Harvest Healthcare WOBURN 6, WOBURN LOW 4 General User Manual

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General User/ Safety Guide

WOBURN 6 AND
WOBURN LOW 4

PROFILING BEDS

www.harvesthealthcare.co.uk

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WARNINGS

TROUBLE SHOOTING

SERVICING

- Principles

- List of Technical Safety Checks according to EN 62353

- Checking the Initial Fault Safety by means of the Integrated Control Box in
the Handset

- Measurement of Overall Electrical System

GUARANTEE

SERVICE LIFE & DISPOSAL

TECHNICAL SPECIFICATION

- Technical Data (Mechanical)

- Technical Data (Electric)

- Technical Data (Surroundings)

- Classication

- Weights of the Individual Components

- Type Plate

- Information about electromagnetic emissions

DECLARATION OF CONFORMITY

DATE OF PURCHASE

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CONTENTS

FOREWORD

GENERAL INFORMATION

- Explanation of the Symbols Used

- Denition of the Groups of Persons Involved

Intended Purpose

- Uses for the Purpose Intended (Application Environment)

- Non-compliant Use

General Regulations for Users

- Qualication of Users
Safety Instructions

- General Safety Instructions

- Safety Information for the Operator

- Safety Information for the User

- Cleaning and Disinfection

- Servicing and Maintenance

- Accessories

- Electromagnetic Compatibility

- Transport and Storage

- Service Life and Disposal

PRE-INSTALLATION CHECK

INSTALLATION AND COMMISSIONING

- Removal from the Transporting Device

- Assembly of the Care Bed

- Connecting the Care Bed to the Mains Supply

- Placing into service

- Disassembly of the Care Bed

DESCRIPTION OF FUNCTIONS

- Bed Overview

- Handset with Locking Function

- Locking Function for Handset

- Operation of the Castors

- Electric Emergency Lowering via the Integrated 9V Battery

- Position and Principle of Operation

- Battery Change

OPTIONAL EXTRA

- In-Built Extension

- Auto-Regression

CARE, CLEANING & DISINFECTION

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8
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9
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11
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12
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13
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14

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1

1.1

1.2

2

2.1

2.2

3

3.1

4

4.1

4.2

4.3

4.4

4.5

4.6

4.7

4.8

4.9

5

6

6.1

6.2

6.3

6.4

6.5

7

7.1

7.2

7.3

7.4

7.5

7.5.1

7.5.2

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8.1

8.2

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11

11.1

11.2

11.3

11.4

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13

14

14.1

14.2

14.3

14.4

14.5

14.6

14.7

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CAUTIONS &
WARNINGS

FOREWORD

Dear Customer,

Myself and the team at Harvest Healthcare would like to thank you for the condence you

have placed in our Woburn care bed.

With your decision to buy a care bed from Harvest Healthcare, you have a product with a high
degree of functionality and the highest level of safety. With the care bed you have purchased,
we can guarantee maximum comfort and a professional standard of care.

All beds are scrupulously tested by our company before leaving our premises.

The care bed delivered to you left our factory in perfect condition. When you accept delivery
of the care bed, the responsibility for proper use according to the purpose intended passes to
you.

This instruction manual informs you as the operator and your users about the functions and
safe handling of this care bed on a daily basis. Please keep the instruction manual near the
care bed at all times.

We are condent that this product will play an important role in caregiving.

Yours sincerely,

Bruce McEwan
Sales Director
Harvest Healthcare Ltd.

READ THIS INSTRUCTION MANUAL AND OBSERVE SAFETY
INSTRUCTIONS.

CAUTION

Please read and observe this instruction manual before each use. In the event the care bed
changes owners, please supply this instruction manual to the new owner.

When the bed is moved on the transport frame take care not to allow it to overbalance. The
narrow, tall design saves storage space but may tip over if handled carelessly.

Please check all xings on your bed at least once a month. Pay special attention to sleeping

platform connections.

Before cleaning and disinfection, the mains plug must be disconnected and hung up safely.
Plugs for the handset and the motors which are inserted into the mattress base control box
and the motor unit must remain plugged in. This is necessary to prevent water ingress to the
control box.

Do not sit on the leg section of the bed when operating the raise function.

Ensure the recommended service and maintenance schedule in this manual is completed.

Failure to do so could invalidate warranty claims.

WARNING

The side rail guards are designed to prevent a person falling out of bed; under no
circumstances should they be climbed or leaned upon.

When lowering the rails, take care not to drop them - they should be lowered carefully.

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GENERAL INFORMATION GENERAL INFORMATION

1 GENERAL INFORMATION

Read through this instruction manual conscientiously

Please note in particular that the various safety instructions must be
observed

Clean and disinfect the care bed before rst use

BEFORE USING THIS BED FOR THE FIRST TIME:

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Harvest Healthcare care beds bear the CE mark and meet all safety and functionality
requirements. These care beds were tested according to the international standards which
contain the safety requirements for medical products. These safety requirements can only

be met however if the user satises himself of the proper state of the care bed (including

accessories) before using the bed.

Please observe the legislation in your country.

1.1 EXPLANATION OF THE SYMBOLS USED

This care bed may only be used indoors

This product must be disposed of in a separate refuse collection in the European

Union. Do not dispose of as normal domestic waste.

Symbol for direct current.

Symbol for alternating current.

Maximum permissible load.

Maximum patient weight.

Read instructions

IPX4

Read information with this symbol carefully and urgently follow instructions. This

information is safety-relevant.

This symbol indicates hazards due to electrical voltage. There is mortal danger!

This symbol indicates general hazards. There is danger to life and health.

Conformity mark in accordance with the Medical Device Directive (93/42 EEC).

The electrical equipment is splash-proof.

Symbol for Protection Class II device, double shock-proof

Symbol for type B device according to DIN EN 60601-1.

1.2 DEFINITION OF THE GROUPS INVOLVED

OPERATOR

An operator is any person who uses the care bed or on whose instruction it is used (e.g.
nursing homes, specialised retailers, health insurance companies, medical suppliers).

USERS

Users are persons who, as a result of their vocational training, experience or brieng are

authorised to operate the care bed or to carry out work on it, or are instructed in handling the
bed. Furthermore the user can recognise and avoid potential dangers and assess the clinical
condition of the patient.

PATIENT / OCCUPANT

Persons in need of care, handicapped or inrm and occupying a care bed.

QUALIFIED PERSONNEL

Qualied personnel are employees of the operator who as a result of their vocational training
or brieng are entitled to deliver, assemble, disassemble and transport the care bed. In

addition, these persons are instructed in the cleaning and disinfection regulations for the care
bed.

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GENERAL INFORMATION GENERAL INFORMATION

2.1 USES FOR THE PURPOSE INTENDED (APPLICATION ENVIRONMENT)

This care bed is intended for accommodating patients or occupants (with body mass
≥150cm to max. 185kg for Woburn and Woburn Low) in residential homes, nursing homes
and in care in the home (application environments 3 and 4) and may only be used under the
conditions for use described in this Instruction Manual.

Any other use shall be regarded as non-compliant with the regulations and is excluded from
any liability.

ATTENTION: The care bed is not designed for use in hospitals.

The care bed is not suitable for medical electrical applications which involve intravascular
or intercardiac processes with the patient. The care bed is not designed for the transport of
patients.

Under certain conditions the care bed can be used for other medical purposes with medical
appliances such as antidecubitus mattresses, aerators, alimentation systems etc. In this
case all bed functions must be locked out with the nurse key on the handset for safety. The
medical appliance providers are liable for the compliance of the device with the directives of
IEC 60601-1-1.

If other electrical devices are used in the bed and to prevent the risk of an electrical shock,
protective measures and precautions must be established to prevent power cords from being
trapped and squeezed in movable parts of the bed.

2 INTENDED PURPOSE

2.2 NON-COMPLIANT USE

All uses deviating from the intended purpose, which may be hazardous as a result.
This includes for example:

• Loading the care bed beyond the safe admissible working load (see section 13.1
and identity label on bed frame).

• Operation of the care bed by patients or occupants who have not been instructed
in its use.

• Use of the care bed for children.

• Attempting to move the care bed when castors are braked.

• Use of the care bed on a non-horizontal surface (max. incline 5°).

3 GENERAL REGULATIONS FOR USERS

The care bed must only be used for the purpose intended. When setting up, operating and
using the care bed, respect the regulations in your country and the general recognised rules
of technology and the occupational health and safety and accident prevention regulations.
If the care bed is in a faulty state, in which the patient/occupant, care personnel or third
persons could be endangered, do not operate.

3.1 QUALIFICATION OF USERS

The care bed must only be operated by persons who have the corresponding training or
experience to enable them to handle the care bed correctly.

4.1 GENERAL SAFETY INSTRUCTIONS

Never store anything under the bed.

Ensure that children cannot operate the control system and check if pets are under
the bed before operating any of the function.
Do not sit on the leg section of the bed when operating the raise function.

During the brieng, specic attention must be drawn to any potential dangers

which can occur despite correct operation. Before putting the care bed into service

for the rst time, the Instruction Manual must be read in detail by the user / care

personnel.

When operating the adjusting functions, there must be no objects or people’s limbs
in the plane of movement of the care bed. Risk of crushing.

If the physical or mental state of the patient requires, the handset should be locked
on the reverse side of the handset when not in use (nurses’ key). See detailed
description of the locking operation at section 7.2. (it may be advisable to keep the
handset out of reach of such a patient to avoid the risk of strangulation with the
handset cord).

Adjustments to the bed must only be carried out by suitably instructed persons or
in the presence of an instructed person.

4 SAFETY INSTRUCTIONS

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GENERAL INFORMATION GENERAL INFORMATION

Unplug the mains plug from the socket before moving the care bed and take care

to avoid dragging the mains plug across the oor when moving the bed.

The mains plug must always remain accessible to enable immediate cut-off by
unplugging the mains plug from the wall socket in case of emergency. The mains
cable must be free and not caught in anything, as it gets carried along when the
bed height is adjusted. Otherwise, the mains cable may be torn out and damaged.
In addition, the mains plug may be pulled out of its socket and electric leads
exposed as a result. If the mains cable or the mains plug are damaged, the relevant
part must be replaced. This work should only be carried out by the manufacturer or
authorised professionals.

When connecting the mains plug do not use multiple sockets since liquids may

penetrate into these (re hazard and electric shock).

Before cleaning and disinfection the mains plug must be unplugged
and hung up safely. Plugs for the handset and the motors which are
inserted into the mattress base control box and motor unit must
remain plugged in. This is necessary to prevent water ingress into the
control box.

When the bed is stationary the castors must always be in the braked position. If
the castors are not braked, the bed can move when the occupant gets into and
out of bed, since the occupant uses the bed for support. Injury can result if the
care bed rolls away.

In order to move the care bed, the brakes on all four castors must be released and
the mattress base be adjusted to the lowest horizontal position.

The maximum duty cycle and the safe working load must not be exceeded
otherwise safe operation cannot be guaranteed (please refer to the Technical Data
in section 14).

The bed must not be used in rooms where there is a risk of explosion.

4.2 SAFETY INFORMATION FOR THE OPERATOR

With the help of this Instruction Manual, instruct each user in the safe operation of

this care bed before it is put into service for the rst time.

Advise the user of any hazards which may occur if not handled correctly.

Only persons who have been properly instructed may operate this care bed. This also applies
for persons who only operate the care bed on a temporary basis.

According to the Medical Products Act (German abbreviation: MPG, Medizinproduktgesetz),
care beds are Class I active medical products.

Please observe your obligations as the operator in accordance with the Operators
of Medical Products Ordinance (Medizinprodukte-Betreiberverordnung, German
abbreviation: MPBetreibV), in order to ensure the permanently safe operation of this medical
product with no risk of danger to patients, users or third parties. If the care bed is used on a
long-term basis, checks for proper functioning and for any visible damage must be performed
and documented at least once a year. There is section 10.2 for this purpose.

4.3 SAFETY INFORMATION FOR THE USER

Ensure that the operator instructs you in the safe operation of this bed.

In addition, pay particular attention to the general safety information as described in 4.1.
Adjustments of the bed must only be carried out by suitably instructed persons or in the
presence of an instructed person.

Make sure that the mattress base has travelled to its lowest position before leaving the patient
unattended. This will minimise the risk of injury to the patient when getting in or out of bed.

If there is a suspected fault or damage, unplug the mains plug from the socket. Clearly mark
the care bed as “Out of Order” and take it immediately out of service. Please inform the
person in charge without delay.

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4.4 CLEANING & DISINFECTION

Before cleaning and disinfection the mains plug must be unplugged
and hung up safely. Plugs for the handset and the motors which are
plugged into the control box must remain in their sockets. This is
necessary to prevent water from getting into the control system.

Do not immerse electrical components in water but wipe clean with a damp cloth.
The electrical components must not be cleaned with a high pressure cleaner or a
water jet! Only disinfection by wiping is allowed.

Always wear waterproof gloves when cleaning and disinfecting to avoid skin
irritation.

Attention: In the event of disinfection by spraying on a large scale with products

containing alcohol there is a danger of explosion and re.

4.5 SERVICING & MAINTENANCE

Servicing work must only be carried out by persons who have at least read the

safety regulations and are qualied according to the MPBetreibV (Operators of

Medical Products Ordinance) § 4 and 6.

A technical check and/or safety inspection must be conducted at least
once a year and after a lengthy break in use and before each further
use. See section 10..

Any defects, damage or signs of wear must be rectied without delay. Only original

spare parts from Harvest Healthcare Ltd may be used, otherwise all guarantees or
warranties will be excluded.

The 9V block battery is the energy store for electrical emergency lowering in the

event of a power failure. The energy store is sufcient for one emergency lowering

at the most and must then be replaced. If the expiry date of the battery has
elapsed, replace immediately. Since batteries are subject to self-discharging, it is
recommended the battery is replaced every two years if not used. Ensure it is a
type 6LR61 alkaline manganese battery and not any other type. Used batteries
must be disposed of in an environmentally compatible way.

Please check all xings on your bed at least once a month. Pay special

attention to sleeping platform connections.

GENERAL INFORMATION GENERAL INFORMATION

4.6 ACCESSORIES

The optional accessories available include a patient lifting pole of which the safe working load
of 80 kg must not be exceeded. The lifting pole may only be used within its admissible

adjusting range which is dened by the sleeve on the bed. Otherwise the bed may tip up and

result in serious injury.

4.7 ELECTROMAGNETIC COMPATIBILITY

Regarding their emitted interference and interference resistance the electric motor units
comply with the requirements of EN 60601-1-2:2007 (see section 13.7). But it is possible
that electrical devices interfere with each other. In this case switch off the care bed for a
short time or remove the interference source. We refer to the paper of the BfArm reference n°
9/0508 (Bundesinstitutfür Arzneimittel und Medizinprodukte).

4.8 TRANSPORT & STORAGE

4.9 SERVICE LIFE & DISPOSAL

The normal service life for care beds in domestic use is approximately 5 years. The
care bed must not be disposed of as normal domestic waste after its service life
has expired. To ensure that it is disposed of in an environmentally compatible way
please contact Harvest Healthcare Ltd.

The care bed can be easily transported
on the transport rack. It can be
maneuvered in very small spaces on the
bed’s castors.

If the bed is stored for a lengthy
period, the 9V block battery should be
removed, as otherwise it would
discharge.

State as delivered

(in cover)

Care bed on the
transport device

When the bed is moved on the transport frame take care not to allow it to
overbalance. The narrow, tall design saves storage space but may tip over
if handled carelessly.

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INSTALLATION INSTALLATION

5 PRE-INSTALLATION CHECK

A

B

D

E

F

Backrest section with mounted
actuator & control box

Legrest section with mounted
kneebreak actuator

2x height adjustable bed ends with
mounted actuators & castors

A

B

C

Power supply with cord and plug

Handset with locking device

4 piece wooden sideguards with 8
plastic cap ends

F

After unpacking check the following parts are present:

On delivery and before installation check that the packaging is
undamaged. Report any visible damage to the transport company
immediately.

6 INSTALLATION & COMMISSIONING

Harvest Healthcare Ltd recommends that a risk assessment is
completed by the Operator before this bed is assembled.

G

Lift the cover from the bed unit and
transporting device.

Please do not dispose of the cover. It
can be used again as a dust cover in the
event that the care bed is later stored in
the transport rack.

Do not remove the cardboard protection from the top of the headboard
/footboard sections at this time as it will protect the bed during
assembly.

Lift the foot end mattress base section out of the transporting device. To prevent ngers getting

trapped please hold the bed section on the inside of the platform section and not on the outer
frame (see images).

Lay the platform section face down, on the oor.

Bed as delivered

Care bed on

transport device

6.1 REMOVAL FROM THE TRANSPORT DEVICE

C

D

E