Huntleigh FD1 User manual

HIGH SENSITIVITY
POCKET DOPPLERS
FD1/FD2/FD3

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
19
10
11
12
13
14
16
17
15
18
19
20
8
3
2
4
5
6
7
1 Jugular Vein
VP4HS, VP5HS
2 Subclavian Vein
VP4HS, VP5HS
3 Fetus
OP2HS, OP3HS
4 Femoral Vein
VP4HS, VP5HS
5 Great Saphenous Vein
VP5HS, VP8HS, EZ8
6 Small Saphenous Vein
VP8HS, EZ8
7 Posterior Tibial Vein
VP8HS, VP10HS, EZ8
8 Posterior Tibial Artery
VP8HS, EZ8
9 Vertebral Artery
VP4HS, VP5HS
10 Carotid Artery
VP5HS, VP8HS, EZ8
11 Subclavian Artery
VP4HS, VP5HS
12 Brachial Artery
VP8HS, EZ8
13 Ulnar Artery
VP8HS, EZ8
14 Radial Artery
VP8HS, EZ8
15 Femoral Artery
VP4HS, VP5HS
16 Digital Artery
VP8HS, VP10HS, EZ8
17 Penis
VP10HS, EZ8
18 Popliteal Artery
VP5HS
19 Metatarsal Artery
VP8HS, VP10HS, EZ8
20 Dorsalis Pedis Artery
VP8HS, VP10HS, EZ8

4
Safety
1. 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.

5
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.

6
Introduction
2. Introduction
2.1 Unpacking / Preliminary Checks
Contents
INSTRUCTIONS
FOR USE
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
123
Note: Remove the battery if the unit is not likely to be used for
some time.

7
Introduction
2.3 Product Controls
12
3
4
5
6
FD1
FD3 FD2
1●●Headphone Socket
2●RS232 Port
3●●LCD Panel
4●●Loud-speaker
5●●On/Off Button
6●●Probe Holder
7●●Volume Control
8●Start/Stop Button
9●Mode Button
10 ●●
Battery
Compartment
11 ●●Pocket Clip
8
9
10
11
7
2.4 Product Labelling
Patient applied parts (ultrasound probes) are type BF according to the
definitions in IEC 60601-1:2005.

8
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
Only
Federal law restricts this device to sale by, or on the order of a licensed
healthcare practitioner.
IP20 Protected against ingress of solid foreign objects >12.5mm diameter. Not
protected against ingress of water.
Manufactured
By:
Huntleigh Healthcare Ltd.
35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom
T: [phone] [e-mail]
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
-10°C
Temperature Limitations
“MAX
93%
RH”
Limits of Relative Humidity
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
recycled. Do not use hook
PVC
PVC FREE
Does not contain PVC
LATEX
LATEX FREE
Does not contain Latex
Limits of Atmospheric Pressure
Note: Product labelling should be read from a distance of no greater than 0.7m.

9
Operation
3. 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.

10
Operation
3.2 Obstetric Mode
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.

11
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.

12
Operation
3.3 After Use
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.

13
Care and Cleaning
4. 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.

14
Care and Cleaning
4.2 General Cleaning and Disinfecting
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
situations include patients
having intact skin and no
known infection.
1. Remove soiling, wipe with a mild
neutral detergent and then wipe
with a cloth dampened in water.
2. Completely dry with a clean lint
free cloth.
Medium The patient has a known
infection, skin is not intact,
the part is heavily soiled,
or the patient has given
birth in a water bath.
1. Follow low risk procedure then
wipe with a cloth dampened in
Sodium Hypochlorite (1,000ppm).
2. After two minutes wipe with a cloth
dampened in water and then dry
with a clean lint free cloth.
High This procedure should
only be used when
the part has been
contaminated by blood.
1. Follow low risk procedure then
wipe with a cloth dampened in
Sodium Hypochlorite (10,000ppm).
2. After two minutes wipe with a cloth
dampened in water and then dry
with a clean lint free cloth.

15
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.

16
Specifications
5. Specifications
5.1 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 particles and/or water.
Main Unit: IP20
FD1 / FD3 probes : IPX7
All other probes (Tip only): IPX1
Degree of safety of
application in the
presence of a flammable
anaesthetic
Equipment not suitable for use in the presence of
a FLAMMABLE ANAESTHETIC MIXTURE WITH
AIR, OXYGEN OR NITROUS OXIDE
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
(FD2 only)
Range - 60-210bpm Resolution - 1bpm
Averaging - 8 beats Accuracy - ±3bpm
Manual Mode
(FD2 only)
Range - 60-210bpm Resolution - 1bpm
Averaging - 10 beats Accuracy - ±3bpm
*(excluding user error)

17
Specifications
5.4 General
Max. Audio Output
(Loudspeaker)
500mW rms typical
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
(FD2 only)
Data format: RS232C
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
condensing)
Relative Humidity 93% maximum
860mb to 1060mb Pressure 860mb to 1060mb

18
End of life Disposal
6. 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.

19
Warranty & Service
7. 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: [phone] - Service (24hr answer machine)
Tel: [phone]
Fax: [phone]
Email: [email protected]
[email protected]
www.huntleigh-diagnostics.com

AW:: 1001048-2
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.
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;
Huntleigh Healthcare Ltd.
35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom
T: [phone] [e-mail]
www.huntleigh-diagnostics.com
ArjoHuntleigh AB
Hans Michelsensgatan 10
211 20 Malmö, Sweden
726332EN-11
(ENGLISH)
03/2021