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.