is provided to detail the operational theory of the eVolution ventilator system. It includes anoverview of the ventilator operation and discusses in detail the operational principals of both the pneumaticand electronic systems. This section also describes the operation of the ventilators firmware in interfacingand controlling the two systems.

OVERVIEW OF OPERATION

The eVolution Ventilator System consists of two major systems; the pneumatic system and the electronicsystem. These systems combine under advanced software control to deliver respiratory support at operatordetermined parameters. The pneumatics, under the control of the microprocessor, supplies conditioned airand oxygen to the patient system. The electronic system applies and supervises the power sources andprovides electronic control of the ventilators components.

Oxygen enters the unit from either an external source via the high pressure oxygen connector or a lowpressure oxygen connector. The gas is conditioned to remove particulate matter. A regulator decreases theoxygen to a consistent level and supplies it to the oxygen servo-controlled proportional valve. The oxygen isthen routed through an internal hot-wire flow sensor and on to a manifold. If low pressure O2 is used, thatgas is delivered directly to the same O2 proportional valve.

Filtered air is supplied by means of an internal high efficiency blower system. Air is routed to the air servo-controlled proportional valve then through an internal hot-wire flow sensor and on to a manifold.

From the manifold gas is delivered through the patient safety valve to the patient port. Feedback from theinternal flow sensors, pressure transducers and patient settings, controls the breath delivery and monitoring.

Exhaled gas is directed through a heater and an active expiratory proportional valve. This is used to regulatepressure levels during inspiration and exhalation.

Ventilation parameters are programmed by the operator using a rotary encoder in conjunction with the touchsensitive user interface display and dedicated keys on the ventilator front panel.

Power to operate the device may come from AC mains, an external 12VDC battery, an external 12 VDCpower source, or from internal batteries. In the event of a loss of AC mains the unit is powered from the

external battery (if available) or from the internal batteries.

Section

4


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PNEUMATIC THEORY OF OPERATION

Figure 5: Pneumatic Diagram The eVolution series ventilator pneumatic system may be categorized into the following subsy

Event Medical - Evolution (Service Manual)

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