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

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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.