Philips SRRFMPBV1 User Manual

Instructions for Use

Avalon Fetal Monitor

FM20/30, FM40/50, Avalon CL

Release L.3 with Software Revision L.3x.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	21

What's New in Release L.3		21
What's New in Release J.3		23
	3 Basic Operation	27
Supported Measurements		28
Avalon FM20 and FM30		29
Avalon FM40 and FM50		30
Getting to Know Your Avalon FM20/FM30		31
Getting to Know Your Avalon FM40/FM50		34
Connecting the Monitor to AC Mains		36
Wired Transducers		36
Operating and Navigating		38
Operating Modes		44
Automatic Screen Layouts		45
Settings		45
Preparing to Monitor		48
After Monitoring		70
Switching the Monitor to the Standby Screen		71
Disconnecting from Power		71
Power On/Power Off Behavior		71
Monitoring After a Power Failure		72
Troubleshooting		72
	4 Cableless Monitoring	73
Avalon CL Transducer System		73
Basics of Cableless Systems		74
Twins and Triplets Support		75
Configuration of Cableless Systems		75
Getting to Know Your Avalon CL		76
Cableless Transducers		84
CL Pods		89
Calling Patients		93
Telemetry		94
Preparing to Monitor Cablelessly		100

Battery Lifetime Management		106
Patient Transport Within the Hospital		107
Underwater Monitoring		108
	5 FM20/30 Battery Option	109

External Power Supply M8023A		109
Using Batteries		110
Optimizing Battery Performance		113
Storing the Battery		115
Cableless Monitoring with FM20/30 Battery Option		116
Patient Transport Within the Hospital		116
	6 Alarms	117
Alarm Mode		118
Nurse Call Systems		118
Visual Alarm Indicators		119
Audible Alarm Indicators		119
Acknowledging Alarms		121
Acknowledging Disconnect INOPs		121
Alarm Reminder		122
Pausing or Switching Off Alarms		122
Alarm Limits		124
Reviewing Alarms		126
Latching Alarms		126
Testing Alarms		128
Alarm Behavior at Power On		128
	7 Patient Alarms and INOPs	129
Alarm Messages		129
Technical Alarm Messages (INOPs)		132
	8 Admitting and Discharging	147

Admit/Discharge on the Monitor		147
New Patient Check		149
OB TraceVue/IntelliSpace Perinatal		149
	9 Non-Stress Test Timer	151
Setting NST Autostart/Autostop		151
Viewing the NST Timer		151
Timer Expiry Notification		151
Accessing the NST Setup Pop-up Keys		152
10 Non-Stress Test Report		153

Setting Up an NST Report		153
NST Report Status Window		154
NST Criteria		157

11 Cross-Channel Verification (CCV)		159

Misidentification of Heart Rates		159
Cross-Channel Verification Functionality		160
Overview of Cross-Channel Comparisons		161
Coincidence Examples		162
Recommended Actions for Coincidence INOP		164
12 Monitoring FHR and FMP Using Ultrasound		165

Technical Description		165
Limitations of the Technology		166
Misidentification of Maternal HR as FHR		166
What You Need		166
Cableless Monitoring - Important Considerations		167
Preparing to Monitor		168
Selecting Fetal Heart Sound		169
Changing the Fetal Heart Sound Volume		170
Fetal Movement Profile		170
Troubleshooting		172
Additional Information		173
13 Monitoring Twin FHRs		183

Important Considerations		183
Monitoring Twins Externally		184
Monitoring Twins Internally		185
Separating FHR Traces		185
Troubleshooting		189
14 Monitoring Triple FHRs		191
Important Considerations		191
Monitoring Triplets		192
Separating FHR Traces		192
"Standard" Separation Order		193
"Classic" Separation Order		194
Switching Trace Separation On and Off		195
When Trace Separation is On		195
When Trace Separation is Off		195
Troubleshooting		196
15 Fetal Heart Rate Alarms		197

Changing Alarm Settings		197
Changing Signal Loss Delay		198
16 Monitoring FHR Using DECG		199

Misidentification of Maternal HR as FHR		199
What You Need		200
Making Connections		202

Monitoring DECG		202
Suppressing Artifacts		204
Troubleshooting		205
Testing DECG Mode		205
17 Monitoring Uterine Activity Externally		207

What You Need		207
External Toco Monitoring		208
Toco Sensitivity		208
Troubleshooting		208
18 Monitoring Uterine Activity Internally		211

What You Need		211
Internal (IUP) Monitoring		213
Troubleshooting		214
19 Monitoring aFHR, aHR, and aToco		215

Fetal Heart Rate aFHR		215
Uterine Activity aToco		216
What You Need		217
At the Monitor		217
Troubleshooting		218
20 Monitoring Maternal Heart / Pulse Rate		221

Priority for Maternal Heart / Pulse Rate		221
Misidentification of Maternal HR for FHR		222
Maternal HR from MECG Electrodes		222
Monitoring MECG Wave		225
Pulse Rate from Toco MP		227
Pulse Rate from SpO2		228
Adjusting the Heart Rate / Pulse Alarm Limits		228
Average Pulse Rate from Noninvasive Blood Pressure		228
Testing MECG Mode		229
21 Printing the ECG Waveform		231

22 Monitoring Noninvasive Blood Pressure		235

Introducing the Oscillometric Noninvasive Blood Pressure Measurement		235
Preparing to Measure Noninvasive Blood Pressure		237
Starting and Stopping Measurements		239
Enabling Automatic Mode and Setting Repetition Time		239
Enabling Sequence Mode and Setting Up the Sequence		240
Choosing the Alarm Source		240
Assisting Venous Puncture		241
Calibrating NBP		241
Troubleshooting		242

23 Monitoring SpO2		243

Selecting an SpO2 Sensor		243
Applying the Sensor		243
Connecting SpO2 Cables		244
Measuring SpO2		244
SpO2 Signal Quality Indicator (FAST SpO2 only)		245
Assessing a Suspicious SpO2 Reading		246
Understanding SpO2 Alarms		246
Setting Up Tone Modulation		247
Setting the QRS Volume		247
24 Monitoring Maternal Temperature		249

Measuring Tympanic Temperature		249
Entering Temperature Manually		254
25 Paper Save Mode for Maternal Measurements		255

26 Recovering Data		257

Recovering Traces on Paper		257
Recovering Traces on an OB TraceVue/IntelliSpace Perinatal System		258
Manually Recording Stored Data		258
27 Care and Cleaning		261

General Points		261
Cleaning and Disinfecting		262
Cleaning and Disinfecting Monitoring Accessories		263
Cleaning and Disinfecting the Tympanic Temperature Accessories		264
Cleaning and Disinfecting CL Transducers and CL Pods		264
Sterilizing		265
28 Maintenance		267

Inspecting the Equipment and Accessories		267
Inspecting the Cables and Cords		268
Maintenance Task and Test Schedule		268
Recorder Maintenance		269
Cleaning the Print Head		273
Returning Equipment for Repair		273
Disposing of the Monitor		274
29 Accessories and Supplies		275

Information on Latex		275
Avalon CL Base Station		275
Transducers		276
Fetal Accessories		276
Noninvasive Blood Pressure Accessories		278
SpO2 Accessories		280

Tympanic Temperature Accessories		285
Recorder Paper		285
Batteries		285
30 Specifications and Standards Compliance		287

Environmental Specifications		287
Physical Specifications		289
Interface Specifications		293
Performance Specifications		295
Recorder Specifications		308
External Displays: FM40/FM50 Only		310
Manufacturer's Information		310
Trademark Acknowledgment		310
Regulatory and Standards Compliance		311
Environment		321
Monitoring After a Loss of Power		321
ESU, MRI, and Defibrillation		321
Cardiac Pacemakers and Electrical Stimulators		322
Fast Transients/Bursts		322
Symbols on the System		322
31 Default Settings Appendix		327

Alarm and Measurement Default Settings		327
Recorder Default Settings		330
	Index	333

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 Avalon CL Transducer System. 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, care, and cleaning that is not repeated in this book.

If you have received this Instruction for Use because your fetal monitor has been upgraded to a newer software version L.3, be aware that the standards compliance information contained in the Instructions for Use for L.3 does not apply to your fetal monitor. Refer to your original Instructions for Use for standards compliance information.

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.

This guide may contain descriptions of functionality and features that are not implemented in the equipment currently shipped to Japan and/or of products that are not currently sold in Japan due to limitations and restrictions under the applicable local laws and regulations in Japan. Please contact your local sales representative and/or Philips Customer Support for details.

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.

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•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.

Avalon CL

Avalon CTS

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

For installation instructions and technical description, see the corresponding Service Guide of the fetal monitors.

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:

•a maternal HR 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 maternal HR 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 maternal HR 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 maternal HR (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).

1 Introduction

•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 165 and “Monitoring FHR Using DECG” on page 199.

To reduce the possibility of mistaking the maternal HR for an FHR, it is recommended that you monitor both maternal and fetal heart rates. The monitor's cross-channel verification (CCV) feature can help by automatically detecting when a maternal HR coincides with an FHR. For further details, see “Cross-Channel Verification (CCV)” on page 159.

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 Fetal Transducer Systems.

Intended Use

The Philips Avalon FM20 (M2702A), FM30 (M2703A), FM40 (M2704A), and FM50 (M2705A) fetal/ maternal monitors are intended for:

•noninvasive monitoring of fetal heart rates and movements.

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

•invasive monitoring of direct fetal heart rate, intrauterine pressure, and for displaying and recording of fetal and maternal electrocardiogram (ECG) (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.

•use 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).

1 Introduction

WARNING

The fetal/maternal monitors are not intended for:

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

•Electrocardiography (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.

•measuring the maternal temperature using the tympanic thermometer (866149) in private households.

WARNING

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

CAUTION

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

All users must read the Instructions for Use before working with the fetal monitor. Disregarding the contents of the Instructions for Use is considered abnormal use.

1 Introduction

Indications for Use

Avalon Fetal/Maternal Monitor FM20

Indicated for use by trained health care professionals whenever there is a need for monitoring 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 the physiological parameters uterine activity, heart rate, electrocardiography (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 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

Electrical Hazards

WARNING

Electrical shock hazard: Do not open the monitor housing. Refer all servicing to qualified service personnel.

•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.

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

•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 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 with an approved isolation transformer that ensures mechanical fixing of the power cords, and covering of any unused power outlets.

•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.

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

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

Radio Frequency Interference

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 IntelliVue CL NBP or CL SpO2 Pods, or a No Host Monitoring, or cl NBP Disconnect, or cl

SpO Disconnect INOP at the fetal monitor. Correct channel configuration is important, refer to the Service Guides and the Configuration Guide for details.

•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.

•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.

1 Introduction

•For paced patients: The radiated SRR power of the CL SpO2, CL NBP Pods, CL F&M Pod, and the CL Wide Range Pod, 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.

Use Environment

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.

•Use only Philips batteries part number M4605A with the FM20 or FM30 with battery option. Use of a different battery may present a risk of fire or explosion.

Environmental Specifications:

•The performance specifications for the monitors, measurements, and accessories apply only for use within the temperature, humidity, and altitude ranges specified in “Environmental Specifications” on page 287.

Liquid Ingress:

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

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

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

•The CL Fetal & Maternal Pod is not intended for underwater monitoring. The contacts between the CL Fetal & Maternal Pod and the electrode patch have to be kept dry at all times. The CL Fetal & Maternal Pod mounted on the electrode patch, can be worn underneath a shower, as long as the CL Fetal & Maternal Pod stays mounted. Radio transmissions in the shower may be compromised.

Heat Exposure:

•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).

Positioning Equipment:

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

1 Introduction

Prohibited Environments:

•The monitors and their transducers, Pods, and accessories are not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers).

Alarms

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.

•Alarm systems of the monitor and those of the connected obstetrical information and surveillance system are independent and not synchronized.

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

Accessories

WARNING

Philips' approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance, and cause a potential hazard.

Reuse: Never reuse disposable transducers, sensors, accessories, and so forth, that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance, and cause a potential hazard.

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

Damage: Do not use a damaged sensor or one with exposed electrical contacts.

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

1 Introduction

Security Information

Protecting Personal Information

Protecting personal health information is a primary component of a security strategy. Each facility using the monitors must provide the protective means necessary to safeguard personal information consistent with country laws and regulations, and consistent with the facility’s policies for managing this information. Protection can only be realized if you implement a comprehensive, multi-layered strategy (including policies, processes, and technologies) to protect information and systems from external and internal threats.

As per its intended use, the patient monitor operates in the patient vicinity and contains personal and sensitive patient data. This also includes the trace print-outs at the monitor.

The monitor also includes controls to allow you to adapt the monitor to the patient's care model.

To ensure the patient's safety and protect their personal health information, you need a security concept that includes:

•Physical security access measures - access to the monitor must be limited to authorized users. It is essential that you consider physical security measures to ensure that unauthorized users cannot gain access.

•Operational security measures - for example, ensuring that patients are discharged after monitoring in order to remove their data from the monitor.

•Procedural security measures - for example, assigning only staff with a specific role the right to use the monitors.

In addition, any security concept must consider the requirements of local country laws and regulations.

Always consider data security aspects of the network topology and configuration when connecting patient monitors to shared networks. Your medical facility is responsible for the security of the network, where sensitive patient data from the monitor may be transferred.

When a monitor is returned for repair, disposed of, or removed from your medical facility for other reasons, always ensure that all patient data is removed from the monitor by ending monitoring for the last patient (see “Discharging a Patient” on page 148). Also select Erase All in the Stored Data Recording menu, to erase all stored data.

NOTE

Log files generated by the monitors and measurement modules are used for system troubleshooting and do not contain protected health data.

About HIPAA Rules

If applicable, your facility’s security strategy should include the standards set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), introduced by the United States Department of Health and Human Services. You should consider both the security and the privacy rules and the HITECH Act when designing policies and procedures. For more information, please visit:

http://www.hhs.gov/ocr/privacy/

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About the EU Directives

If applicable, your facility’s security strategy should include the practices set forth in the Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data (Directive 95/46/EC of the European Parliament and of the Council of

24 October 1995). In addition, your facility should also take into account any additional, more stringent standards put forward by any individual EU countries; that is, Germany, France, and so on.

Philips Product Security Policy Statement

Additional security and privacy information can be found on the Philips product security web site at: http://www.healthcare.philips.com/main/support/equipment-performance/product-security/ index.wpd

Manufacturer Disclosure Statement for Medical Device Security – MDS2

You can view the Manufacturer Disclosure Statements for Medical Device Security (MDS2) for specific devices at: http://www.healthcare.philips.com/main/support/equipment-performance/product-security/ index.wpd

Overview of System Components

The Avalon CL system consists of the Avalon CL base station, the Avalon CL transducers, the Avalon CL Fetal & Maternal Pod, the CL Wide Range Pod, and the IntelliVue CL Pods.

The IntelliVue CL Pods are only used for maternal measurements within the Avalon CL solution. The following table provides an overview of all the devices.

Avalon FM20/FM30 and FM40/	Avalon CL Base Station	CL Pods
FM50	Avalon CL Transducers
Wired Transducers
FM20/FM30
M2702A and M2703A

FM40/FM50	Avalon CL Base Station
M2704A and M2705A	866074

1 Introduction

Avalon FM20/FM30 and FM40/	Avalon CL Base Station	CL Pods
FM50	Avalon CL Transducers
Wired Transducers
US transducer (wired)	Avalon CL US Transducer	Avalon CL Fetal & Maternal Pod
	(cableless)
		866488
M2736A
	866076

Toco/ Toco MP transducer	Avalon CL Toco+ MP Transducer	Avalon CL Wide Range Pod
(wired)	(cableless)
		866487
M2734A and M2734B
	866075

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Avalon FM20/FM30 and FM40/	Avalon CL Base Station	CL Pods
FM50	Avalon CL Transducers
Wired Transducers
Toco+ transducer with ECG/IUP	Avalon CL ECG/IUP Transducer	IntelliVue CL NBP Pod
capability (wired)	(cableless)	(cableless)
M2735A		865216
M2735A
	866077

Patient Module for ECG/IUP		IntelliVue CL SpO2 Pod
		(cableless)
M2738A
		865215

What's New

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

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

What's New in Release L.3

Avalon CL Fetal & Maternal Pod

The Avalon CL Fetal & Maternal Pod is an extension of the Avalon CL solution. The Avalon

CL Fetal & Maternal Pod is used together with a single use patch with five abdominal electrodes. Prior to use, the Avalon CL Fetal & Maternal Pod is charged and assigned at the Avalon CL base station. The Avalon CL Fetal & Maternal Pod is used with singleton pregnancies. This solution provides especially benefits to patients with high body mass index (BMI), although it can be used for all patients.

The Avalon CL Fetal & Maternal Pod includes the following features:

•The Avalon CL Fetal & Maternal Pod measures fetal heart rate (aFHR), maternal heart rate (aHR), and uterine activity (aToco) from electrical signals.

•The cl F&M Electrode Status window at the monitor gives an overview of the current electrode contact status, when the CL Fetal & Maternal Pod is placed on the electrode patch, and the patch, and the electrodes are applied to the patient's abdominal skin. The window can be opened by selecting the new SmartKey cl F&M Status, or selecting the corresponding function in the main setup menu.

•The Avalon CL Fetal & Maternal Pod and the CL Wide Range Pod are assigned at the CL base station in the same easy way as the IntelliVue CL Pods.

•The functions Finder LED and Call Patient work also with the Avalon CL Fetal & Maternal Pod.

See “Avalon CL Fetal & Maternal Pod” on page 21, “CL Fetal & Maternal Electrode Patch” on page 91, “Applying the CL Fetal & Maternal Patch and Pod” on page 100, and “CL Pod Assignment” on page 99.

2 What's New

Avalon CL Wide Range Pod

The Avalon CL Wide Range Pod is an extension of the Avalon CL solution. The Avalon CL Wide Range Pod extends the signal range of the cableless measurements. It transmits the cableless measurement signals via the hospital WLAN/WiFi to the fetal monitors. Wearing the CL Wide Range Pod, the patient can walk freely within the hospital's WLAN/WiFi range during monitoring. Prior to use, the Avalon CL Wide Range Pod is charged and assigned at the Avalon CL base station.

•A new WLAN symbol is printed on the trace to indicate the use of an assigned and active Avalon CL Wide Range Pod.

•During monitoring with an active Avalon CL Wide Range Pod, the sound from the fetal heart rate is replaced by an artificial QRS sound (when the patient is monitored with a CL US transducer or CL F&M Pod).

See “CL Wide Range Pod” on page 91.

Dawes/Redman

Dawes/Redman is a method of fetal monitoring trace interpretation for helping to assess fetal well-being. The algorithm based on the Dawes/Redman criteria uses the parameters fetal heart rate, gestational age, fetal movement, accelerations and decelerations, and long, and short term variability to generate a report.

Not available in the USA and territories relying on FDA market clearance.

Support of XDS Remote Display

The fetal monitor software supports the IntelliVue XDS “Remote Display” functionality only in combination with IntelliSpace Perinatal revision K or higher. From the user interface of the IntelliSpace Perinatal system, you can access all screen-operable functions of the currently connected fetal monitor. These functions include for example, starting and stopping physiological measurements, changing measurement modes, changing alarm limits, and silencing alarms.

New Alarm Behavior of CL Battery Empty INOP

The CL <xxx> Battery Empty INOP issued by the CL devices and the fetal monitor has a new alarm behavior:

•At the fetal monitor, it is issued now with a cyan INOP alarm and tone.

•At CL devices (CL transducers and CL Pods), it is issued now with a tone. See “Patient Alarms and INOPs” on page 129.

Using CL Pods with FM20/30 #E25

The CL Pods can now also be used with a battery operated FM20 or FM30 (option #E25). The CL Pods can be assigned and activated. The CL F&M Pod can also be charged.

See “Using Batteries” on page 110.

Entering Notes - Type a Note

In the menu Enter Note, it is now possible to enter a note manually, instead of selecting one of the pre-configured notes. To enter a note, select the new menu item Type a note. A window with a touch keypad opens. The typed note can be up to 30 characters long.

See “Typing Notes” on page 70.

2 What's New

What's New in Release J.3

Avalon CL Transducer System

The Avalon CL Transducer 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 Transducer System has a straight-forward handling and operating concept. The CL transducers are assigned by simply docking them at the CL base station, no further configuration is necessary.

The Avalon CL Transducer System includes the following features:

•Cableless monitoring of twins and triplets (see “Monitoring Twin FHRs” on page 183 and “Monitoring Triple FHRs” on page 191)

•Cableless maternal measurement Pods CL SpO2 and CL NBP (see “IntelliVue CL Pods” on page 92)

•Maternal pulse from a CL Toco+ MP (Smart Pulse) transducer (see “Monitoring Maternal Heart / Pulse Rate” on page 221)

•A cableless ECG/IUP transducer measuring IUP or fetal/maternal ECG (see “Monitoring MECG Wave” on page 225 and “Monitoring FHR Using DECG” on page 199)

•Watertight cableless transducers that can be used to monitor in water (see “Underwater Monitoring” on page 108)

•Patient call that pages an ambulating mother with an audible signal emitted by the worn CL transducers (see “Calling Patients” on page 93)

•Out-of-range audible signal emitted by the worn CL transducers to inform an ambulating mother that she has reached the limit of the active signal area-of-reach (see “Standard Radio Range of CL Transducers” on page 87)

•A transducer finder LED on all CL transducers to help identify the assigned transducer (see “Cableless Transducer LED Indication” on page 86)

Support For Use of Maternal Cableless Measurement Devices

The IntelliVue CL 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 (see “IntelliVue CL Pods” on page 92).

Maternal Temperature Measurement

To measure maternal temperature, the new optional tympanic thermometer (866149) is available for the Avalon fetal monitors (“Monitoring Maternal Temperature” on page 249). The measurement data is:

•documented and printed out at the local recorder, and transmitted to the obstetrical information and surveillance system.

•displayed as a numeric on the screen.

2 What's New

Manually Entered Maternal Temperature Measurements

Manually measured temperatures can be entered at the fetal monitor. They are displayed as a numeric on screen, and are printed out on the recorder trace (“Monitoring Maternal Temperature” on

page 249).

SpO2 Recordings and Transmissions

SpO2 annotation on local recorder

You can now configure the interval for printing the SpO2 numeric values on the recorder trace. With the new configuration setting Record on Trace, you can set the interval to 1 or 5 minutes.

SpO2 transmission to an obstetrical information and surveillance system

You can now configure the interval for transmitting the SpO2 numeric values to an obstetrical information and surveillance system. With the new configuration setting Send to OB Sys, you can set the interval to 1 or 5 minutes.

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 (see “Operating and Navigating” on page 38).

New SmartKeys

•The Start ECG SmartKey and menu item is renamed to Record ECG.

•With the Call Patient SmartKey, you can now page patients who are ambulating wearing Avalon CL 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 base station.

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

•With the NBP Modes SmartKey, you can access the NBP Mode selection and setup, and can directly start and stop a measurement.

•With the QuickAdmit SmartKey, you can quick admit a patient to the monitor.

All new SmartKeys are optional, and have to be configured in Configuration Mode for use (see “SmartKeys” on page 42).

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 now issued with a tone at the fetal monitor. The Coincidence INOP tone has a configurable delay see “Cross-Channel Verification (CCV)” on page 159.

2 What's New

Increased Internal Back-up Memory

The internal back-up memory is now able to store traces and data from at least the last 3.5 hours with the software revision J.3, and minimum 7 hours with the new mainboard hardware revision A 00.18 (see “Manually Recording Stored Data” on page 258 and “Recovering Data” on page 257).

Dual System Interface Support

If the fetal monitor is connected via a LAN connection to OB TraceVue/IntelliSpace Perinatal, the RS232 interface can be used independently to connect e.g. an EMR system on read-only basis. The system connected to the RS232 interface in this case cannot alter any data (such as ADT data, or the date and time setting), or interfere with functions of the monitor, but is able to read output data. The obstetrical information and surveillance system connected via LAN has priority.

USB Interface

An optional USB interface allows the use of bar code readers and input devices such as a keyboard, or mouse (see “Getting to Know Your Avalon FM20/FM30”/“Bottom” on page 32 and “Getting to Know Your Avalon FM40/FM50”/“Rear” on page 33).

Flexible Nurse Call Interface

An optional Flexible Nurse Call interface allows the connection of a nurse call device to the fetal monitors (see “Getting to Know Your Avalon FM20/FM30”/“Bottom” on page 32 and “Getting to Know Your Avalon FM40/FM50”/“Rear” on page 33).

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.

Data Export Support

You can now export measurement values from the monitor to other devices via the LAN interface, or with the optional MIB RS232 interface (see “Getting to Know Your Avalon FM20/FM30”/“Bottom” on page 32 and “Getting to Know Your Avalon FM40/FM50”/“Rear” on page 33).

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 (see “Enabling Sequence Mode and Setting Up the Sequence” on page 240.

Alarms Enhancements

In addition to the standard cyan INOPs, some INOPs can now be configured as red or yellow INOPs

to provide a severity indication (ECG Leads Off, Cuff Overpress, Cuff NotDeflated, Battery Empty, No

Pulse) (see “Alarms” on page 117).

2 What's New

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 (see “Alarm Reminder” on page 122).

Auto Free

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

Basic 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 on a measurement, 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

Different measurements for the same physiological parameter may have a different appearance on the trace, due to: variability (HR), averaging, delay, amplitude, or artifacts. Before interpreting the trace, regard the fetal monitor setup and transducers used.

The following Fetal measurements are supported:

Measurements	FM20	FM30	FM40	FM50

Fetal Heart Rate (FHR) via	Standard	Standard	Standard	Standard
US (including Twins)

Triple FHR via US	Optional	Optional	Optional	Optional

dFHR via Direct ECG	-	Standard	-	Standard
(DECG)

aFHR via CL F&M Pod	Optional	Optional	Optional	Optional

Toco	Standard	Standard	Standard	Standard

aToco via CL F&M Pod	Optional	Optional	Optional	Optional

Intrauterine Pressure (IUP)	-	Standard	-	Standard

The following Maternal measurements are supported:

Measurements	FM20	FM30	FM40	FM50

Maternal Heart Rate (MHR)	Standard	Standard	Standard	Standard
via Maternal ECG Electrodes

Maternal ECG (MECG wave)	-	Standard	-	Standard

aHR via CL F&M Pod	Optional	Optional	Optional	Optional

Maternal Pulse from Toco	Standard	Standard	Standard	Standard

Noninvasive Blood Pressure	Optional	Optional	Optional	Optional
with Pulse Rate

Pulse Oximetry (Maternal	Optional	Optional	Optional	Optional
SpO2) with Pulse Rate
Maternal Temperature	Optional	Optional	Optional	Optional

3 Basic Operation

Avalon FM20 and FM30

This section outlines the capabilities of your monitor.

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 (SpO2).

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 intrauterine pressure (IUP) catheter together with a Toco+ transducer or patient module.

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

3 Basic Operation

FM20/30 with Battery Option #E25 Only

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.

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 noninvasive 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).

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