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

1Table of Contents

1 Introduction 9

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

2 What's New 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-S tress 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-S tress 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

1Introduction

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.

1 Introduction

• 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 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).

MP, Ultrasound, and

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.

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

1 Introduction

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

No Host Monitoring

cl NBP Disconnect

SpO Disconnect

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 on the IntelliVue CL NBP or CL SpO

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.

Pods, or a

INOP (here the host is the fetal monitor)

, or

• 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.

1 Introduction

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

INOP only

Alarms

Accessories

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).

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

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

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.

Security Information

Erase All

Stored Data Recording

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.

1 Introduction

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 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/

in the

1 Introduction

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/ FM50 Wired Transducers

FM20/FM30

M2702A and M2703A

FM40/FM50

M2704A and M2705A

Avalon CL Base Station Avalon CL Transducers

Avalon CL Base Station

866074

CL Pods

1 Introduction

Avalon FM20/FM30 and FM40/ FM50 Wired Transducers

US transducer (wired)

M2736A

Toco/ Toco MP transducer (wired)

Avalon CL Base Station Avalon CL Transducers

Avalon CL US Transducer (cableless)

866076

Avalon CL Toco+ MP Transducer (cableless)

CL Pods

Avalon CL Fetal & Maternal Pod

866488

Avalon CL Wide Range Pod

M2734A and M2734B

866487

866075

1 Introduction

Avalon FM20/FM30 and FM40/ FM50 Wired Transducers

Toco+ transducer with ECG/IUP capability (wired)

M2735A

Patient Module for ECG/IUP

M2738A

Avalon CL Base Station Avalon CL Transducers

Avalon CL ECG/IUP Transducer (cableless)

866077

CL Pods

IntelliVue CL NBP Pod (cableless)

865216

IntelliVue CL SpO2 Pod (cableless)

865215

2What's New

aFHR

aHR

aToco

cl F&M Electrode Status

cl F&M Status

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 ( and uterine activity (

•The 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 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.

) from electrical signals.

window at the monitor gives an overview of the current electrode

, or selecting the corresponding function in the main

), maternal heart rate (

2 What's New

Enter Note

Type a note

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 pre-configured notes. To enter a note, select the new menu item keypad opens. The typed note can be up to 30 characters long.

See “Typing Notes” on page 70.

, it is now possible to enter a note manually, instead of selecting one of the

. A window with a touch

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 SpO

page 92)

• Maternal pulse from a CL Toco

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)

MP (Smart Pulse) transducer (see “Monitoring Maternal Heart /

2 What's New

and CL NBP (see “IntelliVue CL Pods” on

• 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

and NBP. The devices provide measurement values on the built-in display and communicate

SpO

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

Record on Trace

Send to OB Sys

Start ECG

Record ECG

Call Patient

Tele Info

Enter Temp

NBP Modes

QuickAdmit

Coincidence

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 SpO the new configuration setting

transmission to an obstetrical information and surveillance system

SpO

You can now configure the interval for transmitting the SpO information and surveillance system. With the new configuration setting

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

• With the transducers.

• With the the connected Avalon CL base station.

• With the manually measured maternal temperature values.

• With the start and stop a measurement.

• With the

All new SmartKeys are optional, and have to be configured in Configuration Mode for use (see

“SmartKeys” on page 42).

SmartKey and menu item is renamed to

SmartKey, you can now page patients who are ambulating wearing Avalon CL

SmartKey, you can call up the

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

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

SmartKey, you can access the NBP Mode selection and setup, and can directly

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

numeric values on the recorder trace. With

, you can set the interval to 1 or 5 minutes.

numeric values to an obstetrical

, you can set the

window on the fetal monitor display. In

Coincidence INOP Tone

When the cross-channel verification detects that the signal of the maternal heart rate coincides with the fetal heart rate, the INOP tone has a configurable delay see “Cross-Channel Verification (CCV)” on page 159.

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

Increased Internal Back-up Memory

ECG Leads Off, Cuff Overpress, Cuff NotDeflated, Battery Empty, No

Pulse

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).

2 What's New

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 (

) (see “Alarms” on page 117).

2 What's New

Alarm Reminder

Auto Free

Alarm Reminder

In Configuration Mode, you can set now an 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 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.

setting which discharges a patient automatically

. The

emits an audible

3Basic Operation

This chapter gives you an overview of the monitor and its functions. It tells you how to perform tasks that are common to all measurements (such as entering data, switching 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 US (including Twins)

Triple FHR via US

dFHR via Direct ECG (DECG)

aFHR via CL F&M Pod

To co

aToco via CL F&M Pod

Intrauterine Pressure (IUP)

The following Maternal measurements are supported:

Measurements FM20 FM30 FM40 FM50

Maternal Heart Rate (MHR) via Maternal ECG Electrodes

Maternal ECG (MECG wave)

aHR via CL F&M Pod

Maternal Pulse from Toco

Standard Standard Standard Standard