9 9 Non-Stress Test Timer The non-stress test (NST) timer shows the elapsed time for the non-stress test. The timer counts up to the time you set for the NST. Setting NST Autostart/Autostop You can set the recorder so that it starts automatically (NST Autostart) when the NST timer is started, and stops automatically (NST Autostop) when the NST is complete (when the set run time has elapsed). As default, NST Autostart is On, and NST Autostop is Off.
9 Non-Stress Test Timer Accessing the NST Setup Pop-up Keys You control and set up the NST timer (for example, start, stop, or clear the timer, and set the run time) using a selection of pop-up keys that you access via any one of three possible routes: • Via the Timer SmartKey (Route 1) • Via the Main Setup SmartKey (Route 2) • Via the NST display area at the top left-hand corner of the screen (Route 3).
10 10 Non-Stress Test Report It is generally accepted that a non stress test (NST) allows you to assess fetal well-being. The monitor's NST report process uses fetal ultrasound (but not DECG) heart rate traces and the Maternal Toco trace to generate a printed report when criteria are met and it is an indication of the fetal well-being. The American term Non Stress Test (NST) is used for antepartum testing.
10 Non-Stress Test Report 4 Set your configuration options. Select from: • • NST Analysis choose from On or Off. This switches the report feature on or off. This is linked to the NST timer. Both must be set to On for the NST report to function. choose from: - press the Record Report pop-up key to trigger a manual request. After Recorder Stop - report is recorded as soon as recorder becomes idle. Immediately - if a realtime recording is running, the monitor pauses it.
10 Non-Stress Test Report Example NST Report Field Field Content Report Title, with FHR label and date NST Report for FHR1 on 12 Oct. 2009 Product Information Product DE53102345 G.01.70, OB A.04.24, Toco DE52401090, FHR1 DE00002345 A.05.
10 Non-Stress Test Report Field Field Content Result: Decelerations before Reporting Period Events before Reporting Period: Decelerations: 1 at: 11:38 severe prolonged This field is enabled if there were decelerations between the start of NST and the start of the reporting period.
10 Non-Stress Test Report NST Criteria The patient is monitored for a user-definable period of time (10-60 minutes in steps of 5 minutes). The test is considered reassuring when the following criteria are met: • The fetal heart rate is valid at least 90% (this is configurable) of the specified time span. • The FHR features a user-defined minimum number of accelerations.
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11 Cross-Channel Verification (CCV) 11 The cross-channel verification helps to reduce the possibility of misidentification of the maternal heart rate for the fetal heart rate. It does this by comparing the measured fetal heart rate to the maternal heart rate. If there are multiple fetal rates, they are also compared with each other and the maternal heart rate. Misidentification of Heart Rates FHR detection by the monitor may not always indicate that the fetus is alive.
11 Cross-Channel Verification (CCV) When Fetal Movement Profile (FMP) is enabled: The FMP annotations on a fetal trace alone may not always indicate that the fetus is alive. For example, FMP annotations in the absence of fetal life may be a result of: • Movement of the deceased fetus during or following maternal movement. • Movement of the deceased fetus during or following manual palpation of fetal position (especially if the pressure applied is too forceful). • Movement of the ultrasound transducer.
Cross-Channel Verification (CCV) Overview of Cross-Channel Comparisons Measurements from Transducers Measurement Transducer FHR (US) From Ultrasound or CL Ultrasound transducer dFHR (DECG) From a fetal scalp electrode aFHR (abdom. ECG) From the CL Fetal & Maternal Pod Pulse (Toco) From Toco MP, or CL Toco+ MP transducer Pulse (SpO2) From SpO2 or CL SpO2 Pod HR (MECG) From MECG electrodes aHR (abdom.
11 Cross-Channel Verification (CCV) Coincidence Examples Coincidence of Maternal Pulse and FHR When the maternal pulse and FHR are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitor’s screen above both of the corresponding numerics (in this case maternal pulse and FHR).
11 Cross-Channel Verification (CCV) The coincidence question mark is also printed on the trace paper next to the corresponding FHR and maternal pulse.
11 Cross-Channel Verification (CCV) The coincidence question mark is also printed on the trace paper next to FHR1 and FHR2. 1 Printed coincidence question mark on trace 2 FHR1 and FHR2 traces Recommended Actions for Coincidence INOP 164 1 Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope.
12 Monitoring FHR and FMP Using Ultrasound 12 To monitor a single FHR externally, you use an ultrasound transducer attached to a belt around the mother's abdomen. The ultrasound transducer directs a low-energy ultrasound beam towards the fetal heart and detects the reflected signal. Your monitor can also detect fetal movements and print the fetal movement profile (FMP) on the trace.
12 Monitoring FHR and FMP Using Ultrasound Limitations of the Technology All tissues moving towards or away from the transducer generate Doppler echoes. Therefore, the resulting signal that is provided to the monitor’s speaker, and for further fetal heart signal processing, can contain components of the beating fetal heart wall or valves, fetal movements, fetal breathing or hiccup, maternal movements such as breathing or position changes, and pulsating maternal arteries.
12 Monitoring FHR and FMP Using Ultrasound Cableless Monitoring - Important Considerations When using an Avalon CL or Avalon CTS Fetal Transducer system with your monitor, note the following: Refer to “Cableless Status Indication” on page 95 for general rules regarding the use of cableless transducers from an Avalon CL or Avalon CTS Cableless Fetal Transducer system. CAUTION Never use ultrasound transducers connected to more than one fetal monitor on the same patient.
12 Monitoring FHR and FMP Using Ultrasound WARNING • During ambulant FHR monitoring, the chance of losing the signal or detecting the maternal heart rate is higher than during stationary monitoring. The frequency of the patient's walk may be detected, and mistaken for an FHR signal. • Check the mother’s pulse periodically during monitoring and compare this with the FHR signal. Beware of mistaking a “doubled” maternal heart rate for FHR.
12 Monitoring FHR and FMP Using Ultrasound 3 Adjust the audio volume of the monitor's loudspeaker to a clearly audible level, while moving the transducer over the abdomen. When you have a good signal, secure the transducer in position below the belt. WARNING Periodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to ensure that you are monitoring fetal heart rate. Do not mistake a doubled or elevated maternal HR for FHR.
12 Monitoring FHR and FMP Using Ultrasound Changing the Fetal Heart Sound Volume The FHR volume symbol at the top right of the Fetal Heart Sound Volume window gives you an indication of the current volume. To change the volume: 1 Select the volume symbol. The volume scale pops up. 2 Select the required volume from the volume scale.
12 Monitoring FHR and FMP Using Ultrasound FMP Statistics FMP statistics are printed every ten minutes. 1 FMP enabled 2 FMP started here A Indication of current fetal movement B The FMP statistics are presented as two percentage figures: The first figure shows the percentage of detected fetal movements in the previous ten minutes. C The second figure shows the percentage of detected fetal movements since the start of recording.
12 Monitoring FHR and FMP Using Ultrasound Troubleshooting Problem Possible Causes Solutions Erratic trace Fetal arrhythmia Erratic display Obese patient Consider monitoring FHR using DECG after the rupture of membranes. Transducer position not optimal Reposition transducer until signal quality indicator shows a good signal (at least half-full).
12 Monitoring FHR and FMP Using Ultrasound Testing Ultrasound Transducers If any of the following tests fail, repeat the test using another transducer. If the second transducer passes the tests, confirming that the first transducer is defective, contact your service personnel. If the second transducer also fails the tests, contact your service personnel. To test an ultrasound transducer: 1 Switch on the monitor and the recorder. 2 Connect the transducer to the fetal monitor.
12 Monitoring FHR and FMP Using Ultrasound • When you are unable to determine a baseline rate, and variability occurs between consecutive contractions There are several ways to verify the source and/or accuracy of the recorded fetal heart rate pattern.
12 Monitoring FHR and FMP Using Ultrasound • The maternal heart rate may simulate a normal fetal heart rate pattern (i.e., it may mask an FHR deceleration or fetal demise). Especially during pushing with contractions in the second stage of labor, the maternal heart rate may increase to the point where it may equal or exceed the fetal rate. Here the maternal trace may mimic a normal fetal trace while the fetus may be having decelerations or fetal demise has occurred.
12 Monitoring FHR and FMP Using Ultrasound Obtaining a Good Heart Signal To successfully position the ultrasound transducer, first determine the fetal position using palpation. Position the transducer over the strongest audible fetal heart sound from the monitor’s speaker and wait at least six seconds after each transducer adjustment to verify a good signal quality displayed on the Signal Quality Indicator and a consistent FHR numeric display.
12 Monitoring FHR and FMP Using Ultrasound Signal Quality Indicator The signal quality on the Avalon fetal monitor is indicated by a triangle on the touchscreen that is displayed in one of three ways: 1 Completely filled triangle, indicating good signal quality (good/full). 2 Half-filled triangle, indicating limited signal quality. This condition may indicate a weak or ambiguous signal. If this status persists, reposition the transducer (acceptable/medium).
12 Monitoring FHR and FMP Using Ultrasound Double-Counting Contractions Excessive, coupling, hypertonus Artifact Double-Counting Comment Reassuring tracing. The excessive uterine activity should prompt discontinuation of any oxytocic agent. Remediation The true fetal rate can be confirmed by auscultation or by fetal scalp electrode.
12 Monitoring FHR and FMP Using Ultrasound Maternal-Switching (Maternal Insertion) Baseline Rate 170 - Tachycardia Baseline Variability Moderate Accelerations Unable to determine Decelerations Absent Contractions Absent Artifact Maternal insertion, noise Comment The fetus has an elevated baseline rate of about 170 bpm with minimal to moderate variability. The ability to assess fetal status is limited because about half of the tracing displays the maternal heart rate.
12 Monitoring FHR and FMP Using Ultrasound Noisy/Erratic Signal and Dropout Comment Reassuring tracing. Note that there is episodic drop out of the signal with discontinuity of the fetal tracing. Remediation Either improving the position of the transducer or the application of a fetal scalp electrode will reduce the amount of artifact in the tracing.
12 Monitoring FHR and FMP Using Ultrasound Maternal or Fetal Heart Rate? Avoiding Intrapartum Misidentification by Michelle L. Murray JOGNN Clinical Issues, April 2003, 33, 93-104; 2004. DOI: 10.1177/0884217503261161 Figure 9 "The recording is of the MHR with occasional doubling.
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13 13 Monitoring Twin FHRs The FHRs of twins are externally monitored using two ultrasound transducers. The Avalon CL Transducer system provides the option to monitor twins with cableless transducers. The Avalon CTS system and the CL F&M Pod do not have this option. FM30/50 Twin FHRs are monitored throughout labor and delivery. After rupture of the membranes, you can monitor one twin externally using ultrasound, and the other internally using DECG.
13 Monitoring Twin FHRs • The fetal sensor socket to which a transducer is connected is identified by the transducer position indicator in the setup menu header: FM20/FM30 FM40/FM50 • The trace recorded for FHR1 is thicker (darker) than that recorded for FHR2. This ensures that the two heart rates are easily distinguishable. The thickness of the recorded trace can be changed in Configuration Mode. • Remember that only one fetal heartbeat can be heard from the loudspeaker at a time.
13 Monitoring Twin FHRs Example of the screen showing ultrasound monitoring of twin FHRs: 1 FHR 1 2 Toco parameter 3 FHR 2 Monitoring Twins Internally FM30/50 Monitor one twin using the procedures described in “Monitoring FHR and FMP Using Ultrasound” on page 165. Monitor the second twin using the procedures described in “Monitoring FHR Using DECG” on page 199.
13 Monitoring Twin FHRs Switching Trace Separation On and Off Connect transducers to the monitor to measure FHR. Depending on the measurement method, you need either two ultrasound transducers or, for FM30/FM50, one ultrasound and one Toco+ transducer, or one CL ECG/IUP transducer (to monitor DECG): 1 Enter the Main Setup menu by pressing the Main Setup. 2 Select Fetal Recorder. 3 Select Trace Separation to switch between On and Off. 4 Exit the Main Setup menu.
13 Monitoring Twin FHRs The following trace shows trace separation switched on. Only the FHR2 trace is offset. The numerical FHR value displayed on the monitor remains unchanged. Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2 value. For example, if the recorded trace shows 160, then the true FHR is 140. "Classic" Separation Order To make differentiating the traces easier, the trace for FHR1 is offset by +20 bpm when FHR2 is present. The FHR2 trace is never shifted.
13 Monitoring Twin FHRs When Trace Separation is Off To indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale.
13 Monitoring Twin FHRs Troubleshooting Common problems that may occur when monitoring FHR using ultrasound are listed in “Monitoring FHR and FMP Using Ultrasound” on page 165. See also “Monitoring FHR Using DECG” on page 199 for common problems you might encounter when monitoring FHR directly. The following problem may occur when monitoring twins. Problem The question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued.
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14 14 Monitoring Triple FHRs If your monitor is equipped with the triplets option, it carries the label: You can monitor triple FHRs externally using three ultrasound transducers. With the Avalon CL Transducer system, you can monitor triplets with cableless transducers. The Avalon CTS system and the CL F&M Pod do not have this option. Refer to the appropriate preceding chapters for contraindications, and more information about the available measurement methods.
14 Monitoring Triple FHRs • The transducer finder LED lets you identify at a glance which transducer is monitoring which heart rate channel. • The fetal sensor socket to which a transducer is connected, is identified by the transducer position indicator in the setup menu header: FM20/FM30 FM40/FM50 • The trace recorded for the FHR3 is thicker (darker) than that recorded for FHR1, which is thicker than that for FHR2. This ensures that the three heart rates are easily distinguishable.
14 Monitoring Triple FHRs "Standard" Separation Order To make differentiating the traces easier, the trace for FHR2 is offset by +20 bpm, and the trace for FHR3 is offset by -20 bpm. In other words, the trace for FHR2 is recorded 20 bpm higher than it really is, while the trace for FHR3 is recorded 20 bpm lower than it really is. The trace for FHR1 is never shifted. The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR2.
14 Monitoring Triple FHRs "Classic" Separation Order To make differentiating the traces easier, the trace for FHR1 is offset by +20 bpm when other FHR measurements are present, and the trace for FHR3 is offset by -20 bpm. The FHR2 trace is never shifted. In other words, the FHR traces are always sorted in ascending order from top to bottom. The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR1.
14 Monitoring Triple FHRs Switching Trace Separation On and Off 1 Connect three ultrasound transducers to the monitor to measure FHR. 2 See “Switching Trace Separation On and Off” on page 186 for details of how to switch trace separation on or off. When Trace Separation is On When trace separation is turned on, the recorder prints a dotted line labeled with the three FHRs at the top, and ±20 at the bottom.
14 Monitoring Triple FHRs 2 trace separation switched off here Classic Troubleshooting Common problems that may occur when monitoring FHR using ultrasound are listed in “Monitoring FHR and FMP Using Ultrasound” on page 165. The following problem may occur when monitoring triplets. Problem The question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued.
15 15 Fetal Heart Rate Alarms Fetal heart rate (FHR) alarms can give both audible and visual warning of a non-reassuring fetal condition. Your monitor must be configured to alarm mode All to enable the FHR alarms (see “Alarms” on page 117).
15 Fetal Heart Rate Alarms Changing Alarm Delays You can change the alarm delays if the Alarm Mode is set to All. 1 Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod. 2 Enter the setup menu for a connected FHR measurement. 3 To change the high alarm limit delay time, select High Delay and select the delay time (in seconds) from the pop-up list.
16 16 Monitoring FHR Using DECG FM30/50 This chapter describes how to monitor a single fetal heart rate via direct ECG (DECG), using a spiral fetal scalp electrode in the intrapartum period. Read and adhere to the instructions that accompany the fetal scalp electrode, the DECG adapter cable, and the attachment electrode. Pay attention to all the contraindications, warnings, and for the DECG adapter cable, the cleaning and disinfection procedures.
16 Monitoring FHR Using DECG 4 In case of difficulties deriving a stable maternal pulse reading using the Toco MP or CL Toco+ MP transducer, use SpO2 instead. In case of similar problems with the pulse measurement from SpO2, use MECG instead. Reasons to switch the method for deriving a maternal pulse or heart rate include: motion artifacts, arrhythmia, and individual differences in pulse signal quality on the abdominal skin (via Toco+ MP).
16 Monitoring FHR Using DECG DECG with CL Toco+MP or CL ECG/IUP The figure below shows the equivalent chain using the CL Toco+ MP or CL ECG/IUP transducer.
16 Monitoring FHR Using DECG Making Connections WARNING Follow the instructions supplied with each of the monitoring accessories you are using. Prepare for DECG monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 If you change the monitoring mode from US to DECG, first disconnect the US transducer.
16 Monitoring FHR Using DECG 2 The heart rate monitored via DECG is labeled dFHR1 / dFHR2 / dFHR3 on the screen. If configured, the DECG wave is displayed automatically on the screen, labeled DECG, and fetal. If MECG is being monitored, both waves are displayed, with the DECG wave above the MECG wave. The MECG wave is labeled MECG and maternal. 3 Check the artifact suppression setting and change it if necessary (see “Suppressing Artifacts” on page 204).
16 Monitoring FHR Using DECG WARNING Periodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to ensure that you are monitoring fetal heart rate. If the maternal HR coincides with the FHR, do not misinterpret the maternal HR as the FHR (see also “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 159.
16 Monitoring FHR Using DECG Troubleshooting NOTE In many cases you need to see the DECG wave to check if the signal quality is good enough to derive a valid fetal heart rate. In the dFHR setup menu, switch on the display of the DECG wave. Problem Possible Cause Solutions dFHR1 Equip Malf Malfunctioning equipment See “Patient Alarms and INOPs” on page 129.
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17 Monitoring Uterine Activity Externally 17 You can measure uterine activity externally using a Toco transducer. You can also use a Toco+, Toco MP, or a CL Toco+ MP transducer for the same purpose, although they also have more (ECG/ IUP and Pulse) capabilities. The external Toco transducer allows to monitor the frequency, duration, and relative strength of contractions, but not their absolute intensity.
17 Monitoring Uterine Activity Externally Abdominal Belt (disposable shown) External Toco Monitoring Prepare for Toco monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 Fasten the abdominal transducer belt around the patient. 2 Connect the Toco transducer to a free socket on the monitor. The Toco baseline is automatically reset. The Toco display shows 20.
17 Monitoring Uterine Activity Externally External Toco Monitoring Problem Possible Causes Solutions Quality of the trace deteriorates or the Toco baseline varies The belt is incorrectly fastened and is The belt must be tight enough to ensure too slack or too tight, or the belt has lost good contact between the patient's skin its elasticity. and the entire surface of the transducer without causing discomfort. Ensure you are using the correct belt. Adjust it as necessary.
17 Monitoring Uterine Activity Externally Testing Toco Transducers If any of the following tests fail, repeat the test using another transducer. If the second transducer passes the tests, confirming that the first transducer is defective, contact your service personnel. If the second transducer also fails the tests, contact your service personnel. To test a Toco transducer: 1 Switch on the monitor and the recorder. 2 Connect the transducer to the fetal monitor.
18 Monitoring Uterine Activity Internally 18 FM30/50 You can monitor intrauterine pressure (IUP) using an intrauterine catheter together with a patient module, Toco+, or the CL ECG/IUP or CL Toco+ MP transducer, after rupture of the membranes and the cervix is sufficiently dilated.
18 Monitoring Uterine Activity Internally IUP with Toco+ The figure below shows the complete connection chain from the IUP catheter to the fetal monitor using the Toco+ transducer: 1 Disposable Koala IUP Catheter (M1333A) 2 Reusable Koala IUP Adapter Cable (9898 031 43931) 3 Toco+ transducer (M2735A) IUP with CL ECG/IUP The figure below shows the complete connection chain from the IUP catheter to the fetal monitor using the CL ECG/IUP transducer: 212 1 Disposable Koala IUP Catheter (M1333A) 2 R
18 Monitoring Uterine Activity Internally Internal (IUP) Monitoring Read the instructions that accompany the intrauterine catheter and the adapter cable before you start monitoring. Zero the IUP measurement when instructed. WARNING Do not catheterize if placenta previa is diagnosed, or if uterine bleeding from an undetermined source is present. Prepare for IUP monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions.
18 Monitoring Uterine Activity Internally Troubleshooting Internal (IUP) Monitoring Problem Possible Causes Solutions Only pressure peaks can be seen (baseline not visible). Zero adjustment is incorrect. Zero the IUP measurement. No change in pressure during contraction. Catheter tip not in contact with amniotic fluid or possible extra-ovular placement of the catheter. Refer to catheter Instructions for Use. Trace is a straight line. Connection issue or cable or catheter defective.
19 Monitoring aFHR, aHR, and aToco 19 Introducing the abdominal Avalon CL Fetal & Maternal Pod Measurement The Avalon CL Fetal & Maternal Pod (CL F&M Pod) noninvasively measures fetal heart rate (aFHR), maternal heart rate (aHR), and uterine activity (aToco). The CL F&M Pod is used together with a single-use electrode patch. The electrode patch has five adhesive electrodes. The CL F&M Pod and electrode patch are placed on the maternal abdomen.
19 Monitoring aFHR, aHR, and aToco CAUTION If the aFHR signal quality indicator on the fetal monitor screen continuously indicates an insufficient signal quality (empty triangle), although the CL F&M electrode status is green, then an alternative method to monitor should be used. Uterine Activity aToco The CL F&M Pod measures the electrical activity of the uterus which is different to the mechanical measurements of a Toco transducer or an IUP catheter.
19 Monitoring aFHR, aHR, and aToco aToco Sensitivity Monitoring with the CL F&M Pod, the aToco sensitivity can be set to High or Low at any time. The Low sensitivity setting provides an additional suppression of artifacts, for example artifacts coming from maternal and fetal movements. The additional filtering delays the onset of recording the contraction on the trace and shows a reduced amplitude. The default setting is High and recommended for active labor.
19 Monitoring aFHR, aHR, and aToco 1 Measurement label aFHR 2 Measurement label aToco 3 Measurement label aHR Troubleshooting Problem Possible Causes Solutions Erratic trace Fetal arrhythmia Consider monitoring FHR with alternative methods. Erratic display Electrode contact not optimal Reposition the electrode and repeat the skin preparation until the CL F&M Status shows that all electrodes have good contact.
19 Monitoring aFHR, aHR, and aToco Problem Possible Causes Solutions Signal quality indicator is continuously poor Electrode contact not optimal Repeat the skin preparation until the CL F&M Status shows that all electrodes have good contact. Patient in unfavorable position Make the patient more comfortable, if the abdominal muscles are relaxed it may improve the signal. For example, place a pillow to support the patient’s back.
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20 Monitoring Maternal Heart / Pulse Rate 20 You can monitor the maternal heart/pulse rate using one of five sources: • Maternal heart rate (HR) via MECG electrodes • Maternal heart rate (aHR) via CL F&M Pod • Maternal pulse rate from Toco MP or CL Toco+ MP transducer (Pulse) • Maternal pulse rate from SpO2 (Pulse) • Maternal pulse rate from NBP (Pulse) Maternal heart/pulse rates derived from Toco MP or CL Toco+ MP, SpO2, aHR, and MECG are continuous measurements, and are compared against the F
20 Monitoring Maternal Heart / Pulse Rate Misidentification of Maternal HR for FHR To reduce the possibility of mistaking the maternal HR for FHR, it is recommended that you monitor both maternal and fetal heart rates (see “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 159). Maternal HR from MECG Electrodes You can measure maternal HR using the equipment combinations shown in the following figures.
20 Monitoring Maternal Heart / Pulse Rate MECG with Toco+ The figure below shows the equivalent chain using the Toco+ transducer. 1 Toco+ Transducer (M2735A) 2 MECG Adapter Cable (M1363A) 3 Pre-gelled Foam Electrodes (40493A/B/C/D/E) MECG with CL Toco+MP or CL ECG/IUP The figure below shows the equivalent chain using a CL Toco+ MP transducer or a CL ECG/ IUP transducer.
20 Monitoring Maternal Heart / Pulse Rate Applying Electrodes To derive the maternal HR (when you do not want to view the MECG waveform), you can place the electrodes just below the outer end of the clavicle near each shoulder. 1 MECG Electrodes Making Connections WARNING Follow the instructions supplied with each of the monitoring accessories you are using. Prepare for monitoring maternal HR using the list below. The standard procedures in use in your facility determine the sequence of actions.
20 Monitoring Maternal Heart / Pulse Rate Monitoring MECG Wave WARNING The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform. When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g.
20 Monitoring Maternal Heart / Pulse Rate Viewing the Waveform on the Screen 1 Measurement label dFHR1 2 Measurement label Toco 3 Measurement label FHR2 4 Measurement label HR 5 1mV scale bar 6 MECG wave with maternal label 7 DECG wave with fetal label 8 Measurement label Temp maternal temperature 9 Measurement label NBP NOTE The 1mV scale bar for the DECG and MECG wave is not displayed on the screen if you monitor DECG or MECG with an Avalon CTS system.
20 Monitoring Maternal Heart / Pulse Rate Troubleshooting Problem Possible Causes displayed. One or more MECG leads is not Numeric is displayed with attached.
20 Monitoring Maternal Heart / Pulse Rate Pulse Rate from SpO2 If you are not monitoring maternal HR via MECG electrodes, but you are monitoring SpO2, the maternal pulse rate is derived from the SpO2 measurement. The pulse numeric is labeled Pulse on the screen. WARNING • No QRS tone is audible when the CL SpO2 Pod is the source of the pulse rate. Adjusting the Heart Rate / Pulse Alarm Limits To adjust the pulse alarm limits for SpO2: 1 In the Setup SpO₂ menu, select Pulse (SpO₂).
20 Monitoring Maternal Heart / Pulse Rate Testing MECG Mode See the monitor's Service Guide.
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21 21 Printing the ECG Waveform FM30/50 You can print the ECG wave onto the trace paper. If you are monitoring both DECG and MECG, both waves will be printed. The start of the wave recording is annotated above the wave with MECG for Maternal ECG, with DECG for Direct fetal ECG, and with 25 mm/sec below the wave. When only MECG and/or DECG are measured without any real-time recording, the 25 mm/sec recorder speed is printed in the trace header.
21 Printing the ECG Waveform MECG waveform on its own 1 MECG 2 Recorder speed DECG and MECG waveforms 1 DECG 2 MECG 3 Recorder speed When the recorder is on, there are two choices for printing the ECG wave: • 232 Separate: This recording mode gives you a six-second ECG strip on the fetal trace paper in fast printout mode. The real-time fetal trace recording is temporarily interrupted while the ECG strip prints.
21 Printing the ECG Waveform The following trace shows the MECG waveform: 1 FHR1 trace interrupted 2 MECG 3 Recorder speed 4 FHR1 trace resume • Overlap: This recording mode gives you a delayed six-second snapshot of the maternal and/or direct fetal ECG for documentation on the fetal strip, but without interrupting the fetal trace. It takes 5 minutes to print this six-second snapshot at a recorder speed of 3 cm/min. It is documented as if it was recorded at 25 mm/s.
21 Printing the ECG Waveform The following trace shows both the DECG and MECG waveforms: 1 FHR1 and FHR2 2 DECG header 3 MECG header 4 Recorder speed To make your choice: 1 Enter the Main Setup menu. 2 Select Fetal Recorder to enter the Fetal Recorder menu. 3 Select ECG Wave to switch between Separate and Overlap. To print the ECG wave(s): 1 Select the Record ECG Wave SmartKey (configurable) and the recording trace is started. Or 1 Enter the Main Setup menu by selecting the SmartKey.
22 Monitoring Noninvasive Blood Pressure 22 The noninvasive blood pressure measurement (NBP) is intended for use with maternal patients. This monitor uses the oscillometric method for measuring NBP. A physician must determine the clinical significance of the NBP information. Introducing the Oscillometric Noninvasive Blood Pressure Measurement Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure.
22 Monitoring Noninvasive Blood Pressure Unattended Measurement: Use clinical judgement to decide whether to perform frequent unattended blood pressure measurements. Too frequent measurements can cause blood flow interference potentially resulting in injury to the patient. In cases of severe blood clotting disorders frequent measurements increase the risk of hematoma in the limb fitted with the cuff.
22 Monitoring Noninvasive Blood Pressure Preparing to Measure Noninvasive Blood Pressure If possible, avoid taking measurements during contractions, because the measurement may be unreliable, and may cause additional stress for the patient. 1 Connect the cuff to the air tubing. 2 Plug the air tubing into the red NBP connector. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing.
22 Monitoring Noninvasive Blood Pressure Understanding the Numerics 1 Alarm source 2 Measurement Mode 3 Timestamp/Timer 4 Mean pressure 5 Diastolic 6 Systolic 7 Alarm limits Depending on the numeric size, not all elements may be visible. Your monitor may be configured to display only the systolic and diastolic values. If configured to do so, the pulse from NBP is displayed with the NBP numeric.
22 Monitoring Noninvasive Blood Pressure Starting and Stopping Measurements Use the setup menu or the SmartKeys to start and stop measurements.
22 Monitoring Noninvasive Blood Pressure Enabling Sequence Mode and Setting Up the Sequence 1 In the Setup NBP menu, select Mode and select Sequence from the pop-up menu. 2 Select Setup Sequence to open the Setup Sequence window. Up to four measurement cycles can be set up which run consecutively. For each cycle, you can set the number of measurements and the intervals between them.
22 Monitoring Noninvasive Blood Pressure Assisting Venous Puncture You can use the cuff to cause subdiastolic pressure. The cuff deflates automatically after a set time if you do not deflate it. 1 In the Setup NBP menu, select VeniPuncture. 2 Puncture vein and draw blood sample. 3 Reselect VeniPuncture to deflate the cuff. During measurement, the display shows the inflation pressure of the cuff and the remaining time in venous puncture mode.
22 Monitoring Noninvasive Blood Pressure Troubleshooting Problem Possible Causes Cuff will not inflate Monitor is in Service or Configuration Mode Solutions Technical defect Call service Cuff tubing not connected Connect cuff tubing Contraction occurring Wait until contraction has finished Patient talking before or during measurement Allow patient to rest quietly, then try again after three to five minutes Incorrect cuff size or cuff not at heart level Check cuff size, level, and position No
23 23 Monitoring SpO2 FM30/40/50 The pulse oximetry measurement (SpO2) is intended for use with maternal patients. Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier Artifact Suppression Technology (FAST). It provides two measurements: • Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation).
23 Monitoring SpO2 WARNING Compatibility: Use only the accessories that are specified for use with this fetal monitor, otherwise patient injury can result. Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied.
23 Monitoring SpO2 WARNING • For fully conscious maternal patients, who have a normal function of perfusion and sensory perception at the measurement site: To ensure skin quality and correct optical alignment of the sensor, inspect the application site when the measurement results are suspicious, or when the patient complains about pressure at the application site, but at least every 24 hours. Correct the sensor alignment if necessary. Move the sensor to another site, if the skin quality changes.
23 Monitoring SpO2 Assessing a Suspicious SpO2 Reading Traditionally, pulse rate from SpO2 was compared with heart rate from ECG to confirm the validity of the SpO2 reading. With newer algorithms, such as FAST-SpO2, this is no longer a valid criteria because the correct calculation of SpO2 is not directly linked to the correct detection of each pulse.
23 Monitoring SpO2 Adjusting the Desat Limit Alarm The Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in oxygen saturation. 1 In the Setup SpO₂ menu, select Desat Limit. 2 Adjust the limit. Adjusting the Pulse Alarm Limits See “Adjusting the Heart Rate / Pulse Alarm Limits” on page 228. Setting Up Tone Modulation If tone modulation is on, the QRS tone pitch lowers when the SpO2 level drops.
23 Monitoring SpO2 248
24 Monitoring Maternal Temperature 24 Measuring Tympanic Temperature The tympanic thermometer (866149) measures the patient's temperature in the ear using infrared technology. The result of this measurement can be automatically adjusted to correspond to a different body reference site. The result is displayed on the screen of the thermometer and transmitted to the monitor. The thermometer is used with single-use probe covers for infection control during measurement.
24 Monitoring Maternal Temperature 1 Base station 2 Thermometer Place the thermometer into its base station, when it is not in use. The base station allows flexible mounting of the thermometer at the point of care. The base station is connected to the monitor's MIB/RS232 interface (optional) with a cable. It has storage space for up to 32 probe covers. Thermometer Display and Controls The tympanic thermometer has a liquid crystal display.
24 Monitoring Maternal Temperature Functional Keys Description of Use Press the start measurement key when you are ready to take a patient's temperature. The pulse timer key can be used to time vital signs you take manually. The pulse timer only functions after you have taken a temperature measurement. Press and hold the pulse timer key to enter timer mode. Press the pulse timer key again to start the timer.
24 Monitoring Maternal Temperature Making a Temperature Measurement WARNING Inaccurate measurement results can be caused by: • incorrect application of the thermometer • anatomical variations in the ear • build up of earwax in the ear • excessive patient movement during the measurement • absent, defective, or soiled probe covers • probe covers other than the specified probe covers • external environment temperature outside the range of 16ºC-33ºC (60.8ºF-91.
24 Monitoring Maternal Temperature Possible INOPs Images Description Patient temperature above measurement range. Patient temperature below measurement range. WARNING • Never apply the probe to the patient when the thermometer is not connected to the base station. • Always use a single-use probe cover to limit patient cross-contamination.
24 Monitoring Maternal Temperature Body Reference Sites and Monitor Labels The tympanic thermometer measures the patient's temperature in the ear. The thermometer can be configured to adjust the result of the measurement to correspond to a different body reference site. The measurement label displayed on the monitor corresponds to the body reference site that is configured.
25 Paper Save Mode for Maternal Measurements 25 Your monitor's recorder features a Paper Save Mode, where maternal vital signs are recorded using less paper than during a normal trace recording. When Paper Save Mode is enabled, and if the recorder is stopped, it will start automatically to print data from maternal measurements as they occur, and then stops again to save paper. You enable Paper Save Mode in Configuration Mode (default is off).
25 Paper Save Mode for Maternal Measurements 256
26 26 Recovering Data The monitor stores trace data, including annotations, for a minimum of 3.5 hours with the software revision J.3 or higher, and for a minimum of 7 hours with the new mainboard hardware revision A 00.18, in its internal backup memory. This allows the monitor to recover trace data that would otherwise be lost under certain circumstances.
26 Recovering Data • The change back to a real-time recording from a trace recovery printout prompts the recording to restart. A new vertical trace header annotation consisting of the time, date, and recorder speed is printed, letting you see where the trace recovery printout ends, and where the real-time trace continues. • There can be a gap of up to 30 seconds between the trace recovery printout, and the beginning of the real-time trace.
26 Recovering Data Traces are not available for periods the monitor was switched off, in Service Mode, in Standby, or if the trace period was shorter than one minute. The speed of the printout depends on the configured recorder speed and on the amount of trace data available. The fetal trace printed from the trace data contains all data from the real-time trace, with the exception of the maternal heart rate, the pulse numeric, and the ECG wave.
26 Recovering Data The current patient’s entry is at the top of the list. The oldest entry at the bottom of the list has no start time specified, as part of the data originally stored may have been over-written by the current patient’s data. It may be that you only see one entry (the current patient’s data) in the Stored Data Recording window if that patient was monitored for a period long enough to erase any earlier entries.
27 27 Care and Cleaning Use only the Philips-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. Philips makes no claims regarding the efficacy of the listed chemicals, or methods as a means for controlling infection. Consult your hospital’s Infection Control Officer or Epidemiologist.
27 Care and Cleaning WARNING • Do not operate the monitor if it is wet. If you spill liquid on the monitor, contact your service personnel or Philips service engineer. • Do not perform underwater monitoring (for example, in a bath or shower) using wired transducers. • Place the monitor where there is no chance of contact with, or falling into water or other liquid. • Do not dry equipment using heating devices such as heaters, ovens (including microwave ovens), hair dryers, and heating lamps.
27 Care and Cleaning Take extra care when cleaning the screen of the monitor, because it is more sensitive to rough cleaning methods than the housing. Do not permit any liquid to enter the monitor case and avoid pouring it on the monitor while cleaning. Do not allow water or cleaning solution to enter the measurement connectors. Wipe around and not over connector sockets, or those of the Toco+, CL Toco+ MP transducer, ECG and IUP Patient Modules, CL ECG/IUP transducer and adapter cables.
27 Care and Cleaning Cleaning and Disinfecting the Tympanic Temperature Accessories Probe and Thermometer Body 1 Wipe the thermometer body clean with a damp cloth. The water temperature should not exceed 55°C (130°F). Do not soak, rinse, or submerge the thermometer under water. You may add a mild detergent to the water. 2 Clean the probe tip with a lint free swab. If the probe tip is soiled, clean it with a dampened swab.
27 Care and Cleaning Sterilizing Sterilization is not allowed for this monitor, related products, accessories, or supplies unless otherwise indicated in the Instructions for Use that accompany the accessories and supplies. WARNING Do not put device and accessories in autoclave (for sterilization).
27 Care and Cleaning 266
28 28 Maintenance WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. In case of problems: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. Electric shock hazard: Do not open the monitor housing. Refer all servicing to qualified service personnel.
28 Maintenance Inspecting the Cables and Cords 1 Examine all system cables, the power plug, and cord for damage. Make sure that the prongs of the plug do not move in the casing. If damaged, replace it with an appropriate power cord. 2 Inspect the cables, leads, and their strain reliefs for general condition. Make sure there are no breaks in the insulation. Make sure that the connectors are properly engaged at each end to prevent rotation or other strain.
28 Maintenance Recorder Maintenance Removing the Paper Guide: FM40/FM50 FM40/50 The paper guide is removable, and you can use the recorder without it. When not using the paper guide, ALWAYS tear off the paper along the perforation to avoid possible paper misalignment (see “Tearing Off the Paper” on page 61). To remove the paper guide: 1 Press the paper eject button to open the paper drawer.
28 Maintenance 270 2 Hinge the transparent paper guide forward. 3 A protrusion (A) holds paper guide in closed position.
28 Maintenance 4 Release the paper guide from one side of the holder. 5 Then remove the paper guide.
28 Maintenance 6 Refitting is a reversal of the removal procedure. Storing Recorder Paper Recorder paper is not intended for long-term archival storage. Another medium should be considered if this is required. Dyes contained in thermal papers tend to react with solvents and other chemical compounds that are being used in adhesives. If these compounds come into contact with the thermal print, the print may be destroyed over time.
28 Maintenance Cleaning the Print Head To clean the recorder's thermal print-head: 1 Switch off the monitor. 2 Open the paper drawer, and remove the paper if necessary, to gain access to the thermal print head. 3 Gently clean the thermal print head with a cotton swab, or soft cloth soaked in isopropyl alcohol. FM20/30 FM40/50 NOTE If the print head is heavily coated with dust or dirt, contact your service personnel to clean it.
28 Maintenance Disposing of the Monitor WARNING To avoid contaminating or infecting personnel, the environment, or other equipment, make sure that you disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories such as thermometers, where not otherwise specified, follow local regulations regarding disposal of hospital waste.
29 29 Accessories and Supplies All accessories listed for the fetal monitor may not be available in all geographies. To order parts, accessories, and supplies, consult your local Philips representative for details. For customers in the United States, Australia, and Great Britain you can order at www.philips.com/healthcarestore. All accessories and supplies listed here are reusable, unless indicated otherwise.
29 Accessories and Supplies Transducers Transducer Part Number Avalon Toco Transducer M2734A Avalon Toco+ Transducer for Toco, DECG, MECG, or IUP monitoring M2735A Avalon Toco MP Transducer for Toco and Maternal Pulse M2734B Avalon Ultrasound Transducer M2736A Avalon Ultrasound Transducer USA M2736AA ECG/IUP Patient Module (for DECG, MECG or IUP) M2738A Avalon CL Toco+ MP Transducer 866075 for use with the Avalon CL base station Avalon CL Ultrasound Transducer 866076 for use with the A
29 Accessories and Supplies Accessory Description Part Number Avalon CL Connector Caps Connector Caps for Avalon CL 989803184841 Cableless Smart Transducers (kit of 10) Avalon CL Belt Clip Belt Clip for Avalon CL Cableless 989803184851 Smart Transducers (kit of 10) Avalon CL Battery Replacement Kit 989803184861 Cable Management Kit 989803148841 Avalon CL Wide Range Battery Kit 989803196421 Kit of 20 Mobile CL Transmitter Cradles 989803168881 for use with 866487 Avalon CL Wide Range Pod Aval
29 Accessories and Supplies Noninvasive Blood Pressure Accessories The following accessories are approved for use with the fetal monitor: Adult Multi Patient Reusable Comfort Cuffs Maternal Patient Category Limb Circumference Part Number Adult (Thigh) 42.0-54.0 cm M1576A Large Adult 34.0-43.0 cm M1575A Large Adult XL 34.0-43.0 cm M1575XL Adult 27.0-35.0 cm M1574A Adult XL 27.0-35.0 cm M1574XL Small Adult 20.5-28.0 cm M1573A Small Adult XL 20.5-28.
29 Accessories and Supplies Maternal Patient Category (color) Limb Circumference Part Number Adult (navy blue) pack of 5 cuffs 27.5-36.5 cm M4555B5 Small Adult (royal blue) 20.5-28.5 cm M4554B Small Adult (royal blue) pack of 5 cuffs 20.5-28.
29 Accessories and Supplies IntelliVue CL NBP Pod Accessories Description Limb Circumference Range Contents Part Number Mobile CL Reusable Small Adult 21-27 cm Cuff 1 cuff 989803163171 Mobile CL Reusable Adult Cuff 26.0-34.5 cm 1 cuff 989803163191 Mobile CL Reusable Large Adult 33.5-45.0 cm Cuff 1 cuff 989803163211 Mobile CL Single-Patient Small Adult Cuff 21-27 cm 20 cuffs 989803163181 Mobile CL Single-Patient Adult Cuff 26.0-34.
29 Accessories and Supplies Philips Reusable Sensors Description Part Number Adult sensor (2.0 m cable), for patients over 50 kg. Any finger, except thumb. M1191B M1191A with longer cable (3.0 m) M1191BL Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50. M1192A Ear sensor (1.5 m cable) for patients more than 40 kg. Use only on adult patients with FM30/40/50.
29 Accessories and Supplies Available worldwide: Description Part Number Adult/Pediatric finger sensor (0.45 m cable). Use only on adult patients with FM30/40/ 50. M1131A Adult/Pediatric finger sensor (0.9 m cable) for patients >40 kg. Any finger except thumb. M1133A Use only on adult patients with FM30/40/50. Adult/Pediatric finger sensor (0.9 m cable) for patients >40 kg. Any finger except thumb. M1134A Adhesive-free, use only on adult patients with FM30/40/50. Requires M1943A (1.0 m) or M1943AL (3.
29 Accessories and Supplies Masimo LNOP Reusable Sensors Description Product Number Part Number Adult Finger Sensor (>30 kg) LNOP DC-I 989803140321 Pediatric Finger Sensor (10-50 kg). Use only on adult patients with FM30/40/50. LNOP DC-IP 989803140331 Multi-Site Sensor (>1 kg). Use only on adult patients with FM30/40/50. LNOP YI n/a Ear Sensor (>30 kg). Use only on adult patients with FM30/40/50.
29 Accessories and Supplies Masimo LNCS Disposable Adhesive Sensors Description Product Name Part Number Adult Sensor (>30 kg) LNCS Adtx 989803148231 Pediatric Finger Sensor (10-50 kg). Use only on adult patients with FM30/40/50. LNCS Pdtx 989803148241 Neonatal Foot Sensor (<3 kg) or Adult Finger Sensor LNCS Neo-L (>40 kg). Use only on adult patients with FM30/40/ 50. 989803148271 Appropriate LNOP/LNCS adapter cable required.
29 Accessories and Supplies Description Comments Part Number Adapter Cable for OxiCliq sensors Available from Nellcor OC-3 Masimo MP 12 LNOP MP Series Patient Cable (3.6 m) Adapter Cable for Masimo LNOP sensors M1020-61100 LNC MP10 LNCS MP Series Patient Cable (3.
29 Accessories and Supplies 286
30 Specifications and Standards Compliance 30 The monitors are intended to monitor a mother and her fetus(es), which from an electrical safety point of view, are one person. Environmental Specifications The monitor may not meet the given performance specifications, if stored and used outside the specified temperature and humidity ranges.
30 Specifications and Standards Compliance Monitor (M2702A/M2703A/M2704A/M2705A); Interface Cable for Avalon CTS (M2731-60001 and M2732-60001) Temperature Range Operating Without battery option: 0°C-45°C (32°F-113°F) With battery option/charging: 0°C-35°C (32°F-95°F) With battery option/fully charged: 0°C-40°C (32°F104°F) Humidity Range Altitude Range Storage/Transportation -20°C—60°C (-4°F—140°F) Operating <95% relative humidity @ 40°C (104°F) Storage/Transportation <90% relative humidity @ 60°C
30 Specifications and Standards Compliance Avalon CL Fetal and Maternal Pod (866488) Altitude Range Operating -500-3000 m (-1640-9840 ft) Storage/Transportation -500-13100 m (-1640-43000 ft) Avalon CL Wide Range Pod (866487) Temperature Range Humidity Range Altitude Range Operating 0°C-40°C (32°F-104°F) Charging 0°C-35°C (32°F-95°F) Storage/Transportation -20°C-60°C (-4°F-140°F) Operating <95% relative humidity @ 40°C (104°F) Storage/Transportation <90% relative humidity @ 60°C (140°F) Ope
30 Specifications and Standards Compliance Monitor Physical Specifications M2702A/M2703A M2704A/M2705A Electrical Power Source External (AC) without battery External (AC) option #E25 Internal (Lithium Ion battery) if with battery option #E25 Mode of Operation Continuous operation Water Ingress Protection Code IP X1 (provided recorder drawer is shut) Global Speed (DECG and MECG wave on the screen) 6.25 mm/sec, 12.
30 Specifications and Standards Compliance External Power Supply (Option K60 for the Avalon CL Base Station) Maximum Weight (with cable) 140 g (4.94 oz) (incl. cable, without country-dependent AC adapter) Size (W x H x D) 52.0 x 39.5 x 85.0 mm (2.0 x 1.6 x 3.4 in) Charging cable length 1.6 m (5.2 ft) (incl. power supply) Supply Voltages 100 VAC-240 VAC Supply Frequency Range 50 Hz/60 Hz Power Consumption (current) 0.4-0.
30 Specifications and Standards Compliance Avalon CL Transducers (866075/866076/866077) Degree of Protection Against Electrical Shock Type CF Transducer Identification Optical Signal Element (Finder LED) Avalon CL Fetal & Maternal Pod Avalon CL Fetal & Maternal Pod (866488) Shock Resistance Withstands a 1.5 m drop to concrete surface with possible cosmetic damage only.
30 Specifications and Standards Compliance Interface Specifications Fetal Monitors Interface Specifications Network MIB/RS232 USB Interface RS232 (Standard) Standard 100-Base-TX (IEEE 802.3 Clause 25) Connector RJ45 (8 pin) Isolation Basic isolation (reference voltage: 250 V; test voltage: 1500 V) Standard IEEE 1073-3.2-2000 Connectors RJ45 (8 pin) Mode Software-controllable BCC (RxD/TxD cross over) or DCC (RxD/TxD straight through) Power 5 V ±5%, 100 mA (max.
30 Specifications and Standards Compliance Avalon CL Radio Avalon CL Radio Interface Specifications Electronic Article Surveillance (EAS) EAS tag inside the housing (58 kHz) Short Range Radio Interface* Type Internal SRR interface OBR (WMTS)* OBR (ISM)* OBR (T108)* Technology IEEE 802.15.4 Frequency Band 2.4 GHz ISM (2.400-2.483 GHz) Modulation Technique DSSS (O-QPSK) Effective radiated power max. 0 dBm (1 mW) Range ca.
30 Specifications and Standards Compliance Short Range Radio Specifications Frequency Band 2.4 GHz ISM (2.400-2.483 GHz) MBAN (2.360-2.400 GHz, for US / FCC regulated countries only)1 Modulation DSSS (O-QPSK) Bandwidth 5 MHz Effective Radiated Power (ERP) max. 0 dBm (1 mW) WLAN Specifications Type Internal wireless adapter Technology IEEE 802.11a/b/g/n Frequency Band USA: 2.400-2.483 GHz, 5.15-5.35 GHz, 5.725-5.825 GHz Europe: 2.400-2.483 GHz, 5.15-5.35 GHz, 5.47-5.725 GHz Japan: 2.400-2.
30 Specifications and Standards Compliance Measurement Essential Performance ECG (Monitoring) Measurement of the fetal and maternal heart rate over the specified measurement range and with an accuracy of ± 5 bpm. Alarming on heart rate limit violation within specified delay time. Maternal Pulse from Toco (MP) Measurement of the maternal pulse rate within the specified limits. MP is susceptible to movement artifact potentially resulting in signal loss.
30 Specifications and Standards Compliance Measurement Essential Performance All After electrostatic discharge, fast transients/bursts, surges and electro surgery interference, the equipment will return to previous operation mode within 10 seconds (SpO2 30 seconds) without loss of any stored data. After voltage interruptions the equipment returns to previous state without operator intervention and loss of data.
30 Specifications and Standards Compliance Performance Specification Avalon CL Transducer Battery Operating time With a new and fully charged battery min. 10 hours Charge time From a "low battery" indication to a "fully charged" indication <3 hours Charge time with Avalon FM20/30 Battery Option #E25 From a "low battery" indication to a "fully charged" indication >6 hours. Performance Specification Avalon CL F&M Battery Operating time With a new and fully charged battery min.
30 Specifications and Standards Compliance Performance Specifications US Intensity (M2736A/AA) Average output power P = (7.4 ± 0.4) mW Peak-negative acoustic pressure p_ = (40.4 ± 4.3) kPa Output beam intensity (Iob) Isata = (2.38 ± 0.59) mW/cm2 (= spatial average - temporal average intensity) Spatial-peak temporal average intensity Ispta = (15.0 ± 3.2) mW/cm2 Effective radiating area @ -12 dB (3.11 ± 0.74) cm2 Thermal index (TI) and mechanical index (MI) are always below 1.0.
30 Specifications and Standards Compliance Performance Specifications Update Rate Display 1 per second Printer ~4 per second Auto Offset Correction 3 seconds after connecting the transducer, the Toco value is set to 20 units Auto Zero Adjust Toco value is set to zero following a negative measurement value for 5 seconds Performance Specifications Maternal Pulse from Toco Emitted Light Energy ≤15 mW Wavelength Range 780-1100 nm Range 40-240 bpm Resolution 1 bpm Display Update Rate 1 per sec
30 Specifications and Standards Compliance Performance Specifications ECG Performance Specifications Type DECG Single Lead ECG (derived from Fetal Scalp Electrode) MECG Single Lead ECG (derived from RA and LA electrodes) Measurement Range Resolution 30-240 bpm Display 1 bpm (display update rate 1 per second) Recorder 1/4 bpm Wave Speed (Global Speed) 6.25 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/ sec Accuracy ±1 bpm or 1%, whichever is greater (nonaveraging) Beat-to-Beat change (max.
30 Specifications and Standards Compliance Fetal Heart Rate (Ultrasound/DECG) Alarm Specifications FHR Alarm Limits Range Bradycardia (low limit) 60-200 bpm adjustable in 10 bpm steps Default: 110 bpm Tachycardia (high limit) 70-210 bpm adjustable in 10 bpm steps Default: 170 bpm FHR Alarm Delay Range Bradycardia (low limit) Delay 10-300 seconds in steps of 10 seconds + system alarm delay Default: 240 seconds Tachycardia (high limit) Delay 10-300 seconds in steps of 10 seconds + system alarm delay
30 Specifications and Standards Compliance Maternal ECG Supplemental Information as required by IEC 60601-2-27 Response Time of Heart Rate Meter to Change in Heart Rate HR change from 80-120 bpm: 10 seconds HR change from 80-40 bpm: 14 seconds Tall T-Wave Rejection Capability M2735A 1.2 mV T-Wave amplitude M2738A 1.4 mV T-Wave amplitude CL Toco+ MP, CL ECG/IUP 1.
30 Specifications and Standards Compliance aToco Resolution 0-255 levels representing 100% of the full scale Accuracy ±5% Noninvasive Blood Pressure Complies with IEC 80601-2-30:2009 / EN 80601-2-30:2010. Performance Specifications Measurement Ranges Systolic 30-270 mmHg (4-36 kPa) Diastolic 10-245 mmHg (1.5-32 kPa) Mean 20-255 mmHg (2.5-34 kPa) Accuracy1 Max. Std. Deviation: 8 mmHg (1.1 kPa) Max. Mean Error: ±5 mmHg (±0.
30 Specifications and Standards Compliance Overpressure Settings Adjustment > 300 mmHg (40 kPa) > 2 sec not user adjustable SpO2 Complies with ISO 80601-2-61:2011 / EN 80601-2-61:2011. Measurement Validation: The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter.
30 Specifications and Standards Compliance SpO2 Performance Specifications Sensors Wavelength range 500-1000 nm. Information about the wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed). Emitted Light Energy ≤15mW Pulse Oximeter Calibration Range 70%-100% SpO2 Alarm Specifications Range Adjustment Delay (0, 1, 2, 3,...
30 Specifications and Standards Compliance Performance Specifications 16.0°C-33.0°C (60.8°F-91.4°F) <36.0°C or >39.0°C (<96.8°F or >102.2°F) ±0.3°C (±0.5°F) ASTM laboratory requirement for IR thermometers in the display range 37.0°C-39.0°C (98.0°F-102.0°F) is ±0.2°C (±0.4°F), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM standards E667-86 and E1112-86 is ±0.1°C (±0.2°F). Clinical accuracy characteristics and procedures are available from Covidien llc on request.
30 Specifications and Standards Compliance Physical Specifications Thermometer Dimensions 190 mm x 43 mm x 55 mm (±3 mm) Cable length 60 ±5 cm (spiral cable relaxed) 250 ±15 cm (spiral cable extended) Weight (including cable) 180 ±10 g Ingress protection classification IP 21 Base Station Dimensions 205 mm x 65 mm x 75 mm (±3 mm) Weight (excluding cable) 400 g ±10 g Recorder Specifications Built-in Thermal Array Fetal Trace Recorder Mechanism Thermal Array Recorder Paper & Printing Type Stan
30 Specifications and Standards Compliance Recorder Symbols Symbol Description Parameter is capable of alarming and alarms were enabled at the time of printing the annotation. The low limit is printed before the symbol, and the high limit after it. Parameter is capable of alarming, but alarms were disabled at the time of printing the annotation. (Note: There is no alarm related annotation at all if a parameter does not have alarming capability.
30 Specifications and Standards Compliance Recorder Symbols Symbol Description Trace separation -20 bpm (in trace) Trace separation +20 bpm and -20 bpm (in trace) Coincidence of heart rates is detected Marker Special wave, with different speed and scale (for example, fast printout of MECG wave on FM30) External Displays: FM40/FM50 Only External displays can be connected with a maximum cable run of 10 m. External displays must be approved for medical use (IEC 60601-1).
30 Specifications and Standards Compliance Regulatory and Standards Compliance The fetal monitors are in conformity with the requirements of the European Medical Devices Directive 93/42/EEC and bear the CE marking: The fetal monitors are classified into Class IIb according to Annex IX rule 10. The Avalon CL Transducer System is in conformity with the requirements of the European Radio Equipment and Telecommunications Terminal Equipment Directive 99/5/EC.
30 Specifications and Standards Compliance Radio The Avalon CL Transducer System complies with the following major international radio standards: • ETSI EN 300 220-1:2012 • ETSI EN 300 220-2:2012 • ETSI EN 301 489-1:2011 • ETSI EN 301 489-3:2013 • FCC 47 CFR Part 95 • IC RSS-210 Issue 8 • ARIB STD-T108 • ETSI EN 300 328:2012 • ETSI EN 301 489-17:2012 • FCC 47 CFR Part 2 & 15 • AS/NSZ 4268 • ARIB STD-T66 Safety Tests Fetal Monitor All the safety tests and procedures required after an
30 Specifications and Standards Compliance Electromagnetic Compatibility (EMC) The device and its accessories, listed in the accessories section, comply with the following EMC standards: • IEC 60601-1-2:2007 / EN 60601-1-2:2007+AC:2010 Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment. You must operate your monitoring equipment according to the EMC information provided in this book.
30 Specifications and Standards Compliance EMC Testing CAUTION Fetal parameters, especially ultrasound and ECG, are sensitive measurements involving small signals, and the monitoring equipment contains very sensitive high gain front-end amplifiers. Immunity levels for radiated RF electromagnetic fields and conducted disturbances induced by RF fields are subject to technological limitations.
30 Specifications and Standards Compliance System Characteristics The phenomena discussed above are not unique to this system, but are characteristic of fetal patient monitoring equipment in use today. This performance is due to very sensitive high gain front end amplifiers required to process the small physiological signals from the patient. Among the various monitoring systems already in clinical use, interference from electromagnetic sources is rarely a problem.
30 Specifications and Standards Compliance Table 1 - Guidance and Manufacturer's Declaration: Electromagnetic Emissions Emissions Test Compliance Avoiding Electromagnetic Interference RF emissions CISPR 11 Class B The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes1.
30 Specifications and Standards Compliance Table 2 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity Immunity Test IEC 60601-1-2 Test Level Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% UT (>95% dip in <5% UT (>95% dip in UT) for 0.5 cycles UT) for 0.
30 Specifications and Standards Compliance Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
30 Specifications and Standards Compliance Table 3 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity Conducted RF Immunity Test EN/IEC 61000-4-6 Electromagnetic Environment Guidance: IEC 60601-1-2 Test Level over 150 kHz to 80 MHz Compliance Level 3.0 VRMS 3.
30 Specifications and Standards Compliance location in which the device is used exceeds the applicable RF compliance level above, it should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
30 Specifications and Standards Compliance Environment Before operation, make sure that the fetal monitor is free from condensation. This can form when equipment is moved from one building to another, and is exposed to moisture and differences in temperature. Use the monitor in an environment which is reasonably free from vibration, dust, corrosive or explosive gasses, extremes of temperature, humidity, and so forth. It operates within specifications at ambient temperatures between 0-+45°C (32°F-113°F).
30 Specifications and Standards Compliance Cardiac Pacemakers and Electrical Stimulators WARNING The fetal/maternal monitors are not intended for use for ECG measurements on patients connected to external electrical stimulator, or with cardiac pacemakers. Fast Transients/Bursts The equipment will return to the previous operating mode within 10 seconds without loss of any stored data. Symbols on the System These symbols can appear on the monitor and its associated equipment and packaging.
30 Specifications and Standards Compliance Symbol Description Noninvasive Blood Pressure Socket symbol Type BF Symbol indicating the monitor has the triplets option Symbol indicating the monitor is capable of intrapartum monitoring Button to open paper drawer/paper eject.
30 Specifications and Standards Compliance Symbol Description IP 68 Ingress Protection code according to IEC 60529. All transducers (excluding M2738A) are rated IP 68 (protection against dust, access to hazardous parts, and the effects of continuous immersion in water to a depth of 1.0 meter for five hours) IP X1 Ingress Protection code according to IEC 60529.
30 Specifications and Standards Compliance Symbol Description Association Of Radio Industries And Businesses T108 (Avalon CL frequency band used e.g. in Japan) Wireless Medical Telemetry Service (Avalon CL frequency band used e.g.
30 Specifications and Standards Compliance 326
31 31 Default Settings Appendix This appendix documents the most important default settings of your fetal monitor and the Avalon CL Base Station with the cableless transducers as they are delivered from the factory. For a comprehensive list and explanation of default settings see the Configuration Guide supplied with your fetal monitor. The monitor's default settings can be permanently changed in Configuration Mode.
31 Default Settings Appendix Fetal / Maternal Defaults Settings (US/CAN) FHR, dFHR, aFHR Alarms On/Off Default On Default Color for FHR Numeric: FHR1, dFHR1, aFHR1 Red FHR2, dFHR2, aFHR2 Blue FHR3, dFHR3, aFHR3 Toco, aToco Green Default color for Toco numeric Green Yellow IUP HR, aHR Measurement Default IUP Scale Unit mmHg Default color for IUP numeric White Default Color for MECG Numeric Red Coincidence Default Settings Coincidence Default Settings Coincidence Tone immediately NBP De
31 Default Settings Appendix CL NBP Default Settings NBP Settings Factory Defaults Mode Auto Repeat Time 10 min NBP On VP Pressure 60 mmHg Reference Auscultatory Unit mmHg Done Tone Off Start Time Synchronized Aging Time 10 min Color Red SpO2 Default Settings SpO2 Factory Default Settings Desat Limit 80 Low Limit 90 High Limit 100 Desat Delay 20 seconds Low Alarm Delay 10 seconds High Alarm Delay 10 seconds Average 10 seconds NBP Alarm Suppr.
31 Default Settings Appendix CL SpO2 Default Settings SpO2 Settings Factory Defaults Repeat Time 15 min Signal Quality On NBP Alarm Suppr. On Color Cyan Tympanic Temperature Default Settings pTemp Settings Factory defaults Adult Low Limit 36°C (96.8°F) High Limit 39°C (102.
31 Default Settings Appendix Setting Choice Default Notes Recording Along, Across Along (International) (USA/CAN) Across Change Rec Speed Monitoring, Config Config Auto Start Off, On Off Confirmed Stop Off Bridge Paperout On Paper Save Mode Off On NST Autostart On NST Autostop Off Trace Separation Off (International) (USA/CAN) Separation Order Standard, Classic Standard (International) Classic (USA/CAN) Intensity 4 (medium) n/a Cal.
31 Default Settings Appendix 332
1 A accessories 275, 276, 277, 278, 279, 280, 285 Avalon CL base station 275 cl NBP Pod accessories 280 cl SpO2 Pod accessories 284 fetal accessories 276 electrode patch 276 fetal recorder accessories 285 latex information 275 MECG accessories 277 noninvasive blood pressure accessories 278, 279 adult cuffs 279 multi-patient comfort cuff kits 278 reusable cuffs 278 single-hose disposable cuffs 279 SpO2 accessories 280 Philips sensors (disposable) 280 Philips sensors (reusable) 280 transducer accessories 276
display 49, 238, 298 adjusting display 49 adjusting screen brightness 47 display noninvasive blood pressure 238 fetal display specifications 298 disposal of electronic waste 274 disposal of monitor 274 dyshemoglobins 244 intravascular dyshemoglobins 244 E early systolic blood pressure 238 ECG 202, 222, 298 ECG specifications 298 electrical safety tests 312 electrical surgery precautions.
sequence 25 NBP numerics 238 NBP pediatric cuffs 279 NBP performance specifications 304 NBP reusable cuffs 278 NBP single-hose disposable cuffs 279 NBP site inspection 237 NBP troubleshooting 242 NBP venous puncture 241 preparing to measure NBP 237 non-medical devices 312 non-medical devices in patient vicinity 312 Non-Stress Test timer.
testing 128, 205, 229, 312 DECG testing 205 MECG testing 229 safety testing 312 testing alarms 128 time 47 setting time 47 time from OB TraceVue/IntelliSpace Perinatal System 47 Toco 202, 207, 208, 210, 224, 298 default Toco settings 298 testing a Toco transducer 210 Toco baseline 208 Toco display specifications 298 Toco monitoring 207 Toco sensitivity 208 Toco specifications 298 Toco MP transducer 207, 221 Toco+ transducer 207 tone modulation (SpO2) 247 touch tone volume 47 touchscreen operation 38, 44 tra
Part Number 453564659391 Published in Germany 09/16 *453564659391*
