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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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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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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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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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

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3.4 Side Panel
2
1
1Maternal NIBP * 2Transducer storage
* Depending on model/options purchased.
3.5 Product Labelling
Note: Product labelling should be read from a distance no greater than 0.5m.
Applied parts (Ultrasound Probes /
TOCO) are type CF*
Applied parts (Maternal NIBP/fetal event marker)
are type BF*
This symbol signies 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.
25EA
MEDICAL — PATIENT-MONITORING EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI ES60601-1:2005 + A1:2012, CAN/CSA C22.2 No. 60601-1:14, IEC 60601-1-6:2010 (ed.3) + A1:2013, IEC 60601-
1- 8:2006 (ed.2) + Am.1:2012, IEC 80601-2-30:2009 (ed.1) + A1:2013 , IEC 60601-2-37 (ed.2), Am1, IEC 60601-2-49 (ed.2):2011, ISO 80601-2-61:2011
(ed.1)
This symbol signies that this product complies with the essential requirements of the Medical Device
Directive (93/42/EEC) - Medical Device Regulation (EU/2017/745)
Manufactured By:
Huntleigh Healthcare Ltd.
35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom
T: [phone] [email protected]o.uk
www.huntleigh-diagnostics.com

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YYYY-MM
Legal Manufacturer in association with the CE mark in Europe
ArjoHuntleigh AB
Hans Michelsensgatan 10 211 20 Malmö, Sweden
Warning Attention, consult accompanying documents /
Instructions for Use
~Alternating current (AC) On/Standby
DI Device Identier MD Medical Device
SN
Serial Number
REF
Reference Number
Protective Earth
YYYY-MM
Date of Manufacture
Keep Dry Do not use hook
Fragile Cardboard packaging can be recycled.
40°C
-10°C
Temperature Limitations
93%
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)
Max stack x 4 identical boxes
This side up * As dened by IEC60601-1

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4. Setup
4.1 System Connection
WARNING: These requirements must be met when a Team3 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
conguring 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 An Equipotential earth point is provided on the rear of the monitor for connection to a recommended
earth point at the installation. The earth wire should be run separately from any mains or current
carrying cables and should be kept as short as possible. Connection is achieved using a DIN 42801
type female terminal terminated onto 4mm2 56/28AWG yellow and green earth wire, connected
to the Equipotential Earth Point point at the installation. At no point should a patient be connected
directly to Earth. All external earth connections should be visually inspected to ensure that all cables
and connections are of good condition. Earth bonding checks should be carried out with
a suitable portable appliance tester. The Impedance between the protective earth and
Equipotential earth at the installation shall not exceed 0.1Ω
4.2 Probe/Sensor/Cu󰀨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

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4.4 Handling and Mounting
Cart
If the unit is moved regularly, for maximum safety it is recommended that it is mounted on the purpose-
designed cart, which is available as an accessory. Follow the instructions provided with the cart regarding
assembly and proper mounting of the Team3.
If the Team3 is being used on a cart, make sure the cart brakes are applied, except when the cart is
being moved.
Team3 should not be used whilst being moved between locations.
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 cart, or use the Team3, without ensuring that the unit and all transducers
and cables are secured.
Keep hands clear of the cart wheels while the cart is in motion. Do not attempt to free trapped cables
without stopping the cart and applying the brakes.
When moving Team3, either by hand or when cart mounted, the protective cover with a minimum of
IPX2shouldbettedtopreventingressofuidswhichmaybeencounteredduringtransit.Asuitable
cover is available as an accessory.
Wall bracket
If the unit is seldom moved, a purpose-designed bracket is available as an accessory to allow the Team3 to be
wall mounted with maximum safety. Follow the instructions provided with the bracket regarding assembly and
proper mounting of the Team3.
Bracketsmustbeinstalledbytrainedpersonnelusingxingsappropriateforthewallconstructionand
load. Carry out load tests before use.
EnsurethattheTeam3issecurelytted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.

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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 o󰀨/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 briey display a splash screen, then continue to the Application Screen.
5.2 Application Screen
The application screen will be displayed and automatically congured according to the options / modules
tted 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

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5.2.1 Patient database
The Team3 patient database is intended for short term trace storage & review only. For long term storage, it is
recommended that our Sonicaid Reporter system is used.
Traces are automatically stored to the Team3 database whenever a trace is printed or recorded. Note that
traces viewed on screen before starting the printer or the recording are NOT saved.
The database capacity is ~3.5GB. In typical use, this should store up to 2 years of traces in an intrapartum
setting, more in an antepartum setting.
When the database is ~85% full, a message will prompt the user to archive traces >1 year old. This message
is repeated each time the unit is switched on until this is done. After 7 days, if still not done, the system will
force archiving. Traces are archived to a USB memory stick via one of the 2x USB ports on the rear panel.
There is also an internal archive facility, using the "Recordings Manager" to move selected traces to the
Archive memory, & the "Archive Manager" to restore traces to the live database. Note that this does not
increase the overall database capacity, but in large databases, this does speed up access to traces in the live
database for review. Refer to section 13.5.
5.2.2 Entering Patient Data
Touch and hold the Patient Data region in the top left corner of the screen to enter the Patient Data screen.
Note
If you cannot access the Patient Data screen, this function may be disabled - refer to section 13.5 for
details.
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
Touch and hold the Patient Data region in the top left corner of the screen to enter the Patient Data screen.
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.
Note: To search for patient records stored in the fetal monitor, enter passcode 9 8 7 6 5 after touching
Search.

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Touch the ‘Gestation’ box to enter the ‘Set Gestational Age’ screen.
Touch to return to the Monitoring screen with the details on this form.
Searching for Patient Names
Touch to return to the Monitoring screen with the details of this patient in the Patient Data
region.
Setting Gestational Age
The Set Gestation dialogue allows the operator to change any one of:
• Last menstrual period date2
•
• 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.

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Touch to reset the GA values to zero.
Touch to return to the Patient Data screen with a cleared value of gestational age.
5.2.3 Lock / Unlock Screen
Touch to access the Lock Screen.
Touch to lock screen or to exit with out locking.
Touch to unlock the screen.
The operator will need to enter a 5 digit code via the touchscreen, (default code 0 0 1 2 3 ), to unlock the
screen.

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5.2.4 Date / Time
Touch and hold the Date/Time area of the screen to enter the Data and Time screen. (Note: This screen can
also be accessed via the Settings Menu.)
Use the arrows to set the current date and time.
Press to conrm.
5.3 Control Bar
Displayed along the bottom of the screen is the control bar. Functions depend on the options / modules
installed and the operating mode of the unit.
Record Numeric View
Trace
View
Volume
Up
MenuAnnotation
(EasiNotes)
Paper
Feed
Volume
Down
Settings
Print &
Record

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5.3.1 Record / Print
Touch to print or record.*
Indicates printing or recording is active. Touch to cancel printing or recording. All printed
data is also recorded. The recorded data can be reviewed when required.
Annotation Icon appears in the control bar when printing or recording is active. (See
Annotation - below).
* If option(s) installed.
5.3.2 Paper Feed
Touch and hold to feed the paper through printer.*
* If option(s) installed.
5.3.3 Numeric / Trace View
Touch to toggle between displaying the data in numeric or trace format.
5.3.4 Volume Up/Down
Touch to decrease or increase the volume.
5.3.5 Annotation - EasiNotes
Annotation Icon appears in the control bar when printing or recording is active. This
feature allows the operator to add a pre-stored note to the printout or recorded le.
Touch to access the Annotation menu.
5.3.6 PDF
PDF icon is only visible when reviewing a stored trace with a USB (8GB) plugged into
the rear of the fetal monitor. Touch to store a PDF copy of the trace onto the USB