Huntleigh WoundExpress User manual

WoundExpress Therapy Device
INSTRUCTIONS FOR USE
WoundExpress™
WoundExpress
785344US-9 12/2021
785344US-9 Wound Express IFU.indd 1785344US-9 Wound Express IFU.indd 1 14/12/2021 12:17:1714/12/2021 12:17:17

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
785344US-9 Wound Express IFU.indd 1785344US-9 Wound Express IFU.indd 1 14/12/2021 12:17:1714/12/2021 12:17:17

US
Instructions For Use
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
785344US-9 Wound Express IFU.indd 2785344US-9 Wound Express IFU.indd 2 14/12/2021 12:17:1714/12/2021 12:17:17

US
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.
785344US-9 Wound Express IFU.indd 3785344US-9 Wound Express IFU.indd 3 14/12/2021 12:17:1914/12/2021 12:17:19

4
US
Instructions For Use
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.
785344US-9 Wound Express IFU.indd 4785344US-9 Wound Express IFU.indd 4 14/12/2021 12:17:1914/12/2021 12:17:19