Huntleigh Sonicaid Team 3 Series User manual

Team 3

2
Table of Contents
Table of Contents
1. Safety .................................................................................6
1.1 Warnings.................................................................................................6
1.2 Infection Control....................................................................................7
1.3 Patient Applied Parts.............................................................................7
2. Introduction........................................................................8
2.1 Intended Use and Indications...............................................................9
2.2 Unpacking / Preliminary Checks..........................................................10
2.2.1 Contents ................................................................................................................10
2.3 Operator Positioning.............................................................................10
3. Product Identification.........................................................11
3.1 Front Panel.............................................................................................11
3.2 Rear Panel ..............................................................................................12
3.3 Side Panel...............................................................................................13
3.4 Product Labelling...................................................................................13
4. Setup .................................................................................15
4.1 System Connection ...............................................................................15
4.2 Probe/Sensor/Cuff Connection.............................................................15
4.3 Loading Paper........................................................................................15
4.4 Handling and Mounting.........................................................................16
5. Operation ...........................................................................17
5.1 Switching the Unit ON...........................................................................17
5.2 Application Screen ...............................................................................17
5.2.1 Patient Data............................................................................................................ 18
5.2.2 Lock / Unlock Screen ............................................................................................. 21
5.2.3 Date / Time............................................................................................................. 22
5.3 Control Bar.............................................................................................22
5.3.1 Record / Print ......................................................................................................... 23
5.3.2 Paper Feed............................................................................................................. 23
5.3.3 Numeric / Trace View ............................................................................................. 23
5.3.4 Volume Up/Down.................................................................................................... 23
5.3.5 Dawes-Redman Analysis / Trend function.............................................................. 23
5.3.6 Annotation - EasiNotes........................................................................................... 23
5.3.7 Settings Menu ........................................................................................................ 25
5.3.8 View Menu.............................................................................................................. 33
5.4 Monitoring Parameters .........................................................................37
5.4.1 Numeric Format...................................................................................................... 38
5.4.2 FHR Monitoring ...................................................................................................... 39
5.4.3 TOCO /IUP ............................................................................................................. 39
5.4.4 SpO2/ MHR / MECG .............................................................................................. 39
5.4.5 Maternal NIBP........................................................................................................ 40
5.4.6 Trace Format.......................................................................................................... 40
5.5 Switching the Unit OFF .........................................................................41
5.6 Battery Charging ...................................................................................41

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Table of Contents
6. Monitoring Fetal Parameters ............................................42
6.1 Preliminary .............................................................................................42
6.2 Ultrasound Monitoring ..........................................................................42
6.3 False recording of FHR .........................................................................44
6.4 Twins / Triplets Ultrasound Monitoring ...............................................44
6.5 Fetal ECG (Team 3I models only- using a scalp electrode)...............45
7. Monitoring Maternal Parameters ......................................47
7.1 Contractions (using TOCO transducer)...............................................47
7.2 Contractions (using IUP transducer) ...................................................48
7.3 Fetal Movement Event Marker..............................................................48
7.3.1 Automatic Fetal Movement Event Marker .............................................................. 48
7.3.2 Manual Fetal Movement Event Marker .................................................................. 49
7.4 Maternal ECG .........................................................................................50
7.5 Maternal Blood Pressure.......................................................................51
7.5.1 Taking BP measurements ...................................................................................... 52
7.6 Maternal Oximetry..................................................................................55
7.6.1 Procedure............................................................................................................... 55
8. Alarms ................................................................................58
8.1 What is meant by an alarm....................................................................58
8.2 What is seen and heard.........................................................................58
8.3 Responding to alarms...........................................................................59
8.4 Controlling alarms.................................................................................59
9. Printing ..............................................................................60
9.1 Introduction............................................................................................60
9.2 Paper options.........................................................................................60
9.3 Paper care and handling.......................................................................60
9.4 Print speed and duration.......................................................................61
9.5 Changing paper packs ..........................................................................61
9.6 Loading printer paper............................................................................62
9.7 Using non-Sonicaid paper ....................................................................62
9.8 Sample Trace (Sonicaid paper) ............................................................63
9.9 Turning off the printer ...........................................................................64
9.9.1 Normal recording ................................................................................................... 64
9.9.2 Stopping the printer while Dawes-Redman analysis.............................................. 64
10. Sonicaid Trend .................................................................66
10.1 Introduction............................................................................................66
10.2 Sonicaid Trend.......................................................................................67
10.3 Sonicaid Trend results..........................................................................67
10.4 Viewing Sonicaid Trend data................................................................68

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Table of Contents
11.Dawes-Redman Antepartum Analysis...............................70
11.1 Intended Use ..........................................................................................70
11.2 Overview.................................................................................................70
11.3 The Dawes-Redman Criteria.................................................................71
11.4 Dawes-Redman Analysis ......................................................................71
11.5 Using Dawes-Redman analysis............................................................72
11.6 Dawes-Redman Analysis report...........................................................74
12. Using Team 3 with a CRS System....................................77
12.1 Using Team 3 with Sonicaid FetalCare and Sonicaid Centrale .........77
12.1.1 Connecting Team 3 to Sonicaid FetalCare and Sonicaid Centrale ........................ 77
13. Telemetry – Sonicaid Freedom.........................................78
13.1 Connecting the Sonicaid Freedom telemetry unit..............................78
13.2 Using the telemetry unit........................................................................78
14. Trouble Shooting...............................................................79
14.1 FHR..........................................................................................................79
14.2 Oximetry .................................................................................................79
14.3 Fetal event marker.................................................................................80
14.4 Maternal blood pressure.......................................................................80
14.5 Printing ...................................................................................................80
15. Care and Cleaning ............................................................81
15.1 General Care...........................................................................................81
15.2 General Cleaning and Disinfecting .....................................................82
15.3 Cleaning and Disinfecting Patient Applied Parts................................82
15.4 NIBP Cuff & Maternal Oximetry Sensor...............................................83
15.5 Transducer Belts....................................................................................83
16. Maintenance .....................................................................84
16.1 User maintenance..................................................................................84
16.2 Technical maintenance .........................................................................85
16.3 Corrective maintenance........................................................................85
16.4 Servicing.................................................................................................85
16.5 Secure Settings......................................................................................85
16.6 Customising Easinotes.........................................................................91

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Table of Contents
17. Specifications ..................................................................93
17.1 Equipment Classification .....................................................................93
17.2 General ...................................................................................................93
17.3 Environmental........................................................................................93
17.4 Transducers ..........................................................................................94
17.5 Printer ....................................................................................................97
17.6 Connections *.........................................................................................98
17.7 Display ...................................................................................................99
17.8 Default Settings ....................................................................................99
17.9 General Standards.................................................................................101
18. Accessories .....................................................................102
19. Electromagnetic Compatibility ........................................103
20. Ultrasound Safety Considerations ...................................107
21. End of Life Disposal..........................................................110
22. Warranty & Service ..........................................................111
© Huntleigh Healthcare Ltd
All rights reserved
Manufactured in the UK by Huntleigh Healthcare Ltd.
As part of the ongoing development programme the company reserves the right
to modify specifications and materials without notice.
Sonicaid and Huntleigh are registered trademarks of Huntleigh Technology Ltd.
2016.
© Huntleigh Healthcare Ltd. 2016
Team 3 is in conformity with the Medical Devices Directive 93/42/EEC
as amended by 2007/47/EC and has been subject to the conformity
assurance procedures laid down by the Council Directive

6
Safety
1. Safety
We recommend that exposure to ultrasound should be kept As Low As
Reasonably Achievable - (ALARA guidelines). This is considered to be
good practice and should be observed at all times.
Team 3 provides 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. If there is any doubt concerning the accuracy of
any measurement, an alternative method should be used.
Symbols
General Warning
Attention, consult this manual. Refer to safety section.
Refer to Instructions
for Use
Attention, consult accompanying
documents / Instructions for Use
1.1 Warnings
Do not use in the presence of flammable gases or in oxygen rich
environments.
Do not sterilise the product or its accessories. The product will be
damaged, and there is a risk of patient and user harm.
Do not immerse Team 3 in liquid. Ultrasound and Toco transducers are
IPX7 rated. Team 3 is not intended for use in water birth situations.
Do not use in the sterile field unless additional barrier precautions are
taken.
Use only recommended accessories listed in this manual.
Do not dispose of batteries in fire as this can cause them to explode.
Do not use with defibrillators.
Do not use with electrosurgical devices.
Team 3 can be isolated from the AC mains supply by removing the IEC
mains inlet connector. Ensure that this is fully accessible at all times.
Team 3 is a Class 1 product that relies for safety on its protective earth.
Ensure it is connected to a suitably earthed AC mains supply.

7
Safety
Do not use in the home environment.
Do not use the Team 3 in vehicles or in aircraft.
If this product is connected to another item of electrical equipment,
ensure that the system is fully compliant with IEC60601-1:2005.
This product contains sensitive electronics, therefore, strong radio
frequency fields could possibly interfere with it. This will be indicated
by unusual sounds from the loudspeaker. We recommend that the
source of interference is identified and eliminated.
Do not expose to excessive heat, including prolonged exposure to
sunlight.
This equipment must not be modified.
This equipment is for use only by suitably qualified healthcare
practitioners.
When configuring the system, consider and minimise the risk of
persons tripping over cables.
Do not use during magnetic resonance imaging (MRI) scanning.
Do not use if there is any damage to the unit or its accessories.
1.2 Infection Control
Single use transducer belts are for single patient use only and must not be re-
used.
For other single use accessories refer to the user instructions supplied with
them.
1.3 Patient Applied Parts
As defined in IEC60601-1:2005, the patient applied parts of the Team 3 Fetal
Monitor are the:
• TOCO Transducer • SpO2Sensor
• Ultrasound Transducer • MECG Electrodes
• Patient Event Marker • FECG Scalp Electrodes
• NIBP Cuff

8
Introduction
2. Introduction
This Instructions for Use is compatible with monitors fitted with Version 5
software.
The Team 3 series of fetal/maternal monitors are intended for antepartum
(Team 3A) and intrapartum use (Team 3I).
The following features are standard on all models (Team 3A and Team 3I):
• Dual channel ultrasound fetal heart rate detection with audio.
• External monitoring of maternal contractions
• Maternally sensed fetal movements
• Automatic detection of fetal movement
• Colour 8.4” touchscreen display
• Connections to Central Record System via serial port
• Connection to wireless transducer system (Sonicaid Freedom).
• USB - for upgrading and configuration
The following options are available for all models:
• Dawes-Redman Analysis *
• Triplets
• eCTG models (No printer)
• Integral rechargeable battery
• DVI video output
• Paper tray insert for pre-printed paper
• Maternal Non-Invasive Blood Pressure
• Maternal pulse oximetry (MSpO2)
Team 3I has in addition the following as standard:
• Fetal ECG **
• Maternal ECG ***
• Intra-uterine pressure ***
Team 3I additional options:
• Labour Trend function *
* Not available in all markets
** Electrodes/sensors supplied separately
*** Interface cables and Electrodes/sensors supplied separately

9
Introduction
2.1 Intended Use and Indications
The Team 3 fetal monitors are indicated for use by trained healthcare
professionals in non-invasive and invasive monitoring of physiological
parameters in pregnant women and fetuses, during the intrapartum and
antepartum periods of pregnancy. The devices are intended for use in clinical
and hospital-type facilities.
Sonicaid Team 3 Antepartum is suitable for use when there is a need to monitor
the following physiological applications:
• Single, twin or triplet fetal heart rates by means of ultrasound
• Uterine activity - externally sensed
• Fetal movement - maternally sensed and externally via ultrasound.
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure.
Sonicaid Team 3 Intrapartum is suitable for use when there is a need to monitor
the following physiological applications:
• Single, twin or triplet fetal heart rates by means of ultrasound and/or FECG
• Maternal heart rate via ECG
• Uterine activity - externally or internally sensed
• Fetal movement - maternally sensed and externally via ultrasound
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure.

10
Introduction
2.2 Unpacking / Preliminary Checks
We recommend that a thorough visual inspection is made immediately the unit
is received. Should any damage be evident or any parts missing, ensure that
Huntleigh Healthcare Ltd is informed at once.
2.2.1 Contents
Standard - All models
Item
1 x Team 3 1 x Ultrasound Transducer 1 x Toco transducer
1 x Event marker 1 x Pack of standard paper* 1 x 250ml Ultrasound Gel
Quick Start Guide 1 x Instructions for Use CD 2 x Transducer belt
1 x Power Cord
* except where Philips/GE paper insert option installed
Blood Pressure Option
Item
1 x Medium Cuff 1 x Large Cuff 1 x Connecting Hose
SpO2 Option
Item
1 x Interface lead 1 x Finger sensor (type depends on option selected
with order)
Standard - Team 3I
Item
1 x FECG lead (type depends on option selected with order)
Note: All Team 3 models are twins capable as standard but are supplied
with 1x US transducer. For twins, or triplets if this option is
installed, order extra US transducer separately as required.
2.3 Operator Positioning
Team 3 can be comfortably operated from a standing or seated position in front of
the unit.

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Product Identification
3. Product Identification
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 Huntleigh.
3.1 Front Panel 1 2
46537
1Touchscreen 5FHR2 US/FECG socket
2On/Off Button 6TOCO Transducer socket
3Printer * 7FHR3 US/FECG socket *
4FHR1 US/FECG socket
* Depending on model/options purchased.

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Product Identification
3.2 Rear Panel
653214 879
1Mains Socket 6DVI Socket *
2Equipotential earth point 7Rating Label
3Fetal Event Marker Socket 8USB Port x 2
4RS232/CRS Socket 9Ethernet Port **
5Wireless Telemetry Socket
* Depending on model/options purchased.
** Not enabled - future upgrade.

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Product Identification
3.3 Side Panel
321
4
1Maternal MSpO2* 3Maternal NIBP *
2Maternal ECG * 4Transducer storage
* Depending on model/options purchased.
3.4 Product Labelling
Applied parts (Ultrasound
Probes / TOCO / MECG /
FECG) are type CF*
Applied parts (Maternal NIBP/SpO2/
fetal event marker) are type B*
This symbol signifies that this product, including its accessories and
consumables is subject to the WEEE (Waste Electrical and Electronic
Equipment) regulations and should be disposed of responsibly in accordance
with local procedures.
This symbol signifies that this product complies with the essential requirements
of the Medical Devices Directive
93/42/EEC as amended by 2007/47/EC

14
Product Identification
Warning Attention, consult accompanying
documents / Instructions for Use
~Alternating current (AC) On/Standby
DI Device Identifier Protective Earth
SN Serial Number REF Reference Number
Manufacturer
Y
Date of Manufacture
Keep Dry Do not use hook
Fragile Cardboard packaging can be
recycled.
50°C
-10°C Temperature Limitations
Max 90% RH
Limits of Relative Humidity
PVC
Does not contain PVC
LATEX
Not made with natural rubber latex.
YYYY-MM
Use By Do Not Reuse
Fetal Event Marker Equipotential Earth
Limits of Atmospheric
Pressure IP30 Protected against ingress of solid
foreign objects >2.5mm diameter. Not
protected against ingress of water.
USB Port Ethernet Port
RoHS Compliant
(RoHS - Restriction of
Hazardous Substances)
* As defined by IEC60601-1.

15
Setup
4. Setup
4.1 System Connection
WARNING: These requirements must be met when a Team 3 is
connected to any other electrical equipment, such as 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 Anyone 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 the
requirements of IEC60601-1:2005; clause 16. If there is any doubt as
to whether your system complies, consult the technical service
department or your local Huntleigh representative.
3 If non-medical equipment (e.g. the PC or printer) with enclosure
leakage currents greater than those allowed by IEC60601-1 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 IEC60601-1. This may be achieved by using a medical
grade isolating transformer. Suitable types are available via
Huntleigh sales agents.
4.2 Probe/Sensor/Cuff Connection
Ensure all probe/sensor leads are fully inserted into the appropriate socket.
Do not remove any cables by pulling on the lead.
4.3 Loading Paper
Refer to Section 9.6 - Loading Printer Paper

16
Setup
4.4 Handling and Mounting
Trolley
If the unit is moved regularly, for maximum safety it is recommended that it is
mounted on the purpose-designed trolley, which is available as an accessory.
Follow the instructions provided with the trolley regarding assembly and proper
mounting of the Team 3.
If the Team 3 is being used on a trolley, make sure the trolley
brakes are applied, except when the trolley is being moved.
Take care to ensure that trailing transducer cables and other
connecting leads do not present trip hazards that could lead
to the equipment falling. Always store unused transducers
correctly.
Do not attempt to move the trolley, or use the Team 3, without
ensuring that the unit and all transducers and cables are secured.
Keep hands clear of the trolley wheels while the trolley is in
motion. Do not attempt to free trapped cables without stopping
the trolley and applying the brakes.
Wall bracket
If the unit is seldom moved, a purpose-designed bracket is available as an
accessory to allow the Team 3 to be wall mounted with maximum safety. Follow
the instructions provided with the bracket regarding assembly and proper
mounting of the Team 3.
Brackets must be installed by trained personnel using fixings
appropriate for the wall construction and load. Carry out load
tests before use.
Ensure that the Team 3 is securely fitted to the bracket using the
correct adaptor plate and screws as described in the instructions
supplied with the bracket.
Choose the location carefully to prevent possibility of users,
patients or passers-by striking the unit, causing injury.

17
Operation
5. Operation
5.1 Switching the Unit ON
Connect the monitor to the local mains supply. The unit will automatically power
up.
If the unit is in off/standby mode with power already applied, press and hold
for approximately 2 seconds to switch on. A short tone will be heard.
The unit will briefly display a splash screen, then continue to the Application
Screen.
5.2 Application Screen
The application screen will be displayed and automatically configured according
to the options / modules fitted to the unit. The screen is arranged into a series
of waveforms and numerical indicators. All functions are accessed via the
touchscreen, either through the Control Bar Menus located across the bottom of
the screen or by touching each application.
Note that some applications require you to touch and hold on the relevant area.
Patient Data
Lock/Unlock
Screen
Control Bar
Date/Time Battery
Status
Alarm
Monitoring Parameters

18
Operation
5.2.1 Patient Data
Touch and hold the Patient Data region in the top left corner of the screen to
enter the Patient Data screen.
This screen allows the operator to enter the patient’s name, ID number, navigate
to the ‘Set Gestational Age’ screen and search for previous patients.
Enter Patient Name and Patient ID using the on-screen keyboard.
Touch to remove any details from the form.
Touch to bring up the Search screen which allows the operator to
select the Patient Data of a mother who has been previously monitored.
Touch the ‘Gestation’ box to enter the ‘Set Gestational Age’ screen.
Touch to return to the Monitoring screen with the details on this form.

19
Operation
Searching for Patient Names
Touch to return to the Monitoring screen with the details of this
patient in the Patient Data region.

20
Operation
Setting Gestational Age
The Set Gestation dialogue allows the operator to change any one of:
• Last menstrual period date
• Gestational age
• Estimated due date
Based on the current date, changing any one of these will automatically update
the other two.
Touch any up or down arrow icon to change the values. The maximum value of
gestation age is set at 44 weeks.
Touch to return to the Patient Data screen with the current value of
gestational age.
Touch to return to the Patient Data screen with a cleared value
of gestational age.