Huntleigh Hydroven 3 User manual

INSTRUCTIONS FOR USE
Hydroven 3
779344EN-4 04/20222

Contents
1. Safety ...................................................................................................3
1.1 Warnings................................................................................................... 3
2. Electromagnetic Compatibility...........................................................5
3. Introduction .........................................................................................8
3.1 About this Manual.................................................................................... 8
3.2 Intended Use ............................................................................................ 8
3.3 About the Hydroven 3 system ................................................................ 8
3.4 Use Environment ..................................................................................... 8
4. Clinical Applications ...........................................................................9
4.1 Indications................................................................................................ 9
4.2 Contraindications .................................................................................... 10
5. Preliminary Checks .............................................................................11
6. Clinical Treatment Guide ....................................................................12
7. Garment and Insert Information.........................................................13
7.1 Garment Description ............................................................................... 13
7.2 Selecting the correct Garment................................................................ 13
7.3 Applying the Garment ............................................................................. 14
8. Operation .............................................................................................16
8.1 Pump Description .................................................................................... 16
8.2 Operation.................................................................................................. 17
8.2.1 To Adjust the Pressure Control Knob Position ................................................................ 17
8.2.2 Switch On ....................................................................................................................... 17
8.2.3 To Set the Garment Pressure ......................................................................................... 18
8.2.4 Shut Down ...................................................................................................................... 18
8.2.5 To Remove the Garment................................................................................................. 18
9. Decontamination .................................................................................19
9.1 Cleaning.................................................................................................... 19
9.2 Chemical Disinfection ............................................................................. 19
9.3 Cleaning and Sterilising Garments ........................................................ 19

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10.Routine Maintenance ..........................................................................20
10.1 Hydroven 3 System.................................................................................. 20
10.1.1 Maintenance ................................................................................................................. 20
10.1.2 Servicing ....................................................................................................................... 20
10.1.3 Service Period............................................................................................................... 20
10.2 Hydroven 3 Pump .................................................................................... 20
10.2.1 General Care, Maintenance and Inspection..................................................................20
10.2.2 Serial Labels ................................................................................................................. 20
11.Trouble Shooting.................................................................................21
12.Accessories .........................................................................................22
13.Specications .....................................................................................24
13.1EquipmentClassication....................................................................... 24
13.2 General ..................................................................................................... 24
13.3 Environmental.......................................................................................... 25
13.4 Standards Compliance ............................................................................ 25
14.Product Labelling ................................................................................26
15.End of Life Disposal............................................................................28
16.Warranty & Service..............................................................................29
16.1 Service Returns........................................................................................ 29

3Instructions For Use
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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 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
General Warning/Cautions Follow Instructions for Use
1.1 Warnings
Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise
misuse the Hydroven 3 system. Failure to observe this caution could result in injury, or
in extreme cases, death.
WARNING: A possible explosion hazard exists if used in the presence of
ammableanaesthetics.
WARNING: Do not mount the unit directly above the patient. Locate the
unit so that it will not cause harm should it fall.
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: Use only recommended accessories listed in this manual.
WARNING: If this product is connected to another item of electrical
equipment, it is important that the system is fully compliant with
EN60601-1.
WARNING: It is the responsibility of the care giver to ensure that the user
can use this product safely.
WARNING: Make sure that the mains power cable and tubeset or air
hoses are positioned to avoid causing a trip or other hazard, and are
clear of moving bed mechanisms or other possible entrapment areas.

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WARNING: 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.Nomodicationofthis
equipment is allowed.
WARNING: 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.
WARNING: Disconnect the pump from the mains power socket before
cleaning and inspecting.
WARNING: Only the pump and garment/insert 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.
WARNING: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.
CAUTION:Donotexposethesystemtonakedames,suchascigarettes,
etc.
CAUTION: Do not store the system in direct sunlight.
CAUTION: Do not use phenol-based solutions to clean the system.
CAUTION: Make sure the system is clean and dry prior to use or storage.
CAUTION: Pets and children must be supervised in the vicinity of the
system.
Caution (applicable to the USA market only)
US Federal law restricts this device to sale by or on the order of a
physician.
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.
Huntleigh Healthcare Ltd’s commitment is that the expected service life for this Device
has been dened as 7 years.

5Instructions For Use
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2. Electromagnetic Compatibility
Make sure the environment in which Hydroven 3 is installed is not subject to strong
sources of electromagnetic interference (e.g. radio transmitters, mobile phones).
This equipment generates and uses radio frequency energy. If not installed and used
properly, in strict accordance with the manufacturer’s instructions, it may cause or
be subject to interference. Type-tested in a fully congured system, complies with
EN60601-1-2, the standard intended to provide reasonable protection against such
interference. Whether the equipment causes interference may be determined by turning
the equipment o󰀨 and on. If it does cause or is a󰀨ected by interference, one or more of
the following measures may correct the interference:
• Reorienting the equipment
• Relocating the equipment with respect to the source of interference
• Moving the equipment away from the device with which it is
interfering
• Plugging the equipment into a di󰀨erent outlet so that the devices are
on di󰀨erent branch circuits
If this equipment needs to be used adjacent to other electrical equipment,
normal operation must be checked before use.
Guidance and Manufacturer’s declaration - electromagnetic emissions
The Hydroven 3 is intended for use in the electromagnetic environment specied below. The customer or the
user of the Hydroven 3 should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - guidance
RF emissions
CISPR 11
Group 1 The Hydroven 3 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B The Hydroven 3 is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations /
icker emissions
IEC 61000-3-3
Complies

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Guidance and Manufacturer’s declaration - electromagnetic immunity
The Hydroven 3 is intended for use in the electromagnetic environment specied below. The customer or the
user of the Hydroven 3 should assure that it is used in such an environment.
Immunity Test IEC 60601 test
level
Compliance
level Electromagnetic Environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Hydroven
3, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150kHz to 80MHz 3V d= 1.2 √ P
Radiated RF
IEC 61000-4-3
3 Vrms
80MHz to 2.5MHz 3V/m
d= 1.2 √ P80MHz to 800MHz
d= 2.3 √ P800MHz to 2.5GHz
where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation
distance in metres (m).
Field strengths from xed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of the
equipment marked with the following symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is a󰀨ected by
absorption and reection from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an
electromagnetic site survey should be considered. If the measured eld strength in the location in which the
Hydroven 3 is used exceeds the applicable RF compliance level above, the Hydroven 3 should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the Hydroven 3.
b Over the frequency range 150kHz to 80kHz, eld strengths should be less than 3V/m.

7Instructions For Use
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Recommended separation distances between portable and mobile RF communications equipment
and the Hydroven 3
The Hydroven 3 is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or user of the Hydroven 3 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the Hydroven 3 as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150kHz to 80MHz
d= 1.2 √ P
80MHz to 800MHz
d= 1.2 √ P
800MHz to 2.5GHz
d= 2.3 √ P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where Pis
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is a󰀨ected by
absorption and reection from structures, objects and people.

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Instructions For Use
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3. Introduction
3.1 About this Manual
This manual is your introduction to the Hydroven®3 system.
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 Hydroven 3 system, contact your
local Huntleigh sales representative, listed at the end of this manual.
3.2 Intended Use
The intended use of this product is to manage the list of clinical conditions detailed in
the “Indications” section.
The Hydroven 3 system should be used as part of a prescribed plan of care detailed in
the “Indications” section.
3.3 About the Hydroven 3 system
The pump supplies air via connecting tubes to an inatable garment allowing the
application of controlled pressure to gently compress the limb. This action assists in
increasing the return of blood, excess uids, improves venous stasis and encourages
the reabsorption of waste products.
The pump operates on an automatically timed cycle of 3 minutes, 90 seconds ination
followed by 90 seconds deation. Variable pressure output ranges from 30-100 mmHg.
The garments are inated alternately.
The Hydroven 3 system operates two types of garments:
• Hydroven 1 garments have a single chamber and provide uniform
compression.
• Hydroven 3 garments have three chambers providing graduated
segmental compression, inating distally to proximally.
Optional garment inserts can be used to increase the circumference of the standard
arm and leg garments.
A full technical description of the Hydroven 3 system can be found in the Service
Manual, part No. SER0014, available from your local Huntleigh sales o󰀩ce.
3.4 Use Environment
Hydroven 3 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.

9Instructions For Use
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4. Clinical Applications
4.1 Indications
Intermittent Pneumatic Compression (IPC) is e󰀨ective in the treatment of the following
clinical conditions, when combined with an individualised monitoring programme:
• Oedema.
• Dependent (including secondary to cerebrovascular
incident, pregnancy or paralysis).
• Traumatic (post-surgical or injury).
• Lymphoedema.
• Primary and secondary (including post
surgery, radio or chemotherapy).
• Chronic venous insu󰀩ciency.
• Post phlebotic syndrome.
• Acute and chronic wounds including venous leg ulcers and post-
surgical wounds.
IPC may also be benecial in the management of:
• Fixed exion deformity.
• Arthritic conditions.
• Lower limb pain due to trauma or surgery.
• Lipoedema.
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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4.2 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.
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: Therapy should be interrupted if pain, tingling or numbness
of the limb occurs during or as a result of therapy.
WARNING: In the event of a power failure or fault whereby the
garmentremainsinated,disconnectthetubeset(s)inordertodeate
the garment(s) and then remove the garment(s) from the limb(s).
WARNING: Patients must not walk or stand when wearing leg garments.

11 Instructions For Use
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5. Preliminary Checks
Contents (supplied with each system)
Item Item
1 x Hydroven 3 1 x Instructions for Use
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 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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6. Clinical Treatment Guide
An initial pressure setting of 40 mmHg is suggested at the commencement of
treatment. It may be necessary to start at a lower level of pressure, dependent on the
patient’s tolerance.
The pressure can be gradually increased over time, until the required pressure is
reached. The upper treatment pressure range is generally 60-70 mmHg.
A single treatment session is usually 20-30 minutes.
Note: The above settings and timings are guidelines, and should not
be used as a substitute for clinical judgement and experience.
Note: Loss of mains power will halt therapy.

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7. Garment and Insert Information
7.1 Garment Description
Tubing
Connector
to Pump
Zip Ring Pull
Quick Air-
Release Bung
Bung/Connector
for Insert Tubing
Hydroven 1 Garment Hydroven 3 Garment
Bung/Connector
for Insert Tubing
Tubing
Connector
to Pump
Zip Ring Pull
Note: For Hydroven 1 garments, when an insert is not in use, the bung
can be used as a quick air release.
7.2 Selecting the correct Garment
1. Select the type of garment depending on treatment type:
• Hydroven 1 garments have a single chamber and provide uniform
compression.
• Hydroven 3 garments have three chambers providing graduated
segmental compression, inating distally to proximally.
2. Measure the circumference of the largest part of the limb, and the length in cm/
inch from the heel to the upper thigh for a full leg garment, heel to knee for half leg
garment, from shoulder to nger tips for full arm garment, and from elbow to nger
tips for half arm garment. Refer to “Accessories” section to order the correct size
garment.
SH
W
Half Leg Garment Full Arm Garment
Knee
Circumference
Shoulder
Circumference
Hand
Circumference

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7.3 Applying the Garment
WARNING: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.
Quick air release bung
Leg Garment Arm Garment
Tubing to pump
Tubing to pump
Note: Beforettingthegarmentensureallquickairreleasebungsare 
 closed,asthiswille󰀨ectthee󰀩ciencyofthegarment.
1. If a larger circumference is required, t a matching length insert piece before
applying to the limb. If appropriate, a primary dressing or stockinette may be used
underneath the garments.
2. Undo the zip on the garment.
3. If a garment insert is tted to the garment, fully fasten one of the zips between the
garment and insert, leaving the other unfastened.
4. Before applying the garment (and insert, if tted) to the limb, zip up the rst 150 mm
(6”) of the unfastened garment zip. Put the garment (and insert) onto the limb and
fully fasten the zip. Make sure that the quick air release bung is secured.
5. Make sure the patient is in a comfortable position with the limb supported or
elevated as necessary.
6. Check that the insert piece connecting tube is not kinked and is attached to the
garment using the lower outlet bung as shown below.
7. Attach the garment tubing to the pump ensuring a “click” is heard from each snap-
lock connector.
8. If only one garment is to be used, attach the garment to either port on the pump.
The system will automatically identify that only one garment is to be used.
Note: Ensure that the all zips are fully done up on the garment before
switching the pump on.
9. Switch on the pump and adjust the pressure control accordingly.

15 Instructions For Use
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CAUTION: Do not apply the garment to the limb unless it is partially
zipped, as you may damage the garment zip.
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 zip.
CAUTION:Donotstandorwalkwhileleggarmentsaretted.

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8. Operation
8.1 Pump Description
1
2
3
4
5
Item
No. Description Function
1On/O󰀨 Switch Operation of this switch Starts or Stops the system
2Pressure Control
Knob / Lock Pin*
(* If tted)
Rotate clockwise to increase pressure or
counter-clockwise to decrease pressure
(pressure range 30 ~ 100 mmHg)
The pressure control knob is locked in position, (if Lock
Pin is tted), to prevent accidental movement. Refer to
“To Adjust the Pressure Control Knob Position” .
3Tube Connectors Snap-lock connectors for Garment attachment
4Pressure Gauge Indicates delivery pressure to garment
5Carry Handle For easy handling of the pump
Note: If the operation of performance of the pump changes during use, refer
to “Trouble Shooting” section of this IFU before calling a service
 engineerorcontactingyourlocalHuntleighsaleso󰀩ce.
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 zip.

17 Instructions For Use
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8.2 Operation
It is the responsibility of the care giver to ensure that the user can use
this product safely.
The pump should be placed securely on a at surface.
Before starting the pump ensure that the garments are properly applied, the zippers
are secured and the garment connecting tubes are attached to the pump outlet ports
via the snap-lock connectors (3).
8.2.1 To Adjust the Pressure Control Knob Position
The pressure control knob (2) is locked in position* to prevent accidental rotation.
To adjust the position of the pressure control knob:
B
A
Lock
Pin*
1. Lift the lock pin* (A) to release the control knob.
2. Rotate the control knob (B) whilst the lock pin is
raised.
3. Release the lock pin* when the pressure control
knob is in the desired position to lock the control
knob.
* If lock pin tted.
Note: Rotate the pressure control knob clockwise to increase and
counterclockwise to decrease pressure
Make sure that the pressure control knob is set to minimum i.e. rotated fully
counterclockwise.
WARNING: Ensure that all cables and air hoses are positioned so that
they do not present a trip hazard or strangulation.
WARNING: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 chidren.
8.2.2 Switch On
Connect the pump to the mains power supply using the power cable provided. Turn the
mains power switch (1) to the On (I) position.

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Instructions For Use
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8.2.3 To Set the Garment Pressure
While the garment is inating, rotate the pressure control knob (2) slowly clockwise
until the required pressure is displayed on the gauge (4).
The garments will take approximately three cycles to fully inate. Check and adjust as
necessary after three ination cycles.
Note: It might be necessary to start at a lower pressure level dependant on
the patient’s tolerance. Compression should not cause any discomfort
or pain to the patient.
8.2.4 Shut Down
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.
8.2.5 To Remove the Garment
Make sure the pump power switch is in the o󰀨 (O) position, disconnect the tubing from
the pump by removing the snap-lock connectors (3), and release the quick air release
cap on the garment.
Only open the zip after the garment is completely deated.

19 Instructions For Use
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9. 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 Hydroven 3 system 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.
CAUTION: Do not use Phenol-based solutions or abrasive compounds
or pads during the 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.
9.1 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.
9.2 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.
9.3 Cleaning and Sterilising Garments
Wipe down garments using a neutral detergent or soap powder at 51°C. Dry
thoroughly.
After cleaning gas sterilisation is possible, however:
• Do not exceed 51°C (120°F).
• Do not autoclave.