230V - Aeda Healthcare

U S E R
G U I D E
230V
Key
Definition of symbols used
User guide
Mattress overlay
Wash instruction here
Caution symbol
Zip located here
Electrical hazard
Do not immerse control unit
Infection control
Do not ...
Iron - low
i
Important information
Aeda – a brand actively
supporting your health
A fresh approach to proven
pressure care solutions
The Aeda mattress
and seating category
Control unit
- medium
- high
Do not iron
CL
Bleach - chlorine
Do not bleach
Medical equipment mattress
system with respect to electrical
shock, fire and mechanical hazards
only; in accordance with UL60601-1
and CANCSA N22.2 NO. 601.1
CE Marking (European UnionNew Approach Directives)
Class II Equipment
Type B Applied Part
Manufacturer details
Visual alarm
Power
BLEACH
Tumble dry - low
- medium
- high
Do not tumble dry
OROETH
HL
PER
C
P
70
E
AN
If dry cleaning - do not use a
solution stronger than
perchloroethane
Maximum water temperature
(in this example - 160°F 70ºC)
key
Aeria 5 User Guide
Contents
System overview
2
System features
3
Intended use
4
Safety5
Protection against hazards
5
System set up
6
Dismantling the system
7
Operation8
Control unit layout
8
Establishing pressure
8
Alarm function
9
Care and cleaning
10
Troubleshooting 11
Specifications12
Warranty13
Aeda - Actively supporting your health contentspage 1
System overview
Introducing the Aeria 5 Mattress
Overlay System – this chapter provides
a basic system overview, intended use
guidelines and a summary of system
features and box contents.
•
dynamic mattress overlay with
dual air hoses
•
•
•
•
•
compact analogue control unit
power cord
Aeria 5 User Guide
overlay top cover
overlay base
overlay straps
elastic
Aeria 5 Quick Set Up Guide
carry bag
page 2
dual hoses
system overview
Aeria 5 User Guide
Introducing the Aeria 5 Mattress Overlay System, this chapter provides a basic system overview,
intended use guidelines and a summary of system features and box contents.
•
the Aeria 5 is indicated for the
prevention and treatment of skin
breakdown and pressure ulcers in
patients at low to medium risk
•
constructed from 18 transverse cells –
5 inch 115 mm high – that cyclically
inflate and deflate in an alternating
pattern, providing gentle and dynamic
support
•
cyclic alternation of pressure prevents
arterial and venous capillary occlusion
in the patient’s surface tissue –
maintaining and stimulating the flow of
blood and lymphatic fluids through
these tissues to provide essential
oxygen and remove metabolic waste
•
connected to the control unit via dual air
hoses, mattress cells are inflated by an
electronic control unit, which includes a
pressure sensor for monitoring
mattress pressure and adjustable
pressure settings to match patient
weight and comfort needs
•
suitable for use at home or in long term
or extended care environments
•
•
designed for use on top of your existing
standard single bed mattress
air pressure in the mattress overlay is
continually monitored and a visual
alarm displays in the event mattress
pressure becomes too low
•
operator controls are kept to a minimum
for simplicity and ease of use
System features
Support
Safety
Simplicity
•
18 x 5” 115 mm high density
alternating cells
•
rapid release CPR tag
for emergency deflation
•
machine washable top cover is fully
elasticized for firm fit
•
vapor permeable, waterproof
top cover prevents moisture transfer,
while multi-stretch fabric minimizes
friction and reduces shear
•
strong elastic straps simply and
securely lock the overlay to any
standard single bed mattress
•
•
quick connector air hose attachments
•
static transport function for stable
patient handling and transfer
•
•
visible alarm light to
warn of a pressure failure
overlay can be rotated 180 degrees
for preferred control unit position
at either end of the bed
•
adjustable pressure level to match
users weight and comfort needs
•
supporting users to a maximum weight
of 265 pounds 120 kilograms
Aeda - Actively supporting your health inbuilt rear hanging hooks for easy
mounting and control unit portability
system overviewpage 3
Intended use
Indications
Connecting the system to other devices
The Aeria 5 Mattress Overlay System is
indicated for:
There are other devices necessary for
normal operation.
•
The Aeria 5 mattress overlay can be fitted to
most standard hospital or single bed
mattresses.
the prevention and treatment of skin
breakdown and pressure ulcers in
patients of low to medium risk
Contraindications
Patient conditions for which the application
of pressure relief therapy on the Aeria 5
Mattress Overlay System is contraindicated
include:
•
•
instable spinal cord injury
The Aeria 5 compact analogue control unit
can be fitted to the foot or head board of
most hospital or home care beds.
Alternatively, the control unit can be placed
on the floor, underneath the bed, or on any
other stable surface.
cervical traction
The Aeria 5 Mattress Overlay System is an
aid to the prevention and management of
pressure ulcers. If there is no improvement
in the patient’s condition, clinical advice
should be sought.
Therapeutic devices should only be used in
accordance with manufacturer’s
instructions and under the consent,
supervision and management of a suitably
qualified health professional.
Aeda Healthcare accepts no liability for any
use, change or assembly of the product
other than that stated in this User Guide.
Intended care setting
Intended care settings for the
Aeria 5 Mattress Overlay System are:
•
•
long term or extended care
home care
Working conditions
•
•
Temp: 50°F - 105°F 10°C – 40°C
Humidity: 30% ~ 75%
Shipping/Storage conditions
•
•
Temperature: 15°F - 140°F -10°C –60°C
Humidity: 10% ~ 80%
page 4
intended use
Aeria 5 User Guide
Safety
This chapter provides general safety precautions
and recommended patient specifications.
General safety precautions
Protection against hazards
For your own safety and the safety of
equipment, always take the following
precautions:
Fluids
•
Before commencing set up or
installation, ensure the power is
switched off and disconnect the power
cord from the control unit.
•
Placing layers between patient and seat
cushion should be avoided or kept to a
minimum. As part of sensible pressure
care, avoid wearing clothing that may
cause areas of localized damage due to
creases, seams, objects in pockets, etc.
•
Never use sharp objects or electrically
heated blankets on or under the system.
•
Product top cover is not completely air
permeable and may present a
suffocation risk. It is the responsibility of
the caregiver to ensure that the patient
can use this product safely.
•
Avoid blocking the air intakes of the
control unit, located at the rear of the unit.
•
Only the control unit and mattress
combination as indicated by Aeda
Healthcare should be used, otherwise
the correct function of the product
cannot be guaranteed.
Maximum patient weight
The maximum recommended patient
weight for this system is 265 pounds
120 kilograms.
Aeda - Actively supporting your health Avoid spilling fluids on any part of the
control unit. If spills do occur:
•
Turn off control unit power and
disconnect the unit from the main
electricity supply.
•
Immediately clean fluids from the
casing by wiping with a soft cloth.
Ensure there is no moisture in or near
the power inlet, power switch and
power cord before reconnecting the
power supply.
Check the operation of controls and
other components around the spill area.
Fluid or liquid remaining on the
electronic controls can cause corrosion
that may cause the electronic
components to fail. Component failures
may cause the unit to operate
erratically, possibly producing
potential hazards to patient and carers.
Explosion hazard
Equipment is not suitable for use in the
presence of a flammable anesthetic
mixture with air, oxygen or nitrous
oxide.
•
Do not use in the presence of smoking
materials or open flame – air flowing
through the mattress will support
combustion.
•
Do not open the control unit – risk of
electrical shock. Refer servicing to
qualified service personnel.
Disposal
At the end of useful life, dispose of all
components (air filter, air cells, mattress
cover and base) according to local
procedures and regulations or contact your
local Aeda Healthcare authorized dealer for
advice.
Power cord
The system should never be operated with a
worn or damaged power cord. Should the
power cord be found to be worn or damaged,
contact your local Aeda Healthcare
authorized dealer for a replacement.
Interference
Although this equipment conforms to the
intent of directive IEC 60601-1-2 in relation
to Electromagnetic Compatibility, all
electrical equipment may produce
interference. If interference is suspected,
move equipment from sensitive devices or
contact the manufacturer. (IEC 60601-1-2.
Medical Electrical Equipment - Part 1:
General Equipments for Safety, Amendment
No. 2. Collateral Standard. Electromagnetic
Compatibility Requirements and Test).
safetypage 5
System set up
Preparing the system for use
Carefully unpack the system and locate all
items shown in the picture below.
Inspect each item for any damage that may
have occurred during shipping. Any damage
or missing components should be reported
to your local Aeda Healthcare authorized
dealer as soon as possible.
1.Remove all bedding from your mattress
and place the mattress overlay on the
bed – printed top cover facing upwards
and air hoses towards the base of the
bed.
The control unit can
also be placed on a
flat surface (ie on the
floor or underneath
the bed).
mattress overlay
(top cover & base)
control unit
2.Hang the control
over the foot end of
your bed, using the
inbuilt rear hanging
hooks.
Secure to the bed by sliding the elastic
straps, located on the underside of the
mattress overlay, around each end of
your existing mattress. Ensure the
straps fit firmly, and are not twisted or
pulled towards the corners.
power cord
i
Do not secure mattress straps to bed
side rails – straps will tear.
Ensure the control unit is firmly
secured to the bed. Failure to do so
could result in equipment damage.
The Aeria 5 mattress overlay can be
rotated 180 degrees to position the
control unit at the head of the bed if
preferred.
Ensure that straps do not interfere with
the operation of the bed, and that the
mattress overlay is properly secured.
Failure to do so could result in patient
injury or equipment damage.
page 6
system set up
Aeria 5 User Guide
This chapter describes the steps necessary
to prepare the Aeria 5 system for use.
3.Attach the two air hoses to the control
unit – the quick connectors simply press
into place. The connectors include a press
button release system for ease of use.
Straighten any twists in the air hoses to
ensure uninterrupted air flow between
the control unit and overlay. Also
ensure the hoses are not trapped
between the overlay and bed. Failure to
do so could result in an under inflated
mattress leading to patient injury.
5.Before inflating, pull back the top cover
to ensure the cells are straight and the
cell straps are not twisted. Refit the top
cover, ensuring both air hoses are fitted
through the custom opening in the base
of the cover.
Allow up to 40 minutes for complete
inflation. The green Ready LED
illuminates when the system is ready for
use.
8.Once the overlay is fully inflated,
bedding can be replaced. Secure sheets
loosely enough to ensure they do not
interfere with cell alternation.
Dismantling the system
1. Switch off the control unit.
6.Insert the power cord into the base of
the control unit, then plug into an
appropriate electrical outlet and switch
on mains power.
2.Switch off mains power and unplug the
power cord from the mains outlet.
3.Disconnect both the air hoses from the
control unit. This will allow deflation of
all cells except static head cells.
4.To deflate the head cells, firmly pull the
CPR tag.
2
3
1
4.Locate the CPR tag at the head of the
mattress overlay and ensure the CPR
sealing connectors are fully inserted
into the air hoses, as shown below.
Aeda - Actively supporting your health 5.Once air has been released from the
system, detach the overlay from your
mattress by removing both elastic straps,
then fold and roll the overlay for storage.
6.Return all items to the custom carry
bag for safe keeping.
7.On the control unit, turn the Pressure
dial to maximum and then switch on (the
power switch illuminates to indicate the
system is operational).
Do not store the system
in direct sunlight.
system set uppage 7
Operation
Control unit layout
Power on / off switch
Alarm indicator
Turns system power on and off. The
switch illuminates to indicate power
is on.
This red light displays to alert when
the control unit or mattress pressure
fails. The alarm indicator remains
illuminated until pressure is restored.
Ready indicator
This green light displays when the
system reaches (and maintains)
operational pressure.
Pressure dial
Establishing pressure
‘Bottoming out’ test
1.Prepare the system for use as described
in System Set Up. The green Ready LED
will illuminate once the overlay has
reached the required pressure and is
ready for use.
a. With the patient lying in the supine
position (lying on back, face upwards),
pull back one side of the top cover, just
past the sacral region (lower spine).
2.Cover loosely with a sheet before placing
patient on the overlay.
The patient may lie on the Aeria 5
system during inflation however the
overlay will fill faster if allowed to
inflate first.
3.When the patient is lying comfortably,
turn the Pressure dial to reach the
desired setting for effective patient
comfort and support. When adjusting or
lowering the pressure, ensure the Aeria
5 system is working effectively by
performing a ‘bottoming out’ test
(a test to ensure the patient is adequately
suspended away from the base).
Adjusts overlay pressure from low to
high, in line with patient weight and
comfort requirements.
b. Slide your hand underneath the patient
and feel for a deflated cell under the
patient’s lower spine – your hand should
easily slide between patient and base.
c. If the patient is
adequately suspended,
the pressure setting can be lowered.
After approximately 12 minutes, reassess
system function and patient comfort.
If pressure fails for whatever reason the
red Alarm indicator will display –
immediately increase pressure to the
maximum pressure setting.
After lowering the pressure setting,
always check the Aeria 5 system is
working effectively. Failure to do so
could cause patient injury.
page 8
operation
Aeria 5 User Guide
This chapter describes how to safely operate the Aeria 5 system
including patient set up and control unit function.
Wait at least 12 minutes between any
pressure adjustment or patient
assessment as the Aeria 5 system may
take a full cycle to adjust to the new
pressure setting.
4.Having established a base line, pressure
should be increased to provide added
support when the patient is semirecumbent (sitting up).
Transport function
When transporting a patient on the Aeria 5
system, disconnect both air hoses from the
control unit and snap ends together
(connect the air hoses to each other) to
retain air in the mattress overlay.
The length of time the system remains
inflated during transport will depend
on the weight and height of the patient,
and will vary on a case by case basis.
During transport, regularly perform a
‘bottoming out’ test (see page 8) to
ensure the patient is adequately
suspended on the overlay. Failure to
do so could cause patient injury.
Aeda - Actively supporting your health CPR / Re-inflation
Alarm function
Rapid deflation of the mattress replacement
may be necessary for emergency treatment
(or to decommission the unit).
The Alarm indicator illuminates to indicate
that control unit or overlay pressure has
failed (when pressure drops below the
accepted minimum level).
Pulling the CPR tag, located at mattress
head, will rapidly deflate the entire system.
If CPR or emergency treatment is required,
firmly pull the CPR tag ensuring both
sealing connectors are fully disconnected
from the air hoses.
For maximum deflation rate, also
disconnect both air hoses from the control
unit.
To re-inflate the system after the CPR tag
has been pulled, restore all disconnected air
hoses to the mattress replacement and wait
for the mattress to gain optimal pressure for
patient use.
i
A
“control setting
guide” is included on
the side of the
control unit, to
provide a quick
reference for
recommended
weight setting.
These settings are
a guide only.
Always verify
pressure settings
with a ‘bottoming
out’ test.
The indicator will remain illuminated until
appropriate pressure is restored.
If the Alarm indicator is illuminated, and the
system fails to inflate or loses pressure:
•
check the overlay air hoses are securely
connected to the control unit
•
check all overlay air cells and hoses
for any air leakage
•
check that the air filter
cover is correctly secured
•
check the air filter is clean
If the problem persists, contact your
local Aeda Healthcare authorized
dealer for further advice about repair.
Do not try to open the control unit.
Opening the unit could cause personal
injury or equipment damage.
operationpage 9
Care & cleaning
To prevent cross contamination, it is
recommended the overlay is examined
and disinfected between patient use.
lean the mattress overlay system in
C
accordance with local infection control
policy and government regulations for
blood borne pathogens. Failure to do so
could cause patient or personal injury.
The system is not protected against
excessive amounts of water.
Disconnect power supply before
cleaning. Failure to do so could result
in equipment damage or electric shock.
Do not use high temperature autoclave
steam cleaning devices or phenolicbased products for cleaning. This could
result in damage to the equipment and
loss of waterproof qualities of the top
cover.
Switch off and disconnect the control
unit from mains power supply before
cleaning. Do not immerse in water.
Weekly cleaning & infection control
I t is recommended that the Aeria 5
system is cleaned every two weeks if in
constant use.
Base cleaning
Once deflated, disconnect air cells from the
base by unfastening the press studs at each
end. Remove double tubing from main base
air tubes and slide the cell out from the cell
straps. Swab the cell with a solution of
sodium hypoclorite or similar
page 10
This chapter describes general care and cleaning for the
Aeria 5 system, including basic maintenance procedures.
(up to 10,000ppm available chlorine). Dry
thoroughly before refastening. Do not
machine wash the overlay base.
Top cover cleaning
Remove the top cover from the base before
washing. For basic care and cleaning, wipe
down with warm water containing
detergent. The top cover can also be
machine washed at 160°F 70ºC.
Periodic maintenance
Air filter replacement
1.Switch off power supply to the control
unit and disconnect the air hoses and
power cord.
2.Place the control unit face down on a
soft, flat surface with back panel
uppermost (use a soft cloth to prevent
scratches).
For infection control, swab with a
solution of sodium hypoclorite or similar
(up to 10,000 ppm available chlorine).
Dry thoroughly before use.
3.Use a small screwdriver to carefully
remove the air filter cover. Clean the
dust from the filter or discard and
replace with a new filter.
Refer to the top cover wash tag for cleaning
instructions.
4.Refit the air filter cover to the control
unit before use.
Do not use system without top cover.
Control unit external cleaning
Disconnect control unit from mains power
before cleaning. Gently wipe down the
external case with a soft cloth.
Soak the cloth in warm water containing
detergent, and twist dry any excess water
before use. Repeat the process with a dry
cloth to remove excess moisture.
Ensure the control unit is disconnected
from mains electricity before cleaning.
Disinfection
The mattress overlay, top cover and control
unit may be decontaminated by using ETO
(Ethylene Oxide).
It is recommended that the air filter
be replaced each year. Replacement air
filters are available from your local
Aeda Healthcare authorized dealer.
Fuse replacement
1.Switch off power supply to the control
unit and remove the power cord from the
socket in the base of the unit.
3.Insert a small screwdriver into the
groove and turn anti-clockwise (quarter
turn).
4.Remove the ‘blown’ fuse from the fuse
holder clip and discard.
5.Insert a new fuse into the plug. Push
against the force of the spring and turn
clockwise with the screwdriver (quarter
turn).
When changing the replaceable fuse,
use same rating fuse only (T1AL/250V).
care & cleaning
Aeria 5 User Guide
Troubleshooting
This chapter provides basic troubleshooting
support for the Aeria 5 system.
Problem
Cause
Solution
Control unit does not operate
The control unit may not be attached to a
power source or a fuse may need replacing.
Check the control unit is connected to an
electrical power outlet.
Check the control unit is switched on.
Check the mains plug fuse (3 AMP)
and both control unit fuses (1 AMP).
Control unit operational but red Alarm LED
illuminates
Mattress overlay fails to inflate
The alarm illuminates when mattress
overlay pressure fails to reach or drops
below the accepted minimum level,
this can be an indication of an air leak
in the system.
Check both air hoses are properly
attached to the control unit.
Check all hoses along the inside of the
overlay – each should be firmly connected.
Check each air cell is securely attached
to the connecting air pipe.
Check all cells, pipes and
hoses for any air leakage.
Check that the air filter cover is correctly
secured and the air filter is clean.
Do not try to open the control unit.
Opening the unit could cause personal
injury or equipment damage.
Patient is sinking or “bottoming out” while
lying flat on the mattress overlay The pressure may be set too
low for the patient’s weight
Increase pressure setting – usually an
incremental increase is sufficient however
wait 10-12 minutes (one full cycle) before
checking the increase was sufficient.
heck effective system performance by
C
conducting a ‘bottoming out’
test as described on page 8.
If the problem cannot be resolved, please contact your local Aeda Healthcare authorized dealer for further support.
Aeda - Actively supporting your health troubleshooting page 11
Specifications
This chapter provides the various physical and technical specifications of
the Aeria 5 system, including details of replacement parts.
Technical specifications
Classification
Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air, oxygen or nitrous oxide.
Continuous operation
Type B Equipment
Class II Equipment
Ordinary Equipment
Maximum recommended
patient weight
265 lb 120 kg
Risk category
Low – medium
Control unit
Mattress overlay
Type
Compact analogue
11.5 lb 5.3 kg
Dimensions
5.5” x 4.5” x 10.5”
135 x 115 x 270 mm
Number of cells
18
Weight
4.5 lb 2.1 kg
Cell height
5” 115 mm
Rated voltage
AC 230V 50Hz 0.2A
Alternation type
1 in 2
Rated input power
20 va
Cell material
TPU coated nylon
Protection class
Class 2
TPU coated nylon
Power cord length
16 ft 5 m
Air output (Lpm)
6.5
Cycle time
10 - 12 minutes
Dimensions (inflated)
80” x 35” x 5”
2000 x 880 x 130 mm
Weight
Base material
Top cover materialPU coated
multi-stretch polyester
Cover attachment
Elastic
Skirt seams
Sewn
System part numbers (230V)
page 12
Aeria 5 Mattress Overlay System
MT-A1-101
Compact Control Unit CU-A1-050
Aeria 5 Mattress Base
(18 cells included) MT-S1-006
Aeria 5 Top Cover
MT-S1-034
Aeria 5 Air Cells
MT-S1-017
Aeria 5 Carry Bag MT-S1-022
specifications
Aeria 5 User Guide
Warranty
Aeda Healthcare Ltd warrants each of its
products to perform in accordance with
established specifications for specified time
periods, starting from the date the product is
shipped from Aeda Healthcare Ltd.
During this warranty period, in the unlikely
event of a defect in materials or
workmanship, a local Aeda Healthcare
authorized dealer will repair, replace or
supply replacement parts under standard
warranty terms and conditions in effect at
time of purchase, unless the problem and/or
failure is due to customer damage,
negligence and/or misuse; or unauthorized
repairs.
Aeda - Actively supporting your health In the event of a defect, repair work should
be completed by returning the faulty system
to a local Aeda Healthcare authorized
dealer.
Items not covered under warranty include,
but are not limited to; stains, punctures,
cuts, damage to power cords, rips or tears,
dents, electrical overload, surge, spikes and
lost or missing parts.
Warranty repairs do not extend the length of
the warranty period. Warranty terms and
conditions are subject to change at any time
without notice.
Neither Aeda Healthcare, its distributors,
officers, directors, employees or agents
shall be liable for consequential or other
amages, including but no limited to
personal injury, loss, or any other expense,
directly or indirectly arising from the use of
its products. The sole remedy for breach of
the limited warranty granted herein shall be
repair or replacement of the Aeda
Healthcare products.
Visit www.aeda.com to view a copy of the
manufacturer’s Warranty Statement.
warrantypage 13
Aeda Healthcare is all about
helping people enjoy a freedom
of life, throughout every stage of
life. About improving mobility,
independence, dignity and
offering choice. About making
products that are practical,
reliable, affordable – and stylish.
Aeda Healthcare Limited
15th Floor
100 Queen’s Road Central
Central
Hong Kong
T +852 6832 5199
F +852 6832 5373
E aeda@aeda.com
www.aeda.com Actively supporting your health
AU-1102