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Addendum
This addendum provides additional information for the Instructions for Use - Avalon Fetal Monitor
FM20/30, FM40/50, Release G.0 with Software Revision G.02.xx, part no. 453564290161.

Non-Stress Test Report Functionality

Contrary to what is described in the chapter “Non-Stress Test Report” the interpretation algorithm
and ruleset in the Avalon Fetal Monitor Software Revision G.02.17 (or higher) to generate NST
Reports are equivalent to those implemented in OB TraceVue Revision G.xx, and are based on the
2008 NICHD guidelines.

Specifications
• The following updated and/or corrected specifications supersede the specifications listed in the
“Specifications and Standards Compliance” Chapter:
IUP
Signal Range -99 to 127 mmHg or -13.2 to 16.9 kPa
SpO2
Pulse Range 30 to 300 bpm
Fetal Heart Rate Alarm Limits, Tachycardia
Range 70 to 210 bpm

• The following table replaces the table titled “ECG/Arrhythmia/ST Supplemental Information as
required by IEC 60601-2-27” in the “Specifications and Standards Compliance” Chapter:

Maternal ECG Supplemental Information as required by IEC 60601-2-27

Heart Rate Averaging Method
Display Update Rate
Response Time of Heart Rate
Meter to Change in Heart Rate
The maternal heart rate is computed by averaging the 12 most recent
RR intervals. If each of 3 consecutive RR intervals is greater than 1200
ms (i.e. rate less than 50 bpm), then the 4 most recent RR intervals are
averaged to compute the HR.
2s
HR change from 80 to 120 bpm: 10 sec.
HR change from 80 to 40 bpm: 14 sec.

• Because the CE marking is not depicted in the Instructions for Use in the "Specifications and
Standards Compliance" Chapter, in the paragraph titled "Regulatory and Standards Compliance",
the complete paragraph, including the CE marking is reproduced here (below).

Printed in Germany 5/2012

Part number 4535 643 67561 *453564367561*
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Regulatory and Standards Compliance

The monitor is in conformity with the essential requirements of the European Medical Devices
Directive 93/42/EEC and bears the CE marking:

The monitor is classified into Class IIb according to Annex IX rule 10.

Patient Alarms and INOPs

The following INOP Message and Indication descriptions supersede those listed in the Patient Alarms
and INOPs chapter:

INOP Message, Indication Source What to do

Batt MISSING Battery No Battery found in FM20/30. Contact your service personnel.
INOP tone
BUS MASTER MALFUNC Monitor There is a problem with the monitor's hardware. Contact your service
personnel.
INOP tone
CHECK BATT TEMP Battery The temperature of the battery is too high. Check that the monitor is
not exposed to heat.
INOP tone
CHECK PAPER Recorder Check that there is no paper jam, that the print drawer is properly
shut, that the paper is loaded with the grid facing upwards, and that
the correct Philips paper is being used.
CHECK TI CONFIG Monitor If this INOP appears, the monitor can be used normally, except for
INOP tone the Trace Interpretation feature. Contact your service personnel.

DFHR1 SIGNAL LOSS DECG The input signal quality is not sufficient to process the measurement.
DFHR2 SIGNAL LOSS Reapply the fetal scalp electrode.
DFHR3 SIGNAL LOSS
INOP tone if Alarm Mode is set
to All. No tone if Alarm Mode is
set to INOP only.
FHR1 SIGNAL LOSS FHR The input signal quality is not sufficient to process the
FHR2 SIGNAL LOSS (ultrasound) measurement. Adjust the position of the transducer to obtain a better
FHR3 SIGNAL LOSS signal.
INOP tone if Alarm Mode is set
to All. No tone if Alarm Mode is
set to INOP only.
PAPER END Monitor The end of the paper pack is detected. Insert a new pack of paper.
INOP tone
Pulse(Toco) MALF Toco MP There is a problem with the Toco MP transducer hardware.Contact
INOP tone Maternal Pulse your service personnel.
Measurement

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INOP Message, Indication Source What to do

TimeExpired:NST Toco The time has expired for the NST timer. Clearing the timer clears the
INOP.
INOP tone
(Message and tone only if Setup
NST Timer -> Notification is
set to Alarm.)

Repositioning Transducers
• The following information applies in addition to the sections under “Fastening Belts and
Transducers” in the “Basic Operation” Chapter:
Transducers may be attached to the patient for long periods without interruption. In rare cases, skin
irritations may occur if a transducer is attached to one location for a long time. To avoid this
possibility, inspect the transducer application site at least every three hours to ensure there are no
adverse effects on the skin. If the skin quality changes, move the transducer to another site.
The ultrasound transducer is repositioned quite often to follow the fetal heart as part of the normal
monitoring process, but this is not so for the Toco transducer. Therefore, remember to also check its
application site (between contractions) at the intervals stated above.
To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to remain on the
transducer. Follow all instructions that accompany the specific cleaning and disinfecting agents you are
using. Remove agent residues with a cloth dampened in water before applying a transducer to a patient.
Refer to the chapter "Care and Cleaning" in the Instructions for Use for further information, and a list
of approved agents.

Disposing of the Monitor

• The following information replaces the respective section in the “Maintenance” Chapter:

WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you
disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your
country's laws for equipment containing electrical and electronic parts. For disposal of parts and
accessories such as thermometers, where not otherwise specified, follow local regulations regarding
disposal of hospital waste.

You can disassemble the monitor and the transducers as described in the Installation and Service
Manual.
You will find detailed disposal information on the following web page:
http://www.healthcare.philips.com/main/about/Sustainability/Recycling/pm.wpd
The Recycling Passports located there contain information on the material content of the equipment,
including potentially dangerous materials which must be removed before recycling (for example,
batteries and parts containing mercury or magnesium).

Do not dispose of electrical and electronic equipment as unsorted municipal waste. Collect it
separately, so that it can be safely and properly reused, treated, recycled, or recovered.

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Manufacturer’s Information
You can write to Philips at this address:
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Str. 2
71034 Boeblingen
Germany
Visit our website at: www.healthcare.philips.com/us/.
© Copyright 2012. Koninklijke Philips Electronics N.V. All Rights Reserved.