Arjo Huntleigh Sonicaid Team3 USA User manual

Fetal Monitor
INSTRUCTIONS FOR USE
Team3 USA
777732-1 10/2021

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Instructions For Use
EN
Table of Contents
1. Safety .......................................................................................................................4
1.1 Warnings.......................................................................................................................4
1.2 Infection Control ..........................................................................................................6
1.3 Patient Applied Parts...................................................................................................6
2. Introduction ..............................................................................................................7
2.1 Intended Use and Indications.....................................................................................7
2.2 Contraindications ........................................................................................................7
2.3 Unpacking / Preliminary Checks ................................................................................8
2.3.1 Contents .............................................................................................................................................................................. 8
2.4 Operator Positioning ...................................................................................................8
3.ProductIdentication ..............................................................................................9
3.1 Front Panel ...................................................................................................................9
3.2 Rear Panel ....................................................................................................................10
3.3 Base Panel Label .........................................................................................................10
3.4 Side Panel.....................................................................................................................11
3.5 Product Labelling ........................................................................................................11
4. Setup .......................................................................................................................13
4.1 System Connection .....................................................................................................13
4.2 Probe/Sensor/Cu󰀨Connection ..................................................................................13
4.3 Loading Paper..............................................................................................................13
4.4 Handling and Mounting...............................................................................................14
5. Operation .................................................................................................................15
5.1 Switching the Unit ON .................................................................................................15
5.2 Application Screen .....................................................................................................15
5.2.1 Patient database .................................................................................................................................................................. 16
5.2.2 Entering Patient Data ........................................................................................................................................................... 16
5.2.3 Lock / Unlock Screen ........................................................................................................................................................... 18
5.2.4 Date / Time........................................................................................................................................................................... 19
5.3 Control Bar ...................................................................................................................19
5.3.1 Record / Print ....................................................................................................................................................................... 20
5.3.2 Paper Feed........................................................................................................................................................................... 20
5.3.3 Numeric / Trace View ........................................................................................................................................................... 20
5.3.4 Volume Up/Down.................................................................................................................................................................. 20
5.3.5 Annotation - EasiNotes......................................................................................................................................................... 20
5.3.6 PDF ...................................................................................................................................................................................... 20
5.3.7 Settings Menu ...................................................................................................................................................................... 22
5.3.8 View Menu............................................................................................................................................................................ 29
5.4 Monitoring Parameters ...............................................................................................32
5.4.1 Numeric Format.................................................................................................................................................................... 33
5.4.2 FHR Monitoring .................................................................................................................................................................... 34
5.4.3 TOCO ................................................................................................................................................................................... 34
5.4.4 Maternal NIBP...................................................................................................................................................................... 34
5.4.5 Trace Format........................................................................................................................................................................ 35
5.5 Switching the Unit OFF ...............................................................................................36
5.6 Battery Charging .........................................................................................................36
6. Monitoring Fetal Parameters ..................................................................................37
6.1 Preliminary ...................................................................................................................37
6.2 Ultrasound Monitoring ................................................................................................37
6.3 False recording of FHR ...............................................................................................39
6.4 Twins Ultrasound Monitoring .....................................................................................39
7. Monitoring Maternal Parameters ...........................................................................40
7.1 Contractions (using TOCO transducer).....................................................................40
7.2 Fetal Movement Event Marker ....................................................................................40
7.2.1 Automatic Fetal Movement Event Marker ............................................................................................................................ 40
7.2.2 Manual Fetal Movement Event Marker ................................................................................................................................ 41
7.3 Maternal Blood Pressure ............................................................................................42
7.3.1 Taking BP measurements .................................................................................................................................................... 43
8. Alarms ......................................................................................................................46

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8.1 What is meant by an alarm .........................................................................................46
8.2 What is seen and heard...............................................................................................46
8.3 Responding to alarms .................................................................................................47
8.4 Controlling alarms .......................................................................................................47
9. Printing .....................................................................................................................48
9.1 Introduction..................................................................................................................48
9.2 Paper options...............................................................................................................48
9.3 Paper care and handling .............................................................................................48
9.4 Print speed and duration ............................................................................................49
9.5 Changing paper packs ................................................................................................49
9.6 Loading printer paper..................................................................................................50
9.8 Sample Trace (Sonicaid paper) ..................................................................................50
9.9 Turningo󰀨theprinter .................................................................................................51
9.9.1 Normal recording ................................................................................................................................................................. 51
9.9.2 Stopping the printer while print timer running....................................................................................................................... 51
10.Using Team3 with Sonicaid Reporter ....................................................................52
10.1 Connecting Team3 to Sonicaid Reporter software...................................................52
11.Trouble Shooting .....................................................................................................53
11.1 Essential Performance ................................................................................................53
11.2 FHR ...............................................................................................................................53
11.3 Fetal event marker .......................................................................................................53
11.4Maternal blood pressure .............................................................................................53
11.5 Printing .........................................................................................................................54
12.Care and Cleaning...................................................................................................55
12.1 General Care ................................................................................................................55
12.2 General Cleaning and Disinfecting ...........................................................................55
12.3 Cleaning and Disinfecting Patient Applied Parts......................................................55
12.4NIBPCu󰀨 .....................................................................................................................56
12.5 Transducer Belts..........................................................................................................56
13.Maintenance.............................................................................................................57
13.1 User maintenance........................................................................................................57
13.2 Technical maintenance ...............................................................................................57
13.3 Corrective maintenance ..............................................................................................57
13.4 Servicing.......................................................................................................................57
13.5 Secure Settings............................................................................................................58
13.6 Customising Easinotes ...............................................................................................66
14.Specications .........................................................................................................68
14.1EquipmentClassication...........................................................................................68
14.2 General ........................................................................................................................68
14.3 Environmental..............................................................................................................68
14.4 Transducers ................................................................................................................69
15.5 Printer ..........................................................................................................................71
14.6 Connections *...............................................................................................................71
14.7Display .........................................................................................................................71
14.8 Default Settings .........................................................................................................72
14.9 General Standards.......................................................................................................73
15.Accessories ............................................................................................................74
16.End of Life Disposal................................................................................................75
17.Warranty & Service..................................................................................................76
Appendix 1 - Electromagnetic Compatibility .............................................................77
Manufacturer'sPerformanceCriteriaSpecication .........................................................80
Appendix 2 - Ultrasound Safety Considerations.......................................................81
Sonicaid and Huntleigh are registered trad emarks of Huntleigh Technology Ltd. 2016.

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Instructions For Use
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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.
Team3 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 Refer to Instructions for Use
Caution: Federal law restricts this device to sale by, or on the order of a licensed healthcare
practitioner.
Rx Only Attention, consult accompanying documents / Instructions for Use
1.1 Warnings
Donotuseinthepresenceofammable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.
Keep dry, do not immerse Team3 in liquid. Ultrasound and Toco transducers are IPX7 rated. Team3
with wired transducers is not intended for use in water birth situations.
AlwaystProtectivecovertoprotectagainstuidingresswhenmovingTeam3byhandoronatrolley.
Donotuseinthesterileeldunlessadditionalbarrierprecautionsaretaken.
Use only recommended accessories listed in this manual.
Donotdisposeofbatteriesinreasthiscancausethemtoexplode.
The optional Lithium battery pack is a service replaceable item. Replacement by inadequately trained
personnel could result in a hazard.
Donotusewithdebrillators.EnsurethatallTeam3leadsandappliedpartsareremovedfromthe
patientbeforeapplyingDebrillation.

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Instructions For Use
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Team3seriesmonitorsarenotintendedforusewithpatientsttedwithcardiacpacemakers.
Do not use with electrosurgical devices.
Team3 can be isolated from the AC mains supply by removing the IEC mains inlet connector. Ensure
that this is fully accessible at all times.
Team3 is a Class 1 product that relies for safety on its protective earth. Ensure it is connected to a
suitably earthed AC mains supply.
Do not use in the home environment.
Do not use the Team3 in vehicles or in aircraft.
If this product is connected to another item of electrical equaipment, ensure that the system is fully
compliant with IEC60601-1:2005.
Thisproductcontainssensitiveelectronics,therefore,strongradiofrequencyeldscouldpossibly
interfere with it. This may be indicated by unusual sounds from the loudspeaker. We recommend that
thesourceofinterferenceisidentiedandeliminated.
Do not expose to excessive heat, including prolonged exposure to sunlight.
Thisequipmentmustnotbemodied.
Thisequipmentisforuseonlybysuitablyqualiedhealthcarepractitioners.
Whenconguring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.
The use of the Team3 is restricted to one patient at a time.
The risk of cyber attack on the fetal monitor is negligible. No special means are required to secure the
device or its updates.
The emissions characteristics of this equipment make it suitable for use in individual areas and
hospitals (CISPR 11 Class A). If it is used in a residential environment, (for which CISRR 11 Class
Bisnormallyrequired),thisequipmentmightnoto󰀨eradequateprotectiontoradio-frequency
communication services. The user might need to take mitigation measures, such as re-locating or re-
orienting the equipment.

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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 dened in IEC60601-1:2005, the patient applied parts of the Team3 Fetal Monitor are the:
• TOCO Transducer
• Ultrasound Transducer
• Patient Event Marker
• NIBP Cu󰀨

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Instructions For Use
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2. Introduction
The Team3A fetal/maternal monitor is intended for antepartum use.
The following features are standard on all models:
• Dual channel ultrasound fetal heart rate detection with audio.
• External monitoring of maternal contractions
• Maternally sensed fetal movements
• Automatic detection of fetal movement
• Color 8.4” touchscreen display
• Connections to Sonicaid Reporter software via serial port
• USB - for trace storage, upgrading and conguration
The following options are available for all models:
• eCTG models (Paperless models)
• Integral rechargeable battery
• Maternal Non-Invasive Blood Pressure
Note
This IFU relates to Version 16 software.
2.1 Intended Use and Indications
The Sonicaid Team3 Antepartum fetal monitor (Team3 fetal monitor) is indicated for use by trained healthcare
professionals in non-invasive monitoring of physiological parameters in pregnant women and fetuses, during
the antepartum period of pregnancy. The Team3 fetal monitor is intended for pregnant women from the 28th
week of gestation, through to term. The devices are intended for use in clinical and hospital-type facilities.
Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological
applications:
• Single or twin fetal heart rates by means of ultrasound
• Uterine activity - externally sensed
• Fetal movement - maternally sensed and externally via ultrasound.
• Maternal heart rate
• Maternal non-invasive blood pressure.
2.2 Contraindications
This device is contraindicated for patients tted with pacemakers.

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2.3 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.
2.3.1 Contents
Standard - All models
Item Item Item
1 x Team3 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 2 x Transducer belt
1 x Power Cord
Blood Pressure Option
Item Item Item
1 x Medium Cu󰀨 1 x Large Cu󰀨 1 x Connecting Hose
Note
All Team3 models are twins capable as standard but are supplied with 1x US transducer. For twins,
an extra US transducer is required to be ordered seperately.
2.4 Operator Positioning
Team3 can be comfortably operated from a standing or seated position in front of the unit.

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Instructions For Use
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3. ProductIdentication
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
465 3
1Touchscreen 4FHR1 US socket
2On/O󰀨 Button 5FHR2 US socket
3Printer * 6TOCO Transducer socket
* Depending on model/options purchased.

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3.2 Rear Panel
65321 487 9
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.
3.3 Base Panel Label
DI
777776-1
25EA