Huntleigh D920 User manual

HIGH SENSITIVITY
POCKET DOPPLERS
/
D920/D930

Table of Contents
1. Safety .............................................................................. 3
1.1 Warnings............................................................................................3
1.2 Patient Applied Parts........................................................................4
1.3 Indications for Use............................................................................4
1.4 Positioning ........................................................................................4
2. Introduction .................................................................... 5
2.1 Unpacking / Preliminary Checks.....................................................5
2.2 Battery Insertion / Relacement........................................................5
2.3 Product Controls...............................................................................6
2.4 Product Labelling..............................................................................7
3. Operation ........................................................................ 8
3.1 Obstetric Mode .................................................................................8
3.2 After Use............................................................................................9
4. Care and Cleaning ........................................................... 10
4.1 General Care......................................................................................10
4.2 General Cleaning and Disinfecting ................................................11
4.3 Cleaning and Disinfecting Patient Applied Parts...........................11
4.4 Maintenance and Repair...................................................................12
5. Specifications ................................................................. 13
5.1 Equipment Classification ................................................................13
5.2 Standards Compliance.....................................................................13
5.3 General ..............................................................................................14
5.4 Environmental...................................................................................14
5.5 Accessories.......................................................................................14
6. Electromagnetic Compatibility ....................................... 15
7. End of Life Disposal......................................................... 19
8. Warranty & Service......................................................... 20

3
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.
This equipment is for use only by suitably qualified healthcare
practitioners.
This product may be used in the home healthcare environment by
a qualified healthcare practitioner only, and is for indoor use only.
Experience with use of ultrasonic Dopplers is preferable, but for
novice users training material is provided with the accompanying
documents (CD). This product is not intended for use by the
patient.
Please keep these Instructions for Use to hand for future reference.
General warning
Attention, consult accompanying documents / Instructions for Use
1.1 Warnings
Do not use in the presence of flammable gases or oxygen rich
environments.
Do not use in the sterile field unless additional barrier precautions
are taken.
Do Not :
• immerse in any liquid, (except D920/D930 probe)
• use solvent cleaner,
• use high temperature sterilising processes (such as
autoclaving),
• use E-beam or gamma radiation sterilisation.

4
Safety
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.
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
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 fetal
monitoring. If there is doubt as to fetal well-being after using the
unit, further investigations should be undertaken immediately
using alternative techniques.
This equipment must not be modified.
1.2 Patient Applied Parts
As defined in IEC60601-1:2005, the patient applied parts of the Sonicaid
Dopplers are the ultrasound probes.
1.3 Indications for Use
The D920 and D930 ultrasonic Dopplers are indicated for use by qualified
healthcare practitioners in primary, acute and community healthcare, for the
detection of the fetal heart, to assist diagnosis.
1.4 Positioning
In normal use, the operator may be standing or seated adjacent to the patient
within reach of the device controls and probe, and with the display clearly
visible.

5
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 as
specified in Section 5.4.
2.2 Battery Insertion / Relacement
123
Note: Remove the battery if the unit is not likely to be used for
some time.

6
Introduction
2.3 Product Controls
1
2
3
45
1Headphone Socket
2LED Panel
3Loud-speaker
4On/Off Button
5Probe Holder
6Volume Control
7Battery Compartment
8Pocket Clip
7
8
6

7
Introduction
2.4 Product Labelling
Applied parts (ultrasound probes) are type BF according to the
definitions in IEC60601-1:2005
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.
General warning
Attention, consult accompanying documents / Instructions for Use
This symbol signifies that this product complies with the essential
requirements of the Medical Devices Directive
93/42/EEC as amended by 2007/47/EC
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.
Power On/Off Battery
Manufacturer DI Device Identifier
Volume Headphone Socket
+40°C
-10°C
Temperature
Limitations
“MAX
93%
RH”
Limits of Relative Humidity
SN Serial Number REF Reference Number
Keep Dry Do not use hook
Fragile Cardboard packaging can be
recycled.
Limits of Atmospheric
Pressure
Note: Product labelling should be read from a distance of no
greater than 0.7m.

8
Operation
3. Operation
Note: During use, an automatic noise reduction feature operates on low
level signals to improve sound quality.
LED Indicators
Green LED - indicates power ON
Yellow LED - flashes when battery is low
Coupling Gel
Use water based ultrasound gel ONLY.
3.1 Obstetric Mode
Obstetric Probes
Two probes are available for obstetric examinations:
OP2XS 2MHz ±1%
OP3XS 3MHz ±1%
Audio / Flexi Dopplex (D920/D930)
Both the Audio Dopplex and the Flexi Dopplex have fixed waterproof probes
(IPX7) for underwater use.
The D920/D930 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.

9
Operation
The Dopplex units can detect fetal heart sounds from as early as 9 to 10 weeks
gestation.
Note that early detection (9-12 weeks) is highly depedent on operator skill and
other factors and may not always be possible.
*Note: For D920/D930 : Gel is not required when probe is used underwater.
3.2 After Use
1. Press and release the On/Off button. If you forget to switch the unit
off, it will automatically shut-off after 5 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.

10
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. (Except D920/D930 probes).
Always wipe off disinfectant using a cloth dampened with clean
water.

11
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 and the
probes have not been
contaminated with blood.
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.

12
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.
Warning: Servicing cannot be performed while the unit is in use.

13
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.
Hand Unit: IP20 *
D920/D930 probes : IPX7
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: 2005 + C1 + C2
IEC60601-1-11: 2015
IEC60601-2-37: 2007
IEC60601-1-2: 2014
EN 60601-2-37: Thermal Indices (TI) and Mechanical Index (MI) are
below 1.0 for all device settings.
* For homecare use, this can be upgraded to IPX2 by using the Protective Pouch
(ACC-OBS-080).

14
Specifications
5.3 General
Max. Audio Output
(Loudspeaker) 500mW rms typical
Auto shut-off After 5 minutes continuous operation
Headphones Max. output Power: 25 mW rms (32Ω)
Connector: 3.5mm stereo jack socket
Max. applied voltage: +9Vdc
Battery Type IEC 6LR61 or IEC 6LP3146
Battery Life Typically, 500 x 1 minute examinations
Size Height 140mm, Depth 27mm, Width 74mm
Weight 295g
Service Life 7 years
5.4 Environmental
WARNING: The main unit enclosure does not provide protection from
water ingress. For homecare use, we recommend the use of a protective
pouch (ACC-OBS-080). However, this will not protect the unit from
immersion in liquids.
Operating
Temperature range +5°C to +40°C
Relative Humidity 15% to 93% (non condensing)
Pressure 700hPa to 1060hPa
Transport and Storage between uses
Without relative humidity control -25°C to +5°C
At a relative humidity of up to 93% non-condensing +5°C to +35°C
At a water vapour pressure up to 50hPa >+35°C to +70°C
5.5 Accessories
Item Part No
Protective Pouch ACC-OBS-080

15
Electromagnetic Compatibility
6. 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 EN60601-
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:
• Reorienting the equipment
• Relocating the equipment with respect to the source of interference
• Moving the equipment away from the device with which it is interfering
• Plugging the equipment into a different outlet so that the devices are on
different branch circuits
WARNING: 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.
WARNING: 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
WARNING: 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 D920/D930, including cables
specified by the manufacturer. Otherwise, degradation of the performance
of this equipment could result.
Guidance and Manufacturer’s declaration - electromagnetic emissions
The Doppler is intended for use in the electromagnetic environment specified below. The customer
or the user of the Doppler should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - guidance
RF emissions
CISPR 11 Group 1
The Doppler uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11 Class B
The Doppler is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 N/A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
N/A

16
Electromagnetic Compatibility
Guidance and Manufacturer’s declaration - electromagnetic immunity
The Doppler is intended for use in the electromagnetic environment specified below. The customer or the
user of the Doppler should assure that it is used in such an environment.
Immunity Test IEC 60601 test level Compliance
level Electromagnetic Environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8kV contact
± 15kV air
8kV
15kV
Floors should be wood, concrete
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%,
otherwise permanent damage could
be caused to the Doppler.
Electrical fast
transient/burst IEC
61000-4-4
± 2kV for power supply lines
± 1kV for input/output lines
N/A N/A
Surge
IEC 61000-4-5
± 1kV line(s) to line(s)
± 2kV line(s) to earth
N/A N/A
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT<95% dip in UTfor
0,5 cycle
40% UT<60% dip in UTfor 5
cycles
70% UT<30% dip in UTfor
25 cycles
<5% UT<95% dip in UTfor 5s
N/A N/A
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8
30A/m 30A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
NOTE UTis the a.c. mains voltage prior to application of the test level.

17
Electromagnetic Compatibility
Guidance and Manufacturer’s declaration - electromagnetic immunity
The Doppler is intended for use in the electromagnetic environment specified below. The customer or the
user of the Doppler should assure that it is used in such an environment.
Immunity Test IEC 60601 test level Compliance
level Electromagnetic Environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the Doppler, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150kHz to 80MHz
outside ISM bandsa
6 Vrms
150 kHz to 80 MHz
in ISM and amateur
radio bands
3V
6V
d= 1.2 √P
d= 2.0 ¥P
Radiated RF
IEC 61000-4-3
10 V/m
80MHz to 2.7GHz
10V/m d= 1.2 √P80MHz to 800MHz
d= 2.3 √P800MHz to 2.7GHz
where Pis the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and dis the
recommended separation distance in metres m). b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, c
should be less than the compliance level in each
frequency range d.
Interference may occur in the vicinity of the
equipment marked with the following symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
aThe ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz, to 6,795
MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
bThe compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2,5 GHz are intended to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an
additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these
frequency ranges.
cField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
Dopper is used exceeds the applicable RF compliance level above, the Doppler should be observed to verify
normal operation. If abnormal performancec is observed, additional measures may be necessary, such as
re-orienting or relocating the Doppler.
dOver the frequency range 150kHz to 80kHz, field strengths should be less than 3V/m.

18
Electromagnetic Compatibility
Recommended separation distances between portable and mobile RF communications
equipment and the Doppler
The Doppler is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. the customer or user of the Doppler can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Doppler as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150kHz to 80MHz
d= 1.2 √P
80MHz to 800MHz
d= 1.2 √P
800MHz to 2.5GHz
d= 2.3 √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance din metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where Pis the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

19
End of life Disposal
7. 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.

20
Warranty & Service
8. 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 - D920 / D930’
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:
Service Department.
Huntleigh Healthcare, Diagnostic Products Division,
35, Portmanmoor Rd.,
Cardiff. CF24 5HN
United Kingdom.
Tel: [phone]
Fax: [phone]
Email: [email protected]
[email protected]
www.huntleigh-diagnostics.com