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

Philips Medical Systems North America Co. Patient Monitoring ait fm manual

Contents

User Manual Part 2

91519Non-Stress Test TimerThe 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/AutostopYou 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 TimerYou 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 NotificationWhen the timer expires, the color changes from blue to green, you hear a single tone, and a message appears in the status line on the main screen.The volume of the tone can be set in Configuration Mode.
9 Non-Stress Test Timer152Accessing the NST Setup Pop-up KeysYou control and set up the NST timer (for example, start, stop, or clear the timer, and set the run time) using a selection of pop-up keys that you access via any one of three possible routes:•Via the Timer SmartKey (Route 1)•Via the Main Setup SmartKey (Route 2)• Via the NST display area at the top left-hand corner of the screen (Route 3). When you touch the NST display area, the NST pop-up keys become available at the bottom of the screen.Via the Timer SmartKey (Route 1)Press the Timer SmartKey. The Timers window opens, and the pop-up keys for controlling/setting up the NST timer appear (see “Pop-up Keys for NST Timer Setup” on page 152).Via the Main Setup SmartKey (Route 2)1Enter the Main Setup menu using the SmartKey.2Select NST to enter the Setup NST menu. At the same time, the pop-up keys for setting up the NST timer appear (see “Pop-up Keys for NST Timer Setup” on page 152).Via the NST Display Area (Route 3)Select the NST display area at the top left-hand corner of the screen (when so configured). The pop-up keys for controlling/setting up the NST timer become available at the bottom of the screen (see “Pop-up Keys for NST Timer Setup” on page 152).Pop-up Keys for NST Timer SetupRuntimeThe run time can be set from 10 to 60 minutes. See the Configuration Guide for details how to set the run time.Run TimeThe run time can be set from 10 to 60 minutes. See the Configuration Guide for details how to set the run time.Pop-Up Keys Selecting this pop-up key lets you: CommentsStart 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.
1015310Non-Stress Test ReportIt 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 ReportTo set up NST Report functionality:1Enter the Main Setup menu and select the NST Report.2Or select the NST Report SmartKey.3Press the Setup pop-up key.
10 Non-Stress Test Report1544Set your configuration options.Select from:•NST Analysis choose from On or Off.This switches the report feature on or off. This is linked to the NST timer. Both must be set to On for the NST report to function.•Report Recording choose from:–Manual - press the Record Report pop-up key to trigger a manual request.–After Recorder Stop - report is recorded as soon as recorder becomes idle.–Immediately - if a realtime recording is running, the monitor pauses it. The recording is continued after the report has been recorded.Average short term variability (STV) value is documented in [bpm] and [ms] if STV is configured as part of the NST Report. This parameter is not considered as reassuring criteria.NST Report Status WindowThe NST Report window displays a detailed overview of the current NST status for any available ultrasound fetal heart rate measurement. You can see:• NST Status - whether it is ready, ongoing, or the time and date at which it was stopped, or at which it was finished.• Elapsed time - the time that has elapsed since the NST began.• Accelerations - the number of FHR accelerations detected so far.• Baseline - the average baseline value.• Variability - the average variability value.• Short Term Variability - the current short term variability (STV) value.• Decelerations - the number of FHR decelerations detected so far.• FHR Availability - current statistical FHR availability value.• Sinusoidal - the current status of sinusoidal rhythm detection.For criteria not yet met, a white arrow symbol marks the overall status on the top line, and also appears against every criterion not yet met. A yellow symbol indicates detection of severe or prolonged decelerations.The pop-up keys let you perform the following actions:•FHR1, FHR2, FHR3 - switch to the window showing the current NST status for the fetal heart rate.•Record Report - print the NST Report on paper.•Record Trace - record the trace episode that belongs to the current report. Depending on device usage, the trace recording might be incomplete.•Setup - open the Setup NST Report window.
10 Non-Stress Test Report155Example NST ReportField Field ContentReport Title, with FHR label and dateNST Report for FHR1 on 12 Oct. 2009Product Information Product DE53102345 G.01.70, OB A.04.24,Toco DE52401090, FHR1 DE00002345 A.05.26Patient Information Rogers, AliceAge: 27Gestational Age: Week 34, Day 5Start time, end time, Elapsed time, configured runtime Time: 11:34 – 12:06Elapsed time: 32 minRun time: 20 minOverall one-line NST result summaryNST Criteria*: not metTitle Trace Interpretation SummaryResult Accelerations Accelerations: 2at: 11:59 12:02Result: Contractions Contractions: 3at: 11:57 12:00 12:04Result: Baseline and VariabilityBaseline: 125 bpm (Range: 118-129 bpm)Variability: 23 bpm (Range: 20-24 bpm)Statistics: FHR availability FHR available: 95%Result: Decelerations Decelerations: 1at: 11:58severeprolongedResult:Sinusoidal Rhythm detectedSinusoidal: No
10 Non-Stress Test Report156Result: Decelerations before Reporting PeriodEvents before Reporting Period:Decelerations: 1at: 11:38severeprolongedThis field is enabled if there were decelerations between the start of NST and the start of the reporting period.Guideline/Criteria Information(*) Interpretation criteria based on guideline "NICHD 2008, v01"User-defined criteria for CTG tracing:• valid FHR for 90% of reporting period• baseline heart rate between 120 bpm and 160 bpm• at least 2 accelerations in 10 min• not more than 1 decelerations• moderate baseline variability (6-25 bpm)Additional criteria:• no severe or prolonged decelerations• no sinusoidal pattern in reporting periodField Field Content
10 Non-Stress Test Report157NST CriteriaThe 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 ReportIf 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 TestIf a nonreactive test occurs, and you then use acoustic stimulation, you must exercise caution in interpreting the resulting traces, as artificial stimulation is not taken into account when calculating test results.
10 Non-Stress Test Report158
1115911Cross-Channel Verification (CCV)The cross-channel verification helps to reduce the possibility of misidentification of the maternal heart rate for the fetal heart rate. It does this by comparing the measured fetal heart rate to the maternal heart rate. If there are multiple fetal rates, they are also compared with each other and the maternal heart rate.Misidentification of Heart RatesFHR 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.NOTEWhen an ultrasound transducer is connected to the monitor, but not applied to the patient, the measurement may generate unexpected intermittent FHR readings.
11 Cross-Channel Verification (CCV)160When 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 FunctionalityThe 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 DetectionCoincidence INOP appears on the screen of the fetal monitor.Question mark appears on the screen of the fetal monitor next to the numerics that show the same or similar values.Question mark recorded on the trace from the point where two measured values coincide.
11 Cross-Channel Verification (CCV)161Overview of Cross-Channel ComparisonsMeasurements from TransducersMeasurement Comparison Done by the Fetal Monitor for Cross-Channel Verification* dFHR and aFHR always replace one of the fetal channels (1,2, or 3) and cannot be compared to the channel it replaces. If you monitor for example twins with two ultrasound transducers, you see the numerics FHR1 and FHR2 at the monitor. If you decide to replace the ultrasound transducer for FHR2 with a fetal scalp electrode, the dFHR numeric is then shown as dFHR2.Measurement TransducerFHR (US) From Ultrasound or CL Ultrasound transducerdFHR (DECG) From a fetal scalp electrodeaFHR (abdom. ECG) From the CL Fetal & Maternal PodPulse (Toco) From Toco MP, or CL Toco+ MP transducerPulse (SpO2) From SpO2 or CL SpO2 PodHR (MECG) From MECG electrodesaHR (abdom. ECG) From the CL Fetal & Maternal PodFHR1 (US) FHR2 (US) FHR3 (US) dFHR (DECG)* aFHR* (ECG)FHR1 (US)FHR2 (US)FHR3 (US)dFHR (DECG)*aFHR (abdom. ECG)Pulse (Toco)Pulse (SpO2)HR (MECG)aHR (abdom. ECG)
11 Cross-Channel Verification (CCV)162Coincidence ExamplesCoincidence of Maternal Pulse and FHRWhen the maternal pulse and FHR are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitor’s screen above both of the corresponding numerics (in this case maternal pulse and FHR). Often the signal loss or coincidence happens because the fetal or maternal movement displaced the ultrasound transducer, and a repositioning of the transducer is necessary.Pulse DelaySpO2 pulse rate traces have an averaging calculation of approximately 10 seconds and an overall delay of approximately 12 seconds (depending on recorder speed). This differs from a non-averaged beat-to-beat MECG heart rate trace or an ultrasound heart rate trace calculation (having switched to the maternal HR) with no significant delay. Note that Maternal Pulse from Toco has an averaging of 4 seconds and an overall delay of between 6 and 8 seconds.1Coincidence INOP2Coincidence question mark above FHR13Coincidence question mark above pulse from Toco MP
11 Cross-Channel Verification (CCV)163The coincidence question mark is also printed on the trace paper next to the corresponding FHR and maternal pulse.Coincidence of Twins/Triplets FHRsWhen both FHR1 and FHR2 are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitor’s screen above both of the corresponding numerics (in this case FHR1 and FHR2).1Printed coincidence question mark on trace2Fetal heart rate trace from Ultrasound3Maternal pulse trace from SpO21Coincidence INOP2Coincidence question mark above FHR13Coincidence question mark above FHR2
11 Cross-Channel Verification (CCV)164The coincidence question mark is also printed on the trace paper next to FHR1 and FHR2.Recommended Actions for Coincidence INOP1Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope.2Manual determination of the maternal pulse and comparison with the fetal heart rate sound signals from the loudspeaker.3Reposition the transducer, or ensure that the fetal scalp electrode is placed correctly, until you receive a clear signal and the monitor is no longer issuing the Coincidence INOP.4In case of difficulties deriving a stable maternal pulse reading using the Toco MP or CL Toco+ MP transducer, use SpO2 or the CL SpO2 Pod instead. In case of similar problems with the pulse measurement from SpO2, use MECG instead. Reasons to switch the method for deriving a maternal pulse or heart rate include: motion artifacts, arrhythmia, and individual differences in pulse signal quality on the abdominal skin (via Toco MP).5If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography.1Printed coincidence question mark on trace2FHR1 and FHR2 traces
1216512Monitoring FHR and FMP Using UltrasoundTo 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.WARNINGPerforming ultrasound imaging or Doppler flow measurements together with ultrasound fetal monitoring may cause false FHR readings, and the trace recording may deteriorate.Technical DescriptionFetal monitors use the ultrasound Doppler method for externally monitoring the fetal heart rate. Using the Doppler method, the transducer (in transmitter mode) sends sound waves into the body which are then reflected by different tissues. These reflections (Doppler echoes) are picked up by the transducer (in listening mode). These Doppler echoes are amplified and sent to the monitor’s speaker through which the fetal heart signal can be heard. In parallel the Doppler echoes are processed through an autocorrelation algorithm to determine the fetal heart rate (FHR). The FHR is displayed on the monitor’s numeric display and on the recorded trace.Properly representing the fetal heart rate using a device that derives heartbeats from motion is a formidable task and the limitations of the technology will be discussed shortly. Basic fetal cardiac physiology may contribute to difficulties in obtaining a reliable ultrasound signal.A heart rate pattern of a fetus is capable of extraordinary variation, ranging from a stable pattern with minimal variation while the fetus is “asleep” to robust accelerations of 40-60 bpm above baseline rate over a few seconds, or exaggerated variability when the fetus is active. Decelerations of the rate 60-80 bpm below baseline may develop even more abruptly than the accelerations. Beat-to-beat arrhythmias may further exaggerate the amount of “variability” and can be seen at the bottom of variable decelerations, or in the presence of fetal breathing movements which also tend to lower the fetal heart rate. The recognition of these normal variations in fetal heart rate patterns will greatly assist in the separation of genuine fetal information from the artifact.
12 Monitoring FHR and FMP Using Ultrasound166Limitations of the TechnologyAll 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 FHRFHR detection by the monitor may not always indicate that the fetus is alive. Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the recorded heart rate (see “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 159).What You Need• Ultrasound transducer• Toco MP or CL Toco+ MP transducer•Ultrasound gel• Transducer belt (and optional butterfly belt clip, if applicable)
12 Monitoring FHR and FMP Using Ultrasound167Cableless Monitoring - Important ConsiderationsWhen 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.CAUTIONNever 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.1FHR12Toco parameter
12 Monitoring FHR and FMP Using Ultrasound168WARNING• 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 MonitorPrepare for ultrasound monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions.1Determine fetal position.2Fasten the belt around the patient.3Switch on the monitor and the recorder.4Connect the transducer to a free socket. The signal quality indicator for the heart rate initially displays an invalid signal.5Apply a thin layer of ultrasound gel to the underside of the transducer.CAUTIONUsing ultrasound gel not approved by Philips may reduce signal quality and may damage the transducer. This type of damage is not covered by warranty.1Place the transducer on the abdomen, if possible over the fetal back or below the level of the umbilicus in a full-term pregnancy of cephalic presentation, or above the level of the umbilicus in a full-term pregnancy of breech presentation. Work the transducer in a circular motion to ensure the gel layer makes good contact.2When the transducer is connected correctly and you receive a good signal, the signal quality indicator should be filled out. If an inadequate signal is produced, the signal quality indicator will indicate a poor signal, and no numeric will appear on the screen.
12 Monitoring FHR and FMP Using Ultrasound1693Adjust 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.WARNINGPeriodically 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 SoundYou can listen to the fetal heart sound from one ultrasound transducer at a time. When the fetal heart sound is selected for an FHR channel, you see the audio source symbol next to the FHR numeric label for that channel.To select the audio source for an FHR channel:1Enter the Setup FHR1 menu for the channel you want to hear (FHR1 used as an example).2Press Select Audio. It may take a few seconds for the audio source symbol to appear.1FHR12Audio source symbol
12 Monitoring FHR and FMP Using Ultrasound170Changing the Fetal Heart Sound VolumeThe FHR volume symbol at the top right of the Fetal Heart Sound Volume window gives you an indication of the current volume. To change the volume:1Select the volume symbol. The volume scale pops up.2Select the required volume from the volume scale.Fetal Movement ProfileThe Fetal Movement Profile (FMP) parameter detects fetal movements with an ultrasound transducer connected to the monitor. Only the fetus monitored on the FHR1 channel is monitored for FMP.Once you have enabled FMP (see “Switching FMP On and Off” on page 171), it is triggered automatically whenever:• You connect an ultrasound transducer.• A patient is discharged.When FMP is enabled, the ultrasound transducer detects most fetal body movements. Eye movements are not detected, and movement of the feet and hands may not be detected. Positioning or repositioning of the transducer is recorded as fetal movement. Maternal movement, excessive fetal breathing, or fetal hiccups may also be recorded as fetal movement (also in case of fetal demise or during the second stage of labor). You can mark these artifacts on the trace paper using either the remote event marker, or the event marker key as described in “Marking an Event” on page 60. FMP should be interpreted with care, or disabled when the patient is ambulating or during the second stage of labor. Ignore these movements when you interpret the FMP. When monitoring twins or triplets, only the fetus monitored on the FHR1 channel is monitored for movement, but be aware that movements recorded for FHR1 may also be caused by movement of the second or third fetus.The fetal movement profile (FMP) appears as "activity blocks" along the top of the Toco scale, the length of each block showing the duration of the activity.1Fetal Heart Sound Volume
12 Monitoring FHR and FMP Using Ultrasound171FMP StatisticsFMP statistics are printed every ten minutes.The FMP detection activates after about half a minute of steady heart rate signals (signal indicator half-full, or full) to minimize transducer positioning artifact. You will notice this deliberate delay:• When a new patient is admitted. A patient discharge restarts the FMP statistics from zero.• When you connect an ultrasound transducer.Switching FMP On and OffYou can switch FMP on and off from any FHR channel. For example, to set it from the FHR1 channel:1Enter the Setup FHR1 menu.2Select Fetal Movement to switch between On and Off.3Return to the main screen.1FMP enabled2FMP started hereAIndication of current fetal movementBThe FMP statistics are presented as two percentage figures:The first figure shows the percentage of detected fetal movements in the previous ten minutes.CThe second figure shows the percentage of detected fetal movements since the start of recording.To mark the start of the FMP statistic, FMP is printed on the paper with an arrow.
12 Monitoring FHR and FMP Using Ultrasound172TroubleshootingProblem Possible Causes SolutionsErratic traceErratic displayFetal arrhythmia Consider monitoring FHR using DECG after the rupture of membranes.Obese patientTransducer position not optimal Reposition transducer until signal quality indicator shows a good signal (at least half-full).Belt loose Tighten beltToo much gel Remove excessVery active fetus -Insufficient gel Use enough gel to ensure the transducer makes good contact with the mother's skin.Signal quality indicator is continuously poorTransducer position not optimal Reposition transducer until signal quality indicator shows a good signal (at least half-full).FHR less than 50 bpm (and the FHR is audible)If membranes are ruptured, using a fetal scalp electrode (FM30 and FM50 only) allows measurement of FHR down to 30 bpm.Questionable FHR Recording maternal HR by mistake Reposition transducerConfirm fetal lifeRecording periodic signals when the transducer is not applied to the patientDisconnect all NON-USED ultrasound transducers, as continuous, regular mechanical, or electromagnetic influences can result in an artificial trace.Recorded FHR appears to be suspiciously higher, or suspiciously lower, than real FHR. In very rare cases, half- or double-counting of the FHR can occur.If you have reason to question the validity of the recorded FHR, always verify FHR by independent means (by auscultation, for example). Measure maternal pulse by independent means.FHR not recorded FHR is less than 50 bpm or over 240 bpm If membranes are ruptured, using a fetal scalp electrode (FM30 and FM50 only) allows measurement of FHR down to 30 bpm.If FHR is outside of the specified range, verify FHR by independent means.FHR1 Equip Malf or FHR2 Equip Malf or FHR3 Equip Malf INOP displayed. See “Patient Alarms and INOPs” on page 129.FHR1 Signal Loss or FHR2 Signal Loss or FHR3 Signal Loss INOP displayed.FHR1 Unplugged or FHR2 Unplugged or FHR3 Unplugged INOP displayed.If you suspect the transducer is malfunctioning Test the transducer.
12 Monitoring FHR and FMP Using Ultrasound173Testing Ultrasound TransducersIf any of the following tests fail, repeat the test using another transducer. If the second transducer passes the tests, confirming that the first transducer is defective, contact your service personnel.If the second transducer also fails the tests, contact your service personnel.You can test all ultrasound transducers, including the cableless ones, as described above.Additional InformationArtifact in Fetal Heart Rate MeasurementHow to detect it and reduce its occurrence using the Avalon Fetal MonitorThe 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 FHRTo test an ultrasound transducer:1Switch on the monitor and the recorder.2Connect the transducer to the fetal monitor.3Select the fetal heart sound for this channel.4Increase the loudspeaker volume to an audible level.5Holding the transducer in one hand, move your other hand repeatedly towards and then away from the surface.6Check that a noise is heard from the loudspeaker.
12 Monitoring FHR and FMP Using Ultrasound174• When you are unable to determine a baseline rate, and variability occurs between consecutive contractionsThere 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 electrodeVerification 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 pulseWhenever possible measure the maternal pulse rate to make use of the monitor’s Cross-Channel Verification (CCV) feature, especially during the second stage of labor, or when the maternal pulse is elevated over 100 bpm. The Avalon fetal monitor provides a Toco MP or CL Toco+ MP transducer for maternal pulse detection and the creation of a maternal heart rate pattern plotted on the same recorder as the FHR pattern. In case of difficulties deriving a stable maternal pulse reading using the Toco MP or CL Toco+ MP transducer, use SpO2 or MECG instead. When either of these parameters is utilized, the monitor will automatically and continuously perform a CCV of the maternal heart rate pattern against the FHR pattern displayed on the monitor. If the patterns and rates are similar, the CCV provides an alarm that both rates are probably from the same source (i.e., they both represent the maternal heart rate pattern and the fetus is not being monitored). Repositioning the ultrasound transducer will usually correct this, but it may be necessary to apply a fetal scalp electrode. Advising the mother to temporarily cease pushing during contractions may help to more rapidly resolve any uncertainty in this situation.Doubling: The autocorrelation algorithm can display a doubled fetal or maternal heart rate if the duration of diastole and systole are similar to each other, and if the heart rate is below 120 bpm. Doubling, usually brief, is accompanied by an abrupt switch of the trace to double the baseline value.Halving: With fetal tachycardia (above 180 bpm) and some interference from breathing or maternal arteries the autocorrelation algorithm may only recognize every second beat resulting in a halved rate for a limited time. If the actual FHR is above the maximum limit of the monitor (240 bpm), the algorithm will also half-count. Halving is accompanied by an abrupt switch of the trace to exactly half the prior baseline value. This switch may simulate an FHR deceleration and be referred to by clinicians as a “false deceleration.”Switching to maternal heart rate (also referred to as "Maternal Insertion"): The fetal heart can move partly or fully out of the ultrasound beam and the autocorrelation algorithm may then pick up and display the maternal heart rate. Depending on the signal mix in the ultrasound signal, switching to the maternal heart rate may mimic several conditions with the potential for erroneous interpretation and response as follows:•The switch to the maternal heart rate may simulate an FHR deceleration (i.e., a decrease of the fetal heart rate, and be referred to by clinicians as a “false deceleration”).
12 Monitoring FHR and FMP Using Ultrasound175•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 FetusesWith multiple fetuses, the potential to experience these artifacts is increased. Positioning of the transducer is even more critical. Ultrasound scanning should be used to help with positioning of individual transducers. See also “Monitoring Twin FHRs” on page 183 and “Monitoring Triple FHRs” on page 191.
12 Monitoring FHR and FMP Using Ultrasound176Obtaining a Good Heart SignalTo 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 canalIn 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 SoundThe heart rate sound emitted by the device is a representation of movement that, in most cases, permits accurate auscultation of the FHR corresponding to the FHR displayed on the monitor and rate pattern depicted on the trace recording. On occasion, the user may hear an FHR that differs from the FHR display and the recorded trace. This may occur in situations where the fetal heart moves partly out of the transducer ultrasound beam. In these cases, the user may hear the FHR emitted from the monitor’s speaker, even though another periodic signal (usually the maternal heart rate) has become stronger. The autocorrelation algorithm will display the stronger maternal heart rate, despite the persistence of a weaker fetal signal. These occurrences are usually very brief and, if persistent, can be addressed by repositioning the transducer.
12 Monitoring FHR and FMP Using Ultrasound177Signal Quality IndicatorThe signal quality on the Avalon fetal monitor is indicated by a triangle on the touchscreen that is displayed in one of three ways:Examples of ArtifactsWhen monitoring the maternal ECG, a beat-to-beat maternal heart rate trace is printed alongside the FHR recorded trace. When monitoring the maternal SpO2 derived pulse rate, a filtered and averaged heart rate trace is printed.Following are recorded trace examples of complaints received regarding inaccurate output from the Avalon monitors. Scaling is 3 cm/min and 30 bpm/cm.1Completely filled triangle, indicating good signal quality (good/full).2Half-filled triangle, indicating limited signal quality. This condition may indicate a weak or ambiguous signal. If this status persists, reposition the transducer (acceptable/medium).3Empty triangle, indicating insufficient signal quality. No FHR is displayed on the monitor’s numeric display or the recorded trace. If this status persists, reposition the transducer (poor/no signal).Double-CountingBaseline Rate 120Baseline Variability ModerateAccelerations PresentDecelerations Not apparent
12 Monitoring FHR and FMP Using Ultrasound178Contractions Excessive, coupling, hypertonusArtifact Double-CountingComment Reassuring tracing. The excessive uterine activity should prompt discontinuation of any oxytocic agent.Remediation The true fetal rate can be confirmed by auscultation or by fetal scalp electrode.Double-CountingHalf-CountingBaseline Rate 120Baseline Variability ModerateAccelerations PresentDecelerations Not apparentContractions MinimalArtifact Half-counting, noise, drop outComment Reassuring tracing. The half-count at 4-5 minutes into the tracing may simulate a fetal deceleration, but the abruptness and the lack of any compensatory changes when the normal rate returns suggests that this is half-counting. Insertion of the maternal heart rate (see below) may produce a similar pattern. Note also very brief episodes of half-counting, maternal insertion, and signal dropout.Remediation Auscultation or the application of a direct scalp electrode, if feasible, will reveal the true fetal heart rate.
12 Monitoring FHR and FMP Using Ultrasound179Maternal-Switching (Maternal Insertion)Baseline Rate 170 - TachycardiaBaseline Variability ModerateAccelerations Unable to determineDecelerations AbsentContractions AbsentArtifact Maternal insertion, noiseComment 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 DropoutBaseline Rate 140Baseline Variability ModerateAccelerations PresentDecelerations AbsentContractions MinimalArtifact Noisy signal, drop-out
12 Monitoring FHR and FMP Using Ultrasound180Selection 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. CypherElsevier Ltd, Oxford. 2017, ISBN 978-0-323-40157-9___________________________________________________________Signal ambiguity resulting in unexpected outcome with external fetal heart rate monitoringBy Duncan R. Neilson Jr, MD; Roger K. Freeman, MD; Shelora Mangan, RNC, MSN, CNSAmerican Journal of Obstetrics & Gynecology, June 2008___________________________________________________________Antepartal and Intrapartal Fetal Monitoring, 3rd Edition (2007)By Michelle L. Murray, PhD, RNCSpringer Publishing Company, ISBN 0-8261-3262-6Page 2, Table 2: Limitations of Continuous EFMItem 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 2007Chapter 2: Intrapartum SurveillancePage S35: “Methods of Electronic Fetal Monitoring”“… Among its disadvantages are the need for readjustment with maternal or fetal movements and the following: the transducer may record the maternal pulse, it may be difficult to obtain a clear tracing in obese women or those with polyhydramnios, artifact may be recorded, and there may be doubling or halving of the fetal heart rate when it is outside of the normal range.”___________________________________________________________Comment Reassuring tracing. Note that there is episodic drop out of the signal with discontinuity of the fetal tracing.Remediation Either improving the position of the transducer or the application of a fetal scalp electrode will reduce the amount of artifact in the tracing.Noisy/Erratic Signal and Dropout
12 Monitoring FHR and FMP Using Ultrasound181Maternal or Fetal Heart Rate? Avoiding Intrapartum Misidentificationby Michelle L. MurrayJOGNN Clinical Issues, April 2003, 33, 93-104; 2004. DOI: 10.1177/0884217503261161Figure 9 "The recording is of the MHR with occasional doubling."___________________________________________________________Maternal Heart Rate Pattern – A Confounding Factor In Intrapartum Fetal SurveillanceSchifrin BS, Harwell R, Hamilton-Rubinstein T, Visser G:Prenat Neonat Med 2001; 6:75-82___________________________________________________________Fetal Monitoring in Practice, 2nd Edition 1998By Donald Gibb, S. ArulkumaranButterworth-Heinemann, ISBN 0-7506-3432-2Page 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 InterpretationKlapholz, Henry M, MD; Schifrin, Barry S. MD; Myrick, Richard RSObstetrics & Gynecology, September 1974, Volume 44, Issue 3___________________________________________________________
12 Monitoring FHR and FMP Using Ultrasound182
1318313Monitoring Twin FHRsThe 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 ConsiderationsWhen monitoring:• Ensure that you are recording two different fetal heart rates. The cross-channel verification feature alerts you if the two heart rates coincide (if both transducers are recording the same FHR). If this happens, check the trace and if necessary, reposition an ultrasound transducer to detect the second FHR correctly.• Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates a channel automatically. For instance, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second is labeled FHR2, and so on.If you need to disconnect the transducers measuring the FHR temporarily, with the intention to continue monitoring after the temporary break (for example, if the mother needs to go to the bathroom), it is important that you reconnect the transducers in the same order as you originally connected them to make sure that the measurement labels remain consistent.Upon discharge of the patient all connected transducers are reset from left to right. Example: Only one transducer is still connected to the monitor, it was labeled FHR2 while monitoring the previous discharged patient; it is now reset to FHR1.• The transducer finder LED lets you identify at a glance which transducer is monitoring which heart rate channel.
13 Monitoring Twin FHRs184• The fetal sensor socket to which a transducer is connected is identified by the transducer position indicator in the setup menu header:• The trace recorded for FHR1 is thicker (darker) than that recorded for FHR2. This ensures that the two heart rates are easily distinguishable. The thickness of the recorded trace can be changed in Configuration Mode.• Remember that only one fetal heartbeat can be heard from the loudspeaker at a time.• The audio source symbol shows you which fetus you are listening to. To hear the other fetal heartbeat, select the fetal heart rate sound for this channel (see “Selecting Fetal Heart Sound” on page 169).• Monitor maternal pulse, especially during later stages of labor, to avoid mistaking maternal heart rate for FHR.• Make sure that you are recording the best possible signals by referring to the signal quality indicators and repositioning the transducers if necessary.• For the Avalon CL transducer system, see “Cableless Monitoring - Important Considerations” on page 167.Monitoring Twins ExternallyTo monitor twin FHRs externally, you need two ultrasound transducers. Follow the procedures described in “Monitoring FHR and FMP Using Ultrasound” on page 165. The transducer finder LED lets you identify at a glance which transducer is monitoring which FHR channel, and lights when you select the FHR numeric field on the screen.FM20/FM30 FM40/FM50
13 Monitoring Twin FHRs185Example of the screen showing ultrasound monitoring of twin FHRs:Monitoring Twins InternallyFM30/50 Monitor one twin using the procedures described in “Monitoring FHR and FMP Using Ultrasound” on page 165. Monitor the second twin using the procedures described in “Monitoring FHR Using DECG” on page 199.Example of a screen showing twin monitoring using a combination of US and DECG (the fetal heart rate monitored via DECG is labeled "dFHR1"/"dFHR2"/"dFHR3" on the screen):Separating FHR TracesTo help you to interpret traces with similar baselines, you can separate the baselines by an offset of 20 bpm by switching on trace separation. For details of the offset, see “Separation Order Type” on page 186.1FHR 12Toco parameter3FHR 21dFHR 12Toco parameter3FHR 2
13 Monitoring Twin FHRs186Switching Trace Separation On and OffConnect transducers to the monitor to measure FHR. Depending on the measurement method, you need either two ultrasound transducers or, for FM30/FM50, one ultrasound and one Toco+ transducer, or one CL ECG/IUP transducer (to monitor DECG):1Enter the Main Setup menu by pressing the Main Setup.2Select Fetal Recorder.3Select Trace Separation to switch between On and Off.4Exit the Main Setup menu.Separation Order TypeIn 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 OnWhen 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 OrderTo make differentiating the traces easier, the trace from the ultrasound transducer connected to the FHR2 channel is separated from that of FHR1 by 20 bpm. In other words, the trace for FHR2 is recorded 20 bpm higher than it really is. The trace for FHR1 is never shifted.The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR2. The FHR trace is labeled +20 every 5 cm:The label for FHR2 is annotated with a black filled +20:
13 Monitoring Twin FHRs187The 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 OrderTo make differentiating the traces easier, the trace for FHR1 is offset by +20 bpm when FHR2 is present. The FHR2 trace is never shifted.The recorder prints a dotted line labeled+20 across the FHR scale, to identify the trace for FHR1. The FHR trace is labeled +20 every 5 cm:The label for FHR1 is annotated with a black filled +20:The following trace shows trace separation switched on.Only the FHR1 trace is shifted. The numerical FHR value displayed on the monitor remains unchanged. Subtract 20 from the recorded trace for FHR1 to obtain the true FHR1 value. For example, if the recorded trace shows 160, then the true FHR is 140.
13 Monitoring Twin FHRs188When Trace Separation is OffTo indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale.1Standard trace separation switched off here2Classic trace separation switched off here
13 Monitoring Twin FHRs189TroubleshootingCommon problems that may occur when monitoring FHR using ultrasound are listed in “Monitoring FHR and FMP Using Ultrasound” on page 165. See also “Monitoring FHR Using DECG” on page 199 for common problems you might encounter when monitoring FHR directly.The following problem may occur when monitoring twins.For more information, see “Additional Information” on page 173.Problem Possible Cause SolutionThe question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued.Both transducers are recording the same FHR, or one fetal transducer is recording the maternal HR.Reposition an ultrasound transducer. See “Recommended Actions for Coincidence INOP” on page 164.
13 Monitoring Twin FHRs190
1419114Monitoring Triple FHRsIf your monitor is equipped with the triplets option, it carries the label: You can monitor triple FHRs externally using three ultrasound transducers. With the Avalon CL Transducer system, you can monitor triplets with cableless transducers. The Avalon CTS system and the CL F&M Pod do not have this option.Refer to the appropriate preceding chapters for contraindications, and more information about the available measurement methods.FHR detection by the monitor may not always indicate that the fetuses are alive. Confirm fetal life before monitoring, and continue to confirm that the fetuses are the signal source for the recorded fetal heart rates. See “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 159.Important Considerations• The procedures and any contraindications that apply for twins monitoring also apply for monitoring triplets. In addition, when monitoring triplets: Be aware that monitoring three FHRs is inherently more difficult than monitoring single or twin FHRs. The nature of the application increases the likelihood that a fetal heart rate is monitored by more than one transducer.• Ensure that you are recording three different fetal heart rates. Pay particular attention to any coincidence of heart rates detected by the monitor's cross-channel verification feature.• Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates a channel automatically. For instance, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second is labeled FHR2, and the third FHR3.If you need to disconnect the transducers measuring the FHR temporarily, with the intention to continue monitoring after the temporary break (for example, if the mother needs to go to the bathroom), it is important that you reconnect the transducers in the same order as you originally connected them to make sure that the measurement labels remain consistent.Upon discharge of the patient all connected transducers are reset from left to right. Example: Only one transducer is still connected to the monitor, it was labeled FHR2 while monitoring the previous discharged patient; it is now reset to FHR1.
14 Monitoring Triple FHRs192• The transducer finder LED lets you identify at a glance which transducer is monitoring which heart rate channel.• The fetal sensor socket to which a transducer is connected, is identified by the transducer position indicator in the setup menu header:• The trace recorded for the FHR3 is thicker (darker) than that recorded for FHR1, which is thicker than that for FHR2. This ensures that the three heart rates are easily distinguishable. The thickness of the recorded trace can be changed in Configuration Mode.• Remember that only one fetal heartbeat can be heard from the loudspeaker at a time. The audio source symbol shows you which fetus you are listening to. To hear the other fetal heartbeat, select the fetal heart rate sound for this channel (see “Selecting Fetal Heart Sound” on page 169).• Monitor maternal pulse to avoid mistaking maternal heart rate for FHR.• Ensure you are recording the best possible signals by referring to the signal quality indicators and repositioning the transducers if necessary.For the Avalon CL transducer system, see “Cableless Monitoring - Important Considerations” on page 167.Monitoring TripletsTo 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 TracesTo help you to interpret traces with similar baselines, you can separate the baselines by an offset of 20 bpm by switching on trace separation. For details of the offset, see “Separation Order Type” on page 186.FM20/FM30 FM40/FM50
14 Monitoring Triple FHRs193"Standard" Separation OrderTo make differentiating the traces easier, the trace for FHR2 is offset by +20 bpm, and the trace for FHR3 is offset by -20 bpm. In other words, the trace for FHR2 is recorded 20 bpm higher than it really is, while the trace for FHR3 is recorded 20 bpm lower than it really is. The trace for FHR1 is never shifted.The following trace shows triplets with Trace Separation on, and using Standard separation order.The traces for FHR2 and FHR3 are offset. The numerical FHR values displayed on the monitor remain unchanged. Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2. For example, if the recorded trace shows 160 bpm, then the true FHR is 140 bpm. Similarly, add 20 to the recorded trace for FHR3 to obtain the true FHR3.The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR2.The recorder prints a dotted line labeled -20 across the FHR scale, to identify the trace for FHR3.The FHR trace is labeled every 5 cm.The label for FHR2 is annotated with +20 and the FHR3 label is annotated with -20.
14 Monitoring Triple FHRs194"Classic" Separation OrderTo make differentiating the traces easier, the trace for FHR1 is offset by +20 bpm when other FHR measurements are present, and the trace for FHR3 is offset by -20 bpm. The FHR2 trace is never shifted. In other words, the FHR traces are always sorted in ascending order from top to bottom.The following trace shows triplets with Trace Separation on, and using Classic separation order.The traces for FHR1 and FHR3 are shifted. The numerical FHR values displayed on the monitor remain unchanged. Subtract 20 from the recorded trace for FHR1 to obtain the true FHR1. For example, if the recorded trace shows 160 bpm, then the true FHR is 140 bpm. Similarly, add 20 to the recorded trace for FHR3 to obtain the true FHR3.The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR1.The recorder prints a dotted line labeled -20 across the FHR scale, to identify the trace for FHR3.The FHR trace is labeled every 5 cm.The label for FHR1 is annotated with +20 and the FHR3 label is annotated with -20.
14 Monitoring Triple FHRs195Switching Trace Separation On and Off1Connect three ultrasound transducers to the monitor to measure FHR.2See “Switching Trace Separation On and Off” on page 186 for details of how to switch trace separation on or off.When Trace Separation is OnWhen 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 OffTo indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale.1Standard trace separation switched off here
14 Monitoring Triple FHRs196TroubleshootingCommon problems that may occur when monitoring FHR using ultrasound are listed in “Monitoring FHR and FMP Using Ultrasound” on page 165.The following problem may occur when monitoring triplets.For more information, see “Additional Information” on page 173.2Classic trace separation switched off hereProblem Possible Cause SolutionThe question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued.More than one transducer is recording the same FHR, or a fetal transducer records the same heart rate as the maternal HR.Reposition one or more ultrasound transducer, as appropriate. See “Recommended Actions for Coincidence INOP” on page 164
1519715Fetal Heart Rate AlarmsFetal 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 SettingsWhen 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 delayThe 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 Off1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod.2Enter the setup menu for a connected FHR measurement.3Select Alarms to switch between On and Off.Changing Alarm Limits1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod.2Enter the setup menu for a connected FHR measurement.3To change the high alarm limit, select High Limit and select the alarm limit from the pop-up list.4To change the low alarm limit, select Low Limit and select the alarm limit from the pop-up list.
15 Fetal Heart Rate Alarms198Changing Alarm DelaysYou can change the alarm delays if the Alarm Mode is set to All.1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod.2Enter the setup menu for a connected FHR measurement.3To change the high alarm limit delay time, select High Delay and select the delay time (in seconds) from the pop-up list.4To change the low alarm limit delay time in seconds, select Low Delay and select the delay time (in seconds) from the pop-up list.Changing Signal Loss DelayThe signal loss delay is the configurable delay before a Signal Loss INOP is issued. You can change the delay:1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod.2Enter the setup menu for a connected FHR measurement.3Select SignalLoss Delay and select the signal loss INOP delay time (in seconds) from the pop-up list.
1619916Monitoring FHR Using DECGFM30/50 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 FHRConfirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the FHR during monitoring. Here are two examples where the maternal HR can be misidentified as the FHR when using a fetal scalp electrode:• Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode, appearing to be a fetal signal source.• The recorded maternal HR, and any artifact, can be misinterpreted as an FHR especially when it is over 100 bpm.To reduce the possibility of mistaking the maternal HR for FHR, monitor both maternal and fetal heart rates (see “Monitoring Maternal Heart / Pulse Rate” on page 221). The monitor's cross-channel verification (CCV) facility can help by automatically detecting when the same heart rate is being recorded by different transducers. See “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 159.If the Coincidence INOP is issued at the fetal monitor if you are measuring FHR with DECG:1Confirm that the scalp electrode is placed correctly.2Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope.3If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography.
16 Monitoring FHR Using DECG2004In 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 NeedYou can measure fetal DECG using the equipment combinations shown in the following figures.WARNINGNever attempt to connect the fetal scalp electrode to anything other than the correct DECG adapter cable.DECG with Toco+The figure below shows the complete connection chain from the fetal scalp electrode to the fetal monitor using the Toco+ transducer.1Fetal Scalp Electrode, single spiral (989803137631)2Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)3DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)4Toco+ transducer (M2735A)
16 Monitoring FHR Using DECG201DECG with CL Toco+MP or CL ECG/IUPThe figure below shows the equivalent chain using the CL Toco+ MP or CL ECG/IUP transducer.1Fetal Scalp Electrode, single spiral (989803137631)2Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)3DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)4CL Toco+ MP (866075) or CL ECG/IUP transducer (866077)5Avalon CL base station (866074)DECG with Patient ModuleThe figure below shows the equivalent chain using the patient module.1Fetal Scalp Electrode, single spiral, (989803137631)2Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)3DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)4Patient Module (M2738A)
16 Monitoring FHR Using DECG202Making ConnectionsWARNINGFollow the instructions supplied with each of the monitoring accessories you are using.Prepare for DECG monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions.1If you change the monitoring mode from US to DECG, first disconnect the US transducer.2Depending on the equipment you are using, ensure that the Toco+ transducer, CL Toco+ MP, the CL ECG/IUP transducer, or the patient module is connected to the fetal monitor.3Attach the fetal scalp electrode to the fetus, following the instructions supplied with the fetal scalp electrode.4Attach a pre-gelled attachment electrode to the DECG adapter cable, following the instructions supplied with the DECG adapter cable.5Fix the attachment electrode to the mother's thigh, following the instructions supplied with the attachment electrode.Depending on the equipment you are using, connect the red connector plug on the DECG adapter cable to the red connector on the Toco+ transducer, CL Toco+ MP, the CL ECG/IUP transducer, or the patient module.6Connect the fetal scalp electrode to the DECG adapter cable.You are now ready to begin monitoring DECG.WARNINGThe 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 DECGTo simultaneously measure DECG and MECG, you need the CL ECG/IUP transducer or the patient module for DECG, and a Toco+, CL Toco+ MP, or CL ECG/IUP transducer for MECG (see “Monitoring Maternal Heart / Pulse Rate” on page 221). Alternatively, you can monitor the maternal pulse rate via pulse oximetry (see “Pulse Rate from SpO2” on page 228). You can also monitor maternal pulse with the Toco MP or CL Toco+ MP transducer. In any case where you would use a Toco+ or Toco MP transducer, you can also monitor with a CL Toco+ MP transducer.1Switch on the recorder.
16 Monitoring FHR Using DECG2032The heart rate monitored via DECG is labeled dFHR1 / dFHR2 / dFHR3 on the screen. If configured, the DECG wave is displayed automatically on the screen, labeled DECG, and fetal. If MECG is being monitored, both waves are displayed, with the DECG wave above the MECG wave. The MECG wave is labeled MECG and maternal.3Check the artifact suppression setting and change it if necessary (see “Suppressing Artifacts” on page 204).NOTEThe 1mV scale bar for the DECG and MECG wave is not displayed on the screen if you monitor DECG or MECG with an Avalon CTS system. The Avalon CTS system does not provide a scaled ECG.1Measurement label (dFHR1)2Measurement label (Toco)3Measurement label (FHR2)4Measurement label (HR)51mV scale bar6MECG wave with maternal label7DECG wave with fetal label8Measurement label (Temp) maternal temperature9Measurement label NBP
16 Monitoring FHR Using DECG204WARNINGPeriodically 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 ArtifactsWhen the monitor's artifact suppression is on, instantaneous heart rate changes of 28 bpm or more, however caused, are not recorded. Fetal arrhythmia will also be suppressed. If you suspect fetal arrhythmia, switch artifact suppression off. When artifact suppression is off, all recorded fetal heartbeats within the specified range are shown. The default setting is On (artifacts are suppressed).To change the setting:1Enter the Setup dFHR1 menu.2Select ArtifactSuppress to switch between artifact suppression On (artifacts are suppressed) and Off (no artifact suppression, use this setting if you suspect fetal arrhythmia).When artifact suppression is off, Artifact Suppression Off is annotated on the trace recording.Printing the WaveformYou can print the DECG wave onto the trace paper. Refer to “Printing the ECG Waveform” on page 231.
16 Monitoring FHR Using DECG205TroubleshootingNOTEIn many cases you need to see the DECG wave to check if the signal quality is good enough to derive a valid fetal heart rate. In the dFHR setup menu, switch on the display of the DECG wave.Testing DECG ModeSee the monitor's Service Guide.Problem Possible Cause SolutionsdFHR1 Equip Malf dFHR2 Equip Malf dFHR3 Equip MalfMalfunctioning equipment See “Patient Alarms and INOPs” on page 129.dFHR1 Leads Off dFHR2 Leads Off dFHR3 Leads OffNumeric is displayed with a -?-; INOP toneSee also “Patient Alarms and INOPs” on page 129.Erratic trace Erratic displayFetal scalp electrode detached at connectorReconnect the fetal scalp electrodeIf 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 noisePoor or no contact between leg attachment electrode and motherCheck all connectionsDisconnect and reconnect the connector several timesNo contact between the DECG adapter cable and the leg attachment electrodeNo contact between the fetal scalp electrode connector and the DECG adapter cableCheck all connectionsDisconnect and reconnect the connector several timesIf problem persists, use a new fetal scalp electrodeNo ECG signalPoor contact between the reference electrode and the motherCheck for fetal demiseUse a new fetal scalp electrode if necessarySignal quality indicator continuously shows a poor signalFetal arrhythmia Use a new fetal scalp electrode if necessarydFHR1 Signal Loss dFHR2 Signal Loss dFHR3 Signal LossNo signal See “Patient Alarms and INOPs” on page 129.dFHR1 Unplugged dFHR2 Unplugged dFHR3 UnpluggedNo connection See “Patient Alarms and INOPs” on page 129.
16 Monitoring FHR Using DECG206
1720717Monitoring Uterine Activity ExternallyYou 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 NeedToco, Toco MP, or Toco+ transducerCL Toco+ MP transducers (additionally capable of providing the maternal pulse measurement)
17 Monitoring Uterine Activity Externally208External Toco MonitoringPrepare for Toco monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions.1Fasten the abdominal transducer belt around the patient.2Connect 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.3Place the transducer on the patient's fundus to ensure the optimum recording of uterine activity.4Reset 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 Baseline1Press the Toco Baseline SmartKey. This resets the Toco baseline to 20 on the display and trace.2If the Toco value is negative for more that five seconds, the Toco baseline is automatically reset to 0 units.Toco SensitivityIf 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:1Enter the Setup Toco menu.2Select Gain to switch between 100% and 50%.TroubleshootingAbdominal Belt (disposable shown)
17 Monitoring Uterine Activity Externally209External Toco MonitoringProblem Possible Causes SolutionsQuality of the trace deteriorates or the Toco baseline variesThe belt is incorrectly fastened and is too slack or too tight, or the belt has lost its elasticity.The belt must be tight enough to ensure good contact between the patient's skin 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 traceCheck if belt is not too loose.Maternal movement/change of position Following maternal movement, reset Toco baselineToco sensitivity is too high (above 100 units)Toco trace is exceeding the paper scalePhysical transmission of pressure from the uterus to the sensor is much higher than the average value.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).
17 Monitoring Uterine Activity Externally210Testing Toco TransducersIf any of the following tests fail, repeat the test using another transducer. If the second transducer passes the tests, confirming that the first transducer is defective, contact your service personnel.If the second transducer also fails the tests, contact your service personnel.You can test all Toco transducers, including the cableless ones, as described above.To test a Toco transducer:1Switch on the monitor and the recorder.2Connect the transducer to the fetal monitor.3Gently apply pressure to the pick-up button.4Check if after a few seconds the values on the display and paper show this change in pressure.
1821118Monitoring Uterine Activity InternallyFM30/50 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 NeedIUP with Patient ModuleThe figure below shows the complete connection chain from the IUP catheter to the fetal monitor using the patient module:1Disposable Koala IUP Catheter (M1333A)2Reusable Koala IUP Adapter Cable (9898 031 43931)3Patient Module (M2738A)
18 Monitoring Uterine Activity Internally212IUP with Toco+The figure below shows the complete connection chain from the IUP catheter to the fetal monitor using the Toco+ transducer:1Disposable Koala IUP Catheter (M1333A)2Reusable Koala IUP Adapter Cable (9898 031 43931)3Toco+ transducer (M2735A)IUP with CL ECG/IUPThe figure below shows the complete connection chain from the IUP catheter to the fetal monitor using the CL ECG/IUP transducer:1Disposable Koala IUP Catheter (M1333A)2Reusable Koala IUP Adapter Cable (9898 031 43931)3CL ECG/IUP or CL Toco+ MP transducer (866077)4Avalon CL base station (866074)
18 Monitoring Uterine Activity Internally213Internal (IUP) MonitoringRead the instructions that accompany the intrauterine catheter and the adapter cable before you start monitoring. Zero the IUP measurement when instructed.WARNINGDo 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.1Perform a complete clinical evaluation.2Catheterize after membrane rupture. Insert the catheter according to its accompanying instructions.3Connect the catheter to the socket on the patient module.4Connect 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.5Zero the IUP measurement (see “Zero The IUP Measurement” on page 213).6If 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 MeasurementZero 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 UnitYou can select between mmHg (default) and kPa for the IUP unit.1Enter the Setup IUP menu.2Press Unit to switch between mmHg and kPa.
18 Monitoring Uterine Activity Internally214TroubleshootingInternal (IUP) MonitoringProblem Possible Causes SolutionsOnly 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 catheterTrace is superimposed with noise. Possible extra-ovular placement of catheter.Refer to catheter Instructions for Use.IUP Equip Malf INOP is displayed. See “Patient Alarms and INOPs” on page 129.IUP Unplugged INOP is displayed.
1921519Monitoring aFHR, aHR, and aTocoIntroducing the abdominal Avalon CL Fetal & Maternal Pod MeasurementThe 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.CAUTIONUse 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 aFHRIt 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.
19 Monitoring aFHR, aHR, and aToco216CAUTIONIf 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 aTocoThe 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.CAUTIONThe 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. CAUTIONThe 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.CAUTIONMaternal or fetal movements can cause electrical signals that may result in intrauterine contraction-like artifacts.Maternal movementWhen 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 PriorityWhen several uterine activity measurements are active, the priority given on the monitor display is:• 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 aToco217aToco SensitivityMonitoring 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 Sensitivity1Select the Setup aToco menu.2Select 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 Monitor1Switch on the recorder.2The 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.3aFHR 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.
19 Monitoring aFHR, aHR, and aToco218Troubleshooting1Measurement label aFHR2Measurement label aToco3Measurement label aHRProblem Possible Causes SolutionsErratic traceErratic displayFetal arrhythmia Consider monitoring FHR with alternative methods.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 movementAsk the patient to sit or lie still until the signal improves. If the signal indication does not improve, consider monitoring with alternative methods.
19 Monitoring aFHR, aHR, and aToco219NOTEFor all signal loss, malfunction, or other alerts see “Patient Alarms and INOPs” on page 129.Signal quality indicator is continuously poorElectrode 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.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 not recorded or questionableaFHR is less than 60 bpm or over 240 bpm, fetal demise, fetal arrhythmia, or the baby is bornVerify the FHR by independent means.Problem Possible Causes Solutions
19 Monitoring aFHR, aHR, and aToco220
2022120Monitoring Maternal Heart / Pulse RateYou 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 RateOnly 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, lower-priority numerics may be displayed and recorded instead.Priority Maternal Heart / Pulse Rate SourceAlarming Used for CCV Provides QRS Tone1 HR from MECG measurement Yes Yes Yes2 aHR from CL F&M Pod Yes Yes Yes3 Pulse from CL SpO2 Pod measurementYes Yes No4Pulse from SpO2 measurement Yes Yes Yes5 Pulse from Toco MP measurement cableless or cabled No Yes No6 Pulse from CL NBP Pod measurementNo No No7 Pulse from NBP measurement No No No
20 Monitoring Maternal Heart / Pulse Rate222Misidentification of Maternal HR for FHRTo 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 ElectrodesYou can measure maternal HR using the equipment combinations shown in the following figures.MECG with Patient ModuleThe figure below shows the complete connection chain from the foam electrodes applied to the patient to the fetal monitor using the patient module.1Patient Module (M2738A)2MECG Adapter Cable (M1363A)3Pre-gelled Foam Electrodes (40493A/B/C/D/E)
20 Monitoring Maternal Heart / Pulse Rate223MECG with Toco+The figure below shows the equivalent chain using the Toco+ transducer.1Toco+ Transducer (M2735A)2MECG Adapter Cable (M1363A)3Pre-gelled Foam Electrodes (40493A/B/C/D/E)MECG with CL Toco+MP or CL ECG/IUPThe figure below shows the equivalent chain using a CL Toco+ MP transducer or a CL ECG/IUP transducer.1Avalon CL base station (866074)2CL Toco+ MP (866075) or CL ECG/IUP transducer (866077)3MECG Adapter Cable (M1363A)4Pre-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).
20 Monitoring Maternal Heart / Pulse Rate224Applying ElectrodesTo 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.Making ConnectionsWARNINGFollow 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.1Depending 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.2Connect a pre-gelled foam electrode to each of the two leads on the MECG adapter cable.3Apply the foam electrodes to the patient, following the instructions supplied with the foam electrodes.4Depending 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 HR1Switch on the recorder.2The maternal heart rate is labeled HR on the screen.1MECG Electrodes
20 Monitoring Maternal Heart / Pulse Rate225Monitoring MECG WaveWARNINGThe 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.WARNINGThe 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 ElectrodesTo obtain a satisfactory maternal ECG waveform, you must use the RA to LL (lead II) position of the standard 5-lead ECG.1Place the RA electrode (A) directly below the clavicle and near the right shoulder.2Place the LL electrode (B) on the left lower abdomen.
20 Monitoring Maternal Heart / Pulse Rate226Viewing the Waveform on the ScreenNOTEThe 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.1Measurement label dFHR12Measurement label Toco3Measurement label FHR24Measurement label HR51mV scale bar6MECG wave with maternal label7DECG wave with fetal label8Measurement label Temp maternal temperature9Measurement label NBP
20 Monitoring Maternal Heart / Pulse Rate227TroubleshootingPrinting the WaveformYou can print the MECG wave onto the trace paper. Refer to “Printing the ECG Waveform” on page 231.Pulse Rate from Toco MPThe 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.NOTEIn 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.Problem Possible Causes SolutionsMECG Leads Off displayed.Numeric is displayed with a -?- for 10 seconds; INOP toneSee also “Patient Alarms and INOPs” on page 129One or more MECG leads is not attached.Make sure that all required leads are attachedIf 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 noiseBad electrical contact Check positioning of the electrode, ensuring that none are displacedCheck electrodes and replace if necessaryElectrodes defectiveprints repeatedlyThe ultrasound transducer is measuring maternal pulseReposition the ultrasound transducer. See “Recommended Actions for Coincidence INOP” on page 164MECG Equip Malf displayed Equipment malfunctions See “Patient Alarms and INOPs” on page 129MECG Unplugged Equipment not connected
20 Monitoring Maternal Heart / Pulse Rate228Pulse Rate from SpO2If 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 LimitsTo adjust the pulse alarm limits for SpO2:1In the Setup SpO₂ menu, select Pulse (SpO₂). This opens the Setup Pulse (SpO₂) menu.2Ensure Pulse (SpO₂) is On. Select Pulse (SpO₂) to switch between On and Off.3Set the pulse alarm limit:– Select High Limit then choose the upper alarm limit for tachycardia from the pop-up list.– Select Low Limit then choose the lower alarm limit for bradycardia from the pop-up list.To adjust the pulse alarm limits for MECG:1In the Setup MECG menu, select MECG/Pulse Alarms. This opens the Setup Pulse (MECG) menu.2Ensure Pulse MECG is On. Select Pulse MECG to switch between On and Off.3Set the pulse alarm limit.– Select High Limit then choose the upper alarm limit for tachycardia from the pop-up list.– Select Low Limit then choose the lower alarm limit for bradycardia from the pop-up list.Average Pulse Rate from Noninvasive Blood PressureWARNINGNo alarm is possible when noninvasive blood pressure is the source of the pulse rate.When you are measuring noninvasive blood pressure, the monitor can also calculate the average pulse rate. This occurs in either manual or automatic mode, when neither MECG, SpO2 nor pulse from Toco MP or CL Toco+ MP transducer are measured. The value is displayed on the screen, and printed on the trace. It is not the actual pulse value, but an average pulse rate, taken during the most recent noninvasive blood pressure measurement. The value is updated after each successive measurement. If you need a continuous measurement, you should monitor using MECG, SpO2, or pulse from Toco MP or CL Toco+ MP transducer.
20 Monitoring Maternal Heart / Pulse Rate229Testing MECG ModeSee the monitor's Service Guide.
20 Monitoring Maternal Heart / Pulse Rate230
2123121Printing the ECG WaveformFM30/50 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.WARNING1The 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 own1DECG2Recorder speed
21 Printing the ECG Waveform232MECG waveform on its own1MECG2Recorder speedDECG and MECG waveforms1DECG2MECG3Recorder speedWhen the recorder is on, there are two choices for printing the ECG wave:•Separate: This recording mode gives you a six-second ECG strip on the fetal trace paper in fast printout mode. The real-time fetal trace recording is temporarily interrupted while the ECG strip prints. A new MECG header is printed to mark where the MECG wave starts, and a new trace header and FHR header mark when the fetal trace resumes.
21 Printing the ECG Waveform233The following trace shows the MECG waveform:1FHR1 trace interrupted2MECG header3Recorder speed4FHR1 trace resume•Overlap: This recording mode gives you a delayed six-second snapshot of the maternal and/or direct fetal ECG for documentation on the fetal strip, but without interrupting the fetal trace. It takes 5 minutes to print this six-second snapshot at a recorder speed of 3 cm/min. It is documented as if it was recorded at 25 mm/s.
21 Printing the ECG Waveform234The following trace shows both the DECG and MECG waveforms:1FHR1 and FHR22DECG header3MECG header4Recorder speedTo make your choice:1Enter the Main Setup menu.2Select Fetal Recorder to enter the Fetal Recorder menu.3Select ECG Wave to switch between Separate and Overlap.To print the ECG wave(s):1Select the Record ECG Wave SmartKey (configurable) and the recording trace is started.Or1Enter the Main Setup menu by selecting the SmartKey.2Select Fetal Recorder to enter the Fetal Recorder menu.3Select Record ECG Wave and the recording trace is started.Or1Select the ECG Wave.2Select Record ECG Wave in the ECG wave menu and the recording trace is started.
2223522Monitoring Noninvasive Blood PressureThe 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 MeasurementOscillometric 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.WARNINGIntravenous infusion: Do not use the NBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation.Skin Damage: Do not measure NBP in cases of sickle-cell disease or any condition where skin damage has occurred or is expected.Existing Wounds: Do not apply the cuff over a wound as this can cause further injury.Mastectomy: Avoid applying the cuff on the side of the mastectomy, as the pressure increases the risk of lymphedema. For patients with a bilateral mastectomy, use clinical judgement to decide whether the the benefit of the measurement outweighs the risk.
22 Monitoring Noninvasive Blood Pressure236Unattended 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 LimitationsNBP 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 extremityMeasurement MethodsThere are three measurement methods:•Manual - measurement on demand. Results are displayed for up to one hour.•Auto - continually repeated measurements (between one and 120 minute adjustable interval). You can make a manual measurement between two measurements in Auto Mode.•Sequence- up to four measurement cycles which run consecutively, with a number of measurements and intervals between them configurable for each cycle.Reference MethodThe measurement reference method can be Auscultatory (manual cuff) or Invasive (intra-arterial). For further information, see the Application Note supplied on the monitor documentation DVD.To check the current setting, select Main Setup, Measurements, NBP, and check whether the Reference setting is set to Auscultatory or Invasive. This setting can be changed in Configuration Mode.
22 Monitoring Noninvasive Blood Pressure237Preparing to Measure Noninvasive Blood PressureIf possible, avoid taking measurements during contractions, because the measurement may be unreliable, and may cause additional stress for the patient.1Connect the cuff to the air tubing.2Plug the air tubing into the red NBP connector. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing.WARNINGKinked or otherwise restricted tubing can lead to a continuous cuff pressure, causing blood flow interference, and potentially resulting in injury to the patient.3Make sure that you are using a Philips-approved correct sized cuff, and that the bladder inside the cover is not folded or twisted.A wrong cuff size, and a folded or twisted bladder, can cause inaccurate measurements. The width of the cuff should be in the range from 37% to 47% of the limb circumference. The inflatable part of the cuff should be long enough to encircle at least 80% of the limb.4Apply the cuff to a limb at the same level as the heart. If it is not, you must use the measurement correction formula to correct the measurement.The marking on the cuff must match the artery location. Do not wrap the cuff too tightly around the limb. It may cause discoloration, and ischemia of the extremities.WARNINGInspect 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 LevelTo correct the measurement if the limb is not at heart level, to the displayed value:Recommendations For Measurements Used in Diagnosis of HypertensionTo make a measurement for use in the diagnosis of hypertension, follow the steps below:1Ensure the patient is comfortably seated, with their legs uncrossed, feet flat on the floor, and back and arm supported.2Ask the patient to relax and not talk before and during the measurement.3If possible, wait 5 minutes before making the first measurement.Add 0.75 mmHg (0.10 kPa) for each centimeter higher orDeduct 0.75 mmHg (0.10 kPa) for each centimeter lower orAdd 1.9 mmHg (0.25 kPa) for each inch higher. Deduct 1.9 mmHg (0.25 kPa) for each inch lower.
22 Monitoring Noninvasive Blood Pressure238Understanding the NumericsDepending 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 NumericsThe 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 SourcesIf you have parallel alarm sources, the sources are displayed instead of the alarm limits.NBP Measurement TimestampDepending 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 TimeIn 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 MeasurementsThe cuff pressure is displayed instead of the units and the repeat time. An early systolic value gives you a preliminary indication of the systolic blood pressure during measurement.1Alarm source2Measurement Mode3Timestamp/Timer4Mean pressure5Diastolic6Systolic7Alarm limits
22 Monitoring Noninvasive Blood Pressure239Starting and Stopping MeasurementsUse the setup menu or the SmartKeys to start and stop measurements.Enabling Automatic Mode and Setting Repetition Time1In the Setup NBP menu, select Mode.2Switch between Auto and Manual, if necessary, to pick the measurement method.3If making an automatic measurement, select Repeat Time, or press the Repeat Time SmartKey and set the time interval between two measurements.NOTEBe aware that a combination of a recorder speed of less than 3 cm/min and a repetition time of less than five minutes can result in not all noninvasive blood pressure measurements being recorded on the fetal trace. For example, if the recorder speed is set to 1 cm/min and the repetition time is set to two minutes, due to the low speed setting, the recorder will only be able to record every other noninvasive blood pressure measurement. This affects only the local fetal trace recording, and all measurements are displayed as normal on the monitor's screen.Action to be performed Setup menu SmartKeysStart/Stop manual measurementStart Auto seriesStop current automatic measurementStart/StopStart/ StopStart manual measurementStart Auto series-Start NBPStop manual measurementStop current automatic measurement-Stop NBPStop automatic, or manual measurement AND series Stop All NBPStop All
22 Monitoring Noninvasive Blood Pressure240Enabling Sequence Mode and Setting Up the Sequence1In the Setup NBP menu, select Mode and select Sequence from the pop-up menu.2Select Setup Sequence to open the Setup Sequence window.Up to four measurement cycles can be set up which run consecutively. For each cycle, you can set the number of measurements and the intervals between them. If you want to run fewer than four cycles in a sequence, you can set the number of measurements for one or more cycles to Off.3Select each sequence in turn, and select the number of measurements and the time interval between the measurements.4To have measurements continue after the sequence, set the number of measurements for your last cycle to Continuous and this cycle will run indefinitely.CAUTIONBe 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 SourceYou can monitor for alarm conditions in systolic, diastolic, and mean pressure, either singly or in parallel. Only one alarm is given, with the priority of mean, systolic, diastolic.If mean is not selected as alarm source (Sys., Dia., or Sys & Dia selected), but the fetal monitor can only derive a mean value, mean alarms will nevertheless be announced using the most recent mean alarm limits. Check that the mean alarm limits are appropriate for the patient, even when not using mean as the alarm source. When no value can be derived, an NBP Measure Failed INOP is displayed.Menu option Pressure value monitoredSys. systolicDia. diastolicMean meanSys & Dia systolic and diastolic in parallelDia & Mean diastolic and mean in parallelSys & Mean systolic and mean in parallelSys&Dia&Mean all three pressures in parallel
22 Monitoring Noninvasive Blood Pressure241Assisting Venous PunctureYou can use the cuff to cause subdiastolic pressure. The cuff deflates automatically after a set time if you do not deflate it.1In the Setup NBP menu, select VeniPuncture.2Puncture vein and draw blood sample.3Reselect VeniPuncture to deflate the cuff.During measurement, the display shows the inflation pressure of the cuff and the remaining time in venous puncture mode.Calibrating NBPNBP is not user-calibrated. NBP pressure transducers must be verified at least once every two years by a qualified service professional, and calibrated, if necessary. See the Service Guide for details.1Cuff pressure2Venous puncture measurement mode3Time left in venous puncture mode
22 Monitoring Noninvasive Blood Pressure242TroubleshootingProblem Possible Causes SolutionsCuff will not inflate Monitor is in Service or Configuration ModeTechnical defect Call serviceCuff tubing not connected Connect cuff tubingHigh or low values measured (against clinical expectations)Contraction occurring Wait until contraction has finishedPatient talking before or during measurementAllow patient to rest quietly, then try again after three to five minutesIncorrect cuff size or cuff not at heart levelCheck cuff size, level, and positionNoninvasive blood pressure reference method set incorrectlyCheck the reference method configured (auscultation or intra-arterial) and correct if necessary in Configuration ModeMeasurement limitations have not been taken into accountCheck the list in “Measurement Limitations” on page 236Displays zeros for systolic and diastolic values. Measurement automatically repeatsSevere vasoconstriction at cuff site Move cuff to another limb, check for shock, or verify blood pressure using another methodErratic blood pressure fluctuations due to arrhythmias or rapid-acting drugs or contractionsTry again, if unsuccessful, verify blood pressure using another methodWait until contraction has finishedExcessive patient movement or convulsionsRestrain movement or verify blood pressure using another methodNBP Cuff Overpress INOP is displayedSee “Patient Alarms and INOPs” on page 129.NBP Equip Malf INOP is displayedNBP Interrupted INOP is displayedNBP Measure Failed
2324323Monitoring SpO2FM30/40/50 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 SensorSee “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.CAUTIONDo 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 Sensor1Follow the SpO2 sensor's Instructions for Use, adhering to all warnings and cautions.2Remove colored nail polish from the application site.3Apply the sensor to the patient. The application site should match the sensor size so that the sensor can neither fall off, nor apply excessive pressure.4Check that the light emitter and the photodetector are directly opposite each other. All light from the emitter must pass through the patient's tissue.
23 Monitoring SpO2244WARNINGCompatibility: 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 CablesConnect 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.CAUTIONExtension 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 SpO2During measurement, ensure that the application site:– has a pulsatile flow, ideally with a signal quality indicator of at least medium.– has not changed in its thickness (for example, due to edema), causing an improper fit of the sensor.
23 Monitoring SpO2245WARNING• For fully conscious maternal patients, who have a normal function of perfusion and sensory perception at the measurement site:To ensure skin quality and correct optical alignment of the sensor, inspect the application site when the measurement results are suspicious, or when the patient complains about pressure at the application site, but at least every 24 hours. Correct the sensor alignment if necessary. Move the sensor to another site, if the skin quality changes.• For all other patients:Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. Correct the sensor alignment if necessary. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours.• Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements.• Inaccurate measurements may result when the application site for the sensor is deeply pigmented or deeply colored, for example, with nail polish, artificial nails, dye, or pigmented cream.• Interference can be caused by:– High levels of ambient light (including IR warmers), or strobe lights or flashing lights (such as fire alarm lamps). (Hint: cover application site with opaque material).– Another SpO2 sensor in close proximity (e.g. when more than one SpO2 measurement is performed on the same patient). Always cover both sensors with opaque material to reduce cross-interference.– Electromagnetic interference, especially when the signal quality indicator is below medium.– Excessive patient movement and vibration.SpO2 Signal Quality Indicator (FAST SpO2 only)The SpO2 numeric is displayed together with a signal quality indicator (if configured and enough space is available) which gives an indication of the reliability of the displayed values.The level to which the triangle is filled shows the quality of the signal; the indicator below shows a medium signal quality. The signal quality is at a maximum when the triangle is completely filled.
23 Monitoring SpO2246Assessing a Suspicious SpO2 ReadingTraditionally, 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.WARNINGWith 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 AlarmsThis 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.CAUTIONIf 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 DelaysThere 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 LimitsIn the Setup SpO₂ menu:•Select High Limit then choose the upper alarm limit.•Select Low Limit then choose the lower alarm limit.
23 Monitoring SpO2247Adjusting the Desat Limit AlarmThe Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in oxygen saturation.1In the Setup SpO₂ menu, select Desat Limit.2Adjust the limit.Adjusting the Pulse Alarm LimitsSee “Adjusting the Heart Rate / Pulse Alarm Limits” on page 228.Setting Up Tone ModulationIf 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).NOTEPulse from CL SpO2 and Toco MP does not provide a QRS tone.Setting the QRS VolumeIn the Setup SpO₂ menu, select QRS Volume and set the appropriate QRS tone volume.
23 Monitoring SpO2248
2424924Monitoring Maternal TemperatureMeasuring Tympanic TemperatureThe 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.WARNINGDo not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
24 Monitoring Maternal Temperature250Place 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 ControlsThe tympanic thermometer has a liquid crystal display. The display shows the patient's temperature in numerics and guides you with symbols through the measurement process.1Base station2Thermometer1Eject key2Change unit key: °Celsius/°Fahrenheit3Start measurement key4Pulse timer keyFunctional Keys Description of UsePress the eject key to eject the probe cover. The eject key symbol is shown on the display when a measurement has been taken and transmitted.Press the change unit key after a measurement to switch between °C and °F (only affects the handheld device and not the monitor numerics).
24 Monitoring Maternal Temperature251Status ScreensThe thermometer performs an internal test at every start-up to verify that the system components are functioning properly. It measures the ambient temperature. During start-up and measurement, the thermometer screens communicate the current status.Press the start measurement key when you are ready to take a patient's temperature.The pulse timer key can be used to time vital signs you take manually.The pulse timer only functions after you have taken a temperature measurement.Press and hold the pulse timer key to enter timer mode. Press the pulse timer key again to start the timer.The thermometer will issue a one beep at 15 seconds, two beeps at 30 seconds, three beeps at 45 seconds, and four beeps at 60 seconds.Functional Keys Description of UseImages Description Ambient temperature above specified rangeAmbient temperature below specified rangeSystem errorsSystem error 12 - there is a problem with the settings. Contact your service personnel to have them check the settings and reset them, if necessary.If the display shows any other system error, then reset the thermometer by picking up a probe cover. If the system error does not clear, contact your service personnel.
24 Monitoring Maternal Temperature252Making a Temperature MeasurementWARNINGInaccurate measurement results can be caused by:• incorrect application of the thermometer• anatomical variations in the ear• build up of earwax in the ear• excessive patient movement during the measurement• absent, defective, or soiled probe covers• probe covers other than the specified probe covers• external environment temperature outside the range of 16ºC-33ºC (60.8ºF-91.4ºF)1Ensure that the base station is connected with the appropriate cable to the connector on the monitor.2Remove the thermometer from the base station.The thermometer is latched to the base station to avoid an accidental fall when the base station is moved. To pick up the thermometer from the base station move it slightly up, and then lift it from the base station to release the latch.3Press the eject key on the thermometer to discard any probe that may have been left on the thermometer from a previous use.4Pick up a new probe cover from the container on the base station.5Inspect the probe cover to make sure that it is fully seated (no space between cover and tip base) and that there are no holes, tears, or wrinkles in the plastic film.6Place the thermometer with the probe in the ear canal, sealing the opening with the probe tip. For consistent results, ensure that the probe shaft is aligned with the ear canal.7Press and release the start-up key gently.8Wait until you hear the three beeps.9Remove the probe from the ear.The temperature values are displayed both on the thermometer itself, and on the connected monitor.10 Check that the correct temperature label for the measurement site is displayed: iTrect, iToral, iTcore, or iTtymp.11 Press the eject key to eject the probe cover into a suitable waste receptacle.12 Return the thermometer to the base station.The thermometer switches to stand-by mode after 30 seconds when it is not used.
24 Monitoring Maternal Temperature253Possible INOPsWARNING• 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.WARNINGIf you have dropped the base station or thermometer, or if the unit has been stored below -25°C or above 55°C, have service personnel test the unit for proper functions, and calibrate the unit before further use.The Value Lifetime (length of time the entered value is shown on the screen) can be configured in Configuration Mode.Images DescriptionPatient temperature above measurement range.Patient temperature below measurement range.
24 Monitoring Maternal Temperature254Body Reference Sites and Monitor LabelsThe tympanic thermometer measures the patient's temperature in the ear. The thermometer can be configured to adjust the result of the measurement to correspond to a different body reference site. The measurement label displayed on the monitor corresponds to the body reference site that is configured. The following body reference sites are available:The body reference site can be selected in the Biomed mode of the tympanic thermometer. Refer to the Service Guide for more information.The measured maternal temperature is only transmitted to a connected OB TraceVue/IntelliSpace Perinatal system, when the tympanic thermometer is configured to the iTtymp body reference site, and the iTtymp label is displayed on the fetal monitor screen, and printed on the trace.Entering Temperature ManuallyA temperature measurement can be entered manually.1Press the SmartKey Enter Temp (configurable)or select the SmartKey Main Setup, then select Measurements, Enter Temp. A numeric pad opens.2Enter the temperature values.3Select the Enter key.IntervalUse the Interval setting to define the time after which a manually entered temperature value becomes invalid (no value is then displayed).NOTEA manually entered temperature has to be 25ºC or higher to be transmitted to a connected obstetrical information and surveillance system.Body Reference Site Label on MonitorEar temperature (no adjustment) iTtympOral temperature iToralCore temperature iTcoreRectal temperature iTrect
2525525Paper Save Mode for Maternal MeasurementsYour 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 ReactivationOne of the maternal measurements (see above) is valid again. yesThe recorder is turned off and on again or a report has been recorded (e.g. NST Report).yesThe Paper Advance function is used. yesThe Paper Save Mode setting is set off and on again. yesADT information has changed (e.g. because patient information has been completed or updated).noThe monitor is restarted (e.g. by switching it off and on again). yesThe date has changed (e.g. at midnight). no
25 Paper Save Mode for Maternal Measurements256
2625726Recovering DataThe 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.CAUTIONOnly use Philips paper. Using paper other than Philips paper may result in the failure to recover traces.Recovering Traces on PaperThe monitor is able to recover traces by printing them out at a high speed from the monitor's backup memory. If the monitor runs out of paper, or if the paper drawer is open, the exact time when this happens is stored in the backup memory. If the Bridge Paperout setting is set to On (default), when new paper is loaded and the recorder is started, a trace recovery printout of the data recovered from the backup memory is automatically printed out at high speed (up to 20 mm/s), starting from the time noted in the backup memory. This ensures that no data is lost. A minimum of one hour of trace recovery data is available for printing out from the backup memory. When the trace recovery printout has finished, the recorder automatically switches back to continue recording the current trace at the normal speed.Note the following:• If you press the fetal recorder Start/ Stop SmartKey during a trace recovery printout, the recording stops, and the next recording following a recorder restart will be a normal, real-time trace.After switching off the monitor, and then back on again, or following a power failure, the time of the last Check Paper INOP or paper-out detection is lost, and therefore any trace recovery data in the backup memory is no longer available to print. The next recording made following a restart of the recorder is a normal, real-time trace.
26 Recovering Data258• 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 SystemThe 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 DataIf 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.CAUTIONEnsure that you admit each patient by name, including other patient identification information, and discharge the patient when you have finished monitoring, so that you can identify which trace period (entry in the patient list) refers to which patient.Trace storage can be triggered by:• Discharging a patient• Powering on the monitor•Entering Standby• Entering Service Mode
26 Recovering Data259Traces 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:Either1Select the Stored Data Rec SmartKey.2Select All to print all stored trace data for the selected entry, or select one of the choices on the other pop-up keys to print only a specified portion of the entry (for example, Last 15 min for the last 15 minutes of trace data).Or1Enter the Main Setup menu using the SmartKey.2Select Fetal Recorder to open the Fetal Recorder menu.3Select Stored Data Rec to open the Stored Data Recording window.4Select an entry for a patient.5Select All to print all stored trace data for the selected entry, or select one of the choices on the other pop-up keys to print only a specified portion of the entry (for example, Last 15 min for the last 15 minutes of trace data).To delete all stored trace periods:Either1Select the Stored Data Rec SmartKey.2Select the Erase All key to delete all stored trace periods listed.3Select the Confirm key.Or1Enter the Main Setup menu using the SmartKey.2Select Fetal Recorder to open the Fetal Recorder menu.3Select Stored Data Rec to open the Stored Data Recording window.4Select the Erase All key to delete all stored trace periods listed.5Select the Confirm key.
26 Recovering Data260The 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.
2726127Care and CleaningUse 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 PointsThe transducers and patient modules are sensitive instruments. Handle them with care.Keep your monitor, transducers, patient modules, cables, and accessories free of dust and dirt. After cleaning and disinfection, check the equipment carefully. Do not use if you see signs of deterioration or damage. If you need to return any equipment to Philips, always decontaminate it first before sending it back in appropriate packaging.Observe the following general precautions:• Always follow carefully and retain the instructions that accompany the specific cleaning and disinfecting substances you are using.• Always dilute cleaning agents according to the manufacturer's instructions or use lowest possible concentration.• Do not allow liquid to enter the case.• Do not immerse the monitor in liquid. Protect it against water sprays or splashes.• Do not pour liquid onto the system.• Never use abrasive material (such as steel wool or silver polish).• Never use bleach.
27 Care and Cleaning262WARNING• 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 DisinfectingClean 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).CAUTIONSolutions: 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.WARNINGSkin contact: To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces - wipe it off with a cloth dampened with water, after allowing the appropriate time for the agent to work. Follow the safety instructions of the used cleaning or disinfection agent, especially regarding skin contact.
27 Care and Cleaning263Take 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 DisinfectantsWe recommend that you use one of the following disinfectants:Cleaning and Disinfecting Monitoring AccessoriesTo clean, disinfect and sterilize reusable transducers, sensors, cables, leads, and so forth, refer to the instructions delivered with the accessory.Do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces. Wipe residues off, after allowing the appropriate time to for the agent to work, with a cloth.Product Name Product Type IngredientsIsopropanol liquid Isopropanol 80%Bacillol® AF liquid, spray 100 g concentrate contains: Propan-1-ol 45.0 gPropan-2-ol 25.0 gEthanol 4.7 gBacillol®25 liquid Ethanol 100 mg/gPropan-2-ol (= 2-Propanol) 90 mg/gPropan-1-ol (= 1-Propanol) 60 mg/gMeliseptol® spray 50% 1-PropanolAccel TB RTU liquid 0.5% accelerated hydrogen peroxideOxivir® Tb Cleaner Disinfectant spray 0.5% accelerated hydrogen peroxideOxivir® Tb Wipes wipes 0.5% accelerated hydrogen peroxideCarpe DiemTM/MC TbReady-to-Use General Virucide, Bactericide, Tuberculocide, Fungicide, Sanitizerspray 0.5% accelerated hydrogen peroxideCarpe DiemTM/MC Tb Wipes wipes 0.5% accelerated hydrogen peroxideSuper Sani-ClothGermicidal Disposable Wipeswipes Isopropanol 55%quaternary ammonium chlorides 0.5%SANI-CLOTH® PLUSGermicidal Disposable Wipeswipes Isopropanol 15%quaternary ammonium chlorides 0.25%SANI-CLOTH® HB GermicidalGermicidal Disposable Wipeswipes Isopropanol < 0.15%quaternary ammonium chlorides 0.14%
27 Care and Cleaning264Cleaning and Disinfecting the Tympanic Temperature AccessoriesProbe and Thermometer Body1Wipe the thermometer body clean with a damp cloth. The water temperature should not exceed 55°C (130°F). Do not soak, rinse, or submerge the thermometer under water.You may add a mild detergent to the water.2Clean the probe tip with a lint free swab. If the probe tip is soiled, clean it with a dampened swab.3After you have removed all foreign matter, clean the thermometer lens at the end of the probe tip with a lint free swab or lens wipe. The thermometer lens must be free from fingerprints and/or smudges for proper operation.4Thoroughly dry all surfaces before using the equipment.CAUTIONDo 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 PodsTo 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.NOTEPay especially close attention to cleaning and wiping down the gold connection contacts.
27 Care and Cleaning265SterilizingSterilization 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.WARNINGDo not put device and accessories in autoclave (for sterilization).
27 Care and Cleaning266
2826728MaintenanceWARNINGSchedule: 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 AccessoriesYou should perform a visual inspection before each use, and in accordance with your hospital's policy. With the monitor switched off:1Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are not cracked or broken, that everything is present, that there are no spilled liquids that may have entered the housing, and that there are no signs of abuse.2Inspect all accessories (transducers, sensors and cables, and so forth). Do not use a damaged accessory.3Switch the monitor on, and make sure the display is bright enough. If the brightness is not adequate, contact your service personnel or your supplier.Batteries Preventive MaintenanceFor the FM20/30 with a battery option, see “Using Batteries” on page 110.
28 Maintenance268Inspecting the Cables and Cords1Examine all system cables, the power plug, and cord for damage. Make sure that the prongs of the plug do not move in the casing. If damaged, replace it with an appropriate power cord.2Inspect the cables, leads, and their strain reliefs for general condition. Make sure there are no breaks in the insulation. Make sure that the connectors are properly engaged at each end to prevent rotation or other strain.3Carry out performance assurance checks as described in the monitor's Service Guide.Maintenance Task and Test ScheduleThe 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 FrequencyVisual Inspection Before each use.Clean and disinfect the equipment After each use.Safety checks according to IEC 60601-1, and where applicable, to national standardsAt least once every two years, or as specified by local laws.After any repairs where the power supply has been replaced (by an authorized service professional).If the monitor has been dropped, it must be repaired/checked by an authorized service agent.Performance assurance for all measurementsAt 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 Maintenance269Recorder MaintenanceRemoving the Paper Guide: FM40/FM50FM40/50 The paper guide is removable, and you can use the recorder without it. When not using the paper guide, ALWAYS tear off the paper along the perforation to avoid possible paper misalignment (see “Tearing Off the Paper” on page 61).To remove the paper guide:1Press the paper eject button to open the paper drawer.
28 Maintenance2702Hinge the transparent paper guide forward.3A protrusion (A) holds paper guide in closed position.
28 Maintenance2714Release the paper guide from one side of the holder.5Then remove the paper guide.
28 Maintenance2726Refitting is a reversal of the removal procedure.Storing Recorder PaperRecorder paper is not intended for long-term archival storage. Another medium should be considered if this is required.Dyes contained in thermal papers tend to react with solvents and other chemical compounds that are being used in adhesives. If these compounds come into contact with the thermal print, the print may be destroyed over time. You can take the following precautionary measures to help avoid this effect:• Store the paper in a cool, dry, and dark place.• Do not store the paper at temperatures over 40°C (104°F).• Do not store the paper where the relative humidity exceeds 60%.• Avoid intensive light (UV light), as this may cause the paper to turn gray, or the thermal print to fade.• Avoid storing the thermal paper in combination with the following conditions:– Papers that contain organic solvents. This includes papers with tributyl and/or dibutyl phosphates, for example recycled paper.– Carbon paper and carbonless copy paper.– Products containing polyvinyl chlorides, or other vinyl chlorides for example (but not exclusively) document holders, envelopes, letter files, divider sheets.– Detergents and solvents, such as alcohol, ketone, ester, and others, including cleaning and disinfecting agents.– Products containing solvent-based adhesives such as (but not exclusively) laminating film, transparent film, or labels sensitive to pressure.To ensure long lasting legibility and durability of thermal printouts, store your documents separately in an air-conditioned place and use:• only plasticizer-free envelopes or divider sheets for protection.• laminating films and systems with water-based adhesives.Using such protective envelopes cannot prevent the fading effect caused by other, external agents.
28 Maintenance273Cleaning the Print HeadTo clean the recorder's thermal print-head:1Switch off the monitor.2Open the paper drawer, and remove the paper if necessary, to gain access to the thermal print head.3Gently clean the thermal print head with a cotton swab, or soft cloth soaked in isopropyl alcohol.NOTEIf the print head is heavily coated with dust or dirt, contact your service personnel to clean it.Returning Equipment for RepairBefore returning equipment for repair:• disinfect and decontaminate the equipment appropriately.• ensure that all patient data has been removed (i.e. that no patient is admitted).FM20/30FM40/50
28 Maintenance274Disposing of the MonitorWARNINGTo 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.wpdThe Recycling Passports located on the Philip's web page contain information on the material content of the equipment, including potentially dangerous materials which must be removed before recycling (for example, batteries and parts containing mercury or magnesium).Do not dispose of waste electrical and electronic equipment as unsorted municipal waste. Collect it separately, so that it can be safely and properly reused, treated, recycled, or recovered.
2927529Accessories and SuppliesAll 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.WARNINGReuse: 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 LatexAll Philips transducers and accessories are latex-free, unless indicated otherwise in the following tables.Avalon CL Base StationCL Base Station Part NumberAvalon CL Base Station can either be ordered with the option K30 (red connector), or K40 (black connector), or K60 (charging station)866074
29 Accessories and Supplies276TransducersFetal AccessoriesTransducer Part NumberAvalon Toco Transducer M2734AAvalon Toco+ Transducer for Toco, DECG, MECG, or IUP monitoring M2735AAvalon Toco MP Transducer for Toco and Maternal Pulse M2734BAvalon Ultrasound Transducer M2736AAvalon Ultrasound Transducer USA M2736AAECG/IUP Patient Module (for DECG, MECG or IUP) M2738AAvalon CL Toco+ MP Transducerfor use with the Avalon CL base station866075Avalon CL Ultrasound Transducerfor use with the Avalon CL base station866076Avalon CL ECG/IUP Transducerfor use with the Avalon CL base station866077Avalon CL Fetal & Maternal Podfor use with the Avalon CL base station866488Avalon CL Wide Range Podfor use with the Avalon CL base station866487CL SpO2 Podfor use with the Avalon CL base station865215CL NBP Podfor use with the Avalon CL base station865216Remote Event Marker 989803143411Accessory Description Part NumberBelt (reusable, gray, water resistant) 32 mm wide, 15 m roll M4601A60 mm wide, 5 belts M4602A60 mm wide, 15 m roll M4603A50 mm wide, 5 belts M1562BBelt (disposable, yellow, water resistant) 60 mm wide, pack of 100 M2208AUltrasound gel 12 Bottles 40483A5 liter refill (with dispenser) for 40483A Shelf life: 24 months max.40483BBelt buttons (kit of 10) for wired transducers M273xA M1569ABelt Clips for wired Smart Transducers (kit of 6) 989803143401
29 Accessories and Supplies277MECG AccessoriesAvalon CL Connector Caps Connector Caps for Avalon CL Cableless Smart Transducers (kit of 10)989803184841Avalon CL Belt Clip Belt Clip for Avalon CL Cableless Smart Transducers (kit of 10)989803184851Avalon CL Battery Replacement Kit 989803184861Cable Management Kit 989803148841Avalon CL Wide Range Battery Kit 989803196421Kit of 20 Mobile CL Transmitter Cradlesfor use with 866487 Avalon CL Wide Range Pod989803168881Avalon CL Fetal & Maternal Patch (case with 10 each) 989803196341ECG Skin Preparation Paperfor use with the 989803196341 Avalon CL F&M patch10 sheets, with 10 finger-tip sized skin prep pieces per sheet (100 preps per bag)M4606ADECG Accessories: Philips DECG Solution(NOT compatible with QwikConnectPlus Solution accessories)DECG reusable leg plate adapter cable (with flushing port)989803137651DECG leg attachment electrode for DECG leg plate adapter cable989803139771DECG fetal scalp electrode: single spiral, worldwide availability989803137631DECG fetal scalp electrode: double spiral, Europe only. Not for USA989803137641Disposable Koala IUP catheter M1333AReusable Koala IUP adapter cable 989803143931Accessory Description Part NumberAccessory Part NumberMECG reusable adapter cable M1363AFoam ECG electrodes, snap-fit, for MECG Adapter Cable (disposable) 40493D/E
29 Accessories and Supplies278Noninvasive Blood Pressure AccessoriesThe following accessories are approved for use with the fetal monitor:Adult Multi Patient Reusable Comfort CuffsThe tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult Multi Care Reusable CuffsThe tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult EasyCare Reusable CuffsMaternal Patient Category Limb Circumference Part NumberAdult (Thigh) 42.0-54.0 cm M1576ALarge Adult 34.0-43.0 cm M1575ALarge Adult XL 34.0-43.0 cm M1575XLAdult 27.0-35.0 cm M1574AAdult XL 27.0-35.0 cm M1574XLSmall Adult 20.5-28.0 cm M1573ASmall Adult XL 20.5-28.0 cm M1573XLCuff kit of 4 adult sizes M1578ACuff kit of 4 adult XL sizes M1579XLMaternal Patient Category Limb Circumference Part NumberAdult (Thigh) 42.0-54.0 cm 989803183371Large Adult 34.0-43.0 cm 989803183361Adult 27.0-35.0 cm 989803183341Adult X-Long 27.0-35.0 cm 989803183351Small Adult 20.5-28.0 cm 989803183331Maternal Patient Category (color) Limb Circumference Part NumberAdult Thigh (gray) 45.0-56.5 cm M4559BAdult Thigh (gray) pack of 5 cuffs 45.0-56.5 cm M4559B5Large Adult X-Long (burgundy) 35.5-46.0 cm M4558BLarge Adult X-Long (burgundy) pack of 5 cuffs 35.5-46.0 cm M4558B5Large Adult (burgundy) 35.5-46.0 cm M4557BLarge Adult (burgundy) pack of 5 cuffs 35.5-46.0 cm M4557B5Adult X-Long (navy blue) 27.5-36.5 cm M4556BAdult X-Long (navy blue) pack of 5 cuffs 27.5-36.5 cm M4556B5Adult (navy blue) 27.5-36.5 cm M4555B
29 Accessories and Supplies279The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult Single Patient Soft CuffsThe tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult Single Care CuffsThe tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult Value Care CuffsThe tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult (navy blue) pack of 5 cuffs 27.5-36.5 cm M4555B5Small Adult (royal blue) 20.5-28.5 cm M4554BSmall Adult (royal blue) pack of 5 cuffs 20.5-28.5 cm M4554B5Cuff kits containing one small adult, one adult, one large adult and one thigh cuff864288Cuff kits containing one small adult, one adult, one adult X-long, one large adult, one large adult X-long and one thigh cuff864291Maternal Patient Category (color) Limb Circumference Part NumberMaternal Patient Category Limb Circumference Part NumberAdult (Thigh) 45.0-56.5 cm M4579BLarge Adult X-Long 35.5-46.0 cm M4578BLarge Adult 35.5-46.0 cm M4577BAdult X-Long 27.5-36.5 cm M4576BAdult 27.5-36.5 cm M4575BSmall Adult 20.5-28.5 cm M4574BMaternal Patient Category Limb Circumference Part NumberLarge Adult 35.0-45.0 cm 989803182321Adult X-Long 27.5-36.0 cm 989803182311Adult 27.5-36.0 cm 989803182301Small Adult 20.5-28.5 cm 989803182291Maternal Patient Category Limb Circumference Part NumberLarge Adult 34.0-43.0 cm 989803160861Adult XL 27.0-35.0 cm 989803160851Adult 27.0-35.0 cm 989803160841Small Adult 20.5-28.0 cm 989803160831
29 Accessories and Supplies280IntelliVue CL NBP Pod AccessoriesSpO2 AccessoriesSome Nellcor sensors contain natural rubber latex which may cause allergic reactions. See the Instructions for Use supplied with the sensors for more information. M1901B, M1903B, and M1904B are not available in USA from Philips. Purchase Nellcor OxiCliq sensors and adapter cables directly from Tyco Healthcare. Some sensors may not be available in all countries.Do not use more than one extension cable with any sensors or adapter cables. Do not use an extension cable with Philips reusable sensors or adapter cables with part numbers ending in -L (indicates "Long" version).All listed sensors operate without risk of exceeding 41°C/105.8°F on the skin if ambient temperature is below 37°C/98.6°F.Make sure that you use only the accessories that are specified for use with this device, otherwise patient injury can result.Description Limb Circumference RangeContents Part NumberMobile CL Reusable Small Adult Cuff21-27 cm 1 cuff 989803163171Mobile CL Reusable Adult Cuff 26.0-34.5 cm 1 cuff 989803163191Mobile CL Reusable Large Adult Cuff33.5-45.0 cm 1 cuff 989803163211Mobile CL Single-Patient Small Adult Cuff21-27 cm 20 cuffs 989803163181Mobile CL Single-Patient Adult Cuff26.0-34.5 cm 20 cuffs 989803163201Mobile CL Single-Patient Large Adult Cuff33.5-45.0 cm 20 cuffs 989803163221Mobile CL NBP Cradle Kit - 20 cradles 989803163251Mobile CL Extension Air Hose, 1.0 m- 1 extension air hose 989803163131Mobile CL NBP Battery Kit - 1 Battery 1 disassembly tool 1 front housing989803163261Telemetry Pouch with window - 50 pouches 989803137831Telemetry Pouch with window - 4 boxes of 50 pouches 989803140371White Telemetry Pouch with Snaps- 50 pouches 989803101971 (9300-0768-050)White Telemetry Pouch with Snaps- 4 boxes of 50 pouches 989803101981 (9300-0768-200)
29 Accessories and Supplies281Philips Reusable SensorsNo adapter cable required.Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.No adapter cable required. SE sensors work with FM30/40/50, as well as with OxiMax-compatible SpO2 versions of other Philips monitors.Philips Disposable SensorsNot available in the USA:Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cableDescription Part NumberAdult sensor (2.0 m cable), for patients over 50 kg. Any finger, except thumb. M1191BM1191A with longer cable (3.0 m) M1191BLSmall 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.M1192AEar sensor (1.5 m cable) for patients more than 40 kg. Use only on adult patients with FM30/40/50.M1194AAdult clip sensor (3 m cable) for patients over 40 kg. Any finger except thumb. M1196AAdult clip sensor (2 m cable) for patients over 40 kg. Any finger except thumb. M1196SDescription Part NumberAdult sensor (0.45 m cable), for patients over 50 kg. Any finger except thumb. M1191TSmall 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.M1192TAdult clip sensor (0.9 m cable) for patients over 40 kg. Any finger except thumb. M1196TDescription Part NumberSpecial Edition (SE). Adult sensor (3 m cable), for patients over 50 kg. Any finger except thumb.M1191ANLSpecial Edition (SE). Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50.M1192ANSpecial Edition (SE). Ear sensor (1.5 m cable) for patients more than 40 kg. M1194ANDescription Part NumberIdentical to OxiMax MAX-A M1904BIdentical to OxiMax MAX-P M1903BIdentical to OxiMax MAX-N M1901B
29 Accessories and Supplies282Available worldwide:Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cableNellcor SensorsNellcor sensors must be ordered from Nellcor/Covidien.OxiMax SensorsRequire M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.Oxisensor II SensorsRequires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.OxiCliq SensorsRequires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable together with OC-3 adapter cable.Description Part NumberAdult/Pediatric finger sensor (0.45 m cable). Use only on adult patients with FM30/40/50.M1131AAdult/Pediatric finger sensor (0.9 m cable) for patients >40 kg. Any finger except thumb. Use only on adult patients with FM30/40/50.M1133AAdult/Pediatric finger sensor (0.9 m cable) for patients >40 kg. Any finger except thumb. Adhesive-free, use only on adult patients with FM30/40/50.M1134ADescription Part NumberAdult finger sensor (patient size >30 kg) OxiMax MAX-AOxiMax MAX-A with long cable OxiMax MAX-ALPediatric foot/hand sensor (patient size 10-50 kg). Use only on adult patients with FM30/40/50.OxiMax MAX-PAdult finger or neonatal foot/hand sensor (patient size >40 kg or <3 kg). Use only on adult patients with FM30/40/50.OxiMax MAX-NDescription Part NumberAdult sensor (patient size >30 kg) Oxisensor II D-25Pediatric sensor (patient size 10-50 kg). Use only on adult patients with FM30/40/50. Oxisensor II D-20Neonatal/Adult sensor (patient size <3 kg or >40 kg). Use only on adult patients with FM30/40/50.Oxisensor II N-25Description Part NumberSee OxiMax MAX-A OxiCliq ASee OxiMax MAX-P. Use only on adult patients with FM30/40/50. OxiCliq PSee OxiMax MAX-N. Use only on adult patients with FM30/40/50. OxiCliq N
29 Accessories and Supplies283Masimo LNOP Reusable SensorsFor use with this sensor the adapter cable LNOP MP12 (M1020-61102) is needed.Masimo LNCS Reusable SensorsFor use with this sensor the adapter cable LNC MP10 (989803148221) is needed.Masimo LNOP Disposable Adhesive SensorsAppropriate LNOP/LNCS adapter cable required.Description Product Number Part NumberAdult Finger Sensor (>30 kg) LNOP DC-I 989803140321Pediatric Finger Sensor (10-50 kg). Use only on adult patients with FM30/40/50.LNOP DC-IP 989803140331Multi-Site Sensor (>1 kg). Use only on adult patients with FM30/40/50.LNOP YI n/aEar Sensor (>30 kg). Use only on adult patients with FM30/40/50.LNOP TC-I 989803140341Description Product Number Part NumberAdult Finger Sensor (>30 kg) LNCS DC-I 989803148281Pediatric Finger Sensor (10-50 kg). Use only on adult patients with FM30/40/50.LNCS DC-IP 989803148291Ear Sensor (>30 kg). Use only on adult patients with FM30/40/50.LNCS TC-I 989803148301Description Product Number Part NumberAdult Sensor (>30 kg) LNOP Adt 989803140231Adult Sensor (>30 kg) LNOP Adtx n/aPediatric Sensor (10-50 kg). Use only on adult patients with FM30/40/50.LNOP Pdt 989803140261Pediatric Sensor (10-50 kg). Use only on adult patients with FM30/40/50.LNOP Pdtx n/aNeonatal (<3 kg) or Adult adhesive Sensor (>40 kg). Use only on adult patients with FM30/40/50.LNOP Neo-L 989803140291
29 Accessories and Supplies284Masimo LNCS Disposable Adhesive SensorsAppropriate LNOP/LNCS adapter cable required.IntelliVue CL SpO2 Pod AccessoriesAll listed sensors operate without risk of exceeding 41°C on the skin, if the initial skin temperature does not exceed 35°C.Ensure that you use only the accessories that are specified for use with this device, otherwise patient injury can result.1 May not be available in all geographiesExtension / Adapter CablesDescription Product Name Part NumberAdult Sensor (>30 kg) LNCS Adtx 989803148231Pediatric Finger Sensor (10-50 kg). Use only on adult patients with FM30/40/50.LNCS Pdtx 989803148241Neonatal Foot Sensor (<3 kg) or Adult Finger Sensor (>40 kg). Use only on adult patients with FM30/40/50.LNCS Neo-L 989803148271Description Contents Part NumberMobile CL 20 single patient SpO2 Sensors and Cradles for use on patients >10 kg20 Single-Patient Mobile CL DSpO2-1A Sensors 20 Single-Patient Wristbands 20 Single-Patient Cradles pre-assembled989803165941Mobile CL 20 single patient SpO2 Sensors for use on patients >10 kg20 Single-Patient Mobile CL DSpO2-1A Sensors989803165921Mobile CL reusable SpO2 sensor and Cradles for use on patients >15 kg1 Reusable Mobile CL RSpO2-1A Sensor 20 Single-Patient Cradles with pre-attached Wristbands9898031659311Mobile CL 20 SpO2 Cradles (single patient) 20 Single-Patient Cradles with pre-attached Wristbands989803165951Mobile CL 50 SpO2 Wristbands (single patient)50 Single-Patient Wristbands 989803165961Mobile CL SpO2 Battery Kit 1 Battery 1 disassembly tool 1 front housing989803168861Description Comments Part NumberExtension cable (2 m) For use with Philips reusable sensors and adapter cablesM1941AAdapter cable (1.1 m cable) Adapter cable for Philips/Nellcor disposable sensorsM1943AAdapter cable (3 m cable) M1943AL
29 Accessories and Supplies285Tympanic Temperature AccessoriesRecorder PaperSupplied in cases of 40 packs. Each pack has 150 numbered pages. Single use. Use the paper specified here.*Bradycardia and tachycardia alarm ranges are shaded.BatteriesAdapter Cable for OxiCliq sensors Available from Nellcor OC-3Masimo MP 12 LNOP MP Series Patient Cable (3.6 m) Adapter Cable for Masimo LNOP sensorsM1020-61100LNC MP10 LNCS MP Series Patient Cable (3.0 m) Adapter Cable for Masimo LNCS sensors989803148221Description Comments Part NumberDescription Part NumberTemperature probe 989803180831Disposable probe cover with CE marking (22 boxes each containing 96 covers) 989803179611Disposable probe cover (22 boxes each containing 96 covers) 989803179381Geography FHR Scale Grid Color Scale Units Highlighted 3 cm Lines?Part NumberUSA/Canada/Asia 30-240 Red/Orange mmHg Yes M1910AEurope 50-210 Green mmHg and kPa No M1911AJapan 50-210 Green mmHg Yes M1913AJapan 50-210 Green*mmHg Yes M1913JDescription Comment Part Number.Smart Battery 10.8 V, 6000 mAh, Lithium IonFor Avalon FM20 or Avalon FM30 with battery option #E25M4605AAvalon CL Cableless Smart transducer Battery Replacement KitConsists of one Philips Lithium Ion Battery (Part No. 453564107871), a tool to open and close the cableless transducer for battery replacement and two replacement O-ring seals.989803184861
29 Accessories and Supplies286
3028730Specifications and Standards ComplianceThe monitors are intended to monitor a mother and her fetus(es), which from an electrical safety point of view, are one person.Environmental SpecificationsThe 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 K40Temperature Range Operating 0°C-45°C (32°F-113°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <95% relative humidity @ 45°C (113°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)Avalon CL Base station 866074 with Option K60Temperature Range Operating 0°C-40°C (32°F-104°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <90% relative humidity @ 45°C (113°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating 0-2000 m (0-6562 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)
30 Specifications and Standards Compliance288NOTEDo not locate the M2738A ECG/IUP Module directly on the patient’s skin when operated at an environmental temperature above 37°C (98.6°F). When operated at an environmental temperature of 40°C (104°F), the transducers can reach a temperature of 41-43°C (106-110°F).Monitor (M2702A/M2703A/M2704A/M2705A); Interface Cable for Avalon CTS (M2731-60001 and M2732-60001)Temperature Range Operating Without battery option: 0°C-45°C (32°F-113°F)With battery option/charging: 0°C-35°C (32°F-95°F)With battery option/fully charged: 0°C-40°C (32°F-104°F)Storage/Transportation -20°C—60°C (-4°F—140°F)Humidity Range Operating <95% relative humidity @ 40°C (104°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)Transducers (M2734A/M2734B/M2735A/M2736A/M2738A)Temperature Range Operating 0°C-40°C (32°F-104°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <95% relative humidity @ 40°C (104°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)Avalon CL Transducers (866075/866076/866077)Temperature Range Operating 0°C-40°C (32°F-104°F)Charging 0°C-35°C (32°F-95°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <95% relative humidity @ 40°C (104°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)Avalon CL Fetal and Maternal Pod (866488)Temperature Range Operating 10°C-40°C (50°F-104°F)Charging 10°C-35°C (50°F-95°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <95% relative humidity @ 40°C (104°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)
30 Specifications and Standards Compliance289WARNINGExplosion 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 SpecificationsFetal MonitorsAltitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)Avalon CL Fetal and Maternal Pod (866488)Avalon CL Wide Range Pod (866487)Temperature Range Operating 0°C-40°C (32°F-104°F)Charging 0°C-35°C (32°F-95°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <95% relative humidity @ 40°C (104°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-4600 m (-1640-15092 ft)SpO2 SensorsOperating Temperature Range 0°C-37°C (32°F-98.6°F)Tympanic TemperatureOperating Temperature Range 16ºC-33ºC (60.8ºF-91.4ºF)Monitor Physical Specifications M2702A/M2703A M2704A/M2705APower Supply Voltages 100 VAC-240 VAC ±10%Supply Frequency Range 50 Hz-60 HzPower Consumption (current)0.7-0.4 A (M2702A/M2703A) 1.3-0.7 A (M8023A#E25)1.3-0.7 ADimensions and WeightSize (without options) mm/(in):width x height x depth286 x 134 x 335 mm(11.3 x 5.3 x 13.2 in)425 x 174 x 365 mm(16.6 x 6.9 x 14.4 in)Weight <5.1 kg (11.2 lbs) <8.8 kg (19.5 lbs)Degree of Protection Against Electrical Shock Type CFElectrical Class Class II equipment Class I equipment
30 Specifications and Standards Compliance290Fetal Monitor SoundsAvalon CL Base StationElectrical Power Source External (AC) without battery option #E25Internal (Lithium Ion battery) if with battery option #E25External (AC)Mode of Operation Continuous operationWater 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/secStartup Time Time taken from switching on the monitor to seeing the first parameter labels<30 secondsMonitor Physical Specifications M2702A/M2703A M2704A/M2705ASource DescriptionPatient 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 toneSpO2Optional 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 StationDimension and Weight Size mm/(in)W x H x D 349 x 74 x 183 mm (13.8 x 2.9 x 7.2 in)Weight 1 kg (2.3 lbs)Electrical Class When the base station is connected to the monitors M2702A/M2703A/M2704A/M2705A it is a Class II equipment.Electrical Power Source External (powered by fetal monitor)Mode of Operation Continuous operationInterface cable connector type Connector color Red for FM20/30 left side or FM40/50 front fetal connector socketBlack for FM40/50 rear telemetry connector socketInterface cable length 1.5 m (4.11 ft)Ingress Protection IP 31
30 Specifications and Standards Compliance291Wired TransducersAvalon CL TransducersExternal 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 VACSupply Frequency Range 50 Hz/60 HzPower Consumption (current) 0.4-0.2AElectrical Class Class IIElectrical Power Source AC MainsMode of Operation ContinuousWater Ingress Protection Code IP40Transducers (M2734A/M2734B/M2735A/M2736A/M2738A)Shock Resistance Withstands a 1 m drop to concrete surface with possible cosmetic damage onlyWater Ingress Protection CodeM2734A&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 WeightM2734A&B/35/36A Size (diameter) 83 mm (3.27 in)Weight (without cable) 0.2 kg (0.5 lb)M2738A Maximum size mm/(in): width x height x depth42 x 30 x 123 mm (1.7 x 1.2 x 4.8 in)Cable length 2.5 mWeight 0.2 kg (0.5 lb)Degree of Protection Against Electrical Shock Type CFTransducer Identification Optical Signal Element (Finder LED), not M2738AAvalon 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 WeightAvalon CL Toco+ MP Transducer 866075Size (diameter/height) 76 mm/37 mm (3 in/1.5 in)Weight 0.2 kg (0.5 lb)Avalon CL US Transducer 866076 Size (diameter/height) 76 mm/37 mm (3 in/1.5 in)Weight 0.2 kg (0.5 lb)Avalon CL ECG/IUP Transducer 866077Size (diameter/height) 76 mm/37 mm (3 in/1.5 in)Weight 0.2 kg (0.5 lb)
30 Specifications and Standards Compliance292Avalon CL Fetal & Maternal PodAvalon CL Wide Range PodInterface Cable Avalon CTSExternal Power Supply Option E25Degree of Protection Against Electrical Shock Type CFTransducer Identification Optical Signal Element (Finder LED)Avalon CL Transducers (866075/866076/866077)Avalon CL Fetal & Maternal Pod (866488)Shock Resistance Withstands a 1.5 m drop to concrete surface with possible cosmetic damage only.Water Ingress Protection Code IP 67 (immersion up to 1 m water depth for 30 minutes)Dimensions and Weight W x H x D 63 x 20 x 49 mm (2.5 x 0.8 x 1.9 in)Weight 0.07 kg (0.15 lb)Degree of Protection Against Electrical Shock Type CFPod Identification Optical Signal Element (Finder LED)Avalon CL Wide Range Pod (866487)Shock Resistance Withstands a 1 m drop to concrete surface with possible cosmetic damage only.Water Ingress Protection Code IP 32 (protection from dripping water)Dimensions and Weight W x H x D 55 x 26.5 x 122 mm (2.1 x 1 x 4.8 in)Weight 0.14 kg (0.3 lb)Interface Cable for Avalon CTS (M2731-60001 and M2732-60001)Shock Resistance Withstands a 1 m drop to concrete surface with possible cosmetic damage onlyWater Ingress Protection Code IP X1Dimensions and Weight Maximum size mm/(in): width x height x depth55 x 28 x 50 mm (2.2 x 1.1 x 2.0 in)Cable length 2.5 mWeight 0.2 kg (0.5 lb)M8023A (Option #E25) External Power Supply Weight and DimensionsMaximum Weight 0.6 kg (1.4 lb)Size (W x H x D) 208 x 105 x 89 mm (8.2 x 4.1 x 5.3 in)
30 Specifications and Standards Compliance293Interface SpecificationsFetal Monitors1 The power loss indication functionality of the Nurse Call Relay board is not supported with fetal monitors.Interface SpecificationsNetwork Standard 100-Base-TX (IEEE 802.3 Clause 25)Connector RJ45 (8 pin)Isolation Basic isolation (reference voltage: 250 V; test voltage: 1500 V)MIB/RS232 Standard IEEE 1073-3.2-2000Connectors RJ45 (8 pin)Mode Software-controllable BCC (RxD/TxD cross over) or DCC (RxD/TxD straight through)Power 5 V ±5%, 100 mA (max.)Isolation Basic isolation (reference voltage: 250 V; test voltage: 1500 V)USB Interface Standard USB 2.0 full-speed (embedded host)Connectors USB series "Standard A" receptaclePower Low power port 4.4V min; max. load for all ports together 500 mAIsolation noneRS232 (Standard) Connectors RJ45 (8 pin)Power noneIsolation Basic isolation (reference voltage: 250 V; test voltage: 1500 V)RS232 (Independent display interface option)Connectors RJ45 (8 pin)Power noneIsolation noneFlexible Nurse Call Relay1Connectors 20 pin MDR (Mini D-Ribbon), active open and closed contactsContact ≤100 mA, ≤24 V DCIsolation Basic isolation (reference voltage: 250 V; test voltage: 1500 V)Delay <[Configured Latency +0.5] sec
30 Specifications and Standards Compliance294Avalon CL Radio*Wireless transmissions are encrypted for security.CL Wide Range Pod RadioAvalon CL Radio Interface SpecificationsElectronic Article Surveillance (EAS) EAS tag inside the housing (58 kHz)Short Range Radio Interface* Type Internal SRR interfaceTechnology IEEE 802.15.4Frequency 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 doorsOBR (WMTS)* Frequency Band 608-614 MHzEffective radiated power <10 mW (base station) <1 mW (CL transducers)Range min. 100 m/300 ft (in line of sight)OBR (ISM)* Frequency Band 433.05-434.79 MHzEffective radiated power <10 mW (base station) <1 mW (CL transducers)Range min. 100 m/300 ft (in line of sight)OBR (T108)* Frequency Band 920.6-923.4 MHzEffective radiated power <40 mW (base station) <10 mW (CL transducers)Range min. 100 m/300 ft (in line of sight)OBR (OB Radio)OBR (WMTS) Frequency Band 608-614 MHzEffective radiated power <1 mWRange 5 m/16 ftOBR (ISM) Frequency Band 433.05-434.79 MHzEffective radiated power <1 mWRange 5 m/16 ftOBR (T108) Frequency Band 920.6-923.4 MHzEffective radiated power <5 mWRange 5 m/16 ftShort Range Radio SpecificationsType Built-in interface with integrated antennaTechnology IEEE 802.15.4
30 Specifications and Standards Compliance295Performance SpecificationsEssential PerformanceThis section defines the essential performance for Avalon fetal monitors in combination with the specified wired transducers and sensors, and also with the cableless measurements (Avalon CL, Avalon CTS).Under normal and single fault conditions either at least the performance/functionality listed in the tables below is provided, or failure to provide this performance/functionality is readily identifiable by the user (e.g. technical alarm, no waves and/or numeric values, complete failure of the monitor, readily identifiable distorted signals, etc.).Frequency Band 2.4 GHz ISM (2.400-2.483 GHz) MBAN (2.360-2.400 GHz, for US / FCC regulated countries only)1Modulation DSSS (O-QPSK)Bandwidth 5 MHzEffective Radiated Power (ERP) max. 0 dBm (1 mW)Short Range Radio SpecificationsWLAN SpecificationsType Internal wireless adapterTechnology IEEE 802.11a/b/g/nFrequency Band USA: 2.400-2.483 GHz, 5.15-5.35 GHz, 5.725-5.825 GHzEurope: 2.400-2.483 GHz, 5.15-5.35 GHz, 5.47-5.725 GHzJapan: 2.400-2.483 GHz, 5.150-5.250 GHz, 5.25-5.35 GHz, 5.470-5.725 GHzChina: 2.400-2.483 GHz, 5.725-5.85 GHzModulation Technique 802.11b/gDSSS (DBPSK, DQPSK, CCK)OFDM (BPSK, QPSK, 16-QAM, 64-QAM)802.11aOFDM (BPSK, QPSK, 16-QAM, 64-QAM)Effective Radiated Power (ERP) 2.400-2.483 GHz: max. 18 dBm (63 mW)5.150-5.725 GHz: max. 19 dBm (79 mW)5.745-5.825 GHz: max. 14 dBm (25 mW)Measurement Essential PerformanceGeneral No interruption or cessation of current operating mode (e.g. no reboot, display OK).No spontaneous operation of controls (e.g. no activation of touchscreen without user interaction).
30 Specifications and Standards Compliance296The 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 variationsThe following table identifies minimum performance for transient electromagnetic phenomena according to IEC 60601-1-2:• Electrostatic Discharge (ESD)• Electrical Fast Transients/Bursts•Surges• Voltage interruptionsECG (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 cyclingAlarming on limit violations of systolic, diastolic, and mean blood pressure, and pulse rate.SpO2Measurement of oxygen saturation and pulse rate within the specified accuracy/error limits.Alarming on oxygen saturation and pulse rate limit violation.Temperature (tympanic) Measurement of temperature within specified accuracy/error limits.Alarming on temperature limit violation.Toco extern Measurement of the external Toco ± 5 units on display and recorder (with paper adjusted).Toco intern (IUP) Measurement of the internal Toco within specified accuracy limits on display and recorder (with paper adjusted).Ultrasound Measurement of the fetal heart rate ± 5 bpm on display and recorder (with paper adjusted).Ultrasound energy within safe limits for continuous operation: p_ < 1 MPa, Iob < 20 mW/cm2, Ispta < 100 mW/cm2.Measurement Essential Performance
30 Specifications and Standards Compliance297Fetal MonitorsBattery SpecificationsMeasurement Essential PerformanceAll After electrostatic discharge, fast transients/bursts, surges and electro surgery interference, the equipment will return to previous operation mode within 10 seconds (SpO2 30 seconds) without loss of any stored data.After voltage interruptions the equipment returns to previous state without operator intervention and loss of data.Fetal Monitor Performance SpecificationsAlarm Signal System alarm delay. The system alarm delay is the processing time the system needs for any alarm to be indicated on the fetal monitor, after the measurement has triggered the alarm.less than 4 secondsPause duration 1, 2, 3 minutes or infinite, depending on the configurationExtended alarm pause 5 to 10 minutesSound pressure range min. 0 dB(A) max. 45-85 dB(A)Review Alarms Information all alarms/INOPs, main alarms on/off, alarm silence and time of occurrenceCapacity 300 itemsReal time Clock Range from: January 1, 1997, 00:00 to: December 31, 2080, 23:59Accuracy better than ±1 min. per monthHold Time infinite if powered by AC; otherwise at least 48 hoursBuffered Memory Hold Time if powered by AC infinite without power: at least 8 hoursContents active settings, review alarms, stored trace dataPerformance SpecificationsAvalon FM20/30 Battery Option #E25Operating Time (with new, fully charged battery)Basic monitoring configuration: >2 hours(Display Brightness: 70%, Recorder: "On" at 3 cm/min, NBP: Auto Mode at 15 min, 2 US Transducers, 1 Toco+ with MECG, 1 Patient Module with DECG)Charge Time When monitor is off: approx. 6 hours When monitor is in use: more than 10 hours (depending on monitor configuration)
30 Specifications and Standards Compliance298Fetal / Maternal SpecificationsUltrasoundComplies with IEC 60601-2-37:2007 / EN 60601-2-37:2008Performance SpecificationAvalon CL Transducer BatteryOperating time With a new and fully charged battery min. 10 hoursCharge time From a "low battery" indication to a "fully charged" indication <3 hoursCharge time with Avalon FM20/30 Battery Option #E25From a "low battery" indication to a "fully charged" indication >6 hours.Performance SpecificationAvalon CL F&M Battery Operating time With a new and fully charged battery min. 16 hoursCharge time From a "low battery" indication to a "fully charged" indication <3 hoursCharge time with Avalon FM20/30 Battery Option #E25From a "low battery" indication to a "fully charged" indication >6 hours.Performance SpecificationAvalon CL Wide Range Pod BatteryOperating time With a new and fully charged battery min. 4 hoursCharge time From a "low battery" indication to a "fully charged" indication <3 hoursPerformance SpecificationsUltrasoundMeasurement Method Ultrasound Pulse DopplerMeasurement Range US 50-240 bpmResolution Display 1 bpmPrinter 1/4 bpmJitter @ 200 bpm ≤3 bpmDisplay Update Rate 1 per second
30 Specifications and Standards Compliance299TocoUS Intensity (M2736A/AA) Average output power P = (7.4 ± 0.4) mWPeak-negative acoustic pressure p_ = (40.4 ± 4.3) kPaOutput beam intensity (Iob)(= spatial average - temporal average intensity)Isata = (2.38 ± 0.59) mW/cm2Spatial-peak temporal average intensity Ispta = (15.0 ± 3.2) mW/cm2Effective radiating area @ -12 dB (3.11 ± 0.74) cm2Thermal index (TI) and mechanical index (MI) are always below 1.0.US Intensity CL (866076) Average output power P = (12.4 ± 0.4) mWPeak-negative acoustic pressure p_ = (49.1 ± 5.2) kPaOutput beam intensity (Iob)(= spatial average - temporal average intensity)Isata = (2.77 ± 0.56) mW/cm2Spatial-peak temporal average intensity Ispta = (21.1 ± 5.1) mW/cm2Effective radiating area @ -12 dB A-12dB = (4.47 ± 0.89) cm2Thermal index (TI) and mechanical index (MI) are always below 1.0.Signal Quality Indication Poor Quality emptyAcceptable Quality half-fullGood Quality fullBeat-to-Beat change (max.) for Ultrasound 28 bpmUS Frequency 1 MHz ± 100 HzUS Signal range 3.5 μVpp-350 μVpp @ 200 HzUS Burst Repetition Rate 3.0 kHzDuration ≤100 μsFMP Signal Range @ 33 Hz 200 μVpp-40 mVppPerformance SpecificationsPerformance SpecificationsTocoMeasurement Method Strain Gauge Sensor ElementSensitivity 1 unit = 2.5 gResolution Display 1 unitPrinter 1/4 unitMeasurement Range 400 unitsSignal Range 0-127 unitsMaximum Offset Range -300 unitsBaseline Setting 20 units
30 Specifications and Standards Compliance300IUPECGComplies with IEC 60601-2-27:2011 / EN 60601-2-27:2014 except clauses listed below:• 201.6.2, 201.8.5.5• 201.12.1.101• 202.6.2.101Update Rate Display 1 per secondPrinter ~4 per secondAuto Offset Correction 3 seconds after connecting the transducer, the Toco value is set to 20 unitsAuto Zero Adjust Toco value is set to zero following a negative measurement value for 5 secondsPerformance SpecificationsPerformance SpecificationsMaternal Pulse from TocoEmitted Light Energy ≤15 mWWavelength Range 780-1100 nmRange 40-240 bpmResolution 1 bpmDisplay Update Rate 1 per secondAccuracy ± 2% or 1 bpm, whichever is greaterUpdate Rate every 4 secondsPerformance SpecificationsIUPMeasurement Method Passive Resistive Strain Gauge ElementsMeasurement Range -100-+300 mmHgSignal Range -99-127 mmHg or (-13.2-16.9 kPa)Resolution Display 1 mmHgPrinter 1/4 mmHgSensitivity 5 μV/V/mmHgOffset Compensation +100- -200 mmHgAccuracy (not including sensor accuracy) ±0.5% per 100 mmHgUpdate Rate Display 1 per secondPrinter ~4 per secondAuto Offset Correction 3 seconds after connecting the transducer, the IUP value is set to 0 mmHg
30 Specifications and Standards Compliance301WARNINGThe fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform.When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration).The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS, and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated.Performance SpecificationsECGPerformance Specifications Type DECG Single Lead ECG (derived from Fetal Scalp Electrode)MECG Single Lead ECG (derived from RA and LA electrodes)Measurement Range 30-240 bpmResolution Display 1 bpm (display update rate 1 per second)Recorder 1/4 bpmWave Speed (Global Speed) 6.25 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/secAccuracy ±1 bpm or 1%, whichever is greater (non-averaging)Beat-to-Beat change (max.) MECG: 28 bpmDECG: 28 bpm (with Artifact Suppression On)Differential Input Impedance >15MΩElectrode Offset Potential Tolerance ±400 mVINOP Auxiliary Current (Leads Off Detection) <100 μAInput Signal Range DECG 20 μVpp-6 mVppMECG 150 μVpp-6 mVppDielectric Strength 1500 VrmsDefibrillator Protection NoneESU Protection NonePaced pulse detection None
30 Specifications and Standards Compliance302Fetal Heart Rate (Ultrasound/DECG) Alarm Specifications FHR Alarm Limits Range Bradycardia (low limit) 60-200 bpm adjustable in 10 bpm stepsDefault: 110 bpmTachycardia (high limit) 70-210 bpm adjustable in 10 bpm stepsDefault: 170 bpmFHR Alarm Delay Range Bradycardia (low limit) Delay 10-300 seconds in steps of 10 seconds + system alarm delayDefault: 240 secondsTachycardia (high limit) Delay 10-300 seconds in steps of 10 seconds + system alarm delayDefault: 300 secondsSignal Loss Delay 10-30 seconds in steps of 10 seconds + system alarm delayMECG Alarm SpecificationsRange Adjustment Alarm DelayMECG Alarm Limits High Range: 31-240 bpmDefault: 120 bpm1 bpm steps (30-40 bpm) 5 bpm steps (40-240 bpm)System alarm delay (see “Fetal Monitors” on page 297).Low Range: 30-235 bpmDefault: 50 bpmExtreme Tachycardia Difference to high limit: 0-50 bpmDefault: 20 bpm5 bpm stepsClamping at: 150-240 bpmDefault: 200 bpm5 bpm stepsExtreme Bradycardia Difference to low limit: 0-50 bpmDefault: 20 bpm5 bpm stepsClamping at: 30-100 bpmDefault: 40 bpm5 bpm stepsMaternal ECG Supplemental Information as required by IEC 60601-2-27Heart 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 secondsVentricular tachycardia alarm for waveforms B1 and B2No heart rate is detected for waveforms B1 and B2, resulting in *** Extreme Brady alarm
30 Specifications and Standards Compliance303aFHR, aHR, aTocoResponse Time of Heart Rate Meter to Change in Heart RateHR change from 80-120 bpm: 10 seconds HR change from 80-40 bpm: 14 secondsTall T-Wave Rejection Capability M2735A 1.2 mV T-Wave amplitudeM2738A 1.4 mV T-Wave amplitudeCL Toco+ MP, CL ECG/IUP1.2 mV T-Wave amplitudeResponse Time of Heart Rate meter to Change in Heart RateM2735A, M2738A HR change from 80-120 bpm Average: 12 secondsHR change from 80-40 bpm Average: 15 secondsCL Toco+ MP, CL ECG/IUPHR change from 80-120 bpm Average: 10 secondsHR change from 80-40 bpm Average: 12 secondsHeart Rate Meter Accuracy and Response to Irregular RhythmM2735A, M2738A Ventricular bigeminy 40-60 bpmSlow alternating ventricular bigeminy 45 bpmRapid alternating ventricular bigeminy 163 bpmBidirectional systoles 63-73 bpmCL Toco+ MP, CL ECG/IUPVentricular bigeminy 40-60 bpmSlow alternating ventricular bigeminy 30 bpmRapid alternating ventricular bigeminy 70-163 bpmBidirectional systoles 63-73 bpmMaternal ECG Supplemental Information as required by IEC 60601-2-27aFHRMeasurement Method electrocardiographyMeasurement Range 60-240 bpmResolution Display 1 bpmPrinter 1/4 bpmAccuracy ±1 bpmaHRMeasurement Method electrocardiographyMeasurement Range 40-240 bpmResolution Display 1 bpmPrinter 1/4 bpmAccuracy ±1 bpmaTocoMeasurement Method uterine electromyographyMeasurement Range 0-500 μV
30 Specifications and Standards Compliance304Noninvasive Blood PressureComplies with IEC 80601-2-30:2009 / EN 80601-2-30:2010.*1: Clinical investigation with the auscultatory reference method• The 5th Korotkoff sound (K5) was used to determine the diastolic reference pressures.• The approximation MAP = (2*DIA + SYS) / 3 was used to calculate reference MAP (mean arterial pressure) values from the systolic and diastolic reference pressures.Resolution 0-255 levels representing 100% of the full scaleAccuracy ±5%aTocoPerformance Specifications Measurement RangesSystolic 30-270 mmHg (4-36 kPa)Diastolic 10-245 mmHg (1.5-32 kPa)Mean 20-255 mmHg (2.5-34 kPa)Accuracy1Max. Std. Deviation: 8 mmHg (1.1 kPa) Max. Mean Error: ±5 mmHg (±0.7 kPa)Pulse Rate Range 40-300 bpmAccuracy (average over noninvasive blood pressure measurement cycle)40-100 bpm: ±5 bpm101-200 bpm: ±5% of reading201-300 bpm: ±10% of readingMeasurement Time Typical at HR >60 bpmAuto/manual: 30 seconds (adult)Maximum time: 180 seconds (adult)Cuff Inflation Time Typical for normal adult cuff: Less than 10 secondsInitial Cuff Inflation Pressure 165 ±15 mmHgAuto Mode Repetition Times 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45, 60, or 120 minutesVenipuncture Mode InflationInflation Pressure 20-120 mmHg (3-16 kPa)Automatic deflation after 170 secondsAlarm Specifications Range Adjustment Alarm DelaySystolic Adult: 30-270 mmHg (4-36 kPa)10-30 mmHg: 2 mmHg (0.5 kPa) >30 mmHg: 5 mmHg (1 kPa)System alarm delay (see “Fetal Monitors” on page 297).Diastolic Adult: 10-245 mmHg (1.5-32 kPa)Mean Adult: 20-255 mmHg (2.5-34 kPa)
30 Specifications and Standards Compliance305SpO2Complies with ISO 80601-2-61:2011 / EN 80601-2-61:2011.Measurement Validation: The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements.Display Update Period: Typical: 2 seconds, maximum: 30 seconds. Maximum with noninvasive blood pressure INOP suppression on: 60 seconds.Overpressure Settings Adjustment> 300 mmHg (40 kPa) > 2 sec not user adjustableSpO2 Performance Specifications SpO2The specified accuracy is the root-mean-square (RMS) difference between the measured values and the reference valuesRange 0-100%Accuracy Philips Reusable Sensors: M1191A/B, M1191AL/BL, M1191ANL, M1192A, M1192AN = 2% (70%-100%)M1191T, M1192T, M1194A, M1194AN, M1196A, M1196T = 3% (70%-100%)Philips Disposable Sensors with M1943A(L): M1131A, M1901B, M1903B, M1904B = 3% (70%-100%)M1133A, M1134A = ±2% (70%-100%)Nellcor® Sensors with M1943A(L): MAX-A, MAX-AL, MAX-P, MAX-N, D-25, D-20, N-25, OxiCliq A, P, N = 3% (70%-100%)Masimo Reusable Sensors® with LNOP MP12 or LNC MP10:LNOP DC-I, LNOP DC-IP, LNOP YI, LNCS DC-I, LNCS DC-IP: 2% (70%-100%)LNOP TC-I, LNCS TC-I: 3.5% (70%-100%)Masimo Disposable Sensors® with LNOP MP12 or LNC MP10:LNOP Adt, LNOP Adtx, LNOP Pdt, LNOP Pdtx, LNCS Adtx, LNCS Pdtx: 2% (70%-100%)LNOP Neo-L, LNCS Neo-L: 3% (70%-100%)Resolution 1%Pulse Range 30-300 bpmAccuracy ±2% or 1 bpm, whichever is greaterResolution 1 bpm
30 Specifications and Standards Compliance306Tympanic TemperatureComplies with:• EN 12470-5 (Clinical thermometers - Part 5:2003: Performance of infra-red thermometers)• ASTM E1965-98 (Infrared Thermometers for Intermittent Determination of Patient Temperature)with minor exceptions as noted below.The fetal monitor additionally complies with ISO 80601-2-56:2009 / EN ISO 80601-2-56:2012.Sensors Wavelength range 500-1000 nm. Information about the wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed).Emitted Light Energy≤15mWPulse Oximeter Calibration Range 70%-100%SpO2 Performance Specifications SpO2 Alarm Specifications Range Adjustment DelaySpO250-100% 1% steps (0, 1, 2, 3,... 30) + 4 secondsDesat 50-Low alarm limit 1% stepsPulse 30-300 bpm 1 bpm steps (30-40 bpm) 5 bpm steps (40-300 bpm)max. 14 secondsTachycardia Difference to high limit 0-50 bpm 5 bpm steps max. 14 secondsClamping at 150-300 bpm 5 bpm stepsBradycardia Difference to low limit 0-50 bpm 5 bpm steps max. 14 secondsClamping at 30-100 bpm 5 bpm stepsPerformance SpecificationsTemperature Resolution 0.1°C or 0.1°FResponse Time less than 2 secondsTemperature Calibrated Accuracy Specifications (out of the Factory)Ambient Temperature Target Temperature Accuracy25.0°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 Accuracy16.0°C-33.0°C (60.8°F-91.4°F) 36.0°C-39.0°C (96.8°F-102.2°F) ±0.2°C (±0.4°F)
30 Specifications and Standards Compliance30716.0°C-33.0°C (60.8°F-91.4°F) <36.0°C or >39.0°C (<96.8°F or >102.2°F)±0.3°C (±0.5°F)ASTM laboratory requirement for IR thermometers in the display range 37.0°C-39.0°C (98.0°F-102.0°F) is ±0.2°C (±0.4°F), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM standards E667-86 and E1112-86 is ±0.1°C (±0.2°F).Clinical accuracy characteristics and procedures are available from Covidien llc on request. To verify the accuracy, use a certified black body as specified in EN ISO 80601-2-56, Annex C, or use a Genius 2 Checker/Calibrator - available from Covidien llc under part number 303097.Clinical repeatability: meets section A.5 of EN ISO 80601-2-56(E) per Covidien llc technical report. Data is available from Covidien llc on request.Performance SpecificationsDisplayed Temperature Measurement RangeMode Range °C Range °FEar 33.0-42.0°C 91.4-107.6°FOral (ear + 0.6°C) 33.6-42.0°C 92.5-107.6°FCore (ear + 1.04°C) 34.0-42.0°C 93.2-107.6°FRectal (ear + 1.16°C) 34.2-42.0°C 93.6-107.6°FCaution: ASTM E1965-98 specifies 34.4°C-42.2°C (94°F-108°F)Ambient Temperature RangeMode Range °C Range °FOperating 10%-95% RH, non-condensing16.0-33.0°C 60.8-91.4°FStorage up to 95% RH, non-condensing-25.0-55.0°C -13.0-131.0°FCaution: 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-condensingStoring the thermometer outside the specified temperature/humidity range might adversely affect measurement accuracy. Check the calibration after storage in uncertain conditions.Tympanic Temperature Alarm SpecificationsRange 33.0°C-42.0°C (91.0°F-108.0°F)Adjustment 0.5°C steps (33.0°C-35.0°C)0.1°C steps (35.0°C-42.0°C)1.0°F steps (91.0°F-95.0°F)0.2°F steps (95.0°F-108.0°F)Alarm delay System alarm delay (see “Fetal Monitors” on page 297).
30 Specifications and Standards Compliance308Physical SpecificationsRecorder SpecificationsThermometerDimensions 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 gIngress protection classification IP 21Base StationDimensions 205 mm x 65 mm x 75 mm (±3 mm)Weight (excluding cable) 400 g ±10 gBuilt-in Thermal Array Fetal Trace RecorderMechanism Thermal Array RecorderPaper & Printing Type Standard Z-fold paperStandard Speeds (real-time traces) 3 cm/min, 2 cm/min, 1 cm/minFast Print Speed (stored traces) Max. 20 mm/s Print speed is variable and depends on the print loadECG Wave Print Speed (not real-time)Emulated 25 mm/s Print speed is variable and depends on the print loadPaper Advance 20 mm/sSensing Optical Reflex Sensor for black page marksAccuracy @ 3 cm/min, 2 cm/min, 1 cm/min±5 mm/pageUsable Print Width 128 mmResolution 8 dots/mm (200 dpi)Time Delay to see trace on paper <30s @ 1 cm/minTrace Separation Offset for FHR (Ultrasound and DECG)Twin Standard FHR2 +20 bpmClassic FHR1 +20 bpm in the presence of FHR2 Triplet Standard FHR2 +20 bpm FHR3 -20 bpmClassic FHR1 +20 bpm FHR3 -20 bpm in the presence of FHR2 and/or FHR3
30 Specifications and Standards Compliance309Recorder SymbolsSymbol DescriptionParameter 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 onBeginning of the date/time annotationWarning (INOP)Measurement from a cableless transducer (printed next to measurement label)Measurement from a cableless measurement PodsMeasurement from cableless devices connected with WLAN (CL Wide Range Pod)Pulse from SpO2Pulse from Toco MPPulse from NBPTrace separation +20 bpm (in label)Trace separation -20 bpm (in label)Trace separation Off (in trace)Trace separation +20 bpm (in trace)
30 Specifications and Standards Compliance310External Displays: FM40/FM50 OnlyExternal 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 InformationYou can write to Philips at this address:Philips Medizin Systeme Boeblingen GmbHHewlett-Packard-Str. 271034 BoeblingenGermanyVisit our website for local contact information at: www.healthcare.philips.com© Copyright 2016. Koninklijke Philips N.V. All Rights Reserved.Trademark AcknowledgmentOxisensorTM II, Oxi-CliqTM, and OxiMaxTM are trademarks of Tyco Healthcare Group LP, Nellcor Puritan Bennett Division.Trace separation -20 bpm (in trace)Trace separation +20 bpm and -20 bpm (in trace)Coincidence of heart rates is detectedMarkerSpecial wave, with different speed and scale (for example, fast printout of MECG wave on FM30)Recorder SymbolsSymbol Description
30 Specifications and Standards Compliance311Regulatory and Standards ComplianceThe 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 PerformanceThe 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 3200.1.0-1998The possibility of hazards arising from hardware and software errors was minimized in compliance with ISO 14971:2012, IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013.Alarm sounds are compliant with Standard IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+A1:2013+AC:2014.CompatibilityWhen your fetal monitor is compliant with IEC 60601-1:1988+A1:1991+A2:1995 / EN 60601-1:1990+A1:1993+A2:1995 (Edition 2) and related standards, it can still be used with the Avalon CL Transducer System and the software upgrade J.3 or higher, and all measurement accessories that are compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013 (Edition 3) and related standards.When your fetal monitor is compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013 (Edition 3) and related standards, it can still be used with the Avalon CTS Transducer System, and all measurement accessories that are compliant with IEC 60601-1:1988+A1:1991+A2:1995 / EN 60601-1:1990+A1:1993+A2:1995 (Edition 2) and related standards.
30 Specifications and Standards Compliance312RadioThe 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-T66Safety Tests Fetal MonitorAll the safety tests and procedures required after an installation, or an exchange of system components are described in your monitor's Service Guide. These safety tests are derived from international standards, but may not be sufficient to meet local requirements.WARNING• Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet is used, the resulting system must be compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013• Do not connect any devices that are not supported as part of a system.• Do not use a device in the patient vicinity if it does not comply with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013. The whole installation, including devices outside of the patient vicinity, must comply with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013. Any non-medical device, including a PC running an OB TraceVue/IntelliSpace Perinatal system, placed and operated in the patient's vicinity must be powered via a separating transformer (compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013) that ensures mechanical fixing of the power cords and covering of any unused power outlets.• Do not use USB devices with own power supplies, unless an appropriate separation device is used, (either between USB interface and device or between device and power).During the installation the fetal monitor is configured for your environment. This configuration defines your custom default settings you work with when you switch on your fetal monitor. See the fetal monitor's Service Guide and the Configuration Guide for details on how to configure your fetal monitor.
30 Specifications and Standards Compliance313Electromagnetic 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:2010Take 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.WARNINGThe use of accessories, transducers, and cables other than those specified, may result in increased electromagnetic emissions, or decreased electromagnetic immunity of the device.WARNINGDo 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.WARNINGFor paced patients: The radiated SRR power of the CL SpO2 and CL NBP Maternal Cableless Measurement Devices, and other sources of radio-frequency energy, when used in very close proximity of a pacemaker, might be sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring paced patients.In order to minimize the possibility of interference, avoid positioning and wearing the Cableless Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer for information on the RF susceptibility of their products.
30 Specifications and Standards Compliance314EMC TestingCAUTIONFetal 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 InterferenceWARNINGThe device should not be used adjacent to, or stacked with, other equipment unless otherwise specified.The product and associated accessories can be susceptible to interference from continuous, repetitive, power line bursts, and other RF energy sources, even if the other equipment is compliant with EN 60601-1-2 emission requirements. Examples of other sources of RF interference are other medical electrical devices, cellular products, information technology equipment, and radio/television transmissions.When electromagnetic interference (EMI) is encountered, for example, if you can hear spurious noises on the fetal monitor's loudspeaker, attempt to locate the source. Assess the following:• Is the interference due to misplaced or poorly applied transducers? If so, re-apply transducers correctly according to directions in this book, or in the Instructions for Use accompanying the accessory.• Is the interference intermittent or constant?• Does the interference occur only in certain locations?• Does the interference occur only when in close proximity to certain medical electrical equipment?Once the source is located, there are a number of things that can be done to mitigate the problem:1Eliminating the source. Turn off or move possible sources of EMI to reduce their strength.2Attenuating the coupling. If the coupling path is through the patient leads, the interference may be reduced by moving and/or rearranging the leads. If the coupling is through the power cord, connecting the system to a different circuit may help.3Adding external attenuators. If EMI becomes an unusually difficult problem, external devices such as an isolation transformer or a transient suppressor may be of help. Your service provider can be of help in determining the need for external devices.Where it has been established that electromagnetic interference is affecting physiological parameter measurement values, a physician, or a suitably qualified person authorized by a physician, should determine if it will negatively impact patient diagnosis or treatment.
30 Specifications and Standards Compliance315System CharacteristicsThe 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 ImmunityThe 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 EmissionsEmissions Test Compliance Avoiding Electromagnetic InterferenceRadiofrequency (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 AVoltage fluctuations and flicker IEC 61000-3-3 complies
30 Specifications and Standards Compliance3161 Note that the device is not intended for home use.Electromagnetic ImmunityThe monitor is suitable for use in the specified electromagnetic environment. The user must ensure that it is used in the appropriate environment as described below.RF emissions CISPR 11For the Avalon FM20/30 fetal monitor with all accessories except the IUP/ECG patient module M2738A.Class B The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes1.RF emissions CISPR 11For the Avalon FM40/FM50 with all accessories.For the Avalon FM20/30 fetal monitor whenever used with the IUP/ECG patient module M2738A.For the Avalon CTS Interface Cable (M2731-60001/M2732-60001) whenever used with the Avalon CTS Cableless Fetal Transducer System.For the Avalon CL Base Station with cableless transducers whenever used with the fetal monitors.Class A The device is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes.Table 1 - Guidance and Manufacturer's Declaration: Electromagnetic EmissionsEmissions Test Compliance Avoiding Electromagnetic InterferenceTable 2 - Guidance and Manufacturer's Declaration: Electromagnetic ImmunityImmunity Test IEC 60601-1-2 Test LevelCompliance Level Electromagnetic Environment GuidanceElectrostatic discharge (ESD) IEC 61000-4-2±6 kV contact ±8 kV air±6 kV contact ±8 kV airFloors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient/burst IEC 61000-4-4±2 kV for power supply lines ±1 kV for input/output lines±2 kV for power supply lines ±1 kV for input/output linesMains power quality should be that of a typical commercial and/or hospital environmentSurge IEC 61000-4-5±1 kV differential mode ±2 kV common mode±1 kV differential mode ±2 kV common modeMains power quality should be that of a typical commercial and/or hospital environment
30 Specifications and Standards Compliance317Radio Compliance NoticeAvalon CL with WMTSOperation 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 CanadaInstallation of this telemetry device is permitted in hospitals and health care facilities only. This device shall not be operated in mobile vehicles (including ambulances and other vehicles associated with health care facilities). The installer/user of this device shall ensure that it is at least 80 km from the Dominion Radio Astrophysical Observatory (DRAO) near Penticton, British Columbia. The coordinates of DRAO are: latitude N 49E 19' 15", longitude W 119° 37′ 12″. For medical telemetry systems not meeting this 80 km separation (e.g. the Okanagan Valley, British Columbia) the installer/user must coordinate with, and obtain the written concurrence of, the Director of DRAO before the equipment can be installed or operated. The Director of DRAO may be contacted at 250-497-2300 (telephone) or 250-497-2355 (fax). (Alternatively, the Manager, Regulatory Standards, Industry Canada, may be contacted.)Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11<5% UT (>95% dip in UT) for 0.5 cycles<5% UT (>95% dip in UT) for 0.5 cyclesMains power quality should be that of a typical commercial and/or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device is powered from an uninterruptible power supply.40% UT (60% dip in UT) for 5 cycles40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles70% UT (30% dip in UT) for 25 cycles< 5% UT (>95% dip in UT) for 5 sec< 5%UT (>95% dip in UT) for 5 secPower frequency (50/60 Hz) magnetic field IEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial and/or hospital environmentKey: UT is the AC mains voltage prior to application of the test level.Table 2 - Guidance and Manufacturer's Declaration: Electromagnetic ImmunityImmunity Test IEC 60601-1-2 Test LevelCompliance Level Electromagnetic Environment Guidance
30 Specifications and Standards Compliance318Le 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 T108Japanese 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 DistancesIn the following table, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m).Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter.Field strengths from fixed transmitters, such as land mobile radios, base stations for radio telephones (e.g. cellular, cordless), amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.Interference may occur in the vicinity of equipment marked with this symbol:
30 Specifications and Standards Compliance319Field strengths from fixed transmitters, such as base stations, or radio, (cellular, cordless) telephones, and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the Table 3 - Guidance and Manufacturer's Declaration: Electromagnetic ImmunityConducted RF Immunity Test EN/IEC 61000-4-6IEC 60601-1-2 Test Level over 150 kHz to 80 MHz Compliance LevelElectromagnetic Environment Guidance:Recommended Separation Distance (d)(in Meters, at Frequency Range Tested) for Ultrasound and ECG Measurements3.0 VRMS 3.0 VRMS d = 1, 2√PKey: d = Recommended separation distance in meters (m)P = maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturerV1 = Tested compliance level (in Volts) for the Conducted RF Immunity test IEC 61000-4-6The 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√PTable 4 - Guidance and Manufacturer's Declaration: Electromagnetic ImmunityRadiated RF Immunity Test EN/IEC 61000-4-3IEC 60601-1-2 Test Level over 80 MHz to 2.5 GHz Compliance LevelElectromagnetic Environment Guidance:Recommended Separation Distance (d)(in Meters, at Frequency Range Tested) for Ultrasound and ECG Measurements3.0 V/m 3.0 V/m Over 80 MHz—800 MHz:d = 1, 2√POver 800 MHz—2.5 GHz:d = 2, 3√PKey: d = Recommended separation distance in meters (m)P = maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturerE1 = Tested compliance level (in Volts/meter) for the Radiated RF Immunity test IEC 61000-4-3The 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√POver the frequency range 800 MHz—2.5 GHz, the recommended separation distance in meters (d) is found by the following equation:For a compliance level of 3.0 VRMS:d = 2, 3√P
30 Specifications and Standards Compliance320location 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 EquipmentThe device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the device as recommended below, according to the maximum output power of the communications equipment.Radio Frequency Radiation Exposure InformationThe radiated output power of the Avalon CL Transducer System is far below the FCC radio frequency exposure limits.CL Wide Range PodFor body worn operation, this device has been tested and meets FCC RF exposure guidelines when used in the standard configuration with the rear side towards the body, without a gap. Alternatively, it can be used with any accessory that positions the front side of the device a minimum of 10 mm from the body. The accessory itself must not contain any metal parts. Use of other accessories may not ensure compliance with FCC RF exposure guidelines.Nevertheless it is strongly recommended to operate the CL Wide Range Pod with the rear side towards the body to achieve best possible radio performance.Table 5 - Separation Distance (d) in Meters According to Frequency of Transmitter at IEC 60601-1-2 Test Compliance LevelRated Maximum Output Power (P) of Transmitter (in Watts)150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz0.01 W d= 0.1 m d= 0.1 m d= 0.23 m0.1 W d= 0.4 m d= 0.4 m d= 0.7 m1 W d= 1.2 m d= 1.2 m d= 2.3 m10 W d= 3.8 m d= 3.8 m d= 7.3 m100 W d= 12.0 m d= 12.0 m d= 23.0 m
30 Specifications and Standards Compliance321EnvironmentBefore 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 PowerIf 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,FM40/50When 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 DefibrillationWARNINGThe fetal/maternal monitors are NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result.
30 Specifications and Standards Compliance322Cardiac Pacemakers and Electrical StimulatorsWARNINGThe fetal/maternal monitors are not intended for use for ECG measurements on patients connected to external electrical stimulator, or with cardiac pacemakers.Fast Transients/BurstsThe equipment will return to the previous operating mode within 10 seconds without loss of any stored data.Symbols on the SystemThese symbols can appear on the monitor and its associated equipment and packaging.Symbol DescriptionThis 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 OptionPower-On/StandBy button - FM40/FM50 and FM20/30 with Battery OptionPower-On LEDElectrical Class II equipment, in which the protection against electric shock relies on double or reinforced insulation (FM20/FM30)Fetal Sensor Socket symbolSpO2 Socket symbol
30 Specifications and Standards Compliance323Noninvasive Blood Pressure Socket symbolType BFSymbol indicating the monitor has the triplets optionSymbol indicating the monitor is capable of intrapartum monitoringButton 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 radiationConnection direction indicator FM20/FM30 with battery optionMouse 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/FM50IP 67 Ingress Protection code according to IEC 60529. The IUP/ECG patient module (M2738A) is rated IP 67 (protection against dust, access to hazardous parts, and the effects of continuous immersion in water to a depth of 0.5 meter for 30 minutes)Symbol Description
30 Specifications and Standards Compliance324IP 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 proofIndicates location of service numberIndicates location of serial numberIndicates location of catalog numberIndicates location of the date of manufacture and/or name and address of manufacturerIdentifies year and month of manufactureChina RoHSSymbol indicating separate collection for waste electrical and electronic equipmentEAC markCSA US markFCC ID Federal Communications Commission: FCC ID xxxxCMIIT ID Chinese Radio marking: CMIIT ID (China Ministry of Industry and Information Technology)CE marking accompanied by the Notified Body number 0123Industrial, Scientific, & Medical radio frequency band (Avalon CL frequency band used e.g. in the EU)Symbol Description
30 Specifications and Standards Compliance325Association Of Radio Industries And Businesses T108 (Avalon CL frequency band used e.g. in Japan)Wireless Medical Telemetry Service (Avalon CL frequency band used e.g. in North America)Symbol DescriptionIC-ID (Industry Canada ID)One IC-ID labeling for each built in radio: OBR, SRR Japanese Radio marking: Radio mark + [R]-symbol + IDTaiwan Radio Label (NCC Logo) + ID Korea radio mark: KC logo, KCC ID number, and Conformity assessment information
30 Specifications and Standards Compliance326
3132731Default Settings AppendixThis 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 SettingsAlarm Defaults SettingsAlarm Settings Choice DefaultAlarm Mode INOP only, All INOP only (international)All (USA/CAN)Alarm Volume 0..10 5Alarms Off 1 min, 2 min, 3 min, Infinite 2 minAlarm Text Standard/Enhanced StandardVisual Latching Red & Yellow/Red Only/Off Red & YellowAudible Latching Red & Yellow/Red Only/Off Red & YellowAlarm Sounds Traditional/ISO TraditionalAlarm Low 0..10 4Fetal / Maternal Defaults Settings (International)FHR, dFHR, aFHR Alarms On/Off Default OnDefault Color for FHR Numeric (for all FHR numerics)OrangeToco, aToco Default color for Toco numeric GreenIUP Default IUP Scale Unit mmHgDefault color for IUP numeric GreenHR, aHR Measurement Default Color for MECG Numeric Red
31 Default Settings Appendix328Coincidence Default SettingsNBP Default SettingsFetal / Maternal Defaults Settings (US/CAN)FHR, dFHR, aFHR Alarms On/Off Default OnDefault Color for FHR Numeric:FHR1, dFHR1, aFHR1 FHR2, dFHR2, aFHR2 FHR3, dFHR3, aFHR3Red Blue GreenToco, aToco Default color for Toco numeric Green (Toco) Yellow (aToco)IUP Default IUP Scale Unit mmHgDefault color for IUP numeric WhiteHR, aHR Measurement Default Color for MECG Numeric RedCoincidence Default SettingsCoincidence Tone immediatelyFactory Default Settings Mode ManualRepeat Time 15 minAlarms from Sys. (International)Sys&Dia&Mean (USA/CAN)NBP Sys/Dia only Yes (International)No (USA/CAN)Low Limit 90/50 (60)High Limit 160/90 (110)VP Pressure 60 mmHgDone Tone OffVeni Puncture n/aStart Time SynchronizedNBP OnAlarms OnColor RedReference Auscultatory
31 Default Settings Appendix329CL NBP Default SettingsSpO2 Default SettingsNBP Settings Factory DefaultsMode AutoRepeat Time 10 minNBP OnVP Pressure 60 mmHgReference AuscultatoryUnit mmHgDone Tone OffStart Time SynchronizedAging Time 10 minColor RedSpO2 Factory Default SettingsDesat Limit 80Low Limit 90High Limit 100Desat Delay 20 secondsLow Alarm Delay 10 secondsHigh Alarm Delay 10 secondsAverage 10 secondsNBP Alarm Suppr. OnAlarms OnColor CyanPulse Default SettingsPulse (SpO₂)OnHigh Limit 120 bpmLow Limit 50 bpmΔ ExtrBrady Bradycardia: Difference to Low Limit20 bpmBrady Clamp 40 bpmΔ ExtrTachy Tachycardia: Difference to High Limit20 bpmTachy Clamp 200 bpm
31 Default Settings Appendix330CL SpO2 Default SettingsTympanic Temperature Default SettingsManually Entered Values Default SettingsRecorder Default SettingsSpO2 Settings Factory DefaultsRepeat Time 15 minSignal Quality OnNBP Alarm Suppr. OnColor CyanpTemp Settings Factory defaultsAdultLow Limit 36°C (96.8°F)High Limit 39°C (102.2°F)Unit °CAlarms OnColor WhiteManual Entered Values Default SettingsLabel Temp (fixed)Unit °CColor WhiteInterval 1 hMsmnt OffSetting Choice DefaultRecorder Speed 1, 2, or 3 cm/min 3 cm/minScale Type US, Internat'l USTrace Style FHR1 Thin, Medium, Thick, Extra Thick ThickTrace Style FHR2 MediumTrace Style FHR3 Extra ThickTrace Style Toco ThickTrace Style HR ThinWave Style ECG ThinECG Wave printing choice Separate, Overlap Separate
31 Default Settings Appendix331Notes Recording Along, Across Along (International) Across (USA/CAN)Change Rec Speed Monitoring, Config ConfigAuto Start Off, On OffConfirmed Stop OffBridge Paperout OnPaper Save Mode Off (International) On (USA/CAN)NST Autostart OnNST Autostop OffTrace Separation OffSeparation Order Standard, Classic Standard (International) Classic (USA/CAN)Intensity 4 (medium) n/aCal. Offset 5 n/aSetting Choice Default
31 Default Settings Appendix332
3331IndexAaccessories 275, 276, 277, 278, 279, 280, 285Avalon CL base station 275cl NBP Pod accessories 280cl SpO2 Pod accessories 284fetal accessories 276electrode patch 276fetal recorder accessories 285latex information 275MECG accessories 277noninvasive blood pressure accessories 278, 279adult cuffs 279multi-patient comfort cuff kits 278reusable cuffs 278single-hose disposable cuffs 279SpO2 accessories 280Philips sensors (disposable) 280Philips sensors (reusable) 280transducer accessories 276tympanic temperature 285tympanic temperature accessories 285ACOG technical bulletin 60actions after monitoring 70adjusting display 49admitting a patient 147, 148auto free 26editing information 148OB TraceVue/IntelliSpace Perinatal 149quick admit 148aging numerics 238alarms 117, 119, 120, 121, 122, 123, 124, 126, 128, 129, 197, 198, 240, 246, 298, 304, 305, 327acknowledging alarms 121active alarms 117alarm behavior at on/off 128alarm latching 127alarm limit delay 300alarm reminder 122alarm standards 119audible alarm indicators 119changing alarm delays 198high priority alarms 117latching alarms 126, 127latching alarm behavior 127pausing alarms 122red alarms 117restarting paused alarms 123reviewing alarms 126reviewing alarms window 126standard philips alarms 120yellow alarms 117applying the fetal & maternal pod 100artifact suppression 204artifact suppression and fetal arrhythmia 204explanation of artifact suppression 204switching on and off artifact suppression 204Bbaseline measurement 185, 192, 208Battery Option 109using batteries 109belt actions 50, 51, 52belt fastening 50, 51belt fixing button 51Ccableless monitoring 73Avalon CL 73cableless transducers 84assignment 99audio signal 87cl belt clip 88connector cap 85LED indication 86radio range 87cl pods 92audio signal 93battery status LED 93configuration cableless system 75important considerations 167LED indication 86paging patients 93prompts 96Tele Info window 94Telemetry 95Underwater monitoring 108calibration 241, 268calibrating noninvasive blood pressure 268cautions 9changing FHR alarm delays 198changing FHR alarm limits 197CL Fetal & Maternal Pod 89applying 100CL Wide Range Pod 91cleaning monitor actions 261, 262, 263, 273cleaning method 262cleaning monitoring accessories 263general cleaning requirements 261infection control 261printhead cleaning 273configuration mode 44configuring alarm tone 119confirming fetal life 10, 166, 183, 191cross-channel verification 10, 183, 191, 222CCV and triplets 191CCV and twins 183coincidence examples 162comparing FHR with MHR 160functionality 160misidentification of heart rates 159overview 161recommended actions 164Ddata recovery 257date from OB TraceVue/IntelliSpace Perinatal System 47date setting 47Dawes/Redman 22DECG 202, 205, 298DECG INOPs 205DECG specifications 298DECG testing 205DECG troubleshooting 205default settings 298alarm default settings 327FHR default settings 298IUP default settings 298MECG default settings 298noninvasive blood pressure default settings 304recorder factory default settings 308SpO2 factory default settings 305Toco default settings 298user defaults 46defibrillation precautions 225, 275, 321demo mode 44device classification 18disabling touchscreen 44discharging a patient 148disinfecting 261, 262, 263infection control 261recommended substances 263
334display 49, 238, 298adjusting display 49adjusting screen brightness 47display noninvasive blood pressure 238fetal display specifications 298disposal of electronic waste 274disposal of monitor 274dyshemoglobins 244intravascular dyshemoglobins 244Eearly systolic blood pressure 238ECG 202, 222, 298ECG specifications 298electrical safety tests 312electrical surgery precautions. See ESU 225, 244, 275, 321electrodes 224applying electrodes 224EMC 313electromagnetic compatibility 313electromagnetic emissions 315electromagnetic interference 314how to reduce electromagnetic interference 314EMC and compliant accessories 313EMC precautions 313EMC standards 313entering notes 42ESU precautions 225, 275, 321extension cable for SpO2 244external monitoring 165, 184, 192, 208external monitoring - Toco 208external monitoring - triplets 192external monitoring - twins 184external monitoring - ultrasound 165FFAST 243Fourier Artifact Suppression Technology 243fetal accessories 276fetal arrhythmia 204fetal demise 10fetal display specifications 298IUP - fetal display specifications 298Toco - fetal display specifications 298US - fetal display specifications 298fetal heart rate alerting. See FHR 197fetal heart rate. See FHR 165fetal movement 170fetal movement profile. See FMP 165FHR 10, 166, 172, 183, 185, 191, 192, 197, 198, 222, 298alerting 197cross-channel verification 222misidentification 10trace separation 185, 192FHR alarms 298finder LED 36, 53, 183, 191finding monitor revision 48flexible nurse call 25, 32, 35FMP 170, 171FMP and twins 170FMP statistics 171functional arterial oxygen saturation 243Gglobal settings 46Iinfection control 261infection and sterilizing 261INOPs 117, 121CCV INOPcoincidence tone 24disconnect INOPs 121INOP alarms 117red or yellow INOPs 24, 25INOPs indicators 117silencing INOPs 121interference 313, 314how to reduce interference 314interference from RF equipment 313internal monitoring 185, 199, 213intrauterine pressure. See IUP 211intravascular dyshemoglobins 244intravascular dyshemoglobins effects on (SpO2) 244IUP 211, 213, 298IUP specifications 298Mmains power (AC) 71disconnecting from mains power 71maintenance 267, 268maintenance schedule 267, 268visual inspection 267manual data entry 254maternal ECG 204, 225, 227electrode position 225printing waveform 204, 227viewing waveforms 225maternal heart rate 221, 222maternal heart rate and cross-channel verification 222maternal heart rate and priorities 221maternal heart rate from MECG 222sources of maternal heart rate 221maternal HR 166, 221, 222, 224Maternal HR from MECG 222Maternal HR priorities 221Maternal HR sources 221maternal temperature 23measurement settings 46changing measurement settings 46entering setup menu 46measurements 45, 46, 295setting up measurements 46switching on and off measurements 45MECG 204, 222, 224, 225, 227, 229, 231, 277, 298accessories 277alarm limits 300connection illustration 222default settings 298electrodes 224specifications 298waveform printing 204, 227MECG alarm limits 298methemoglobin (SpO2) 244monitor settings 10, 31, 47, 48, 49, 71, 257changing monitor settings 47major parts and keys 31power on/off behavior 71Standby 71starting monitoring 168switching on 48, 49monitoring mode 44monitoring triplets and FHR 191monitoring twins and FHR 183MR imaging and the SpO2 transducer 244MRI precautions 225, 275, 321NNBP. See noninvasive blood pressure 235NIBP. See noninvasive blood pressure 235Noninvasive Blood Pressure (NBP) 228, 235, 236, 237, 238, 239, 240, 241, 242, 268, 278, 279, 304automatic noninvasive blood pressure repeat time 239calibration interval 268comfort cuff kits 278factory defaults 304how the measurement works 235measurement 236, 239limitations 236methods 236starting 239stopping 239NBP accessories 278NBP adult cuffs 279NBP automatic mode 239NBP configurable measurement
335sequence 25NBP numerics 238NBP pediatric cuffs 279NBP performance specifications 304NBP reusable cuffs 278NBP single-hose disposable cuffs 279NBP site inspection 237NBP troubleshooting 242NBP venous puncture 241preparing to measure NBP 237non-medical devices 312non-medical devices in patient vicinity 312Non-Stress Test timer. See NST timer 152NST ReportTrace Interpretation 153, 157NST timer 151, 152OOB TraceVue 29, 30, 258connection to OB TraceVue/IntelliSpace Perinatal System 29, 30LAN connection 258operating modes 44configuration mode 44demo mode 44monitoring mode 44service mode 44operating temperatures 321oscillometric measurement method 235PPaging Patient 93paper 60, 61, 62, 65, 272, 285default recorder speed 60loading paper 62, 65paper out INOP 62paper speed 60changing 60default 60defaults 60setting 60paper, when to reload 62recorder paper 285removing paper 62, 65storing paper 272tearing off a trace 61Paper Advance key 42Paper-Out indication 62passcode protection 44patient alarms 129Patient Demographics window 147patient module 202, 222paused alarms 122, 123restarting paused alarms 123performance specifications 295, 304, 305noninvasive blood pressure specifications 304SpO2 specifications 305physiological alarms 117pop-up keys 96power 71disconnecting from 71power failure 72power on/ power off behavior 71pulse 228pulse from noninvasive blood pressure 228pulse rate 221QQRS tone pitch 247Rrecorder 56, 72, 272, 273, 285, 308factory defaults 308paper storage 272printhead cleaning 273recorder paper 285recorder specifications 308recorder troubleshooting 72recording elements 59recording stored data 42recovering traces 257trace recovery printout 257recycling 274regulatory compliance 311remote event marker 60Ssafety 268, 311maintenance interval 268safety information 13safety standards 311screen layouts 45selftest 48, 49, 56, 128sensor 243disposable SpO2 sensors 243selecting SpO2 sensors 243separating FHR traces 185, 192separating triplet traces 192separating twin traces 185service mode 44settings 45, 46, 47active settings 45changing settings 47factory default settings 46global settings 46monitor settings 47user default settings 46short range radio 92, 317, 320signal loss delay 198signal quality 70, 246signal quality during monitoring 70signal quality of SpO2 246silencing alarms 121specifications 289, 295, 298, 308built-in recorder specifications 308DECG specifications 298ECG specifications 298IUP specifications 298measurement specifications 295MECG specifications 298performance specifications 295, 298Toco specifications 298transducer specifications 289US specifications 298SpO2 243, 244, 246, 280, 305accessories 280alarm specifications 305connecting the cables 244disposable sensors 243factory defaults 305FAST technology 243performance specifications 305Philips sensors (disposable) 280Philips sensors (reusable) 280signal quality 246tone modulation 247SpO2 alarms 246, 305standards 311, 313EMC standards 313safety standards 311standards compliance 311Standby 42starting monitoring 48sterilizing 261, 265infection control 261storage temperatures 321stored data recording 42suppressing artifacts 204suspended alarm 123suspicious SpO2 reading 246switching on and off 171switching on and off alarms 124switching on monitor 48, 49switching on recorder 56symbols on the system 322Ttechnical alarm messages. See INOPs 132temperatures 321operating temperatures 321storage temperatures 321
336testing 128, 205, 229, 312DECG testing 205MECG testing 229safety testing 312testing alarms 128time 47setting time 47time from OB TraceVue/IntelliSpace Perinatal System 47Toco 202, 207, 208, 210, 224, 298default Toco settings 298testing a Toco transducer 210Toco baseline 208Toco display specifications 298Toco monitoring 207Toco sensitivity 208Toco specifications 298Toco MP transducer 207, 221Toco+ transducer 207tone modulation (SpO2) 247touch tone volume 47touchscreen operation 38, 44trace actions 61, 257, 258tearing off traces 61trace recovery on OB TraceVue/IntelliSpace Perinatal System 258trace recovery on paper 257transducer 36, 51, 53, 173, 183, 191, 207, 210, 289connecting transducer to monitor 53fixing transducer to belt 51repositioning transducers 53Toco transducer 207Toco+ transducer 207transducer belt clip 51transducer specifications 289transducer testing 173, 210Toco 210ultrasound 173triplets 191, 192, 193, 194, 196cross-channel verification 191external monitoring 192importance of monitoring MHR 191monitoring triplets 191offsetting baselines 192troubleshooting 72, 172, 189, 196, 205, 208, 214, 227, 242DECG 205FHR 172IUP 214MECG 227twins 170, 183, 184, 185, 186, 187, 189cross-channel verification 183external monitoring 184importance of monitoring MHR 183invasive monitoring 185monitoring FHR 183monitoring twins 183offsetting baselines 185twins and FMP 170Tympanic Temperature 249body reference sites 254display and controls 250manual data entry 254status screens 251taking temperature 252tympanic temperature accessories 285Uultrasound 165, 168, 173, 298applying gel 168testing a transducer 173ultrasound display specifications 298ultrasound monitoring 165ultrasound specifications 298understanding screens 45USB 25using the adapter cable 202uterine activity 202, 207, 208, 211, 213, 214, 224external monitoring 207internal monitoring 211monitoring uterine activity 202, 208, 211, 213, 224troubleshooting uterine activity 208, 214Vvelcro belt 52venous puncture 241visual alarm indicators 119volume 47, 120alarm volume 120IUP, zeroing 213touch tone volume 47Wwarnings 9
Part Number 453564659391 Published in Germany 09/16*453564659391*

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