Aeria Sit - Aeda Healthcare

U S E R
G U I D E
Key
Definition of symbols used
User guide
- medium
- high
i
Important information
Caution symbol
Electrical hazard
Iron - low
Type B Applied Part
Manufacturer details
Visual alarm
Alternating mode
Static mode
Do not iron
CL
Bleach - chlorine
Do not bleach
BLEACH
Aeda – a brand actively
supporting your health
A fresh approach to proven
pressure care solutions
Tumble dry - low
- medium
- high
Do not tumble dry
Switch ON/OFF
The Aeda mattress
and seat category
If dry cleaning - do not use a
solution stronger than
perchloroethane
System ready/functioning normally
Serial number
Seating overlay
70
Operating instructions
Disposal: Do not dispose of this
product as unsorted municipal
waste. Collection of such waste
separately for special treatment is
necessary.
Wash instruction here
Zip located here
Do not immerse control unit
Infection control
Do not ...
OROETH
HL
P
E
AN
PER
C
Power
Maximum water temperature
(in this example - 160°F 70ºC)
Control unit
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
key
Symbol for ”Authoristed Representative in
the European Community”
Aeria Sit 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 Sit Seating Overlay
System – this chapter provides
a basic system overview, intended use
guidelines and a summary of system
features and box contents.
Box contents
•
dynamic seating overlay
with dual air hoses
•
•
•
•
compact analogue control unit
power cord
Aeria Sit User Guide
Aeria Sit Quick Set Up Guide
Applied part.
The cushion is treated as an applied part.
page 2
system overview
Aeria Sit User Guide
Introducing the Aeria Sit Seating Overlay System, this chapter provides a basic system overview,
intended use guidelines and a summary of system features and box contents.
•
in conjunction with the appropriate
Aeria dynamic mattress surface and
under constant supervision from a
healthcare professional, the Aeria Sit is
indicated for the prevention and
treatment of skin breakdown and
pressure ulcers in patients at all grades
of risk
•
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
products
•
suitable for transitory periods of day
chair use, the seating overlay is
constructed from two layers of 7 cells.
The bottom layer and 1 top layer cell are
static, and the other 6 cells cyclically
inflate and deflate in an alternating
pattern, providing gentle and dynamic
support
•
suitable for use at home or in long term
or extended care environments
•
designed for use on standard hospital
and normal domestic chairs
•
a static front edge and the bottom layer
aids user stability and supports strong
posture
•
connected to the control unit via dual air
hoses, seating overlay cells are inflated
by an electronic control unit, which
includes a pressure sensor for
monitoring seating pressure and
adjustable pressure settings to match
patient weight and comfort needs
•
operator controls are kept to a minimum
for simplicity and ease of use
System features
Support
•
two layers of 7 cells - the bottom cells
and the front cell in the top layer are
static to provide static support for
optimum user comfort
•
vapor permeable, waterproof cushion
top cover prevents moisture transfer,
while multi-stretch fabric minimizes
friction and reduces shear
•
adjustable pressure level to match users
weight and comfort needs
•
supporting users to a maximum weight
of 220 pounds 100 kilograms
Aeda - Actively supporting your health Safety
Simplicity
•
non slip mat maintains
stability on all surfaces
•
easily removable, machine washable
cover with 360 degree zipper
•
visible alarm light to warn
of pressure failure
•
•
quick connector air hose attachments
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 Sit Seating Overlay System is
indicated for:
There are other devices necessary for
normal operation.
•
The Aeria Sit seating overlay can be fitted to
most standard hospital or normal domestic
chairs.
the prevention of skin breakdown and
pressure ulcers in patients at low to
medium risk (when used in conjunction
with an appropriate Aeria dynamic
mattress surface and under the
consent, supervision and management
of a suitable qualified health
professional)
The Aeria Sit compact analogue control unit
can be fitted to the back of the chair.
Alternatively the control unit can be placed
on the floor, underneath the chair or on any
other stable surface.
Contraindications
Patient conditions for which the application
of pressure relief therapy on the Aeria Sit
Seating Overlay System is contraindicated
include:
•
•
•
The Aeria Sit Seating 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.
instable spinal cord injury
cervical traction
patients with poor sitting balance
Intended care setting
Intended care settings for the Aeria Sit
Seating 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 Sit 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
seating overlay 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 /
seating cushion combination as
indicated by Aeda Healthcare should be
used, otherwise the correct function of
the product cannot be guaranteed.
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.
Do not position the system so that it is
difficult to operate the disconnection
device.
Check the operation of controls and
other components around the spill
area.
Explosion hazard
Aeda - Actively supporting your health Do not open the control unit – risk of
electrical shock. Refer servicing to
qualified service personnel.
•
Do not modify this system without the
authorization of the manufacturer.
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
Significant risks of reciprocal interference
may be posed by the presence of the system
during specific investigations or treatments.
Potential electromagnetic or other
interference between the system and other
devices may occur. If interference is
suspected, move equipment from sensitive
devices of contact the manufacturer.
Equipment is not suitable for use in the
presence of a flammable anesthetic
mixture with air, oxygen or nitrous
oxide.
Maximum patient weight
The maximum recommended patient
weight for this system is 220 pounds
100 kilograms.
luid or liquid remaining on the
F
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.
•
•
Do not use in the presence of smoking
materials or open flame – air flowing
through the seat cushion will support
combustion.
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.
seat cushion
1.Check the chair for any sharp objects
that may puncture the cushion.
2.Unzip the top cover and place the
seating cushion on top of the chair
surface, with the static cell edge to the
front. Standing to face the chair, check
the following:
a. the air cells are in a horizontal position across the chair
b.the air hoses appear from the back
right corner of the cushion
c. with the static cell edge to the front
Always use the Aeria Sit in the correct
orientation and with the protective top
cover. Failure to do so could cause
equipment or patient injury.
4.Hang the control unit over the back of
your chair, using the inbuilt rear
hanging hooks, or place on a flat surface
(ie on the floor, underneath the chair or
a solid table).
control unit
power cord
Avoid trailing power cords – ensure
that any cords or hoses are positioned
beneath the chair to avoid causing a
hazard.
3.Place the top cover over the seating
cushion, ensuring the printed logo is
uppermost and faces forwards. Re-zip
the cover on to the seating cushion,
taking care not to trap any material in
the zip.
Before attaching the control unit to the
floor or the back of the chair, ensure
they are sufficiently robust and free of
damage.
The non-slip mat located on the
base of the seating cushion provides
added security and stability.
page 6
system set up
Aeria Sit User Guide
This chapter describes the steps necessary
to prepare the Aeria Sit system for use.
5.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.
6.Insert the power cord into the base of
the control unit, then plug into an
appropriate electrical outlet and switch
on mains power.
Dismantling the system
1. Switch off the control unit.
2.Switch off mains power and unplug the
power cord from the mains outlet.
3.Disconnect both the air hoses
from the control unit to deflate all cells.
2
Straighten any twists in the air hoses to
ensure uninterrupted air flow between
the control unit and seating cushion.
Also ensure the hoses are not trapped
between the seating cushion and chair.
Failure to do so could result in an under
inflated seat cushion leading to patient
injury.
Aeda - Actively supporting your health 3
1
4.Remove the seating cushion from
the chair and store all items safely.
Do not store the system
in direct sunlight.
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).
Allow up to 10 minutes for complete
inflation.The green Ready LED
illuminates when the system is ready
for use.
system set uppage 7
Operation
Control unit layout
Power switch
Establishing pressure
Turns system power on and off.
The switch illuminates to indicate
power is on.
1.Prepare the system for use as described
in System Set Up.
Ready indicator
This green light displays to indicate
the system has reached (and
maintains) operational pressure.
Alarm indicator
This red light displays to alert when
seating cushion or control unit
pressure fails. The alarm indicator
remains illuminated until pressure is
restored.
Pressure dial
Adjusts seating cushion pressure
from low to high, in line with patient
weight and comfort requirements.
The patient may sit on the Aeria Sit
system during inflation however the
seating cushion will fill faster if allowed
to inflate first.
2.When the patient is sitting comfortably,
turn the Pressure dial to reach the
desired setting for effective patient
comfort and support.
After lowering the pressure setting,
always check the Aeria Sit system is
working effectively. Failure to do so
could cause patient injury.
Wait at least 10 minutes between any
pressure adjustment or patient
assessment as the Aeria Sit system
may take a full cycle to adjust to the
new pressure setting.
Static / Alternating switch
No special skills, training or knowledge
are required to operate the control unit.
page 8
Switches between Static and
Alternating operational modes.
The orange Static Mode indicator
illuminates when the mattress is
operating in static mode (all cells fully
inflated with no dynamic alternation).
When the static mode indicator is not
illuminated, the mattress is operating
in dynamic Alternating Mode
(alternate cells cyclically inflating and
deflating).
operation
Aeria Sit User Guide
This chapter describes how to safely operate the Aeria Sit system
including patient set up and control unit function.
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.
Transport function
Alarm function
When transporting a patient on the Aeria Sit
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 seating overlay.
The Alarm indicator illuminates to indicate
that control unit or seating cushion pressure
has failed (when pressure drops below the
accepted minimum level). 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:
System Removal
•
turn off the control unit by unplugging
the mains cable
•
to deflate the cushion, pull the
connectors and open the quick
connector on the umblical cord
•
place the control unit and mains cable
on top of the seat cushion and remove it
from the chair
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.
•
check the air hoses are securely
connected to the control unit
•
check all cells, pipes and hoses
are securely connected, and look
for air leaks
•
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.
uring transport, regularly check to
D
ensure the patient is adequately
suspended on the seating overlay.
Failure to do so could cause patient
injury.
Note: deflate the cushion by opening quick
connectors as shown above.
Aeda - Actively supporting your health operationpage 9
Care & cleaning
To prevent cross contamination, it is
recommended the seating overlay is
examined and disinfected between
patient use.
Clean the seating overlay in 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.
o not use high temperature autoclave
D
steam cleaning devices or phenolicbased products for cleaning. This could
result in damage to the equipment and
loss of waterproof qualities of the seat
cover.
Switch off and disconnect the control
unit from mains power supply before
cleaning. Do not immerse the control
unit in water.
Disinfection
The seating cushion, top cover and control
unit may be decontaminated by using ETO
(Ethylene Oxide).
This chapter describes general care and cleaning for the
Aeria Sit system, including basic maintenance procedures.
Cleaning & infection control
I t is recommended that the
system be cleaned regularly if in
constant use.
Base cleaning
Once deflated, slide air cells from the cell
straps to detach from the base – cells will
remain permanently connected to the dual
air hoses. Swab the cells and cell strap
base with a solution of sodium hypoclorite
or similar (up to 10,000ppm available
chlorine). Dry thoroughly before reattaching.
Do not machine wash the base.
Top cover cleaning
Unzip the seat 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.
For infection control, swab with a solution of
sodium hypoclorite or similar (up to
10,000ppm available chlorine). Dry
thoroughly before use.
Refer to the seating cover wash tag for
cleaning instructions.
Do not use the system
without the 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.
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).
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.
4.Refit the air filter cover to the control
unit before use.
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.
2.Insert a small screwdriver into the
groove and turn anti-clockwise (quarter
turn).
3.Remove the ‘blown’ fuse from the fuse
holder clip and discard.
4.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).
Preventive inspections and calibration
are not required.
page 10
care & cleaning
Aeria Sit User Guide
Troubleshooting
This chapter provides basic troubleshooting
support for the Aeria Sit 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
indicator illuminates
Seating overlay fails to inflate
The alarm illuminates when seating 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 each air cell is securely attached to
the connecting air pipe.
Check all cells 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
sitting on the seating 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 to the increase was sufficient.
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 Sit 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
220 lb 100 kg
Risk category
Low - medium
Seaing overlay
Control unit
Type
Compact analogue
Dimensions
5.5” x 4.5” x 10.5”
135 x 115 x 270 mm
4.5 lb 2.1 kg
Dimensions (inflated)
18” x 18” x 5”
460 x 460 x 130 mm
Weight
Weight
2.6 lb 1.18 kg
Rated voltage
Number of cells
6 alternating 8 static
Cell height
2.5” 65 mm
Alternation type
1 in 2
Cell material
TPU coated nylon
Base material
TPU coated nylon
Top cover materialPU coated
multi-stretch polyester
Cover attachment
Quick release zipper
Skirt seams
RF welded
Foam
No
US
110-120VAC 50/60Hz 0.2A
EU
220 - 240VAC 50/60Hz 0.2A
Rated input power
20 va
Protection class
Class 2
Power cord length
16 ft 5 m
Air output (Lpm)
6.5
Cycle time (mins)
10 - 12
System part numbers
Aeria Sit Seat Cushion System:
US:
SC-A3-001
SC-A3-002
EU: Aeria Sit Control Unit:
page 12
US:
MT-S4-035
EU:
MT-S4-030
Aeria Sit Cushion:
MT-S4-100
specifications
Aeria Sit User Guide
This chapter provides the various physical and technical specifications of
the Aeria Sit system, including details of replacement parts.
Specifications
Electromagnetic emissions for all Aeria EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emission
The Aeria Sit is intended for use in the electromagnetic environment specified below. The customer or the user of
the Aeria Sit should ensure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment – guidance
Harmonic emissions
Class A
The Aeria Sit is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
IEC 61000-3-2
Voltage fluctuations/ flicker
emissions
Complies
IEC 61000-3-3
RF emissions
CISPR 14-1
Complies
The Aeria Sit is not suitable for interconnection
with other equipment.
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.
specifications & warranty Neither Aeda Healthcare, its distributors,
officers, directors, employees or agents
shall be liable for consequential or other
damages, 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.
page 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
developing quality healthcare
products that simply look good.
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
3VB8
E336602
AU-8204