FETALGARD Lite ®

FETALGARD Lite – NIBP

®

Fetal Monitor

OPERATOR’S MANUAL
 Proprietary Material
Information and descriptions contained in this manual are the property of Analogic Corporation
and may not be copied, reproduced, disseminated, or distributed without express written permis-
sion from Analogic Corporation.

Information furnished by Analogic Corporation is believed to be accurate and reliable. However,

no responsibility is assumed by Analogic for its use, or any infringements of patents or other
rights of third parties that may result from its use. No license is granted by implication or other-
wise under any patent or patent rights of Analogic.

Trademarks: FETALGARD Lite® is a trademark of Analogic Corporation and is registered in

the United States patent and trademark office.

Windows NT™, Windows 2000™, and Windows XP™ are trademarks of Microsoft
Corporation.

Adobe Acrobat® is a registered trademark of Adobe Systems Incorporated.

OB TraceVue™ is a trademark of Philips Medical Systems.

16-00259-01 Revision 02
September 2006

Copyright © Analogic Corporation 2006. All rights reserved.

8 Centennial Drive
Peabody, MA 01960
Tel: (978) 326-4000

Printed in U.S.A.

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FETALGARD Lite Operator’s Manual

Preface

Note: The information contained in this manual is valid only for the operating version(s)
printed in the inside front cover.

The FETALGARD Lite and FETALGARD Lite — NIBP Operator’s Manual contains all the
information needed to operate the FETALGARD Lite and FETALGARD Lite — NIBP monitor
including:

Monitor Software Version 3.xx

If the software version of your product is not in the range from 3.00 to 3.99, please contact your
sales representative to obtain addendum pages or a replacement manual that describes the opera-
tion of your version of the product. The monitor’s software revision number can be located dur-
ing the boot up sequence in the lower center of the screen.

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

This Manual is intended for trained medical personnel (including midwives, nurses, and physi-
cians) who are familiar with obstetric procedures. Keep this operator’s manual with the unit for
use by the operator.

The product and accessories covered in this manual from Analogic

CE Marking

Corporation, carry the mark in accordance with MDD

Europe

93/42/EEC and 0197

WEEE Directive 2002/96/EC

Accessories from other companies other than Analogic Corporation carry CE mark-
ings appropriate to the accessory.
Authorized EU-representative:
Villy Braender
Mileparken 34
2730 Herlev
Denmark
Tel: +45 44 52 8100
Fax: +45 44 52 8199

ii
 Table of Contents
1 SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
1.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
1.2 Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
1.3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
1.4 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
1.5 Definitions of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
1.6 Recorder Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7
1.7 Shipping Label and Definitions of Symbols . . . . . . . . . . . . . . . . . . . . . . .1-7
1.8 Front Panel Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8
1.9 Display Symbols and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9
1.10 Accessories — Labels and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10

2 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
2.2 Brief Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
2.3 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
2.4 Product Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
2.5 Models, Options, and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
2.5.1 FETALGARD Lite Strip-Chart Recorder . . . . . . . . . . . . . . . . . . .2-2
2.5.2 Ordering a FETALGARD Lite Monitor . . . . . . . . . . . . . . . . . . . .2-2
2.6 Unpacking Your Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

3 INSTALLATION, SETUP AND OPERATION . . . . . . . . . .3-1

3.1 Description of the Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
3.2 FETALGARD Lite — NIBP Accessory Configuration . . . . . . . . . . . . .3-2
3.3 Patient Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
3.4 NIBP Cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
3.5 Patient Marker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
3.6 Battery Eliminator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
3.7 FETALGARD Lite Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
3.7.1 Installation and Loading Paper . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
3.7.2 Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
3.7.3 Recorder Power Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
3.8 Roll Stand Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
3.8.1 Roll Stand Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
3.8.2 FGL Optional Recorder, Adapter Bracket Mounting Plate . . . . .3-6
3.8.3 Mounting the FETALGARD Lite Monitor on the Roll Stand . . .3-7
3.8.4 Mounting the FETALGARD Lite Recorder on the Roll Stand . .3-7
3.9 Mounting the GCX Adapter Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7
3.10 Operator Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7
3.11 FETALGARD Lite Monitor Display Screen . . . . . . . . . . . . . . . . . . . . . .3-7
3.11.1 Heart Rate Numeric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
3.11.2 Heart Rate Trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
3.11.3 TOCO Numeric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
3.11.4 TOCO Trend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
3.11.5 Power Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9
3.11.6 Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9
3.11.7 Message Frames . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9
3.11.8 Error Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10
3.12 FETALGARD Lite Monitor Controls and Indicators . . . . . . . . . . . . . .3-10
3.13 FETALGARD Lite Monitor Control Knob . . . . . . . . . . . . . . . . . . . . . .3-10
3.14 Startup 3-11
3.14.1 Power-On Self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11
3.14.2 Configuration Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11
3.14.3 Setting U/S Trace Separation . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
3.14.4 Setting TOCO Baseline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13
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FETALGARD Lite Operator’s Manual

3.14.5 Setting Time, Date, and Display Format . . . . . . . . . . . . . . . . . .3-14

3.14.6 Setting Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15
3.14.6.1 Setting ID after Startup . . . . . . . . . . . . . . . . . . . . . . . .3-15
3.14.6.2 Setting ID at Startup . . . . . . . . . . . . . . . . . . . . . . . . . .3-16
3.14.7 Setting the Language Configuration . . . . . . . . . . . . . . . . . . . . .3-17
3.14.8 Setting Data Output Parameters . . . . . . . . . . . . . . . . . . . . . . . .3-17
3.14.9 Adjusting Speaker Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18
3.14.10 Adjusting the Display Contrast . . . . . . . . . . . . . . . . . . . . . . . . .3-18

4 ALARMS & LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1

4.1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
4.2 Alarm Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1
4.2.1 Visual Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
4.2.2 Audible Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2
4.3 Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
4.3.1 Setting the FHR Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . .4-3
4.3.2 Setting the Maternal NIBP Alarm Settings . . . . . . . . . . . . . . . . .4-4
4.3.3 Modifying the NIBP Alarm Limits . . . . . . . . . . . . . . . . . . . . . . .4-5
4.4 Technical Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
4.5 Alarm System Delays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
5 MONITORING FETAL HEART RATE . . . . . . . . . . . . . . . .5-1
6 MONITORING UTERINE ACTIVITY (UA) . . . . . . . . . . . . .6-1
7 NIBP MONITORING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
7.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
7.1.1 Measuring Mean Arterial Pressure . . . . . . . . . . . . . . . . . . . . . . .7-1
7.1.2 Required Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
7.1.3 Applying Cuff to Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1
7.2 Setup Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
7.3 Measuring Blood Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4
7.3.1 Three Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4
7.3.2 NIBP Measurement Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4
7.4 NIBP Frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6
7.4.1 NIBP Frame Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6
7.4.2 Special Requirements for Auto and STAT Modes . . . . . . . . . . .7-7
7.4.3 Stop Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-7
7.5 NIBP Result Popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9
7.6 NIBP Strip Chart Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9

8 REMOTE PATIENT MARKER AND

CLINICIAN MARKER . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

8.1 Clinician Marker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

8.2 Patient Marker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

9 USING GRATICULES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-1

10 USING TREND SCROLL . . . . . . . . . . . . . . . . . . . . . . . . .10-1

11 PRINTING PATIENT FILES . . . . . . . . . . . . . . . . . . . . . . .11-1

12 TRANSFERRING PATIENT DATA . . . . . . . . . . . . . . . . . .12-1

12.1 Data Transfer Via Modem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-1
12.2 Setting Modem Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-2

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 12.3 Communications to the Remote Computer . . . . . . . . . . . . . . . . . . . . . .12-2
12.4 Data Transfer via Direct RS-232 Serial Connection . . . . . . . . . . . . . . .12-4
12.5 Additional Protocol Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-5
12.6 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-6

13 FETALGARD LITE VIEW . . . . . . . . . . . . . . . . . . . . . . . . .13-1

13.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-1
13.2 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-1
13.3 Starting FETALGARD Lite View . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-1
13.4 Display Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-2
13.5 Menu System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-2

14 FETALGARD LITE RECEIVER AND RECORDER . . . .14-1

14.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-1
14.2 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-1
14.3 Starting FETALGARD Lite Receiver . . . . . . . . . . . . . . . . . . . . . . . . . .14-1
14.4 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-2
14.5 Installation of the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-3

15 CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15-1
15.1 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15-1
15.2 Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15-2
15.3 Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15-2
15.4 NIBP Cuffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15-3
15.5 Belts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15-3
15.6 Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15-3

16 SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16-1

17 TROUBLESHOOTING AND MAINTENANCE . . . . . . . .16-1

17.1 Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17-1
17.2 Ultrasound Transducer Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17-1
17.3 TOCO Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17-1
17.4 Operator Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17-1
17.4.1 Testing the Out-of-Limits Measurement Alarm Response . . . .17-1
17.4.2 Testing the Faulty-Air-Hose Alarm Response . . . . . . . . . . . . . .17-2
17.5 Battery Disposal and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17-3
17.6 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17-3

APPENDIX A
Guidance and Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1

APPENDIX B
Technical Services and Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1

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 Section 1
Safety

Safety
1.1 General
The FETALGARD Lite (FGL) and FETALGARD Lite – NIBP (FGL – NIBP) monitors are in-
tended for trained medical personnel (including midwives, nurses, and physicians) who are famil-
iar with obstetric procedures. Keep this operator’s manual with the unit for use by the operator.

This chapter describes safety precautions that may appear within the manual and those that
appear as labels on the instrument surfaces. This chapter also includes a group of precautions that
are applicable, in general, while using the monitor.

1.2 Warnings, Cautions, and Notes

The precautions are grouped into two (2) main categories, WARNINGS and Cautions.

In addition, the manual highlights Notes of significant information relevant to the monitor dis-
play, operator instruction, or operator action being described in the text.

Warnings advise against certain actions or situations that could result in personal injury or
death.

Cautions advise against actions or situations that could damage equipment, produce inaccu-
rate data, or invalidate a procedure.

Notes provide useful information regarding a function or procedure.

1.3 Warnings
The following are warnings that define precautions that must be observed to avoid injury to per-
sonnel. Some of these precautions are specific to particular operator actions. They will appear in
the text. Others may be of a “general-purpose” nature, and may not be duplicated in the many
places in which they may be relevant.

WARNING
EXPLOSION HAZARD — Do not use the FETALGARD Lite in a flammable
atmosphere where concentrations of flammable anesthetics or other materials
may occur.

WARNING
SHOCK HAZARD — The power receptacle must be a three-wire grounded outlet.
Never adapt the three-prong plug from the Battery Eliminator or accessory to fit a
two-slot outlet. If the outlet has only two slots, make sure that it is replaced with a
three-slot grounded outlet before attempting to operate the monitor.

WARNING
Do not connect to an electrical outlet controlled by a wall switch or a multi-socket
strip.

WARNING
Take precautions to use proper cable management to prevent possible strangula-
tion. Unused lengths of cables should be neatly placed out of harm’s way.

WARNING
Do not attempt to attach the recorder to a wall mount. It is intended to be used on
a flat, stable surface or on an Analogic recommended roll stand.

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FETALGARD Lite Operator’s Manual

WARNING
SHOCK HAZARD — Do not attempt to connect or disconnect a power cord with
wet hands. Make certain that your hands are clean and dry before touching a
power cord.

WARNING
Use only patient cables and transducers supplied with the monitor. Use of any
other patient cables may result in out-of-specification performance and possible
safety hazards.

WARNING
Unplug the battery eliminator from the AC power source and detach all accessories
before cleaning. Do not immerse the unit in water or allow liquids to enter the case.

WARNING
Unplug the recorder from the AC power source and detach all accessories before
cleaning. Do not immerse the unit in water or allow liquids to enter the case.

WARNING
Examine the monitor and any accessories periodically to ensure that the cables,
line cords, transducers, and instruments do not have visible evidence of damage
that may affect patient safety or monitoring performance. The recommended
inspection interval is once per week or less. Do not use the monitor if there is any
visible sign of damage.

WARNING
Only the AC line cord supplied with the FETALGARD Lite Recorder, or one
approved for use by Analogic, is acceptable for use with the Recorder.

WARNING
Do not attempt to service the FETALGARD Lite monitor or recorder. Only qualified
service personnel should attempt any needed internal servicing.

WARNING
The FETALGARD Lite is not specified or intended for operation in conjunction with
any other type of monitoring equipment except the specific devices that have been
identified for use in this Operator’s Manual.

WARNING
Do not operate the FETALGARD Lite monitor if it fails to pass the power-on self-
test procedure.

WARNING
Accessory equipment connected to the monitor must be certified according to
IEC/EN 60950 for data-processing equipment or IEC/EN 60601-1 for electro-
medical equipment. All combinations of equipment must be in compliance with
IEC/EN 60601-1-1 systems requirements.

WARNING
All IEC/EN 60950 equipment, including printers, to be positioned no closer than
1.5 meters from the patient’s bed.

WARNING
When operating the monitor from a position higher than the patient, ensure that it
is securely mounted.

WARNING
Use of accessories, transducers, and cables other than those specified may result
in increased EMISSION and/or decreased IMMUNITY of the FETALGARD Lite.

1-2
 Safety

WARNING
Because Alarm Limits are configurable, they must be checked before beginning a
new monitoring session or moving to a different type of area, to ensure that they
are appropriate for the next patient.

WARNING
Fetal cardiac arrhythmias and abnormalities can adversely affect FHR readings.

NIBP Safety Information

WARNING
The FETALGARD Lite — NIBP was not designed for unattended MHR monitoring.
The operator should observe MHR.

WARNING
The operator must always be in attendance when STAT Mode is used.

WARNING
Use only Analogic recommended blood pressure tubing and cuffs. Using other
cuffs or tubing can result in inaccuracies.

WARNING
Do not use the monitor on patients who are linked to heart or lung machines.

WARNING
The monitor cannot operate effectively on patients who are experiencing convul-
sions or tremors.

WARNING
Inaccurate measurements can be caused by:
• incorrect cuff application or use, such as placing the cuff too loosely on the
patient, using the incorrect cuff size, not placing the cuff at the same level as the
heart or placing the cuff in the wrong direction.
• a leak in the cuff or tubing
• excessive patient motion

WARNING
The monitor displays results of the last blood pressure measurement until another
measurement is started. If a patient’s condition changes during the time interval
between measurements, the monitor does not detect the change or indicate an
alarm condition.

WARNING
Sometimes, electrical signals at the heart do not produce a peripheral pulse. If a
patient’s beat-to-beat pulse amplitude varies significantly (for example, pulsus
alternans, atrial fibrillation, rapid-cycling artificial ventilator), blood pressure and
pulse rate readings can be erratic and an alternate measuring method should be
used for confirmation.

WARNING
A patient’s vital signs can vary dramatically during administration of agents affect-
ing the cardiovascular system, such as those used to raise or lower blood pres-
sure or raise or lower heart rate.

WARNING
Continuous cuff measurements (prolonged impairment of circulation) can cause
injury to patient being monitored. This should be considered when using the STAT
mode of NIBP monitoring.

WARNING
Do not use STAT mode when using the thigh cuff to monitor NIBP. Use of this
mode causes a loss-of-monitoring alarm and shuts down all monitor functionality.

1-3
FETALGARD Lite Operator’s Manual

WARNING
As with all automatically inflatable blood pressure devices, continual cuff measure-
ments can cause injury to the patient being monitored. Weigh the advantages of
frequent measurement and/or use of STAT mode against the risk of injury.

WARNING
In some cases, rapid, prolonged cycling of an oscillometric, non-invasive blood
pressure monitor cuff has been associated with any or all of the following:
ischemia, purpura, or neuropathy. Apply the oscillometric cuff appropriately,
according to the manufacturer’s directions for use, and check the cuff site and
cuffed extremity regularly when blood pressure is measured at frequent intervals
or over extended periods of time.
• Check the patient’s limb on which the cuff is applied to assure that circulation is
not constricted. Constriction of circulation is indicated by discoloration of the
extremity. This check should be performed at the clinician’s discretion at regular
intervals based on the circumstances of the specific situation.
• Do not place the cuff on an extremity being used for intravenous infusion or any
area where circulation is compromised or has the potential to be compromised.
• Do not apply the blood pressure cuff to the same extremity as the one to which
an SpO2 sensor is attached because the cuff inflation disrupts SpO2 monitoring
and leads to nuisance alarms.
• When in use on patients, ensure that heavy objects are not placed on the tubing.
Avoid crimping or excessive bending, twisting, or entangling the tubes.

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

Caution
Keep the operating environment free of dust, vibrations, corrosive, or flammable
materials, and extremes of temperature and humidity. The unit should be kept
clean and free of transducer gel and other substances.

Caution
When placing the unit into a cabinet, allow for adequate ventilation, accessibility
for servicing, and room for adequate visualization and operation.

Caution
Do not operate the unit if it is damp or wet because of condensation or spills.
Avoid using the equipment immediately after moving it from a cold environment to
a warm, humid location.

Caution
Never use sharp or pointed objects to operate the front-panel switches.

Caution
General-purpose personal computers and modems are not designed to meet the
electrical safety requirements of medical devices. The RS-232 connector on the
FETALGARD Lite is electrically isolated to permit safe connections to non-medical
devices, which should be connected with a cable of sufficient length, but no longer
than 3 meters, to prevent the non-medical equipment from contacting the patient.

Caution
Before using a 3-hole punch on the FGL–VIEW printouts, be aware that the anno-
tation circled numbers potentially line up with where the holes will be punched.

Caution
Do not use Sodium Hypochlorite (e.g., bleach) to clean or disinfect the transducers
or cables.

1-4
 Safety

Caution
When washing transducer belts, the water temperature must not exceed 40°C
(104°F). Do not use chlorine bleach.

Caution
Take extra care when cleaning the display surfaces, which are sensitive to rough
handling. Rub the lens that covers them with a soft, dry cloth.

Caution
Only the Battery Eliminator supplied with the device is approved for use in supply-
ing external power for operation and recharging the internal batteries.

Caution
The FETALGARD Lite is not specified or intended for operation during the use of
defibrillators or during defibrillator discharge.

Caution
The FETALGARD Lite is not specified or intended for operation in the presence of
electrosurgical equipment.

Caution
The FETALGARD Lite is not intended for use on more than one maternal patient
at a time.

Caution
When disposing of internal lead acid battery, adhere to all applicable laws regard-
ing recycling. Avoid storing battery above 60°C (140°F). If clothing or skin comes
in contact with material from inside the battery, immediately wash with plenty of
clean water.

Caution
Always start a new monitoring session after changing the time or date. Although
the new time is shown on the monitoring screen, it is not stored in the current trend
record.

Caution
Always start a new monitoring session after exiting DEMO mode to avoid potential
loss of patient data on entering Standby.

Caution
If for any reason the batch communication is broken or interrupted, the indication
is a loss of icon in the Communications frame.

Caution
Pressing the Esc (Escape) Key on the PC will cause the Receiver Application to exit.

Caution
The maternal heart rate (MHR) should be taken by some independent means as it
is possible to mistake MHR for FHR under certain circumstances.

Caution
Do not autoclave, use gas sterilization, or irradiate using Gamma Radiation.

Caution
When a new monitoring session is started, check that the alarm status, indicated
by the icon in the parameter window, is in the state required for this session.

1-5
FETALGARD Lite Operator’s Manual

Caution
When using cleaning or disinfecting solutions, use clean wipes to avoid fluids
entering transducers that are not liquid tight.
NIBP Safety Information
Caution
A less severe NIBP artifact measurement may produce an NIBP measurement.
The “NIBP Artifact” message displays and a low priority alarm tone sounds, but
pressing the U/S Volume Alarm button clears the message and alarm tone.

Caution
Do not wrap the cuff too tightly around the limb. It may cause discoloration and
ischemia of the extremities.

Caution
Inspect the application site regularly to ensure skin quality and inspect the extremity
of the cuffed limb for normal color, warmth and sensitivity. If the skin quality changes,
or if the extremity circulation is being affected, move the cuff to another site or stop
the blood pressure measurements immediately. Check more frequently when mak-
ing automatic or STAT measurements.

Caution
If the values appear questionable, it is the clinician’s responsibility to repeat the
measurements.

Caution
Excessive stress on accessory cables can cause faulty operation. Damage to the
cables can be avoided by maintaining some slack in the cables.

Caution
If the NIBP Control Button or Trend Scroll Button is depressed during a batch
transfer, the batch communication is broken.
Caution
Ensure that there are no kinks in the air hose, or that the flow of air is not impeded
by the placement of any object that might constrict the air hose.

Caution
The FETALGARD Lite automatically retries if the initial cuff pressure is less than
the patient systolic pressure. The subsequent initial pressure is increased by 30
mmHg. There is a time-out period at which time the monitor stops trying to get
readings. If the patient’s systolic pressure is known to be extremely high, it is rec-
ommended that the initial cuff pressure be raised to 240 mmHg.

1.5 Definitions of Symbols

Monitor Rear Panel: NIBP Transducer Input

Monitor Rear Panel: Ultrasound Transducer Input Connector.

Monitor Rear Panel: Tocotonometer Transducer Input Connector.

Monitor Rear Panel: Remote Marker Input Connector.

Marker

Monitor Rear Panel: RS-232 Connector

RS-232

15V ~ 1A
Monitor Rear Panel: Battery Eliminator Connector

1-6
 Safety

Monitor Rear Panel: Class II Equipment Symbol (double insulation).

Monitor Rear Panel: Type BF Applied Part Symbol.

Monitor and Recorder Rear Panel: Refer to Accompanying Documents.

IPX1 Degree of protection against ingress of water.

Certification symbol in accordance with MDD 93/42/EEC.

01970123

WEEE Directive 2002/96/EC.

Monitor and Recorder Rear Panel: U.S. and Canada safety certification.

107546

Recorder Rear Panel: Input/Output Cable Connector.

IPX7 Degree of protection against effects of temporary immersion in water up to 1

meter. (USWB-1, USWB-1Y and USWB-2)

1.6 Recorder Label

Observe the recorder’s rear label to see that it is the correct voltage for you facility. The example
below is factory set for 220-240 VAC.

100-120V~, 50-60 HZ, 0.4A

220-240V~, 50-60 HZ, 0.2A
YEAR OF
BAR CODE SN XXXXXXXX MANUFACTURE
OF S/N
YYYY

FETALGARD LiteTM Recorder

MANUFACTURED BY: ANALOGIC CORP., LIFE CARE SYSTEMS
8 CENTENNIAL DRIVE, PEABODY, MA 01960 U.S.A.

1.7 Shipping Label and Definitions of Symbols

Observe the labels on the shipping carton that indicate the precautions that should have been
observed in shipping and handling. Copies of the symbols used on the label and their definition
are shown on the following page.

TM
ETF etiLDRGA
BOX____OF_____ 1SPA

1TPA

SCH
S/N
TCH

ERDCOL—GF

+60 C

0197 9
20%–90% RH –20 C

1-7
FETALGARD Lite Operator’s Manual

Symbol Definition

Certification symbol in accordance with MDD 93/42/EEC.

0197

0123
Keep environment relative humidity limits between 20% and 90%.

Keep environmental temperature limits between –20°C and +60°C.

20%–90% RH

+60 C

Protect from direct sunlight.

–20 C

Protect from water damage.

Handle with care. Fragile contents.

Keep this side up.

1.8 Monitor and Recorder Front Panel Controls and Indicators

FGL – NIBP Power On/Standby button — switches monitor between Power On and Standby.

FGL – NIBP U/S Volume/Alarm button — selects an ultrasound channel in order to adjust
its audio volume. The control knob is then used to increase or decrease volume settings.
This button is also used to silence the audible warning indicator that accompanies a heart
rate alarm condition.

FGL Power On/Standby button — switches monitor between Power On and Standby.

FGL U/S Volume/Alarm button — selects an ultrasound channel in order to adjust its
audio volume. The control knob is then used to increase or decrease volume settings. This
button is also used to silence the audible warning indicator that accompanies a heart rate
alarm condition.
NIBP Control button — initiates or cancels an NIBP measurement or sequence of mea-
surements if in Auto mode.

TOCO Zero button — resets the TOCO baseline.

Clinician Event Marker button — inserts a nurse event mark on the display and strip chart
paper when pressed.

Contrast Adjust button — changes the operation of the control knob to adjust the display
contrast.

Trend Scroll button — this button puts the monitor into trend scroll mode. the trend frames
shows historical patient data and the control knob provides navigation capability.

1-8
 Safety

Graticule button — displays a pair of horizontal level lines, 15 BPM apart, on the FHR
trend frame. Rotating the control knob moves these lines up or down on the display.

This symbol and the LED next to it, when lit, indicate that the monitor is operating on bat-
tery power only.
This symbol and the LED next to it, when lit, indicate that the monitor is running off the
external battery eliminator and that it is plugged into an AC source.

Paper Advance button, Recorder — this button is used to fast-forward the recorder paper.

Printing Enable/Disable button, Recorder — this button is used to toggle the recorder
mode between printing and nonprinting. The indicator LED next to the icon at the left will
be on when printing is enabled and off when disabled.
Power-on Indicator, Recorder — this indicator will be on whenever the unit is connected

RXOnly
to an AC line source and the AC mains switch on the rear of the recorder is on.

This device restricted to sale by or on the order of a physician.

1.9 Display Symbols and Definitions

This displayed icon indicates that the FETALGARD Lite is operating from AC power.

This displayed icon indicates that the FETALGARD Lite is operating on internal battery power.

A heart shaped icon is used to indicate the ultrasound frame of the

display.
A pulsating heart icon, located in the ultrasound heart rate frame of the display, along with the
displayed numeric rate indicates a signal has been obtained.

A volume icon, located in the ultrasound heart rate frame of the display, changes with knob
rotations to provide visual feedback of the volume setting.

This bell shaped icon, when displayed, indicates that alarms are enabled.

This bell shaped icon with an X through it indicates alarm is

disabled for the parameter displayed in that frame.

This icon appears when the connected modem is making a call to another modem. The call is in
process and an attempt is being made to connect to another device.

This icon appears when the attached modem is transferring patient data files.

This icon appears when the monitor is connected directly to an external computer and they are
able to communicate with each other.

This icon appears when the monitor is connected to the FETALGARD Lite Recorder. This icon
is accompanied by the present setting for print speed.

Desktop icon used to start Receiver program.

1-9
FETALGARD Lite Operator’s Manual

Nurse Marker icon.

Patient Marker icon.

t NIBP Marker icon.

NIBP scroll icon distinguishes a recalled NIBP value from a real-time value.

This icon appears when the modem’s power supply is properly connected to the AC power
source and then to the input of the modem, then to the RS-232 input of the monitor.

NIBP auto mode icon and interval are displayed if auto mode is selected.

STAT mode (short term automatic mode) icon is displayed if STAT measurements are in
progress.

Clock icon and elapsed time in minutes since last NIBP measurement was made.
3

NIBP frame indicator and display of initial inflation pressure setting or cuff pressure while
mmHg xxx a measurement is in progress.

MHR Maternal Heart Rate in beats per minute (bpm).

FHR Fetal heart rate in beats per minute (bpm).

NIBP Non-invasive blood pressure in millimeters of mercury (mmHg).

SYS Systolic Pressure

DIA Diastolic Pressure

MAP Mean Arterial Pressure

TOCO Tocotonometer, measure of uterine activity

ERROR The error screen will be displayed when the monitor is unable to operate properly. If this
screen appears, discontinue use of monitor. Refer to qualified service personnel for appro-
priate action.

1.10 Accessories — Labels and Symbols

BAT-ELIM-A BAT-ELIM-B

1-10
 Safety

REF REF REF

USWB-1 USWB-1Y USWB-2

0197 2005 0197 2005 0197 2005

Accessory Label Symbols

Label Symbol Definition

Input power description

100-120V~, 50-60 Hz, 0.15A or 220-240V~, 50-60 Hz, 0.08A

Output power description: 15V~1A

U.S. and Canada Safety Certification

107546

Certification symbol in accordance with MDD 93/42/EEC.

0123

0197

Electrical isolation classification

Functional Earth

IPX1 Degree of protection against ingress of water.

For indoor use

Refer to manual for additional information

Alternating Current

Year of Manufacture
2005

REF Reference Number

1-11
 Section 2
Introduction

Introduction
2.1 General
This chapter provides a general description of the FETALGARD Lite and
FETALGARD Lite – NIBP monitors including:

• Brief Device Description

• Product Features

• Model Configurations

2.2 Brief Device Description

The FETALGARD Lite is a family of microprocessor-based fetal monitors, providing continu-
ous monitoring, display, and recording of fetal heart rate (FHR) and uterine activity (UA) for
antepartum testing and monitoring. Monitors equipped with an NIBP option will monitor mater-
nal NIBP and maternal heart rate (MHR). The monitor is battery-powered, providing continuous
operation even when local mains power is lost.

2.3 Intended Use

The FETALGARD Lite (FGL) and the FETALGARD Lite – NIBP (FGL-NIBP) are Perinatal
Monitoring Systems for non-invasively measuring and graphically showing maternal abdominal
contractions, fetal heart rate, maternal non-invasive blood pressure (FGL-NIBP model) and
maternal heart rate (FGL-NIBP model) by means of display on a non-permanent graphical dis-
play and optionally on a strip chart recorder. This data is intended to aid in assessing the well
being of the fetus during the final trimester of pregnancy (Non-Stress Test). This device is for use
only by trained medical personnel located in hospitals, clinics, doctors’ offices and in the
patient’s home.

2.4 Product Features

The monitored data can be recorded continuously or intermittently on a strip-chart recorder at the
operator’s discretion. The recorded information includes graphic trend data and text information of
monitor hardware and software configuration, date and time, patient identification, changes to oper-
ational settings, clinician and patient event marks, and recorder model and paper configurations.

2.5 Models, Options, and Accessories

There are two basic models in the FETALGARD Lite family.
• FGL – FETALGARD Lite external monitor
• FGL – NIBP – FETALGARD Lite – NIBP external monitor with non-invasive maternal
blood pressure and MHR option
Configuring the FGL or FGL – NIBP for either single-fetus or twin-fetus monitoring is accom-
plished by simply connecting the proper ultrasound transducers to the front end. (See Ordering a
FETALGARD Lite Monitor (page 2-2) for correct model numbers.) The monitored data can be
recorded continuously on a strip-chart recorder accessory at the operator’s discretion.

2-1
 FETALGARD Lite Operator’s Manual

Table 2-1. FETALGARD Lite Configurations

Monitoring Features Abdominal Single- Twin- Maternal Maternal

Contractions fetus HR fetus HR NIBP HR
FGL with transducers
U/S1 or USWB-1 4 4
FGL – NIBP with transducers
U/S1 or USWB-1 4 4 4 4
FGL with Transducers
US1-Twins or USWB-Twins 4 4 4
FGL – NIBP with transducers
US1-Twins or USWB-Twins 4 4 4 4 4

2.5.1 FETALGARD Lite Recorder

The FETALGARD Lite strip-chart recorder, models FGL-RECORDER-A or
FGL-RECORDER-B, are used to continuously record monitored data and can be configured for
use with any of the above configurations.
2.5.2 Ordering a FETALGARD Lite Monitor
Each FETALGARD Lite or FETALGARD Lite – NIBP monitor is supplied standard with the
following accessories:
• Tocotonometer with attachment button on top — with belt (2)
• Bottle of ultrasound transmission gel
• Operator’s manual – multi-language CD
• NIBP Extension hose, non-latex (for NIBP equipped monitors only)
Choose either Monitor:
q FGL External Fetal monitor
q FGL-NIBP External Fetal Monitor with NIBP
To complete the FETALGARD Lite monitoring system, you must choose from the following
accessories. (See Table 2-2 for the complete list of FETALGARD Lite accessories.)

(For single-fetus monitoring):

q U/S1 Single with belts (2)

q USWB-1 Compact, Waterproof, Single with belts (2)

(For twin-fetus monitoring):

q US1-TWINS Pair of U/S transducers, one with “Y” connector
and a twins transducer, includes belts (4)
(includes U/S1&2 and U/S2)
q USWB-TWINS Pair of compact, waterproof, U/S transducers, one with “Y” connector
and a twins transducer, includes belts (4) (includes USWB-1Y and
USWB-2)

Battery Eliminator with Power Cord (Select one):

q BAT-ELIM-A 100 - 120V AC power

q BAT-ELIM-B 220 - 240V AC power

Optional Strip-Chart Recorder with I/O Cable (Includes 1 pack 30-240 BPM; 1 pack 50-210 BPM):

q FGL-RECORDER-A For use with 100 - 120V AC

q FGL-RECORDER-B For use with 220 - 240V AC

2-2
 Introduction

Table 2-2. FETALGARD Lite Accessories

Analogic Order
Parameter Description Number
Ultrasound Single ultrasound transducer with belts (2) U/S1
Ultrasound transducer, single with belts (2) and U/S1&2
“Y” connector for twins
Twins ultrasound transducer with belt (2) U/S2
Single ultrasound transducer, compact, waterproof, USWB-1*
with belts (2)
Single ultrasound transducer, compact, waterproof, USWB-1Y*
with belts (2) and “Y” connector for twins
Twins ultrasound transducer, compact, waterproof, with USWB-2*
belts (2)
Ultrasound transmission gel; 12 bottles per box U/S-GEL
Tocotonometer Tocotonometer with belts (2) TOCO-B-6
Latex-free cuff, small adult, 18-26 cm (7.1-10.2 in) AN4K-AC018
Latex-free cuff, adult, 25-35 cm (9.9-13.8 in) AN4K-AC017
NIBP Latex-free cuff, adult plus, 33-47 cm (13.0-18.5 in) AN4K-AC016
Latex-free cuff, thigh, 46-66 cm (18.1-26.0 in) AN4K-AC020
Latex-free extension hose AN4K-AC019
Software FGL View Program FGL-VIEW
FETALGARD Lite Operator’s Manual FGL-OP-MAN
Manuals
FETALGARD Lite Service Manual FGL-SERV-MAN
Roll stand with adapter (Trolley) FGL-AC080
Stands and
Mounts GCX Adapter for Monitor GCX-ADAPT
Abdominal transducer belts ABDOM-BELT-4
Printer Paper, 30-240 BPM scale; 40 per box PAPER-USA-3
Printer Paper, 50-210 BPM scale; 40 per box PAPER-INT-3
Miscellaneous
FG Lite carrying case FGL-CARRY-CASE
Accessories
Battery eliminator 100V - 120V BAT-ELIM-A
Battery eliminator 220V - 240V BAT-ELIM-B
Power Cord, 110 VAC -120 VAC 10-61526-070
Power Cord, 220VAC - 230 VAC 10-61526-071
FG Lite 220V Y power cable configuration 10-64783-01
Remote Marker RM-3
Recorder FGL recorder with cable 100V–120V AC FGL-RECORDER-A
FGL recorder with cable 220V–240V AC FGL-RECORDER-B
FGL recorder interconnect cable FGL-REC-CABLE

* Note: The USWB-1, USWB-1Y and USWB-2 transducers are IPX7 rated and can be submersed in water.

2-3
FETALGARD Lite Operator’s Manual

2.6 Unpacking Your Monitor

Examine the carton and look for any evidence of mishandling in the shipment. Follow institu-
tional procedures for reporting such evidence. (See Appendix B for factory contact information.)

Remove the contents from the shipping carton. Compare the shipped items with the packing slip
and your order.

Each FETALGARD Lite monitor shipment will vary dependent upon configuration and acces-
sories order. A minimum shipment includes the items listed below.

• One FETALGARD Lite monitor

• One Recorder (optional)*

• One or more Ultrasound Transducers

• One Tocotonometer (Toco)

• One Battery Eliminator*

• Two AC Power Cords (one optional with recorder)

• One Monitor to Recorder Interconnect Cable (optional with recorder)

• One Operator’s Manual

• One Bottle of Ultrasound Gel

• Two Packages of Recorder Paper — One of each type (optional with recorder)

• One Recorder Spacer —to be used with Philips/HP Paper (not supplied) (optional with
recorder)

• Two or more Abdominal Belts

• NIBP Extension Hose (FGL-NIBP model only)

If contents are accurate and the equipment functions properly, as described in the following
chapters, then discard shipping material in accordance to local ordinances and/or institutional
practices.
*Note: These items are available with either 100VAC - 120 VAC or 220 VAC - 240 VAC power options. Be sure to check
that you have received the correct device and power cord for your location.

2-4
 Section 3
Installation, Setup, and Operation

Installation, Setup, and Operation

3.1 Description of the Front Panel

LCD Display Screen Speaker

Power
On/Standby
Button Navigation
NIBP Control Clinician Event Trend Scroll Graticule Knob
Button* Marker Button Button Button
U/S TOCO Zero Contrast Adjust
Volume/Alarm Button Button
Button
*The NIBP button is absent on the non-NIBP model.

Figure 3-1. FETALGARD Lite — NIBP Monitor

This figure shows the location of the various parts and controls on the front of the
FETALGARD Lite – NIBP monitor.

10-43421-002
FA001610
FET GARDLite ®
2003
MARKER
MANUFACTURED BY: ANALOGIC CORP.,
LIFE CARE SYSTEMS DIVISION,
8 CENTENNIAL DRIVE, PEABODY, MA 01960 U.S.A.
This ISM device complies with Canadian ICES-001.
Cet appareil ISM est conforme a la norme NMB-001 du Canada. RS-232

RXOnly IPX1
15V 1A
11-4387REV05 0197 107546

Figure 3-2. FETALGARD Lite — Rear Label

3-1
FETALGARD Lite Operator’s Manual

3.2 FETALGARD Lite — NIBP Accessory Configuration

Battery Eliminator

RS-232 Connector

NIBP
Patient Marker

Ultrasound Tocotonometer

Figure 3-3. FETALGARD Lite — NIBP Monitor, with Accessories Attached

3.3 Patient Cables

WARNING
Take precautions to use proper cable management to prevent possible strangula-
tion. Unused lengths of cables should be neatly placed out of harm’s way.

WARNING
Use only patient cables and transducers supplied with the monitor. Use of any
other patient cables may result in out-of-specifications performance and possible
safety hazards.
The ultrasound transducer and TOCO transducer are attached to the rear of the monitor. Each
cable has a tab located on the connector housing to insure proper insertion into the appropriate
connector on the monitor. The location of the connectors is shown on the label located on the
rear of the monitor.

The cables are inserted or removed by squeezing the narrow ends of the connector housing. This
releases the connector locking mechanism.

A second ultrasound transducer and cable can be used with either version of the FETALGARD
Lite or FETALGARD Lite — NIBP, to provide the capability of monitoring two fetuses. This
second transducer comes with a shorter cable that inserts into a connector located on the primary
ultrasound transducer cable. To install the second transducer, remove the protective cover from
the connector on the primary cable and insert the second transducer cable.

3.4 NIBP Cuff

For FGL – NIBP models, connect the NIBP extension to the rear NIBP connector. Press until
firmly engaged. Connect cuff to extension cable. Press until firmly engaged.

3-2
 Installation, Setup, and Operation

3.5 Patient Marker

The patient marker cable is inserted into a connector on the rear. The rear label shows the loca-
tion of the connector. The cable connector is inserted into the connector firmly until it is fully
engaged.

3.6 Battery Eliminator

The battery eliminator is used to charge the monitor’s internal battery. The battery can be
charged either during normal fetal monitoring or when the monitor is in Standby. The battery
eliminator consists of a tabletop box with a permanently attached cable and a separate AC line
cord. The attached cable is inserted into its mating connector located on the rear of the
monitor.The label on the rear of the monitor shows the location of this mating connector. (See
Figures 3-2 and 3-3.) Insert the cable into this connector firmly until it is fully engaged.

Insert the AC line cord into the three-pronged IEC receptacle on the battery eliminator. The other
end of the AC line cord is then inserted into an appropriate wall outlet.

WARNING
SHOCK HAZARD — The power receptacle must be a three-wire grounded outlet.
Never adapt the three-prong plug from the Battery Eliminator or accessory to fit a
two-slot outlet. If the outlet has only two slots, make sure that it is replaced with a
three-slot grounded outlet before attempting to operate the monitor.

WARNING
Do not connect to an electrical outlet controlled by a wall switch.

WARNING
SHOCK HAZARD — Do not attempt to connect or disconnect a power cord with
wet hands. Make certain that your hands are clean and dry before touching a
power cord.

3.7 FETALGARD Lite Recorder

3.7.1 Installation and Loading Paper
Unpack the recorder and accessories and place the recorder on a stable surface. Connect the com-
munications cable to the connector on the rear of the recorder. The other end of the cable con-
nects to its mating connector on the rear of the monitor.

Attach the AC line cord to the IEC receptacle on the rear of the recorder and to an appropriate
AC outlet.

WARNING
SHOCK HAZARD — The power receptacle must be a three-wire grounded outlet.
Never adapt the three-prong plug from the Battery Eliminator or accessory to fit a
two-slot outlet. If the outlet has only two slots, make sure that it is replaced with a
three-slot grounded outlet before attempting to operate the recorder.

WARNING
Do not connect to an electrical outlet controlled by a wall switch or a multi-socket
strip.

WARNING
SHOCK HAZARD — Do not attempt to connect or disconnect a power cord with
wet hands. Make certain that your hands are clean and dry before touching a
power cord.

3-3
FETALGARD Lite Operator’s Manual

WARNING
Do not attempt to attach the recorder to a wall mount. It is intended to be used on
a flat, stable surface or on an Analogic recommended roll stand.

The paper is loaded by first sliding the paper drawer forward as shown below.

A spacer, which was shipped with the monitor, is required in the paper tray when Philips/HP
paper is used. This spacer is supplied with the recorder and is installed into the left side of the
paper tray. This spacer must be installed to properly align the paper to the print head. Make sure
this spacer is installed properly prior to proceeding with loading paper. The Analogic replace-
ment part number for the spacer is 10-43254SP-13.

Unwrap a pack of paper and slide it into the paper tray as shown below.

Figure 3-4. Loading a Paper

Several pages from the top of the pack of paper should drape forward over the top of the paper
drawer. The orientation of the paper is with the printed grid facing up (unfolding from the top of
the pack) and the TOCO grid area closest to the recorder keypad.

Slide the paper drawer into the recorder. The recorder is now ready for use.

Turn the recorder on using the AC mains switch on the rear of the recorder.

An indicator LED on the front of the recorder will confirm the unit is attached to an AC source
and the unit is powered on.

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 Installation, Setup, and Operation

3.7.2 Controls and Indicators

This section describes the fixed buttons and indicator lights on the Recorder.

Paper Advance button — This button is used to fast-forward the recorder paper. A
Icon Description

press and hold of this button will advance the recorder paper at high speed until the
button is releases. The recorder will resume its original activity when the button is
released. Any text and graphics in the process of being printed during a paper advance
event will be lost. When the button is released, printing will resume normally.
Printing Enable/Disable button — A single press and release of this button will toggle
the recorder mode between printing and nonprinting. The indicator LED next to the icon at
the left will be on when printing is enabled and off when disabled.

At power-on, the unit will default to printing enabled. If the recorder is connected to an
active monitor, the recorder will automatically begin printing as instructed by the monitor.

Power-on Indicator — This indicator will be on whenever the recorder is connected

to an AC line source and the AC mains switch on the rear of the recorder is on.

NOTE
The communication link between the monitor and recorder requires a few seconds
to complete. During this time, the paper may begin to advance but the recording
will not begin until the recorder icon appears in the Communications frame of the
monitor.

3.7.3 Recorder Power Loss

The recorder is not battery powered. A loss of power to the recorder while the monitor is still
recording will cause a loss of printed data on the recorder for the duration of the power loss. This
can be caused by either a loss of the AC mains or the AC mains switch being turned off. The
recorder will acknowledge the return of power by a double row of test patterns with a unique
header in between. (See Figure 3-4 below.)

Since the FETALGARD Lite and FETALGARD Lite — NIBP monitors are battery-powered,
any lost printed data can be retrieved. If a printed record is required, the lost data can be retrieved
by “Printing Patient Files.” (See Section 11.)

Figure 3-5. Recorder Power Loss Indication.

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FETALGARD Lite Operator’s Manual

3.8 Roll Stand Option

The FETALGARD Lite monitor can be mounted on an Analogic-recommended roll stand, the
FGL-AC080. The instructions below are for the attachment of the recorder mounting plate,
assembly instructions for the roll stand and mounting of the monitor.

3.8.1 Roll Stand Assembly

The Analogic Roll Stand is shipped in one box containing three (3) assemblies:
• Base unit with casters attached
• Pole unit, complete with handle, wire basket, monitor adapter bracket, recorder frame, and
recorder adapter bracket
• Recorder Adapter Mounting Plate

Roll Stand Assembly Procedure:

1. Remove all roll stand assemblies from the box.
2. Remove bolt and washers from the bottom of the pole unit.
3. Insert the pole unit into its coupling on the base unit.
4. Turn the unit on its side in order to access the bottom of the base and reinstall the bolt and
washers removed in step 2 through the base unit while screwing it securely into the pole unit.
The large flat washer should be flush against the base and the lock washer between the head of
the bolt and the flat washer. An adjustable wrench or 9/16" open-ended or box wrench should
be used for tightening the bolt.
5. Return the completed assembly to an upright position and ensure that the pole unit is straight
and secure in the base unit.
3.8.2 FGL Optional Recorder, Adapter Bracket Mounting Plate
A mounting plate is required for securing the FETALGARD Lite recorder to the roll stand
adapter bracket and must be installed on the bottom of the recorder prior to mounting it on the
roll stand.

Attaching the mounting plate to the FETALGARD Lite recorder to the roll stand adapter bracket
and must be installed on the bottom of the recorder prior to mounting it on the roll stand.

Attaching the mounting plate to the FETALGARD Lite recorder is easily accomplished by using
the hardware provided with the mounting plate. The recorder mounting plate comes supplied
with 4 machine screws, (pan head cross recess 6-32 x 5/16" Lg. S.S.) and 4 flat washers (No. 6
S.S.) bagged with the mounting plate. Simply remove the four screws and washers and mount
the plate to the bottom of the recorder. (See Figure 3-5.)

Figure 3-6. Attaching the FETALGARD Lite Recorder Adapter Mounting Plate.

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 Installation, Setup, and Operation

3.8.3 Mounting the FETALGARD Lite Monitor on the Roll Stand

The FETALGARD Lite monitor mounts to the roll stand by gently guiding the narrow piece of the
adapter bracket into the slot on the bottom of the monitor. The spring-loaded plunger will snap into
place when the adapter bracket is fully engaged. Test for secure engagement by attempting to
remove the monitor from the docking plate without disengaging the spring-loaded plunger.
To remove the FETALGARD Lite monitor from the roll stand docking plate, simply pull the
spring-loaded plunger while simultaneously sliding the monitor from the docking plate.

3.8.4. Mounting the FETALGARD Lite Recorder on the Roll Stand

The FETALGARD Lite recorder mounts to the roll stand by gently guiding the narrow piece of
the adapter bracket mounting plate into the slot on the recorder adapter bracket, inside the
recorder frame. The spring-loaded plunger will snap into place when the adapter bracket is fully
engaged. Test for secure engagement by attempting to remove the recorder from the adapter
bracket without disengaging the spring-loaded plunger.
To remove the FETALGARD Lite Recorder from the roll stand adapter bracket, simply pull the
spring-loaded plunger while simultaneously sliding the recorder from the adapter bracket.

3.9 Mounting the GCX Adapter Plate

It is possible to mount the FETALGARD Lite and FETALGARD Lite – NIBP monitors to GCX
roll stands by use of a GCX adapter plate, Analogic part number GCX-ADAPT.
The GCX adapter plate mounts to the monitor by gently guiding the narrow piece of the adapter
bracket into the slot on the bottom of the monitor. The spring-loaded plunger will snap into place
when the adapter bracket is fully engaged. Test for secure engagement by attempting to remove
the monitor from the docking plate without disengaging the spring-loaded plunger.
The optional recorder can be mounted to a GCX roll stand. Consult the mounting instructions
provided by GCX.

WARNING
When operating the monitor from a position higher than the patient, ensure that it
is securely mounted.

3.10 Monitor Positioning

Be sure to position the monitor in a location and position such that the display is easily seen, the
alarms can be heard and that the front panel controls are conveniently reached without obstruction.

To check that the alarms can be clearly heard, intentionally cause an alarm condition by setting
the FHR alarm limit beyond what is currently being measured.

3.11 FETALGARD Lite Monitor Display Screen

Main Monitoring Screen with NIBP and Markers

119
US1 240

160

99
US2
120

30 t

16
TOCO 100

(5) 0

3
cm/min. mmHg 160 1 MHR 80 bpm
130/85 (95)

12:49:40 AM 1/2/2001

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FETALGARD Lite Operator’s Manual

Main Monitoring Screen without NIBP Installed

119
US1 240

109
120
US2
90

30

11
TOCO 100

(5) 0

3 3:03:32 PM 5/12/2005
cm/min.

JANE DOE

3.11.1 Heart Rate Numeric

The heart rate numeric frame displays the fetal heart rate, a heart icon, alarm status icon, and a
speaker volume icon. This channel is labeled “US1.” The heart rate value shows the most recent
calculated fetal heart rate. The heart rate icon blinks at the measured heart rate interval when a
valid rate is present.

The volume icon provides an indication of the speaker volume setting for the fetal echo sounds.
This icon changes when the speaker volume setting is adjusted.

The alarm icon is a bell. An X through the bell indicates alarms are disabled. A bell without an X
indicates alarms are enabled.

When the second ultrasound transducer is installed, the heart rate frame will include additionally the
fetal heart rate, a heart rate icon, alarm status icon, and a speaker volume icon for the second ultra-
sound channel. These function identically as described above. This channel is labeled “US2.”

The trace-offset icon will also appear in the heart rate frame if two ultrasound transducers are installed
and ultrasound trace offset has been enabled. The trace-offset icon is a downward pointing arrow.

3.11.2 Heart Rate Trend

The Heart Rate Trend Frame displays a graphical representation of the fetal heart rate. The verti-
cal scale is labeled and corresponds to the selection of recorder paper (30 to 240 BPM for U.S.
style paper, 50 to 210 BPM for international style paper). The graph displays 6 minutes of data if
the monitor is set for a print speed of 3 cm per minute, 9 minutes of data when set for 2 cm per
minute, and 18 minutes when set to 1 cm per minute.

This frame will show two heart rate trends when two ultrasound transducers are installed.

Two horizontal graticule lines are included to make it easier for the caregiver to observe heart
rate variability or heart rates that exceed limits. The position of these two lines is initially at the
alarm limit values. When the caregiver presses the graticule button, the upper line moves to a
position 15 BPM above the low alarm limit, and then the position of both these lines becomes
adjustable.

This graphical frame is also used to display heart rate data when scrolling through historical
patient data.

3.11.3 TOCO Numeric

This frame contains the numeric value from the TOCO transducer representing uterine activity.
This frame also shows the present TOCO baseline value. The TOCO baseline is user adjustable.

3.11.4 TOCO Trend

The TOCO Trend Frame displays uterine activity trend data. The scale is from zero to 100 in rela-
tive units. The graph displays 6 minutes of data if the monitor is set for a print speed of 3 cm per

3-8
 Installation, Setup, and Operation

minute, 9 minutes of data when set for 2 cm per minute, and 18 minutes when set to 1 cm per
minute. This graphical frame also displays uterine activity data when scrolling through patient data.

3.11.5 Power Status

This frame contains either a battery icon or an AC power connector icon. If the unit is operating
on AC power then an AC power connector icon is displayed. If the monitor is operating on inter-
nal battery power then a battery icon is displayed. The battery icon also includes a scale indicat-
ing battery charge status.

This displayed icon indicates that the FETALGARD Lite is operating from AC power.

This displayed icon indicates that the FETALGARD Lite is operating on internal battery power.
The number of bars displayed is proportional to the remaining battery run-time.

The battery icon will flash when the battery is low (less than 30 minutes of remaining time). The
battery eliminator should then be connected to the monitor to charge the battery. The monitor
will operate normally while the battery eliminator is charging the battery. The battery will be
fully recharged in 8 hours if the monitor is not in use, or in 14 hours while in normal use.

3.11.6 Communications
This frame shows the status of devices connected to the monitor’s serial interface port.

Icon Description

This phone icon appears if the monitor is connected to an external modem and no call is
in process.

This icon appears when the connected modem is making a call to another modem. The
call is in process and an attempt is being made to connect to another device.

This icon appears when the attached modem is transferring patient data files.

This icon appears when the monitor is connected directly to an external computer and
they are able to communicate with each other.

This icon appears in the lower left-hand corner of the monitor’s screen when it is con-
nected to the FETALGARD Lite Recorder and the data “Destination” in the
Communications Menu has been set for “Recorder.” This icon is accompanied by the
current setting for print speed. This icon has two states: If it is on and not flashing, the
setup and communication are complete and the recorder is printing. If the icon is flash-
ing, it could mean one of the following problems: • Out of paper; • The drawer is not
properly closed; or • The monitor is on but the Recorder Printing Enable/Disable button
is disabled.

3.11.7 Message Frames

The two frames located below the trend graphs are the Message Frames.

In the non-NIBP model of the FETALGARD Lite, the upper frame always contains the Date and
Time and the lower frame always contains the Patient ID.

In the FETALGARD Lite — NIBP, the upper frame always contains the NIBP information. The
lower frame alternates between the Patient ID and the Date and Time at four-second intervals.

The monitor is able to store a user defined Startup ID, for reuse when the monitor is next pow-
ered “On.”

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FETALGARD Lite Operator’s Manual

3.11.8 Error Display

ERROR 4660

The error screen will be displayed when the monitor is unable to operate properly. If this screen
appears, discontinue use of monitor. The error tone will continue until power is turned off or any
button is pressed. Refer to qualified service personnel for appropriate action.

3.12 FETALGARD Lite Monitor Controls and Indicators

There are seven buttons located on the front panel of the FGL and 8 on the FGL — NIBP. The
buttons are activated by pushing with the finger until an audible click and an audible tone is heard.

Caution
Never use sharp or pointed objects to operate the front-panel switches.

The operation of the buttons is summarized below.

Icon Description

FGL — NIBP Power On/Standby button — turns monitor power On and to Standby.

FGL — NIBP U/S Volume Alarm button — selects an ultrasound channel in order to
adjust its audio volume. The control knob is then used to increase or decrease volume set-
tings. This button is also used to silence the audible warning indicator that accompanies a
heart rate alarm condition.

FGL Power On/Standby button — switches monitor between power On and Standby.

FGL U/S Volume/Alarm button — selects an ultrasound channel in order to adjust its
audio volume. The control knob is then used to increase or decrease volume settings. This
button is also used to silence the audible warning indicator that accompanies a heart rate
alarm condition.

NIBP control button — initiates or cancels NIBP measurement.

TOCO Zero button — resets the TOCO baseline.

Clinician Event Marker button — inserts a nurse event mark on the display and strip chart
paper when pressed.

Contrast Adjust button — changes the operation of the control knob to adjust the display
contrast

Trend Scroll button — this button puts the monitor into trend scroll mode. The trend
frames shows historical patient data and the control knob provides navigation capability.

Graticule button — displays a pair of horizontal level lines, 15 BPM apart, on the FHR
trend frame. Rotating the control knob moves these lines up or down on the display.
The keypad has two LED indicators. The indicator next to the battery symbol is on whenever the
monitor is powered from the internal battery. The indicator next to the power cord connector sym-
bol is on whenever the monitor is powered from AC mains via the external battery eliminator.

3.13 FETALGARD Lite Monitor Control Knob

The Control Knob is the primary method of adjusting parameters and navigating through the
menu system. Rotating the knob while in the main monitoring screen moves a selection frame to
each of the frames in the display. When the knob is pressed, a menu appears that contains moni-
tor settings that are relevant to the display frame that was selected.

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 Installation, Setup, and Operation

If the knob is rotated while in a menu, the cursor moves throughout the items within the menu.
This process is used to select a menu item for modification. The knob is then pressed to select
this item for editing.

Once a menu item has been selected for change, the knob is rotated to scan through the available
choices for this parameter. Pressing the knob stores the new value.

Pressing the knob when “Return” is selected will exit the present menu. In some cases this action
will return the monitor to the main monitoring screen. In other cases the monitor will display the
previous menu.

Specific Control Knob procedures are included in the chapters describing setup, monitoring,
recording and viewing patient data.

3.14 Startup
3.14.1 Power-on Self-test

NOTE
Prior to a battery-powered monitoring session, always check the battery icon to
ensure sufficient, available monitoring time.
The monitor performs a self-test each time it is turned on. This process allows the monitor to
check various systems for proper operation. The monitor displays the startup screen seen below,
and sounds a series of audible tones during the power-on self-test. The tones are an indication
that the speaker and audio circuits are functioning. When the test is successfully completed the
FETALGARD Lite displays the monitoring screen.

BOOTCODE V1.1
APPLICATION V3.00
SN: FA00000000
Copyright 2005 Analogic Corporation

If a malfunction is detected an error screen, such as that in section 3.11.8, appears and an error
tone is sounded. The error tone will continue until the power is turned off. If this occurs, remove
the monitor from service until appropriate action is taken.

3.14.2 Configuration Settings

The monitor has several configuration settings that the user can change. Some of these settings are
reset to the default value each time the monitor is powered down. Other parameter settings are
saved in the monitor until the next time they are changed. These parameters are unaffected when
the monitor is powered down. A complete list of these parameters is shown in Table 3-1.

NOTE
If the monitor has been stored in temperatures exceeding the operating range,
allow adequate time for the internal temperature to return to the operating range.
(See Specifications, Section 16.)

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FETALGARD Lite Operator’s Manual

Table 3-1. Default and Retained Configuration Settings

Configuration Parameter Factory Default Saved Until Changed

U/S Trace Separation 0 BPM No
TOCO Baseline Set Point 5 Yes
Time EST Yes
Time Format 12-hour Yes
Date “today” Yes
Date Format mm/dd/yy Yes
Patient Id Time/Date encoded No
Language English Yes
Modem Initialization String — Yes
Modem Phone Number — Yes
Modem Data Transfer Disabled No
Recorder Paper Speed 3 cm/min Yes
Recorder Paper Vendor Analogic Yes
Recorder Paper Style U.S.A. Yes
FHR Alarms Disabled NO*
FHR Upper Alarm Limit 160 BPM NO*
FHR Lower Alarm Limit 120 BPM NO*
FHR Alarm Delay 15 seconds NO*
Loss of FHR Alarm Delay 120 seconds No
Display Contrast — Yes
Speaker Volume — Yes
Startup ID — Yes
NIBP Measurement Mode Single NO*
NIBP Initial Inflate 160 mmHg NO*
SYS Upper Alarm Limit 140 mmHg NO*
SYS Lower Alarm Limit 80 mmHg NO*
DIA Upper Alarm Limit 110 mmHg NO*
DIA Lower Alarm Limit 60 mmHg NO*
MAP Upper Alarm Limit 120 mmHg NO*
MAP Lower Alarm Limit 60 mmHg NO*
NIBP Alarm Status Enabled NO*

*These parameters can be configured as institutional defaults. Consult factory.

3-12
 Installation, Setup, and Operation

3.14.3 Setting U/S Trace Separation

When ultrasound trace separation is enabled, the trend data for ultrasound channel 2 is shifted
down by 20 BPM. This feature is provided to clearly see separate heart rate trends when both
heart rates are similar. The heart rate value shown in the numeric frame is not affected.

Follow the steps below to change the heart rate separation setting.
Knob Desired
Activity Result

Rotate To highlight the heart rate frame.

Press To view the ultrasound menu (shown below).

122
US1 Ultrasound Menu
Trace Separation 0 bpm
FHR Upper Limit 160 bpm

141
US2 FHR Lower Limit 120 bpm
FHR Alarm Delay 15 SEC
Loss of FHR Delay 120 sec

4
Alarm Status Disable
TOCO

Return
(5)

3
cm/min. mmHg 160 42 MHR 60 bpm
120/80 [90]

12:15:50 AM 1/2/2001

Rotate To select Trace Separation.

Press To select this parameter for change.
Rotate To select “0 BPM,” or “20 BPM.”
Press To keep this selection.
Rotate To select “Return.”
Press To exit this submenu and return to the main monitoring screen

When trace separation is activated, it is indicated on the monitoring display by an arrow pointing
downward next to the U/S 2 numeric value. This indicator will flash at a rate of once per second.

3.14.4 Setting TOCO Baseline

This section describes the procedure for setting the TOCO baseline.
Knob Desired
Activity Result

Rotate To highlight the TOCO numeric frame.

Press To view the TOCO menu (shown below).

116
US1 TOCO Menu
TOCO Baseline 5

146
US2

10
TOCO

Return
(5)

3 120/80 [90]
cm/min. mmHg 160 53 MHR 60 bpm
12:26:52 AM 1/2/2001

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FETALGARD Lite Operator’s Manual

Rotate To highlight “TOCO Baseline.”

Press To select this parameter for change.
Rotate To highlight the desired baseline value (“5,” “10,” “15,” or “20”).
Press To keep this selection.
Rotate To select “Return.”
Press To exit this submenu and return to the main monitoring screen.

The new baseline value is displayed in parentheses in the TOCO numeric frame.

3.14.5 Setting Time, Date, and Display Format

This section describes the procedure used to change the time and date settings of the monitor.

Caution
Always start a new monitoring session after changing the time or date. Although
the new time is shown on the monitoring screen, it is not stored within the fetal
trend record.

Knob Desired
Activity Result

Rotate To highlight the Time and Date Frame with a heavy border.
Press To view the Time/Date menu (shown below). Next to each parameter is the present
setting in parentheses.

US1 Time/Date Menu

Set Time
Set Date

US2 Set Time Format 24 Hour

Set Date Format MM/DD/YY

TOCO

Return
(5)

3 12:26:52 AM 1/2/2001
cm/min.

Patient ID

Rotate To highlight the item you want to change (“Set Time,” “Set Time Format,” “Set
Date,” or “Set Date Format”).
Press To select this item for editing.
Rotate To highlight the parameter value for editing. The options for each parameter in the
submenu are:
Time {hours, minutes, seconds}
Date {month, day, year}
Time Format {12 Hour, 24 Hour}
Date Format {MM/DD/YYYY, DD/MM/YYYY}

3-14
 Installation, Setup, and Operation

Press To select the parameter value for editing.

Rotate To choose new values for the parameter.
Press To keep the displayed value for this parameter.
Repeat the previous steps for each parameter you wish to change.
Rotate To select “Return.”
Press To exit this menu.

The new time, date, and format selections are displayed on the main monitoring screen.

NOTE
Setting Time and Date procedure will have to be performed if the battery has been
disconnected for any reason.

3.14.6 Setting Patient ID

3.14.6.1 Setting ID after Startup

This section describes the procedure used to change the patient ID. When the monitor is turned
on, either a default patient ID is created by the monitor based upon the present time and date, or
the user may choose to use the saved Startup ID, if one has previously been saved. When this
patient ID is changed, the new patient ID will be incorporated into the stored patient record with-
in the monitor and presented on the display. However, this will not replace the previously stored
Patient ID as the power-up default ID. The previously stored default Patient ID CANNOT be
changed without entering the password-protected Patient ID Menu.

NOTE
The previously stored default Patient ID CANNOT be changed without entering
the password-protected Patient ID Menu. Consult your facility’s qualified service
personnel or your local distributor.

Knob Desired
Activity Result
Rotate To highlight the Patient ID Frame with a heavy border.
Press To view the Patient ID menu (shown below). The present patient ID is displayed. If
the unit was started without a saved Startup ID, the screen appears as shown below.

US Patient ID Menu
Patient ID 010201002950
Set Patient ID
Save As Startup Id
JANE DOE
Set Time
194848
Set Date
Set Time Format 12 Hour
TOCO OK Cancel
Set Date Format
Clear
MM/DD/YYYY

Return
(5)

3
cm/min. mmHg 160 57 MHR 60 bpm
120/80 (90)

12:30:280 AM 1/2/2001

Rotate To highlight “Patient ID.”

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FETALGARD Lite Operator’s Manual

Press To select “Patient ID” for editing. The Set Patient ID submenu will appear (shown
below).

US Patient ID Menu
Patient ID 010201002950

Save As Startup Id

TOCO

Return
(5)

3
cm/min. mmHg 160 57 MHR 60 bpm
120/80 (90)

12:30:280 AM 1/2/2001

Rotate To highlight a character in the patient ID for edit or to highlight “Clear,” “OK,” or
“Cancel.”
Press To activate the highlighted selection.
If the knob is pressed when “Clear” is highlighted, characters within the Patient ID
field will be set to blanks.
If the knob is pressed when a character in the Patient ID is highlighted, this character
is selected for editing.
Rotate To select new values for this character in the patient ID. The characters available are
0-9, A-Z, and space.
Press To keep the displayed value.
Repeat the previous steps for each character you wish to change.
Rotate To highlight “Return,” “OK,” or “Cancel.”
Press If the knob is pressed when “OK” is highlighted, the patient ID will be updated with
the displayed characters and the Set Patient ID dialog box will be removed. If the
patient ID contains all spaces when “OK” is pressed, the monitor will sound the
invalid beep tone and not close the dialog box.
If the knob is pressed when “Cancel” is highlighted, the Set Patient ID dialog box
will be removed with the original patient ID unchanged.
Rotate To highlight “Return.”
Press To exit the Patient ID menu and return to the main monitoring screen.
3.14.6.2 Setting ID at Startup
After powering "ON" the unit, a Startup patient ID screen will appear.

The user may choose to use either the previously saved ID or create a new ID based on the cur-
rent date and time as described in paragraph 3.14.6.1. The Main Screen will appear next with
either option.

The unit is about to start with

this saved patient ID

Ursula22

OK Create new ID

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 Installation, Setup, and Operation

3.14.7 Setting the Language Configuration

The language displayed on the monitor screen was preset by your local Analogic distributor or
facility’s technical personnel. The language CANNOT be changed without entering the pass-
word-protected Service Menu. Consult your facility’s qualified service personnel or your local
distributor.

3.14.8 Setting Data Output Parameters

This section describes the procedure used to set the paper speed, paper vendor, paper style, and
paper output. Paper output is used to select between real-time (current record) and batch output
(patient records) for destinations capable of both types of transfer. For example, a recorder can print
data currently being collected by the monitor (real-time), or it can print a patient record, collected
previously, at a faster speed (batch output). These past records are selected for transfer using the
selection screen, which is displayed after starting the data transfer to a properly connected output
device using the "Data Transfer" menu item.
Knob Desired
Activity Result

Rotate To highlight the Communications Frame with a heavy border.

Press To display the Communications Menu shown below.

US1 Communications Menu

113 Data Transfer Stopped
Destination FGL View Batch
US2 Paper Output Patient Records

130
Paper Speed 3 cm/min
Paper Style USA
Paper Vendor Analogic
TOCO
Number To Dial (978) 555-1>

9 (5) Return

3 90
cm/min. mmHg 140 bpm

1:06:45 PM 7/15/2005

Rotate To highlight “Paper Speed,” “Paper Style,” “Paper Vendor,”

Or “Paper Output. ”
Press To select the highlighted parameter for editing.
A dialog box will appear with the available options for this parameter.
Rotate To highlight the desired value.
The list below shows the values that are available for each parameter.

Paper speed {1 cm/minute, 2 cm/minute, 3 cm/minute}

Paper style {U.S., International}

Paper vendor {Analogic, GE/Coro, Philips/HP}

Paper output {Patient Records, Current Record}

Press To keep the highlighted value and exit the dialog box.
Repeat the previous steps until “Paper Speed,” “Paper Style,” “Paper Output,” and
“Paper Vendor” are properly configured.
Rotate To highlight “Return” in the Service Menu.
Press To exit the Service Menu and return to the main monitoring screen.

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FETALGARD Lite Operator’s Manual

3.14.9 Adjusting Speaker Volume

Speaker volume can be increased or decreased by pressing the U/S Volume/Alarm button fol-
lowed by clockwise or counterclockwise rotation of the knob. This volume adjustment affects
only the amplitude of the ultrasound heart sounds.

A volume icon, located in the ultrasound heart rate frame of the display, changes with knob rota-
tions to provide visual feedback of the volume setting.

Pressing the volume button a second time completes the adjustment process. The new volume
setting is saved until the next time it is changed. Knob inactivity for more than 10 seconds also
completes the adjustment process.

The adjustment process varies slightly for a monitor with two ultrasound channels. The first
press of the volume button followed by knob rotation adjusts the volume for ultrasound channel
one. The second press of the volume button completes the adjustment for channel one and
enables the adjustment of channel two. Knob rotation will now change the volume setting for
ultrasound channel two. A volume indicator icon for channel two, located in the heart rate frame
for channel two, operates the same as described above for channel one. Pressing the volume but-
ton a third time completes the adjustment process for channel two and saves the desired setting.
Knob inactivity for more than 10 seconds also completes the adjustment process.

NOTE
If a sub-menu or service menu is being displayed, the Speaker adjustment is
not available.

3.14.10 Adjusting the Display Contrast

Display contrast is set to a default value at the factory. This setting is adjustable to optimize the
display for best viewing. The contrast button and the control knob are used for this adjustment.

Pressing the contrast button initiates the process and resets the contrast to the factory default.
This is done to ensure the display contrast is centered and the display is reasonably viewable. The
knob is rotated clockwise to lighten the contrast or counterclockwise to darken the contrast.

Pressing the contrast button a second time completes the adjustment process. The new contrast
setting is saved until the next time it is changed. Knob inactivity for more than 10 seconds will
also complete the adjustment process as if the button were pressed a second time.

NOTE
If a sub-menu or service menu is being displayed, the Contrast adjustment is
inactive.

3-18
 Section 4
Alarms & Limits

Alarms & Limits

Caution
When a new monitoring session is started, check that the alarm status, indicated
by the icon in the parameter window, is in the state required for this session.

NOTE
Throughout this section, references are made to the maternal NIBP function.
These descriptions pertain only to the FGL — NIBP model. If your monitor does
not support the NIBP feature, disregard these references.

4.1 General Information

The FETALGARD Lite monitor has the capability to alert the caregiver in the event a fetal heart
rate or the maternal NIBP goes above or below an alarm limit. The fetal heart rate also includes a
selectable time delay. The limit values and the delay from onset to alert are user selectable
through the Ultrasound Menu. FHR alarm limits are set by selecting an Upper and Lower Limit
and also selecting the amount of time, in seconds, that the FHR must exceed these limits before
an audible and visual alarm occurs. An alarm event results in an audible tone and blinking of the
heart rate value on the display.

The maternal NIBP alarm limits are set through the NIBP frame by selecting an upper and lower
limit for systolic (SYS), diastolic (DIA) and mean (MAP). Pressing the U/S Volume/Alarm but-
ton on the monitor’s keypad can silence the alarm tone. When the alarm is silenced, the audible
alarm will not sound again until the condition that caused the alarm has moved into acceptable
range and then out again, or a completely different parameter goes into an alarm state. While the
alarm is silenced, a blinking heart rate will be displayed as long as the alarm condition persists or
until alarms are disabled. Additionally, when the alarm is silenced, the bell icon is replaced by a
blinking bell shaped icon with an X through it. Please refer to Table 4-3, Alarm Settings, for
default and other Alarm Parameters.

The monitor also has the capability of alerting the clinician if a loss of fetal heart rate detection
occurs. This alert occurs if a valid heart rate is followed by no measurable heart rate for a selec-
table time delay. The heart rate frame will display blinking dashes and the audible warning tone
will sound if this condition happens. The audible warning tone can be silenced by pressing the
speaker button on the monitor’s keypad. The display of blinking dashes will continue as long as
the alarm condition persists or until alarms are disabled. The loss of heart rate alarm delay time is
adjustable by the user through the Ultrasound Menu.

FHR alarms are enabled or disabled by accessing the Alarm Status selection in the Ultrasound
Menu. This selection enables or disables all FHR alarms.

4.2 Alarm Descriptions

The monitor’s alarms alert you to conditions that require immediate attention. The alarm priority,
medium (physiological) or low (technical or INOPs), determine the monitor’s visual and audible
response. All Limit Alarms are medium priority and all Technical Alarms are low priority.

4-1
FETALGARD Lite Operator’s Manual

4.2.1 Visual Alarm Indicators

Alarm Status is provided to the operator using a display icon in the Heart Rate Numeric Display
frame. Twins configuration provide two of these same icons in that same frame.

This bell shaped icon, when displayed, indicates that alarms are enabled.

This bell shaped icon with an X through it indicates alarms are disabled.

FHR visual alarm indicators appear on the display only when an alarm is enabled. Maternal
NIBP visual alarm indicators shall never be disabled.

Table 4-1. Visual Alarm Descriptions

Alarm Category Flashing Frequency Duty Cycle

High Priority 1.4 Hz to 2.8 Hz 20% to 60% on
Medium Priority 0.4 Hz to 0.8 Hz 20% to 60% on
Low Priority Constant (on) * 100%

* Whenever a parameter is in Low Priority alarm, the parameter value shall be displayed as “- - -.”

The FGL does not have any High Priority alarms, but the High Priority flashing frequency is
used for the STAT mode icon. All Limit Alarms are Medium Priority, and all Technical Alarms
are Low Priority.

4.2.2 Audible Alarm Indicators

FHR or Maternal NIBP audible alarm indicators are active only if alarms are enabled. Maternal
NIBP Technical or Low Priority audible alarms are always active.

Table 4-2. Audible Alarm Descriptions

Description Medium Priority Low Priority

Pitch 550 Hz ±5% 450 Hz ±5%
Harmonics 1100, 1650, 2200, 2750 Hz 900, 1350, 1800, 2250 Hz
Amplitude (at one meter) 75 dBa ±5 dB 75 dBa ±5 dB
Duration 185 ms ±20% 185 ms ±20%
Rise/fall Time 30/45 ms ±20% 30/45 ms ±20%
Pulses per Group 3 2
Pulse Rate Interval 200 ms ±20% 200 ms ±20%
Pulse Group Rate Interval 25s ±5s 25s ±5s

Pressing the U/S Volume Alarm button during a Limit Alarm shall temporarily silence the alarm,
causing a crossed bell icon to flash at the Medium Priority rate. The FHR Limit Alarm shall
remain silenced for 120 seconds, and the NIBP Limit Alarm shall be silenced until there is a new
limit violation. Pressing the U/S Volume Alarm button during a Technical Alarm shall acknowl-
edge the alarm, causing the Warning Tone to cease and the Alarm Message to be removed from
the NIBP Popup. The associated parameters shall continue to be displayed as “- - -” until the next
valid measurement.

4-2
 Alarms & Limits

4.3 Alarm Settings

The following section describes the procedure used to set the Medium Priority (physiological)
alarm parameters for FHR or Maternal NIBP.

WARNING
Because Alarm Limits are configurable, they must be checked before beginning a
new monitoring session or moving to a different type of area, to ensure that they
are appropriate for the next patient.

Table 4-3. Alarm Settings

Parameter Default Adjustable Setting Range
FHR Upper Limit 160 BPM 120-220 BPM
FHR Lower Limit 120 BPM 60-120 BPM
FHR Alarm Delay 15 seconds 15-120 seconds
Loss of FHR Delay 120 seconds 30-120 seconds
NIBP SYS Upper Limit 200 mmHg 100-240 mmHg but not less than or equal to SYS low limit
NIBP SYS Lower Limit 80 mmHg 60-150 mmHg but not more than or equal to SYS high limit
NIBP DIA Upper Limit 110 mmHg 80-180 mmHg but not less than or equal to DIA low limit
NIBP DIA Lower Limit 60 mmHg 40-120 mmHg but not more than or equal to DIA high limit
NIBP MAP Upper Limit 120 mmHg 90-200 mmHg but not less than or equal to MAP low limit
NIBP MAP Lower Limit 60 mmHg 45-130 mmHg but not more than or equal to MAP high limit
Uterine Activity 100 Units >100 units for more than 15 seconds: visual alarm only
Alarm Status Enabled Enable/Disable

4.3.1 Setting the FHR Alarm Settings

Follow the instructions below to set the FHR Alarms within the Ultrasound Menu.

Knob Desired
Activity Result

Rotate To highlight the Ultrasound Frame with a heavy border.

Press To view the Ultrasound Menu (shown below).

122
US1 Ultrasound Menu
Trace Separation 0 bpm
FHR Upper Limit 160 bpm

141
US2 FHR Lower Limit 120 bpm
FHR Alarm Delay 15 SEC
Loss of FHR Delay 120 sec

4
Alarm Status Disable
TOCO

Return
(5)

3 120/80 [90]
cm/min. mmHg 160 42 MHR 60 bpm

12:15:50 AM 1/2/2001

Rotate To highlight “Heart Rate Upper Limit,” “Heart Rate Lower Limit,” “Heart Rate
Alarm Delay,” or “Loss of Heart Rate Delay.”

Press To select the highlighted parameter for editing

A dialog box will appear with the available options for this parameter.

4-3
FETALGARD Lite Operator’s Manual

Rotate To highlight the desired value.

The list below shows the values that are available for each parameter.
FHR Upper Limit {120–220 BPM, 5 BPM increments}

FHR Lower Limit {60–120 BPM, 5 BPM increments}

FHR Alarm Delay {15–120 sec., 15 sec. increments}

Loss of Heart Rate Delay {30–120 sec., 30 sec. increments}

Press To keep the highlighted value and exit the dialog box.

Repeat the previous steps until “FHR Upper Limit,” “FHR Lower Limit,” “FHR
Alarm Delay,” or “Loss of FHR Delay” are properly configured.

Rotate To highlight “Alarm Status.”

Press To select “Alarm Status” for a new setting.

Rotate To highlight “Enabled,” or “Disabled.”

“Enable” enables audible and visual alarms for FHR
“Disable” disables both audible and visual FHR alarms
Press To keep the highlighted selection.

Rotate To highlight “Return.”

Press To exit the Ultrasound Menu and return to the main monitoring screen.

NOTE
If the Loss of FHR alarm occurs on an ultrasound channel that is no longer in use,
it can be disabled by disconnecting that ultrasound transducer from the monitor.
When disconnected, the U/S field on the display will be blank.

4.3.2 Setting the Maternal NIBP Alarm Settings

The instruction below should be followed to set the maternal NIBP Alarms within the NIBP
Menu and Set NIBP Alarm Limits sub-menu.

The NIBP Menu is reached by pressing the knob when the NIBP Frame is highlighted. The
NIBP Menu allows the user to select the Auto Mode Interval, the initial Inflate Pressure, and
NIBP Alarm Status (Enable/Disable). Disabling the NIBP Alarm disables only the audible alarm.
NIBP Alarm Limits are set in a sub-menu.

121
US1 NIBP Menu
Auto Mode Int Off
Inflate Press 140 mmHg

152
US2 Set Alarm Limits
Alarm Status Disable

9
TOCO

Return
(5)

3
cm/min. mmHg 140

4:48:30 PM 1/21/2005

4-4
 Alarms & Limits

4.3.3 Modifying the NIBP Alarm Limits:

1. Rotate the navigation knob to highlight “Set Alarm Limits.”

2. Rotate the navigation knob to highlight the alarm limit to be changed.

3. Press the knob. Rotate the knob until the desired value is reached.

4. Press the knob. Either select another parameter or select OK.

5. Select Return to exit the NIBP setup menu.

US1 NIBP Menu

121 SetTransfer
Data NIBP AlarmStopped
Limits
Destination
SYS Upper Limit FGL
140View
mmHgBatch
US2 Paper Output Limit
SYS Lower Patient
80 mmHgRecords

152
Paper
MAP Speed
Upper Limit 3 120
cm/min
mmHg
MAP Style
Paper Lower Limit USA
70 mmHg
Paper Vendor Analogic
TOCO
DIA Upper Limit 110 mmHg
Number To Dial
DIA Lower Limit (978) 555-1>
60 mmHg

9 (5) OK

3
cm/min. mmHg 140

4:48:30 PM 1/21/2005

4.4 Technical Alarms

This section details the Technical or Low Priority alarms.

Audible Indication: 1 beep every 25 seconds, ±5 seconds

Alarm Message Parameter What To Do Visual Indication

Low Battery Charge the battery. Alarm commences Battery indicator flashes
when the monitor has a minimum of once per second.
30 minutes operating time remaining.
NIBP – ARTIFACT NIBP Measurement affected by artifacts. Message displays in the
Insure proper fit of cuff and restrict NIBP result popup frame.
patient movement.
NIBP – BLOCKED HOSE NIBP NIBP tubing blocked, measurement Message displays in the
not possible. NIBP result popup frame.
NIBP – NO CUFF NIBP Monitor not able to detect cuff. Message displays in the
NIBP result popup frame.
NIBP OVERPRESSURE NIBP Remove the cuff from the patient. Make Message displays in the
sure the rubber tube to the NIBP cuff NIBP result popup frame.
is not kinked. This message appears
when the NIBP cuff pressure increases
above overpressure safety limits.
NIBP – TIME OUT NIBP NIBP measurement took too long to Message displays in the
complete. NIBP result popup frame.
NIBP – ERROR NIBP Hardware malfunction. Consult Message displays in the
authorized service personnel. NIBP result popup frame.

4-5
FETALGARD Lite Operator’s Manual

4.5 Alarm System Delays

The following table lists the distribution of alarm delays in the system. The Total Alarm System
Delay consists of the Alarm Condition Delay and the Alarm Signal Generation Delay

Min. Alarm Max. Alarm Min. Alarm Max. Alarm Min. Total Max. Total
Alarm Condition Condition Signal Signal Alarm System Alarm System
Condition Delay Delay Generation Generation Delay Delay
FETAL
FHR upper
limit 1s 4s 15s 120s 16s 124s
FHR lower
limit 1s 7s 15s 120s 16s 127s
Loss of FHR 1s 7s 30s 120s 31s 127s
MATERNAL
NIBP NIBP MTa NIBP MT + 0s 1s 15s Indeterminatec
outside (15s min.) TBM b
limits

a. NIBP MT = NIBP Measurement Time from start of cuff inflation to end of cuff deflation. This varies between 15s and 120s.

b. NIBP TBM = Time Between Measurements. If a patient’s blood pressure changes immediately after a NIBP measurement com-
pletes, the delay to alarm condition is as long as the interval between measurements. This can be between 17 seconds (STAT
mode plus NIBP MT) and 90 minutes (max. Auto Mode Interval) or longer if Auto Mode is off.

4-6
 Section 5
Monitoring Fetal Heart Rate

Monitoring Fetal Heart Rate

Electromagnetic Interference
Certain strong electromagnetic fields can interfere with the ultrasound transducer and cause a
false heart rate reading that does not originate from the patient. This interference is rare, and usu-
ally found in the vicinity of large machinery. In order to avoid the possibility of these interfering
signals being misinterpreted as fetal heart rates, the following procedure should be followed
whenever the monitor is to be used in a new location, or if it is known that electrical machinery is
being operated in the vicinity.

After connecting the ultrasound transducer(s), turn on the monitor and observe the heart rate indi-
cations on the screen for 30 seconds. Intermittent display of random heart rates is acceptable.
However, if there is a constant display of a physiological heart rate lasting more than 5 seconds,
this is an indication that there is a source of electromagnetic interference in the vicinity. The fol-
lowing steps should be taken to determine if it is possible to use the monitor in this environment.

• Move all line cords and line-powered equipment at least 6 feet away from the FETALGARD
Lite. Check for extension cords running behind or under the bed and equipment in adjacent
rooms. If the artifact heart rate indication ceases, the monitor may be used normally.

• Remove the line cord from the monitor’s power supply. If the artifact heart rate indication
ceases, the monitor may be used normally.

• Shutoff and then unplug the FETALGARD Lite recorder and move it out of the vicinity. If
the artifact heart rate indication ceases, the monitor may be used normally.

If these measures do not result in cessation of the heart rate artifact, the monitor cannot be safely
used in this environment.

Fetal heart rate is measured by placing an ultrasound transducer on the maternal abdomen and
processing the Doppler echo signal to produce a heart rate and an audio representation of the
echo signal.

WARNING
Fetal cardiac arrhythmias and abnormalities can adversely affect FHR readings.

Caution
The maternal heart rate (MHR) should be taken by some independent means as it
is possible to mistake MHR for FHR under certain circumstances.

Step 1: Preparing the Monitor

Turn the monitor on and verify that the normal monitoring screen appears on the display.
Remove the monitor from service if an error occurs.

Determine whether the monitor is powered from the internal battery or the battery eliminator. If
operating on the internal battery, check the power status frame on the display to determine
whether the battery has sufficient charge to complete the monitoring session. Use the battery
eliminator if the battery is too low.

Check the ultrasound transducer to verify proper attachment to the monitor. For twins monitor-
ing, make sure the second ultrasound transducer is properly connected.

Adjust heart rate channel one speaker volume to mid level. Adjust channel two speaker volume
to off if monitoring twins.

Apply ultrasound gel to the face of the transducer.

5-1
FETALGARD Lite Operator’s Manual

Step 2: Acquiring the Fetal Heart Signal

Determine the location of the fetal heart using palpation or a fetoscope.

Place the transducer on the maternal abdomen and listen for the fetal heart signal. Reposition the
transducer for the loudest fetal heart signal and verify the indicator LED on the transducer is
blinking at the fetal heart rate.

Secure the ultrasound transducer with the elastic belt. Do not over-tighten. Make sure the trans-
ducer is still positioned for the loudest fetal heart signal.

Verify the monitor is displaying fetal heart rate values and that the heart rate indicator on the
ultrasound transducer is blinking.

119
US1 240

160

99
US2
120

30 t

16
TOCO 100

(5) 0

3 130/85 (95)
cm/min. mmHg 160 1 MHR 80 bpm

12:49:40 AM 1/2/2001

A pulsating heart icon, located in the ultrasound heart rate frame of the display, along with the
displayed numeric rate indicates a signal has been obtained.

Step 3: Acquiring Twin–fetal Heart Rates

Follow the steps outlined in step 2 above to acquire the heart rate for the first fetus.

Adjust the ultrasound audio volume for channel one down and channel two up so that the second
heart sounds can be heard.

Determine the location of the second fetal signal using palpation or fetoscope.

Apply gel to the second ultrasound transducer and place it on the maternal abdomen where the
second fetal signal was located. Adjust the position of the transducer to find the fetal signal and
to maximize its loudness.

Secure the ultrasound transducer with the elastic belt. Make sure the transducer is still positioned
for the loudest fetal heart signal. Also verify the position of transducer one has not changed.

Verify the monitor is displaying fetal heart rate values for both fetuses and that the heart rate
indicators in both ultrasound transducers are blinking at the measured heart rate.

Step 4: Monitor Adjustments

Readjust the volume settings for the desired loudness.

5-2
 Section 6
Monitoring Uterine Activity (UA)

Monitoring Uterine Activity (UA)

Uterine activity is measured externally by placing a pressure sensitive device (Tocotonometer)
on the maternal abdomen and recording relative pressure changes.

Step 1: Preparing the Monitor

Turn the monitor on and verify that the normal monitoring screen appears on the display.
Remove the monitor from service if an error occurs.

Determine whether the monitor is powered from the internal battery or the battery eliminator. If
operating on the internal battery, check the power status frame on the display to determine
whether the battery has sufficient charge to complete the monitoring session. Use the battery
eliminator if the battery is too low.
Check the TOCO transducer to verify proper attachment to the monitor.

Check for the proper setting for TOCO baseline. Adjust as needed.

Step 2: Acquiring Uterine Activity Data

Place the face (button side) of the Tocotonometer on the fundus of the uterus when contractions
are not occurring. No gel is required.

Secure the Tocotonometer with the belt. The uterine activity reading at this point should be
greater than 30 and less than 90 units. If the readings fall outside this range, the belt may be too
tight or too loose. If the belt is over tightened, the contraction peaks may have a flat-top at less
than 100 on the TOCO scale. If the belt is under tightened, the position of the transducer may
wander and cause unusable readings. Readjust the belt pressure as needed.

Step 3: Monitor Adjustments

Press the TOCO Zero button on the front panel to adjust the values to the baseline. This must be
done during non-contraction intervals.

NOTE
If uterine activity exceeds 100 units for more than 15 seconds, the units displayed
in the TOCO numerical frame will flash off and on every second.

6-1
 Section 7
NIBP Monitoring

NIBP Monitoring

7.1 General
This chapter provides operator instructions for FETALGARD Lite monitoring of Non-Invasive
Blood Pressure (NIBP). It includes preparation of the patient, selecting the mode of NIBP
measurement, configuring the displays, setting alarm limits, and obtaining selected recording of
monitored data.

FETALGARD Lite monitoring uses a stepped oscillometric measuring technique. A motorized

pump inflates the cuff until the flow of blood is practically occluded. The pressure is then bled in
steps, and blood begins to flow. A pressure transducer measures the changing air pressure. The
pressure at which the oscillation increases sharply is defined as the systolic pressure.
The pressure at which the oscillations peak is defined as the mean arterial pressure, and the
point at which a loss of oscillation is detected is defined as the diastolic pressure.

7.1.1 Measuring Mean Arterial Pressure

The monitor measures MAP (Mean Arterial Pressure), which is the Diastolic Pressure times 2
plus the Systolic Pressure divided by 3.
(Diastolic Pressure x 2) + Systolic Pressure
MAP =
3

7.1.2 Required Accessories

NIBP Cuff — There are four cuffs available for different sized patients. See Table 7-1.

7.1.3 Applying Cuff to Patient

WARNING
Use only Analogic recommended blood pressure tubing and cuffs. Using other
cuffs or tubing can result in inaccuracies.

WARNING
Do not use the monitor on patients who are linked to heart or lung machines.

WARNING
The monitor cannot operate effectively on patients who are experiencing convul-
sions or tremors.

WARNING
Inaccurate measurements can be caused by:
• incorrect cuff application or use, such as placing the cuff too loosely on the
patient, using the incorrect cuff size, or not placing the cuff at the same level as
the heart
• a leak in the cuff or tubing
• excessive patient motion

WARNING
Continuous cuff measurements (prolonged impairment of circulation) can cause
injury to patient being monitored. This should be considered when using the STAT
mode of NIBP monitoring.

7-1
FETALGARD Lite Operator’s Manual

WARNING
The monitor displays results of the last blood pressure measurement until another
measurement is started. If a patient’s condition changes during the time interval
between measurements, the monitor does not detect the change or indicate an
alarm condition.

WARNING
Sometimes, electrical signals at the heart do not produce a peripheral pulse. If a
patient’s beat-to-beat pulse amplitude varies significantly (for example, pulsus
alternans, atrial fibrillation, rapid-cycling artificial ventilator), blood pressure and
pulse rate readings can be erratic and an alternate measuring method should be
used for confirmation.

WARNING
A patient’s vital signs can vary dramatically during administration of agents affect-
ing the cardiovascular system, such as those used to raise or lower blood pres-
sure or raise or lower heart rate.

WARNING
As with all automatically inflatable blood pressure devices, continual cuff measure-
ments can cause injury to the patient being monitored. Weigh the advantages of
frequent measurement and/or use of STAT mode against the risk of injury.

WARNING
In some cases, rapid, prolonged cycling of an oscillometric, non-invasive blood
pressure monitor cuff has been associated with any or all of the following:
ischemia, purpura, or neuropathy. Apply the oscillometric cuff appropriately
according to the manufacturer's directions for use, and check the cuff site and
cuffed extremity regularly when blood pressure is measured at frequent intervals
or over extended periods of time.
• Check the patient’s limb on which the cuff is applied to assure that circulation is
not constricted. Constriction of circulation is indicted by discoloration of the
extremity. This check should be performed at the clinician’s discretion at regular
intervals based on the circumstances of the specific situation.
• Do not place the cuff on an extremity being used for intravenous infusion or any
area where circulation is compromised or has the potential to be compromised.
• Do not apply the blood pressure cuff to the same extremity as the one to which
an SpO2 sensor is attached because the cuff inflation disrupts SpO2 monitoring
and leads to nuisance alarms.
• When in use on patients, ensure that heavy objects are not placed on the tubing.
Avoid crimping or excessive bending, twisting, or entangling the tubes.

WARNING
Do not use STAT mode when using the thigh cuff to monitor NIBP. Use of this
mode causes a loss-of-monitoring alarm and shuts down all monitor functionality.

WARNING
The FETALGARD Lite — NIBP was not designed for unattended MHR monitoring.
The operator should observe MHR.

Caution
Do not wrap the cuff too tightly around the limb. It may cause discoloration, and
ischemia of the extremities.

Caution
Inspect the application site regularly to ensure skin quality and inspect the extrem-
ity of the cuffed limb for normal color, warmth and sensitivity. If the skin quality
changes, or if the extremity circulation is being affected, move the cuff to another
site or stop the blood pressure measurements immediately. Check more frequent-
ly when making automatic or STAT measurements.

7-2
 NIBP Monitoring

Caution
A less severe NIBP artifact measurement may produce an NIBP measurement.
The “NIBP Artifact” message displays and a low priority alarm tone sounds, but
pressing the U/S Volume Alarm button clears the message and alarm tone.

Caution
If the values appear questionable, it is the clinician’s responsibility to repeat the
measurements.

Caution
Ensure that there are no kinks in the air hose, or that the flow of air is not impeded
by the placement of any object that might constrict the air hose.

Caution
The FETALGARD Lite automatically retries if the initial cuff pressure is less than
the patient systolic pressure. The subsequent initial pressure is increased by 30
mmHg. There is a time-out period at which time the monitor stops trying to get
readings. If the patient’s systolic pressure is known to be extremely high, it is rec-
ommended that the initial cuff pressure be raised to 240 mmHg.

NOTE
The NIBP cuff and hose will not be affected by wetting.

Measure the patient’s limb and select the proper size cuff (Table 7-1). The cuff width should
span approximately two-thirds of the distance between the patient’s elbow and shoulder. Follow
directions for use for applying cuff to arm or thigh.
Table 7-1. Cuff Sizes
Order Code Description Limb Circumference (range)
AN4K-AC018 Small Adult Latex-free 18 to 26 cm
AN4K-AC017 Adult–Non Latex-free 25 to 35 cm
AN4K-AC016 Adult Plus Latex-free 33 to 47 cm
AN4K-AC020 Thigh Latex-free 46 to 66 cm
AN4K-AC019 Latex-free extension hose —

7.2 Setup Connections

Instructions for Cuff Use
1. Remove the cuff from its package. Inspect for damage before each use. Do not use a cuff
whose structural integrity is suspect.

2. Connect one end of an AN4K-AC019 hose to the monitor connector as described.

3. To connect the hose to the cuff, grasp both connectors, align, and push together. The connec-
tors will snap into place. A

AN4K-AC019

4. Squeeze all the air out of the cuff and wrap it around the patient’s upper arm. When the arm
cannot be used, the ankle is preferred over the thigh because measurement on the adult thigh
tends to be uncomfortable.

7-3
FETALGARD Lite Operator’s Manual

5. Position the cuff so that the symbol is at the bottom of the cuff and is directly over the
patient’s artery and the Analogic labeling is facing out. B The tension of the wrapped cuff
should be such that only two fingers can be inserted between the limb and the cuff. If the cuff
is wrapped too loosely, errors may occur during measurement.

Note: Analogic supplied blood pressure cuffs have a double-headed arrow between two lines to
indicate proper size range. The edge of the cuff has a white index line. A If the index line does
not fall between the two range lines when the cuff is wrapped around the patient’s limb, select a
larger or smaller cuff size.

Removal/Cleaning
To remove the cuff from the hose, grasp the hose connector and pull back the outer metal ring at
the end of the connector. C

The cuffs are intended for reuse and may be cleaned by wiping with a cleaning agent such as
70% isopropyl alcohol.

Caution
Federal law (U.S.) restricts this device to sale by or on the order of a physician.

7.3 Measuring Blood Pressure

7.3.1 Three Modes
Blood pressure can be measured in three modes:

• Single: In which one measurement of each of the three blood pressures (Systolic/Mean Arterial
Pressure/Diastolic) is made and displayed in the NIBP frame.

• Automatic: In which measurements are made in preset intervals.

• STAT: In which as many measurements as possible are made within a

5-minute period.

7.3.2 NIBP Measurement Setup

The FETALGARD Lite provides the capability for the operator to modify the factory-set initial
160 mmHg value of pump pressure that is intended to occlude blood flow in an adult patient.
Operator adjustment of this value is accomplished with the navigation knob within the NIBP
menu.

To access the NIBP menu

1. Rotate the navigation knob to select (highlight border around the parameter box) the NIBP
frame.

2. Press the knob. The NIBP menu is displayed in the Graphical Frame (Figure 7-1).

7-4
 NIBP Monitoring

123
US1 NIBP Menu

Auto Mode Interval Off

Inflate Pressure 160 mmHg

128
US2
Set NIBP alarm limits
Alarm Status Enable

20
TOCO
Return
(5)

3
cm/min. mmHg 160 bpm

12:43:59 AM 1/2/2001

Figure 7-1. Accessing the NIBP First-Level Menu

Note that the displayed options include the monitoring mode selection, the initial cuff inflation
value setting, and the alarm status and access to the “set NIBP alarm limits” sub-menu. It also
indicates that the factory set initial cuff pressurization has been changed to 160 mmHg.
To enable/disable the audio alarm:
In the parameter frame, use the navigation knob to highlight and select the alarm status, then
press the knob to toggle the state of the alarm to DISABLE or ENABLE.

121
US1 Set NIB P Alar m Limits

SYS Upper Limit 140 mmHg

SYS Lower Limit 80 mmHg

152
US2
MAP Upper Limit 120 mmHg
MAP Lower Limit 70 mmHg
DIA Upper Limit 110 mmHg

9
TOCO DIA Lower Limit 60 mmHG

OK
(5)

3
cm/min. mmHg 140

4:48:309 AM 1/2/2001

Figure 7-2. NIBP Alarm Menu.

To modify the NIBP alarm limits:

1. Rotate the navigation knob to highlight “Set Alarm Limits.”

2. Rotate the navigation knob to highlight the alarm limit to be changed.

3. Press the knob. Rotate the knob until the desired value is reached.
4. Press the knob. Either select another parameter or select OK.

5. Select Return to exit the NIBP setup menu.

Adjustable Initial Inflation Pressure

The initial inflation pressure is selectable from the NIBP Menu. The available selections shall be
120 to 240 mmHg in steps of 20 mmHg.

Initial Inflation Pressure/Cuff Pressure Display

The cuff inflation pressure is displayed in the NIBP frame below the NIBP icon. The value dis-
played shall reflect the instantaneous cuff pressure during a measurement. When no
measurement is underway, the displayed pressure shall represent the initial inflation pressure to
be used for the next measurement.

7-5
FETALGARD Lite Operator’s Manual

Initial inflation pressure is determined in one of two ways:

• Upon power up, and immediately after making a change via the NIBP Menu, the initial infla-
tion pressure is determined by the setting indicated in the NIBP Menu.

• Immediately after an NIBP reading has been successfully completed, the initial inflation value
will be changed to be the just completed Systolic pressure + 30 mmHg. Initial inflation pressure
shall be rounded to the nearest 5 mmHg.
Any changes to initial inflation pressure value must be reflected in the numeric value shown in the
NIBP frame. When an initial inflation value is determined from a successful NIBP measurement,
it is possible that the value will not correspond to any of the settings available in the NIBP Menu.
For example, if the systolic pressure was 137 mmHg, the initial inflation pressure will become
165 mmHg; all the selections available in the menu are integer multiples of 20 mmHg. If the user
enters the NIBP Menu and selects the Initial Inflation Pressure item, the user will be forced to
accept one of the inflation values from the list.
To modify the initial inflation pressure:

1. Rotate the navigation knob to highlight the Inflate Press.

2. Rotate the knob to change the initial pressure value.

3. Press the knob when the desired value is displayed.

NOTE
The monitor will increase the initial pressure in 30 mmHg steps automatically if the
initial value does not occlude the flow of blood. The monitor initiates a new blood
pressure test with the changed value.
The incremental increases of initial cuff pressure continue until a maximum allow-
able value is reached or a valid measurement is obtained. At that time, the mes-
sage “NIBP-Overpressure” is displayed.

NOTE
If an attempt is made to modify the initial inflation pressure during a measurement,
the new entry will be ignored.

7.4 NIBP Frame

7.4.1 NIBP Frame Layout
For monitors equipped with the NIBP option, an NIBP frame is displayed in place of the Time
and Date frame. Typical initial appearance of the NIBP frame is shown below. In this example,
Auto mode is enabled for a 3 minute interval, and alarm sound is disabled.

3
mmHg 240

Figure 7-3. Initial NIBP Frame

The NIBP frame displays the most recently acquired values for systolic, diastolic and mean arter-
ial blood pressure. When the NIBP Alarm Status is Enabled, a bell icon shall be displayed in
the NIBP frame; when it is Disabled, a crossed bell icon shall be displayed. When alarms
have been silenced, the shall be replaced by which shall flash at the Medium Priority rate
(see Table 4-1). Dashes shall be displayed for readings that are invalid.

NIBP measurements are obtained in one of three modes; Single, STAT and Automatic. Single
and STAT modes are controlled by the NIBP button. Upon conclusion of a measurement, the
results are displayed in the NIBP frame and in the NIBP Result Popup (see Section 7.5).

7-6
 NIBP Monitoring

The numeric display of NIBP values and MHR shall be blanked while a single manual or auto-
matic measurement is in progress and then be replaced by the new values.

The numeric display of NIBP values and MHR shall remain when a STAT measurement initially
begins. At the completion of the first measurement, new values shall be displayed. These values
shall remain until the next measurement is complete. If the measurement is interrupted by press-
ing the NIBP button, or cannot be completed due to a Technical Alarm, then dashes (“- - -”) shall
be displayed in place of numeric NIBP values and MHR.

3 220/180 [210]
mmHg 240 0 MHR 92 bpm

Figure 7-4. NIBP Frame with measurement

After a successful measurement, a clock icon and the number of elapsed minutes since the
NIBP measurement was made shall also be displayed. The clock icon, the NIBP measurement,
and the Maternal Heart Rate shall be removed (display blanks) after 60 minutes have elapsed
between NIBP measurements.

The NIBP auto mode icon and auto interval shall be displayed if automatic mode has
been enabled.

The STAT mode icon shall be displayed when a STAT measurement cycle is in progress.
The STAT icon shall blink at the High Priority alarm rate as described in Table 4-1.

The clock icon and elapsed time shall not be displayed while a measurement (Single, Auto
or STAT) is in progress.

The NIBP frame is selectable by rotating the knob to highlight the frame and then pressing the
knob button. Selecting the NIBP frame causes the NIBP Menu to be displayed.

7.4.2 Special Requirements for Auto and STAT Modes

The interval between Auto mode measurements shall be extended if necessary to ensure that no
less than 30 seconds elapse between the end of a previous automatic measurement (cuff pressure
less than 10 mmHg) and the beginning of a new one. The Auto mode interval timer shall be reset
at the completion of a user initiated manual measurement (Single or STAT).

In STAT mode the cuff shall inflate to the specified pressure, then deflate completely, producing
a measurement of systolic, diastolic and MAP. Once the cuff has deflated (pressure less than
10 mmHg), it will wait at least 2 seconds before beginning to re-inflate, beginning a new
measurement. These measurements will repeat as many times as possible within a 5 minute peri-
od. If a STAT measurement is terminated before the end of 5 minutes because the user pressed
the NIBP button, and at least one measurement had been successfully completed, then the values
from the last successful measurement will be displayed.

7.4.3 Stop Measurement

Any time an NIBP measurement is underway (Single, STAT or Auto), a press of the NIBP but-
ton terminates the measurement and deflates the cuff. If STAT mode was enabled, this press of
the button will cancel STAT mode. If Auto mode was enabled, the press of the button will termi-
nate that particular measurement, but the interval timer will be reset and the next auto
measurement will occur on schedule.

If you wish to use the Single measurement mode, you are now ready to initiate the NIBP mea-
surements via the front-panel keypad NIBP button.

A momentary press on the NIBP button initiates the Single measurement mode.

7-7
FETALGARD Lite Operator’s Manual

NOTE
If the time between the initiation of a blood-pressure measurement and its comple-
tion is prolonged (indicating an impairment of the function), the monitor ends the
measurement mode and displays an error message “NIBP TIME OUT” in the sta-
tus frame.

To enable Automatic Mode NIBP measurement:

1. Rotate the navigation knob to highlight the Auto Mode Int parameter.

2. Press the knob. The value box will pop up.

3. Rotate the knob to scroll through the selectable values (see Table 7-2).

4. Press the knob to latch the desired value. This initiates the Automatic mode at the interval
selected. Selecting Off removes that mode and returns control to the front panel keypad.

NOTE
You must exit the menu in order to initiate the selected Automatic mode. The first
measurement is made upon exiting the setup menu.

NOTE
If automatic mode has been selected as the institutional default, initiating a
measurement after power-on requires a NIBP keypad button press.

Table 7-2. NIBP Automatic Mode Interval Options

Off
1 min
3 min
5 min
10 min
15 min
30 min
60 min
90 min

To initiate STAT Mode of NIBP Operation:

NOTE
STAT Mode cannot be initiated while a NIBP measurement is in progress.

Press the front-panel NIBP Control Button and hold it for at least 2 seconds.

While STAT mode is active (5 minutes), the STAT icon appears in the numeric frame;
the clock icon and minutes displays are removed.

Upon completion of STAT mode, the monitor displays the last measurement made in that mode.
Both the clock icon and elapsed time numeric return to the display.

60 minutes after completion of the STAT measurements, the displayed NIBP measurement and
the clock icon are removed.

WARNING
The operator must always be in attendance when STAT Mode is used.

7-8
 NIBP Monitoring

7.5 NIBP Result Popup

Upon completion of an NIBP measurement, a menu shall appear displaying the NIBP results in a
large font. This menu will persist until the user clicks OK, or it will time out after 30 seconds
unless there is an unsilenced NIBP alarm.

Figure 7-5. NIBP Result Popup

The NIBP and MHR values in the popup are slaved to the ones in the NIBP frame. If the NIBP
values in the NIBP frame are flashing, the ones in the NIBP popup will also flash.

If an NIBP Technical Alarm is active, the Technical Alarm message will replace MHR in the
popup. When the Technical Alarm is silenced, the message will be removed and MHR will be
displayed as invalid (“MHR - - -”).

7.6 NIBP Strip Chart Recording

The strip chart recording in the figure below shows a twin fetal heart rate (FHR), TOCO and the
maternal NIBP and heart rate (MHR). The diamond shaped NIBP Marker icon u indicates
where in time the maternal NIBP measurement occurred.

NOTE
Older FGL Recorders with software V1.01 or prior will support the FGL-NIBP mon-
itors but do not support the u character. They will instead mark the maternal NIBP
measurement with a square .

Fetal Heart Rate

Maternal NIBP

Software
Revision

TOCO

7-9
 Section 8
Remote Patient Marker and Clinician Marker

Remote Patient Marker and Clinician

Marker
8.1 Clinician Event Marker
The clinician’s marker arrow is provided so that the clinician can record the time of important
events. The clinician merely presses the Clinician Event Marker button located on the front-panel
keypad at the time an event occurs. This marker time is recorded in the patient record in the mon-
itor.

The clinician marker icon is a downward pointing arrow. The monitor will display this down-
ward pointing arrow in the information frame of the display. A strip chart printout of the patient
record will also show this mark accompanied by the time and date.

8.2 Remote Patient Marker

The patient marker arrow is provided so that the patient can record the time of important events.
The patient merely presses the Remote Patient Marker button located on the end of the marker
cable at the time an event occurs. This marker time is recorded in the patient record in the monitor.

The patient marker icon is an upward pointing arrow. The monitor will display this upward
pointing arrow in the information frame of the display. A strip chart printout of the patient record
will also show this mark.

Clinician Marker Icon.

Patient Marker Icon.

8-1
 Section 9
Using Graticules

Using Graticules
Graticules are reference lines on a chart that are helpful in interpreting plotted data. The FETAL-
GARD Lite has two horizontal graticule lines in the ultrasound trend frame located at the alarm
limits, which become 2 movable lines 15 BPM apart after the user presses the graticule button.
These graticule lines provide a reference for estimating heart rate.

The TOCO trend frame also has a graticule reference line. It is located at the TOCO baseline
value. The reference line is used to show the distance between the UA trace and the baseline.
This graticule line is relocated when the baseline value is changed to one of the other values.

When the operator presses the graticule button on the keypad, the two reference graticule lines in
the ultrasound trend frame are replaced with two new graticule lines. These lines are 15 BPM
apart and can be moved up and down by rotating the control knob. This pair of moveable gratic-
ule lines will stay on the screen until there is 20 seconds of knob inactivity at which point they
will change back to the fixed lines at the upper and lower alarm limits. The purpose for these
moveable graticule lines is to aid in establishing heart rate variability. The lower line can be
placed on a reference heart rate value and the upper line used to locate the reference point where
the heart rate change equaled 15 BPM. Since the ultrasound trend frame consists of 6, 9, or 18
minutes of data (depending on the print speed setting) the time between the two heart rate values
can be estimated.

9-1
 Section 10
Using Trend Scroll

Using Trend Scroll

The FETALGARD Lite can store up to 12 hours of patient data. Only the most recent 6, 9, or 18
minutes (depending on the print speed) of this data is observable at any point in time. Scrolling
capability is a feature that enables viewing stored data from the present session or from previous
monitoring sessions.

Pressing the trend scroll button on the keypad enters scroll mode. This button is labeled with an
image of two opposing arrows. Two opposing arrows will be displayed above the ultrasound
trend frame indicating the monitor is in scroll mode. Knob inactivity for 20 seconds exits scroll
mode.

US 240
114 : 139

160

120

t
TOCO 30
100

(5) 0 4
3 120/80 [90]
cm/min. mmHg MHR 60 bpm
11:33:26 PM 1/1/2001

A second press of the scroll button displays a menu for navigating the stored patient records and
displaying file details, such as duration and start time. This allows the operator to jump to a par-
ticular patient record without having to first scroll through more recent patients. To exit this
screen, highlight "Real-time" and press knob button.

US1 Trend Scroll Select

150
Record 1 of 2
Go To Jane Doe 194848 ?
Start - 6:58:00 AM 9/3/2004
Duration - 2:17:37

No - Different Record

20
Real-Time Older
TOCO
Yes - Position
Beginning Middle End

(5)

3 120/80 [110]
cm/min. mmHg MHR 92 bpm

2:13:49 PM 1/18/2005

The monitor will display a vertical reference line centered in the ultrasound trend frame and a
vertical reference line centered in the TOCO trend frame.TOCO and heart rate values pass the
vertical reference line as the data is scrolled through the display. The heart rate values at the ref-
erence line are displayed above the vertical reference line in the ultrasound trend frame and the
TOCO values at the reference line are displayed below the vertical reference line in the TOCO
trend frame.

The heart rate numeric frames, TOCO numeric frame, power status frame, and the communica-
tions frame are unaffected when in scroll mode and continue displaying the most current data and
status information pertinent to the present monitoring session.

10-1
FETALGARD Lite Operator’s Manual

The patient ID frame displays the appropriate ID for the stored data. The ID will be for the cur-
rent patient when scrolling through the data from the current monitoring session. When scrolling
further back into previous records, the displayed ID will reflect the record being viewed. The
Patient ID will change after the present record has scrolled fully off the display and the next
record begins to scroll onto the display.

The time and date frame will display the time and date when the data values were recorded as
they pass the vertical reference lines.
Rotating the control knob slides the heart rate and TOCO values synchronously left and right.
Clockwise rotation views older data and counterclockwise rotation views more recent data.
Rotating the knob slowly slides the values through the display at the rate that is convenient for
viewing. Rotating the knob quickly slides the data through the display at a faster rate. This pro-
vides a quicker way to move ahead or back.

10-2
 Section 11
Printing Patient Files

Printing Patient Files

This section describes the procedure used to print stored patient files. Printing stored files occurs
at a faster rate than printing current data and is referred to as “batch printing.”

Knob Desired

Rotate To highlight the Communications Frame with a heavy border.

Activity Result

Press To view the Communications menu (shown below).

US Communications Menu
Data Transfer Stopped
Destination Recorder
Paper Output Patient Records
Paper Speed 3 cm/min
Paper Style USA
Paper Vendor Analogic
TOCO Number to Dial

Return
(5)

3 120/80 (90)
cm/min. mmHg 160 35 MHR 60 bpm

12:09:18 AM 1/2/2001

Rotate To highlight “Destination.”

Press To select “Destination.”
NOTE: "Data Transfer" must be "Stopped" in order to select a destination.
Rotate To highlight “Recorder.”
Press To select “Recorder.”
Rotate To highlight “Paper Output.”
Press To display Batch/Real-Time menu.
Rotate To highlight "Patient Records."
Press To select "Patient Records," which is a batch transfer. Note that Selecting "Current
Record" would, after starting data transfer, instruct the recorder to print only data
currently arriving at the monitor (real-time) from the sensors.
Rotate To highlight “Data Transfer.”
Press To display the “Start Data Transfer” window.
Rotate To highlight "Yes."
Press To start the data transfer. After detecting the recorder the record Selection window
will appear.
US Communications Menu
Recorder Batch Transfer
Record 1 of 2, 0 selected
Print Jane Doe 194848 ?

Start - 6:58:00 AM 9/3/2004

Duration - 2:17:37

Yes No Cancel
TOCO None Remaining All Remaining

Return
(5)

3 120/80 (90)
cm/min. mmHg 160 35 MHR 60 bpm

12:09:18 AM 1/2/2001

11-1
FETALGARD Lite Operator’s Manual

Rotate To select "Yes," "No," Cancel," "All Remaining," or "None Remaining."

Selecting "Yes" will queue the patient file shown for printing, and display file details
of the next patient.
Selecting "No" will skip over this file, and display details of the Next patient file.
Selecting "All Remaining" causes all the rest of the stored patient files to be queued
for printout.
Selecting "None Remaining" skips over all the rest of the stored patient files.
Selecting "Cancel" closes the dialog box and returns to the Communications menu.
Repeat the selection process until all desired patient files have been chosen for print-
ing.
After concluding selection, the transfer begins.
Starting a data transfer without an output device attached, or a Wrong output device
attached, will display the following message.

US Communications Menu
Recorder Batch Transfer

Check output device or protocol

Cancel

TOCO

Return
(5)

3 120/80 (90)
cm/min. mmHg 160 35 MHR 60 bpm

12:09:18 AM 1/2/2001

Press To select "Cancel" and close the dialog box.

Rotate To highlight "Return."
Press To exit the Communications menu and return to the main monitoring screen.
Printing of the patient files will occur at approximately 30 cm per minute until all selected files
have been printed.

11-2
 Section 12
Transferring Patient Data

Transferring Patient Data

12.1 Data Transfer via Modem
The communications port on the rear of the monitor is connected to a tabletop modem using an
RS-232 cable with a female DB9 connector and a male DB25 connector. The Analogic FGL-
REC-CABLE supplied with the FETALGARD Lite Recorder will also work in this application.

Caution
General-purpose personal computers and modems are not designed to meet the
electrical safety requirements of medical devices. The RS-232 connector on the
FETALGARD Lite is electrically isolated to permit safe connections to non-medical
devices, which should be connected with a cable of sufficient length, but no longer
than 3 meters, to prevent the non-medical equipment from contacting the patient.

In order to transfer patient data files from the monitor to a remote computer, the monitor must be
configured with the destination telephone number. The number is entered by selecting the
"Number To Dial" item in the Communications Menu. Enter the number using the control knob.
Placing the cursor at the desired location and pressing the knob will activate a pop-up window
from which you can select numbers and characters. Enter the number exactly as it would be
dialed. Enter a comma where a pause is required, such as dialing for an outside line from an
office, for example; 9,18005555555.

In some cases the modem initialization string may have to be modified (this is usually not neces-
sary since the default modem initialization string will work most of the time). The modem initial-
ization string is accessible from the Service Menu. Editing this entry is accomplished using the
control knob. Placing the cursor at the desired location and pressing the knob will activate a pop-
up window from which you can select numbers and letters. Make changes as required and then
select OK.

Lastly, the remote computer must have a modem installed AND be RUNNING the FETAL-
GARD Lite Receiver program. Installation and operation of FETALGARD Lite Receiver pro-
gram is discussed in this section.

The user must purchase an approved modem in order to comply with safety requirements as
Modem Required:

described above. The FETALGARD Lite monitor has been successfully tested on the modem
below.

Multi-Tech Model MT5600ZDX; 56K Data/Fax Modem

Multi-Tech Systems Inc.
2205 Woodale Drive
Mounds View, MN 55112
Phone: (800) 328-9717 or (888) 288-5470 or (763) 785-3500
Fax: (763) 785-9874
E-mail: [email protected]

Note: The Multi-Tech modem described must be used on the transmit side (FETALGARD Lite
monitor) of the transfer. The receive side (PC) will operate successfully with the modem already
resident within the PC or with most other external modems.

12-1
FETALGARD Lite Operator’s Manual

12.2 Setting Modem Parameters

This section describes the procedure used to establish the correct modem settings for proper
operation. These settings control the operation of the external modem.

The number to dial appears in the Communications Menu. The modem initialization, which is
not often changed, is located in the Service Menu.

Knob Desired
Activity Result
Rotate To highlight the Communications Frame with a heavy border.
Press To view the Communications menu (shown below).
US Communications Menu
Data Transfer Stopped
Destination Recorder
Paper Output Patient Records
Paper Speed 3 cm/min
Paper Style USA
Paper Vendor Analogic
TOCO Number to Dial

Return
(5)

3
cm/min. mmHg 160 35 MHR 60 bpm
120/80 (90)

12:09:18 AM 1/2/2001

Rotate To highlight “Number To Dial.”

Press To select “Number To Dial” for editing.
Rotate To highlight the desired character.
Press To select this character for editing.
Rotate To choose a new value for this character.
Press To keep the new value for this character.
Repeat the previous four steps until modem number has the desired changes.
Rotate To highlight “OK.”
Press To exit the "Number To Dial" dialog box and return to the Communications Menu.
Rotate To highlight “Return.”
Press To exit the Service Menu and return to the main monitoring screen.
Use similar steps to set the "Modem Initialization" in the Service Menu, if necessary
(usually not required ).

12.3 Communications to the Remote Computer

WARNING
All IEC/EN 60950 equipment, including printers, to be positioned no closer than
1.5 meters to the patient’s bed.
• Connect the FETALGARD Lite monitor to the modem using the FGL-REC-CABLE.

• Connect the telephone line to the modem's "Line" input. (As an option a telephone or fax
machine can be added to the "Phone" input.)

• Connect the modem's power supply to the AC power source and then to the power input of the
modem. Turn the modem on. If the connection is properly made, the Communications Window
in the lower left corner of the monitor's screen will display a single, white telephone icon.

12-2
 Transferring Patient Data

Make sure the remote PC is properly configured and running the FETALGARD Lite View
Receiver program, as described in this section.

The section below describes the procedure used at the monitor to complete a transfer of patient
records in the monitor to a remote computer.

Knob Desired
Activity Result

Rotate To highlight the Communications frame with a heavy border.

Press To view the Communications menu (shown below).

US Communications Menu
Data Transfer Stopped
Destination Recorder
Paper Output Patient Records
Paper Speed 3 cm/min
Paper Style USA
Paper Vendor Analogic
TOCO Number to Dial

Return
(5)

3
cm/min. mmHg 160 35 MHR 60 bpm
120/80 (90)

12:09:18 AM 1/2/2001

Rotate To highlight “Destination.”

Press To select “Destination.”
Rotate To highlight “FGL View Batch.”
Press To select “FGL View Batch.”
Rotate To highlight “Paper Output.”
Press To display Batch/Real-Time menu.
Rotate To highlight “Patient Records.”
Press To select “Patient Records,” which is a batch transfer. Note that selecting "Current
Record" would be equivalent to "Patient Records," as the monitor assumes you did
not really mean "Current Record," since there is no FGL View Online protocol. In
other words, this step is not necessary for protocols which are either online or batch
but not both.
Rotate To highlight “Data Transfer.”
Press To display the “Start Data Transfer” window
Rotate To highlight “Yes.”

Press To start the data transfer. After detecting the modem, the record selection window
will appear.

US Communications Menu
FGL View Batch Transfer
Record 1 of 2, 0 selected
Print Jane Doe 194848 ?

Start - 6:58:00 AM 9/3/2004

Duration - 2:17:37

Yes No Cancel
TOCO None Remaining All Remaining

Return
(5)

3
cm/min. mmHg 160 35 MHR 60 bpm
120/80 (90)

12:09:18 AM 1/2/2001

12-3
FETALGARD Lite Operator’s Manual

After records selection, the monitor instructs the modem to dial the number and
make the connection. If a dialing number is not available, a reminder message will
so indicate. Otherwise the protocol dialog box will show the dialing number. You
will hear the dial tone and dialing process from the modem speaker, if the speaker is
enabled in the modem initialization. If it is not enabled, you can enable it by adding
M1 (use M0 to disable the speaker) to the modem initialization string using the
"Modem Initialization" menu item in the Service Menu. See the modem manual for
further options. Note that you should NOT precede these modem settings with the
usual "AT," as this is done automatically. After modem detection, the
Communications frame will display a two-handset icon with one handset dark and
one handset light (shown below).

Transferring patient data files occurs automatically when the monitor and remote
computer are connected. The Data Transfer dialog box will show the record number
being transferred, the total number of files, and percent complete.

Caution
If for any reason the batch communication is broken or interrupted, the indication
is a loss of icon in the Communications frame.

Caution
If the NIBP Control Button or Trend Scroll Button is depressed during a batch
transfer, the batch communication is broken
The Communications frame will display a two-handset icon with both handsets dark (shown
below); meaning a link to the remote modem has been established.

When all files have successfully transferred the Data Transfer dialog box will display a message
confirming completion.

Press To exit the Data Transfer dialog box and display the Communications menu.
Rotate To highlight “Return.”
Press To exit the Communications menu and return to the main monitoring screen.

12.4 Data Transfer via Direct RS-232 Serial Connection

The cable between the monitor and the PC serial port must be a shielded, female DB9 to a
Cable Required:

female DB9, null modem cable that is less than 3 meters in length, with a pin-out is as follows:

9 Pin D Female 9 Pin D Female

1, 6 4
2 3
3 2
4 1, 6
5 5
7 8
8 7
9 nc

To Send Data Direct - From FETALGARD Lite to a PC

• Connect the FETALGARD Lite monitor to the PC using the DB9 to DB9 null modem cable
described above to the 9-pin serial com-port on the PC.

12-4
 Transferring Patient Data

• Power up the FETALGARD Lite monitor.

• Start the Receiver Program on the PC by double-clicking on the Receiver icon. Make sure
the communications port is selected with a checkmark in the appropriate box (as seen in the
figure below), and select start.

After approximately 10 or 15 seconds the FETALGARD Lite monitor will display a computer
icon in the lower left corner of the screen, signaling that communications is made.

Rotate To highlight the Communications frame with a heavy border.

Press To view the Communications menu.
Rotate To highlight “Data Transfer.”
Press To Start Data Transfer.

Selected data will be automatically transferred to the PC. For confirmation the communications
port selected will indicate "Active" in the information window of the PC.

When the data transfer is complete the FETALGARD Lite monitor screen will indicate "Transfer
Complete." The data transfer of the current data being recorded at this time will also terminate,
although the monitor will continue to collect patient data. Subsequent data transfers will add this
further accumulated data to the previously transferred record.

12.5 Additional Protocol Support

The FETALGARD Lite monitor has two additional protocols or "destinations." These are
"Pegasus" and "Series 50." Both of these protocols communicate to the Philips OB TraceVue™
application. This application will require you to enter the serial number of the monitor in its data-
base before it can receive data from the monitor. The monitor serial number is available both on
the startup screen, but only momentarily, and via the "View Versions" menu item in the Service
Menu.

A Corometrics "destination" is also available.

NOTE
The Corometrics protocol is a one-way protocol. The monitor gets no information
from the receiver, so it cannot verify whether or not it is connected to the correct
device. This must be done by the user.

NOTE
The Corometrics protocol will not restart if disconnected and reconnected. The
FGL must be power-cycled.

12-5
FETALGARD Lite Operator’s Manual

12.6 Troubleshooting
Note that there are several protocols, also referred to as “destinations” in the communications
menu (Recorder, FGL View, Pegasus), and several different output devices (modem, recorder,
pc). It is likely that an unintentional mismatch can occur. If the monitor senses that the output
device required by the selected protocol is missing, or that there is a mismatch, the “Check out-
put device or protocol” message may be displayed. The operator should make sure the correct
destination is selected, the attached device is turned “on”, and the appropriate receiving applica-
tion has been started at the receiving site.

Also, if there is only a single 12 hour record in the monitor, trying to transfer it using a batch pro-
tocol, such as FGL View, would not be permissible, because this record is not yet complete, and
therefore only a real-time protocol is allowed access. To transfer it as a batch file you must first
close it, that is, either change the patient ID (e.g. PATIENT PART2), or power the monitor off,
then on. Both of these actions close the current patient record, and start a new one.

Here are some additional comments that may help when the process doesn’t go smoothly.

Behavior Reason Possible Remedy

The monitor dialed a number Remote Modem did not Check that the remote modem is
but did not make a connection answer. connected and turned on.
to the remote computer
Dialed number was busy Check the number by calling using
the phone. Wait for current call to
complete.
Remote Modem connected Check that the FETALGARD View
but Data Transfer timed out Receiver is running and that the
before any data was trans- modem is selected to receive data
ferred on the remote computer.

No dial tone or dialing was The modem may be set to Examine the modem documenta-
heard when the monitor disable the speaker. tion and initialization strings to
dialed the remote computer. enable the modem speaker during
dialing.
Faulty modem or faulty con- Watch the modem lights for activity
nection to the modem. during dialing. If the modem lights
show no activity then check the
cable connections between the
monitor and the modem. Check
the modem operation.
Modem not connected to the Check the modem connection to
phone jack. the phone jack.

File transfers were cut Disconnect from modem or Check the phone line connections
off/terminated before com- phone line @ monitor or between the modem and phone
pletion. remote computer. jack on the local and remote com-
puters.
Poor phone connection. Check the phone connection. Poor
or noisy phone lines will cause the
transfer of data to be terminated.

Insufficient remote Check that the computer running

processor. the FETALGARD Receiver soft-
ware meets the minimum system
requirements.
Extension was taken off Check that another extension on
hook. the same phone line was not used.

12-6
 Section 13
FETALGARD Lite View

FETALGARD Lite View

13.1 Overview
FETALGARD Lite View is an application program that is used to view, annotate, and store
patient data files originating from the FETALGARD Lite or FETALGARD Lite – NIBP moni-
tors. The program runs on a personal computer with either WindowsNT™ , Windows 2000™ or
Windows XP™ operating systems.

Patient data files are transferred to the computer using either a serial port hook-up between the
monitor and computer or via a modem connection.

The program uses a Windows-like user interface with pull-down menus and mouse operation.

NOTE
FGL View Program, Version 2.00, as a minimum is required to support the
FGL — NIBP fetal monitor. Prior versions will not display the maternal NIBP
results.

13.2 Installation
System Requirements:
• IBM-compatible personal computer
• Standard VGA graphics
• CD-ROM drive
• 2 megabytes (minimum) available hard drive free space
• WindowsNT, 2000 or XP operating system

Procedure:
• Insert View CD in the CD-ROM drive.
• Follow the on-screen instructions.
• The View program will be installed in the default directory or in one selected by the opera-
tor during the installation process.
• In order to install FETALGARD Lite View, administrative rights to your computer may be
needed. If an error message is displayed during the installation process, contact the system
administrator.
• Upon completion of the installation, wait one full minute while the system registers new
components, then restart the PC.
13.3 Starting FETALGARD Lite View
Running the View program is accomplished by clicking on the “Viewer” contained in the
Program selection of the Start menu.

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FETALGARD Lite Operator’s Manual

13.4 Display Screen

The picture below shows the FETALGARD Lite View program with a patient record open. The
Main menu selections are shown at the top of the screen.

Each patient file is identified at the top of the window by its file name and location. The patient
data is displayed in a format similar to the strip chart printout from the recorder. All graphical data
and text information is included. Annotations made within the View program are displayed in the
bottom section of the window.

Elevator controls are used to scroll left and right, or up and down to view the desired section of
the patient record.

13.5 Menu System

The main menu system contains the following selections:

Starts the dialog box used for opening patient records. This dialog shows a multi-column list box
File…Open…

containing all of the records in the currently selected FETALGARD Lite Viewer database.
Patient ID, start time, duration, and monitor serial number are shown for each file.

The records can be sorted (ascending or descending) by any of the headings by clicking on the
heading.

The user can select one or more records in the list box by left clicking on it, select a group of
records with Shift-Left click, or select/de-select a record with Control-Left-click.

The “…” button allows the user to select another database via a Windows File dialog box. The
user can select a file and then click Open.

Closes the window containing the currently active patient data.

File…Close

Starts the dialog used for deleting patient records. This menu entry provides a mechanism for
File…Delete…

removing all records corresponding to a specific patient from the currently selected database.
13-2
 FETALGARD Lite View

Deletes are final. There will be no way to undelete.

The File Delete dialog will list all patients in the currently selected database. Entries will be sort-
ed alphabetically by user ID.

The user would initiate the file delete by selecting a patient name and clicking the “DELETE”
button.

If the user tries to delete patient records which have not been backed up, then the application will
inform the user of this and allow the operation to be cancelled.

Starts the dialog used for storing patient records to other media. This menu entry provides a
File…Backup…

mechanism for copying all records corresponding to one or more patients to backup media such
as a zip drive.

The File Backup dialog will list all patients in the currently selected database. Entries will be
sorted alphabetically by user ID.

The user must select a destination file. If the destination file already exists then the user will be
prompted to overwrite the file.

The user would initiate the file archive by selecting one or more patient IDs and clicking the
“BACKUP” button.

The page setup dialog enables the user to specify the display format.
File…Page Setup…

The user can select from Analogic, Philips/HP or GE/Corometrics style paper, U.S. or
International format, and print speed (1, 2 or 3 cm/min.).

To change the display format, the user must select one of the six paper types or one of the print
speeds from the pull-down menu.

This will bring up the standard Windows print dialog for selecting the printer. By default, the
File…Print…

printed output will be the entire trend data set. The user can choose to print just the highlighted
portion by clicking on “Selection” in the Print Menu. If a FETALGARD Lite Recorder has been
installed, it will appear as an option.

Note: Original chart paper numbers will not coincide with FETALGARD Lite Viewer numbers.

This will bring up a summary of all files within the Viewer.

File…Print Summary

This will cancel the current printing job. (Note: The Recorder will finish with a few pages of
File…Purge FGLite Recorders

blank paper.)

Ends the program.

File…Exit

Starts the Enter Annotation dialog. The Edit Menu provides tools for annotating the patient
Edit…Annotate…

record and for searching within the patient record. The user can add annotations, search for
markers and annotations, jump to specific times during the test and change the patient ID to fix
data entry errors.

When Annotate is selected, an annotation marker (a circled number) will be superimposed on the
patient data to show the location of the annotation. It will show who made the annotation and
when it was made. To enter the annotation, the user must type their annotation text and click OK.

Annotations are stored immediately and cannot be deleted or modified.

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FETALGARD Lite Operator’s Manual

Caution
Before using a 3-hole punch on the FGL-VIEW printouts, be aware that the anno-
tation circled numbers potentially line up with where the holes will be punched.

Starts the Find dialog box for finding markers and annotations. The Find dialog allows the user
Edit…Find…

to re-center the display around markers and annotations in the patient data.

This dialog box has four radio buttons that can be used to set the type of data being searched:
Annotation, Patient Marker, Clinician Marker and NIBP measurement.

The dialog box has a “PREVIOUS” button, a “NEXT” button and a “CLOSE” button.

Finds the next object in the record. The type of object is the same as the last “Find.”
Edit… Find Next

Finds the previous object in the record. The type of object is the same as the last “Find.”
Edit…Find Previous

Starts the Go To dialog box for re-centering the data to specific times. The dialog has an edit
Edit… Go To…

control for entering the time. This edit control is initialized to the time of the current cursor posi-
tion and will display time in either 12/24- hour format. The user can enter the desired time and
click the “Go” button. The program will find the specified time and redraw the display centered
on that data.

This dialog box provides a way to edit the patient ID to handle the case where it was incorrectly
Edit…Patient ID

entered when the test was originally performed. If the patient ID has been modified from what
was originally in the record it will be displayed followed by an asterisk and an annotation will be
displayed indicating a change was made.

This function will allow a larger section of stored data to be displayed on the screen at one time.
View…

This item opens a language selection dialog box to allow the user to select the language of all
Configure…Language

menus and dialogs from a list of supported languages. The dialog box displays a list of the avail-
able languages with the currently selected language checked. Language selection is the fourth
pull-down menu and the first option.

When new patient records are transferred from a monitor to the PC, they will be added to the
Configure…Add patient records to…

database file specified in this dialog box. If the file does not exist; FETALGARD Lite Viewer
will create it.

Once specified, the name of this database will appear in the lower right corner of the FETAL-
GARD Lite Viewer screen.

This menu entry allows the user to set the time and date formats for the FG Lite Recorder.
Configure…Time Format for FG Lite Recorder

Choices for time format are 12 hour or 24 hour. Choices for date format are MM/DD/YY or
DD/MM/YY.

Compacts the database. This command is used to remove deleted files from the database and
Utility…Compact Database

compact the database to the smallest size possible.

Splits the data window so that two or more records can be viewed simultaneously.
Window…Tile

13-4
 FETALGARD Lite View

Cascade the windows so that one patient record dominates the window and the top window
Window…Cascade

mostly obstructs other open patient records.

Allows the user to switch between opened patient files by selecting the “Patient ID” of interest.
Window… “Patient ID”

Phone number and email address for tech support.

Help…Contact Information

This menu entry will display a dialog containing revision and copyright information.
Help…About…

13-5
 Section 14
FETALGARD Lite Receiver and Recorder

FETALGARD Lite Receiver and Recorder

14.1 Overview
The FETALGARD Lite Receiver is a Windows application that is used to transfer data from the
FETALGARD Lite monitor to a database on a PC and is supplied with the FETALGARD Lite
View software (FGL-VIEW). The Receiver runs as an application on Windows NT , Windows
2000 or XP. An icon representing the FETALGARD Lite Receiver will appear in the System
Tray.

This program must be installed on the computer which has the patient data base files. This can be
the same computer that has the FETALGARD Lite View program or a separate computer.

The FETALGARD Lite Recorder program is a Windows application for adding the FETAL-
GARD Lite Recorder to the printer menu. This enables the FETALGARD Lite Viewer user to
print to the FETALGARD Lite Recorder.

14.2 Installation
System Requirements:
• IBM-compatible personal computer (200 MHz Pentium or equivalent)
• Standard VGA graphics
• CD-ROM drive
• 2 megabytes (minimum) available hard drive free space
• WindowsNT, 2000 or XP operating systems

Procedure:
• All applications will be installed when FETALGARD Lite View is installed.
• The Receiver program will be installed in the default directory or in one selected by the
operator during the installation process.
• The Recorder program will be installed in the system folder.

14.3 Starting FETALGARD Lite Receiver

The FETALGARD Lite Receiver can be started from the desktop icon or the Start menu.

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FETALGARD Lite Operator’s Manual

14.4 User Interface

The user interface allows the user to select which communication ports will be answered by this
program. The user interface screen is shown below.

To enable or disable a port, the user must select the port by clicking its description in the list box.
Then, if a port is disabled, it can be enabled with the “Start” button. If a port is enabled, it can be
disabled with the “Stop” button. Enabled ports are indicated by a check mark next to the port
description. Only one of the “Start” and “Stop” buttons will be enabled at any time.

The “quit” button closes the Receiver program. When the program is closed, the FETALGARD
Lite Receiver will answer no incoming data calls. This leaves the port available for other modem
transfers such as Internet access.

Caution
Pressing the Esc (Escape) Key on the PC will cause the Receiver Application to exit.

If the user clicks the Statistics button while a port is selected, the statistics summary will be
shown for that port. The statistics screen is shown below.

14-2
 FETALGARD Lite Receiver and Recorder

14.5 Installation of the Recorder

Adding the FETALGARD Lite Recorder to the printer menu is accomplished by running the
FETALGARD Lite Recorder program.

Select the FETALGARD Lite Recorder icon in the Control Panel. The Control Panel is found by
using the start button and the settings menu. The “Recorder Properties” box will appear and click
on “Add.”

The “Install New Recorder” box will appear. Type the name of the Recorder. Then select the
port to which the Recorder is connected and click on “OK.”

Then select “close” in the “Recorder Properties” box.

14-3
 Section 15
Cleaning

Cleaning
General
This section includes recommended maintenance procedures that can be performed by qualified
operator personnel. Maintenance actions are generally limited to visual inspections and cleaning,
as necessary, of instrument and cable surfaces. The section also includes the recommended
schedule for accomplishing the routine preventive maintenance procedures.

Daily Visual Tasks

Maintenance Task Action
Inspect the monitor and optional Examine the exterior of the monitor and recorder for cleanliness and general
recorder. physical 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.
Inspect the Cables and cords. Inspect all accessories (cables and battery eliminator) external to the
monitor and recorder.
Refer to the accessories documentation.
Examine the power plug and cord of the battery eliminator and recorder for
damage.
If damaged, replace defective part.
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.
With the transducers 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.
Check brightness of screen backlight. 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.
Check battery charge condition. If you are operating the monitor from battery, verify that the battery is
adequately charged before you begin use.

15.1 Monitor
WARNING
Unplug the monitor from the AC power source and place into Standby. Detach all
accessories before cleaning. Do not immerse the unit in water or allow liquids to
enter the case.

Caution
Take extra care when cleaning the display surfaces, which are sensitive to rough
handling. Rub the lens that covers them with a soft, dry cloth.

Keep the external surface clean and free of dust, dirt, and residual liquids To clean and disinfect
the monitor, dampen a cloth with a commercial, nonabrasive cleaner, such as 70% isopropyl
alcohol and wipe the top, bottom, and front surfaces lightly.

15-1
FETALGARD Lite Operator’s Manual

15.2 Recorder
WARNING
Unplug the recorder from the AC power source and detach all accessories before
cleaning. Do not immerse the unit in water or allow liquids to enter the case.

Keep the external surface clean and free of dust, dirt, and residual liquids To clean and disinfect
the recorder, dampen a cloth with a commercial, nonabrasive cleaner, such as 70% isopropyl
alcohol and wipe the top, bottom, and front surfaces lightly.

Maximum time between print head cleaning is one year, more frequent cleaning may be required
depending on operating environments.

To clean, wipe the print head and roller with a Q-tip soaked in isopropyl alcohol while lifting the
head, or run 6" x 6" cleaning paper pre-soaked in 70% isopropyl alcohol through the recorder.
Pre-saturated thermal printer cleaning cards are available in boxes of 25 cards or in bulk. They
may be ordered directly from:

Clean Team Company™

960 Enchanted Way Building 108
Simi Valley, California 93065
Phone: 805-581-1000
Fax: 805-581-1058

15.3 Transducers
Cleaning and Disinfecting the Tocotonometer and Ultrasound Transducer
To avoid damage to the transducers, clean and disinfect only according to the following instruc-
tions.

DO NOT remove, conceal, or deface the transducer labels.

Caution
Do not autoclave, use gas sterilization, or irradiate using Gamma Radiation.

Caution
When using cleaning or disinfecting solutions, use clean wipes to avoid fluids
entering transducers that are not liquid tight.

Caution
Do not use Sodium Hypochlorite (e.g., bleach) to clean or disinfect the transducers
or cables.
1. Using cleaning tissues soaked in enzymatic detergent (e.g., ENZOL), wipe the external sur-
faces of the transducers and cables to remove visible dirt and debris.

Where stubborn or dried-on dirt or debris remains, do not scrape the transducer. Use a soft
bristle toothbrush and the enzymatic detergent in small circular patterns for approximately
five minutes or until all of the dirt or debris has been removed.

NOTE 1
Be careful when cleaning the cable to avoid getting cleaning solution into the
connector.

NOTE 2
Follow the institution’s standard protocol for Personal Protective Equipment
(PPE) and ventilation when cleaning and disinfecting the transducer, cable, and
connector.

15-2
 Cleaning

2. Wipe the transducer, cable, and connector three times or more with distilled water to remove
the enzymatic detergent residue.

3. Wipe the transducer and cable three times or more with a cleaning wipe soaked in either Cidex
or 70% isopropyl alcohol depending on the level of contamination.

NOTE
HCV is an enveloped virus; general disinfection measures against hepatitis B virus
are applicable to HCV (1% sodium hypochlorite, 70% ethanol, 2% glutaraldehyde,
formaldehyde).
4. If Cidex was used as the disinfectant, wipe the transducer using a cleaning wipe three times
with distilled water to remove the residue.

5. Dry the transducer, cable, and connector thoroughly.

6. Store the transducer, cable, and connector in a dry, clean environment.

15.4 NIBP Cuffs

The cuffs are intended for reuse and may be cleaned by wiping with a cleaning agent such as
70% isopropyl alcohol.

15.5 Belts
Washing Instructions

Caution
When washing transducer belts, the water temperature must not exceed 40°C
(104°F). Do not use chlorine bleach.

Machine wash soiled belts with a mild soap and water at a gentle setting (reduced agitation).
Tumble dry at a low temperature and remove belts from the machine as soon as they are dry.
Avoid over-drying. If ironing is required, iron rapidly and don’t leave the iron in one place too
long. Use a low temperature setting on the iron (not exceeding 110°C (230°F)). Dry clean, with
caution.

15.6 Battery Maintenance

If the monitor has not been used for a long period of time, the battery will need charging. To
charge the battery, connect the Battery Eliminator to an appropriate power supply. Connect the
Battery Eliminator output to the monitor rear-panel connector.

Storing the monitor for a long period of time without charging the battery may degrade the bat-
tery’s capacity to store charge. A complete battery recharge requires 8 hours in standby mode or
14 hours in operational mode.

Follow local governing ordinances and recycling plans regarding disposal or recycling of batter-
ies and other device components.

15-3
 Section 16
Specifications

Specifications
FETALGARD Lite Monitor Specifications:

Dimensions — 18 cm H x 24.2 cm W x 13 cm D
Physical Characteristics

Weight — approx. 1.9 kg

Internal: Lead-acid, rechargeable

Power

2-hours operation fully charged at 10°C

14 hours to full recharge during monitoring
8 hours to full recharge when monitor is off.
External: AC-powered Battery Eliminator, two models:
P/N 10-62467-03, 100-120V~, 50-60 Hz, 0.15A
P/N 10-62467-04, 220-240V~, 50-60 Hz, 0.08A
Power Dissipation: Battery-powered: 6 watts, maximum
AC-powered 10 watts, maximum

Operating Temperature: 10°C to 45°C (50°F to 110°F)

Environmental

Storage and Transit Temperature: –20°C to 60°C (–4°F to 140°F)

Relative Humidity: 20% to 90% non-condensing
Altitude: 0—3048m (0—10,000 ft)
Water Resistance: IEC 60529 Class IPX1
Water Resistance: IEC 60529 Class IPX7 (USWB-1, USWB-1Y, USWB-2 Ultrasound
Transducers only)
Mechanical Shock: IEC 60068-2-27
Operating Altitude: 0 to 3,048 meters (0 to 10,000 feet)
Operating Pressure: 1013 hPA to 696 hPA
Storage Altitude: IEC 60068-2-13
Storage Pressure: 1060 hPA to 500 hPA
Sinusoidal Vibration: IEC 60068-2-6
Random Vibration: IEC 60068-2-64
Drop: IEC 60068-2-32
Transport Testing: ISTA Project 2A

NOTE
If the monitor has been stored in temperatures exceeding the operating range,
allow adequate time for the internal temperature to return to the operating range.

Compliance and Approvals

Parameter Specification
United States Federal law restricts this device to sale by or on the order of
a physician.
CE per 93/42/EEC
IEC60601-1, UL 60601-1, CAN/CSA C22 No. 601.1-M90, EN 60601-1,
IEC 60601-1-1, IEC 60601-2-49
Electromagnetic Compatibility: EN 60601-1-2, Class B
Degree of Protection Monitor only: Type BF Applied Parts
Mode of Operation Continuous
Classification:
Monitor Class II Internally Powered
Printer Class I

16-1
FETALGARD Lite Operator’s Manual

Doppler Ultrasound FHR Monitoring

Ultrasonic frequency: 1.024 MHz ±0.5%

Parameter Value

Pulse duration: 97.65625 microseconds

Pulse repetition frequency: 3.2 kHz
BPM Range:
USA Paper 30-240 BPM
International Paper 50-210 BPM
Accuracy: ±1% ±1 BPM
Leakage: <10 µA @ 264 VAC applied to transducer
Isolation: >4 kV RMS, Type BF applied part

I(SATA) at the transducer face: 0.766 mW/cm2 +27.8/–23.6%

U/S1, U/S1&2, and U/S2 Ultrasound Transducers

Entrance beam dimensions: 19.95 cm2, circular

Ultrasonic power: 15.28 mW +27.8/–23.6%

I(SATA) at the transducer face: 0.965 mW/cm2 ±25%

USWB-1, USWB-1Y, USWB-2 Ultrasound Transducers

Entrance beam dimensions: 2.85 cm2, circular

Ultrasonic power: 2.75 mW ±25.4%

Tocotonometer Uterine Activity (TOCO) Monitoring

TOCO Range: 0-100 relative units

Parameter Value

Resolution: 1 Count
Accuracy: ±1% ±1 relative unit
Leakage: <10 µA @ 264 VAC applied to transducer
Isolation: >4 kV RMS, Type BF applied part
Non-Invasive Blood Pressure

Blood Pressure
Technique: Oscillometric

Measurement Range: Systolic: 40 to 260 mmHg

Diastolic: 25 to 200 mmHg
Mean Arterial: 45 to 235 mmHg

Measurement Modes Manual: Single measurement

Auto: Automatic intervals of 1, 3, 5, 10, 15, 30, 60 and 90 minutes
STAT: Consecutive measurements for 5 minutes

Cuff pressure display: 10 to 300 mmHg

Selectable Initial Inflate

Pressure Range: 120 to 260 mmHg

Pulse rate range: 40 to 200 bpm

Blood Pressure Accuracy: ANSI/AAMI SP10

Overpressure threshold: IEC/EN 60601-2-30

Time Out period: 180 sec.
Pulse Rate Accuracy: ±2 mmHg or ±2%, whichever is larger

Patient Data 12 hours minimum; sequential, non-volatile buffer

Trend Data

16-2
 Specifications

FETALGARD Lite Recorder Specifications:

Dimensions — 11.5 cm H x 24.2 cm W x 20.4 cm D

Physical Characteristics

Weight — approx. 3.4 kg

100-120V~, 50-60 Hz, 0.4A

Power

220-240V~, 50-60 Hz, 0.2A

Power consumption: 20 watts maximum at nominal supply voltage

Operating Temperature: 10°C to 45°C (50°F to 110°F)

Environmental

Storage Temperature: –20°C to 60°C (–29°F to 175°F)

Relative Humidity: 20% to 90% non-condensing
Water Resistance: IEC 60529 Class IPX1
Mechanical Shock: IEC 60068-2-27
Operating Altitude: 0 to 3,048 meters (0 to 10,000 feet)
Operating Pressure: 1013 hPA to 696 hPA
Storage Altitude: IEC 60068-2-13
Storage Pressure: 1060 hPA to 500 hPA
Sinusoidal Vibration: IEC 60068-2-6
Random Vibration: IEC 60068-2-64
Drop: IEC 60068-2-32
Transport Testing: ISTA Project 2A

Pack Style: Z-Fold. USA or International

Paper

Pack Size: 152 mm x 90 mm

End-of-Pack: Mark along paper edge
Loading: Front-door, drop-in, self aligning
Paper Detectors: Paper Out
Loading Door Open

Normal: 1, 2, and 3 cm/min ±1%

Paper Speeds

High-Speed: 30 cm/min
Paper Tracking Accuracy: ±1% (exclusive of paper accuracy)

16-3
 Section 17
Troubleshooting and Maintenance

Troubleshooting and Maintenance

17.1 Self Test
The monitor performs a self test each time the unit is turned on.
1. Make sure the monitor and optional recorder are properly interconnected.
2. Check the recorder for paper.
3. Connect the monitor to the Battery Eliminator.
4. Make sure both the Battery Eliminator and the optional recorder are connected to the appropri-
ate mains supply.
5. Turn on the monitor and recorder.

Check that the monitor successfully powered on and is displaying the main monitoring screen. If
an error occurs the monitor will display the error screen. The unit should be removed from ser-
vice if this occurs.

Check that the recorder is feeding paper and the power on test pattern printed properly. Remove
from service if this does not occur.

17.2 Ultrasound Transducer Test

To test an ultrasound transducer:

1. Properly connect the transducer to the rear of the monitor.

2. Turn on the monitor and recorder.

3. Adjust the speaker volume to an audible level.

4. Hold the transducer on one hand and tap on the transducer face with the other hand. The tap-
ping should be heard from the monitor.

The transducer is operating properly if you can hear noise from the speaker. Remove from ser-
vice if no noise is heard or until the proper cause is identified and repaired.

17.3 TOCO Test

To test the TOCO transducer:

1. Properly connect the transducer to the rear of the monitor.

2. Turn on the monitor and recorder if present.

3. Gently apply pressure to the button centered on the face of the transducer.

The display and printout (if recorder is present) should show a change in pressure if the transduc-
er is operating properly. Remove from service if this does not occur.

17.4 Operator Troubleshooting

17.4.1 Testing the Out-of-Limits Measurement Alarm Response
This test is performed by forcing an out-of-limits alarm condition and noting the monitor’s
response.

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FETALGARD Lite Operator’s Manual

Table 17.1 Testing the Alarm Limits Function

Step Action
1 Using Table 7-1, obtain the proper size cuff for the operator’s arm, assuming that the operator is a
healthy person.
2 Attach the NIBP cable to the cuff and to the air valve in the rear panel of the monitor.
3 Following standard institutional procedures, apply the cuff to the arm.
4 Press the front-panel NIBP button to start the blood pressure measurement.
5 When a measured value is displayed, note the systolic value.
6 Using the procedure described in paragraph 7.3.2, adjust the value of systolic (SYS) alarm upper limit
at least 10 points below the observed measurement.
7 Repeat Step 4, above. An alarm condition should be generated if the new systolic value is above the
new limit. If the systolic value is below the limit, lower the limit another 20 units and repeat Step 4.
Verify that the audible alarm is sounded, the the NIBP frame fill color is changed, and that the NIBP
frame blinks as specified for a visual alarm.
8 Reset the SYS upper alarm limit to its initial value.

17.4.2 Testing the Faulty-Air-Hose Alarm Response

Table 17.2 Testing No-Cuff Alarm Function
Step Action
1 Connect cuff air hose cable to monitor valve.
2 Press front-panel NIBP button to start the blood pressure measurement. Observe the attempt to
inflate the cuff to the initial pressure value.
3 Disconnect the air hose from the monitor.
4 Check for specified monitor’s responses to the alarm condition: display changes the background fill
color in the NIBP frame; a no-signal display of dashes appears in place of any numerals; and a warn-
ing message NIBP NO CUFF appears in the status frame.

Table 17.3 Testing Cuff-Inflation Alarm Function

Step Action
1 Connect air hose cable to monitor valve.
2 Press front-panel NIBP button to start the blood pressure measurement. Note the attempt to inflate
the cuff to the initial pressure value.
3 Bend air hose sufficiently to occlude any air passage.
4 Check for specified monitor’s responses to the alarm condition: display changes the background fill
color in the NIBP frame; a no-signal display of dashes appears in place of any numerals; and a warn-
ing message NIBP BLOCKED HOSE appears in the status frame.

17-2
 Troubleshooting and Maintenance

17.5 Battery Disposal and Handling

Caution
When disposing of internal lead acid battery, adhere to all applicable laws regard-
ing recycling. Avoid storing battery above 60°C (140°F). If clothing or skin comes
in contact with material from inside the battery, immediately wash with plenty of
clean water.

NOTE
Setting Time and Date procedure will have to be performed if the battery has been
disconnected for any reason.

17.6 Calibration
The FETALGARD Lite monitor, recorder and accessories require no periodic calibration or
adjustment.

17-3
 Appendix A
Appendix A

Guidance and Manufacturer’s Declaration — Electromagnetic Compatibility IEC

60601-1-2
The FETALGARD Lite is suitable for use in the specified electromagnetic environment. The
operator of the FETALGARD Lite should assure that it is used in such an environment.

Instructions for Use

Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in this manual.

WARNING
Use of accessories, transducers, and cables other than
those specified may result in increased EMISSION and/or decreased IMMUNITY
of the FETALGARD Lite.

WARNING
The FETALGARD Lite should not be used adjacent to or stacked with other equip-
ment. If adjacent or stacked use is necessary, the FETALGARD Lite should be
observed to verify normal operation in the configuration in which it is used.

WARNING
There are minimum amplitudes for the FETALGARD Lite to measure physiological
signals. Operation of the FETALGARD Lite below the minimum amplitudes may
cause inaccurate results.

WARNING
Certain strong electromagnetic fields can interfere with the ultrasound transducer
and cause a false heart rate reading that does not originate from the patient. This
interference is rare, and usually found in the vicinity of large machinery. In order to
avoid the possibility of these interfering signals being misinterpreted as fetal heart
rates, the following procedures should be followed whenever the monitor is to be
used in a new location, or if it is known that electrical machinery is being operated
in the vicinity.

After connecting the ultrasound transducer(s), turn on the monitor and observe the heart rate indi-
cations on the screen for 30 seconds. Intermittent display of random heart rates is acceptable.
However, if there is a constant display of a physiological heart rate lasting more than 5 seconds,
this is an indication that there is a source of electromagnetic interference in the vicinity. The fol-
lowing steps should be taken to determine if it is possible to use the monitor in this environment.

• Move all cords and line-powered equipment at least six feet away from the FETALGARD
Lite. Check for extension cords running behind or under the bed and equipment in adjacent
rooms. If the artifact heart rate indication ceases, the monitor may be used normally.

• Remove the line cord from the monitor’s power supply. If the artifact heart rate indication
ceases, the monitor may be used normally.

• Unplug the FGL recorder and move it out of the vicinity. If the artifact heart rate indication
ceases, the monitor may be used normally.

If these measures do not result in cessation of the heart rate artifact, the monitor cannot be safely
used in this environment.

A-1
FETALGARD Lite Operator’s Manual

Electromagnetic Emissions
Table A-1. Electromagnetic Emissions

Emissions Test Compliance Level Electromagnetic Environment Guidance

RF emissions CISPR 11 Group 1 The FETALGARD Lite uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class B The FETALGARD Lite is suitable for use in all establishments
including domestic establishments and those directly connect-
Harmonic Emissions IEC Class A ed to the public low-voltage power supply network that sup-
61000-3-2 plies buildings used for domestic purposes.

Voltage Fluctuation/ Flicker Complies

emissions IEC 61000-3-3

Table A-2. Surge, Voltage Dips/Interruptions and Magnetic Field Immunity

Immunity Test Compliance Electromagnetic

Test Level Level Environment Guidance
Electrostatic discharge Floors should be wood, concrete, or
(ESD) ceramic tile. If floors are covered with
synthetic material, the relative humidi-
IEC 61000-4-2
ty should be at least 30%.
Contact ± 6 kV ± 6 kV
Air ± 8 kV ± 8 kV

Electrical fast transient/ Mains power quality should be that of

Burst (EFT) a typical commercial or hospital envi-
IEC 61000-4-4 ronment.
AC Line to Line ± 1 kV ± 0.251 kV No Input/Output cables greater than
AC Line to Earth ± 2 kV ± 0.251 kV 3 meters may be used with the
FETALGARD Lite.
I/O Cables ±1 kV Not Applicable

Surge Mains power quality should be that of

IEC 61000-4-5 a typical commercial and/or hospital
± 1 kV environment.
Line to Line ± 1 kV
Line to Earth ± 2 kV ± 2 kV

Voltage dips, short <5% UT <5% UT Mains power quality should be that of
interruptions and volt- (>95% dip in UT) for 0.5 cycle a typical commercial and/or hospital
age variations on power for 0.5 cycle environment.
supply input lines
40% UT 40% UT
IEC 61000-4-11
(60% dip in UT) for 5 cycles
for 5 cycles

70% UT 70% UT
(30% dip in UT) for 25 cycles
for 25 cycles

<5% UT <5% UT
(>95% dip in UT) for 5 seconds
for 5 seconds

Power Frequency 3 A/m 1 A/m1 Power frequency magnetic fields

(50/60 Hz) should be levels characteristic of a
typical location in a typical commer-
Magnetic field
cial and/or hospital environment.
IEC 61000-4-8

1The FETALGARD Lite is susceptible to Electrical Fast Transient energy. See the fourth WARNING state-
ment on the first page of this appendix for instructions for use and methods of mitigation.
NOTE: UT is the AC mains voltage prior to application of the test level.

A-2
 Appendix A

Table A-3. Electromagnetic Immunity (RF radiated and conducted)

Immunity Test Compliance Electromagnetic

Test Level Level Environment Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the FETAL-
GARD Lite, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended Separation Distance:
3.5
d= P ; 0.150 to 80 MHz
V1

Conducted RF 3 V rms 3c V rms (V1) 3.5

d= P ; 80 to 800 MHz
IEC 61000-4-6 0.15 to 80 MHz E1

Radiated RF 3 V/m 3 V/m (E1) 7

d= P ; 800 to 2500 MHz
IEC 61000-4-3 80 to 2500 MHz E1

Where P is the maximum output power of the transmit-

ter in watts (W) according to the transmitter manufac-
turer and d is the recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters, as deter-
mined by an electromagnetic site survey, a should be
less than the compliance level in each frequency
range. b
Interference may occur in the vicinity of equipment with
the following symbol:

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the FETALGARD Lite is used exceeds the applicable RF compliance level above, the FETALGARD Lite
should be observed to verify normal operation. If abnormal performance is observed, additional mea-
sures may be necessary, such as re-orienting or relocating the FETALGARD Lite.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c The FETALGARD Lite is susceptible to RF energy at 1.024 MHz. This is the frequency that the ultra-
sound sensor operates. It is necessary to remove the source of RF energy for continued operation.
False heartbeats can be determined by removing the sensors from the patient. If the heartbeat contin-
ues, it is due to a source of RF energy at 1.024 MHz. See also the fourth WARNING on page one of this
appendix for additional methods of mitigation
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.

A-3
FETALGARD Lite Operator’s Manual

Table A-4. Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the FETALGARD Lite.

The FETALGARD Lite is intended for use in the electromagnetic environment in which radiated
RF disturbances are controlled. The user of the FETALGARD Lite can help prevent electromag-
netic interference by maintaining a minimum distance between portable and mobile RF commu-
nications equipment (transmitters) and the FETALGARD Lite as recommended below, according
to the maximum output power of the communications equipment.
Frequency of Transmitter 150 kHz to 80 MHz 80 to 800 MHz 800 MHz to 2.5 GHz

3.5 3.5 7
Equation d= P d= P d= P
V1 E1 E1

Rated Maximum Output Separation Distance Separation Distance Separation Distance

Power of Transmitter (d) (d) (d)
(Watts) (meters) (meters) (meters)
0.01 0.35 0.12 0.23
0.1 1.11 0.37 0.74
1 3.50 1.17 2.33
10 11.1 3.69 7.38
100 35.0 11.7 23.3

For transmitters rated at a maximum output power not listed above, the separation distance d can be
estimated, in meters, using the equation in the corresponding column, where P is the maximum out-
put power rating of the transmitter in watts according to the transmitter manufacturer and V1 or E1 is
from Table A-4.

NOTE
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

A-4
 Appendix B
Appendix B

TECHNICAL SERVICES AND SUPPORT

B.1 General
Appendix B includes instructions for obtaining technical assistance and for returning the monitor
for repairs.

B.2 Obtaining Technical Assistance

The Life Care Systems Support Group is the resource for providing installation, preventative and
corrective maintenance, technical and operator support, and parts, and documentation provision-
ing for Analogic-supplied products.

To Contact the Life Care Systems Support Group:

Spare Parts: 978-326-4700
Repairs: 978-326-4700
For all else: +1 978-326-4000 (MA and International)
Fax: +1 978-977-6854
email: [email protected]

B.3 Return Material Procedure

To return a defective product to Analogic, you will need to obtain a Return Material
Authorization (RMA) number from our Life Care Systems Support Group. Please contact a
Service Coordinator at:

Call: +1 978-326-4700
Fax: +1 978-977-6854
email: [email protected]

You will need to supply the Service Coordinator with the following information:
• The quantity of items,
• The "Bill to" address for invoice purposes,
• The "Ship to" address,
• A Purchase Order number, and
• Details of the reported failure.

The Service Coordinator will then inform you of:

• The Return Material Authorization (RMA) number,
• The warranty or non-warranty status of the units being returned,
• Any repair charge.

All returned material must be shipped “PREPAID” to the address below. Please reference your
RMA number on both your purchase order and the shipping paperwork.

Analogic Corporation
Life Care Systems
8 Centennial Drive
Peabody, MA 01960
Attn: Receiving Dock B
RMA#:______________

B-1
Analogic Corporation
Life Care Systems Division
8 Centennial Drive Printed in the U.S.A.
Peabody, MA 01960-7987, USA ®Analogic Corporation
Tel: 978-326-4000 16-00259-01 Rev. 02
September, 2006