Philips OBBSBV1 User Manual

Instructions fo r U s e

Avalon Fetal Monitor

FM20/30, FM40/50, Avalon CL

Re l eas e J. 3 wi t h S o ftw a re R evi s ion J. 3 x .x x

Pa t i en t Mo n i to r i ng

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 19

What's New in Release J.3 19 What's New in Release G.0 22

3 Basic Operation 25

Supported Measurements 26 Avalon FM20 and FM30 27 Avalon FM40 and FM50 28 Avalon CL Transducer System 29 Getting to Know Your Avalon FM20/FM30 30 Getting to Know Your Avalon FM40/FM50 32 Connecting the Monitor to AC Mains 34 Wired Transducers 34 Getting to Know Your Avalon CL 36 Cableless Transducers 39 CL Pods 44 Operating and Navigating 46 Operating Modes 51 Automatic Screen Layouts 52 Settings 52 Preparing to Monitor 55 After Monitoring 88 Switching the Monitor to Standby 88 Disconnecting from Power 89 Power On/Power Off Behavior 89 Monitoring After a Power Failure 89 Troubleshooting 90

4 FM20/30 Battery Option 91

External Power Supply M8023A 92 Using Batteries 92 Optimizing Battery Performance 95 Storing the Battery 98 Cableless Monitoring with FM20/30 Battery Option 98 Patient Transport Within the Hospital 98

5 Alarms 99

Alarm Mode 100 Nurse Call Systems 100 Visual Alarm Indicators 100 Audible Alarm Indicators 101 Acknowledging Alarms 103 Acknowledging Disconnect INOPs 103 Alarm Reminder 103 Pausing or Switching Off Alarms 104 Alarm Limits 107 Reviewing Alarms 108 Latching Alarms 109 Testing Alarms 110 Alarm Behavior at Power On 111

6 Patient Alarms and INOPs 113

Alarm Messages 113 Technical Alarm Messages (INOPs) 115

7 Admitting and Discharging 125

Admit/Discharge on the Monitor 125 New Patient Check 127 OB TraceVue/IntelliSpace Perinatal 127

8 Non-Stress Test Timer 129

Setting NST Autostart/Autostop 129 Viewing the NST Timer 129 Timer Expiry Notification 129 Accessing the NST Setup Pop-up Keys 130

9 Non-Stress Test Report 131

Setting Up an NST Report 131 NST Report Status Window 132 NST Criteria 134

10 Cross-Channel Verification (CCV) 135

Misidentification of Heart Rates 135 Cross-Channel Verification Functionality 136 Overview of Cross-Channel Comparisons 136 Coincidence Examples 138 Recommended Actions for Coincidence INOP 140

11 Monitoring FHR and FMP Using Ultrasound 141

Technical Description 141 Limitations of the Technology 142 Misidentification of MHR as FHR 142

What You Need 142 Cableless Monitoring - Important Considerations 142 Preparing to Monitor 145 Selecting Fetal Heart Sound 146 Changing the Fetal Heart Sound Volume 146 Fetal Movement Profile 147 Troubleshooting 149 Additional Information 150

12 Monitoring Twin FHRs 159

Important Considerations 159 Monitoring Twins Externally 160 Monitoring Twins Internally 161 Separating FHR Traces 161 Troubleshooting 165

13 Monitoring Triple FHRs 167

Important Considerations 167 Monitoring Triplets 168 Separating FHR Traces 168 "Standard" Separation Order 168 "Classic" Separation Order 169 Switching Trace Separation On and Off 170 When Trace Separation is On 171 When Trace Separation is Off 171 Troubleshooting 172

14 Fetal Heart Rate Alarms 173

Changing Alarm Settings 173 Changing Signal Loss Delay 174

15 Monitoring Uterine Activity Externally 175

What You Need 175 External Toco Monitoring 176 Toco Sensitivity 176 Troubleshooting 176

16 Monitoring Uterine Activity Internally 179

What You Need 179 Internal (IUP) Monitoring 181 Troubleshooting 182

17 Monitoring FHR Using DECG 183

Misidentification of MHR as FHR 183 What You Need 185 Making Connections 187

Monitoring DECG 188 Suppressing Artifacts 190 Troubleshooting 190 Testing DECG Mode 191

18 Monitoring Noninvasive Blood Pressure 193

Introducing the Oscillometric Noninvasive Blood Pressure Measurement 193 Preparing to Measure Noninvasive Blood Pressure 194 Starting and Stopping Measurements 197 Enabling Automatic Mode and Setting Repetition Time 197 Enabling Sequence Mode and Setting Up the Sequence 197 Choosing the Alarm Source 198 Assisting Venous Puncture 199 Calibrating NBP 199 Troubleshooting 199

19 Monitoring Maternal Temperature 201

Measuring Tympanic Temperature 201 Entering Temperature Manually 206

20 Monitoring SpO2 207

Selecting an SpO2 Sensor 207 Applying the Sensor 207 Connecting SpO2 Cables 208 Measuring SpO2 209 SpO2 Signal Quality Indicator (FAST SpO2 only) 210 Assessing a Suspicious SpO2 Reading 210 Understanding SpO2 Alarms 210 Setting Up Tone Modulation 211 Setting the QRS Volume 211

21 Monitoring Maternal Heart / Pulse Rate 213

Priority for Maternal Heart / Pulse Rate 213 Misidentification of MHR for FHR 214 MHR from MECG Electrodes 214 Monitoring MECG Wave 217 Pulse Rate from Toco MP 219 Pulse Rate from SpO2 220 Adjusting the Heart Rate / Pulse Alarm Limits 221 Average Pulse Rate from Noninvasive Blood Pressure 221 Testing MECG Mode 221

22 Printing the ECG Waveform 223

23 Paper Save Mode for Maternal Measurements 227

24 Recovering Data 229

Recovering Traces on Paper 229 Recovering Traces on an OB TraceVue/IntelliSpace Perinatal System 230 Manually Recording Stored Data 230

25 Care and Cleaning 233

General Points 233 Cleaning and Disinfecting 234 Cleaning and Disinfecting Monitoring Accessories 235 Cleaning and Disinfecting the Tympanic Temperature Accessories 235 Sterilizing 237

26 Maintenance 239

Inspecting the Equipment and Accessories 239 Inspecting the Cables and Cords 239 Maintenance Task and Test Schedule 241 Recorder Maintenance 241 Cleaning the Print Head 246 Disposing of the Monitor 247

27 Accessories and Supplies 249

Information on Latex 249 Avalon CL Base Station 249 Transducers 250 Fetal Accessories 250 MECG Accessories 252 Noninvasive Blood Pressure Accessories 252 SpO2 Accessories 254 Tympanic Temperature Accessories 259 Recorder Paper 259 Batteries 260

28 Specifications and Standards Compliance 261

Environmental Specifications 261 Physical Specifications 263 Interface Specifications 266 Performance Specifications 267 Recorder Specifications 278 Compatible External Displays: FM40/FM50 Only 280 Manufacturer's Information 280 Trademark Acknowledgment 280 Regulatory and Standards Compliance 281

Environment 290 Monitoring After a Loss of Power 291 ESU, MRI and Defibrillation 291 Cardiac Pacemakers and Electrical Stimulators 291 Fast Transients/Bursts 291 Symbols on the System 291

29 Default Settings Appendix 295

Alarm and Measurement Default Settings 295 Recorder Default Settings 298

Index 299

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 (J.3), be aware that the standards compliance information contained in the Instructions for Use for (J.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:

• 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).

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 141 and “Monitoring FHR Using DECG” on page 183.

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) feature can help by automatically detecting when an MHR coincides with an FHR. For further details, see “Cross-Channel Verification (CCV)” on page 135.

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

US 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.

1 Introduction

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.

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.

1 Introduction

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

o Host Monitoring INOP (here the host is the fetal monitor)

on the IntelliVue CL NBP or CL SpO

Pods, or a N

o 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.

• For paced patients: The radiated SRR power of the CL SpO

and CL NBP Pods, 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.

1 Introduction

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 261.

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.

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.

Prohibited Environments:

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

1 Introduction

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

NOP 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.

Overview of System Components

New cableless measurements for fetal and maternal monitoring supplement the Avalon fetal monitor family. The Avalon CL system consists of the Avalon CL base station, the Avalon CL transducers, and support of 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 Pods are also referred to as maternal measurement Pods. The following table provides an overview of all the devices.

1 Introduction

Avalon FM20/FM30 and FM40/ FM50 Wired Transducers

Avalon CL Base Station Avalon CL Transducers

IntelliVue CL Pods

FM20/FM30

M2702A and M2703A

FM40/FM50

M2704A and M2705A

Avalon CL Base Station

866074

US transducer (wired)

M2736A

Avalon CL US Transducer (cableless)

866076

IntelliVue CL NBP Pod (cableless)

865216

Toco/ Toco MP transducer (wired)

M2734A and M2734B

Avalon CL Toco+ MP Transducer (cableless)

866075

IntelliVue CL SpO2 Pod (cableless)

865215

1 Introduction

Toco+ transducer with ECG/IUP capability (wired)

M2735A

Avalon CL ECG/IUP Transducer (cableless)

866077

Patient Module for ECG/IUP

M2738A

Avalon FM20/FM30 and FM40/ FM50 Wired Transducers

Avalon CL Base Station Avalon CL Transducers

IntelliVue CL Pods

2What's New

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

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

What's New in Release J.3

Avalon CL Transducer System

The Avalon CL 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 159 and “Monitoring Triple FHRs” on page 167)

• Cableless maternal measurement Pods CL SpO

and CL NBP (see “CL Pods” on page 44)

• Maternal pulse from a CL Toco

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

Pulse Rate” on page 213)

• A cableless ECG/IUP transducer measuring IUP or fetal/maternal ECG (see “Monitoring MECG Wave” on page 217 and “Monitoring FHR Using DECG” on page 183)

• Watertight cableless transducers that can be used to monitor in water (see “Underwater Monitoring” on page 87)

• Patient call that pages an ambulating mother with an audible signal emitted by the worn CL transducers (see “Calling Patients” on page 87)

• 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 “Radio Range of CL Transducers” on page 40)

• A transducer finder LED on all CL transducers to help identify the assigned transducer (see “Cableless Transducer LED Indication” on page 42

2 What's New

Support For Use of Maternal Cableless Measurement Devices

The IntelliVue CL measurement Pods are patient-worn, battery-powered measurement devices for SpO

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 “CL Pods” on page 44).

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 201). 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.

Manually Entered Maternal Temperature Measurements

Manually measured temperatures can be entered at 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 (“Monitoring Maternal Temperature” on page 201).

SpO2 Recordings and Transmissions

SpO2 annotation on local recorder

You can now configure the interval for printing the SpO

numeric values on the recorder trace. With

the new configuration setting

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

SpO

transmission to an obstetrical information and surveillance system

You can now configure the interval for transmitting the SpO

numeric values to an obstetrical

information and surveillance system. With the new configuration setting

end 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 46).

New SmartKeys

• The S

tart ECG SmartKey and menu item is renamed to Record ECG.

• With the

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

transducers.

• With the

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

the

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

connected Avalon CL base station.

• With the

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

manually measured maternal temperature values.

2 What's New

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

• With the

uickAdmit 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 49).

Coincidence INOP Tone

When the cross-channel verification detects that the signal of the maternal heart rate coincides with the fetal heart rate, the

oincidence 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 135).

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 230 and “Recovering Data” on page 229).

Dual System Interface Support

If the fetal monitor is connected via a LAN connection to OB TraceVue/IntelliSpace Perinatal or another obstetrical information and surveillance system, 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 31 and “Getting to Know Your Avalon FM40/FM50”/“Rear” on page 32).

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 31 and “Getting to Know Your Avalon FM40/FM50”/“Rear” on page 32).

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 31 and “Getting to Know Your Avalon FM40/FM50”/“Rear” on page 32).

2 What's New

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 197.

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 (

CG Leads Off, NBP Cuff Overpress, Cuff Not Deflated, Battery Empty,

pO No Pulse) (see “Alarms” on page 99).

Alarm Reminder

In Configuration Mode you can set now an A

larm 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 22).

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.

What's New in Release G.0

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

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

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

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

Maternal Pulse from Toco MP Transducer

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

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

Toco MP transducer, and using a measurement technology similar to SpO

, it automatically gives

you an additional maternal pulse source for Cross-Channel Verification (CCV).

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

2 What's New

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

• The optional N

ST Report Trace Interpretation feature allows you to automatically interpret FHR

traces and to generate a printed NST report, equivalent to the NST report functionality in OB TraceVue Rev. F and based on the NICHD guidelines from 1997.

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

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

FHR Sound Source

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

udio Select setting).

FHR Numeric Display

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

Improved FHR and DFHR Label Concept

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

FHR1,

FHR2, or DFHR3) to allow easier identification of the related trace in OB TraceVue/IntelliSpace

Perinatal.

New SmartKeys

You can control fetal heart sound volume directly with the configurable SmartKeys (F

HR Vol. Up and

HR Vol.Down) on the monitor’s screen.

Now the

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

IUP measurement.

Trace Separation On/Off Operation

Now you can switch the T

race Separation on or off in every FHR setup menu.

NBP

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

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

• Algorithm enhancements (more tolerant of movement artifacts).

Alarms

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

• The new alarm settings available in Configuration Mode are: –

utoIncrease Vol and IncreaseVolDelay

– AlarmsOffAtStart

2 What's New

– ConfirmAlarmsOff

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

CCV INOP

There is a new INOP (technical alarm) C

oincidence after 1 minute of persistent coincidence warning.

New Demographic Fields

• D

ate of Birth and Gestational Age can be entered for complete documentation in an NST Report

(supporting the optional NST Trace Interpretation software feature).

• A

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

• Two additional ID fields

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

names can be customized to fit hospital requirements. The default label of the

ifetime ID is MRN.

Recorder

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

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

Stored Data Recording

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

FHR Sound Volume

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

Avalon CTS

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

3Basic Operation

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

3 Basic Operation

Supported Measurements

The following Fetal measurements are supported:

The following Maternal measurements are supported:

Measurements FM20 FM30 FM40 FM50

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

Standard Standard Standard Standard

Triple FHR via US

Optional Optional Optional Optional

Toco

Standard Standard Standard Standard

FHR via Direct ECG (DECG)

- Standard - Standard

Intrauterine Pressure (IUP)

- Standard - Standard

Measurements FM20 FM30 FM40 FM50

Maternal Heart Rate (MHR) via Maternal ECG Electrodes

Standard Standard Standard Standard

Maternal ECG (MECG)

- Standard - Standard

Maternal Pulse from Toco

Standard Standard Standard Standard

Non-invasive Blood Pressure with Pulse Rate

Optional Optional Standard Standard

Pulse Oximetry (Maternal SpO

) with Pulse Rate

- Optional Standard Standard

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 intra-uterine 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 non-invasive blood pressure and maternal oxygen saturation (SpO

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

Avalon FM50

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

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

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

transducer or patient

module.

3 Basic Operation

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

Avalon CL Transducer System

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

or CL Toco+ MP transducer with the direct electrocardiogram (DECG). The uterine activity can be monitored using an external CL Toco

MP transducer. The fetal and maternal parameters are measured and transmitted via radio frequency from the CL transducers to the CL base station, eliminating the need for patient cables. With the Avalon CL Transducer System you can monitor a single fetus, twins and triplets.

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

shower using the CL Toco

MP and the CL Ultrasound transducers.

3 Basic Operation

Getting to Know Your Avalon FM20/FM30

Overview

Right Side

with Battery

Option

1 Touchscreen display (tilt and fold) 2 Power LED 3 Paper drawer 4 Paper drawer release 5 Connectors

1 On/Off switch 2 Power connector

1 On/Standby button with power LED 2 MSL connector

+ 274 hidden pages

Philips OBBSBV1 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual