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

Table 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

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

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

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

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

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

Introduction

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.

1 Introduction

Avalon CTS Whenever one of these identifiers appear to the left of a heading or paragraph, it means that the Avalon CL 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.

1 Introduction

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+ MP, Ultrasound, and 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.

CAUTION

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

1 Introduction

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 Global Settings menu.

•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.

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.

1 Introduction

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.

1 Introduction

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 No Host Monitoring INOP (here the host is the fetal monitor) on the NBP or SpO2 Pods, or a cl NBP Disconnect or cl SpO Disconnect INOP at the fetal monitor. Correct

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

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.

1 Introduction

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.

1 Introduction

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.

1 Introduction

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.

1 Introduction

WARNING

•Ensure that the conductive parts of the fetal scalp electrode and the maternal leg plate electrode do not contact other conductive parts, including earth.

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

•During ambulant FHR monitoring, the chance of losing the signal or detecting the maternal heart rate is higher than during stationary monitoring. The frequency of the patient's walk may be detected, and mistaken for a FHR signal.

•Check the mother’s pulse periodically during monitoring and compare this with the FHR signal. Beware of mistaking a “doubled” maternal heart rate for FHR. 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.

•Do not interpret maternal movements as fetal movements.

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

1 Introduction

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.

1 Introduction

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:

–probe covers other than the specified probe covers are used (see “Tympanic Temperature Accessories” on page 267)

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

•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 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.

1 Introduction

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 SpO2 sensor in close proximity (e.g. when more than one SpO2 measurement is performed on the same patient). Always cover both sensors with opaque material to reduce cross-interference.

–Electromagnetic interference, especially 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 SpO2 INOP can occur. If the fetal monitor is configured to suppress this alarm there may be a delay of up to 60 seconds in indicating a critical status, such as sudden pulse loss or hypoxia.

1 Introduction

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.

1 Introduction

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.

1 Introduction

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).

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.

1 Introduction

WARNING

•Leakage currents: If several items of equipment used to monitor a patient are interconnected, the resulting leakage current may exceed allowable limits.

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

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.

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/	Avalon CL Base Station	IntelliVue CL Pods
FM50	Avalon CL Transducers
Wired Transducers
FM20/
FM30
M2702A and M2703A
FM40/	Avalon CL
FM40/	Avalon CL
FM50	Base Station
M2704A and M2705A
M2704A and M2705A	866074
US	Avalon CL	IntelliVue
transducer	Toco+ MP	CL NBP
wired	Transducer	Pod
	cableless	cableless
M2736A		865216
	866075

1 Introduction

Avalon FM20/FM30 and FM40/	Avalon CL Base Station	IntelliVue CL Pods
FM50	Avalon CL Transducers
Wired Transducers
Toco/ Toco	Avalon CL	IntelliVue
MP	US	CL SpO2
transducer	Transducer	Pod
wired	cableless	cableless
M2734A and M2734B		865215
M2734A and M2734B
	866076
Toco+	Avalon CL
transducer	ECG/IUP
with ECG/	Transducer
IUP	cableless
capability
wired
M2735A
	866077
Patient
Module for
ECG/IUP
M2738A

2 What'sNew

What'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:

•Cableless monitoring of twins and triplets

•Cableless maternal measurement Pods CL SpO2 and CL NBP

•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

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.

2 What'sNew

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

•With the Tele Info SmartKey you can call up the Tele Info window on the fetal monitor display. In the Tele Info window you can control and view the status of the cableless transducers from the connected Avalon CL system.

•With the Enter Temp SmartKey a pop-up window opens showing a numeric pad for entering externally measured maternal temperature values.

Coincidence INOP Tone

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

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.

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