Philips OBRTBV1, OBRBSBV1 User Manual

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Instructions for Use

Avalon Fetal Monitor

FM20/30, FM40/50, Avalon CL

Release J.3. with Software Revision J.30.xx

Patient Monitoring

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1Table of Contents

1 Introduction 9

Who this Book is For 9 Confirm Fetal Life Before Using the Monitor 10 Introducing the Avalon Family of Fetal Monitors 11

2 What's New 29

What's New in Release J.3 29 What's New in Release G.0 32

3 Basic Operation 35

Supported Measurements 35 Avalon FM20 and FM30 36 Avalon FM40 and FM50 39 Avalon CL Transducer System 40 Getting to Know Your Avalon FM20/FM30 40 Getting to Know Your Avalon FM40/FM50 43 Transducers 45 Getting to Know Your Avalon CL 47 Cableless Transducers 51 CL Pods 55 Operating and Navigating 56 Operating Modes 63 Automatic Screen Layouts 64 Settings 64 Preparing to Monitor 67 Switching the Monitor to Standby 98 After Monitoring 98 Disconnecting from Power 99 Power On/Power Off Behavior 99 Monitoring After a Power Failure 99 Troubleshooting 100

4 FM20/30 Battery Option 101

External Power Supply M8023A 102 Using Batteries 102 Optimizing Battery Performance 105

5 Alarms 109

Alarm Mode 110 Nurse Call Systems 110

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Visual Alarm Indicators 110 Audible Alarm Indicators 111 Acknowledging Alarms 114 Acknowledging Disconnect INOPs 114 Alarm Reminder 114 Pausing or Switching Off Alarms 115 Alarm Limits 117 Reviewing Alarms 118 Latching Alarms 118 Testing Alarms 120 Alarm Behavior at Power On 121

6 Patient Alarms and INOPs 123

Alarm Messages 123 Technical Alarm Messages (INOPs) 126

7 Admitting and Discharging 137

Admit/Discharge on the Monitor 137 New Patient Check 139 OB TraceVue/IntelliSpace Perinatal 139

8 Non-Stress Test Timer 141

Setting NST Autostart/Autostop 141 Viewing the NST Timer 141 Timer Expiry Notification 142 Accessing the NST Setup Pop-up Keys 142

9 Non-Stress Test Report 145

Setting Up an NST Report 145 NST Report Status Window 146 NST Criteria 148 Non-Reassuring Report 149 Non-Reactive NST Test 149

10 Cross-Channel Verification (CCV) 151

Misidentification of Heart Rates 151 Cross-Channel Verification Functionality 152 Overview of Cross-Channel Comparisons 152 Coincidence Examples 154 Recommended Actions for INOP Coincidence 156

11 Monitoring FHR and FMP Using Ultrasound 157

Technical Description 157 Limitations of the Technology 158 Misidentification of MHR as FHR 158 What You Need 158

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Cableless Monitoring - Important Considerations 159 Preparing to Monitor 160 Selecting Fetal Heart Sound 161 Changing the Fetal Heart Sound Volume 161 Fetal Movement Profile 163 Troubleshooting 165 Additional Information 166 Testing Ultrasound Transducers 173

12 Monitoring Twin FHRs 175

Important Considerations 175 Monitoring Twins Externally 176 Monitoring Twins Internally 177 Separating FHR Traces 177 Troubleshooting 181

13 Monitoring Triple FHRs 183

Important Considerations 183 Monitoring Triplets 184 Separating FHR Traces 184 "Standard" Separation Order 184 "Classic" Separation Order 185 Switching Trace Separation On and Off 186 When Trace Separation is On 187 When Trace Separation is Off 188 Troubleshooting 188

14 Fetal Heart Rate Alarms 191

Changing Alarm Settings 191 Changing Signal Loss Delay 192

15 Monitoring Uterine Activity Externally 193

What You Need 193 External Toco Monitoring 194 Toco Sensitivity 195 Troubleshooting 195 Testing Toco Transducers 195

16 Monitoring Uterine Activity Internally 197

What You Need 197 Internal (IUP) Monitoring 199 Troubleshooting 199

17 Monitoring FHR Using DECG 201

Misidentification of MHR as FHR 201 What You Need 203

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Making Connections 205 Monitoring DECG 206 Suppressing Artifacts 208 Troubleshooting 209 Testing DECG Mode 209

18 Monitoring Noninvasive Blood Pressure 211

Introducing the Oscillometric Noninvasive Blood Pressure Measurement 211 Preparing to Measure Noninvasive Blood Pressure 212 Starting and Stopping Measurements 214 Enabling Automatic Mode and Setting Repetition Time 215 Enabling Sequence Mode and Setting Up The Sequence 215 Choosing the Alarm Source 216 Assisting Venous Puncture 216 Calibrating NBP 216 Troubleshooting 217

19 Monitoring Maternal Temperature 219

Measuring Tympanic Temperature 219

20 Monitoring SpO2 227

Selecting an SpO2 Sensor 227 Applying the Sensor 227 Connecting SpO2 Cables 228 Measuring SpO2 228 SpO2 Signal Quality Indicator (Fast SpO2 only) 229 Assessing a Suspicious SpO2 Reading 230 Understanding SpO2 Alarms 230 Setting Up Tone Modulation 231 Setting the QRS Volume 231

21 Monitoring Maternal Heart / Pulse Rate 233

Priority for Maternal Heart / Pulse Rate 233 Misidentification of MHR for FHR 234 MHR from MECG Electrodes 235 Monitoring MECG Wave 238 Pulse Rate from Toco MP 240 Pulse Rate from SpO2 241 Adjusting the Heart Rate / Pulse Alarm Limits 241 Average Pulse Rate from Noninvasive Blood Pressure 242 Testing MECG Mode 242

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22 Printing the ECG Waveform 243 23 Paper Save Mode for Maternal Measurements 249 24 Recovering Data 251

Recovering Traces on Paper 251 Recovering Traces on an OB TraceVue/IntelliSpace Perinatal System 252 Recording Stored Data 252

25 Care and Cleaning 255

General Points 255 Cleaning and Disinfecting 256 Cleaning and Disinfecting Monitoring Accessories 257 Cleaning and Disinfecting the Tympanic Temperature Accessories 258 Sterilizing 258

26 Maintenance 259

Inspecting the Equipment and Accessories 259 Inspecting the Cables and Cords 259 Maintenance Task and Test Schedule 260 Recorder Maintenance 260 Cleaning the Print Head 265 Disposing of the Monitor 266

27 Accessories and Supplies 267

Information on Latex 267 Avalon CL Base Station 268 Transducers 268 Fetal Accessories 268 MECG Accessories 270 Noninvasive Blood Pressure Accessories 270 SpO2 Accessories 273 Tympanic Temperature Accessories 277 Recorder Paper 277 Batteries 277

28 Specifications and Standards Compliance 279

Environmental Specifications 279 Physical Specifications 281 Performance Specifications 285 Recorder Specifications 294 Compatible External Displays: FM40/FM50 Only 296 Manufacturer's Information 296 Trademark Acknowledgment 296 Regulatory and Standards Compliance 297 Environment 306

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Monitoring After a Loss of Power 307 ESU, MRI and Defibrillation 307 Cardiac Pacemakers and Electrical Stimulators 307 Fast Transients/Bursts 307 Symbols on the System 308

29 Default Settings Appendix 311

Alarm and Measurement Default Settings 311 Recorder Default Settings 314

Index 317

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Who this Book is For

This book is for trained healthcare professionals using the Avalon FM20, FM30, FM40 and FM50 Fetal/Maternal monitors, and the cableless monitoring system Avalon CL. It describes how to set up and use the monitor and transducers. Familiarize yourself with all instructions including warnings and cautions before starting to monitor patients. Read and keep the Instructions for Use that come with any accessories, as these contain important information about application and care and cleaning that is not repeated in this book.

You should be:

• Trained in the use of fetal heart rate (FHR) monitors.

• Trained in the interpretation of FHR traces.

• Familiar with using medical devices and with standard fetal monitoring procedures.

For information on how to configure and service the monitor, see the Configuration Guide and the Service Guides, or contact your authorized service provider.

Your monitor may not have all of the features and options described in this guide. The exact appearance of the monitor may differ slightly from that shown in the illustrations.

In this guide:

•A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.

•A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in:

– minor or moderate personal injury, – damage to the product or other property, – possibly in a remote risk of more serious injury.

• Monitor refers to the entire fetal/maternal monitor. Display refers to the physical display unit. Screen refers to everything you see on the monitor's display, such as measurements, alarms, patient data, and so forth.

FM30 • Whenever a monitor’s identifier appears to the left of a heading or paragraph, it means that the

information applies to that monitor only. Where the information applies to all models, no distinction is made.

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Avalon CTS

Avalon CL

Whenever one of these identifiers appear to the left of a heading or paragraph, it means that the information applies to that cableless monitoring system. Where the information applies to both systems, no distinction is made.

Confirm Fetal Life Before Using the Monitor

Fetal monitoring technology available today is not always able to differentiate a fetal heart rate (FHR) signal source from a maternal heart rate (MHR) source in all situations. Therefore, you should confirm fetal life by independent means before starting to use the fetal monitor, for example, by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope. If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography. Continue to confirm that the fetus is the signal source for the FHR during monitoring.

Be aware that:

• an MHR trace can exhibit features that are very similar to those of an FHR trace, even including accelerations and decelerations. Do not rely solely on trace pattern features to identify a fetal source.

• Fetal Movement Profile (FMP) annotations on a fetal trace alone may not always indicate that the fetus is alive. The body of a deceased fetus can move and cause the monitor to annotate fetal body movements.

Here are some examples where the MHR can be misidentified as the FHR.

• When using an ultrasound transducer: – It is possible to pick up maternal signal sources, such as the aorta or other large vessels. – Misidentification may occur when the MHR is higher than normal (especially when it is over

100 bpm).

• 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 cable, appearing to be a fetal signal source.

– The recorded MHR (and any artifact) can be misinterpreted as an FHR (especially when it is

over 100 bpm).

• When Fetal Movement Profile (FMP) is enabled: 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 movement

(especially if the pressure applied is too forceful). – Movement of the ultrasound transducer. – The ultrasound transducer detecting a maternal movement source, such as the mother

coughing.

See also “Monitoring FHR and FMP Using Ultrasound” on page 155 and “Monitoring FHR Using DECG” on page 195.

To reduce the possibility of mistaking the MHR for an FHR, it is recommended that you monitor both maternal and fetal heart rates. The monitor's cross-channel verification (CCV) facility can help by automatically detecting when an MHR coincides with an FHR. For further details, see “Cross-Channel Verification (CCV)” on page 149.

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Introducing the Avalon Family of Fetal Monitors

The Avalon family of fetal monitors consists of the Avalon FM20, FM30, FM40 and FM50. While the FM20/FM30 and the FM40/FM50 have different form factors, the method of operation is very similar for all monitors. The Avalon fetal monitors also share transducers, accessories, software, and are compatible with the Avalon CL, and Avalon CTS Cableless Fetal Transducer Systems.

Intended Use

The Philips Avalon FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A) Fetal/ Maternal Monitors are intended for:

• non-invasive monitoring of fetal heart rates and movements.

• non-invasive monitoring of maternal heart rates, maternal pulse rates, uterine activity, maternal noninvasive blood pressure, maternal oxygen saturation, and maternal temperature.

• invasive monitoring of fetal Direct ECG and intrauterine pressure and for displaying and recording of fetal and maternal ECG waves. (FM30 and FM50 only).

• displaying, storing, and recording patient data and parameter values, and for generating alarms from fetal and maternal parameters.

• transmitting patient data and parameter values to a patient information and surveillance system used by trained health care professionals.

• use in antepartum testing areas, in labor and delivery rooms, and during postpartum recovery in the hospital environment. They are not intended for use in intensive care units or operating rooms.

• monitoring in a bath or shower. (Avalon CL cableless transducers Toco ECG/IUP only)

• transport situations in healthcare facilities, for healthcare facilities outside hospitals, such as doctors’ offices, and for use in private households. (FM20 and FM30 only)

WARNING

The fetal/maternal monitors are not intended for:

• use during defibrillation, electro-surgery, or magnetic resonance imaging (MRI).

• ECG measurements on patients connected to electrical stimulator or with cardiac pacemakers.

• use of the invasive measurements IUP and fetal DECG, use of the patient module (M2738A) and use of the Avalon CL system in domestic establishments and those connected directly to the public low-voltage supply network that supplies buildings used for domestic purposes.

WARNING

No modification of the fetal monitors, transducers, and the Avalon CL base station is allowed.

MP, Ultrasound, and

CAUTION

US federal law restricts this device to sale by, or on the order of, a physician.

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Connecting the Monitor to AC Mains

WARNING

• Always use the supplied power cord with the earthed mains plug to connect to an earthed AC mains socket. Never adapt the mains plug from the fetal monitor to fit an unearthed AC mains socket.

• Check that the line frequency is correctly configured in the

• FM20/FM30 only: The protective earth conductor is required for EMC purposes. It has no protective function against electric shock. Double and/or reinforced insulation protects this device against electric shock.

• Do not use AC mains extension cords or multiple portable socket-outlets.

Indications for Use

Avalon Fetal/Maternal Monitor FM20

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate, and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Avalon Fetal/Maternal Monitor FM30

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, noninvasive blood pressure, and pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.

Global Settings menu.

Avalon Fetal/Maternal Monitor FM40

Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, and pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

Avalon Fetal/Maternal Monitor FM50

Safety Information

In this guide:

• A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.

• A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.

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WARNING

The fetal/maternal monitors are not intended for:

• use during defibrillation, electro-surgery, or magnetic resonance imaging (MRI).

• ECG measurements on patients connected to electrical stimulator or with cardiac pacemakers.

WARNING

No modification of the fetal monitors, transducers, and the Avalon CL base station is allowed.

CAUTION

US federal law restricts this device to sale by, or on the order of, a physician.

WARNING

• Always use the supplied power cord with the earthed mains plug to connect to an earthed AC mains socket. Never adapt the mains plug from the fetal monitor to fit an unearthed AC mains socket.

• Check that the line frequency is correctly configured in the Global Settings menu.

• Do not use AC mains extension cords or multiple portable socket-outlets.

WARNING

• To avoid magnetic interference affecting the mode of the pacemaker, ensure that the Avalon CL base station does not come into close contact with implanted pacemakers.

• This equipment generates, uses, and radiates radio-frequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications. Operation of this equipment in a residential area may cause interference, in which case the users must take whatever measures may be required to correct the interference.

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WARNING

Do not change the date and time setting, if the fetal monitor is connected to a Philips OB TraceVue/ IntelliSpace Perinatal system via a LAN -setup. The monitor uses the OB TraceVue/IntelliSpace Perinatal system date and time, including daylight saving time changes. As long as the fetal monitor is connected to the OB TraceVue/IntelliSpace Perinatal system via the LAN-setup (locomotive icon displayed on the monitor's screen), the option to change the date and time settings at the fetal monitor are disabled, this is not valid for RS232 connections, or the connection to other systems.

WARNING

Short range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a SpO

channel configuration is important, refer to the Configuration Guide for details.

No Host Monitoring INOP (here the host is the fetal monitor) on the NBP or

Pods, or a cl NBP Disconnect or cl SpO₂ Disconnect INOP at the fetal monitor. Correct

CAUTION

Check the fetal monitors housing for damage before you start to monitor as part of your safety precautions.

WARNING

When connecting devices for acquiring measurements, always position cables and NBP tubing carefully to avoid entanglement or potential strangulation.

CAUTION

Using recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead. This type of damage is not covered by warranty.

WARNING

Never immerse the base station in liquid. You must protect it against water sprays or splashes. Place the base station where there is no chance of contact with, or falling into water or other liquids.

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CAUTION

Avoid the use of pulsating water jets in the bath or shower while monitoring, as these can be misinterpreted as an incorrect (or totally artificial) heart rate.

Toco Baseline drift: The accuracy specified for baseline drift cannot be guaranteed for underwater usage. When using transducers under warm water the temperature increase causes a significant baseline change due to internal pressure increase. The depth under water at which the Toco transducer is used also has an effect on the Toco baseline, as the water pressure increases with depth. After immersion, allow one to two minutes for the pressure to stabilize, then adjust the Toco baseline (between contractions), and check it frequently.

When using the transducers underwater, the radio transmission range is reduced, and signal loss may occur.

WARNING

• Always use the supplied power cord with the earthed mains plug to connect the external power supply M8023A (option #E25) to an earthed AC mains socket. Never adapt the mains plug from the power supply to fit an unearthed AC mains socket.

• Do not use AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet without an approved isolation transformer is used, the interruption of its protective earthing may result in enclosure leakage currents equal to the sum of the individual earth leakage currents, so exceeding allowable limits.

• Do not connect any devices that are not supported as part of a system.

• Any non-medical device placed and operated in the patient’s vicinity must be powered via an approved isolation transformer that ensures mechanical fixing of the power cords and covering of any unused power outlets.

WARNING

Do not touch the charging contacts for the cableless transducers at the Avalon base station while you are touching the patient.)

CAUTION

Condition the battery with a monitor not currently in use. The monitor switches off automatically when there is no battery power left.

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WARNING

Use only Philips batteries part number M4605A. Use of a different battery may present a risk of fire or explosion.

Do not open batteries, or dispose of them in fire, or cause them to short circuit. They may ignite, explode, leak or heat up, causing personal injury.

If battery leakage should occur, avoid contact with skin. Refer to qualified and authorized service personnel.

Dispose of used batteries promptly and in an environmentally-responsible manner. Do not dispose of the battery in normal waste containers. Consult your hospital administrator to find out about local arrangements. Do not expose batteries to liquids.

Do not crush, drop or puncture batteries - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally.

If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not:

• discontinue use

• dispose of the battery in accordance with the disposal instructions above.

Keep batteries out of the reach of children.

CAUTION

Do not disassemble, heat above 100°C (212°F) or incinerate the batteries, to avoid the risk of fire and burns. Keep batteries out of the reach of children and in their original package until you are ready to use them.

If battery leakage should occur, use caution in removing the battery. Avoid contact with skin. Refer to qualified and authorized service personnel.

Do not install or use pre-damaged batteries.

WARNING

Alarm systems of the monitor and those of the connected OB system are independent and not synchronized.

WARNING

In INOP only mode, no fetal/maternal patient alarms are enabled or indicated.

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WARNING

Do not rely exclusively on the audible alarm system for fetal monitoring. Adjustment of alarm volume to a low level or off during monitoring may result in a dangerous situation. Remember that the most reliable method of fetal monitoring combines close personal surveillance with correct operation of monitoring equipment.

WARNING

Be aware that the monitors in your care area may each have different alarm settings, to suit different scenarios. Always check that the alarm settings are appropriate before you start monitoring.

CAUTION

In order to ensure that the settings are reset to user defaults for a new patient, always discharge the previous patient from the fetal monitor.

WARNING

Performing ultrasound imaging or Doppler flow measurements together with ultrasound fetal monitoring may cause false FHR readings, and the trace recording may deteriorate.

CAUTION

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

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WARNING

• Ensure that the conductive parts of the fetal scalp electrode and the maternal leg plate electrode do

• Indication of the heart-rate may be adversely affected by the operation of cardiac pacemaker pulses

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

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

• Do not interpret maternal movements as fetal movements.

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

not contact other conductive parts, including earth.

or by cardiac arrhythmias.

rate is higher than during stationary monitoring. The frequency of the patient's walk may be detected, and mistaken for a FHR signal.

Beware of mistaking a “doubled” maternal heart rate for FHR. In the case of a dead fetus, 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) is encouraged.

position, therefore Philips 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 (FMP Off) if the mother is walking.

• Gaps and 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.

CAUTION

Using ultrasound gel not approved by Philips may reduce signal quality and may damage the transducer. This type of damage is not covered by warranty.

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 MHR for FHR.

WARNING

Do not catheterize if placenta previa is diagnosed, or if uterine bleeding from an undetermined source is present.

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WARNING

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

WARNING

The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform.

When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g. checking ECG cable connections or adapting the fetal

ArtifactSuppress configuration).

The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e. P, QRS and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated.

WARNING

Intravenous infusion: Do not use the NBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation.

Skin Damage: Do not measure NBP in cases of sickle-cell disease or any condition where skin damage has occurred or is expected.

Unattended measurement: Use clinical judgment to decide whether to perform frequent unattended blood pressure measurements in cases of severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff.

WARNING

Do not use the thermometer in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen or nitrous oxide.

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WARNING

• Never apply the probe to the patient when the probe is not connected to the unit.

• Always use a single-use probe cover to limit patient cross-contamination.

• Measurement errors or inaccurate readings may result when:

• Insert the probe slowly and carefully to avoid damage to the ear canal and the tympanic

• Inspect the probe 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 unit, probe and accessories, refer to the cleaning

– probe covers other than the specified probe covers are used (see “Tympanic Temperature

Accessories” on page 267)

membrane.

procedures in the “Cleaning and Disinfecting” on page 246 chapter.

CAUTION

Do not use OxiCliq disposable sensors in a high humidity environment, or in the presence of fluids, which may contaminate sensor and electrical connections causing unreliable or intermittent measurements. Do not use disposable sensors when there is a known allergic reaction to the adhesive.

WARNING

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.

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WARNING

• For fully conscious pediatric or adult 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 SpO

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 at perfusion indicator values below 1.0 or signal

quality indicator below medium.

– Excessive patient movement and vibration.

WARNING

With pulse oximetry, sensor movement, ambient light (especially strobe lights or flashing lights) or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might occur when the sensor is dangling.

CAUTION

If you measure SpO2 on a limb that has an inflated noninvasive blood pressure cuff, a non-pulsatile SpO

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.

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WARNING

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.

WARNING

The fetal/maternal monitor is NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result.

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.

WARNING

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

CAUTION

Only use Philips paper. Using paper other than Philips paper may result in the failure to recover traces.

CAUTION

Ensure that you admit each patient by name, including other patient identification information, and discharge the patient when you have finished monitoring, so that you can identify which trace period (entry in the patient list) refers to which patient.

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WARNING

• Do not operate the monitor if it is wet. If you spill liquid on the monitor, contact your service personnel or Philips service engineer.

• Do not perform underwater monitoring (for example, in a bath or shower) using wired transducers.

• Place the monitor where there is no chance of contact with, or falling into water or other liquid.

• Do not dry equipment using heating devices such as heaters, ovens (including microwave ovens), hair dryers and heating lamps.

• Do not put equipment or accessories in autoclave (for sterilization).

CAUTION

Solutions: Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gasses may result.

Skin contact: To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces - wipe it off with a cloth dampened with water, after allowing the appropriate time for the agent to work, or before applying to a patient.

Hospital policy: Disinfect the product as determined by your hospital's policy, to avoid long term damage to the product.

Local requirements: Observe local laws governing the use of disinfecting agents.

Touch display: To clean and disinfect the touch-enabled display, disable the touch operation by

switching off the monitor during the cleaning procedure, or by selecting and holding the Main Screen key until the padlock symbol appears on it, indicating that touch operation is disabled. Select and hold again to re-enable touch operation.

WARNING

Do not put device and accessories in autoclave (for sterilization).

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.

Page 24

1Introduction

WARNING

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

WARNING

Reuse: Disposable accessories and supplies intended for single use, or single use only, and 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.

WARNING

Explosion Hazard: Do not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen, nitrous oxide, or in oxygen rich environment. Use of the devices in such an environment may present an explosion hazard.

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/EN 60601-1 A1:

2012.

• 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/EN 60601-1 A1: 2012. The whole installation, including devices outside of the patient vicinity, must comply with IEC/ EN 60601-1 A1: 2012. Any non-medical device, including a PC running an OB TraceVue system, placed and operated in the patient's vicinity must be powered via a separating transformer (compliant with IEC/EN 60601-1 A1: 2012) 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).

Page 25

1 Introduction

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.

CAUTION

The use of accessories, transducers and cables other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device.

WARNING

Do not use cordless/mobile phones or any other portable RF communication system within the patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system.

WARNING

For paced patients: The radiated SRR power of the CL SpO2 and NBP Maternal Cableless Measurement Devices, the CL Transmitter, 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

CAUTION

Fetal parameters, especially ultrasound and ECG, are sensitive measurements involving small signals, and the monitoring equipment contains very sensitive high gain front-end amplifiers. Immunity levels for radiated RF electromagnetic fields and conducted disturbances induced by RF fields are subject to technological limitations. To ensure that external electromagnetic fields do not cause erroneous measurements, it is recommended to avoid the use of electrically radiating equipment in close proximity to these measurements.

CAUTION

The device should not be used adjacent to, or stacked with, other equipment unless otherwise specified.

Page 26

1Introduction

WARNING

• Leakage currents: If several items of equipment used to monitor a patient are interconnected,

• ECG electrodes: NEVER allow ECG electrodes to contact other electrical conductive parts,

WARNING

The fetal/maternal monitors are NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result.

WARNING

The fetal/maternal monitors are not intended for use for ECG measurements on patients connected to external electrical stimulator or with cardiac pacemakers.

the resulting leakage current may exceed allowable limits.

including earth.

Page 27

Device Classification and Names within this Manual

New cableless measurements for fetal and maternal monitoring supplement the Avalon fetal monitor family. The Avalon CL solution consists of the Avalon CL base station, the Avalon CL transducers, and the IntelliVue CL Pods.

The IntelliVue CL Pods are only used for maternal measurements within the Avalon CL solution. To differentiate between the CL transducers and the CL Pods, the CL Pod are also referred to as maternal measurement Pods. The following table provides an overview of all the devices within the solution.

Avalon FM20/FM30 and FM40/ FM50 Wired Transducers

FM20/ FM30

M2702A and M2703A

FM40/ FM50

M2704A and M2705A

US transducer

wired

Avalon CL Base Station Avalon CL Transducers

Avalon CL Base Station

866074

Avalon CL Toco + MP Transducer

cableless

IntelliVue CL Pods

IntelliVue CL NBP Pod

cableless

M2736A

865216

866075

Page 28

1Introduction

Avalon FM20/FM30 and FM40/ FM50 Wired Transducers

Toco/ To co MP transducer

wired

M2734A and M2734B

To co + transducer with ECG/ IUP capability

wired

M2735A

Avalon CL Base Station Avalon CL Transducers

Avalon CL US Transducer

cableless

866076

Avalon CL ECG/IUP Transducer

cableless

IntelliVue CL Pods

IntelliVue CL SpO2 Pod

cableless

865215

Patient Module for ECG/IUP

866077

M2738A

Page 29

2What's New

This section lists the most important new features and improvements to the fetal monitors and their user interface introduced with Release J.3.

You may not have all of these features, depending on the fetal monitor configuration purchased.

What's New in Release J.3

Avalon CL Transducer System

The Avalon CL system provides cableless monitoring with the Avalon FM20/FM30 and FM40/FM50 with the same functionality and performance as the wired measurement devices (e.g. twin and triplets monitoring). The Avalon CL has a straight-forward handling and operating concept. The cableless transducers are assigned by simply docking them at the base station, no further configurations are necessary.

The Avalon CL system includes the following features:

2What's New

• Cableless monitoring of twins and triplets

• Cableless maternal measurement Pods CL SpO

• Maternal pulse from a CL Toco+MP (Smart Pulse) transducer

• A cableless ECG/IUP transducer measuring IUP and fetal/maternal ECG

• Watertight cableless transducers that can be used to monitor in water

• Patient call that pages an ambulating mother with an audible signal emitted by the worn CL transducers.

• Out of range audible signal emitted by the worn CL transducers to inform an ambulating mother that she is approaching the limit of the active signal area of reach.

• A transducer finder LED on all cableless transducers to help identify the assigned transducer

and CL NBP

Support For Use of Maternal Cableless Measurement Devices

The IntelliVue measurement pods are patient-worn, battery powered measurement devices for SpO2 and NBP. The devices provide measurement values on the built-in display and communicate them to

the fetal monitor using the wireless short range radio (SRR) interface of the Avalon CL base station.

Maternal Temperature Measurement

To measure maternal temperature, the new optional Tympanic Temperature device (866149) is available for the Avalon fetal monitors. The measurement data is:

• fully documented at the local recorder and the OB system,

• can be displayed as a numeric on the screen,

• and is printed out on the recorder trace strip.

Page 30

2What's New

Manually Entered Maternal Temperature Measurements

Manually measured temperatures can be entered manually into the fetal monitor and stored in the database. They are also displayed as a numeric on screen, and are printed out on the recorder trace if required.

New Design for the User Interface

The user interface for the fetal monitors has been redesigned to bring the presented information into the foreground, letting the structural elements such as keys and frames retreat into the background. Additionally special regard was given to making the "look and feel" similar to that of standard software products.

New SmartKeys

•The Start ECG SmartKey is renamed to Record ECG .

•With the transducers.

•With the the connected Avalon CL system.

•With the externally measured maternal temperature values.

Call Patient SmartKey you can now page patients who are ambulating wearing cableless

Tele Info SmartKey you can call up the Tele Info window on the fetal monitor display. In

Tele Info window you can control and view the status of the cableless transducers from the

Enter Temp SmartKey a pop-up window opens showing a numeric pad for entering

Coincidence INOP Tone

When the cross-channel verification detects that the signal of the maternal heart rate coincides with the fetal heart rate, the INOP tone has a configurable delay.

Coincidence INOP is issued with a tone at the fetal monitor. The Coincidence

Increased Internal Back-up Memory

The internal back-up memory is now able to store data at least 3 hours.

USB Interface

An optional USB interface allows the use of USB printers, bar code readers, and input devices such as a keyboard or mouse.

Flexible Nurse Call Interface

An optional Flexible Nurse Call interface allows now the connection of a nurse call device to the fetal monitors.

DHCP Support

The DHCP support offers an alternative to BOOTP. DHCP (dynamic host configuration protocol) enables the fetal monitors to request an IP address (internet protocol address) from the connected network (OB TraceVue/IntelliSpace Perinatal) automatically.

Page 31

Data Export Support

You can now export measurement values from the monitor to other devices via the LAN or RS232 interface.

NBP Configurable Measurement Sequence

Up to four measurement cycles can be set up which will run consecutively. For each cycle you can set the number of measurements and the interval between them. By setting the last cycle to run continuously you can have regular measurements continue after the sequence has run.

Alarms Enhancements

• In addition to the standard blue INOPs, some INOPs can now be configured as red or yellow INOPs to provide a severity indication ( A small number of INOPs are always yellow or red to indicate a severity corresponding to red and yellow alarms.

• For the invasive pressure measurement, the extreme pressure alarms Extreme High and Extreme Low can be made available for your monitor in Configuration Mode and are additional to the standard High and Low limit alarms.

ECG Leads Off, NBP Cuff Overpress, Cuff Not Deflated).

2What's New

•The

• In order to improve alarming on asystole under certain conditions, you can set

Review Alarms window now shows when the monitor was switched on (after being switched

off for longer than 1 minute) and any changes made to the Standby and paired status.

Asystole Detect. in

Configuration Mode to to five seconds if a valid beat-to-beat Pulse is detected from a Pressure.

Enhanced. In enhanced mode an asystole alarm will be suppressed for up

Alarm Reminder

In Configuration Mode you can set now an Alarm Reminder. The Alarm Reminder emits an audible reminder of alarm conditions that remain active after the alarm is acknowledged. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). The interval between silencing the alarm and sounding the reminder tone can be set to one, two, or three minutes.

Auto Free

In Configuration Mode you can now set an Auto Free setting which discharges a patient automatically when the fetal monitor is powered off, or is in standby mode for a set time. Only the demographic patient data is deleted, the trace data is not affected.

What's New in Release G.0

Battery Option and Patient Transport Improvements for the Avalon FM20 and FM30

• For the FM20/FM30, you can now switch between battery-powered and mains-powered operation without interrupting monitoring. The monitor is connected to the AC mains power with the external power supply.

• Traces of multiple patients can be recorded during transport and can automatically be uploaded to OB TraceVue/IntelliSpace Perinatal (Rev. G or higher) when reconnected.

Page 32

2What's New

• A bed hanger is available as a mounting option, especially for patient transport purposes within healthcare facilities.

Maternal Pulse from Toco MP Transducer

• The new Toco MP transducer can measure the maternal pulse rate, in addition to the other available sources; MECG, SpO

MP transducer, and using a measurement technology similar to SpO additional maternal pulse source for Cross-Channel Verification (CCV).

• The new Toco MP transducer is standard for the whole product family, Avalon FM20 to FM50.

, and NBP. With sensors built-into the bottom cover of the Toco

, it automatically gives you an

Non Stress Test (NST) Analysis as Clinical Decision Support (CDS) Application

• The optional NST Report Trace Interpretation feature allows you to automatically interpret FHR traces and to generate a printed NST report, equivalent to the NST report functionality in OB TraceVue Rev. F and based on the NICHD guidelines from 1997.

• The application can be adapted to domestic or hospital guidelines. A report of the NST analysis can be printed automatically or on demand.

• This software option is available for the whole product family, Avalon FM20 to FM50.

FHR Sound Source

A newly-connected fetal measurement (FHR or DFHR) automatically becomes the FHR sound source, without the need for manual intervention. If you prefer the previous behavior, this can be changed in Configuration mode (

Audio Select setting).

FHR Numeric Display

The FHR numeric display shows changes in fetal heart rate faster and is updated more frequently.

Improved FHR and DFHR Label Concept

A DFHR numeric (fetal heart rate from DECG measurement) now also has a unique number (DFHR1,

DFHR2, or DFHR3) to allow easier identification of the related trace in OB TraceVue/IntelliSpace

Perinatal.

New SmartKeys

You can control fetal heart sound volume directly with the configurable SmartKeys (FHR Vol. Up and

FHR Vol.Down) on the monitor’s screen.

Now the IUP measurement.

Toco Baseline SmartKey automatically turns into the Zero IUP SmartKey when switching to

Trace Separation On/Off Operation

Now you can switch the Trace Separation on or off in every FHR setup menu.

NBP

• To prevent the NBP measurement from being switched on or off accidentally, this operation is now only available in Configuration Mode.

Page 33

Alarms

CCV INOP

• You can enter the NBP setup menu by touching the NBP numeric (on the screen) before the first measurement is taken.

• Algorithm enhancements (more tolerant of movement artifacts).

• There is an individual Alarm Tone Volume setting for Yellow, Red and Cyan alarms.

• The new alarm settings available in Configuration Mode are:

AutoIncrease Vol and IncreaseVolDelay

– – AlarmsOffAtStart – ConfirmAlarmsOff

For a detailed description of the settings see the Configuration Guide.

There is a new INOP (technical alarm) Coincidence after 1 minute of persistent coincidence warning.

New Demographic Fields

• Date of Birth and Gestational Age can be entered for complete documentation in an NST Report (supporting the optional NST Trace Interpretation software feature).

Middle Name field is now available in the admission form - whether it appears is configurable.

•A

• Two additional ID fields names can be customized to fit hospital requirements. The default label of the

Recorder

• It can now be configured whether the recorder speed can only be adjusted in Configuration mode, or also in Monitoring mode.

• When recorder speed is changed, a new trace header is printed. Date and/or time changes are annotated in real time recording.

Stored Data Recording

Printing progress is shown while printing a trace from the internal back-up memory.

FHR Sound Volume

Volume steps are optimized in the low range to allow finer FHR sound volume adjustments.

Avalon CTS

Lifetime ID and Encounter ID can also be configured to appear, and their

Lifetime ID is MRN.

An antenna symbol is displayed next to MECG waves if an Avalon CTS is used.

Page 34

2What's New

Page 35

3Basic Operation

This chapter gives you an overview of the monitor and its functions. It tells you how to perform tasks that are common to all measurements (such as entering data, switching a measurement on, changing some monitor settings, and setting up the recorder). The alarms section gives an overview of alarms. The remaining sections tell you how to perform individual measurements, and how to care for and maintain the equipment.

3 Basic Operation

Supported Measurements

The following Fetal measurements are supported:

Fetal

Monitor or

Model

FM20

FM30

FM40

FM50

Fetal Heart Rate

(FHR) via US

(including Twins)

Standard Optional Standard - -

Optional Optional Standard - -

Standard Optional Standard Standard Standard

Optional Optional) Standard Standard Standard

Standard Optional Standard - -

Optional Optional Standard - -

Standard Optional Standard Standard Standard

Optional Optional Standard Standard Standard

Triple FHR via US Toco

FHR via Direct ECG

(DECG)

Intrauterine

Pressure (IUP)

Page 36

3 Basic Operation

The following Maternal measurements are supported:

Maternal Heart

Fetal

Monitor or

Model

FM20

FM30

FM40

FM50

Rate (MHR) via

Maternal ECG

Electrodes

Standard

Standard Standard Standard Optional (built-in) Optional (built-in) Optional

Standard Standard Standard Optional

Standard

Standard Standard Standard Standard (built-in) Standard (built-in) Optional

Standard Standard Standard Optional

Maternal ECG (MECG) Wave

Non-invasive

Maternal Pulse

from Toco

Standard Optional (built-in)

Standard Optional

Standard Standard (built-in) Standard (built-in) Optional

Standard Optional

Blood Pressure

with Pulse Rate

(cableless)

Pulse Oximetry

(Maternal SpO2)

with Pulse Rate

Optional (cableless)

Maternal

Temp er atur e

Optional (Interface cable and manual entry)

(Interface cable and manual entry)

Avalon FM20 and FM30

This section outlines the capabilities of your monitor.

Page 37

Avalon FM20

The Avalon FM20 fetal/maternal monitor provides a solution for external fetal monitoring applications, and optional noninvasive maternal vital signs.

You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity and maternal pulse using an external Toco transducer, and the maternal heart rate (MHR) with maternal ECG electrodes, and optionally, noninvasive blood pressure and maternal oxygen saturation (SpO

Measurements are displayed on a 6.5-inch color display as numerics. The display is a touchscreen, and you operate the monitor using this touchscreen interface. The integrated recorder documents fetal and maternal measurements as well as the user-defined annotations.

You can connect the monitor to an OB TraceVue/IntelliSpace Perinatal system via the RS232 connection, or over a LAN connection (with OB TraceVue Revision E.00.00 and later, or IntelliSpace Perinatal Revision H.0 and later).

Avalon FM30

The Avalon FM30 fetal/maternal monitor offers a solution for both external and internal fetal monitoring applications, and optional noninvasive maternal vital signs.

The Avalon FM30 shares all the features and capabilities of the Avalon FM20. In addition, you can monitor one FHR internally with a direct fetal electrocardiogram (DECG), uterine activity internally

using an intra-uterine pressure (IUP) catheter together with a Toco

3 Basic Operation

transducer or patient module.

FM20/30

with

Battery

Option

#E25 Only

The Avalon FM30 carries the IP label, indicating that it is capable of intrapartum monitoring.

The battery option for the FM20/30 provides support for the in-transport monitoring of all measurements when disconnected from a power supply. Existing data storage is automatically uploaded to OB TraceVue or IntelliSpace Perinatal after reconnecting it to the system. Trace printing during transport is also possible.

Page 38

3 Basic Operation

Avalon FM40 and FM50

This section outlines the capabilities of your monitor.

Avalon FM40

The Avalon FM40 fetal/maternal monitor provides a solution for external fetal monitoring applications, and noninvasive maternal vital signs.

You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity using an external Toco transducer, and the maternal heart rate (MHR) via maternal ECG electrodes, and non-invasive blood pressure and maternal oxygen saturation (SpO2).

You can connect the monitor to an OB TraceVue/IntelliSpace Perinatal system with the RS232 connection, or over a LAN connection (with OB TraceVue Revision E.00.00 and later, or IntelliSpace Perinatal Revision H.0 and later).

Avalon FM50

The Avalon FM50 fetal/maternal monitor offers a solution for both external and internal fetal monitoring applications, and noninvasive maternal vital signs.

The Avalon FM50 shares all the features and capabilities of the Avalon FM40. In addition, you can monitor one FHR internally with a direct fetal electrocardiogram (DECG), and uterine activity

internally using an intra-uterine pressure (IUP) catheter together with a Toco module.

The Avalon FM50 carries the IP label, indicating that it is capable of intrapartum monitoring.

transducer or patient

Page 39

Avalon CL Transducer System

The Avalon CL Fetal Transducer System lets you monitor the patient continuously with cableless transducers during the antepartum period, labor, and delivery. You can monitor the fetal heart rate (FHR) using noninvasive CL Ultrasound transducers, or invasively using the CL ECG/IUP transducer with the direct electrocardiogram (DECG). The uterine activity can be monitored using an external

CL Toco frequency from the CL transducers to the CL base station, eliminating the need for patient cables. With the Avalon CL Transducer System you can monitor a single fetus, twins and triplets.

MP transducer. The fetal and maternal parameters are measured and transmitted via radio

3 Basic Operation

The Avalon fetal monitor (FM20-FM50) connected to the CL base station displays and records the parameters. All the CL transducers are watertight. You can continuously monitor patients in a bath or

shower using the CL Toco

The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner, who is trained in the use of FHR monitors and in the interpretation of FHR traces.

MP and the CL Ultrasound transducers.

Getting to Know Your Avalon FM20/FM30

Overview

1 Touchscreen Display (tilt and fold)

2 Power LED

3 Paper Drawer

4 Paper Drawer release

5 Connectors

Page 40

3 Basic Operation

Right Side

with

Battery

Option

1 On/Off Switch

2 Power Connector

1 On/Standby Switch

2 MSL Connector

Left Side

1 SpO

2 Noninvasive Blood Pressure Socket

3 Fetal Sensor Sockets

Each of the fetal sensor sockets accepts any fetal transducer, one Avalon CL or one Avalon CTS Cableless Fetal Transducer System base station, or an event marker.

Socket (optional)

(optional)

Page 41

Bottom

3 Basic Operation

There are five optional interfaces available for the Avalon FM20/30 monitor:

• LAN/RS232 system interface

• Dual PS/2 interface

• MIB/RS232 interface

• Flexible Nurse Call

• USB port

You can use two of the five optional interfaces at the same time.

1 LAN/RS232 system

interface

2 Dual PS/2 system

interface

Optional Interfaces Description

Flexible nurse call interface card

USB ports

Page 42

3 Basic Operation

Rear

1 Display Release

2 Carrying Handle

3 Built-in Stand

Getting to Know Your Avalon FM40/FM50

Front

1 Touchscreen color display

2 Transparent paper guide with

tear-off edge

3 Paper eject button

4 Power LED

5 On/Standby switch

6 Recorder paper table

7 Fetal sensor sockets

8 Noninvasive blood pressure socket

9 SpO

Connect any fetal sensor or patient module at the fetal sensor sockets, including an Avalon CL or an Avalon CTS via interface cable (with red connector).

socket

Page 43

Rear

3 Basic Operation

1 Reserved for future use: protective

earth intended for use in system installations.

2 Equipotential grounding point

3 Power cord connector

4 Loudspeaker

5 Slot 01 for optional LAN/RS232

system interface (for connection to an obstetrical information and surveillance system)

6 Slot 03 reserved for future use

7 Video output (VGA)

8 Telemetry interface

9 Slot 02 for optional interfaces: Either

dual PS/2 system interface (A) for mouse and keyboard connection) Or MIB interface (B) for external touch screen connection.

Two Avalon CL, or one Avalon CTS can be also connected to the Telemetry interface sockets using the interface cable (with black connector).

Additional Optional Interfaces

Optional Interfaces Description

Flexible nurse call interface card

USB ports

Page 44

3 Basic Operation

Transducers

Toco (M2734A) and Toco MP Transducer (M2734B)

1 Transducer finder LED - lights up

on the transducer providing the measurement source

2 "MP" for M2734B "Toco MP"

transducers (additionally capable of providing the maternal pulse measurement)

3 Belt Button

1 Cable - connects to any of the

four fetal sensor sockets on the monitor

The M2736AA US transducer is identical to the M2736A US transducer, including all specifications

Ultrasound Transducer (M2736A)

Transducer with ECG/IUP capability

Toco (M2735A)

1 Connector - for connecting

ECG/IUP adapter cables

(M2735A Toco

transducer only)

Page 45

Patient Module for ECG/IUP (M2738A)

3 Basic Operation

Butterfly belt clip (shown fitted; for use with belts without button holes)

2 Close-up of MECG adapter cable

connected to Toco

3 Close-up of active finder LED

1 Connector - for connecting ECG/

transducer

IUP adapter cables (same as for

transducer)

Toco

2 Cable - connects to any of the four

fetal sensor sockets on the monitor

Page 46

3 Basic Operation

Getting to Know Your Avalon CL

Front

1 Transducer docking slots

2 On/Standby button with power LED

3 Device label

4 LED for optional cableless pods

5 Docking slots for cableless pods

WARNING

• To avoid magnetic interference affecting the mode of the pacemaker, ensure that the Avalon CL base station does not come into close contact with implanted pacemakers.

Page 47

Docking Slot for Cableless Transducers

The Avalon CL base station has three docking slots to mechanically hold the CL transducers. The flexible electronic contacts identify the transducer type after docking. The transducers are charged while docked. The base station has a built-in radio interface with an integrated antenna to communicate with the transducers for assignment, configuration, and for transducer firmware updates. The transducers can be controlled with the base station and the fetal monitor.

On/Standby Button

Pressing the On/Standby button switches the Avalon CL base station between the two modes On and Standby.

3 Basic Operation

1 On/Standby button

If you switch the base station to On, the LED button lights up green. The base station is ready for use. The CL transducers are charging. When the transducers are picked up from their docking slot, the base station sets up the radio communication to the CL transducer automatically. Wired transducers connected to the fetal monitor are disabled, and the antenna symbol for the CL transducer is displayed on the screen of the fetal monitor.

If you switch the base station to Standby, the LED button turns off. The base station is now in Standby mode. The docked CL transducers continue charging. No radio communication occurs, any existing radio communication is stopped.

If the LED of the On/Standby button turns red, it indicates a technical problem has occurred that needs your attention. Check your monitor for a possible related INOP message.

Page 48

3 Basic Operation

Docking Slots for Cableless Measurement Pods

The Avalon CL base station has one docking slot to mechanically hold an IntelliVue CL pod. The electronic contacts identify the CL pod type after docking. The CL pod is charged while docked. The LED under the docking slot indicates the battery status of the CL pod. The base station has a built-in short range radio interface with an integrated antenna to communicate with the CL pod for assignment and configuration. The CL pod can be controlled with the base station and the fetal monitor.

1 Docking slot for CL pods

WARNING

Pods, or a cl NBP Disconnect or cl SpO₂ Disconnect INOP at the fetal monitor. Correct

No Host Monitoring INOP (here the host is the fetal monitor) on the NBP or

channel configuration is important, see the Configuration Guide for details.

Page 49

Rear and Bottom

3 Basic Operation

1 Name plate

1 Manufacturer label

2 Cable reel

Page 50

3 Basic Operation

Cableless Transducers

The cableless Avalon CL transducers have a built-in radio interface with an on-board, integrated antenna. The fetal monitor connected to the Avalon CL base station can control the transducer using radio communication. The transducer transmits measured values, alarms, and status information to the fetal monitor.

The cableless transducers are assigned by simply docking them at the Avalon CL base station. If they are picked up from their docking slot at the base station, they are automatically activated.

CAUTION

To ensure the correct assignment of CL transducers to the fetal monitor in use, always dock them at the base station connected to that fetal monitor before use. This is particularly important when you add an additional CL transducer that was previously docked at another base station.

1 Transducer finder LED - lights

up on the transducer providing the measurement source.

2 CL Toco

(additionally capable of providing the maternal pulse measurement)

MP transducers

3 Belt button

CL Ultrasound transducer

Page 51

Radio Range of CL Transducers

The CL transducers have a operating range around the base station of at least 70 m in the line of sight. Obstructions as walls, metal doors, elevators and other environment structures can lead to signal loss.

The Tele symbol indicator and the Tele Info window on the monitor's display (see

Elements” on page 56

provide information on the status of the signal strength.

When a patient is approaching the end of range, the US sound is replaced by an artificial QRS sound (like DECG), and the DECG and MECG waves are no longer displayed on the monitor.

and “Tele Info Window” on page 92)

3 Basic Operation

CL ECG/IUP transducer

“Screen

Connector Cap for the CL Toco+ MP Transducer

The CL Toco+MP transducer is delivered with a connector cap covering the MECG/DECG/IUP connector. The connector cap is designed to cover the connector, not to protect it from water. (The connector itself is water-proof and may be immersed in water). You can reorder lost connector caps in a kit of 10 (989803184841).

Page 52

3 Basic Operation

Cableless Transducer LED Indication

The cableless transducers have a multi-color LED that indicates the status of the transducer with specific colors. This LED remains visible when the transducer is correctly attached to the transducer belt (Philips standard belt).

1 LED

LED Status Meaning

White The LED lights up to identify the US transducer among other US

transducers, and to easily verify the correct transducer assignment (transducer finder). The transducer finder LED is controlled by the fetal monitor. Click on the numerics to identify the corresponding US transducer.

The LED also lights up when the mother is paged with the

SmartKey.

Patient

Call

White one short blink The LED shortly lights up to indicate that the transducer

successfully opened a radio communication with the base station and that it is ready to use.

Green The LED lights up green when the transducer is fully charged and

docked at the base station.

Yellow The LED lights up yellow when the transducer is charging and

docked at the base station.

Red The LED lights up red when the transducer is out of battery and

has to be recharged.

Cyan The LED lights up cyan to indicate a technical problem that needs

your attention. Check your fetal monitor for a related INOP.

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CL Transducer Battery

Battery replacement is recommended after 500 charge/discharge cycles *2) or if the battery is older than 4 years whatever is reached first. If the battery of a cableless transducer has aged and an exchange of the battery is highly recommended, a prompt message is displayed at the fetal monitor for ca. 60 seconds. The prompt is repeated whenever the replaced.

Depending on the transducer type the following messages are displayed:

cl US battery has aged. Replacement strongly recommended

cl Toco battery has aged. Replacement strongly recommended

cl ECG/IUP batt has aged. Replacement strongly recommended

If you are getting this message contact your service personnel so they can replace the CL transducer's battery.

The date of manufacture and number of charge/discharge cycles can be inquired on the connected fetal monitor.

3 Basic Operation

Tele Info window is opened until the battery is

For battery cycle and battery life specification of the CL pods (NBP and SpO Service Guide of the Cableless Measurements.

Charge Cycle

The CL transducer batteries are designed for frequent recharging. A complete charging cycle is only reached and counted, when all recharging periods equal a 100% charge (900 mAh equal 8 hours continued operation).

Audio Signal CL Transducers

The Avalon CL transducers have two audio signals:

• If a tone sequence is played, the transducer was triggered by the fetal monitor to page the patient wearing it, or to locate a not docked transducer.

• An INOP tone indicates that the transducer has detected a technical problem (INOP). Check your fetal monitor for a related INOP message.

) please refer to the

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3 Basic Operation

CL Pods

The two CL Pods provide measurement values for SpO2 and NBP on the built-in display, and communicate them to other system components using a wireless short range radio (SRR) interface.

They are controlled with SRR from the Avalon CL base station and the connected fetal monitor.

The maternal measurement pods are easily assigned by docking them at the Avalon CL base station.

CL NBP Pod

The SpO the device to a patient:

Pod and the NBP Pod have an LCD display and three keys for basic operation e.g. to assign

CL SpO

1 Integrated LCD display

2 Hard keys

3 Measurement identifier

Pod

For further operational details read the IntelliVue Cableless Measurements Instruction for Use.

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Battery Status LED for CL Pods

The CL Pods do not have their own battery status LED. On the Avalon CL base station the battery status LED for the CL Pods is located directly under the docking slot.

1 Battery status LED for CL Pods

The battery status LED shows five different states:

Status Meaning

Green The docked CL Pod is fully charged.

Yellow The docked CL Pod is charging.

Yellow blinking The communication is established with the docked CL Pod.

Cyan Indicates that the docked CL Pod or the charging slot has a technical

problem that needs your attention. Check your fetal monitor for a related INOP message.

Off The battery status LED is off, when no CL Pod is docked.

3 Basic Operation

Audio Signal

The Avalon CL base station has audio signals to let you know when a transducer's battery has to be recharged, or if the base station cannot set up radio communication with a CL transducer or a CL Pod. Only active CL transducers and CL Pods emit an audio signal.

• If the base station issues a descending tone sequence, the attempt to set up radio communication to a CL transducer or a CL Pod has failed.

• If an interval tone is played, the battery of one or more the CL transducers or CL Pods need to be recharged.

Operating and Navigating

Your monitor has a touchscreen. Everything you need to operate the monitor, except the on and off switch, is contained on its screen. Most screen elements are interactive. Screen elements include measurement numerics, screen keys, information fields, status indicators, alarms fields, and menus.

Operator

Position

The typical operator's position is in front of the monitor.

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3 Basic Operation

FM40/50

If an optional external touch display is connected to the monitor, you can operate the monitor using the external touch display.

Screen Elements

Monitor Information Line

1 Monitor Information line

2 Measurement area

3 Key area

1 LAN connection status indicator

only. RS232 system connection is not indicated. The train icon indicates if the fetal monitor is connected to OB TraceVue/IntelliSpace Perinatal, via a LAN cable or not.

2 Patient identification

3 Date and time

4 Bed label (when connected to a

Philips OB TraceVue/IntelliSpace Perinatal system)

5 Fetal heart sound volume adjust/

indicator

6 Alarm volume adjust/indicator

7 INOP and alarm status area - shows

active alarm messages

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Measurement Area

3 Basic Operation

1 Antenna symbol (indicates a cableless measurement from a connected Avalon CL or Avalon CTS

system).

2 Configurable alarm limits

3 NST test

4 Audio source symbol

5 Measurement numeric

6 Alarms off symbol

7 Fetal trace recorder - status indicator

8 Avalon CL or Avalon CTS system - status indicator

9 Battery status indicator

10 Status line - shows status and prompt messages

11 Signal quality indicator: good, acceptable, poor

12 Fetal heart rate measurement label

13 Measurement unit (configurable)

14 Cross-Channel Verification symbol (see “Cross-Channel Verification (CCV)” on page 149)

15 NST timer, if configured (default is Off)

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3 Basic Operation

Screen Details

Icon Description

The antenna symbol indicates a cableless measurement (Avalon CL or Avalon CTS).

Indicates a short range radio measurement (IntelliVue CL Pods).

Signal quality indicator:

1 Good

2 Acceptable

3 Poor

Fetal trace recorder - status indicator

Fetal recorder is on

Fetal recorder is off (when

Paper Save Mode is off)

Paper Save Mode is on)

There is a user-solvable recorder error (paper out, paper jam, wrong paper scale set)

Fetal recorder is defective: call service

Avalon CL or Avalon CTS system - status indicator: An interface cable is connected to the monitor, a base station is connected, powered on, and at least one cableless transducer has been taken from the base station and is active. Any connected wired transducers are disabled.

An interface cable is connected to the monitor, the base station is connected, powered on, and cableless transducers are ready to use, but no cableless transducers are currently active (all are still docked at the base station).

An interface cable is connected to the monitor, but the base station is not connected to the interface cable, or it is disconnected from AC mains, or is in Standby mode.

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Icon Description

The CL transducer is moved away from the base station approaching the limit of the area of reach. The US sound is replaced by an artificial QRS sound (like DECG). The DECG and MECG waves are no longer displayed.

Key Area

3 Basic Operation

1 SmartKeys - these

can vary according to your monitor's configuration

2 Main Screen -

which closes all open menus and windows and returns to main screen

Keys

The monitor has three different types of keys.

Permanent Keys

A permanent key is a graphical key that remains permanently on the screen, giving you fast access to functions.

Key Name Function

3 Scroll to display

more SmartKeys

4 Silence - key

which acknowledges all active alarms by switching off audible alarm indicators

Silence Acknowledges all active alarms by switching off audible

alarm indicators.

Main Screen Closes all open menus and windows and returns to the

main screen.

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3 Basic Operation

SmartKeys

SmartKeys are configurable graphical keys, located at the bottom of the main screen. They give you fast access to functions. The selection of SmartKeys available on your monitor depends on your monitor configuration, and on the options purchased.

SmartKey Name Function

Main Setup Enters main setup menu

Pause Alarms Pauses alarm indicators. Pause duration depends on

monitor configuration. If the pause duration is infinite, this key is labeled

Alarms Off

Select again to immediately re-enable alarm indicators

Start Recordng Turns the trace recorder on

Record ECG Wave Starts printing the MECG, DECG or both waves, when

both are available

Patient Demogr. Enters the patient identification menu to admit/discharge

QuickAdmit Quick admits the patient for monitoring

Toco Baseline Resets Toco baseline

Zero IUP Zeros IUP measurement

Start/ Stop • Starts/stops manual noninvasive blood pressure

measurement

• Starts auto series

• Stops current automatic measurement within series

Start NBP • Starts manual noninvasive blood pressure

measurement

• Starts auto series

Repeat Time Sets the time interval between two noninvasive blood

pressure measurements

Sound Vol. Up Increases the fetal heart rate volume

Monitor Standby Enters the Standby mode, suspends monitoring. All

numerics and waves disappear from the display. All settings and patient data information are retained

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SmartKey Name Function

Recorder Start/ Stop Turns the trace recorder on or off

Paper Advance Advances the paper automatically to the next fold

Stop Recordng Turns the trace recorder off

Stored Data Rec Prints trace data from the monitor's memory

Enter Notes Enters notes

Timer Enters NST timer window

Set Marker Marks an event

3 Basic Operation

Stop All Stops all noninvasive blood pressure measurements

Stop NBP Stops manual noninvasive blood pressure measurement

Stops current automatic measurement within series

NBP Modes Access NBP mode selection and setup, with direct start/

stop function

Defaults Loads User Default

Sound Vol. Down Decreases the Fetal Heart Rate volume

NST Report Initiates an NST trace interpretation and obtains a Non-

stress test (NST) report

Call Patient Pages the patient. Only enabled if at least one

CL transducer is currently active

Tele Info Calls up the Tele Info window

Enter Temp Allows the manual input of the patient's temperature

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Pop-Up Keys

Pop-up keys are context-sensitive graphical keys that appear automatically on the monitor screen when required. E.g. the

Confirm pop-up key appears when you need to confirm a change.

Using the Touchscreen

Select screen elements by pressing them directly on the monitor's screen.

Disabling Touchscreen Operation

1 To temporarily disable the touchscreen operation of the monitor, press and hold the Main Screen

permanent key for about three seconds. A red padlock will blink on the key.

2 Press and hold the Main Screen permanent key again for about three seconds to re-enable the

touchscreen operation.

Operating Modes

Main Screen permanent

When you switch on the monitor, it starts up in Monitoring Mode. To change to a different mode:

1 Select the Main Setup menu.

2 Select Operating Modes and select a mode.

Your monitor has four operating modes. Some are passcode protected.

Mode Description Password

Protected

Monitoring Mode The Monitoring Mode is the normal operating mode to

monitor patients. You can change elements such as alarm limits. When you discharge the patient, these elements return to their default values.

You cannot select or change grayed out items. These items are for your information only. To change these items, switch to the Configuration Mode.

Demo Mode The Demo Mode is used for demonstration and training

purposes. Do not change into Demo Mode during monitoring. When transducers are connected to the monitor and the recorder is on, a demo trace is recorded. But the demo trace is not transmitted to an information and surveillance system such as OB TraceVue/IntelliSpace Perinatal.

yes

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3 Basic Operation

Mode Description Password

Protected

Configuration Mode The Configuration Mode is for personnel trained in

configuration tasks. You can change and store the default values and patient profiles permanently in the Configuration Mode. These tasks are described in the Configuration Guide. During installation, the fetal monitor is configured for use in your environment. This configuration defines the default settings you work with when you switch on the fetal monitor.

Service Mode The Service Mode is for trained and authorized service

personnel only.

A field displayed at the fetal monitor screen indicates if the monitor is in Demonstration Mode, Configuration Mode, or Service Mode. To change to a different mode, select this field.

Automatic Screen Layouts

Your monitor's preconfigured screen layouts define how measurement information is arranged on the screen. The monitor automatically applies the correct screen layout for the measurements you are monitoring. No user action is required.

Connecting or disconnecting transducers, or switching the noninvasive blood pressure measurement on or off, results in an automatic adjustment of the screen layout. When a measurement is off, its numerics are removed from the monitor's screen. The monitor stops acquiring data and generating alarms for this measurement. If you disconnect a transducer while it is performing a measurement, the monitor issues a disconnect INOP (and in the case of SpO

question mark).

yes

, replaces the measurement numeric with a

Settings

This section describes the various settings available on the monitor.

Active Settings

What the monitor displays, and the way it operates, is controlled by its settings. They determine screen content, layout, high and low alarm limits and so forth.

The "active settings" are the current settings the monitor uses, including any adjustments made by the last user. Active settings are not permanent, but are retained after a loss of mains power.

There are also two preconfigured default settings:

•User Default

•Factory Default

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3 Basic Operation

User Default

The User Default is a complete configuration stored in the monitor's long-term memory. You can store the active settings, modified to your preference, in the User Default (in Configuration Mode).

In monitoring mode, you can load the User Default settings to return to your preferred settings:

1 Select the Defaults SmartKey

2 Select Confirm in the dialog box to load the User Default.

Factory Default

The Factory Default is a complete configuration pre-defined at the factory. You cannot modify it. In Configuration Mode, you can load the Factory Default as the active settings.

CAUTION

This resets all settings to factory defined values, but be aware that some values will differ from those with which the fetal monitor was originally shipped from the factory (recorder speed and paper scale type will need to be corrected, for instance). After loading the Factory Default, check the settings and, if necessary, change them to the settings you normally use.

You can use the Factory Default as the basis for producing your User Default. See the Service Guide for details.

Global Settings

General monitor configuration settings are stored in the Global Settings. These include settings for line frequency, QRS type, and whether the monitor is automatically reset to the User Default after a power interruption of more than one minute. You can change the Global Settings in Configuration Mode.

Changing Measurement Settings

Each measurement has a setup menu in which you can adjust all of its settings. You can enter a setup menu:

1 with the measurement numeric - select the measurement numeric on the screen to enter its setup

menu. For example, to enter the

2 with the Main Setup SmartKey - if you want to setup a measurement when the measurement is

switched off, use the measurement name from the pop-up list. With this SmartKey you can access any setup menu in the monitor.

This guide always describes the entry method using the measurement's setup menu. You can use the method you prefer.

Main Setup SmartKey and select Measurements. Then select the

Setup FHR1 menu, select the FHR1 (fetal heart rate 1) numeric.

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Switching the Noninvasive Blood Pressure Measurement On and Off

The noninvasive blood pressure measurement is the only measurement that you can manually switch on and off. To do this:

1 Enter the noninvasive blood pressure measurement's setup menu.

2 Select NBP to toggle between on and off. The screen display indicates the active setting.

Changing Monitor Settings

To change monitor settings such as brightness, or touch tone volume:

1 Enter the Main Setup menu.

2 Select the setting you want to change, or select User Interface to enter a sub menu where you can

change user interface settings.

Adjusting the Screen Brightness

1 Enter the Main Setup menu.

2 Select User Interface.

3 Select Brightness.

4 Select the appropriate setting for the screen brightness. 10 is the brightest, 1 is the least bright.

Optimum is suitable for most situations.

Adjusting Touch Tone Volume

The touch tone is the tone you hear when you select any field on the monitor screen. To adjust the touch tone volume:

1 Enter the Main Setup menu.

2 Select User Interface.

3 Select Touch ToneVolume, then select the appropriate setting for the touch tone volume: 10 is the

loudest and 1 is the quietest. Selecting zero switches the touch tone volume off.

Setting the Date and Time

The current date and time is displayed in its own element in the information section of the monitor screen.

1 Select the date and time screen element from the monitor's information line to enter the Date,

menu.

Time

2 Select, in turn, the Year, Month, Day, Hour (in 24 hour format) and Minute, as necessary.

3 Select Store Date, Time to change the date and time.

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3 Basic Operation

WARNING

When disconnected from AC power, the monitor retains the date and time setting for at least two months. If the monitor is off longer than two month, and the operating system detects that the date and time settings are invalid, the monitor initiates a "cold" start and sets the date to 1 Jan 1997 and the time to 00:00.

Checking Your Monitor Revision

1 Select Main Setup, Revisions to open the Monitor Revision menu.

2 From the Monitor Revision menu, select the monitor component for which you need revision

information.

Preparing to Monitor

Confirm fetal life before you begin fetal monitoring. Familiarize yourself with the basic operation principles before you start to monitor.

CAUTION

Check the fetal monitors housing for damage before you start to monitor as part of your safety precautions.

After you switch on the monitor:

1 Check that you have the correct patient cables and transducers plugged in for the measurement

you want to monitor.

2 If you use an Avalon CL or Avalon CTS system, check if the cableless transducers are ready and

charged (apparent by either a lit up green or yellow LED indicator).

3 Admit your patient to the monitor (see “Admitting a Patient” on page 135).

4 Check that the alarm limits, alarm and fetal heart rate volumes, patient category, and so forth are

appropriate for your patient. Change the settings if necessary.

5 Refer to the appropriate measurement section for details of how to perform the measurements

you require.

6 Start recording.

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Switching On: FM20/FM30

FM20/30 1 Connect the monitor to AC mains and switch the monitor on.

– The green power-on LED lights up. – The monitor performs a self-test as it starts up.

for the software and firmware are printed on the fetal trace paper (if recorder

configured to – The monitor display comes on. – There is a start-up tone from the loudspeaker.

On).

3 Basic Operation

Selftest: OK, the serial number, and revisions

Auto Start is

FM20/30

Battery

Option

• If this option has been chosen, the green power-on LED on both the external power supply and the battery LED indicator will light up.

Switching On: FM40/FM50

FM40/50 1 Connect the monitor to AC mains.

– The green LED lights up.

2 Press the On/Standby switch.

– The monitor performs a self-test as it starts up.

for the software and firmware are printed on the fetal trace paper (if recorder configured to

On).

Selftest: OK, the serial number, and revisions

Auto Start is

– The monitor display comes on. – There is a start-up tone from the loudspeaker.

Adjusting the Display Angle (FM20/FM30)

FM20/30 You can tilt the display on the FM20 and FM30 to one of five different positions, or you can fold it

completely down. The tilt/fold mechanism works on a one-way ratchet system. You hear a click as each of the five positions is reached. The screen can be folded back down only after tilting the display forwards as far as it will go.

To tilt the display from the folded position:

1 Unlock the display by releasing the catch.

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3 Basic Operation

3 To fold the display, pull the display forwards as far as it will go

Lift the display forward. You will hear a click as the first position engages. If you want to tilt the display further, lift the display further forward until you reach the desired angle.

4 Then push the display all the way back until it clicks shut.

If your monitor is wall-mounted, the display should be folded flat.

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Fastening Belts and Transducers

You can use more than one belt if, for example, you are monitoring uterine activity and FHR simultaneously. There are two basic ways to fasten belts and transducers:

• Belts with button fixings.

• Velcro belts together with the butterfly belt clip.

What You Need

• Ultrasound transducer

• Toco MP or CL Toco

•Ultrasound gel

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

Using Belts with Button Fixings

1 Place the transducer belt across the bed, so that the fixing button will face away from the mother

when it is fastened.

2 Lie the patient on the bed and arrange the belt around her until it is tight but still comfortable.

MP transducer

3 Basic Operation

3 Fasten the belt by pushing the fixing button through the overlapping section of the belt. Ensure

that the fixing button and the loose ends of the belt are at the patient's side.

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3 Basic Operation

When you have positioned a transducer satisfactorily, you can attach it to the belt by pushing the belt button on the transducer through one of the holes in the belt.

5 Alternatively, attach the butterfly belt clip to the transducer belt button and use this to attach the

transducer to the belt. The clip allows you to slide the transducer for easy repositioning.

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Using CL Transducers with a Belt Clip

The Avalon CL transducers have their own belt clip. They can be optional ordered in a kit of 10 (989803184851).

3 Basic Operation

1 Avalon CL belt clip

Using Belt with Velcro Fixings

Insert one end of the belt between the belt guides on one side of the butterfly belt clip, and secure with the velcro fixing. Insert the other end of the belt between the belt guides on the other side of the butterfly belt clip, adjust for the correct tension, then secure with the velcro fixing.

1 Vel cro fix ing

2 Belt guides

3 Ve lcr o fixing

WARNING

When connecting devices for acquiring measurements, always position cables and NBP tubing carefully to avoid entanglement or potential strangulation.

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3 Basic Operation

Repositioning Transducers

A patient possibly wears transducers for long periods without interruption. In rare cases, skin irritations may occur if a transducer is attached to one location for a longer period. To ensure there are no adverse effects on the patient's skin, inspect the transducer application site at least every three hours. If the skin quality changes, move the transducer to another site.

The ultrasound transducer is often repositioned to follow the fetal heart as part of the normal monitoring process, but this is not so for the Toco transducer. Therefore, remember to check its application site (between contractions) at least every three hours.

To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to remain on the transducer. Follow all instructions that accompany the specific cleaning and disinfecting agents you are using. Remove agent residues with a cloth dampened in water before applying a transducer to a patient.

See “Care and Cleaning” on page 245 for further information, and a list of approved agents.

Connecting a Transducer to the Monitor

1 SpO

2 Noninvasive blood pressure socket

3 Fetal sensor sockets

socket

You can plug a fetal transducer, an ECG/IUP patient module, an Avalon CL or Avalon CTS Cableless Fetal Transducer System interface cable (red connector), or an external event marker into any of the four fetal sensor sockets marked by the fetal icon, or "Fetal Sensors" (depending on geography).

For measuring maternal SpO SpO

icon or "SpO2" (depending on geography).

, connect the sensor to the socket marked with the

For maternal non-invasive blood pressure, connect the cuff to the socket marked with the NBP icon or "NBP" (depending on geography).

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For the FM20 and FM30, you can connect an Avalon CL Cableless Fetal Transducer system interface cable (red connector) to one of the fetal sensor sockets at the left side of the monitor.

For the FM40 and FM50, you can connect an Avalon CL or Avalon CTS Cableless Fetal Transducer System interface cable (black connector) to one of the two dedicated black sockets marked "Tele" at the rear of the monitor, as an alternative to using one of the fetal sensor sockets (red connector) at the front.

What You See on the Monitor

When you connect a transducer or sensor, the measurement numeric appears on the screen.

3 Basic Operation

1 Interface cable to Avalon CL and

Avalon CTS Cableless Fetal Transducer System.

2 Connect the black connector to one

of the two black sockets (marked "Tele") on the rear of the monitor.

for FM20/FM30

for FM40/FM50

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, when monitoring triplets, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second FHR2, and the third FHR3. See also chapters “Monitoring Twin FHRs” on page 171 and “Monitoring Triple FHRs” on page 179.

When you touch a measurement numeric on the screen, the setup menu for that measurement opens. The fetal sensor socket to which the transducer for this measurement is connected is identified by the transducer position indicator in the blue setup menu header.

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3 Basic Operation

The blue finder LED on a wired fetal transducer lights up when you touch the measurement on the screen, allowing you to identify the corresponding transducer.

The white finder LED on a cableless fetal transducer lights up when you touch the measurement on the screen, allowing you to identify the corresponding transducer.

1 Finder LED

The recorder prints an annotation showing the date, time, paper speed, and monitoring mode. It repeats this every 10 minutes.

Start Recording

Checking/Setting Paper Scale

You can check the paper Scale Type (US for USA, or Internat'l for other geographies) in the Fetal

Recorder

them. They can be changed in Configuration Mode, see the Configuration Guide.

menu. In Monitoring Mode, you can see these settings (grayed out), but you cannot change

1 Finder LED cableless transducer

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Paper Guide FM40/FM50

FM40/50 The recorder in the FM40 and FM50 features a transparent paper guide which:

• facilitates correct alignment of the paper, both during loading and while the recorder is running. See “Loading Paper FM40/FM50” on page 84.

• incorporates a tear-off edge, which not only allows you to tear off the trace paper where you like (not necessarily at a fold), but also helps to avoid paper misalignment while doing so (see “Tearing Off the Paper” on page 80).

• is removable (see “Removing the Paper Guide: FM40/FM50” on page 250).

Switching the Recorder On and Off

In addition to the normal recording of real-time traces, you will sometimes see a trace recovery printout from the monitor's internal backup memory at high speed when the recorder is started. For details, see “Recovering Traces on Paper” on page 241.

For an explanation of the various symbols that can appear on the trace recording, see “Recorder Specifications” on page 284.

3 Basic Operation

To switch the recorder on, select in SmartKeys:

Start/ Stop or Start Recordng.

Main Setup the menu item Fetal Recorder, or press one of the

The "recorder on" status indicator is displayed in the bottom right-hand corner of the screen when you switch on the recorder.

The paper advances quickly for 2 cm and then returns to the set speed. Whenever the recorder is switched on, a trace header is printed vertically on the trace paper, containing the following:

Selftest: OK: confirmation that the monitor's self-test completed successfully, and that it is ready

• to use.

• the software revision and firmware revision

•the serial number

•the time

•the date

• patient name and medical record number (if entered)

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3 Basic Operation

•the Recorder Speed

1 Fetal heart rate label

2 Uterine activity label

The current monitoring modes (if any transducers are connected to the monitor) are printed. Whenever a transducer's mode is changed, the following are printed:

•the time

•the date

• trace identification symbols

•the

Recorder Speed

The monitor prints the time, date, Recorder Speed, and monitoring modes in the trace header when first switched on, in a periodic time stamp every ten minutes after, and if the monitoring modes change. The time stamp begins with the symbol shown below. The data is reprinted in the header if the

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3 Basic Operation

time and date are locally adjusted, or if an OB system is connected that readjusts the time and date automatically.

1 Time stamp printed every ten

minutes

The trace records maternal parameters also. When measuring noninvasive blood pressure, the annotation is made at the end of the measurement. If the noninvasive blood pressure measurement repetition time is short, the noninvasive blood pressure numeric may not always be printed.

The recording of notes (see “Entering Notes” on page 88) or time/date information may be interrupted by connecting, or unplugging a transducer, or by a change in measurement-related setting (for example, artifact suppression, Toco sensitivity, or alarm settings).

A new patient admission or a change to the paper scale setting stops all annotations, and prompts a new vertical trace header to be printed.

To switch off the recorder:

1 Either select Start/Stop from the Fetal Recorder menu.

2 Or press one of the SmartKeys (depending on configuration): fetal recorder Start/ Stop or Stop

Recordng

If your recorder is configured with

Confirmed Stop on (a Configuration Mode setting), you will

need to confirm that you want to stop the recorder, before it will stop.

When the recorder is off, the "recorder off" status indicator is displayed in the bottom right-hand corner of the screen: When the and when

Paper Save Mode is On the icon shows a paper trace icon.

Paper Save Mode is set to Off the paper icon shows an x mark,

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3 Basic Operation

Recording Elements

The trace paper of the recorder has much information printed on it. Here is an exemplary trace with the most common print outs and their meaning. Each trace header contains the last name and first name, the patient ID, patient date of birth, the current date and time, patient's bed label, and the gestational age of the pregnancy.

1 Name, patient ID, date of birth, current date and time

2 Recorder Speed

3 Gestational age and patient bed label

4 FMP - Fetal Movement Profile

5 Other measurement for the patient such as temperature, arterial oxygen saturation, and pulse.

6 Entered notes such as patient repositioned, or MD notified, or others

7 Time stamp

8 Trace separation

9 Recorder Speed

10 Maternal ECG

11 Direct ECG

12 Coincidence of heart rate detected

13 HR with Cross Bell

14 Alarm Limits

15 DFHR2 (second fetal heart rate from DECG)

16 FHR1 (first fetal heart rate)

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Choosing Paper Speed

You can choose a Recorder Speed of 1, 2, or 3 centimeters per minute (cm/min). The default setting is 3 cm/min.

The ACOG technical bulletin on FHR monitoring states that "accurate pattern recognition is difficult if not

impossible at 1 cm/min and that 1 cm/min is only recommended for more economic screening. When FHR abnormalities arise, the faster paper speeds will enhance FHR pattern recognition".

3 Basic Operation

Additionally, because a change in trace, you are advised to ensure ALL monitors in your institution are set to the same speed.

To set the

Recorder Speed (in Configuration Mode) see the Configuration Guide.

Advancing the Paper

You can advance the paper automatically to the next fold by pressing the Paper Advance SmartKey at any time except during a stored data recording. This is also possible using the

Marking an Event

You can record significant events on the trace paper (for example, when pain medication is administered or when the mother changes position). The mother can use the remote event marker to mark events herself. You connect the remote event marker to any free fetal sensor socket.

To mark an event on the trace paper you can:

1 Either select the Set Marker SmartKey.

Recorder Speed results in a change in the appearance of an FHR

Fetal Recorder menu.

2 Or press the button on the remote event marker. The remote event marker is connected to the

monitor via any fetal transducer socket.

A small arrow is printed on the heart rate scale on the trace paper.

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3 Basic Operation

This reflects exactly when the marker button was first pressed; keeping the button pressed has no influence on the annotation.

Tearing Off the Paper

CAUTION

Never pull on the paper to advance it, as this can cause misalignment of the paper. Always tear off the paper along the perforation.

FM40/FM50 The recorder's paper guide incorporates a tear-off edge, allowing you to tear off the trace paper cleanly

where you like (not necessarily at a fold). When not using the paper guide, always tear off the paper along the perforation.

To tear off the trace paper after monitoring using the paper guide:

1 If the recorder is running (the "recorder on" status indicator is displayed), turn off the recorder by

selecting the fetal recorder

Start/ Stop SmartKey or the Stop Recordng SmartKey.

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3 Basic Operation

Tear off the paper as shown in the picture. To ensure a clean tear, always tear in an upwards

motion, as indicated by the arrows. You can start tearing from the left or right (right-handed user shown). You may want to use both hands to guarantee that the paper is not misaligned during the tear off.

3 If you wish to tear off the paper at a fold, select the Paper Advance SmartKey, wait for the paper

to stop, then tear it off.

FM20/FM30 The FM20/FM30 does not have a paper guide. The procedure is the same as described for the FM40/

FM50 with the exception that you should advance the paper to a perforation.

If you wish to tear off the paper at a perforation, select the

Paper Advance SmartKey, wait for the

paper to stop, then tear it off.

Paper-Out Indication

Each pack of paper has 150 pages. The monitor issues a paper-out warning in the status line at the bottom of the screen, when there are five pages to go. If you switch on the recorder or press the paper advance key when there are fewer than five pages remaining, it may take two pages before the alarm is activated. Load a new pack in time.

If the recorder runs out of paper, an audible paper-out alarm is sounded, if so configured. See “Loading Paper FM40/FM50” on page 84and “Loading Paper FM20/FM30” on page 82 to learn how to reload paper.

Fetal traces continue to be recorded into the monitor's backup memory, and can be retrieved and printed completely if new paper is loaded within one hour, when the enabled in Configuration Mode. See “Recovering Traces on Paper” on page 241 for further information.

Bridge Paperout setting is

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3 Basic Operation

Loading Paper FM20/FM30

CAUTION

Using recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead. This type of damage is not covered by warranty.

FM20/FM30 To load a pack of paper:

1 If the recorder is on, press the recorder Start/ Stop SmartKey or the Stop Recordng SmartKey to

turn it off before loading a new pack of paper.

1 Press the paper table release to unlock the paper drawer and then pull the table forward to open it

fully.

2 Lift out any remaining paper from the tray.

3 Prepare to place the new pack of paper in the tray with the bottom side down. The bottom side is

indicated by the word STOP printed on the final page of the new pack.

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Unfold the top page of the pack and position the uterine activity scale on the right.

3 Basic Operation

5 Slide the pack into the tray.

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3 Basic Operation

7 Press the recorder Start/ Stop SmartKey or the Start Recordng SmartKey to switch on the

Push the paper drawer back until it "clicks" closed.

recorder.

Annotations of trace information are printed on the trace paper (see “Switching the Recorder On and Off ” on page 75 for details).

Loading Paper FM40/FM50

CAUTION

Using recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead. This type of damage is not covered by warranty.

FM40/FM50 To load a pack of paper:

1 If the recorder is on, press the Start/ Stop Rec SmartKey or the Stop Recordng SmartKey to turn

it off before loading a new pack of paper.

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3 Basic Operation

Press the paper eject button to open the paper drawer.

3 Lift out any remaining paper from the tray.

4 Press and hold the paper eject button to partially eject the paper, thus making it easier to remove.

5 Hinge the transparent paper guide forward. It is held in the closed position by a small protrusion

on each side of the holder.

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3 Basic Operation

7 Prepare to place the new pack of paper in the tray with the bottom side down. The bottom side is

8 Unfold the top page of the pack and position the uterine activity scale on the right.

A - Protrusion holds paper guide in closed position.

indicated by the word STOP printed on the final page of the new pack.

9 Slide the pack into the tray.

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Feed the paper evenly through the paper guide. Do not close the paper guide yet.

11 Close the paper drawer.

3 Basic Operation

12 Now close the paper guide.

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3 Basic Operation

Annotations of trace information are printed on the trace paper (see “Switching the Recorder On and Off ” on page 75 for details).

Press the recorder Start/ Stop SmartKey or the Start Recordng SmartKey to switch on the recorder.

Entering Notes

Your monitor has a set of 15 factory pre-configured notes (see below). The maximum length of one single note is 30 characters. It is possible to edit the notes in Configuration mode (see the Configuration Guide).

To enter a note:

1 Press the Enter Notes SmartKey to open the Enter Note menu.

2 Scroll if necessary, then select the note you wish to enter. A confirmation dialog box opens:

3 Select Confirm to enter the note. The note is then shown in the status line of the display, and is

annotated on the fetal trace if the fetal recorder is on.

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3 Basic Operation

By default, notes are printed lengthwise in the direction of the trace, in the space between the FHR

grid and the uterine activity grid. If you prefer, you can configure the recorder to print across the trace.

5 You can change this in Configuration Mode by changing the Notes Recording setting in the Fetal

Recorder

menu from Along (default) to Across (notes print width wise across the trace).

The following are the pre-configured notes from which to choose:

1 Patient Repositioned

2 Vaginal Examination

3 MD Notified

4 Sitting

5 On Back

6 Left Lateral

7 Ambulating

8 Tocolytic Given

9 Membranes Ruptured

10 Amniotomy

11 Amniotic Fluid Clear

12 Amniotic Fluid Not Clear

13 Oxytocin

14 Urinary Catheter

15 Micro Blood Analysis

Up to two notes can be printed directly, and the monitor can temporarily store up to a further two notes, and these are printed after the first two have been recorded. Any further notes are discarded. For example, if you enter six notes in quick succession, the first two notes you entered are recorded right away, the next two are stored in memory and then printed when the first two have been recorded, and the last two are discarded.

If the printing of two notes happens to coincide with the regular recording of the time stamp that takes place once every ten minutes, the time stamp is delayed until the notes have finished printing.

Signal Quality

During monitoring, if the fetal heart rate signal quality fluctuates, and becomes poor, it does not necessarily mean that the transducer needs repositioning. The fluctuation may be caused by fetal movement. Allow time for the signal to stabilize before deciding whether to reposition the transducer (ultrasound), or apply a new electrode (ECG). For the best trace quality, the signal quality indicator should be full, indicating good signal quality, even though it may be possible to make traces at a lower signal quality level.

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3 Basic Operation

Cableless Monitoring

Basics of Cableless Systems

The fetal monitors FM20/FM30 and FM40/FM50 are compatible with the Avalon CL and Avalon CTS Cableless Fetal Transducer system. Regard the following points for cableless monitoring:

• You can connect one Avalon CL with a red connector to a FM20/FM30 or a FM40/FM50 (fetal socket).

• You can connect up to two Avalon CLs with a black connector to a FM40/FM50 (Tele socket).

• You can connect one Avalon CTS system to a FM20/FM30 or FM40/FM50 at a time (either fetal or Tele socket).

•You cannot connect Avalon CTS and an Avalon CL at the same time to the same fetal monitor.

• Monitoring multiple pregnancy using cableless transducers is supported by the Avalon CL system only.

• Using a mixture of wired and cableless fetal transducers is not supported. You can use either wired or cableless fetal transducers.

• If you cannot get sufficient signal quality using Avalon CTS transducers, switch to wired transducers.

Avalon CL Transducer System Avalon CTS Transducer System

Assigning Cableless Transducers

The cableless transducers of the Avalon CL are assigned by simply docking them at the base station connected to the patient’s fetal monitor. See the Avalon CTS Instruction for Use for the assignment of the cableless transducers of this system.

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Activating Cableless Transducers

The CL transducers of the Avalon CL are activated by picking them up from the base station. If the CL transducer is activated, an antenna symbol is displayed on the fetal monitor screen next to the numeric of the measurement. See the Avalon CTS Instruction for Use for the activation of the cableless transducers of this system.

Unassigning Cableless Transducers

The CL transducers of the Avalon CL are unassigned by manually removing them in the corresponding setup menu from the group of assigned cableless devices, or by unassigning them directly in the

Tele Info window. See the Avalon CTS Instruction for Use for the unassignment of the

cableless transducers of this system.

Deactivating Cableless Transducers

The CL transducers of the Avalon CL are deactivated by redocking them at a base station. To deactivate all cableless transducers at once press the Standby button of the Avalon CL base station. See the Avalon CTS Instruction for Use for the deactivation of the cableless transducers of this system.

Configuration of Cableless Systems

For the Avalon CL and Avalon CTS Cableless Fetal Transducer system and the corresponding channels have to be configured for the radio communication to work and not to interfere with any other telemetry devices.

3 Basic Operation

The configuration of a connected Avalon CL system is done in Configuration Mode or Service Mode of the fetal monitor. Service Mode functions can be used to identify channel assignment conflicts in the hospital environment. The configuration should be carried out by authorized and qualified service personnel, either by the hospital's biomedical department, or by Philips Support.

Setup OBR

Revisions A.00.00

Frequency Band

Channel

Scan Duration

Start Scan

Stop Scan

Start RSSI Trace

Stop RSSI Trace

WMTS

15 min

For a detailed description of the configuration see the Avalon CL Service Guide and the Fetal Monitor Configuration Guide. For details regarding the configuration of a connected Avalon CTS system see the Avalon CTS Service Guide.

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3 Basic Operation

Tele Info Window

The Tele Info window of the fetal monitors allows you to manage the Avalon CL system. Below is an exemplary view of the connected system.

Tele Info window. Your window may differ depending on the status of the

To open the

1 Configure a Tele Info SmartKey to open the window,

2 click on the TELE icon on the main screen, or

3 select the Main Setup and then Tele Info.

Tele Info window you can:

1 Transducer icon assigned with the parameter label

2 Cableless module icon and equipment ID

3 Base station icon with docking indication (the white slot indicates a

charging transducer)

4 Key Remove

5 Key Find

6 Key Battery Report

7 Tele icon

8 Remaining battery time

9 Out of battery icon

10 Indication of signal quality

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Telemetry

When the monitor recognizes a connected Avalon CL or Avalon CTS interface cable (red or black connector), it confirms the recognition with the following status indicators displayed in the lower right-hand corner of the screen:

Indicator Avalon CTS Avalon CL

3 Basic Operation

Avalon CTS interface cable is connected to the monitor, but the Avalon CTS base station

A base station is connected to the monitor, but the

base station is in Standby mode. is not connected to the interface cable, or it is disconnected from AC mains, or is in Standby mode.

Avalon CTS interface cable is connected to the monitor, Avalon CTS base station is connected, powered on, and cableless transducers are ready to use, but no cableless

A base station is connected to the monitor but no

cableless transducers and no cableless Pods are

currently active. All are still docked at the base

station, or the base station holds no transducers. transducers are currently active (all are still docked at the base station).

Avalon CTS interface cable is connected to the monitor, Avalon CTS base station is connected, powered on, and at least one

A base station is connected to the monitor, it is on,

and minimum one cableless transducer or cableless

Pod is active and assigned. cableless transducer is active and assigned.

Not applicable for Avalon CTS. The CL transducer is moved away from the base

station approaching the end of range (at least 70 m).

The US sound is replaced by an artificial QRS

sound (like DECG). The DECG and MECG waves

are no longer displayed.

NOTE

A cableless transducer is considered still active, even if it has an INOP condition (e.g. cl US

Disconnect

removed from the

), until it is either deactivated by docking it at the base station, or until it is manually

Tele Info window.

CL transducers have priority over wired transducers. If an Avalon CL or Avalon CTS base station is connected to the fetal monitor, and both wired and cableless transducers are connected to the monitor, the wired transducers are disabled whenever one cableless transducer is active. If an CL Pod is activated it does not automatically deactivate all wired transducers, just the one with the corresponding measurement.

To switch back to using wired transducers, redock the cableless transducers at the base station, or switch the base station to Standby mode, and continue monitoring with the wired transducers. If you cannot get sufficient ultrasound signal quality using the Avalon CTS base station, try repositioning the transducers, or switch to wired transducers. Using a Avalon CL base station you should get a better signal by reducing the distance between CL transducer and base station.

• 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. Maternal movements are likely to create artifact in the FMP output. See also “Switching FMP On and Off ” on page 161, the sections “Cableless Monitoring - Important Considerations” on page 156 and “Fetal Movement Profile” on page 160.

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3 Basic Operation

• With the Avalon CL Transducer system you can now monitor twins and triplets with CL

About RF Signal Quality

Signal transmission can be disturbed if:

• the patient is out of range of the receiving area.

• there is interference from another, possibly stronger, RF signal (a broadcasting station, for

• the patient is near material that absorbs electromagnetic waves (for example, metal-reinforced

Pop-up Keys

Pop-Up Key Function

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

instance).

concrete, elevator doors) or the base station antenna is in an enclosed metal rack.

Remove Selecting the

Remove key deactivates and unassigns the selected active

transducer or cableless Pod and removes it from the list. This key is disabled if no active device is selected.

Find Selecting the

Find key pages the selected active CL transducer or CL Pod.

This key is disabled if no active device is selected.

Battery Report Selecting the

Battery Report key prints a combined battery report on the

built in recorder. The report contains at least the following information for each CL transducer or CL Pod currently in the list:

• Cableless device identification (like in the

Tele Info window list)

• Battery identification (e.g. part no.)

• Battery serial number

• Battery manufacturing date

• Battery capacity: remaining/when fully charged/battery temperature

• Number of cycles

This key is only available and enabled in Service mode.

Prompts

The fetal monitor issues prompt messages to certain user interactions. For example if the CL SpO2 Pod is picked up from the base station to activate it, the monitor displays the prompt message

and the equipment lable of the Pod.

Added

cl SpO₂

CL Transducer Assignment

The cableless transducers of the Avalon CL are assigned by simply docking them at the base station connected to the patient’s fetal monitor.

Since twins and triplets can be monitored with the Avalon CL base station, it can be delivered with up

to seven CL transducers: one CL Toco up to four CL transducer can be assigned at one time to the Avalon CL base station. Four assigned CL

transducers enable monitoring combinations such as 1 CL Toco

transducers for monitoring triplets externally, or 1 CL Toco 1 CL ECG/IUP transducer for monitoring twins.

MP, three CL US, and three CL ECG/IUP transducers. Only

MP transducer + 3 CL US

MP transducer + 2 CL US transducer +

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3 Basic Operation

Three CL transducers can be docked and charged at the Avalon CL base station at the time. If a fourth transducer should be assigned to the Avalon CL base station:

1 Remove first the three already docked CL transducers from the base station and place them on the

patient.

2 Then dock the remaining fourth transducer at the base station and wait until the LED of the

fourth transducer signals that it has communication with the base station.

3 Place the fourth CL transducer on the patient and check on the fetal monitor in the Tele Info

window if the base station and the monitor have communication with all four transducers, and if their numerics are displayed on the screen of the fetal monitor.

CL Transducer Unassignment

The cableless transducer are not unassigned by simply removing them from the base station. To unassign a cableless transducer, there are two methods:

1 Open the setup menu of the measurement e.g. FHR1 by pressing the numeric on the screen.

2 Select Remove from the open setup menu.

3 A confirmation window opens with the prompt Please Confirm and Device will be removed.

4 Press the pop-up key Confirm. A prompt states then clDev has been removed.

1 Open the Tele Info window.

2 Select the symbol of the cableless transducer you want to unassign, and select Remove from the

pop-up menu.

3 A confirmation window opens with the prompt Please Confirm and Device will be removed.

4 Press the pop-up key Confirm. A prompt states then clDev has been removed.

NOTE

When a cableless transducer is unassigned, all the measurements from this transducer are no longer

monitored; e.g. if you unassign a CL Toco possibly no longer monitored.

CL Pods Assignment

The cableless Pods of the Avalon CL are assigned by simply docking them at the base station connected to the patient’s fetal monitor.

CL Pods Unassignment

To unassign a cableless Pods, there are four methods:

1 Open the setup menu of the measurement e.g. SpO₂ by pressing the numeric on the screen.

2 Select Remove from the open setup menu.

3 A confirmation window opens with the prompt Please Confirm and Device will be removed.

MP, the Toco measurement, SpO2, and MECG are

4 Press the pop-up key Confirm. A prompt states then clDev has been removed.

1 Open the Tele Info window.

2 Select the symbol of the cableless Pod you want to unassign, and select Remove from the pop-up

menu.

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3 Basic Operation

A confirmation window opens with the prompt Please Confirm and Device will be removed.

4 Press the pop-up key Confirm. A prompt states then clDev has been removed.

Unassign the cableless Pods via it's user interface. See the Cableless Measurement Instruction for Use.

Dock the cableless Pod at another base station or charger and therefore assigning it to the new device.

Paging Patients

To page a patient currently not near the fetal monitor and base station select the SmartKey Call

at the fetal monitor. The base station will then select the cableless transducer with the best

Patient

signal quality to emit the tone sequence to notify the patient.

Underwater Monitoring

Only the cableless transducers of the Avalon CL and Avalon CTS systems can be used to monitor under water. You can use them to monitor patients in a bathtub or shower. This does not apply to the maternal cableless SpO

Cableless transmission distances are shorter when monitoring under water. A metal bathtub is likely to further reduce the operating range.

and NBP Pods, do not immerse the CL Pods into water.

WARNING

CAUTION

Avoid the use of pulsating water jets in the bath or shower while monitoring, as these can be misinterpreted as an incorrect (or totally artificial) heart rate.

When using the transducers underwater, the radio transmission range is reduced, and signal loss may occur.

Water-proof belts like M1562B are recommended for the cableless transducers when monitoring in water.

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Switching the Monitor to Standby

To switch the monitor to Standby:

Either

1 Select the Monitor Standby SmartKey.

1 Enter the Main Setup menu using the SmartKey.

2 Select Monitor Standby.

3 Pressing any key or selecting any field on the screen will resume monitoring.

Note

If a Avalon CL base station is connected to your FM 20/30 monitor, do not turn off the monitor if you need to recharge the batteries of the CL transducers. They can only be recharged if the FM20/30 monitor is on. If an Avalon CL base station is connected to an FM40/50, the batteries of the CL transducers can be recharged while the monitor is in Standby mode.

After Monitoring

1 Discharge the patient.

2 Remove the transducer from the patient and, using a soft tissue, remove any gel from it. Then

clean the transducer.

3 Dock CL transducers to their base station so they can recharge.

4 Tear off the paper at the fold. To avoid misalignment of the recorder mechanism, NEVER pull on

the paper to advance it, or try to tear it other than at a fold (unless using the paper guide with the FM40/FM50).

5 Switch off the monitor.

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3 Basic Operation

Disconnecting from Power

FM20/30 To disconnect the monitor from AC power, switch the monitor off using the On/Off switch located

on the right side of the device, or unplug the power cord from the AC mains socket.

FM40/FM50

and FM20/

FM30 with

Battery

Option

The On/Standby button does not disconnect the monitor from the AC power source. To disconnect, unplug the power cord from the AC mains socket. Note that if the power cord is unplugged from the AC mains socket before the monitor is put into Standby, a beeper is activated. The beeper warns you if the monitor is accidentally disconnected from AC mains.

Power On/Power Off Behavior

The general rules determining the behavior of the fetal monitors when connected to, or disconnected from power are as follows:

• A fetal monitor that was switched on prior to a temporary power loss, switches on again when power is restored.

• A fetal monitor that was switched off prior to a temporary power loss, remains off when power is restored.

• When AC mains power is lost, a battery powered monitor (FM20/30) continues to run without interruption on battery power.

Monitoring After a Power Failure

• A fetal monitor that was switched on prior to a temporary power loss switches on again when power is restored.

• A fetal monitor that was switched off prior to a temporary power loss remains off when power is restored.

• If the fetal monitor is without power for less than one minute, monitoring will resume with all active settings unchanged.

• If the fetal monitor is without power for more than one minute, the behavior depends on your configuration.

Automat. Default is set to Yes, the default profile will be loaded when power is restored.

–If –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.

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3 Basic Operation

Troubleshooting

Problem Possible Causes Solutions

Light or no trace. Wrong paper. Use recommended paper.

Dirty printhead. Clean printhead. See “Cleaning the Print

Head” on page 255.

FM20/30 only: Paper misaligned due to drawer not being correctly shut.

End of paper noted when pack not finished.

Check Paper INOP is displayed. INOP messages always indicate

FetRec Equip Malf INOP is

displayed.

Paper End INOP is displayed.

Wrong Paper Scale INOP is

displayed.

Bad paper feed or wrong paper. Check paper feed and use recommended

equipment problems.

Shut the drawer fully, pushing evenly with both hands.

paper.

See “Patient Alarms and INOPs” on page 121.

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3 Basic Operation

100

Philips OBRTBV1, OBRBSBV1 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1Introduction

Who this Book is For

Confirm Fetal Life Before Using the Monitor

Introducing the Avalon Family of Fetal Monitors

Intended Use

Connecting the Monitor to AC Mains

Indications for Use

Safety Information

Device Classification and Names within this Manual

2What's New

What's New in Release J.3

Avalon CL Transducer System

Support For Use of Maternal Cableless Measurement Devices

Maternal Temperature Measurement

Manually Entered Maternal Temperature Measurements

New Design for the User Interface

New SmartKeys

Coincidence INOP Tone

Increased Internal Back-up Memory

USB Interface

Flexible Nurse Call Interface

DHCP Support

Data Export Support

NBP Configurable Measurement Sequence

Alarms Enhancements

Alarm Reminder

Auto Free

What's New in Release G.0

Battery Option and Patient Transport Improvements for the Avalon FM20 and FM30

Maternal Pulse from Toco MP Transducer

Non Stress Test (NST) Analysis as Clinical Decision Support (CDS) Application

FHR Sound Source

FHR Numeric Display

Improved FHR and DFHR Label Concept

New SmartKeys

Trace Separation On/Off Operation

Alarms

CCV INOP

New Demographic Fields

Recorder

Stored Data Recording

FHR Sound Volume

Avalon CTS

3Basic Operation

Supported Measurements

Avalon FM20 and FM30

Avalon FM20

Avalon FM30

Avalon FM40 and FM50

Avalon FM40

Avalon FM50

Avalon CL Transducer System

Getting to Know Your Avalon FM20/FM30

Overview

Right Side

Left Side

Bottom

Rear

Getting to Know Your Avalon FM40/FM50

Front

Rear

Transducers

Getting to Know Your Avalon CL

Front

Docking Slot for Cableless Transducers

On/Standby Button

Docking Slots for Cableless Measurement Pods

Rear and Bottom

Cableless Transducers

Radio Range of CL Transducers

Connector Cap for the CL Toco+ MP Transducer

Cableless Transducer LED Indication

CL Transducer Battery

Audio Signal CL Transducers

CL Pods

Battery Status LED for CL Pods