ARJO HUNTLEIGH Flowtron ACS800 Bedienungsanleitung

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.

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).

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

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.

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,

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