Huntleigh SonicaidTeam User manual

SonicaidTeam
Operator’s Manual
¤Huntleigh HEALTHCARE Ltd 2006
All rights reserved
738311-A
February 2006

Sonicaid Team Operator’s Manual
2
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.

Sonicaid Team Operator’s Manual
3
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
2 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

Sonicaid Team Operator’s Manual
4
Contents
3 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
4 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
5 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
6 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
7 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
5
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
9 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

Sonicaid Team Operator’s Manual
6
Standards compliance
Sonicaid Team complies with:
EN60601-1: 1990 Medical Electrical Equipment Part 1
General Requirements for Safety
EN60601-1-1: 1993 Safety Requirements for Medical Electrical Systems
[collateral standard]
EN60601-1-2: 1993 Medical Electrical Equipment Part 1. General require-
ments for safety Section 1.2 Collateral standard: Electro-
magnetic compatibility – Requirements and tests.
EN61157: 1995 Requirements for the declaration of the acoustic output
[IEC61157:1992] 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:
zMaternal ECG
zRimkus Telemetry
zUse of Team with GMT Argus central review
zSonicaid 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.

Sonicaid Team Operator’s Manual
7
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 ultra-
sound transducers, and uterine activity with an external toco transducer.
Sonicaid Team IP monitors twin fetal heart rates either by two ultrasound trans-
ducers, 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 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.

Sonicaid Team Operator’s Manual
8
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.

Sonicaid Team Operator’s Manual
9
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.

Sonicaid Team Operator’s Manual
10
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:
zReorienting the equipment
zRelocating the equipment with respect to the source of interference
zMoving the equipment away from the device with which it is interfering
zPlugging 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.

Sonicaid Team Operator’s Manual
11
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.

Sonicaid Team Operator’s Manual
12
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 cardiotocograph
EFM electronic fetal monitoring
NST non-stress test
FHR 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.

Sonicaid Team Operator’s Manual
13
Addresses
UK
Sonicaid Products
Huntleigh Healthcare Ltd
Diagnostic Products Division
35 Portmanmoor Road,Cardiff,CF24 5HN,UK.
Telephone [phone]
Fax [phone]
E-mail [e-mail]
Web page www.huntleigh-healthcare.com

Sonicaid Team Operator’s Manual
14
Addresses

Sonicaid Team Operator’s Manual
15
1Introduction
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 trans-
ducer, 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.

Sonicaid Team Operator’s Manual
16
1.2 Main unit: front panel
21
76543
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
6 Keypad, with eight control buttons
7 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.

Sonicaid Team Operator’s Manual
17
1.3 Main unit: rear panel
12 3 4 5 6 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. O 1
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.
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.

Sonicaid Team Operator’s Manual
18
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:
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.
Serial number
Team frequency
Date of manufacture

Sonicaid Team Operator’s Manual
19
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.

Sonicaid Team Operator’s Manual
20
1.6 Team printer: rear panel
1 2
Key
1 Printer setting switches. See below.
2Connector to main unit (7-pin DIN). Connect to the printer
connector on the Team main unit.
Printer switch settings
Paper speed Switch 5 Switch 6
1 cm/min Down Down
2 cm/min Up Down
3 cm/min Up Up
Scale Switch 4
20 bpm/cm Down
30 bpm/cm Up
Dual monitoring Switch 3
Side-by-side Up
Full-width Down
Graticule Switch 2
5 bpm Up
10 bpm Down
Diagram on printer
Note: switch 1 should always be Up.