Service Manual
440 Pages
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GUARANTEE All equipment sold by GE Medical Systems Information Technologies, is fully guaranteed as to materials and workmanship for a period of 1 year. GE reserves the right to perform guarantee service operations in its own factory, at an authorized repair station, or in the customer’s installation. Our obligation under this guarantee is limited to repairing, or, at our option, replacing any defective parts of our equipment, except fuses or batteries, without charge, if such defects occur in normal service. Claims for damage in shipment should be filed promptly with the transportation company. All correspondence covering the instrument should specify the model and serial numbers. GE MEDICAL SYSTEMS Information Technologies A GE Medical Systems Company
GE Medical Systems Information Technologies will make available on request such circuit diagrams, component diagrams, component parts lists, descriptions, calibration instructions, or other information which will assist the users or appropriately qualified technical personnel to repair those parts of the equipment which are classified by GE as repairable.
! CAUTION: In the United States of America, Federal Law restricts this device to sale by or on the order of a physician.
Corometrics and Marquette are registered trademarks of GE Medical Systems Information Technologies. GE is a registered trademark of General Electric Company. All other product and brand names are trademarks or registered trademarks of their respective companies. ©2003-2004 GE Medical Systems Information Technologies. All rights reserved. No part of this manual may be reproduced without the permission of GE Medical Systems Information Technologies.
CE MARKING INFORMATION 0459
Compliance
This monitor bears the CE Mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices.
Components of the Certified Systems
The IEC electromagnetic compatibility (EN) standards require individual equipment (components and accessories) to be configured as a system for evaluation. For systems that include a number of different equipments that perform a number of functions, one of each type of equipment shall be included in the evaluation. The equipment listed below is representative of all possible combinations. For individual equipment certification, refer to the appropriate declarations of conformity.
Component Description
120 Series Maternal/Fetal Monitor Model 146 Fetal Acoustic Stimulator Intrauterine Pressure Transducer FECG Cable/Legplate Ultrasound Transducers (x2) Blood Pressure Hose and Cuff MSpO2 Interconnect Cable and Sensor MECG Cable FECG/MECG Adapter Cable Remote Event Marker RS-232C Interconnect Cables (x3) COROLAN Interconnect Cable Central Nurses Station Interconnect Cable Model 2116B Interconnect Cable
Exceptions
None
Monitor System EMC: Immunity Performance
Be aware that adding accessories or components, or modifying the medical device or system may degrade the EMI performance. Consult with qualified personnel regarding changes to the system configuration.
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CE MARKING INFORMATION 0459
For Your Notes
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Contents
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Safety... 1-1 General Information... 1-2 General Use... 1-2 Responsibility of the Manufacturer... 1-2 Responsibility of the User... 1-2 Definitions of Terminology... 1-3 Monitor Contraindications, Warnings, and Precautions... 1-4 Warnings... 1-4 Cautions... 1-7 Electromagnetic Interference... 1-8 Equipment Symbols... 1-9
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Introduction... 2-1 Indications for Use... 2-2 Fetal Monitoring... 2-2 Maternal Monitoring... 2-2 Blood Pressure... 2-2 Pulse Oximetry... 2-2 Heart/Pulse Rate... 2-2 Series Overview... 2-3 The Model 126 Monitor... 2-3 The Model 128 Monitor... 2-5 The Model 129 Monitor... 2-6 Upgrading Your Monitor... 2-6 Adding Fetal Movement Detection... 2-6 About the Manual... 2-7 Purpose... 2-7 Intended Audience... 2-7 Illustrations... 2-7 Design Changes... 2-8 References to Persons, Places, and Institutions... 2-8
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Controls, Indicators, and Connectors... 3-1 Front Panel Description... 3-2 Front Panel Displays... 3-5 Display Example... 3-5 Primary Labor Parameters... 3-7 FHR Display... 3-7 UA Display... 3-9 Additional Parameters... 3-10 Maternal NBP... 3-10 MHR/P Area... 3-11 FSpO2 Area... 3-12 MSpO2 Area... 3-13 Waveform Area... 3-13 Time and Waveform Message Area... 3-13 Battery-Backed RAM Status... 3-14 Softkeys... 3-14 Mode Title Softkeys... 3-14 Waveform Softkeys... 3-14 Dedicated Softkey Area... 3-14 Rear Panel Description... 3-17 Communication Option... 3-20 J101 Connector... 3-20 J102 Connector... 3-20 J103 Connector... 3-20 J104 Connector... 3-20 Corolan Option... 3-20
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Theory of Operation... 4-1 Main Motherboard... 4-2 Functional Overview... 4-2 Switch/Status Input Data Flow Diagram... 4-2 External/Internal Communication Data Flow... 4-2 Audio Control Flow... 4-2 Control Block... 4-20 Corolan Module... 4-20 Options Interface... 4-22 Rear Panel Interface... 4-22 Audio Section... 4-22 Recorder Interface Section... 4-23 RS-232C Communications Section... 4-23 DSP Board... 4-24
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Functional Overview... 4-24 DSP Section... 4-24 Control Module... 4-24 Watchdog Module... 4-24 Status/Control Module... 4-25 Front-End Control/Status Interface... 4-25 IUP Interface... 4-25 Analog Conversion Module... 4-25 Front Panel Interface Section Theory... 4-25 EL Panel Interface... 4-25 Front Panel Switch Interface... 4-27 Recorder LED Board Interface... 4-34 NBP Board... 4-35 NBP Board with DINAMAP or Marquette Electronics Technology... 4-35 Pressure Transducer and Amplifier... 4-35 DC Pressure Amplifier and Filter... 4-35 AC Amplifier and Filter... 4-35 MUX and A/D... 4-36 Microcontroller and Host Interface... 4-36 Pump/Valve Control... 4-36 NBP Board Manufactured by CAS Medical Systems, Inc... 4-37 Processor Circuitry... 4-37 A/D Conversion... 4-37 Watchdog Circuitry... 4-37 Instrumentation Amplifier... 4-38 Valves... 4-38 Communications Board... 4-39 Central Systems Interface... 4-39 Model 2116B Keyboard Interface... 4-40 Model 340 Telemetry Interface... 4-40 System Power Supply... 4-44 Display Board... 4-45 Dual Ultrasound Board... 4-46 Overview... 4-46 The Ultrasound Transducer... 4-46 Ultrasound Oscillator... 4-46 Digital Control Section... 4-47 Channel A Pin Diode Circuitry... 4-48 Channel B Pin Diode Circuitry... 4-48 Transmission, Channel A or Channel B... 4-49 Reception, Channel A or Channel B... 4-49 Channel A Filtering... 4-50 Main Filters... 4-50 Audio Circuitry... 4-50 Ultrasound Envelope... 4-51
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Fetal Movement Filters... 4-51 UA/FECG Board... 4-52 Isolated FECG Circuitry... 4-52 Isolated UA Circuitry... 4-53 MECG Board... 4-61 Defibrillator Protection... 4-61 Input Lead Switching... 4-61 Single-Wire ECG Amplifier with Right Leg Drive... 4-62 Pacemaker Detection... 4-63 Leads Off Detection... 4-65 Test Generator... 4-66 Linear Isolation Amplifier... 4-66 Low-Pass and Notch Filters... 4-67 Oximeter Carrier Board... 4-70 MSpO2 Board... 4-71 Nellcor Module... 4-71 Functional Overview... 4-71 LED Driver Circuitry... 4-71 Input Source Selection Circuits... 4-71 Input Amplifier and Synchronous Detector... 4-72 Filters/Amplifiers... 4-72 Analog-to-Digital Conversion Circuitry... 4-73 Communications... 4-73 Processor Circuitry... 4-73 Masimo Module... 4-73 Principle of Operation... 4-73 Isolated Power Supply Board... 4-76 Controller... 4-76 External Synchronization... 4-77 Fly-back Transformer, Output Rectification, and Filtering... 4-77 Isolated Feedback... 4-78 Short Circuit Protection... 4-79 Input Filter/Isolation Barrier... 4-79 Recorder Board... 4-82
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Setup Procedures... 5-1 Loading Strip Chart Recorder Paper... 5-2 Mounting a Strain Gauge for IUP Monitoring... 5-5 User Setup Screens... 5-6 Using the Trim Knob Control... 5-6
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FECG Setup Screen... 5-8 Volume... 5-8 FHR Alarm Limits... 5-8 FHR Audio Alarm... 5-8 Alarm Volume... 5-8 US/US2 Setup Screen... 5-9 Fetal Movement Detection... 5-9 Fetal Heart Rate Offset... 5-9 Volume... 5-10 FHR Audio Alarm... 5-10 Alarm Volume... 5-10 Maternal NBP Setup Screen... 5-11 Display Timer... 5-11 Mode... 5-11 NBP Done Volume... 5-12 Alarm Limits... 5-12 Audio Alarm... 5-12 Master Alarm Volume... 5-12 MSpO2 Setup Screen... 5-13 Response Time (Nellcor Module Only)... 5-13 Sensitivity (Masimo Module Only)... 5-13 Averaging Time (Masimo Module Only)... 5-14 Print Interval... 5-14 %O2 Trace... 5-14 Alarm Limits... 5-14 Audio Alarm... 5-14 Alarm Volume... 5-14 MHR/P Setup Screen... 5-15 Source... 5-15 MHR/P Trace... 5-15 Volume... 5-16 Alarm Limits... 5-16 Audio Alarms... 5-16 Alarm Volume... 5-16 MECG Lead... 5-16 MECG Pacer... 5-17 Response Time... 5-17 Master Alarm Setup Screen... 5-18 Audio Alarms... 5-18 Re-Alarm... 5-18 Alarm Limits... 5-18 Volume... 5-18
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FSpO2 Setup Screen... 5-19 Response Time... 5-19 Print Interval... 5-19 %O2 Trace... 5-20 FSpO2 Display Area... 5-20 Single versus Dual Display of SpO2... 5-20 FSpO2 Status Icons... 5-20 Sensor Unplugged... 5-20 Sensor Lifted... 5-20 Pulse Search... 5-20 General Setup Screen... 5-22 Time... 5-22 Date... 5-22 Song Player... 5-22 Song Player Volume... 5-22 SpO2 Scale... 5-23 Paper Speed... 5-23 Paper Chime... 5-23 Recorder Light... 5-23 Paper Chime Volume... 5-24 MSpO2 Print Interval... 5-24 FSpO2 Print Interval... 5-24 FSpO2 Trace... 5-24 Service Mode Screens... 5-25 Service Lock Screen... 5-25 Install Options Screen... 5-26 Default Settings... 5-27 Factory Defaults... 5-27 Current (Last-Used) Settings... 5-27 Hospital Defaults... 5-27 Volume Exceptions... 5-27 New Hospital... 5-28 Line Frequency... 5-28 ECG Artifact Elimination... 5-28 Scaling... 5-28 Language... 5-28 NBP One-Minute Interval... 5-28 HR Offset... 5-28 What is it?... 5-29 10 Min... 5-29 On... 5-29 Off... 5-29 Default TOCO Reference... 5-29 FM Remote Mark... 5-29 Corolan Address Checking... 5-30 Heartbeat Coincidence... 5-30 Smart BP... 5-30
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VS Print Interval... 5-30 Recorder Font Size... 5-30 Fetal Alert/Alarms... 5-31 Alert Suspend... 5-31 Printing System Setup Information... 5-31 Communications Setup Screen... 5-33 Baud Rate... 5-33 Mode... 5-33 Hardware Switches... 5-34
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Functional Checkout Procedure... 6-1 Before You Begin... 6-2 Equipment Required... 6-2 General... 6-2 Self-Test Routine... 6-3 Front Panel Pushbutton Test... 6-5 Connecting the Simulator... 6-6 MECG Test... 6-7 FECG Test... 6-11 Ultrasound Test... 6-16 Fetal Movement Detection Test... 6-19 Ultrasound Transducer Test... 6-21 Uterine Activity Test... 6-22 Tocotransducer Test... 6-25 Strain Gauge Transducer Test... 6-26 Pattern Memory Test... 6-27 Dual Heart Rate Test (Non-Pattern)... 6-28 FECG/US Modes... 6-28 Dual Ultrasound Modes... 6-31 Alarm Test... 6-32 MSpO2 Test... 6-35
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NBP Test... 6-35 Preventative Maintenance Inspection Report... 6-36 Configuration... 6-36 Tools Required... 6-36 Visual Inspection... 6-36 Inspection Checklist... 6-37
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Calibration... 7-1 Before You Begin... 7-2 General... 7-2 Handling Precautions... 7-2 Power Supply Voltages-Verification... 7-3 Main Board Power Supply Voltages... 7-3 Isolated Power Supply Board Voltages... 7-4 Isolated FECG/UA Board Voltages... 7-4 Recorder Photosensor Calibration... 7-5 Adjusting the Paper-Low Photosensor... 7-5 Adjusting the Paper-Out Photosensor... 7-6 Adjusting the Paper-Loading Sensor... 7-6 Display Check... 7-7 Checking a 3” x 3.75” Display... 7-8 Verifying the DSP Board Operation (3”x 3.75” Display)... 7-8 Removing the Display Assembly... 7-9 Replacing the Display Assembly... 7-10 Upgrading to a 3.5” x 4.5” Display... 7-11 Equipment Required... 7-11 Disassembly... 7-11 Reassembly... 7-12 Testing... 7-16 Checking a 3.5” x 4.5” Display... 7-17 Verifying the DSP Board Operation... 7-17 Removing the Display Assembly... 7-18 Replacing the Display Assembly... 7-19 Trimline Tocotransducer Calibration... 7-20 Equipment Required... 7-20 Procedure... 7-20 Nautilus Tocotransducer Calibration... 7-23 Equipment Required... 7-24 Calibration Procedure... 7-25 Disassembly... 7-25 Calibration for Cat. No. (REF) 2264 GAX/HAX/JAX/KAX/LAX/MAX... 7-25
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Calibration for Cat. No. (REF) 2264 AAX/BAX/CAX/DAX/EAX/FAX... 7-26 Reassembly... 7-27 Testing the Tocotransducer... 7-27 Maternal SpO2 Calibration... 7-28
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Self-Tests... 8-1 Power-On Diagnostic Tests... 8-2 Monitor Self-Test... 8-3 Error Log Screen... 8-5 Diagnostic Control Screen... 8-11 Recorder Calibration Test... 8-12 CPU Version... 8-12 DSP Version... 8-13 Run Time... 8-13 Recorder Time... 8-13 Main Board SW1 Switch Settings... 8-13 Corolan Network Status... 8-14 Corolan Address Check... 8-17 J102 Analog Output Connector DAC Static Test... 8-18 Verification... 8-18 Analog Ground... 8-18 HR1 and HR2... 8-18 UA... 8-18 HR1 Mode... 8-19 HR2 Mode... 8-19 UA Mode... 8-19 Markout*, Check Paper*, FMD1, and FMD2... 8-19 Calibration... 8-19 RS-232C Connector Loopback Test... 8-21 Making a Loopback Test Connector... 8-21 Testing the Port(s)... 8-21
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General Maintenance... 9-1 Cleaning... 9-2 Cleaning the Monitor Exterior... 9-2 Cleaning the Electroluminescent Panel... 9-2 Cleaning the Tocotransducer, Ultrasound Transducer, and MECG Cables... 9-3
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Cleaning the UA Strain Gauge... 9-4 Cleaning the Maternal NBP Cuffs and Hoses... 9-4 Main Board Battery... 9-5 Maternal Blood Pressure Tests... 9-6 Accessing the Diagnostic Control Screen... 9-6 Manometer Pressure Check... 9-9 Pneumatic Pressure Check... 9-11 Electrical Safety Tests... 9-12 Initial Conditions... 9-12 AC Line... 9-12 Ground Impedance... 9-12 Unit to Primary Leakage... 9-13 Patient-to-Ground Leakage for ECG... 9-14 Patient-to-Line Leakage for ECG... 9-15 Patient-to-Ground Leakage for IUP... 9-16 Patient-to-Line Leakage for IUP... 9-17 Patient-to-Ground Leakage for MSpO2... 9-18 Patient-to-Line Leakage for MSpO2... 9-19 Patient-to-Ground Leakage for FSpO2... 9-20 Patient-to-Line Leakage for FSpO2... 9-21 Patient-to-Ground Leakage for US... 9-22 Patient-to-Line Leakage for US... 9-23 Patient-to-Ground Leakage for US2... 9-24 Patient-to-Line Leakage for US2... 9-25 Ground Continuity... 9-25 Dielectric (Hi-Pot) Tests... 9-26 Patient–to–AC-Line Using DC Voltage for One Minute... 9-26 Patient–to–Chassis Using AC Voltage for One Minute... 9-28 Mains–to–Chassis Using DC Voltage for One Minute... 9-29
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Strip Chart Recorder Servicing... 10-1 Removing the Strip Chart Recorder... 10-2 Installing the Strip Chart Recorder... 10-3 Periodic Thermal Printhead Cleaning... 10-4 Field Serviceable Assemblies... 10-5 Stepper Motor and Harness... 10-5 Removing the Stepper Motor... 10-5 Replacing the Stepper Motor... 10-5 Printhead Adjustments... 10-6 Vertical Offset Adjustment... 10-6 Horizontal Offset Adjustment... 10-6
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Thermal Printhead... 10-8 Removing the Printhead... 10-8 Replacing the Printhead... 10-8 Paper-Low/Paper-Out Photosensor... 10-12 Removing the Paper-Low/Paper-Out Photosensor... 10-12 Replacing the Paper-Low/Paper-Out Photosensor... 10-12 Adjusting the Paper-Low Photosensor... 10-12 Adjusting the Paper-Out Photosensor... 10-13 Paper-Loading Sensor... 10-14 Removing the Paper-Loading Photosensor... 10-14 Replacing the Paper-Loading Sensor... 10-14 Adjusting the Paper-Loading Sensor... 10-15
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Peripheral Devices... 11-1 Standard Input/Output Connectors... 11-2 Remote Marks Connector... 11-2 Remote Marks Connector... 11-2 ECG Out Connector... 11-2 J108 Connector (Corolan Interface)... 11-2 J109, J110, and J111 Connectors (RS-232C)... 11-3 Baud Rate... 11-3 Mode... 11-3 Nellcor Puritan Bennett Model N-200 Maternal Pulse Oximeter... 11-5 Nellcor Puritan Bennett Model N-400 Fetal Pulse Oximeter... 11-6 DINAMAP Models 1846, 1846SX, and 1846SX/Oxytrack, 8100, and 8100T... 11-7 Quantitative Sentinel/Perinatal System... 11-8 Model 115-Compatible Communications Protocols... 11-9 115 Update Mode... 11-9 115 Transmit/Receive Mode... 11-10 Requested Data Format... 11-10 Monitor Type... 11-10 Data Field... 11-10 End of Text... 11-10 Transmitted Data Format... 11-11 Monitor Type... 11-11 Response Type... 11-11 Monitor ID... 11-11 Data Field... 11-11 Event Mark... 11-11 Heart Rate... 11-11 Uterine Activity... 11-11
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Modes... 11-11 Annotations... 11-11 Fetal Movement... 11-12 Recorder Status... 11-12 End of Text... 11-12 Limitations... 11-12 Error Conditions... 11-12 Transmission Errors... 11-12 Request Errors... 11-13 Cabling Information... 11-15 Monitor RS-232 Connector... 11-15 Request to Send (RTS)... 11-15 Transmit Data (TXD)... 11-15 Clear to Send (CTS)... 11-15 Receive Data (RXD)... 11-15 Standard RS-232C Rules... 11-15 Cable Distance... 11-15 Data Terminal Equipment Cabling... 11-15 Data Communications Equipment Cabling... 11-16 Optional Communication Package... 11-18 J101 Connector (Model 340 Telemetry System Interface)... 11-18 J102 Connector (Spectra 400 Analog Interface)... 11-18 J103 Connector (Model 2116B Data Entry Interface)... 11-18
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Upgrading a 120 Series Monitor... 12-1 General Information... 12-2 Handling Precautions... 12-2 Equipment Required... 12-2 Testing... 12-2 Communications Option Upgrade Kit... 12-3 Unpacking... 12-3 Installation... 12-3 Nellcor MSpO2 and NBP Option Upgrade Kit... 12-7 Monitors with a 3-inch x 3.75-inch Display... 12-7 Unpacking... 12-7 Installation... 12-7 Monitors with a 3.5-inch x 4.5-inch Display... 12-17 Unpacking... 12-17 Installation... 12-17 Masimo MSp02 Upgrade Kit... 12-27 MECG Option Upgrade Kit... 12-28 Unpacking... 12-28
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Installation... 12-28 Software Version 3.5... 12-34 Flasher Software Utility Upgrade Method... 12-34 EEPROM Replacement Method... 12-34 Display Upgrade... 12-40 Fetal Movement Detection... 12-40
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Technical Specifications... 13-1 General Monitor... 13-2 Operating Modes
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Strip Chart Recorder... 13-8
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Replacement Parts... 14-1 Replacement Parts Table... 14-2 Calibration Parts... 14-6 Trimline Tocotransducer Calibration... 14-6 CMR Jack Components... 14-6 Nautilus Tocotransducer... 14-6
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Troubleshooting... 15-1 General Troubleshooting... 15-2 Ultrasound Troubleshooting... 15-3 FECG Troubleshooting... 15-4 Fetal Pulse Oximetry Troubleshooting... 15-5 External Uterine Activity Troubleshooting... 15-8 Internal UA Troubleshooting... 15-9 MECG Troubleshooting... 15-10 Blood Pressure Troubleshooting... 15-11
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Maternal Pulse Oximetry Troubleshooting... 15-12
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Factory Defaults...A-1 Table of Defaults... A-2
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Alarms Summary...B-1 Table of Alarms... B-2
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Drawings...C-1
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Chapter 1
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Safety
1
The information presented in this section is important for the safety of both the patient and operator. This chapter describes how the terms Danger, Warning, Caution, Important, and Note are used throughout the manual. In addition, standard equipment symbols are defined. This section includes the following important information: General Information... 1-2 Definitions of Terminology... 1-3 Monitor Contraindications, Warnings, and Precautions... 1-4 Equipment Symbols... 1-9
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Safety: General Information
General Information General Use If the monitor is cold to the touch or below ambient temperature, allow it to reach ambient, room temperature before use. To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies. Parts and accessories used shall meet the requirements of EN60601.1.1. Disposable devices are intended for single use only. They should not be reused. Periodically, and whenever the integrity of the monitor is in doubt, test all functions. Refer to “Chapter 6, Functional Checkout Procedure”. Refer to the “Maternal/Fetal Monitoring Operator’s Manual” for information concerning the limitations of internal and external fetal heart rate monitoring techniques.
Responsibility of the Manufacturer GE is responsible for the effects on safety, reliability, and performance if:
assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE;
the electrical installation of the relevant room complies with the requirements of appropriate regulations; and
the monitor is used in accordance with the instructions of use.
Responsibility of the User This device is intended for use by clinical professionals who are expected to know the medical procedures, practices, and terminology required to monitor obstetrical patients. This manual documents all possible parameters available in the 120 Series of monitors. It is the responsibility of each hospital to ensure that the Labor and Delivery staff is trained in all aspects of the selected model. The 120 Series Monitor is designed to assist the perinatal staff by providing information regarding the clinical status of the mother and fetus during labor. The monitor does not replace observation and evaluation of the mother and fetus at regular intervals, by a qualified care provider, who will make diagnoses and decide on treatments or interventions. Visual assessment of the monitor display and strip chart must be combined with knowledge of patient history and risk factors to properly care for the mother and fetus.
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Safety: Definitions of Terminology
Definitions of Terminology Six types of special notices are used throughout this manual. They are: Danger, Warning, Caution, Contraindication, Important, and Note. The warnings and cautions in this Safety section relate to the equipment in general and apply to all aspects of the monitor. Be sure to read the other chapters because there are additional warnings and cautions which relate to specific features of the monitor. When grouped, warnings and cautions are listed alphabetically and do not imply any order of importance.
Table 1-1. Definitions of Terminology
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Danger
A DANGER notice indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
Warning
A WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Caution
A CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. Cautions are also used to avoid damage to equipment.
Contraindication
A CONTRAINDICATION describes any special symptom or circumstance that renders the use of a remedy or the carrying out of a procedure inadvisable, usually because of a risk.
Important
An IMPORTANT notice indicates an emphasized note. It is something you should be particularly aware of; something not readily apparent.
Note
A NOTE indicates a particular point of information; something on which to focus your attention.
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