Service Manual
256 Pages
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Page 1
Corometrics®170 Series SERVICE MANUAL
MANUAL P/N 2000947-004 REV. G
© 2018 General Electric company All Rights Reserved
Corometrics® 170 Series SERVICE MANUAL
MANUAL P/N 2000947-004 REV. G
© 2018 General Electric company All Rights Reserved
GUARANTEE All equipment sold by GE Healthcare, is fully guaranteed as to materials and workmanship for a period of 1 year. GE Healthcare 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 Healthcare
GE Healthcare 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 Healthcare as repairable. Refer to the service manual for further information.
! 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 Healthcare. GE is a registered trademark of General Electric Company. All other product and brand names are trademarks or registered trademarks of their respective companies. ©2002-2004 GE Healthcare. All rights reserved. No part of this manual may be reproduced without the permission of GE Healthcare.
Contents
1
Safety... 1-1 General Information... 1-2 Definitions of Terminology... 1-3 Monitor Contraindications, Warnings, and Precautions... 1-4 Equipment Symbols... 1-9
2
Introduction... 2-1 Indications for Use... 2-2 Monitoring Methods... 2-3 Features... 2-4 About Your Monitor... 2-5
3
Controls, Indicators, and Connectors... 3-1 Front Panel Controls... 3-2 Front Panel Displays and Indicators... 3-6 Front Panel Connectors... 3-8 Strip Chart Recorder... 3-12 Rear Panel Connectors... 3-14
4
Setup Procedures... 4-1 Loading Strip Chart Paper... 4-2 Turning the Monitor On... 4-7
Corometrics 170 Series 2000947-004
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Monitor Self-Test Routines... 4-8 Customizing the Monitor... 4-10 Quick Reference Card... 4-18 Flasher Software Utility Upgrade... 4-20
5
Theory of Operation... 5-1 Functional Overview... 5-2 Main Board Theory of Operation... 5-17 FECG/IUP Board Theory of Operation... 5-36
6
Functional Checkout Procedure... 6-1 Equipment Required... 6-2 General... 6-3 Monitor Self-Test... 6-4 Front Panel Pushbutton Test... 6-5 Connecting the Simulator... 6-6 FECG Test... 6-7 Legplate Inspection... 6-12 Ultrasound Test... 6-13 Fetal Movement Detection Test... 6-16 Ultrasound Transducer Test... 6-18 Uterine Activity Test... 6-19 Tocotransducer Test... 6-21 Strain Gauge Transducer Test... 6-22 Pattern Memory Test... 6-23 Dual Heart Rate Test (Non-Pattern)... 6-24
6
Corometrics 170 Series 2000947-004
Alarm Test... 6-28
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Serviceable Assemblies... 7-1 General Anti-Static Handling Precautions... 7-2 Transducer Plug Replacement Kits... 7-3 Nautilus Transducer Cable Replacement... 7-15 Removing the Monitor Top Cover... 7-19 Tocotransducer Calibration... 7-20 Nautilus Ultrasound Transducer Top Cover Replacement... 7-30 Nautilus Transducer Reassembly... 7-32 Testing a Repaired Transducer (TOCO or US)... 7-34 Replacing the Main Board... 7-35 Replacing the FECG/IUP Board... 7-36 Replacing the Membrane Switch Panel... 7-37 Replacing a Front Panel Connector... 7-40 Servicing the Recorder... 7-41 Boot ROM Error Codes... 7-49
8
Peripheral Devices... 8-1 Remote Marks Connectors... 8-2 Telemetry Connector... 8-3 RS-232 Connectors... 8-4
9
Maintenance... 9-1 Cleaning... 9-2 Preventative Maintenance Inspection... 9-5
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Specifications... 10-1 General Monitor... 10-2 Operating Modes... 10-3 Strip Chart Recorder... 10-4
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Parts Lists... 11-1 2000268-188, Model 171 Final Assembly... 11-2 2000268-189, Model 172 Final Assembly... 11-5 2001972-037, Model 173 Final Assembly... 11-8 2001972-038, Model 174 Final Assembly... 11-11 2264AAX, Button-Style Nautilus Tocotranducer Assembly Parts List... 11-14 5700GAX, Button-Style Nautilus Ultrasound Transducer Assembly Parts List 11-15 5700KAX, Loop-Style Nautilus Ultrasound Transducer Assembly Parts List . 11-16 2264DAX, Loop-Style Nautilus Tocotransducer Assembly Parts List (5-ft cord) 11-17 1509AAO/BAO, Qwik Connect Plus Legplate Assembly Parts List... 11-18 Block Diagrams... 11-19
Addendum to use PS320 Simulator...12-1
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Corometrics 170 Series 2000947-004
Chapter 1
!
Safety
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The information presented in this section is important for the safety of both the patient and operator and also serves to enhance equipment reliability. 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: Revision History
Revision History
Revision A B
Each page of this manual has a revision letter located at the bottom of the page. This letter identifies the revision level of the entire manual. This may be important if you have different manuals and you do not know which is the most current.
Date 22 July 2002 26 Mar 2004
For the initial release, all pages have the revision letter A. For the second update, all pages receive the revision letter B. The latest letter of the alphabet added to the table below corresponds to the most current revision.
Comment
1) 2) 3)
C D
14 Nov 2007 10 Feb 2012
1) 2) 3) 4) 5) 6)
1-2
Initial Release Updated GE Asia and Europe addresses and phone numbers on back cover and deleted GE addresses and Revision letter and date on the Title Guarantee page. On page 4-15, changed code #21 (HBC) from "0=off, 1=off" to "0=off, 1=on" On page 7-49, added Boot ROM error codes Addition of TYPE CF equipment symbol Addition of addendum for use of PS320 Simulator Updated Electrical Safety Test section for Patient Leakage tests with reference to IEC 60601-2-49 standard. Updated procedure to test Ultrasound and TOCO Transducer. Corrected the Symbol for FAST. Added Service Manual Disclaimer Functional Checkout Procedure: Connecting the simulator Section: Added note to”Refer addendum for using PS320 Simulator”.
170 Series Monitor 2000947-004
Safety: General Information
General Information General Use If the monitor is cold to the touch or below ambient temperature, allow it to stabilize before use. To ensure patient safety, use only parts and accessories manufactured or recommended by GE Healthcare. 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 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 170 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 170 Series Monitor is designed to assist the perinatal staff by providing information regarding the clinical status of the 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.
170 Series Monitor 2000947-004
Safety: Monitor Contraindications, Warnings, and Precautions
Monitor Contraindications, Warnings, and Precautions Warnings WARNINGS ACCIDENTAL SPILLS-In the event that fluids are accidentally spilled on the monitor, take the monitor out of operation and inspect for damage. APPLICATION-This monitor is not designed for direct cardiac connection. CONDUCTIVE CONNECTIONS-Avoid making any conductive connections to applied parts (patient connection) which are likely to degrade safety. CONDUCTIVE PARTS-Ensure that the conductive parts of the lead electrodes and associated connectors do not contact other conductive parts including earth. DEFIBRILLATION-During defibrillation, all personnel must avoid contact with the patient and monitor to avoid a dangerous shock hazard. In addition, proper placement of the paddles in relation to the electrodes is required to minimize harm to the patient. ELECTRICAL SHOCK-To reduce the risk of electrical shock, do not remove monitor cover. Refer servicing to qualified personnel. ELECTROMAGNETIC INTERFERENCE-Be aware that strong electromagnetic fields may interfere with monitor operation. Interference prevents the clear reception of signals by the monitor. If the hospital is close to a strong transmitter such as TV, AM or FM radio, police or fire stations, a HAM radio operator, an airport, or cellular phone, their signals could be picked up as signals by the monitor. If you feel interference is affecting the monitor, contact your Service Representative to check the monitor in your environment. Refer to page 1-8 for additional information.
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Safety: Monitor Contraindications, Warnings, and Precautions
WARNINGS ELECTROSURGERY-The monitor is not designed for use with high-frequency surgical devices. In addition, measurements may be affected in the presence of strong electromagnetic sources such as electrosurgery equipment. EXPLOSION HAZARD-Do not use this equipment in the presence of flammable anesthetics or inside an oxygen tent. GROUNDING-Do not defeat the three-wire grounding feature of the power cord by means of adaptors, plug modifications, or other methods. A dangerous shock hazard to both patient and operator may result. INSTRUCTIONS-For continued and safe use of this equipment, it is necessary to follow all listed instructions. However, the instructions provided in this manual in no way supersede established medical procedures concerning patient care. The monitor does not replace observation and evaluation of the patient, at regular intervals, by a qualified care provider who will make diagnoses and decide on treatments and interventions. INTERFACING OTHER EQUIPMENT-Monitoring equipment must be interfaced with other types of medical equipment by qualified biomedical engineering personnel. Be certain to consult manufacturers’ specifications to maintain safe operation. LEAKAGE CURRENT TEST-The interconnection of auxiliary equipment with this device may increase the total leakage current. When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients. Serious injury or death could result if the leakage current exceeds applicable standards. The use of accessory equipment not 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 evidence that the safety certification of the accessory has been performed in accordance with the appropriate EN60601.1 and/or EN60601.1.1 harmonized national standard.
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170 Series Monitor 2000947-004
Safety: Monitor Contraindications, Warnings, and Precautions
WARNINGS LINE ISOLATION MONITOR TRANSIENTS-Line isolation monitor transients may resemble actual cardiac waveforms, and thus cause incorrect heart rate determinations and alarm activation (or inhibition). STRANGULATION-Make sure all patient cables, leadwires, and tubing are positioned away from the patient’s head to minimize the risk of accidental strangulation. WATER BIRTHS-Do not use the monitor to directly monitor patients during water births, in whirlpool or submersion water baths, during showers, or in any other situation where the mother is immersed in water. Doing so may result in electrical shock hazard.
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Safety: Monitor Contraindications, Warnings, and Precautions
Cautions CAUTIONS ANNUAL SERVICING-For continued safety and performance of the monitor, it is recommended that the calibration, accuracy, and electrical safety of the monitor be verified on an annual basis by an GE Service Representative. DAILY TESTING-It is essential that the monitor and accessories be inspected every day. It is recommended practice to initiate the monitor’s self-test feature at the beginning of each monitoring session; follow the instructions in “Chapter 4, Setup Procedures”. ENVIRONMENT-The performance of the monitor has not been tested in certain areas, such as x-ray and imaging suites. The monitor is not recommended for use in these environments. PERFORMANCE-Report all problems experienced with the monitor. If the monitor is not working properly, contact your Service Representative for service. The monitor should not be used if it is not working properly. PINCHING-Keep fingers clear of the paper roller because the roller could pinch your fingers. TRAPPING-Keep hands, hair, jewelry, and loose clothing away from the paper roller because the roller could trap these items. TRIPPING-Arrange monitoring equipment so that cords and cables do not present a tripping hazard.
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170 Series Monitor 2000947-004
Safety: Monitor Contraindications, Warnings, and Precautions
Electromagnetic Interference This device has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1993, EN60601-1-2:1994, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in the health-care and home environments (for example, cellular phones, mobile two-way radios, electrical appliances), it is possible that high levels of such interference due to close proximity or strength of a source, may result in disruption of performance of this device. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with these instructions, may cause harmful interference with other devices in the vicinity. Disruption or interference may be evidenced by erratic readings, cessation of operation, or incorrect functioning. If this occurs, the site of use should be surveyed to determine the source of this disruption, and actions taken to eliminate the source. The user is encouraged to try to correct the interference by one or more of the following measures:
Turn equipment in the vicinity off and on to isolate the offending equipment.
Reorient or relocate the other receiving device.
Increase the separation between the interfering equipment and this equipment.
If assistance is required, contact your GE Service Representative.
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Safety: Equipment Symbols
Equipment Symbols The following is a list of symbols used on products manufactured by GE. Some symbols may not appear on your unit. Table 1-2. Equipment Symbols
!
ATTENTION: Consult accompanying documents. TYPE B EQUIPMENT. Type B equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. TYPE BF EQUIPMENT. Type BF equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment has an F-type applied part. TYPE CF EQUIPMENT. Type CF equipment is suitable for intentional external and internal application to the patient, including direct cardiac application. Type CF equipment has an F-type applied part. ALTERNATING CURRENT (AC). EQUIPOTENTIALITY. ON/STANDBY: button toggles between full power and standby.
CAUTION AC MAINS-The On/Standby switch does not disconnect the monitor from AC mains power. To completely remove power, you must disconnect the power cord from the AC wall outlet.
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170 Series Monitor 2000947-004
Chapter 2
Introduction
2
This section lists the indications for use for monitors in the 170 Series as well as provides an explanation of the different patient monitoring modalities. This section summarizes the clinical applications of monitors in the 170 Series: Indications for Use... 2-2 Monitoring Methods... 2-3 Features... 2-4 About Your Monitor... 2-5
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Introduction: Indications for Use
Indications for Use Models 171 and 172 Models 171 and 172 Fetal Monitors are indicated for use in the monitoring of the fetus during the antepartum period as well as throughout labor and delivery. Each monitor also has an optional monitoring mode to detect fetal body movements.
Models 173 and 174 Models 173 and 174 Fetal Monitors are indicated for use in the monitoring of the fetus throughout labor and delivery. Each monitor also has an optional monitoring mode to detect fetal body movements.
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170 Series Monitor 2000947-004
Introduction: Monitoring Methods
Monitoring Methods The following is a summary of all the clinical monitoring methods found in the 170 Series.
Fetal Heart Rate External Method, Pulsed Doppler Ultrasound Ultrasound monitoring is available on all 170 Series Monitors. Models 171 and 173 provide a single ultrasound channel, while Models 172 and 174 provide two ultrasound channels. Fetal heart rate can be measured externally using pulsed Doppler Ultrasound. A transducer placed on the mother’s abdomen is used to direct an ultrasonic beam toward the fetal heart and to sense Doppler shifted echoes created by moving cardiac structures. A patented autocorrelation process is used to determine the timing of successive cardiac cycles. The resulting fetal heart rate (FHR) pattern is recorded on the strip chart paper and the FHR appears on the digital display.
Internal Method, Direct Fetal Electrocardiogram (FECG) FECG is available on Models 173 and 174 only. The Model 173 provides a dedicated FECG connector. The Model 174 provides a combi-connector which can be used for either FECG or US. FECG signals are obtained via a spiral electrode attached to the fetal presenting part. FHR is computed on a beat-to-beat basis using the R-to-R time interval of the QRS complexes. The instantaneous FHR pattern is printed on the strip chart paper and the FHR appears on the digital display.
Maternal Uterine Activity External Method, Tocotransducer (TOCO) Maternal uterine activity is measured externally using a tocotransducer (toco). Relative pressure within the uterus is measured using a tocotransducer attached to the mother’s abdomen in the area of the uterine fundus. The readings are plotted on the strip chart paper in a relative scale from 0 to 100 as well as shown on the digital display. All 170 Series Monitors provide external uterine activity monitoring.
Internal Method, Intrauterine Pressure Catheter and Strain Gauge (IUP) IUP is available on Models 173 and 174 only. Intrauterine pressure is measured using a transcervical catheter. The pressure trend is plotted over the range of 0 to 100 mmHg and the readings appear on the digital display.
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