Arjo Flowtron ACS900 User guide

Flowtron ACS900

INSTRUCTIONS FOR USE

526933EN_I • 12/2020

WARNING

To avoid injury, always read this Instructions for Use and accompanied
documents before using the product.

Mandatory to read the Instructions for Use

Design Policy and Copyright
® and ™ are trademarks belonging to the Arjo group of companies.
© Arjo 2020.
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 Arjo.

Contents

General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

About the Flowtron ACS900 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Pump: Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Pump: Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Guidelines and Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Controls, Alarms and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Control Panel with Typical LCD Screen View in Run Mode . . . . . . . . . . . . . . . . . . . 6

LCD Screen Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

LED Indicators on the Pump Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Installing the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Standby Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Starting Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Stopping Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Switching Off the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Warnings/Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Settings Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Flowtron ACS900 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Serial Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Troubleshooting Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Technical Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Pump Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

(i)

Intentionally left blank

(ii)

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:

• EN60601-1:2006/A1:2013 and IEC 60601-1:2005/A1:2012

• ANSI/AAMI ES 60601-1(2005)+AMD(2012) and CAN/CSA C22.2 No.60601-1
(2008)+(2014).

Safety Warnings

• It is the responsibility of the caregiver 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 combination as indicated by Arjo should be used. The
correct function of the product cannot be guaranteed if incorrect pump and
garment combinations are used.

• The

Flowtron® ACS900 system is NOT intended for use in the home healthcare

environment (for example private dwellings).

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.

• If a serious incident occurs in relation to this medical device, affecting the user, or the
patient then the user or patient should report the serious incident to the medical device
manufacturer or the distributor.In the European Union, the user should also report the
serious incident to the Competent Authority in the member state where they are located.

(iii)

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 (for example
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 Arjo service personnel.

Expected Service Life

The 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 Arjo
distributor.

Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse
the system. Failure to observe this caution could result in injury, or in extreme cases, death.

End of Life Disposal

• Garment material or any other textiles, polymers or plastic materials etc. should be sorted
as combustible waste.

• Pump units have electrical and electronic components should be disassembled and
recycled per Waste of Electrical and Electronic Equipment (WEEE) or in accordance with
local or national regulation.

(iv)

1. Introduction

About this Manual This manual is your introduction to the Flowtron

ACS900 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 ACS900 system, contact your local Arjo
sales office, listed at the end of this manual.

Intended Use The intended use of this product is to help prevent

Deep Vein Thrombosis (DVT). The garments are
single patient use - do not re-use. It is not for use
in the home healthcare environment.

The Flowtron ACS900 system should be used as
part of a prescribed plan of care (refer to “Indications”
on page 3).

About the Flowtron

ACS900 System

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 is comprised of a pump that can be used
in conjunction with an extensive range of Arjo
inflatable uniform (DVT), sequential (Tri Pulse) and
foot garments. Refer to “Accessories” on page 28 for
a complete list of the calf, calf & thigh and foot
garments which can be used with the Flowtron
ACS900 pump.

The pump automatically adjusts to the correct
therapy profile depending upon which garment type
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, which is a secondary power source to back
up the pump in the event of failure of or disconnection
from (accidental or deliberate) the mains power
supply.

The Flowtron ACS900 system is intended for use
ONLY in professional healthcare facilities. It is
not intended for use in the home healthcare
environment (for example private dwellings).

1

Pump: Front View

LCD Screen

LED Indicators

Garment

Tubeset Connector 1

Control Buttons

Connectors

Tubeset Connector 2

(Blue Button)

(Orange Button)

Swing-out

Bed-Hooks

Mains Power Cord

Tubeset Retention Clips

Mains Power Cord Retention Clip

Power Button

Swing-out

Bed-Hooks

Integral Carry Handle

Mains Power

LED Indicator

Integral Tube and

Cable Management

System

Cord

(on underside)

USB Port

(refer to Service

Manual SER0026)

A full technical description of the Flowtron ACS900
system can be found in the Flowtron ACS900
Service Manual, part number SER0026, available
from your local Arjo sales office.

Pump: Rear View

2

2. Clinical Applications

Indications The intended use of the Flowtron ACS900 system is

to help prevent Deep Vein Thrombosis (DVT).
The system should be 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 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

Uniform & Sequential

Calf and Calf & Thigh

Garments

Foot Garments The system, when used with the foot garments,

The system, when used with calf or 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.

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.

3

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. If using
apparatus with straps or securing devices, for
example lithotomy stirrups, make sure that the
tubing is not placed inside the strap next to the
patient’s skin, and regularly check the patient's
skin for signs of redness or pressure points. The
garment is most effective in preventing venous
stasis when the garment air bladders are located
in the posterior position. If the air bladders
cannot be placed at the posterior, the garment
can be rotated around the calf to alternative
positions all of which will still help to prevent
venous stasis.

3. Lower limb positioning in relation to the garment
and tubing should also be considered
particularly in a patient that is unconscious,
cannot feel or has reduced sensation and/or
ability to move their leg(s).

4. The patient’s skin should be inspected frequently
during every shift.

 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
appropriate skin care.

5. Clinical judgement is required to determine if the
patient's skin condition requires additional
protective measures, or if the therapy should be
discontinued and an alternative modality used.

6. Garments should be removed immediately if the
patient experiences tingling, numbness, or pain,
and the physician notified.

4

7. When used for DVT prevention, continuous
external pneumatic compression is
recommended until the patient is fully
ambulatory. Uninterrupted use of the system is
encouraged.

8. The 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

• The system should be initiated immediately once

the risk of DVT formation is identified and the plan
of care has been prescribed.

• If compression stockings 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.

• For surgical patients, the system should be

applied to the patient preoperatively, 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.

5

3. Controls, Alarms and Indicators

Mains Indicator

Right Control Button

Power Button

LCD Screen

Left Control Button Middle Control Button

Control Panel with Typical LCD Screen View in Run Mode

Power Button

and Mains Indicator

To switch the pump on:

• Connect the pump to mains power and the pump
will run its internal diagnostic tests and go to
Standby (refer to “Standby Screens” on page 12).

• If the pump is already connected to mains power,
press and hold the Power button for
approximately 2 seconds, and the pump will go
directly to Standby.

• If the pump is not connected to mains power,
press and hold the Power button for
approximately 2 seconds, and the pump will run
its internal diagnostic tests and go to Standby.

The Mains indicator above the Power button shows
the mains power status of the pump:

• Extinguished: mains power is disconnected.

• Illuminated green: mains power is connected to
the pump.

To switch off the pump, press and hold the Power
button for approximately 2 seconds. Then,

• If the pump is connected to mains power, the LCD
screen backlight will be extinguished and only the
mains power and battery indication icons will be
displayed. Release the button.

• If the pump is not connected to mains power, the
pump will power down and the LCD screen will be
blank. Release the button.

6

Middle Control Button When the pump is in Standby and one or two

Garment Mains Power

Battery Level

Pressure

Indication

Not Connected

Mains Power

Connected

Indication

High Temperature

Warning/Alarm

Hardware Fault/

Patient

Run Hours

Wait/

Initialising

Start/Stop

Therapy

Kinked/

Blocked Tube

Low Pressure/

Leak

Audible

Audible

Audible Alarm

Volume

Garment Type

and Inflation

Indication

Alarm

Indication

Alarm Status

Tubeset

Connector

Number

Alarm

Muted

Service Required

garments are connected, press this button to put the
pump into the Run mode and start therapy; the LED
indicators on the front and underside of the case will
be illuminated green.

To stop the therapy and put the pump into Standby,
press and hold this button for approximately 2
seconds until the Standby screen is displayed and
then release the button. The LED indicators on the
front case will be extinguished.

Left Control Button If an audible alarm sounds during therapy, press this

button to mute the audible alarm.

 Only certain alarms can be muted.
 Refer to “Troubleshooting” on page 22 for details

of the various alarm conditions and possible
corrective actions to rectify the faults.

When the pump is in Standby, press this button to
change the alarm volume (refer to “To Change the
Audible Alarm Volume Setting” on page 18).

Right Control Button Press this button to reset the patient run hours. This

can be done either at power up, after the pump has
initialised or if the therapy is stopped and the pump is
in Standby (refer to “Resetting the Patient Run
Hours” on page 19).

LCD Screen Icons This screen shows the position and description of all

possible icons which can be displayed. The actual
icons which will be displayed will depend
on the pump status, patient therapy and whether
a fault has been detected.

7

Garment Type and

Inflation Indication

These show which garment type is connected to
each tubeset and when each garment is being
inflated.

 A garment connected but not inflated is shown as

an outline on the leg icon. When it is inflated, the
garment outline is filled in black.

Uniform (DVT) Calf

(or Calf & Thigh)

Sequential (Tri Pulse) Calf

(or Calf & Thigh)

Tubeset Connector

Number

Garment

Foot

Connected and

Not Inflated

The garment connector on the end of each tubeset
has a push button which is colour-coded and has a

Connected and

Inflated

number marked on it: blue “1” or orange “2”. The
numbers correspond with the “1” and “2” on the left
side of the LCD screen adjacent to the leg icons.

Start/Stop Therapy The icon above the Middle Control button changes

between Run and Standby modes, as follows.

Garment Pressure

Indication

Start Therapy icon. In normal operation, this
icon is displayed when the pump is in
Standby and at least one garment is
connected. Press the button to start therapy.

Stop Therapy icon. In normal operation, this
icon is displayed when the pump is in Run
mode. Press the button to stop therapy.

The default target inflation pressure for each garment
is as follows:

• Foot: 130 mmHg.

• Uniform calf and calf & thigh: 40 mmHg.

• Sequential calf and calf & thigh: 45 mmHg.

8

Mains Power

Indication

The pump is connected to the mains power
supply.

The pump is NOT connected to the mains
power supply.

Battery Indication

When the pump is connected to the mains power
supply:

• 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 “Battery Empty” to the current battery
capacity for example “Battery ½ Full”, to indicate
that the pump is being charged.

When the pump is NOT connected to the mains
power supply, the indicator is static and shows the
approximate charge remaining in the battery.

Battery Empty Battery ¼ Full

Battery ½ Full Battery ¾ Full

Battery Full

 If the pump is not connected to the mains power

supply and the battery is fully charged and in
good condition, the pump will continue to operate
normally for approximately 12 hours for calf and
calf and thigh garments, and for approximately 6
hours for foot garments.

 The battery has a service life of 5 years

(approximately 600 charge cycles). It is not user
replaceable and must be replaced as part of the
service procedure.

Wait/Initialising This is a rotating 6-segment circular icon, which

indicates that the pump is initialising after power up.

Patient Run Hours This shows the total pump run time in hours. Refer to

“Resetting the Patient Run Hours” on page 19 to
clear the patient run hours.

 This is the pump run time since the patient run

hours was last reset.

Audible Alarm Status When an alarm which is able to be muted is shown

on the LCD screen, this icon is shown to indicate that
the alarm can now be muted.

9

When the pump is in Standby, this icon indicates that
the alarm volume can be changed (refer to “To
Change the Audible Alarm Volume Setting” on
page 18).

Audible Alarm Muted This icon indicates that the audible alarm has been

muted.

Warning and Alarm

Indications

The following five icons indicate that a fault has been
detected in the system. Refer to “Troubleshooting”
on page 22) for a list of fault conditions, the
corresponding warning and alarm indications, and
possible corrective actions to rectify the faults.

Alarm detected which may cause an
interruption in therapy.

Low pressure or garment leak.

Kinked or blocked tubeset.

High temperature.

Hardware fault detected or periodic service
required.

LED Indicators on the

Pump Case

There are additional LED indicators on the pump to
show pump status and alarms:

• Two sets on the front of the pump.

• One set on the underside of the pump.

Their status is as follows:

LED Colours Pump Status Warnings/Alarms

Extinguished Off or Standby - -

Green Run

Yellow Run Fault detected with full audible and visual alarm.

• No fault detected.

• Warning only detected.

10

4. Operation

Mains Power Connected Mains Power Disconnected

General These instructions cover the routine 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 Arjo sales
office.

Installing the Pump 1. The pump should be placed feet down on any

convenient horizontal surface or alternatively
suspend the unit with the use of bed hooks
(integral hanging brackets).

2. Beyond placing the pump on the bed frame or on

the floor, the use of IV Pole Bracket or Wall
Bracket should be considered.

3. Depending on the therapy environment, the

pump may also be secured with the use of
alternative solutions, such as the additional
bracket mounted to the bed frame. The
appropriate solution should be chosen to ensure
patient safety.

Start Up 1. To switch on the pump, do one of the following:

• Connect the pump to the mains power supply
using the power cable provided.

• If operating on battery (the pump is
disconnected from the mains power supply),
press the Power button.

2. The pump will power up automatically and start
running a diagnostic test and initialising the
pump. One of the following screens will be
displayed, with a rotating 6-segment circular
icon:

11

3. During the last part of the initialisation process,

Major Revision

Minor Revision

the software version will be displayed,
comprised of:

• Major revision in top left.

• Minor revision in bottom right.
This screen shows software version “V1.047”.

4. At the end of the successful diagnostic test, the
“No Garments” Standby screen is displayed.

5. The Patient Run Hours value can now be reset
by pressing the Right Control button (refer to
“Resetting the Patient Run Hours” on page 19).

6. The alarm volume can also be set by pressing
the Left Control button (refer to “To Change the
Audible Alarm Volume Setting” on page 18).

Standby Screens The “No Garments” Standby screen (above) shows

two leg icons on the left side of the LCD screen with
no garment outlines on them, indicating that no
garments are currently connected to either tubeset.

 The Start Therapy icon does not appear until at

least one garment is connected to a tubeset
connector.

Apply the prescribed Arjo garment(s) to the patient
by following the instructions included in the garment
packaging.

 Do not re-use the garments. Do not use the

garments on multiple patients.

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” (refer to
“Garment Type and Inflation Indication” on page 8).

12

The following four screens show typical Standby
screens with different garment configurations.

 A garment connected but not inflated is shown as

an outline on the leg icon. When it is inflated, the
garment outline is filled in black.

 The same garment outline is used for both calf

and calf & thigh garments.

Tubeset
Connector 1

Tubeset
Connector 2

Tubeset
Connector 1

Tubeset
Connector 2

Tubeset
Connector 1

Tubeset
Connector 2

No garment connected

Foot garment

Sequential (Tri Pulse) calf or
calf & thigh garment

No garment connected

Uniform (DVT) calf or calf &
thigh garment

Uniform (DVT) calf or calf &
thigh garment

Tubeset
Connector 1

Tubeset
Connector 2

Foot garment

Uniform (DVT) calf or calf &
thigh garment

Starting Therapy Make sure the garment(s) are fitted correctly to the

patient and the pump.
While the pump is in Standby, the LED indicators on

the front and underside of the pump remain
extinguished.

Press the Middle Control button below the Start
Therapy icon to start the therapy. The LEDs on the
front and underside of the pump change to green.

13

 If the pump is switched on and one or more

garments are connected to the pump, but therapy
is not started within 15 minutes, an alarm will
occur. If no action is taken to start therapy or
silence the alarm, then 15 minutes after the alarm
starts, the pump will go into an “Off” state (refer
to “Troubleshooting” on page 22).

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 there are no fault indicators displayed
and that the correct pressure is being supplied.
The default target inflation pressures for the
different garments are:

• Foot garment: 130 mmHg.

• Uniform calf and calf & thigh garments:

40 mmHg.

• Sequential calf and calf & thigh garments:

45 mmHg.

• Check that there are no kinks in the tubeset.

• Check that the tubeset 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 the garment connected
to tubeset connector 1. The garment pressure is
displayed in the top left side of the screen. The
Patient Run Hours are displayed in the bottom right
of the screen.

 The following example shows two foot garments

fitted to the pump.

1. Both garments are initially deflated, and the
garment icons are shown as outlines.

2. Foot garment 1 is inflated to the target pressure,
with an inflate time of 3 seconds and a deflate

14

time of 27 seconds. The foot garment icon is
black while it is inflated.

3. The foot garment is deflated to zero. Both
garment icons are outlines.

4. Foot garment 2 is then inflated to the target
pressure, with an inflate time of 3 seconds and a
deflate time of 27 seconds. The foot garment
icon is black while it is inflated.

5. The foot garment is deflated to zero. Both
garment icons are outlines.

6. This cycle of alternate garment inflations repeats
from step 2 (above) until the therapy is stopped.

If calf (or calf & thigh) garments are attached to the
pump, then each of these garments is inflated to the
target pressure, with an inflate time of 12 seconds
and a deflate time of 48 seconds.

If a foot garment and a calf (or calf & thigh) garment
are attached to the pump, then since the inflate and
hold times for a foot garment are shorter than for a
calf (or calf & thigh) garment, there is a modified
inflation sequence: the foot garment is always

15

inflated twice in succession and then the calf
(or calf & thigh) garment is inflated, as follows.

1. Inflate the foot garment.

2. Deflate the foot garment.

3. Repeat the inflation of the foot garment.

4. Deflate the foot garment.

5. Inflate the calf (or calf & thigh) garment.

6. Deflate the calf (or calf & thigh) garment.

7. This cycle of garment inflations repeats from
step 1 until the therapy is stopped.

Stopping Therapy To stop the therapy and put the pump into Standby,

press and hold the Middle Control button for
approximately 2 seconds until the Standby screen is
displayed (refer to “Standby Screens” on page 12)
and then release it.

The LEDs on the front and underside of the pump are
extinguished.

If the pump stays in Standby, then:

1. After 5 minutes the LCD display backlight is
dimmed.

2. After a further 10 minutes (15 minutes total) the
pump automatically goes into an “Off” state:

• On mains power, the LCD screen backlight

will be extinguished and only the mains power
and battery indication icons will be displayed.

• On battery power, the pump will power down

and the screen will be blank.

 The Mains indicator above the Power button will

remain green if the pump is connected to the
mains power and extinguished if the mains power
is disconnected.

To switch off the pump, press and hold the Power
button for approximately 2 seconds. Then,

• On mains power, the LCD screen backlight will be

extinguished and only the mains power and
battery indication icons will be displayed.

• On battery power, the pump will power down and

the screen will be blank.

16

Switching Off

the Pump

1. Make sure the therapy is stopped and the pump
is in Standby (refer to “Stopping Therapy” on
page 16).

2. If connected, disconnect the mains power.

3. Press and hold the Power button for
approximately 2 seconds until the LCD screen
goes blank.

 The Mains indicator above the Power button will

remain green if the pump is connected to the
mains power and extinguished if the mains power
is disconnected.

17

Warnings/Alarms On detection of a fault condition, the pump provides

a visual-only warning followed by an audible and
visual alarm if the fault is not cleared.

1. The visual-only warning is a fault icon on the
LCD screen. The LED indicators remain
unchanged and there is no audible alarm.

2. If the fault is not cleared then the warning is
replaced by an audible and visual alarm, which
consists of:

• A fault icon on the LCD screen.

• The LED indicators on the front and underside

of the pump change to yellow.

• An audible alarm will sound.

The warning and alarm can be cleared by either:

• Rectifying the fault on the system, or

• Pressing the Middle Control button to put the

pump into Standby.

Refer to Section 7, Page 22 “Troubleshooting” for
the alarms, their possible causes and their remedies.

To Change the Audible

Alarm Volume Setting

1. When the pump is in Standby, press the Left
Control button for 2 seconds to enter Audible
Alarm Volume Setting mode.

2. The Audible Alarm Volume and Audible Alarm
Status icons will be displayed in the bottom left
of the screen.

Audible Alarm
Volume

Audible Alarm
Status

3. Each time the Middle Control button is pressed
the volume setting increases; if the volume
setting is at maximum, pressing the button again
will cycle back to the minimum setting.

4. The pump will save the selected volume setting
when the Left Control button is pressed.

 If the Left Control button is not pressed for more

than 2 minutes, the selected setting will be
stored, the Volume and Audible icons will be
removed and the pump will exit the Audible Alarm
Volume Setting mode.

Minimum
Volume

18

Medium
Volume

Maximum
Volume

Resetting the Patient

Run Hours

1. When the pump is in Standby, press and hold
the Right Control button for 2 seconds. The
Patient Run Hours value will flash for 2 minutes.
Press and hold the Middle Control button for 3
seconds to reset the Patient Run Hours to zero.

 This is the pump run time since the patient run

hours was last reset.

2. Press the Right Control button again to save the
new setting. If there is no action within the 2
minutes of flashing, the selected setting will be
saved.

Settings Adjustment The pump is configured to give the recommended

therapy for each garment type and does not require
any direct setting by the clinician or nurse.

If the physician requires different therapy settings for
uniform calf and/or calf & thigh garments, then limited
changes can be made to the pump pressure setting.
These changes, and returning the pump to the
default settings, can only be made either:

• By contacting service personnel through your

local Arjo sales office, or

• By trained authorised technical personnel at the

facility.

 The pump pressures for foot garments and

sequential calf and calf & thigh garments are
fixed and cannot be changed.

 The pressure range and factory default pressure

for the uniform calf and calf & thigh garments are
detailed in the Pressure Range on page 29.

19

5. Cleaning and Disinfection

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 system should be routinely decontaminated between patients and at
regular intervals while in use; as is good practice for all reusable medical
devices

Remove the electrical supply to the pump by disconnecting the mains
power cable from the mains power supply before cleaning.

Protective clothing should always be worn when carrying out
decontamination procedures.

Do not use Phenol-based solutions or abrasive compounds or pads
during the decontamination process as these will damage the surface
coating.

.

WARNING

Caution

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.

Garments are single patient use and hence cannot be cleaned or reused.

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.
Do not use anything abrasive to clean the LCD window on the pump.

Chemical Disinfection

Arjo recommends 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.
Make sure the product is dry before storage.
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.

20

6. Routine Maintenance

Flowtron ACS900 System

Maintenance The equipment has been designed to be

maintenance-free between service periods.

Servicing Arjo will make available on request service manuals,

component parts lists and other information
necessary for Arjo trained personnel to repair the
system.

Service Manual The Flowtron ACS900 Service Manual, part number

SER0026, is available from your local Arjo sales
office.

Service Period Arjo recommend that the pump is serviced every

12 months by an Arjo authorised service agent.

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, for example 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

rear of the pump case.
Quote this serial number when requesting service.

21

7. Troubleshooting

General

On detection of a fault condition, the pump provides a visual-only warning
followed by an audible and visual alarm if the fault is not cleared.

Warning Conditions

The visual-only warning is a fault icon on the LCD screen. The LED indicators
remain unchanged and there is no audible alarm.

The warning can be cleared by either:

• Rectifying the fault on the system, or

• Pressing the Middle Control button to put the pump into Standby.

Alarm Conditions

If the fault is not cleared then the warning is replaced by an audible and visual
alarm, which consists of:

• A fault icon on the LCD screen.

• The LED indicators on the front and underside of the pump change to yellow.

• An audible alarm will sound.

• All the alarm conditions are low priority.
The alarm can be cleared by either:

• Rectifying the fault on the system, or

• Pressing the Middle Control button to put the pump into Standby.

 For simplicity, the following screens (except Battery Low, Hardware Fail and

High Temperature) show a fault detected on garment 1; similar fault messages
are displayed if the fault is detected on garment 2 (or both garments).

 If the trouble shooting procedures do not return the system to normal

performance, stop using the system immediately and call the service engineer.

Service Manual

Where reference is made in the following Troubleshooting table to the Flowtron
ACS900 Service Manual, this is part number SER0026 and is available from
your local Arjo sales office.

Troubleshooting Table

The following table provides typical warning and alarm conditions shown on
the LCD screen.

For each condition, there is a description and the relevant corrective action
required.

22

Condition Description and Corrective Action

Low Pressure/Leak

Kinked/Blocked Tube

Garment Disconnected

The warning is activated after 4 minutes and shows
a leak in garment 1 or its tubing.

The warning changes to an alarm after an additional
6 minutes (10 minutes total).

Examine the garment and tubing for leaks. The
warning or alarm will be cleared if the leak is
repaired. If the alarm continues, replace the affected
garment.

The warning is activated after 4 minutes and shows
garment 1 has a kinked or blocked tube.

The warning changes to an alarm after an additional
6 minutes (10 minutes total).

Examine the garment and tubing for kinks or
blockages. The warning or alarm will be cleared if
the kink or blockage is repaired. If the alarm
continues, replace the affected garment.

This warning is activated after 1 minute if the pump
detects that a garment has been disconnected while
the pump is in the Run state; it shows that garment 1
has been disconnected. The “garment type” icon
flashes.

Service Required

The warning changes to an alarm after an additional
9 minutes (10 minutes total) if the pump continues to
detect that a garment has been disconnected while
the pump is in the Run state; it shows that garment 1
has been disconnected.

Reconnect or replace the garment. The warning or
alarm will be cleared if the garment is reconnected.

The service “spanner” icon appears at the right side
of the screen to indicate that the pump requires
service attention. This will normally occur after the
preset service interval has expired.

The LED indicators on the front and underside of the
pump remain green.

Therapy can continue until service is available.

Call the service engineer.

23

Condition Description and Corrective Action

Battery Low

The Battery Low warning and alarm will only be
activated when the pump is operating from the
battery (the mains power is disconnected).

When any of these Battery Low warning or alarm
screens are activated, connect the pump to the
mains power supply to recharge the battery and
continue therapy.

If the pump is in Standby:

• The warning will be activated when the remaining
charge in the battery is less than 15%. The
battery icon flashes. Therapy can be started.
Connect to the mains power supply to clear the
warning.

• When the charge in the battery is less than 10%,
therapy cannot be started.
Connect to the mains power supply to clear the
warning and start therapy.

If the pump is in the Run state:

• The alarm will be activated when the remaining
charge in the battery is less than 10%. There is
an audible tone and the battery icon flashes. The
LED indicators on the front and underside of the
pump change to yellow.
Therapy can continue. Pressing the Left Control
button will silence the audible tone.
Connect to the mains power supply to clear the
warning and continue therapy.

• If the audible alarm is muted when the remaining
charge in the battery is less than or equal to 7%,
then an audible tone will sound and the LED
indicator will change to yellow. The audible tone
can no longer be silenced. The pump should be
connected to the mains power supply
immediately.

• When the remaining charge in the battery is
less than 5%, the pump will shut down with
no additional visible or audible indications.

24

Condition Description and Corrective Action

Faulty Tubeset

The Faulty Tubeset warning and alarm are activated
if the pump detects a fault in the tubeset.

For both conditions:

• Switch off the pump.

• Call the service engineer.

If the pump is in Standby when the faulty tubeset is
detected:

• A warning is activated.

The leg icon and garment icon (if present) will
flash, and show a faulty tubeset and affected
connector.
Therapy cannot be started.

If the pump is in the Run state when the faulty
tubeset is detected:

• An alarm is activated.

The leg icon and garment icon (if present) flash
and show a faulty tubeset and affected
connector.
The LED indicators on the front and underside of
the pump change to yellow.
Therapy can continue as if the same garment(s)
is attached.

• When the operator next stops the pump and puts

it into Standby, the alarm reverts back to the
Standby warning screen above with the flashing
leg icon and garment icon (if present).
Therapy cannot be restarted.

High Temperature

This warning occurs if the temperature inside the
pump exceeds 55°C. The High Temperature icon is
displayed and an audible alarm sounds. Therapy
can continue.
Make sure the pump is not close to a heat source, or
covered by blankets.

If the temperature inside the pump exceeds 60°C,
this screen is shown. Therapy is stopped.
Switch off the pump and allow pump to cool. Then
switch back on and continue therapy.

If either alarm continues, switch off the pump
and call the service engineer.

25

Condition Description and Corrective Action

Hardware Fail

Tubeset Disconnected/
Calibration Required

This alarm is activated if the pump detects an
internal fault:

• The “spanner” symbol is permanently displayed.

• “ERR” is displayed in the top left of the screen.

• A 2 or 3 digit fault code is displayed in the bottom
right of the screen.

Therapy is suspended.

Switch off the pump.
Call the service engineer.

The fault codes and their descriptions can be
found in the Flowtron ACS900 Service Manual,
part number SER0026.

The Tubeset Disconnected alarm is activated if the
pump detects that the tubeset has been
disconnected from the pump:

• An alarm is activated.

• Both leg icons flash.

• “CAL” is displayed in the top left.

• Therapy is suspended.

The pump must be recalibrated by Arjo authorised
service personnel before therapy can continue.

Switch off the pump.
Call the service engineer.

26

Condition Description and Corrective Action

Battery Fault

The Battery Fault alarm is activated if the pump
detects a fault in the internal battery.

If the pump is in Standby, on battery power:

• An alarm is activated which can be muted.

• The battery icon flashes and shows the last

known charge remaining in the battery.

• The “spanner” symbol flashes.

• Therapy cannot be started.

• Call the service engineer.

If the pump is in the Run state, on battery power:

• An alarm is activated which can be muted.

• The battery icon flashes and shows the last

known charge remaining in the battery.

• The “spanner” symbol flashes.

• Therapy can continue until the battery has

expired.

• Call the service engineer.

If the pump is in Standby, on mains power:

• An alarm is activated which can be muted.

• The battery icon flashes and shows the last

known charge remaining in the battery.

• The “spanner” symbol flashes.

• Therapy can be started.

• Call the service engineer.

If the pump is in the Run state, on mains power:

• An alarm is activated which can be muted.

• The battery icon flashes and shows the last

known charge remaining in the battery.

• The “spanner” symbol flashes.

• Therapy can continue.

• Call the service engineer.

27

8. Accessories

The Flowtron ACS900 pump should only be used with the following garments:

CALF GARMENTS

Order

Code

DVT5 DVT5 Small Calf Garment Up to 36 cm (14") Uniform

DVT10 DVT10 Standard Calf Garment Up to 43 cm (17”) Uniform

L501-M L501-M Standard Calf Garment Up to 43 cm (17") Uniform

DVT20 DVT20 Large Calf Garment Up to 58 cm (23") Uniform

DVT60L DVT60L Bariatric Calf Garment Up to 81 cm (32") Uniform

TRP10 Tri Pulse TRP10 Regular Calf Garment Up to 43 cm (17") Sequential

TRP20 Tri Pulse TRP20 Large Calf Garment Up to 58 cm (23") Sequential

TRP60L Tri Pulse TRP60L Bariatric Calf Garment Up to 81cm (32") Sequential

Type Calf

Circumference

Therapy

CALF & THIGH GARMENTS

Order

Code

DVT30 DVT30 Standard Thigh Garment Up to 71cm (28") Uniform

L503-M L503-M Standard Thigh Garment Up to 71cm (28") Uniform

DVT40 DVT40 Large Thigh Garment Up to 89cm (35") Uniform

TRP30 Tri Pulse TRP30 Regular Thigh Garment Up to 71cm (28") Sequential

Type Thigh

Circumference

Therapy

TRP40 Tri Pulse TRP40 Large Thigh Garment Up to 89cm (35") Sequential

FOOT GARMENTS

Order

Code

FG100 Foot Garment - Regular UK Men/Women up to size 7

FG200 Foot Garment - Large UK Men/Women size 7½ or above

Type Shoe Size Therapy

Uniform

US Women up to size 9

US Men up to size 7

EURO up to size 40

Uniform

US Women size 9½ or above

US Men size 7½ or above

EURO size 41 or above

28

9. Technical Specification

Pump Specification

PUMP

Part numbers 526000-XX

526000-17/18 (KSA)

Supply Voltage (V) 100 - 230V

230V (KSA)

Supply Frequency (Hz) 50 - 60Hz

60Hz (KSA)

Power Input 10 - 40 VA

Size 230 x 228 x 190 mm (9.1 x 9.0 x 7.5 in.)

Weight 4.1 kg (9.0 lb)

a. Configuration: STD is the Standard pump which has a standard length tubeset (2.1 m / 7 ft).
OR is the Operating Room pump which has a longer tubeset (4 m / 13 ft long).

Case Material Flame Retardant ABS Plastic

Mains Power Plug
Fuse Rating

Degree of protection
against electric
shock

Degree of protection
against liquid
ingress

Mode of operation Continuous

Pressure Range Foot Garment: 130 ± 10 mmHg

5A to BS1362 (UK ONLY)

Class II, Double Insulated
Type BF

IPX3 - Protected against spraying water

Uniform (DVT) Calf and Calf & Thigh Garments: Range: 35 - 65 ± 5 mmHg

Factory Default: 40 ± 5 mmHg

Sequential (Tri Pulse) Calf and Calf & Thigh Garments: 45 ± 5 mmHg

ENVIRONMENTAL INFORMATION

Condition Temperature Range Relative Humidity Atmospheric Pressure

Operating +10 °C to +40 °C

(+50 °F to +104 °F)

Storage and Transport
(Long Term)

Storage and Transport
(Short Term)

+10 °C to +40 °C

(+50 °F to +104 °F)

-20 °C to +50 °C

(-4 °F to +122 °F)

30% to 75%

(non-condensing)

20% to 95%

(non-condensing)

20% to 95% 500 hPa to 1060 hPa

700 hPa to 1060 hPa

700 hPa to 1060 hPa

 If the pump is stored in conditions outside of the “Operating” ranges, it should be allowed time to stabilise at

normal operating conditions before use.

29

Electromagnetic Compatibility

Product has been tested for compliance with current regulatory standards
regarding its capacity to block EMI (electromagnetic interference) from external
sources.

Some procedures can help reduce electromagnetic interferences:

• Use only Arjo cables and spare parts to avoid increased emissions or
decreased immunity which can compromise the correct functioning of the
equipment.

• Ensure that other devices in patient-monitoring and/or life-support areas
comply to accepted emissions standards.

WARNING

Wireless communications equipment such as wireless computer
network devices, mobile phones, cordless telephones and their base
stations, walkie-talkies, etc. can affect this equipment and should be kept
at least 1.5m away from the equipment.

Intended Environment: Home Healthcare Environment and Professional
Healthcare facility environment.

Exceptions: HF Surgical Equipment and the RF Shielded room of an ME
SYSTEM for magnetic resonance imaging

WARNING

Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.

Guidance and manufacturer’s declaration - electromagnetic emissions

Emissions Test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/
flicker emissions

Group 1 This equipment uses RF energy only for its

internal functions. Therefore its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.

Class A

This equipment is suitable for use in all

Class A

Complies

establishments, other than domestic
establishments and those directly connected to
the public low voltage power supply network that
supplies buildings used for domestic purposes.

IEC 61000-3-3

30

Guidance and manufacturer’s declaration - electromagnetic immunity

Immunity Test IEC 60601-1-2

Test Level

Electrostatic
discharge
(ESD)

EN 61000-4-2

Conducted
disturbances
inducted by RF
fields

EN 61000-4-6

Radiated RF
electromagnetic
field

EN 61000-4-3

±2kV, ±4kV, ±8kV,
±15kV air

±8kV contact

3V in 0,15 MHz to
80 MHz

6V in ISM and
amateur radio
bands between
0,15 MHz and 80
MHz

80% AM at 1 kHz

Home Healthcare
environment

10 V/m

80 MHz to 2,7 GHz

80% AM at 1 kHz

Compliance

Level

±2kV, ±4kV,
±8kV, ±15kV
air

±8kV contact

3V in 0,15
MHz to 80
MHz

6V in ISM
and amateur
radio bands
between
0,15 MHz
and 80 MHz

80% AM at 1
kHz

Home
Healthcare
environment

10 V/m

80 MHz to
2,7 GHz

80% AM at 1
kHz

Electromagnetic environment - guidance

Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material the relative humidity level should be
at least 30%

Portable and mobile RF communications
equipment should be used no closer to any
part of the product, including cables, than

1.0m, if the transmitter’s output power rating

exceeds 1W
transmitters, as determined by an
electromagnetic site survey, should be less
than the compliance level in each frequency

range

Interference may occur in the vicinity of
equipment marked with this symbol:

a

Field strengths from fixed RF

b

Electrical fast
transient/burst

EN 61000-4-4

Power
frequency
Magnetic field

EN 61000-4-8

±1kV SIP/SOP
ports

±2kV AC port

100 kHz repetition
frequency

30 A/m 30 A/m Power frequency magnetic fields should be

±1kV SIP/
SOP ports

±2kV AC port

100kHz
repetition
frequency

Mains power supply should be that of a
typical commercial or hospital environment.

at levels characteristic of a typical location in
a typical commercial or hospital environment.

31

Guidance and manufacturer’s declaration - electromagnetic immunity

Surge

IEC 61000-4-5

Voltage dips,

short
interruptions
and voltage
variations

on power supply

input lines

IEC 61000-4-11

±0,5kV ±1kV; ±2 kV,
AC Mains, Line to
Ground

±0,5kV ±1kV, AC
Mains, Line to Line

0 % UT; 0,5 cycle

At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°

0 % UT; 1 cycle

and 70 % UT;

25/30 cycles

Single phase: at 0°

±0,5kV ±1kV;
±2 kV, AC
Mains, Line
to Ground

±0,5kV ±1kV,
AC Mains,
Line to Line

0 % UT;

0,5 cycle

At 0°, 45°,
90°, 135°,
180°, 225°,
270° and
315°

0 % UT;

1 cycle and

70 % UT;

25/30 cycles

Single
phase: at 0°

Mains power quality should be that of

a typical commercial or hospital

environment.

Mains power quality should be that of

a typical commercial or hospital

environment.

If the user of the pump requires

continued operation during power

mains interruptions, it is

recommended that the pump be

powered from an uninterruptible

power supply or a battery.

0 % UT; 250/300
cycle

Note: UT is the AC mains voltage prior to application of the test level.

a

Field 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 product is used exceeds the applicable RF compliance level above, the product
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.

0 % UT;

250/300
cycle

32

Symbols

E348583

(2008) + (2014)

ANSI/AAMI ES 60601-1

(2005) +AMD (2012)

i

CE marking indicating
conformity with European
Community harmonised
legislation
Figures indicate Notified
Body supervision.

The operator must read this
document (Instructions for
Use) before use.
Note: This symbol is blue
on the product label.

Indicates the product is a
Medical Device according
to EU Medical Device
Regulation 2017/745

Refer to this document
(Instructions for Use) for a
description of the product
classification (2nd Edition).

Manufacturer: This symbol
is accompanied by the
name and the address of
the manufacturer.

IPX3

With respect to electric
shock, fire and
mechanical hazards only
in accordance with CAN/
CSA-C22.2 No. 60601.1
(2008) + (2014).
ANSI/AAMI ES 60601-1
(2005) +AMD (2012)

MEDICAL
EQUIPMENT

Refer to this document
(Instructions for Use)
for a description of the
product classification
(3rd Edition).

Degree of protection
against liquid ingress:
Protected against
spraying water.

Power
Note: Pump is not
isolated from mains
power supply.

Date of Manufacture in
Year-Month-Day
format.

Serial
Number

Model
Number

Type BF

Double

Insulated

Do not
dispose of in
the domestic
refuse.

(a)

Rx Only

Temperature Limits
(Typically +10°C minimum
to +40°C maximum).

Humidity Limits
(Typically 20% minimum to
95% maximum).

Caution: US Federal law
restricts this device to sale
by or on the order of a
physician.
Note: Applicable to the
USA market only.

When the garment is
placed on the leg, the arrow
must point to the heel.

Indicates that the cutout in
the garment must be
positioned behind the knee.

Shows position on calf for
garment size
measurement.

Non-ionising
electromagnetic
radiation.

Do not use if package
is damaged.

Sterilised using
ethylene oxide.

Shows position on foot
for garment size
measurement.

Shows position on
thigh for garment size
measurement.

Use by date.

Alternating
Current

Batch code.

Do not stand
or walk.

Latex free

Do not
re-use.

a. Based on the UL mark, this pump is considered to be electrically safe. Double insulated products rely on

two independent electrical insulation systems that are isolated from metal parts. Grounding is not required,
and the pump shall not be modified to ground the pump.

33

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AUSTRALIA
Arjo Australia
Building B, Level 3
11 Talavera Road
Macquarie Park, NSW, 2113,
Australia
Phone: [phone]

BELGIQUE / BELGIË
Arjo Belgium
Evenbroekveld 16
9420 Erpe-Mere
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

BRASIL
Arjo Brasil Equipamentos Médicos Ltda
Rua Marina Ciufuli Zanfelice, 329 PB02
Galpão - Lapa
São Paulo – SP – Brasil
CEP: 05040-000
Phone: [phone]
E-mail: [e-mail]
E-mail: [e-mail]

CANADA
Arjo Canada Inc.
90 Matheson Boulevard West
Suite 300
CA-MISSISSAUGA, ON, L5R 3R3
Tel/Tél: [phone]
Free: [phone] Institutional
Free: [phone] Home Care
Fax: [phone]
E-mail: [e-mail]

ý(6.È5(38%/,.$

Arjo Czech Republic s.r.o.
Na Strzi 1702/65
140 00 Praha
Czech Republic
Phone No: [phone]
e-mail: [e-mail]

'$10$5.

Arjo A/S
Vassingerødvej 52

'./<1*(

Tel: [phone]
Fax: [phone]
E-mail:
[e-mail]

DEUTSCHLAND
Arjo GmbH
Peter-Sander-Strasse 10

'(0$,1=.$67(/

Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

ESPAÑA
ARJO IBERIA S.L.
Poligono Can Salvatella
c/ Cabanyes 1-7
08210 Barberà del Valles
Barcelona - Spain
Telefono 1: [phone]
Telefono 2: [phone]

FRANCE
Arjo SAS
2 Avenue Alcide de Gasperi
CS 70133
FR-59436 RONCQ CEDEX
Tél: [phone]
Fax: [phone]
E-mail: [e-mail]

+21*.21*
$UMR+RQJ.RQJ/LPLWHG

Room 411-414, 4/F, Manhattan Centre,

.ZDL&KHRQJ5RDG.ZDL&KXQJ17
+21*.21*

Tel: [phone]
Fax: [phone]

ITALIA
Arjo Italia S.p.A.
Via Giacomo Peroni 400-402
IT-00131 ROMA
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

MIDDLE EAST
Arjo Middle East FZ-LLC

2ႈFHWK)ORRU
+4%XLOGLQJ1RUWK7RZHU

Dubai Science Park,
Al Barsha South
P.O Box 11488, Dubai,
United Arab Emirates
Direct [phone]
Fax [phone]
Email: [e-mail]

NEDERLAND
Arjo Nederland BV

%LH]HQZHL

4004 MB TIEL
Postbus 6116
4000 HC TIEL
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

NEW ZEALAND
Arjo Ltd
34 Vestey Drive
Mount Wellington

1=$8&./$1'

Tel: [phone]
Free Call: 0800 000 151
Fax: [phone]
E-mail: [e-mail]

NORGE

$UMR1RUZD\$6

Olaf Helsets vei 5
N-0694 OSLO
Tel: [phone]
Faks: [phone]
E-mail: [e-mail]

ÖSTERREICH
Arjo GmbH
Lemböckgasse 49 / Stiege A / 4.OG
A-1230 Wien
Tel: [phone]
Fax: [phone]

32/6.$

Arjo Polska Sp. z o.o.

XO.V3LRWUD:DZU]\QLDND
3/.20251,.,3R]QDĔ

Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

PORTUGAL
Arjo em Portugal
MAQUET Portugal, Lda.
(Distribudor Exclusivo)
Rua Poeta Bocage n.º 2 - 2G
PT-1600-233 Lisboa
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

SUISSE / SCHWEIZ
Arjo AG
Fabrikstrasse 8
Postfach
CH-4614 HÄGENDORF
Tél/Tel: [phone]
Fax: [phone]

SUOMI
Arjo Scandinavia AB
Riihitontuntie 7 C
02200 Espoo
Finland
Puh: [phone]

(PDLO$VLDNDVSDOYHOX¿QODQG#DUMRFRP

SVERIGE
Arjo International HQ
Hans Michelsensgatan 10
SE-211 20 MALMÖ
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

81,7('.,1*'20
$UMR8.DQG,UHODQG

Houghton Hall Park
Houghton Regis

8.'8167$%/(/8;)

Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

USA
Arjo Inc.
2349 W Lake Street Suite 250
US-Addison, IL 60101
Tel: [phone]
Free: [phone] Institutional
Free: [phone] Home Care
Fax: [phone]
E-mail: [e-mail]

JAPAN

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ϧϱυΡρέ୊ލό໵ϑϩ֌

Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

www.arjo.com

Address page Rev 26 • 11/2020

At Arjo, we are committed to improving the everyday lives of people affected by reduced mobility and age-related health challenges.

526933EN

With products and solutions that ensure ergonomic patient handling, personal hygiene, disinfection, diagnostics, and the effective
prevention of pressure ulcers and venous thromboembolism, we help professionals across care environments to continually raise

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ArjoHuntleigh AB
Hans Michelsensgatan 10
211 20 Malmö, Sweden

www.arjo.com