FD1/FD2/FD3

HIGH SENSITIVITY
POCKET DOPPLERS
Table of Contents
Doppler Measurement Sites and Recommended Probes ......3
1. Safety .................................................................................4
1.1 Warnings................................................................................................. 4
1.2 Patient Applied Parts ............................................................................. 5

2. Introduction .......................................................................6
2.1 Unpacking / Preliminary Checks .......................................................... 6
2.2 Battery Insertion / Relacement ............................................................. 6
2.3 Product Controls.................................................................................... 7
2.4 Product Labelling................................................................................... 7

3. Operation ...........................................................................9
3.1 Vascular Mode (FD2 Only) .................................................................... 9
3.2 Obstetric Mode ...................................................................................... 10
3.3 After Use ................................................................................................. 12

4. Care and Cleaning ..............................................................13

4.1 General Care........................................................................................... 13
4.2 General Cleaning and Disinfecting ..................................................... 14
4.3 Cleaning and Disinfecting Patient Applied Parts ................................ 14
4.4 Maintenance and Repair........................................................................ 15

5. Specifications ....................................................................16
5.1 Equipment Classification ..................................................................... 16
5.2 Standards Compliance .......................................................................... 16
5.3 FHR Performance................................................................................... 16
5.4 General ................................................................................................... 17
5.5 Environmental ........................................................................................ 17

6. End of Life Disposal............................................................18

7. Warranty & Service ............................................................19

Dopplex, and Huntleigh are registered trademarks of Huntleigh Technology Ltd.

2004.

© Huntleigh Healthcare Ltd. 2004-2014

 Doppler Measurement Sites and Recommended
Probes

1 Jugular Vein 11 Subclavian Artery

VP4HS, VP5HS VP4HS, VP5HS
2 Subclavian Vein
VP4HS, VP5HS
9 12 Brachial Artery
VP8HS, EZ8
1
3 Fetus 10 13 Ulnar Artery
OP2HS, OP3HS VP8HS, EZ8
4 Femoral Vein 2 11 14 Radial Artery
VP4HS, VP5HS VP8HS, EZ8
5 Great Saphenous Vein 15 Femoral Artery
VP5HS, VP8HS, EZ8 VP4HS, VP5HS
12
13
3
14

4 17 16
15

5
6 Small Saphenous Vein 16 Digital Artery
VP8HS, EZ8 VP8HS, VP10HS, EZ8
7 Posterior Tibial Vein
18 17 Penis
VP8HS, VP10HS, EZ8 VP10HS, EZ8
8 Posterior Tibial Artery 6 18 Popliteal Artery
VP8HS, EZ8 VP5HS
9 Vertebral Artery
8 19 Metatarsal Artery
VP4HS, VP5HS 7 20 VP8HS, VP10HS, EZ8
10 Carotid Artery 19 20 Dorsalis Pedis Artery
VP5HS, VP8HS, EZ8 VP8HS, VP10HS, EZ8
 1. Safety
Safety

Before using this equipment, please study this manual carefully

and familiarise yourself with the controls, display features and
operation. Ensure that each user fully understands the safety and
operation of the unit, as mis-use may cause harm to the user or
patient, or damage to the product.
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.

Please keep these Instructions for Use to hand for future reference.

Attention, consult this manual. Refer to safety section.

Attention, consult accompanying documents / Instructions for Use

1.1 Warnings

Do not use in the presence of flammable gases such as

anaesthetic agents

Do not use in the sterile field unless additional barrier

precautions are taken.

Do Not :
• immerse in any liquid, (except FD1/FD3 probe)
• use solvent cleaner,
• use high temperature sterilising processes (such as
autoclaving),
• use E-beam or gamma radiation sterilisation.
The main unit is not waterproof and must not be immersed. For
underwater use where contamination or cross-infection may
occur, additional barrier precautions must be taken.

Do not use on the eye.

4
 Safety
Do not dispose of batteries in fire as this can cause them to
explode.

Do not attempt to recharge normal dry-cell batteries. They may

leak, cause a fire or even explode.

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

Any equipment connected to RS232 interface must be compliant

with IEC60601-1:2005.

Connect headphones only to the headphone socket.

Dopplex Dopplers are screening tools to aid the healthcare

professional and should not be used in place of normal vascular
or fetal monitoring. If there is doubt as to vascularity or fetal
well-being after using the unit, further investigations should be
undertaken immediately using alternative techniques.

1.2 Patient Applied Parts

As defined in IEC60601-1:2005, the patient applied parts of the Dopplex
Dopplers are the ultrasound probes.

5
 2. Introduction
Introduction

2.1 Unpacking / Preliminary Checks

Contents

IN RU
FOR ST
USE CTIONS

Delivery Inspection

Huntleigh takes every precaution to ensure that goods reach you in perfect
condition. However, accidental damage can occur in transit and storage.
For this reason 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 or your distributor is informed at once.

Storage

Should the unit not be required for immediate use, it should be re-sealed into
its original packing after carrying out the initial delivery inspection, and stored
under covered conditions at a temperature between -10°C to +40°C, and
relative humidity of 10% to 93% non-condensing.

2.2 Battery Insertion / Replacement

1 2 3

Note: Remove the battery if the unit is not likely to be used for
some time.
6
2.3 Product Controls

Introduction
1 FD1
3 2 FD3
FD2

1 ● ● Headphone Socket
2 ● RS232 Port
4 3 ● ● LCD Panel
4 ● ● Loud-speaker
5 ● ● On/Off Button
6 ● ● Probe Holder

6 7 ● ● Volume Control
8 ● Start/Stop Button
5
9 ● Mode Button
Battery
10 ● ●
Compartment
11 ● ● Pocket Clip

11

10

8
9

2.4 Product Labelling

Patient applied parts (ultrasound probes) are type BF according to the

definitions in IEC 60601-1:2005. 7
Introduction
Attention, consult this manual.

Attention, consult accompanying documents / Instructions for Use

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).
Rx Federal law restricts this device to sale by, or on the order of a licensed
Only healthcare practitioner.
Protected against ingress of solid foreign objects >12.5mm diameter. Not
IP20
protected against ingress of water.
Huntleigh Healthcare Ltd.
Manufactured 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

Power On/Off Battery

+40°C “MAX
Temperature Limitations 93% Limits of Relative Humidity
-10°C
RH”

SN Serial Number REF Reference Number

MD Medical Device DI Device Identifier

Fragile Keep Dry

Headphone Socket Volume

RS232 Interface Alignment mark

Cardboard packaging can be

Do not use hook
recycled.

PVC PVC FREE LATEX LATEX FREE

Does not contain PVC Does not contain Latex

Limits of Atmospheric Pressure

8 Note: Product labelling should be read from a distance of no greater than 0.7m.
3. Operation

Operation
Refer to diagram on inside front cover for Doppler
Measuring sites and Recommended Probes.

To connect the probe, align the arrow on the connector with the slot on the
probe and push firmly.

To disconnect the probe, pull the connector sharply. DO NOT pull the cable.

Note: During use, an automatic noise reduction feature operates on low

level signals to improve sound quality.

Coupling Gel

Use water based ultrasound gel ONLY.

3.1 Vascular Mode (FD2 Only)

The FD2 will select vascular mode when a vascular probe is connected to the
control unit.

Vascular Probes

Five probes are available for vascular examinations:

VP4HS 4MHz ±1% for deep lying vessels

VP5HS 5MHz ±1% for deep lying vessels and oedematous limbs
VP8HS 8MHz ±1% for peripheral vessels
VP10HS 10MHz ±1% for specialist superficial applications.
EZ8 8MHZ ±1% “Widebeam” for peripheral vessels.

In this mode, blood flow is audible in the loudspeaker. Probe frequency is

displayed.

Clinical Use

Apply a liberal amount of gel on the site to be examined. Place the probe at
45° to the skin surface over the vessel to be examined. Adjust the position of
the probe to obtain the loudest audio signal. High pitched pulsatile sounds are
emitted from arteries while veins emit a non-pulsatile sound similar to a rushing
wind.
For best results, keep the probe as still as possible once the optimum position
has been found. Adjust the audio volume as required.
9
 3.2 Obstetric Mode
Operation

Fetal Dopplex II (FD2)

Obstetric mode is automatically selected when an obstetric probe (OP2HS/

OP3HS) is connected. Fetal Heart Rate (FHR) is displayed with 3 operating
modes, and an RS232 interface provides for FHR printing when connected to
the Dopplex Printa Package.

Obstetric Probes

Two probes are available for obstetric examinations:

OP2HS 2MHz ±1%

OP3HS 3MHz ±1%

Fetal Dopplex (FD1/FD3)

Operates in standard mode to provide FHR display. The probe/cable are

waterproof and can be fully immersed for use in waterbirths.

The FD1/FD3 main unit is not waterproof and must not be

immersed.

Clinical Use

Apply a liberal amount of gel to the abdomen*. Place the faceplate of the probe
flat against the abdomen above the symphysis pubis. Adjust the probe to obtain
an optimum audio signal ideally by angling the probe around. Avoid sliding it
over the skin.

In early pregnancy a full bladder may improve sound detection. In later

pregnancy the best signals are generally located higher on the abdomen. The
fetal heart sounds like a galloping horse at approximately twice the maternal
rate. A wind-like sound is heard from the placenta.

*Note: For FD1/FD3 : Gel is not required when probe is used underwater.

Standard Mode - FD1/FD2/FD3

In this mode the FHR, averaged over 4-heart beats, is displayed on the 3-digit
readout. The LCD displays an outline heart symbol.
10
 Operation
Smoothed Mode - FD2 Only

This mode is used to obtain more stable heart rate readings. In this mode, FHR
is averaged over 8 beats. The LCD displays a solid heart symbol.

Manual Mode - FD2 Only

This mode is used when a fetal heart beat is audible in the loudspeaker or
headphones but, due to noise or a low signal level, the FD2 cannot reliably
calculate the heart rate. In this mode, the heart rate can be manually counted
over a period of 10 audible heart beats (see below). The FD2 will automatically
calculate and display the derived FHR on the LCD. The LCD displays a clock
symbol.

Mode Selection

Press the Mode button to select mode.

Use of Manual Mode (FD2 Only)

1. Press and hold Start/Stop button and immediately count the audible
heart beats, counting the first beat as the button is pressed. The
LCD displays the flashing clock symbol and the FHR reading is
shown as three dashes.

2. Release the Start/Stop button immediately on the count of 10 (i.e.

After nine beat intervals). The FD2 will automatically calculate the
derived FHR averaged over the 10 beat period and display the
result. This rate value is retained until the measurement is repeated
or the unit is switched off. If the button is held for a period less than
about 3 seconds the display will clear the previous rate value and
reset.

Connection to Printa II™ (FD2 Only)

Hard copy printing is automatically selected when the plug of the interface buffer
box is inserted into the RS232 socket on the top panel of the FD2. Printing is
then initiated by using the Start/Stop button.
11
 3.3 After Use
Operation

1. Press and release the On/Off button. If you forget to switch the unit
off, it will automatically shut-off after 3 minutes.

2. Refer to the cleaning section before storing or using the unit on

another patient.

3. Store unit together with probe and accessories in the soft carry case
provided.

12
4. Care and Cleaning

Care and Cleaning

4.1 General Care
All Huntleigh products have been designed to withstand normal clinical use,
however they can contain 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 the IFU. If there are
any defects to the housing contact Huntleigh or your distributor for repair or to
order a replacement.

Please ensure that you 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).

Do not use abrasive cloths or cleaners.

Do not use automatic washers or autoclaves.

Phenolic detergent based disinfectants, solutions containing

cationic surfactants, ammonia based compounds or perfumes
and antiseptic solutions such as Steriscol or Hibiscrub should
never be used.

If detergent or disinfectant wipes are used ensure that excess

solution is squeezed from the wipe prior to use.

Do not allow any fluid to enter the products and do not immerse
in any solution.

Always wipe off disinfectant using a cloth dampened with clean

water.

13
 4.2 General Cleaning and Disinfecting
Care and Cleaning

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

1. Wipe any fluids from the surface of the product using a clean dry
cloth.
2. Wipe with a cloth dampened in 70% Isopropyl Alcohol.
3. Completely dry with a clean, dry lint free cloth.
4. If the product has been contaminated use the methods described for
patient applied parts.

4.3 Cleaning and Disinfecting Patient Applied Parts

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

14
 Care and Cleaning
Warning: Sodium Hypochlorite @ 10,000 ppm for disinfecting
should only be used in situations described in the High Risk
definition. Unnecessary use of this concentrated solution for
Low and Medium risk situations may 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.

4.4 Maintenance and Repair

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 crackling or intermittent behaviour should be investigated.

This product does not require periodic maintenance.

Suitable test equipment and a full range of spare parts are also available.
Please refer to service manual for further information and part numbers.

A full technical description is provided in the Service Manual 726374.

15
 5. Specifications
Specifications

5.1 Equipment Classification

Type of protection Internally powered equipment

against electric shock.
Degree of protection
against electric shock Type BF - equipment with an applied part.

Mode of operation. Continuous

Degree of protection Main Unit: IP20
against harmful ingress FD1 / FD3 probes : IPX7
of particles and/or water. All other probes (Tip only): IPX1
Degree of safety of Equipment not suitable for use in the presence of
application in the a FLAMMABLE ANAESTHETIC MIXTURE WITH
presence of a flammable AIR, OXYGEN OR NITROUS OXIDE
anaesthetic

5.2 Standards Compliance

IEC60601-1: 1988 + A1:1991 +A2:1995

UL60601-1 : 2006
CSA C22.2 No 601.1-M90 (R2005)

5.3 FHR Performance*

Standard Mode Range - 60-210bpm Resolution - 1bpm

Averaging - 4 beats Accuracy - ±3bpm
Smoothed Mode Range - 60-210bpm Resolution - 1bpm
(FD2 only) Averaging - 8 beats Accuracy - ±3bpm

Manual Mode Range - 60-210bpm Resolution - 1bpm

(FD2 only) Averaging - 10 beats Accuracy - ±3bpm

*(excluding user error)

16
5.4 General

Specifications
Max. Audio Output 500mW rms typical
(Loudspeaker)
Auto shut-off 3 minute no signal
10 minute unconditional
Headphones Max. output Power: 25 mW rms (32Ω)
Connector: 3.5mm stereo jack socket
Max. applied voltage: +9Vdc
RS232 Interface Data format: RS232C
(FD2 only) Connector: 8pin subminiature DIN socket
Max. applied voltage: +5Vdc
Battery Type IEC 6LR61 or IEC 6LP3146

Battery Life Typically, 250 x 1 minute examinations

Size Height 140mm, Depth 27mm, Width 74mm
Weight 295g

5.5 Environmental

Operating Storage
+10°C to +30°C Temperature range -10°C to +40°C
10% to 90% (non Relative Humidity 93% maximum
condensing)
860mb to 1060mb Pressure 860mb to 1060mb

17
 6. End of Life Disposal
End of life Disposal

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.

18
7. Warranty & Service

Warranty & Service

Huntleigh Healthcare Ltd. 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

If for any reason Dopplex unit has to be returned, 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.

• Mark the package ‘Service Department - FD1 / FD2 / FD3’

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

Huntleigh Healthcare Ltd reserve the right to return product that does not
contain a decontamination certificate.

For service, maintenance and any questions regarding this, or any other
Huntleigh Healthcare Dopplex product, please contact:

Customer Care Department.

Huntleigh Healthcare, Diagnostic Products Division,
35, Portmanmoor Rd.,
Cardiff. CF24 5HN
United Kingdom.

Tel: +44 (0)29 20496793 - Service (24hr answer machine)

Tel: +44 (0)29 20485885
Fax: +44 (0)29 20492520
Email: [email protected]
[email protected]
www.huntleigh-diagnostics.com

19
If a serious incident occurs in relation to this medical device, affecting the user, or the patient then the user or
patient should report the serious incident to the medical device manufacturer or the distributor.
In the European Union, the user should also report the serious incident to the Competent Authority in the
member state where they are located.
Manufactured in the UK by Huntleigh Healthcare Ltd on behalf of;
ArjoHuntleigh AB
Hans Michelsensgatan 10
211 20 Malmö, Sweden
Huntleigh Healthcare Ltd.
35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom
T: +44 (0)29 20485885 [email protected]
www.huntleigh-diagnostics.com

Registered No: 942245 England & Wales. Registered Office:

ArjoHuntleigh House, Houghton Hall Business Park, Houghton Regis, Bedfordshire, LU5 5XF
©Huntleigh Healthcare Limited 2004-2014

A Member of the Arjo Family

® and ™ are trademarks of Huntleigh Technology Limited
As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice.

726332EN-11 03/2021
AW:: 1001048-2 (ENGLISH)