Huntleigh Hydroven 3 User manual

Hydroven 3

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

2
Table of Contents
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.Specifications ................................................................24
13.1 Equipment Classification .......................................................................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

3
Safety
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 Hydroven 3 system. 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 anaesthetics.
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
EN60601-1.
It is the responsibility of the care giver to ensure that the user
can use this product safely.

4
Safety
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.
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
modification of this equipment is allowed.
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.
Disconnect the pump from the mains power socket before
cleaning and inspecting.
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.
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.
Caution (applicable to the USA market only)
US Federal law restricts this device to sale by or on the order of
a physician.
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.
Make sure the system is clean and dry prior to use or storage.
Pets and children must be supervised in the vicinity of the
system.
Expected Service Life
The Hydroven 3 has an expected service life of 7 years. To maintain the
condition of the pump have it serviced regularly according to the schedule
recommended by your Huntleigh distributor.

5
Electromagnetic Compatibility
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 configured
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 off and on. If it does
cause or is affected 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 different outlet so that the devices are
on different 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 specified 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 fluctuations /
flicker emissions
IEC 61000-3-3
Complies

6
Electromagnetic Compatibility
Guidance and Manufacturer’s declaration - electromagnetic immunity
The Hydroven 3 is intended for use in the electromagnetic environment specified 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 fixed RF transmitters,
as determined by an electromagnetic
site survey, ashould 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 affected
by absorption and reflection from structures, objects and people.
aField strengths from fixed 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
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
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.
bOver the frequency range 150kHz to 80kHz, field strengths should be less than 3V/m.

7
Electromagnetic Compatibility
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 din 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 affected
by absorption and reflection from structures, objects and people.

8
Introduction
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 difficulties 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 inflatable garment allowing
the application of controlled pressure to gently compress the limb. This action
assists in increasing the return of blood, excess fluids, improves venous stasis
and encourages the reabsorption of waste products.
The pump operates on an automatically timed cycle of 3 minutes, 90 seconds
inflation followed by 90 seconds deflation. Variable pressure output ranges from
30-100 mmHg. The garments are inflated 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, inflating 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
office.
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.

9
Clinical Applications
4. Clinical Applications
4.1 Indications
Intermittent Pneumatic Compression (IPC) is effective 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 insufficiency.
• Post phlebotic syndrome.
• Acute and chronic wounds including venous leg ulcers and post-
surgical wounds.
IPC may also be beneficial in the management of:
• Fixed flexion 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.

10
Clinical Applications
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 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.
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 inflated, remove the garment(s) from the
patient’s limbs.
WARNING: Patients must not walk or stand when wearing leg
garments.

11
Preliminary Checks
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.

12
Clinical Treatment Guide
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.

13
Garment and Insert Information
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, inflating 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 finger tips for full arm garment, and
from elbow to finger 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

14
Garment and Insert Information
7.3 Applying the Garment
WARNING: 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.
Quick air release bung
Leg Garment Arm Garment
Tubing to pump
Tubing to pump
Note: Before fitting the garment ensure all quick air release bungs are
closed, as this will effect the efficiency of the garment.
1. If a larger circumference is required, fit 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 fitted 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 fitted) to the limb, zip up the first
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
Garment and Insert Information
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 fitted.

16
Operation
8. Operation
8.1 Pump Description
1
2
3
4
5
Item
No. Description Function
1 On/Off Switch Operation of this switch Starts or Stops the system
2 Pressure Control
Knob / Lock Pin*
(* If fitted)
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 fitted), to prevent accidental movement.
Refer to “To Adjust the Pressure Control Knob
Position” .
3 Tube Connectors Snap-lock connectors for Garment attachment
4 Pressure Gauge Indicates delivery pressure to garment
5 Carry 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 office.
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
Operation
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 flat 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 fitted.
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
suffocation risk; to avoid the risk of suffocation 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.

18
Operation
8.2.3 To Set the Garment Pressure
While the garment is inflating, 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 inflate. Check and
adjust as necessary after three inflation 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 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.
8.2.5 To Remove the Garment
Make sure the pump power switch is in the off (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 deflated.

19
Decontamination
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 confirmed with the chemical supplier prior to use.
9.3 Cleaning and Sterilising Garments
Wipe down garments using a neutral detergent or soap powder at 40°C. Dry
thoroughly.
After cleaning gas sterilisation is possible, however:
• Do not exceed 51°C (120°F).
• Do not autoclave.