Corometrics Maternal / Fetal Monitoring Clinical Application Operators Manual Rev G

GE Healthcare

Maternal/Fetal Monitoring Clinical Application Operator’s Manual

GE Healthcare Information Technologies Maternal/Fetal Monitoring Clinical Application  Operator’s Manual P/N 15457AA Rev. G © 2020 General Electric Company All Rights Reserved

GUARANTEE All equipment sold by GE Healthcare Information Technologies is fully guaranteed as to materials and workmanship for a period of 1 year. GE Healthcare 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 Healthcare Information Technologies A GE Healthcare Company

GE Healthcare 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 Healthcare Information Technologies as repairable. Refer to the monitor 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 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. ©1999-2020 GE Healthcare Information Technologies. All rights reserved. No part of this manual may be reproduced without the permission of GE Healthcare Information Technologies. Portions of this manual related to fetal pulse oximetry have been reprinted by permission of Nellcor Puritan Bennett.

Contents

1

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...1-7 Equipment Symbols...1-8

2

Introduction... 2-1 Fetal Monitoring Intended Uses... 2-2 Surveillance...2-2 Maternal Monitoring Intended Uses... 2-3 Blood Pressure...2-3 Pulse Oximetry...2-3 Heart Rate...2-3

3

Fetal Heart Rate Monitoring... 3-1 Verifying the Fetal Signal... 3-2 External Method (Ultrasound)... 3-3 Methodology...3-3 Limitations... 3-4 Determining the Probable Transducer Site...3-5 Ultrasound Transducer... 3-6 Internal Method (FECG)... 3-9 ECG Artifact Elimination...3-9 About the Connector...3-9 Safety Precautions... 3-10 Using a Disposable Legplate Attachment Pad... 3-11 Removing a Spiral Electrode... 3-13

Revision G

Maternal/Fetal Monitoring: Clinical Application 15457AA

i

Dual Fetal Heart Rate Monitoring... 3-14 External Monitoring of Twins (Dual Ultrasound)... 3-14 Internal/External Monitoring of Twins (FECG/Ultrasound)... 3-15 Heartbeat Coincidence... 3-16 Fetal Heart Rate Offset Mode... 3-16

4

Fetal Movement Detection... 4-1 Limitations... 4-2 Strip Chart Annotation... 4-3 Using the Remote Event Marker to Complement the Patient Record . . . 4-4

5

Uterine Activity Monitoring... 5-1 External Method (Tocotransducer)... 5-2 Establishing a Baseline...5-2 Tocotransducer Patient Application... 5-3 More About Referencing...5-4 Internal Method (IUPC)... 5-7 Cautions for Use...5-7 Why You Must Zero the System... 5-7

6

MECG Monitoring... 6-1 Overview... 6-2 MHR Data...6-2 Theory and Methodology...6-2 About the Connector...6-2 Safety Precautions... 6-3 Patient Application... 6-4 Equipment Required...6-4 About Disposable Electrodes...6-4 Procedure... 6-5

ii

Maternal/Fetal Monitoring: Clinical Application 15457AA

Revision G

7

Maternal Non-Invasive Blood Pressure Monitoring... 7-1 Blood Pressure Safety Precautions... 7-2 Warnings... 7-3 NIBP Determination... 7-4 SuperSTAT NIBP Determination... 7-4 Systolic Search...7-5 Patient Application... 7-6 Equipment Required...7-6 Procedure...7-6 Venous Return in Auto Mode...7-8

8

Maternal Pulse Oximetry Monitoring... 8-1 Safety Precautions... 8-2 Overview... 8-4 Theory...8-4 Methodology...8-4 Patient Application... 8-5 Equipment Required...8-5 Procedure...8-5

Revision G

Maternal/Fetal Monitoring: Clinical Application 15457AA

iii

iv

Maternal/Fetal Monitoring: Clinical Application 15457AA

Revision G

Preface

About the Manual

1

GE Healthcare Information Technologies offers a variety of Corometrics brand fetal and maternal/fetal monitors. This "Maternal/Fetal Monitoring: Clinical Application Operator’s Manual" is intended to serve as a guide in the Labor and Delivery department. The manual provides patient application instructions for Corometrics brand equipment-from the most basic antepartum fetal monitor through high-risk patient maternal/fetal monitors.

NOTE: Not all functions may be present on your monitor. This manual should be used in conjunction with the operator’s manual specific to your monitor. Refer to the monitor’s operator’s manual for cleaning instructions, supplies ordering information, or troubleshooting guidelines.

Maternal/Fetal Monitoring • Preface

v

For your notes

vi

Maternal/Fetal Monitoring: Clinical Application 15457AA

Revision G

Chapter 1

!

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 Healthcare Information Technologies’ 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... 1-8

Revision G

Maternal/Fetal Monitoring: Clinical Application 15457AA

1-1

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 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. Test all functions periodically and whenever the integrity of the monitor is in doubt. Refer to this manual for information concerning the limitations of internal and external fetal heart rate monitoring techniques.

Responsibility of the Manufacturer GE Healthcare 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 Healthcare Information Technologies;



the electrical installation of the relevant room complies with the requirements of appropriate regulations; and



the equipment is used in accordance with the instructions of use.

Responsibility of the User A fetal or maternal/fetal monitor 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 Corometrics 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 monitor. The monitor is only one clinical indicator of fetal status during labor. The monitor is designed to assist the perinatal staff in assessing the status of a patient. 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.

1-2

Maternal/Fetal Monitoring: Clinical Application 15457AA

Revision G

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 maternal/fetal monitoring. Be sure to read the safety information in your monitor’s 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

Revision G

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.

Maternal/Fetal Monitoring: Clinical Application 15457AA

1-3

Safety: Monitor Contraindications, Warnings and Precautions

Monitor Contraindications, Warnings and Precautions Warnings WARNINGS ACCIDENTAL SPILLS-In the event that fluids are accidentally spilled onto the monitor, remove the monitor from 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. CONNECTIONS-The correct way to connect a patient to the monitor is to plug the electrode leads into the patient cable which in turn connects to the monitor. The monitor is connected to the wall socket by the power cord. Do not plug the electrode leads into the power cord, a wall socket, or an extension cord. 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. DEFIBRILLATION PROTECTION-When used with the GE Healthcare Information Technologies-recommended accessories, the monitor is protected against the effects of defibrillator discharge. If monitoring is disrupted by the defibrillation, the monitor will recover. 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 monitor signals. If you feel interference is affecting the monitor, contact your Service Representative to check the monitor in your environment. Refer to “Electromagnetic Interference” on page 1-7 for additional information.

1-4

Maternal/Fetal Monitoring: Clinical Application 15457AA

Revision G

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. EQUIPMENT USE-The use of this equipment is restricted to one patient at a time. 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. INOPERABLE MECG-The MECG trace is not visible during a MECG LEADS OFF condition or an overload (saturation) of the frontend amplifier during differential input voltage of more than ± 300mV. 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. 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). MRI USE-Do not use the electrodes during MRI scanning; conducted current could potentially cause burns.

Revision G

Maternal/Fetal Monitoring: Clinical Application 15457AA

1-5

Safety: Monitor Contraindications, Warnings and Precautions

WARNINGS PATIENT CABLES AND LEADWIRES-Do not use patient cables and electrode leads that permit direct connection to electrical sources. Use only “safety” cables and leadwires. Use of non-safety patient cables and lead wires creates risk of inappropriate electrical connection which may cause patient shock or death. PACEMAKER PATIENTS-Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. Refer to the Corometrics 250 or 250cx Series Monitor Operator’s Manual for disclosure of the pacemaker pulse rejection capability of the your monitor. RF INTERFACE-Known RF sources, such as cell phones, radio or TV stations, and two-way radios, may cause unexpected or adverse operation of this device. SIMULTANEOUS DEVICES-Do not simultaneously connect more than one device that uses electrodes to detect ECG and/or respiration to the same patient. Use of more than one device in this manner may cause improper operation of one or more of the devices. 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. EXTERNAL VGA CONNECTIONS-Connect only to GE recommended display. ONLY remove cover plate if external display is used. TELEMETRY CONNECTIONS-Connect only to GE recommended telemetry systems. Contact your GE service representative for more information. COLOR DISPLAY-Certain colors may have limited visibility at a distance. Color-blind individuals may experience this more often. DISPOSAL-This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor display contain mercury.)

1-6

Maternal/Fetal Monitoring: Clinical Application 15457AA

Revision G

Safety: Monitor Contraindications, Warnings and Precautions

Cautions CAUTION STATIC ELECTRICITY-This assembly 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 Healthcare Information Technologies 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. If the monitor’s self-test feature is not automatic, the TEST function should be initiated at start-up. Follow the instructions in the monitor’s Operator’s Manual. 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. EQUIPMENT CONFIGURATION-The equipment or system should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the equipment or system should be tested to verify normal operation in the configuration in which it is being used. 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.

Electromagnetic Interference This device has been tested and found to comply with the Medical Electrical Equipment-General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility, 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 (e.g. cellular phones, mobile two-way radios, electrical appliances), it is possible that high levels of such interference due to proximity or strength of a source, may result in disruption of performance of this device. Refer to the Electromagnetic Immunity information in this product’s service manual for EN 60601-1-2 (2001) compliance information and safety information for this product. Revision G

Maternal/Fetal Monitoring: Clinical Application 15457AA

1-7

Safety: Monitor Contraindications, Warnings and Precautions

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 use site should be surveyed to determine the source of this disruption, and actions should be 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 Healthcare Service Representative.

Equipment Symbols The following is a list of symbols used on products manufactured by GE Healthcare Information Technologies. Some symbols may not appear on your unit. Equipment Symbols ATTENTION: Consult accompanying documents. WASTE OF ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE): This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. 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.

1-8

Maternal/Fetal Monitoring: Clinical Application 15457AA

Revision G

Safety: Monitor Contraindications, Warnings and Precautions

Equipment Symbols DEFIBRILLATOR-PROOF TYPE BF EQUIPMENT: Type BF equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment is type B equipment with an F-type isolated (floating) part. The paddles indicate the equipment is defibrillator proof. TYPE CF EQUIPMENT: Type CF equipment is suitable for intentional external and internal application to the patient including direct cardiac application. Type CF equipment is F-type applied part that provides a higher degree of protection against electric shock than that provided by Type BF applied parts. ALTERNATING CURRENT (AC). EQUIPOTENTIALITY.

O

POWER OFF: disconnection from the mains.

I

POWER ON: connection to the mains. VGA connection.

Revision G

Maternal/Fetal Monitoring: Clinical Application 15457AA

1-9

Safety: Monitor Contraindications, Warnings and Precautions

1-10

Maternal/Fetal Monitoring: Clinical Application 15457AA

Revision G

Chapter 2

Introduction

2

This section lists the intended uses of the monitor: Fetal Monitoring Intended Uses... 2-2 Maternal Monitoring Intended Uses... 2-3

Revision G

Maternal/Fetal Monitoring: Clinical Application 15457AA

2-1