SonicaidTeam Operators Manual Feb 2006

Sonicaid Team Operator’s Manual

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

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Sonicaid Team Operator’s Manual

Contents Contents... 3 Standards compliance... 6 Indications for use... 7 System Installation ... 8 Calibration ... 8 Multiple Portable Socket Outlets... 9 Electromagnetic compatibility ... 10 Copyright... 11 Trademarks ... 11 Note on terminology ... 12 Sensors ... 12 Addresses ... 13 1

Introduction ... 15 1.1 Team fetal monitors ... 15 1.2 Main unit: front panel... 16 1.3 Main unit: rear panel ... 17 1.4 Contrast control... 18 1.5 Team printer: front panel ... 19 1.6 Team printer: rear panel ... 20 1.7 Team printer wedge assembly (option) ... 21 1.8 Team printer to Team base unit assembly ... 22 1.9 Team base unit to Team trolley assembly... 23 1.10 Transducers and cables... 24 1.11 Team display panel... 26 1.12 The Team Keypad ... 28

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Getting Started ... 29 2.1 Summary of recording procedure ... 29 2.2 The Team printer ... 31 2.3 Trace annotation ... 32 2.4 Loading printer paper ... 34 2.5 Printer operation ... 35 2.6 Team menu system ... 36 2.7 User name ... 37 2.8 Date and time ... 37 2.9 Version ... 38 2.10 Changing language ... 38 2.11 Entering Patient Details ... 39

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Sonicaid Team Operator’s Manual

Contents

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Monitoring ... 40 3.1 Ultrasound transducers ... 40 3.2 External Toco (contractions) transducer ... 43 3.3 Fetal ECG scalp electrode (TeamIP only) ... 44 3.4 Twin heart rate monitoring ... 46 3.5 Intrauterine pressure catheter (contractions)... 47 3.6 Maternal Heart Rate monitoring (not available in the USA and Canada) . 47 3.7 Team connected to FetalCare or System8002... 48

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Events and Alarms... 50 4.1 Recording fetal movement events ... 50 4.2 Actogram ... 50 4.3 Recording clinical events... 53 4.4 Alarms ... 54

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Storing Records ... 56 5.1 Storing... 56 5.2 Selecting a stored record for review ... 58 5.3 Displaying a stored record ... 58 5.4 Printing a stored record ... 58 5.5 Transferring a stored record to Sonicaid FetalCare or System8002 ... 59 5.6 Deleting a stored record ... 60

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Care Printer (option)... 61 6.1 Overview ... 61 6.2 Intended use ... 61 6.3 The Dawes/Redman criteria ... 62 6.4 Care analysis option ... 62 6.5 Using the analysis ... 64 6.6 The analysis report ... 66 6.7 Plotting trend data... 70 6.8 Analysis parameters and calculations... 70 6.9 References... 74

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Trend Printer (option) ... 75 7.1 Introduction ... 75 7.2 Team Trend analysis ... 76 7.3 Using the analysis ... 77 7.4 Analysis results... 78 7.5 Viewing trend data ... 80 7.6 Analysis parameters and calculations... 80

Sonicaid Team Operator’s Manual

Contents 8

Team DM (Distance Monitoring) ... 83 8.1 Description ... 83 8.2 Manual mode setup ... 83 8.3 Home mode setup ... 84 8.4 Modem setup... 85 8.5 Team DM connections... 86 8.6 Procedures... 87

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Troubleshooting ... 88 9.1 General questions... 88 9.2 Problems when you first switch on ... 89 9.3 Problems replaying or printing traces... 90 9.4 Team cycling from Logo screen to off ... 90

10 User Maintenance ... 91 10.1 Cleaning and sterilisation ... 91 10.2 Printer paper... 92 10.3 Technical maintenance... 92 10.4 Corrective maintenance ... 93 10.5 Accessories, consumables and spares ... 94 10.6 Servicing and guarantee ... 95 11 Specifications... 96 11.1 Physical and environmental ... 96 11.2 AC supply voltage and fuse values... 96 11.3 Printer... 97 11.4 Transducers ... 97 11.5 Safety... 99 11.6 Ultrasound safety considerations ... 101 Appendix 1: External Connections... 103 Appendix 2: Transducer Problems ... 106 Appendix 3: Procedures for Distance Monitoring ... 108

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Sonicaid Team Operator’s Manual

Standards compliance Sonicaid Team complies with: EN60601-1: 1990 Medical Electrical Equipment Part 1 General Requirements for Safety EN60601-1-1: 1993 [collateral standard]

Safety Requirements for Medical Electrical Systems

EN60601-1-2: 1993

Medical Electrical Equipment Part 1. General requirements for safety Section 1.2 Collateral standard: Electromagnetic compatibility – Requirements and tests.

EN61157: 1995 [IEC61157:1992]

Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment.

Notes Some features on the Team monitor have not been approved for sale in the USA and Canada. The following features are therefore not available on Team monitors sold in those countries: z Maternal ECG z Rimkus Telemetry z Use of Team with GMT Argus central review z Sonicaid Trend analysis In addition, for FECG the use of FDA-compliant fetal scalp electrodes is required in the USA and Canada.

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. THIS FETAL MONITORING SYSTEM IS A PRESCRIPTION DEVICE IN THE USA.

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Sonicaid Team Operator’s Manual

Indications for use Sonicaid Team fetal monitors are indicated for use during labour and delivery (Intrapartum) and to monitor fetal and maternal vital signs during the antepartum period. Sonicaid Team Standard monitors one channel of fetal heart rate with an ultrasound transducer, and uterine activity with an external toco transducer. Sonicaid Team Duo offers two channels of fetal heart rate monitoring using ultrasound transducers, and uterine activity with an external toco transducer. Sonicaid Team IP monitors twin fetal heart rates either by two ultrasound transducers, or invasively by a fetal ECG scalp electrode and an ultrasound transducer. Uterine activity can be measured either with an external toco transducer or an intrauterine catheter pressure transducer. Team IP can also measure the maternal heart rate (this feature not currently available in the USA). Sonicaid Team DM (Distance Monitoring) is for use in a remote clinic or the patient’s home. It provides the same facilities as Team, but includes a modem for transmitting stored data. Note: US Federal Law restricts this device to sale on or by the order of a physician.

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Sonicaid Team Operator’s Manual

System Installation The following requirements must be met when you connect a Sonicaid Team fetal monitor to a central review and archiving system, or to 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, medical safety standard. 3 The configured system must comply with the system standard IEC601-1-1/EN60601-1-1, medical safety standard 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 Sonicaid Products 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 Sonicaid Products representative. The connection of extra equipment to the patient or to Sonicaid Team could lead to the summation of leakage currents. In such circumstances the user must ensure that safe leakage currents are not exceeded.

Calibration There is no special procedure for calibrating Sonicaid Team.

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Sonicaid Team Operator’s Manual

Multiple Portable Socket Outlets (including isolation transformers) 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. Note: an isolation transformer is a particular kind of multiple socket outlet.

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 Team Operator’s Manual

Electromagnetic compatibility Make sure the environment in which Sonicaid Team 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: 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.

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Sonicaid Team Operator’s Manual

Copyright All rights reserved. This manual contains proprietary information which is protected by copyright and may not be copied in whole or in part except with the prior written permission of Huntleigh Healthcare Ltd. The copyright and the foregoing restrictions on the copyright use extend to all media in which this information may be preserved. This copy of the Operator’s Manual shall be used only in accordance with the conditions of sale of Huntleigh Healthcare Ltd or its distributors. Huntleigh Healthcare Ltd makes no representations or warranties of any kind whatsoever with respect to this document. Huntleigh Healthcare Ltd disclaims all liabilities for loss or damage arising out of the possession, sale or use of this document. Sonicaid is a registered trademark of Huntleigh Healthcare Ltd in the UK and other countries. Microsoft Office and Microsoft Windows are registered trademarks of Microsoft Corporation. Intel Pentium is a registered trademark of INTEL Corporation.

Trademarks Sonicaid is a registered trademark of Huntleigh Healthcare Ltd in the UK and other countries. Safelinc is a registered trademark of Tyco.

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Sonicaid Team Operator’s Manual

Note on terminology The Sonicaid Team fetal monitor was developed in the UK, where CTG is a recognised abbreviation for cardiotocograph. In the USA and some other countries, the terms EFM and NST are more commonly used. When the Sonicaid Team display refers to CTG, this means the printed or recorded trace showing the fetal heart rate and contractions. In this manual the trace showing the fetal heart rate and contractions is referred to simply as ‘the trace’. Where the manual refers to CTG, it does so because ‘CTG’ is what appears on the Sonicaid Team display. CTG EFM NST FHR

cardiotocograph electronic fetal monitoring non-stress test fetal heart rate

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.

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Sonicaid Team Operator’s Manual

Addresses UK Sonicaid Products Huntleigh Healthcare Ltd Diagnostic Products Division 35 Portmanmoor Road, Cardiff, CF24 5HN, UK. Telephone +44 (0)2920 485885 Fax +44 (0)2920 492520 E-mail [email protected] Web page www.huntleigh-healthcare.com

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Sonicaid Team Operator’s Manual

Addresses

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Sonicaid Team Operator’s Manual

1 Introduction 1.1 Team fetal monitors Sonicaid Team fetal monitors provide accurate and reliable monitoring throughout the antepartum and intrapartum periods. The fetal monitor consists of a base unit which collects the monitored information and a printer unit. Four base unit models are available: Team Standard Monitoring of single fetal heart rate with an ultrasound transducer, and uterine activity with an external toco transducer. Team Duo As Team, above, but with a second ultrasound transducer for monitoring twin fetal heart rates. Team IP Twin fetal heart rate monitoring either by two ultrasound transducers, or invasively by a fetal ECG scalp electrode and an ultrasound transducer. Uterine activity can be measured either with an external toco transducer or an intra-uterine pressure catheter. Team IP can also measure the maternal heart rate. * Team DM For use in a remote clinic or the patient’s home, Team DM provides the same facilities as Team Standard, but includes a modem for transmitting stored data. * This is an optional feature not currently available in the USA or Canada. There are three Team printers available: Standard Thermal printer for a continuous paper record of monitored data. Care Incorporates analysis for use during the antepartum period. Trend Incorporates analysis for use during the intrapartum period. This user manual covers the whole Team range and may describe some facilities not available in your Team unit.

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Sonicaid Team Operator’s Manual

1.2 Main unit: front panel 1

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4

2

5

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Key 1

CARDIO input, blue connector: 2 MHz ultrasound transducer, OR MECG input: maternal ECG lead (optional)*, OR FECG input for fetal ECG lead

2

Model identification: Team Standard, Team Duo, Team DM or Team IP

3

CARDIO input, yellow connector: 1.5 MHz ultrasound transducer

4

Power-on indicator light

5

EXT input, pink connector: external contractions (Toco) transducer, OR INT input: precalibrated IUP catheter-transducer

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Keypad, with eight control buttons

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Display panel

* MECG is not available in the USA or Canada. Explanation of symbols This symbol, beside the CARDIO and EXT input sockets, indicates that these connections are classed as Type B. This symbol, beside the MECG*, FECG and INT TOCO input sockets, indicates that these connections are classed as Type BF. This symbol, by the power-on indicator light, denotes AC input. * MECG is not available in the USA or Canada.

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Sonicaid Team Operator’s Manual

1.3 Main unit: rear panel

1

2

3

4

5

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7

Key 1

AC mains on/off switch: O = off, 1 = on. When you switch on, the power on indicator on the front panel shows green.

2

Input socket for the AC mains supply

3*

RS485 Interface for Axis.(1.5kV DC isolation). Pluggable cord connector (PCC-type).*

4*

RS232 interface to a PC running Sonicaid FetalCare, Sonicaid System8002 or a central review system (500V DC isolation). 9-way D-type connector.*

5*

Modem connection for distance monitoring. 25-way D-type. Connect only modems which comply with EN60950.

O1

Same connector used for the Rimkus Telemetry system.** 6*

Team printer connector 8-way DIN-type.*

7*

Fetal event marker socket. 1/4" stereo jack socket.* Date of manufacture symbol.

* for details of pin connections, see Appendix 1. ** not available on Teams sold in the USA or Canada.

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Sonicaid Team Operator’s Manual

Rear panel label The label on the rear of the Team unit shows the manufacturing serial number, the Team frequency and the date of manufacture:

Serial number

Team frequency

Date of manufacture

1.4 Contrast control In the base of the Team main unit is a display contrast control, marked with this symbol This control is for the use of service engineers only.

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Sonicaid Team Operator’s Manual

1.5 Team printer: front panel

Key 1 Printer control button. Press once for on-off. Press and hold down for fast forward. 2 Printer on indicator.

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Sonicaid Team Operator’s Manual

1.6 Team printer: rear panel

1

2

Key 1

Printer setting switches. See below.

2

Connector to main unit (7-pin DIN). Connect to the printer connector on the Team main unit.

Printer switch settings Paper speed

Switch 5

Scale

Switch 4

Dual monitoring

Switch 3

Graticule

Switch 2

1 cm/min 2 cm/min 3 cm/min

20 bpm/cm 30 bpm/cm Side-by-side Full-width 5 bpm 10 bpm

Down Up Up

Switch 6

Down Down Up

Down Up

Up Down

Up Down

Diagram on printer Note: switch 1 should always be Up.

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