ARJO HUNTLEIGH FLOWTRON UNIVERSAL User manual

FLOWTRON UNIVERSAL
Instructions for Use
...with people in mind
0086

(i)
Contents
General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About Flowtron Universal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Guidelines and Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Garment Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Typical garment options and therapy parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Recommended Checks: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
To Use One Garment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
To Use Different Garments on Each Limb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Settings Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Connecting the Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Battery Pack in Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Battery Storage and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Checking the Status of the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Recharging the Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Alternative Method of Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Flowtron Universal System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Flowtron Universal Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Serial Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Technical Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

(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.
• The Flowtron® Universal system is NOT intended for use in the Home Healthcare
Environment (e.g. private dwellings or nursing homes).
Caution (applicable to the USA market only)
• US Federal law restricts this device to sale by or on the order of a physician.
Safety Warnings - Battery Pack (Optional)
The following instructions are important for the safe use of the battery pack and to
keep the user (resident/care giver) from harm:
• The battery pack BBP600 for the Flowtron® Universal is rechargeable.
• Only use the battery pack designed for use with the pump. If unsure, do not use the
battery pack. Make sure the battery pack belongs to the pump by comparing the
battery pack label with the“Technical Specification” on page 20. If the battery pack
type cannot be confirmed, contact your local ArjoHuntleigh office.
• Do not expose the battery pack or charger to open flames.
• Do not expose the battery pack connector to water.
• To avoid bodily injury, do not crush, puncture, open, dismantle or otherwise
mechanically interfere with the battery pack.
• Should the battery pack casing crack and cause contents to come in contact with
skin or clothing, rinse immediately with plenty of water.

(iv)
• If contents come in contact with the eyes, rinse immediately with plenty of water
and seek medical attention.
• Inhalation of the contents can cause respiratory irritation. Provide fresh air and
medical attention.
• Stop using the battery pack if any damage or deformation is noted. Contact your
local ArjoHuntleigh office before further use.
• Refer to the “Battery Storage and Disposal” on page 13 for the correct disposal and
recycling of the battery pack.
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.
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.
• 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® Universal 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 Universal 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®
Universal.
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 Universal system, contact your local
ArjoHuntleigh sales representative, listed at the end of
this manual.
Intended Use The intended use of this product is to prevent Deep Vein
Thrombosis (DVT). The garments are single use only. It
is not for use in the home healthcare environment.
The Flowtron Universal system should be used as part of
a prescribed plan of care (refer to “Indications” on
page 2).
About Flowtron
Universal
The pump automatically adjusts to the correct therapy
profile depending upon which garment type (foot, calf
or thigh length) is connected.
An optional battery pack is available which allows the
pump to be used independently of a mains power outlet.
The Flowtron Universal is intended for use ONLY in
Professional Healthcare Facilities (e.g. hospitals or
physicians’ offices).
A full technical description of the Flowtron Universal
system can be found in the Service Manual, part number
SER0009, available from your local ArjoHuntleigh
sales representative.

2
2. Clinical Applications
Indications The primary application of the Flowtron Universal
system is for the prevention of Deep Vein Thrombosis
(DVT), when combined with an individualised
monitoring programme.
These systems represent one aspect of a DVT 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.
Depending on the garment type used, other clinical
applications are also appropriate.
The FG foot garment, in particular, has a wide range of
clinical applications.
Full details for clinical applications are included in the
packaging of every garment.
The type of garment used on an individual patient
must be specified by a physician.
Contraindications
DVT Calf / Thigh
Garments
The Flowtron Universal system, when used with the
DVT Calf / Thigh Garments, should not be used in the
following conditions:
1. Severe arteriosclerosis or other ischaemic vascular
diseases.
2. Severe congestive cardiac failure or any condition
where an increase of fluid to the heart may be
detrimental.
3. Known or suspected acute deep vein thrombosis,
thrombophlebitis or pulmonary embolism.
4. Any local condition in which the garments would
interfere, including:
• Gangrene
• Recent skin graft
• Dermatitis
• On untreated, infected leg wounds.
Foot Garments The Flowtron Universal system, when used with the
Foot Garments, should not be used in the following
conditions:

3
1. Severe congestive cardiac failure or any condition
where an increase of fluid to the heart may be
detrimental.
2. Known or suspected acute deep vein thrombosis,
thrombophlebitis or pulmonary embolism.
3. Any local condition in which the garments would
interfere, including:
• Gangrene
• Recent skin graft
• Dermatitis
• On untreated, infected leg wounds.
If you are unsure of any contraindications refer to
the patient’s physician before using the device.
Cautions 1. Proper garment application and connection to the
pump is essential.
2. Garments should be positioned in such a way that
they do not create any potential for constant
pressure points on the patient’s limb. Additional
care should be taken when placing the garments on
any deformed leg or foot, or on legs with significant
oedema.
3. Garments should be removed immediately if the
patient experiences tingling, numbness, or pain, and
the physician notified.
4. When used for DVT prevention, continuous
external pneumatic compression is recommended
until the patient is fully ambulatory. Uninterrupted
use of the Flowtron Universal system is
encouraged.
5. The Flowtron Universal system should be USED
WITH CAUTION on patients with:
• Insensitive extremities
• Diabetes
• Impaired circulation
• Fragile or impaired skin
These are guidelines only and should not replace
clinical judgement and experience.
Guidelines and Recommendations
General
Recommendations:
• While using the system, the patient’s limbs
should be checked during every shift, and more
often if the patient has known circulatory or skin
problems, or is diabetic.

4
• Note: Many patients are at risk for pressure
ulcers on the heel. Use of the foot garments does
not negate the necessity for heel protection and
proper skin care.
• Clinical judgment should be used to determine if
the patient’s skin condition requires additional
measures, or if the treatment should be
discontinued and alternative modalities used.
• ArjoHuntleigh does not recommend the use of
compression stockings with its system. If these
are ordered by the physician, the clinician should
ensure that the compression stockings are
properly measured, applied and worn by the
patient. Any compression stocking used should
be routinely checked to ensure continued proper
fit and application, in addition to assessing the
condition of the skin.
• Where appropriate patients should be instructed
in the proper use of the system, the purpose of
therapy and that any problems should be reported
to the nursing staff.
Loss of mains power will halt therapy.
DVT prophylaxis • The Flowtron Universal system should be
applied to the patient pre-operatively, prior to the
induction of anaesthesia.
• The system should be used continuously for no
less than 72 hours post-operatively or until the
patient becomes fully ambulatory.
• If the garment cannot be applied to the operative
limb during surgery, it may be applied to the limb
once the patient reaches the recovery unit.
• In the non-surgical patient, the system should be
initiated immediately the risk of DVT formation
is identified.

5
3. Operation
The Flowtron Universal system does not require any setting or adjustment of controls
before use. It automatically senses the type of garment connected and adjusts the
therapy cycle and pressure profile accordingly.
If the operation or performance of the pump changes during use, Refer to
“Troubleshooting” on page 18 of this IFU before calling a service engineer or
contacting your local ArjoHuntleigh sales office.
Plug the pump into an electrical outlet.
Make sure system has been arranged so that the
power cable and garment hoses do not pose a trip or
strangulation hazard.
Standby Mode The pump will first go through a self-test routine and
then remain in until required for use.
Run/Standby Button
LCD Display and
Function Buttons
Hose Set
Connectors Power/Alarm
Indicators

6
Garment Application Use the correct garment type as ordered by the patient’s
physician.
For detailed instructions on correct fitting and use,
carefully read and follow the instruction provided with
every garment set.
Connect the garments to the pump hose set connectors
and ensure the connectors click into place.
Check that the connection and garment type are
confirmed correctly on the display.
Typical garment options and therapy parameters
TO START, press and hold the green RUN button
on the pump. The green power indicators will illuminate
and therapy will begin.
Garment Type/
LCD Display
Inflation Pressure
(mmHg)
Inflation Hold
(seconds)
Cycle (seconds)
Foot garments
e.g., FG100-200
130 3 30
Single chamber
garments
e.g., DVT10-40,60
40 12½ 60

7
This example shows the pump running and the left
garment inflated to 40 mmHg.
Refer to “Battery Operation” on page 12 when
operating the pump under battery power.
TO STOP press and hold the green RUN button a
second time. The green power indicators will go out and
therapy will stop.
Recommended
Checks: • Check display symbols to confirm that the
correct type of garment has been connected.
• During garment inflation, check the display to
confirm that the correct pressure is being applied
and that there are no fault messages appearing.
• Check that there are no kinks in the pump hoses
and garment tubing.
• Check that the pump hoses and connectors do not
cause the patient any discomfort.
• Regularly check that the garments remain
correctly fitted to the patient.
To Use One Garment When the pump is in standby (see “Standby Mode” on
page 5) connect one garment to either pump hose
connector.
The display will confirm that only one garment is
connected.
If a garment is disconnected while the pump is
running, the system will alarm Lo. If the single
garment option is still required, press the RUN
button to reset the system and press RUN
again to restart therapy.
If, at any time, a second garment is connected while
the pump is running, the pump will automatically
change to two garment operation.

8
To Use Different
Garments on Each
Limb
It is possible to use different garment types on each limb
(if prescribed by the patient’s physician).
Connect the garments to either tubing outlet and the
correct therapy cycle will be administered.
Check on the display panel to confirm the garment types
connected.
The system is not designed to be used with different
garment types (e.g. foot and calf/thigh) on the same
limb.

9
4. Settings Adjustment
The pump is configured to give the recommended
therapy for each garment type and does not require any
setting by the clinician or nurse.
If the physician requires different therapy settings,
limited changes can be made through a service link.
Contact your local ArjoHuntleigh Sales Representative
for details.

10
5. Options
Pressing the option button will bring up a multi-choice
menu of options.
The option can be set using a combination of the three
function buttons on the display.
To return to the previous menu at any time, highlight
Back using the arrow buttons and press the button to
confirm.
To exit the options menu at any time, highlight Exit
using the arrow buttons and press the button to
confirm.
Audio Alarm Volume 1. Press the function button adjacent to .
2. Use the arrow buttons to highlight
Audio Alarm Volume.
3. Press the button to display the volume setting
controls.
4. Use buttons to select either high or low volume
setting.
5. Press the button to confirm.
6. The selected volume setting will remain in place,
during subsequent uses of the pump.
Patient Hours Meter 1. Press the function button adjacent to .
2. Use the arrow buttons to highlight
Patient Hours Meter.
3. Press the button to display the total hours run.
Clear the Patient
Hours Meter
1. In the Patient Hours Meter menu use the arrow
buttons to select Clear Patient
Hours.
2. Press the button to clear the hours to 0.
Change The Language
Shown on The Pump
1. Press the function button adjacent to “Options”.

11
2. Use the arrow buttons to highlight ‘Language’.
3. Press the button to confirm.
4. Use the arrow buttons to scroll through the
available languages.
5. Press the button to confirm.
6. Press the button again to confirm.
7. Use the arrow buttons to highlight ‘Exit’. Note the
word ‘Exit’ will be displayed in language selected.
8. Press the button to confirm.

12
6. Battery Operation
When used with the optional battery pack, the system
can be run independently of the mains power supply.
Typically, 6-8 hours of operation can be expected from
a fully charged battery pack.
Connecting the
Battery Pack From the front of the pump, engage the pack on the
runners and slide into place until a click is heard.
To remove the pack, depress the latch at the rear of the
unit and slide pack forward and out.
Battery Pack in Use The battery pack will automatically take over powering
the pump whenever the mains power cord is removed
from the wall outlet.
Reset/Status Latch
Battery Pack

13
When running under battery power, a battery symbol
appears in the top right hand corner of the display.
In order to maximize battery life, the power alarm
indicators will not illuminate when operating the
Flowtron Universal under battery power. You may
verify therapy is, or is not, being provided via the
LCD screen.
The amount of charge remaining in the battery pack is
indicated by the black block inside the battery symbol.
When the battery has only 5% of the charge remaining,
the battery symbol will flash and the remaining charge
will be displayed as a percentage. Recharge the battery
as soon as possible.
Then, when the battery has 1% charge, the audible alarm
will sound and the pump will stop running. Recharge the
battery.
Battery Storage and
Disposal
If the device is not to be used for an extended period,
charge (refer to “Recharging the Battery Pack” on
page 15), remove and store the battery pack. If the
battery pack is to be put into long term storage it should
be recharged at least once every three to six months.
A faulty battery pack should be sent back to
ArjoHuntleigh for recycling or correct disposal.

14
Checking the Status of the Battery
Battery Label
To Check the Battery
Status:
1. Remove the battery from the pump unit.
2. Press the Reset/Status Latch which will activate the
2 LEDs on the top of the battery.
If the battery pack is not on charge, the LEDs will
display one of the following conditions:
If the battery pack is on charge via the optional battery
charger, the LEDs will display one of the following
conditions:
+
-
LED 1 LED 2
80-100% Charge
Battery Pack OK
Battery Pack
needs recycling
Battery Pack
Fault
30-80% Charge
<30% Charge
Press Reset / Status Latch
Jack Socket Polarity
LED 1 LED 2 Battery Status
Green Green The Battery Pack is OK. It has > 80% charge.
Green Green The Battery Pack is OK. It has between 30-80% charge.
Green The Battery Pack is OK. It has < 30% charge.
Red Green The Battery Pack needs recycling*. It has between 30-80% charge.
Red The Battery Pack needs recycling*. It has < 30% charge.
Red The Battery Pack has an error. Press Reset/Status Latch.
The Battery Pack has an error. Try recharging.
LED 1 LED 2 Battery Status
Green Green The Battery Pack is OK. It is fully charged.
Green The Battery Pack is charging.