Huntleigh D900 User manual

HIGH SENSITIVITY
POCKET DOPPLERS
D900

Table of Contents
Doppler Measurement Sites and Recommended Probes ... 3
1. Safety .............................................................................. 4
1.1 Warnings............................................................................................4
1.2 Patient Applied Parts........................................................................5
1.3 Indications for Use............................................................................5
1.4 Positioning ........................................................................................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..............................................................................8
3. Operation ........................................................................ 9
3.1 Vascular Mode...................................................................................9
3.2 After Use............................................................................................10
4. Care and Cleaning ........................................................... 11
4.1 General Care......................................................................................11
4.2 General Cleaning and Disinfecting ................................................12
4.3 Cleaning and Disinfecting Patient Applied Parts...........................12
4.4 Maintenance and Repair...................................................................13
5. Specifications ................................................................. 14
5.1 Equipment Classification ................................................................14
5.2 Standards Compliance.....................................................................14
5.3 General ..............................................................................................15
5.4 Environmental...................................................................................15
5.5 Accessories.......................................................................................15
6. Electromagnetic Compatibility ....................................... 16
7. End of Life Disposal......................................................... 20
8. Warranty & Service......................................................... 21

Doppler Measurement Sites and Recommended
Probes
18
910
11
12
13
15
16 14
17
18
19
7
2
3
4
5
6
1 Jugular Vein
VP4XS, VP5XS
2 Subclavian Vein
VP4XS, VP5XS
3 Femoral Vein
VP4XS, VP5XS
4 Great Saphenous Vein
VP5XS, VP8XS, EZ8XS
5 Small Saphenous Vein
VP8XS, EZ8XS
6 Posterior Tibial Vein
VP8XS, VP10XS, EZ8XS
7 Posterior Tibial Artery
VP8XS, EZ8XS
8 Vertebral Artery
VP4XS, VP5XS
9 Carotid Artery
VP5XS, VP8XS, EZ8XS
10 Subclavian Artery
VP4XS, VP5XS
11 Brachial Artery
VP8XS, EZ8XS
12 Ulnar Artery
VP8XS, EZ8XS
13 Radial Artery
VP8XS, EZ8XS
14 Femoral Artery
VP4XS, VP5XS
15 Digital Artery VP8XS,
VP10XS, EZ8XS
16 Penis
VP10XS, EZ8XS
17 Popliteal Artery
VP5XS
18 Metatarsal Artery
VP8XS, VP10XS, EZ8XS
19 Dorsalis Pedis Artery
VP8XS, VP10XS, EZ8XS
The D900 is compatible with HS and XS Doppler probes.

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.
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,
• use solvent cleaner,
• use high temperature sterilising processes (such as
autoclaving),
• use E-beam or gamma radiation sterilisation.

5
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.
Any equipment connected to the waveform output socket 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
monitoring. If there is doubt as to vascularity 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 Dopplex
Dopplers are the ultrasound probes.
1.3 Indications for Use
The D900 ultrasonic Doppler is indicated for use by qualified healthcare
practitioners in primary, acute and community healthcare, for the assessment of
vascular blood flow 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.

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 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.

7
Introduction
2.3 Product Controls
12
3
4
56
1Headphone Socket
2Waveform Socket
3LED Panel
4Loud-speaker
5On/Off Button
6Probe Holder
7Volume Control
8Cal Button
9Battery Compartment
10 Pocket Clip
8
9
10
7

8
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
Alignment mark 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 Manufacturer
Waveform Output
Socket
Note: Product labelling should be read from a distance of no
greater than 0.7m.

9
Operation
3. Operation
Refer to diagram on page 3 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.
LED Indicators
Green LED - indicates power ON
Yellow LED - flashes when battery is low
Coupling Gel
Use water based ultrasound gel ONLY.
3.1 Vascular Mode
The D900 will select vascular mode when a vascular probe is connected to the
control unit.
Vascular Probes
Five probes are available for vascular examinations:
VP4XS 4MHz ±1% for deep lying vessels
VP5XS 5MHz ±1% for deep lying vessels and oedematous limbs
VP8XS 8MHz ±1% for peripheral vessels
VP10XS 10MHz ±1% for specialist superficial applications.
EZ8XS 8MHZ ±1% “Widebeam” for peripheral vessels.

10
Operation
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.
Waveform Recording -
The D900 can be connected to a chart recorder by using a suitable lead that
plugs into the Waveform socket. (For more information on the chart recorder,
refer to the manufacturer’s handbook).
Cal Function
The baseline and sensitivity of the chart recorder can be set up using the Cal
function. This generates a zero velocity baseline and a sequence of pulses as
shown below:
Cal Pulse
Two levels of calibration pulses are provided. While Cal is active, calibration
tones synchronised to the calibration pulses are superimposed on the audio
signal.
If the button is pressed and held, then the calibration sequence is repeated.
When the calibration sequence is complete, normal operation is resumed.
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.