Operators Manual
112 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 Medical Systems Information Technologies 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 Medical Systems Information Technologies 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 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. ©2001-2004 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
CE Marking Information
0459
Compliance A Corometrics brand 170 Series Monitor 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. The device is manufactured in the United States; the CE mark is applied under the authority of Notified Body GMED (0459). The country of manufacture and appropriate Notified Body can be found on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility-Medical Electrical Equipment” and standard EN 60601-1 “General Requirements for Safety.”
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:
170 Series Fetal Monitor
AC-to-DC Power Supply
Tocotransducer
Ultrasound Transducers (x2)
FECG Cable/Legplate
Model 146 Fetal Acoustic Stimulator
Remote Event Marker
RS-232C Interconnect Cables (x2)
Telemetry Interconnect Cable
Exceptions The Monitor System EMC: Immunity Performance None
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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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Contents
1
Safety... 1-1 General Information... 1-2 General Use... 1-2 Responsibility of the Manufacturer... 1-2 Definitions of Terminology... 1-3 Monitor Safety Information... 1-4 Warnings... 1-4 Cautions... 1-6 Definitions of Symbols... 1-7
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Introduction... 2-1 Indications for Use... 2-2 Models 171 and 172... 2-2 Models 173 and 174... 2-2 Risk Conditions... 2-3 Maternal Conditions Which Place the Fetus at Risk... 2-3 Fetal Indications of Potential Fetal Compromise... 2-3 Monitoring Methods... 2-4 Fetal Heart Rate... 2-4 Internal Method, Pulsed Doppler Ultrasound... 2-4 Internal Method, Direct Fetal Electrocardiogram (FECG)... 2-4 Maternal Uterine Activity... 2-4 External Method, Tocotransducer (TOCO)... 2-4 Internal Method, Intrauterine Pressure Catheter and Strain Gauge (IUP) . . . 2-4
3
Controls, Indicators, and Connectors... 3-1 Front Panel Controls... 3-2 Power Button and Indicator... 3-3 Record Button and Indicator... 3-3 Paper Advance Button... 3-3 Mark/Offset Button... 3-3 Mark... 3-3 Offset (Models 172, 173, and 174 Only)... 3-3 Setup Button... 3-4 Volume Buttons... 3-4
Model 171... 3-4 Models 172, 173, and 174... 3-4 Setup Mode... 3-4 UA Reference Button... 3-5 Setting a Baseline for External Monitoring (Tocotransducer)... 3-5 Setting a Baseline for Internal Monitoring (IUPC)... 3-5 Setup Mode... 3-5 Alarm Silence Button... 3-5 Front Panel Displays and Indicators... 3-6 Fetal Heart Rate Display(s) and Indicator(s)... 3-6 FHR Display... 3-6 Heartbeat Indicator... 3-6 Primary Versus Secondary (Models 172, 173, and 174 only)... 3-6 Uterine Activity Display... 3-6 Tocotransducer... 3-6 IUP (Models 173 and 174 Only)... 3-6 Alarms Disabled Indicator... 3-7 Audio Alarm Indicator... 3-7 Active Patient Alarms... 3-7 Resolved Patient Alarms... 3-7 Signal Quality Alarms... 3-7 Front Panel Connectors... 3-8 Model 171 Connectors... 3-8 Ultrasound Connector... 3-8 Uterine Activity Connector... 3-8 Model 172 Connectors... 3-9 Primary Ultrasound Connector... 3-9 Secondary Ultrasound Connector... 3-9 Uterine Activity Connector... 3-9 Model 173 Connectors... 3-10 Ultrasound Connector... 3-10 FECG Connector... 3-10 Uterine Activity Connector... 3-10 Model 174 Connectors... 3-11 Combi-Connector (Primary Ultrasound or FECG)... 3-11 Secondary Ultrasound Connector... 3-11 Uterine Activity Connector... 3-11 Strip Chart Recorder... 3-12 Heart Rate Grid... 3-12 Uterine Activity Grid... 3-13 Annotation Area... 3-13 Rear Panel Connectors... 3-14 Power Supply Connector... 3-14 Remote Mark Connector... 3-14 Remote Mark Connector... 3-14 Nurse Call Interface... 3-15 RS-232C Connectors... 3-15 Telemetry Connector... 3-15
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Setup Procedures... 4-1 Loading Strip Chart Paper... 4-2 Turning the Monitor On... 4-7 Monitor Self-Test Routines... 4-8 Customizing the Monitor... 4-10 Mounting the Strain Gauge for IUP Monitoring... 4-14 Preparing the Monitor for Patient Use... 4-15
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Fetal Heart Rate Monitoring... 5-1 Ultrasound (External Method)... 5-2 Methodology... 5-2 Fetal Movement Detection... 5-2 Methodology... 5-2 Enabling/Disabling Fetal Movement Detection... 5-2 Strip Chart Annotations... 5-3 Using the Remote Event Marker to Complement the Patient Record... 5-3 FECG (Internal Method)... 5-4 Methodology... 5-4 Artifact Elimination... 5-4 Enabling/Disabling Artifact Elimination... 5-4 Theory and Methodology... 5-4 Fetal Heart Rate Offset... 5-5 Enabling/Disabling the Fetal Heart Rate Offset Mode... 5-5 Activating the Fetal Heart Rate Offset Mode... 5-6 De-Activating the Fetal Heart Rate Offset Mode... 5-6 Heartbeat Coincidence... 5-7 Enabling/Disabling Heartbeat Coincidence Detection... 5-7 Display Indicator... 5-7 Strip Chart Annotation... 5-8 Fetal Heart Rate Alarms... 5-9 FHR Threshold Alarms... 5-9 Latching Alarms... 5-10 FHR High Alarm... 5-10 FHR Low Alarm... 5-11 Sample Clinical Exceptions... 5-11 Signal Quality Alarms... 5-12 Active Signal Quality Alarm... 5-12 Resolved Signal Quality Alarm... 5-12 100% Signal Loss... 5-12
Intermittent Signal Loss... 5-13 Silencing an Audio Alarm... 5-13 Summary... 5-13
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Uterine Activity Monitoring... 6-1 Tocotransducer (External Method)... 6-2 Methodology... 6-2 Establishing a Baseline... 6-2 Initial Referencing... 6-3 Accounting for Belt Tension... 6-3 More About Referencing... 6-4 Out of Range Condition... 6-4 Manually Setting the Baseline at the Default Value... 6-4 Manually Overriding the Baseline Default Value... 6-4 Automatic Baseline “Zeroing”... 6-4 Intrauterine Pressure Monitoring (Internal Method)... 6-5 Methodology... 6-5 Why Zeroing is Important... 6-5
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Strip Chart Recorder... 7-1 Strip Chart Paper... 7-2 Trends... 7-5 Annotations... 7-6 Standard Annotations... 7-6 Peripheral Equipment Data... 7-6 Data from a Maternal Non-Invasive Blood Pressure Monitor... 7-6 Data from a Fetal Oxygen Saturation Monitor... 7-7 Annotations from a Central Information System... 7-8 Multiple Annotations... 7-8 Paper Error Conditions... 7-12 Paper-Out Condition... 7-12 Paper-Load–Error Condition... 7-12 Removing Unused Paper from the Recorder... 7-13
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Cleaning... 8-1 Monitor Exterior (Including Displays)... 8-2 Tocotransducer, Ultrasound Transducer, and Legplate... 8-3 UA Strain Gauge... 8-4
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, GE Medical Systems Information Technologies’ standard equipment symbols are defined. This section includes the following important information: General Information... 1-2 Definitions of Terminology... 1-3 Monitor Safety Information... 1-4 Definitions of Symbols... 1-8
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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 to 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 the accompanying “Maternal/Fetal Monitoring Operator’s Manual” for detailed instructions on fetal monitoring using the modalities available on a 170 Series Monitor.
Responsibility of the Manufacturer GE Medical Systems Information Technologies 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 Medical Systems Information Technologies;
the electrical installation of the relevant room complies with the requirements of appropriate regulations; and
the monitor is used in accordance with the instructions for 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. (See Table 1-1.) The warnings and cautions in this Safety section relate to the equipment in general and apply to all aspects of fetal monitoring. Be sure to read the safety information in the “Maternal/Fetal Monitoring Operator’s Manual” as well as the other chapters in this manual because there are additional warnings and cautions which relate to specific features. 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 Safety Information
Monitor Safety Information 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 the 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 signal 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. 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.
WARNINGS GROUNDING-Do not defeat the three-wire grounding feature of the power cord by means of adapters, plug modifications, or other methods. A dangerous shock hazard to both patient and 1-4
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Safety: Monitor Safety Information
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 other equipment, a test of 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 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. 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 Safety Information
Cautions CAUTIONS STATIC SENSITIVITY-This monitor is extremely static sensitive and should be handled using electrostatic discharge precautions. 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 a GE Medical Systems Information Technologies Service Representative. DAILY TESTING-It is essential that the monitor and accessories be inspected every day. It is recommended practice to ensure the monitor passes its self-test routine-initiated each time the monitor is turned on. Refer to “Monitor Self-Test Routines” on page 4-8. 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. The monitor should not be used if it is not working properly.
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Safety: Electromagnetic Interference
Electromagnetic Interference This device has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1993, EN60601-1-2:2001, 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.
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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Definitions of Symbols NOTE: Refer to “Controls, Indicators, The following is a list of symbols used on products manufactured by GE Medical Systems Information Technologies. Some symbols may not appear on your unit. and Connectors” on page 3-1 for additional information. 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: Definitions of 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 Risk Conditions... 2-3 Monitoring Methods... 2-4
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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 antepartum testing of fetal well-being, particularly in the high-risk pregnancy; and for routine noninvasive monitoring throughout labor and delivery.
Models 173 and 174 Models 173 and 174 Fetal Monitors can be used for routine non-invasive and invasive monitoring throughout labor and delivery.
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Introduction: Risk Conditions
Risk Conditions NOTE: There may be other factors or conditions that place a patient at risk.
The goal of electronic fetal monitoring for antepartum testing is to differentiate the fetus who is tolerating the intrauterine environment well, from the fetus who may be compromised and require further evaluation or delivery. Some of these conditions are summarized below.
Maternal Conditions Which Place the Fetus at Risk The following conditions were summarized from ACOG Technical Bulletin Number 188, “Antepartum Fetal Surveillance,” January 1994.
Postdate pregnancy (42 weeks or more)
Previous unexplained fetal demise
Isoimmunization (moderate to severe)
Hyperthyroidism
Diabetes mellitus (insulin treated)
Hypertensive disorders
Cyanotic heart disease
Chronic renal disease
Systemic lupus erythematosus
Hemoglobinopathies (hemoglobin SS, hemoglobin SC [presence of both hemoglobin S and hemoglobin C], or hemoglobin S-thalassemia)
Fetal Indications of Potential Fetal Compromise The following conditions were summarized from ACOG Technical Bulletin Number 188, “Antepartum Fetal Surveillance,” January 1994.
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Intrauterine Growth Restriction (IUGR)
Decrease fetal movement
Oligohydramnios
Multiple gestation with significantly discordant growth
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