Philips 862474, 862478 User Manual

Philips C3 Patient Monitor

C3 Service Guide
Models: 862474, 862478

989803129451

Part Number 989803129451

Printed in the U.S.A. March 2003

Edition 1

About this Manual

Proprietary Information

This document contains proprietary information, which is protected by copyright. All Rights
Reserved. Reproduction, adaptation, or translation without prior written permission is
prohibited, except as allowed under the copyright laws.

Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810-1085
[phone]

Publication number
989803129451
Printed in USA

Warranty The information contained in this document is subject to change without notice.

Philips Medical Systems makes no warranty of any kind with regard to this material,
including, but not limited to, the implied warranties or merchantability and fitness for Philips
Medical Systems shall not be liable for errors contained herein or for incidental or
consequential damages in connection with the furnishing, performance, or use of this material.

Copyright Copyright © 2003 Philips Electronics North America Corporation

Microstream

®

is a registered trademark of Oridion Medical Inc.

Printing History

Additional Documents

New editions of this document incorporate all material updated since the previous edition.
Update packages may be issued between editions and contain replacement and additional
pages to be merged by a revision date at the bottom of the page. Pages that are rearranged due
to changes on a previous page are not considered revised.

The documentation printing date and part number indicate its current edition. The printing
date changes when a new edition is printed. (Minor corrections and updates that are
incorporated at reprint do not cause the date to change.) The document part number changes
when extensive technical changes are incorporated.

First Edition............................................................... March 2003

Use this document in conjunction with the C3 Instructions for Use guide (pn

989803228691).

ii

Safety

All warnings, precautions and notes are located in the chapters that follow. You must read all
of this safety information before you begin monitoring with your C3 patient monitor.

Safety Standards

CE Marking

Europe The following products and accessories from Philips Medical Systems carry the CE mark

The C3 Patient Monitor is compliant with the following safety standards:

• UL 2601-1

• CAN/CSA C22.2 No. 601.1-M90

• EN60601-1

• EN60601-2-27

• EN60601-2-30

• EN60601-2-49

•EN865

to Council Directive 93/42/EEC.

0123

C3 Products: - 862474 - 862478

Accessories: - 21075A - 21076A - 21078A - 21090A

- M1837A - M4820A - M4818A

The following accessories from Philips Medical Systems carry one of the following CE
marks: or to Council Directive 93/42/EEC.

Accessories: - M1191A - M1192A - M1194A - M1941A

- 40493D - 40493E - M1980A - M1981A

- M1510A - M1550C - M1611A - M1613A

- M1615A - M1879A - M1878A - M1877A

- M1876A - M1875A - M1874A - M1576A

- M1575A - M1574A - M1573A - M1572A

- M1571A - M1577A - M1578A - M1579A

- 40401E - 40401D - 40401C - 40401B

- 40401A - M1598B - M1599B - M2526A

- M2525A - M2524A - M2528A - M2522A

- M2521A - M2520A - M1920A - M1922A

- M1921A - M4816A - M4817A

0366

Accessories from companies other than Philips Medical Systems carry CE markings
appropriate to the accessory.

Additional accessories not identified above fall outside the definition of a medical device.

The Former Agilent Technologies’ Healthcare Solutions Group is now a part of Philips
Medical Systems. Some accessories may still be branded with the Agilent name.

iii

Authorized EU-representative: Philips Medizinsystems Böblingen GmbH, Hewlett Packard
Str., 71034, Böblingen Germany

Note

United States

Canada This ISM device complies with Canadian ICES-001.

United States Federal Law restricts this device to sale by or on the order of a physician.

Cet appareil ISM est conforme a la norme NMB-001 du Canada.

Philips Software License Terms

ATTENTION: USE OF THE SOFTWARE IS SUBJECT TO THE PHILIPS SOFTWARE LICENSE

TERMS SET FORTH BELOW. USING THE SOFTWARE INDICATES YOUR
ACCEPTANCE OF THESE LICENSE TERMS. IF YOU DO NOT ACCEPT THESE
LICENSE TERMS, YOU MAY RETURN THE SOFTWARE FOR A FULL REFUND. IF
THE SOFTWARE IS BUNDLED WITH ANOTHER PRODUCT, YOU MAY RETURN
THE ENTIRE UNUSED PRODUCT FOR A FULL REFUND.

PHILIPS SOFTWARE LICENSE TERMS

The following License Terms govern your use of the accompanying Software unless you have
a separate signed agreement with Philips Medical Systems.

License Grant. Philips Medical Systems grants you a license to Use one copy of the
Software. "Use" means storing, loading, installing, executing or displaying the Software. You
may not modify the Software or disable any licensing or control features of the Software. If
the Software is licensed for "concurrent use", you may not allow more than the maximum
number of authorized users to Use the Software concurrently.

Ownership. The Software is owned and copyrighted by Philips or its third party suppliers.
Your license confers no title to, or ownership in, the Software and is not a sale of any rights in
the Software. Philips’ third party suppliers may protect their rights in the event of any
violation of these License Terms.

Copies and Adaptations. You may only make copies or adaptations of the Software for
archival purposes or when copying or adaptation is an essential step in the authorized Use of
the Software. You must reproduce all copyright notices in the original Software on all copies
or adaptations. You may not copy the Software onto any public network.

No Disassembly or Decryption. You may not disassemble or decompile the Software unless
Philips prior written consent is obtained. In some jurisdictions, Philips consent may not be
required for limited disassembly or decompilation. Upon request, you will provide Philips
with reasonably detailed information regarding any disassembly or decompilation. You may
not decrypt the Software unless decryption is a necessary part of the operation of the
Software.

iv

Transfer. Your license will automatically terminate upon any transfer of the Software. Upon
transfer, you must deliver the Software, including any copies and related documentation, to
the transferee. The transferee must accept these License Terms as a condition to the transfer.

Termination. Philips Medical Systems may terminate your license upon notice for failure to
comply with any of these License Terms. Upon termination, you must immediately destroy
the Software, together with all copies, adaptations and merged portions in any form.

Export Requirements. You may not export or re-export the Software or any copy or
adaptation in violation of any applicable laws or regulations.

U.S. Government Restricted Rights. The Software and any accompanying documentation
have been developed entirely at private expense. They are delivered and licensed as
"commercial computer software" as defined in DFARS 252.227-7013 (Oct. 1988), DFARS

252.211-7015 (May 1991) or DFARS 252.227-7014 (Jun. 1995), as a "commercial item" as
defined in FAR 2.101(a), or as "Restricted computer software" as defined in FAR 52.227-19
(Jun. 1987)(or any equivalent agency regulation or contract clause), whichever is applicable.
You have only those rights provided for such Software and any accompanying documentation
by the applicable FAR or DFARS clause or the Philips standard software agreement for the
product involved.

v

Text

Conventions

The following conventions for Notes, Cautions, and Warnings are used in this manual.

WarningWarning

A Warning calls attention to a condition or possible situation that could cause injury to
the user and/or patient.

Caution

A Caution calls attention to a condition or possible situation that could damage or destroy the
product or the user’s work.

Note

A Note calls attention to an important point in the text.

Explanation of Symbols

Symbols on products and packaging mean the following. All symbols found in this section are
used this Instructions For Use guide.

Reference Number

Serial Number

0123

5% to 95% RH

CE Marking

Humidity

vi

Temperature Limits

Keep out of Sun

Keep Dry

Fragile

Keep Upright

AC LED

Battery LED

NBP

Volume

Contrast

On/Standby

Snapshot

Continuous

Defibrillator-proof type CF equipment

vii

ECG

T

SpO

CO

2

2

Temperature

SpO

2

NBP

Carbon Dioxide

Alarm

Alarm Limits Menu

Audio Off

Silence/Reset

viii

NBP Automatic Interval Mode

Big Numbers

Clock

Up Alarm Arrow Limit

Down Alarm Arrow Limit

Empty Battery

Perfusion Indicator Bar

Heart Rate

Powering Down

Heart Rate taken from ECG

Heart Rate taken from NBP

Heart Rate taken from SpO

Respiration

Stat Mode

Audio Pause

Setup Menu

ECG Size Bar

RF Interference

2

ix

T1AL 250V

Battery Compartment

RS-232 I/O

Equipotential Grounding Post

Defib Sync

Attention, consult accompanying documents

Alternating Current

Fuse Type

x

YYYY-XX

IPX1

Date of Manufacture (Y= year; X = Month)

Drip-proof

ETL Mark

Sales and Support Offices

Please call your local Philips Medical Systems sales office listed in your telephone directory,
or a Philips Medical Systems regional office listed below for the location of your nearest sales
office or for information on how to contact the Philips Response Center.

CORPORATE HEADQUARTERS:

Philips Medical Systems
Netherlands B.V.
Postbus 10.000
5680 DA Best
Netherlands

CORPORATE HEADQUARTERS:

Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810
United States
[phone]

CANADA:

Philips Medical Systems Canada
281 Hillmount Road
Markham, ON
L6C 2S3
[phone]

EUROPE, MIDDLE EAST AND AFRICA:

Philips Medizinsysteme Böblingen GmbH
Cardiac and Monitoring Systems
Hewlett-Packard Str. 2
71034 Böblingen
Germany
Fax: [phone]

xi

LATIN AMERICA HEADQUARTERS:

Philips Medical Systems
1550 Sawgrass Corporate Parkway #300
Sunrise, FL 33323
Telephone: [phone]
Fax: [phone]

ASIA PACIFIC HEADQUARTERS:

Philips Medical Systems
30/F Hopewell Centre
17 Kennedy Road
Wanchai
Hong Kong
Tel: [phone]
Fax: [phone]

xii

Contents

1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

General Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

C3 Patient Monitor Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

Features and Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Front Panel Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Front of Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Rear of Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

Screen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

Additional Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

2. Site Preparations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

General Site Preparation Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2

Site Preparation Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3

Warning, Cautions and Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3

Patient Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3

Preparing to Use the Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Power Source Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Protecting Against Electrical Shock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Equipotential Grounding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Combining Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Disposing of the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

Unpacking the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

Checking the Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

Returning System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6

Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7

Warnings, Cautions, and Safety Precautions Relating to Wall Mount Installation . . . . . . . . . . . .2-8

Mounting the GCX Wall Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Attaching the Mounting Plate to the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Attaching the Monitor to the Wall Channel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

Contents-1

3. Maintaining the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Maintenance Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Light Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Battery Conditioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Recommendations for Maintenance Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Maintenance Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Inspecting the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Inspecting the Cables and Cords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

About the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Battery Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Checking the Battery Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Identifying Battery Strength. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Conditioning a Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Why is Battery Conditioning Necessary?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

When Should Battery Conditioning be Performed? . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

How to Condition a Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Battery INOP Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

4. Testing the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Testing Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Functionality Assurance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Performance and Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Testing Checklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Test Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Recommendations for Testing Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Test Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Serial Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Visual Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Power On Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Functionality Assurance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Contents-2

Performance Assurance Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Power-On Self-Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Alarm Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

Volume Control Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

Preventative Maintenance Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14

Documenting NBP Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15

Pneumatic System Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16

To Zero the Simulator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16

Pressure Transducer Accuracy Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

Pneumatic Leakage Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

Inflation Rate Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-18

Over-Pressure Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19

Deflation Rate Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-20

Basic Pneumatic Leakage (BPL) Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

Performance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22

Battery Performance Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-22

Temperature Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

ECG/Respiration Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25

ECG Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25

Respiration Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26

SpO2 Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27

Dynamic Operating Range Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27

LED Excitation Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28

CO2 Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29

Documenting CO2 Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-30

Barometric Pressure Check and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-31

Leakage Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-32

Pump Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-33

Flow Rate Check and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-33

CO2 Gas Measurement Calibration Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-34

Calibration Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-35

Reset Pump Operating Time Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-35

Serial Interface and Nurse Call Signal Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-36

ECG Sync Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-38

Patient Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-39

Ground Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-39

Electrical Leakage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-41

Earth Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-41

Enclosure Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-42

Patient Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43

Contents-3

Patient Leakage Current, with Mains Voltage on the Applied Part . . . . . . . . . . . . . . . 4-44

5. Configuring the Power-up Defaults Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

General Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Power-Up Defaults Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Menu Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Diagnostic Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

System Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

System A/D Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8

NBP Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

CO2 Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Restoring Factory Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

6. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

General Troubleshooting Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Trouble-shooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Part 1 Troubleshooting Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Checks for Obvious Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Checks Before Opening the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Part 2 Isolating and Solving Monitor Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

INOP Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Isolating the Defective Component . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

Part 3 Using Support Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11

Serviceable Hardware Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Error Code Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12

Other Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13

7. Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Tools Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Disassembly Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3

Disassembly Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Closed Case Disassembly Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Removing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Removing the Navigation Wheel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Removing the Keypad on the Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Contents-4

Removing the Optional, External Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6

Separating the Front from the Rear Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-7

Front Case Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8

Replacing the Speaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9

Replacing the Backlight Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9

Rear Case Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10

Removing the Main PCB Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12

Removing the Patient Monitoring I/O Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13

Removing the SpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-14

Removing the CO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15

Removing the NBP Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-16

Removing the Power Supply Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-17

8. Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Small Parts Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

C3 Top Level Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

Front Panel Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4

Rear Panel Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6

Power Cords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-9

Exchange Unit Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10

9. Packing for Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

General Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2

Repacking the Original Carton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2

Repacking in a Different Carton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2

10. RS-232 Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

General RS-232 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-2

About the RS-232 Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3

Cable Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3

Nurse-Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-4

Contents-5

11. Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

Levels of Involvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

Preventative Maintenance Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

Phone Support or Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

Training Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Essential Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Optional Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

Support Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4

Unit Exchange . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4

Bench Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4

Theory of Operation and System Architecture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Isolated Front End . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

NBP Front End . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Power System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Micro-processor, Memory and Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

Navigation Wheel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8

RS-232 I/O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8

Defib Sync Pulse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8

Speaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8

Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9

ECG Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9

Respiration Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9

NBP Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-10

SpO2 Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10

CO2 Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-10

Temperature Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-11

Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12

Monitor Applications and Algorithms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13

Contents-6

12. Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1

Hardware Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-2

Safety Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-2

Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-3

Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-3

Measuring and Displaying Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-4

ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-4

ECG Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-5

Respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-6

NBP (Non-Invasive Blood Pressure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-7

Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-7

SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-8

CO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-9

Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-10

Contents-7

Contents-8

1

Overview

This chapter provides a brief overview of the C3 patient monitor. It also provides a list of the
monitor’s features and parameters.

Overview 1-1

General Safety Information

General Safety Information

WarningWarning

This monitor is not intended for neonates.

If you connect the monitor to any instrument, verify proper operation before clinical

use. Refer to that instrument’s Instructions for Use guide for full
instructions.

Accessory equipment connected to the monitor’s data interface must be certified

according to IEC Standard 60950 for data-processing equipment or
IEC Standard 60601-1 for electromedical equipment. All combinations
of equipment must be in compliance with IEC Standard 60601-1-1
systems requirements.

Anyone who connects additional equipment to the signal input port or signal output port

configures a medical system and is therefore responsible to ensure that
the system complies with the requirements of system standard IEC
Standard 60601-1-1. If in doubt, contact the Philips’ Response Center
or your local Philips representative.

Note

The monitor and its accessories must be tested by qualified service personnel at regular
intervals to verify proper operation, according to the procedures of the user’s institution.

Other important safety information is located in this Service Guide where appropriate.

1-2 Overview

Introduction

This manual contains information for servicing the C3 patient monitor, subsequently referred
to as "the monitor" throughout this manual. Only qualified service personnel should service
this product. Before servicing the monitor, carefully read the C3 Instructions for Use guide
for a thorough understanding of operation.

C3 Patient Monitor Description

The purpose and function of the C3 family of patient monitors is to monitor ECG, heart rate,
non-invasive blood pressure (NBP), functional arterial oxygen saturation (SpO
rate, temperature and carbon dioxide
and hospital-type facilities, such as clinics.The monitors may be used by clinical users during
hospital transport.

The intended users of the C3 patient monitors are clinicians and nursing staffs within hospital,
out-patient, and ambulatory settings. This monitor is not intended for helicopter transport or
home use.

Introduction

), respiration

1

(CO2) for adult and pediatric patients in hospital areas

2

The physical and operational characteristics of the monitor are described in the C3
Instructions for Use guide.

1. Carbon Dioxide monitoring is available within the C3 Sedation monitors only.

Overview

1-3

Features and Options

Features and Options

The measurement parameters and features for each model are indicated below.

Front Panel Description

Order

Number

Description Display Measurements Printout

Color ECG NBP Temp SpO2CO2Recorder

862474 Standard Color ••••• (optional)

862478 Sedation Color ••••••(optional)

The following diagram illustrates the controls located on the front panel of your C3.

A
B

C

D

1-4 Overview

E

Callout Button/LED

A. AC LED

B. Battery LED

C. Audio Alarm Control button

D. NBP button

E. Volume button

F. Contrast button

G. On/Standby button

F

G

Features and Options

Front of Monitor

Use the following diagram to familiarize yourself with the main features of your C3 monitor.
The recorder module and all patient input connectors are located on the monitor’s side panels.

C

B

/min

85

mV

1.0

cm

SpO

2

A

CO

2

x

X

Adult

mmHg

183/ 107

(149 )

SpO

%

2

93

etCO

2

mmHg

33

awRR
/min

23

°

T °C

37.8

01/06/03 01:09:17

180

imCO

1

D

2

E

Callout Description

A. Patient Monitoring Input Connectors

B. Main Monitoring Screen

C. Handle

D. Recorder (optional. Not available in all models)

E. Navigation Wheel

Overview

1-5

Features and Options

Rear of Monitor

100-230V~

50-60 Hz. 1.0A

The following diagram is of the rear panel. For an explanation of the symbols located on this
panel, see “Explanation of Symbols” on page vi.

The C3 has four connections on its rear panel. The diagram below is of the rear panel. It
shows you how to make the four possible connections (Defib Sync, Equipotential, AC Input,
and RS-232 I/O).

A

T1AL 250VT1AL 250V

C

9700859

IPX1

YYYY-XX

CE

0123

100-230V~

50-60 Hz. 1.0A

T1AL 250VT1AL 250V

970085

YYYY-XX

CE

0123

IPX1

PHILIPS C3 PATIENT MONITOR
Manufactured for Philips for
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810
Made in U.S.A.

B

D

Callout Connector Connector Type Label

A. AC Input 3-line connector IEC 320 receptacle

100 - 240V ~

50 - 60Hz

1A

B. RS-232 I/O DB-9 (male)

C. Equipotential

Equipotential

Grounding Post

The equipotential grounding post
may be used by facilities as required
by their procedures.

D. Defib Sync 2.5mm subminiature phone jack

1-6 Overview

Features and Options

Screen Display

The LCD displays parameter values, real-time waveforms, alarm messages and screen
selection icons.

• Numeric frames displays icons and numeric values of
real-time physiologic parameter.

• Waveform frames displays real-time waveforms, graphical
trend, or tabular trend data.

• Message and Icon frames displays alarm messages and screen
selection icons.

Standard Model

/min

85

%

SpO

2

93

mmHg

183 / 107

(149 )

/min

14

Numeric
Frames

180

Waveform
Frames

1.0

SpO

mV

cm

2

Message
and Icon
Frames

T °C

37.8

x

X

Adult

01/06/03 01:09:17

Overview

1-7

Additional Documentation

Frames

Message
and Icon
Frames

1.0

SpO

CO

mV

Sedation Model

/min

85

cm

2

2

x

X

Adult

mmHg

183/107

SpO

(149 )

%

2

180

93

etCO

2

mmHg

33

awRR
/min

T °C

01/06/03 01:09:17

23

37.8

imCO
1

Numeric
Frames

2

Additional Documentation

To perform test and troubleshooting procedures and to understand the principles of operation
and circuit analysis sections of this manual, you must know how to operate the monitor. Refer
to the C3 Instructions For Use guide to understand the various sensors, ECG leads, blood
pressure cuffs, CO
monitor. Instructions for cleaning and caring for the accessories can also be found in the
individual Directions for Use that accompany these accessories.

2

parameters and accessories and temperature probes that work with the

1-8 Overview

Site Preparations

This chapter describes how to perform site preparation and how to comply with safety
guidelines and requirements.

2

Site Preparations 2-1

General Site Preparation Safety Information

General Site Preparation Safety Information

WarningWarning

To avoid contaminating or infecting personnel, the service environment or other

equipment, make sure that equipment which has been used before has
been appropriately disinfected and decontaminated.

Disconnect the monitor from the AC source by unplugging the power cable from the AC

power connector located on the rear of the monitor. The On/Standby
button does not disconnect the monitor from the AC mains supply

Accessory equipment connected to the monitor’s data interface must be certified

according to IEC Standard 60950 for data-processing equipment or
IEC Standard 60601-1 for electromedical equipment. All combinations
of equipment must be in compliance with IEC Standard 60601-1-1
systems requirements.

Explosion Hazard. Equipment not suitable for use in the presence of a flammable

anaesthetic mixture with air, or with oxygen or nitrous oxide.

Make sure that you have read all applicable instructions before attempting to install the

wall mount.

Wall mounts that are intended to support monitors must be capable of supporting 4

times the weight of the monitor when properly installed.

Do not mount any portion of a monitoring instrument over a patient’s bed.

Do not exceed the maximum rated load specified for each wall mount.

Ensure that no electrical wiring, utilities, or piping interfere with the selected wall

mounting location.

Note

Do not return sensors, patient cables, NBP tubing and cuff, or the power cord.

2-2 Site Preparations

Site Preparation Guidelines

• Check that the environment is reasonably free from dust, vibration, corrosive or
explosive gases and is within specified temperature and humidity ranges. See

Chapter 12, “Specifications”

• Position the monitor so that the display is clearly visible and the controls are easy to
reach.

Warning, Cautions and Safety Precautions

Site Preparation Guidelines

Patient Safety

Patient Leakage Current

To better secure patient safety, become familiar with the details in
Chapter 12, “Specifications.”

The patient leakage current is <= 50µA @ 250 V. The monitor has patient input connectors
(Type CF) that are protected against the effects of defibrillation and electrosurgery.

You will find the following heart symbol on the side of the monitor where the patient
monitoring input connectors are located. The symbol indicates that the monitor is Type CF
and is designed to have special protection against electric shocks (particularly regarding
allowable leakage currents, having a F-Type applied part, according to the standards IEC
60601-1/EN60601-1/CSAC22.2 601.1/UL 2601-1), and is defibrillator proof.

Site Preparations

2-3

Preparing to Use the Monitor

Preparing to Use the Monitor

WarningWarning

To avoid contaminating or infecting personnel, the service environment or other

equipment, make sure that equipment which has been used before has
been appropriately disinfected and decontaminated.

Power
Source

Requirements

Protecting Against Electrical Shock

Equipotential

Grounding

See the section titled, “Electrical” on page 12- 3 for all electrical specifications.

The C3 patient monitor is classified as Class I Equipment with an internal power source
according to IEC 60601-1/CSAC22.2 601.1/UL 2601-1, which means that it is a monitor
included in the protective grounding (protective earth) system of the room by way of
grounding contacts in the power plug.

WarningWarning

Disconnect the monitor from the AC source by unplugging the power cable from the AC

power connector located on the rear of the monitor. The On/Standby
button does not disconnect the monitor from the AC mains supply.

To eliminate potential differences between difference pieces of equipment, the monitor must
have a separate connection to the equipotential grounding system.

One end of the equipotential grounding cable (potential equalization conductor) is connected
to the equipotential grounding post on the rear of the monitor, and the other end is connected
to one point of the equipotential grounding system.

Combining Equipment

2-4 Site Preparations

All combinations of medical equipment with non-medical equipment must comply with IEC
60601-1-1.

WarningWarning

Accessory equipment connected to the monitor’s data interface must be certified

according to IEC Standard 60950 for data-processing equipment or
IEC Standard 60601-1 for electromedical equipment. All combinations
of equipment must be in compliance with IEC Standard 60601-1-1
systems requirements.

Unpacking the Monitor

Disposing of the Monitor

To avoid contaminating or infecting personnel, the environment or other equipment, make
sure you disinfect and decontaminate the monitor appropriately before disposing of it in
accordance with your country’s law for equipment containing electrical and electronic parts.

For disposal of parts and accessories, such as ECG and SpO
follow local regulations regarding disposal of hospital waste.

For disposal of the lead-acid battery, follow local regulations for safe disposal of lead.

WarningWarning

Explosion Hazard. Equipment not suitable for use in the presence of a flammable

Unpacking the Monitor

The box comes with the following:

• the C3 Instructions for Use guide

• the C3 patient monitor

• an AC power cord

In addition, you should receive all of the accessories and options that you have ordered.

, where not otherwise specified,

2

anaesthetic mixture with air, or with oxygen or nitrous oxide.

If there is anything missing, contact your Philips Medical Systems representative
immediately.

Checking the Shipment

Examine the carton carefully for evidence of damage in transit. If you discover any damage,
contact the carrier immediately. Retain all packing material.

If you have to return the monitor, contact the Philips Response Center or your local Philips
representative for shipping instructions.

To pack the monitor for return, disconnect all cables. Pack the monitor in its original shipping
carton. If this is unavailable, use a suitable carton with appropriate packing material to protect
the monitor during shipping.

Note

Do not return sensors, patient cables, NBP tubing and cuff, or the power cord.

Site Preparations

2-5

Returning System Components

Returning System Components

If it is necessary to return the monitor for service, call the Philips Response Center or your
local Philips representative for shipping instructions. Have all equipment serial numbers
available when calling.

To pack the monitor for return, disconnect all cables. It is not necessary to return sensors,
patient cables, NBP tubing and cuff or power cord. Pack the monitor to be returned in its
original shipping carton if available. If not, use a suitable carton with appropriate packing
material to protect the monitor during shipping.

2-6 Site Preparations

Mounting

Mounting

WarningWarning

Make sure that you have read all applicable instructions before attempting to install the

wall mount.

Wall mounts that are intended to support monitors must be capable of supporting 4

times the weight of the monitor when properly installed.

Do not mount any portion of a monitoring instrument over a patient’s bed.

Do not exceed the maximum rated load specified for each wall mount.

Ensure that no electrical wiring, utilities, or piping interfere with the selected wall

mounting location.

The rear panel includes threaded standoffs for attaching a mounting system accessory.

Mounting
Standoffs

100-230V~
50-60 Hz.

T1AL 250VT1AL 250V

97008

YYYY-XX

CE

0123

IPX1

PHILIPS C3 PATIENT MONITOR
Manufactured for Philips for
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810

Site Preparations

2-7

Warnings, Cautions, and Safety Precautions Relating to Wall Mount Installation

Warnings, Cautions, and Safety Precautions Relating to Wall Mount

Installation

• Make sure that you have read all applicable instructions before attempting to install the
wall mount.

• Wall mounts that are intended to support monitors must be capable of supporting four
times the weight of the monitor when properly installed.

• If wall mounts are to be installed on plaster board walls, we recommend that the mounts
be installed using steel or plywood plates sufficient to distribute the load over a large
section of the wall. Lead expansion bolts are neither adequate nor safe for this
purpose.

• It is the responsibility of the hospital, institution, or its designated representatives to
determine that the wall is adequate to safely mount monitoring instrumentation. This
includes the selection of and proper installation of the appropriate fasteners and mounts.
In a new construction, or in a remodelled construction where the wall can be completely
or partially removed, a 16-gauge steel stud should be mounted for the purpose of
attaching the wall channel. This design safety factor is based on four times (4x) the
maximum rated load.

• GCX Wall Channel: Always reposition the adjustable channel safety stop under the
adapter plate when the height of the monitor is changed.

• The channel safety stop prevents the mounting device from inadvertently falling or
being pulled out of the wall channel. Do not remove this stop while the mount is
supporting a monitor.

• Do not mount any portion of the monitor over a patient’s bed.

• Do not exceed the maximum rated load specified for each wall mount.

• Ensure that no electrical wiring, utilities, or piping interface with the selected wall
mounting location.

• Do not install wall channel onto solid brick or brick veneer walls. Do not attempt to
install wall mounts onto crumbly wall material.

• Check the mounting hardware holding the wall channel or bracket to the wall every 12
months. Tighten if necessary.

2-8 Site Preparations

Mounting the GCX Wall Channel

To install the GCX Wall Channel and Tilt/Swivel mount, follow the documentation packaged
with the channel.

Attaching the Mounting Plate to the Monitor

Mounting the GCX Wall Channel

Step Action

1 Unpack the mounting plate and check all parts are present.

2 Unscrew the 5 screws from the mounting standoffs located on the rear of the

monitor.

3 Place the Wall Plate over the mounting standoffs.

4 Re-insert and tighten the screws to secure the wallplate to the monitor.

Site Preparations

2-9

Attaching the Monitor to the Wall Channel

Attaching the Monitor to the Wall Channel

r

o

t

r

i

o

n

f

o

s

M

p

i

t

l

i

n

h

s

e

i

P

t

m

r

a

e

t

o

P

f

s

3

y

d

d

S

a

C

e

l

r

o

s

a

u

R

t

p

c

i

i

l

c

n

i

d

a

0

a

f

h

e

1

u

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t

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p

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i

n

l

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.

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h

M

,

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P

.

r

0

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0

S

.

v

0

U

o

3

d

n

i

n

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A

d

a

M

Latch

3

2

1

0

9

5

8

0

0

7

9

1

X

P

I

Step Action

1 Slide the Tilt/Swivel mount into the Wall Plate as illustrated by the above

diagram.

2 Make sure the latch snaps into the hole on the upper right-hand corner of the

wallplate.

2-10 Site Preparations

Maintaining the Monitor

This chapter describes how to clean your monitor and how to keep your monitor in the best
working condition.

3

Maintaining the Monitor 3-1

Maintenance Safety Information

Maintenance Safety Information

WarningWarning

Follow local governing ordinances and recycling plans regarding disposal or recycling

batteries and other device components.

If the battery shows signs of damage or signs of leakage, replace it immediately. Do not

use a faulty battery in the monitor.

Never use a monitor that is monitoring a patient to perform battery conditioning.

Caution

Do not immerse the monitor in liquid or use caustic or abrasive cleaners.

Do not spray or pour any liquid on the monitor or its accessories.

Do not allow any liquid to penetrate connectors or openings in the monitor’s chassis.

3-2 Maintaining the Monitor

Objectives

Concepts

Objectives

In order to meet this chapter’s objectives, you should be able to perform light maintenance
and preventative maintenance for the monitor through the following tasks:

• Inspection of the monitor

• Cleaning the monitor

• Battery Maintenance

Light

Maintenance

Battery

Conditioning

Light maintenance tasks can be defined as those tasks required to maintain the monitor in
clean, functional working order. These include inspection, cleaning practice and battery
maintenance as well as the continuous observation of replaceable parts for wear.

A rechargeable battery must be conditioned at regular intervals to prepare it for further
charge/discharge cycles. Conditioning a battery refers to the complete discharge of a charged
battery by allowing it to die out while in non-critical use. The empty battery may then be
recharged and put back into use.

Maintaining the Monitor

3-3

Recommendations for Maintenance Frequency

Recommendations for Maintenance Frequency

The following table is the recommended maintenance schedule for your C3 monitor. The
maintenance checklist appears in the next section of this chapter. The checklist may be
photocopied and should be completed by the maintainer. It should be filed for future
reference. The owner of the equipment is responsible for the performance of the maintenance
activities with the schedule below.

Maintenance Frequency Procedure

Inspect the monitor, cables
and cords

Cleaning As needed “Cleaning”on page 3-7

Safety checks according to
IEC 60601-1

Functional testing
procedures

Performance Assurance At least once every year, or

Replace backlight 20,000 hours (about 4

NBP Maintenance Every year, or as needed, if

Battery Maintenance Every two years “Battery Maintenance”on page 3-7

Battery Conditioning Approximately every 200

Daily “Inspecting the Monitor”on page 3-6

At least once every 2 years,
after any repairs, if the
monitor has been dropped
or as needed.

When functional defects in
the measurements are
suspected.

as needed (if you suspect
defects in the
measurements).

years) of continuous use, or
as needed.

the monitor has been
opened, or you suspect
defects in the measurement.

deep discharges.

and “Inspecting the Cables and

Cords”on page 3-6

“Patient Safety Tests”on page 4-39

“Functionality Assurance”on page 4-3

“Performance Assurance Test”on page
4-11

“Replacing the Backlight Tube”on
page 7-9

“Preventative Maintenance Tests”on
page 4-14

“Conditioning a Battery”on page 3-10

3-4 Maintaining the Monitor

Maintenance Checklist

Maintenance Checklist

Topics See Page....

Inspect Cables, Cords and Housing 3-6

Replacing the Backlight Tube
Assembly

NBP Preventative Maintenance 4-14

Cleaning Guidelines 3-7

Checking the Battery Status 3-8

Charging the Battery 3-9

Conditioning the Battery 3-10

Testing the Monitor 4-1

7-9

Check Here if

Completed

Date

Completed

Maintaining the Monitor

3-5

Inspecting the Monitor

Inspecting the Monitor

If you discover a problem while inspecting monitor, contact your biomedical department or
Philips Medical Systems.

With the monitor turned Off:

Step Action

Examine the exterior of the monitor for cleanliness and general physical

1

condition. Verify that the housing is not cracked or broken, that
everything is present, that there are no spilled liquids and that there are
no signs of abuse.

2 Inspect all accessories (cables and sensors) external to the monitor,

referring to the accessories’ documentation.

3 Switch the monitor On and verify that the backlight is bright enough.

Check that screen is at its full brightness. If the brightness is not
adequate, contact your biomedical department. Philips Medical Systems
recommends replacing the backlight about every 4 years.

4 If you are operating the monitor from battery, verify that the battery is

adequately charged before you begin use.

Inspecting the Cables and Cords

If you discover a problem while inspecting the cables and cords, replace the cable, or contact
your biomedical department.

Step Action

Examine the power plug and cord for damage. Make sure that the prongs

1

of the plug do not move in the casing. If damaged, replace the entire cord
with the appropriate Philips power cord.

2 Inspect the patient cables and leads and their strain reliefs for general

condition. Make sure there are no breaks in the insulation. Make sure
that the connectors are properly engaged at each end to prevent rotation
or other strain.

3 With the sensor or electrodes applied to the patient, and the monitor

turned On, flex the patient cables near each end to make sure that there
are no intermittent faults.

3-6 Maintaining the Monitor

Cleaning

Cleaning

Caution

Do not immerse the monitor in liquid or use caustic or abrasive cleaners.

Do not spray or pour any liquid on the monitor or its accessories.

Do not allow any liquid to penetrate connectors or openings in the monitor’s chassis.

To clean the monitor, dampen a cloth with a commercial, nonabrasive cleaner and wipe the
top, bottom, and front surfaces lightly. For cables, sensors and cuffs, follow the cleaning
instructions in the Directions for Use shipped with those components.

If liquid is accidentally spilled on the monitor, clean and dry it thoroughly before reuse.

If in doubt about monitor safety, refer the unit to qualified service personnel.

Battery Maintenance

This section provides some information on how to handle and maintain the battery.

WarningWarning

Follow local governing ordinances and recycling plans regarding disposal or recycling

About the Battery

Storing the monitor for a long period of time without charging the battery can degrade the
battery capacity. A complete battery recharge (>90%) requires 8 hours in standby mode or 14
hours in operational mode. If the battery needs charging, connect the monitor to the AC outlet
as described “Charging the Battery”on page 3-9

If the monitor operates for less than one hour on battery power before the low battery alarm
occurs, the battery should be conditioned. See “Electrical”on page 12-3 for typical battery
operating times and conditions.

If the same symptom persists after the battery is conditioned and indicating a full charge, the
battery should be replaced (see “Removing the Battery”on page 7-4 for more information).

batteries and other device components.

Maintaining the Monitor

3-7

Battery Maintenance

Battery Guidelines

Checking the Battery Status

To get the most out of the battery, observe the following guidelines:

• The shelf-life of a fully charged battery is about 6 months.

• After a battery has been activated, keep it charged. If it is not in use, recharge it every 3
to 4 months.

• Condition the battery approximately every 200 deep discharges.

• Remove the battery from the monitor if it is not being used regularly. (Leaving the
battery in a monitor that is not in regular use using the battery will shorten the life of
the battery).

• Battery Disposal - We recommend replacing the monitor’s sealed, lead-acid battery at 2
year intervals. Follow local governing ordinances and recycling plans regarding
disposal or recycling of batteries and other device components.

• Do not dispose of the battery in normal waste containers.

WarningWarning

If the battery shows signs of damage or signs of leakage, replace it immediately. Do not

use a faulty battery in the monitor.

When the monitor is connected to the AC (mains) power supply, the battery charges
automatically.

Battery status is indicated several ways:

• LEDs on the front panel of the monitor.

• Battery gauge on the monitor’s main monitoring screen.

• INOP messages

The AC LED is only on when the power cord is connected and the AC power is available to
the monitor. In this case, the battery can be either charging or fully charged.

3-8 Maintaining the Monitor

Battery Maintenance

Identifying Battery Strength

You can determine the monitor’s battery strength by the color of the battery icon, or by the
number of illuminated bars on the battery icon. The following table describes the battery icon
behavior:

Number of Bars
Illuminated

3, 4, or 5 Green Constant display

2 Yellow Constant display

1 Red Constant display

0 Red Battery icon flashes

Color Used Behavior

and message displays

• If the battery operating time is less than 30 minutes, the battery icon flashes. A low
priority audio alarm sounds (1 beep every 4 seconds).

• When the battery is empty, a "Low Battery" INOP message displays in the Message
frame and the audible alarm sounds. Pressing any front panel button clears the INOP
and silences the audible alarm. The battery icon continues to flash until the monitor is
powered down or automatically switches off.

If the new battery is partly or fully charged, the monitor starts operating.

Charging the Battery

A complete battery recharge (>90%) requires 8 hours in standby mode or 14 hours in
operational mode.

To charge the battery:

Step Action

1 Connect the monitor to the AC power source using the proper power cord.

2 Verify that the AC Input Indicator LED is lit.

3 Charge the battery for at least 8 hours. The battery may require a full discharge/

charge cycle to restore it to its normal capacity.

4 To check for a full charge, perform the procedure described in “Battery

Performance Test”on page 4-22.

Maintaining the Monitor

3-9

Battery Maintenance

Conditioning

a Battery

Why is Battery

Conditioning

Necessary?

When Should

Battery

Conditioning

be Performed?

How to

Condition a

Battery

Battery conditioning re-calibrates the battery to ensure that it has accurate information on the
actual battery capacity.

WarningWarning

Never use a monitor that is monitoring a patient to perform battery conditioning.

The capacity of a battery decreases gradually over the lifetime of the battery. Each time a
battery is charged its capacity decreases slightly. Therefore, the operating time of a monitor
running off the battery also decreases with each charge cycle.

Battery conditioning ensures that the value storied in the battery for its fully capacity takes
account of this decrease, so that the remaining battery charge can be calculated accurately,
and the low battery warning given at the right time.

Battery conditioning should be performed:

• Every 200 deep discharge cycles.

We recommend two full charge and discharge cycles to ensure proper conditioning,
independent of the initial condition of the battery.

If you need to continue battery powered monitoring, replace the battery in the monitor with a
different charged and conditioned battery. You cannot condition a battery in a monitor that is
being used.

3-10 Maintaining the Monitor

Step Action

1 Insert the battery that is to be conditioned into a monitor that is not currently

being used.

2 Disconnect the monitor from the AC power supply.

3 Turn on the monitor, and leave it on until it switches off automatically.

4 Turn the monitor Off using the On/Standby button located on the front panel.

5 Reconnect the monitor the AC power supply.

6 Charge the battery until it is full. (When you turn the monitor On, the 5 bars in

the battery gauge on the main monitoring screen will be illuminated).

7 Repeat steps 2 to 6.

Battery Maintenance

Battery INOP Messages

The following battery-related INOP messages are issued by the monitor. All Battery INOPs
continue until the monitor is plugged into the AC power or the INOP condition is fixed.

• "Low Battery" - This is an INOP which indicates that the remaining battery-operating
time is less than approximately 30 minutes.

Maintaining the Monitor

3-11

Battery Maintenance

3-12 Maintaining the Monitor

Testing the Monitor

This chapter provides a checklist of testing procedures used to verify performance following
repairs or during routine maintenance. All tests can be performed without removing the
monitor’s covers.

If the monitor fails to perform as specified in any test, repairs must be done to correct the
problem before the monitor is returned to the user.

4

Testing the Monitor 4-1

Testing Safety Information

Testing Safety Information

WarningWarning

Perform all leakage tests any time the unit is opened.

AC mains voltage is present on the applied part terminals during this test. Exercise

caution to avoid electrical shock hazard.

Note

The monitor must be placed in Diagnostic Mode, with the NBP test screen active for each of
the NBP tests.

If the test fails, ensure the integrity of the cuff and tubing, then test again. If the test fails
again, verify the integrity of all the pneumatic tubing inside the monitor.

Before beginning the Battery Performance test, ensure that the monitor is disconnected from
the AC power source.

4-2 Testing the Monitor

Objectives

Concepts

Objectives

In order to meet this chapter’s objectives, you should be able to test the monitor through the
following types of tests:

• Performance Assurance Check List

• Accuracy, Calibration and Performance Procedures

• Patient Safety Checks

For inspection procedures; preventative maintenance procedures; cleaning procedures; and
battery maintenance, refer to this chapter and Chapter 2, “Site Preparations”.

Functionality

Assurance

Preventative

Maintenance

Performance

and Safety
Tests

This refers to the combined Performance Assurance Test and Functionality Testing
Procedures found in this chapter. These tests verify correct monitor functionality in general
terms.

Preventative Maintenance refers specifically to the service calibration tests required to ensure
the monitor measurement results are accurate. When authorized Philips personnel service the
monitor, they report these results back to Philips. The collected data forms a database to be
used in product development. These specific tests are required for the NBP parameter. It is not
necessary for hospital personnel to report results.

This concept refers to all the remaining accuracy and performance tests available on the
monitor, including safety tests and checks for the monitor.

Testing the Monitor

4-3

Testing Checklist

Testing Checklist

The tests described in this chapter are listed in the table below. Use this table
as a checklist.

Topics See...

Functionality Assurance Tests

Performance Assurance Test page 4-11

Power-On Self-Test page 4-11

Alarm Test page 4-12

Volume Control Test page 4-12

Preventive Maintenance Tests

NBP page 4-14

Performance Procedures

Battery Performance Test page 4-22

Temperature Test page 4-23

ECG Performance page 4-25

Respiration Performance page 4-25

SpO

Performance page 4-27

2

CO2 Performance page 4-29

Serial Interface and Nurse Call Signal Test page 4-36

ECG Sync Performance Test page 4-38

Patient Safety Tests

S(1) Ground Integrity page 4-39

S(2) Electrical Leakage page 4-41

S(3) Earth Leakage Current page 4-41

S(4) Enclosure Leakage Current page 4-42

S(5) Patient Leakage Current page 4-43

S(6) Patient Leakage Current with Mains page 4-44

Check Here

if Completed

Date

Completed

4-4 Testing the Monitor

Test Reporting

Test Reporting

The following table shows what must be recorded on the Service Record after completing the
tests in this chapter.

Test What to Record

Functionality Assurance Tests

Visual V:P or V:F

Power On PO:P or PO:F

Preventive Maintenance Tests

P NBP

Performance Procedures

Performance PCO2: P/X1/X2/X3/X4/X5/X6/X7 or

CO

2

Patient Safety Tests

Safety(1) Ground Integrity S(1):P or S(1):F

Safety(2) Earth Leakage Current S(2):P or S(2):F

Safety(3) Enclosure Leakage Current S(3):P or S(3):F

Safety(4) Patient Leakage Current S(4):P or S(4):F

Safety(5) Patient Leakage Current with Mains S(5):P or S(5):F

PN:P/X1/X2/X3/X4/X5 or
PN:F/X1/X2/X3/X4/X5
See page 4-15 for details

PCO2: F/X1/X2/X3/X4/X5/X6/X7
See page 4-30 for details

Where P = Pass, F = Fail and X is the measured value as defined in the tests described in this
chapter.

Testing the Monitor

4-5

Recommendations for Testing Frequency

Recommendations for Testing Frequency

The testing checklist appears in the next section of this chapter. Perform the procedure as
indicated in the suggested testing timetable. These timetable recommendations do not
supersede local requirements.

Suggested Testing Frequency

Functionality Assurance

• Performance Assurance Test

• System Self-Test

Preventative Maintenance Tests (NBP) Every year, or as needed.

Performance Tests

• Battery Performance

• Temperature Accuracy

• ECG Performance

• Resp Performance

•SpO

•CO2 Performance

Performance

2

When functional defects in the measurements are
suspected, after any repairs, if the monitor has been
dropped or opened.

The battery performance test must be performed every
two years, before monitor repairs, or whenever the
battery is suspected as being the source of the problems.

All other test must be performed at least once every
year, if the monitor has been opened, or if you suspect
defects in the measurements.

• Serial Interface and Nurse Call
Signal Test

• ECG Sync Performance

Safety Checks (in accordance with IEC
60601-1)

• Ground Integrity

• Electrical Leakage

• Earth Leakage Current

• Enclosure Leakage Current

• Patient Leakage Current

• Patient Leakage Current with Mains
Voltage on the Applied Part

a. Only when in use as part of hospital protocol safety checks.

a

At least once every 2 years, after any repairs, if the
monitor has been dropped or opened.

4-6 Testing the Monitor

Test Map

Test Map

The Test Map shows which tests are required in which situations.

Service Event
(When performing...)

Test Block Required
(...complete these test)

Installation • Visual

• Power On

Monitor exchange • Visual

•Power On

Monitor opened • Power On

• Pneumatic Leakage Test

• All Safety tests

Battery replacement • Power On

• Battery Performance

• All Safety tests

Speaker replacement • Power On

• Pneumatic Leakage Test

• All Safety tests

Backlight tube replacement • Power On

• Pneumatic Leakage Test

• All Safety tests

NBP pump replacement • Power On

• Pneumatic Leakage Test

• All Safety tests

• Preventative Maintenance Tests

module replacement • Power On

SpO

2

• Pneumatic Leakage Test

• All Safety tests

•SpO

module replacement • Power On

CO

2

Tests

2

• Pneumatic Leakage Test

• All Safety tests
Tests

•CO

2

Power supply module replacement • Power On

• Pneumatic Leakage Test

• Safety Tests

Patient monitoring I/O module
replacement

•Power On

• Pneumatic Leakage Test

• All Safety tests

• All Performance tests

Communications module replacement • Power On

• Pneumatic Leakage Test

• All Safety tests

Testing the Monitor

4-7

Equipment

Equipment

The following table lists the equipment required for performance verification.

Equipment Description

Digital multimeter (DMM) Fluke model 87 or equivalent

Defib Sync Cable and
Switchcraft 3.5 mm phone plug

SpO

adapter cable M1943A

2

SpO

reusable sensor, adult finger M1191A

2

ECG trunk cable M1540C (ICU, AAMI) or M1550C (ICU, IEC)

ECG electrodes Standard

ECG lead sets M1605A (AAMI) or M1615A (IEC)

NBP tubing M1599B

NBP reusable cuff, adult 40401C

Pulse oximeter tester Clinical Dynamics Corp - SmartSat simulator with

ECG simulator Dynatech Nevada medSim 300 or equivalent

NBP simulator Bio-Tek BP Pump 2 or equivalent

Temperature simulator MedSim 300 or equivalent

Respiration simulator MedSim 300 or equivalent

Safety analyzer Bio-Tek 601 Pro or equivalent

Stopwatch Manual or electronic

Screwdriver flathead and philips

Tweezers any model

Electronic flowmeter M1026-60144

Cal 1 gas (5% CO

Cal 2 gas (10% CO

) 15210-64010

2

) 15210-64020

2

Cal gas flow regulator M2267A

Cal tube 13907A

M4820A (see page 4-38 to use a substitute cable)
Switchcraft 750 or equivalent

Nellcor simulator cable

4-8 Testing the Monitor

Serial Numbers

When recording test results, these are always associated with a particular monitor by means of
the serial number. The serial number is 10 characters and is located on the back of the
monitor.

Serial Numbers

Serial

Number

Passwords

100-230V~

50-60 Hz. 1.0A

T1AL 250VT1AL 250V

USC3xxxxxx

9700859

IPX1

YYYY-XX

CE

0123

PHILIPS C3 PATIENT MONITOR
Manufactured for Philips for
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810
Made in U.S.A.

Some of the test may require that you enter the Power-Up Default Menu located in the
Setup Menu. To access Power-Up Default Menu you must enter a password. The password

is:

2 - 1 - 5

Testing the Monitor

4-9

Visual Test

Visual Test

Power On Test

Inspect the system for obvious signs of damage. Also check external leads and accessories.

What to record on the service record:

V:P or V:F

Step Action

1 Switch the monitor On.

2 Observe whether the system boots up successfully without displaying any error

codes. The main monitoring screen should display.

What to record on the service record:

PO:P or PO:F

.

4-10 Testing the Monitor

Functionality Assurance Tests

The following assurance checks are recommended to verify proper operation daily before the
monitor is used to monitor a patient.

During functionality assurance checks, verify the overall operation by completing the
following Performance Assurance Tests.

Functionality Assurance Tests

Performance

Assurance
Test

Power-On Self-Test

To verify your monitor works properly, perform the following test:

Step Action

1 Using the supplied AC power cord, connect the monitor to the AC power source.

2 Verify that the AC LED is lit.

3 Do not connect any patient monitoring input connectors or cables to the monitor.

If there are any such connections, disconnect them.

4 If the monitor is Off, press the On/Standby button. The monitor must perform

the following sequence:

a. The screen backlight illuminates.

b. Three consecutively higher pitched "chimes" sound while the version

numbers of the boot and operational software display.

c. After successful completion, the main monitoring screen displays. No vital

sign numeric values or waveforms display.

5 If any error codes display, or the screen remains blank, refer to

Chapter 6, “Troubleshooting”.

After you first press the On/Standby button, the monitor displays a startup screen and
conducts a set of self-diagnostic test routines.

Testing the Monitor

4-11

Functionality Assurance Tests

Alarm Test Tools Needed:

•SpO

adapter cable (M1943A)

2

• Clinical Dynamics Corp - SmartSat simulator (with Nellcor simulator cable)

Step Action

1 Connect SpO

the SpO

2 Set the simulator as follows:

3Press the On/Standby button to turn the monitor On.

4 After the normal power-up sequence, verify that the SpO

indicates zero, or is blank.

5 Verify that the following monitor reaction occurs:

a. After approximately 45 seconds, the monitor displays saturation and heart rate

as specified by the tester. Verify that the values are within the following
tolerances:

– Oxygen Saturation Range 79% to 83%
– Heart Rate Range 33 to 39 bpm

simulator cable to the SpO2 adapter cable. Connect the cable to

2

patient monitoring input connector.

2

Item Setting

Oximeter Nellcor

SpO2%

BPM 36

Pulse Mod 0.50%

81

% display initially

2

Volu me Control Test

b. The audible alarm sounds and both the SpO

flash, indicating both parameters have violated the default alarm limits.

c. The HR tone is heard. For this test, the HR tone source must be set to SpO2

from the Heart Rate Menu.

6Press the Alarm Silence button to temporarily silence the audible alarm.

7 Verify the following:

a. The audible alarm remains silenced.
b. The crossed-out bell icon displays in each numeric frame on the screen.
c. The SpO
d. The HR tone remains audible.
e. The audible alarm returns in approximately 120 seconds.

% and HR displays continue flashing.

2

% and Heart Rate (HR) displays

2

Tools Needed:

•SpO

adapter cable (M1943A)

2

• Clinical Dynamics Corp - SmartSat simulator (with Nellcor simulator cable)

4-12 Testing the Monitor

Functionality Assurance Tests

Step Action

1 Connect SpO

simulator cable to the SpO2 adapter cable. Connect the cable to

2

the SpO2 patient monitoring input connector.

2 Set the simulator as follows:

Item Setting

Oximeter Nellcor

SpO2%

81

BPM 70

Pulse Mod 5.00%

3 a. Power the monitor On. Verify that the values are within the following

tolerances:

– Oxygen Saturation Range 79% to 83%
– Heart Rate Range 67 to 73 bpm

4Press the Alarm Silence button to temporarily silence the audible alarm.

5 Verify that the heart rate tone source, found in the Heart Rate Menu, is set to

.

SpO

2

6Press the Volume button on the monitor’s front panel. Within 3 seconds of

having pressed the button, rotate the navigation wheel clockwise to verify that
the beeping heart rate tone sound level increases.

7 Wait 3 seconds. Press the Volume button and rotate the wheel counter-clockwise

and verify that the beeping heart rate tone decreases until it is no longer audible.
Rotate the wheel clockwise to return the beep volume to a comfortable level.

After 3 seconds with no wheel activity, the volume adjust function terminates.

Testing the Monitor

4-13

Preventative Maintenance Tests

Preventative Maintenance Tests

Preventative maintenance refers specifically to the service tests required to make sure the
monitor measurement results accurate. In cases where the performance of NBP is in question
or could have been configured during repair, the complete set of NBP tests described in this
service manual should be used.

The tests in this section verify the functionality of the monitor’s pneumatic system. All of
these tests, which the exception of the Basic Pneumatic Leakage (BPL) Test, require the use
of an NBP simulator.

Note

The monitor must be placed in Diagnostic Mode, with the NBP test screen active for each of
the NBP tests. To place your monitor into this mode see page 4-9.

Tools Needed for NBP Testing:

• NBP cuff (40401C)

• NBP tubing (M1599B)

• Bio-Tek BP Pump 2 simulator or equivalent, with an internal test volume of 310 ml.

4-14 Testing the Monitor

Documenting

NBP Test
Results

Preventative Maintenance Tests

The following table lists the tests that should be documented and summarizes how to
document the NBP test results.

Test Expected Test Results

Pressure Transducer Accuracy Test X1 = difference between the pressure on

the monitor and on the simulator

Difference less than or equal to 5
mmHg (0.7 kPa)

Pneumatic Leakage Test X2 = difference between the pressure at

the start (P1) and after one minute (P2)

Difference less than or equal to 6
mmHg (0.8 kPa)

Inflation Rate Test X3 = number of seconds for the monitor

to inflate

Rate between 1 and 6 seconds

Over-Pressure Test X4 = peak value

Peak value between 270 and 330 mmHg
(36 kPa and 44 kPa)

Deflation Rate Test X5 = mmHg (kPa) per second to deflate

1.8 mmHg/s to 4.8 mmhg/s

What to record on
service record

PN:P/X1/X2/X3/X4/X5

or

PN:F/X1/X2/X3/X4/X5

P = passed, F = failed

Testing the Monitor

4-15

Preventative Maintenance Tests

Pneumatic
System

Functionality

To Z e ro the

Simulator

The following tests must be performed to verify pneumatic system functionality. Perform
these tests in the following order:

1. Pressure Transducer Accuracy

2. Pneumatic Leakage

3. Inflation Rate

4. Over-Pressure

5. Deflation Rate

Note

The pneumatic system includes an over-pressure safety limit function and a safety period
time-out function. These safety functions may interfere with NBP tests described in this
section. In order to avoid activating these safety functions, do not pressurize the system
above 270 mmHg (36 kPa) and do not pressurize the system for time periods that exceed 150
seconds.

If the simulator does not display a "0" before starting a test, use the following procedure to
zero the simulator:

1. Disconnect the hose from the simulator.

2. Press Home.

3. Press SETUP.

4. Press MORE.

5. Press MORE again

6. Press ZERO PRESSURE.

7. Press ZERO.

8. Press Home to return to main menu.

9. Reconnect the hose.

Before beginning the above test sequence, perform the following three steps:

4-16 Testing the Monitor

Step Action

1 Turn the NBP simulator On.

2 Perform the following sequence:

a. Press the Home button.
b. Press the Pressure Tests button.
c. Press the Pressure Leak Test button.
d. Press the Setup button.
e. Press 2, 5, 0, then Enter.

f. Set the Cuff to Internal.

3 Connect the simulator tubing to the NBP patient monitoring input connector.

4 Place the monitor in Diagnostic Mode with the NBP test screen active.

Preventative Maintenance Tests

Pressure

Transducer

Accuracy Test

This test verifies the pressure accuracy of the monitor’s pressure transducer.

Step Action

1 Confirm that the simulator displays "Leak Test" (see steps 1 and 2, in the

previous table).

2Press the Volume button to ensure that both valves are closed.

3 Perform an offset adjustment so that the simulator and monitor both display a

pressure of 0 mmHg or kPa by doing the following:

a. Press the Contrast button on the monitor’s front panel.
b. If needed, zero the simulator (see “To Zero the Simulator” on page 4-16).

4Press Start on the simulator.

5 Allow 15-20 seconds for the pressure to stabilize. The pressure displayed on the

monitor and on the simulator should be within 5 mmHg (0.7 kPa) of one another.
Document the difference between the simulator value and the monitor value
(X1).

6Press the Stop button on the simulator to stop the test.

7 Press and hold the Volume button until the monitor displays a pressure of 0

mmHg or kPa.

8 If no further NBP tests are to be conducted, turn the monitor Off. Normal

monitoring operation returns the next time the monitor is turned On.

Pneumatic

Leakage Test

This test verifies the integrity of the pneumatic system.

Step Action

1 Turn the simulator on.

2 Perform the following sequence:

a. Press the Home button.
b. Press the Pressure Tests button.
c. Press the Pressure Leak Test button.
d. Press the Setup button.
e. Press 3, 0, 0, then Enter.
f. Set the Cuff to Internal.

3 Confirm that the simulator test screen is active and displays "Leak Test".

4Press the Volume button to ensure that both valves are closed.

5 Perform an offset adjustment so that the simulator and monitor both display a

pressure of 0 mmHg or kPa by doing the following:

a. Press the Contrast button on the monitor’s front panel.
b. If needed, zero the simulator (see “To Zero the Simulator” on page 4-16).

6Press the NBP button on the monitor’s front panel to activate the pump. Hold the

button until the monitor displays a pressure of approximately 250 mmHg
(33.3 kPa).

7 Allow 15-20 seconds for the pressure to stabilize. Record the pressure displayed

on the monitor (P1).

Testing the Monitor

4-17

Preventative Maintenance Tests

Step Action

8 Start a one minute timer. After one minute, record the pressure displayed again

(P2). The pressure should drop by no more than 6 mmHg (0.8 kPa) during the
one minute period. Calculate (P1 - P2) and document the leakage test value (X2).

9 Press and hold the Volume button until the monitor displays a pressure of 0

mmHg or kPa.

10 If no further NBP tests are to be conducted, turn the monitor Off. Normal

monitoring operation returns the next time the monitor is turned On.

Inflation Rate

Test

This test verifies the inflation rate of the monitor.

Step Action

1 Turn the simulator on.

2 Perform the following sequence:

a. Press the Home button.
b. Press the Pressure Tests button.
c. Press the Pressure Leak Test button.
d. Press the Setup button.
e. Press 3, 0, 0, then Enter.
f. Set the Cuff to Internal.

3Press the Volume button to ensure that both valves are closed.

4 Perform an offset adjustment so that the simulator and monitor both display a

pressure of 0 mmHg or kPa by doing the following:

a. Press the Contrast button on the monitor’s front panel.
b. If needed, zero the simulator (see “To Zero the Simulator” on page 4-16).

5Press the NBP button on the monitor’s front panel to activate the pump, and

simultaneously start the timer. Hold the button until the monitor displays a
pressure of 250 mmHg (33.3 kPa), then stop the timer. The inflation rate should
be between 1 and 6 seconds. Document the number of seconds (X3).

6 Press and hold the Volume button until the monitor displays a pressure of 0

mmHg or kPa.

7 If no further NBP tests are to be conducted, turn the monitor Off. Normal

monitoring operation returns the next time the monitor is turned On.

Note

The over-pressure relief may activate and automatically deflate the cuff. For more information
on the NBP safety functions, see page 4-16.

4-18 Testing the Monitor

Preventative Maintenance Tests

Over-Pressure

Test

This test verifies the functionality of the over-pressure relief system of the monitor.

Step Action

1 Turn the simulator on.

2 Perform the following sequence:

a. Press the Home button.
b. Press the Pressure Tests button.
c. Press the Pressure Relief button.
d. Press the Setup button.
e. Press 3, 3, 5, then Enter.

3 Confirm that the simulator is active and displays "Relief Valve Test".

4Press the Volume button to ensure that both valves are closed.

5 Perform an offset adjustment so that the simulator and monitor both display a

pressure of 0 mmHg or kPa by doing the following:

a. Press the Contrast button on the monitor’s front panel.
b. If needed, zero the simulator (see “To Zero the Simulator” on page 4-16).

6Press the Start button on the simulator. The peak value (X4) shown on the

simulator should be between 270 mmHg and 330 mmHg (35.9 kPa and 43.9
kPa). The pressure should return to 0 automatically on the monitor and
simulator). Both conditions should be true for the monitor to pass this test.

7 If no further NBP tests are to be conducted, turn the monitor Off. Normal

monitoring operation returns the next time the monitor is turned On.

Testing the Monitor

4-19

Preventative Maintenance Tests

Deflation Rate

Test

This test verifies the deflation rate of the monitor.

Step Action

1 Turn the simulator on.

2 Perform the following sequence:

a. Press the Home button.
b. Press the Pressure Tests button.
c. Press the Pressure Leak Test button.
d. Set the Cuff to Internal.

3 Confirm that the simulator is active and displays "Leak Test".

4Press the Volume button to ensure that both valves are closed.

5 Perform an offset adjustment so that the simulator and monitor both display a

pressure of 0 mmHg or kPa by doing the following:

a. Press the Contrast button on the monitor’s front panel.
b. If needed, zero the simulator (see “To Zero the Simulator” on page 4-16).

6 Note—Complete steps 6-9 within 150 seconds.

Press and hold the NBP button on the monitor’s front panel and inflate to 250
±10. Don’t go over 270, or safety deflation may occur. (Slow the inflation rate by
pulsing the button when the pressure is over 200).

7 Allow 15-20 seconds for the pressure to stabilize. Record the pressure displayed

on the monitor (P1).

8 Press and hold the "Alarm off" button on the monitor to release the pressure in

steps of 3 mmHg (.4 kPa). Simultaneously, start the timer.

9 Stop the timer when the pressure drops below 150 mmHg (20 kPa). Calculate the

deflation rate (X5): (starting pressure - 150)/# of seconds. The deflation rate
should be 3.3 mmHg/s ±1.5 mmHg/s (0.44 kPa/s ± 0.2 kPa/s).

10 Press and hold the Volume button until the monitor displays a pressure of 0

mmHg or kPa.

11 If no further NBP tests are to be conducted, turn the monitor Off. Normal

monitoring operation returns the next time the monitor is turned On.

4-20 Testing the Monitor

Preventative Maintenance Tests

Basic Pneumatic Leakage (BPL) Test

The purpose of this test is to verify the integrity of the NBP pneumatic system after the
monitor has been opened. This includes all external and internal tubing connections.

No simulator is required for this test, and results are not required to be reported.

Step Action

1 Attach the NBP cuff to the NBP tubing and the tubing to the NBP patient

monitoring input connector.

2 Wrap the cuff around itself and place it on a table for the test. DO NOT place the

cuff on your arm.

3 Turn the monitor On and enter the NBP test screen located within Diagnostic

Mode.

4Press the Volume button to close valves.

5 a. Press and hold the NBP Start/Stop switch until the monitor’s screen reads

"250 mmHg" or "33.3 kPa".

b. Wait 15-20 seconds to allow the pressure to stabilize.

6 a. Note the value on the screen (P1), then start a timer.

b. After one minute, note the value on the screen (P2).
c. Calculate the difference between the two values (P1 - P2). The value should

be less than or equal to 6 mmHg (0.8 kPa).

7 Press and hold the Volume button until the screen shows the pressure has

released and the value is 0 mmHg or kPa.

8 Turn the monitor Off.

Note

If the test fails, ensure the integrity of the cuff and tubing, then test again. If the test fails
again, verify the integrity of all the pneumatic tubing inside the monitor.

Testing the Monitor

4-21

Performance Procedures

Performance Procedures

The following accuracy and performance procedures are designed to be completed to verify
the accuracy and performance of the monitor. They must be performed, according to the
frequency specified in the section titled, “Recommendations for Testing Frequency” on
page 4-6.

Battery

Performance

Test

The battery performance test should be performed every two years, before monitor repairs, or
whenever the battery is suspected as being a source of the problems. Before performing the
battery performance test, verify that the battery is fully charged (see “Charging the Battery”
on page 3-9).

Note

Before beginning this test, ensure that the monitor is disconnected from the AC power source.

Tools Needed:

•SpO

adapter cable (M1943A)

2

• Clinical Dynamics Corp - SmartSat simulator (with Nellcor simulator cable)

• NBP tubing (M1599B)

• Bio-Tek BP Pump 2 simulator or equivalent, with an internal test volume of 310 ml

Note

The instructions below apply to the Bio-Tek BP Pump 2 simulator.

4-22 Testing the Monitor

Step Action

1 Connect SpO

the SpO

2 Connect the NBP simulator to the monitor via the NBP tubing.

3 Set the SpO

4 Set the NBP simulator to a pressure setting of 120/80 mmHg (16/11 kPa), and a

heart rate of 80 bpm.

simulator cable to the SpO2 adapter cable. Connect the cable to

2

patient monitoring input connector.

2

simulator switches as follows:

2

Item Setting

Oximeter Nellcor

SpO2%

BPM 36

Pulse Mod 0.50%

81

Performance Procedures

Step Action

5 With the monitor Off, press the On/Standby button. (When the monitor is turned

on, the battery icon may initially indicate a higher charge then it actually holds ­wait 5 minutes or until after an NBP measurement for an accurate battery
reading.)

6 Verify that the monitor is responding to the SpO

audible alarm is sounding. Use the navigation wheel to select the SpO2 Menu
and permanently silence the SpO2 audible alarm. Select the Heart Rate Menu
and silence the Heart Rate alarm.

7 Use the navigation wheel to select the NBP Menu and set the Automatic

Interval Mode option to 15 minutes. Select Return to exit the menu.

8Press the NBP button on the monitor’s front panel to start the first NBP

measurement. Subsequent NBP measurements are taken automatically every 15
minutes.

9 Verify that the battery icon displays at the bottom of the display. Note the time.

(At least one segment of the battery icon should be filled.)

10 Keep the monitor On until the low battery warning alarm occurs. Note the time.

Verify that alarm sounds 15-30 minutes before the battery fully discharges.

11 Keep the monitor On until it automatically powers down due to low battery

condition. Verify that the audible alarm sounds when the monitor automatically
shuts down. Note the time.

simulator signal and that the

2

Temperature

Test

Press any front panel button, on the monitor, to terminate this audible
alarm.

12 If the monitor passes this test, immediately recharge the battery. If it fails the

test, replace the battery. (See “Removing the Battery” on page 7-4 for more
information).

The accuracy of the monitor’s temperature measurements is ±0.1°C (±0.2°F). In the procedure
below, add the tolerance of the simulator to the acceptable range o

f readings.

Tools Needed:

•

Dynatech Nevada MedSim 300 or equivalent simulator

• Temperature cable (supplied with the temperature simulator)

Note

The instructions below apply to the Dynatech Nevada MedSim 300.

Step Action

1 Verify the monitor is turned Off. Connect the temperature cable to the

appropriate connector on the temperature simulator.

2 Connect the temperature cable to the Temperature patient monitoring input

connector.

Testing the Monitor

4-23

Performance Procedures

Step Action

3 Set the temperature simulator as follows:

a. Temperature: 37
b. Probe Type: YSI 400 Series

4Press the On/Standby button to turn the monitor On.

5 After the power-up sequence, verify the temperature reads 37°C ±0.1°C (98.6°F

±0.2°F if Fahrenheit is selected as the temperature unit).

6 Turn the monitor Off.

°C (98.6°F).

4-24 Testing the Monitor

Performance Procedures

ECG/

This section includes tests for both ECG and Respiration.

Respiration

Performance

ECG Test The accuracy of the monitor’s ECG measurements is ±5 bpm. In the following procedure, add

Tools Needed for both ECG and Respiration testing:

• ECG leads - M1605A (AAMI) or M1615A (IEC)

• ECG trunk cables - M1540C (ICU, AAMI) or M1550C (ICU, IEC)

• Dynatech Nevada MedSim 300 or equivalent simulator

the tolerance of the simulator to the acceptable range of readings.

Step Action

1 Verify that the monitor is turned Off. Connect the ECG leads to the appropriate

jacks on the ECG simulator.

2 Connect the leads to the ECG trunk cable. Connect the cable to the ECG patient

monitoring input connector.

3 Set the ECG simulator as follows:

Set... To...

Heart Rate (HR) 30 bpm

Lead select II

4Press the On/Standby button to turn the monitor On.

5 After the power-up sequence, verify the following monitor reactions:

a. After at least five heartbeats, the monitor displays a heart rate of 30 ±5 bpm

b. The audible alarm sounds and the Heart Rate frame flashes, indicating heart

rate is below the default lower alarm limit.

6Press the Alarm Silence button twice (on the monitor’s front panel) to invoke

the Silence/Reset mode.

7 Increase the heart rate setting on the ECG simulator to 240 bpm. After at least

five heartbeats, verify that the monitor displays a heart rate of 240

8 Verify that the audible alarm sounds and the Heart Rate frame flashes, indicating

that the heart rate is above the default upper alarm limit.

9Press the Alarm Silence button twice (on the monitor’s front panel) to invoke

the Silence/Reset mode.

10 Decrease the heart rate setting on the ECG simulator to 120 bpm. After at least

five heartbeats, verify that the monitor displays a heart rate of 120

11 Disconnect the LL lead from the ECG simulator. Verify that the Leads Off alarm

message displays. -?- displays in the Heart Rate frame, and the low priority
"Leads Off" INOP sounds.

12 Reconnect the LL lead to the ECG simulator. Verify that the Leads Off alarm

message no longer displays and the audible alarm is silenced.

13 Repeat steps 11 and 12 for LA and RA leads, then turn your monitor Off.

±5 bpm.

±5 bpm.

.

Testing the Monitor

4-25

Performance Procedures

Respiration

Test

The accuracy of the monitor’s respiration measurements is ±3 breaths per minute. In the
procedure below, add the tolerance of the simulator to the acceptable range of readings.

Step Action

1 Verify that the monitor is turned Off. Connect the ECG leads to the appropriate

jacks on the ECG simulator.

2 Connect the ECG leads to the ECG trunk cable.

3 Connect the cable to the ECG patient monitoring input connector.

4 Set the simulator for a respiration rate of 120 breaths per minute.

5Press the On/Standby button to turn the monitor On.

6 After the power-up sequence, verify the following monitor reactions:

a. The monitor displays a respiration rate of 120 ±3 breaths per minute.
b. The audible alarm sounds and the Respiration Rate frame flashes, indicating

the respiration rate is above the default upper alarm limit.

7Press the Alarm Silence button to silence the alarm.

8 Decrease the respiration rate setting on the respiration simulator to 20 breaths per

minute. Verify that the monitor displays a respiration rate of 20
minute.

±3 breaths per

4-26 Testing the Monitor

Performance Procedures

SpO2

Performance

Dynamic

Operating

Range Test

SpO2 testing includes the following tests:

• Dynamic Operating Range

• LED Excitation Test

Tools Needed for SpO

Tests:

2

• Clinical Dynamics Corp - SmartSat simulator (with Nellcor simulator cable)

•SpO

•SpO

adapter cable (M1943A)

2

reusable sensor, adult finger (M1191A)

2

The following test sequence verifies proper monitor operation over a range of input signals.

Step Action

1 Connect SpO

the SpO2 patient monitoring input connector.

2 Set the simulator as indicated in the table below. Verify that the monitor readings

are within the indicated tolerances. Allow the monitor several seconds to
stabilize the readings.

3 Turn the monitor Off.

simulator cable to the SpO2 adapter cable. Connect the cable to

2

Table 4-1. Settings and Monitor Indications

Simulator Settings Monitor Indications

SpO2% Pulse Rate

81 36 120 200 0.50% 79-83* 33-39*

81 112 120 200 5.00% 79-83* 109-115

81 201

81 201

a

a

Ambient
Light Freq

120 10 0.50% 79-83* 195-207*

120 200 5.00% 79-83* 195-207*

Ambient
Light Ac
Level

Modulation SpO

2

Pulse Rate

An * indicates values that produce an alarm. Press the Alarm Silence button to temporarily
silence the audible alarm.

a. For the pulse rate setting of 201 bpm, the pulse rate tolerance of 195 to 207 bpm is greater than ±3 bpm accuracy

specification on the monitor, due to the performance characteristics of the simulator.

Testing the Monitor

4-27

Performance Procedures

LED Excitation

Test

This procedure uses normal system components to test circuit operation. A SpO2, adult
finger, reusable sensor is used to examine LED intensity control. The red LED is used to
verify intensity modulation caused by the LED intensity control circuit.

Step Action

1 Connect an SpO

2Press the On/Standby button to turn the monitor On.

3 After the monitor completes its normal power-up sequence, verify that the sensor

LED is brightly lit.

4 Slowly move the sensor LED in proximity to the photo detector element of the

sensor. Verify, as the LED approaches the optical sensor, that the LED intensity
decreases.

5 Open the sensor and take note that the LED intensity increases.

6 Repeat Step 5 and the intensity again decreases. This variation is an indication

that the micro-processor is in proper control of LED intensity.

7 Turn the monitor Off.

sensor to the monitor.

2

4-28 Testing the Monitor

Performance Procedures

CO2

Performance

This test checks the performance of your CO

calibration equipment that can be ordered (contact your Philips representative). Refer to the
documentation accompanying the equipment for detailed instructions. The procedure is summarized in
the following steps:

measurement for the monitor. This test uses

2

• Barometric Pressure Check and Calibration, if required

• Leakage Check

• Pump Check

• Flow Check and Calibration, if required

•CO

•CO

Cal Check and Calibration, if required

2

Cal Verification using Cal 2 gas

2

Note

Allow 5 seconds between individual service procedures in order to ensure stable equipment
conditions.

Tools Needed for CO

Tests:

2

• Screwdriver

• Tweezers

• Cal 1 gas (5% CO

• Cal 2 gas (10% CO

)

2

)

2

• Cal gas flow regulator

•Cal tube

You also need a local barometric pressure rating received from a reliable local source, such as
an airport, regional weather station, or hospital weather station. The pressure rating must be
located at the same altitude as the hospital.

Note

All steps must be performed in the same session.

Testing the Monitor

4-29

Performance Procedures

Documenting

The following table lists the CO2 tests and summarizes how to document the test results.

CO2 Test
Results

Test Expected Test Results What to record on service record

Barometric Pressure Check X1 = difference between the reference

pressure and the measured ambient
pressure displayed on the monitor
(-12 mmHg < X1 < +12 mmHg)

Leakage Check parts 1 and 2 X2 = value of part 1 leakage check on

flowmeter (X2 </= 4.0 ml/min)

X3 = value of part 2 leakage check on
flowmeter (X3</= 4.0 ml/min)

Pump Check X4 > 120 mmHg below the ambient

pressure

Flow Rate Check X5 = CO

<65 ml/min).

Gas Measurement Calibration

CO

2

Check

Calibration Verification X7 = difference between measured

X6 = difference between measured
CO
on 5% CO2 cal. gas (X7<2.6 mmHg,
or 0.35 kPa)

CO
on 10% CO2 cal. gas.

flow rate (42.5 ml/min <X5

2

value and calculated value, based

2

value and calculated value, based

2

: P/X1/X2/X3/X4/X5/X6/X7

PCO

2

or

PCO2: F/X1/X2/X3/X4/X5/X6/X7

P = passed, F = failed

X1: xx (two digits)

X2: x.x

X3: x.x

X4: xxx

X5: x.x

X6: x.x

X7: x.x

(X7±{0.07 x value calculated})

4-30 Testing the Monitor

Performance Procedures

Barometric

Pressure

Check and

Calibration

Check the barometric pressure value in the CO

Step Action

1Enter the Power-Up Defaults Menu (see ““Power-Up Defaults Menu” on

page 5-3“for instructions on accessing this menu).

2 Select the Enter Diagnostic Mode? option.

3 From the popup menu, select Yes. The Diagnostic Menu displays.

4 Select the CO

5 Connect a FilterLine to the CO

activates the pump in the CO

6 Check the status line at the top of the screen. It will display "CO

mmHg (ambient/cell) xxx/yyy" where xxx is the ambient pressure and yyy is the
measured cell pressure. The values are displayed with a resolution of 2 mmHg
(0.3 kPa) up to 475 mmHg (63.2 kPa) and a resolution of 1 mmHg (0.1 kPa)
from 475 mmHg (63.2 kPa) to 825 mmHg (109.7 kPa). Check whether the
ambient pressure (X1) matches (within the acceptable tolerance of ±12 mmHg)
the reference value you have received. If so, proceed to the “Leakage Check”. If
the value is not correct, calibrate as follows.

7 Select Set Barometric Pressure (mmHg). An adjustable value in mmHg is

activated.

8 Select the value that matches the reference value received from a reliable local

source, such as an airport, regional weather station or hospital weather station.

9 If the selected value is not with ±12mmHg (1.6 kPa) of the current measured

ambient pressure, verify the reference value by getting another reading from a
different source. If the ambient pressure displayed also differs from the new
reference by more than ±12mmHg (1.6 kPa), the CO
replaced.

10 Confirm the barometric pressure setting by clicking on the adjusted value so that

it is no longer highlighted.

11 Check that the ambient pressure displayed in the CO

the screen is the same as the value that you selected from the list in Step 8.

Test option.

2

module as follows:

2

patient monitoring input connector. This

2

module.

2

pressure in

2

module should be

2

Pressure line at the top of

2

Testing the Monitor

4-31

Performance Procedures

Leakage

Check

The Leakage Check consists of two parts:

• Part 1 - Checking the tubing between the pump outlet and the

CO

module outlet.

2

• Part 2 - Checking the tubing between the pump inlet and the FilterLine inlet.

Note

Check the flowmeter’s user guide for details on how to make a correct flow reading.

Part 1

Step Action

1 Check the ambient and cell pressure shown in the status line on the screen. The

cell pressure should be approximately 20 mmHg (2.7 kPa) lower than the
ambient pressure.

2 Connect the flowmeter outlet to the FilterLine inlet using a flexible connecting

tube.

3Block the CO

display. The value on the flowmeter (X2) should decrease to between 0 and 4 ml/
minute. If the value is not within the tolerance limits, there is a leakage between
the pump outlet and the CO

4 If a leakage is found in Step 3, open the CO

connections at the pump outlet and the module CO2 gas outlet. If the connections
are good, then there is leakage in the module and the CO2 module must be
exchanged.

module outlet using your fingertip and observe the flowmeter

2

module gas outlet.

2

module and check the tubing

2

Part 2

4-32 Testing the Monitor

Step Action

1 Disconnect the flowmeter from the Part 1 setup and connect the flowmeter inlet

to the CO

2 Leave the FilterLine connected to the CO

module gas outlet.

2

module inlet.

2

3 Block the inlet of the FilterLine using your fingertip and observe the flowmeter

display. The value on the flowmeter (X3) should decrease to between 0 and 4 ml/
minute. If the value is within the tolerance limits, there are no leakages and the
leakage check is completed. You can proceed to the “Pump Check”.

4 If the value is not within the tolerance limits, there is a leakage between the

FilterLine inlet and the pump inlet.

5 Check the FilterLine connections and open the monitor to check the tubing

connections at the pump inlet and the CO

module gas inlet. If the connections

2

are good, try replacing the FilterLine and repeating the leakage check. If the
situation remains, there is a leakage in the tubing and the CO

module must be

2

exchanged.

Pump Check

Flow Rate

Check and

Calibration

Performance Procedures

Step Action

1 Connect the flowmeter inlet to the CO

2 Connect the FilterLine to the CO

module gas outlet.

2

module inlet.

2

3 Block the inlet of the FilterLine using your fingertip and observe the cell

pressure to the right of the slash symbol on the top row of the CO

Test display

2

screen.

The cell pressure (X4) should be more than 120 mmHg below the ambient
pressure shown. If the pressure difference is less than 120 mmHg, the pump is
not strong enough and should be replaced (regardless of the Pump Op Time).

Step Action

1 Connect the flowmeter to the CO

2 On the flowmeter, check the flow that the CO

FilterLine.

2

Pump draws (X5). The nominal

2

value is 50; the acceptable limits are 42.5 and 65 ml/minute. If the value is
within these limits, proceed to the CO

Gas calibration check. If not within the

2

limits, calibrate as follows.

3 Select Flow Rate Check and Calibration. Adjust the flow in the monitor by

selecting Increase Flow or Decrease Flow until it is as close as possible to 50
ml per minute as indicated on the flowmeter gauge. The pump voltage displayed
on the second row of the CO

Test screen will vary as the flow is changed.

2

4 When you are satisfied that the flow is set as close as possible to 50 ml per

minute, select Store Flow to confirm the setting

Note

If the adjusted flow is not stored within 60 seconds of the adjustment, the old flow setting is
restored. If the flow cannot be adjusted to within tolerance, the pump should be replaced. If
the flow adjustment still cannot be made, this indicates a fault in the

CO

module, which must

2

be replaced.

Testing the Monitor

4-33

Performance Procedures

CO2 Gas

Measurement

Calibration

Check

After switching the monitor on, or after turning on the etCO2 On/Off setting in the etCO2
frame, wait at least 20 minutes before checking the calibration.

Step Action

1 Check that the 5% calibration gas and flow regulator are connected.

2 Calculate the expected measurement value in mmHg as follows:

0.05 x (ambient pressure) / 1.03 = value mmHg

i.e. 0.05 x 736 mmHg / 1.03 = 35.7 mmHg (with an ambient pressure of 736
mmHg)

Note: Dividing by 1.03 compensates for the dry calibration gas at room
temperature, relative to breath gases containing water vapor and at body
temperature.

3 Select CO

progress" to disappear. Open the valve on the flow regulator to allow 5% CO2
gas to flow into the monitor. Allow the displayed CO
Test menu) to stabilize.

4 Check that the CO

±2.6 mmHg. If the value is outside the tolerance, calibrate as described in Step 9
to 13.

5 Disconnect the 5% calibration gas and connect the 10% calibration gas.

6 Calculate the expected measurement value and tolerance in mmHg as follows:

Calibration. Wait for the status message "CO2 module reset in

2

value (third row of CO2

2

value on the monitor matches the calculated mmHg value

2

0.1 x (ambient pressure) / 1.03 = value mmHg

±0.07 x (value mmHg) = tolerance

i.e. 0.1 x 737 mmHg / 1.03 = 71.6 mmHg (with an ambient pressure of 737
mmHg)

±0.07 x 71.6 mmHg = ±5.01 mmHg tolerance

7 Open the valve on the flow regulator to allow 10% CO

gas to flow into the

2

monitor. Allow the value to stabilize.

8 Check that the value on the monitor (X6) matches the calculated mmHg value

within the calculated tolerance. If so, the CO

module is correctly calibrated. If

2

the value is outside the tolerance, calibrate as follows.

9 If not already connected, connect the 5% calibration gas.

10 Select CO

message "CO

Calibration to enter the Calibration sub-menu. Wait for the status

2

module reset in progress" to disappear.

2

11 Select the value for the calibration gas (The default value is 5%).

12 Select Start Calibration and open the valve on the calibration gas to allow CO

gas to flow into the monitor. Allow the value to stabilize before the start of the
calibration. Leave the valve open until the monitor gives a prompt that the gas
can be removed.

13 The CO

module calibrates and prompts when calibration is successful.

2

2

4-34 Testing the Monitor

Calibration

Verification

Performance Procedures

Step Action

1 Reopen the 5% gas valve and allow the value to stabilize.

2 Check that the value displayed on the monitor is correct and within the tolerance

(see Step 2 in above section).

3 Disconnect the 5% calibration gas and connect the 10% calibration gas.

4 Open the valve on the flow regulator to allow 10% CO

monitor. Allow the value to stabilize.

5 Check that the value displayed on the monitor (X7) is correct and within the

tolerance (see Step 6 above). If one or both values are not within tolerances, the

module must be exchanged.

CO

2

gas to flow into the

2

Reset Pump

Operating

Time Counters

If the pump in the CO2 module is replaced, the Pump Operating Time counter should be reset
to start counting operating time for the new pump.

Step Action

1 In the CO2 Test menu, select Pump Op Time.

2 Select Reset to Zero.

Note

When the Pump Op Time has been reset a "CO2 Equipment Malfunction" INOP will be
generated on restarting the monitor. To clear this INOP you must perform a flow check and
store the flow in Diagnostic Mode (select Store Flow).

Testing the Monitor

4-35

Performance Procedures

Serial Interface and Nurse Call Signal Test

Perform the following procedure to test the serial port voltages. The test is qualitative and
only verifies that the serial interface port is powered correctly, and that the Nurse Call signal
is operational. The serial connector is a male DB-9 located on the monitor’s rear panel,
identified by the RS-232 symbol.

Tools Needed:

• Clinical Dynamics Corp - SmartSat simulator (with Nellcor simulator cable)

•SpO

adapter cable (M1943A)

2

Step Action

1 Turn the monitor On.

2 Set up the DMM with the function set to VDC at a range of 10 volts.

3 Connect the DMM negative lead to connector pin 5 (GND), or the shell of the

RS-232 connector.

4 Referring to Table 4-2, Serial Interface Voltages, connect the DMM positive

lead to each pin in turn, and verify the voltage values listed. Voltage for pin 9 is
that listed from the No Alarm condition.

5 Connect SpO

the SpO

6 Set the simulator switches as follows:

simulator cable to the SpO2 adapter cable. Connect the cable to

2

patient monitoring input connector.

2

Item Setting

Oximeter Nellcor

SpO2%

BPM 36

Pulse Mod 0.50%

7 Verify that the monitor is responding to the SpO

audible alarm is sounding. If desired, press the Alarm Silence button to
temporarily silence the audible alarm.

8 Connect the DMM positive lead to pin 9 and verify the voltage value listed in

Table 4-2, Serial Interface Voltages. The voltage for pin 9 is that listed for the
Alarm Underway condition.

81

simulator signal and the

2

Table 4-2. Serial Interface Voltages

Pin Signal Direction Measurement (V)

Min. Typical Max.

1 not used -0.4 0.0 0.4

2 RXD <<< input -0.4 0.0 0.4

3 TXD<<< output -5.0 -7.0 -15.0

4 DTR<<< output 5.0 7.0 15.0

5 GND -0.4 0.0 0.4

6 DSR<<< input -0.4 0.0 4.0

7 RTS>>> output 5.0 7.0 15.0

4-36 Testing the Monitor

Performance Procedures

Pin Signal Direction Measurement (V)

8 CTS<<< input -0.4 0.0 0.4

9 Alarm Out>>>

(no alarm)

9 Alarm Out>>>

(alarm underway)

output -5.0 -7.0 -15.0

output 5.0 7.0 15.0

Testing the Monitor

4-37

Performance Procedures

ECG Sync Test

This test checks the performance of ECG synchronization between the monitor and a
defibrillator. The ECG sync performance test is required once every year and when the
monitor is repaired or when the monitor’s parts are replaced.

Tools Needed:

• Dynatech Nevada MedSim 300 or equivalent simulator

• Defib Sync Cable (M4820A) or Switchcraft 850

• Switchcraft 750

Two sections are needed to complete the connection from the monitor to the simulator.

1. If a Defib Sync Cable is available, connect it the ECG Sync output on the monitor, then
to the Switchcraft 750.
or
If a Switchcraft 850 is available, connect it the ECG Sync output on the monitor, then
to the Switchcraft 750.

2. Connect the Switchcraft 750 to the SYNC/A PACE input on the simulator

Connect to the monitor Connect to the simulator

Defib Sync Cable Switchcraft 750

Switchcraft 850 Switchcraft 750

Step Action

1 Connect the ECG leads and trunk cables between the monitor and the simulator

(as described above).

2 Turn on the monitor and the simulator

3 On the simulator main menu select DEFB, then CARD to set the simulator to

Defibrillator Tests/Cardioversion.

4Press Start to begin the test. If the monitor is working properly, the following

sequence of text messages will appear on the simulator over a period of
approximately 3 seconds: "cardioversion: afib", "cardioversion: sync ok", and
"cardioversion: converted" (this message will persist on the simulator)

5 If the monitor isn’t working properly, messages such as the following may

appear: "cardioversion: vfib", "cardioversion: late".

4-38 Testing the Monitor

Patient Safety Tests

Philips safety tests meet the standards of, and are performed in accordance with IEC 60601-1,
Clause 19 (EN60601-1, Second Edition, 1988; Amendment 1, 1991-11, Amendment 2, 1995-

03).

The C3 patient monitor is a Class I device. It requires a protective earth (ground) wire. Keep
this in mind when performing the following test procedures.

There are two categories of safety tests:

• Ground Integrity

• Electrical Leakage

Patient Safety Tests

Ground Integrity

Table 4-3. Ground Integrity

Test or “Inspection” to Perform Expected Test Results

Protective Earth

See “Safety Test Diagram - Protective

Earth” on page 4-40.

With mains cable:

Maximum impedance = x <= 100 mOhms

Testing the Monitor

4-39

Patient Safety Tests

Figure 4-1 Safety Test Diagram - Protective Earth

Test or Inspection to Perform

Measures impedance of Protective Earth (PE) terminal to all exposed metal parts of IUT,
which are for safety reasons connected to the Protective Earth (PE). Max. 100 mOhm. Test
current 25 Amps applied for 5 to 10 seconds. We recommend to flex the main cable during
the test in order to identify potential bad contact or damage of the earth wire. Safety test
according to EN60601-1 (Clause 18). Report largest value.

What to record on this service record:

S(1): P or S(1): F

4-40 Testing the Monitor

Patient Safety Tests

Electrical Leakage

Earth Leakage

Current

The following tests verify the electrical leakage of the monitor:

• Earth Leakage Current

• Enclosure Leakage Current

• Patient Leakage Current

• Patient Source Current, with Mains Voltage on the Applied Part

WarningWarning

Perform all leakage tests any time the unit is opened.

This test is in compliance with IEC 60601-1 (Earth Leakage Current). In locations where
mains voltage is 100-120 volts, the applied voltage is 132 volts. In locations where mains
voltage is 220-240 volts, the applied voltage is 264 volts. The applied AC frequency should
be the same as the local mains (50 or 60 Hz).

All measurements shall be made with the power switch in both On and Off positions.

1. Connect the monitor AC plug to the electrical safety analyzer as recommended by the
analyzer operating instructions.

2. Perform test as recommended by analyzer operating instructions.

Earth leakage current is measured under various conditions of the AC mains and protective
earth conductor. For each condition, the measured leakage current must not exceed that
indicated below.

Table 4-4. Earth Leakage Current Values

Test Condition Polarity Allowable Leakage Current

Normal Normal 300 µA

Reversed 300 µA

a

S.F.C

Open Supply

a. S.F.C = Single Fault Condition

Normal 1000 µA

Reversed 1000 µA

What to record on the service record:

S(2): P or S(2): F

Testing the Monitor

4-41

Patient Safety Tests

Enclosure

Leakage

Current

This test is compliance with EN60601-1 (Enclosure Leakage Current). Test at 110% of the
nominal line voltage.

Step Action

1 Connect the AC mains power cord to the analyzer as recommended by the

analyzer operating instructions.

2 Using the appropriate test cable, connect the analyzer to either of the screws on

the back of the monitor, next to the handle.

3 Turn the monitor on.

4 Perform the test as recommended by the analyzer operating instructions.

The analyzer leakage current indication must not exceed the values listed below.

Table 4-5. Enclosure Leakage Current

EN60601-1 (1990 + A1, A2, A11, A12, A13) and UL2601 (2

Test Condition Polarity Allowable Leakage Current

Normal Normal 100 µA

Reversed 100 µA

1

S.F.C

Open

Normal 300 µA

nd

Ed. 1997) US Deviations

Protective Earth

Reversed 300 µA

What to record on your service record:

S(3): P or S(3): F

4-42 Testing the Monitor

Patient Safety Tests

Patient

Leakage

Current

This test measures patient leakage current in accordance with EN60601-1, Clause 19, for
Class I, type CF equipment. Patient leakage current in this test is measured from any
individual patient connection to earth (power ground).

This test requires a sample patient cable for each device parameter. These must be configured
as recommended by the safety analyzer operating instructions.

Step Action

1 Configure the electrical safety analyzer as recommended by the analyzer

operating instructions.

2 Connect the monitor’s AC mains power cord to the analyzer as recommended by

analyzer operating instructions.

3 Connect the ECG test cable between the ECG connector on the monitor and the

appropriate input connector on the analyzer.

4 Turn the monitor On.

5 Perform the test as recommended by the analyzer operating instructions.

Patient leakage current is measured under various conditions of the AC mains
and protective earth conductor. For each condition, the measured leakage current
must not exceed that indicated below.

Repeat the test for SpO2 and temperature patient connections, using

6

appropriate test cables.

Table 4-6. Patient Leakage Current Values

Allowable Leakage

Test Condition Polarity

Normal Normal 10 µA

Reversed 10 µA

S.F.C.(Open Earth/Ground) Normal 50 µA

Reversed 50 µA

Current (Max.)

Type CF

What to record on the service record:

S(4): P or S(4): F

Testing the Monitor

4-43

Patient Safety Tests

Patient

Leakage

Current, with

Mains Voltage

on the Applied

Part

This test measures patient leakage current in accordance with EN60601-1, Clause 19, for
Class I, type CF equipment. In this test, 110% of mains voltage is applied between each
patient connection and earth (power ground). Patient leakage current is then measured from
any individual patient connection to earth.

WarningWarning

AC mains voltage is present on the applied part terminals during this test. Exercise

caution to avoid electrical shock hazard.

Table 4-7. Safety Tests - Patient Leakage Current, with Mains Voltage on the

Applied Part

Test or “Inspection” to Perform Expected Test Results

Patient Leakage Current - AC

See “Safety Test Diagram - Patient

Leakage Current - AC” on page 4-44

Maximum leakage current = x

<= 50 µA @ 250V (IEC601-1 or UL2601-1)

Test at 110% of the nominal line voltage.

Figure 4-2 Safety Test Diagram - Patient Leakage Current - AC

Test or Inspection to Perform

Measures patient leakage current from Applied Part to earth caused by external mains
voltage on Applied Part with switch S5 open and closed. Each polarity combination
possible is tested using S2 and S6.

Safety test according to EN60601-1 (Clause 19.4.h). Report largest value.

What to record on the service record:

S(5): P or S(5): F

4-44 Testing the Monitor

Patient Safety Tests

Testing the Monitor

4-45

Patient Safety Tests

4-46 Testing the Monitor

5

Configuring the Power-up Defaults Menu

This chapter discusses the use of the Power-up Defaults Menu to configure power-on default
settings. It also explains how to use Diagnostic Mode to obtain service-related information
about the monitor.

Configuring the Power-up Defaults Menu 5-1

General Safety Information

General Safety Information

WarningWarning

A blood pressure cuff, connected to the monitor, should never be applied to a human
being while the monitor is in Diagnostic Mode. Injury could result.

A FilterLine, connected to the monitor, should never be applied to a human being while

the monitor is in Diagnostic Mode. Injury could result.

Caution

In addition to restoring factory defaults, this procedure clears the contents of trend memory.

Note

Before performing the first step, read this procedure COMPLETELY.

5-2 Configuring the Power-up Defaults Menu

Power-Up Defaults Menu

The purpose of the Power-up Defaults Menu is to allow the authorized user to create a
power-up default for each setting in the monitor. Power-up defaults are the settings in effect
each time the monitor is power on. After you enter the Power-up Defaults Menu,
physiological monitoring is terminated. The screen layouts do not display any information
associated with normal monitoring operation.

After configuring the main monitoring screen and connecting the appropriate accessories, as
not in the C3 Information for Use guide, use the following procedure to configure the
power-up default settings for the monitor:

Step Action

1 From the main monitoring screen, use the navigation wheel to highlight the

2 From the Set-Up Menu, select Enter Power -up Default Menu. A popup box

3 Use the wheel to enter the passcode. The passcode is: 2 1 5.

Power-Up Defaults Menu

Setup icon. Press the wheel to select the icon.

displays.

Note: This passcode is configured at the factory and CANNOT be changed.

4 The Power-Up Defaults Menu displays.

POWER-UP DEFAULT MENU

Accept Current Settings?

Selected Audio Off (Make Available)
Audio Off (Make Available)
Auto-Set Limits (Make Available)
Audio Pause Period (180s)
Enter Diagnostic Mode?
Language
Enter Demo Mode?

Return

The available menu items are described in the next section. You can configure
these menu items as desired.

5 After making the desired change, highlight Access Current Settings? Press the

wheel to select this option.

6 From the popup menu, select Yes.

7 Select Return.

After selecting Return, a notice displays instructing you to power down the
monitor. Next time you power on, the changes you made to the defaults are
implemented.

Configuring the Power-up Defaults Menu

5-3

Power-Up Defaults Menu

Menu Options

Below are the menu options you can configure from the Power-up Defaults Menu.

Menu Item Choices Explanation

Accept Current Settings Yes

No

Selected Audio Off Make Available (default)

Deny Access

Audio Off Make Available (default)

Deny Access

Auto-Set Limits Make Available (default)

Deny Access

If Yes is chosen, the current monitor
settings become the power-up defaults.

If Make Available is chosen, audible
alarms are permanently silenced for a
particular parameter via the Alarm
Limits Menu.

Some institutions may want to prevent
audible alarms from being permanently
silenced. If so, select Deny Access.

If Make Available is chosen, Alarm
Suspend Mode can be invoked by
pressing and holding the Alarm Silence
button for 2 seconds.

Some institutions may wish to prevent
Alarm Suspend from being invoked. If so,
select Deny Access.

If Make Available is chosen, Auto-Set
Limits are invoked via the Alarm/Limits
Menu.

Some institutions may wish to prevent
Auto-Set Limits from being invoked. Is
so, select Deny Access.

Silence Period 30, 60, 90, 120, 180 s (default) Time is indicated in seconds. Pressing the

front panel Alarm Silence button
temporarily silences audible alarms for
the time indicated

Enter Diagnostic Mode Yes

No

Language

Return When selected, the Power-Up Defaults

a

a. Although the language choices are shown here in English, they display on the screen in their

English, French, German,
Italian, Japanese, Portuguese,
Spanish, Russian, Chinese,
Dutch, Turkish, Arabic,
Norwegian, Swedish, Finnish,
Polish, Czech

respective language and script on the Boot Up screen and in the Power-Up Defaults Menu.

If Yes is chosen, the Power-Up Defaults

Menu is existed and the Diagnostic
Menu displays. For more information see

“Diagnostic Mode” on page 5-5.

All text shown on the screen is in the
selected language. The selected language
is effective the next time the monitor is
powered up.

Menu is immediately exited and you are
instructed to power down the monitor.

5-4 Configuring the Power-up Defaults Menu