Huntleigh dopplex ABIlity User manual

Table of Contents
1. Safety .................................................................................4
1.1 Warnings.................................................................................................4
1.2 Residual Risks .......................................................................................5
1.3 Patient Applied Parts.............................................................................5
2. Infection Control.................................................................6
3. Intended Use ......................................................................6
3.1 User Requirements................................................................................6
4. Limitations of Use / Contraindications..............................7
5. Preliminary Checks ............................................................9
6. Initial Set-up .......................................................................10
6.1 Battery Re-Connection..........................................................................10
6.2 Setting the Language ............................................................................11
6.3 Battery Conditioning .............................................................................11
7. Use Environment ...............................................................12
8. Line (Mains) Power Operation............................................13
8.1 Fuses.......................................................................................................13
9. Battery Operation...............................................................14
10. Product Identification.......................................................15
10.1 Front Panel.............................................................................................15
10.2 Rear Panel ..............................................................................................15
10.3 Base ........................................................................................................16
10.4 Product Labelling...................................................................................16
11. System Connection...........................................................18
11.1 USB Port.................................................................................................18
12. Operation .........................................................................19
12.1 Getting Started ......................................................................................19
12.2 Loading Paper........................................................................................20
12.3 User Settings..........................................................................................21
12.3.1 System Settings .....................................................................................................21
12.4 Making a Measurement .........................................................................25
12.4.1 Patient Preparation.................................................................................................25
12.4.2 Setting Patient Type ..............................................................................................26
12.4.3 Fitting the Cuffs......................................................................................................26
12.4.4 Performing the test.................................................................................................30
12.4.5 Viewing the results ................................................................................................30
12.4.6 Example reports.....................................................................................................31
12.4.7 Paper Low Indication .............................................................................................32
12.4.8 Report Storage Guidance ......................................................................................32
12.5 Switching the Unit Off ...........................................................................32

3
Table of Contents
13. Troubleshooting................................................................33
13.1 Error Messages......................................................................................34
13.2 Cuff Leak Test ........................................................................................36
13.3 Guidance for Reliable Performance.....................................................37
14. Care and Cleaning ...........................................................38
14.1 General Care...........................................................................................38
14.2 Cleaning and Disinfecting Cuffs and Tubing ......................................39
14.3 Cleaning and Disinfecting the Ability Unit ..........................................40
15. Maintenance .....................................................................40
16. Accessories ......................................................................41
16.1 Carry bag................................................................................................41
16.2 Roll Stand...............................................................................................42
17. Specifications ..................................................................45
17.1 Equipment Classification .....................................................................45
17.2 Performance...........................................................................................45
17.3 General ...................................................................................................46
17.4 Environmental........................................................................................46
17.5 Standards Compliance..........................................................................46
17.6 Batteries .................................................................................................47
17.7 Accessories ...........................................................................................47
18. Electromagnetic Compatibility ........................................48
18.1 Electrostatic Discharge.........................................................................51
19. End of Life Disposal..........................................................52
20. Warranty & Service ..........................................................53

4
Safety
1. Safety
Before using this equipment, please study this manual
carefully and familiarize 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.
Please keep these Instructions for Use to hand for future reference.
Symbols
WARNING: .....
Indicates the possibility of death or serious injury
CAUTION: ......
Indicates the possibility of personal injury or material damage.
Attention, consult accompanying documents / Instructions for Use
1.1 Warnings
WARNING: A possible explosion hazard exists if used in the
presence of flammable anesthetics.
WARNING: Do not operate the unit from the mains supply if the
mains cable is damaged.
WARNING: Do not immerse any portion of the unit in water or
other liquids.
WARNING: If this product is connected to another item of
electrical equipment, it is important that the system is fully
compliant with IEC60601-1:2005.
WARNING: Do not apply cuff directly to non-intact skin. If a
wound is present, ensure a suitable wound dressing is applied,
followed by an infection control barrier sleeve.

5
Safety
WARNING: When configuring the system, consider and
minimise the risk of persons tripping over the tubing and
electrical cables.
1.2 Residual Risks
Residual risks are those risks that require a warning or
caution to be entered into this manual. They are identified by
the proximity of this symbol.
1.3 Patient Applied Parts
As defined in IEC60601-1:2005, the patient applied parts of the dopplex Abillity
are the four dual chamber cuffs.

6
Infection Control / Intended Use
2. Infection Control
WARNING: Before fitting cuffs to the patient, evaluate the cross
contamination risk. For medium/high risk situations, where
the patient has a known infection or skin is not intact, use an
infection control barrier sleeve with aseptic technique.
Infection control barrier sleeves are available as an accessory, Part No.ACC-
VAS-016.
Refer to Section 12.4 for sleeve and cuff fitting instructions.
Refer to Section 14.2 for care and cleaning instructions.
WARNING: Infection control barrier sleeves are single use
devices and must not be re-used. They must be disposed of as
infectious clinical waste.
3. Intended Use
Dopplex Ability is intended to be used on all patients considered to be at risk of
having, or developing peripheral arterial disease (PAD).
Dopplex Ability is intended for the rapid measurement of ankle-brachial pressure
index (ABPI) or ankle-brachial index (ABI) in adults and pulse volume recording
(PVR) / volume plethysmography.
Ability is suitable for use in woundcare assessment, for assessing symptomatic
PAD, and as a screening device for PAD.
It may also be used on patients with venous or arterial ulcers prior to the
application of compression therapy.
Dopplex Ability can be used on patients with unilateral lower limb amputation.
3.1 User Requirements
Dopplex Ability is intended for use only by a suitably qualified healthcare
professional. If an ABI test is undertaken by a Healthcare Support Worker,
then patient selection and assessment of results must be performed by a
qualified clinician in conjunction with a clinical assessment.
It is recommended that all users familiarize themselves with the information
provided in this user manual and in the enclosed Training Pack before using this
product.

7
Limitations of Use / Contraindications
4. Limitations of Use /
Contraindications
CAUTION: Federal law restricts this device to sale by or on the
order of a physician or a properly licensed practitioner.
CAUTION: Dopplex Ability provides just one indicator of
vascular condition. This should be used as part of an holistic
approach to venous or arterial leg ulcer assessment together
with other factors in forming the clinical diagnosis. The results
from dopplex Ability must not be solely relied upon. A complete
vascular assessment including clinical history and symptoms
must be made before taking appropriate action.
CAUTION: If the results from the dopplex Ability do not match
the clinical history and symptoms of the patient, then further
tests, e.g. Doppler waveform analysis, are recommended.
WARNING: Dopplex Ability is not intended to be used in the
following patient conditions:
• a suspected or present Deep Vein Thrombosis (DVT)
• severe congestive cardiac failure or similar condition
• gangrene
• recent skin graft
• untreated leg or foot wounds
• dermatitis
CAUTION: Dopplex Ability is not intended to be used in the
following patient conditions:
• cellulitis
• management of pulmonary hypertension
• patients who cannot remain still or lie flat
• patients under 18 years of age
CAUTION: False high ABI results may occur in diabetic patients
when the leg cuff is unable to compress calcified distal arteries
on the ankle effectively.
CAUTION: Ensure all cuffs are fitted correctly and aligned on
limbs according to the instructions. Measurement error may
occur if cuffs are fitted incorrectly.
CAUTION: The ABI Classification thresholds, which are
adjustable via the front panel function buttons, should only be
adjusted by a suitably qualified clinician.

8
Limitations of Use / Contraindications
CAUTION: Always observe ABI value, not only classifications,
as marginal results could be overlooked.
CAUTION: Do not sterilize the product or its accessories. The
product will be damaged, and there is a risk of patient and user
harm.
CAUTION: If using the dopplex Ability roll stand, ensure the unit
is properly locked in place, otherwise it could fall, and cause
personal injury.
WARNING: Systolic pressures are displayed for information only,
and should not be used to form a clinical diagnosis.

9
Preliminary Checks
5. Preliminary Checks
Contents (supplied with each system)
Item Item Item
1 x dopplex Ability Allen Key 1 x Training pack:
(Training CD,
Instructions for Use CD,
Quick Reference Guide,
FAQ’s,
PVR Application,
Battery Leaflet,
Registration Leaflet)
4 x Adult Dual Chamber
Cuffs with Colour Coded
tubes
2 x Rolls Printer Paper
(1 x plain, 1 x label)
1 x Box Infection Control
Barrier Sleeves 1 x Mains Cable
Delivery Inspection
Huntleigh Healthcare Ltd 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 Healthcare Ltd is informed as soon as
possible.
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 -4°F (-20°C) to +122°F
(+50°C), and relative humidity of 10% to 90% non-condensing.
If it is necessary to store the unit after a period of use, it is advisable to
first disconnect the battery (remove battery cover as described below and
disconnect battery – DO NOTAPPLY STRAIN TO THE WIRES), and remove
pressure from the printer roller by opening the printer lid slightly. Then follow
the above storage instructions.
Note: Expected battery lifetime depends on care. With correct care,
frequent charging and storage at room temperature, the battery life
can be prolonged.
If the unit is stored in high ambient temperatures and/or for an
extended period without re-charging, it is likely that battery capacity
will be degraded.
Replace the battery every two years.
For long term storage, the internal Real Time Clock backup battery should also
be removed. Refer to the service manual for details.

10
Initial Set-up
6. Initial Set-up
6.1 Battery Re-Connection
The dopplex Ability is supplied with the internal battery
disconnected. To re-connect the battery, please see instructions
below.
1. Invert the unit and remove the battery cover by removing the
securing screw using the allen key provided.
2. Lift the battery out, and connect the battery to the unit.
3. Replace the battery. Re-fit the battery cover and replace the securing
screw with the allen key provided. DO NOT OVERTIGHTEN!

11
Initial Set-up
4. Connect the unit to the mains supply (1) and switch it on by pressing
the On/Off button (2).
1
V1.2
2
6.2 Setting the Language
When switched on for the first time, the operating language must be selected.
The language selection screen will be displayed.
English
Deutsch
Francais
Italiano
CONFIRM
English
SET LANGUAGE
Press to highlight the required language. Press to Select.
6.3 Battery Conditioning
Immediately after the language has been selected, the battery conditioning
screen will be displayed.
Battery Conditioning
(Do Not Disconnect From Mains)
Note: The battery must be conditioned
before the unit is first used. If the battery is
not conditioned, battery operation will be
unreliable.
To start battery conditioning, press the centre
softkey.
When conditioning is complete, the unit will switch off automatically. It can then
be switched on and used from mains supply or battery.
Note: Battery conditioning can take up to 10 hours to complete.

12
Use Environment
7. Use Environment
Dopplex Ability is suitable for use in hospital, primary care and community
settings. It must not be used outdoors, or in any environment where it may
come into contact with water.
A couch, or similar level support surface is required for the patient to lie on, and
the main unit requires a table or similar for support. Alternatively, a roll stand is
available as an accessory, part number ACC-VAS-013.
WARNING: It is important for safety that the use environment is
well-lit to reduce the risk of persons tripping over the cables and
tubes. Use is not recommended in areas that are used as access
walkways.
Use in strong sunlight should be avoided as display visibility is greatly reduced.
The patient support surface must be wide enough for the patient to be able to
allow their arms to lie comfortably at their sides. The patient’s arms must be
completely relaxed during the test and not pulled tight against the body. The
couch should be separated from adjacent walls etc. as pressure on the arms or
cuffs must be avoided. The patients heels must be supported on the couch and
not be allowed to overhang the end.
The test environment should be reasonably quiet, as excessive ambient noise
may prevent the patient from relaxing; an important test requirement.

13
Line (Mains) Power Operation
8. Line (Mains) Power Operation
Dopplex Ability is supplied with a plug-in mains lead, fitted with a 3 pin line plug.
Connect the power cable to the line power socket. If a good, reliable earth is
not available operate the dopplex Ability from its internal battery pack.
Note: To isolate the dopplex Ability from the mains or line supply, disconnect the
power cable from the mains inlet at the rear of the unit.
8.1 Fuses
Internal fuses are fitted in both the live and neutral lines. Correctly rated fuses
must be fitted as below:-
T1AH 250VAC
Fuses must only be replaced by a suitably qualified technician.

14
Battery Operation
9. Battery Operation
The internal battery, when fully charged, provides enough power for
approximately ten ABI measurements.
An on-screen indicator shows the state of charge at all times.
Battery charging takes place when the unit is connected to the line (mains)
power. During battery charging, the battery symbol fills from left to right. The
time required to fully charge a completely discharged battery is approximately
two hours.
When the battery reaches a critically low level of charge such that further
use is not possible, the battery symbol will appear in outline, and will flash
continuously. The unit will then switch off automatically when the battery is
completely discharged.
If the battery is disconnected for any reason, it must be conditioned immediately
after re-connection. Refer to section 12.3.1 (h) for instructions. Failure to do this
will result in unreliable operation from the battery.
Power Save Functions
When operated from the internal battery, power save functions are enabled:
• After three minutes of no keypad use, the display backlight will switch off.
To switch backlight back on, simply press any of the buttons below the
display once.
• After ten minutes of no keypad use, the unit will switch off. To switch the
unit back on, press the power on/off button and hold for three seconds.
Note: Any results will be lost unless a printout has been produced.

15
Product Identification
10. Product Identification
10.1 Front Panel
V1.2
1
4
3
2
1On/Off button
2Display
3Function Buttons
4Colour Coded Tubes
10.2 Rear Panel
1
2
3
1Mains Inlet
2Printer Cover
3COM Port Connector (USB)

16
Product Identification
10.3 Base
2
1
3
4
1Battery Cover
2Battery Cover Retaining Screw
3Slide plate Mounting boss
4Air Filter
10.4 Product Labelling
Dopplex Ability is Class II, double insulated according to the
definitions in BS EN 60601-1:1990
Applied parts (cuffs) are type BF according to the definitions in BS
EN 60601-1:1990
Functional Earth Power On/Off
Alternating current (AC)
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.

17
Product Identification
WARNING: ..... Indicates the possibility of death or serious injury
CAUTION: ...... Indicates the possibility of personal injury or
material damage.
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
Medical
Electrical
Equipment
ANSI/AAMI ES60601-1 (2005, 3rd ed.)
CAN/CSA-C22.2 No 60601-1 (2008)
UL60601-1, CAN/CSA C22.2 No 601.1
E364052
The UL mark indicates that Dopplex Ability
complies with Underwriters Laboratories
requirements for safety, and is subject to
UL’s follow up services program which
verifies that the manufactured product
continues to comply with UL’s safety
requirements.
YYYY-MM
Use By Do Not Reuse
50°C
-10°C
Temperature
Limitations
25°C Upper Limit of Temperature
SN Serial Number REF Reference Number
Manufacturer
YYYY-MM
Date of Manufacture
Keep Dry Do not use hook
This way up Contents can be recycled
Returnable
packaging Cardboard packaging can be recycled.
PVC
PVC FREE
Does not contain
PVC
LATEX
LATEX FREE
Does not contain Latex
Max 90% RH
Limits of Relative
Humidity

18
System Connection
11. System Connection
WARNING: These requirements must be met when a dopplex
Ability is connected to any other electrical equipment, such as a
PC.
1 Non-medical equipment must comply with the relevant IEC or
ISO safety standard. For Information Technology equipment, this
standard is IEC950/ EN60950.
2 Medical equipment must comply with IEC60601-1, or equivalent.
3 The configured system must comply with the requirements of
IEC60601-1:2005; clause 16.
4 If non-medical equipment (e.g. the PC or printer) with enclosure
leakage currents greater than those allowed by IEC60601-1 is to
be used in the patient environment (within 1.5m of the patient),
the enclosure leakage currents must be brought within the limits laid
down by IEC60601-1. This may be achieved by using a medical
grade isolating transformer. Suitable types are available via
Huntleigh sales agents.
5 Anyone who connects additional equipment to signal input or signal
output parts of the system is configuring a medical system, and is
therefore responsible for ensuring that the system complies with the
requirements of IEC60601-1:2005; clause 16. If there is any doubt as
to whether your system complies, consult the technical service
department or your local Huntleigh representative.
11.1 USB Port
Dopplex Ability is fitted with a standard USB port (see item 3, section 10.2 ‘Rear
Panel’) for connection to a personal computer (PC).
Connections to this port should only be made by suitably technically qualified
personnel. For technical specifications of this interface, refer to section 16.3.
It is intended to be used for software upgrade purposes, and has no
functionality in normal use.
For further information, contact the service department at the address given in
section 18 of this manual.

19
Operation
12. Operation
12.1 Getting Started
1. Connect to mains
supply.
V1.2
2. Press .
3. Connect colour coded
tubing
Note : Use the function buttons below the display to access and
change the system setting and patient measurement menus.
V1.2
Function Buttons

20
Operation
12.2 Loading Paper
1. Grasp printer door firmly and pull gently backwards.
2. Insert paper roll as shown and close printer door. A ‘click’ will be
heard when door is fully engaged.
3. To tear paper, hold firmly and tear from one edge towards the front of
the unit.
Note: If using label paper, ensure roll ends are smooth. If not, press end of
roll onto a flat surface.
CAUTION: Only use paper approved by Huntleigh.
Note: The printer lid is designed to detach if forced. To replace, hook the
two lid pivots over the metal rod and press firmly downwards. A
positive ‘click’ will be heard as each pivot snaps into place.
Note: Standard (Plain) paper will allow approximately 55 printouts.
Label paper will allow approximately 35 printouts.