Philips Medical Systems North America OBRWRPBV1 Patient Monitoring User Manual ait fm manual

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Non-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.
Or
•
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.
151
9 Non-Stress Test Timer
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)
Enter the Main Setup menu using the SmartKey.
Select 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 “Popup Keys for NST Timer Setup” on page 152).
Pop-up Keys for NST Timer Setup
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.
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.
152
10
10
Non-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:
Enter the Main Setup menu and select the NST Report.
Or select the NST Report SmartKey.
Press the Setup pop-up key.
153
10 Non-Stress Test Report
Set 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.
choose from:
- 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.
Report Recording
–
–
–
Manual
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:
154
•
FHR1, FHR2, FHR3
- switch to the window showing the current NST status for the fetal heart rate.
•
Record Report
•
Record Trace - record the trace episode that belongs to the current report. Depending on device
usage, the trace recording might be incomplete.
•
Setup
- print the NST Report on paper.
- open the Setup NST Report window.
10 Non-Stress Test Report
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: 11:34 – 12:06
time, configured runtime
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)
Statistics: FHR availability
FHR available: 95%
Result: Decelerations
Decelerations: 1
Variability: 23 bpm (Range: 20-24 bpm)
at: 11:58
severe
prolonged
Result:
Sinusoidal: No
Sinusoidal Rhythm detected
155
10 Non-Stress Test Report
Field
Field Content
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:
156
•
no severe or prolonged decelerations
•
no sinusoidal pattern in reporting period
10 Non-Stress Test Report
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.
157
10 Non-Stress Test Report
158
11
Cross-Channel Verification
(CCV)
11
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.
159
11 Cross-Channel Verification (CCV)
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.
160
11 Cross-Channel Verification (CCV)
Overview of Cross-Channel Comparisons
Measurements from Transducers
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
Measurement Comparison Done by the Fetal Monitor for Cross-Channel Verification
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)
* 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.
161
11 Cross-Channel Verification (CCV)
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.
INOP
Coincidence
Coincidence question mark
above FHR1
Coincidence question mark
above pulse from Toco MP
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-tobeat 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.
162
11 Cross-Channel Verification (CCV)
The coincidence question mark is also printed on the trace paper next to the corresponding FHR and
maternal pulse.
Printed coincidence
question mark on trace
Fetal heart rate trace from
Ultrasound
Maternal pulse trace from
SpO2
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).
INOP
Coincidence
Coincidence question
mark above FHR1
Coincidence question
mark above FHR2
163
11 Cross-Channel Verification (CCV)
The coincidence question mark is also printed on the trace paper next to FHR1 and FHR2.
Printed coincidence question mark on
trace
FHR1
and FHR2 traces
Recommended Actions for Coincidence INOP
164
Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a
fetoscope, stethoscope, or Pinard stethoscope.
Manual determination of the maternal pulse and comparison with the fetal heart rate sound signals
from the loudspeaker.
Reposition 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.
In 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).
If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation,
confirm fetal life using obstetric ultrasonography.
12
Monitoring FHR and FMP
Using Ultrasound
12
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.
165
12 Monitoring FHR and FMP Using Ultrasound
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
166
•
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
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.
FHR1
Toco parameter
167
12 Monitoring FHR and FMP Using Ultrasound
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.
Determine fetal position.
Fasten the belt around the patient.
Switch on the monitor and the recorder.
Connect the transducer to a free socket. The signal quality indicator for the heart rate initially
displays an invalid signal.
Apply 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.
168
Place 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.
When 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
Adjust 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.
FHR1
Audio source symbol
To select the audio source for an FHR channel:
Enter the Setup FHR1 menu for the channel you want to hear (FHR1 used as an example).
Press Select Audio. It may take a few seconds for the audio source symbol to appear.
169
12 Monitoring FHR and FMP Using Ultrasound
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:
Select the volume symbol. The volume scale pops up.
Select the required volume from the volume scale.
Fetal Heart Sound Volume
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.
170
12 Monitoring FHR and FMP Using Ultrasound
FMP Statistics
FMP statistics are printed every ten minutes.
FMP enabled
FMP started here
Indication of current fetal movement
The FMP statistics are presented as two percentage figures:
The first figure shows the percentage of detected fetal movements in the previous ten
minutes.
The 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.
The FMP detection activates after about half a minute of steady heart rate signals (signal indicator halffull, 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:
Enter the Setup FHR1 menu.
Select Fetal Movement to switch between On and Off.
Return to the main screen.
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12 Monitoring FHR and FMP Using Ultrasound
Troubleshooting
Problem
Possible Causes
Solutions
Erratic trace
Fetal arrhythmia
Erratic display
Obese patient
Consider monitoring FHR using DECG after
the rupture of membranes.
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
Signal quality indicator is Transducer position not optimal
continuously poor
Questionable FHR
Use enough gel to ensure the transducer
makes good contact with the mother's skin.
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.
Recording maternal HR by mistake
Reposition transducer
Confirm fetal life
FHR not recorded
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 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.
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
FHR1 Equip Malf
displayed.
FHR1 Unplugged
displayed.
or FHR2 Unplugged or FHR3 Unplugged INOP
If you suspect the transducer is malfunctioning
172
Test the transducer.
12 Monitoring FHR and FMP Using Ultrasound
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.
To test an ultrasound transducer:
Switch on the monitor and the
recorder.
Connect the transducer to the fetal
monitor.
Select the fetal heart sound for this
channel.
Increase the loudspeaker volume
to an audible level.
Holding the transducer in one
hand, move your other hand
repeatedly towards and then away
from the surface.
Check that a noise is heard from
the loudspeaker.
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
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12 Monitoring FHR and FMP Using Ultrasound
•
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:
•
174
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
•
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.
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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.
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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:
Completely filled triangle, indicating good signal
quality (good/full).
Half-filled triangle, indicating limited signal quality.
This condition may indicate a weak or ambiguous
signal. If this status persists, reposition the
transducer (acceptable/medium).
Empty 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).
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.
Double-Counting
Baseline Rate
120
Baseline Variability
Moderate
Accelerations
Present
Decelerations
Not apparent
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12 Monitoring FHR and FMP Using Ultrasound
Double-Counting
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.
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.
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12 Monitoring FHR and FMP Using Ultrasound
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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Noisy/Erratic Signal and Dropout
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.
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.”
___________________________________________________________
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12 Monitoring FHR and FMP Using Ultrasound
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
___________________________________________________________
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182
13
13
Monitoring 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.
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13 Monitoring Twin FHRs
•
The fetal sensor socket to which a transducer is connected is identified by the transducer position
indicator in the setup menu header:
FM20/FM30
FM40/FM50
•
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.
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13 Monitoring Twin FHRs
Example of the screen showing ultrasound monitoring of twin FHRs:
FHR 1
Toco parameter
FHR 2
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):
dFHR 1
Toco parameter
FHR 2
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.
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13 Monitoring Twin FHRs
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):
Enter the Main Setup menu by pressing the Main Setup.
Select Fetal Recorder.
Select Trace Separation to switch between On and Off.
Exit 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:
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13 Monitoring Twin FHRs
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.
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13 Monitoring Twin FHRs
When Trace Separation is Off
To indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale.
Standard
trace separation switched
off here
188
trace separation switched
off here
Classic
13 Monitoring Twin FHRs
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.
Problem
The question mark is
printed repeatedly, and
appears on the screen and
the INOP Coincidence is
issued.
Possible Cause
Solution
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.
For more information, see “Additional Information” on page 173.
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13 Monitoring Twin FHRs
190
14
14
Monitoring 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.
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14 Monitoring Triple FHRs
•
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:
FM20/FM30
FM40/FM50
•
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.
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14 Monitoring Triple FHRs
"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 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.
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.
193
14 Monitoring Triple FHRs
"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 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.
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.
194
14 Monitoring Triple FHRs
Switching Trace Separation On and Off
Connect three ultrasound transducers to the monitor to measure FHR.
See “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.
Standard trace separation switched
off here
195
14 Monitoring Triple FHRs
trace separation switched
off here
Classic
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.
Problem
The question mark is
printed repeatedly, and
appears on the screen
and the INOP
Coincidence is issued.
Possible Cause
Solution
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
For more information, see “Additional Information” on page 173.
196
15
15
Fetal 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
Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the
CL F&M Pod.
Enter the setup menu for a connected FHR measurement.
Select Alarms to switch between On and Off.
Changing Alarm Limits
Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the
CL F&M Pod.
Enter the setup menu for a connected FHR measurement.
To change the high alarm limit, select High Limit and select the alarm limit from the pop-up list.
To change the low alarm limit, select Low Limit and select the alarm limit from the pop-up list.
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15 Fetal Heart Rate Alarms
Changing Alarm Delays
You can change the alarm delays if the Alarm Mode is set to All.
Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the
CL F&M Pod.
Enter the setup menu for a connected FHR measurement.
To change the high alarm limit delay time, select High Delay and select the delay time (in seconds)
from the pop-up list.
To 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:
198
Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the
CL F&M Pod.
Enter the setup menu for a connected FHR measurement.
Select SignalLoss Delay and select the signal loss INOP delay time (in seconds) from the pop-up
list.
16
16
Monitoring 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:
Confirm that the scalp electrode is placed correctly.
Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a
fetoscope, stethoscope, or Pinard stethoscope.
If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation,
confirm fetal life using obstetric ultrasonography.
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16 Monitoring FHR Using DECG
In 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.
200
Fetal Scalp Electrode, single spiral (989803137631)
Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)
DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)
Toco+ transducer (M2735A)
16 Monitoring FHR Using DECG
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.
Fetal Scalp Electrode, single spiral (989803137631)
Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)
DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)
CL Toco+ MP (866075) or CL ECG/IUP transducer (866077)
Avalon CL base station (866074)
DECG with Patient Module
The figure below shows the equivalent chain using the patient module.
Fetal Scalp Electrode, single spiral, (989803137631)
Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)
DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)
Patient Module (M2738A)
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16 Monitoring FHR Using DECG
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.
If you change the monitoring mode from US to DECG, first disconnect the US transducer.
Depending 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.
Attach the fetal scalp electrode to the fetus, following the instructions supplied with the fetal scalp
electrode.
Attach a pre-gelled attachment electrode to the DECG adapter cable, following the instructions
supplied with the DECG adapter cable.
Fix 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.
Connect 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.
202
Switch on the recorder.
16 Monitoring FHR Using DECG
The 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.
Check the artifact suppression setting and change it if necessary (see “Suppressing Artifacts” on
page 204).
Measurement label (dFHR1)
Measurement label (Toco)
Measurement label (FHR2)
Measurement label (HR)
1mV scale bar
MECG wave with maternal label
DECG wave with fetal label
Measurement label (Temp) maternal temperature
Measurement label NBP
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.
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16 Monitoring FHR Using DECG
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:
Enter the Setup dFHR1 menu.
Select 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.
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16 Monitoring FHR Using DECG
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.
Problem
Possible Cause
Solutions
dFHR1 Equip Malf
Malfunctioning equipment
See “Patient Alarms and INOPs” on
page 129.
Fetal scalp electrode detached at
connector
Reconnect the fetal scalp electrode
Poor or no contact between leg
attachment electrode and mother
Check all connections
dFHR2 Equip Malf
dFHR3 Equip Malf
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.
Erratic trace
Erratic display
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
Disconnect and reconnect the connector
several times
No contact between the DECG adapter Check all connections
cable and the leg attachment electrode
Disconnect and reconnect the connector
No contact between the fetal scalp
several times
electrode connector and the DECG
If problem persists, use a new fetal scalp
adapter cable
electrode
No ECG signal
Check for fetal demise
Poor contact between the reference
electrode and the mother
Use a new fetal scalp electrode if
necessary
Signal quality indicator
Fetal arrhythmia
continuously shows a poor signal
dFHR1 Signal Loss
Use a new fetal scalp electrode if
necessary
No signal
See “Patient Alarms and INOPs” on
page 129.
No connection
See “Patient Alarms and INOPs” on
page 129.
dFHR2 Signal Loss
dFHR3 Signal Loss
dFHR1 Unplugged
dFHR2 Unplugged
dFHR3 Unplugged
Testing DECG Mode
See the monitor's Service Guide.
205
16 Monitoring FHR Using DECG
206
17
Monitoring Uterine Activity
Externally
17
You can measure uterine activity externally using a Toco transducer. You can also use a Toco+,
Toco MP, or a CL Toco+ MP transducer for the same purpose, although they also have more (ECG/
IUP and Pulse) capabilities.
The external Toco transducer allows to monitor the frequency, duration, and relative strength of
contractions, but not their absolute intensity. Amplitude and sensitivity depend on various factors such
as the position of the transducer, the belt tension, and the size of the patient.
What You Need
Toco, Toco MP, or Toco+ transducer
CL Toco+ MP transducers (additionally capable of providing the
maternal pulse measurement)
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17 Monitoring Uterine Activity Externally
Abdominal Belt (disposable shown)
External Toco Monitoring
Prepare for Toco monitoring using the list below. The standard procedures in use in your facility
determine the sequence of actions.
Fasten the abdominal transducer belt around the patient.
Connect the Toco transducer to a free socket on the monitor. The Toco baseline is automatically
reset. The Toco display shows 20. "Toco", indicating external uterine measurement, is printed on
the trace at intervals.
Place the transducer on the patient's fundus to ensure the optimum recording of uterine activity.
Reset the Toco baseline as necessary (see “Resetting the Toco Baseline” on page 208), but not
during a contraction.
The following example trace shows two contractions.
Resetting the Toco Baseline
Press the Toco Baseline SmartKey. This resets the Toco baseline to 20 on the display and trace.
If the Toco value is negative for more that five seconds, the Toco baseline is automatically reset to
0 units.
Toco Sensitivity
If the Toco sensitivity is too high, and the Toco trace exceeds the paper scale, you can reduce the Toco
sensitivity to 50%. The default setting is 100%.
To change the Toco sensitivity:
Enter the Setup Toco menu.
Select Gain to switch between 100% and 50%.
Troubleshooting
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17 Monitoring Uterine Activity Externally
External Toco Monitoring
Problem
Possible Causes
Solutions
Quality of the trace deteriorates
or the Toco baseline varies
The belt is incorrectly fastened and is
The belt must be tight enough to ensure
too slack or too tight, or the belt has lost good contact between the patient's skin
its elasticity.
and the entire surface of the transducer
without causing discomfort. Ensure you
are using the correct belt. Adjust it as
necessary.
Fetal movement
Check if the belt is correctly fastened
and adjust it as necessary. Reposition the
transducer and reset the Toco baseline if
necessary.
Maternal respiration superimposed on
trace
Check if belt is not too loose.
Maternal movement/change of position Following maternal movement, reset
Toco baseline
Toco sensitivity is too high
(above 100 units)
Physical transmission of pressure from
the uterus to the sensor is much higher
Toco trace is exceeding the paper than the average value.
scale
Check if the belt is too tightly fastened.
Select 50% Toco sensitivity.
Toco Equip Malf
is displayed.
See “Patient Alarms and INOPs” on
page 129.
Toco Unplugged
is displayed.
See “Patient Alarms and INOPs” on
page 129.
If you suspect the signal from the transducer.
Test the Transducer (see “Testing Toco
Transducers” on page 210 below).
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17 Monitoring Uterine Activity Externally
Testing Toco 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.
To test a Toco transducer:
Switch on the monitor and the
recorder.
Connect the transducer to the fetal
monitor.
Gently apply pressure to the pickup button.
Check if after a few seconds the
values on the display and paper
show this change in pressure.
You can test all Toco transducers, including the cableless ones, as described above.
210
18
Monitoring Uterine Activity
Internally
18
FM30/50
You can monitor intrauterine pressure (IUP) using an intrauterine catheter together with a patient
module, Toco+, or the CL ECG/IUP or CL Toco+ MP transducer, after rupture of the membranes
and the cervix is sufficiently dilated.
What You Need
IUP with Patient Module
The figure below shows the complete connection chain from the IUP catheter to the fetal monitor
using the patient module:
Disposable Koala IUP Catheter (M1333A)
Reusable Koala IUP Adapter Cable (9898 031 43931)
Patient Module (M2738A)
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18 Monitoring Uterine Activity Internally
IUP with Toco+
The figure below shows the complete connection chain from the IUP catheter to the fetal monitor
using the Toco+ transducer:
Disposable Koala IUP Catheter (M1333A)
Reusable Koala IUP Adapter Cable (9898 031 43931)
Toco+ transducer (M2735A)
IUP with CL ECG/IUP
The figure below shows the complete connection chain from the IUP catheter to the fetal monitor
using the CL ECG/IUP transducer:
212
Disposable Koala IUP Catheter (M1333A)
Reusable Koala IUP Adapter Cable (9898 031 43931)
CL ECG/IUP or CL Toco+ MP transducer (866077)
Avalon CL base station (866074)
18 Monitoring Uterine Activity Internally
Internal (IUP) Monitoring
Read the instructions that accompany the intrauterine catheter and the adapter cable before you start
monitoring. Zero the IUP measurement when instructed.
WARNING
Do not catheterize if placenta previa is diagnosed, or if uterine bleeding from an undetermined source
is present.
Prepare for IUP monitoring using the list below. The standard procedures in use in your facility
determine the sequence of actions.
Perform a complete clinical evaluation.
Catheterize after membrane rupture. Insert the catheter according to its accompanying
instructions.
Connect the catheter to the socket on the patient module.
Connect the patient module to a free socket on the monitor. The monitor is automatically zeroed.
The IUP display shows 0. IUP, indicating internal measurement is printed at intervals on the trace.
Zero the IUP measurement (see “Zero The IUP Measurement” on page 213).
If you suspect the catheter is not responding appropriately, flush as directed in the catheter's
Instructions for Use. A pressure spike appears on the trace if you flush after connecting the
transducer to the monitor.
Zero The IUP Measurement
Zero the IUP measurement by selecting the Zero IUP SmartKey, or selecting Zero IUP in the Setup IUP
menu. This resets the display and trace to 0. If you do not zero the monitor properly, the pressure trace
may exceed the paper scaling.
Selecting the IUP Unit
You can select between mmHg (default) and kPa for the IUP unit.
Enter the Setup IUP menu.
Press Unit to switch between mmHg and kPa.
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18 Monitoring Uterine Activity Internally
Troubleshooting
Internal (IUP) Monitoring
Problem
Possible Causes
Solutions
Only pressure peaks can be seen
(baseline not visible).
Zero adjustment is incorrect.
Zero the IUP measurement.
No change in pressure during
contraction.
Catheter tip not in contact with
amniotic fluid or possible extra-ovular
placement of the catheter.
Refer to catheter Instructions for
Use.
Trace is a straight line.
Connection issue or cable or catheter
defective.
•
Unplug/replug catheter
•
Unplug/replug or exchange
adapter cable
•
Try new catheter
Trace is superimposed with noise.
IUP Equip Malf
INOP is displayed.
IUP Unplugged
INOP is displayed.
214
Possible extra-ovular placement of
catheter.
Refer to catheter Instructions for
Use.
See “Patient Alarms and INOPs” on page 129.
19
Monitoring aFHR, aHR, and
aToco
19
Introducing the abdominal Avalon CL Fetal & Maternal Pod Measurement
The Avalon CL Fetal & Maternal Pod (CL F&M Pod) noninvasively measures fetal heart rate (aFHR),
maternal heart rate (aHR), and uterine activity (aToco). The CL F&M Pod is used together with a
single-use electrode patch. The electrode patch has five adhesive electrodes. The CL F&M Pod and
electrode patch are placed on the maternal abdomen. It picks up the fetal and maternal
electrocardiography (ECG) signals, and the uterine electromyography (EMG) signals. The CL F&M
Pod separates and processes the signals, and transmits aFHR, aHR, and aToco to the fetal monitor via
the CL base station.
CAUTION
Use the CL F&M Pod and electrode patch with singleton pregnancies only. The measurements have
been validated with a gestational age of >36 weeks.
NOTE
•
Fetal ECG and uterine EMG signals are very small. Therefore, skin preparation is required when
applying the electrodes.
•
Different measurements for the same physiological parameter may have a different appearance on
the trace, due to variability (HR), averaging, delay, amplitude, or artifacts.
•
The beat-to-beat variability of aFHR may appear lower than FHR from ultrasound and lower than
dFHR from DECG due to averaging. The accuracy of all FHR parameters is sufficient for
diagnosis following commonly agreed guidelines.
Fetal Heart Rate aFHR
It is recommended to verify the presence of the fetal heart beat, for example with a stethoscope, before
starting continuous monitoring with the CL F&M Pod.
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19 Monitoring aFHR, aHR, and aToco
CAUTION
If the aFHR signal quality indicator on the fetal monitor screen continuously indicates an insufficient
signal quality (empty triangle), although the CL F&M electrode status is green, then an alternative
method to monitor should be used.
Uterine Activity aToco
The CL F&M Pod measures the electrical activity of the uterus which is different to the mechanical
measurements of a Toco transducer or an IUP catheter. Depending on the measurement method, the
shape of a recorded contraction can look different. The uterine EMG signals can be interfered with by
the electrical activity of other muscles, for example during maternal or fetal movements or position
changes.
CAUTION
The aToco measurement does not represent the absolute intrauterine pressure. If aToco seems
questionable, verify uterine activity by other means (maternal perception, manual palpation, or
intrauterine pressure (IUP) measurement). For monitoring the real intrauterine pressure in mmHg or
kPa, an IUP catheter is required.
CAUTION
The duration of the contraction measured by the CL F&M Pod can be shorter than the physical
contractions. When you palpate the uterus, there is a delay between the manual detection of
contraction, and when it is displayed at the monitor.
CAUTION
Maternal or fetal movements can cause electrical signals that may result in intrauterine contraction-like
artifacts.
Maternal movement
When consistent maternal movement is detected:
•
A question mark is displayed in front of the aToco numeric at the monitor (?aToco).
•
The aToco trace is printed with a lighter intensity for the duration of the maternal movements,
indicating that the signal may be compromised and not suitable for trace interpretation.
Uterine Activity Measurement Priority
When several uterine activity measurements are active, the priority given on the monitor display is:
216
•
IUP (Intrauterine pressure from the connection with an IUP catheter)
•
aToco (CL F&M Pod)
•
Toco (CL Toco+MP transducer, Toco+ or Toco MP wired transducer)
19 Monitoring aFHR, aHR, and aToco
aToco Sensitivity
Monitoring with the CL F&M Pod, the aToco sensitivity can be set to High or Low at any time. The
Low sensitivity setting provides an additional suppression of artifacts, for example artifacts coming
from maternal and fetal movements. The additional filtering delays the onset of recording the
contraction on the trace and shows a reduced amplitude.
The default setting is High and recommended for active labor.
Setting the aToco Sensitivity
Select the Setup aToco menu.
Select the Sensitivity by toggling between High and Low.
What You Need
•
For monitoring with the CL F&M Pod, see “Avalon CL Fetal & Maternal Pod” on page 21 and
“CL Fetal & Maternal Electrode Patch” on page 91.
•
For assigning the CL F&M Pod, see “CL Pod Assignment” on page 99.
•
For applying the electrode patch and the CL F&M Pod, see “Applying the CL Fetal & Maternal
Patch and Pod” on page 100.
At the Monitor
Switch on the recorder.
The fetal heart rate is labeled aFHR1, aFHR2, or aFHR3 on the screen. The CL F&M Pod monitors
only singletons, but if in addition to aFHR a CL US transducer and/or a scalp electrode (DECG)
are used to monitor FHR, the aFHR numeric is labeled 1 to 3 depending on the sequence in which
the other measurement methods are added.
aFHR and aHR have a QRS tone. The volume can be set in the measurement's setup menu, see
“Selecting Fetal Heart Sound” on page 169.
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19 Monitoring aFHR, aHR, and aToco
Measurement label aFHR
Measurement label aToco
Measurement label aHR
Troubleshooting
Problem
Possible Causes
Solutions
Erratic trace
Fetal arrhythmia
Consider monitoring FHR with alternative methods.
Erratic display
Electrode contact not optimal
Reposition the electrode and repeat the skin
preparation until the CL F&M Status shows that all
electrodes have good contact.
Obese patient
If a patient is obese, re-position the lower electrode
on the midline 1-2 in/3-5 cm below the original
placement, or on the underside of the panniculus just
below the turn.
Too much maternal or fetal
movement
Ask the patient to sit or lie still until the signal
improves. If the signal indication does not improve,
consider monitoring with alternative methods.
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19 Monitoring aFHR, aHR, and aToco
Problem
Possible Causes
Solutions
Signal quality indicator is
continuously poor
Electrode contact not optimal
Repeat the skin preparation until the CL F&M Status
shows that all electrodes have good contact.
Patient in unfavorable position Make the patient more comfortable, if the abdominal
muscles are relaxed it may improve the signal. For
example, place a pillow to support the patient’s back.
If the signal indication does not improve, consider
monitoring with alternative methods.
aFHR not recorded or
questionable
Mobile abdomen
If the abdomen is mobile, or patient position has
changed, use a rolled blanket/towel or pillow to
support abdomen to keep the patch centered on the
uterus. If the signal indication does not improve,
consider monitoring with alternative methods.
aFHR is less than 60 bpm or
over 240 bpm, fetal demise,
fetal arrhythmia, or the baby is
born
Verify the FHR by independent means.
NOTE
For all signal loss, malfunction, or other alerts see “Patient Alarms and INOPs” on page 129.
219
19 Monitoring aFHR, aHR, and aToco
220
20
Monitoring Maternal Heart /
Pulse Rate
20
You can monitor the maternal heart/pulse rate using one of five sources:
•
Maternal heart rate (HR) via MECG electrodes
•
Maternal heart rate (aHR) via CL F&M Pod
•
Maternal pulse rate from Toco MP or CL Toco+ MP transducer (Pulse)
•
Maternal pulse rate from SpO2 (Pulse)
•
Maternal pulse rate from NBP (Pulse)
Maternal heart/pulse rates derived from Toco MP or CL Toco+ MP, SpO2, aHR, and MECG are
continuous measurements, and are compared against the FHR for cross-channel verification. Average
pulse rate derived from noninvasive blood pressure is an intermittent measurement, and is therefore
not used for cross-channel verification.
Priority for Maternal Heart / Pulse Rate
Priority
Maternal Heart / Pulse Rate
Source
Alarming
Used for CCV
Provides QRS
Tone
HR from MECG measurement
Yes
Yes
Yes
aHR from CL F&M Pod
Yes
Yes
Yes
Pulse from CL SpO2 Pod
measurement
Yes
Yes
No
Pulse from SpO2 measurement
Yes
Yes
Yes
Pulse from Toco MP measurement
cableless or cabled
No
Yes
No
Pulse from CL NBP Pod
measurement
No
No
No
Pulse from NBP measurement
No
No
No
Only one maternal heart rate/pulse rate numeric is displayed and recorded at a time (see priority table).
If higher-priority measurements are connected but temporarily not providing valid numerics, lowerpriority numerics may be displayed and recorded instead.
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20 Monitoring Maternal Heart / Pulse Rate
Misidentification of Maternal HR for FHR
To reduce the possibility of mistaking the maternal HR for FHR, it is recommended that you monitor
both maternal and fetal heart rates (see “Confirm Fetal Life Before Using the Monitor” on page 10 and
“Cross-Channel Verification (CCV)” on page 159).
Maternal HR from MECG Electrodes
You can measure maternal HR using the equipment combinations shown in the following figures.
MECG with Patient Module
The figure below shows the complete connection chain from the foam electrodes applied to the
patient to the fetal monitor using the patient module.
222
Patient Module (M2738A)
MECG Adapter Cable (M1363A)
Pre-gelled Foam Electrodes (40493A/B/C/D/E)
20 Monitoring Maternal Heart / Pulse Rate
MECG with Toco+
The figure below shows the equivalent chain using the Toco+ transducer.
Toco+ Transducer (M2735A)
MECG Adapter Cable (M1363A)
Pre-gelled Foam Electrodes (40493A/B/C/D/E)
MECG with CL Toco+MP or CL ECG/IUP
The figure below shows the equivalent chain using a CL Toco+ MP transducer or a CL ECG/
IUP transducer.
Avalon CL base station (866074)
CL Toco+ MP (866075) or CL ECG/IUP transducer (866077)
MECG Adapter Cable (M1363A)
Pre-gelled Foam Electrodes (40493A/B/C/D/E)
To simultaneously measure DECG and MECG, you can use a Toco+, a CL Toco+ MP, or a
CL ECG/IUP transducer for MECG. For measuring DECG, you need a CL ECG/IUP transducer or
a patient module (see also “Monitoring FHR Using DECG” on page 199).
223
20 Monitoring Maternal Heart / Pulse Rate
Applying Electrodes
To derive the maternal HR (when you do not want to view the MECG waveform), you can place the
electrodes just below the outer end of the clavicle near each shoulder.
MECG Electrodes
Making Connections
WARNING
Follow the instructions supplied with each of the monitoring accessories you are using.
Prepare for monitoring maternal HR using the list below. The standard procedures in use in your
facility determine the sequence of actions.
Depending on the equipment you are using, ensure that either the Patient Module or the Toco+
transducer is connected to the fetal monitor. If you are using cableless monitoring, use the
CL ECG/IUP or the CL Toco+ MP transducer.
Connect a pre-gelled foam electrode to each of the two leads on the MECG adapter cable.
Apply the foam electrodes to the patient, following the instructions supplied with the foam
electrodes.
Depending on the equipment you are using, connect the pink connector plug on the MECG
adapter cable to the pink connector on either the Patient Module or the Toco+ transducer. If you are
using cableless monitoring, connect the MECG Adapter cable to the connectors of the CL ECG/
IUP or the CL Toco+ MP transducer.
You are now ready to monitor maternal HR.
Monitoring Maternal HR
224
Switch on the recorder.
The maternal heart rate is labeled HR on the screen.
20 Monitoring Maternal Heart / Pulse Rate
Monitoring MECG Wave
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.
FM30/50
When measuring MECG with the Avalon FM30 or FM50, the MECG waveform, along with the heart
rate numeric, is displayed on the screen when using a Toco+, CL Toco+ MP transducer, a patient
module, or a CL ECG/IUP transducer. If a maternal ECG wave analysis is required, use a patient
monitor.
WARNING
The fetal/maternal monitor is 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.
Applying Electrodes
To obtain a satisfactory maternal ECG waveform, you must use the RA to LL (lead II) position of the
standard 5-lead ECG.
Place the RA electrode
(A) directly below the
clavicle and near the right
shoulder.
Place the LL electrode
(B) on the left lower
abdomen.
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20 Monitoring Maternal Heart / Pulse Rate
Viewing the Waveform on the Screen
Measurement label dFHR1
Measurement label Toco
Measurement label FHR2
Measurement label HR
1mV scale bar
MECG wave with maternal label
DECG wave with fetal label
Measurement label Temp maternal temperature
Measurement label NBP
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.
For the FM30/50, the MECG wave is displayed automatically on the screen, labeled MECG. If DECG is
also being monitored (FM30/50), and the DECG Wave is configured to On, both waves are displayed,
with the DECG Wave above the MECG wave. The DECG Wave is labeled DECG.
226
20 Monitoring Maternal Heart / Pulse Rate
Troubleshooting
Problem
Possible Causes
displayed. One or more MECG leads is not
Numeric is displayed with attached.
Solutions
MECG Leads Off
Make sure that all required leads are attached
a -?- for 10 seconds;
INOP tone
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
See also “Patient Alarms Bad electrical contact
and INOPs” on page 129 Electrodes defective
Check positioning of the electrode, ensuring that
none are displaced
Check electrodes and replace if necessary
The ultrasound transducer is
measuring maternal pulse
Reposition the ultrasound transducer. See
“Recommended Actions for Coincidence
INOP” on page 164
prints repeatedly
MECG Equip Malf
displayed Equipment malfunctions
See “Patient Alarms and INOPs” on page 129
Equipment not connected
MECG Unplugged
Printing the Waveform
You can print the MECG wave onto the trace paper. Refer to “Printing the ECG Waveform” on
page 231.
Pulse Rate from Toco MP
The maternal pulse is taken from the Toco MP or CL Toco+ MP transducer when SpO2 or MECG
measurements are not used or have signal loss. When the pulse rate is very low, or strong arrhythmia is
present, the pulse rate measured by the Toco MP or CL Toco+ MP transducer may differ from the
heart rate calculated from MECG. If the mother is moving about, or began pressing during the second
stage of labor, this can cause longer gaps in the recording of the maternal pulse signal. In this case, use
the SpO2 or MECG measurement to derive the maternal heart rate.
WARNING
•
No alarm is possible when Toco MP or CL Toco+ MP transducer is the source of the pulse rate.
•
No QRS tone is audible when Toco MP or CL Toco+ MP transducer is the source of the pulse
rate.
•
The Toco MP or CL Toco+ MP transducer signal is significantly less reliable, if the patient is up
and moving about, or is pushing during the second stage of labor.
NOTE
In rare cases, it is possible to pick up a fetal signal source. When a Toco MP or CL Toco+ MP
transducer is connected to the monitor, but not applied to the patient, the measurement may generate
unexpected intermittent pulse readings.
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20 Monitoring Maternal Heart / Pulse Rate
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:
In the Setup SpO₂ menu, select Pulse (SpO₂). This opens the Setup Pulse (SpO₂) menu.
Ensure Pulse (SpO₂) is On. Select Pulse (SpO₂) to switch between On and Off.
Set 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:
In the Setup MECG menu, select MECG/Pulse Alarms. This opens the Setup Pulse (MECG) menu.
Ensure Pulse MECG is On. Select Pulse MECG to switch between On and Off.
Set 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.
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20 Monitoring Maternal Heart / Pulse Rate
Testing MECG Mode
See the monitor's Service Guide.
229
20 Monitoring Maternal Heart / Pulse Rate
230
21
21
Printing 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
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.
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
DECG
Recorder speed
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21 Printing the ECG Waveform
MECG waveform on its own
MECG
Recorder speed
DECG and MECG waveforms
DECG
MECG
Recorder speed
When the recorder is on, there are two choices for printing the ECG wave:
•
232
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
The following trace shows the MECG waveform:
FHR1 trace interrupted
MECG
Recorder speed
FHR1 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.
header
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21 Printing the ECG Waveform
The following trace shows both the DECG and MECG waveforms:
FHR1 and FHR2
DECG
header
MECG
header
Recorder speed
To make your choice:
Enter the Main Setup menu.
Select Fetal Recorder to enter the Fetal Recorder menu.
Select ECG Wave to switch between Separate and Overlap.
To print the ECG wave(s):
Select the Record ECG Wave SmartKey (configurable) and the recording trace is started.
Or
Enter the Main Setup menu by selecting the SmartKey.
Select Fetal Recorder to enter the Fetal Recorder menu.
Select Record ECG Wave and the recording trace is started.
Or
234
Select the ECG Wave.
Select Record ECG Wave in the ECG wave menu and the recording trace is started.
22
Monitoring Noninvasive Blood
Pressure
22
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.
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22 Monitoring Noninvasive Blood Pressure
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:
- measurement on demand. Results are displayed for up to one hour.
•
Manual
•
Auto
•
Sequence-
- continually repeated measurements (between one and 120 minute adjustable interval). You
can make a manual measurement between two measurements in Auto Mode.
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.
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22 Monitoring Noninvasive Blood Pressure
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.
Connect the cuff to the air tubing.
Plug 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.
Make 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.
Apply 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:
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.
Recommendations For Measurements Used in Diagnosis of
Hypertension
To make a measurement for use in the diagnosis of hypertension, follow the steps below:
Ensure the patient is comfortably seated, with their legs uncrossed, feet flat on the floor, and back
and arm supported.
Ask the patient to relax and not talk before and during the measurement.
If possible, wait 5 minutes before making the first measurement.
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22 Monitoring Noninvasive Blood Pressure
Understanding the Numerics
Alarm source
Measurement Mode
Timestamp/Timer
Mean pressure
Diastolic
Systolic
Alarm limits
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.
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22 Monitoring Noninvasive Blood Pressure
Starting and Stopping Measurements
Use the setup menu or the SmartKeys to start and stop measurements.
Action to be performed
Start/Stop manual measurement
Setup menu
SmartKeys
Start/Stop
Start Auto series
Start/ Stop
Stop current automatic measurement
Start manual measurement
Start Auto series
Stop manual measurement
Start NBP
Stop current automatic measurement
Stop automatic, or manual measurement AND series
Stop NBP
Stop All NBP
Stop All
Enabling Automatic Mode and Setting Repetition
Time
In the Setup NBP menu, select Mode.
Switch between Auto and Manual, if necessary, to pick the measurement method.
If 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.
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22 Monitoring Noninvasive Blood Pressure
Enabling Sequence Mode and Setting Up the
Sequence
In the Setup NBP menu, select Mode and select Sequence from the pop-up menu.
Select 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.
Select each sequence in turn, and select the number of measurements and the time interval
between the measurements.
To 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.
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
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.
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22 Monitoring Noninvasive Blood Pressure
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.
In the Setup NBP menu, select VeniPuncture.
Puncture vein and draw blood sample.
Reselect VeniPuncture to deflate the cuff.
During measurement, the display shows the inflation pressure of the cuff and the remaining time in
venous puncture mode.
Cuff pressure
Venous puncture measurement mode
Time left 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.
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22 Monitoring Noninvasive Blood Pressure
Troubleshooting
Problem
Possible Causes
Cuff will not inflate
Monitor is in Service or Configuration
Mode
Solutions
Technical defect
Call service
Cuff tubing not connected
Connect cuff tubing
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
Severe vasoconstriction at cuff site
and diastolic values.
Measurement automatically
repeats
Erratic blood pressure fluctuations due
to arrhythmias or rapid-acting drugs or
contractions
Move cuff to another limb, check for shock,
or verify blood pressure using another
method
High or low values
measured (against clinical
expectations)
Excessive patient movement or
convulsions
NBP Cuff Overpress
INOP is
displayed
NBP Interrupted
INOP is
displayed
NBP Measure Failed
242
Wait until contraction has finished
Restrain movement or verify blood pressure
using another method
INOP is See “Patient Alarms and INOPs” on page 129.
displayed
NBP Equip Malf
Try again, if unsuccessful, verify blood
pressure using another method
23
23
Monitoring 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
Follow the SpO2 sensor's Instructions for Use, adhering to all warnings and cautions.
Remove colored nail polish from the application site.
Apply 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.
Check that the light emitter and the photodetector are directly opposite each other. All light from
the emitter must pass through the patient's tissue.
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23 Monitoring SpO2
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:
–
–
244
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
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.
245
23 Monitoring SpO2
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:
246
•
Select High Limit then choose the upper alarm limit.
•
Select Low Limit then choose the lower alarm limit.
23 Monitoring SpO2
Adjusting the Desat Limit Alarm
The Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in
oxygen saturation.
In the Setup SpO₂ menu, select Desat Limit.
Adjust 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.
247
23 Monitoring SpO2
248
24
Monitoring Maternal
Temperature
24
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.
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24 Monitoring Maternal Temperature
Base station
Thermometer
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.
Functional Keys
Eject key
Change unit key: °Celsius/°Fahrenheit
Start measurement key
Pulse timer key
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).
250
24 Monitoring Maternal Temperature
Functional Keys
Description of Use
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.
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.
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.
251
24 Monitoring Maternal Temperature
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)
Ensure that the base station is connected with the appropriate cable to the connector on the
monitor.
Remove 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.
Press the eject key on the thermometer to discard any probe that may have been left on the
thermometer from a previous use.
Pick up a new probe cover from the container on the base station.
Inspect 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.
Place 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.
Press and release the start-up key gently.
Wait until you hear the three beeps.
Remove 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.
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24 Monitoring Maternal Temperature
Possible INOPs
Images
Description
Patient temperature above measurement range.
Patient temperature below measurement range.
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.
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24 Monitoring Maternal Temperature
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:
Body Reference Site
Label on Monitor
Ear temperature (no adjustment)
iTtymp
Oral temperature
iToral
Core temperature
iTcore
Rectal temperature
iTrect
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.
Press the SmartKey Enter Temp (configurable)
or select the SmartKey Main Setup, then select Measurements, Enter Temp. A numeric pad opens.
Enter the temperature values.
Select 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.
254
25
Paper Save Mode for Maternal
Measurements
25
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).
no
The monitor is restarted (e.g. by switching it off and on again).
yes
The date has changed (e.g. at midnight).
no
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25 Paper Save Mode for Maternal Measurements
256
26
26
Recovering 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.
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26 Recovering Data
•
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:
258
•
Discharging a patient
•
Powering on the monitor
•
Entering Standby
•
Entering Service Mode
26 Recovering Data
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
Select the Stored Data Rec SmartKey.
Select 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).
Or
Enter the Main Setup menu using the SmartKey.
Select Fetal Recorder to open the Fetal Recorder menu.
Select Stored Data Rec to open the Stored Data Recording window.
Select an entry for a patient.
Select 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
Select the Stored Data Rec SmartKey.
Select the Erase All key to delete all stored trace periods listed.
Select the Confirm key.
Or
Enter the Main Setup menu using the SmartKey.
Select Fetal Recorder to open the Fetal Recorder menu.
Select Stored Data Rec to open the Stored Data Recording window.
Select the Erase All key to delete all stored trace periods listed.
Select the Confirm key.
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26 Recovering Data
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.
260
27
27
Care 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.
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27 Care and Cleaning
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.
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27 Care and Cleaning
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:
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
spray
0.5% accelerated hydrogen peroxide
Carpe DiemTM/MC Tb Wipes
wipes
0.5% accelerated hydrogen peroxide
Super Sani-Cloth
wipes
Isopropanol 55%
Carpe
DiemTM/MC
Tb
Ready-to-Use General Virucide,
Bactericide, Tuberculocide,
Fungicide, Sanitizer
Germicidal Disposable Wipes
SANI-CLOTH® PLUS
quaternary ammonium chlorides 0.5%
wipes
Germicidal Disposable Wipes
SANI-CLOTH® HB Germicidal
Germicidal Disposable Wipes
Isopropanol 15%
quaternary ammonium chlorides 0.25%
wipes
Isopropanol < 0.15%
quaternary ammonium chlorides 0.14%
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.
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27 Care and Cleaning
Cleaning and Disinfecting the Tympanic
Temperature Accessories
Probe and Thermometer Body
Wipe 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.
Clean the probe tip with a lint free swab. If the probe tip is soiled, clean it with a dampened swab.
After 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.
Thoroughly 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.
264
27 Care and Cleaning
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).
265
27 Care and Cleaning
266
28
28
Maintenance
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:
Examine 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.
Inspect all accessories (transducers, sensors and cables, and so forth). Do not use a damaged
accessory.
Switch 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.
267
28 Maintenance
Inspecting the Cables and Cords
Examine 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.
Inspect 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.
Carry 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, At least once every two years, or as specified by local
and where applicable, to national
laws.
standards
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.
268
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
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:
Press the paper eject button to open the paper drawer.
269
28 Maintenance
270
Hinge the transparent paper guide forward.
A protrusion (A) holds paper guide in closed position.
28 Maintenance
Release the paper guide from one side of the holder.
Then remove the paper guide.
271
28 Maintenance
Refitting 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.
272
28 Maintenance
Cleaning the Print Head
To clean the recorder's thermal print-head:
Switch off the monitor.
Open the paper drawer, and remove the paper if necessary, to gain access to the thermal print
head.
Gently clean the thermal print head with a cotton swab, or soft cloth soaked in isopropyl alcohol.
FM20/30
FM40/50
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).
273
28 Maintenance
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
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.
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).
274
29
29
Accessories 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
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29 Accessories and Supplies
Transducers
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
866075
for use with the Avalon CL base station
Avalon CL Ultrasound Transducer
866076
for use with the Avalon CL base station
Avalon CL ECG/IUP Transducer
866077
for use with the Avalon CL base station
Avalon CL Fetal & Maternal Pod
866488
for use with the Avalon CL base station
Avalon CL Wide Range Pod
866487
for use with the Avalon CL base station
CL SpO2 Pod
865215
for use with the Avalon CL base station
CL NBP Pod
865216
for use with the Avalon CL base station
Remote Event Marker
989803143411
Fetal Accessories
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
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29 Accessories and Supplies
Accessory
Description
Part Number
Avalon CL Connector Caps
Connector Caps for Avalon CL 989803184841
Cableless Smart Transducers (kit
of 10)
Avalon CL Belt Clip
Belt Clip for Avalon CL Cableless 989803184851
Smart Transducers (kit of 10)
Avalon CL Battery Replacement Kit
989803184861
Cable Management Kit
989803148841
Avalon CL Wide Range Battery Kit
989803196421
Kit of 20 Mobile CL Transmitter Cradles
989803168881
for use with 866487 Avalon CL Wide Range Pod
Avalon CL Fetal & Maternal Patch (case with 10 each)
ECG Skin Preparation Paper
for use with the 989803196341 Avalon CL F&M patch
DECG Accessories: Philips DECG Solution
(NOT compatible with QwikConnect
Plus Solution accessories)
989803196341
10 sheets, with 10 finger-tip sized M4606A
skin prep pieces per sheet (100
preps per bag)
DECG reusable leg plate adapter 989803137651
cable (with flushing port)
DECG leg attachment electrode 989803139771
for DECG leg plate adapter cable
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
MECG Accessories
Accessory
Part Number
MECG reusable adapter cable
M1363A
Foam ECG electrodes, snap-fit, for MECG Adapter Cable (disposable)
40493D/E
277
29 Accessories and Supplies
Noninvasive Blood Pressure Accessories
The following accessories are approved for use with the fetal monitor:
Adult Multi Patient Reusable Comfort 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
The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).
Adult Multi Care Reusable Cuffs
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
The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).
Adult EasyCare Reusable Cuffs
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
278
29 Accessories and Supplies
Maternal Patient Category (color)
Limb Circumference
Part Number
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
The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).
Adult Single Patient Soft Cuffs
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
The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).
Adult Single Care Cuffs
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
The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).
Adult Value Care Cuffs
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
The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).
279
29 Accessories and Supplies
IntelliVue CL NBP Pod Accessories
Description
Limb Circumference
Range
Contents
Part Number
Mobile CL Reusable Small Adult 21-27 cm
Cuff
1 cuff
989803163171
Mobile CL Reusable Adult Cuff
26.0-34.5 cm
1 cuff
989803163191
Mobile CL Reusable Large Adult 33.5-45.0 cm
Cuff
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)
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.
280
29 Accessories and Supplies
Philips Reusable Sensors
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
No adapter cable required.
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
Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.
Description
Part Number
Special Edition (SE). Adult sensor (3 m cable), for patients over 50 kg. Any finger except M1191ANL
thumb.
Special Edition (SE). Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg M1192AN
and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50.
Special Edition (SE). Ear sensor (1.5 m cable) for patients more than 40 kg.
M1194AN
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:
Description
Part Number
Identical to OxiMax MAX-A
M1904B
Identical to OxiMax MAX-P
M1903B
Identical to OxiMax MAX-N
M1901B
Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable
281
29 Accessories and Supplies
Available worldwide:
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. M1133A
Use only on adult patients with FM30/40/50.
Adult/Pediatric finger sensor (0.9 m cable) for patients >40 kg. Any finger except thumb. M1134A
Adhesive-free, use only on adult patients with FM30/40/50.
Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable
Nellcor Sensors
Nellcor sensors must be ordered from Nellcor/Covidien.
OxiMax Sensors
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/ OxiMax MAX-P
40/50.
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
Require M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.
Oxisensor II Sensors
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
Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.
OxiCliq Sensors
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
Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable together with OC-3 adapter cable.
282
29 Accessories and Supplies
Masimo LNOP Reusable Sensors
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
For use with this sensor the adapter cable LNOP MP12 (M1020-61102) is needed.
Masimo LNCS Reusable Sensors
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
For use with this sensor the adapter cable LNC MP10 (989803148221) is needed.
Masimo LNOP Disposable Adhesive Sensors
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 LNOP Pdt
with FM30/40/50.
989803140261
Pediatric Sensor (10-50 kg). Use only on adult patients LNOP Pdtx
with FM30/40/50.
n/a
Neonatal (<3 kg) or Adult adhesive Sensor (>40 kg).
Use only on adult patients with FM30/40/50.
989803140291
LNOP Neo-L
Appropriate LNOP/LNCS adapter cable required.
283
29 Accessories and Supplies
Masimo LNCS Disposable Adhesive Sensors
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 LNCS Neo-L
(>40 kg). Use only on adult patients with FM30/40/
50.
989803148271
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.
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
9898031659311
20 Single-Patient Cradles with pre-attached
Wristbands
Mobile CL 20 SpO2 Cradles (single patient) 20 Single-Patient Cradles with pre-attached 989803165951
Wristbands
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
May not be available in all geographies
Extension / Adapter Cables
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)
284
M1943AL
29 Accessories and Supplies
Description
Comments
Part Number
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
Tympanic Temperature Accessories
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
Recorder Paper
Supplied in cases of 40 packs. Each pack has 150 numbered pages. Single use. Use the paper specified
here.
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
50-210
Green*
mmHg
Yes
M1913J
Japan
*Bradycardia
and tachycardia alarm ranges are shaded.
Batteries
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 989803184861
(Part No. 453564107871), a tool to open
and close the cableless transducer for
battery replacement and two replacement
O-ring seals.
285
29 Accessories and Supplies
286
30
Specifications and Standards
Compliance
30
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
Humidity Range
Altitude Range
Operating
0°C-45°C (32°F-113°F)
Storage/Transportation
-20°C-60°C (-4°F-140°F)
Operating
<95% relative humidity @ 45°C (113°F)
Storage/Transportation
<90% relative humidity @ 60°C (140°F)
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
Humidity Range
Altitude Range
Operating
0°C-40°C (32°F-104°F)
Storage/Transportation
-20°C-60°C (-4°F-140°F)
Operating
<90% relative humidity @ 45°C (113°F)
Storage/Transportation
<90% relative humidity @ 60°C (140°F)
Operating
0-2000 m (0-6562 ft)
Storage/Transportation
-500-13100 m (-1640-43000 ft)
287
30 Specifications and Standards Compliance
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°F104°F)
Humidity Range
Altitude Range
Storage/Transportation
-20°C—60°C (-4°F—140°F)
Operating
<95% relative humidity @ 40°C (104°F)
Storage/Transportation
<90% relative humidity @ 60°C (140°F)
Operating
-500-3000 m (-1640-9840 ft)
Storage/Transportation
-500-13100 m (-1640-43000 ft)
Transducers (M2734A/M2734B/M2735A/M2736A/M2738A)
Temperature Range
Humidity Range
Altitude Range
Operating
0°C-40°C (32°F-104°F)
Storage/Transportation
-20°C-60°C (-4°F-140°F)
Operating
<95% relative humidity @ 40°C (104°F)
Storage/Transportation
<90% relative humidity @ 60°C (140°F)
Operating
-500-3000 m (-1640-9840 ft)
Storage/Transportation
-500-13100 m (-1640-43000 ft)
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).
Avalon CL Transducers (866075/866076/866077)
Temperature Range
Humidity Range
Altitude 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)
Operating
<95% relative humidity @ 40°C (104°F)
Storage/Transportation
<90% relative humidity @ 60°C (140°F)
Operating
-500-3000 m (-1640-9840 ft)
Storage/Transportation
-500-13100 m (-1640-43000 ft)
Avalon CL Fetal and Maternal Pod (866488)
Temperature Range
Humidity Range
288
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)
Operating
<95% relative humidity @ 40°C (104°F)
Storage/Transportation
<90% relative humidity @ 60°C (140°F)
30 Specifications and Standards Compliance
Avalon CL Fetal and Maternal Pod (866488)
Altitude Range
Operating
-500-3000 m (-1640-9840 ft)
Storage/Transportation
-500-13100 m (-1640-43000 ft)
Avalon CL Wide Range Pod (866487)
Temperature Range
Humidity Range
Altitude 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)
Operating
<95% relative humidity @ 40°C (104°F)
Storage/Transportation
<90% relative humidity @ 60°C (140°F)
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)
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
Monitor Physical Specifications
M2702A/M2703A
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
1.3-0.7 A (M8023A#E25)
Dimensions and
Weight
M2704A/M2705A
Size (without options) mm/ 286 x 134 x 335 mm
(in):
(11.3 x 5.3 x 13.2 in)
width x height x depth
425 x 174 x 365 mm
Weight
<8.8 kg (19.5 lbs)
<5.1 kg (11.2 lbs)
Degree of Protection Against Electrical Shock
Type CF
Electrical Class
Class II equipment
(16.6 x 6.9 x 14.4 in)
Class I equipment
289
30 Specifications and Standards Compliance
Monitor Physical Specifications
M2702A/M2703A
M2704A/M2705A
Electrical Power Source
External (AC) without battery External (AC)
option #E25
Internal (Lithium Ion battery)
if with battery option #E25
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 <30 seconds
on the monitor to seeing the
first parameter labels
Fetal Monitor Sounds
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
SpO2
Optional 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
Avalon CL Base Station
Dimension and Weight
Size mm/(in)
WxHxD
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
290
30 Specifications and Standards Compliance
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
Wired Transducers
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)
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)
M2738A
Degree of Protection Against Electrical Shock
Type CF
Transducer Identification
Optical Signal Element (Finder LED), not M2738A
Avalon CL Transducers
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+
866075
MP Transducer Size (diameter/height)
Weight
Avalon CL US Transducer 866076 Size (diameter/height)
Weight
Avalon CL ECG/IUP Transducer Size (diameter/height)
866077
Weight
76 mm/37 mm (3 in/1.5 in)
0.2 kg (0.5 lb)
76 mm/37 mm (3 in/1.5 in)
0.2 kg (0.5 lb)
76 mm/37 mm (3 in/1.5 in)
0.2 kg (0.5 lb)
291
30 Specifications and Standards Compliance
Avalon CL Transducers (866075/866076/866077)
Degree of Protection Against Electrical Shock
Type CF
Transducer Identification
Optical Signal Element (Finder LED)
Avalon CL Fetal & Maternal Pod
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
WxHxD
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
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
WxHxD
55 x 26.5 x 122 mm
(2.1 x 1 x 4.8 in)
Weight
0.14 kg (0.3 lb)
Interface Cable Avalon CTS
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)
External Power Supply Option E25
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)
292
30 Specifications and Standards Compliance
Interface Specifications
Fetal Monitors
Interface Specifications
Network
MIB/RS232
USB Interface
RS232 (Standard)
Standard
100-Base-TX (IEEE 802.3 Clause 25)
Connector
RJ45 (8 pin)
Isolation
Basic isolation (reference voltage: 250 V; test voltage:
1500 V)
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)
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
Connectors
RJ45 (8 pin)
Power
none
Isolation
Basic isolation (reference voltage: 250 V; test voltage:
1500 V)
RS232 (Independent display Connectors
interface option)
Power
Flexible Nurse Call Relay1
RJ45 (8 pin)
none
Isolation
none
Connectors
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
The power loss indication functionality of the Nurse Call Relay board is not supported with fetal
monitors.
293
30 Specifications and Standards Compliance
Avalon CL 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
OBR (WMTS)*
OBR (ISM)*
OBR (T108)*
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
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)
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)
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)
*Wireless transmissions are encrypted for security.
CL Wide Range Pod Radio
OBR (OB Radio)
OBR (WMTS)
OBR (ISM)
OBR (T108)
Frequency Band
608-614 MHz
Effective radiated power
<1 mW
Range
5 m/16 ft
Frequency Band
433.05-434.79 MHz
Effective radiated power
<1 mW
Range
5 m/16 ft
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
294
30 Specifications and Standards Compliance
Short Range Radio Specifications
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)
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)
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.).
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).
295
30 Specifications and Standards Compliance
Measurement
Essential Performance
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.
SpO2
Measurement 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.
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:
296
•
Electrostatic Discharge (ESD)
•
Electrical Fast Transients/Bursts
•
Surges
•
Voltage interruptions
30 Specifications and Standards Compliance
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 Monitors
Fetal Monitor Performance Specifications
Alarm Signal
Review Alarms
Real time Clock
Buffered Memory
System alarm delay.
less than 4 seconds
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.
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)
Information
all alarms/INOPs, main alarms on/off, alarm
silence and time of occurrence
Capacity
300 items
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
Hold Time
if powered by AC infinite
without power: at least 8 hours
Contents
active settings, review alarms, stored trace data
Battery Specifications
Performance Specifications
Avalon FM20/30 Battery
Option #E25
Operating Time (with new,
fully charged battery)
Basic monitoring configuration: >2 hours
Charge Time
When monitor is off: approx. 6 hours
When monitor is in use: more than 10 hours (depending
on monitor configuration)
(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)
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30 Specifications and Standards Compliance
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
Fetal / Maternal Specifications
Ultrasound
Complies with IEC 60601-2-37:2007 / EN 60601-2-37:2008
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
298
30 Specifications and Standards Compliance
Performance Specifications
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)
Isata = (2.38 ± 0.59) mW/cm2
(= spatial average - temporal average
intensity)
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)
Isata = (2.77 ± 0.56) mW/cm2
(= spatial average - temporal average
intensity)
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
200 μVpp-40 mVpp
FMP Signal Range @ 33 Hz
Toco
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
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30 Specifications and Standards Compliance
Performance Specifications
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
IUP
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
ECG
Complies with IEC 60601-2-27:2011 / EN 60601-2-27:2014 except clauses listed below:
300
•
201.6.2, 201.8.5.5
•
201.12.1.101
•
202.6.2.101
30 Specifications and Standards Compliance
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
Resolution
30-240 bpm
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 (nonaveraging)
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
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.
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30 Specifications and Standards Compliance
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
MECG Alarm Limits
High Range: 31-240 bpm
1 bpm steps (30-40 bpm) System alarm delay (see
5 bpm steps (40-240 bpm) “Fetal Monitors” on
page 297).
Default: 120 bpm
Low Range: 30-235 bpm
Alarm Delay
Default: 50 bpm
Extreme Tachycardia
Difference to high limit: 050 bpm
5 bpm steps
Default: 20 bpm
Clamping at: 150-240 bpm
5 bpm steps
Default: 200 bpm
Extreme Bradycardia
Difference to low limit: 050 bpm
5 bpm steps
Default: 20 bpm
Clamping at: 30-100 bpm
5 bpm steps
Default: 40 bpm
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
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30 Specifications and Standards Compliance
Maternal ECG Supplemental Information as required by IEC 60601-2-27
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
Toco+
CL
MP,
CL ECG/IUP
Heart Rate Meter Accuracy and
Response to Irregular Rhythm
HR change from 80-120 bpm Average: 10 seconds
HR change from 80-40 bpm Average: 12 seconds
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
aFHR, aHR, aToco
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
Accuracy
Display
1 bpm
Printer
1/4 bpm
±1 bpm
aToco
Measurement Method
uterine electromyography
Measurement Range
0-500 μV
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30 Specifications and Standards Compliance
aToco
Resolution
0-255 levels representing 100% of
the full scale
Accuracy
±5%
Noninvasive Blood Pressure
Complies with IEC 80601-2-30:2009 / EN 80601-2-30:2010.
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)
Accuracy1
Max. Std. Deviation: 8 mmHg (1.1 kPa)
Max. Mean Error: ±5 mmHg (±0.7 kPa)
Pulse Rate
Range
40-300 bpm
Accuracy (average over 40-100 bpm: ±5 bpm
noninvasive blood
101-200 bpm: ±5% of reading
pressure measurement
201-300 bpm: ±10% of reading
cycle)
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
*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.
Alarm
Specifications
Range
Adjustment
Alarm Delay
Systolic
Adult: 30-270 mmHg (436 kPa)
10-30 mmHg: 2 mmHg (0.5 kPa)
>30 mmHg: 5 mmHg (1 kPa)
Diastolic
Adult: 10-245 mmHg (1.532 kPa)
System alarm delay (see
“Fetal Monitors” on
page 297).
Mean
Adult: 20-255 mmHg (2.534 kPa)
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30 Specifications and Standards Compliance
Overpressure Settings
Adjustment
> 300 mmHg (40 kPa) > 2 sec
not user adjustable
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.
SpO2 Performance Specifications
SpO2
Range
The specified accuracy is Accuracy
the root-mean-square
(RMS) difference
between the measured
values and the reference
values
0-100%
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%)
Pulse
Resolution
1%
Range
30-300 bpm
Accuracy
±2% or 1 bpm, whichever is greater
Resolution
1 bpm
305
30 Specifications and Standards Compliance
SpO2 Performance Specifications
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 Alarm Specifications Range
Adjustment
Delay
(0, 1, 2, 3,... 30) +
4 seconds
SpO2
50-100%
1% steps
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
Difference to low limit 0-50 bpm
5 bpm steps
Clamping at 30-100 bpm
5 bpm steps
Bradycardia
max. 14 seconds
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.
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)
306
30 Specifications and Standards Compliance
Performance Specifications
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.
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, noncondensing
16.0-33.0°C
60.8-91.4°F
Storage up to 95% RH, noncondensing
-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).
307
30 Specifications and Standards Compliance
Physical 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
Recorder Specifications
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
Triplet
308
Standard
FHR2 +20 bpm
Classic
FHR1 +20 bpm
in the presence of FHR2
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
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)
309
30 Specifications and Standards Compliance
Recorder Symbols
Symbol
Description
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)
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
© Copyright 2016. Koninklijke Philips N.V. All Rights Reserved.
Trademark Acknowledgment
OxisensorTM II, Oxi-CliqTM, and OxiMaxTM are trademarks of Tyco Healthcare Group LP, Nellcor
Puritan Bennett Division.
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30 Specifications and Standards Compliance
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 60601-18:2007+A1:2013+AC:2014.
Compatibility
When your fetal monitor is compliant with IEC 60601-1:1988+A1:1991+A2:1995 / EN 606011:1990+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 606011:2006+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.
311
30 Specifications and Standards Compliance
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 606011:2005+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 606011:2005+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.
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30 Specifications and Standards Compliance
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.
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30 Specifications and Standards Compliance
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:
Eliminating the source. Turn off or move possible sources of EMI to reduce their strength.
Attenuating 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.
Adding 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.
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30 Specifications and Standards Compliance
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
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30 Specifications and Standards Compliance
Table 1 - Guidance and Manufacturer's Declaration: Electromagnetic Emissions
Emissions Test
Compliance
Avoiding Electromagnetic Interference
RF emissions CISPR 11
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.
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.
For the Avalon FM20/30 fetal monitor with all
accessories except the IUP/ECG patient
module M2738A.
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 (M273160001/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.
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.
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/ ±2 kV for power
burst
supply lines
IEC 61000-4-4
±1 kV for input/
output lines
Surge
IEC 61000-4-5
316
±2 kV for power supply Mains power quality should be that of a
lines
typical commercial and/or hospital
±1 kV for input/output environment
lines
±1 kV differential
±1 kV differential mode Mains power quality should be that of a
mode
±2 kV common mode
typical commercial and/or hospital
±2 kV common mode
environment
30 Specifications and Standards Compliance
Table 2 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity
Immunity Test
IEC 60601-1-2 Test
Level
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
<5% UT (>95% dip in <5% UT (>95% dip in
UT) for 0.5 cycles
UT) for 0.5 cycles
40% UT (60% dip
in UT) for 5 cycles
70% UT
(30% dip in UT) for
25 cycles
< 5% UT
(>95% dip in UT) for
5 sec
Power frequency (50/
60 Hz) magnetic field
IEC 61000-4-8
3 A/m
Compliance Level
Electromagnetic Environment
Guidance
Mains power quality should be that of a
typical commercial and/or hospital
40% UT (60% dip in UT) environment. If the user of the device
requires continued operation during
for 5 cycles
power mains interruptions, it is
70% UT (30% dip in UT) recommended that the device is
for 25 cycles
powered from an uninterruptible power
supply.
< 5%UT (>95% dip in
UT) for 5 sec
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.
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.)
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30 Specifications and Standards Compliance
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:
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30 Specifications and Standards Compliance
Table 3 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity
Conducted RF Immunity Test EN/IEC 61000-4-6
Electromagnetic Environment Guidance:
IEC 60601-1-2 Test Level
over 150 kHz to 80 MHz
Compliance Level
3.0 VRMS
3.0 VRMS
Recommended Separation Distance (d)
(in Meters, at Frequency Range Tested)
for Ultrasound and ECG Measurements
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
Electromagnetic Environment Guidance:
IEC 60601-1-2 Test Level
over 80 MHz to 2.5 GHz
Compliance Level
3.0 V/m
3.0 V/m
Recommended Separation Distance (d)
(in Meters, at Frequency Range Tested)
for Ultrasound and ECG Measurements
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
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
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30 Specifications and Standards Compliance
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.
Table 5 - Separation Distance (d) in Meters According to Frequency of Transmitter at IEC 60601-1-2 Test
Compliance Level
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
1W
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
Rated Maximum Output
Power (P) of Transmitter (in
Watts)
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.
320
30 Specifications and Standards Compliance
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.
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30 Specifications and Standards Compliance
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
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30 Specifications and Standards Compliance
Symbol
Description
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)
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30 Specifications and Standards Compliance
Symbol
Description
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
CMIIT ID
Federal Communications Commission: FCC ID xxxx
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)
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30 Specifications and Standards Compliance
Symbol
Description
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)
IC-ID (Industry Canada ID)
One IC-ID labeling for each built in radio: OBR, SRR
Japanese Radio marking: Radio mark + [R]-symbol +
ID
Taiwan Radio Label (NCC Logo) + ID
Korea radio mark: KC logo, KCC ID number, and
Conformity assessment information
325
30 Specifications and Standards Compliance
326
31
31
Default 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
All
(international)
(USA/CAN)
Alarm Volume
0..10
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
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
Default Color for MECG Numeric
Red
HR, aHR
Measurement
327
31 Default Settings Appendix
Fetal / Maternal Defaults Settings (US/CAN)
FHR, dFHR, aFHR
Alarms On/Off Default
On
Default Color for FHR Numeric:
FHR1, dFHR1, aFHR1
Red
FHR2, dFHR2, aFHR2
Blue
FHR3, dFHR3, aFHR3
Toco, aToco
Green
Default color for Toco numeric
Green
Yellow
IUP
HR, aHR
Measurement
Default IUP Scale Unit
mmHg
Default color for IUP numeric
White
Default Color for MECG Numeric
Red
Coincidence Default Settings
Coincidence Default Settings
Coincidence Tone
immediately
NBP Default Settings
Factory Default Settings
Mode
Manual
Repeat Time
15 min
Alarms from
Sys.
(International)
Sys&Dia&Mean
NBP Sys/Dia only
Yes
No
(USA/CAN)
(International)
(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
328
(Toco)
(aToco)
31 Default Settings Appendix
CL NBP 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 Default Settings
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
20 bpm
Brady Clamp
40 bpm
Δ ExtrTachy
20 bpm
Tachy Clamp
200 bpm
Bradycardia: Difference to Low Limit
Tachycardia: Difference to High Limit
329
31 Default Settings Appendix
CL SpO2 Default Settings
SpO2 Settings
Factory Defaults
Repeat Time
15 min
Signal Quality
On
NBP Alarm Suppr.
On
Color
Cyan
Tympanic Temperature Default Settings
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
Manually Entered Values Default Settings
Manual Entered Values
Default Settings
Label
Temp
Unit
°C
Color
White
Interval
1h
Msmnt
Off
(fixed)
Recorder Default Settings
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
330
printing choice
Separate, Overlap
Separate
31 Default Settings Appendix
Setting
Choice
Default
Notes Recording
Along, Across
Along
(International)
(USA/CAN)
Across
Change Rec Speed
Monitoring, Config
Config
Auto Start
Off, On
Off
Confirmed Stop
Off
Bridge Paperout
On
Paper Save Mode
Off
On
NST Autostart
On
NST Autostop
Off
Trace Separation
Off
(International)
(USA/CAN)
Separation Order
Standard, Classic
Standard
(International)
Classic (USA/CAN)
Intensity
4 (medium)
n/a
Cal. Offset
n/a
331
31 Default Settings Appendix
332
1
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
Index
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
333
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
334
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
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
335
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
336
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*

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