Harvest Healthcare Duke HR440 Installation and operating manual

[e-mail] www.harvesthealthcare.co.uk
1
General User/ Safety Guide
DUKE / DUKE EXTRA
REPLACEMENT
SYSTEM
ACTIVE MATTRESSES
www.harvesthealthcare.co.uk

T+44 (0)1709 377172 F+44 (0)1709 377173 [e-mail] www.harvesthealthcare.co.uk
23
CONTENTS
WARNINGS & CAUTIONS
GENERAL INFORMATION
1 DEFINITION OF THE GROUPS MENTIONED
2 NON-COMPLIANT USE
3 SAFETY INSTRUCTIONS
3.1 GENERAL SAFETY INSTRUCTIONS
3.2 SAFETY INFORMATION FOR THE OPERATOR
3.3 SAFETY INFORMATION FOR THE USER
3.4 SYMBOLS USED
3.5 CLEANING & DISINFECTION
3.6 SERVICING & MAINTENANCE
3.7 SERVICE LIFE & DISPOSAL
TECHNICAL SPECIFICATION
OVERVIEW
INSTALLATION
OPERATION
CLEANING & CARE
ROUTINE MAINTENANCE
PARTS LIST
TROUBLESHOOTING
EMC STATEMENT
GUARANTEES & WARRANTIES
DECLARATION OF CONFORMITY
4-5
6-10
7
7
7
7
8
8
9
10
10
10
11
12 -14
15-17
18-20
21-22
23-24
25
26-29
30-34
35
36-37

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45
WARNINGS &
CAUTIONS
READ THIS INSTRUCTION MANUAL AND OBSERVE SAFETY
INSTRUCTIONS.
WARNING
Disconnect the battery when not in use. Replace the battery if less than 12 Volts. Work
should only be undertaken by an authorised person.
This system must be properly installed and operated as directed by this user manual.
The system should be checked regularly to ensure correct operation. Loss of function
will remove all pressure relieving properties that this system provides.
This system is intended for use as part of a pressure ulcer prevention program; do not
rely solely on this device to achieve the result. The medical professional is responsible
for applying best medical judgment when using this system.
Select the correct setting for the occupant’s weight and therapy required (see pages
18-19). Care should be taken not to accidently change pressures once set as the
effectiveness of the therapy may be reduced.
In order for alternating air pressure range to be effective, avoid placing objects on
the surface that may obstruct the movement of air between the cells. For the same
reason, discourage people from sitting on the edge or on the end of the mattress
whilst it is in use.
All hoses must be free of kinks, twists and must be properly connected and positioned
so as not to cause any obstruction.
Do not position the system in a way that prevents access to the disconnection device
(mains power plug).
Ensure the mains lead or pump cannot become trapped or crushed, e.g. by raising or
lowering of bed or bed rails or any other moving object.
Check the mains lead is damage free and positioned so as not to cause an
obstruction, or injury, e.g. Strangulation or trip hazard.
Ensure that the electricity supply is of the type stated on the pump unit.
Protect your system from open ames. Ensure that the system is not used in the
presence of ammable anaesthetics.
Do not place device on or near a heat source or cover pump with bedding.
Harvest Healthcare advise against smoking whilst the system is in use, to prevent the
accidental ignition of associated items which may be ammable, such as bed linen.
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Do no expose the pump to liquids.
Do not use with hot water bottles or electric blankets.
Wireless equipment such as mobile phones should be kept at least 10ft / 3m away
from the system.
Do not allow sharp objects to puncture the mattress material.
The mattress and pump should be cleaned between patient uses.
Do not use bleach, chlorine releasing agents in concentrations over 1000 ppm,
solvents or alcohol-based cleansers, e.g. Phenicol, Hibiscrub, Clearsol, Stericol,
Hycoline as these will destroy the mattress material. Full cleaning instructions can be
found on page 21-22.
Suitable for continuous use.
Do not modify the mattress or pump unit in any way.
Do not connect to any other medical device or equipment.
Not for use in an oxygen enriched environment.
Not for use in an outdoor environment.
Store the system in a clean and dry environment, out of direct sunlight.
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Electrical equipment can be hazardous. Only authorised technical
personnel should remove the rear pump case for maintenance.
Removal of the case by unqualied personnel will invalidate the
warranty.
Before cleaning the unit ensure that the electrical supply to the pump
has been disconnected by removing the plug from the power supply.
Do not use this system for lifting the patient. This will damage the
system and could put the patient at risk.
This product is re rated. The mattress cover material on the
mattress is tested to BS7175:1989 Crib 5. The internal cells are
tested to BS EN 597-1:1995. Use of this product should be subject to
a risk assessment in which all hazards are considered.
WARNINGS &
CAUTIONS

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67
GENERAL
INFORMATION
The Duke System is an alternating pressure relieving mattress system used in the prevention
and treatment of pressure ulcers, and is recommended for use by a patient who is at risk from
developing pressure sores. The mattress is tted with a vapour permeable two way stretch
cover.
By using the established principles of alternating therapy, the Duke System offers the patient
comfortable and relaxing support that can both prevent tissue breakdown and enhance
healing.
The Duke Pump unit is lightweight and compact; its features include an audible and visual
low-pressure warning, intergrated battery backup and a manual pressure / comfort control
function.
The Duke Mattress is made up of 30 individual cells. 25 alternating air cells and 5 static cells
at the head end. The alternating cells are split into 2 sections - odd cells e.g. 1,3,5 etc and
even cells e.g. 2,4,6 etc. These two sections will alternate through a 10 minute cycle in which
time both sets of air cells will have inated and deated sequentially. All air cells are individually
replaceable should any damage occur.
The quick release 3 pipe connector complete with transport cap enables easy patient
transport arrangements. For rapid deation of the system simply twist open the CPR.
The Duke Extra Mattress is based on the Duke Replacement Mattress System with an
additional foam surround, suitable for wider beds The mattress has 25 alternating air cells and
3 static cells at the head end. Available in 1200mm and 1370mm width, the mattresses have
an increased maximum weight limit of 50 stones / 317 kg. The surround is visco topped for
comfort and can be used on a proling bed.
GENERAL INFORMATION
Read through this instruction manual conscientiously from start to nish.
Please note that the various safety instructions must be observed.
BEFORE USING THIS SYSTEM FOR THE FIRST TIME:
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Harvest Healthcare products bear the CE mark and meet all safety and functionality
requirements.
These safety requirements can only be met if the user is satised with the proper condition of
the product (including accessories) before use.
GENERAL
INFORMATION
1 DEFINITION OF THE GROUPS MENTIONED
OPERATOR
An operator is any natural or legal person who uses the equipment or on whose instruction
it is used (e.g. nursing homes, specialised retailers, health insurance companies, medical
suppliers).
USER / CARE PERSONNEL
Users are persons who as a result of their vocational training, experience or brieng are
authorised to operate the equipment.
Furthermore, the user/ care personnel can recognise and avoid potential dangers and assess
the clinical condition of the service user.
PATIENT / OCCUPANT / SERVICE USER
The person in need of care, handicapped or inrm.
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 product.
2 NON-COMPLIANT USE
All uses deviating from the intended purpose, which may also be hazardous as a result.
This includes for example:
• Incorrect installation.
• Operation by persons who have not been instructed in its use.
• Using the system with non-approved parts/accessories.
• Using the system if any of the components are damaged or faulty.
3.1 GENERAL SAFETY INSTRUCTIONS
During the brieng, specic attention must be drawn to any potential dangers
which can occur despite correct operation. Before putting the product into service
for the rst time, the Instruction Manual must be read conscientiously and in detail
by the user / care personnel.
3 SAFETY INSTRUCTIONS

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89
GENERAL
INFORMATION
This symbol indicates general hazards. There is a danger to life and health.
Danger acid, including battery acid.
Danger risk of explosion,
Conformity mark in accordance with the Medical Device Directive (93/42 EEC).
The symbol for Protection Class II device, double insulated.
The symbol for type B device according to EN 60601-1.
Handle with care
This way up
Keep dry
Recycling symbol. Refers to packaging that can be recycled (cardboard)
Fragile, handle with care
This product must be disposed of in a designated refuse bin for waste
electronic devices (WEEE) in the European Union. Do not dispose of as normal
domestic waste.
Symbol for direct current.
This product may only be used indoors.
IP: Ingress protection (protection from vertically dripping water)
Wear protective goggles.
No smoking. No naked ames.
Children should not be allowed to play with or attempt to open this battery.
Read instructions / consult manufacturers guide
3.4 SYMBOLS USED
IPX1
GENERAL
INFORMATION
The mains cable must be free and not be allowed to be caught up in the bed’s
moving mechanisms. The mains cable may be torn out of its strain relief and
damaged or it 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 be carried out by the manufacturer or authorised
service agents.
When connecting the mains plug do not use multiple sockets since liquids may
penetrate into these (re hazard and electric shock).
3.2 SAFETY INFORMATION FOR THE OPERATOR
With the help of this Instruction Manual, instruct each user in the safe operation of
this system 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 system. This
also applies for persons who only operate the system on a temporary basis.
3.3 SAFETY INFORMATION FOR THE USER
Ensure that the operator instructs you in the safe operation of this system.
In addition, pay particular attention to the Warnings and Cautions (page 4-5) and the general
safety information as described in 3.1.
If there is a suspected fault or damage, unplug the mains plug from the socket and follow
the power down procedure (page 19). Clearly mark “Out of Order” and take out of service
immediately, and inform the person in charge without delay.
Programming of the system should be carried out by competent trained personnel.
Use only spares and accessories supplied or approved by Harvest Healthcare.
Only suitably trained personnel are allowed to operate the system.