Harvest Healthcare AIR-TECH HHAIRT001 Installation and operating manual

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HYBRID MATTRESSES
www.harvesthealthcare.co.uk
General User/ Safety Guide
AIR-TECH
HYBRID MATTRESS

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CONTENTS
WARNINGS & CAUTIONS
GENERAL INFORMATION
TECHNICAL SPECIFICATION
OVERVIEW
INSTALLATION
OPERATION
CLEANING & CARE
ROUTINE MAINTENANCE
TROUBLESHOOTING
PARTS LIST
GUARANTEES & WARRANTIES
DECLARATION OF CONFORMITY
4-5
6-10
11
12 -13
14-15
16-17
18-19
20-21
22-25
26
27
28

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WARNINGS &
CAUTIONS
READ THIS INSTRUCTION MANUAL AND OBSERVE SAFETY
INSTRUCTIONS.
WARNING
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 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.
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 18-19.
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.
WARNINGS &
CAUTIONS

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GENERAL
INFORMATION
The Air-Tech Integrated Hybrid System is a pressure relieving mattress suitable for patients
at VERY HIGH RISK of obtaining pressure ulcer. Offering high levels of patient comfort, this
unique system has the facility to “step up” to the level of a dynamic mattress when clinically
required. Similarly, the mattress’s function can be downgraded as the patient’s condition
improves. These features make it particularly benecial for use within the patient’s home or
palliative care environment and help reduce logistic and decontamination costs.
The clinical benets of a single system are equally applicable to those of a modern
hospital setting. A higher maximum weight capacity, up to 39 stone (250kg), allows the
product to meet the modern challenges of those heavier clients. All component parts are
interchangeable and replaceable, maximising product life and reducing environmental impact.
The mattress consists of a foam head section and a series of 7 pairs of transverse air cells,
each containing a unique foam proled insert, which are in turn held within a foam U Core,
all protected by a vapour permeable waterproof cover. The transverse cells are arranged into
alternate pairs of A and B cells which are lled and emptied in sequence.
When used without a pump, the foam mattress maintains its pressure relieving properties.
When the pump is connected and is in alternating mode the mattress is able to offer similar
properties to a pressure relieving active (dynamic) system. The pump monitors the air
pressure within the mattress and in the event of mains supply failure or over or under ination
the audible/visual warning system will indicate. A CPR Valve located at the pump end of the
umbilical hose permits the rapid deation of the mattress in an emergency.
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.

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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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GENERAL
INFORMATION
3.3 SAFETY INFORMATION FOR THE USER
Ensure 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 switch the
pump unit off. Clearly mark “Out of Order” and take out of service immediately, and inform the
person in charge without delay.
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.

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This symbol indicates general hazards. There is a danger to life and health.
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.
No smoking. No naked ames.
Read instructions / consult manufacturers guide
3.4 SYMBOLS USED
GENERAL
INFORMATION

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GENERAL
INFORMATION
3.5 CLEANING & DISINFECTION
Do not immerse electrical components in water but wipe with a damp cloth only.
The electrical components must not be cleaned with a high-pressure cleaner or
water jet. Disinfection by wiping only is allowed.
Full cleaning and disinfection instructions can be found on pages 18-19.
3.6 SERVICING & MAINTENANCE
Servicing must only be carried out by qualied personnel.
A technical check and/or safety inspection must be conducted at least once a year
and after a lengthy break in use.
Any defects, damage or signs of wear must be rectied without delay. Only original
spare parts from Harvest Healthcare may be used, otherwise all guarantees or
warranties will be excluded.
See pages 20-21 for Routine Maintenance and Servicing.
3.7 SERVICE LIFE & DISPOSAL
Our Full Terms & Conditions including product warranties are available by request or can be
found on our website www.harvesthealthcare.co.uk.
PARTS AND DATA MAY UNDERGO FURTHER DEVELOPMENT AND
THEREFORE DEVIATE FROM THE DETAILS GIVEN.
The system must not be disposed of as normal domestic waste after its service life,
but 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.

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TECHNICAL
SPECIFICATION
AIR-TECH TECHNICAL SPECIFICATION
Product Code
Pump Model No.
Pressure Sore Risk Level
Minimum Patient Weight
Maximum Patient Weight
Inated Mattress Dimensions
Mattress Weight
HHAIRT001
HPU4
Very High Risk
5 Stone / 32 kg
39 Stone / 247 kg
2000 x 900 x 150 mm
14 kg
PUMP POWER REQUIREMENTS
Power Rating
Voltage
Noise Level
Fuse
Medical Classication
Safety Standards
10 Watts
220- 240 Volt / 50Hz
Approx. 25 dB (A)
TA1H250V
Type B Applied Part
EN 60601-1. EN 60601-1-2

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OVERVIEW
Air-Tech Cells
The Air-Tech has 7 pairs of independent
cells which can be individually removed
and replaced to allow for cost effective
repair and in-depth cleaning.
Combination of Foam Inside the Cells
Combining the comfort of a static mattress
with the pressure relief of alternating cells.
Our foam within cells technology enables the
mattress to be stepped up or down with or
without a pump.
Harvest 4 Pump
The pump has a moulded ABS case and
integrated bed hooks.
Feed Tubes
The Feed tubes are exible, durable
and have excellent anti-kink
properties.
SYSTEM OVERVIEW
Mattress Cover
The cover comprises of a two-way vapour permeable
and a welded stretch PU top with a durable base
fabric.

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OVERVIEW
Feed Tube Connection
Power Switch
A
B
C
D
PUMP OVERVIEW
B
D
C
A
Visual Low-Pressure Warning
Bed Hooks

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INSTALLATION
INSTALLING THE AIR-TECH SYSTEM
Remove the mattress from its packaging and lay the parts out on the oor.
You should have the following items:
• Mattress with feed tubes attached
• Pump
• Instruction booklet
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If you intend to keep this mattress system in storage please retain the
packaging. This will lengthen the life of the mattress.
Prior to installing the mattress, check that there are no protruding/
sharp objects which may puncture the cover or air cells.
Carefully place the mattress on to the bed base. Ensure the pipes at both the head
and foot ends are kink free to prevent restriction of air ow. Ensure the air tubing to the
pump is at the foot of the bed.
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Please ensure that the mattress is correctly sized for the bed and that the mattress is
positioned (using the mattress guides) onto the mattress base before operating the
bed.
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The pump has integral bed hooks for hanging the pump on the foot end of the bed.
4
The pump and feed tubes should be at the foot end of the bed.
Connect the feed pipes to the pump using the quick release coupling and ensure the
connection has securely clicked into place.
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When the mattress is ready to be inated, insert the mains plug into the wall socket
and turn on the power.
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INSTALLATION
If the pump sounds an alarm, this is an indication of low
pressure. Switch off the pump to silence the alarm. If the fault
cannot be rectied, the system must be replaced.
1. Power Switch (audible warning reset)
The power switch simply switches the mains power to the pump on and off. When the
pump detects an audible warning condition, this can be silenced and reset by switching the
pump off and then back on again.
2. LED Indicators
The Blue LED indicates the pump is turned ‘on’.
The Red LED indicates a pressure issue in the mattress.
3. CPR Valve
Please ensure that the CPR connector is always placed fully home, prior to inating the
mattress. The mattress will NOT inate properly should this not be the case. The CPR
connector is only to be used in the event of a clinical emergency for priority use. However,
disconnecting this function will cleverly deate air rapidly from the mattress in readiness for
transport / static mode.

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OPERATION
INFLATING THE MATTRESS
Switch the pump On/Off switch to On: both LEDs on the control panel will illuminate to
show the pump is switched on.
The low pressure / system running LED will now illuminate to indicate the mattress
is being inated. When the mattress is up to the correct pressure, the low pressure
warning light will go off and the pump will beep.
The mattress is now ready to be used.
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DEFLATING THE MATTRESS / CPR VALVE & SWITCHING OFF THE SYSTEM
To deate the mattress, simply disconnect the tube set from the pump.
If rapid deation is required, simply pull the CPR connection.
To turn off the system; press the power button to OFF and unplug
from the mains supply.

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OPERATION
Audible / Visual Warning conditions are indicated by a ashing red display
accompanied by an audible warning. In each case the user should respond by turning
the Power Unit’s switch off and investigating the cause.
1. High Pressure Warning
If the system pressure exceeds 100mmHg this warning will be activated. This may be
triggered by, for example, a kinked Umbilical Hose or another person suddenly sitting
on the mattress.
2. Low Pressure Warning
If the system pressure falls below 15mmHg this warning will be activated. This may be
triggered by, for example, incorrect tting of the air inlet connector, opening of the CPR
Valve or a leak in the Mattress due to a cut or puncture.
3. Mains Failure Warning
If mains power is lost then all LED lights will turn off. In such an event, the Mains
Failure audible warning will sound.
AUDIBLE/ VISUAL WARNING

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CLEANING & CARE
MATTRESS
During general use the mattress and internal tubes can be cleaned by wiping with a mild
detergent solution.
Where necessary the mattress cover can be removed for laundering or sterilisation. Where
there is staining or body uids on the mattress, cells or tubing, wash thoroughly with soap
and water, then wipe with a sodium hypochlorite solution diluted to 1000ppm before
laundering.
Mattress covers may be laundered as follows:
1Pre-wash Cold 10 minutes
2Main Wash 60°C - 95°C 10 minutes
3Followed by cold rinses and extraction.
WARNING
Ensure that the mains power supply to the pump is disconnected before cleaning
Eye protection, gloves and protective clothing should be worn when carrying out cleaning
and disinfection procedures
When disinfecting the system, Harvest Healthcare recommends the following guidelines
which have been developed to comply with recognised infection control procedures.
These procedures are also to be used to prevent cross infection when transferring the
system between patients.
Do not use abrasive cleaners, phenol disinfectants, solvents or alcohol-based
cleansers, e.g. Dettol, Phenicol, Hibiscrub, Clearsol, Stericol, Hycoline, as these
will damage the cover materials.
Do not iron.
Ensure that the mattress/cushion is thoroughly dried before remaking the bed
or placing in storage.
HYPERCARBONATE AND PHENOL-BASED SOLUTIONS SHOULD NOT
BE USED AS THESE WILL DAMAGE THE MATTRESS COVER.

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CLEANING & CARE
PUMPS
For general cleaning wipe with a soft cloth dampened with a mild detergent and water
solution. This may be followed by either wiping with a sodium hypochlorite solution to a
dilution of 1000ppm (parts per million) or by using alcohol wipes.
DO NOT USE HYPERCARBONATE, PHENOL-BASED CLEANING
SOLUTIONS, ABRASIVE COMPOUNDS OR CLEANING PADS.
NOTES
Following the use of a detergent and or disinfectant solution rinse the mattress cover
with clean water using a clean cloth and allow to dry.
Frequent or prolonged exposure to high concentrations of disinfectant solutions will
reduce the useful life of the mattress cover.
Where high concentration disinfectants e.g. > 10,000ppm chlorine releasing
agent (e.g. Haztab or bleach) or combined cleaning/chlorine releasing agent (e.g.
Chlorcleam, Actichlor) and detergent solutions are used to remove blood or other
body uids, mattresses should be thoroughly rinsed with clean water to remove any
residues. This will help prevent any long term compatibility issues associated with
disinfectant residues.
Alternatively, disinfection may be achieved by laundering at temperatures not
exceeding 80°C for 10 minutes which may include a chlorine rinse.
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TRANSPORT & STORAGE
Storage conditions as follows:
–15 °C without relative humidity control; and +40 °C at a relative humidity up
to 93%, non-condensing. An atmospheric pressure range of 700 hPa to 1 060 hPa.
Suitable for all standard modes of transport when in the correct packaging.
Operation Conditions:
A temperature range of +5 °C to +35 °C; A relative humidity range of 15% to 93%, non-
condensing; and Operational Atmospheric Pressure: 700 hPa to 1060 hPa. Suitable for
pollution degree 2. Operational altitude ≤2 000 m.

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ROUTINE
MAINTENANCE
MATTRESS
The mattress cover, which is made from waterproof and vapour permeable material, should
be kept clean. Take care to avoid puncturing cover with sharp objects whilst performing the
maintenance checks:
1Remove cover and inspect for damage, tears or staining, which could lead to
contamination of the internal parts.
2Check that the zips are sound and in good working order.
3 Check that all connectors are tted properly to prevent leaking of air.
4Check that all cells are attached.
These checks should be carried out at each decontamination process, i.e.
between patients or patient occupancy and weekly for longer term patients.
PUMP
1Check the pump casing for cracks or other damage that could be dangerous.
2Check the power cord (ensure there are no bare wires).
If any faults are detected report to your distributor for replacements to facilitate repairs.
COMPONENTS
Check air cells and mattress interior for signs of damage or contamination, e.g.
staining or uid ingress at each decontamination process, i.e. between patients or
patient occupancy (or weekly for longer term patients).
The individual cells can be wiped clean with a mild antiseptic solution.
All cells are replaceable and can be sourced from Harvest Healthcare.
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POWER UNIT
Disconnect the power unit from the electricity supply before carrying out maintenance, repairs
or cleaning.
Check all electrical connections and power lead for signs of wear and damage.
The power unit can be wiped down with detergent, disinfectant solution or wipe*. Do not use
solvents. Unsuitable for sterilisation.