Huntleigh WoundExpress User manual

WoundExpress Therapy Device
INSTRUCTIONS FOR USE
WoundExpress™
WoundExpress
785344US-9 12/2021
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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O󰀨............................................................................................ 16
7.6 Removing the Garment ........................................................................... 16
8. Decontamination .................................................................................17
8.1 Cleaning.................................................................................................... 17
8.1.1 Wound Express Therapy Device .................................................................................... 17
8.1.2 Garments ........................................................................................................................ 17
8.2 Chemical Disinfection ............................................................................. 17
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Instructions For Use
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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.Specications .....................................................................................21
12.1EquipmentClassication....................................................................... 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............................................................................27
16.Warranty ...............................................................................................28
17.Service..................................................................................................30
Service Returns ....................................................................................................................... 30
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Instructions For Use
3
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 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
RX
Only
Caution: Federal law restricts this device to sale by, or on the order of
a licensed healthcare practitioner.
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ammable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.
Make sure the system is
clean and dry prior to use or
storage.
Do not expose the system
tonakedames,suchas
cigarettes, etc.
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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.
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
su󰀨ocationrisk;toavoidthe
riskofsu󰀨ocationkeepthe
bags away from babies and
small children.
Disconnect the pump from the
mains power socket before
cleaning and inspecting.
Do not store the system in
direct sunlight.
Do not use phenol-based
solutions to clean the system.
This device must not be
modied.
Pets and children must be
supervised in the vicinity of
the system.
The garment must not be
cleaned.
Do not use during magnetic
resonance imaging (MRI)
scanning.
Service Life
This has been dened as the minimum time period during which the device is expected
to remain safe and suitable to meet its intended use, and all risk control measures
remain e󰀨ective.
The expected service life for the WoundExpress pump device is 7 years.
The WoundExpress Therapy garment has an expected service life of 8 weeks.
If the garment becomes soiled or is otherwise compromised, we recommend that it is
changed immediately.
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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 di󰀩culties in setting-up or using the WoundExpress Therapy Device,
contact your local ArjoHuntleigh representative.
2.1 Intended Use
The intended use of this product is to aid in the management and treatment of
leg ulcers, when combined with an individualised monitoring programme.
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 inations and deations of the distal (lower), central (middle)and proximal
(upper) chamber.
Compression Cycle Delay to cycle start Inatedstate Deated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 ArjoHuntleigh 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
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Instructions For Use
may come into contact with water.
3. Clinical Applications
3.1 Indications
WoundExpress aids in the treatment of the following clinical conditions:-
- Chronic wounds including leg ulcers (venous leg ulcers and mixed aetiology
leg ulcers).
- the management of Lower limb pain
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 signicant limb oedema or any condition
where an increase of uid to the heart may be detrimental.
• Severe arteriosclerosis or other ischaemic vascular disease.
• Active metastatic disease a󰀨ecting the limb.
• Severe peripheral artery disease (ABI ≤ 0.6).
• 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.
CAUTION
For patients with an ABI < 0.8: WoundExpress therapy should only be
instigated and thereafter supervised by an appropriate physician or
specialist nurse who has deemed that the arterial and venous status of
the limb are suitable for IPC therapy.
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o󰀨thepumpandremovethegarment.
WARNING
In the event of a power failure or fault remove the garment.
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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
ArjoHuntleigh 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
ArjoHuntleigh 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 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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