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151

9Non-Stress Test Timer

The non-stress test (NST) timer shows the elapsed time for the non-stress test. The timer counts up to

the time you set for the NST.

Setting NST Autostart/Autostop

You can set the recorder so that it starts automatically (NST Autostart) when the NST timer is started,

and stops automatically (NST Autostop) when the NST is complete (when the set run time has elapsed).

As default, NST Autostart is On, and NST Autostop is Off.

Viewing the NST Timer

You can configure the timer notification symbol, (the NST label), a progress bar and the elapsed time

to be displayed in the top left-hand corner of the screen. By default, the NST timer is not displayed on

the screen.

Alternatively, you can view the timer in the Timers window.

To open the Timers window:

Either

• Press the Timer SmartKey.

• Access the NST pop-up keys (see “Accessing the NST Setup Pop-up Keys” on page 152), and

press the Timers key.

Timer Expiry Notification

When the timer expires, the color changes from blue to green, you hear a single tone, and a message

appears in the status line on the main screen.

The volume of the tone can be set in Configuration Mode.

9 Non-Stress Test Timer

152

Accessing the NST Setup Pop-up Keys

You control and set up the NST timer (for example, start, stop, or clear the timer, and set the run time)

using a selection of pop-up keys that you access via any one of three possible routes:

•Via the Timer SmartKey (Route 1)

•Via the Main Setup SmartKey (Route 2)

• Via the NST display area at the top left-hand corner of the screen (Route 3). When you touch the

NST display area, the NST pop-up keys become available at the bottom of the screen.

Via the Timer SmartKey (Route 1)

Press the Timer SmartKey. The Timers window opens, and the pop-up keys for controlling/setting up

the NST timer appear (see “Pop-up Keys for NST Timer Setup” on page 152).

Via the Main Setup SmartKey (Route 2)

1Enter the Main Setup menu using the SmartKey.

2Select NST to enter the Setup NST menu. At the same time, the pop-up keys for setting up the NST

timer appear (see “Pop-up Keys for NST Timer Setup” on page 152).

Via the NST Display Area (Route 3)

Select the NST display area at the top left-hand corner of the screen (when so configured). The pop-up

keys for controlling/setting up the NST timer become available at the bottom of the screen (see “Pop-

up Keys for NST Timer Setup” on page 152).

Pop-up Keys for NST Timer Setup

Runtime

The run time can be set from 10 to 60 minutes. See the Configuration Guide for details how to set the

run time.

Run Time

The run time can be set from 10 to 60 minutes. See the Configuration Guide for details how to set the

run time.

Pop-Up Keys Selecting this pop-up key lets you: Comments

Start Start the timer.

Stop Stop the timer, allowing either restarting after a

pause (Start) or clearing (Clear key).

Setup NST Enter the Setup NST menu. From here you can set

the run time.

This pop-up key is not available with

Route 2, as the Setup NST menu is

already open.

Timer Return to the Timers window. This pop-up key is not available with

Route 1, as the Timers window is already

open.

153

10Non-Stress Test Report

It is generally accepted that a non stress test (NST) allows you to assess fetal well-being. The monitor's

NST report process uses fetal ultrasound (but not DECG) heart rate traces and the Maternal Toco

trace to generate a printed report when criteria are met and it is an indication of the fetal well-being.

The American term Non Stress Test (NST) is used for antepartum testing. The interpretation

algorithm and rule set are equivalent to those implemented in OB TraceVue Revision G.xx or

IntelliSpace Perinatal Revision H.xx and higher, and are based on the 2008 NICHD guidelines.

An NST report is a diagnostic aid, but it does not replace the clinician’s judgment. The interpretation

and the appropriate clinical response remain with the clinician.

A fetus normally produces characteristic heart rate patterns. Average baseline variability and

acceleration of the FHR in response to fetal movement are considered reassuring signs. This test does

not take into account any form of external fetal stimulation.

For every active ultrasound fetal heart rate measurement, one NST report can reside in the monitor’s

memory. The reports are cleared when you discharge a patient and when you start a new NST report.

When the NST Report option is available and the NST Report feature is "on", the NST status for all

available ultrasound fetal heart rate measurements are displayed on the screen.

The minimum displayed information is:

• NST identification (by FHR number: 1, 2, 3)

• Current NST status (by color: inverse for "not started yet", white for "running", yellow for

"stopped", green for "finished")

Setting Up an NST Report

To set up NST Report functionality:

1Enter the Main Setup menu and select the NST Report.

2Or select the NST Report SmartKey.

3Press the Setup pop-up key.

10 Non-Stress Test Report

154

4Set your configuration options.

Select from:

•NST Analysis choose from On or Off.

This switches the report feature on or off. This is linked to the NST timer. Both must be set to On

for the NST report to function.

•Report Recording choose from:

–Manual - press the Record Report pop-up key to trigger a manual request.

–After Recorder Stop - report is recorded as soon as recorder becomes idle.

–Immediately - if a realtime recording is running, the monitor pauses it. The recording is

continued after the report has been recorded.

Average short term variability (STV) value is documented in [bpm] and [ms] if STV is configured as

part of the NST Report. This parameter is not considered as reassuring criteria.

NST Report Status Window

The NST Report window displays a detailed overview of the current NST status for any available

ultrasound fetal heart rate measurement. You can see:

• NST Status - whether it is ready, ongoing, or the time and date at which it was stopped, or at which

it was finished.

• Elapsed time - the time that has elapsed since the NST began.

• Accelerations - the number of FHR accelerations detected so far.

• Baseline - the average baseline value.

• Variability - the average variability value.

• Short Term Variability - the current short term variability (STV) value.

• Decelerations - the number of FHR decelerations detected so far.

• FHR Availability - current statistical FHR availability value.

• Sinusoidal - the current status of sinusoidal rhythm detection.

For criteria not yet met, a white arrow symbol marks the overall status on the top line, and also appears

against every criterion not yet met. A yellow symbol indicates detection of severe or prolonged

decelerations.

The pop-up keys let you perform the following actions:

•FHR1, FHR2, FHR3 - switch to the window showing the current NST status for the fetal heart rate.

•Record Report - print the NST Report on paper.

•Record Trace - record the trace episode that belongs to the current report. Depending on device

usage, the trace recording might be incomplete.

•Setup - open the Setup NST Report window.

10 Non-Stress Test Report

155

Example NST Report

Field Field Content

Report Title, with FHR label

and date

NST Report for FHR1 on 12 Oct. 2009

Product Information Product DE53102345 G.01.70, OB A.04.24,

Toco DE52401090, FHR1 DE00002345 A.05.26

Patient Information Rogers, Alice

Age: 27

Gestational Age: Week 34, Day 5

Start time, end time, Elapsed

time, configured runtime

Time: 11:34 – 12:06

Elapsed time: 32 min

Run time: 20 min

Overall one-line NST result

summary

NST Criteria*: not met

Title Trace Interpretation Summary

Result Accelerations Accelerations: 2

at: 11:59 12:02

Result: Contractions Contractions: 3

at: 11:57 12:00 12:04

Result: Baseline and

Variability

Baseline: 125 bpm (Range: 118-129 bpm)

Variability: 23 bpm (Range: 20-24 bpm)

Statistics: FHR availability FHR available: 95%

Result: Decelerations Decelerations: 1

at: 11:58

severe

prolonged

Result:

Sinusoidal Rhythm detected

Sinusoidal: No

10 Non-Stress Test Report

156

Result: Decelerations before

Reporting Period

Events before Reporting Period:

Decelerations: 1

at: 11:38

severe

prolonged

This field is enabled if there were decelerations between the start of

NST and the start of the reporting period.

Guideline/Criteria

Information

(*) Interpretation criteria based on guideline "NICHD 2008, v01"

User-defined criteria for CTG tracing:

• valid FHR for 90% of reporting period

• baseline heart rate between 120 bpm and 160 bpm

• at least 2 accelerations in 10 min

• not more than 1 decelerations

• moderate baseline variability (6-25 bpm)

Additional criteria:

• no severe or prolonged decelerations

• no sinusoidal pattern in reporting period

Field Field Content

10 Non-Stress Test Report

157

NST Criteria

The patient is monitored for a user-definable period of time (10-60 minutes in steps of 5 minutes). The

test is considered reassuring when the following criteria are met:

• The fetal heart rate is valid at least 90% (this is configurable) of the specified time span.

• The FHR features a user-defined minimum number of accelerations.

• The FHR features a user-defined maximum number of tolerated decelerations, and does not

include severe or prolonged decelerations, which are never tolerated.

• The average baseline fetal heart rate lies within the user-defined limits for low heart rate and high

heart rate over the whole time span.

• The FHR exhibits a moderate variability (user-defined) for the specified time span.

An NST Report is generated when the reassuring criteria are met the first time in the current

monitoring phase. When performing NST with twins or triplets, a separate NST Report is generated

for each fetus.

After the reassurance criteria have been met, the clinician can print the NST Report and then turn the

fetal monitor off, or may continue fetal monitoring and print the report at any time.

Non-Reassuring Report

If the reassurance criteria are not met when the test has run for 90 minutes, or if you stop anytime

during the 90 minute period, then the test is stopped, and a report is generated stating the reassurance

criteria have not been met.

Nonreactive NST Test

If a nonreactive test occurs, and you then use acoustic stimulation, you must exercise caution in

interpreting the resulting traces, as artificial stimulation is not taken into account when calculating test

results.

10 Non-Stress Test Report

158

159

11Cross-Channel Verification

(CCV)

The cross-channel verification helps to reduce the possibility of misidentification of the maternal heart

rate for the fetal heart rate. It does this by comparing the measured fetal heart rate to the maternal

heart rate. If there are multiple fetal rates, they are also compared with each other and the maternal

heart rate.

Misidentification of Heart Rates

FHR detection by the monitor may not always indicate that the fetus is alive. Confirm fetal life before

monitoring, and continue to confirm that the fetus is the signal source for the recorded fetal heart rate

(see “Confirm Fetal Life Before Using the Monitor” on page 10).

To reduce the possibility of mistaking the maternal HR or pulse for FHR, or FHR1 for FHR2 or

FHR3, it is recommended that you monitor both maternal HR/pulse and the heart rates of all fetuses

(see “Monitoring FHR and FMP Using Ultrasound” on page 165, “Monitoring Twin FHRs” on

page 183, “Monitoring Triple FHRs” on page 191, and “Monitoring Maternal Heart / Pulse Rate” on

page 221).

Here are some examples where the maternal HR can be misidentified as the FHR, or one FHR for

another FHR (twins/triplets).

When using an ultrasound transducer:

– It is possible to pick up maternal signal sources, such as the maternal heart, aorta, or other

large vessels. Especially if the recorded maternal HR, and any other artifact is over 100 bpm.

– It is possible to pick up the same fetal heart rate simultaneously with multiple transducers.

NOTE

When an ultrasound transducer is connected to the monitor, but not applied to the patient, the

measurement may generate unexpected intermittent FHR readings.

11 Cross-Channel Verification (CCV)

160

When Fetal Movement Profile (FMP) is enabled:

The FMP annotations on a fetal trace alone may not always indicate that the fetus is alive. For

example, FMP annotations in the absence of fetal life may be a result of:

• Movement of the deceased fetus during or following maternal movement.

• Movement of the deceased fetus during or following manual palpation of fetal position (especially

if the pressure applied is too forceful).

• Movement of the ultrasound transducer.

When using a scalp electrode (DECG):

• Electrical impulses from the maternal heart can be transmitted to the fetal monitor through a

recently deceased fetus via the spiral scalp electrode, appearing to be a fetal signal source.

Cross-Channel Verification Functionality

The cross-channel verification functionality (CCV) of the fetal monitors compares all monitored heart

rates (maternal and fetal), and indicates automatically whether any two channels are picking up the

same signal, or monitoring similar values.

If the fetal monitor detects that any channels have the same or similar values, the Coincidence INOP is

issued with an INOP tone that can have a configurable delay. In addition, yellow question marks

appear next to the numerics on the touchscreen that have the same or similar values. On the recording

trace there is also a question mark from the point where recorded traces continuously overlap.

Visual Aids for CCV Detection

Coincidence INOP appears on the screen of the fetal monitor.

Question mark appears on the screen of the fetal monitor next to the

numerics that show the same or similar values.

Question mark recorded on the trace from the point where two

measured values coincide.

11 Cross-Channel Verification (CCV)

161

Overview of Cross-Channel Comparisons

Measurements from Transducers

Measurement Comparison Done by the Fetal Monitor for Cross-Channel Verification

* dFHR and aFHR always replace one of the fetal channels (1,2, or 3) and cannot be compared to the

channel it replaces. If you monitor for example twins with two ultrasound transducers, you see the

numerics FHR1 and FHR2 at the monitor. If you decide to replace the ultrasound transducer for

FHR2 with a fetal scalp electrode, the dFHR numeric is then shown as dFHR2.

Measurement Transducer

FHR (US) From Ultrasound or CL Ultrasound transducer

dFHR (DECG) From a fetal scalp electrode

aFHR (abdom. ECG) From the CL Fetal & Maternal Pod

Pulse (Toco) From Toco MP, or CL Toco+ MP transducer

Pulse (SpO2) From SpO2 or CL SpO2 Pod

HR (MECG) From MECG electrodes

aHR (abdom. ECG) From the CL Fetal & Maternal Pod

FHR1 (US) FHR2 (US) FHR3 (US) dFHR (DECG)* aFHR* (ECG)

FHR1 (US)

FHR2 (US)

FHR3 (US)

dFHR (DECG)*

aFHR (abdom. ECG)

Pulse (Toco)

Pulse (SpO2)

HR (MECG)

aHR (abdom. ECG)

11 Cross-Channel Verification (CCV)

162

Coincidence Examples

Coincidence of Maternal Pulse and FHR

When the maternal pulse and FHR are being monitored, and the measured values are very similar or

the same, the coincidence question mark is displayed on the monitor’s screen above both of the

corresponding numerics (in this case maternal pulse and FHR). Often the signal loss or coincidence

happens because the fetal or maternal movement displaced the ultrasound transducer, and a

repositioning of the transducer is necessary.

Pulse Delay

SpO2 pulse rate traces have an averaging calculation of approximately 10 seconds and an overall delay

of approximately 12 seconds (depending on recorder speed). This differs from a non-averaged beat-to-

beat MECG heart rate trace or an ultrasound heart rate trace calculation (having switched to the

maternal HR) with no significant delay. Note that Maternal Pulse from Toco has an averaging of

4 seconds and an overall delay of between 6 and 8 seconds.

1Coincidence INOP

2Coincidence question mark

above FHR1

3Coincidence question mark

above pulse from Toco MP

11 Cross-Channel Verification (CCV)

163

The coincidence question mark is also printed on the trace paper next to the corresponding FHR and

maternal pulse.

Coincidence of Twins/Triplets FHRs

When both FHR1 and FHR2 are being monitored, and the measured values are very similar or the same,

the coincidence question mark is displayed on the monitor’s screen above both of the corresponding

numerics (in this case FHR1 and FHR2).

1Printed coincidence

question mark on trace

2Fetal heart rate trace from

Ultrasound

3Maternal pulse trace from

SpO2

1Coincidence INOP

2Coincidence question

mark above FHR1

3Coincidence question

mark above FHR2

11 Cross-Channel Verification (CCV)

164

The coincidence question mark is also printed on the trace paper next to FHR1 and FHR2.

Recommended Actions for Coincidence INOP

1Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a

fetoscope, stethoscope, or Pinard stethoscope.

2Manual determination of the maternal pulse and comparison with the fetal heart rate sound signals

from the loudspeaker.

3Reposition the transducer, or ensure that the fetal scalp electrode is placed correctly, until you

receive a clear signal and the monitor is no longer issuing the Coincidence INOP.

4In case of difficulties deriving a stable maternal pulse reading using the Toco MP or CL Toco+ MP

transducer, use SpO2 or the CL SpO2 Pod instead. In case of similar problems with the pulse

measurement from SpO2, use MECG instead. Reasons to switch the method for deriving a

maternal pulse or heart rate include: motion artifacts, arrhythmia, and individual differences in

pulse signal quality on the abdominal skin (via Toco MP).

5If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation,

confirm fetal life using obstetric ultrasonography.

1Printed coincidence question mark on

trace

2FHR1 and FHR2 traces

165

12Monitoring FHR and FMP

Using Ultrasound

To monitor a single FHR externally, you use an ultrasound transducer attached to a belt around the

mother's abdomen. The ultrasound transducer directs a low-energy ultrasound beam towards the fetal

heart and detects the reflected signal. Your monitor can also detect fetal movements and print the fetal

movement profile (FMP) on the trace. Monitoring using ultrasound is recommended from the

25th week of gestation for non-stress testing or routine fetal monitoring.

WARNING

Performing ultrasound imaging or Doppler flow measurements together with ultrasound fetal

monitoring may cause false FHR readings, and the trace recording may deteriorate.

Technical Description

Fetal monitors use the ultrasound Doppler method for externally monitoring the fetal heart rate. Using

the Doppler method, the transducer (in transmitter mode) sends sound waves into the body which are

then reflected by different tissues. These reflections (Doppler echoes) are picked up by the transducer

(in listening mode). These Doppler echoes are amplified and sent to the monitor’s speaker through

which the fetal heart signal can be heard. In parallel the Doppler echoes are processed through an

autocorrelation algorithm to determine the fetal heart rate (FHR). The FHR is displayed on the

monitor’s numeric display and on the recorded trace.

Properly representing the fetal heart rate using a device that derives heartbeats from motion is a

formidable task and the limitations of the technology will be discussed shortly. Basic fetal cardiac

physiology may contribute to difficulties in obtaining a reliable ultrasound signal.

A heart rate pattern of a fetus is capable of extraordinary variation, ranging from a stable pattern with

minimal variation while the fetus is “asleep” to robust accelerations of 40-60 bpm above baseline rate

over a few seconds, or exaggerated variability when the fetus is active. Decelerations of the rate

60-80 bpm below baseline may develop even more abruptly than the accelerations. Beat-to-beat

arrhythmias may further exaggerate the amount of “variability” and can be seen at the bottom of

variable decelerations, or in the presence of fetal breathing movements which also tend to lower the

fetal heart rate. The recognition of these normal variations in fetal heart rate patterns will greatly assist

in the separation of genuine fetal information from the artifact.

12 Monitoring FHR and FMP Using Ultrasound

166

Limitations of the Technology

All tissues moving towards or away from the transducer generate Doppler echoes. Therefore, the

resulting signal that is provided to the monitor’s speaker, and for further fetal heart signal processing,

can contain components of the beating fetal heart wall or valves, fetal movements, fetal breathing or

hiccup, maternal movements such as breathing or position changes, and pulsating maternal arteries.

The fetal heart signal processing uses an autocorrelation algorithm to obtain periodic events such as

heart beats. If the signal is erratic such as from a fetal arrhythmia, the ultrasound device may have

trouble tracking the abrupt changes, and may misrepresent the true FHR pattern. Signals such as those

from moving fetal limbs are usually very strong, thereby masking the fetal heart signal. During

prolonged movements where the fetal heart signal is masked, the FHR appears blank on the numeric

display and as a gap on the recorded trace. Fetal position changes, maternal position changes, or

uterine contractions can move the fetal heart partly or fully out of the ultrasound beam resulting in

signal loss, or even picking up Doppler echoes from pulsating maternal arteries. In these cases a

maternal heart rate or sometimes even a rate resulting from the mixture of fetal and maternal signals

may be displayed on the monitor’s numeric display and on the recorded trace.

In contrast to the timely well-defined R-peak of an ECG signal obtained with a fetal scalp electrode,

the ultrasound Doppler signal from a fetal heart consists of multiple components from atria (diastole),

ventricles (systole), valves, and pulsating arteries. These components vary depending on fetal and

transducer position and angle, and are further modulated by factors such as fetal or maternal breathing.

These effects may produce what is called “artifact”. Optimal transducer positioning therefore is key to

minimizing these effects and thereby minimizing artifact.

Misidentification of Maternal HR as FHR

FHR detection by the monitor may not always indicate that the fetus is alive. Confirm fetal life before

monitoring, and continue to confirm that the fetus is the signal source for the recorded heart rate (see

“Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)”

on page 159).

What You Need

• Ultrasound transducer

• Toco MP or CL Toco+ MP transducer

•Ultrasound gel

• Transducer belt (and optional butterfly belt clip, if applicable)

12 Monitoring FHR and FMP Using Ultrasound

167

Cableless Monitoring - Important Considerations

When using an Avalon CL or Avalon CTS Fetal Transducer system with your monitor, note the

following:

Refer to “Cableless Status Indication” on page 95 for general rules regarding the use of cableless

transducers from an Avalon CL or Avalon CTS Cableless Fetal Transducer system.

CAUTION

Never use ultrasound transducers connected to more than one fetal monitor on the same patient.

• When using an Avalon CL or Avalon CTS you should be aware that FMP is not recommended

when the mother is likely to move, and you should disable Fetal Movement Profile (FMP) on the

fetal monitor (Fetal Movement Off) if the mother is walking. See also “Fetal Movement Profile” on

page 170.

• With the Avalon CL Transducer System, you can monitor twins and triplets with cableless

transducers. The Avalon CTS System does not have this option.

The wireless symbol appears next to the measurement label, indicating that the

measurement is being made by a cableless transducer.

1FHR1

2Toco parameter

12 Monitoring FHR and FMP Using Ultrasound

168

WARNING

• During ambulant FHR monitoring, the chance of losing the signal or detecting the maternal heart

rate is higher than during stationary monitoring. The frequency of the patient's walk may be

detected, and mistaken for an FHR signal.

• Check the mother’s pulse periodically during monitoring and compare this with the FHR signal.

Beware of mistaking a “doubled” maternal heart rate for FHR. If a fetus is dead, there is a risk that

the maternal heart rate is monitored and misinterpreted as the fetal heart rate. Therefore, the

simultaneous monitoring of maternal heart rate (preferably, the maternal ECG) and the fetal heart

rate is encouraged.

• Do not interpret maternal movements as fetal movements.

• Artifacts: FMP artifacts are generated during fetal heart rate searching by changing the transducer

position, therefore the fetal monitors enable the FMP only after detecting a valid heart rate signal

for several seconds. FMP is not recommended when the mother is likely to move, and you should

disable Fetal Movement Profile (FMP) at the fetal monitor (Fetal Movement Off) if the mother is

walking.

• Gaps in maternal heart rate detection can occur:

– if the transducer is not correctly positioned.

– due to the pulsation of uterine blood vessels.

–if the fetus moves.

Preparing to Monitor

Prepare for ultrasound monitoring using the list below. The standard procedures in use in your facility

determine the sequence of actions.

1Determine fetal position.

2Fasten the belt around the patient.

3Switch on the monitor and the recorder.

4Connect the transducer to a free socket. The signal quality indicator for the heart rate initially

displays an invalid signal.

5Apply a thin layer of ultrasound gel to the underside of the transducer.

CAUTION

Using ultrasound gel not approved by Philips may reduce signal quality and may damage the

transducer. This type of damage is not covered by warranty.

1Place the transducer on the abdomen, if possible over the fetal back or below the level of the

umbilicus in a full-term pregnancy of cephalic presentation, or above the level of the umbilicus in

a full-term pregnancy of breech presentation. Work the transducer in a circular motion to ensure

the gel layer makes good contact.

2When the transducer is connected correctly and you receive a good signal, the signal quality

indicator should be filled out. If an inadequate signal is produced, the signal quality indicator will

indicate a poor signal, and no numeric will appear on the screen.

12 Monitoring FHR and FMP Using Ultrasound

169

3Adjust the audio volume of the monitor's loudspeaker to a clearly audible level, while moving the

transducer over the abdomen. When you have a good signal, secure the transducer in position

below the belt.

WARNING

Periodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to

ensure that you are monitoring fetal heart rate. Do not mistake a doubled or elevated maternal HR for

FHR.

The ultrasound transducer may warm slightly (less than 1°C/1.8°F above ambient temperature) when

applied to the patient. When not applied, the transducer can reach a maximum temperature of 44°C/

112.2°F at an air temperature of 40°C/104°F.

Selecting Fetal Heart Sound

You can listen to the fetal heart sound from one ultrasound transducer at a time. When the fetal heart

sound is selected for an FHR channel, you see the audio source symbol next to the FHR numeric label

for that channel.

To select the audio source for an FHR channel:

1Enter the Setup FHR1 menu for the channel you want to hear (FHR1 used as an example).

2Press Select Audio. It may take a few seconds for the audio source symbol to appear.

1FHR1

2Audio source symbol

12 Monitoring FHR and FMP Using Ultrasound

170

Changing the Fetal Heart Sound Volume

The FHR volume symbol at the top right of the Fetal Heart Sound Volume window gives you an

indication of the current volume. To change the volume:

1Select the volume symbol. The volume scale pops up.

2Select the required volume from the volume scale.

Fetal Movement Profile

The Fetal Movement Profile (FMP) parameter detects fetal movements with an ultrasound transducer

connected to the monitor. Only the fetus monitored on the FHR1 channel is monitored for FMP.

Once you have enabled FMP (see “Switching FMP On and Off” on page 171), it is triggered

automatically whenever:

• You connect an ultrasound transducer.

• A patient is discharged.

When FMP is enabled, the ultrasound transducer detects most fetal body movements. Eye movements

are not detected, and movement of the feet and hands may not be detected. Positioning or

repositioning of the transducer is recorded as fetal movement. Maternal movement, excessive fetal

breathing, or fetal hiccups may also be recorded as fetal movement (also in case of fetal demise or

during the second stage of labor). You can mark these artifacts on the trace paper using either the

remote event marker, or the event marker key as described in “Marking an Event” on page 60. FMP

should be interpreted with care, or disabled when the patient is ambulating or during the second stage

of labor. Ignore these movements when you interpret the FMP. When monitoring twins or triplets,

only the fetus monitored on the FHR1 channel is monitored for movement, but be aware that

movements recorded for FHR1 may also be caused by movement of the second or third fetus.

The fetal movement profile (FMP) appears as "activity blocks" along the top of the Toco scale, the

length of each block showing the duration of the activity.

1Fetal Heart Sound Volume

12 Monitoring FHR and FMP Using Ultrasound

171

FMP Statistics

FMP statistics are printed every ten minutes.

The FMP detection activates after about half a minute of steady heart rate signals (signal indicator half-

full, or full) to minimize transducer positioning artifact. You will notice this deliberate delay:

• When a new patient is admitted. A patient discharge restarts the FMP statistics from zero.

• When you connect an ultrasound transducer.

Switching FMP On and Off

You can switch FMP on and off from any FHR channel. For example, to set it from the FHR1

channel:

1Enter the Setup FHR1 menu.

2Select Fetal Movement to switch between On and Off.

3Return to the main screen.

1FMP enabled

2FMP started here

AIndication of current fetal movement

BThe FMP statistics are presented as two percentage figures:

The first figure shows the percentage of detected fetal movements in the previous ten

minutes.

CThe second figure shows the percentage of detected fetal movements since the start of

recording.

To mark the start of the FMP statistic, FMP is printed on the paper with an arrow.

12 Monitoring FHR and FMP Using Ultrasound

172

Troubleshooting

Problem Possible Causes Solutions

Erratic trace

Erratic display

Fetal arrhythmia Consider monitoring FHR using DECG after

the rupture of membranes.

Obese patient

Transducer position not optimal Reposition transducer until signal quality

indicator shows a good signal (at least

half-full).

Belt loose Tighten belt

Too much gel Remove excess

Very active fetus -

Insufficient gel Use enough gel to ensure the transducer

makes good contact with the mother's skin.

Signal quality indicator is

continuously poor

Transducer position not optimal Reposition transducer until signal quality

indicator shows a good signal (at least

half-full).

FHR less than 50 bpm (and the FHR is

audible)

If membranes are ruptured, using a fetal scalp

electrode (FM30 and FM50 only) allows

measurement of FHR down to 30 bpm.

Questionable FHR Recording maternal HR by mistake Reposition transducer

Confirm fetal life

Recording periodic signals when the

transducer is not applied to the patient

Disconnect all NON-USED ultrasound

transducers, as continuous, regular

mechanical, or electromagnetic influences can

result in an artificial trace.

Recorded FHR appears to be suspiciously

higher, or suspiciously lower, than real FHR.

In very rare cases, half- or double-counting

of the FHR can occur.

If you have reason to question the validity of

the recorded FHR, always verify FHR by

independent means (by auscultation, for

example). Measure maternal pulse by

independent means.

FHR not recorded FHR is less than 50 bpm or over 240 bpm If membranes are ruptured, using a fetal scalp

electrode (FM30 and FM50 only) allows

measurement of FHR down to 30 bpm.

If FHR is outside of the specified range, verify

FHR by independent means.

FHR1 Equip Malf or FHR2 Equip Malf or FHR3 Equip Malf INOP displayed. See “Patient Alarms and INOPs” on

page 129.

FHR1 Signal Loss or FHR2 Signal Loss or FHR3 Signal Loss INOP

displayed.

FHR1 Unplugged or FHR2 Unplugged or FHR3 Unplugged INOP

displayed.

If you suspect the transducer is malfunctioning Test the transducer.

12 Monitoring FHR and FMP Using Ultrasound

173

Testing Ultrasound Transducers

If any of the following tests fail, repeat the test using another transducer. If the second transducer

passes the tests, confirming that the first transducer is defective, contact your service personnel.

If the second transducer also fails the tests, contact your service personnel.

You can test all ultrasound transducers, including the cableless ones, as described above.

Additional Information

Artifact in Fetal Heart Rate Measurement

How to detect it and reduce its occurrence using the Avalon Fetal Monitor

The ultrasound derived FHR measurement technique in Avalon fetal monitors, like all other

ultrasound fetal monitors’ FHR measurement techniques, has limitations that can lead to

misrepresentation of the fetal heart rate pattern and potential misinterpretation of the fetal condition.

An incorrect interpretation of the trace may lead to either unnecessary interventions, or to failure to

detect fetal distress, and the need for intervention. Thus, the on-going evaluation of the recorded trace

requires regular confirmation that the trace represents the true FHR. Specific situations requiring such

confirmation include the following:

• After starting a measurement or changing a transducer

• After maternal position changes, for example during pushing with contractions

• When the tracing shows abrupt changes in baseline rate, variability, or pattern (decelerations to

accelerations) especially in the second stage of labor

• When the baseline maternal heart rate is within about 15 bpm of the FHR

To test an ultrasound transducer:

1Switch on the monitor and the

recorder.

2Connect the transducer to the fetal

monitor.

3Select the fetal heart sound for this

channel.

4Increase the loudspeaker volume

to an audible level.

5Holding the transducer in one

hand, move your other hand

repeatedly towards and then away

from the surface.

6Check that a noise is heard from

the loudspeaker.

12 Monitoring FHR and FMP Using Ultrasound

174

• When you are unable to determine a baseline rate, and variability occurs between consecutive

contractions

There are several ways to verify the source and/or accuracy of the recorded fetal heart rate pattern.

These include:

Verification of the FHR with:

• An obstetric stethoscope

• Ultrasound imaging

• A fetal scalp electrode

Verification of the maternal heart rate:

• Using pulse oximetry - for a maternal heart rate pattern displayed simultaneously with the FHR

(Cross-Channel Verification (CCV) feature)

• Using Maternal ECG - for a maternal heart rate pattern displayed simultaneously with the FHR

(CCV feature)

• Manual determination of the maternal pulse

Whenever possible measure the maternal pulse rate to make use of the monitor’s Cross-Channel

Verification (CCV) feature, especially during the second stage of labor, or when the maternal pulse is

elevated over 100 bpm. The Avalon fetal monitor provides a Toco MP or CL Toco+ MP transducer

for maternal pulse detection and the creation of a maternal heart rate pattern plotted on the same

recorder as the FHR pattern. In case of difficulties deriving a stable maternal pulse reading using the

Toco MP or CL Toco+ MP transducer, use SpO2 or MECG instead.

When either of these parameters is utilized, the monitor will automatically and continuously perform a

CCV of the maternal heart rate pattern against the FHR pattern displayed on the monitor. If the

patterns and rates are similar, the CCV provides an alarm that both rates are probably from the same

source (i.e., they both represent the maternal heart rate pattern and the fetus is not being monitored).

Repositioning the ultrasound transducer will usually correct this, but it may be necessary to apply a

fetal scalp electrode. Advising the mother to temporarily cease pushing during contractions may help

to more rapidly resolve any uncertainty in this situation.

Doubling: The autocorrelation algorithm can display a doubled fetal or maternal heart rate if the

duration of diastole and systole are similar to each other, and if the heart rate is below 120 bpm.

Doubling, usually brief, is accompanied by an abrupt switch of the trace to double the baseline value.

Halving: With fetal tachycardia (above 180 bpm) and some interference from breathing or maternal

arteries the autocorrelation algorithm may only recognize every second beat resulting in a halved rate

for a limited time. If the actual FHR is above the maximum limit of the monitor (240 bpm), the

algorithm will also half-count. Halving is accompanied by an abrupt switch of the trace to exactly half

the prior baseline value. This switch may simulate an FHR deceleration and be referred to by clinicians

as a “false deceleration.”

Switching to maternal heart rate (also referred to as "Maternal Insertion"): The fetal heart can

move partly or fully out of the ultrasound beam and the autocorrelation algorithm may then pick up

and display the maternal heart rate. Depending on the signal mix in the ultrasound signal, switching to

the maternal heart rate may mimic several conditions with the potential for erroneous interpretation

and response as follows:

•The switch to the maternal heart rate may simulate an FHR deceleration (i.e., a decrease of

the fetal heart rate, and be referred to by clinicians as a “false deceleration”).

12 Monitoring FHR and FMP Using Ultrasound

175

•The maternal heart rate may simulate a normal fetal heart rate pattern (i.e., it may mask an

FHR deceleration or fetal demise).

Especially during pushing with contractions in the second stage of labor, the maternal heart rate

may increase to the point where it may equal or exceed the fetal rate. Here the maternal trace may

mimic a normal fetal trace while the fetus may be having decelerations or fetal demise has

occurred. This change from fetal to maternal heart rate pattern may not be at all obvious unless

CCV is used and represents the most dangerous pitfall of all the artifacts because fetal distress may

go unrecognized.

•The maternal heart rate may simulate an FHR acceleration, which is an increase of the fetal

heart rate.

During expulsive efforts, the maternal heart rate normally accelerates and may be at or above the

normal FHR range.

•The FHR may display gradual appearing decelerations. Generally, the “false decelerations”

described above are abrupt. Rarely, combinations of “noisy/erratic signal” associated with changes

in maternal and/or fetal rate or movement will produce more gradual appearing “false

decelerations” but these are usually short-lived with an abrupt return to an obviously stable FHR

baseline.

“Noisy/Erratic” signals: With mixed or weak signals the tracing may reveal very brief episodes of

erratic recorded traces. These represent the autocorrelation algorithm finding brief sequences of

apparent and persistent heartbeats amidst a mixed or weak signal. These erratic recorded traces are

commonplace, especially in association with fetal or maternal movement. During prolonged periods

of such noisy/erratic signals, the fetus is not being adequately monitored.

Drop out: With mixed or weak signals there may be no heart rate tracing at all. These episodes reflect

that if the algorithm does not find an apparent and persistent heartbeat amidst a mixed or weak signal,

it will not print a heart rate on the tracing. Brief episodes of drop out are commonplace, especially in

association with fetal or maternal movement. During prolonged periods of drop out, the fetus is

not being adequately monitored.

Multiple Fetuses

With multiple fetuses, the potential to experience these artifacts is increased. Positioning of the

transducer is even more critical. Ultrasound scanning should be used to help with positioning of

individual transducers. See also “Monitoring Twin FHRs” on page 183 and “Monitoring Triple FHRs”

on page 191.

12 Monitoring FHR and FMP Using Ultrasound

176

Obtaining a Good Heart Signal

To successfully position the ultrasound transducer, first determine the fetal position using palpation.

Position the transducer over the strongest audible fetal heart sound from the monitor’s speaker and

wait at least six seconds after each transducer adjustment to verify a good signal quality displayed

on the Signal Quality Indicator and a consistent FHR numeric display. Having determined the position

that provides a strong fetal signal, fix the transducer on the abdomen with the belt.

If the quality of the signal or the appearance of the heart rate trace from the ultrasound transducer is

questionable, the transducer should be repositioned as described above. Alternatively, the use of an

ultrasound scanner will greatly facilitate the determination of the optimal site for the ultrasound heart

rate transducer. Factors during the second stage of labor that may influence the quality of the FHR

tracing obtained with ultrasound include:

• Uterine contractions

• Changing contour of the maternal abdomen

• Maternal body movement - positioning

• Maternal expulsive efforts - pushing

• Maternal tachycardia/accelerations with contractions

• Fetal decelerations, Fetal tachycardia

• Delayed return of the fetal heart rate from a deceleration

• Descent of the fetus in the birth canal

• Rotation of the fetus in the birth canal

In some cases during the second stage of labor, a good and reliable ultrasound FHR signal may not be

obtainable, and the use of a fetal scalp electrode must be considered (fetal ECG).

Heart Rate Sound

The heart rate sound emitted by the device is a representation of movement that, in most cases,

permits accurate auscultation of the FHR corresponding to the FHR displayed on the monitor and rate

pattern depicted on the trace recording. On occasion, the user may hear an FHR that differs from the

FHR display and the recorded trace. This may occur in situations where the fetal heart moves partly

out of the transducer ultrasound beam. In these cases, the user may hear the FHR emitted from the

monitor’s speaker, even though another periodic signal (usually the maternal heart rate) has become

stronger. The autocorrelation algorithm will display the stronger maternal heart rate, despite the

persistence of a weaker fetal signal. These occurrences are usually very brief and, if persistent, can be

addressed by repositioning the transducer.

12 Monitoring FHR and FMP Using Ultrasound

177

Signal Quality Indicator

The signal quality on the Avalon fetal monitor is indicated by a triangle on the touchscreen that is

displayed in one of three ways:

Examples of Artifacts

When monitoring the maternal ECG, a beat-to-beat maternal heart rate trace is printed alongside the

FHR recorded trace. When monitoring the maternal SpO2 derived pulse rate, a filtered and averaged

heart rate trace is printed.

Following are recorded trace examples of complaints received regarding inaccurate output from the

Avalon monitors. Scaling is 3 cm/min and 30 bpm/cm.

1Completely filled triangle, indicating good signal

quality (good/full).

2Half-filled triangle, indicating limited signal quality.

This condition may indicate a weak or ambiguous

signal. If this status persists, reposition the

transducer (acceptable/medium).

3Empty triangle, indicating insufficient signal

quality. No FHR is displayed on the monitor’s

numeric display or the recorded trace. If this status

persists, reposition the transducer (poor/no signal).

Double-Counting

Baseline Rate 120

Baseline Variability Moderate

Accelerations Present

Decelerations Not apparent

12 Monitoring FHR and FMP Using Ultrasound

178

Contractions Excessive, coupling, hypertonus

Artifact Double-Counting

Comment Reassuring tracing. The excessive uterine activity should prompt discontinuation of any

oxytocic agent.

Remediation The true fetal rate can be confirmed by auscultation or by fetal scalp electrode.

Double-Counting

Half-Counting

Baseline Rate 120

Baseline Variability Moderate

Accelerations Present

Decelerations Not apparent

Contractions Minimal

Artifact Half-counting, noise, drop out

Comment Reassuring tracing. The half-count at 4-5 minutes into the tracing may simulate a fetal

deceleration, but the abruptness and the lack of any compensatory changes when the

normal rate returns suggests that this is half-counting. Insertion of the maternal heart rate

(see below) may produce a similar pattern. Note also very brief episodes of half-counting,

maternal insertion, and signal dropout.

Remediation Auscultation or the application of a direct scalp electrode, if feasible, will reveal the true

fetal heart rate.

12 Monitoring FHR and FMP Using Ultrasound

179

Maternal-Switching (Maternal Insertion)

Baseline Rate 170 - Tachycardia

Baseline Variability Moderate

Accelerations Unable to determine

Decelerations Absent

Contractions Absent

Artifact Maternal insertion, noise

Comment The fetus has an elevated baseline rate of about 170 bpm with minimal to moderate

variability. The ability to assess fetal status is limited because about half of the tracing

displays the maternal heart rate.

Remediation The application of a maternal transducer (ECG or pulse oximeter) will likely resolve any

possible confusion with the tracing. Repositioning the transducer may produce a more

reliable tracing. Consideration must also be given to applying a fetal scalp electrode.

Noisy/Erratic Signal and Dropout

Baseline Rate 140

Baseline Variability Moderate

Accelerations Present

Decelerations Absent

Contractions Minimal

Artifact Noisy signal, drop-out

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Selection of Literature References on Artifacts

___________________________________________________________

Mosby's Pocket Guide to Fetal Monitoring: A Multidisciplinary Approach (Nursing Pocket

Guides) 8th Edition (May 2016).

Lisa A. Miller, David A. Miller, Rebecca L. Cypher

Elsevier Ltd, Oxford. 2017, ISBN 978-0-323-40157-9

___________________________________________________________

Signal ambiguity resulting in unexpected outcome with external fetal heart rate monitoring

By Duncan R. Neilson Jr, MD; Roger K. Freeman, MD; Shelora Mangan, RNC, MSN, CNS

American Journal of Obstetrics & Gynecology, June 2008

___________________________________________________________

Antepartal and Intrapartal Fetal Monitoring, 3rd Edition (2007)

By Michelle L. Murray, PhD, RNC

Springer Publishing Company, ISBN 0-8261-3262-6

Page 2, Table 2: Limitations of Continuous EFM

Item 15: “The US may detect maternal aortic wall movement and the maternal HR will be printed. A

failure to recognize the lack of an FHR may delay appropriate management.”

Page 38, “Solving Equipment Problems”, Table 3: The Ultrasound Transducer

___________________________________________________________

JOGC (Journal of Obstetrics and Gynecology Canada)

Volume 29, Number 9, September 2007

Chapter 2: Intrapartum Surveillance

Page S35: “Methods of Electronic Fetal Monitoring”

“… Among its disadvantages are the need for readjustment with maternal or fetal movements and the

following: the transducer may record the maternal pulse, it may be difficult to obtain a clear tracing in

obese women or those with polyhydramnios, artifact may be recorded, and there may be doubling or

halving of the fetal heart rate when it is outside of the normal range.”

___________________________________________________________

Comment Reassuring tracing. Note that there is episodic drop out of the signal with discontinuity of the

fetal tracing.

Remediation Either improving the position of the transducer or the application of a fetal scalp electrode

will reduce the amount of artifact in the tracing.

Noisy/Erratic Signal and Dropout

12 Monitoring FHR and FMP Using Ultrasound

181

Maternal or Fetal Heart Rate? Avoiding Intrapartum Misidentification

by Michelle L. Murray

JOGNN Clinical Issues, April 2003, 33, 93-104; 2004. DOI: 10.1177/0884217503261161

Figure 9 "The recording is of the MHR with occasional doubling."

___________________________________________________________

Maternal Heart Rate Pattern – A Confounding Factor In Intrapartum Fetal Surveillance

Schifrin BS, Harwell R, Hamilton-Rubinstein T, Visser G:

Prenat Neonat Med 2001; 6:75-82

___________________________________________________________

Fetal Monitoring in Practice, 2nd Edition 1998

By Donald Gibb, S. Arulkumaran

Butterworth-Heinemann, ISBN 0-7506-3432-2

Page 65, “False or erroneous baseline because of double counting of low baseline FHR”

Page 66, “Bradycardia: fetal or maternal”

___________________________________________________________

Role of Maternal Artifact in Fetal Heart Rate Pattern Interpretation

Klapholz, Henry M, MD; Schifrin, Barry S. MD; Myrick, Richard RS

Obstetrics & Gynecology, September 1974, Volume 44, Issue 3

___________________________________________________________

12 Monitoring FHR and FMP Using Ultrasound

182

183

13Monitoring Twin FHRs

The FHRs of twins are externally monitored using two ultrasound transducers. The Avalon CL

Transducer system provides the option to monitor twins with cableless transducers. The Avalon CTS

system and the CL F&M Pod do not have this option.

FM30/50 Twin FHRs are monitored throughout labor and delivery. After rupture of the membranes, you can

monitor one twin externally using ultrasound, and the other internally using DECG.

Refer to the appropriate preceding chapters for contraindications, and more information about the

available measurement methods.

FHR detection by the monitor does not always indicate that the fetuses are alive. Confirm fetal life

before monitoring, and continue to confirm that the fetuses are the signal source for the recorded fetal

heart rates. See “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel

Verification (CCV)” on page 159.

Important Considerations

When monitoring:

• Ensure that you are recording two different fetal heart rates. The cross-channel verification feature

alerts you if the two heart rates coincide (if both transducers are recording the same FHR). If this

happens, check the trace and if necessary, reposition an ultrasound transducer to detect the second

FHR correctly.

• Fetal heart rate measurements are labeled in the order in which you plug in the transducers for

those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates

a channel automatically. For instance, the first transducer you connect is automatically allocated a

channel, and the measurement is labeled FHR1, the second is labeled FHR2, and so on.

If you need to disconnect the transducers measuring the FHR temporarily, with the intention to

continue monitoring after the temporary break (for example, if the mother needs to go to the

bathroom), it is important that you reconnect the transducers in the same order as you originally

connected them to make sure that the measurement labels remain consistent.

Upon discharge of the patient all connected transducers are reset from left to right. Example: Only one

transducer is still connected to the monitor, it was labeled FHR2 while monitoring the previous

discharged patient; it is now reset to FHR1.

• The transducer finder LED lets you identify at a glance which transducer is monitoring which

heart rate channel.

13 Monitoring Twin FHRs

184

• The fetal sensor socket to which a transducer is connected is identified by the transducer position

indicator in the setup menu header:

• The trace recorded for FHR1 is thicker (darker) than that recorded for FHR2. This ensures that

the two heart rates are easily distinguishable. The thickness of the recorded trace can be changed in

Configuration Mode.

• Remember that only one fetal heartbeat can be heard from the loudspeaker at a time.

• The audio source symbol shows you which fetus you are listening to. To hear the other fetal

heartbeat, select the fetal heart rate sound for this channel (see “Selecting Fetal Heart Sound” on

page 169).

• Monitor maternal pulse, especially during later stages of labor, to avoid mistaking maternal heart

rate for FHR.

• Make sure that you are recording the best possible signals by referring to the signal quality

indicators and repositioning the transducers if necessary.

• For the Avalon CL transducer system, see “Cableless Monitoring - Important Considerations” on

page 167.

Monitoring Twins Externally

To monitor twin FHRs externally, you need two ultrasound transducers. Follow the procedures

described in “Monitoring FHR and FMP Using Ultrasound” on page 165. The transducer finder LED

lets you identify at a glance which transducer is monitoring which FHR channel, and lights when you

select the FHR numeric field on the screen.

FM20/FM30 FM40/FM50

13 Monitoring Twin FHRs

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Example of the screen showing ultrasound monitoring of twin FHRs:

Monitoring Twins Internally

FM30/50 Monitor one twin using the procedures described in “Monitoring FHR and FMP Using Ultrasound”

on page 165. Monitor the second twin using the procedures described in “Monitoring FHR Using

DECG” on page 199.

Example of a screen showing twin monitoring using a combination of US and DECG (the fetal heart

rate monitored via DECG is labeled "dFHR1"/"dFHR2"/"dFHR3" on the screen):

Separating FHR Traces

To help you to interpret traces with similar baselines, you can separate the baselines by an offset of

20 bpm by switching on trace separation. For details of the offset, see “Separation Order Type” on

page 186.

1FHR 1

2Toco parameter

3FHR 2

1dFHR 1

2Toco parameter

3FHR 2

13 Monitoring Twin FHRs

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Switching Trace Separation On and Off

Connect transducers to the monitor to measure FHR. Depending on the measurement method, you

need either two ultrasound transducers or, for FM30/FM50, one ultrasound and one Toco+ transducer,

or one CL ECG/IUP transducer (to monitor DECG):

1Enter the Main Setup menu by pressing the Main Setup.

2Select Fetal Recorder.

3Select Trace Separation to switch between On and Off.

4Exit the Main Setup menu.

Separation Order Type

In Configuration Mode, you can choose between two methods, Standard and Classic, for dealing with

the trace offsets on the recording (the order in which they are separated) when Trace Separation is On.

•Standard: the FHR2 trace is shifted up by 20 bpm (it is recorded 20 bpm higher than it really is).

No offset is ever applied to the FHR1 trace - it stays where it is (a third FHR would be shifted

down by 20 bpm).

•Classic: the FHR1 trace is shifted up by 20 bpm when there is more than one FHR measurement.

No offset is ever applied to the FHR2 trace - it stays where it is (a third FHR would be shifted

down by 20 bpm).

When Trace Separation is On

When trace separation is turned on, the recorder prints a dotted line labeled with the two FHRs at the

top, and +20 at the bottom.

Examples of the two methods (Standard, Classic) for determining the trace separation order are

provided here.

"Standard" Separation Order

To make differentiating the traces easier, the trace from the ultrasound transducer connected to the

FHR2 channel is separated from that of FHR1 by 20 bpm. In other words, the trace for FHR2 is

recorded 20 bpm higher than it really is. The trace for FHR1 is never shifted.

The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR2. The

FHR trace is labeled +20 every 5 cm:

The label for FHR2 is annotated with a black filled +20:

13 Monitoring Twin FHRs

187

The following trace shows trace separation switched on.

Only the FHR2 trace is offset. The numerical FHR value displayed on the monitor remains

unchanged. Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2 value. For

example, if the recorded trace shows 160, then the true FHR is 140.

"Classic" Separation Order

To make differentiating the traces easier, the trace for FHR1 is offset by +20 bpm when FHR2 is

present. The FHR2 trace is never shifted.

The recorder prints a dotted line labeled+20 across the FHR scale, to identify the trace for FHR1. The

FHR trace is labeled +20 every 5 cm:

The label for FHR1 is annotated with a black filled +20:

The following trace shows trace separation switched on.

Only the FHR1 trace is shifted. The numerical FHR value displayed on the monitor remains

unchanged. Subtract 20 from the recorded trace for FHR1 to obtain the true FHR1 value. For

example, if the recorded trace shows 160, then the true FHR is 140.

13 Monitoring Twin FHRs

188

When Trace Separation is Off

To indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale.

1Standard trace separation switched

off here

2Classic trace separation switched

off here

13 Monitoring Twin FHRs

189

Troubleshooting

Common problems that may occur when monitoring FHR using ultrasound are listed in “Monitoring

FHR and FMP Using Ultrasound” on page 165. See also “Monitoring FHR Using DECG” on

page 199 for common problems you might encounter when monitoring FHR directly.

The following problem may occur when monitoring twins.

For more information, see “Additional Information” on page 173.

Problem Possible Cause Solution

The question mark is

printed repeatedly, and

appears on the screen and

the INOP Coincidence is

issued.

Both transducers are recording the

same FHR, or one fetal transducer is

recording the maternal HR.

Reposition an ultrasound

transducer. See “Recommended

Actions for Coincidence INOP” on

page 164.

13 Monitoring Twin FHRs

190

191

14Monitoring Triple FHRs

If your monitor is equipped with the triplets option, it carries the label:

You can monitor triple FHRs externally using three ultrasound transducers. With the Avalon CL

Transducer system, you can monitor triplets with cableless transducers. The Avalon CTS system and

the CL F&M Pod do not have this option.

Refer to the appropriate preceding chapters for contraindications, and more information about the

available measurement methods.

FHR detection by the monitor may not always indicate that the fetuses are alive. Confirm fetal life

before monitoring, and continue to confirm that the fetuses are the signal source for the recorded fetal

heart rates. See “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel

Verification (CCV)” on page 159.

Important Considerations

• The procedures and any contraindications that apply for twins monitoring also apply for

monitoring triplets. In addition, when monitoring triplets: Be aware that monitoring three FHRs is

inherently more difficult than monitoring single or twin FHRs. The nature of the application

increases the likelihood that a fetal heart rate is monitored by more than one transducer.

• Ensure that you are recording three different fetal heart rates. Pay particular attention to any

coincidence of heart rates detected by the monitor's cross-channel verification feature.

• Fetal heart rate measurements are labeled in the order in which you plug in the transducers for

those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates

a channel automatically. For instance, the first transducer you connect is automatically allocated a

channel, and the measurement is labeled FHR1, the second is labeled FHR2, and the third FHR3.

If you need to disconnect the transducers measuring the FHR temporarily, with the intention to

continue monitoring after the temporary break (for example, if the mother needs to go to the

bathroom), it is important that you reconnect the transducers in the same order as you originally

connected them to make sure that the measurement labels remain consistent.

Upon discharge of the patient all connected transducers are reset from left to right. Example: Only

one transducer is still connected to the monitor, it was labeled FHR2 while monitoring the previous

discharged patient; it is now reset to FHR1.

14 Monitoring Triple FHRs

192

• The transducer finder LED lets you identify at a glance which transducer is monitoring which

heart rate channel.

• The fetal sensor socket to which a transducer is connected, is identified by the transducer position

indicator in the setup menu header:

• The trace recorded for the FHR3 is thicker (darker) than that recorded for FHR1, which is thicker

than that for FHR2. This ensures that the three heart rates are easily distinguishable. The thickness

of the recorded trace can be changed in Configuration Mode.

• Remember that only one fetal heartbeat can be heard from the loudspeaker at a time. The audio

source symbol shows you which fetus you are listening to. To hear the other fetal heartbeat, select

the fetal heart rate sound for this channel (see “Selecting Fetal Heart Sound” on page 169).

• Monitor maternal pulse to avoid mistaking maternal heart rate for FHR.

• Ensure you are recording the best possible signals by referring to the signal quality indicators and

repositioning the transducers if necessary.

For the Avalon CL transducer system, see “Cableless Monitoring - Important Considerations” on

page 167.

Monitoring Triplets

To monitor triple FHRs, you need three ultrasound transducers. Follow the procedures described in

“Monitoring FHR and FMP Using Ultrasound” on page 165 and in “Monitoring Twin FHRs” on

page 183. The transducer finder LED lets you identify at a glance which transducer is monitoring

which heart rate channel.

Separating FHR Traces

To help you to interpret traces with similar baselines, you can separate the baselines by an offset of

20 bpm by switching on trace separation. For details of the offset, see “Separation Order Type” on

page 186.

FM20/FM30 FM40/FM50

14 Monitoring Triple FHRs

193

"Standard" Separation Order

To make differentiating the traces easier, the trace for FHR2 is offset by +20 bpm, and the trace for

FHR3 is offset by -20 bpm. In other words, the trace for FHR2 is recorded 20 bpm higher than it

really is, while the trace for FHR3 is recorded 20 bpm lower than it really is. The trace for FHR1 is

never shifted.

The following trace shows triplets with Trace Separation on, and using Standard separation order.

The traces for FHR2 and FHR3 are offset. The numerical FHR values displayed on the monitor

remain unchanged. Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2. For

example, if the recorded trace shows 160 bpm, then the true FHR is 140 bpm. Similarly, add 20 to the

recorded trace for FHR3 to obtain the true FHR3.

The recorder prints a dotted line labeled +20 across the FHR scale, to identify the

trace for FHR2.

The recorder prints a dotted line labeled -20 across the FHR scale, to identify the

trace for FHR3.

The FHR trace is labeled every 5 cm.

The label for FHR2 is annotated with +20 and the FHR3 label is annotated with

-20.

14 Monitoring Triple FHRs

194

"Classic" Separation Order

To make differentiating the traces easier, the trace for FHR1 is offset by +20 bpm when other FHR

measurements are present, and the trace for FHR3 is offset by -20 bpm. The FHR2 trace is never

shifted. In other words, the FHR traces are always sorted in ascending order from top to bottom.

The following trace shows triplets with Trace Separation on, and using Classic separation order.

The traces for FHR1 and FHR3 are shifted. The numerical FHR values displayed on the monitor

remain unchanged. Subtract 20 from the recorded trace for FHR1 to obtain the true FHR1. For

example, if the recorded trace shows 160 bpm, then the true FHR is 140 bpm. Similarly, add 20 to the

recorded trace for FHR3 to obtain the true FHR3.

The recorder prints a dotted line labeled +20 across the FHR scale, to identify the

trace for FHR1.

The recorder prints a dotted line labeled -20 across the FHR scale, to identify the

trace for FHR3.

The FHR trace is labeled every 5 cm.

The label for FHR1 is annotated with +20 and the FHR3 label is annotated with

-20.

14 Monitoring Triple FHRs

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Switching Trace Separation On and Off

1Connect three ultrasound transducers to the monitor to measure FHR.

2See “Switching Trace Separation On and Off” on page 186 for details of how to switch trace

separation on or off.

When Trace Separation is On

When trace separation is turned on, the recorder prints a dotted line labeled with the three FHRs at the

top, and ±20 at the bottom. Examples of the two methods (Standard, Classic) for determining the trace

separation order are provided here.

When Trace Separation is Off

To indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale.

1Standard trace separation switched

off here

14 Monitoring Triple FHRs

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Troubleshooting

Common problems that may occur when monitoring FHR using ultrasound are listed in “Monitoring

FHR and FMP Using Ultrasound” on page 165.

The following problem may occur when monitoring triplets.

For more information, see “Additional Information” on page 173.

2Classic trace separation switched

off here

Problem Possible Cause Solution

The question mark is

printed repeatedly, and

appears on the screen

and the INOP

Coincidence is issued.

More than one transducer is

recording the same FHR, or a fetal

transducer records the same heart

rate as the maternal HR.

Reposition one or more

ultrasound transducer, as

appropriate. See

“Recommended Actions

for Coincidence INOP” on

page 164

197

15Fetal Heart Rate Alarms

Fetal heart rate (FHR) alarms can give both audible and visual warning of a non-reassuring fetal

condition. Your monitor must be configured to alarm mode All to enable the FHR alarms (see

“Alarms” on page 117).

Changing Alarm Settings

When you do any of the following actions for any FHR measurement channel, this applies for all active

FHR measurements, ultrasound, DECG, and aFHR:

• Turning FHR alarms on or off

• Changing alarm limits

• Changing alarm delays

• Changing signal loss delay

The monitor retains these settings, even when switched off. The alarm limits are printed on the trace

every few pages if alarms are on.

Turning Alarms On or Off

1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the

CL F&M Pod.

2Enter the setup menu for a connected FHR measurement.

3Select Alarms to switch between On and Off.

Changing Alarm Limits

1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the

CL F&M Pod.

2Enter the setup menu for a connected FHR measurement.

3To change the high alarm limit, select High Limit and select the alarm limit from the pop-up list.

4To change the low alarm limit, select Low Limit and select the alarm limit from the pop-up list.

15 Fetal Heart Rate Alarms

198

Changing Alarm Delays

You can change the alarm delays if the Alarm Mode is set to All.

1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the

CL F&M Pod.

2Enter the setup menu for a connected FHR measurement.

3To change the high alarm limit delay time, select High Delay and select the delay time (in seconds)

from the pop-up list.

4To change the low alarm limit delay time in seconds, select Low Delay and select the delay time (in

seconds) from the pop-up list.

Changing Signal Loss Delay

The signal loss delay is the configurable delay before a Signal Loss INOP is issued. You can change the

delay:

1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the

CL F&M Pod.

2Enter the setup menu for a connected FHR measurement.

3Select SignalLoss Delay and select the signal loss INOP delay time (in seconds) from the pop-up

list.

199

16Monitoring FHR Using DECG

FM30/50 This chapter describes how to monitor a single fetal heart rate via direct ECG (DECG), using a spiral

fetal scalp electrode in the intrapartum period.

Read and adhere to the instructions that accompany the fetal scalp electrode, the DECG

adapter cable, and the attachment electrode. Pay attention to all the contraindications,

warnings, and for the DECG adapter cable, the cleaning and disinfection procedures.

Before starting to monitor, first define the fetal position, and ensure that it is suitable for DECG

monitoring.

Misidentification of Maternal HR as FHR

Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the

FHR during monitoring. Here are two examples where the maternal HR can be misidentified as the

FHR when using a fetal scalp electrode:

• Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor

through a recently deceased fetus via the spiral scalp electrode, appearing to be a fetal signal

source.

• The recorded maternal HR, and any artifact, can be misinterpreted as an FHR especially when it is

over 100 bpm.

To reduce the possibility of mistaking the maternal HR for FHR, monitor both maternal and fetal

heart rates (see “Monitoring Maternal Heart / Pulse Rate” on page 221). The monitor's cross-channel

verification (CCV) facility can help by automatically detecting when the same heart rate is being

recorded by different transducers. See “Confirm Fetal Life Before Using the Monitor” on page 10 and

“Cross-Channel Verification (CCV)” on page 159.

If the Coincidence INOP is issued at the fetal monitor if you are measuring FHR with DECG:

1Confirm that the scalp electrode is placed correctly.

2Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a

fetoscope, stethoscope, or Pinard stethoscope.

3If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation,

confirm fetal life using obstetric ultrasonography.

16 Monitoring FHR Using DECG

200

4In case of difficulties deriving a stable maternal pulse reading using the Toco MP or CL Toco+ MP

transducer, use SpO2 instead. In case of similar problems with the pulse measurement from SpO2,

use MECG instead. Reasons to switch the method for deriving a maternal pulse or heart rate

include: motion artifacts, arrhythmia, and individual differences in pulse signal quality on the

abdominal skin (via Toco+ MP).

What You Need

You can measure fetal DECG using the equipment combinations shown in the following figures.

WARNING

Never attempt to connect the fetal scalp electrode to anything other than the correct DECG adapter

cable.

DECG with Toco+

The figure below shows the complete connection chain from the fetal scalp electrode to the fetal

monitor using the Toco+ transducer.

1Fetal Scalp Electrode, single spiral (989803137631)

2Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)

3DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)

4Toco+ transducer (M2735A)

16 Monitoring FHR Using DECG

201

DECG with CL Toco+MP or CL ECG/IUP

The figure below shows the equivalent chain using the CL Toco+ MP or CL ECG/IUP transducer.

1Fetal Scalp Electrode, single spiral (989803137631)

2Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)

3DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)

4CL Toco+ MP (866075) or CL ECG/IUP transducer (866077)

5Avalon CL base station (866074)

DECG with Patient Module

The figure below shows the equivalent chain using the patient module.

1Fetal Scalp Electrode, single spiral, (989803137631)

2Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)

3DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)

4Patient Module (M2738A)

16 Monitoring FHR Using DECG

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Making Connections

WARNING

Follow the instructions supplied with each of the monitoring accessories you are using.

Prepare for DECG monitoring using the list below. The standard procedures in use in your facility

determine the sequence of actions.

1If you change the monitoring mode from US to DECG, first disconnect the US transducer.

2Depending on the equipment you are using, ensure that the Toco+ transducer, CL Toco+ MP, the

CL ECG/IUP transducer, or the patient module is connected to the fetal monitor.

3Attach the fetal scalp electrode to the fetus, following the instructions supplied with the fetal scalp

electrode.

4Attach a pre-gelled attachment electrode to the DECG adapter cable, following the instructions

supplied with the DECG adapter cable.

5Fix the attachment electrode to the mother's thigh, following the instructions supplied with the

attachment electrode.

Depending on the equipment you are using, connect the red connector plug on the DECG

adapter cable to the red connector on the Toco+ transducer, CL Toco+ MP, the CL ECG/IUP

transducer, or the patient module.

6Connect the fetal scalp electrode to the DECG adapter cable.

You are now ready to begin monitoring DECG.

WARNING

The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal

ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the

ECG waveform.

When in doubt, it can be used to identify sources of compromised signal quality, such as noise or

muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g.

checking ECG cable connections or adapting the fetal ArtifactSuppress configuration).

The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e. P, QRS, and T

segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated.

Monitoring DECG

To simultaneously measure DECG and MECG, you need the CL ECG/IUP transducer or the patient

module for DECG, and a Toco+, CL Toco+ MP, or CL ECG/IUP transducer for MECG (see

“Monitoring Maternal Heart / Pulse Rate” on page 221). Alternatively, you can monitor the maternal

pulse rate via pulse oximetry (see “Pulse Rate from SpO2” on page 228). You can also monitor

maternal pulse with the Toco MP or CL Toco+ MP transducer. In any case where you would use a

Toco+ or Toco MP transducer, you can also monitor with a CL Toco+ MP transducer.

1Switch on the recorder.

16 Monitoring FHR Using DECG

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2The heart rate monitored via DECG is labeled dFHR1 / dFHR2 / dFHR3 on the screen. If

configured, the DECG wave is displayed automatically on the screen, labeled DECG, and fetal. If

MECG is being monitored, both waves are displayed, with the DECG wave above the MECG

wave. The MECG wave is labeled MECG and maternal.

3Check the artifact suppression setting and change it if necessary (see “Suppressing Artifacts” on

page 204).

NOTE

The 1mV scale bar for the DECG and MECG wave is not displayed on the screen if you monitor

DECG or MECG with an Avalon CTS system. The Avalon CTS system does not provide a scaled

ECG.

1Measurement label (dFHR1)

2Measurement label (Toco)

3Measurement label (FHR2)

4Measurement label (HR)

51mV scale bar

6MECG wave with maternal label

7DECG wave with fetal label

8Measurement label (Temp) maternal temperature

9Measurement label NBP

16 Monitoring FHR Using DECG

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WARNING

Periodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to

ensure that you are monitoring fetal heart rate. If the maternal HR coincides with the FHR, do not

misinterpret the maternal HR as the FHR (see also “Confirm Fetal Life Before Using the Monitor” on

page 10 and “Cross-Channel Verification (CCV)” on page 159.

Suppressing Artifacts

When the monitor's artifact suppression is on, instantaneous heart rate changes of 28 bpm or more,

however caused, are not recorded. Fetal arrhythmia will also be suppressed. If you suspect fetal

arrhythmia, switch artifact suppression off. When artifact suppression is off, all recorded fetal

heartbeats within the specified range are shown. The default setting is On (artifacts are suppressed).

To change the setting:

1Enter the Setup dFHR1 menu.

2Select ArtifactSuppress to switch between artifact suppression On (artifacts are suppressed) and Off

(no artifact suppression, use this setting if you suspect fetal arrhythmia).

When artifact suppression is off, Artifact Suppression Off is annotated on the trace recording.

Printing the Waveform

You can print the DECG wave onto the trace paper. Refer to “Printing the ECG Waveform” on

page 231.

16 Monitoring FHR Using DECG

205

Troubleshooting

NOTE

In many cases you need to see the DECG wave to check if the signal quality is good enough to derive

a valid fetal heart rate. In the dFHR setup menu, switch on the display of the DECG wave.

Testing DECG Mode

See the monitor's Service Guide.

Problem Possible Cause Solutions

dFHR1 Equip Malf

dFHR2 Equip Malf

dFHR3 Equip Malf

Malfunctioning equipment See “Patient Alarms and INOPs” on

page 129.

dFHR1 Leads Off

dFHR2 Leads Off

dFHR3 Leads Off

Numeric is displayed with a -?-;

INOP tone

See also “Patient Alarms

and INOPs” on page 129

One or more MECG leads is not

attached.

Make sure that all required leads are attached

If the wave is configured to be displayed on the

monitor, you can observe if the ECG signal is

clear, or if it shows interruptions and noise

Bad electrical contact Check positioning of the electrode, ensuring that

none are displaced

Check electrodes and replace if necessary

Electrodes defective

prints repeatedly

The ultrasound transducer is

measuring maternal pulse

Reposition the ultrasound transducer. See

“Recommended Actions for Coincidence

INOP” on page 164

MECG Equip Malf displayed Equipment malfunctions See “Patient Alarms and INOPs” on page 129

MECG Unplugged Equipment not connected

20 Monitoring Maternal Heart / Pulse Rate

228

Pulse Rate from SpO2

If you are not monitoring maternal HR via MECG electrodes, but you are monitoring SpO2, the

maternal pulse rate is derived from the SpO2 measurement. The pulse numeric is labeled Pulse on the

screen.

WARNING

• No QRS tone is audible when the CL SpO2 Pod is the source of the pulse rate.

Adjusting the Heart Rate / Pulse Alarm Limits

To adjust the pulse alarm limits for SpO2:

1In the Setup SpO₂ menu, select Pulse (SpO₂). This opens the Setup Pulse (SpO₂) menu.

2Ensure Pulse (SpO₂) is On. Select Pulse (SpO₂) to switch between On and Off.

3Set the pulse alarm limit:

– Select High Limit then choose the upper alarm limit for tachycardia from the pop-up list.

– Select Low Limit then choose the lower alarm limit for bradycardia from the pop-up list.

To adjust the pulse alarm limits for MECG:

1In the Setup MECG menu, select MECG/Pulse Alarms. This opens the Setup Pulse (MECG) menu.

2Ensure Pulse MECG is On. Select Pulse MECG to switch between On and Off.

3Set the pulse alarm limit.

– Select High Limit then choose the upper alarm limit for tachycardia from the pop-up list.

– Select Low Limit then choose the lower alarm limit for bradycardia from the pop-up list.

Average Pulse Rate from Noninvasive Blood

Pressure

WARNING

No alarm is possible when noninvasive blood pressure is the source of the pulse rate.

When you are measuring noninvasive blood pressure, the monitor can also calculate the average pulse

rate. This occurs in either manual or automatic mode, when neither MECG, SpO2 nor pulse from

Toco MP or CL Toco+ MP transducer are measured. The value is displayed on the screen, and printed

on the trace. It is not the actual pulse value, but an average pulse rate, taken during the most recent

noninvasive blood pressure measurement. The value is updated after each successive measurement. If

you need a continuous measurement, you should monitor using MECG, SpO2, or pulse from

Toco MP or CL Toco+ MP transducer.

20 Monitoring Maternal Heart / Pulse Rate

229

Testing MECG Mode

See the monitor's Service Guide.

20 Monitoring Maternal Heart / Pulse Rate

230

231

21Printing the ECG Waveform

FM30/50 You can print the ECG wave onto the trace paper. If you are monitoring both DECG and MECG,

both waves will be printed. The start of the wave recording is annotated above the wave with MECG for

Maternal ECG, with DECG for Direct fetal ECG, and with 25 mm/sec below the wave. When only

MECG and/or DECG are measured without any real-time recording, the 25 mm/sec recorder speed is

printed in the trace header.

WARNING

1The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/

maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived

from the ECG waveform.

When in doubt, it can be used to identify sources of compromised signal quality, such as noise or

muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them

(e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration).

The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS, and T

segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated.

The ECG waveform is printed along the bottom of the heart rate grid, and the three different

possibilities look like this:

DECG waveform on its own

1DECG

2Recorder speed

21 Printing the ECG Waveform

232

MECG waveform on its own

1MECG

2Recorder speed

DECG and MECG waveforms

1DECG

2MECG

3Recorder speed

When the recorder is on, there are two choices for printing the ECG wave:

•Separate: This recording mode gives you a six-second ECG strip on the fetal trace paper in fast

printout mode. The real-time fetal trace recording is temporarily interrupted while the ECG strip

prints. A new MECG header is printed to mark where the MECG wave starts, and a new trace

header and FHR header mark when the fetal trace resumes.

21 Printing the ECG Waveform

233

The following trace shows the MECG waveform:

1FHR1 trace interrupted

2MECG header

3Recorder speed

4FHR1 trace resume

•Overlap: This recording mode gives you a delayed six-second snapshot of the maternal and/or

direct fetal ECG for documentation on the fetal strip, but without interrupting the fetal trace. It

takes 5 minutes to print this six-second snapshot at a recorder speed of 3 cm/min. It is

documented as if it was recorded at 25 mm/s.

21 Printing the ECG Waveform

234

The following trace shows both the DECG and MECG waveforms:

1FHR1 and FHR2

2DECG header

3MECG header

4Recorder speed

To make your choice:

1Enter the Main Setup menu.

2Select Fetal Recorder to enter the Fetal Recorder menu.

3Select ECG Wave to switch between Separate and Overlap.

To print the ECG wave(s):

1Select the Record ECG Wave SmartKey (configurable) and the recording trace is started.

1Enter the Main Setup menu by selecting the SmartKey.

2Select Fetal Recorder to enter the Fetal Recorder menu.

3Select Record ECG Wave and the recording trace is started.

1Select the ECG Wave.

2Select Record ECG Wave in the ECG wave menu and the recording trace is started.

235

22Monitoring Noninvasive Blood

Pressure

The noninvasive blood pressure measurement (NBP) is intended for use with maternal patients.

This monitor uses the oscillometric method for measuring NBP.

A physician must determine the clinical significance of the NBP information.

Introducing the Oscillometric Noninvasive Blood

Pressure Measurement

Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff

deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through

the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude,

reach a maximum (which approximates to the mean pressure), and then diminish.

Studies show that, especially in critical cases (arrhythmia, vasoconstriction, hypertension, shock),

oscillometric devices are more accurate and consistent than devices using other noninvasive measuring

techniques.

WARNING

Intravenous infusion: Do not use the NBP cuff on a limb with an intravenous infusion or arterial

catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or

blocked during cuff inflation.

Skin Damage: Do not measure NBP in cases of sickle-cell disease or any condition where skin

damage has occurred or is expected.

Existing Wounds: Do not apply the cuff over a wound as this can cause further injury.

Mastectomy: Avoid applying the cuff on the side of the mastectomy, as the pressure increases the risk

of lymphedema. For patients with a bilateral mastectomy, use clinical judgement to decide whether the

the benefit of the measurement outweighs the risk.

22 Monitoring Noninvasive Blood Pressure

236

Unattended Measurement: Use clinical judgement to decide whether to perform frequent

unattended blood pressure measurements. Too frequent measurements can cause blood flow

interference potentially resulting in injury to the patient. In cases of severe blood clotting disorders

frequent measurements increase the risk of hematoma in the limb fitted with the cuff.

Temporary Loss of Function: The pressurization of the cuff can temporarily cause loss of function

of monitoring equipment used simultaneously on the same limb.

Measurement Limitations

NBP readings can be affected by the position of the subject, their physiological condition, the

measurement site, and physical exercise. Thus a physician must determine the clinical significance of

the NBP information.

The measurement may be inaccurate or impossible:

• with excessive and continuous patient movement such as during contractions

• if a regular arterial pressure pulse is hard to detect

• with cardiac arrhythmias

• with rapid blood pressure changes

• with severe shock or hypothermia that reduces blood flow to the peripheries

• with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from

the artery

• on an edematous extremity

Measurement Methods

There are three measurement methods:

•Manual - measurement on demand. Results are displayed for up to one hour.

•Auto - continually repeated measurements (between one and 120 minute adjustable interval). You

can make a manual measurement between two measurements in Auto Mode.

•Sequence- up to four measurement cycles which run consecutively, with a number of

measurements and intervals between them configurable for each cycle.

Reference Method

The measurement reference method can be Auscultatory (manual cuff) or Invasive (intra-arterial). For

further information, see the Application Note supplied on the monitor documentation DVD.

To check the current setting, select Main Setup, Measurements, NBP, and check whether the Reference

setting is set to Auscultatory or Invasive. This setting can be changed in Configuration Mode.

22 Monitoring Noninvasive Blood Pressure

237

Preparing to Measure Noninvasive Blood Pressure

If possible, avoid taking measurements during contractions, because the measurement may be

unreliable, and may cause additional stress for the patient.

1Connect the cuff to the air tubing.

2Plug the air tubing into the red NBP connector. Avoid compression or restriction of pressure

tubes. Air must pass unrestricted through the tubing.

WARNING

Kinked or otherwise restricted tubing can lead to a continuous cuff pressure, causing blood flow

interference, and potentially resulting in injury to the patient.

3Make sure that you are using a Philips-approved correct sized cuff, and that the bladder inside the

cover is not folded or twisted.

A wrong cuff size, and a folded or twisted bladder, can cause inaccurate measurements. The width

of the cuff should be in the range from 37% to 47% of the limb circumference. The inflatable part

of the cuff should be long enough to encircle at least 80% of the limb.

4Apply the cuff to a limb at the same level as the heart. If it is not, you must use the measurement

correction formula to correct the measurement.

The marking on the cuff must match the artery location. Do not wrap the cuff too tightly around

the limb. It may cause discoloration, and ischemia of the extremities.

WARNING

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 making automatic measurements.

Correcting the Measurement if Limb is not at Heart Level

To correct the measurement if the limb is not at heart level, to the displayed value:

Recommendations For Measurements Used in Diagnosis of

Hypertension

To make a measurement for use in the diagnosis of hypertension, follow the steps below:

1Ensure the patient is comfortably seated, with their legs uncrossed, feet flat on the floor, and back

and arm supported.

2Ask the patient to relax and not talk before and during the measurement.

3If possible, wait 5 minutes before making the first measurement.

Add 0.75 mmHg (0.10 kPa) for each centimeter

higher or

Deduct 0.75 mmHg (0.10 kPa) for each

centimeter lower or

Add 1.9 mmHg (0.25 kPa) for each inch higher. Deduct 1.9 mmHg (0.25 kPa) for each inch

lower.

22 Monitoring Noninvasive Blood Pressure

238

Understanding the Numerics

Depending on the numeric size, not all elements may be visible. Your monitor may be configured to

display only the systolic and diastolic values. If configured to do so, the pulse from NBP is displayed

with the NBP numeric.

Aging Numerics

The measured NBP value, together with the corresponding pulse rate, if this is switched on, are

displayed for one hour. After that the values are regarded as invalid and are no longer displayed.

During this time, measurement values may be grayed out, or disappear from the screen after a set time,

if configured to do so. This avoids older numerics being misinterpreted as current data. The time can

be set in Configuration Mode. In Auto Mode, the measurement values may disappear more quickly (to

be replaced by new measurement values), if the repeat time is set to less than one hour.

Alarm Sources

If you have parallel alarm sources, the sources are displayed instead of the alarm limits.

NBP Measurement Timestamp

Depending on your configuration, the time shown beside the NBP numeric can be:

– the time of the most recent NBP measurement, also known as the "timestamp", or

– the time until the next measurement in an automatic series, displayed with a graphic

representation of the remaining time, as shown here.

• The NBP timestamp will normally show the completion time of the NBP measurement.

NBP Measurement Start Time

In Auto or Sequence mode, the monitor is configured to synchronize the measurements in a

measurement series to an "easy-to-document" time. For example, if you start the first measurement at

08:23, and the Repeat Time is set to 10 min, the monitor automatically performs the next measurement

at 8:30, then 8:40, and so on, unless it has been configured to NotSynchron..

During Measurements

The cuff pressure is displayed instead of the units and the repeat time. An early systolic value gives you

a preliminary indication of the systolic blood pressure during measurement.

1Alarm source

2Measurement Mode

3Timestamp/Timer

4Mean pressure

5Diastolic

6Systolic

7Alarm limits

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239

Starting and Stopping Measurements

Use the setup menu or the SmartKeys to start and stop measurements.

Enabling Automatic Mode and Setting Repetition

Time

1In the Setup NBP menu, select Mode.

2Switch between Auto and Manual, if necessary, to pick the measurement method.

3If making an automatic measurement, select Repeat Time, or press the Repeat Time SmartKey and

set the time interval between two measurements.

NOTE

Be aware that a combination of a recorder speed of less than 3 cm/min and a repetition time of less

than five minutes can result in not all noninvasive blood pressure measurements being recorded on the

fetal trace. For example, if the recorder speed is set to 1 cm/min and the repetition time is set to

two minutes, due to the low speed setting, the recorder will only be able to record every other

noninvasive blood pressure measurement. This affects only the local fetal trace recording, and all

measurements are displayed as normal on the monitor's screen.

Action to be performed Setup menu SmartKeys

Start/Stop manual measurement

Start Auto series

Stop current automatic measurement

Start/Stop

Start/ Stop

Start manual measurement

Start Auto series

Start NBP

Stop manual measurement

Stop current automatic measurement

Stop NBP

Stop automatic, or manual measurement AND series Stop All NBP

Stop All

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240

Enabling Sequence Mode and Setting Up the

Sequence

1In the Setup NBP menu, select Mode and select Sequence from the pop-up menu.

2Select Setup Sequence to open the Setup Sequence window.

Up to four measurement cycles can be set up which run consecutively. For each cycle, you can set

the number of measurements and the intervals between them. If you want to run fewer than four

cycles in a sequence, you can set the number of measurements for one or more cycles to Off.

3Select each sequence in turn, and select the number of measurements and the time interval

between the measurements.

4To have measurements continue after the sequence, set the number of measurements for your last

cycle to Continuous and this cycle will run indefinitely.

CAUTION

Be aware that, if none of the cycles are set to Continuous, NBP monitoring will end after the last

measurement of the cycle.

When the NBP measurement mode is set to Sequence, the repetition time for Auto Mode cannot be

changed.

Choosing the Alarm Source

You can monitor for alarm conditions in systolic, diastolic, and mean pressure, either singly or in

parallel. Only one alarm is given, with the priority of mean, systolic, diastolic.

If mean is not selected as alarm source (Sys., Dia., or Sys & Dia selected), but the fetal monitor can only

derive a mean value, mean alarms will nevertheless be announced using the most recent mean alarm

limits. Check that the mean alarm limits are appropriate for the patient, even when not using mean as

the alarm source. When no value can be derived, an NBP Measure Failed INOP is displayed.

Menu option Pressure value monitored

Sys. systolic

Dia. diastolic

Mean mean

Sys & Dia systolic and diastolic in parallel

Dia & Mean diastolic and mean in parallel

Sys & Mean systolic and mean in parallel

Sys&Dia&Mean all three pressures in parallel

22 Monitoring Noninvasive Blood Pressure

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Assisting Venous Puncture

You can use the cuff to cause subdiastolic pressure. The cuff deflates automatically after a set time if

you do not deflate it.

1In the Setup NBP menu, select VeniPuncture.

2Puncture vein and draw blood sample.

3Reselect VeniPuncture to deflate the cuff.

During measurement, the display shows the inflation pressure of the cuff and the remaining time in

venous puncture mode.

Calibrating NBP

NBP is not user-calibrated. NBP pressure transducers must be verified at least once every two years by

a qualified service professional, and calibrated, if necessary. See the Service Guide for details.

1Cuff pressure

2Venous puncture measurement mode

3Time left in venous puncture mode

22 Monitoring Noninvasive Blood Pressure

242

Troubleshooting

Problem Possible Causes Solutions

Cuff will not inflate Monitor is in Service or Configuration

Mode

Technical defect Call service

Cuff tubing not connected Connect cuff tubing

High or low values

measured (against clinical

expectations)

Contraction occurring Wait until contraction has finished

Patient talking before or during

measurement

Allow patient to rest quietly, then try again

after three to five minutes

Incorrect cuff size or cuff not at heart

level

Check cuff size, level, and position

Noninvasive blood pressure reference

method set incorrectly

Check the reference method configured

(auscultation or intra-arterial) and correct if

necessary in Configuration Mode

Measurement limitations have not been

taken into account

Check the list in “Measurement Limitations”

on page 236

Displays zeros for systolic

and diastolic values.

Measurement automatically

repeats

Severe vasoconstriction at cuff site Move cuff to another limb, check for shock,

or verify blood pressure using another

method

Erratic blood pressure fluctuations due

to arrhythmias or rapid-acting drugs or

contractions

Try again, if unsuccessful, verify blood

pressure using another method

Wait until contraction has finished

Excessive patient movement or

convulsions

Restrain movement or verify blood pressure

using another method

NBP Cuff Overpress INOP is

displayed

See “Patient Alarms and INOPs” on page 129.

NBP Equip Malf INOP is

displayed

NBP Interrupted INOP is

displayed

NBP Measure Failed

243

23Monitoring SpO2

FM30/40/50 The pulse oximetry measurement (SpO2) is intended for use with maternal patients.

Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier Artifact

Suppression Technology (FAST). It provides two measurements:

• Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to

the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation).

• Pulse rate - detected arterial pulsations per minute. This is derived from the SpO2 value, and is one

of four sources of the maternal heart/pulse rate used for cross-channel verification (see

“Monitoring Maternal Heart / Pulse Rate” on page 221 and “Cross-Channel Verification (CCV)”

on page 159).

Selecting an SpO2 Sensor

See “Accessories and Supplies” on page 275 for a list of sensors, and the patient population and

application sites for which they are appropriate.

Familiarize yourself with the Instructions for Use supplied with your sensor before using it.

CAUTION

Do not use OxiCliq disposable sensors in a high humidity environment, or in the presence of fluids,

which may contaminate sensor and electrical connections causing unreliable or intermittent

measurements. Do not use disposable sensors when there is a known allergic reaction to the adhesive.

Applying the Sensor

1Follow the SpO2 sensor's Instructions for Use, adhering to all warnings and cautions.

2Remove colored nail polish from the application site.

3Apply the sensor to the patient. The application site should match the sensor size so that the

sensor can neither fall off, nor apply excessive pressure.

4Check that the light emitter and the photodetector are directly opposite each other. All light from

the emitter must pass through the patient's tissue.

23 Monitoring SpO2

244

WARNING

Compatibility: Use only the accessories that are specified for use with this fetal monitor, otherwise

patient injury can result.

Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it

is too tight, for example because the application site is too large or becomes too large due to edema,

excessive pressure may be applied. This can result in venous congestion distal from the application site,

leading to interstitial edema, hypoxemia, and tissue malnutrition. Skin irritations or lacerations may

occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and

lacerations, periodically inspect the sensor application site and change the application site regularly.

Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may

severely obstruct circulation and lead to inaccurate measurements.

Ambient Temperature: At elevated ambient temperatures, be careful with measurement sites that are

not well perfused, because this can cause severe burns after prolonged application. All listed sensors

operate without risk of exceeding 41°C on the skin if the initial skin temperature does not exceed

35°C.

Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff,

or an intravascular venous infusion line.

Connecting SpO2 Cables

Connect the sensor cable to the color-coded socket on the monitor. If you are using a disposable

sensor, plug the sensor into the adapter cable and connect this to the monitor. Connect reusable

sensors directly to the monitor.

CAUTION

Extension cables: Do not use more than one extension cable (M1941A). Do not use an extension

cable with Philips reusable sensors or adapter cables with part numbers ending in -L (indicates "long"

cable version).

Electrical Interference: Position the sensor cable and connector away from power cables, to avoid

electrical interference.

Measuring SpO2

During measurement, ensure that the application site:

– has a pulsatile flow, ideally with a signal quality indicator of at least medium.

– has not changed in its thickness (for example, due to edema), causing an improper fit of the

sensor.

23 Monitoring SpO2

245

WARNING

• For fully conscious maternal patients, who have a normal function of perfusion and sensory

perception at the measurement site:

To ensure skin quality and correct optical alignment of the sensor, inspect the application site

when the measurement results are suspicious, or when the patient complains about pressure at

the application site, but at least every 24 hours. Correct the sensor alignment if necessary.

Move the sensor to another site, if the skin quality changes.

• For all other patients:

Inspect the application site every two to three hours to ensure skin quality and correct optical

alignment. Correct the sensor alignment if necessary. If the skin quality changes, move the

sensor to another site. Change the application site at least every four hours.

• Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin

and carboxyhemoglobin may lead to inaccurate measurements.

• Inaccurate measurements may result when the application site for the sensor is deeply pigmented

or deeply colored, for example, with nail polish, artificial nails, dye, or pigmented cream.

• Interference can be caused by:

– High levels of ambient light (including IR warmers), or strobe lights or flashing lights (such as

fire alarm lamps). (Hint: cover application site with opaque material).

– Another SpO2 sensor in close proximity (e.g. when more than one SpO2 measurement is

performed on the same patient). Always cover both sensors with opaque material to reduce

cross-interference.

– Electromagnetic interference, especially when the signal quality indicator is below medium.

– Excessive patient movement and vibration.

SpO2 Signal Quality Indicator (FAST SpO2 only)

The SpO2 numeric is displayed together with a signal quality indicator (if configured and enough space

is available) which gives an indication of the reliability of the displayed values.

The level to which the triangle is filled shows the quality of the signal; the indicator below shows a

medium signal quality. The signal quality is at a maximum when the triangle is completely filled.

23 Monitoring SpO2

246

Assessing a Suspicious SpO2 Reading

Traditionally, pulse rate from SpO2 was compared with heart rate from ECG to confirm the validity of

the SpO2 reading. With newer algorithms, such as FAST-SpO2, this is no longer a valid criteria because

the correct calculation of SpO2 is not directly linked to the correct detection of each pulse.

When the pulse rate is very low, or strong arrhythmia is present, the SpO2 pulse rate may differ from

the heart rate calculated from ECG, but this does not indicate an inaccurate SpO2 value.

WARNING

With pulse oximetry, sensor movement, ambient light (especially strobe lights, or flashing lights), or

electromagnetic interference can give unexpected intermittent readings when the sensor is not

attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might

occur when the sensor is dangling.

Understanding SpO2 Alarms

This refers to SpO2 specific alarms. See the “Alarms” on page 117 chapter for general alarm

information. SpO2 offers high and low limit alarms, and a high priority desat alarm. You cannot set the

low alarm limit below the desat alarm limit.

CAUTION

If you measure SpO2 on a limb that has an inflated noninvasive blood pressure cuff, a non-pulsatile

SpO2 INOP can occur. If the fetal monitor is configured to suppress this alarm, there may be a delay

of up to 60 seconds in indicating a critical status, such as sudden pulse loss or hypoxia.

Alarm Delays

There is a delay between a physiological event at the measurement site and the corresponding alarm at

the monitor. This delay has two components:

• The general system delay time is the time between the occurrence of the physiological event and

when this event is represented by the displayed numerical values. This delay depends on the

algorithmic processing and the averaging time.

• The time between the displayed numerical values crossing an alarm limit and the alarm indication

on the monitor. This delay is the combination of the configured alarm delay time plus the general

system alarm signal delay time.

Adjusting the SpO2 Alarm Limits

In the Setup SpO₂ menu:

•Select

High Limit then choose the upper alarm limit.

•Select

Low Limit then choose the lower alarm limit.

23 Monitoring SpO2

247

Adjusting the Desat Limit Alarm

The Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in

oxygen saturation.

1In the Setup SpO₂ menu, select Desat Limit.

2Adjust the limit.

Adjusting the Pulse Alarm Limits

See “Adjusting the Heart Rate / Pulse Alarm Limits” on page 228.

Setting Up Tone Modulation

If tone modulation is on, the QRS tone pitch lowers when the SpO2 level drops. Remember, the QRS

tone is derived from either heart rate (from MECG or the CL F&M Pod) or pulse (from built-in SpO2)

depending on which is currently displayed (see “Priority for Maternal Heart / Pulse Rate” on

page 221).

NOTE

Pulse from CL SpO2 and Toco MP does not provide a QRS tone.

Setting the QRS Volume

In the Setup SpO₂ menu, select QRS Volume and set the appropriate QRS tone volume.

23 Monitoring SpO2

248

249

24Monitoring Maternal

Temperature

Measuring Tympanic Temperature

The tympanic thermometer (866149) measures the patient's temperature in the ear using infrared

technology.

The result of this measurement can be automatically adjusted to correspond to a different body

reference site. The result is displayed on the screen of the thermometer and transmitted to the

monitor.

The thermometer is used with single-use probe covers for infection control during measurement.

WARNING

Do not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air,

oxygen, or nitrous oxide.

24 Monitoring Maternal Temperature

250

Place the thermometer into its base station, when it is not in use. The base station allows flexible

mounting of the thermometer at the point of care. The base station is connected to the monitor's

MIB/RS232 interface (optional) with a cable. It has storage space for up to 32 probe covers.

Thermometer Display and Controls

The tympanic thermometer has a liquid crystal display. The display shows the patient's temperature in

numerics and guides you with symbols through the measurement process.

1Base station

2Thermometer

1Eject key

2Change unit key: °Celsius/°Fahrenheit

3Start measurement key

4Pulse timer key

Functional Keys Description of Use

Press the eject key to eject the probe cover. The eject key symbol is shown

on the display when a measurement has been taken and transmitted.

Press the change unit key after a measurement to switch between °C and °F

(only affects the handheld device and not the monitor numerics).

24 Monitoring Maternal Temperature

251

Status Screens

The thermometer performs an internal test at every start-up to verify that the system components are

functioning properly. It measures the ambient temperature. During start-up and measurement, the

thermometer screens communicate the current status.

Press the start measurement key when you are ready to take a patient's

temperature.

The pulse timer key can be used to time vital signs you take manually.

The pulse timer only functions after you have taken a temperature

measurement.

Press and hold the pulse timer key to enter timer mode. Press the pulse

timer key again to start the timer.

The thermometer will issue a one beep at 15 seconds, two beeps at

30 seconds, three beeps at 45 seconds, and four beeps at 60 seconds.

Functional Keys Description of Use

Images Description

Ambient temperature above specified range

Ambient temperature below specified range

System errors

System error 12 - there is a problem with the settings. Contact your

service personnel to have them check the settings and reset them, if

necessary.

If the display shows any other system error, then reset the thermometer by

picking up a probe cover. If the system error does not clear, contact your

service personnel.

24 Monitoring Maternal Temperature

252

Making a Temperature Measurement

WARNING

Inaccurate measurement results can be caused by:

• incorrect application of the thermometer

• anatomical variations in the ear

• build up of earwax in the ear

• excessive patient movement during the measurement

• absent, defective, or soiled probe covers

• probe covers other than the specified probe covers

• external environment temperature outside the range of 16ºC-33ºC (60.8ºF-91.4ºF)

1Ensure that the base station is connected with the appropriate cable to the connector on the

monitor.

2Remove the thermometer from the base station.

The thermometer is latched to the base station to avoid an accidental fall when the base station is

moved. To pick up the thermometer from the base station move it slightly up, and then lift it from

the base station to release the latch.

3Press the eject key on the thermometer to discard any probe that may have been left on the

thermometer from a previous use.

4Pick up a new probe cover from the container on the base station.

5Inspect the probe cover to make sure that it is fully seated (no space between cover and tip base)

and that there are no holes, tears, or wrinkles in the plastic film.

6Place the thermometer with the probe in the ear canal, sealing the opening with the probe tip. For

consistent results, ensure that the probe shaft is aligned with the ear canal.

7Press and release the start-up key gently.

8Wait until you hear the three beeps.

9Remove the probe from the ear.

The temperature values are displayed both on the thermometer itself, and on the connected

monitor.

10 Check that the correct temperature label for the measurement site is displayed: iTrect, iToral,

iTcore, or iTtymp.

11 Press the eject key to eject the probe cover into a suitable waste receptacle.

12 Return the thermometer to the base station.

The thermometer switches to stand-by mode after 30 seconds when it is not used.

24 Monitoring Maternal Temperature

253

Possible INOPs

WARNING

• Never apply the probe to the patient when the thermometer is not connected to the base station.

• Always use a single-use probe cover to limit patient cross-contamination.

• Measurement errors or inaccurate readings may result when probe covers other than the specified

probe covers are used (see “Tympanic Temperature Accessories” on page 285).

• Insert the probe slowly and carefully to avoid damage to the ear canal and the tympanic

membrane.

• Inspect the probe cover for damage, holes, tears, or sharp edges to avoid injuring the skin.

• Always ensure that the used probe cover is removed before attaching a new probe cover.

CAUTION

• Do not immerse the probe in fluids, or drop fluids on the probe.

• Do not use a probe cover that has been dropped or is damaged.

• Do not autoclave. To prevent damage to the base station, thermometer and accessories, refer to

the cleaning procedures in the “Care and Cleaning” on page 261 chapter.

WARNING

If you have dropped the base station or thermometer, or if the unit has been stored below -25°C or

above 55°C, have service personnel test the unit for proper functions, and calibrate the unit before

further use.

The Value Lifetime (length of time the entered value is shown on the screen) can be configured in

Configuration Mode.

Images Description

Patient temperature above measurement range.

Patient temperature below measurement range.

24 Monitoring Maternal Temperature

254

Body Reference Sites and Monitor Labels

The tympanic thermometer measures the patient's temperature in the ear. The thermometer can be

configured to adjust the result of the measurement to correspond to a different body reference site.

The measurement label displayed on the monitor corresponds to the body reference site that is

configured. The following body reference sites are available:

The body reference site can be selected in the Biomed mode of the tympanic thermometer. Refer to

the Service Guide for more information.

The measured maternal temperature is only transmitted to a connected OB TraceVue/IntelliSpace

Perinatal system, when the tympanic thermometer is configured to the iTtymp body reference site, and

the iTtymp label is displayed on the fetal monitor screen, and printed on the trace.

Entering Temperature Manually

A temperature measurement can be entered manually.

1Press the SmartKey Enter Temp (configurable)

or select the SmartKey Main Setup, then select Measurements, Enter Temp. A numeric pad opens.

2Enter the temperature values.

3Select the Enter key.

Interval

Use the Interval setting to define the time after which a manually entered temperature value becomes

invalid (no value is then displayed).

NOTE

A manually entered temperature has to be 25ºC or higher to be transmitted to a connected obstetrical

information and surveillance system.

Body Reference Site Label on Monitor

Ear temperature (no adjustment) iTtymp

Oral temperature iToral

Core temperature iTcore

Rectal temperature iTrect

255

25Paper Save Mode for Maternal

Measurements

Your monitor's recorder features a Paper Save Mode, where maternal vital signs are recorded using less

paper than during a normal trace recording.

When Paper Save Mode is enabled, and if the recorder is stopped, it will start automatically to print

data from maternal measurements as they occur, and then stops again to save paper. You enable Paper

Save Mode in Configuration Mode (default is off).

• A header is printed first before the measurements are recorded. A new header is also printed when

there is a date change at midnight.

• Each NBP measurement is recorded. The time when the measurement ended is recorded.

• Each Temperature measurement is recorded. The time when the measurement ended is recorded.

• Other maternal parameters (SpO2, maternal heart rate, or Pulse) are recorded every five minutes.

The rules described in the section “Priority for Maternal Heart / Pulse Rate” on page 221 apply.

• Paper Save Mode recording stops if there are no valid maternal measurements for more than one

hour, and a message will notify you that there are no active parameters. Paper Save Mode recording

will restart automatically when another valid measurement is made.

Event Paper Save Mode

Reactivation

One of the maternal measurements (see above) is valid again. yes

The recorder is turned off and on again or a report has been recorded

(e.g. NST Report).

yes

The Paper Advance function is used. yes

The Paper Save Mode setting is set off and on again. yes

ADT information has changed (e.g. because patient information has

been completed or updated).

The monitor is restarted (e.g. by switching it off and on again). yes

The date has changed (e.g. at midnight). no

25 Paper Save Mode for Maternal Measurements

256

257

26Recovering Data

The monitor stores trace data, including annotations, for a minimum of 3.5 hours with the software

revision J.3 or higher, and for a minimum of 7 hours with the new mainboard hardware revision

A 00.18, in its internal backup memory. This allows the monitor to recover trace data that would

otherwise be lost under certain circumstances. In the event of the paper running out, this trace

recovery data can be automatically retrieved and printed, or automatically transmitted to an

OB TraceVue/IntelliSpace Perinatal system (LAN connection only), allowing continuity of data.

The fetal trace printed from the trace recovery data contains all data from the real-time trace.

Note that the data in the memory is cleared when a software upgrade is performed.

CAUTION

Only use Philips paper. Using paper other than Philips paper may result in the failure to recover traces.

Recovering Traces on Paper

The monitor is able to recover traces by printing them out at a high speed from the monitor's backup

memory. If the monitor runs out of paper, or if the paper drawer is open, the exact time when this

happens is stored in the backup memory. If the Bridge Paperout setting is set to On (default), when new

paper is loaded and the recorder is started, a trace recovery printout of the data recovered from the

backup memory is automatically printed out at high speed (up to 20 mm/s), starting from the time

noted in the backup memory. This ensures that no data is lost. A minimum of one hour of trace

recovery data is available for printing out from the backup memory. When the trace recovery printout

has finished, the recorder automatically switches back to continue recording the current trace at the

normal speed.

Note the following:

• If you press the fetal recorder Start/ Stop SmartKey during a trace recovery printout, the recording

stops, and the next recording following a recorder restart will be a normal, real-time trace.

After switching off the monitor, and then back on again, or following a power failure, the time of

the last Check Paper INOP or paper-out detection is lost, and therefore any trace recovery data in

the backup memory is no longer available to print. The next recording made following a restart of

the recorder is a normal, real-time trace.

26 Recovering Data

258

• The change back to a real-time recording from a trace recovery printout prompts the recording to

restart. A new vertical trace header annotation consisting of the time, date, and recorder speed is

printed, letting you see where the trace recovery printout ends, and where the real-time trace

continues.

• There can be a gap of up to 30 seconds between the trace recovery printout, and the beginning of

the real-time trace.

Recovering Traces on an OB TraceVue/IntelliSpace

Perinatal System

The trace recovery data stored in the monitor's backup memory can also be uploaded at high speed to

an OB TraceVue/IntelliSpace Perinatal system connected over the LAN interface (OB TraceVue

Revision E.00.00 or later, and IntelliSpace Perinatal H.0 or later).

When the OB TraceVue/IntelliSpace Perinatal system reconnects to the fetal monitor and detects that

there is trace recovery data in the monitor's backup memory that has not yet been transmitted to the

system, this data is transferred at high speed to the system. No user action is required.

The exact length of the recovered trace will vary depending on the amount of trace information, but it

will cover at least 3.5 hours of trace data with the software revision J.3 or higher, and 7 hours with

the new mainboard hardware revision A 00.18, depending on the number of active parameters.

To recover traces on an OB TraceVue/IntelliSpace Perinatal system, the following applies:

• The trace data in the monitor's internal memory must relate to a specific patient in the

OB TraceVue/IntelliSpace Perinatal system. In other words, there were no discharge events made

on the monitor that would change the patient context.

• The patient must have an open episode. No data will be uploaded if the patient is not admitted to

OB TraceVue/IntelliSpace Perinatal. For further details see the OB TraceVue/IntelliSpace

Perinatal Instructions for Use.

• Current online trace data is held back until the fast upload is complete.

Manually Recording Stored Data

If the recorder is not running, you can choose to print trace data from the monitor's memory at any

time. You can see a list of all stored traces, showing patient identification and trace period, in the

Stored Data Recording window, from which you can choose one of the entries at a time.

CAUTION

Ensure that you admit each patient by name, including other patient identification information, and

discharge the patient when you have finished monitoring, so that you can identify which trace period

(entry in the patient list) refers to which patient.

Trace storage can be triggered by:

• Discharging a patient

• Powering on the monitor

•Entering Standby

• Entering Service Mode

26 Recovering Data

259

Traces are not available for periods the monitor was switched off, in Service Mode, in Standby, or if

the trace period was shorter than one minute.

The speed of the printout depends on the configured recorder speed and on the amount of trace data

available. The fetal trace printed from the trace data contains all data from the real-time trace, with the

exception of the maternal heart rate, the pulse numeric, and the ECG wave.

Information for scale type, trace separation, and recorder speed are not stored in the trace memory,

but is applied when the stored recording starts. While the stored recording is printing, all functions are

disabled, except that for stopping the recorder.

To start a stored data recording:

Either

1Select the Stored Data Rec SmartKey.

2Select All to print all stored trace data for the selected entry, or select one of the choices on the

other pop-up keys to print only a specified portion of the entry (for example, Last 15 min for the

last 15 minutes of trace data).

1Enter the Main Setup menu using the SmartKey.

2Select Fetal Recorder to open the Fetal Recorder menu.

3Select Stored Data Rec to open the Stored Data Recording window.

4Select an entry for a patient.

5Select All to print all stored trace data for the selected entry, or select one of the choices on the

other pop-up keys to print only a specified portion of the entry (for example, Last 15 min for the

last 15 minutes of trace data).

To delete all stored trace periods:

Either

1Select the Stored Data Rec SmartKey.

2Select the Erase All key to delete all stored trace periods listed.

3Select the Confirm key.

1Enter the Main Setup menu using the SmartKey.

2Select Fetal Recorder to open the Fetal Recorder menu.

3Select Stored Data Rec to open the Stored Data Recording window.

4Select the Erase All key to delete all stored trace periods listed.

5Select the Confirm key.

26 Recovering Data

260

The current patient’s entry is at the top of the list. The oldest entry at the bottom of the list has no start

time specified, as part of the data originally stored may have been over-written by the current patient’s

data.

It may be that you only see one entry (the current patient’s data) in the Stored Data Recording window if

that patient was monitored for a period long enough to erase any earlier entries.

If you make a stored data recording for an old entry (that is, not for the current patient), the recorder

performs a fast trace printout of the stored data, advances the paper to the next paper fold, then stops.

If you make a stored data recording for the current patient, the recorder performs a fast trace printout

of the stored data, and then reverts automatically to recording the real-time trace.

261

27Care and Cleaning

Use only the Philips-approved substances and methods listed in this chapter to clean or disinfect your

equipment. Warranty does not cover damage caused by using unapproved substances or methods.

Philips makes no claims regarding the efficacy of the listed chemicals, or methods as a means for

controlling infection. Consult your hospital’s Infection Control Officer or Epidemiologist. For

comprehensive details on cleaning agents and their efficacy refer to “Guideline for Disinfection and

Sterilization in Healthcare Facilities” issued by the U.S. Department of Health and Human Services,

Public Health Service, Centers for Disease Control, Atlanta, Georgia, 2008. See also any local policies

that apply within your hospital, and country.

General Points

The transducers and patient modules are sensitive instruments. Handle them with care.

Keep your monitor, transducers, patient modules, cables, and accessories free of dust and dirt. After

cleaning and disinfection, check the equipment carefully. Do not use if you see signs of deterioration

or damage. If you need to return any equipment to Philips, always decontaminate it first before

sending it back in appropriate packaging.

Observe the following general precautions:

• Always follow carefully and retain the instructions that accompany the specific cleaning and

disinfecting substances you are using.

• Always dilute cleaning agents according to the manufacturer's instructions or use lowest possible

concentration.

• Do not allow liquid to enter the case.

• Do not immerse the monitor in liquid. Protect it against water sprays or splashes.

• Do not pour liquid onto the system.

• Never use abrasive material (such as steel wool or silver polish).

• Never use bleach.

27 Care and Cleaning

262

WARNING

• Do not operate the monitor if it is wet. If you spill liquid on the monitor, contact your service

personnel or Philips service engineer.

• Do not perform underwater monitoring (for example, in a bath or shower) using wired

transducers.

• Place the monitor where there is no chance of contact with, or falling into water or other liquid.

• Do not dry equipment using heating devices such as heaters, ovens (including microwave ovens),

hair dryers, and heating lamps.

• Do not put equipment or accessories in autoclave (for sterilization).

Cleaning and Disinfecting

Clean and disinfect the Avalon FM20, FM30, FM40, and FM50 fetal monitors and the transducers

M2734A, M2734B, M2735A, M2736A, and M2738A (including ECG adapter cables) and the

Avalon CL base station and the cableless transducers after each use. Clean equipment before

disinfecting. For other accessories, see “Cleaning and Disinfecting Monitoring Accessories” on

page 263.

Clean with a lint-free cloth, moistened with warm water (40°C/104°F maximum) and soap, a diluted

non-caustic detergent, tenside, or phosphate-based cleaning agent. Do not use strong solvents such as

acetone or trichloroethylene. After cleaning, disinfect using only the approved disinfecting agents listed

(see “Recommended Disinfectants” on page 263).

CAUTION

Solutions: Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may

result.

Hospital policy: Disinfect the product as determined by your hospital's policy, to avoid long-term

damage to the product.

Local requirements: Observe local laws governing the use of disinfecting agents.

Touch display: To clean and disinfect the touch-enabled display, disable the touch operation by

switching off the monitor during the cleaning procedure, or by selecting and holding the Main Screen

key until the padlock symbol appears on it, indicating that touch operation is disabled. Select and hold

again to re-enable touch operation.

WARNING

Skin contact: To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to

leave residues on any of the equipment surfaces - wipe it off with a cloth dampened with water, after

allowing the appropriate time for the agent to work. Follow the safety instructions of the used cleaning

or disinfection agent, especially regarding skin contact.

27 Care and Cleaning

263

Take extra care when cleaning the screen of the monitor, because it is more sensitive to rough cleaning

methods than the housing. Do not permit any liquid to enter the monitor case and avoid pouring it on

the monitor while cleaning. Do not allow water or cleaning solution to enter the measurement

connectors. Wipe around and not over connector sockets, or those of the Toco+, CL Toco+ MP

transducer, ECG and IUP Patient Modules, CL ECG/IUP transducer and adapter cables.

Wash soiled reusable belts with soap and water. Water temperature must not exceed 60°C/140°F.

Recommended Disinfectants

We recommend that you use one of the following disinfectants:

Cleaning and Disinfecting Monitoring Accessories

To clean, disinfect and sterilize reusable transducers, sensors, cables, leads, and so forth, refer to the

instructions delivered with the accessory.

Do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces. Wipe

residues off, after allowing the appropriate time to for the agent to work, with a cloth.

Product Name Product Type Ingredients

Isopropanol liquid Isopropanol 80%

Bacillol® AF liquid, spray 100 g concentrate contains:

Propan-1-ol 45.0 g

Propan-2-ol 25.0 g

Ethanol 4.7 g

Bacillol®25 liquid Ethanol 100 mg/g

Propan-2-ol (= 2-Propanol) 90 mg/g

Propan-1-ol (= 1-Propanol) 60 mg/g

Meliseptol® spray 50% 1-Propanol

Accel TB RTU liquid 0.5% accelerated hydrogen peroxide

Oxivir® Tb Cleaner Disinfectant spray 0.5% accelerated hydrogen peroxide

Oxivir® Tb Wipes wipes 0.5% accelerated hydrogen peroxide

Carpe DiemTM/MC Tb

Ready-to-Use General Virucide,

Bactericide, Tuberculocide,

Fungicide, Sanitizer

spray 0.5% accelerated hydrogen peroxide

Carpe DiemTM/MC Tb Wipes wipes 0.5% accelerated hydrogen peroxide

Super Sani-Cloth

Germicidal Disposable Wipes

wipes Isopropanol 55%

quaternary ammonium chlorides 0.5%

SANI-CLOTH® PLUS

Germicidal Disposable Wipes

wipes Isopropanol 15%

quaternary ammonium chlorides 0.25%

SANI-CLOTH® HB Germicidal

Germicidal Disposable Wipes

wipes Isopropanol < 0.15%

quaternary ammonium chlorides 0.14%

27 Care and Cleaning

264

Cleaning and Disinfecting the Tympanic

Temperature Accessories

Probe and Thermometer Body

1Wipe the thermometer body clean with a damp cloth. The water temperature should not exceed

55°C (130°F). Do not soak, rinse, or submerge the thermometer under water.

You may add a mild detergent to the water.

2Clean the probe tip with a lint free swab. If the probe tip is soiled, clean it with a dampened swab.

3After you have removed all foreign matter, clean the thermometer lens at the end of the probe tip

with a lint free swab or lens wipe. The thermometer lens must be free from fingerprints and/or

smudges for proper operation.

4Thoroughly dry all surfaces before using the equipment.

CAUTION

Do not use cleaners and disinfectants such as Spray-Nine™, Phisohex™, Hibiclens™, or

Vesta-Syde™ as they may result in damage to the thermometer case.

Occasional use of a 10:1 water and hypochlorite mixture or a damp isopropyl alcohol wipe or Cidex™

or ManuKlenz™ or VIROX™ or CaviWipes™ cleansing agents is acceptable, however, prolonged or

repeated use of these chemicals may result in damage to the thermometer case and display area.

Use of a cloth or sponge is recommended for cleaning. Never use an abrasive pad or an abrasive

cleaner on the thermometer.

The thermometer is non-sterile. Do not use ethylene oxide gas, heat, autoclave, or any other harsh

method to sterilize this thermometer.

Cleaning and Disinfecting CL Transducers and CL

Pods

To clean, disinfect and sterilize reusable CL transducers and CL Pods refer to the instructions

delivered with the accessory.

Do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces. Wipe

residues off, after allowing the appropriate time to for the agent to work, with a cloth damp with water.

NOTE

Pay especially close attention to cleaning and wiping down the gold connection contacts.

27 Care and Cleaning

265

Sterilizing

Sterilization is not allowed for this monitor, related products, accessories, or supplies unless otherwise

indicated in the Instructions for Use that accompany the accessories and supplies.

WARNING

Do not put device and accessories in autoclave (for sterilization).

27 Care and Cleaning

266

267

28Maintenance

WARNING

Schedule: Failure on the part of the responsible individual hospital or institution employing the use of

this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure

and possible health hazards.

In case of problems: If you discover a problem with any of the equipment, contact your service

personnel, Philips, or your authorized supplier.

Electric shock hazard: Do not open the monitor housing. Refer all servicing to qualified service

personnel.

Inspecting the Equipment and Accessories

You should perform a visual inspection before each use, and in accordance with your hospital's

policy. With the monitor switched off:

1Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings

are not cracked or broken, that everything is present, that there are no spilled liquids that may have

entered the housing, and that there are no signs of abuse.

2Inspect all accessories (transducers, sensors and cables, and so forth). Do not use a damaged

accessory.

3Switch the monitor on, and make sure the display is bright enough. If the brightness is not

adequate, contact your service personnel or your supplier.

Batteries Preventive Maintenance

For the FM20/30 with a battery option, see “Using Batteries” on page 110.

28 Maintenance

268

Inspecting the Cables and Cords

1Examine all system cables, the power plug, and cord for damage. Make sure that the prongs of the

plug do not move in the casing. If damaged, replace it with an appropriate power cord.

2Inspect the cables, 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.

3Carry out performance assurance checks as described in the monitor's Service Guide.

Maintenance Task and Test Schedule

The following tasks are for Philips-qualified service professionals. All maintenance tasks and

performance tests are documented in detail in the service documentation supplied on the monitor's

documentation DVD.

Ensure that these tasks are carried out as indicated by the monitor's maintenance schedule, or as

specified by local laws, whichever comes sooner. Contact a Philips-qualified service professional, if

your monitor needs a safety or performance test. Clean and disinfect equipment to decontaminate it

before testing or maintaining it.

Maintenance and Test Schedule Frequency

Visual Inspection Before each use.

Clean and disinfect the equipment After each use.

Safety checks according to IEC 60601-1,

and where applicable, to national

standards

At least once every two years, or as specified by local

laws.

After any repairs where the power supply has been

replaced (by an authorized service professional).

If the monitor has been dropped, it must be repaired/

checked by an authorized service agent.

Performance assurance for all

measurements

At least once every two years, or if you suspect the

measurement values are incorrect.

Noninvasive blood pressure calibration At least once every two years, or as specified by local

laws.

Tympanic Thermometer Calibration Once a year. If the unit is dropped or damaged, or if the

unit was stored at less than -25ºC or above 55ºC, check it

and calibrate it before further use.

Clean the thermal printhead At each paper pack change, or every 500 m of paper run.

28 Maintenance

269

Recorder Maintenance

Removing the Paper Guide: FM40/FM50

FM40/50 The paper guide is removable, and you can use the recorder without it. When not using the paper

guide, ALWAYS tear off the paper along the perforation to avoid possible paper misalignment (see

“Tearing Off the Paper” on page 61).

To remove the paper guide:

1Press the paper eject button to open the paper drawer.

28 Maintenance

270

2Hinge the transparent paper guide forward.

3A protrusion (A) holds paper guide in closed position.

28 Maintenance

271

4Release the paper guide from one side of the holder.

5Then remove the paper guide.

28 Maintenance

272

6Refitting is a reversal of the removal procedure.

Storing Recorder Paper

Recorder paper is not intended for long-term archival storage. Another medium should be considered

if this is required.

Dyes contained in thermal papers tend to react with solvents and other chemical compounds that are

being used in adhesives. If these compounds come into contact with the thermal print, the print may

be destroyed over time. You can take the following precautionary measures to help avoid this effect:

• Store the paper in a cool, dry, and dark place.

• Do not store the paper at temperatures over 40°C (104°F).

• Do not store the paper where the relative humidity exceeds 60%.

• Avoid intensive light (UV light), as this may cause the paper to turn gray, or the thermal print to

fade.

• Avoid storing the thermal paper in combination with the following conditions:

– Papers that contain organic solvents. This includes papers with tributyl and/or dibutyl

phosphates, for example recycled paper.

– Carbon paper and carbonless copy paper.

– Products containing polyvinyl chlorides, or other vinyl chlorides for example (but not

exclusively) document holders, envelopes, letter files, divider sheets.

– Detergents and solvents, such as alcohol, ketone, ester, and others, including cleaning and

disinfecting agents.

– Products containing solvent-based adhesives such as (but not exclusively) laminating film,

transparent film, or labels sensitive to pressure.

To ensure long lasting legibility and durability of thermal printouts, store your documents separately in

an air-conditioned place and use:

• only plasticizer-free envelopes or divider sheets for protection.

• laminating films and systems with water-based adhesives.

Using such protective envelopes cannot prevent the fading effect caused by other, external agents.

28 Maintenance

273

Cleaning the Print Head

To clean the recorder's thermal print-head:

1Switch off the monitor.

2Open the paper drawer, and remove the paper if necessary, to gain access to the thermal print

head.

3Gently clean the thermal print head with a cotton swab, or soft cloth soaked in isopropyl alcohol.

NOTE

If the print head is heavily coated with dust or dirt, contact your service personnel to clean it.

Returning Equipment for Repair

Before returning equipment for repair:

• disinfect and decontaminate the equipment appropriately.

• ensure that all patient data has been removed (i.e. that no patient is admitted).

FM20/30

FM40/50

28 Maintenance

274

Disposing of the Monitor

WARNING

To avoid contaminating or infecting personnel, the environment, or other equipment, make sure that

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 Service Guide. 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 on the Philip's web page 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 waste electrical and electronic equipment as unsorted

municipal waste. Collect it separately, so that it can be safely and properly reused,

treated, recycled, or recovered.

275

29Accessories and Supplies

All accessories listed for the fetal monitor may not be available in all geographies. To order parts,

accessories, and supplies, consult your local Philips representative for details. For customers in the

United States, Australia, and Great Britain you can order at www.philips.com/healthcarestore. All

accessories and supplies listed here are reusable, unless indicated otherwise.

WARNING

Reuse: Disposable accessories and supplies intended for single use, or single patient use only, are

indicated as such on their packaging. Never reuse disposable accessories and supplies, such as

transducers, sensors, electrodes, and so forth, that are intended for single use, or single patient use

only.

Approved accessories: Use only Philips-approved accessories.

Packaging: Do not use a sterilized accessory if its packaging is damaged.

Protection against electric shocks: The transducers and accessories listed in this chapter are

not defibrillator proof.

Electro-Surgery, Defibrillation and MRI: The fetal/maternal monitors are not intended for use

during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before

performing electro-surgery, defibrillation, or MRI, otherwise harm can result.

Information on Latex

All Philips transducers and accessories are latex-free, unless indicated otherwise in the following tables.

Avalon CL Base Station

CL Base Station Part Number

Avalon CL Base Station can either be ordered with the option K30 (red connector), or

K40 (black connector), or K60 (charging station)

866074

29 Accessories and Supplies

276

Transducers

Fetal Accessories

Transducer Part Number

Avalon Toco Transducer M2734A

Avalon Toco+ Transducer for Toco, DECG, MECG, or IUP monitoring M2735A

Avalon Toco MP Transducer for Toco and Maternal Pulse M2734B

Avalon Ultrasound Transducer M2736A

Avalon Ultrasound Transducer USA M2736AA

ECG/IUP Patient Module (for DECG, MECG or IUP) M2738A

Avalon CL Toco+ MP Transducer

for use with the Avalon CL base station

866075

Avalon CL Ultrasound Transducer

for use with the Avalon CL base station

866076

Avalon CL ECG/IUP Transducer

for use with the Avalon CL base station

866077

Avalon CL Fetal & Maternal Pod

for use with the Avalon CL base station

866488

Avalon CL Wide Range Pod

for use with the Avalon CL base station

866487

CL SpO2 Pod

for use with the Avalon CL base station

865215

CL NBP Pod

for use with the Avalon CL base station

865216

Remote Event Marker 989803143411

Accessory Description Part Number

Belt (reusable, gray, water resistant) 32 mm wide, 15 m roll M4601A

60 mm wide, 5 belts M4602A

60 mm wide, 15 m roll M4603A

50 mm wide, 5 belts M1562B

Belt (disposable, yellow, water resistant) 60 mm wide, pack of 100 M2208A

Ultrasound gel 12 Bottles 40483A

5 liter refill (with dispenser) for

40483A

Shelf life: 24 months max.

40483B

Belt buttons (kit of 10) for wired transducers M273xA M1569A

Belt Clips for wired Smart Transducers (kit of 6) 989803143401

29 Accessories and Supplies

277

MECG Accessories

Avalon CL Connector Caps Connector Caps for Avalon CL

Cableless Smart Transducers (kit

of 10)

989803184841

Avalon CL Belt Clip Belt Clip for Avalon CL Cableless

Smart Transducers (kit of 10)

989803184851

Avalon CL Battery Replacement Kit 989803184861

Cable Management Kit 989803148841

Avalon CL Wide Range Battery Kit 989803196421

Kit of 20 Mobile CL Transmitter Cradles

for use with 866487 Avalon CL Wide Range Pod

989803168881

Avalon CL Fetal & Maternal Patch (case with 10 each) 989803196341

ECG Skin Preparation Paper

for use with the 989803196341 Avalon CL F&M patch

10 sheets, with 10 finger-tip sized

skin prep pieces per sheet (100

preps per bag)

M4606A

DECG Accessories: Philips DECG Solution

(NOT compatible with QwikConnect

Plus Solution accessories)

DECG reusable leg plate adapter

cable (with flushing port)

989803137651

DECG leg attachment electrode

for DECG leg plate adapter cable

989803139771

DECG fetal scalp electrode:

single spiral, worldwide

availability

989803137631

DECG fetal scalp electrode:

double spiral, Europe only. Not

for USA

989803137641

Disposable Koala IUP catheter M1333A

Reusable Koala IUP adapter cable 989803143931

Accessory Description Part Number

Accessory Part Number

MECG reusable adapter cable M1363A

Foam ECG electrodes, snap-fit, for MECG Adapter Cable (disposable) 40493D/E

29 Accessories and Supplies

278

Noninvasive Blood Pressure Accessories

The following accessories are approved for use with the fetal monitor:

Adult Multi Patient Reusable Comfort Cuffs

The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).

Adult Multi Care Reusable Cuffs

The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).

Adult EasyCare Reusable Cuffs

Maternal Patient Category Limb Circumference Part Number

Adult (Thigh) 42.0-54.0 cm M1576A

Large Adult 34.0-43.0 cm M1575A

Large Adult XL 34.0-43.0 cm M1575XL

Adult 27.0-35.0 cm M1574A

Adult XL 27.0-35.0 cm M1574XL

Small Adult 20.5-28.0 cm M1573A

Small Adult XL 20.5-28.0 cm M1573XL

Cuff kit of 4 adult sizes M1578A

Cuff kit of 4 adult XL sizes M1579XL

Maternal Patient Category Limb Circumference Part Number

Adult (Thigh) 42.0-54.0 cm 989803183371

Large Adult 34.0-43.0 cm 989803183361

Adult 27.0-35.0 cm 989803183341

Adult X-Long 27.0-35.0 cm 989803183351

Small Adult 20.5-28.0 cm 989803183331

Maternal Patient Category (color) Limb Circumference Part Number

Adult Thigh (gray) 45.0-56.5 cm M4559B

Adult Thigh (gray) pack of 5 cuffs 45.0-56.5 cm M4559B5

Large Adult X-Long (burgundy) 35.5-46.0 cm M4558B

Large Adult X-Long (burgundy) pack of 5 cuffs 35.5-46.0 cm M4558B5

Large Adult (burgundy) 35.5-46.0 cm M4557B

Large Adult (burgundy) pack of 5 cuffs 35.5-46.0 cm M4557B5

Adult X-Long (navy blue) 27.5-36.5 cm M4556B

Adult X-Long (navy blue) pack of 5 cuffs 27.5-36.5 cm M4556B5

Adult (navy blue) 27.5-36.5 cm M4555B

29 Accessories and Supplies

279

The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).

Adult Single Patient Soft Cuffs

The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).

Adult Single Care Cuffs

The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).

Adult Value Care Cuffs

The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).

Adult (navy blue) pack of 5 cuffs 27.5-36.5 cm M4555B5

Small Adult (royal blue) 20.5-28.5 cm M4554B

Small Adult (royal blue) pack of 5 cuffs 20.5-28.5 cm M4554B5

Cuff kits containing one small adult, one adult, one

large adult and one thigh cuff

864288

Cuff kits containing one small adult, one adult, one

adult X-long, one large adult, one large adult X-long

and one thigh cuff

864291

Maternal Patient Category (color) Limb Circumference Part Number

Maternal Patient Category Limb Circumference Part Number

Adult (Thigh) 45.0-56.5 cm M4579B

Large Adult X-Long 35.5-46.0 cm M4578B

Large Adult 35.5-46.0 cm M4577B

Adult X-Long 27.5-36.5 cm M4576B

Adult 27.5-36.5 cm M4575B

Small Adult 20.5-28.5 cm M4574B

Maternal Patient Category Limb Circumference Part Number

Large Adult 35.0-45.0 cm 989803182321

Adult X-Long 27.5-36.0 cm 989803182311

Adult 27.5-36.0 cm 989803182301

Small Adult 20.5-28.5 cm 989803182291

Maternal Patient Category Limb Circumference Part Number

Large Adult 34.0-43.0 cm 989803160861

Adult XL 27.0-35.0 cm 989803160851

Adult 27.0-35.0 cm 989803160841

Small Adult 20.5-28.0 cm 989803160831

29 Accessories and Supplies

280

IntelliVue CL NBP Pod Accessories

SpO2 Accessories

Some Nellcor sensors contain natural rubber latex which may cause allergic reactions. See the

Instructions for Use supplied with the sensors for more information. M1901B, M1903B, and M1904B

are not available in USA from Philips. Purchase Nellcor OxiCliq sensors and adapter cables directly

from Tyco Healthcare. Some sensors may not be available in all countries.

Do not use more than one extension cable with any sensors or adapter cables. Do not use an extension

cable with Philips reusable sensors or adapter cables with part numbers ending in -L (indicates "Long"

version).

All listed sensors operate without risk of exceeding 41°C/105.8°F on the skin if ambient temperature

is below 37°C/98.6°F.

Make sure that you use only the accessories that are specified for use with this device, otherwise patient

injury can result.

Description Limb Circumference

Range

Contents Part Number

Mobile CL Reusable Small Adult

Cuff

21-27 cm 1 cuff 989803163171

Mobile CL Reusable Adult Cuff 26.0-34.5 cm 1 cuff 989803163191

Mobile CL Reusable Large Adult

Cuff

33.5-45.0 cm 1 cuff 989803163211

Mobile CL Single-Patient Small

Adult Cuff

21-27 cm 20 cuffs 989803163181

Mobile CL Single-Patient Adult

Cuff

26.0-34.5 cm 20 cuffs 989803163201

Mobile CL Single-Patient Large

Adult Cuff

33.5-45.0 cm 20 cuffs 989803163221

Mobile CL NBP Cradle Kit - 20 cradles 989803163251

Mobile CL Extension Air Hose,

1.0 m

- 1 extension air hose 989803163131

Mobile CL NBP Battery Kit - 1 Battery

1 disassembly tool

1 front housing

989803163261

Telemetry Pouch with window - 50 pouches 989803137831

Telemetry Pouch with window - 4 boxes of 50 pouches 989803140371

White Telemetry Pouch with

Snaps

- 50 pouches 989803101971

(9300-0768-050)

White Telemetry Pouch with

Snaps

- 4 boxes of 50 pouches 989803101981

(9300-0768-200)

29 Accessories and Supplies

281

Philips Reusable Sensors

No adapter cable required.

Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.

No adapter cable required. SE sensors work with FM30/40/50, as well as with OxiMax-compatible

SpO2 versions of other Philips monitors.

Philips Disposable Sensors

Not available in the USA:

Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable

Description Part Number

Adult sensor (2.0 m cable), for patients over 50 kg. Any finger, except thumb. M1191B

M1191A with longer cable (3.0 m) M1191BL

Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any

finger except thumb. Use only on adult patients with FM30/40/50.

M1192A

Ear sensor (1.5 m cable) for patients more than 40 kg. Use only on adult patients with

FM30/40/50.

M1194A

Adult clip sensor (3 m cable) for patients over 40 kg. Any finger except thumb. M1196A

Adult clip sensor (2 m cable) for patients over 40 kg. Any finger except thumb. M1196S

Description Part Number

Adult sensor (0.45 m cable), for patients over 50 kg. Any finger except thumb. M1191T

Small adult, pediatric sensor (0.45 m cable) for patients between 15 kg and 50 kg. Any

finger except thumb. Use only on adult patients with FM30/40/50.

M1192T

Adult clip sensor (0.9 m cable) for patients over 40 kg. Any finger except thumb. M1196T

Description Part Number

Special Edition (SE). Adult sensor (3 m cable), for patients over 50 kg. Any finger except

thumb.

M1191ANL

Special Edition (SE). Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg

and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50.

M1192AN

Special Edition (SE). Ear sensor (1.5 m cable) for patients more than 40 kg. M1194AN

Description Part Number

Identical to OxiMax MAX-A M1904B

Identical to OxiMax MAX-P M1903B

Identical to OxiMax MAX-N M1901B

29 Accessories and Supplies

282

Available worldwide:

Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable

Nellcor Sensors

Nellcor sensors must be ordered from Nellcor/Covidien.

OxiMax Sensors

Require M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.

Oxisensor II Sensors

Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.

OxiCliq Sensors

Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable together with OC-3 adapter cable.

Description Part Number

Adult/Pediatric finger sensor (0.45 m cable). Use only on adult patients with FM30/40/

50.

M1131A

Adult/Pediatric finger sensor (0.9 m cable) for patients >40 kg. Any finger except thumb.

Use only on adult patients with FM30/40/50.

M1133A

Adult/Pediatric finger sensor (0.9 m cable) for patients >40 kg. Any finger except thumb.

Adhesive-free, use only on adult patients with FM30/40/50.

M1134A

Description Part Number

Adult finger sensor (patient size >30 kg) OxiMax MAX-A

OxiMax MAX-A with long cable OxiMax MAX-AL

Pediatric foot/hand sensor (patient size 10-50 kg). Use only on adult patients with FM30/

40/50.

OxiMax MAX-P

Adult finger or neonatal foot/hand sensor (patient size >40 kg or <3 kg). Use only on

adult patients with FM30/40/50.

OxiMax MAX-N

Description Part Number

Adult sensor (patient size >30 kg) Oxisensor II D-25

Pediatric sensor (patient size 10-50 kg). Use only on adult patients with FM30/40/50. Oxisensor II D-20

Neonatal/Adult sensor (patient size <3 kg or >40 kg). Use only on adult patients with

FM30/40/50.

Oxisensor II N-25

Description Part Number

See OxiMax MAX-A OxiCliq A

See OxiMax MAX-P. Use only on adult patients with FM30/40/50. OxiCliq P

See OxiMax MAX-N. Use only on adult patients with FM30/40/50. OxiCliq N

29 Accessories and Supplies

283

Masimo LNOP Reusable Sensors

For use with this sensor the adapter cable LNOP MP12 (M1020-61102) is needed.

Masimo LNCS Reusable Sensors

For use with this sensor the adapter cable LNC MP10 (989803148221) is needed.

Masimo LNOP Disposable Adhesive Sensors

Appropriate LNOP/LNCS adapter cable required.

Description Product Number Part Number

Adult Finger Sensor (>30 kg) LNOP DC-I 989803140321

Pediatric Finger Sensor (10-50 kg). Use only on adult

patients with FM30/40/50.

LNOP DC-IP 989803140331

Multi-Site Sensor (>1 kg). Use only on adult patients

with FM30/40/50.

LNOP YI n/a

Ear Sensor (>30 kg). Use only on adult patients with

FM30/40/50.

LNOP TC-I 989803140341

Description Product Number Part Number

Adult Finger Sensor (>30 kg) LNCS DC-I 989803148281

Pediatric Finger Sensor (10-50 kg). Use only on adult

patients with FM30/40/50.

LNCS DC-IP 989803148291

Ear Sensor (>30 kg). Use only on adult patients with

FM30/40/50.

LNCS TC-I 989803148301

Description Product Number Part Number

Adult Sensor (>30 kg) LNOP Adt 989803140231

Adult Sensor (>30 kg) LNOP Adtx n/a

Pediatric Sensor (10-50 kg). Use only on adult patients

with FM30/40/50.

LNOP Pdt 989803140261

Pediatric Sensor (10-50 kg). Use only on adult patients

with FM30/40/50.

LNOP Pdtx n/a

Neonatal (<3 kg) or Adult adhesive Sensor (>40 kg).

Use only on adult patients with FM30/40/50.

LNOP Neo-L 989803140291

29 Accessories and Supplies

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Masimo LNCS Disposable Adhesive Sensors

Appropriate LNOP/LNCS adapter cable required.

IntelliVue CL SpO2 Pod Accessories

All listed sensors operate without risk of exceeding 41°C on the skin, if the initial skin temperature

does not exceed 35°C.

Ensure that you use only the accessories that are specified for use with this device, otherwise patient

injury can result.

1 May not be available in all geographies

Extension / Adapter Cables

Description Product Name Part Number

Adult Sensor (>30 kg) LNCS Adtx 989803148231

Pediatric Finger Sensor (10-50 kg). Use only on adult

patients with FM30/40/50.

LNCS Pdtx 989803148241

Neonatal Foot Sensor (<3 kg) or Adult Finger Sensor

(>40 kg). Use only on adult patients with FM30/40/

50.

LNCS Neo-L 989803148271

Description Contents Part Number

Mobile CL 20 single patient SpO2 Sensors

and Cradles for use on patients >10 kg

20 Single-Patient Mobile CL DSpO2-1A

Sensors

20 Single-Patient Wristbands

20 Single-Patient Cradles pre-assembled

989803165941

Mobile CL 20 single patient SpO2 Sensors

for use on patients >10 kg

20 Single-Patient Mobile CL DSpO2-1A

Sensors

989803165921

Mobile CL reusable SpO2 sensor and

Cradles for use on patients >15 kg

1 Reusable Mobile CL RSpO2-1A Sensor

20 Single-Patient Cradles with pre-attached

Wristbands

9898031659311

Mobile CL 20 SpO2 Cradles (single patient) 20 Single-Patient Cradles with pre-attached

Wristbands

989803165951

Mobile CL 50 SpO2 Wristbands (single

patient)

50 Single-Patient Wristbands 989803165961

Mobile CL SpO2 Battery Kit 1 Battery

1 disassembly tool

1 front housing

989803168861

Description Comments Part Number

Extension cable (2 m) For use with Philips reusable sensors and

adapter cables

M1941A

Adapter cable (1.1 m cable) Adapter cable for Philips/Nellcor

disposable sensors

M1943A

Adapter cable (3 m cable) M1943AL

29 Accessories and Supplies

285

Tympanic Temperature Accessories

Recorder Paper

Supplied in cases of 40 packs. Each pack has 150 numbered pages. Single use. Use the paper specified

here.

*Bradycardia and tachycardia alarm ranges are shaded.

Batteries

Adapter Cable for OxiCliq sensors Available from Nellcor OC-3

Masimo MP 12 LNOP MP Series Patient Cable (3.6 m)

Adapter Cable for Masimo LNOP sensors

M1020-61100

LNC MP10 LNCS MP Series Patient Cable (3.0 m)

Adapter Cable for Masimo LNCS sensors

989803148221

Description Comments Part Number

Description Part Number

Temperature probe 989803180831

Disposable probe cover with CE marking (22 boxes each containing 96 covers) 989803179611

Disposable probe cover (22 boxes each containing 96 covers) 989803179381

Geography FHR Scale Grid Color Scale Units Highlighted

3 cm Lines?

Part Number

USA/Canada/Asia 30-240 Red/Orange mmHg Yes M1910A

Europe 50-210 Green mmHg and kPa No M1911A

Japan 50-210 Green mmHg Yes M1913A

Japan 50-210 Green*mmHg Yes M1913J

Description Comment Part Number.

Smart Battery 10.8 V, 6000 mAh, Lithium

Ion

For Avalon FM20 or Avalon FM30 with

battery option #E25

M4605A

Avalon CL Cableless Smart transducer

Battery Replacement Kit

Consists of one Philips Lithium Ion Battery

(Part No. 453564107871), a tool to open

and close the cableless transducer for

battery replacement and two replacement

O-ring seals.

989803184861

29 Accessories and Supplies

286

287

30Specifications and Standards

Compliance

The monitors are intended to monitor a mother and her fetus(es), which from an electrical safety point

of view, are one person.

Environmental Specifications

The monitor may not meet the given performance specifications, if stored and used outside the

specified temperature and humidity ranges.

Avalon CL Base station 866074 with Option K30 and K40

Temperature Range Operating 0°C-45°C (32°F-113°F)

Storage/Transportation -20°C-60°C (-4°F-140°F)

Humidity Range Operating <95% relative humidity @ 45°C (113°F)

Storage/Transportation <90% relative humidity @ 60°C (140°F)

Altitude Range Operating -500-3000 m (-1640-9840 ft)

Storage/Transportation -500-13100 m (-1640-43000 ft)

Avalon CL Base station 866074 with Option K60

Temperature Range Operating 0°C-40°C (32°F-104°F)

Storage/Transportation -20°C-60°C (-4°F-140°F)

Humidity Range Operating <90% relative humidity @ 45°C (113°F)

Storage/Transportation <90% relative humidity @ 60°C (140°F)

Altitude Range Operating 0-2000 m (0-6562 ft)

Storage/Transportation -500-13100 m (-1640-43000 ft)

30 Specifications and Standards Compliance

288

NOTE

Do not locate the M2738A ECG/IUP Module directly on the patient’s skin when operated at an

environmental temperature above 37°C (98.6°F). When operated at an environmental temperature of

40°C (104°F), the transducers can reach a temperature of 41-43°C (106-110°F).

Monitor (M2702A/M2703A/M2704A/M2705A); Interface Cable for Avalon CTS (M2731-60001 and

M2732-60001)

Temperature Range Operating Without battery option: 0°C-45°C (32°F-113°F)

With battery option/charging: 0°C-35°C (32°F-95°F)

With battery option/fully charged: 0°C-40°C (32°F-

104°F)

Storage/Transportation -20°C—60°C (-4°F—140°F)

Humidity Range Operating <95% relative humidity @ 40°C (104°F)

Storage/Transportation <90% relative humidity @ 60°C (140°F)

Altitude Range Operating -500-3000 m (-1640-9840 ft)

Storage/Transportation -500-13100 m (-1640-43000 ft)

Transducers (M2734A/M2734B/M2735A/M2736A/M2738A)

Temperature Range Operating 0°C-40°C (32°F-104°F)

Storage/Transportation -20°C-60°C (-4°F-140°F)

Humidity Range Operating <95% relative humidity @ 40°C (104°F)

Storage/Transportation <90% relative humidity @ 60°C (140°F)

Altitude Range Operating -500-3000 m (-1640-9840 ft)

Storage/Transportation -500-13100 m (-1640-43000 ft)

Avalon CL Transducers (866075/866076/866077)

Temperature Range Operating 0°C-40°C (32°F-104°F)

Charging 0°C-35°C (32°F-95°F)

Storage/Transportation -20°C-60°C (-4°F-140°F)

Humidity Range Operating <95% relative humidity @ 40°C (104°F)

Storage/Transportation <90% relative humidity @ 60°C (140°F)

Altitude Range Operating -500-3000 m (-1640-9840 ft)

Storage/Transportation -500-13100 m (-1640-43000 ft)

Avalon CL Fetal and Maternal Pod (866488)

Temperature Range Operating 10°C-40°C (50°F-104°F)

Charging 10°C-35°C (50°F-95°F)

Storage/Transportation -20°C-60°C (-4°F-140°F)

Humidity Range Operating <95% relative humidity @ 40°C (104°F)

Storage/Transportation <90% relative humidity @ 60°C (140°F)

30 Specifications and Standards Compliance

289

WARNING

Explosion Hazard: Do not use in the presence of flammable anesthetics, such as a flammable

anesthetic mixture with air, oxygen, nitrous oxide, or in oxygen rich environment. Use of the devices in

such an environment may present an explosion hazard.

Physical Specifications

Fetal Monitors

Altitude Range Operating -500-3000 m (-1640-9840 ft)

Storage/Transportation -500-13100 m (-1640-43000 ft)

Avalon CL Fetal and Maternal Pod (866488)

Avalon CL Wide Range Pod (866487)

Temperature Range Operating 0°C-40°C (32°F-104°F)

Charging 0°C-35°C (32°F-95°F)

Storage/Transportation -20°C-60°C (-4°F-140°F)

Humidity Range Operating <95% relative humidity @ 40°C (104°F)

Storage/Transportation <90% relative humidity @ 60°C (140°F)

Altitude Range Operating -500-3000 m (-1640-9840 ft)

Storage/Transportation -500-4600 m (-1640-15092 ft)

SpO2 Sensors

Operating Temperature Range 0°C-37°C (32°F-98.6°F)

Tympanic Temperature

Operating Temperature Range 16ºC-33ºC (60.8ºF-91.4ºF)

Monitor Physical Specifications M2702A/M2703A M2704A/M2705A

Power Supply Voltages 100 VAC-240 VAC ±10%

Supply Frequency Range 50 Hz-60 Hz

Power Consumption

(current)

0.7-0.4 A (M2702A/M2703A)

1.3-0.7 A (M8023A#E25)

1.3-0.7 A

Dimensions and

Weight

Size (without options) mm/

(in):

width x height x depth

286 x 134 x 335 mm

(11.3 x 5.3 x 13.2 in)

425 x 174 x 365 mm

(16.6 x 6.9 x 14.4 in)

Weight <5.1 kg (11.2 lbs) <8.8 kg (19.5 lbs)

Degree of Protection Against Electrical Shock Type CF

Electrical Class Class II equipment Class I equipment

30 Specifications and Standards Compliance

290

Fetal Monitor Sounds

Avalon CL Base Station

Electrical Power Source External (AC) without battery

option #E25

Internal (Lithium Ion battery)

if with battery option #E25

External (AC)

Mode of Operation Continuous operation

Water Ingress Protection Code IP X1 (provided recorder drawer is shut)

Global Speed (DECG and MECG wave on the

screen)

6.25 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/sec

Startup Time Time taken from switching

on the monitor to seeing the

first parameter labels

<30 seconds

Monitor Physical Specifications M2702A/M2703A M2704A/M2705A

Source Description

Patient alarms and INOPs See the sections on “Patient Alarms and INOPs” on page 129, “Standard

Philips Alarms” on page 120, and “ISO/IEC Standard Audible Alarms” on

page 120.

Ultrasound Doppler Direct transmission of Doppler echoes to the speaker of the fetal monitor.

Pulse from SpO2, MECG, DECG QRS tone

SpO2Optional modulation of the QRS tone for changes in the SpO2 level.

NST Timer Tone for Timer expired.

Status/Prompt tone Configurable volume tone sounded when status or prompt messages are

issued by the fetal monitor.

Touch feed back tone Anytime the user touches the display a low beep is issued in response.

Avalon CL Base Station

Dimension and Weight

Size mm/(in)

W x H x D 349 x 74 x 183 mm (13.8 x 2.9 x 7.2 in)

Weight 1 kg (2.3 lbs)

Electrical Class When the base station is connected to the monitors M2702A/M2703A/M2704A/

M2705A it is a Class II equipment.

Electrical Power Source External (powered by fetal monitor)

Mode of Operation Continuous operation

Interface cable connector type Connector color Red for FM20/30 left side or FM40/50 front fetal

connector socket

Black for FM40/50 rear telemetry connector

socket

Interface cable length 1.5 m (4.11 ft)

Ingress Protection IP 31

30 Specifications and Standards Compliance

291

Wired Transducers

Avalon CL Transducers

External Power Supply (Option K60 for the Avalon CL Base Station)

Maximum Weight (with cable) 140 g (4.94 oz) (incl. cable, without country-dependent AC adapter)

Size (W x H x D) 52.0 x 39.5 x 85.0 mm (2.0 x 1.6 x 3.4 in)

Charging cable length 1.6 m (5.2 ft) (incl. power supply)

Supply Voltages 100 VAC-240 VAC

Supply Frequency Range 50 Hz/60 Hz

Power Consumption (current) 0.4-0.2A

Electrical Class Class II

Electrical Power Source AC Mains

Mode of Operation Continuous

Water Ingress Protection Code IP40

Transducers (M2734A/M2734B/M2735A/M2736A/M2738A)

Shock Resistance Withstands a 1 m drop to concrete surface with possible cosmetic

damage only

Water Ingress

Protection Code

M2734A&B/35/36A IP 68 (immersion up to 1 m water depth for 5 hours)

M2738A IP 67 (immersion up to 0.5 m water depth for 30 minutes)

Dimensions and

Weight

M2734A&B/35/36A Size (diameter) 83 mm (3.27 in)

Weight (without cable) 0.2 kg (0.5 lb)

M2738A Maximum size mm/(in):

width x height x depth

42 x 30 x 123 mm

(1.7 x 1.2 x 4.8 in)

Cable length 2.5 m

Weight 0.2 kg (0.5 lb)

Degree of Protection Against Electrical Shock Type CF

Transducer Identification Optical Signal Element (Finder LED), not M2738A

Avalon CL Transducers (866075/866076/866077)

Shock Resistance Withstands a 1.5 m drop to concrete surface with possible

cosmetic damage only.

Water Ingress Protection Code IP 68 (immersion up to 1 m water depth for 5 hours)

Dimensions

and Weight

Avalon CL Toco+ MP Transducer

866075

Size (diameter/height) 76 mm/37 mm (3 in/1.5 in)

Weight 0.2 kg (0.5 lb)

Avalon CL US Transducer 866076 Size (diameter/height) 76 mm/37 mm (3 in/1.5 in)

Weight 0.2 kg (0.5 lb)

Avalon CL ECG/IUP Transducer

866077

Size (diameter/height) 76 mm/37 mm (3 in/1.5 in)

Weight 0.2 kg (0.5 lb)

30 Specifications and Standards Compliance

292

Avalon CL Fetal & Maternal Pod

Avalon CL Wide Range Pod

Interface Cable Avalon CTS

External Power Supply Option E25

Degree of Protection Against Electrical Shock Type CF

Transducer Identification Optical Signal Element (Finder LED)

Avalon CL Transducers (866075/866076/866077)

Avalon CL Fetal & Maternal Pod (866488)

Shock Resistance Withstands a 1.5 m drop to concrete surface with possible

cosmetic damage only.

Water Ingress Protection Code IP 67 (immersion up to 1 m water depth for 30 minutes)

Dimensions and Weight W x H x D 63 x 20 x 49 mm

(2.5 x 0.8 x 1.9 in)

Weight 0.07 kg (0.15 lb)

Degree of Protection Against Electrical Shock Type CF

Pod Identification Optical Signal Element (Finder LED)

Avalon CL Wide Range Pod (866487)

Shock Resistance Withstands a 1 m drop to concrete surface with possible

cosmetic damage only.

Water Ingress Protection Code IP 32 (protection from dripping water)

Dimensions and Weight W x H x D 55 x 26.5 x 122 mm

(2.1 x 1 x 4.8 in)

Weight 0.14 kg (0.3 lb)

Interface Cable for Avalon CTS (M2731-60001 and M2732-60001)

Shock Resistance Withstands a 1 m drop to concrete surface with possible cosmetic damage only

Water Ingress Protection Code IP X1

Dimensions and Weight Maximum size mm/(in):

width x height x depth

55 x 28 x 50 mm (2.2 x 1.1 x 2.0 in)

Cable length 2.5 m

Weight 0.2 kg (0.5 lb)

M8023A (Option #E25) External Power Supply Weight and Dimensions

Maximum Weight 0.6 kg (1.4 lb)

Size (W x H x D) 208 x 105 x 89 mm (8.2 x 4.1 x 5.3 in)

30 Specifications and Standards Compliance

293

Interface Specifications

Fetal Monitors

1 The power loss indication functionality of the Nurse Call Relay board is not supported with fetal

monitors.

Interface Specifications

Network Standard 100-Base-TX (IEEE 802.3 Clause 25)

Connector RJ45 (8 pin)

Isolation Basic isolation (reference voltage: 250 V; test voltage:

1500 V)

MIB/RS232 Standard IEEE 1073-3.2-2000

Connectors RJ45 (8 pin)

Mode Software-controllable

BCC (RxD/TxD cross over) or

DCC (RxD/TxD straight through)

Power 5 V ±5%, 100 mA (max.)

Isolation Basic isolation (reference voltage: 250 V; test voltage:

1500 V)

USB Interface Standard USB 2.0 full-speed (embedded host)

Connectors USB series "Standard A" receptacle

Power Low power port 4.4V min; max. load for all ports

together 500 mA

Isolation none

RS232 (Standard) Connectors RJ45 (8 pin)

Power none

Isolation Basic isolation (reference voltage: 250 V; test voltage:

1500 V)

RS232 (Independent display

interface option)

Connectors RJ45 (8 pin)

Power none

Isolation none

Flexible Nurse Call Relay1Connectors 20 pin MDR (Mini D-Ribbon), active open and

closed contacts

Contact ≤100 mA, ≤24 V DC

Isolation Basic isolation (reference voltage: 250 V; test voltage:

1500 V)

Delay <[Configured Latency +0.5] sec

30 Specifications and Standards Compliance

294

Avalon CL Radio

*Wireless transmissions are encrypted for security.

CL Wide Range Pod Radio

Avalon CL Radio Interface Specifications

Electronic Article Surveillance (EAS) EAS tag inside the housing (58 kHz)

Short Range Radio Interface* Type Internal SRR interface

Technology IEEE 802.15.4

Frequency Band 2.4 GHz ISM (2.400-2.483 GHz)

Modulation Technique DSSS (O-QPSK)

Effective radiated power max. 0 dBm (1 mW)

Range ca. 5 m without any physical obstructions as walls

and doors

OBR (WMTS)* Frequency Band 608-614 MHz

Effective radiated power <10 mW (base station)

<1 mW (CL transducers)

Range min. 100 m/300 ft (in line of sight)

OBR (ISM)* Frequency Band 433.05-434.79 MHz

Effective radiated power <10 mW (base station)

<1 mW (CL transducers)

Range min. 100 m/300 ft (in line of sight)

OBR (T108)* Frequency Band 920.6-923.4 MHz

Effective radiated power <40 mW (base station)

<10 mW (CL transducers)

Range min. 100 m/300 ft (in line of sight)

OBR (OB Radio)

OBR (WMTS) Frequency Band 608-614 MHz

Effective radiated power <1 mW

Range 5 m/16 ft

OBR (ISM) Frequency Band 433.05-434.79 MHz

Effective radiated power <1 mW

Range 5 m/16 ft

OBR (T108) Frequency Band 920.6-923.4 MHz

Effective radiated power <5 mW

Range 5 m/16 ft

Short Range Radio Specifications

Type Built-in interface with integrated antenna

Technology IEEE 802.15.4

30 Specifications and Standards Compliance

295

Performance Specifications

Essential Performance

This section defines the essential performance for Avalon fetal monitors in combination with the

specified wired transducers and sensors, and also with the cableless measurements (Avalon CL,

Avalon CTS).

Under normal and single fault conditions either at least the performance/functionality listed in the

tables below is provided, or failure to provide this performance/functionality is readily identifiable by

the user (e.g. technical alarm, no waves and/or numeric values, complete failure of the monitor, readily

identifiable distorted signals, etc.).

Frequency Band 2.4 GHz ISM (2.400-2.483 GHz)

MBAN (2.360-2.400 GHz, for US / FCC regulated countries only)1

Modulation DSSS (O-QPSK)

Bandwidth 5 MHz

Effective Radiated Power (ERP) max. 0 dBm (1 mW)

Short Range Radio Specifications

WLAN Specifications

Type Internal wireless adapter

Technology IEEE 802.11a/b/g/n

Frequency Band USA: 2.400-2.483 GHz, 5.15-5.35 GHz, 5.725-5.825 GHz

Europe: 2.400-2.483 GHz, 5.15-5.35 GHz, 5.47-5.725 GHz

Japan: 2.400-2.483 GHz, 5.150-5.250 GHz, 5.25-5.35 GHz, 5.470-5.725 GHz

China: 2.400-2.483 GHz, 5.725-5.85 GHz

Modulation Technique 802.11b/g

DSSS (DBPSK, DQPSK, CCK)

OFDM (BPSK, QPSK, 16-QAM, 64-QAM)

802.11a

OFDM (BPSK, QPSK, 16-QAM, 64-QAM)

Effective Radiated Power (ERP) 2.400-2.483 GHz: max. 18 dBm (63 mW)

5.150-5.725 GHz: max. 19 dBm (79 mW)

5.745-5.825 GHz: max. 14 dBm (25 mW)

Measurement Essential Performance

General No interruption or cessation of current operating mode (e.g. no

reboot, display OK).

No spontaneous operation of controls (e.g. no activation of

touchscreen without user interaction).

30 Specifications and Standards Compliance

296

The table above also represents the minimum performance when operating under non-transient

electromagnetic phenomena according to IEC 60601-1-2:

• Radiated electromagnetic fields

• Conducted disturbances induced by RF fields

• Conducted disturbances induced by magnetic fields

• Voltage dips/voltage variations

The following table identifies minimum performance for transient electromagnetic phenomena

according to IEC 60601-1-2:

• Electrostatic Discharge (ESD)

• Electrical Fast Transients/Bursts

•Surges

• Voltage interruptions

ECG (Monitoring) Measurement of the fetal and maternal heart rate over the

specified measurement range and with an accuracy of ± 5 bpm.

Alarming on heart rate limit violation within specified delay time.

Maternal Pulse from Toco (MP) Measurement of the maternal pulse rate within the specified limits.

MP is susceptible to movement artifact potentially resulting in

signal loss. It is not intended for continuous maternal HR

monitoring. Limit alarms are not provided.

NBP Measurement of noninvasive systolic, diastolic, and mean blood

pressure and pulse rate within specified accuracy and error limits.

Automatic cycling

Alarming on limit violations of systolic, diastolic, and mean blood

pressure, and pulse rate.

SpO2Measurement of oxygen saturation and pulse rate within the

specified accuracy/error limits.

Alarming on oxygen saturation and pulse rate limit violation.

Temperature (tympanic) Measurement of temperature within specified accuracy/error

limits.

Alarming on temperature limit violation.

Toco extern Measurement of the external Toco ± 5 units on display and

recorder (with paper adjusted).

Toco intern (IUP) Measurement of the internal Toco within specified accuracy limits

on display and recorder (with paper adjusted).

Ultrasound Measurement of the fetal heart rate ± 5 bpm on display and

recorder (with paper adjusted).

Ultrasound energy within safe limits for continuous operation:

p_ < 1 MPa, Iob < 20 mW/cm2, Ispta < 100 mW/cm2.

Measurement Essential Performance

30 Specifications and Standards Compliance

297

Fetal Monitors

Battery Specifications

Measurement Essential Performance

All After electrostatic discharge, fast transients/bursts, surges and electro surgery

interference, the equipment will return to previous operation mode within

10 seconds (SpO2 30 seconds) without loss of any stored data.

After voltage interruptions the equipment returns to previous state without

operator intervention and loss of data.

Fetal Monitor Performance Specifications

Alarm Signal System alarm delay.

The system alarm delay is the processing

time the system needs for any alarm to be

indicated on the fetal monitor, after the

measurement has triggered the alarm.

less than 4 seconds

Pause duration 1, 2, 3 minutes or infinite, depending on the

configuration

Extended alarm pause 5 to 10 minutes

Sound pressure range min. 0 dB(A) max. 45-85 dB(A)

Review Alarms Information all alarms/INOPs, main alarms on/off, alarm

silence and time of occurrence

Capacity 300 items

Real time Clock Range from: January 1, 1997, 00:00 to:

December 31, 2080, 23:59

Accuracy better than ±1 min. per month

Hold Time infinite if powered by AC; otherwise at least

48 hours

Buffered Memory Hold Time if powered by AC infinite

without power: at least 8 hours

Contents active settings, review alarms, stored trace data

Performance Specifications

Avalon FM20/30 Battery

Option #E25

Operating Time (with new,

fully charged battery)

Basic monitoring configuration: >2 hours

(Display Brightness: 70%, Recorder: "On" at 3 cm/min,

NBP: Auto Mode at 15 min, 2 US Transducers, 1 Toco+

with MECG, 1 Patient Module with DECG)

Charge Time When monitor is off: approx. 6 hours

When monitor is in use: more than 10 hours (depending

on monitor configuration)

30 Specifications and Standards Compliance

298

Fetal / Maternal Specifications

Ultrasound

Complies with IEC 60601-2-37:2007 / EN 60601-2-37:2008

Performance Specification

Avalon CL Transducer

Battery

Operating time With a new and fully charged battery min.

10 hours

Charge time From a "low battery" indication to a "fully

charged" indication <3 hours

Charge time with Avalon FM20/30

Battery Option #E25

From a "low battery" indication to a "fully

charged" indication >6 hours.

Performance Specification

Avalon CL F&M Battery Operating time With a new and fully charged battery min.

16 hours

Charge time From a "low battery" indication to a "fully

charged" indication <3 hours

Charge time with Avalon FM20/30

Battery Option #E25

From a "low battery" indication to a "fully

charged" indication >6 hours.

Performance Specification

Avalon CL Wide Range

Pod Battery

Operating time With a new and fully charged battery min. 4 hours

Charge time From a "low battery" indication to a "fully

charged" indication <3 hours

Performance Specifications

Ultrasound

Measurement Method Ultrasound Pulse Doppler

Measurement Range US 50-240 bpm

Resolution Display 1 bpm

Printer 1/4 bpm

Jitter @ 200 bpm ≤3 bpm

Display Update Rate 1 per second

30 Specifications and Standards Compliance

299

Toco

US Intensity (M2736A/AA) Average output power P = (7.4 ± 0.4) mW

Peak-negative acoustic pressure p_ = (40.4 ± 4.3) kPa

Output beam intensity (Iob)

(= spatial average - temporal average

intensity)

Isata = (2.38 ± 0.59) mW/cm2

Spatial-peak temporal average intensity Ispta = (15.0 ± 3.2) mW/cm2

Effective radiating area @ -12 dB (3.11 ± 0.74) cm2

Thermal index (TI) and mechanical index (MI) are always below 1.0.

US Intensity CL (866076) Average output power P = (12.4 ± 0.4) mW

Peak-negative acoustic pressure p_ = (49.1 ± 5.2) kPa

Output beam intensity (Iob)

(= spatial average - temporal average

intensity)

Isata = (2.77 ± 0.56) mW/cm2

Spatial-peak temporal average intensity Ispta = (21.1 ± 5.1) mW/cm2

Effective radiating area @ -12 dB A-12dB = (4.47 ± 0.89) cm2

Thermal index (TI) and mechanical index (MI) are always below 1.0.

Signal Quality Indication Poor Quality empty

Acceptable Quality half-full

Good Quality full

Beat-to-Beat change (max.) for Ultrasound 28 bpm

US Frequency 1 MHz ± 100 Hz

US Signal range 3.5 μVpp-350 μVpp @ 200 Hz

US Burst Repetition Rate 3.0 kHz

Duration ≤100 μs

FMP Signal Range @ 33 Hz 200 μVpp-40 mVpp

Performance Specifications

Toco

Measurement Method Strain Gauge Sensor Element

Sensitivity 1 unit = 2.5 g

Resolution Display 1 unit

Printer 1/4 unit

Measurement Range 400 units

Signal Range 0-127 units

Maximum Offset Range -300 units

Baseline Setting 20 units

30 Specifications and Standards Compliance

300

IUP

ECG

Complies with IEC 60601-2-27:2011 / EN 60601-2-27:2014 except clauses listed below:

• 201.6.2, 201.8.5.5

• 201.12.1.101

• 202.6.2.101

Update Rate Display 1 per second

Printer ~4 per second

Auto Offset Correction 3 seconds after connecting the transducer, the Toco value is set

to 20 units

Auto Zero Adjust Toco value is set to zero following a negative measurement

value for 5 seconds

Performance Specifications

Maternal Pulse from Toco

Emitted Light Energy ≤15 mW

Wavelength Range 780-1100 nm

Range 40-240 bpm

Resolution 1 bpm

Display Update Rate 1 per second

Accuracy ± 2% or 1 bpm, whichever is greater

Update Rate every 4 seconds

Performance Specifications

IUP

Measurement Method Passive Resistive Strain Gauge Elements

Measurement Range -100-+300 mmHg

Signal Range -99-127 mmHg or (-13.2-16.9 kPa)

Resolution Display 1 mmHg

Printer 1/4 mmHg

Sensitivity 5 μV/V/mmHg

Offset Compensation +100- -200 mmHg

Accuracy (not including sensor accuracy) ±0.5% per 100 mmHg

Update Rate Display 1 per second

Printer ~4 per second

Auto Offset Correction 3 seconds after connecting the transducer, the IUP value is

set to 0 mmHg

30 Specifications and Standards Compliance

301

WARNING

The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal

ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the

ECG waveform.

When in doubt, it can be used to identify sources of compromised signal quality, such as noise or

muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them

(e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration).

The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS, and T

segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated.

Performance Specifications

ECG

Performance Specifications Type DECG Single Lead ECG (derived from Fetal Scalp

Electrode)

MECG Single Lead ECG (derived from RA and LA

electrodes)

Measurement Range 30-240 bpm

Resolution Display 1 bpm (display update rate 1 per second)

Recorder 1/4 bpm

Wave Speed (Global Speed) 6.25 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/

sec

Accuracy ±1 bpm or 1%, whichever is greater (non-

averaging)

Beat-to-Beat change (max.) MECG: 28 bpm

DECG: 28 bpm (with Artifact Suppression On)

Differential Input Impedance >15MΩ

Electrode Offset Potential Tolerance ±400 mV

INOP Auxiliary Current (Leads Off Detection) <100 μA

Input Signal Range DECG 20 μVpp-6 mVpp

MECG 150 μVpp-6 mVpp

Dielectric Strength 1500 Vrms

Defibrillator Protection None

ESU Protection None

Paced pulse detection None

30 Specifications and Standards Compliance

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Fetal Heart Rate (Ultrasound/DECG) Alarm Specifications

FHR Alarm Limits Range Bradycardia (low limit) 60-200 bpm adjustable in 10 bpm

steps

Default: 110 bpm

Tachycardia (high limit) 70-210 bpm adjustable in 10 bpm

steps

Default: 170 bpm

FHR Alarm Delay Range Bradycardia (low limit) Delay 10-300 seconds in steps of 10

seconds + system alarm delay

Default: 240 seconds

Tachycardia (high limit) Delay 10-300 seconds in steps of

10 seconds + system alarm delay

Default: 300 seconds

Signal Loss Delay 10-30 seconds in steps of

10 seconds + system alarm delay

MECG Alarm

Specifications

Range Adjustment Alarm Delay

MECG Alarm Limits High Range: 31-240 bpm

Default: 120 bpm

1 bpm steps (30-40 bpm)

5 bpm steps (40-240 bpm)

System alarm delay (see

“Fetal Monitors” on

page 297).

Low Range: 30-235 bpm

Default: 50 bpm

Extreme Tachycardia Difference to high limit: 0-

50 bpm

Default: 20 bpm

5 bpm steps

Clamping at: 150-240 bpm

Default: 200 bpm

5 bpm steps

Extreme Bradycardia Difference to low limit: 0-

50 bpm

Default: 20 bpm

5 bpm steps

Clamping at: 30-100 bpm

Default: 40 bpm

5 bpm steps

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

Heart Rate Averaging Method The maternal heart rate is computed by averaging the 12 most recent R-R

intervals. If each of three consecutive R-R intervals is greater than 1200 ms (i.e.

rate less than 50 bpm), then the four most recent R-R intervals are averaged to

compute the HR.

Display Update Rate 2 seconds

Ventricular tachycardia alarm for

waveforms B1 and B2

No heart rate is detected for waveforms B1 and B2, resulting in *** Extreme Brady

alarm

30 Specifications and Standards Compliance

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aFHR, aHR, aToco

Response Time of Heart Rate

Meter to Change in Heart Rate

HR change from 80-120 bpm: 10 seconds

HR change from 80-40 bpm: 14 seconds

Tall T-Wave Rejection Capability M2735A 1.2 mV T-Wave amplitude

M2738A 1.4 mV T-Wave amplitude

CL Toco+ MP,

CL ECG/IUP

1.2 mV T-Wave amplitude

Response Time of Heart Rate

meter to Change in Heart Rate

M2735A, M2738A HR change from 80-120 bpm Average: 12 seconds

HR change from 80-40 bpm Average: 15 seconds

CL Toco+ MP,

CL ECG/IUP

HR change from 80-120 bpm Average: 10 seconds

HR change from 80-40 bpm Average: 12 seconds

Heart Rate Meter Accuracy and

Response to Irregular Rhythm

M2735A, M2738A Ventricular bigeminy 40-60 bpm

Slow alternating ventricular bigeminy 45 bpm

Rapid alternating ventricular bigeminy 163 bpm

Bidirectional systoles 63-73 bpm

CL Toco+ MP,

CL ECG/IUP

Ventricular bigeminy 40-60 bpm

Slow alternating ventricular bigeminy 30 bpm

Rapid alternating ventricular bigeminy 70-163 bpm

Bidirectional systoles 63-73 bpm

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

aFHR

Measurement Method electrocardiography

Measurement Range 60-240 bpm

Resolution Display 1 bpm

Printer 1/4 bpm

Accuracy ±1 bpm

aHR

Measurement Method electrocardiography

Measurement Range 40-240 bpm

Resolution Display 1 bpm

Printer 1/4 bpm

Accuracy ±1 bpm

aToco

Measurement Method uterine electromyography

Measurement Range 0-500 μV

30 Specifications and Standards Compliance

304

Noninvasive Blood Pressure

Complies with IEC 80601-2-30:2009 / EN 80601-2-30:2010.

*1: Clinical investigation with the auscultatory reference method

• The 5th Korotkoff sound (K5) was used to determine the diastolic reference pressures.

• The approximation MAP = (2*DIA + SYS) / 3 was used to calculate reference MAP (mean

arterial pressure) values from the systolic and diastolic reference pressures.

Resolution 0-255 levels representing 100% of

the full scale

Accuracy ±5%

aToco

Performance Specifications

Measurement

Ranges

Systolic 30-270 mmHg (4-36 kPa)

Diastolic 10-245 mmHg (1.5-32 kPa)

Mean 20-255 mmHg (2.5-34 kPa)

Accuracy1Max. Std. Deviation: 8 mmHg (1.1 kPa)

Max. Mean Error: ±5 mmHg (±0.7 kPa)

Pulse Rate Range 40-300 bpm

Accuracy (average over

noninvasive blood

pressure measurement

cycle)

40-100 bpm: ±5 bpm

101-200 bpm: ±5% of reading

201-300 bpm: ±10% of reading

Measurement Time Typical at HR >60 bpm

Auto/manual: 30 seconds (adult)

Maximum time: 180 seconds (adult)

Cuff Inflation Time Typical for normal adult cuff: Less than 10 seconds

Initial Cuff Inflation Pressure 165 ±15 mmHg

Auto Mode Repetition Times 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45, 60, or 120 minutes

Venipuncture Mode Inflation

Inflation Pressure 20-120 mmHg (3-16 kPa)

Automatic deflation after 170 seconds

Alarm

Specifications

Range Adjustment Alarm Delay

Systolic Adult: 30-270 mmHg (4-

36 kPa)

10-30 mmHg: 2 mmHg (0.5 kPa)

>30 mmHg: 5 mmHg (1 kPa)

System alarm delay (see

“Fetal Monitors” on

page 297).

Diastolic Adult: 10-245 mmHg (1.5-

32 kPa)

Mean Adult: 20-255 mmHg (2.5-

34 kPa)

30 Specifications and Standards Compliance

305

SpO2

Complies with ISO 80601-2-61:2011 / EN 80601-2-61:2011.

Measurement Validation: The SpO2 accuracy has been validated in human studies against arterial

blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically

distributed, only about two-thirds of the measurements can be expected to fall within the specified

accuracy compared to CO-oximeter measurements.

Display Update Period: Typical: 2 seconds, maximum: 30 seconds. Maximum with noninvasive blood

pressure INOP suppression on: 60 seconds.

Overpressure Settings Adjustment

> 300 mmHg (40 kPa) > 2 sec not user adjustable

SpO2 Performance Specifications

SpO2

The specified accuracy is

the root-mean-square

(RMS) difference

between the measured

values and the reference

values

Range 0-100%

Accuracy Philips Reusable Sensors:

M1191A/B, M1191AL/BL, M1191ANL, M1192A, M1192AN = 2%

(70%-100%)

M1191T, M1192T, M1194A, M1194AN, M1196A, M1196T = 3%

(70%-100%)

Philips Disposable Sensors with M1943A(L):

M1131A, M1901B, M1903B, M1904B = 3% (70%-100%)

M1133A, M1134A = ±2% (70%-100%)

Nellcor® Sensors with M1943A(L):

MAX-A, MAX-AL, MAX-P, MAX-N, D-25, D-20, N-25, OxiCliq A,

P, N = 3% (70%-100%)

Masimo Reusable Sensors® with LNOP MP12 or LNC MP10:

LNOP DC-I, LNOP DC-IP, LNOP YI, LNCS DC-I, LNCS DC-IP:

2% (70%-100%)

LNOP TC-I, LNCS TC-I: 3.5% (70%-100%)

Masimo Disposable Sensors® with LNOP MP12 or LNC

MP10:

LNOP Adt, LNOP Adtx, LNOP Pdt, LNOP Pdtx, LNCS Adtx,

LNCS Pdtx: 2% (70%-100%)

LNOP Neo-L, LNCS Neo-L: 3% (70%-100%)

Resolution 1%

Pulse Range 30-300 bpm

Accuracy ±2% or 1 bpm, whichever is greater

Resolution 1 bpm

30 Specifications and Standards Compliance

306

Tympanic Temperature

Complies with:

• EN 12470-5 (Clinical thermometers - Part 5:2003: Performance of infra-red thermometers)

• ASTM E1965-98 (Infrared Thermometers for Intermittent Determination of Patient

Temperature)

with minor exceptions as noted below.

The fetal monitor additionally complies with ISO 80601-2-56:2009 / EN ISO 80601-2-56:2012.

Sensors Wavelength range 500-1000 nm.

Information about the wavelength range can be especially useful to

clinicians (for instance, when photodynamic therapy is performed).

Emitted Light

Energy

≤15mW

Pulse Oximeter Calibration Range 70%-100%

SpO2 Performance Specifications

SpO2 Alarm Specifications Range Adjustment Delay

SpO250-100% 1% steps (0, 1, 2, 3,... 30) +

4 seconds

Desat 50-Low alarm limit 1% steps

Pulse 30-300 bpm 1 bpm steps (30-40 bpm)

5 bpm steps (40-300 bpm)

max. 14 seconds

Tachycardia Difference to high limit 0-50 bpm 5 bpm steps max. 14 seconds

Clamping at 150-300 bpm 5 bpm steps

Bradycardia Difference to low limit 0-50 bpm 5 bpm steps max. 14 seconds

Clamping at 30-100 bpm 5 bpm steps

Performance Specifications

Temperature Resolution 0.1°C or 0.1°F

Response Time less than 2 seconds

Temperature Calibrated Accuracy Specifications (out of the Factory)

Ambient Temperature Target Temperature Accuracy

25.0°C (77.0°F) 37.7°C-38.9°C (98.4°F-102.0°F) ±0.1°C (±0.2°F)

16.0°C-33.0°C (60.8°F-91.4°F) 33.0°C-42.0°C (91.4°F-107.6°F) ±0.2°C (±0.4°F)

Temperature Calibrated Accuracy Specifications (after recalibration using Genius 2 Checker/Calibrator)

Ambient Temperature Target Temperature Accuracy

16.0°C-33.0°C (60.8°F-91.4°F) 36.0°C-39.0°C (96.8°F-102.2°F) ±0.2°C (±0.4°F)

30 Specifications and Standards Compliance

307

16.0°C-33.0°C (60.8°F-91.4°F) <36.0°C or >39.0°C

(<96.8°F or >102.2°F)

±0.3°C (±0.5°F)

ASTM laboratory requirement for IR thermometers in the display range 37.0°C-39.0°C (98.0°F-102.0°F) is ±0.2°C

(±0.4°F), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM standards E667-86

and E1112-86 is ±0.1°C (±0.2°F).

Clinical accuracy characteristics and procedures are available from Covidien llc on request. To verify the accuracy, use

a certified black body as specified in EN ISO 80601-2-56, Annex C, or use a Genius 2 Checker/Calibrator - available

from Covidien llc under part number 303097.

Clinical repeatability: meets section A.5 of EN ISO 80601-2-56(E) per Covidien llc technical report. Data is available

from Covidien llc on request.

Performance Specifications

Displayed Temperature Measurement Range

Mode Range °C Range °F

Ear 33.0-42.0°C 91.4-107.6°F

Oral (ear + 0.6°C) 33.6-42.0°C 92.5-107.6°F

Core (ear + 1.04°C) 34.0-42.0°C 93.2-107.6°F

Rectal (ear + 1.16°C) 34.2-42.0°C 93.6-107.6°F

Caution: ASTM E1965-98 specifies 34.4°C-42.2°C (94°F-108°F)

Ambient Temperature Range

Mode Range °C Range °F

Operating 10%-95% RH, non-

condensing

16.0-33.0°C 60.8-91.4°F

Storage up to 95% RH, non-

condensing

-25.0-55.0°C -13.0-131.0°F

Caution: EN ISO 80601-2-56 specifies 16.0°C-35.0°C (60.8°F-95.0°F), 10%-95% RH, non-condensing

ASTM E1965-98 specifies 16.0°C-40.0°C (60.8°F-104.0°F), up to 95% RH, non-condensing

Storing the thermometer outside the specified temperature/humidity range might adversely affect measurement

accuracy. Check the calibration after storage in uncertain conditions.

Tympanic Temperature Alarm Specifications

Range 33.0°C-42.0°C (91.0°F-108.0°F)

Adjustment 0.5°C steps (33.0°C-35.0°C)

0.1°C steps (35.0°C-42.0°C)

1.0°F steps (91.0°F-95.0°F)

0.2°F steps (95.0°F-108.0°F)

Alarm delay System alarm delay (see “Fetal Monitors” on page 297).

30 Specifications and Standards Compliance

308

Physical Specifications

Recorder Specifications

Thermometer

Dimensions 190 mm x 43 mm x 55 mm (±3 mm)

Cable length 60 ±5 cm (spiral cable relaxed)

250 ±15 cm (spiral cable extended)

Weight (including cable) 180 ±10 g

Ingress protection classification IP 21

Base Station

Dimensions 205 mm x 65 mm x 75 mm (±3 mm)

Weight (excluding cable) 400 g ±10 g

Built-in Thermal Array Fetal Trace Recorder

Mechanism Thermal Array Recorder

Paper & Printing Type Standard Z-fold paper

Standard Speeds (real-time traces) 3 cm/min, 2 cm/min, 1 cm/min

Fast Print Speed (stored traces) Max. 20 mm/s

Print speed is variable and depends on

the print load

ECG Wave Print Speed

(not real-time)

Emulated 25 mm/s

Print speed is variable and depends on

the print load

Paper Advance 20 mm/s

Sensing Optical Reflex Sensor for black page

marks

Accuracy @ 3 cm/min, 2 cm/min,

1 cm/min

±5 mm/page

Usable Print Width 128 mm

Resolution 8 dots/mm (200 dpi)

Time Delay to see trace on paper <30s @ 1 cm/min

Trace Separation Offset for FHR

(Ultrasound and DECG)

Twin Standard FHR2 +20 bpm

Classic FHR1 +20 bpm

in the presence of FHR2

Triplet Standard FHR2 +20 bpm

FHR3 -20 bpm

Classic FHR1 +20 bpm

FHR3 -20 bpm

in the presence of FHR2 and/or FHR3

30 Specifications and Standards Compliance

309

Recorder Symbols

Symbol Description

Parameter is capable of alarming and alarms were enabled at the time of printing the annotation.

The low limit is printed before the symbol, and the high limit after it.

Parameter is capable of alarming, but alarms were disabled at the time of printing the annotation.

(Note: There is no alarm related annotation at all if a parameter does not have alarming

capability.)

FMP detection is on

Beginning of the date/time annotation

Warning (INOP)

Measurement from a cableless transducer (printed next to measurement label)

Measurement from a cableless measurement Pods

Measurement from cableless devices connected with WLAN (CL Wide Range Pod)

Pulse from SpO2

Pulse from Toco MP

Pulse from NBP

Trace separation +20 bpm (in label)

Trace separation -20 bpm (in label)

Trace separation Off (in trace)

Trace separation +20 bpm (in trace)

30 Specifications and Standards Compliance

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External Displays: FM40/FM50 Only

External displays can be connected with a maximum cable run of 10 m. External displays must be

approved for medical use (IEC 60601-1). The video output of the Avalon FM40/FM50 has VGA

resolution.

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 for local contact information at: www.healthcare.philips.com

Trademark Acknowledgment

OxisensorTM II, Oxi-CliqTM, and OxiMaxTM are trademarks of Tyco Healthcare Group LP, Nellcor

Puritan Bennett Division.

Trace separation -20 bpm (in trace)

Trace separation +20 bpm and -20 bpm (in trace)

Coincidence of heart rates is detected

Marker

Special wave, with different speed and scale (for example, fast printout of MECG wave on

FM30)

Recorder Symbols

Symbol Description

30 Specifications and Standards Compliance

311

Regulatory and Standards Compliance

The fetal monitors are in conformity with the requirements of the European Medical Devices

Directive 93/42/EEC and bear the CE marking:

The fetal monitors are classified into Class IIb according to Annex IX rule 10.

The Avalon CL Transducer System is in conformity with the requirements of the European Radio

Equipment and Telecommunications Terminal Equipment Directive 99/5/EC. The Avalon CL base

station used in this system is class 1 and the Avalon CL transducers of this system are class 1 under the

scope of the R&TTE Directive.

To obtain a copy of the original Declaration of Conformity, please contact Philips at the address given

in the “Manufacturer's Information” on page 310 section of this manual.

Safety and Performance

The fetal monitors comply with the following major international safety and performance standards:

• IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013

• IEC 60601-1-6:2010 / EN 60601-1-6:2013

• IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+AC:2013

• IEC 60601-2-49:2011 / EN 60601-2-49:2015

• ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010

• CAN/CSA C22.2#60601-1-08

• JIS T 1303 2005

• AS/NZS 3200.1.0-1998

The possibility of hazards arising from hardware and software errors was minimized in compliance

with ISO 14971:2012, IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013.

Alarm sounds are compliant with Standard IEC 60601-1-8:2006+A1:2012 / EN 60601-1-

8:2007+A1:2013+AC:2014.

Compatibility

When your fetal monitor is compliant with IEC 60601-1:1988+A1:1991+A2:1995 / EN 60601-

1:1990+A1:1993+A2:1995 (Edition 2) and related standards, it can still be used with the Avalon

CL Transducer System and the software upgrade J.3 or higher, and all measurement accessories that

are compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013 (Edition 3) and related

standards.

When your fetal monitor is compliant with IEC 60601-1:2005+A1:2012 / EN 60601-

1:2006+AC:2013 (Edition 3) and related standards, it can still be used with the Avalon CTS

Transducer System, and all measurement accessories that are compliant with

IEC 60601-1:1988+A1:1991+A2:1995 / EN 60601-1:1990+A1:1993+A2:1995 (Edition 2) and

related standards.

30 Specifications and Standards Compliance

312

Radio

The Avalon CL Transducer System complies with the following major international radio standards:

• ETSI EN 300 220-1:2012

• ETSI EN 300 220-2:2012

• ETSI EN 301 489-1:2011

• ETSI EN 301 489-3:2013

• FCC 47 CFR Part 95

• IC RSS-210 Issue 8

•ARIB STD-T108

• ETSI EN 300 328:2012

• ETSI EN 301 489-17:2012

• FCC 47 CFR Part 2 & 15

• AS/NSZ 4268

•ARIB STD-T66

Safety Tests Fetal Monitor

All the safety tests and procedures required after an installation, or an exchange of system components

are described in your monitor's Service Guide. These safety tests are derived from international

standards, but may not be sufficient to meet local requirements.

WARNING

• Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple

portable socket-outlet is used, the resulting system must be compliant with IEC 60601-

1:2005+A1:2012 / EN 60601-1:2006+AC:2013

• Do not connect any devices that are not supported as part of a system.

• Do not use a device in the patient vicinity if it does not comply with IEC 60601-

1:2005+A1:2012 / EN 60601-1:2006+AC:2013. The whole installation, including devices outside

of the patient vicinity, must comply with IEC 60601-1:2005+A1:2012 /

EN 60601-1:2006+AC:2013. Any non-medical device, including a PC running an OB TraceVue/

IntelliSpace Perinatal system, placed and operated in the patient's vicinity must be powered via a

separating transformer (compliant with IEC 60601-1:2005+A1:2012 /

EN 60601-1:2006+AC:2013) that ensures mechanical fixing of the power cords and covering of

any unused power outlets.

• Do not use USB devices with own power supplies, unless an appropriate separation device is used,

(either between USB interface and device or between device and power).

During the installation the fetal monitor is configured for your environment. This configuration

defines your custom default settings you work with when you switch on your fetal monitor. See the

fetal monitor's Service Guide and the Configuration Guide for details on how to configure your fetal

monitor.

30 Specifications and Standards Compliance

313

Electromagnetic Compatibility (EMC)

The device and its accessories, listed in the accessories section, comply with the following EMC

standards:

• IEC 60601-1-2:2007 / EN 60601-1-2:2007+AC:2010

Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical

equipment. You must operate your monitoring equipment according to the EMC information

provided in this book. Before using the device, assess the electromagnetic compatibility of the device

with surrounding equipment.

This ISM device complies with Canadian ICES-003:2012. Cet appareil ISM est conforme à la norme

NMB-003 du Canada.

CAUTION

•FM20/FM30 only: Although this is an electrical Class II device, it has a protective earth

conductor which is needed for EMC purposes.

• Always use the supplied power cord with the three-prong plug to connect the monitor to AC

mains. Never adapt the three-prong plug from the power supply to fit a two-slot outlet.

WARNING

The use of accessories, transducers, and cables other than those specified, may result in increased

electromagnetic emissions, or decreased electromagnetic immunity of the device.

WARNING

Do not use cordless/mobile phones, or any other portable RF communication system within the

patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system.

WARNING

For paced patients: The radiated SRR power of the CL SpO2 and CL NBP Maternal Cableless

Measurement Devices, and other sources of radio-frequency energy, when used in very close proximity

of a pacemaker, might be sufficient to interfere with pacemaker performance. Due to shielding effects

of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However,

caution should be exercised when monitoring paced patients.

In order to minimize the possibility of interference, avoid positioning and wearing the Cableless

Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer

for information on the RF susceptibility of their products.

30 Specifications and Standards Compliance

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EMC Testing

CAUTION

Fetal parameters, especially ultrasound and ECG, are sensitive measurements involving small signals,

and the monitoring equipment contains very sensitive high gain front-end amplifiers. Immunity levels

for radiated RF electromagnetic fields and conducted disturbances induced by RF fields are subject to

technological limitations. To ensure that external electromagnetic fields do not cause erroneous

measurements, it is recommended to avoid the use of electrically radiating equipment in close

proximity to these measurements.

Reducing Electromagnetic Interference

WARNING

The device should not be used adjacent to, or stacked with, other equipment unless otherwise

specified.

The product and associated accessories can be susceptible to interference from continuous, repetitive,

power line bursts, and other RF energy sources, even if the other equipment is compliant with

EN 60601-1-2 emission requirements. Examples of other sources of RF interference are other medical

electrical devices, cellular products, information technology equipment, and radio/television

transmissions.

When electromagnetic interference (EMI) is encountered, for example, if you can hear spurious noises

on the fetal monitor's loudspeaker, attempt to locate the source. Assess the following:

• Is the interference due to misplaced or poorly applied transducers? If so, re-apply transducers

correctly according to directions in this book, or in the Instructions for Use accompanying the

accessory.

• Is the interference intermittent or constant?

• Does the interference occur only in certain locations?

• Does the interference occur only when in close proximity to certain medical electrical equipment?

Once the source is located, there are a number of things that can be done to mitigate the problem:

1Eliminating the source. Turn off or move possible sources of EMI to reduce their strength.

2Attenuating the coupling. If the coupling path is through the patient leads, the interference may be

reduced by moving and/or rearranging the leads. If the coupling is through the power cord,

connecting the system to a different circuit may help.

3Adding external attenuators. If EMI becomes an unusually difficult problem, external devices such

as an isolation transformer or a transient suppressor may be of help. Your service provider can be

of help in determining the need for external devices.

Where it has been established that electromagnetic interference is affecting physiological parameter

measurement values, a physician, or a suitably qualified person authorized by a physician, should

determine if it will negatively impact patient diagnosis or treatment.

30 Specifications and Standards Compliance

315

System Characteristics

The phenomena discussed above are not unique to this system, but are characteristic of fetal patient

monitoring equipment in use today. This performance is due to very sensitive high gain front end

amplifiers required to process the small physiological signals from the patient. Among the various

monitoring systems already in clinical use, interference from electromagnetic sources is rarely a

problem.

Electromagnetic Emissions and Immunity

The EMC standards state that manufacturers of patient-coupled equipment must specify immunity

levels for their systems. See Tables 1 to 4 for this detailed immunity information. See Table 5 for

recommended minimum separation distances between portable and mobile communications

equipment and the product.

Immunity is defined in the standard as the ability of a system to perform without degradation in the

presence of an electromagnetic disturbance.

Caution should be exercised in comparing immunity levels between different devices. The criteria used

for degradation are not always specified by the standard, and can therefore vary with the manufacturer.

In the table below, the term "device" refers to the Avalon FM20/30/40/50 fetal monitor together with

its accessories. The table gives details of the electromagnetic emissions, and how these are classified,

for the device, and the electromagnetic environments in which the device is specified to technically

function.

Table 1 - Guidance and Manufacturer's Declaration: Electromagnetic Emissions

Emissions Test Compliance Avoiding Electromagnetic Interference

Radiofrequency (RF) emissions Group 1 The device 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.

Harmonic emissions IEC 61000-3-2 Class A

Voltage fluctuations and flicker IEC 61000-3-3 complies

30 Specifications and Standards Compliance

316

1 Note that the device is not intended for home use.

Electromagnetic Immunity

The monitor is suitable for use in the specified electromagnetic environment. The user must ensure

that it is used in the appropriate environment as described below.

RF emissions CISPR 11

For the Avalon FM20/30 fetal monitor with all

accessories except the IUP/ECG patient

module M2738A.

Class B The device is suitable for use in all

establishments, including domestic

establishments and those directly connected to

the public low-voltage supply network that

supplies buildings used for domestic purposes1.

RF emissions CISPR 11

For the Avalon FM40/FM50 with all

accessories.

For the Avalon FM20/30 fetal monitor

whenever used with the IUP/ECG patient

module M2738A.

For the Avalon CTS Interface Cable (M2731-

60001/M2732-60001) whenever used with the

Avalon CTS Cableless Fetal Transducer System.

For the Avalon CL Base Station with cableless

transducers whenever used with the fetal

monitors.

Class A The device is suitable for use in all

establishments other than domestic

establishments and those directly connected to

the public low-voltage supply network that

supplies buildings used for domestic purposes.

Table 1 - Guidance and Manufacturer's Declaration: Electromagnetic Emissions

Emissions Test Compliance Avoiding Electromagnetic Interference

Table 2 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity

Immunity Test IEC 60601-1-2 Test

Level

Compliance Level Electromagnetic Environment

Guidance

Electrostatic discharge

(ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete, or

ceramic tile. If floors are covered with

synthetic material, the relative humidity

should be at least 30%.

Electrical fast transient/

burst

IEC 61000-4-4

±2 kV for power

supply lines

±1 kV for input/

output lines

±2 kV for power supply

lines

±1 kV for input/output

lines

Mains power quality should be that of a

typical commercial and/or hospital

environment

Surge

IEC 61000-4-5

±1 kV differential

mode

±2 kV common mode

±1 kV differential mode

±2 kV common mode

Mains power quality should be that of a

typical commercial and/or hospital

environment

30 Specifications and Standards Compliance

317

Radio Compliance Notice

Avalon CL with WMTS

Operation of this equipment requires the prior coordination with a frequency coordinator designated

by the FCC for the Wireless Medical Telemetry Service.

This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is

subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this

device must accept any interference received, including interference that may cause undesired

operation. Any changes or modifications to this equipment not expressly approved by Philips Medical

Systems may cause harmful radio frequency interference and void your authority to operate this

equipment.

Radio Information Canada

Installation of this telemetry device is permitted in hospitals and health care facilities only. This device

shall not be operated in mobile vehicles (including ambulances and other vehicles associated with

health care facilities). The installer/user of this device shall ensure that it is at least 80 km from the

Dominion Radio Astrophysical Observatory (DRAO) near Penticton, British Columbia. The

coordinates of DRAO are: latitude N 49E 19' 15", longitude W 119° 37′ 12″. For medical telemetry

systems not meeting this 80 km separation (e.g. the Okanagan Valley, British Columbia) the installer/

user must coordinate with, and obtain the written concurrence of, the Director of DRAO before the

equipment can be installed or operated. The Director of DRAO may be contacted at 250-497-2300

(telephone) or 250-497-2355 (fax). (Alternatively, the Manager, Regulatory Standards, Industry Canada,

may be contacted.)

Voltage dips, short

interruptions and voltage

variations on power

supply input lines

IEC 61000-4-11

<5% UT (>95% dip in

UT) for 0.5 cycles

<5% UT (>95% dip in

UT) for 0.5 cycles

Mains power quality should be that of a

typical commercial and/or hospital

environment. If the user of the device

requires continued operation during

power mains interruptions, it is

recommended that the device is

powered from an uninterruptible power

supply.

40% UT (60% dip

in UT) for 5 cycles

40% UT (60% dip in UT)

for 5 cycles

70% UT

(30% dip in UT) for

25 cycles

70% UT (30% dip in UT)

for 25 cycles

< 5% UT

(>95% dip in UT) for

5 sec

< 5%UT (>95% dip in

UT) for 5 sec

Power frequency (50/

60 Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should

be at levels characteristic of a typical

location in a typical commercial and/or

hospital environment

Key: UT is the AC mains voltage prior to application of the test level.

Table 2 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity

Immunity Test IEC 60601-1-2 Test

Level

Compliance Level Electromagnetic Environment

Guidance

30 Specifications and Standards Compliance

318

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts

de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas produire

de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si

le brouillage est susceptible d'en compromettre le fonctionnement.

L'utilisation de cet appareil de télémesure est permise seulement dans les hôpitaux et établissements de

soins de santé. Cet appareil ne doit pas être mis en marche dans des véhicules (y compris les

ambulances et autres véhicules associés aux établissements de santé). La personne qui installe/utilise

cet appareil doit s’assurer qu’il se trouve à au moins 80 km de l’Observatoire fédéral de

radioastrophysique (OFR) de Penticton en Colombie-Britannique. Les coordonnées de l’OFR sont:

latitude N 49° 19’ 15», longitude O 119° 37 12 ′′. La personne qui installe/utilise un système de

télémesure médicale ne pouvant respecter cette distance de 80 km (p. ex. dans la vallée de l’Okanagan

(Colombie-Britannique), doit se concerter avec le directeur de l’OFR et obtenir de sa part une

autorisation écrite avant que l’équipement ne puisse être installé ou mis en marche. Le directeur de l’

OFR peut être contacté au 250-497-2300 (tél.) ou au 250-497-2355 (télécopieur). (Le Directeur des

Norm es réglementaires d’Industrie Canada peut également être contacté).

Avalon CL with T108

Japanese Radio Law and Japanese Telecommunications Business Law Compliance.

This device should not be modified (otherwise the granted designation number will become invalid).

Finding Recommended Separation Distances

In the following table, P is the maximum output power rating of the transmitter in watts (W) according

to the transmitter manufacturer, and d is the recommended separation distance in meters (m).

Portable and mobile RF communications equipment should be used no closer to any part of the

device, including cables, than the recommended separation distance calculated from the equation

appropriate for the frequency of the transmitter.

Field strengths from fixed transmitters, such as land mobile radios, base stations for radio telephones

(e.g. cellular, cordless), 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.

Interference may occur in the vicinity of equipment marked with this symbol:

30 Specifications and Standards Compliance

319

Field strengths from fixed transmitters, such as base stations, or 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

Table 3 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity

Conducted RF Immunity Test EN/IEC 61000-4-6

IEC 60601-1-2 Test Level

over 150 kHz to 80 MHz Compliance Level

Electromagnetic Environment Guidance:

Recommended Separation Distance (d)

(in Meters, at Frequency Range Tested)

for Ultrasound and ECG Measurements

3.0 VRMS 3.0 VRMS d = 1, 2√P

Key: d = Recommended separation distance in meters (m)

P = maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer

V1 = Tested compliance level (in Volts) for the Conducted RF Immunity test IEC 61000-4-6

The device meets the compliance level of 3.0 VRMS according to IEC 60601-1-2 over the specified test frequency

range. Over the frequency range 150 kHz—80 MHz, the recommended separation distance in meters (d) is found by

the following equation:

For a compliance level of 3.0 VRMS:d = 1, 2√P

Table 4 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity

Radiated RF Immunity Test EN/IEC 61000-4-3

IEC 60601-1-2 Test Level

over 80 MHz to 2.5 GHz Compliance Level

Electromagnetic Environment Guidance:

Recommended Separation Distance (d)

(in Meters, at Frequency Range Tested)

for Ultrasound and ECG Measurements

3.0 V/m 3.0 V/m Over 80 MHz—800 MHz:d = 1, 2√P

Over 800 MHz—2.5 GHz:d = 2, 3√P

Key: d = Recommended separation distance in meters (m)

P = maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer

E1 = Tested compliance level (in Volts/meter) for the Radiated RF Immunity test IEC 61000-4-3

The device meets the compliance level of 3.0 VRMS according to IEC 60601-1-2 over the specified test frequency

range.

Over the frequency range 80 MHz—800 MHz, the recommended separation distance in meters (d) is found by the

following equation:

For a compliance level of 3.0 VRMS:d = 1, 2√P

Over the frequency range 800 MHz—2.5 GHz, the recommended separation distance in meters (d) is found by the

following equation:

For a compliance level of 3.0 VRMS:d = 2, 3√P

30 Specifications and Standards Compliance

320

location in which the device is used exceeds the applicable RF compliance level above, it should be

observed to verify normal operation. If abnormal performance is observed, additional measures may

be necessary, such as reorienting or relocating the device.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects, and people.

If you require further information or assistance, please contact Philips Support.

Recommended Separation Distances from Other RF Equipment

The device is intended for use in an electromagnetic environment in which radiated RF disturbances

are controlled. The customer or user of the device can help prevent electromagnetic interference by

maintaining a minimum distance between portable and mobile RF communications equipment and the

device as recommended below, according to the maximum output power of the communications

equipment.

Radio Frequency Radiation Exposure Information

The radiated output power of the Avalon CL Transducer System is far below the FCC radio frequency

exposure limits.

CL Wide Range Pod

For body worn operation, this device has been tested and meets FCC RF exposure guidelines when

used in the standard configuration with the rear side towards the body, without a gap. Alternatively, it

can be used with any accessory that positions the front side of the device a minimum of 10 mm from

the body. The accessory itself must not contain any metal parts. Use of other accessories may not

ensure compliance with FCC RF exposure guidelines.

Nevertheless it is strongly recommended to operate the CL Wide Range Pod with the rear side towards

the body to achieve best possible radio performance.

Table 5 - Separation Distance (d) in Meters According to Frequency of Transmitter at IEC 60601-1-2 Test

Compliance Level

Rated Maximum Output

Power (P) of Transmitter (in

Watts)

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01 W d= 0.1 m d= 0.1 m d= 0.23 m

0.1 W d= 0.4 m d= 0.4 m d= 0.7 m

1 W d= 1.2 m d= 1.2 m d= 2.3 m

10 W d= 3.8 m d= 3.8 m d= 7.3 m

100 W d= 12.0 m d= 12.0 m d= 23.0 m

30 Specifications and Standards Compliance

321

Environment

Before operation, make sure that the fetal monitor is free from condensation. This can form when

equipment is moved from one building to another, and is exposed to moisture and differences in

temperature.

Use the monitor in an environment which is reasonably free from vibration, dust, corrosive or

explosive gasses, extremes of temperature, humidity, and so forth. It operates within specifications at

ambient temperatures between 0-+45°C (32°F-113°F). Ambient temperatures that exceed these limits

can affect the accuracy of the system, and can damage the components and circuits.

Ambient temperature ranges for storage are -20°C-+60°C (-4°F-140°F) for the monitor, and -40°C-

+60°C (-40°F-140°F) for transducers.

The transducers are watertight to a depth of 1.0 m for at least five hours (rated IP 68).

WARNING

•Leakage currents: If several items of equipment used to monitor a patient are interconnected,

the resulting leakage current may exceed allowable limits.

•ECG electrodes: NEVER allow ECG electrodes to contact other electrical conductive parts,

including earth.

Monitoring After a Loss of Power

If the monitor is without power for less than one minute, monitoring will resume with all active

settings unchanged. If the monitor is without power for more than one minute, the behavior depends

on your configuration. If Automat. Default is set to Yes, the User Defaults will be loaded when power is

restored. If Automat. Default is set to No, all active settings are retained, if power is restored within

48 hours. The Automat. Default setting is made in Configuration Mode.

FM20/30 with

Battery

Option,

FM40/50

When power is lost - no power is available from the AC power source, or from the battery - a beeper

will sound. The tone can be silenced by pressing the On/Standby button.

ESU, MRI, and Defibrillation

WARNING

The fetal/maternal monitors are NOT intended for use during defibrillation, electro-surgery, or MRI.

Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or

MRI, otherwise harm to the patient or the user can result.

30 Specifications and Standards Compliance

322

Cardiac Pacemakers and Electrical Stimulators

WARNING

The fetal/maternal monitors are not intended for use for ECG measurements on patients connected

to external electrical stimulator, or with cardiac pacemakers.

Fast Transients/Bursts

The equipment will return to the previous operating mode within 10 seconds without loss of any

stored data.

Symbols on the System

These symbols can appear on the monitor and its associated equipment and packaging.

Symbol Description

This safety symbol indicates that you have to consult the Instructions for Use (this document),

and particularly any warning messages. The symbol can be also printed out black and white.

This symbol indicates that you have to consult the Instructions for Use (this document).

This symbol indicates that you should consult the Instructions for Use (this document).

Power-On/Off Switch - FM20/FM30 without Battery Option

Power-On/StandBy button - FM40/FM50 and FM20/30 with Battery Option

Power-On LED

Electrical Class II equipment, in which the protection against electric shock relies on double or

reinforced insulation (FM20/FM30)

Fetal Sensor Socket symbol

SpO2 Socket symbol

30 Specifications and Standards Compliance

323

Noninvasive Blood Pressure Socket symbol

Type BF

Symbol indicating the monitor has the triplets option

Symbol indicating the monitor is capable of intrapartum monitoring

Button to open paper drawer/paper eject. (FM40/FM50)

Protective earth terminal (FM40/FM50)

Equipotential grounding point (FM40/FM50)

Socket for connecting Avalon CTS interface cable M2732-60001 or Avalon CL interface cable

(with black connector, FM40/FM50)

Symbol indication for non-ionizing radiation

Connection direction indicator FM20/FM30 with battery option

Mouse connection indicator (optional)

Keyboard connection indicator (optional)

Serial/MIB connector (optional)

USB interface (optional)

Video Analog interface indicator for connection to any analog video display (VGA resolution) FM40/

FM50

IP 67 Ingress Protection code according to IEC 60529. The IUP/ECG patient module (M2738A) is

rated IP 67 (protection against dust, access to hazardous parts, and the effects of continuous

immersion in water to a depth of 0.5 meter for 30 minutes)

Symbol Description

30 Specifications and Standards Compliance

324

IP 68 Ingress Protection code according to IEC 60529. All transducers (excluding M2738A) are rated

IP 68 (protection against dust, access to hazardous parts, and the effects of continuous

immersion in water to a depth of 1.0 meter for five hours)

IP X1 Ingress Protection code according to IEC 60529. The monitors and interface cable for the

Avalon CTS (M2731-60001/M2732-60001) are rated IP X1 (protection against water dripping

vertically only)

IP 31 Ingress Protection code according to IEC 60529 (protection against condensation only)

IP 21 Ingress Protection code according to IEC 60529 (protection against ingress of water when the

water is dripping vertically)

Type CF equipment, not defibrillation proof

Indicates location of service number

Indicates location of serial number

Indicates location of catalog number

Indicates location of the date of manufacture and/or name and address of manufacturer

Identifies year and month of manufacture

China RoHS

Symbol indicating separate collection for waste electrical and electronic equipment

EAC mark

CSA US mark

FCC ID Federal Communications Commission: FCC ID xxxx

CMIIT ID Chinese Radio marking: CMIIT ID (China Ministry of Industry and Information Technology)

CE marking accompanied by the Notified Body number 0123

Industrial, Scientific, & Medical radio frequency band (Avalon CL frequency band used e.g. in the

EU)

Symbol Description

30 Specifications and Standards Compliance

325

Association Of Radio Industries And Businesses T108 (Avalon CL frequency band used e.g. in

Japan)

Wireless Medical Telemetry Service (Avalon CL frequency band used e.g. in North America)

Symbol Description

IC-ID (Industry Canada ID)

One IC-ID labeling for each built in radio: OBR, SRR

Japanese Radio marking: Radio mark + [R]-symbol +

Taiwan Radio Label (NCC Logo) + ID

Korea radio mark: KC logo, KCC ID number, and

Conformity assessment information

30 Specifications and Standards Compliance

326

327

31Default Settings Appendix

This appendix documents the most important default settings of your fetal monitor and the Avalon CL

Base Station with the cableless transducers as they are delivered from the factory. For a comprehensive

list and explanation of default settings see the Configuration Guide supplied with your fetal monitor.

The monitor's default settings can be permanently changed in Configuration Mode.

Alarm and Measurement Default Settings

Alarm Defaults Settings

Alarm Settings Choice Default

Alarm Mode INOP only, All INOP only (international)

All (USA/CAN)

Alarm Volume 0..10 5

Alarms Off 1 min, 2 min, 3 min, Infinite 2 min

Alarm Text Standard/Enhanced Standard

Visual Latching Red & Yellow/Red Only/Off Red & Yellow

Audible Latching Red & Yellow/Red Only/Off Red & Yellow

Alarm Sounds Traditional/ISO Traditional

Alarm Low 0..10 4

Fetal / Maternal Defaults Settings (International)

FHR, dFHR, aFHR Alarms On/Off Default On

Default Color for FHR Numeric (for all

FHR numerics)

Orange

Toco, aToco Default color for Toco numeric Green

IUP Default IUP Scale Unit mmHg

Default color for IUP numeric Green

HR, aHR Measurement Default Color for MECG Numeric Red

31 Default Settings Appendix

328

Coincidence Default Settings

NBP Default Settings

Fetal / Maternal Defaults Settings (US/CAN)

FHR, dFHR, aFHR Alarms On/Off Default On

Default Color for FHR Numeric:

FHR1, dFHR1, aFHR1

FHR2, dFHR2, aFHR2

FHR3, dFHR3, aFHR3

Red

Blue

Green

Toco, aToco Default color for Toco numeric Green (Toco)

Yellow (aToco)

IUP Default IUP Scale Unit mmHg

Default color for IUP numeric White

HR, aHR Measurement Default Color for MECG Numeric Red

Coincidence Default Settings

Coincidence Tone immediately

Factory Default Settings

Mode Manual

Repeat Time 15 min

Alarms from Sys. (International)

Sys&Dia&Mean (USA/CAN)

NBP Sys/Dia only Yes (International)

No (USA/CAN)

Low Limit 90/50 (60)

High Limit 160/90 (110)

VP Pressure 60 mmHg

Done Tone Off

Veni Puncture n/a

Start Time Synchronized

NBP On

Alarms On

Color Red

Reference Auscultatory

31 Default Settings Appendix

329

CL NBP Default Settings

SpO2 Default Settings

NBP Settings Factory Defaults

Mode Auto

Repeat Time 10 min

NBP On

VP Pressure 60 mmHg

Reference Auscultatory

Unit mmHg

Done Tone Off

Start Time Synchronized

Aging Time 10 min

Color Red

SpO2 Factory Default Settings

Desat Limit 80

Low Limit 90

High Limit 100

Desat Delay 20 seconds

Low Alarm Delay 10 seconds

High Alarm Delay 10 seconds

Average 10 seconds

NBP Alarm Suppr. On

Alarms On

Color Cyan

Pulse Default Settings

Pulse (SpO₂)On

High Limit 120 bpm

Low Limit 50 bpm

Δ ExtrBrady

Bradycardia: Difference to Low Limit

20 bpm

Brady Clamp 40 bpm

Δ ExtrTachy

Tachycardia: Difference to High Limit

20 bpm

Tachy Clamp 200 bpm

31 Default Settings Appendix

330

CL SpO2 Default Settings

Tympanic Temperature Default Settings

Manually Entered Values Default Settings

Recorder Default Settings

SpO2 Settings Factory Defaults

Repeat Time 15 min

Signal Quality On

NBP Alarm Suppr. On

Color Cyan

pTemp Settings Factory defaults

Adult

Low Limit 36°C (96.8°F)

High Limit 39°C (102.2°F)

Unit °C

Alarms On

Color White

Manual Entered Values Default Settings

Label Temp (fixed)

Unit °C

Color White

Interval 1 h

Msmnt Off

Setting Choice Default

Recorder Speed 1, 2, or 3 cm/min 3 cm/min

Scale Type US, Internat'l US

Trace Style FHR1 Thin, Medium, Thick, Extra Thick Thick

Trace Style FHR2 Medium

Trace Style FHR3 Extra Thick

Trace Style Toco Thick

Trace Style HR Thin

Wave Style ECG Thin

ECG Wave printing choice Separate, Overlap Separate

31 Default Settings Appendix

331

Notes Recording Along, Across Along (International)

Across (USA/CAN)

Change Rec Speed Monitoring, Config Config

Auto Start Off, On Off

Confirmed Stop Off

Bridge Paperout On

Paper Save Mode Off (International)

On (USA/CAN)

NST Autostart On

NST Autostop Off

Trace Separation Off

Separation Order Standard, Classic Standard (International)

Classic (USA/CAN)

Intensity 4 (medium) n/a

Cal. Offset 5 n/a

Setting Choice Default

31 Default Settings Appendix

332

333

1Index

accessories 275, 276, 277, 278, 279, 280, 285

Avalon CL base station 275

cl NBP Pod accessories 280

cl SpO2 Pod accessories 284

fetal accessories 276

electrode patch 276

fetal recorder accessories 285

latex information 275

MECG accessories 277

noninvasive blood pressure

accessories 278, 279

adult cuffs 279

multi-patient comfort cuff kits 278

reusable cuffs 278

single-hose disposable cuffs 279

SpO2 accessories 280

Philips sensors (disposable) 280

Philips sensors (reusable) 280

transducer accessories 276

tympanic temperature 285

tympanic temperature accessories 285

ACOG technical bulletin 60

actions after monitoring 70

adjusting display 49

admitting a patient 147, 148

auto free 26

editing information 148

OB TraceVue/IntelliSpace

Perinatal 149

quick admit 148

aging numerics 238

alarms 117, 119, 120, 121, 122, 123, 124, 126,

128, 129, 197, 198, 240, 246, 298, 304, 305,

327

acknowledging alarms 121

active alarms 117

alarm behavior at on/off 128

alarm latching 127

alarm limit delay 300

alarm reminder 122

alarm standards 119

audible alarm indicators 119

changing alarm delays 198

high priority alarms 117

latching alarms 126, 127

latching alarm behavior 127

pausing alarms 122

red alarms 117

restarting paused alarms 123

reviewing alarms 126

reviewing alarms window 126

standard philips alarms 120

yellow alarms 117

applying the fetal & maternal pod 100

artifact suppression 204

artifact suppression and fetal

arrhythmia 204

explanation of artifact suppression 204

switching on and off artifact

suppression 204

baseline measurement 185, 192, 208

Battery Option 109

using batteries 109

belt actions 50, 51, 52

belt fastening 50, 51

belt fixing button 51

cableless monitoring 73

Avalon CL 73

cableless transducers 84

assignment 99

audio signal 87

cl belt clip 88

connector cap 85

LED indication 86

radio range 87

cl pods 92

audio signal 93

battery status LED 93

configuration cableless system 75

important considerations 167

LED indication 86

paging patients 93

prompts 96

Tele Info window 94

Telemetry 95

Underwater monitoring 108

calibration 241, 268

calibrating noninvasive blood

pressure 268

cautions 9

changing FHR alarm delays 198

changing FHR alarm limits 197

CL Fetal & Maternal Pod 89

applying 100

CL Wide Range Pod 91

cleaning monitor actions 261, 262, 263, 273

cleaning method 262

cleaning monitoring accessories 263

general cleaning requirements 261

infection control 261

printhead cleaning 273

configuration mode 44

configuring alarm tone 119

confirming fetal life 10, 166, 183, 191

cross-channel verification 10, 183, 191, 222

CCV and triplets 191

CCV and twins 183

coincidence examples 162

comparing FHR with MHR 160

functionality 160

misidentification of heart rates 159

overview 161

recommended actions 164

data recovery 257

date from OB TraceVue/IntelliSpace

Perinatal System 47

date setting 47

Dawes/Redman 22

DECG 202, 205, 298

DECG INOPs 205

DECG specifications 298

DECG testing 205

DECG troubleshooting 205

default settings 298

alarm default settings 327

FHR default settings 298

IUP default settings 298

MECG default settings 298

noninvasive blood pressure default

settings 304

recorder factory default settings 308

SpO2 factory default settings 305

Toco default settings 298

user defaults 46

defibrillation precautions 225, 275, 321

demo mode 44

device classification 18

disabling touchscreen 44

discharging a patient 148

disinfecting 261, 262, 263

infection control 261

recommended substances 263

334

display 49, 238, 298

adjusting display 49

adjusting screen brightness 47

display noninvasive blood pressure 238

fetal display specifications 298

disposal of electronic waste 274

disposal of monitor 274

dyshemoglobins 244

intravascular dyshemoglobins 244

early systolic blood pressure 238

ECG 202, 222, 298

ECG specifications 298

electrical safety tests 312

electrical surgery precautions. See ESU 225,

244, 275, 321

electrodes 224

applying electrodes 224

EMC 313

electromagnetic compatibility 313

electromagnetic emissions 315

electromagnetic interference 314

how to reduce electromagnetic

interference 314

EMC and compliant accessories 313

EMC precautions 313

EMC standards 313

entering notes 42

ESU precautions 225, 275, 321

extension cable for SpO2 244

external monitoring 165, 184, 192, 208

external monitoring - Toco 208

external monitoring - triplets 192

external monitoring - twins 184

external monitoring - ultrasound 165

FAST 243

Fourier Artifact Suppression

Technology 243

fetal accessories 276

fetal arrhythmia 204

fetal demise 10

fetal display specifications 298

IUP - fetal display specifications 298

Toco - fetal display specifications 298

US - fetal display specifications 298

fetal heart rate alerting. See FHR 197

fetal heart rate. See FHR 165

fetal movement 170

fetal movement profile. See FMP 165

FHR 10, 166, 172, 183, 185, 191, 192, 197, 198,

222, 298

alerting 197

cross-channel verification 222

misidentification 10

trace separation 185, 192

FHR alarms 298

finder LED 36, 53, 183, 191

finding monitor revision 48

flexible nurse call 25, 32, 35

FMP 170, 171

FMP and twins 170

FMP statistics 171

functional arterial oxygen saturation 243

global settings 46

infection control 261

infection and sterilizing 261

INOPs 117, 121

CCV INOP

coincidence tone 24

disconnect INOPs 121

INOP alarms 117

red or yellow INOPs 24, 25

INOPs indicators 117

silencing INOPs 121

interference 313, 314

how to reduce interference 314

interference from RF equipment 313

internal monitoring 185, 199, 213

intrauterine pressure. See IUP 211

intravascular dyshemoglobins 244

intravascular dyshemoglobins effects on

(SpO2) 244

IUP 211, 213, 298

IUP specifications 298

mains power (AC) 71

disconnecting from mains power 71

maintenance 267, 268

maintenance schedule 267, 268

visual inspection 267

manual data entry 254

maternal ECG 204, 225, 227

electrode position 225

printing waveform 204, 227

viewing waveforms 225

maternal heart rate 221, 222

maternal heart rate and cross-channel

verification 222

maternal heart rate and priorities 221

maternal heart rate from MECG 222

sources of maternal heart rate 221

maternal HR 166, 221, 222, 224

Maternal HR from MECG 222

Maternal HR priorities 221

Maternal HR sources 221

maternal temperature 23

measurement settings 46

changing measurement settings 46

entering setup menu 46

measurements 45, 46, 295

setting up measurements 46

switching on and off measurements 45

MECG 204, 222, 224, 225, 227, 229, 231, 277,

298

accessories 277

alarm limits 300

connection illustration 222

default settings 298

electrodes 224

specifications 298

waveform printing 204, 227

MECG alarm limits 298

methemoglobin (SpO2) 244

monitor settings 10, 31, 47, 48, 49, 71, 257

changing monitor settings 47

major parts and keys 31

power on/off behavior 71

Standby 71

starting monitoring 168

switching on 48, 49

monitoring mode 44

monitoring triplets and FHR 191

monitoring twins and FHR 183

MR imaging and the SpO2 transducer 244

MRI precautions 225, 275, 321

NBP. See noninvasive blood pressure 235

NIBP. See noninvasive blood pressure 235

Noninvasive Blood Pressure (NBP) 228,

235, 236, 237, 238, 239, 240, 241, 242, 268,

278, 279, 304

automatic noninvasive blood pressure

repeat time 239

calibration interval 268

comfort cuff kits 278

factory defaults 304

how the measurement works 235

measurement 236, 239

limitations 236

methods 236

starting 239

stopping 239

NBP accessories 278

NBP adult cuffs 279

NBP automatic mode 239

NBP configurable measurement

335

sequence 25

NBP numerics 238

NBP pediatric cuffs 279

NBP performance specifications 304

NBP reusable cuffs 278

NBP single-hose disposable cuffs 279

NBP site inspection 237

NBP troubleshooting 242

NBP venous puncture 241

preparing to measure NBP 237

non-medical devices 312

non-medical devices in patient

vicinity 312

Non-Stress Test timer. See NST timer 152

NST Report

Trace Interpretation 153, 157

NST timer 151, 152

OB TraceVue 29, 30, 258

connection to OB TraceVue/

IntelliSpace Perinatal System 29, 30

LAN connection 258

operating modes 44

configuration mode 44

demo mode 44

monitoring mode 44

service mode 44

operating temperatures 321

oscillometric measurement method 235

Paging Patient 93

paper 60, 61, 62, 65, 272, 285

default recorder speed 60

loading paper 62, 65

paper out INOP 62

paper speed 60

changing 60

default 60

defaults 60

setting 60

paper, when to reload 62

recorder paper 285

removing paper 62, 65

storing paper 272

tearing off a trace 61

Paper Advance key 42

Paper-Out indication 62

passcode protection 44

patient alarms 129

Patient Demographics window 147

patient module 202, 222

paused alarms 122, 123

restarting paused alarms 123

performance specifications 295, 304, 305

noninvasive blood pressure

specifications 304

SpO2 specifications 305

physiological alarms 117

pop-up keys 96

power 71

disconnecting from 71

power failure 72

power on/ power off behavior 71

pulse 228

pulse from noninvasive blood

pressure 228

pulse rate 221

QRS tone pitch 247

recorder 56, 72, 272, 273, 285, 308

factory defaults 308

paper storage 272

printhead cleaning 273

recorder paper 285

recorder specifications 308

recorder troubleshooting 72

recording elements 59

recording stored data 42

recovering traces 257

trace recovery printout 257

recycling 274

regulatory compliance 311

remote event marker 60

safety 268, 311

maintenance interval 268

safety information 13

safety standards 311

screen layouts 45

selftest 48, 49, 56, 128

sensor 243

disposable SpO2 sensors 243

selecting SpO2 sensors 243

separating FHR traces 185, 192

separating triplet traces 192

separating twin traces 185

service mode 44

settings 45, 46, 47

active settings 45

changing settings 47

factory default settings 46

global settings 46

monitor settings 47

user default settings 46

short range radio 92, 317, 320

signal loss delay 198

signal quality 70, 246

signal quality during monitoring 70

signal quality of SpO2 246

silencing alarms 121

specifications 289, 295, 298, 308

built-in recorder specifications 308

DECG specifications 298

ECG specifications 298

IUP specifications 298

measurement specifications 295

MECG specifications 298

performance specifications 295, 298

Toco specifications 298

transducer specifications 289

US specifications 298

SpO2 243, 244, 246, 280, 305

accessories 280

alarm specifications 305

connecting the cables 244

disposable sensors 243

factory defaults 305

FAST technology 243

performance specifications 305

Philips sensors (disposable) 280

Philips sensors (reusable) 280

signal quality 246

tone modulation 247

SpO2 alarms 246, 305

standards 311, 313

EMC standards 313

safety standards 311

standards compliance 311

Standby 42

starting monitoring 48

sterilizing 261, 265

infection control 261

storage temperatures 321

stored data recording 42

suppressing artifacts 204

suspended alarm 123

suspicious SpO2 reading 246

switching on and off 171

switching on and off alarms 124

switching on monitor 48, 49

switching on recorder 56

symbols on the system 322

technical alarm messages. See INOPs 132

temperatures 321

operating temperatures 321

storage temperatures 321

336

testing 128, 205, 229, 312

DECG testing 205

MECG testing 229

safety testing 312

testing alarms 128

time 47

setting time 47

time from OB TraceVue/IntelliSpace

Perinatal System 47

Toco 202, 207, 208, 210, 224, 298

default Toco settings 298

testing a Toco transducer 210

Toco baseline 208

Toco display specifications 298

Toco monitoring 207

Toco sensitivity 208

Toco specifications 298

Toco MP transducer 207, 221

Toco+ transducer 207

tone modulation (SpO2) 247

touch tone volume 47

touchscreen operation 38, 44

trace actions 61, 257, 258

tearing off traces 61

trace recovery on OB TraceVue/

IntelliSpace Perinatal System 258

trace recovery on paper 257

transducer 36, 51, 53, 173, 183, 191, 207, 210,

289

connecting transducer to monitor 53

fixing transducer to belt 51

repositioning transducers 53

Toco transducer 207

Toco+ transducer 207

transducer belt clip 51

transducer specifications 289

transducer testing 173, 210

Toco 210

ultrasound 173

triplets 191, 192, 193, 194, 196

cross-channel verification 191

external monitoring 192

importance of monitoring MHR 191

monitoring triplets 191

offsetting baselines 192

troubleshooting 72, 172, 189, 196, 205, 208,

214, 227, 242

DECG 205

FHR 172

IUP 214

MECG 227

twins 170, 183, 184, 185, 186, 187, 189

cross-channel verification 183

external monitoring 184

importance of monitoring MHR 183

invasive monitoring 185

monitoring FHR 183

monitoring twins 183

offsetting baselines 185

twins and FMP 170

Tympanic Temperature 249

body reference sites 254

display and controls 250

manual data entry 254

status screens 251

taking temperature 252

tympanic temperature accessories 285

ultrasound 165, 168, 173, 298

applying gel 168

testing a transducer 173

ultrasound display specifications 298

ultrasound monitoring 165

ultrasound specifications 298

understanding screens 45

USB 25

using the adapter cable 202

uterine activity 202, 207, 208, 211, 213, 214,

224

external monitoring 207

internal monitoring 211

monitoring uterine activity 202, 208, 211,

213, 224

troubleshooting uterine activity 208, 214

velcro belt 52

venous puncture 241

visual alarm indicators 119

volume 47, 120

alarm volume 120

IUP, zeroing 213

touch tone volume 47

warnings 9

Part Number 453564659391

Published in Germany 09/16

*453564659391*

Philips Medical Systems North America OBRWRPBV1 Patient Monitoring User Manual ait fm manual

Philips Medical Systems North America Co. Patient Monitoring ait fm manual

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