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,