Huntleigh Hydroven 3 Manual de usuario

INSTRUCTIONS FOR USE

Hydroven 3

779344EN-4 04/20222

Contents

1. Safety ...................................................................................................3

1.1 Warnings................................................................................................... 3

2. Electromagnetic Compatibility...........................................................5

3. Introduction .........................................................................................8

3.1 About this Manual.................................................................................... 8

3.2 Intended Use ............................................................................................ 8

3.3 About the Hydroven 3 system ................................................................ 8

3.4 Use Environment ..................................................................................... 8

4. Clinical Applications ...........................................................................9

4.1 Indications................................................................................................ 9

4.2 Contraindications .................................................................................... 10

5. Preliminary Checks .............................................................................11

6. Clinical Treatment Guide ....................................................................12

7. Garment and Insert Information.........................................................13

7.1 Garment Description ............................................................................... 13

7.2 Selecting the correct Garment................................................................ 13

7.3 Applying the Garment ............................................................................. 14

8. Operation .............................................................................................16

8.1 Pump Description .................................................................................... 16

8.2 Operation.................................................................................................. 17

8.2.1 To Adjust the Pressure Control Knob Position ................................................................ 17

8.2.2 Switch On ....................................................................................................................... 17

8.2.3 To Set the Garment Pressure ......................................................................................... 18

8.2.4 Shut Down ...................................................................................................................... 18

8.2.5 To Remove the Garment................................................................................................. 18

9. Decontamination .................................................................................19

9.1 Cleaning.................................................................................................... 19

9.2 Chemical Disinfection ............................................................................. 19

9.3 Cleaning and Sterilising Garments ........................................................ 19

Instructions For Use

10.Routine Maintenance ..........................................................................20

10.1 Hydroven 3 System.................................................................................. 20

10.1.1 Maintenance ................................................................................................................. 20

10.1.2 Servicing ....................................................................................................................... 20

10.1.3 Service Period............................................................................................................... 20

10.2 Hydroven 3 Pump .................................................................................... 20

10.2.1 General Care, Maintenance and Inspection..................................................................20

10.2.2 Serial Labels ................................................................................................................. 20

11.Trouble Shooting.................................................................................21

12.Accessories .........................................................................................22

13.Specications .....................................................................................24

13.1EquipmentClassication....................................................................... 24

13.2 General ..................................................................................................... 24

13.3 Environmental.......................................................................................... 25

13.4 Standards Compliance ............................................................................ 25

14.Product Labelling ................................................................................26

15.End of Life Disposal............................................................................28

16.Warranty & Service..............................................................................29

16.1 Service Returns........................................................................................ 29

3Instructions For Use

1. Safety

Before using this equipment, please study this manual carefully and

familiarise yourself with the controls, display features and operation.

Ensure that each user fully understands the safety and operation

of the unit, as mis-use may cause harm to the user or patient, or

damage to the product.

Please keep these Instructions for Use to hand for future reference.

Symbols

General Warning/Cautions Follow Instructions for Use

1.1 Warnings

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

misuse the Hydroven 3 system. Failure to observe this caution could result in injury, or

in extreme cases, death.

WARNING: A possible explosion hazard exists if used in the presence of

ammableanaesthetics.

WARNING: Do not mount the unit directly above the patient. Locate the

unit so that it will not cause harm should it fall.

WARNING: Do not operate the unit from the mains supply if the mains

cable is damaged.

WARNING: Do not immerse any portion of the unit in water or other

liquids.

WARNING: Use only recommended accessories listed in this manual.

WARNING: If this product is connected to another item of electrical

equipment, it is important that the system is fully compliant with

EN60601-1.

WARNING: It is the responsibility of the care giver to ensure that the user

can use this product safely.

WARNING: 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.

Instructions For Use

WARNING: 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modicationofthis

equipment is allowed.

WARNING: 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.

WARNING: Disconnect the pump from the mains power socket before

cleaning and inspecting.

WARNING: Only the pump and garment/insert combination as indicated

by Huntleigh should be used. The correct function of the product cannot

be guaranteed if incorrect pump and garment combinations are used.

WARNING:Bagssuppliedwiththisequipmentmaypresentasu󰀨ocation

risk;toavoidtheriskofsu󰀨ocation,keepthebagsawayfrombabiesand

small children.

CAUTION:Donotexposethesystemtonakedames,suchascigarettes,

etc.

CAUTION: Do not store the system in direct sunlight.

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

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

CAUTION: Pets and children must be supervised in the vicinity of the

system.

Caution (applicable to the USA market only)

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

physician.

Service Life

This has been dened as the minimum time period during which the device is expected

to remain safe and suitable to meet its intended use, and all risk control measures

remain e󰀨ective.

Huntleigh Healthcare Ltd’s commitment is that the expected service life for this Device

has been dened as 7 years.

5Instructions For Use

2. Electromagnetic Compatibility

Make sure the environment in which Hydroven 3 is installed is not subject to strong

sources of electromagnetic interference (e.g. radio transmitters, mobile phones).

This equipment generates and uses radio frequency energy. If not installed and used

properly, in strict accordance with the manufacturer’s instructions, it may cause or

be subject to interference. Type-tested in a fully congured system, complies with

EN60601-1-2, the standard intended to provide reasonable protection against such

interference. Whether the equipment causes interference may be determined by turning

the equipment o󰀨 and on. If it does cause or is a󰀨ected by interference, one or more of

the following measures may correct the interference:

• Reorienting the equipment

• Relocating the equipment with respect to the source of interference

• Moving the equipment away from the device with which it is

interfering

• Plugging the equipment into a di󰀨erent outlet so that the devices are

on di󰀨erent branch circuits

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

normal operation must be checked before use.

Guidance and Manufacturer’s declaration - electromagnetic emissions

The Hydroven 3 is intended for use in the electromagnetic environment specied below. The customer or the

user of the Hydroven 3 should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - guidance

RF emissions

CISPR 11

Group 1 The Hydroven 3 uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to cause

any interference in nearby electronic equipment.

RF emissions

CISPR 11

Class B The Hydroven 3 is suitable for use in all establishments, including

domestic establishments and those directly connected to the public

low-voltage power supply network that supplies buildings used for

domestic purposes.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage uctuations /

icker emissions

IEC 61000-3-3

Complies

Instructions For Use

Guidance and Manufacturer’s declaration - electromagnetic immunity

The Hydroven 3 is intended for use in the electromagnetic environment specied below. The customer or the

user of the Hydroven 3 should assure that it is used in such an environment.

Immunity Test IEC 60601 test

level

Compliance

level Electromagnetic Environment - guidance

Portable and mobile RF communications equipment

should be used no closer to any part of the Hydroven

3, including cables, than the recommended

separation distance calculated from the equation

applicable to the frequency of the transmitter.

Conducted RF

IEC 61000-4-6

3 Vrms

150kHz to 80MHz 3V d= 1.2 √ P

Radiated RF

IEC 61000-4-3

3 Vrms

80MHz to 2.5MHz 3V/m

d= 1.2 √ P80MHz to 800MHz

d= 2.3 √ P800MHz to 2.5GHz

where Pis the maximum output power rating of the

transmitter in watts (W) according to the transmitter

manufacturer and dis the recommended separation

distance in metres (m).

Field strengths from xed RF transmitters, as

determined by an electromagnetic site survey, a

should be less than the compliance level in each

frequency range b.

Interference may occur in the vicinity of the

equipment marked with the following symbol:

NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is a󰀨ected by

absorption and reection from structures, objects and people.

a Field strengths from xed 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 xed RF transmitters, an

electromagnetic site survey should be considered. If the measured eld strength in the location in which the

Hydroven 3 is used exceeds the applicable RF compliance level above, the Hydroven 3 should be observed

to verify normal operation. If abnormal performance is observed, additional measures may be necessary,

such as re-orienting or relocating the Hydroven 3.

b Over the frequency range 150kHz to 80kHz, eld strengths should be less than 3V/m.

7Instructions For Use

Recommended separation distances between portable and mobile RF communications equipment

and the Hydroven 3

The Hydroven 3 is intended for use in an electromagnetic environment in which radiated RF disturbances

are controlled. The customer or user of the Hydroven 3 can help prevent electromagnetic interference by

maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)

and the Hydroven 3 as recommended below, according to the maximum output power of the communications

equipment.

Rated maximum

output power of

transmitter

Separation distance according to frequency of transmitter

150kHz to 80MHz

d= 1.2 √ P

80MHz to 800MHz

d= 1.2 √ P

800MHz to 2.5GHz

d= 2.3 √ P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d

in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where Pis

the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is a󰀨ected by

absorption and reection from structures, objects and people.

Instructions For Use

3. Introduction

3.1 About this Manual

This manual is your introduction to the Hydroven®3 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 di󰀩culties in setting-up or using the Hydroven 3 system, contact your

local Huntleigh sales representative, listed at the end of this manual.

3.2 Intended Use

The intended use of this product is to manage the list of clinical conditions detailed in

the “Indications” section.

The Hydroven 3 system should be used as part of a prescribed plan of care detailed in

the “Indications” section.

3.3 About the Hydroven 3 system

The pump supplies air via connecting tubes to an inatable garment allowing the

application of controlled pressure to gently compress the limb. This action assists in

increasing the return of blood, excess uids, improves venous stasis and encourages

the reabsorption of waste products.

The pump operates on an automatically timed cycle of 3 minutes, 90 seconds ination

followed by 90 seconds deation. Variable pressure output ranges from 30-100 mmHg.

The garments are inated alternately.

The Hydroven 3 system operates two types of garments:

• Hydroven 1 garments have a single chamber and provide uniform

compression.

• Hydroven 3 garments have three chambers providing graduated

segmental compression, inating distally to proximally.

Optional garment inserts can be used to increase the circumference of the standard

arm and leg garments.

A full technical description of the Hydroven 3 system can be found in the Service

Manual, part No. SER0014, available from your local Huntleigh sales o󰀩ce.

3.4 Use Environment

Hydroven 3 is suitable for use in hospital, primary care and community settings. It must

not be used outdoors, or in any environment where it may come into contact with water.

9Instructions For Use

4. Clinical Applications

4.1 Indications

Intermittent Pneumatic Compression (IPC) is e󰀨ective in the treatment of the following

clinical conditions, when combined with an individualised monitoring programme:

• Oedema.

• Dependent (including secondary to cerebrovascular

incident, pregnancy or paralysis).

• Traumatic (post-surgical or injury).

• Lymphoedema.

• Primary and secondary (including post

surgery, radio or chemotherapy).

• Chronic venous insu󰀩ciency.

• Post phlebotic syndrome.

• Acute and chronic wounds including venous leg ulcers and post-

surgical wounds.

IPC may also be benecial in the management of:

• Fixed exion deformity.

• Arthritic conditions.

• Lower limb pain due to trauma or surgery.

• Lipoedema.

Selection should be based upon a holistic assessment of the patients’ individual care

needs.

Note: These systems represent one aspect of a treatment strategy;

if the patient’s condition changes the overall therapy regimen

should be reviewed by the prescribing clinician.

Note: The above are guidelines only and should not replace clinical

judgement

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