GE Corometrics 170 Series User manual

Corometrics®170 Series
OPERATOR’S MANUAL MANUAL P/N 2003023-001 REV. D


Corometrics® 170 Series
OPERATOR’S MANUAL MANUAL P/N 2003023-001 REV. D

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.
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.
!

Revision D 170 Series Monitor CE-1
2003023-001
CE Marking Information
0459
CE Marking Information
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

CE-2 170 Series Monitor Revision D
2003023-001
CE Marking Information
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.

Contents
1Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
2Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
3Controls, 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

4Setup 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
5Fetal 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
6Uterine 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
7Strip 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
8Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Monitor Exterior (Including Displays) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Tocotransducer, Ultrasound Transducer, and Legplate . . . . . . . . . . . . . . . . . . . . 8-3
UA Strain Gauge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

9Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
General Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Ultrasound Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
FECG Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
External UA Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Internal UA Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
10 Supplies and Accessories . . . . . . . . . . . . . . . . . . . . . . . 10-1
11 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . 11-1
General Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Strip Chart Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4


Revision D 170 Series Monitor 1-1
2003023-001
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 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
!

1-2 170 Series Monitor Revision D
2003023-001
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.

Revision D 170 Series Monitor 1-3
2003023-001
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
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.

1-4 170 Series Monitor Revision D
2003023-001
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

Revision D 170 Series Monitor 1-5
2003023-001
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.

1-6 170 Series Monitor Revision D
2003023-001
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.

Revision D 170 Series Monitor 1-7
2003023-001
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:
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.

1-8 170 Series Monitor Revision D
2003023-001
Definitions of Symbols
NOTE: Refer to “Controls, Indicators,
and Connectors” on page 3-1 for
additional information.
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.
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.
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.
!
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