ARJO HUNTLEIGH FLOWTRON HYDROVEN 3 User manual

FLOWTRON HYDROVEN 3
Instructions for Use
...with people in mind
0086
I
20
4060
80
100
120
mmHg

(i)
Contents
General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About Flowtron Hydroven 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Clinical Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Clinical Treatment Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Garment and Insert Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Garment Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Selecting the correct Garment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Applying the Garment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Pump Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Flowtron Hydroven 3 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Flowtron Hydroven 3 Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Serial Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Service Returns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Garments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Inserts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Technical Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Cleaning Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

(ii)

(iii)
GENERAL SAFETY
Before you connect the system pump to a mains socket, read carefully all the installation
instructions contained within this manual.
The system has been designed to comply with regulatory safety standards including:
• EN60601-1:1990/A13:1996 and IEC 60601-1:1988/A2:1995
• UL60601-1, UL2601-1 and CAN/CSA C22.2 No. 601.1-M90
• EN60601-1:2006 and IEC 60601-1:2005
• AAMI/ANSI ES60601-1:2006 and CAN/CSA C22.2 No.60601.1(2008)
Safety Warnings
• It is the responsibility of the care giver to ensure that the user can use this product
safely.
• 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.
• Keep the pump away from sources of liquids and do not immerse in water.
• Do not use the pump in the presence of uncontained flammable liquids or gasses.
• Only the pump and garment/insert combination as indicated by ArjoHuntleigh
should be used. The correct function of the product cannot be guaranteed if
incorrect pump and garment combinations are used.
Caution (applicable to the USA market only)
• US Federal law restricts this device to sale by or on the order of a physician.
Precautions
For your own safety and the safety of the equipment, always take the following precautions:
• 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.
Electromagnetic Compatibility (EMC)
This product complies with the requirements of applicable EMC Standards. Medical electrical
equipment needs special precautions regarding EMC and needs to be installed in accordance
with the following instructions:
• The use of accessories not specified by the manufacturer may result in increased
emissions by, or decreased immunity of, the equipment, affecting its performance.
• Portable and mobile radio frequency (RF) communications equipment (e.g. mobile/cell
phones) can affect medical electrical equipment.

(iv)
• If this equipment needs to be used adjacent to other electrical equipment, normal
operation must be checked before use.
• For detailed EMC information contact ArjoHuntleigh service personnel.
Expected Service Life
The Flowtron®Hydroven 3 has an expected service life of seven years. To maintain the
condition of the pump have the pump serviced regularly according to the schedule
recommended by your ArjoHuntleigh distributor.
Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse
the Flowtron Hydroven 3 system. Failure to observe this caution could result in injury, or in
extreme cases, death.
Environmental Protection
Incorrect disposal of this equipment and its component parts, particularly batteries or other
electrical components, may produce substances that are hazardous to the environment. To
minimise these hazards, contact ArjoHuntleigh for information on correct disposal.
Design Policy and Copyright
® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. As our policy is
one of continuous improvement, we reserve the right to modify designs without prior notice.
The content of this publication may not be copied either whole or in part without the consent
of ArjoHuntleigh.
© ArjoHuntleigh 2012

1
1. Introduction
About this Manual This manual is your introduction to the Flowtron®
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
Flowtron Hydroven 3 system, contact your local
ArjoHuntleigh sales office, listed at the end of this
manual.
Intended Use The intended use of this product is to manage the list of
clinical conditions detailed in the “Indications” (refer to
page 2).
The Flowtron Hydroven 3 system should be used as part
of a prescribed plan of care detailed in the “Indications”
(refer to page 2).
About Flowtron
Hydroven 3
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 Flowtron 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 Flowtron Hydroven 3
system can be found in the Service Manual, part No.
SER0014, available from your local ArjoHuntleigh
sales office.

2
2. Clinical Application
Indications Intermittent Pneumatic Compression (IPC) is effective
in the treatment of the following clinical conditions,
when combined with an individualised monitoring
programme:
• Edema.
• Dependent (including secondary to
cerebrovascular incident, pregnancy or paralysis).
• Traumatic (post-surgical or injury).
• Lymphedema.
• 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.
• Lipedema.
Selection should be based upon a holistic assessment of
the patients' individual care needs.
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.
The above are guidelines only and should not
replace clinical judgement.
Contraindications IPC should NOT be used in the following
circumstances:
• Known or suspected deep vein thrombosis (DVT),
pulmonary embolism, thrombophlebitis.
• Acute infections of the skin such as cellulitis.
• Untreated, infected wounds.

3
• Decompensated / severe congestive cardiac failure,
pulmonary edema associated with significant limb
edema 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.
If you are uncertain whether you have any of the
above conditions please consult a physician before
use.
Cautions 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 and physician notified
if pain, tingling or numbness of the limb occurs
during, or as a result of therapy.
• In the event of a power failure, or fault whereby the
garment remains inflated, remove the garment.
• Patients must not walk or stand when wearing leg
garments.

4
3. 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 dependant 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.
The above settings and timings are guidelines, and should not be used as a
substitute for clinical judgement and experience.
Loss of mains power will halt therapy.

5
4. Garment and Insert Information
Garment Description
For Hydroven 1 garments, when an insert is not in use, the bung can be used
as a quick air release.
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” on
page 14 to order the correct size garment.
Zip Ring Pull
Quick Air
Release Bung
Bung/Connector
Tubing Connector
Garment
(To Pump)
For Insert Tubing
Zip Ring Pull
Garment
Bung/Connector
For Insert Tubing
Hydroven 3 Garment Hydroven 1 Garment
Tubing Connector
(To Pump)
Half Leg Garment Full Arm Garment
Hand Circumference
Shoulder Circumference
Knee
Circumference

6
Applying the Garment
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.
Leg Garment Arm Garment
Quick air release bung
Tubing to pump Tubing to pump

7
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.
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.
Leg Garment Arm Garment
With Insert Fitted With Insert Fitted
Caution
Do not apply the garment to the limb unless it is partially zipped, as
you may damage the garment zip.
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.
Do not stand or walk while leg garments are fitted.

8
5. Operation
Pump Description
If the operation or performance of the pump changes during use, refer to
“Troubleshooting” on page 13 of this IFU before calling a service engineer
or contacting your local ArjoHuntleigh sales office.
Control
Number Description Function
1On/Off Switch Operation of this switch starts or stops the
system
2Pressure Control Knob Rotates clockwise to increase and
counterclockwise to decrease pressure (user
range 30 - 100 mmHg)
3Tube Connectors For garment attachment (snap-lock)
4Pressure Gauge Indicates delivery pressure to garment (mmHg)
5Carry Handle For easy handling of pump
Flowtron Hydroven 3 Pump
1
23
4
5

9
Operation The pump should be placed securely on a flat surface.
Before starting the pump ensure that the garments are
properly applied, the zips are secured and the garment
connecting tubes are attached to the pump outlet ports via
snap-lock connectors.
Make sure the system has been arranged so that the
power cable and garment hoses do not pose a trip or
strangulation hazard.
Ensure that the pressure level is set at minimum i.e. the
knob (2) is fully rotated in a counterclockwise direction.
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.
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.
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.
Shut Down Turn the power switch (1) to the off (O) position.
Turning the power off will stop the patient therapy.
If it is required to completely isolate the pump from
the mains power, remove the plug from the mains
power socket.
To Remove the Garment Make sure the pump power switch is in the off (O)
position, disconnect the tubes from the pump by releasing
the snap-lock connectors (3), and release the quick air
release bung on the garment.
Only open the zip after the garment is completely deflated.
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.

10
6. 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 Flowtron 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.
To clean 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.
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.
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.

11
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.
To Clean and Sterilise
Garments
Wipe down garments using a neutral detergent or soap
powder at 40°C (104°F). Dry thoroughly.
After cleaning gas sterilisation is possible, however:
• Do not exceed 51°C (120°F).
• Do not autoclave.

12
7. Routine Maintenance
Flowtron Hydroven 3 System
Maintenance The equipment has been designed to be maintenance-
free between service periods.
Servicing ArjoHuntleigh will make available on request service
manuals, component parts lists and other information
necessary for ArjoHuntleigh trained personnel to repair
the system.
Service Period ArjoHuntleigh recommend that the Flowtron
Hydroven 3 pump is serviced every 12 months by an
ArjoHuntleigh authorised service agent.
Flowtron Hydroven 3 Pump
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.
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.

13
8. Troubleshooting
If you should encounter a problem, please follow the fault finding guide below. If the
fault cannot be rectified, please refer to Service.
Service Returns If for any reason your Flowtron Hydroven 3 is being
returned, please:
1. Clean the product following the instructions in
section “Decontamination” on page 10.
2. Enclose a covering letter explaining the reasons for
the return, with documentation (including an
appropriate decontamination certificate if possible).
3. To prevent damage in transport please pack the
pump in a suitably robust box.
If the trouble shooting procedures do not return the
system to normal performance, stop using the
system immediately and call the service engineer.
Fault Check Remedy
Pump does not
power up
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
inflate.
Blockage in garment
supply tube.
Garment not correctly fitted
to pump.
Pressure control set too
low.
Air leak in garment.
Ensure that the tube airway is
clear.
Check connections.
Increase pressure control.
Check garment. Replace if
defective.

14
9. Accessories
To order garments, please contact your distributor quoting the appropriate codes as
shown below:
Refer to diagrams on page 5 of this manual.
Garments
HYDROVEN 1 LEG GARMENTS
Order Code Type Length (L) Circumference (W)
5101L50 Half Leg 19.7" (50cm) 24" (61cm)
5101L66 Full Leg 26" (66cm) 25.2" (64cm)
5101L71 Full Leg 28" (71cm) 26" (66cm)
5101L76 Full Leg 29.9" (76cm) 28” (72cm)
5101L84 Full Leg 33.1" (84cm) 28" (72cm)
5101L92 Full Leg 36.2" (92cm) 28" (72cm)
HYDROVEN 1 ARM GARMENTS
Order Code Type Length (L) Circumference
Hand (H)
Circumference
Shoulder (S)
5101A51 Half Arm 20.1" (51cm) 17.3" (44cm) 22" (56cm)
5101A68 Full Arm 26.8" (68cm) 17.3" (44cm) 24.4" (62cm)
5101A78 Full Arm 30.7" (78cm) 17.3" (44cm) 24.4" (62cm)
HYDROVEN 3 LEG GARMENTS
Order Code Type Length (L) Circumference (W)
5103L50 Half Leg 19.7" (50cm) 24" (61cm)
5103L66 Full Leg 26" (66cm) 25.2" (64cm)
5103L71 Full Leg 28" (71cm) 26" (66cm)
5103L76 Full Leg 29.9" (76cm) 28" (72cm)
5103L84 Full Leg 33.1" (84cm) 28" (72cm)
5103L92 Full Leg 36.2" (92cm) 28" (72cm)
HYDROVEN 3 ARM GARMENTS
Order Code Type Length (L) Circumference
Hand (H)
Circumference
Shoulder (S)
5103A68 Full Arm 26.8" (68cm) 17.3" (44cm) 24.4" (62cm)
5103A78 Full Arm 30.7" (78cm) 17.3" (44cm) 24.4" (62cm)