Sonicaid FM800 Series Reference Manual Sept 2007

Sonicaid FM800 Series Reference Manual

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

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Sonicaid FM800 Series Reference Manual

Contents Contents ... 3 Standards compliance... 7 Indications for use ... 8 System Installation ... 9 Calibration ... 9 Multiple Portable Socket Outlets ... 10 Electromagnetic compatibility... 11 Trademarks ... 12 Sensors ... 12 Addresses ... 13 1 Introduction... 14 1.1 The FM800 series... 14 1.2 Main unit: front panel ... 16 1.3 Connection sockets for transducers ... 17 1.4 Main unit: rear connectors ... 18 1.5 Connector module ... 19 1.6 Event marker connection ... 20 1.7 The FM800 display ... 20 1.8 Transducers and cables ... 21 1.9 FM800 trolley or wall mounting... 22 2

FM800 Controls and Display... 23 2.1 Controls and on/off indicator... 23 2.2 FM800 main screen ... 24 2.3 Software control buttons ... 25 2.4 Audio controls ... 26 2.5 Printer controls... 27 2.6 Loading printer paper... 28

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Setup ... 29 3.1 Overview ... 29 3.2 Current alarms ... 29 3.3 Default alarms... 30 3.4 System settings... 30 3.5 Analysis... 30 3.6 Time and date ... 30 3.7 Patient details ... 31 3.8 Timer... 32 3.9 Actogram settings ... 33

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Sonicaid FM800 Series Reference Manual

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System Settings and Default Alarms ... 34 4.1 Overview ... 34 4.2 Changing the default alarms... 35 4.3 Printer setup... 35 4.4 Audio/graphic settings ... 37 4.5 International settings... 38 4.6 Serial interface ... 39

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Monitoring Fetal Parameters... 40 5.1 Preliminary ... 40 5.2 Audio signal ... 40 5.3 Ultrasound monitoring... 41 5.4 The FHR confidence indicator ... 43 5.5 False recording of low baseline FHR... 43 5.6 Ultrasound for twins ... 44 5.7 Fetal ECG (using a scalp electrode)... 45 5.8 Accidentally recording the wrong signal ... 50

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Monitoring Maternal Parameters ... 51 6.1 Contractions (using Toco transducer) ... 51 6.2 Contractions (using IUP transducer) ... 52 6.3 Maternal ECG ... 52 6.4 Maternal Blood Pressure ... 56 6.5 Maternal Oximetry ... 58 6.6 Maternal temperature ... 61

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Events and Alarms ... 62 7.1 What is meant by an alarm? ... 62 7.2 What do you see and hear?... 62 7.3 Responding to alarms... 64 7.4 Controlling alarms... 65 7.5 Recording fetal movements ... 65 7.6 Actogram... 66 7.7 Recording clinical events (EasiNotes) ... 68

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Setting Alarm Thresholds... 69 8.1 Default alarm thresholds... 69 8.2 FHR thresholds (Ultrasound and FECG)... 70 8.3 Maternal blood pressure thresholds ... 73 8.4 MECG thresholds ... 73 8.5 Maternal oximetry threshold ... 74 8.6 Temperature thresholds... 74

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SonicaidTrend Intrapartum Analysis... 75 9.1 Introduction ... 75 9.2 SonicaidTrend analysis... 76 9.3 Using SonicaidTrend analysis ... 77 9.4 SonicaidTrend analysis results... 78 9.5 Viewing trend data ... 78

Sonicaid FM800 Series Reference Manual

10 SonicaidCare Antepartum Analysis ... 79 10.1 Intended use ... 79 10.2 Overview ... 79 10.3 The Dawes/Redman criteria ... 80 10.4 Care analysis ... 80 10.5 Using SonicaidCare analysis... 81 10.6 SonicaidCare analysis report... 82 11 Using FM800 with a PC System ... 85 11.1 Using FM800 with FetalCare or System8002... 85 11.2 Using FM800 with Sonicaid Axis ... 86 11.3 Using FM800 with Sonicaid Centrale, Philips TraceVue™ or GMT Argus ... 86 12 Telemetry ... 88 12.1 Connecting the telemetry unit ... 88 12.2 Using the telemetry unit ... 88 13 Troubleshooting ... 89 13.1 FHR... 89 13.2 Oximetry... 89 13.3 Fetal event marker... 89 13.4 Maternal blood pressure error codes... 90 13.5 Printing... 90 13.6 What to do next?... 91 14 Cleaning and Maintenance ... 92 14.1 The FM800 main unit... 92 14.2 Transducers: NBP cuff, maternal oximetry sensor, temperature probe ... 92 14.3 Transducers and leads: Ultrasound, FECG, MECG, internal Toco and external Toco 93 14.4 User maintenance... 94 14.5 Technical maintenance... 95 14.6 Corrective maintenance... 96 14.7 Servicing ... 96 14.8 Accessories, consumables and spares ... 97 15 Specifications ... 99 15.1 Physical and environmental... 99 15.2 AC supply voltage and fuse values ... 99 15.3 Transducers ... 100 15.4 Controls... 104 15.5 Printer ... 104 15.6 Connections ... 105 15.7 Display ... 106 15.8 Safety... 107 15.9 Ultrasound safety considerations ... 108 16 Appendix 1: Service and Warranty ... 110 17 Appendix 2: External Connections... 111

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Sonicaid FM800 Series Reference Manual

18 Appendix 3: Transducer Problems ... 113 19 Appendix 4: Getting Started with T800 ... 115

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Sonicaid FM800 Series Reference Manual

Standards compliance SonicaidFM800 complies with: EN60601-1, 1990 EN60601-1-1, 1993 [collateral standard]

Medical Electrical Equipment Part 1 General Requirements for Safety Safety Requirements for Medical Electrical Systems

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 symbol Indicates Type CF applied part.

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Sonicaid FM800 Series Reference Manual

Indications for use Huntleigh Healthcare Ltd Sonicaid FM800 series fetal monitors are indicated for use in monitoring fetal and maternal vital signs during the intrapartum and antepartum periods. Sonicaid FM820 provides comprehensive fetal monitoring facilities, offering twin ultrasound fetal heart rate, separate fetal and maternal ECG channels, external and internal uterine activity monitoring and maternally sensed fetal movements. Sonicaid FM830 provides additional maternal monitoring with facilities for simultaneous monitoring of maternal pulse oximetry, blood pressure and temperature without the need for additional stand-alone devices. Notes US Federal Law restricts this device to sale on or by the order of a physician. Sonicaid Care analysis and Sonicaid Trend analysis are not approved for sale in the USA and Canada.

Warning: 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.

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Sonicaid FM800 Series Reference Manual

System Installation These requirements must be met when you connect an FM800 fetal monitor to any of the following pieces of equipment: ● a central review and archiving system ● ●

a PC a VGA monitor:

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. 3 The configured system must comply with the system standard IEC601-1-1/EN60601-1-1. 4 If non-medical equipment (eg 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), you must bring the enclosure leakage currents within the limits laid down by IEC601-1/EN60601-1. This may be done by using an isolating transformer such as the one supplied by Huntleigh Healthcare Ltd. 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 you are in any doubt 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 FM800 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 14.5. Apart from this, there is no special procedure for calibrating FM800.

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Sonicaid FM800 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 Annexe EEE.2 of IEC601-1-1/EN60601-1-1 Amendment 1. WARNINGS 1 Do not exceed the power rating for the multiple portable socket outlet. 2 Do not place multiple portable socket-outlets on the floor. This is to protect against mechanical damage and the ingress of liquids. 3 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. 4 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. 5 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 Series Reference Manual

Electromagnetic compatibility Make sure the environment in which FM800 is installed is not subject to strong sources of electromagnetic interference (eg 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: ● Reorienting the equipment ● Relocating the equipment with respect to the source of interference ● Moving the equipment away from the device with which it is interfering ● 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.

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Sonicaid FM800 Series Reference Manual

Trademarks Sonicaid™ is a registered trademark of Huntleigh Healthcare Ltd. TempHearts™ is a registered trademark of YSI Corporation. 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 The use of original oximetry sensors supplied by the manufacturer is strongly recommended.

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Sonicaid FM800 Series Reference Manual

Addresses UK Huntleigh Healthcare Ltd 35 Portmanmoor Road, Cardiff. CF24 5HN. UK. Tel: +44 (0) 2920 485885 Fax: +44 (0) 2920492520 E-mail: [email protected] Web page www.huntleigh-healthcare.com

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Sonicaid FM800 Series Reference Manual

1 Introduction 1.1 The FM800 series FM800 series monitors are designed for antepartum and intrapartum monitoring. There are four monitors in the series: FM820

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 FM820 also provides external and internal monitoring of uterine activity, and maternally sensed fetal movements

FM830

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

This reference manual covers the whole FM800 range and may describe some facilities not available in the FM800 you have bought. Note that FM820 can be upgraded to FM830.

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Sonicaid FM800 Series Reference Manual

FM820: standard features The following features are available on all monitors in the FM800 range: ● Alarms ● Annotation ● Audio ● ● ● ● ● ● ● ● ●

Display autodim Direct FECG via scalp electrode Fetal event marker Interface to Rimkus telemetry Interface to Sonicaid Axis Interface to Sonicaid System 8002 / Fetalcare Interface to Sonicaid Centrale and other CMS packages IUP: internal uterine activity Maternal Heart Rate via ECG (MECG lead supplied as option)

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Toco: external uterine activity Ultrasound 1: 1.5MHz Ultrasound 2: 2.0MHz Thermal printer SonicaidCare (antepartum) analysis*

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SonicaidTrend (intrapartum) analysis*

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* Not approved for sale is USA and Canada.

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Sonicaid FM800 Series Reference Manual

1.2 Main unit: front panel 1

3

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2

1

5

1 Software control buttons 2 Display: see chapter 2 3 Connector module for oximetry, blood pressure and temperature 4 Connection sockets for transducers 5 Printer drawer 6 Controls and on/off indicators: see chapter 2.

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Sonicaid FM800 Series Reference Manual

1.3 Connection sockets for transducers

ULT1

1.5 MHz Ultrasound transducer, yellow

ULT2/FECG

2.0 MHz Ultrasound transducer, blue Fetal ECG electrode, blue (connected via leg plate)

OR MECG

Maternal ECG transducer, blue

TOCO/IUP OR

Toco contractions transducer, pink IUP catheter-transducer, pink

Classification symbol This symbol indicates Type CF applied part.

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Sonicaid FM800 Series Reference Manual

1.4 Main unit: rear connectors 1

2

3

6

7

4

1

Input socket for the AC mains supply

2

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

3

RS232 connector for external FspO2, 9-way D-type socket (reserved for future use)

4*

RS485 Interface for Axis (1.5kV DC isolation) (not used)

5*

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

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RS232 connector for Sonicaid Centrale, FetalCare, Philips TraceVue™, GMT Argus** 9-way D-type socket NB this connector will also accept an RS232 to RS422 adaptor lead for connection to Philips TraceVue™

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RS232 connector for external MSpO2 9-way D-type socket (reserved for future use)

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VGA connector, 15-way compact D-type socket See notes on page 9 This symbol means Date of Manufacture

* For pin connections, see Appendix 2. ** Not approved for use with Sonicaid FM800 in the USA or Canada.

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Sonicaid FM800 Series Reference Manual

1.5 Connector module FM830 offers additional features via a connector module.

NBP

Maternal blood pressure

TEMP

Maternal temperature

MSpO2

Maternal pulse oximetry

Type CF patient applied part

FM830 The connector module has connectors for maternal blood pressure, maternal oximetry and maternal temperature. The fetal oximetry connector is blanked off.

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Sonicaid FM800 Series Reference Manual

1.6 Event marker connection

Event marker connector

1.7 The FM800 display The FM800’s high-performance display combines superior visual performance with environmental ruggedness, making it suitable for a wide range of environments. The principal benefits of the FM800 display are: ● ● ● ● ●

High brightness and contrast Wide viewing angle: >160° Display auto-dims when FM800 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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