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Equipment Overview

2002938-002E

Cardiolab® II Plus Amplifier Manual

2-17

Components

The CardioLab II Plus Amplifier comes with the following components:

Table 7. CardioLab II Plus Amplifier Components

Component Name

Part Number

CardioLab II Plus Catheter Input Module

301-00202-08

3 ft. Touchproof Stimulator Input Cable

301-00204-03

15 ft. 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 Set

2003421-001

10 Lead ECG Cable

2003419-001

Power Cord

80274-006
405535-013 (Japan)

75ft. ST to FDDI Fiber Optic cable

2003434-001

Содержание Cardiolab II Plus

Страница 1: ...Service Manual 2002938 002 Revision E Cardiolab II Plus Amplifier Manual ...

Страница 2: ...isted below are GE Medical Systems Information Technologies trademarks used in this document MAC LAB CARDIOLAB CENTRICITY TRAM TRAMNET and TRAM RAC are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office All other trademarks contained herein are the property of their respective owners GE Medical Systems Information Technologies 2006...

Страница 3: ...r 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 IEC601 1 2 clause 36 ...

Страница 4: ...ng actions can be taken managing increasing distance between sources of EMI and susceptible devices managing removing devices that are highly susceptible to EMI 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 ...

Страница 5: ...ty Messages 1 4 Manufacturer Responsibility 1 5 General 1 5 Electromagnetic Interference 1 6 Equipment Symbols 1 7 Classifications 1 8 Underwriters Laboratories Inc UL 1 10 Equipment Safety 1 10 Dangers Warnings and Cautions 1 10 Service Information 1 14 Service Requirements 1 14 Equipment Identification 1 15 New Identification Tags 1 15 Old Identification Tags 1 16 2 Equipment Overview 2 1 Genera...

Страница 6: ...put Cable 2 19 ECG 10 Lead Set 2 19 10 Lead ECG Cable 2 20 Power Cord 2 20 3 Operation 3 1 Getting Started 3 2 Connecting Cables to the Amplifier 3 3 Disconnecting Cables From the Amplifier 3 3 Installation Checkout 3 4 A Appendix A Maintenance and Troubleshooting A 1 Overview A 2 Maintenance Repair Log A 2 Environmental Protection A 2 Inspection and Cleaning A 2 Precautions A 3 Cleaning A 4 Ampli...

Страница 7: ...2002938 002E Cardiolab II Plus Amplifier Manual i iii B Appendix B Technical Information B 1 Technical Specifications B 2 ...

Страница 8: ...i iv Cardiolab II Plus Amplifier Manual 2002938 002E ...

Страница 9: ...2002938 002E Cardiolab II Plus Amplifier Manual 1 1 1 Introduction ...

Страница 10: ...r safely in accordance with its function and intended use These instructions include but are not limited to Describing fundamental controls and indicators Operating procedures Connecting and disconnecting detachable parts and accessories Troubleshooting and service procedures Intended Audience This manual is intended for the person who maintains and troubleshoots this equipment Revision History PN...

Страница 11: ...rview 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 m...

Страница 12: ...o designate a degree or level or seriousness Familiarize yourself with their definitions and significance Hazard is defined as a source of potential injury to a person DANGER DEATH OR SERIOUS INJURY A message which indicates an imminent hazard which if not avoided will result in death or serious personal injury or product property damage WARNING POTENTIAL DEATH OR SERIOUS INJURY A message which in...

Страница 13: ...ent recommended for interaction with the amplifier General 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 accessori...

Страница 14: ...fety 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 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...

Страница 15: ... 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 the EMI environment in the hospital The following actions can be taken managing increasing distance between sources of EMI and susceptible devices managing removing devices that are highly susc...

Страница 16: ...601 1 Medical Standards to provide a higher degree of protection against electric shock than that provided by BF applied parts Equipotentiality A nonessential electrical connection which may be used to connect the chassis to other equipment to achieve the same potential Classifications The CardioLab II Plus Amplifier is classified according to IEC 60601 1 as Type of protection against electrical s...

Страница 17: ... Class I equipment CF Type CF applied part 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 ...

Страница 18: ... of the product The order in which safety statements are presented in no way implies order of importance Dangers Warnings and Cautions There are no dangers that refer to the equipment in general Specific Danger statements may be given in the respective sections of this manual DANGER EXPLOSION Do not use in the presence of flammable anesthetics or other flammable gases WARNING EQUIPMENT DAMAGE Only...

Страница 19: ...e to your equipment do not disable the power cord grounding feature This equipment is designed for connection to a earth grounded power outlet The grounding plug is an important safety feature WARNING ELECTRICAL SHOCK To reduce the risk of electric shock DO NOT remove cover or back This equipment contains no user serviceable parts Refer servicing to qualified service personnel WARNING BACK UP MONI...

Страница 20: ...C 601 1 certified product Ablation operations should NOT be executed when a stimulator unit is connected WARNING DEFIBRILLATOR PRECAUTIONS DO NOT contact the system or patient during defibrillation Standby defibrillation equipment is required in the event that the patient needs to be cardioverted or defibrillated WARNING PATIENT EQUIPMENT SAFETY The system should be tested yearly for adequate grou...

Страница 21: ...nd capable of delivering 20A Route the AC power cable away from moving parts Connect only to a properly earth grounded outlet WARNING REPLACEMENT PARTS Replace only with the same type and rating of fuse WARNING INDICATIONS OF USE This device is intended for use under the direct supervision of a licensed health care practitioner CAUTION RESTRICTED SALE Federal USA law restricts this device to sale ...

Страница 22: ...rotected 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 CAUTION POWER SUPPLY The CardioLab II Plus Amplifier may be safely powered by line voltages of 100 240 VAC with frequenci...

Страница 23: ...ment failure and possible health hazards Regular maintenance irrespective of usage is essential to ensure that the CardioLab II Plus Amplifier will always be functional when required Equipment Identification Every GE Medical Systems Information Technologies device has a unique serial number for identification The serial number appears on the back of the CardioLab II Plus Amplifier New Identificati...

Страница 24: ...eek G Product Sequence Number H Manufacturing Site I Misc Identification Tags Item Name NAME OF DEVICE GE MEDICAL SYSTEMS MILWAUKEE WI MADE IN USA A2PX1808F A 2 PX 1808 XX A B C D E F G H Identification Tag Item Name Description A Name of Device CLABII Plus Amplifier B Manufacturer GE Medical Systems Information Technologies C Serial Number Unique Identifier ...

Страница 25: ...quence Number Manufacturing number of total units manufactured F Product Code Two character product descriptor XJ CLAB II Plus Amplifier G Year Manufactured 9 1999 0 2000 and so on H Month Manufactured A January B February C March D April E May F June G July H August J September K October L November M December Identification Tag Item Name Description ...

Страница 26: ...1 18 Cardiolab II Plus Amplifier Manual 2002938 002E Introduction ...

Страница 27: ...2002938 002E Cardiolab II Plus Amplifier Manual 2 1 2 Equipment Overview ...

Страница 28: ...ftware versions The CardioLab II 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 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 Amplif...

Страница 29: ...ational users need to order a power cord the following part numbers can be ordered separately The following table lists the options for each configuration of the Acquisition system Table 2 International Power Cord Part Numbers Part Number Description 422845 001 Power cord for Continental Europe 10 Amp 422845 002 Power cord for Britain 10 Amp 422845 003 Power cord for Italy 10 Amp 422845 004 Power ...

Страница 30: ...city of 1 2 inch Phillips screwdriver Physiologic signal simulator with ECG and pressure outputs 2 mm pin jack to ECG jumper wires Bourn s potentiometer tool Adapter cable to interface pressure simulator to amplifier inputs Torx T10 driver Table 2 Accessory Parts List Accessory Name Part Number Abbott Transpac IV Disposable Transducer with 4 ft extension Cable Abbott 42582 08 Abbott Transpac Reusa...

Страница 31: ...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 II Plus Amplifier Catheter Inputs Up to three catheter inputs will each accept a 32 pole catheter input module Use the CardioL...

Страница 32: ...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 II 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 E...

Страница 33: ...nput 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 II Plus Amplifier Catheter Inputs Up to seven catheter inputs will each accept a 32 pole catheter input module Use the CardioLab II...

Страница 34: ...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 II 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 II Plus Amplif...

Страница 35: ...formation from the CPU and sends commands to other boards Table 6 Back View CardioLab II Plus Amplifier Name Description 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 supplied power cord connects to the Power Input Equipotentiality Terminal...

Страница 36: ...2 10 Cardiolab II Plus Amplifier Manual 2002938 002E Equipment Overview ...

Страница 37: ...Equipment Overview 2002938 002E Cardiolab II Plus Amplifier Manual 2 11 ...

Страница 38: ...rview ECG Pressure Calibration Board P N 2002834 004 Processes ECG leads and calculates augmented leads using the Wilson Central Terminal Contains high and low pass filters gains and notch filters Contains four strain gauge pressure transducers Protects defibrillation ...

Страница 39: ...PA PN 2002506 004 Contains high and low pass filters gains and notch filters Performs A D conversion and sends information to the control board Contains 32 inputs 16 channels per board Identifies switches used to assign addresses when swapping boards Relays route stim inputs to correct catheter inputs ...

Страница 40: ... ECG inputs Allows stim inputs to pass through Allows signals to pass through catheter inputs Contains ribbon cables that connect to the back plane board Provides four LEDs 1 XMT DATA Transmit Data Always green indicating real time data being sent to CPU 2 RCV CMD Receive Command Only flashes when the amplifier receives commands from the CPU 3 RCV Error Receive Error Lights when the amplifier rece...

Страница 41: ... Amplifier Manual 2 15 Back Plane Board The part numbers for the back plane boards are as follows 64 32 Channel PN 2002604 001 128 96 Channel PN 2002705 001 Provides the interface for the ECG Pressure Calibration Board XPA boards and the control board ...

Страница 42: ...ardiolab II Plus Amplifier Manual 2002938 002E Equipment Overview Power Board PN 2002648 001 Converts 15 V to 15 V and 5 V Supplies power to the power subassembly fan Sends a TTL signal equivalent 50 or 60Hz ...

Страница 43: ...nt Name Part Number CardioLab II Plus Catheter Input Module 301 00202 08 3 ft Touchproof Stimulator Input Cable 301 00204 03 15 ft 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 Set 2003421 001 10 Lead ECG Cable 2003419 001 Power Cord 80274 006 405535 013 Japan 75ft ST to FDDI Fiber Optic cable 2003...

Страница 44: ... see photo below connect to the stimulator Each Catheter Input Module is broken down into two groups of 16 poles each For example Block A 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 each group For detailed instructions on how to ...

Страница 45: ...Equipment Overview 2002938 002E Cardiolab II Plus Amplifier Manual 2 19 Stimulator Input Cable ECG 10 Lead Set ...

Страница 46: ...2 20 Cardiolab II Plus Amplifier Manual 2002938 002E Equipment Overview 10 Lead ECG Cable Power Cord ...

Страница 47: ...2002938 002E Cardiolab II Plus Amplifier Manual 3 1 3 Operation ...

Страница 48: ...o the CardioLab II Plus Amplifier discontinue using the amplifier and contact GE Medical Systems Information Technologies 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 hu...

Страница 49: ...o 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 If 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 ...

Страница 50: ... transmission of data is successful or not The RCV ERR indicator 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 II Plus Amplifier If the RCV ERR indicator is on the acquisition computer may be having difficulty transmitting data to the computer The RCV ERR indicat...

Страница 51: ...2002938 002E Cardiolab II Plus Amplifier Manual A 1 A Appendix A Maintenance and Troubleshooting ...

Страница 52: ... 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 Take care to avoid extremes of temperature moisture and humidity The amplifier is not waterproof Protect the amplifier from spills or other debris Eating drinking and smoking should no...

Страница 53: ...dule 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 Clean all dust and debris from the fiber optic cable connectors Yearly Check the summation of the leakage ...

Страница 54: ...oes not send signals to the CardioLab system or you receive an unable to communicate with amplifier message Ensure that the amplifier is plugged in and turned on Verify that the external cables are connected properly and are securely attached Replace the fiber optic cable FOC Clean the FOC with isopropyl rubbing alcohol and blow out the connectors with compressed air Disconnect the FOC from back o...

Страница 55: ... Input Module CIM and that these poles have been correctly entered into the study configuration Remove replace the catheter extender cables especially if they have been re sterilized For real time testing during a case Make duplicate channels If the noisy signal is set to poles x and y set up another channel one with a high quality intracardiac signal for example HRA or RVA with the same poles and...

Страница 56: ...produce an identical signal the pole in the catheter input module may be bad Ensure that you are not placing the CIM in sterile bags and then pushing the catheter pins through the plastic and into the CIM This plastic can become lodged in the CIM and create problems Catheters with long pins 1 2 inch normally produce less noise than catheters with short pins This is due to the long pins deep penetr...

Страница 57: ...m Also make sure the amplifier is not plugged into a power strip The amplified should always be plugged into its own dedicated outlet Install a harmonic filter isolation transformer between the power source and the amplifier to further reduce noise It may be necessary to replace the ECG cable the cable from the front oh the amplifier to the limb leads Ensure that all AC outlets which CardioLab int...

Страница 58: ...oft scale value can lead to flatlines Values of 1 8 and 1 4 are recommended Select Reset Hardware from the amplifier test window under the Administration menu It may be necessary to replace the ECG cable the cable between the amplifier and the limb leads If using a simulator to test the ECG signals always make sure the right leg lead is attached to the ground of the simulator Stimulus Artifact on ...

Страница 59: ...ect the catheter directly to the stimulator If the artifact is no longer present the problem may be with the amplifier or one of the cables connected to the amplifier For continued problems with stim artifact please fax a snapshot of the signals to customer support for evaluation Stimulus Artifact on ECG Signals Does the artifact appear on all of the surface leads If Lead I is clean and all other ...

Страница 60: ... of the catheter input module These poles are directly wired from the front of the amplifier If you are still unable to pace connect the distal poles of the catheter directly to the stimulator bypassing the amp If you still cannot pace the problem is not with the CardioLab equipment and most likely lies with the stimulator or catheter Check the output of the stimulator with a multi meter or oscill...

Страница 61: ...e zero key on the keyboard Run pressure data on the channel and verify the pressure signal Repeat the same procedure for all pressure waveforms Change the Real Time display to page 3 and connect your simulator to pins 1 and 2 of catheter block A Run signal data into pins 1 and 2 verify that all of the signals on the page look identical Run through this same procedure for each of the successive pag...

Страница 62: ...ration menu and select Amplifier Test Choose Register readback and perform the readback function The values sent should be the same ones as the ones received Click on the walking ones tab and perform the walking ones test only once Make sure there are no errors during the test Errors imply communication problems with the channels Select the Stim Walking Ones tab and perform the test once Once agai...

Страница 63: ...Appendix A Maintenance and Troubleshooting 2002938 002E Cardiolab II Plus Amplifier Manual A 13 Maintenance Repair Log Unit Serial Number Institution Name Date Maintenance Repair Technician ...

Страница 64: ...A 14 Cardiolab II Plus Amplifier Manual 2002938 002E Appendix A Maintenance and Troubleshooting Unit Serial Number Institution Name Date Maintenance Repair Technician ...

Страница 65: ...2002938 002E Cardiolab II Plus Amplifier Manual B 1 B Appendix B Technical Information ...

Страница 66: ...B 2 Cardiolab II Plus Amplifier Manual 2002938 002E Appendix B Technical Information Technical Specifications ...

Страница 67: ...Appendix B Technical Information 2002938 002E Cardiolab II Plus Amplifier Manual B 3 ...

Страница 68: ...B 4 Cardiolab II Plus Amplifier Manual 2002938 002E Appendix B Technical Information ...

Страница 69: ......

Страница 70: ...opean Representative GE Medical Systems Information Technologies GmbH Munzinger Straße 3 5 D 79111 Freiburg Germany Tel 49 761 45 43 0 Fax 49 761 45 43 233 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 ...

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