Information Technologies ST. JUDE MEDICAL 1091
Contents
1. 1 7 Classifications 0 iia errant genres di eas Weak dae 1 8 Underwriters Laboratories Inc UL 1 8 CON sav Erden rta 1 9 Safety Messages ii via Meanie ike orsa tpa PX e C eed Gem ard 1 9 Danger Warnings and Cautions 1 10 Service Information 4 4 4 4444 1 13 Service Requiremerils ona e enr Rp hr dada de 1 13 Equipment Identification 1 14 Revision B CardioLab Il Plus Amplifier Operator s Manual 1 1 2002938 001 SJM03075104 000009 For your notes 1 2 CardioLab li Plus Amplifier Operator s Manual Revision B 2002938 001 000010 SJM03075105 Introduction Manual Information Manual Information Revision History Manual Purpose intended Audience Intended Use Each page of the document has the document part number and revision letter at the bottom of the page The revision letter identifies the document s update level The revision history of this document is summarized in the table below Table 1 Revision History PN 2002938 001 B November 15 2000 Release B of this manual This manual contains the instructions necessary to operate the CardioLab II Plus Amplifier safely in accordance with its function and intended use These instructions include but are not limited to B a fundamental description of controls and indicators E operat2. 4444444 nnn 3 3 Connecting Cables to the Amplifier 3 3 Disconnecting Cables From the Amplifier 34 Installation Checkout s 22 sus cetera saga eee e e s 34 Related Manuals oia dot IA Rr RU ETE nent 3 4 Stimulator Bypass Connections for Emergency Pacing 3 6 Revision B CardioLab li Plus Amplifier 3 1 2002938 001 SJM03075128 000033 For your notes CardioLab II Plus Amplifier Operator s Manual 2002938 001 000034 Revision B SJM03075129 Operation Gelting Started Getting Started WARNING Do not allow any foreign materials such as fluids to come in contact with the CardioLab II Plus Amplifier If fluid of any kind should leak into the CardioLab II Plus Amplifier discontinue using the amplifier and contact GE Marquette Medical Systems DO NOT allow hydraulic fluid from any device to contact any conductive surface Hydraulic fluid is electrically conductive NOTE Connect the CardioLab II Plus Amplifier and all accompanying components in a clean and dry environment with a temperature between 0 C and 35 C and a humidity less than 95 relative at 35 C non condensing Connecting Cables to the Amplifier When making connections to the CardioLab II Plus Amplifier make sure that the cables are connected securely in the appropriate locations Refer to Chapter 2 Eq
3. A Any defect or deficiency including failure to conform to Product Specifications that in our reasonable determination results in whole or in part from 1 any alteration improper storage handling use or maintenance or any extraordinary use of the Products by anyone other than us 2 failure to maintain the Products in the manner described in any applicable instructions or specifications including upper and lower date limits 3 damage resulting from the use of electrodes paper batteries magnetic media patient sample line filters cuvettes or other supplies not recommended by us 4 using or combining the Products with any item or data except as specified in the applicable Product Specifications or using or combining the Products with any item or data that does not properly and unambiguously exchange data with the Products in accordance with the applicable Product Specifications 5 any of your designs specifications or instructions 6 any failure of any product to use or process correct dates except as specified in the Year 2000 Compliance Warranty and 7 any cause external to the Products as furnished by us or beyond our reasonable control Our warranty only applies to Products purchased or supplied from us Service repairs resulting from failures of equipment not purchased from us are billable at standard rates SJM03075098 B The payment or reimbursment of any facility costs arising from repair or replac
4. TRIM KNOB Trimline UNION STATION UNITY logo UNITY NETWORK Vari X Vari X Cardiomatic VariCath VARIDEX VAS and Vision Care Filter are trademarks of GE Marquette Medical Systems Inc registered in the United States Patent and Trademark Office 12SL 15SL Access AccuSpeak ADVANTAGE BAM BODYTRODE Cardiomatic CardioSpeak CardioQuick System CD TELEMETRY LAN CENTRALSCOPE Corolation EDIC EK Pro Event Link Cirrus Event Link Cumulus Event Link Nimbus HI RES ICMMS IMAGE VAULT IMPACT wf INTER LEAD IQA LIFEWATCH Managed Use MARQUETTE PRISM MARQUETTE RESPONDER MENTOR MicroSmart MMS MRT MUSE CardioWindow NST PRO NAUTILUS O SENSOR Octanet OMRS PHi Res Premium Prism QUIK CONNECT V QUICK CONNECT QT Guard SMART PAC SMARTLOOK Spiral Lok Sweetheart UNITY Universal Waterfall and Walkmom are trademarks of GE Marquette Medical Systems Inc l GE Marquette Medical Systems Inc 2000 AH rights reserved T 2 CardioLab Il Plus Amplifier Operator s Manual Revision B 2002938 001 15 June 2000 000002 SJM03075097 marquette Warranty Information Warranties Cardiology Products Scope of Warranties Product Warranty We warrant to you that all new cardiology Products made by us and sold by us or our authorized representatives the Warranted Products will 1 be free from defects in title and in material and workmanship under normal use and service and 2 except for Warranted Products manufactured
5. cords and cables for fraying or other damage u Inspect all plugs cables and connectors for bent prongs or pins a Verify that all cords and connectors are securely seated u Inspect controls for proper operation Weekly a Clean the external cables such as ECG blood pressure and catheter inputs and the Catheter Input Module with isopropyl alcohol by wiping the surface with a soft clean cloth DO NOT immerse and external cables or the Catheter Input Module in isopropyl alcohol or in fluids of any kind Monthly Inspect all tips of the fiber optic cables and if necessary clean them with alcohol and a cotton swab amp Clean all dust and debris from the fiber optic cable connectors Yearly Check the summation of the leakage current The total system earth leakage current must not exceed 50 microamperes a With the power supply disconnected from the line voltage check the earth ground connection by verifying that the resistance between the earth terminal of the AC inlet on the amplifier and any exposed metal surface of the enclosure is less than 0 1 ohms Check the electrical integrity of the signal connections in the catheter input modules NOTE Yearly maintenance activities on the CardioLab Il Plus Amplifier should only be done by qualified technical personnel Precautions Do not open the CardioLab IT Plus Amplifier unless instructed to do so by a qualified t
6. in compliance with your designs or specifications substantially comply with our technical written specifications on the date such Warranted Products are shipped to you the Product Specifications The Product Specifications are available upon request Year 2000 Compliance Warranty We warrant to you that the Warranted Products are Year 2000 Compliant or will be made by us Year 2000 Compliant at no additional cost to you prior to the time when dates in 1999 or later could affect their operation Year 2000 Compliant means that 1 each Warranted Product will correctly accept store retrieve compare calculate export display print out sequence and otherwise process dates on before and after January 1 2000 including leap years in accordance with the applicable Product Specifications and 2 each Warranted Product s performance and functionality will not be materially adversely affected as a result of the date change from 1999 to 2000 Patent and Copyright Warranty We warrant to you that when the Warranted Products are delivered to you they will not be subject to any valid U S patent or copyright infringement claim Warranty Limitations and Requirements The Product Warranty is limited in time as follows Prucka CardioLab System One year Prucka Mac Lab System One year Prucka ComboLab System One year Ambulatory Holter Recorders One year SEERG XT and SEERG MC Two years MARS Analog Remote System
7. parts be used with the CardioLab II Plus Amplifier Table 3 Accessory Paris List Accessory Name Part Number Abbott Transpac IV Disposable Transducer with 4 ft extension Cable Abbott 42582 08 Abbott Transpac Reusable Cable 3M Disposable Electrode for ECG Monitoring Abbott 42661 04 42 3M Red Dot 2256 This accessory is not stocked by GE Marquette Medical Systems Inc 2 4 CardioLab II Plus Amplifier Operator s Manual 2002938 001 000026 SJM03075121 Revision B Equipment Overview Front View Front View p PRESSURE INPUTS CATHETER INPUTS gt OO M j O O Q LECG INPUT STIMULATOR INPUT Calica TION INDICATORS L AUXILIARY INPUTS Table 4 Front View 64 32 Channels CardioLab li Plus Amplifier Name Description Pressure Inputs Four pressure inputs will each accept a pressure transducer that is calibrated to 5uV VimmHg See the Accessory Parts List for GE Marquette recommended pressure transducers ECG Input The ECG input connector will accept a 10 lead ECG input cable Stimulator Input The stimulator input will accept a stimulator input cable Use the 3 ft 15 ft or 30 ft Touchproof Stimulator Cables part numbers 301 00204 03 301 00204 15 301 00204 30 respectively with the CardioLab Il Plus Amplifier Cathete
8. you If we elect not to assume the defense we shall also indemnify you for all expenses incurred in the defense of such infringement action In like manner you agree to indemnify and hold us harmless from claims of patent infringements relating to our compliance with your designs or specifications The above describes your exclusive remedies and our sole liability for any warranty claims You agree that we and our representatives have no liability to you for 1 any penal incidental or consequential damages including without limitation loss of business goodwill profit or revenue 2 any assistance not required under the Quotation or 3 anything occurring after the warranty period ends This exclusive remedy shall not have failed of its essential purpose as that term is used in the Uniform Commercial Code provided that we remain willing to repair or replace defective Warranted Products within a commercially reasonable time after receiving such Warranted Products You specifically agree that our price for our Warranted Products is based upon the limitation of our liability as set forth in these terms and conditions SJM03075099 CE Marking Information CE Marking Information 0459 Compliance The CardioLab II Plus Amplifier bears CE mark CE 0459 indicating its conformity with the provisions of the Council Directive 93 42 EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive F
9. 00 mmHg Stimulator 1 input B 4 CardioLab ll Plus Amplifier Operator s Manual Revision B 2002938 001 000050 SJM03075145 Appendix B Technical Information Technical Specifications Table 1 Technical Specifications CardioLab Il Plus Amplifier 4 input channels Each group of 16 poles can only have one active positive stim and one active negative stim Revision B CardioLab il Plus Amplifier Operator s Manual B 5 2002938 001 000051 SJM03075146 Appendix B Technical Information Technical Specifications B 6 CardioLab li Plus Amplifier Operator s Manual 2002938 001 000052 Revision B SJM03075147 Index Revision B CardioLab Il Plus Amplifier Operator s Manual Index 1 2002938 001 SJM03075148 000053 Index 2 CardioLab Il Plus Amplifier Operator s Manual Revision B 2002938 001 000054 SJM03075149 Index A amplifier back view 2 7 front view 2 5 authorized service 1 13 C cables connecting 3 3 disconnecting 3 4 catheter input module 2 8 chapter content 1 4 Classifications 1 8 classifications 1 8 components 10 lead ecg cable 2 10 catheter input module 2 8 ecg 10 lead set 2 9 power cord 2 10 stimulator input cable 2 9 D device name 1 14 E emergency pacing 3 6 environmental protection A 3 equipment general description 2 3 identification 1 14 symbols 1 7 H how to read label 1 14 how to reach us 1 5 I install
10. 2001 and so on E ji product code ENS product descriptor XJ CLAB 1I Plus Amplifier G product seguence number Four character manufacturing number of total units manufactured H plant designator F Cardiology G Monitoring H I device characteristics One or two characters that further describe the unit for example P prototype not conforming to marketing specification R refurbished equipment S special product documented under Specials part numbers U upgraded unit 1 14 CardioLab il Plus Amplifier Operator s Manual Revision B 2002938 001 000022 SJM03075117 2 Equipment Overview General Description 444444 44 23 CardioLab Il Plus Amplifier Hardware 2 4 Amplifier Part N mbefs eei cese eee o e 2 4 Accessory Parts Disk ci at A a CES tite 2 4 FOM WW ie ace ca a A AA 2 5 Back VIe AI ii AAA LEVA lea 2 1 Components 4 44 444 44 recrear a rr 2 8 CardioLab Il Plus Catheter Input Module 2 8 Catheter Input Modules 2 9 Stimulator put Cable rit eid ion c HER rrr nd ane 2 9 ECG 10 Lead Set vsus meter A ocio RE TEA DARA 2 9 WA ECG Cable cas lid eee eee ced ee C SR Pje 2 10 POWER Gord sus Lee tro eta Ee Pee p b Pa pas d Pa 2 10 Revision B CardioLab Il Plus Amplifier Operator s Manual 2 1 2002938 001 SJM03075118 000023 For your notes 2 2 CardioLa
11. 3
12. CardioLabSll Plus Amplifier Operator s Manual 2002938 001 Revision B GE Medical Systems Information Technologies gemedicalsystems com SJM03075096 ST JUDE MEDICAL 1091 000001 Trademarked names appear throughout this document Rather than list the names and entities that own the trademarks or insert a trademark symbol with each mention of the trademarked name the publisher states that it is using the names only for editorial purposes and to the benefit of the trademark owner with no intention of improperly using that trademark 900 SC ACCUSKETCH AccuVision APEX AQUA KNOT ARCHIVIST Autoseq BABY MAC C Qwik Connect CardioLab CardioServ CardioSmart CardioSys CardioWindow CASE CD TELEMETRY CENTRA CHART GUARD CINE 35 CORO COROLAN COROMETRICS Corometrics Sensor Tip CRG PLUS DASH Digistore Digital DATAQ E for M EAGLE Event Link FMS 101B FMS 111 HELLIGE IMAGE STORE INTELLIMOTION IQA LASER SXP MAC MAC LAB MACTRODE MARQUETTE MARQUETTE MAC MARQUETTE MEDICAL SYSTEMS MARQUETTE UNITY NETWORK MARS MAX MEDITEL MEI MEI in the circle logo MEMOPORT MEMOPORT C MINISTORE MINNOWS Monarch 8000 MULTI LINK MULTISCRIPTOR MUSE MUSE CV Neo Trak NEUROSCRIPT OnlineABG OXYMONITOR Pres R Cuff PRESSURE SCRIBE QMI QS Quantitative Medicine Quantitative Sentinel RAC RAMS RSVP SAM SEER SILVERTRACE SOLAR SOLARVIEW Spectra 400 Spectra Overview Spectra Tel ST GUARD TRAM TRAM NET TRAM RAC TRAMSCOPE
13. MD indicator is on the CardioLab I Plus Amplifier is receiving data from the acquisition computer The RCV CMD indicator will turn on as long as an instruction is being received by the amplifier When the RCV ERR indictoris on the CardioLab Il Plus Amplifier may not be receiving data from the acquisition computer in a valid format or there may be a problem with the fiber optic cable 2 6 CardioLab Il Plus Amplifier Operator s Manual Revision B 2002938 001 000028 SJM03075123 Equipment Overview Back View Back View FDDI Connection to Computer Power Input Equipotentiality Terminal Table 6 Back View CardioLab II Plus Amplifier FDDI Connection to Computer This connector will accept a FDDI type fiber optic cable The fiber optic cable allows for two way communication between the amplifier and the CardioLab system Power Input The GE Marquette supplied power cord connects to the Power Input Equipotentiality Terminal The Equipotentiality Terminal is connected to earth ground m Revision B CardioLab Il Plus Amplifier Operator s Manual 2 7 2002938 001 SJM03075124 000029 Equipment Overview Components Components The CardioLab 11 Plus Amplifier comes with the following components Table 7 CardioLab Il Plus Amplifier Components Component Name GE Marquette Part Number CardioLab II Plus Catheter Input Module 301 00202 08 3 fl Touchproof Stimulator Input Cable 301 00204 03 15 fl
14. Medical Systems does not in any manner assume the responsibility for performing the recommended maintenance procedures The sole responsibility rests with the individual or institution using the equipment GE Marquette Medical Systems Inc service personnel may at their discretion follow the procedures provided in this manual as a guide during visits to the equipment site Environmental Protection Even though the amplifier will be operated in many different environments some precautions must be observed 8 Take care to avoid extremes of temperature moisture and humidity The amplifier is not waterproof 8 Protect the amplifier from spills or other debris Eating drinking and smoking should not be permitted near the amplifier during patient hookup or amplifier maintenance Revision B CardioLab Il Plus Amplifier Operator s Manual A 3 2002938 001 SJM03075136 000041 Appendix A Maintenance and Troubleshooting Inspection and Cleaning Inspection and Cleaning Since the CardioLab II Plus Amplifier has no moving parts except for the fan it requires little maintenance However to prolong the use of the amplifier GE Marquette recommends the following maintenance schedule be performed on the amplifier to maintain safe and efficient operation of the unit Table 1 Preventative Maintenance Schedule CardioLab Il Plus Amplifier Maintenance Time Maintenance Actions m Check the case for cracks or other damage a Inspect all
15. One year MARS Digital Remote System One and one half years Defibrillators One year Resting ECG analysis and exercise testing systems except batteries One year Resting ECG analysis and exercise testing system batteries Ninety days MAC 500 and MAC 1000 Three years Cath Lab products One year The Year 2000 Compliance warranty extends through the 000003 term of the underlying Product Warranty The warranty period begins on the date the Warranted Products are delivered to you If we assemble or install the Warranted Products however the warranty period begins on the earlier of 1 five days after the date we notify you that we have completed assembly or installation and the Warranted Products are operating in accordance the applicable Product Specifications or 2 the date you first use Warranted Products for patient use If assembly or installation is delayed for thirty days or more after the date of delivery for a reason beyond our reasonable control the warranty period will begin on the thirtieth day after date of delivery but under no circumstances will the warranty term begin later than six months following the delivery date regardless of cause The warranty period for any Warranted Product or part furnished to you to correct a warranty failure will be the unexpired term of the warranty applicable to the repaired or replaced Product Warranty Exclusions These warranties do not cover
16. Technical Information Technical Specifications Table 1 Technical Specifications CardioLab Il Plus Amplifier Chassis Leakage lt 100 uA ECG Input High Pass Filter 0 05 Hz 0 5 Hz 5 Hz Low Pass Filter 100 Hz RF Filtering All inputs Gain 50 10 000 in 8 settings Saturation Recovery Less than 1 sec Notch Filter Power line 50 60 Hz Catheter Inputs 32 channel 32 intracardiac inputs 4 pressure inputs 10 ECG inputs 64 channel 96 intracardiac inputs 4 pressure inputs 10 ECG inputs 96 channel 160 intracardiac inputs 4 pressure inputs 10 ECG inputs 128 channel 224 intracardiac inputs 4 pressure inputs 10 ECG inputs Outputs 16 channels Block Up to 112 channels 32 channel Block A 64 channel Blocks A C 96 channel Blocks A E 128 channel Blocks A G Switching Any input can be switched to any output within a Block High Pass Filter DC 0 05 Hz 0 5 Hz 5 0 Hz 30 Hz 100 Hz Low Pass Filter 500 Hz 2 000 Hz RF Filtering All inputs Gain 50 10 000 in 8 settings Saturation Recovery Less than 1 sec Notch Filter Power line 50 60 Hz Pressure 4 inputs Compatible with all standard external pressure transducers 5uV V mmHg gt 1 Milion Ohms Up to 4 pressure channels 6 Hz 25 Hz 100 Hz 400 Hz Output Impedance lt 0 050 Ohms Range 400mm Hg to 4
17. Touchproof Stimulator Input Cable 301 00204 15 30 ft Touchproof Stimulator Input Cable 301 00204 30 Auxiliary Input Cable 301 00205 08 ECG 10 Lead Sel 2003421 001 10 Lead ECG Cable 2003419 001 Power Cord 80274 006 CardioLab Il Plus Catheter Input Module PD 1000 016 2 8 CardioLab II Plus Amplifier Operator s Manual Revision B 2002938 001 SJM03075125 000030 Equipment Overview Components Catheter Input Modules The four stimulus inputs on the Stimulator Input Cable see photo below connect to the stimulator Each Catheter Input Module is broken down into two groups of 16 poles each For example Block is broken into A 1 16 and A 17 32 Each pacing channel requires one positive and one negative pole In order to maximize the number of pacing channels only one positive and one negative designation should be made for cach group For detailed instructions on how to designate pacing channels and enable pacing for particular sites refer to the on line help in the software application Stimulator Input Cable PD 1000 017 ECG 10 Lead Set PD 1000 018 Revision B CardioLab II Plus Amplifier Operator s Manual 2 9 2002938 001 SJM03075126 000031 Equipment Overview Components 10 Lead ECG Cable PD 1000 019 Power Cord PD 1000 020 2 10 CardioLab II Plus Amplifier Operator s Manual Revision B 2002938 001 SJM03075127 000032 3 Operation Getting Started
18. anger Warnings and Cautions 1 10 Service Information Mines ess 1 13 Service Requirements E 1 13 Equipment Identification DEP P aaa 1 14 2 Equipment Overview Lass ii General Description 2 3 CardioLab Il Plus Amplifier Hardware e 24 Amplifier Part Numbers 4 24 Accessory Parts List Liga ies eseeretvr dot Y EAR nous te ERU EON 2 4 d AJ coito A rad A 2 5 Back View aca ra rc i n sabor a ou Kad ARN e 27 Components cocoa a a a dra a 2 8 CardioLab Il Plus Catheter Input Module 2 8 Catheter Input Modules 2 9 Stimulator Input Cable 2 9 Revision B CardioLab Il Plus Amplifier Operator s Manual i 2002938 001 SJM03075102 000007 ECGAO Lead iii di AN ia 2 9 10 Lead ECG Cables rebus Maury Ai KIA 2 10 Power Cord ius ci A o ee va 2 10 3 Operation s 3 1 Getting Started 4444 3 3 Connecting Cables to the Amplifier 3 3 Disconnecting Cables From the Amplifier 3 4 Installation Checkout 6 cece menn 3 4 Related Manuals 2 0 0 0 ccc cece cette cnc 3 4 Sti
19. any patient cables m Place the amplifier in an environment with a temperature between 15 C to 50 C and a non condensing humidity less than 95 relative at 35 C A 6 CardioLab I Plus Amplifier Operator s Manual Revision B 2002938 001 000044 SJM03075139 Appendix A Maintenance and Troubleshooting Maintenance Repair Log Maintenance Repair Log Unit Serial Number Institution Name Date Maintenance Repair Technician es PS N Revision B CardioLab Il Plus Amplifier Operator s Manual A 2002938 001 000045 SJM03075140 Appendix A Maintenance and Troubleshooting Maintenance Repair Log Unit Serial Number Institution Name Maintenance Repair Technician A 8 CardioLab I Plus Amplifier Operator s Manual Revision B 2002938 001 000046 l SJM03075141 D Appendix B Technical Information Technical Specifications B 3 Revision B CardioLab li Plus Amplifier Operator s Manual B 1 2002938 001 03075142 000047 SJM0307514 For your notes B 2 CardioLab Il Plus Amplifier Operator s Manual Revision B 2002938 001 000048 SJM03075143 Appendix B Technical Information Technical Specifications Technical Specifications Table 1 Technical Specifications CardioLab Il Plus Ampli
20. ation checkout 3 4 M maintenance inspection and cleaning A 4 repair log 3 schedule 1 13 manual purpose 1 3 revision history 1 3 N name of device 1 14 P product code 1 14 R related manuals 1 5 revision history 1 3 S safety cautions 1 10 dangers 1 10 information 1 5 warnings 1 9 serial number 1 14 service information 1 13 requirements 1 13 stimulator bypass connections emergency pacing 3 6 storage 6 T technical specifications B 3 troubleshooting A 5 Revision B CardioLab Il Plus Amplifier Operator s Manual 2002938 001 000055 Index 3 SJM03075150 Index Index 4 CardioLab ll Plus Amplifier Operator s Manual Revision B 2002938 001 000056 SJM03075151 SJM03075152 000057 CE GE Medical Systems 0459 Information Technologies gemedical com World Headquarters GE Medical Systems Information Technologies Inc 8200 West Tower Avenue Milwaukee WI 53223 USA Tel 1 414 355 5000 1 800 558 5120 US only Fax 1 414 355 3790 European Representative GE Medical Systems Information Technologies GmbH Munzinger Stra e 3 5 D 79111 Freiburg Germany Tel 49 761 45 43 0 Fax 49 761 45 43 233 000058 Asia Headquarters GE Medical Systems Information Technologies Asia GE China Co Ltd 24th Floor Shanghai MAXDO Center 8 Xing Yi Road Hong Qiao Development Zone Shanghai 200336 P R China Tel 86 21 5257 4650 Fax 86 21 5208 2008 SJM0307515
21. b ll Plus Amplifier Operator s Manual Revision B 2002938 001 000024 SJM030751 19 Equipment Overview General Description General Description The CardioLab II Plus Amplifier is designed to amplify various types of cardiac signals that are acquired from a patient and transmit them back to the Prucka CardioLab Mac Lab system referred to in this manual as the acquisition computer These signals include 12 Lead ECG intra cardiac and pressure signals The CardioLab II Plus Amplifier is fully supported by CardioLab EP software versions 3 1 and above and CardioLab Cath software versions 1 0 and above However the CardioLab II Plus Amplifier was designed specifically for use with the Prucka CardioLab Mac Lab system The following table lists the functionality of the CardioLab II Plus Amplifier with the different software versions Table 1 CardioLab li Plus Functionality for Different Versions of CardioLab Software CardioLab EP 3 1 and Above CardioLab CardioLab Il Plus Functionality Prucka CardioLab Mac Lab System Cath 1 0 and Above Intracardiac Blocks A and B Only All Blocks Available Stimulator CardioLab Il Amplifier Equivalent Enhanced Switching Options Auxiliary Input Not Available RF Filtered and Unipolar Inputs The CardioLab IT Plus Amplifier supports 32 64 96 and 128 channel configurations The following list illustrates the number of Catheter Input Modules CIM used with the four
22. brillated Do NOT come in contact with the unit or patient during defibrillation LEAKAGE CURRENT TEST When more than two electrical devices are interconnected the summation of leakage currents must be checked before use and rechecked yearly Keep leakage current within acceptable limits when connecting auxiliary equipment to this device Total system earth leakage current must not exceed 50 microamperes MAINTENANCE Check the electrical integrity of the signal connections in the catheter input modules and cabling yearly Replace only with the same type and rating of fuse POWER SUPPLY To reduce the risk of electric shock or damage to your equipment do not disable the power cord grounding feature This equipment is designed for connection to a grounded earthed power outlet The grounding plug is an important safety feature Electrostatic discharge ESD can damage electronic components Be sure you are properly grounded when using the CardioLab IT Plus Amplifier Connect only to a properly earth grounded outlet SUPERVISED USE This device is intended for use under the direct supervision of a licensed health care practitioner Revision B CardioLab Il Plus Amplifier Operator s Manual 1 11 2002938 001 000019 SJM03075114 Introduction Danger Warnings and Cautions CAUTIONS Caution Federal USA law restricts this device to sale by or on the order of a physician ACCURACY Erroneous values
23. configurations of the CardioLab II Plus Amplifier 32 Channels 1 CIM 64 Channels 3 CIMs 96 Channels 5 CIMs 128 Channels 7 CIMs The Catheter Input Modules for the four configurations of the CardioLab II Plus Amplifier connect to the following catheter inputs on the front of the amplifier 32 Channels Input 64 Channels Inputs A C 96 Channels Inputs A E 128 Channels Inputs A G 9 9 Revision B CardioLab Il Plus Amplifier Operator s Manual 2 3 2002938 001 SJM03075120 000025 Equipment Overview CardioLab Il Plus Amplifier Hardware CardioLab ll Plus Amplifier Hardware Amplifier Part Numbers The GE Marquette part numbers for the CardioLab II Plus Amplifier are as follows 32 Channel 2003232 001 64 Channel 2003232 002 96 Channel 2003232 003 H a a m 128 Channel 2003232 004 If international users need to order a power cord the following part numbers can be Ll ordered separately Tahle 2 International Power Cord Part Numbers Part Number Description 422845 001 Power cord for Continental Europe 10 Amp 7 422845 002 Power cord for Britain 10 Amp 422845 003 Power cord for Italy 10 Amp 422845 004 Power cord far Swiss 10 Amp 422845 005 Power cord for India 10 Amp 422845 006 Power cord for Australia 10 Amp Accessory Parts List GE Marquette recommends the following accessory
24. ction in Chapter 3 for information on configuring and diagnosing the CardioLab II Plus Amplifier using the acquisition computer Refer to the following related manuals for information on configuring channels stimulus switching stimulus detection and enabling and disabling stimulus connections with the CardioLab II Plus Amplifier 34 CardioLab H Plus Amplifier Operator s Manual Revision B 2002938 001 000036 SJM03075131 Operation Relaled Manuals Table 1 Related Manuals CardioLab EP 4 3 Update Guide CardioLab EP 4 2 Update Guide CardioLab EP 4 1 Update Guide CardioLab System EP 4 0 Operator s Manual CardioLab EP 3 1 Update Guide CardioLab Cath 1 1 User s Guide CardioCath 1 0 User s Guide Prucka CardioLab Mac Lab ComboLab 2000 4000 7000 Field Service Manual CardioLab System Field Support Manual 003 00603 02 Revision B CardioLab Il Plus Amplifier Operator s Manual 3 5 2002938 001 SJM03075132 000037 Operation Stimulator Bypass Connections for Emergency Pacing Stimulator Bypass Connections for Emergency Pacing The CardioLab II Plus Catheter Input Module features four direct connections to the stimulator that do not rely on the switching capabilities of the amplifier and the acquisition computer These connections are labeled positive and negative in the Direct Stimulator Connection section of the catheter input module In an emergency pacing situation you can bypass the switching capabili
25. dical systems Installation of the equipment should only be performed by qualified GE Marquette Medical Systems service representatives Contact GE Marquette Medical Systems before connecting any device to equipment that is not recommended in this manual Only cables nd accessory equipment purchased from GE Marquette Medical Systems should be used in conjunction with the amplifier It is important that all of the instructions in this manual be followed however these instructions in no way supersede current medical practices regarding patient care and safety Parts and accessories used must meet the requirements of the applicable IEC 601 series safety standards and or the system configuration must meet the requirements of the IEC 601 1 1 medical electrical systems standard Refer servicing of amplifiers under warranty to GE Marquette Medical Systems authorized service personnel Any attempt to repair equipment under warranty will void that warranty It is the responsibility of users of systems needing service to contact GE Marquette Medical Systems for servicing of the equipment Failure on the part of responsible individuals or institutions to implement a satisfactory equipment maintenance schedule may lead to undue equipment failure and possible health hazards Revision B CardioLab Il Plus Amplifier Operator s Manual 1 5 2002938 001 SJM03075108 000013 introduction Safety Information The use of ACCESSORY equipment no
26. echnical personnel Do not immerse any part of the amplifier in water Do not use organic solvents ammonia based solutions or abrasive cleaning agents which may damage equipment surfaces Cleaning Clean the exterior surfaces with a clean soft cloth and a mild dishwashing detergent diluted in water m Wring the excess water from the cloth Avoid contact with open vents plugs or connectors Do not spray or spill fluid directly on the amplifier Dry the surfaces with a clean cloth or paper towel A 4 CardioLab il Plus Amplifier Operator s Manual Revision B 2002938 001 000042 SJM03075137 Appendix Maintenance and Troubleshooting Troubleshooting Troubleshooting If the CardioLab II Plus Amplifier does not transmit and receive signals to and from the CardioLab system check that 8 The amplifier is plugged in a The amplifier power supply is turned on m All the cable connections are properly and securely attached See the How to Reach Us section in Chapter 1 for information on contacting GE Marquette for customer service product support supplies and service parts Revision B CardioLab Il Plus Amplifier Operator s Manual A 5 2002938 001 000043 SJM03075138 Appendix A Maintenance and Troubleshooting Storing and Transporting the Amplifier Storing and Transporting the Amplifier When the amplifier is transported or will not be in use for a long period of time a Disconnect and properly store
27. ement of the Warranted Products or parts C Any adjustment such as alignment calibration or other normal preventative maintenance required of you D Expendable supply items including without limitation electrodes magnetic media leadwires patient cables all external cabling on the Prucka CardioLab and Prucka Mac Lab ink and ribbons THE FOREGOING WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHER REPRESENTATIONS WARRANTIES AND COVENANTS EXPRESS OR IMPLIED WITH RESPECT TO THE PRODUCTS AND ANY DEFECTS THEREIN OF ANY NATURE WHATSOEVER WE MAKE NO WARRANTIES RELATING TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE UNDER NO CIRCUMSTANCES SHALL WE BE LIABLE TO YOU UNDER ANY TORT NEGLIGENCE STRICT LIABILITY OR PRODUCT LIABILITY CLAIM AND YOU AGREE TO WAIVE ANY SUCH CLAIMS Exclusive Warranty Remedies Product Warranty and Year 2000 Compliance Warranty Our sole responsibility for any breach of any warranty is at our option to repair or replace the Warranted Products or parts not conforming to the warranty in accordance with any limitations listed above provided that you promptly notify us of your warranty claim and make such Warranted Products available for service Warranty service will be performed without charge from 8 00am to 5 00pm Monday through Friday excluding our holidays and outside those hours and days at our prevailing service rates and subject to the availability of personnel Warranty s
28. ervice for defibrillators and the MACO PC resting ECG analysis systems will be provided on site if the installation is located within 100 miles of any of our existing authorized service personnel otherwise such Warranted Products must be returned to our factory For return to factory warranty service at your request we will provide to you at no additional cost except that you must pay all shipping charges substantially similar temporary replacement Product until such warranty service is completed Such temporary replacement Product will be loaned to you subject to these terms and conditions Patent and Copyright Warranty We shall indemnify you for all direct and actual damages recovered from you by a third person in any legal proceedings for infringement that would be a breach of the Patent and Copyright warranty provided that you promptly notify us in writing of the claimed infringement permit us to assume full control of the defense 000004 thereof and cooperate with us with respect to such defense If the infringement claim is determined by a court of competent jurisdiction to be valid we will at our option also obtain a license for you to continue using the infringing Warranted Product provide a non infringing replacement alter the Warranted Product so that it is non infringing or remove the infringing Warranted Product and refund the price less reasonable depreciation and any return transportation costs paid by
29. fier Item Description Physical Specifications Height 64 32 channel 9 5 in 128 96 channel 13 0 in 64 32 channel 13 0in 128 96 channel 13 0 in Width Depth 64 32 channel 13 0in 128 96 channel 13 0 in Weight 64 32 channel 25 lbs 128 96 channel 31 lbs Environmental Specifications Temperature Operating 0 C to 30 C non condensing for Clab Il Plus 128 and Clab Il Plus 96 Operating 0 C to 35 C non condensing for Clab II Plus 64 and Clab II Plus 32 Transport Storage 15 C to 50 C non condensing Humidity Operating 9596 relative at 35 C non condensing Transport Storage 95 relative at 35 C non condensing Power Specifications Power Requirements 100 240 V AC 50 60 Hz Power Input 0 0 0 5 Amps 64 32 channel Class Type CF Continuous operation Power Input 0 5 0 75 Amps 128 96 channel Class Type CF Continuous operation Design Sampling and Hold Each channel sampled prior to acquisition Sampling Rate 1K 2K and 4K CMMR 100 dB min Input Impedance 1 Million Ohms Leakage Current Patient Source 10 uA Patient Sink 10 uA Patient Sink mains voltage on applied part single fault conditions 50 uA Revision B CardioLab Il Plus Amplifier Operator s Manual B 3 2002938 001 000049 SJM03075144 Appendix B
30. imulator input P1 Power Communication Indicator indicators Table 5 Front View 128 96 Channels CardioLab ll Plus Amplifier Name Description Pressure Inputs Four pressure inputs will each accept a pressure transducer that is calibrated to 5uV VImmHg See the Accessory Parts List for GE Marquette recommended pressure transducers ECG Input The ECG input connector will accept a 10 lead ECG input cable Stimulator Input The stimulator input will accept a stimulator input cable Use the 3 ft 15 ft or 30 ft Touchproof Stimulator Cables part numbers 301 00204 03 301 00204 15 301 00204 30 respectively with the CardioLab Il Plus Amplifier Catheter Inputs Up to seven catheter inputs will each accept a 32 pole catheter input module Use the CardioLab Il Plus Catheter Input Modules part number 301 00202 08 with the CardioLab Il Plus Amplifier Auxiliary Inputs The auxiliary input will accept the Auxiliary Input Cable part number 301 00205 08 Power Indicator The power indicator is on as long as the CardioLab Il Plus Amplifier is turned on Communication Indicators Three communication indicators show the status of the communication between the acquisition computer and the CardioLab 1 Plus Amplifier When the XMT indicator is on the CardioLab II Plus Amplifier is transmitting data to the acquisition computer The XMT indicator should remain on as long as the power indicator is on When the RCV C
31. in accordance with UL 2601 1 CAN CSA C22 2 No 601 1 IEC 60601 1 and if required IEC 60601 2 27 IEC 60601 2 30 IEC 60601 2 34 IEC 60601 1 1 CardioLab H Plus Amplifier Operator s Manual 2002938 001 000016 Revision B SJM03075111 Introduction Conventions Conventions These are the conventions used in this manual Safety Messages DANGER safety messages indicate an imminently hazardous situation which if not avoided WILL result in death or serious injury WARNING safety messages indicate a potentially hazardous situation which if not avoided COULD result in death or serious injury CAUTION safety messages indicate a potentially hazardous situation which if not avoided may result in minor or moderate injury NOTE messages provide additional user information Revision B CardioLab Il Plus Amplifier Operator s Manual 1 9 2002938 001 075 000017 SJM03075112 introduction Danger Warnings and Cautions Danger Warnings and Cautions DANGER EXPLOSION HAZARD Do not use in the presence of flammable anesthetics or other flammable gases WARNINGS ACCESSORIES Only connect to UL 544 or UL 2601 1 listed or IEC certified medical equipment Use only Catheter Input Module CIM 301 00202 08 or 301 00203 08 with the CardioLab II Plus Amplifier All equipment not complying with IEC 601 1 should be placed outside the patient environment ACCIDENTAL SPILLS If fluid of any kind shou
32. ing procedures and B connection and disconnection of detachable parts and accessories Where necessary the manual identifies additional sources of relevant information and or technical assistance This manual is intended for the person who uses maintains and or troubleshoots this equipment The CardioLab II Plus Amplifier is intended for use in an electrophysiological catheter laboratory or catheterization laboratory where ECC direct cardiac intracardiac and pressure signals need to be recorded from a patient This device is intended for use under the direct supervision of a licensed health care practitioner Revision B CardioLab Il Plus Amplifier Operator s Manual 1 3 2002938 001 SJM03075106 000011 introduction Manual Information Chapter Content This manual is organized into the following chapters 1 Introduction Describes the manual contents and provides general information about safety precautions service requirements equipment symbols and serial number identification 2 Equipment Overview Gives a description of the equipment and components 3 Operation Describes how to connect and disconnect cables to the amplifier and provides a list of related user s manuals and update guides Describes the stimulator bypass connections for emergency pacing Appendix A Maintenance and Troubleshooting Describes how to maintain the equipment and keep it in good working order with a recommended maintenance sched
33. ld leak into the CardioLab II Plus Amplifier discontinue using the amplifier and contact GE Marquette Medical Systems DO NOT allow hydraulic fluid from any device to contact any conductive surface Hydraulic fluid is electrically conductive Do not allow any foreign materials such as fluids to come in contact with the CardioLab II Plus Amplifier BACKUP MONITORS Back up patient monitors should always be available while using CardioLab II Plus Amplifiers CONDUCTIVE CONNECTIONS Proper connections to the patient are critical for the proper operation of the CardioLab II Plus Amplifier and patient safety Use extreme caution when making patient connections Do NOT connect non isolated equipment to the amplifier Proper connections to the stimulator are critical for the proper operation of the CardioLab II Plus Amplifier and patient safety Use extreme caution when making stimulator connections The stimulator must be a IEC 601 1 certified product Ablation operations should NOT be executed when a stimulator unit is connected 1 10 CardioLab I Plus Amplifier Operator s Manual Revision B 2002938 001 000018 SJM03075113 Introduction Danger Warnings and Cautions Keep the conductive parts of lead electrodes and associated parts away from other conducting parts including earth ground DEFIBRILLATOR PRECAUTIONS Standby defibrillation equipment is required in the event that the patient needs to be cardioverted or defi
34. may occur if unused catheter inputs are not properly connected DO NOT display any channels which are based on unused catheter input modules Otherwise erroneous values may occur CABLES Route optical cables though a conduit in the ceiling or floor to avoid damage to the cables or cable connectors DEFIBRILLATOR PRECAUTIONS ECG inputs are protected against the use of a defibrillator in conjunction with the use of the ECG cable The pressure inputs on the CardioLab II Plus Amplifier are protected against the use of a defibrillator in conjunction with the use of the recommended pressure trandsucer and reusable cable MAINTENANCE Remove air that is trapped in the transducer or associated tubing by flushing the system according to cath lab procedures To reduce the risk of electric shock DO NOT remove cover or back Refer servicing to qualified personnel This equipment contains no user serviceable parts Refer servicing to qualified service personnel POWER SUPPLY The CardioLab II Plus Amplifier may be safely powered by line voltages of 100 240 VAC with frequencies of 50 60 Hz CardioLab Il Plus Amplifier Operator s Manual Revision B 2002938 001 000020 SJM03075115 Introduction Service Information Service Information Service Requirements Follow the service requirements listed below B Refer equipment servicing to GE Marquette Medical Systems authorized service personnel only m Any una
35. mulator Bypass Connections for Emergency Pacing 44444444 rara rra era hh ar 3 6 Move Connections a rta ai tcov Segue Deo bre ee DAT a wai 3 6 Appendices Appendix A Maintenance and Troubleshooting A 1 Ei MEUM ER A 3 Maintenance Repair Lag A 3 Environmental Protection ciiin A3 Inspection and Cleaning TS A 4 Precaulions aio ta rd ox ease bale ra A 4 Cl iria ORE Nec a ada a pcena A4 Troubleshooting 4 4 A 5 Storing and Transporting the Amplifier A 6 Maintenance Repair Log A 7 Appendix B Technical Information B 1 Technical Specifications B 3 Index a IX 1 CardioLab H Plus Amplifier Operator s Manual Revision B 2002938 001 000008 SJM03075103 1 Introduction Manual Information Sete 1 3 Revision History ee Ho ex erar ew eau v Pr PN I OR 13 Manual Purposes disent ant de Le PvE pain ad a ees 1 3 Intended AUDIENCIA IR re Oo e peu a bs 13 Intended Use cara ste ihe A be OR IS 13 Chapter COMER iaa id de tit 1 4 Safety Information TO 15 Manufacturer Responsibility 1 5 General rica a aa 1 5 Equipment Symbols
36. or devices manufactured in the United States the CE mark is applied under the authority of Notified Body GMED 0459 The country of manufacture and appropriate Notified Body can be found on the equipment labeling The safety and effectiveness of this device has been verified against previously distributed devices Although all standards applicable to presently marketed devices may not be appropriate for prior devices i e electromagnetic compatibility standards this device will not impair the safe and effective use of those previously distributed devices The CardioLab II meets the requirements of EN60601 1 2 1993 04 Medical Electrical Equipment Part 1 General Requirements for Safety 2 Collateral Standard Electromagnetic compatibility Requirements and tests Exception ECG Parameter TEC601 1 2 clause 36 202 1 Immunity Radiated Immunity The level of compliance is less than 1 V m If operating under the conditions defined in EMC Standard EN60601 1 2 Radiated Immunity 3V m field strengths less than 1V m may cause waveform distortions and erroneous numeric data at various electromagnetic interference EMT frequencies Recommendations Review the AAMI EMC Committee technical information report TIR 18 titled Guidance on electromagnetic compatibility of medical devices for clinical biomedical engineers Part 1 Radiated radio frequency electromagnetic energy This TIR provides a means to evaluate and manage
37. r Inputs Up to three catheter inputs will each accept a 32 pole catheter input module Use the CardioLab Il Plus Catheter Input Modules part number 301 00202 08 with the CardioLab Il Plus Amplifier The auxiliary input will accept the Auxiliary Input Cable part number 301 00205 08 Auxiliary Inputs Power Indicator The power indicator is on as long as the CardioLab II Plus Amplifier is turned on Communication Indicators Three communication indicators show the status of the communication between the acquisition computer and the CardioLab ll Plus Amplifier When the XMT indicator is on the CardioLab II Plus Amplifier is transmitting data to the acquisition computer The XMT indicator should remain on as long as the power indicator is on When the RCV CMD indicator is on the CardioLab I Plus Amplifier is receiving data from the acquisition computer The RCV CMD indicator will turn on as long as an instruction is being received by the amplifier When the RCV ERR indictor is on the CardioLab Il Plus Amplifier may not be receiving data from the acquisition computer in a valid format or there may be a problem with the fiber optic cable Revision B CardioLab Il Plus Amplifier Operator s Manual 2 5 2002938 001 SJM03075122 000027 Equipment Overview Front View Catheter OO Pressure G di C C inputs ECG Input Le O C Auxiliary inputs o Q St
38. t complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system Consideration relating to the choice shall include use of the accessory in the PATIENT VICINITY and a evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 601 1 and or IEC 601 1 1 harmonized national standard The CardioLab II Plus Amplifier is a component accessory of a Class II medical device 1 6 CardioLab Il Plus Amplifier Operator s Manual Revision B 2002938 001 000014 SJM03075109 Introduction Equipment Symbols Equipment Symbols The following symbols appear on the equipment Attention Pay attention to the documents delivered with the equipment Type CF Equipment ie Type CF equipment is specifically designed for applications where a conductive connection to the heart is directly established Type CF Equipment 19 Type CF equipment that is defibrillator proof Isolated floating applied part suitable for intentional external and internal application to the patient including direct cardiac application Paddles outside the box indicate the applied part is defibrillator proof Medical Standard Definition F type applied part floating isolated complying with the specified requirements of IEC 60601 1 UL 2601 1 CSA 601 1 Medical Standards to provide a higher degree of protection against electric shock than tha
39. t provided by BF applied parts Equipotentiality nonessential electrical connection which may be used to connect the chassis to other equipment to achieve the same potential PD 1000 001 002 003 004 005 Revision B CardioLab Ii Plus Amplifier Operator s Manual 1 7 2002938 001 000015 3JM03075110 introduction Classifications Classifications The CardioLab IT Plus Amplifier is classified according to IEC 60601 1 as Type of protection against electrical shock Degree of protection against electrical shock CF ECG BP CIM Auxiliary Inputs Degree of protection against harmful ingress of water Ordinary Degree of safety of application in the presence of a flammable anesthetic mixture wilh air or with oxygen or nitrous oxide Method s of sterilization or disinfection recommended by the manufacturer Not suitable Not Applicable Mode of operation I Class 1 equipment CF Type CF applied part Continuous operation Ordinary Ordinary equipment enclosed equipment without protection against ingress of water Not Suitable Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Underwriters Laboratories Inc UL Underwriters Laboratories Inc SSSA amp y Classified by Underwriters Laboratories Inc with respect to electric shock fire mechanical C US and other specified hazards only
40. the EMI environment in the hospital The following actions can be taken B managing increasing distance between sources of EMI and susceptible devices m managing removing devices that are highly susceptible to EMI B lower power from internal EMI sources under hospital control i e paging systems labeling devices susceptible to EMI educating staff nurses and doctors to be aware of and to recognize potential EMI related problems Revision B CardioLab Il Plus Amplifier Operator s Manual CE 1 2002938 001 JM03075100 000005 SJM030791 CE Marking Information CE 2 CardioLab Il Plus Amplifier Operator s Manual Revision B 2002938 001 000006 SJM03075101 Contents 1 Introduction DM Manual Information aa AA n 1 3 Revision History ira a d e a 13 Manual Purpose unissent a te En ne RR Ce Reed A eet 1 3 Intended Audience 4 4 44 44444444 sise sueur 13 Intended USE 572 cre manne t TOI eh Ee do 13 Chapter Content curie entendent vasa ASE 14 Safety Information 15 Manufacturer Responsibility 15 General ai piunt seis rere per v Nr RSS a aia 1 5 Equipment Symhols oi irc re hr3 aie era a ss 1 7 Classifications a a a A en 1 8 Underwriters Laboratories Inc UL 1 8 Conventions ia AA A te 1 9 Safety Messages 544 4 raer roren a 1 9 D
41. ties of the system by simply moving the positive and negative connections from the Catheter Input Module section to the Direct Stimulator Connection section on the CardioLab II Plus Catheter Input Module WARNING Back up patient monitors should always be available while using CardioLab II Plus Amplifiers Move Connections 3 6 CardioLab II Plus Amplifier Operator s Manual Revision B 2002938 001 SJM03075133 000038 Appendix Maintenance and Troubleshooting OVA ras dt RR aaa Maintenance Repair Log Environmental Protection Inspection and Cleaning Precautl ns ciere HE UE late aa Cleaning uo ts A sit A Troubleshooting Storing and Transporting the Amplifier Maintenance Repair Log Revision B CardioLab li Plus Amplifier Operator s Manual 2002938 001 000039 A 1 JM03075134 For your notes A 2 CardioLab li Plus Amplifier Operator s Manual 2002938 001 000040 Revision B SJM03075135 Appendix A Maintenance and Troubleshooting Overview Overview Maintenance Repair Log A Maintenance RepairLog is included in this appendix to aid in keeping a record of the work done on the amplifier NOTE Unless you have an Equipment Maintenance Contract GE Marquette
42. uipment Overview for a description of all equipment and components To connect the pressure ECC and catheter cables to the amplifier line the pins with the appropriate connection and firmly push the head of the cable into place Turn the connector ring to the right clockwise to secure the cable into the connection To connect the stimulator and auxiliary inputs cables to the amplifier line the pins with the appropriate connection hold the head of the cable by the shell and firmly push the cable into place Revision B CardioLab il Plus Amplifier Operator s Manual 3 3 2002938 001 000035 SJM03075130 Operation Related Manuals To connect the power cord to the back of the amplifier line the pins with the connection and firmly push the head of the cord into place To connect the fiber optic cable to the back of the amplifier remove the protective cap hold the cable by the head and firmly push it into place The cable will only connect in one orientation DO NOT force the fiber optic cable into the connection Tf the cable does not connect with ease flip the cable and try to connect it again Disconnecting Cables From the Amplifier To disconnect the pressure ECG and catheter cables from the amplifier turn the connector ring to the left counter clockwise and firmly pull the cable straight back To disconnect the stimulator and auxiliary inputs cables from the amplifier hold the head of the cable by the shell and firmly p
43. ule cleaning guidelines checkout procedure and safety tests Appendix B Technical Information Provides a complete table of technical specifications for the CardioLab IT Plus Amplifier 1 4 CardioLab Il Plus Amplifier Operator s Manual Revision B 2002938 001 000012 SJM03075107 Introduction Safety Information Safety Information Please read all of these instructions carefully Follow all of the instructions and warnings marked on this product or included in this manual Save these instructions for later use Manufacturer Responsibility General GE Marquette Medical Systems is responsible for the effects of safety reliability and performance only if a Installation operations extensions readjustments modifications or repairs are carried out by persons authorized by GE Marquette The equipment is used in accordance with the instructions for use B The user attaches only accessory equipment recommended for interaction with the amplifier The CardioLab II Plus Amplifier maintains leakage currents below medical limits with an isolation transformer which is incorporated into the design of the amplifier Amplifier power should be supplied by a dedicated power supply on an isolated circuit for proper behavior of the amplifier To ensure patient safety use only parts and accessories manufactured or recommended by GE Marquette Medical Systems This equipment should only be connected as specified by GE Marquette Me
44. ull the cable straight back The stimulator and auxiliary input cables will not disconnect from the amplifier when pulled by the cord To disconnect the power cord from the back of the amplifier hold the cord by the head and firmly pull the cord straight back To disconnect the fiber optic cable from the back of the amplifier hold the head of the cable while pinching the sides Firmly pull the cable straight back and attach the protective cap Installation Checkout Related Manuals Once the appropriate cable connections have been made to the CardioLab II Plus Amplifier the communication indicators on the front of the amplifier should turn on If the indicators do not turn on check the fiber optic cable for cracks and wear If the XMT indicator is on the CardioLab II Plus Amplifier is transmitting data to the acquisition computer The XMT indicator will turn on regardless if the transmission of data is successful or not The RCV ERR indicat r will turn on if the amplifier is having difficulty transmitting data to the computer The RCV CMD indicator will turn on when the acquisition computer is sending data to the CardioLab IT Plus Amplifier If the RCV ERR indicator is on the acquisition computer may be having difficulty transmitting data to the computer The RCV ERR indicator may also turn on if the fiber optic cable has been connected to the amplifier incorrectly Refer to the manuals listed in the table in the Related Manuals se
45. uthorized attempt to repair equipment under warranty voids that warranty m It is the user s responsibility to report the need for service to GE Marquette Medical Systems or to one of their authorized agents B Failure on the part of the responsible individual hospital or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards 8 Regular maintenance irrespective of usage is essential to ensure that the CardioLab II Plus Amplifier will always be functional when required Revision B CardioLab Il Plus Amplifier Operator s Manual 1 13 2002938 001 SJM03075116 000021 Introduction Service Information Equipment Identification Every GE Marquette Medical Systems device has a unique serial number for identification The serial number appears on the back of the CardioLab IT Plus Amplifier CLAB II Plus Amplifier Bar Code A0X J0001 EP GE a e ii NS Table 1 Equipment Identifications Item Name Description A manufacturer GE Marquette Medical Systems Inc B name of device CLAB II Plus Amplifier C serial number Unique identifier D month manufactured January B February C March D April E May F June G July H August J September K October L November M December E year manufactured 9 1999 0 2000 1
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