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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2
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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Instructions For Use
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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Instructions For Use
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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Instructions For Use
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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6. Pump Description
WoundExpress
1
3
4
2
3B
3A
5
Item
No. Description Function
1On/O󰀨 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
ArjoHuntleigh service department.
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6.1 Status Indicator Description
Normal
Operating
Range
Error
Refer to
Service
RestandO󰀨
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 o󰀨.
2. The green zone indicates the proper functioning of the device. The needle will
uctuate within this area during a compression cycle.
3. The yellow zone indicates that the device is operating above the recommended
pressure setting. Turn o󰀨 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 ‘nished’ with a sewn nylon binding with a nylon
thread.
The garment has a hook and loop fastener to enable adjustable tting.
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
WoundExpressTM
WE100G
Designed in the UK
Assembled in China
PATIENT NAME
THERAPY START DATE
__ __ / __ __ / __ __
05051968040374
DI
1001049-1
Manufactured in the UK by Huntleigh Healthcare
Ltd on behalf of;
Huntleigh He althcare Ltd .
35 Portmanmoo r Road, Card iff, CF24 5HN ,
United Kingdom
T: [phone]
sales@hunt leigh-diagn ostics.co. uk
www.huntle igh-diagnos tics.com
ArjoHuntleigh AB
Hans Michelsensgatan 10
211 20 Malmö, Sweden
LATEX
MD
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.
Garment Size
The garment is suitable for limb circumferences in the range 16 ¾ inches (426mm) to
28 ¾ inches (731mm).
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Instructions For Use
Fit the garment to the thigh (left or right) of the limb a󰀨ected by the chronic wound.
Ensure it is a snug t and fasten using the velcro strip.
PATIENTNAME
THERAPYSTART DATE
__ __ / __ __ / __ __
WoundExpress
TM
WE100G
Designedin the UK
Assembledin China
05051968040374
DI
1001049-1
Manufactured in the UK by Huntleigh Healthcare
Ltd on behalf of;
Huntleigh Healthcare Ltd.
35 Portmanmoor Road, Cardiff, CF24 5HN,
United Kingdom
T: [phone]
sales@huntleigh-di agnostics.co.uk
www.huntleigh-diagnostics.c om
ArjoHuntleigh AB
Hans Michelsensgatan 10
211 20 Malmö, Sweden
LATEX
MD
Tubing Connector
to the Pump
Attach the garment tubing to the pump.
WoundExpress
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Instructions For Use
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 at surface.
Placing the pump on a at surface at least 1m away from the patient’s head ensures
that any noise experienced is at a comfortably low level.
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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Instructions For Use
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.
11
765
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 ination followed by 2min of deation.
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.
It is normal during the ination 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o󰀨thepumpandremovethegarment.
WARNING
The garment is intended for single patient use only.
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Instructions For Use
7.5 SwitchingO󰀨
Turn the power switch (1) to the o󰀨 (O) position. Turning the power o󰀨 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 o󰀨 (O) position and disconnect the
tubing from the pump by removing the tube connectors (3). This will allow removal of
excess air from the garment. The garment can then be removed by undoing the velcro
strip.
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Instructions For Use
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 Pump 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
8.1.1 Wound Express Therapy Pump
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.
8.1.2 Garments
Garments are single patient use and cannot be reprocessed or cleaned.
The garment should be treated as domestic waste and disposed of accordingly.
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 conrmed with the chemical supplier prior to use.
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Instructions For Use
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
ArjoHuntleigh will make available on request service manuals, component parts lists
and other information necessary for ArjoHuntleigh trained personnel to repair the
system.
9.1.3 Service Period
ArjoHuntleigh recommend that the WoundExpress Therapy Device pump is serviced
every 24 months by an ArjoHuntleigh 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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Instructions For Use
10. Trouble Shooting
If you should encounter a problem, please follow the fault nding guide below. If the
fault cannot be rectied, 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 inate.
Blockage in garment supply
tube.
Garment not tted 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 ArjoHuntleigh service
department.
Note
If the trouble shooting procedures do not return the system to normal
performance, stop using the system immediately and contact ArjoHuntleigh
service department. Refer to “Warranty & Service” .
WARNING
Therapy should be interrupted if pain, tingling or numbness of the limb
occurs during or as a result of therapy.
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