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INSTRUCTIONS FOR USE FR

SR Range DE

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NL

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Digital Handheld Doppler

Instructions for Use · Mode d’emploi · Gebrauchsanleitung · Istruzioni per l’uso ·

Instrucciones de uso · Instruções de utilização · Bruksanvisning · Gebruiksinstructies ·
Brugervejledning· Bruksanvisning · Käyttöohjeet · Návod k použití

772638-01 10/2021
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INSTRUCTIONS FOR USE SR range

Contents
1. Introduction
1.1 Unpacking / Preliminary Checks
2. Safety
2.1 Warnings
2.2 Patient Applied Parts
2.3 Intended Use & Indications
2.4 Contraindications
2.5 Patient Population
3. Warranty & Service
3.1 Service Life
3.2 Maintenance and Repair
4. Product Identification
4.1 Product Controls
4.2 Symbol Identification
4.3 Display Status Bar
5. Prepare the Doppler for Use
5.1 Battery Insertion / Replacement
5.2 Probe Connection
5.3 Change the Doppler Settings
6. Operation
6.1 SRX Probe options
6.2 SR2 & SR3 Waterproof Probes
6.3 Obstetric Monitoring
6.4 Frozen Trace
6.5 Battery Charging
6.6 Data transfer to a PC
6.7 After Use
7. Care and Cleaning
7.1 General Care
7.2 Cleaning and Disinfecting the Doppler
7.3 Cleaning and Disinfecting Probes
8. Troubleshooting
9. Specifications
9.1 Equipment Classification
9.2 FHR Performance
9.3 General
9.4 Environmental
9.5 Standards Compliance
10. Electromagnetic Compatibility
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1. Introduction
The SR range are multi-function, battery powered, hand-held Dopplers intended for obstetric use. The SRX
is compatible with Huntleigh’s interchangeable probes. The range provides an audible fetal heart sound and
a numeric/graphical display of fetal heart rate. This equipment is for use only by suitably qualified healthcare
practitioners and is not intended for use by the patient.

Before using this equipment, study this manual carefully and familiarise yourself with the controls, display
features and operation.

Experience with use of ultrasonic dopplers is preferable, but for novice users training material is provided with
the online documents. Exposure to ultrasound should be kept As Low As Reasonably Achievable - (ALARA
guidelines).

Scan the QR code on the rear cover of this IFU with a smartphone, or visit the Huntleigh website for electronic
copies of user literature. All documents are available to download as PDF files. To read them, you must have a
PDF reader installed on your device. Alternatively paper copies are available upon request.

1.1 Unpacking / Preliminary Checks

On receipt of your Doppler, check that all items are present and undamaged. If items are missing or have been
damaged in transit, inform Huntleigh Healthcare immediately.

Digital Handheld Doppler IFU (this document) Batteries

Charger & USB lead* Ultrasound Gel Carry bag
*selected Dopplers

2. Safety
2.1 Warnings
• Dopplers are screening tools to aid the healthcare professional. If there is doubt as to fetal status, further
investigations should be undertaken immediately using alternative techniques.
• Always ensure that Maternal HR or any Artefacts are not misinterpreted as fetal heartrate. If in doubt, feel
the mother’s pulse during the examination.
• Do not use in the presence of flammable gases.
• Do not use in a sterile field unless additional barrier precautions are taken.
• Do not sterilise the product or its accessories. The product will be damaged.
• Do not expose to excessive heat, including prolonged exposure to sunlight.
• Do not dispose of batteries in fire as this can cause them to explode.
• The Doppler is not waterproof and must not be immersed.
• This product contains sensitive electronics, which are susceptible to interference, this will be indicated by
unusual sounds.
• Any equipment connected to the USB port must be compliant with IEC 60601-1.
• This equipment must not be modified.

2.2 Patient Applied Parts

As defined in IEC 60601-1, the patient applied parts of the SR Doppler are the ultrasound probes.

2.3 Intended Use & Indications

The Dopplers are intended for use by qualified healthcare practitioners in primary, acute and community
healthcare environments, for the assessment of fetal heart rate.

They are indicated for routine screening of pregnant women of all ages from early gestation through to full term,
and for low risk labour management.

2.4 Contraindications
• Do not use on broken or fragile skin.
• Do not use on the eye.
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2.5 Patient Population

The SR Range is suitable for use on all patient populations.

3. Warranty & Service

Huntleigh Healthcare Diagnostic Products Division standard terms and conditions apply to all sales. A copy
is available on request. These contain full details of warranty terms and do not limit the statutory rights of the
consumer.

Service Returns: To return the Doppler, please:

• Clean the product following the instructions in this manual.

• Pack it in suitable packing.
• Attach a decontamination certificate (or other statement declaring that the product has been cleaned) to the
outside of the package. (Huntleigh Healthcare Ltd reserve the right to return product that does not contain a
decontamination certificate).
• Mark the package ‘Service Department‘.

For further details, refer to NHS document HSG(93)26 (UK only).

Service Department. Tel: +44 (0)29 20485885

Huntleigh Healthcare, Fax: +44 (0)29 20492520
Diagnostic Products Division, Email: [email protected]
35, Portmanmoor Rd., [email protected]
Cardiff. CF24 5HN Website: www.huntleigh-diagnostics.com
United Kingdom.

3.1 Service Life

This is defined as the period during which the device is expected to remain safe and suitable to meet its
intended use, and all risk control measures remain effective.
The service life for this device is seven years.

3.2 Maintenance and Repair

There are no user serviceable parts inside the Doppler unit or probes. This product does not require periodic
maintenance. Inspection is recommended each time the product is used, paying particular attention to the tip
of the probes, checking for cracks etc., and to the cable and connector. Any unusual sounds or intermittent
behaviour should be investigated.

Spare parts are available. Please refer to service manual for further information and part numbers. A full
technical description is provided in the Service Manual 772490.

Caution
Servicing cannot be carried out while the Doppler is in use.
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4. Product Identification
4.1 Product Controls

1 1 Headphone Socket
2
2 USB Port
3 LCD Panel
Function Button 1 /
4 On/Off Button
3
5 Function Button 2
6
6 Function Button 3 / Setup
5 7 Loudspeaker
4 8 Probe Holder
9 Trolley Mount
10 Volume Up
7
11 Volume Down

8 12 Pocket Clip
Battery Compartment + Micro
13 SD Card Slot
14 Rear Panel Label

12
13
14

9
10
11
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4.2 Symbol Identification

Patient applied parts (ultrasound probes) are type BF according to the definitions in IEC 60601-1.

Attention, consult accompanying

General Warning documents / Instructions for Use

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
Device Directive (93/42/EEC) - Medical Device Regulation (EU/2017/745).

RxOnly Federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.
Made in Huntleigh Healthcare Ltd.
in the UK 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom
by: T: +44 (0)29 20485885 [email protected]
www.huntleigh-diagnostics.com
Legal Manufacturer in association with the CE mark in Europe
ArjoHuntleigh AB
Hans Michelsensgatan 10 211 20 Malmö, Sweden

IP20 Protected against ingress of solid foreign objects >12.5 mm diameter.

Not protected against ingress of water.

IPx7 Protected against ingress of water 1 m immersion for up to 30 minutes.

IPx1 Protected against vertically falling water drops.

Power On/Standby USB Port

DI Device Identifier SN Serial Number

REF Reference Number MD Medical Device

Fragile Keep Dry

Atmospheric Pressure Limitations Relative Humidity Limitations

Temperature Limitations Cardboard packaging can be recycled

LATEX
LATEX FREE PVC
PVC FREE
Does not contain Latex Does not contain PVC

Headphone Socket Alignment mark

Volume Up Volume Down

Note: Product labelling should be readable from a distance of up to 0.7m.

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4.3 Display Status Bar

The Status Bar appears at the top of most screens, the
information displayed depends on the operating mode.

Status Bar Icons

Battery Level Low 27/01/2015 14.30 Date / Time

USB Connected USB Transmitting

USB Receiving Signal Strength

Standard Mode - FHR outside Standard Mode - FHR within user set
user set range range

Smooth Mode - FHR outside Smooth Mode - FHR within user set
user set range range

Manual Mode

5. Prepare the Doppler for Use

5.1 Battery Insertion / Replacement
Disconnect the Doppler from any other equipment before removing the battery cover.

Insert a suitable tool into the recess, release the Insert the batteries according to the diagram,
clip and gently lever off the battery cover. observing polarity.

• Use either alkaline LR6 (non-rechargeable) or NiMH HR6 (rechargeable) batteries.

• Do not mix rechargeable and non-rechargeable batteries.
Note: If the Doppler will not be used for an extended period, remove the batteries.

5.2 Probe Connection

To connect the probe to the SRX Doppler, align the arrow on the connector with the slot on the probe and push
together firmly. (Doppler models SR2 and SR3 have captive probes).

To disconnect the probe, pull the connector from the probe. DO NOT pull the cable.
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5.3 Change the Doppler Settings

5.3.1 Setup Screen
Note: A probe must be connected before the Setup Screen can be accessed.

Press to turn the unit ON, then press and hold button 3 to enter Setup mode.

Date and Time

Brightness
Setup
Battery type
Lock screen
Selection
FHR Averaging
Trace Options
Mode

Audio Recording Timer

Press Button 1 to move the selection, Button 2 to accept, or Button 3 to go back.

5.3.2 Set the Screen Brightness

5.3.3 Set the Date and Time

Press to accept or to
discard the changes.
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5.3.4 Battery Type Selection

HR6 = rechargeable NiMH batteries, LR6 = non-rechargeable alkaline batteries

6. Operation
Press and hold for one second to turn the unit ON. The Doppler displays the Obstetric Live Waveform
Screen.

6.1 SRX Probe options

Two types of probe are available:
OP2XS 2 MHz ± 1% OP3XS 3 MHz ± 1%

The Obstetric FHR Numeric Screen is displayed when an obstetric probe is detected. The strength of the
Doppler signal is displayed in the status bar at the top of the display.

6.2 SR2 & SR3 Waterproof Probes

SR2 is supplied with a captive waterproof 2 MHz probe and cable while SR3 is supplied with a captive
waterproof 3 MHz probe and cable.
When used underwater, refer to the Cleaning Instructions in section 7, to prevent cross-contamination.

Patient Preparation
Make the patient comfortable in a semi-recumbant or sitting position. Apply a liberal amount of gel to the
abdomen. Place the faceplate of the probe flat against the abdomen above the symphis pubis. Adjust the probe
to get an optimum audio signal, ideally by angling the probe around while maintaining firm pressure. Avoid
sliding the probe over the skin. Best performance is from the fetal heart itself, characterised by ‘slapping’ valve
sounds rather than umbilical artery or placental sounds. The FHR, averaged over 4-heart beats, is displayed on
the 3-digit readout.

*Note: Gel is not required when SR2 and SR3 model probes are used underwater.

6.3 Obstetric Monitoring

Obstetric FHR Numeric Mode Screen

In this Mode, the FHR is displayed (in beats per minute) in large digits and is continually updated. When the rate
cannot be determined, 3 x dashes are displayed.

Press to switch to FHR Trace Display.

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6.3.1 Obstetric FHR Trace Mode Screen*

Trace display mode is for indication only and is not a replacement for conventional fetal monitoring. If
any concern arises from viewing this trace, alternative means (e.g. full CTG) must be used to determine
fetal condition.

This screen displays the FHR as a trace on a graph. The horizontal and vertical scales are determined in
setup**. The trace displays from left to right until it fills the screen then scrolls to the left as each new data point
is added.

FHR Trace Mode Icons

Numeric Display Mode

Register fetal movement and place marker

Stop Trace and display Frozen Trace option

** Trace scaling is equivalent to 1 or 3 cm/min and 20 or 30 beats per cm, scaled down to screen size,
maintaining the same aspect ratio to avoid distortion of the trace for easy visual interpretation.

*Note: These options are only available if the FHR Trace Mode screen has been enabled.

6.3.2 Trace Scroll section

Press when the desired information is displayed.

6.4 Frozen Trace

Press at any time to return to the live trace screen.

To Save a trace:

To open a saved trace:

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6.5 Battery Charging

• Only HR6 (NiMH) batteries can be charged. Check the battery type before connecting the charger.
• Do not attempt to recharge normal alkaline batteries. They may leak, cause a fire or even explode.
• Only use the charger and USB lead supplied by Huntleigh.
• Switch off the Doppler before charging.
• Do not use the Doppler on patients when the charger is connected.

• Insert the supplied charger lead into the USB socket at the top of the
Doppler.
• Connect the charger and switch on mains power.

Charging will take approximately 5 - 6 hours, depending on battery

status.

If the battery level is low, a symbol will appear on the Status bar.

During charging, a symbol will be displayed on the screen.

When fully charged, the symbol will change to .

6.6 Data transfer to a PC

The Doppler does not contain patient information however, stored traces and data can be transferred to a PC
running Huntleigh reporting software, via the same USB socket as for battery charging. Consult your local sales
representative for details.
Note: Please observe the safety warnings in the Huntleigh software IFU.

6.7 After Use

Press and hold the On/Off button for one second to switch the unit off.
Refer to the cleaning section before storing or using the unit on another patient.

7. Care and Cleaning

7.1 General Care
The Doppler contains delicate components, for example the probe tip, which should be handled and treated
with care. Periodically, and whenever the integrity of the system is in doubt, carry out a check of all functions
as described in the relevant section of this IFU. If there are any defects, contact Huntleigh or your distributor for
repair or to order a replacement.

Cautions
• Check with your facility’s local infection control policy and medical equipment cleaning procedures.
• Observe warnings and guidance on cleaning fluid labelling regarding use and personal protective
equipment (PPE).
• If detergent or disinfectant wipes are used ensure that excess solution is squeezed from the wipe
prior to use.
• Always switch off the Doppler and disconnect from the AC supply before cleaning and disinfecting.
• Always wipe off disinfectant using a cloth dampened with clean water.
• Do not allow any fluid to enter the products and do not immerse in any solution.
• Do not use abrasive cloths or cleaners.
• Do not use automatic washers or autoclaves.
• Do not use Phenolic detergent based disinfectants, solutions containing cationic surfactants,
ammonia based compounds or perfumes and antiseptic solutions.
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7.2 Cleaning and Disinfecting the Doppler

Always keep the external surfaces clean and free of dirt and fluids using a clean dry cloth.

• Wipe any fluids from the surface of the product using a clean dry cloth.
• Wipe with a cloth dampened in 70% Isopropyl Alcohol.
• Completely dry with a clean, dry cloth.
• If the product has been contaminated use the methods described for probes.

7.3 Cleaning and Disinfecting Probes

Clean the probes before examining a patient using low risk cleaning method below.
Following patient examination, clean and/or disinfect the probes by the appropriate method based upon the level
of cross contamination risk, as defined below:

Risk Definitions Procedure

Low Normal use or low risk situations 1. Remove soiling, wipe with a mild neutral detergent and
include patients having intact then wipe with a cloth dampened in water.
skin and no known infection. 2. Completely dry with a clean cloth.
Medium The patient has a known 1. Follow low risk procedure then wipe with a cloth
infection, skin is not intact, the dampened in Sodium Hypochlorite (1,000ppm).
part is heavily soiled. 2. After two minutes wipe with a cloth dampened in water
and then dry with a clean cloth.
High This procedure should only be 1. Follow low risk procedure then wipe with a cloth
used when the part has been dampened in Sodium Hypochlorite (10,000ppm).
contaminated by blood. 2. After two minutes wipe with a cloth dampened in water
and then dry with a clean cloth.

Caution
Repeated and unnecessary use of concentrated solutions will result in damage to the product. Do not
allow Sodium Hypochlorite solutions to come into contact with metal parts.
The use of disinfectant materials other than those listed is the responsibility of the user for their efficacy and
compatibility with the device.

8. Troubleshooting
This section lists some of the more common problems encountered during use together with possible causes. If
the problem cannot be located after consulting the table in this section, turn off the Doppler and consult a qualified
technician. Before attempting trouble-shooting, verify that the batteries are charged.

SYMPTOM POSSIBLE CAUSE / REMEDY

Doppler will not turn on. Replace / recharge batteries.
Audio Only Doppler model does not support visual functionality
No Audio signal Incorrect volume setting
Poor Signal Probe / sensor incorrectly positioned, or Insufficient Gel
No Signal Damaged probe / sensor, or Incorrect probe / sensor
Screen Damaged probe / sensor, or No Probe
displays:
Incompatible probe / sensor, or Incorrect Probe / sensor

Incorrect battery fitted

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9. Specifications
9.1 Equipment Classification
Type of protection against electric shock. Internally powered equipment
Degree of protection against electric shock Type BF - equipment with an applied part

Mode of operation. Continuous

Degree of protection against harmful ingress of Main Unit: IP20*,
particles and/or water. SR2/SR3 probes : IPX7
Protective Pouch : IP22
Degree of safety of application in the presence of Equipment not suitable for use in the presence of a
a flammable anaesthetic FLAMMABLE ANAESTHETIC MIXTURE WITH AIR,
OXYGEN OR NITROUS OXIDE

*For home use, this can be upgraded to IPx2 when using the protective pouch (ACC-OBS-080).

9.2 FHR Performance

Standard Mode Range: 60 - 210 bpm Resolution: 1 bpm
Averaging: 4 beats Accuracy: ± 3 bpm Range
Smoothed Mode Range: 60 - 210 bpm Resolution: 1 bpm
Averaging: 8 beats Accuracy: ± 3 bpm
Manual Mode Range: 60 - 210 bpm Resolution: 1 bpm
Averaging: 10 beats Accuracy: ± 3 bpm

9.3 General
Charger- ‘R’ models only
Protection : Class II
(Part No. 772559) Input Voltage : 100-240 V AC ±10%
Output Voltage : 5VDC ± 5%
Input Frequency : 50 - 60Hz
Standby power consumption: 230V AC ≤ 0.1W
Max. Audio Output 500 mW rms typical (loudspeaker)
Auto shut-off 3 minutes
Headphone output Max. output Power: 25 mW rms (32Ω)
Connector: 3.5 mm stereo jack socket
USB Port Micro USB SD Card Slot Micro SD
Real Time clock battery RENATA CR1025, 3V Lithium
Battery Type LR6 (Alkaline cells 1.5V) or HR6 (NiMH rechargeable 1.2V)
Battery Life Typically, 500 x 1 minute examinations
Note: Battery life is typically 2 years or 500 charge/discharge cycles
Size 140 x 33 x 75 mm Weight 280 g
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9.4 Environmental
Operating
Temperature range +5°C to +40°C
Relative Humidity 15% to 90% (non condensing)
Pressure 700 hPa to 1060 hPa
Transport and Storage between uses
Without relative humidity control -25°C to +5°C
At a r.h. of up to 90% non-condensing +5°C to +35°C
At a water vapour pressure up to 50 hPa >+35°C to +70°C

9.5 Standards Compliance

IEC 60601-1: 2012 IEC 60601-1-11: 2015
EN 60601-2-37: 2015 Thermal Indices (TI) and Mechanical IEC 60601-1-2: 2014
Index (MI) are below 1.0 for all device settings.

9.6 Accessories
Use only the recommended accessories. See www.huntleigh-diagnostics.com for a list of accessories.

10. Electromagnetic Compatibility

Make sure the environment in which the Doppler is installed is not subject to strong sources of electromagnetic
interference (e.g. 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, complies with IEC 60601-1-2,
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:
• Reorient the equipment
• Relocate the equipment with respect to the source of interference
• Move the equipment away from the device with which it is interfering

Warnings
• The use of accessories, transducers and cables other than those specified, with the exception of
transducers and cables sold by the manufacturer of the Doppler as replacement parts for internal
components, may result in increased emissions or decreased immunity of the Doppler.
• The Doppler should not be used adjacent to or stacked with other equipment and that if adjacent
or stacked use is necessary, the Doppler should be observed to verify normal operation in the
configuration in which it will be used.
• Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the Doppler including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
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This section is only applicable to United Kingdom (UK) market when UK

marking is applied to the Arjo medical device labelling.

UK Symbol:

UK marking indicating conformity with UK Medical Devices

Regulations 2002 (SI 2002 No 618, as amended)
Figures indicate UK Approval Body supervision.


UK Responsible Person:

Arjo (UK) Ltd., ArjoHuntleigh House, Houghton Regis. LU5 5XF

Is the appointed UK Responsible Person as defined in UK Medical Devices

Regulations 2002 (SI 2002 No 618, as amended).

For Northern Ireland (NI) CE marking will still apply until further amendment to
applicable regulations.

1001071-1