ARJO HUNTLEIGH Flowtron ACS800 User manual

Flowtron ACS800
Instructions for Use
...with people in mind
513933EN_03 • 05/2016

(i)
Contents
General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About Flowtron ACS 800 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Pump: Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Pump: Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Guidelines and Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Controls, Alarms and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Control Panel With Typical LCD Screen View in Run Mode . . . . . . . . . . . . . . . . . . . 6
LED Indicators on the Front Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Standby Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Starting Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Stopping Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Switching Off the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Changing Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Settings Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Flowtron ACS 800 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Flowtron ACS 800 Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Serial Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Technical Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

(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 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®ACS 800 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.
Precautions
For your own safety and the safety of the equipment, always take the following precautions:
• Do not expose the system to open 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.

(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 ACS 800 pump 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 ACS 800 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®
ACS 800 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 ACS 800 system, contact your local
ArjoHuntleigh sales office, 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 patient use
only. It is not for use in the home healthcare
environment.
The Flowtron ACS 800 system should be used as part of
a prescribed plan of care (refer to “Indications” on
page 3).
About Flowtron
ACS 800
The application of external pneumatic compression has
two effects:
• Augments venous blood flow velocity, thereby
reducing stasis.
• Enhances fibrinolytic activity to reduce the risk of
early clot formation.
The system comprises a pump that can be used in
conjunction with an extensive range of ArjoHuntleigh
inflatable garments, including foot, calf and calf & thigh
versions. The pump automatically adjusts to the correct
therapy profile depending upon which garment type
(foot, calf or calf & thigh) is connected.
The tubeset is integral to the system and cannot be
disconnected from the pump.
The mains power supply is the primary power source for
the pump. The pump incorporates an internal battery
pack, which is a secondary power source to back up the
pump in the event of failure or disconnection
(accidentally or deliberately) from the mains power
supply.
The Flowtron ACS 800 system is intended for use
ONLY in Professional Healthcare Facilities (e.g.
hospitals or physicians’ offices).

2
A full technical description of the Flowtron ACS 800
system can be found in the Service Manual, part number
SER0020, available from your local ArjoHuntleigh
sales office.
Pump: Front View
Pump: Rear View
LCD Screen
Integral
Integral Carry Handle
LED Indicator
Garment
Tubeset 1
Tubesets
and Controls
Connectors
Tubeset 2
(Blue Button)
(Orange Button)
Swing-out
Bed-Hooks
Mains Power Cord
Tubeset 1
Tubeset 2
Integral
Tubesets

3
2. Clinical Applications
Indications The primary application of the Flowtron ACS 800
system is for the prevention of Deep Vein Thrombosis
(DVT) when combined with an individualised
monitoring programme.
This system represents 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 ACS 800 system, when used with the
DVT Calf / Thigh Garments, should not be used in the
following conditions:
1. Severe arteriosclerosis or other ischemic 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 ACS 800 system, when used with the
Foot Garments, should not be used in the following
conditions:
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.

4
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 ACS 800 system is encouraged.
5. The Flowtron ACS 800 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.
• 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,

5
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.
DVT Prophylaxis • The Flowtron ACS 800 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.

6
3. Controls, Alarms and Indicators
Control Panel With Typical LCD Screen View in Run Mode
On/Off Button
and LED Indicator
Press the On/Off button to power up the pump from its
unpowered state and put it into Standby (refer to
“Standby Screens” on page 11).
Connecting the pump to the mains power supply will
automatically power up the pump from its
unpowered state and put it into Standby, without
having to press the On/Off button.
Make sure the system has been arranged so that the
power cable and garment hoses do not pose a trip or
strangulation hazard.
The adjacent LED indicator shows the pump status:
To switch off the pump, press and hold the On/Off
button for approximately 2 seconds until the LCD screen
goes blank, and then release.
If you switch off the pump and then press the On/Off
button to power it back up:
Stop 2 h
LED Indicator
“Up” Select Button
On/Off Button
LCD Screen
“Down” Select Button Start/Stop Button
Pressure
Mains/Power Indicator
Foot Therapy Indicator Calf (or Calf & Thigh) Therapy Indicator
Battery Indicator
Start/Stop
Therapy
Indicator
Patient
Hours Meter
LED Colour Mains Power Pump Status
Extinguished Disconnected Off
Amber Connected Off
Amber Connected or disconnected Standby
Green Connected or disconnected Run

7
• If the mains power is disconnected, the pump runs
the diagnostic tests and then goes into Standby.
• If the mains power remains connected, the pump
goes into Standby and does not run diagnostic tests.
Start/Stop Button This has the following functions depending on the text
or icon displayed above the button:
• To start or stop therapy.
• To confirm the option selected in the Options menu.
When the pump is in Standby, press the Start/Stop
button to put the pump into the Run mode and start
therapy; the LED indicator adjacent to the On/Off button
will change to green and the LEDs on the front case will
be illuminated green.
To stop the therapy and put the pump into Standby, press
and hold the Start/Stop button for approximately 2
seconds until the Standby screen is displayed and then
release the button. The LED indicator adjacent to the
On/Off button changes to amber and the LEDs on the
front case are extinguished.
“Up” and “Down”
Select Buttons
These have the following functions depending on the
text or icon displayed above the buttons:
• To select the Options menu.
• To move up and down the Options menu.
• To mute certain audible alarm conditions.
LCD Screen This displays the pump operating mode and status:
1. Foot or Calf (or Calf & Thigh) therapy indications.
These show what garment type is connected to each
tubeset and when each garment is being inflated:
• All therapy indications are initially shown as
grey to indicate they are deflated.
• A therapy indication changes to black to show it
is inflating.
• The therapy indication reverts to grey when it
starts to deflate.
• The garment connector on the end of each
tubeset has a push button which is colour-coded
and has a number marked on it: blue “1” or
orange “2”. The numbers corresponds with the
“1” and “2” on the right side of the LCD screen.
Foot Garment Calf or Calf & Thigh
Garment

8
Where the tubesets enter the side of the pump,
the top tubeset is marked “1”.
2. Pressure indication: this is the inflation pressure
applied to the garment, as follows:
• Foot Garment: 130 mmHg.
• Calf and Calf & Thigh Garments: 40 mmHg.
3. Mains power indications:
4. Battery indication:
• When the pump is connected to the mains power
supply, then:
•• If the battery is fully charged, the indicator
will be static and show “full”.
•• If the battery is not fully charged, the indicator
will “scroll” from “empty” to “full” to indicate
that the pump is being charged.
• When the pump is NOT connected to the mains
power supply, then the indicator is static and
shows the charge remaining in the battery:
The battery has a service life of 5 years (600 charge
cycles). It is not user replaceable and must be
replaced as part of the service procedure.
5. Patient Hours Meter: if this is selected, the total
therapy time is shown (in hours). Refer to
“Changing Options” on page 16 to select and/or
clear the Patient Hours Meter.
• This is the pump run time since the Patient Hours
Meter was last cleared.
• The factory default is to NOT show the Patient
Hours Meter on the LCD screen.
6. Warning and alarm indications (refer to
“Troubleshooting” on page 22).
The pump is connected to the mains power supply.
The pump is not connected to the mains power supply,
but is powered by the internal battery only.
Battery Empty Battery 1/3 Full
Battery 2/3 Full Battery Full

9
LED Indicators on the
Front Case
There are two sets of LED indicators on the front case of
the pump. Their status is as follows:
LED Colours Pump Status Warnings/Alarms
Extinguished Off or Standby - -
Green (Static) Run • No fault detected.
• Warning only detected.
Red (Flashing) Run Fault detected with full audible and visual alarm

10
4. Operation
General These instructions cover the day-to-day operation of the
system. Other operations, such as maintenance and
repair, should only be carried out by suitably qualified
personnel.
Refer to “Controls, Alarms and Indicators” on page 6 for
a description of the controls, indicators and LCD screen.
If the operation or performance of the pump
changes during use, refer to “Troubleshooting” on
page 22 of this IFU before calling a service
engineer or contacting your local ArjoHuntleigh
sales office.
Start Up To switch on the pump, do one of the following:
• Connect the pump to the mains power supply using
the power cable provided. The pump will power up
automatically and start running a diagnostic test, and
display the following screen:
• If operating from just the battery (disconnected from
the mains power supply), press the On/Off button.
The pump will power up and start running the
diagnostic test, and display the following screen.
Note the “Checking Battery” text and the “Mains
power not connected” icon at the top of the screen:
Progress
Bar
Checking Battery
“Mains power not
connected” icon

11
After a few seconds, the following screen is
displayed, showing “Battery OK”:
If the text at the top of the screen says “Low
Battery” then you must connect mains power before
you can start therapy.
• At the end of the diagnostic test, the following screen
is displayed, showing the “Hours Run” at the top and
the software version of the pump at the bottom:
The “Hours Run” value displayed on this screen is
for service use only, and is different to the “Patient
Hours Meter” displayed during therapy. Refer to
“Controls, Alarms and Indicators” on page 6 for
the “Patient Hours Meter”.
Standby Screens The “No Garments” Standby screen is then displayed:
There are two “leg” icons with no garments attached and
the text “Attach garments” at the top of the screen; this
indicates that no garments are currently connected to
either tubeset.
There is no text above the Start/Stop button until at
least one garment is connected to a tubeset.
Apply the prescribed ArjoHuntleigh garment(s) to the
patient by following the instructions included in the
garment packaging.
Battery OK
XX.XXXX-XXX
Hours Run: 145
Attach garments
Options
“Mains power
connected” icon
Battery
Indication

12
Garments are for single patient use only. Do not use
the garments on a different patient after treatment.
Connect the garment(s) to the pump by pushing the
garment connector firmly into the pump tubeset
connector until it “clicks”.
The pump LCD screen will show which garments are
connected to each tubeset connector: the garment
connector with the blue push button is “1” and the one
with the orange push button is “2”.
If any pump options (Audio Alarm Volume, Patient
Hours Meter or Language) need to be changed, they
must be changed before the patient therapy is started.
Refer to “Changing Options” on page 16.
The following four screens show typical Standby
screens with different garment configurations:
Starting Therapy Make sure the garment(s) are fitted correctly to the
patient and the pump.
Make sure any pump options have been changed if
necessary.
If the pump is to be positioned under a bed, make
sure it is placed horizontally (with the bed-hooks
underneath) to prevent damage to the pump.
While the pump is in Standby, the LEDs on the front
case remain extinguished.
Start Options Start Options
Foot Garment Calf (or Calf & Thigh) Garment
Two Calf (or Calf & Thigh) Foot and Calf (or Calf & Thigh)
Start Options Start Options
Connected to Tubeset 1
Garments Connected Garments Connected
Connected to Tubeset 1

13
Press the button below “Start” to start the therapy. The
LEDs on the front case change to static green.
It is recommended that the following checks are carried
out at the start of, and throughout, the therapy:
• Check the LCD screen icons to confirm that the
correct type of garment(s) have been connected.
• During garment inflation, check the LCD screen to
confirm that the correct pressure is being applied and
that there are no fault messages displayed. The
inflation pressures for the different garments are:
• Foot Garment: 130 mmHg.
• Calf and Calf & Thigh Garments: 40 mmHg.
Initial inflation cycles (up to 10) may not show the
correct inflation pressure. This is to be expected.
• Check that there are no kinks in the pump tubesets.
• Check that the pump tubesets and connectors do not
cause the patient any discomfort.
• Regularly check that the garments remain correctly
fitted to the patient.
The pump will inflate and deflate each garment in turn,
as follows, starting with garment 1:
The following example shows two foot garments
fitted to the pump.
1. Both garments are initially deflated. The garment
pressure is displayed on the left side of the screen.
If the Patient Hours Meter is selected in the
“Options” menu (refer to “Changing Options” on
page 16), the total elapsed time (in hours) is shown
in the bottom right of the screen:
Stop
Patient Hours Meter

14
2. Foot garment 1 is inflated to 130 mmHg, with a
ramp up and hold time of 3 seconds. The foot
garment indicator is black while it is inflated:
3. The foot garment is deflated to zero. Both garment
indicators are grey:
4. Foot garment 2 is then inflated to 130 mmHg, with
a ramp up and hold time of 3 seconds. The foot
garment indicator is black while it is inflated:
5. The foot garment is deflated to zero. Both garment
indicators are grey:
6. This cycle of alternate garment inflations repeats
from step 2 (above) until the therapy is stopped.
If one or two calf (or calf & thigh) garments are attached
to the pump, then each garment is inflated to 40 mmHg,
with a ramp up and hold time of 12 seconds.
If a foot garment and a calf (or calf & thigh) garment are
attached to the pump, then since the inflate and hold
Stop 2 h
Stop
Stop
Stop