GE Cardiolab II Plus Service Manual
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GE Cardiolab II Plus Service Manual

GE Cardiolab II Plus Service Manual

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Cardiolab
II Plus Amplifier Manual
Service Manual
2002938-002
Revision E

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Summary of Contents for GE Cardiolab II Plus

  • Page 1 ® Cardiolab II Plus Amplifier Manual Service Manual 2002938-002 Revision E...
  • Page 2 Due to continuing product innovation, specifications in this manual are subject to change without notice. CARTO is a trademark of Biosense Webster, Inc. Listed below are GE Medical Systems Information Technologies trademarks used in this document. ® ® ® ®...

  • Page 3: Ce Marking Information

    CE Marking Information 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. For devices manufactured in the United States, the CE mark is applied under the authority of Notified Body GMED (0459).
  • Page 4 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 susceptible to EMI lower power from internal EMI sources under hospital control (i.e.

  • Page 5: Table Of Contents

    CardioLab II Plus Amplifier Hardware........
  • Page 6 Components ............2-17 CardioLab II Plus Catheter Input Module .......2-18 Stimulator Input Cable .
  • Page 7 Appendix B– Technical Information ....B-1 Technical Specifications ..........B-2 2002938-002E Cardiolab®...
  • Page 8 i-iv Cardiolab® II Plus Amplifier Manual 2002938-002E...

  • Page 9: Introduction

    Introduction 2002938-002E Cardiolab® II Plus Amplifier Manual...

  • Page 10: Revision History

    Updated per GEHmk15561 Manual Purpose This manual contains the instructions necessary to service the CardioLab II Plus Amplifier safely in accordance with its function and intended use. These instructions include but are not limited to: Describing fundamental controls and indicators.

  • Page 11: Intended Use

    Introduction Intended Use The CardioLab II Plus Amplifier is intended for use in an electrophysiological catheter laboratory or catheterization laboratory where ECG, 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.

  • Page 12: Manual Conventions

    Introduction Part Number Document 2027332-107 Mac-Lab/Cardiolab System Installation Manual 2027332-109 Mac-Lab/Cardiolab System Service Manual Manual Conventions Hardware and Software Terms The following is a list of conventions used throughout the text of the manual: Hardware items shown in Bold text are keys on the keyboard. Italicized items are software terms that identify menu items or options in various windows.

  • Page 13: Manufacturer Responsibility

    GE Medical Systems Information Technologies is responsible for the effects of safety, reliability, and performance only if: Installation operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE Medical Systems Information Technologies. The equipment is used in accordance with the instructions for use.

  • Page 14: Electromagnetic Interference

    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. Electromagnetic Interference Interference with the operation or signal integrity of this equipment is unlikely as a result of proximity to general equipment.

  • Page 15: Equipment Symbols

    Introduction 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests. Exception ECG Parameter IEC601-1-2 clause 36.202.1 - Immunity: Radiated Immunity – The level of compliance is less than 1V/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 (EMI) frequencies.

  • Page 16: Classifications

    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, Type of protection against electrical shock Degree of protection against electrical CF—ECG, BP, CIM, Auxiliary Inputs...
  • Page 17 Introduction I: 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 2002938-002E Cardiolab®...

  • Page 18: Underwriters Laboratories Inc. (Ul)

    2601-1 listed or IEC certified medical equipment. If fluid of any kind that should leak into the system, discontinue use of the equipment and contact GE Medical Systems Information Technologies immediately. Do not allow any foreign materials such as fluids to come in contact with the CardioLab II Plus Amplifier.
  • Page 19 Introduction WARNING ELECTRICAL SHOCK — DO NOT allow hydraulic fluid from any device to contact any conductive surface. Hydraulic fluid is electrically conductive. An electrical shock hazard exists between chassis ground and isolated (floating) ground when power is applied. Unplug the unit from the power source before proceeding. To reduce the risk of electric shock or damage to your equipment, do not disable the power cord grounding feature.
  • Page 20 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...
  • Page 21 Introduction WARNING MAINTENANCE — Use only Catheter Input Module (CIM) #301-00202-08 or #30100203-08 with the CardioLab II Plus Amplifier. Check the electrical integrity of the signal connections in the catheter input modules and cabling yearly. WARNING POWER SUPPLY — Connect the system to a power outlet equipped with emergency power.

  • Page 22: Service Information

    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.

  • Page 23: Equipment Identification

    Introduction It is the user’s responsibility to report the need for service to GE Medical Systems - Information Technologies or to one of their authorized agents. 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.

  • Page 24: Old Identification Tags

    GE MEDICAL SYSTEMS MILWAUKEE MADE IN USA A2PX1808F A 2 PX 1808 Identification Tag Item Name Description Name of Device CLABII Plus Amplifier Manufacturer GE Medical Systems Information Technologies Serial Number Unique Identifier 1-16 Cardiolab® II Plus Amplifier Manual 2002938-002E...
  • Page 25 Introduction Identification Tag Item Name Description Facility Code F or G = Milwaukee, P = Bangalore, S = Border Ops (Juarez/El Paso) Product Sequence Manufacturing number of total units manufactured Number Product Code Two character product descriptor; XJ= CLAB II Plus Amplifier Year Manufactured 9 = 1999, 0 = 2000 (and so on) Month Manufactured...
  • Page 26 Introduction 1-18 Cardiolab® II Plus Amplifier Manual 2002938-002E...

  • Page 27: Equipment Overview

    Equipment Overview 2002938-002E Cardiolab® II Plus Amplifier Manual...

  • Page 28: General Description

    Equipment Overview 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 CardioLab/Mac-Lab system, referred to in this manual as the acquisition computer. These signals include 12 Lead ECG, intra-cardiac and pressure signals.

  • Page 29: Cardiolab Ii Plus Amplifier Hardware

    Equipment Overview CardioLab II Plus Amplifier Hardware Amplifier Part Numbers The part numbers for the CardioLab II Plus Amplifier are as follows: 32 Channel: 2003232-001 64 Channel: 2003232-002 96 Channel: 2003232-003 128 Channel: 2003232-004 If international users need to order a power cord, the following part numbers can be ordered separately.

  • Page 30: Accessory Parts List

    Monitoring* * This accessory is not stocked by GE Medical Systems Information Technologies. Required Tools and Supplies The following is a list of tools needed to service the CardioLab II Plus amplifier: Adjustable wrench with a capacity of 1/2 inch...

  • Page 31: Front View

    Equipment Overview Front View Table 4. Front View 64/32 Channels- CardioLab II Plus Amplifier Name Description Pressure Inputs Four pressure inputs will each accept a pressure transducer that is calibrated to 5uV/V/mmHg. See the Accessory Parts List for GE Medical Systems - Information Technologies recommended pressure transducers.
  • Page 32 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 II Plus Amplifier is turned on. Communication Three communication indicators show the status of the...
  • Page 33 Equipment Overview Table 5. Front View 128/96 Channels- CardioLab II Plus Amplifier Name Description Pressure Inputs Four pressure inputs will each accept a pressure transducer that is calibrated to 5uV/V/mmHg. See the Accessory Parts List for GE Medical Systems - Information Technologies recommended pressure transducers.

  • Page 34: Back View

    Equipment Overview Table 5. Front View 128/96 Channels- CardioLab II Plus Amplifier Power Indicator The power indicator is on as long as the CardioLab II Plus Amplifier is turned on. Communication Three communication indicators show the status of the Indicators communication between the acquisition computer and the CardioLab II Plus Amplifier.

  • Page 35: Internal Assembly

    Equipment Overview Table 6. Back View - CardioLab II Plus Amplifier Name Description FDDI Connection to This connector will accept a FDDI type fiber optic cable. The Computer fiber optic cable allows for two-way communication between the amplifier and the CardioLab system.
  • Page 36 Equipment Overview 2-10 Cardiolab® II Plus Amplifier Manual 2002938-002E...
  • Page 37 Equipment Overview 2002938-002E Cardiolab® II Plus Amplifier Manual 2-11...

  • Page 38: Ecg/Pressure/Calibration Board (P/N 2002834-004)

    Equipment Overview 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. 2-12 Cardiolab® II Plus Amplifier Manual 2002938-002E...

  • Page 39: Cross-Point Amplifier Board (Xpa)(Pn: 2002506-004)

    Equipment Overview Cross-Point Amplifier Board (XPA)(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.

  • Page 40: Front Panel Board

    Equipment Overview Front Panel Board The part numbers for the front panel boards are as follows: 32 Channel: PN: 2002754-004 64 Channel: PN: 2002754-003 96 Channel: PN: 2002758-004 128 Channel: PN: 2002758-003 Allows RF filtering. Protects defibrillation for ECG inputs. Allows stim inputs to pass through.

  • Page 41: Back Plane Board

    Equipment Overview 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. 2002938-002E Cardiolab® II Plus Amplifier Manual 2-15...

  • Page 42: Power Board (Pn: 2002648-001)

    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) 2-16 Cardiolab® II Plus Amplifier Manual 2002938-002E...

  • Page 43: Components

    Equipment Overview 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.

  • Page 44: Cardiolab Ii Plus Catheter Input Module

    Equipment Overview CardioLab II Plus Catheter Input Module The equivalent to the Stimulus Inputs 1-4 on the Stimulator Input Cable are labelled on the CardioLab II Amplifier as Stimulus Inputs A1, A2, B1 and B2. The four stimulus inputs on the Stimulator Input Cable (see photo below) connect to the stimulator.

  • Page 45: Stimulator Input Cable

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

  • Page 46: 10 Lead Ecg Cable

    Equipment Overview 10 Lead ECG Cable Power Cord 2-20 Cardiolab® II Plus Amplifier Manual 2002938-002E...

  • Page 47: Operation

    Operation 2002938-002E Cardiolab® II Plus Amplifier Manual...

  • Page 48: Getting Started

    CardioLab II Plus Amplifier. If fluid of any kind should leak into the CardioLab II Plus Amplifier, discontinue using the amplifier and contact GE Medical Systems - Information Technologies.

  • Page 49: Connecting Cables To The Amplifier

    Operation 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 Equipment Overview for a description of all equipment and components.

  • Page 50: Installation Checkout

    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.

  • Page 51: Appendix A - Maintenance And Troubleshooting

    Appendix A – Maintenance and Troubleshooting 2002938-002E Cardiolab® II Plus Amplifier Manual...

  • Page 52: Overview

    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 Medical Systems - Information Technologies recommends...

  • Page 53: Precautions

    Yearly maintenance activities on the CardioLab II Plus Amplifier should only be done by qualified technical personnel. Precautions Do not open the CardioLab II Plus Amplifier unless instructed to do so by a qualified technical personnel. Do not immerse any part of the amplifier in water. 2002938-002E...

  • Page 54: Cleaning

    Dry the surfaces with a clean cloth or paper towel. Amplifier Troubleshooting See the How to Reach Us section in the front of this manual for information on contacting GE Medical Systems - Information Technologies for customer service, product support, supplies, and service parts.

  • Page 55: Noise On Intracardiac Signals

    Appendix A – Maintenance and Troubleshooting Clean the FOC contacts with a non-abrasive, lint-free cloth and isopropyl alcohol. Replace the fiber optic cable. If the waveforms only exist on one channel, try replacing either the catheter, catheter extender, or catheter junction box. You may also try another Catheter Input Module.
  • Page 56 Appendix A – Maintenance and Troubleshooting Bicath type setting No notch filter and identical high and low pass settings. Make sure each signals is displayed on an active page. All of the signals should be identical. If one channel does not produce an identical signal, the channel may be bad.
  • Page 57 Appendix A – Maintenance and Troubleshooting If changing the patch does not help, swap the suspected limb lead with any of the other lead wires. For example, if Lead I is clean, and all other signals are noisy, swap the LL with a V wire. Ensure that all patches on the patient are of the same type.
  • Page 58 ECGs may contribute to an offset problem. Check the filter settings for the signal. Continued problems with signal offset may mean that the amplifier needs calibration. Calibration must be performed by a trained GE Service personnel. ECGs are Flat...
  • Page 59 Appendix A – Maintenance and Troubleshooting catheter with the stim artifact is connected. Pace through the new catheter. If no artifact is present, the problem is with the original catheter. If artifact is still present, move the catheter to poles on the CIM which are seldom used.
  • Page 60 Appendix A – Maintenance and Troubleshooting Ensure that you are not placing the CIM in sterile bags and pushing the catheters through the bag into the poles. This plastic can become lodged in the junction box and create problems. Catheters with long pins (1/2 inch) normally produce less artifact than catheters with short pins.

  • Page 61: Cardiolab Amplifier Testing

    Appendix A – Maintenance and Troubleshooting CardioLab Amplifier Testing NOTE When testing the amplifier, always make sure the RL ECG lead wire is connected to the ground of the simulator or function generator. All signals in the amplifier use this lead as a reference. Make sure the patient catalog is set to System.

  • Page 62: Storing And Transporting The Amplifier

    Appendix A – Maintenance and Troubleshooting Display the stim channels on one of the empty pages. Using the lab’s stimulator, stimulate to each of the four inputs to ensure that the amplifier recognizes the stimulus. If no stimulator is available, connect the 2 mm pins from your stimulator to each of the stim inputs one at a time.

  • Page 63: Maintenance/Repair Log

    Appendix A – Maintenance and Troubleshooting Maintenance/Repair Log Unit Serial Number: Institution Name: Date Maintenance/Repair Technician 2002938-002E Cardiolab® II Plus Amplifier Manual A-13...
  • Page 64 Appendix A – Maintenance and Troubleshooting Unit Serial Number: Institution Name: Date Maintenance/Repair Technician A-14 Cardiolab® II Plus Amplifier Manual 2002938-002E...
  • Page 65 Appendix B– Technical Information 2002938-002E Cardiolab® II Plus Amplifier Manual...

  • Page 66: Technical Specifications

    Appendix B– Technical Information Technical Specifications Cardiolab® II Plus Amplifier Manual 2002938-002E...
  • Page 67 Appendix B– Technical Information 2002938-002E Cardiolab® II Plus Amplifier Manual...
  • Page 68 Appendix B– Technical Information Cardiolab® II Plus Amplifier Manual 2002938-002E...
  • Page 70 Asia Headquarters World Headquarters GE Medical Systems GE Medical Systems GE Medical Systems Information Technologies GmbH Information Technologies Asia; GE (China) Co., Ltd. Information Technologies, Inc. Munzinger Straße 3-5 24th Floor, Shanghai MAXDO Center, 8200 West Tower Avenue D-79111 Freiburg...

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