ARJO HUNTLEIGH FLOWTRON UNIVERSAL Bedienungsanleitung

FLOWTRON UNIVERSAL

Instructions for Use

...with people in mind

0086

(i)

Contents

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

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

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

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

About Flowtron Universal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Clinical Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Guidelines and Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Garment Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Typical garment options and therapy parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Recommended Checks: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

To Use One Garment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

To Use Different Garments on Each Limb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Settings Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Connecting the Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Battery Pack in Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Battery Storage and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Checking the Status of the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Recharging the Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Alternative Method of Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Flowtron Universal System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Flowtron Universal Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Serial Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Technical Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

(ii)

(iii)

GENERAL SAFETY

Before you connect the system pump to a mains socket, read carefully all the installation

instructions contained within this manual.

The system has been designed to comply with regulatory safety standards including:

• EN60601-1:1990/A13:1996 and IEC 60601-1:1988/A2:1995

• UL60601-1, UL2601-1 and CAN/CSA C22.2 No. 601.1-M90

• EN60601-1:2006 and IEC 60601-1:2005

• AAMI/ANSI ES60601-1:2006 and CAN/CSA C22.2 No.60601.1(2008)

Safety Warnings

• It is the responsibility of the care giver to ensure that the user can use this product

safely.

• Make sure that the mains power cable and tubeset or air hoses are positioned to

avoid causing a trip or other hazard, and are clear of moving bed mechanisms or

other possible entrapment areas.

• Electrical equipment may be hazardous if misused. There are no user-serviceable

parts inside the pump. The pump's case must only be removed by authorised

technical personnel. No modification of this equipment is allowed.

• The mains power socket/plug must be accessible at all times. To disconnect the

pump completely from the electricity supply, remove the plug from the mains

power socket.

• Disconnect the pump from the mains power socket before cleaning and inspecting.

• Keep the pump away from sources of liquids and do not immerse in water.

• Do not use the pump in the presence of uncontained flammable liquids or gasses.

• Only the pump and garment/insert combination as indicated by ArjoHuntleigh

should be used. The correct function of the product cannot be guaranteed if

incorrect pump and garment combinations are used.

• The Flowtron® Universal system is NOT intended for use in the Home Healthcare

Environment (e.g. private dwellings or nursing homes).

Caution (applicable to the USA market only)

• US Federal law restricts this device to sale by or on the order of a physician.

Safety Warnings - Battery Pack (Optional)

The following instructions are important for the safe use of the battery pack and to

keep the user (resident/care giver) from harm:

• The battery pack BBP600 for the Flowtron® Universal is rechargeable.

• Only use the battery pack designed for use with the pump. If unsure, do not use the

battery pack. Make sure the battery pack belongs to the pump by comparing the

battery pack label with the“Technical Specification” on page 20. If the battery pack

type cannot be confirmed, contact your local ArjoHuntleigh office.

• Do not expose the battery pack or charger to open flames.

• Do not expose the battery pack connector to water.

• To avoid bodily injury, do not crush, puncture, open, dismantle or otherwise

mechanically interfere with the battery pack.

• Should the battery pack casing crack and cause contents to come in contact with

skin or clothing, rinse immediately with plenty of water.

(iv)

• If contents come in contact with the eyes, rinse immediately with plenty of water

and seek medical attention.

• Inhalation of the contents can cause respiratory irritation. Provide fresh air and

medical attention.

• Stop using the battery pack if any damage or deformation is noted. Contact your

local ArjoHuntleigh office before further use.

• Refer to the “Battery Storage and Disposal” on page 13 for the correct disposal and

recycling of the battery pack.

Precautions

For your own safety and the safety of the equipment, always take the following precautions:

• Do not expose the system to naked flames, such as cigarettes, etc.

• Do not store the system in direct sunlight.

• Do not use phenol-based solutions to clean the system.

• Make sure the system is clean and dry prior to use or storage.

Electromagnetic Compatibility (EMC)

This product complies with the requirements of applicable EMC Standards. Medical electrical

equipment needs special precautions regarding EMC and needs to be installed in accordance

with the following instructions:

• The use of accessories not specified by the manufacturer may result in increased

emissions by, or decreased immunity of, the equipment, affecting its performance.

• Portable and mobile radio frequency (RF) communications equipment (e.g. mobile/cell

phones) can affect medical electrical equipment.

• If this equipment needs to be used adjacent to other electrical equipment, normal

operation must be checked before use.

• For detailed EMC information contact ArjoHuntleigh service personnel.

Expected Service Life

The Flowtron® Universal has an expected service life of seven years. To maintain the

condition of the pump have the pump serviced regularly according to the schedule

recommended by your ArjoHuntleigh distributor.

Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse

the Flowtron Universal system. Failure to observe this caution could result in injury, or in

extreme cases, death.

Environmental Protection

Incorrect disposal of this equipment and its component parts, particularly batteries or other

electrical components, may produce substances that are hazardous to the environment. To

minimise these hazards, contact ArjoHuntleigh for information on correct disposal.

Design Policy and Copyright

® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. As our policy is

one of continuous improvement, we reserve the right to modify designs without prior notice.

The content of this publication may not be copied either whole or in part without the consent

of ArjoHuntleigh.

1. Introduction

About this Manual This manual is your introduction to the Flowtron®

Universal.

You must read and fully understand this manual before

using the system.

Use this manual to initially set-up the system, and keep

it as a reference for day-to-day routines and as a guide to

maintenance.

If you have any difficulties in setting-up or using the

Flowtron Universal system, contact your local

ArjoHuntleigh sales representative, listed at the end of

this manual.

Intended Use The intended use of this product is to prevent Deep Vein

Thrombosis (DVT). The garments are single use only. It

is not for use in the home healthcare environment.

The Flowtron Universal system should be used as part of

a prescribed plan of care (refer to “Indications” on

page 2).

About Flowtron

Universal

The pump automatically adjusts to the correct therapy

profile depending upon which garment type (foot, calf

or thigh length) is connected.

An optional battery pack is available which allows the

pump to be used independently of a mains power outlet.

The Flowtron Universal is intended for use ONLY in

Professional Healthcare Facilities (e.g. hospitals or

physicians’ offices).

A full technical description of the Flowtron Universal

system can be found in the Service Manual, part number

SER0009, available from your local ArjoHuntleigh

sales representative.

2. Clinical Applications

Indications The primary application of the Flowtron Universal

system is for the prevention of Deep Vein Thrombosis

(DVT), when combined with an individualised

monitoring programme.

These systems represent one aspect of a DVT strategy;

if the patient's condition changes the overall therapy

regimen should be reviewed by the prescribing clinician.

The above are guidelines only and should not replace

clinical judgement.

Depending on the garment type used, other clinical

applications are also appropriate.

The FG foot garment, in particular, has a wide range of

clinical applications.

Full details for clinical applications are included in the

packaging of every garment.

The type of garment used on an individual patient

must be specified by a physician.

Contraindications

DVT Calf / Thigh

Garments

The Flowtron Universal system, when used with the

DVT Calf / Thigh Garments, should not be used in the

following conditions:

1. Severe arteriosclerosis or other ischaemic vascular

diseases.

2. Severe congestive cardiac failure or any condition

where an increase of fluid to the heart may be

detrimental.

3. Known or suspected acute deep vein thrombosis,

thrombophlebitis or pulmonary embolism.

4. Any local condition in which the garments would

interfere, including:

• Gangrene

• Recent skin graft

• Dermatitis

• On untreated, infected leg wounds.

Foot Garments The Flowtron Universal system, when used with the

Foot Garments, should not be used in the following

conditions:

1. Severe congestive cardiac failure or any condition

where an increase of fluid to the heart may be

detrimental.

2. Known or suspected acute deep vein thrombosis,

thrombophlebitis or pulmonary embolism.

3. Any local condition in which the garments would

interfere, including:

• Gangrene

• Recent skin graft

• Dermatitis

• On untreated, infected leg wounds.

If you are unsure of any contraindications refer to

the patient’s physician before using the device.

Cautions 1. Proper garment application and connection to the

pump is essential.

2. Garments should be positioned in such a way that

they do not create any potential for constant

pressure points on the patient’s limb. Additional

care should be taken when placing the garments on

any deformed leg or foot, or on legs with significant

oedema.

3. Garments should be removed immediately if the

patient experiences tingling, numbness, or pain, and

the physician notified.

4. When used for DVT prevention, continuous

external pneumatic compression is recommended

until the patient is fully ambulatory. Uninterrupted

use of the Flowtron Universal system is

encouraged.

5. The Flowtron Universal system should be USED

WITH CAUTION on patients with:

• Insensitive extremities

• Diabetes

• Impaired circulation

• Fragile or impaired skin

These are guidelines only and should not replace

clinical judgement and experience.

Guidelines and Recommendations

General

Recommendations:

• While using the system, the patient’s limbs

should be checked during every shift, and more

often if the patient has known circulatory or skin

problems, or is diabetic.

• Note: Many patients are at risk for pressure

ulcers on the heel. Use of the foot garments does

not negate the necessity for heel protection and

proper skin care.

• Clinical judgment should be used to determine if

the patient’s skin condition requires additional

measures, or if the treatment should be

discontinued and alternative modalities used.

• ArjoHuntleigh does not recommend the use of

compression stockings with its system. If these

are ordered by the physician, the clinician should

ensure that the compression stockings are

properly measured, applied and worn by the

patient. Any compression stocking used should

be routinely checked to ensure continued proper

fit and application, in addition to assessing the

condition of the skin.

• Where appropriate patients should be instructed

in the proper use of the system, the purpose of

therapy and that any problems should be reported

to the nursing staff.

Loss of mains power will halt therapy.

DVT prophylaxis • The Flowtron Universal system should be

applied to the patient pre-operatively, prior to the

induction of anaesthesia.

• The system should be used continuously for no

less than 72 hours post-operatively or until the

patient becomes fully ambulatory.

• If the garment cannot be applied to the operative

limb during surgery, it may be applied to the limb

once the patient reaches the recovery unit.

• In the non-surgical patient, the system should be

initiated immediately the risk of DVT formation

is identified.

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