Arjo Huntleigh WoundExpress User manual

WoundExpress Therapy Device
INSTRUCTIONS FOR USE
WoundExpress™
WoundExpress
785344EN-2

Contents
1. Safety .............................................................................. 3
1.1 Warnings..............................................................................................3
2. Introduction ..................................................................... 5
2.1 Intended Use .......................................................................................5
2.2 About the WoundExpress Therapy Device ......................................5
2.3 Use Environment ................................................................................5
3. Clinical Applications ....................................................... 6
3.1 Indications...........................................................................................6
3.2 Contraindications ...............................................................................7
4. Preliminary Checks ......................................................... 8
5. Clinical Treatment Guide ................................................ 9
6. Pump Description ............................................................ 10
6.1 Status Indicator Description..............................................................11
7. Operation ......................................................................... 12
7.1 Garment Description ..........................................................................12
7.2 Applying the Garment ........................................................................12
7.3 Switching On.......................................................................................14
7.4 Therapy................................................................................................15
7.5 Switching Off.......................................................................................16
7.6 Removing the Garment ......................................................................16
8. Decontamination ............................................................. 17
8.1 Cleaning...............................................................................................17
8.2 Chemical Disinfection ........................................................................17
8.3 Cleaning and Sterilising Garments ...................................................17

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9. Routine Maintenance ...................................................... 18
9.1 WoundExpress Therapy Device ........................................................18
9.1.1 Maintenance ............................................................................................................18
9.1.2 Servicing ...................................................................................................................18
9.1.3 Service Period ..........................................................................................................18
9.2 WoundExpress Therapy Device Pump .............................................18
9.2.1 General Care, Maintenance and Inspection .............................................................18
9.2.2 Serial Labels .............................................................................................................18
10. Trouble Shooting............................................................ 19
11. Accessories ................................................................... 20
12. Specifications ............................................................... 21
12.1 Equipment Classification .................................................................. 21
12.2 General ................................................................................................ 21
12.3 Environmental.....................................................................................22
12.4 Standards Compliance .......................................................................22
13. Product Labelling........................................................... 23
14. Electromagnetic Compatibility ..................................... 24
15. End of Life Disposal....................................................... 28
16. Warranty & Service ....................................................... 29
Service Returns ..........................................................................................29

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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 misuse 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
General Warning Follow Instructions for Use
1.1 Warnings
Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise
misuse the WoundExpress Therapy Device. Failure to observe this caution could result
in injury, or in extreme cases, death.
A possible explosion hazard
exists if used in the presence
of flammable gases.
Do not operate the unit from
the mains supply if the mains
cable is damaged.
Do not immerse any portion
of the unit in water or other
liquids.
Use only recommended
accessories listed in this
manual.
If this product is connected
to another item of electrical
equipment, it is important that
the system is fully compliant
with IEC60601-1.
It is the responsibility of the
care giver to ensure that the
user can use this product
safely.
Only the pump and garment
combination as indicated by
Huntleigh should be used.
The correct function of the
product cannot be guaranteed
if incorrect pump and garment
combinations are used.
Ensure that all cables and
tubesets or air hoses are
positioned so that they do not
present a trip, strangulation
or other hazard and they
are clear of moving bed
mechanisms or other possible
entrapment areas.

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Electrical equipment may be
hazardous if misused. There
are no user-serviceable parts
inside the pump. The pump’s
case must only be removed
by authorised technical
personnel.
The mains power socket/
plug must be accessible at all
times. To disconnect the pump
completely from the electricity
supply, remove the plug from
the mains power socket.
Bags supplied with this
equipment may present a
suffocation risk; to avoid the
risk of suffocation keep the
bags away from babies and
small children.
Disconnect the pump from the
mains power socket before
cleaning and inspecting.
Make sure the system is
clean and dry prior to use or
storage.
Do not expose the system
to naked flames, such as
cigarettes, etc.
Do not store the system in
direct sunlight.
Do not use phenol-based
solutions to clean the system.
This device must not be
modified.
Pets and children must be
supervised in the vicinity of
the system.
Expected Service Life
The WoundExpress Therapy Device Pump has an expected service life of seven years.
To maintain the condition of the pump have the pump serviced regularly according to
the schedule recommended by Huntleigh.
The WoundExpress Therapy Device garment has an expected service life of 12 weeks.

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2. Introduction
The WoundExpress Therapy Device is a system consisting of a pump and garment
which operates by using low pressure air to deliver a compression therapy.
You must read and fully understand this manual before using the system.
Use this manual to initially set up the system, and keep it as a reference for day-to-day
routines and as a guide to maintenance.
If you have any difficulties in setting-up or using the WoundExpress Therapy Device,
contact your local Huntleigh representative.
2.1 Intended Use
The intended use of this product is to manage the list of clinical conditions detailed in
the “Indications” (section 3.1).
The WoundExpress Therapy Device should be used as part of a prescribed plan of
care detailed in the “Indications” section.
2.2 About the WoundExpress Therapy Device
The pump operates on a 4 minute automatically timed cycle, consisting of a 2 minute
venous emptying phase and a 2 minute rest phase. The venous emptying phase
consists of six 20 second compression cycles, while no compression takes place during
the rest phase. Each 20 second compression cycle is characterised by overlapping
synchronous inflations and deflations of the distal (lower), central (middle)and proximal
(upper) chamber.
Compression Cycle Delay to cycle start Inflated state Deflated state
Chamber 1 (lower) 0s 15s 5s
Chamber 2 (middle) 5s 10s 10s
Chamber 3 (upper) 12s 10s 10s
The maximum pressure in each chamber is 60mmHg.
The segments within the garments are designed to prevent ridging and ensure high
patient comfort and concordance.
A full technical description of the WoundExpress Therapy Device can be found in the
Service Manual, part No. 785345, available from your local Huntleigh Service dept.
2.3 Use Environment
WoundExpress Therapy Device is suitable for use in hospital, primary care, community
settings and in the home. It must not be used outdoors, or in any environment where it
may come into contact with water.

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3. Clinical Applications
3.1 Indications
Intermittent Pneumatic Compression (IPC) is effective in the treatment of the following
clinical condition when combined with an individualised monitoring programme:
• Chronic wounds including leg ulcers (venous leg ulcers and mixed
aetiology leg ulcers).
IPC may also be beneficial in the management of:
• Lower limb pain
Selection should be based upon a holistic assessment of the patients’ individual care
needs.
Note
These systems represent one aspect of a treatment strategy; if the patient’s
condition changes the overall therapy regimen should be reviewed by the
prescribing clinician.
Note
The above are guidelines only and should not replace clinical judgement.

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3.2 Contraindications
IPC should NOT be used in the following circumstances:
• Known or suspected deep vein thrombosis (DVT), pulmonary
embolism, thrombophlebitis and acute infections of the skin, such as
cellulitis.
• Decompensated/severe congestive cardiac failure, pulmonary
oedema associated with significant limb oedema or any condition
where an increase of fluid to the heart may be detrimental.
• Severe arteriosclerosis or other ischaemic vascular disease.
• Active metastatic disease affecting the limb.
• Severe peripheral artery disease.
• Known malignancy
Note to Patient
If you are uncertain whether you have any of the above conditions please
consult a physician before use.
CAUTION
IPC should be used with care in patients with the following symptoms or
conditions:
• Peripheral neuropathy, pain or numbness in the limb.
• Undiagnosed, untreated or infected wounds, fragile skin, grafts
or dermatological conditions that may be aggravated by the
garment.
• Extreme limb deformity which may practically impede the correct
application of the garment.
WARNING
The garment must not be applied to open wounds or non-intact skin.
WARNING
If the user feels any numbness, tingling or has any other concerns,
switch off the pump and remove the garment.
WARNING
In the event of a power failure or fault whereby the garment remains
inflated, remove the garment(s) from the patient’s limbs.

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4. Preliminary Checks
Contents (supplied with each system)
Item Item
1 x WoundExpress Therapy Device 1 x Instructions for Use
1 x Quick Reference Guide 1 x WoundExpress Diary
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 is informed
at once.
Storage
If 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 -20°C to +50°C, and relative humidity of 20% to
95% non-condensing.
After exposure to extreme temperatures during storage, the pump must be allowed to
adjust to normal operating temperatures for a minimum of 12 hours before use. Failure
to do this may result in accelerated wear of mechanical components.

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5. Clinical Treatment Guide
The WoundExpress Therapy Device has a preset pressure of 60mmHg.
The recommended therapy time is 2 continuous hours per day.
A diary is included with the pump for the patient to complete, to monitor concordance
with the therapy.
Note
Loss of mains power will halt therapy.

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6. Pump Description
WoundExpress
1
3
4
2
3B
3A
5
Item
No. Description Function
1On/Off Switch Operation of this switch Starts or Stops the system
2Status Indicator Indicates the pressure in the garment
3Tube connectors For garment attachment (3A and 3B)
4Carry Handle For easy handling of the pump
5Power status LED Indicates the power status of the pump
Note
If the operation of performance of the pump changes during use, refer to
“Trouble Shooting” section of this IFU before contacting your local Huntleigh
service department.

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6.1 Status Indicator Description
Normal
Operating
Range
Error
Refer to
Service
Rest and Off
Status Indicator
1. The sand timer symbol indicates that the device is not currently delivering a
compression cycle. This can be during the 2 minute rest phase, or when the
device is turned off.
2. The green zone indicates the proper functioning of the device. The needle
will fluctuate within this area during a compression cycle.
3. The yellow zone indicates that the device is operating above the
recommended pressure setting. Turn off the pump and consult the
Troubleshooting section of this IFU.

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7. Operation
7.1 Garment Description
The garment Inner and Outer panels are made from a laminate of brushed polyester
and Polyurethane foam.
The outer edges of the garment are ‘finished’ with a sewn nylon binding with a nylon
thread.
The garment has a hook and loop fastener to enable adjustable fitting.
Air is delivered to the 3 bladder chambers through PU tubing connector via grommets
in the bladders.
The patient name and therapy start date can be written onto the garment in the area
provided, (1 - shown in diagram below), using a ball point pen.
PATIENT NAME
THERAPY START DATE
__ __ / __ __ / __ __
1
Huntleigh Healthcare Ltd.,
35 Portmanmoor Road
Cardiff. CF24 5HN. UK
TEL : [phone]
www.huntleigh-diagnostics.com
0088
LATEX
SINGLE
PATIENT
USE
WoundExpress
TM
WE100G
Designed in the UK
Assembled in China
PATIENT NAME
THERAPY START DATE
__ __ / __ __ / __ __
05051968040374
DI
Garment
Tubing Connector
to Pump
7.2 Applying the Garment
Note
Optimal therapy is performed over thin clothing, Any sharp or hard objects
must be removed from clothing before applying the garment.

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Fit the garment to the thigh (left or right) of the limb affected by the chronic wound.
Ensure it is a snug fit and fasten using the velcro strip.
PATIENT NAME
THERAPY START DATE
__ __ / __ __ / __ __
Huntleigh Healthcare Ltd.,
35 Portmanmoor Road
Cardiff. CF24 5HN. UK
TEL : [phone]
www.huntleigh-diagnostics.com
0088
LATEX
SINGLE
PATIENT
USE
WoundExpress
TM
WE100G
Designed in the UK
Assembled in China
05051968040374
DI
Tubing Connector
to the Pump
Attach the garment tubing to the pump.
WoundExpress

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Note
Ensure that the garment is applied correctly before switching the pump on.
CAUTION
Do not apply or remove the garment while it is attached to the pump and the
pump is in operation, as you may damage the garment.
WARNING
Patients must not walk or stand when wearing leg garments.
7.3 Switching On
The pump should be placed securely on a flat surface.
Connect the pump to the mains power supply using the power cable provided. Turn the
mains power switch (1) to the On (I) position. The power status LED will illuminate.
WoundExpress

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7.4 Therapy
During therapy the user should lie down or sit with the leg elevated.
Check that the garment remains snugly in place and does not move down the leg,
reposition as necessary.
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4
3
1
9
10
8
2hrs
12
2
Check occasionally to ensure the pump is running its normal cycle and is reaching a
pressure in the green zone on the gauge on top of the pump.
The normal cycle is approximately 2min of inflation followed by 2min of deflation.
The recommended therapy time is 2 continuous hours per day.
A diary is included with the pump for the patient to complete, to monitor concordance
with the therapy.
It is normal during the inflation phase for the pressure to vary within the green segment
shown on the status indicator, and to drop to zero for 2 mins.
In use, the patient will feel a gentle massaging.
Compression should not cause any discomfort or pain to the patient.
WARNING
If the user feels any numbness, tingling or has any other concerns,
switch off the pump and remove the garment.
WARNING
The garment is intended for single patient use only.

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7.5 Switching Off
Turn the power switch (1) to the off (O) position. Turning the power off will stop the
patient therapy.
Note
If it is required to completely isolate the pump from the mains power, remove
the plug from the mains power socket.
7.6 Removing the Garment
Make sure the pump power switch (1) is in the off (O) position and disconnect the
tubing from the pump by removing the tube connectors (3).

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8. Decontamination
The following processes are recommended, but should be adapted to comply with the
local or national guidelines (Decontamination of Medical Devices) which may apply
within the Healthcare Facility or the country of use. If you are uncertain, you should
seek advice from your local Infection Control Specialist.
The WoundExpress Therapy Device should be routinely decontaminated between
patients and at regular intervals while in use; as is good practice for all reusable
medical devices.
WARNING
Remove the electrical supply to the pump by disconnecting the mains
power cord from the mains power supply before cleaning.
Protective clothing should always be worn when carrying out
decontamination procedures.
WARNING
Do not use Phenol-based solutions or abrasive compounds or pads
during the cleaning or decontamination process as these will damage
the surface coating. Avoid immersing electrical parts in water during
the cleaning process. Do not spray cleaning solutions directly onto the
pump. Do not immerse the tubeset in water.
8.1 Cleaning
Clean all exposed surfaces and remove any organic debris by wiping with a cloth
moistened with a simple (neutral) detergent and water.
Do not allow water or cleaning solutions to collect on the surface of the pump.
8.2 Chemical Disinfection
We recommend a chlorine-releasing agent, such as sodium hypochlorite, at a strength of
1,000ppm available chlorine (this may vary from 250ppm to 10,000ppm depending on local policy
and contamination status).
Wipe all cleaned surfaces with the solution, then wipe using a cloth moistened with water and dry
thoroughly.
Alcohol based disinfectants (strength 70%) may be used as an alternative.
Ensure the product is dry before storage.
If an alternative disinfectant is selected from the wide variety available we recommend that
suitability for use is confirmed with the chemical supplier prior to use.
8.3 Cleaning and Sterilising Garments
Garments are single patient use and cannot be reprocessed.
The garment should be treated as domestic waste and disposed of accordingly.

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9. Routine Maintenance
9.1 WoundExpress Therapy Device
9.1.1 Maintenance
The equipment has been designed to be maintenance-free between service periods.
9.1.2 Servicing
Huntleigh will make available on request service manuals, component parts lists and
other information necessary for Huntleigh trained personnel to repair the system.
9.1.3 Service Period
Huntleigh recommend that the WoundExpress Therapy Device pump is serviced every
24 months by an Huntleigh authorised service agent.
9.2 WoundExpress Therapy Device Pump
9.2.1 General Care, Maintenance and Inspection
Check all electrical connections and power cable for signs of excessive wear.
Check the tubeset and connectors for any damage.
In the event of the pump being subjected to abnormal treatment, e.g. immersed in
water or dropped, the unit must be returned to an authorised service centre.
9.2.2 Serial Labels
The serial number for the pump is on the label on the back of the pump case. Quote
this serial number when requesting service.

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10. Trouble Shooting
If you should encounter a problem, please follow the fault finding guide below. If the
fault cannot be rectified, please refer to Service.
Fault Check Remedy
Pump does not
operate.
Is power switch on?
Is power cord plugged in
correctly?
Fuse blown?
Check switch.
Check connections.
Call service engineer.
Pump operates
but garment will
not inflate.
Blockage in garment supply
tube.
Garment not fitted correctly to
pump.
Air leak in garment.
Ensure that the tube airway is
clear.
Check for kinked tubing.
Check connections.
Check garment. Replace if
defective.
Needle on
status indicator
is in yellow zone
Contact Huntleigh service
department.
Note
If the trouble shooting procedures do not return the system to normal
performance, stop using the system immediately and contact Huntleigh
service department. Refer to “Warranty & Service” .