PremiumLift AirCare Max-8 User manual

AirCare Max-8
Alternating Air Mattress Replacement
User Manual

2 T [phone] F [phone]

E [e-mail] www.harvesthealthcare.co.uk
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
CLEANING & CARE
ROUTINE MAINTENANCE
TROUBLESHOOTING
PARTS LIST
GUARANTEES & WARRANTIES
4-5
6-10
6
7
7
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8
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10
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12
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14-15
16-17
18-21
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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 bechecked regularly toensure 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
relysolelyonthisdevicetoachievetheresult.Themedicalprofessionalisresponsible
for applying best medical judgment when using thissystem.
• Select the correct setting for the occupant’s weight andtherapy required. Care should
be taken not to accidently change pressures once set as the effectiveness of the
therapy may be reduced.
• Inorder foralternatingair pressurerange tobe effective, avoid placingobjects on
the surface that may obstruct the movement of air betweenthe cells. For thesame
reason, discourage people from sitting on the edge or on the end of the mattress
whilst it is in use.
• All hoses must befreeof 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 tothe disconnection device
(mains power plug).
• Ensure the mains lead or pump cannot become trapped orcrushed, e.g. by raising or
lowering of bed or bed rails or any other movingobject.
• Check the mains lead is damagefree and positionedso as not tocause an
obstruction, or injury, e.g. strangulation or triphazard.
• Ensure that the electricity supply is of the type stated on the pumpunit.
• Protectyoursystemfromopenflames.Ensurethatthesystemisnotusedinthe presence
of flammableanaesthetics.
• Do not place device on or near a heat source or cover pump withbedding.
• PremiumLift advise against smoking whilst the system is in use, to prevent the
accidental ignition of associated items which may be flammable, such as bed linen.
WARNINGS &
CAUTIONS

5
• Do no expose the pump to liquids.
• Do not use with hot water bottles or electric blankets.
• Wireless equipment such as mobile phones should bekept at least 10ft / 3m away
from the system.
• Do not allow sharp objects to puncture the mattressmaterial.
• The mattress and pump should be cleaned between patientuses.
• Do not use bleach, chlorine releasing agents in concentrations over 1000 ppm,
solvents or alcohol-based cleansers, e.g. Phenicol, Hibiscrub, Clearsol, Stericol,
Hycolineasthesewilldestroythemattressmaterial.Fullcleaninginstructionscanbe
found on page 14-15.
• Suitable for continuous use.
• Do not modify the mattress or pump unit in anyway.
• 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 directsunlight.
Electrical equipment can be hazardous. Only authorised technical
personnel should remove the rear pump case for maintenance.
Removal of the case by unqualified 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 fire rated. Use of this product should be subject to a
risk assessment in which all hazards are considered.
WARNINGS &
CAUTIONS

6
BEFORE USING THIS SYSTEM FOR THE FIRST TIME:
- Read through this Instruction Manual conscientiously from start to finish.
- Please note that the various safety instructions must be observed.
PrmiumLiftproductsbeartheCEand TGA markandmeetallsafetyandfunctionality
requirements.
These safety requirements can only be met if the user is satisfied with the proper condition of
the product (including accessories) before use.
GENERAL INFORMATION
The AirCare Max-8 Replacement System is an alternating pressure relieving mattress
system used inthe prevention andtreatment of pressure ulcers, and is recommendedfor
use by a patient who is at risk from developing pressure sores. The mattress is fitted with a
vapour permeable two way stretch cover.
By using the established principles of alternating therapy, the AirCare Max-8
Replacement System offers the patient comfortable andrelaxing support that can both
prevent tissue breakdown and enhance healing.
The mattress is made up of 18 individual cells. 15 alternating air cells and 3 static pillow
section cells. The alternating cells aresplit into 2 sections - oddcells e.g. 1,3,5 etc andeven
cells e.g. 2,4,6 etc. These twosections will alternate through a cycle in which time both sets
of air cells will have inflated and deflated sequentially. All air cells are individually
replaceable should any damage occur.
Theconnectorhas transportcap tomaintain the air pressure withinthe mattress, for easy
patient transport arrangements. For rapid deflation of the system simply pull open the CPR
and disconnect the pump.
1 DEFINITION OF THE GROUPS MENTIONED
OPERATOR
Anoperatorisany natural orlegal person who usesthe equipment oron whose instruction
itisused(e.g.nursinghomes,specialisedretailers,healthinsurancecompanies,medical
suppliers).
GENERAL
INFORMATION

7
USER / CARE PERSONNEL
Users are persons who as a result of their vocational training, experience or briefing are
authorised to operate the equipment.
Furthermore,theuser/carepersonnelcanrecogniseandavoidpotentialdangersandassess
the clinical condition of the service user.
PATIENT / OCCUPANT / SERVICE USER
The person in need of care, handicapped or infirm.
QUALIFIED PERSONNEL
Qualified personnel are employees of the operator who as a result of their vocational
training or briefing are entitled to deliver, assemble, disassemble and transport the product.
2 NON-COMPLIANT USE
All usesdeviatingfromtheintendedpurpose,whichmayalsobehazardous as aresult.
This includes for example:
• Incorrect installation.
• Operation by persons who have not been instructed in itsuse.
• Using the system with non-approved parts/accessories.
• Using the system if any of the components are damaged orfaulty.
3 SAFETY INSTRUCTIONS
3.1 GENERAL SAFETY INSTRUCTIONS
During the briefing, specific attention must be drawn to any potential dangers
which can occur despite correct operation. Before putting the product into service
for the first time, the Instruction Manual must be read conscientiously and indetail
by the user / care personnel.
Programmingof thesystemshouldbe carriedout by competenttrained personnel.
Use only spares and accessories supplied or approvedby PremiumLift.
Only suitably trained personnel are allowed to operate the system.
GENERAL
INFORMATION

8
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.
Ifthe mains cable orthe mains plug are damaged, the relevant part must be
replaced. This work shouldbe carried outby the manufacturer or authorised
service agents.
When connecting the mains plug do not use multiple sockets since liquids may
penetrate into these (fire 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 first time.
Advise the user of any hazards which may occur if not handled correctly.
Onlypersonswhohavebeenproperlyinstructedmayoperatethissystem.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.
Inaddition, pay particularattention tothe Warnings and Cautions (page 4-5) and thegeneral
safety information as described in 3.1.
Ifthere is a suspected fault or damage, unplug the mains plug from the socket and follow
the power down procedure (page 16). Clearly mark “Out of Order” and take out of service
immediately, and inform the person in charge withoutdelay.
GENERAL
INFORMATION

9
3.4 SYMBOLS USED
Thissymbolindicatesgeneralhazards.Thereisadangertolifeandhealth.
ConformitymarkinaccordancewiththeMedicalDeviceDirective(93/42EEC).
The symbol for Protection Class I device, doubleinsulated.
The symbol for Medical device according to EN 60601-
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
electronicdevices(WEEE)intheEuropeanUnion.Donotdisposeofasnormal
domestic waste.
No smoking. No naked flames.
Read instructions / consult manufacturers guide
This symbol indicates electrical hazards. There is danger to life and health.
GENERAL
INFORMATION

10
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 14-15.
3.6 SERVICING & MAINTENANCE
Servicing must only be carried out by qualified personnel.
A technical check and/or safety inspection must beconducted at least once a year
and after a lengthy break in use.
Any defects, damage or signs of wear must be rectified without delay. Only original
spare parts from PremiumLift may be used, otherwise all guarantees or
warranties will be excluded.
See pages 16-17 for Routine Maintenance and Servicing.
3.7 SERVICE LIFE & DISPOSAL
The systemmust not bedisposedof 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.
OurFullTerms&Conditionsincludingproductwarrantiesareavailablebyrequestorcanbe
found on our website www.premiumlift.com.au
PARTS AND DATA MAY UNDERGO FURTHER DEVELOPMENT AND
THEREFORE DEVIATE FROM THE DETAILS GIVEN.
GENERAL
INFORMATION

11
AIRCARE MAX-8 TECHNICAL SPECIFICATION
Product Code
PressureSoreRiskLevel
Minimum Patient Weight
MaximumPatientWeight:
Dimensions
Mattress Weight
ACMAX8S/ ACMAX8KS
Very High Risk
30 kg
210 kg
2000 x 900/1060 x 200 mm
8 kg
SPECIFICATION

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SYSTEM OVERVIEW
CPR Pull Tab
The mattress can be rapidly deflated
through the use of the CPR pulltab, allowing
emergencypersonneltobeginresuscitation.
Mattress Cover
The cover comprises of a two-way
vapour permeable and a stitched
stretch PU top with a durable base
fabric.
AirCare Max-8 Cells
The Max-8 has 18 independent cells which
can be individually removed and replaced to
allow for cost effective repair and in-depth
cleaning.
OVERVIEW

13
INSTALLING THE AIRCARE MAX-8 SYSTEM
1 Remove the mattress from its packaging and lay the parts out on the floor.
You should have the following items:
• System Packaging
• Mattress with feed tubes attached
• Instruction booklet
If you intend to keep this mattress system in storage at some
point 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.
2 Carefully unrollthe mattress.Ensure that the pipes at boththe head and foot ends are
kink free and straight to prevent restriction of air flow. Ensure that the air tubing to the
pump is at the foot of the bed.
3 Tuck and secure the straps to the bed
profiling parts, do not fix to the bed
frame.
4 Thepump has integral bed hooks for hanging the
pump on the foot end of the bed.
The pump and feed tubes should be at the foot end of the bed.
5 Check that the CPR pull tab is CLOSED.
The mattress will not inflate if the CPR pull tab is open.
6 Connect the feed pipes to the pump using the quick release couplingand ensure the
connection has securely clicked into place.
7 When the mattress is ready to be inflated, insert the mains plug into the wall
socket and turn on the power to the pump. Refer to the pump user guide.
INSTALLATION

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MATTRESS
Duringgeneral use the mattress and internal tubes can becleaned by wiping with amild
detergent solution.
Wherenecessarythemattresscovercanberemovedforlaunderingorsterilisation.Where
there is staining or body fluids 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:
1 Pre-wash Cold 10 minutes
2 Main Wash 85°C 10 minutes
3 Followed by cold rinses and extraction.
Donot useabrasivecleaners,phenol disinfectants,solvents oralcohol-based
cleansers,e.g.Dettol,Phenicol,Hibiscrub,Clearsol,Stericol,Hycoline,asthese
will damage the cover materials.
Do not iron.
Ensurethatthemattress/cushion isthoroughly dried before remakingthebed
or placing in storage.
HYPERCARBONATE AND PHENOL-BASED SOLUTIONS SHOULD NOT
BE USED AS THESE WILL DAMAGE THE MATTRESS COVER
Ensure that the mains power supply to the pump is disconnected before cleaning
Eyeprotection,glovesand protectiveclothingshouldbe wornwhencarryingoutcleaning
and disinfection procedures
Whendisinfectingthesystem,HarvestHealthcarerecommendsthefollowingguidelines
which have been developed tocomply with recognised infection control procedures.
Theseproceduresarealsotobeusedtopreventcross infection whentransferringthe
system between patients.
WARNING
CLEANING & CARE

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PUMP
For general cleaning wipe with a soft cloth dampened with a mild detergent and water
solution. This may befollowedby either wipingwith a sodium hypochlorite solution toa
dilution of 1000ppm (parts per million) or by using alcoholwipes.
DO NOT USE HYPERCARBONATE, PHENOL-BASED CLEANING
SOLUTIONS, ABRASIVE COMPOUNDS OR CLEANING PADS.
NOTES
• Followingtheuseof a detergentandor disinfectantsolutionrinsethe mattresscover
with clean water using a clean cloth and allow to dry.
• Frequentor prolongedexposuretohighconcentrationsof disinfectantsolutions will
reduce the useful life of the mattresscover.
• Where high concentration disinfectants e.g. > 10,000ppm chlorine releasing
agent(e.g.Haztaborbleach)orcombinedcleaning/chlorinereleasingagent(e.g.
Chlorcleam, Actichlor) and detergent solutions are used to remove blood or other
body fluids, mattresses should be thoroughly rinsed with clean water to remove any
residues.Thiswillhelppreventanylongtermcompatibilityissuesassociatedwith
disinfectant residues.
• Alternatively,disinfectionmaybeachievedbylaunderingattemperaturesnot
exceeding 80°C for 10 minutes which may include a chlorine rinse.
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 hPato 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 OperationalAtmosphericPressure:700hPato 1060hPa.Suitablefor
pollution degree 2. Operational altitude 2 000 m.
Transportation of the mattress system:
Themattressshouldbelooselyrolledlengthwisewith thecoverinnermost,takingcarenot
to strain the feed pipes. It can then be stored / transported in the carry bag with the pump,
mains cable and this booklet. Do not stack bagged mattresses more than two high.
CLEANING & CARE

16
These checks should be carried out at each decontamination process, i.e.
between patients or patient occupancy and weekly for longer term patients.
MATTRESS
Themattresscover,whichis madefrom waterproof andvapourpermeable material, should
be kept clean. Takecare to avoid puncturing cover with sharp objects whilst performing the
maintenance checks:
1 Removecover and inspectfor damage, tears orstaining, whichcould lead to
contamination of the internal parts.
2 Check that the zips are sound and in good working order.
3 Check that all connectors are fitted properly to prevent leaking of air.
4 Check that all cells are attached to the base sheet by the pop fittings provided.
5 Check the stitchingonthe straps and the seams to ensureno tearingor fraying
has occurred.
PUMP
1 Check the pump casing for cracks or other damage that could bedangerous.
2 Check the power cord (ensure there are no barewires).
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 fluid ingress at each decontamination process, i.e. between patients or
patient occupancy (or weekly for longer termpatients).
• Theindividualcellscanbewipedcleanwith amildantisepticsolution.
• AllcellsarereplaceableandcanbesourcedfromHarvestHealthcare.
POWER UNIT
Disconnectthe powerunitfromtheelectricitysupplybeforecarryingoutmaintenance,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.
MAINTENANCE

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• * In line with the MHRA Medical Device Alert (MDA/2013/019), PremiumLift advises
customers to use pH neutral, high-level disinfectant cleaning products to sanitise
reusablemedicaldevicestopreventdamagetomaterialsandthedegradation of
plastic surfaces after prolonged use.
• Theuseofinappropriatecleaninganddetergentmaterialsonmedicalequipment
coulddamagesurfacesandmaycompromise the abilitytodecontaminatemedical
devices adequately or may interfere with devicefunction
Atend of use dispose of the pump / mattress inaccordance withthe local regulations
including WEEE requirements, which apply to the pump and SMPS only.
SERVICING YOUR SYSTEM
TheAirCare Max-8systemshouldbe serviced every 12 months by PremiumLift approved
personnel using genuine PremiumLift spareparts.
Failure to follow the AirCare Max-8 service schedule may invalidate
future warranty claims (Gurantees & Warranties can be found on
page 23).
MAINTENANCE

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TROUBLE SHOOTING
FAULT
CHECK THAT
STAGE 2 CHECK
IF PROBLEM PERSISTS
Pump shows no
indication that it is
powered up.
1. Mains plug is plugged inand
power switched on.
2. The power switch onthe
pump is switched on.
3. Thefuseinthe mainsplug is
not blown.
4. The wall socket that the
pump is connected to is
working correctly.
1. Connect the pump to the
nearest(working)mainsoutlet.
2. Replace theplug fuse withthe
correct 5A fuse.
3. Tryadifferentdeviceinthe
mains outlet.
Contact PremiumLift technical
support.
Before calling:
Pleaseensureyouhavetheserial
numberandmodelofequipment.
Please record details of the results of
the recommended tests. (Notes pages
are provided at the back of this user
manual).
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FAULT
CHECK THAT
STAGE 2 CHECK
IF PROBLEM PERSISTS
The Pump appears
to be running but the
mattress is not inflating
correctly and / or the
low pressure light is
illuminated.
PLEASE NOTE
Inflation can take up to 30
minutes.
1. The hoses are routed
correctly (not kinked) and
connected to the pump
correctly.
1. Disconnect and then re-
connect the hoses to the outlet
on the side of the pump.
2. OpenthenreclosetheCPR
valve,makesurethevalve
is not trapped in the bed
mechanism.
Contact PremiumLift technical
support.
Before calling:
Pleaseensureyouhavetheserial
numberandmodelofequipment.
2. The CPR valve is not trapped
and is in the closed position.
Please record details of the results of
the recommended tests. (Notes pages
are provided at the back of this user
manual).
1. Therearenoleaksinthe
mattress.
2. Thetubesinthe mattress are
not disconnected orkinked.
1. Replace any damaged or
leaking mattress parts with
the correct genuine
PremiumLift spare parts.
2. Straighten out any kinked
pipes and reconnect any
disconnected joints.
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TROUBLE SHOOTING
FAULT
CHECK THAT
STAGE 2 CHECK
IF PROBLEM PERSISTS
Some of the cells
appear to be deflated.
This is normal for alternating pressure therapy.
Themattressismade up of individual air cells. The alternating sectionis split up into 2sections consistingof 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 minutecycle in
which time both sets of alternating air cells will have inflated and deflated sequentially.
The system does
not appear to be
alternating.
1. Check that the static
mode is not turned on.
2. Carefully mark one ofthe
inflated cells with a pen.
3. Ensure that there are no
kinks in the pipeworkdown
the side of themattress.
1. Monitor the cell for 7minutes
to see if it deflates.
2. Straightenoutanykinked
pipes.
Contact PremiumLift technical
support.
Before calling:
Pleaseensureyouhavetheserialnumber
and model of equipment.
Please record details of the results of the
recommended tests. (Notes pages are
provided at the back of this user manual).
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