Corometrics 170 Service Manual Rev C

Contents

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Safety... 1-1 General Information... 1-2 Definitions of Terminology... 1-3 Monitor Contraindications, Warnings, and Precautions... 1-4 Equipment Symbols... 1-9

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Introduction... 2-1 Indications for Use... 2-2 Monitoring Methods... 2-3 Features... 2-4 About Your Monitor... 2-5

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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

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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

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Theory of Operation... 5-1 Functional Overview... 5-2 Main Board Theory of Operation... 5-17 FECG/IUP Board Theory of Operation... 5-36

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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

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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

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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

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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 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: 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 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 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

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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.

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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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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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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:

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Turn equipment in the vicinity off and on to isolate the offending equipment.

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Reorient or relocate the other receiving device.

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Increase the separation between the interfering equipment and this equipment.

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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

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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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Safety: Equipment Symbols For your notes

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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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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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Introduction: Features

Features The 170 Series is a family of fetal monitors offering various combinations of modalities to suit your institution’s needs. Each monitor boasts the following qualities:

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The strip chart recorder is a quiet, easy-to-load, high resolution thermal array printer. The recorder prints continuous trends and alphanumeric data on one strip chart.

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Automatic mode selection is provided simply by inserting the appropriate transducer plug into the front panel receptacle.

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Wide beam ultrasound transducer provides an advanced level of system performance.

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Transducer connectors are easy-to-use, color-coded, and durable.

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Frequently-used functions are controlled by front panel buttons-including audio volume, uterine activity reference, alarm silence, event mark, paper advance, and user setup controls.

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The ultrasound mode provides clean accurate traces with few “dropouts” because of a patented autocorrelation processing.

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Fetal heart rate alarm limits are user-defined, with pre-set defaults.

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Alarm silencing is controlled by a front panel pushbutton-colored for easy recognition.

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Fetal heart rate alarm conditions have both audible and visual indications. The audible indicator can be silenced on an alarm-by-alarm basis.

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Two RS-232C ports provide interfacing to external devices.

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Introduction: About Your Monitor

About Your Monitor This manual describes all monitors in the 170 Series; therefore some sections may not apply to your model monitor. Refer to Table 2-1.

Model 171 The Model 171 Antepartum Fetal Monitor provides singleton ultrasound and external uterine activity monitoring.

Model 172 The Model 172 Antepartum Fetal Monitor provides dual ultrasound and external uterine activity monitoring.

Model 173 The Model 173 Intrapartum Monitor provides dual heart rate monitoring using FECG and ultrasound. The monitor also provides external uterine activity monitoring using a tocotransducer or internal monitoring using an intrauterine pressure catheter (IUPC).

Model 174 The Model 174 Intrapartum Monitor provides dual heart rate monitoring using FECG/ultrasound or dual ultrasound. The monitor also provides external uterine activity monitoring using a tocotransducer or internal monitoring using an IUPC. Table 2-1. Summary of Features Feature External uterine activity (TOCO)

171

172

173

174

9

9

9

9

9

9

9

9

Internal uterine activity (IUPC) Ultrasounda

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Dual ultrasound

9 9

FECGa

9 9

9

Fetal heart rate alarms

9

9

9

9

Fetal movement detection (optional)

9

9

9

9

Heartbeat coincidence

9

9

9

Fetal heart rate offset

9

9

9

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The Model 174 has a combi-connector for the primary FHR that can be used for either US or FECG.

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