Sonicaid FM800 ENCORE User Manual Sept 2008

Part no. 751321 © Huntleigh Healthcare Ltd All rights reserved September 2008

The Sonicaid™ FM800 Encore is in conformity with the Medical Devices Directive (93/42/EEC) and has been subject to the conformity assurance procedures laid down in the Council Directive.

Sonicaid FM800 Encore Series Reference Manual

Contents Contents ... 3 Standards compliance... 7 Indications for use ... 8 Limitations for use ... 8 System Installation ... 9 Calibration ... 9 Multiple Portable Socket Outlets ... 10 Electromagnetic compatibility... 11 Service & Warranty ... 11 Trademarks ... 12 Sensors ... 12 Addresses ... 12 1

Introduction ... 13 1.1 The FM800E series ... 13 1.2 Main unit: front panel ... 15 1.3 Connection sockets for transducers ... 16 1.4 Main unit: rear connectors ... 17 1.5 The FM800E display ... 19 1.6 Transducers and cables ... 20 1.7 FM800E trolley or wall mounting ... 21

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FM800E Controls and Display ... 22 2.1 Controls and on/off indicator ... 22 2.2 FM800E main screen ... 23 2.3 Software control buttons ... 24 2.4 Audio controls ... 25 2.5 Printer controls ... 26

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Setup ... 28 3.1 Overview ... 28 3.2 Current alarms ... 28 3.3 Default alarms ... 28 3.4 System settings... 28 3.5 Analysis... 29 3.6 Time and date ... 29 3.7 Patient details ... 29 3.8 Timer ... 30 3.9 Actogram settings ... 31

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Sonicaid FM800 Encore Series Reference Manual

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System Settings and Default Alarms ... 32 4.1 Overview ... 32 4.2 Changing the default alarms ... 33 4.3 Printer setup... 33 4.4 Audio/graphic settings ... 35 4.5 International settings ... 36 4.6 Serial interface ... 37

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Monitoring Fetal Parameters... 38 5.1 Preliminary ... 38 5.2 Audio signal ... 38 5.3 Ultrasound monitoring... 39 5.4 The FHR confidence indicator ... 41 5.5 False recording of low baseline FHR... 41 5.6 Ultrasound for twins ... 42 5.7 Fetal ECG (using a scalp electrode)... 43 5.8 Accidentally recording the wrong signal ... 48

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Monitoring Maternal Parameters ... 49 6.1 Contractions (using Toco transducer) ... 49 6.2 Contractions (using IUP transducer) ... 49 6.3 Maternal ECG ... 50 6.4 Maternal Blood Pressure ... 53 6.5 Maternal Oximetry ... 55

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Events and Alarms ... 58 7.1 What is meant by an alarm? ... 58 7.2 What is seen and heard? ... 58 7.3 Responding to alarms ... 60 7.4 Controlling alarms ... 61 7.5 Recording fetal movements ... 61 7.6 Actogram... 62 7.7 Recording clinical events (EasiNotes) ... 64

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Setting Alarm Thresholds... 65 8.1 Default alarm thresholds ... 65 8.2 FHR thresholds (Ultrasound and FECG) ... 66 8.3 Maternal blood pressure thresholds ... 69 8.4 MECG thresholds ... 69 8.5 Maternal oximetry threshold ... 70

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CTG Chart View ... 71 9.1 Introduction ... 71 9.2 Screen Layout ... 71 9.3 Button Functions ... 72 9.4 Trace Buffer ... 73

Sonicaid FM800 Encore Series Reference Manual

10 SonicaidTrend Intrapartum Analysis ... 74 10.1 Introduction ... 74 10.2 SonicaidTrend analysis... 75 10.3 Using SonicaidTrend analysis ... 76 10.4 SonicaidTrend analysis results ... 77 10.5 Viewing trend data ... 77 11 SonicaidCare Antepartum Analysis ... 78 11.1 Intended use ... 78 11.2 Overview ... 78 11.3 The Dawes/Redman criteria ... 79 11.4 Care analysis ... 79 11.5 Using SonicaidCare analysis ... 80 11.6 SonicaidCare analysis report ... 81 12 Using FM800E with a PC System ... 83 12.1 Using FM800E with FetalCare ... 83 12.2 Using FM800E with Sonicaid Centrale, Philips TraceVue™ ... 84 13 Telemetry ... 86 13.1 Connecting the telemetry unit ... 86 13.2 Using the telemetry unit ... 86 14 Troubleshooting ... 87 14.1 FHR ... 87 14.2 Oximetry... 87 14.3 Fetal event marker ... 87 14.4 Maternal blood pressure error codes... 88 14.5 Printing ... 88 14.6 What to do next? ... 89 15 Cleaning and Maintenance ... 90 15.1 The FM800E main unit ... 90 15.2 Transducers: NBP cuff, maternal oximetry sensor ... 90 15.3 Transducers and leads: Ultrasound, FECG, MECG, external Toco... 91 15.4 User maintenance ... 92 15.5 Technical maintenance ... 93 15.6 Corrective maintenance ... 94 15.7 Servicing ... 94 15.8 Accessories, consumables and spares ... 95

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Sonicaid FM800 Encore Series Reference Manual

16 Specifications ... 96 16.1 Physical and environmental ... 96 16.2 AC supply voltage and fuse values ... 96 16.3 Transducers ... 97 16.4 Controls... 101 16.5 Printer ... 101 16.6 Connections ... 102 16.7 Display ... 103 16.8 Safety ... 104 16.9 Ultrasound safety considerations ... 105 Appendix 1: External Connections ... 107 Appendix 2: Transducer Problems ... 109 Appendix 3: Getting Started with T800 ... 111

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Sonicaid FM800 Encore Series Reference Manual

Standards compliance Sonicaid FM800 Encore complies with: EN60601-1, 2006

Medical Electrical Equipment Part 1 General Requirements for Safety

EN60601-1-1, 2001 [collateral standard] EN60601-1-2, 2007 [collateral standard]

Safety Requirements for Medical Electrical Systems

EN60601-1-4, 1997 [collateral standard]

General requirements for safety: Programmable electrical medical systems

EN60601-2-30, 2000 [collateral standard]

Particular requirements for safety, including essential performance, of automatic cycling noninvasive blood pressure monitoring equipment

ISO9919, 2005

Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

General requirements for safety: Electromagnetic compatibility

Patient safety WARNING: DO NOT TOUCH LIVE PARTS OF ANY EQUIPMENT (eg COM PORT CONNECTOR PINS ON A PC) AND THE PATIENT AT THE SAME TIME. CE Mark Denotes conformity with the European Council Directive 93/42/EEC concerning medical devices. Classification Shock Protection - Class

Class 1 mains powered equipment

Shock Protection – Degree

Type CF Applied Parts

Water Ingress Protection

Ordinary equipment

Safety in presence of Flammable Gases

Not suitable for use in presence of flammable gases

Operation Mode

Continuous

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Sonicaid FM800 Encore Series Reference Manual

Indications for use Huntleigh Healthcare Ltd Sonicaid FM800 Encore series fetal monitors (henceforth referred to as FM800E series) are indicated for use in monitoring fetal and maternal vital signs during the intrapartum and antepartum periods. Sonicaid FM820E provides comprehensive fetal monitoring facilities, offering twin ultrasound fetal heart rate, separate fetal and maternal ECG channel, external and internal uterine activity monitoring and maternally/automatically sensed fetal movements. Sonicaid FM830E provides additional maternal monitoring with the facility for simultaneous monitoring of maternal pulse oximetry and non-invasive blood pressure without the need for additional stand-alone devices. Notes Sonicaid Care analysis and Sonicaid Trend analysis are not approved for sale in the USA and Canada. Do not use the maternal oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could cause burns. The oximeter may affect the MRI image, and the MRI unit may affect the accuracy of oximetry measurements.

Limitations for use Fetal monitors provide just one indicator of fetal condition. This should be assessed as part of an holistic approach to obstetric care together with other factors. A complete assessment must be made before taking appropriate action. FM800E series monitors are intended to show trends in fetal and maternal life signs to give a “first line” indication. On-screen displays and printouts should not be used as a basis for clinical diagnosis; always confirm vital sign parameters by other means before making treatment decisions. Ultrasound monitoring should be performed in accordance with current guidelines. The ALARA guideline (AIUM) recommends that ultrasound exposure should be kept As Low As Reasonably Achievable. FM800E series monitors are not intended to be used in conjunction with defibrillator equipment. All transducers should be removed from the patient prior to using a defibrillator to avoid possible equipment damage and/or injury.

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Sonicaid FM800 Encore Series Reference Manual

System Installation These requirements must be met when an FM800E fetal monitor is connected to any of the following pieces of equipment: z z

a central review and archiving system a PC

1 Non-medical equipment must comply with the relevant IEC or ISO safety standard. For Information Technology equipment, this standard is IEC950/ EN60950. 2 Medical equipment must comply with IEC601-1/EN60601-1, or equivalent. 3 The configured system must comply with the system standard IEC601-1-1/ EN60601-1-1. 4 If non-medical equipment (e.g. the PC or printer) with enclosure leakage currents greater than those allowed by IEC601-1/EN60601-1 is to be used in the patient environment (within 1.5m of the patient), the enclosure leakage currents must be brought within the limits laid down by IEC601-1/EN60601-1. This may be done by using an isolating transformer. Suitable types are available via Huntleigh Healthcare sales agents. 5 Anybody who connects additional equipment to signal input or signal output parts of the system is configuring a medical system, and is therefore responsible for ensuring that the system complies with IEC601-1-1/ EN60601-1-1. If there is any doubt as to whether your system does comply, consult the technical service department of your local Huntleigh Healthcare Ltd representative. The connection of extra equipment to the patient or FM800E could lead to the summation of leakage currents. In such circumstances the user must ensure that safe leakage currents are not exceeded.

Calibration The NBP module should be calibrated every 12 months. See Section 15.5. Apart from this, there is no special procedure for calibrating FM800E.

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Sonicaid FM800 Encore Series Reference Manual

Multiple Portable Socket Outlets (including isolation transformers) Note: an isolation transformer is a particular kind of multiple socket outlet. It is not recommended to power a medical system from a multiple portable socket outlet which is not supplied from an isolation transformer (IEC601-1-1/EN60601-1-1 Amendment 1). If such an outlet is in use, it should comply with the requirements of Annex EEE.2 of IEC601-1-1/EN60601-1-1 Amendment 1. Do not exceed the power rating for the multiple portable socket outlet. Do not place multiple portable socket-outlets on the floor. This is to protect against mechanical damage and the ingress of liquids. Multiple portable socket-outlets supplied with the system must not be used for powering equipment which does not form part of the system. This is to prevent increased leakage currents, and overload of the multiple portable socket outlet. If the system has been specified for use with an isolation transformer, do not connect any non-medical electrical equipment which forms part of the system directly to the wall outlet. This is to prevent excessive leakage currents Non-medical electrical equipment situated in the patient environment (within 1.5 metres of the patient) must be powered via an isolation transformer, to limit leakage current. For more information on the connection and use of isolation transformers, consult the user manual for the medical system you have purchased.

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Sonicaid FM800 Encore Series Reference Manual

Electromagnetic compatibility Make sure the environment in which FM800E is installed is not subject to strong sources of electromagnetic interference (e.g. radio transmitters, mobile phones). This equipment generates and uses radio frequency energy. If not installed and used properly, in strict accordance with the manufacturer's instructions, it may cause or be subject to interference. Type-tested in a fully configured system, it has been found to comply with IEC601-1-2/EN60601-1-2, the standard intended to provide reasonable protection against such interference. Whether the equipment causes interference may be determined by turning the equipment off and on. If it does cause or is affected by interference, one or more of the following measures may correct the interference: z

Reorienting the equipment

z

Relocating the equipment with respect to the source of interference

z

Moving the equipment away from the device with which it is interfering

z

Plugging the equipment into a different outlet so that the devices are on different branch circuits

Adding accessories or components to a system, or modifying a medical device or system, may degrade the immunity performance. Consult qualified personnel before making changes to the system configuration.

Service & Warranty Huntleigh Healthcare's standard terms and conditions apply to all sales. These contain full details of warranty terms and do not limit the statutory rights of the consumer. A copy is available on request. If there is any reason to return the FM800E unit, please: 1.

Clean the product, as described in the cleaning section.

2.

Pack it in suitable packing.

3.

Attach the decontamination certificate (or other written statement declaring that the product has been cleaned) to the outside of the package.

4.

Mark the package "Service Department – FM800E” and return to the address below.

UK only - For further details refer to the NHS document HSG(93) 26.

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Sonicaid FM800 Encore Series Reference Manual

Trademarks Sonicaid™ is a registered trademark of Huntleigh Healthcare Ltd. TraceVue™ is a registered trademark of Philips. Safelinc™ is a registered trademark of Tyco.

Sensors Care and disposal Re-usable probes and sensors: store and maintain in accordance with the instructions supplied by the manufacturer. Probes and sensors which do not work, or which are no longer required, should be disposed of in accordance with local regulations. Single-use probes and sensors: dispose of these after use in accordance with local regulations. Oximeter sensors Sensor types

BCI (Smiths Industries) 3444 Finger Sensor NELLCOR DS100A

Addresses UK Huntleigh Healthcare Ltd 35 Portmanmoor Road, Cardiff. CF24 5HN. UK. Tel: Fax: E-mail: Web page:

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+44 (0) 2920 485885 +44 (0) 2920 492520 [email protected] www.huntleigh-diagnostics.com

Sonicaid FM800 Encore Series Reference Manual

1 Introduction 1.1 The FM800E series FM800E series monitors are designed for antepartum and intrapartum monitoring. There are two monitors in the series: FM820E

Standard monitor Comprehensive monitoring using twin ultrasound and separate ECG channels. Gives great flexibility in monitoring multiple pregnancies. For example: Twin ultrasound and maternal ECG Ultrasound, fetal ECG and maternal ECG Twin ultrasound plus fetal ECG FM820E also provides external and internal monitoring of uterine activity, and maternally/automatically sensed fetal movements

FM830E

Standard monitor plus Maternal pulse oximetry Maternal non-invasive blood pressure

This reference manual covers the whole FM800E range and may describe some facilities not available in the FM800E you have purchased. Note that FM820E can be upgraded to FM830E.

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Sonicaid FM800 Encore Series Reference Manual

FM820E: standard features The following features are available on all monitors in the FM800E range: z Alarms z Annotation z Audio z Display autodim z Direct FECG via scalp electrode z Fetal event marker z Ethernet connection to Central Review System z Interface to Rimkus telemetry z Interface to Sonicaid Fetalcare z Interface to Sonicaid Centrale and other CMS Packages z IUP: internal uterine activity z Maternal Heart Rate via ECG (MECG lead supplied as option) z Toco: external uterine activity z Ultrasound 1: 1.0MHz z Ultrasound 2: 1.0MHz z Thermal printer z SonicaidCare (antepartum) analysis * z SonicaidTrend (intrapartum) analysis * z Printing of Mean Arterial Blood Pressure * z Actogram * Not approved for sale in USA and Canada FM830E: standard features In addition to the above, the following features are available on FM830E monitors: z Maternal pulse oximetry (MSpO2) z Maternal non-invasive blood pressure (NBP)

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Sonicaid FM800 Encore Series Reference Manual

1.2 Main unit: front panel 1

3 1 2 3 4 5 6

4

2

1

5

6

Software control buttons Display: see chapter 2 Connector module for oximetry and blood pressure (FM830E only) Connection sockets for transducers Printer drawer Controls and on/off indicators: see chapter 2.

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Sonicaid FM800 Encore Series Reference Manual

1.3 Connection sockets for transducers

ULT1

1.0 MHz Ultrasound transducer, green

ULT2

1.0 MHz Ultrasound transducer, green

MECG/FECG OR

Maternal ECG transducer, white Fetal ECG electrode, white (connected via leg plate)

OR

Toco contractions transducer, pink IUP catheter-transducer, pink

TOCO/IUP

Classification symbol This symbol indicates Type CF applied part.

Safety and performance are only assured when used in conjunction with the correct types of transducer. Do not attempt to connect any devices via these sockets other than those supplied or recommended by your Sonicaid dealer.

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Sonicaid FM800 Encore Series Reference Manual

1.4 Main unit: rear connectors 1

2

3

4

1

Input socket for the AC mains supply

2

RS232 connector for Sonicaid Centrale, FetalCare, Philips TraceVue™, GMT Argus** Central Review Systems. 9-way D-type socket*

3

RS232 EXT 1 connector for external NBP, 9-way D-type socket (reserved for future use)*

4

LAN connector for connection to CRS via 10/100Mbps local area network. RJ45 socket

5

This symbol denotes Date of Manufacture

6

Connector for Rimkus Telemetry** 15-way D-type socket

5

6

* For pin connections, see Appendix 1. ** Not approved for use with Sonicaid FM800E in the USA or Canada.

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Sonicaid FM800 Encore Series Reference Manual

Connector module The FM830E incorporates additional connectors for maternal blood pressure and maternal oximetry on a connector module.

NBP

Maternal blood pressure Type CF patient applied part

MSpO2 Maternal pulse oximetry

Event marker connection

Event marker connectors

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Sonicaid FM800 Encore Series Reference Manual

1.5 The FM800E display The FM800E’s high-performance colour display combines superior visual performance with environmental ruggedness, making it suitable for a wide range of environments. The principal benefits of the FM800E display are: • High brightness and contrast • Range of colours helps distinguish between displayed items • Wide viewing angle: >160° • Display auto-dims when FM800E is used in subdued lighting • Extremely rugged and durable • Reliable, long operating life Note: as with other light-emitting displays, displaying fixed patterns on the screen can cause a limited degree of burn-in. Some slight variation in luminance, as a result of this, is perfectly normal.

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Sonicaid FM800 Encore Series Reference Manual

1.6 Transducers and cables Supplied with all units Ultrasound transducers Toco transducer Transducer belts Fetal ECG lead (5 different types available) FECG lead leg belts/electrode pads Fetal movement event marker Mains lead

Green, 1.0MHz (2-off) Pink 3 pairs White 2 1 1

Supplied with FM830E NBP air line NBP adult cuff Maternal SpO2 patient lead Maternal SpO2 re-useable probe

1 1 1 1

Accessories supplied with all monitors in the FM800E range Ultrasound gel Printer paper Reference Manual (CD) Getting Started card

8oz 2 packs 1 1

Supplied as options (with any monitor in the FM800E range) IUP lead IUP single-use transducers Maternal ECG lead NBP small adult cuff NBP large adult cuff Trolley Wall-mounting kit Rimkus wireless transducer system

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Pink White