GE Healthcare 250cx Service Manual

0 (0)

GE Healthcare

Corometrics250cx Series Monitor

Service Manual

Corometrics 250cx Series Monitor

English

2036947-001 Rev. C (paper)

© 2007 General Electric Company.

All Rights Reserved.

GE Healthcare

Corometrics250cx Series Monitor

Service Manual

Corometrics 250cx Series Monitor

English

2036947-001 Rev. C (paper)

© 2007 General Electric Company.

All Rights Reserved.

GE Healthcare 250cx Service Manual

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 Healthcare 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 250cx Series Service Manual for further information.

NOTE: In addition to software version 4.50, the information in this manual also applies to previous software revisions of Corometrics 250cx Series Monitor. There are no user-apparent differences among these software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice.

NOTE: For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies

Ohmeda Oximetry and other trademarks (OxyTip+®, PIr™, TruSat™, TruSignal™, TruTrak+®, SuperSTAT™) are the property of GE Medical Systems Information Technologies, a division of General Electric Corporation. All other product and company names are the property of their respective owners.

MASIMO SET® is a trademark of Masimo Corporation. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to the device.

NELLCOR®, OxiMax®, C-LOCK® and SatSeconds™ are trademarks of Nellcor Puritan Bennett. TAT-5000™, Exergen®, and TemporalScanner™ are trademarks of Exergen Corporation.

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. ©2005, 2006, 2007 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.

T-2

Corometrics 250cx Series Monitor

Revision C

 

2036947-001

26-Sept-2007

 

CE

 

 

0086

Compliance

 

 

 

A GE brand Corometrics 250cx Series Monitor bears CE mark CE-0086

 

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 India; the CE mark is applied under the

 

authority of Notified Body BSI (0086).

 

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

The IEC electromagnetic compatibility (EN) standards require

Certified Systems

individual equipment (components and accessories) to be configured

as a system for evaluation. For systems that include a number of

 

 

different equipment 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

Exceptions

Monitor System EMC:

Immunity Performance

250cx Series Maternal/Fetal Monitor

Model 146 Fetal Acoustic Stimulator

Intrauterine Pressure Transducer

FECG Cable/Legplate

Ultrasound Transducers (x2)

Blood Pressure Hose and Cuff

MSpO2 Interconnect Cable and Sensor

MECG Cable

FECG/MECG Adapter Cable

Remote Event Marker

RS-232C Interconnect Cables (x3)

Central Nurses Station Interconnect Cable

Model 2116B Keyboard and Interconnect Cable

Model 1563AAO Telemetry Cable

Exergen® TAT-5000™

None

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.

CE- i

CE

0086

CEii

1

2

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Responsibility of the User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 References to Persons, Places, and Institutions . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Hazard Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Product Specific Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Service Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Equipment ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Related Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13

Equipment Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Equipment Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Front Panel Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Front Panel Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Display Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Setup Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Softkeys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Mode Title Softkeys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Waveform Softkeys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Dedicated Softkey Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Rear Panel Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Optional Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Software Upgrades . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Adding Spectra Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Adding Fetal Movement Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Revision C

250cx Series Maternal/Fetal Monitor

i

 

2036947-001

 

 

Peripheral Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-14

 

Nellcor® Puritan Bennett Model N-200 Maternal Pulse Oximeter . . . . . . . . . . . .

2-14

 

Nellcor Puritan Bennett Model N-400 Fetal Pulse Oximeter . . . . . . . . . . . . . . . .

2-15

 

DINAMAP® Models PRO Series 100-400 and ProCare . . . . . . . . . . . . . . . . . . . . .

2-16

 

ILC-1926 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-16

 

Centricity Perinatal (QS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-16

 

Exergen® TAT-5000™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-16

 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-17

 

GE Healthcare Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-17

 

250Plus Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-17

 

115 and 115X/R protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-17

 

Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-18

 

Systems Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-18

3

Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-1

 

Tools Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-3

 

Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-3

 

Fetal Acoustic Stimulator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 3-3

 

Remote Marks Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 3-3

 

ECG Out Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 3-3

 

J101 Connector (Model 340 Telemetry System Interface) . . . . . . . . . . . . . . . . .

. 3-4

 

J109, J110, and J111 Connectors (RS-232C) . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 3-5

 

Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-6

 

J112 (External Display Connector) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-7

 

Self-Test Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-7

 

Battery-Backed RAM Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 3-8

 

Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-9

 

Loading Strip Chart Recorder Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 3-9

 

Mounting a Strain Gauge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-12

 

Setup Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-12

 

Service Mode Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-12

 

Service Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-13

 

Install Options Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-14

 

Printing System Setup Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-20

ii

250cx Series Maternal/Fetal Monitor

Revision C

 

2036947-001

 

 

Communications Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-21

 

Baudrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-21

 

Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-21

 

Configuration Switches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-22

 

Factory Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-23

4

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-1

 

Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-3

 

Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 4-4

 

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-5

 

Monitor Exterior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 4-5

 

Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 4-6

 

Tocotransducer and Ultrasound Transducer . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 4-6

 

Leg Plates and MECG Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 4-6

 

Maternal NIBP Cuffs and Hoses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 4-7

 

SpO2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 4-8

 

Periodic Thermal Printhead Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 4-8

 

Cleaning the UA Strain Gauge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 4-8

 

Disposal of Product Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-9

 

Patient Applied Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 4-9

 

Packaging Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-10

 

Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-10

 

Electrical Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-10

 

Initial Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-10

 

AC Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-10

 

Ground Impedance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-10

 

Chassis Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-11

 

Patient-to-Ground Leakage for MECG/FECG . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-11

 

Patient-to-Line (ISO) Leakage for MECG/FECG . . . . . . . . . . . . . . . . . . . . . . . . .

4-11

 

Patient-to-Ground Leakage for IUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-12

 

Patient-to-Line (ISO) Leakage for IUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-12

 

Patient-to-Ground Leakage for US1/US2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-12

 

Patient-to-Line (ISO) Leakage for US1/US2 . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-13

 

Patient-to-Ground Leakage for SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-13

 

Patient-to-Line Leakage for SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-13

 

Dielectric (Hi-Pot) Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-14

 

Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-16

 

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-16

 

Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-17

 

Self-Test Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-17

Revision C

250cx Series Maternal/Fetal Monitor

iii

 

2036947-001

 

Front Panel Button Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

Connecting the Simulator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

MECG Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

FECG Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Ultrasound Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

Fetal Movement Detection Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

Ultrasound Transducer Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

Uterine Activity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

Testing the Tocotransducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32

Strain Gauge Transducer Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

Pattern Memory Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Dual Heart Rate Test (Non-Pattern) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35

FECG/US Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35

Dual Ultrasound Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

Alarm Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-37

MSpO2 Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-39

NIBP Calibration and Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40

Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40

Required Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40

General Calibration Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41

Calibration Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41

Calibrate Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41

Overpressure Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-42

System Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-42

Display Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43

Checking a Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43

Verifying the DSP Board Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43

External Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-44

Maternal SpO2 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-44

Hardware Switches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-44

Main Board SW1 Switch Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-45

J102 Analog Output Connector DAC Static Test . . . . . . . . . . . . . . . . . . . . . . . . . 4-45

iv

250cx Series Maternal/Fetal Monitor

Revision C

 

2036947-001

 

Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-46

 

RS-232C Connector Loopback Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-48

 

Making a Loopback Test Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-48

 

Testing the Port(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-48

 

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-50

 

Before You Begin Electronic Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-50

 

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-50

 

Handling Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-50

 

Power Supply Voltages—Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-50

 

Main Board Power Supply Voltages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-50

 

Isolated Power Supply Board Voltages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-51

 

Isolated FECG/UA Board Voltages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-51

 

Recorder Photosensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-52

 

Adjusting the Paper-Low Photosensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-52

 

Adjusting the Paper-Out Photosensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-52

 

Adjusting the Paper-Loading Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-53

 

Repair Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-54

 

Preventative Maintenance Inspection Report . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-55

 

Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-55

 

Tools Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-55

 

Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-55

 

Comments: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-59

5

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-1

 

Diagnostic Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-3

 

Main Motherboard and DSP Board Self-Test . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 5-3

 

Monitor Self-Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-3

 

Error Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-3

 

Diagnostic Control Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-5

 

Recorder Calibration Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 5-6

 

CPU Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 5-6

 

DSP Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 5-6

 

Run Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 5-7

 

Recorder Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 5-7

 

Recorder Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 5-7

 

FAQs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-16

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v

 

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System Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-37

 

General Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-46

 

Ultrasound Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-47

 

FECG Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-47

 

External Uterine Activity Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-48

 

Internal UA Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-49

 

MECG Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-49

 

Blood Pressure Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-50

 

Maternal Pulse Oximetry Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-51

6

Parts List, Drawings, and Replacement . . . . . . . . . . . . .

6-1

 

Ordering Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-3

 

Service Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-3

 

Field-Replaceable Units (FRUs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-4

 

FRU List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 6-4

 

FRU Main Reference Guide Drawing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 6-6

 

Assembly/Disassembly of FRUs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-8

 

2025177-003 Speaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 6-8

 

2025177-037 Main Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 6-8

 

2025177-005 DSP Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. 6-9

 

2025177-006 Main Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-10

 

2025177-007 Dual Ultrasound Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-10

 

2025177-008 FECG/UA Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-11

 

2025177-009 Isolated Power Supply Board . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-12

 

2025177-010 SpO2 Carrier Board with Nellcor MSpO2 Module . . . . . . . . . . . . .

6-12

 

2025177-011 SpO2 Carrier Board with Masimo MSpO2 Module . . . . . . . . . . . .

6-13

 

2025177-012 SpO2 Carrier Board with TruSignal MSpO2 Module . . . . . . . . . . .

6-13

 

2025177-013 Front-end Motherboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-14

 

2025177-036 Chassis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-15

 

2025177-016 COMM Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-18

 

2025177-017 Recorder Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-18

 

2025177-018 Recorder Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-20

 

2025177-019 Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-21

 

2025177-020 Pneumatics Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-22

 

2025177-021 Display Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-23

 

2025177-022 Front Bezel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-24

 

2025177-023 Keypads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-26

 

2025177-026 Trim Knob and Encoder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-27

 

2025177-027 Power Switch Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-28

 

2025177-028 Main Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-29

 

2025177-029 MECG Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-30

 

2025177-031 Top Cover Gasket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-31

vi

250cx Series Maternal/Fetal Monitor

Revision C

 

2036947-001

 

A Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . .A-1

General Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Strip Chart Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11

B Alarms Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1

C Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . .C-1

Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions . . . . . . .C-3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity . . . . . . . .C-4 Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-6 Compliant Cables and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-7

Revision C

250cx Series Maternal/Fetal Monitor

vii

 

2036947-001

 

viii

250cx Series Maternal/Fetal Monitor

Revision C

 

2036947-001

 

1 Introduction

Revision History

Each page of this manual has a revision letter located at the bottom of the page. This letter identifies the revision level of the entire manual. This may be important if you have different manuals and you do not know which is the most current.

For the initial release, all pages have the revision letter A. For the second update, all pages receive the revision letter B. The latest letter of the alphabet added to the table below corresponds to the most current revision.

Revision

 

Date

Comment

 

 

 

 

A

23

July, 2007

Initial release

 

 

 

 

B

26

July, 2007

Change selected FRU nos. Modify selected

 

 

 

wording.

 

 

 

 

C

16

September, 2007

Add Exergen® TAT-5000™

 

 

 

 

Revision C

250cx Series Maternal/Fetal Monitor

1-1

 

2036947-001

 

For your notes

1-2

250cx Series Maternal/Fetal Monitor

Revision C

 

2036947-001

 

Introduction: Safety Information

Safety Information

The information presented in this section is important for the safety of both the patient and operator. This chapter describes how the terms Danger, Warning, Caution, Important, and Note are used throughout the manual. In addition, standard equipment symbols are defined.

Responsibility of the Manufacturer

GE is responsible for the effects on safety, reliability, and performance if:

assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE;

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

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

Responsibility of the User

This device is intended for use by clinical professionals who are expected to know the medical procedures, practices, and terminology required to monitor obstetrical patients. This manual documents all possible parameters available in the 250cx 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 250cx Series Monitor is designed to assist the perinatal staff by providing information regarding the clinical status of the mother and 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.

References to Persons, Places, and Institutions

References to persons, places, and institutions used within this manual are solely intended to facilitate user comprehension of the 250cx Series Monitor’s use and functions. Extreme care has been taken to use fictitious names and related information in the examples and illustrations provided herein. Any similarity of this data to persons either living or dead and to either current or previously existing medical institutions should be regarded as coincidental.

Revision C

250cx Series Maternal/Fetal Monitor

1-3

 

2036947-001

 

Introduction: Safety Information

Hazard Definitions

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.

 

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

250cx Series Maternal/Fetal Monitor

Revision C

 

2036947-001

 

Introduction: Safety Information

Product Specific Hazards

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.

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 Medical Systems 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 p. 1-7 for additional information.

Revision C

250cx Series Maternal/Fetal Monitor

1-5

 

2036947-001

 

Introduction: Safety Information

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.

INOPERABLE MECG—The MECG trace is not visible during a 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.

1-6

250cx Series Maternal/Fetal Monitor

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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).

MRI USE—Do not use the electrodes during MRI scanning; conducted current could potentially cause burns.

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 leadwires 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 “Appendix A, Technical Specifications” for disclosure of the pacemaker pulse rejection capability of the 250cx Series 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 system. 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.

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EXERGEN® TAT-5000™ —Cable assembly 2036641-001 cannot be field serviced. Do NOT attempt any repairs to this assembly. This assembly must be returned to the factory for any repairs. This assembly, as shipped, is important to patient safety.

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 contain mercury.)

Cautions

CAUTIONS

ANNUAL SERVICING—For continued safety and performance of the monitor, verify the calibration, accuracy, and electrical safety of the monitor annually. Contact your 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 initiate the monitor’s selftest feature at the beginning of each monitoring session; follow the instructions in “Chapter 5, 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.

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.

PINCHING—Keep fingers clear of the paper roller because the roller could pinch your fingers.

STATIC ELECTRICITY—This assembly is extremely static sensitive and should be handled using electrostatic discharge precautions.

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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Introduction: 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.

Refer to the Electromagnetic Immunity information in this product’s service manual for EN 60601-1-2 (2001) Edition 2 compliance information and safety information for this product.

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 evidences 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 Medical Systems

Information Technologies Service Representative.

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Introduction: 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.

Equipment Symbols

 

 

 

 

 

 

 

ATTENTION: Consult accompanying documents.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 the manufacturer or

 

 

 

 

 

 

 

other authorized disposal company to

 

 

 

 

 

 

 

decommission 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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.

 

 

 

 

 

 

 

 

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Service Requirements

Follow the service requirements listed below.

Refer equipment servicing to GE Medical Systems Information Technologies authorized service personnel only.

Any unauthorized attempt to repair equipment under warranty voids that warranty.

It is the user’s responsibility to report the need for service to GE Medical Systems Information Technologies or to one of GE’s authorized agents.

Failure on the part of the responsible individual, hospital or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.

Regular maintenance, irrespective of usage, is essential to ensure that the equipment will always be functional when required.

Equipment ID

The following graphic illustrates the components of the monitor’s serial number.

GEMS IT Global Serial Number Format

13Digit

# # # # # # # # # # # # #

Misc. : Prototype, refurbish, etc.

Manufacturing site

Sequential serial number (up to 9999)

Fiscal week

Year

3-character product code

Global Serial Number Format

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Intended Audience

This manual is intended for trained service professionals.

Intended Use

General Use

If the monitor is cold to the touch or below ambient temperature, allow it to reach ambient, 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 “Checkout” on page 4-16.

Refer to the “Maternal/Fetal Monitoring, Clinical Applications Manual” for information concerning the limitations of internal and external fetal heart rate monitoring techniques.

Fetal Monitoring

A Corometrics 250cx Series Monitor can be used for routine non-invasive and invasive fetal monitoring throughout labor and delivery (i.e., fetal heart rate and uterine activity monitoring). Fetal movement detection and Spectra Alerts are options that may be purchased.

Maternal Monitoring

A Corometrics 250cx Series Maternal/Fetal Monitor is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured with either of these monitors are summarized below.

Blood Pressure

This parameter is intended for use in the non-invasive monitoring of maternal blood pressure (NIBP). This monitor is not intended for use in neonatal or pediatric blood pressure monitoring.

Pulse Oximetry

This parameter is intended for use in the non-invasive monitoring of the functional oxygen saturation of maternal arterial blood (MSpO2).

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Heart/Pulse Rate

This parameter is intended for use in the non-invasive monitoring of the maternal heart/pulse rate (MHR/P).

Related Manuals

Manual

Title

 

 

2020550-001

250cx Series Operator’s Manual

 

 

15457

Maternal/Fetal Monitoring, Clinical Application

 

 

2004435-001

Information For Prescribers

 

 

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2 Equipment Overview

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For your notes

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