OSKA Alternating Air Overlay Pressure Care Mattress User Guide
- August 27, 2024
- Oska
Table of Contents
Alternating Air Overlay Pressure Care Mattress
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Specifications
-
Product: OSKA Air Overlay
-
Description: Alternating pressure air overlay system
-
Number of Air Cells: 17 (3 static head cells, 14 active
alternating cells) -
Cover: Waterproof, breathable, multi-stretch
-
User Weight Range: 40Kg to 160Kg
-
Intended Environments: Hospital, Professional Healthcare
facilities, Home Healthcare
Product Usage Instructions
Setup
-
Place the OSKA Air Overlay on top of a suitable base mattress
or underlay. -
Connect the umbilical air hose from the overlay to the electric
pump unit. -
Ensure the air cells are arranged transversely across the
patient support surface.
Operation
-
Plug in and switch on the pump unit.
-
The air cells will inflate and deflate in an alternating
pattern every ten minutes. -
Monitor the overlay to ensure proper inflation and
functioning.
Maintenance
-
Clean the waterproof cover regularly following manufacturer’s
instructions. -
Inspect the air cells for any leaks or damages
periodically. -
Store the system in a dry and safe place when not in use.
Frequently Asked Questions (FAQ)
Q: Can the OSKA Air Overlay be used without a base mattress or
underlay?
A: No, it is not recommended to use the overlay directly on the
bed base as it may pose additional risks to the patient. Always use
it on top of a suitable mattress or underlay.
Q: What is the intended user group for the OSKA Air
Overlay?
A: The overlay is intended to support a single patient weighing
between 40Kg and 160Kg. For patients outside this weight range,
clinical judgment should be used to determine suitability.
Q: How often should the air cells alternate in the OSKA Air
Overlay?
A: The air cells alternate in a 1-in-2 cell cycle every ten
minutes to reduce the risk of pressure ulcers.
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3:20.06.2024
02 Product Description
The OSKA Air Overlay is an alternating pressure air overlay system, designed
to be used on top of a base mattress or underlay. It consists of a single
layer of air cells attached via an umbilical air hose to an electrically
powered pump
The overlay consists of a series of seventeen air cells.The three `head cells’
at the top of the overlay are static and do not alternate; the remaining
fourteen air cells are active, alternating air cells.The cells are arranged
transversely (side to side) across the patient support surface.
When attached to the pump, these air cells inflate and deflate in an
alternating pattern (referred to as a 1-in-2 cell cycle) every ten minutes.
The overlay cover is waterproof, breathable and multi-stretch to help it
conform to patients.
WARNING
It is NOT designed to be placed directly on the bed base and using it without
a suitable mattress or underlay underneath it may expose the patient to
additional risks.
Waterproof, moisture vapour permeable, multi stretch cover.
Umbilical air hose
Overlay pump unit
Air Overlay User Guide
Overlay with 17 air cells running side to side across the overlay.
03 Indications for Use
Intended use The intended use of the OSKA Air Overlay system is to reduce the
risk of pressure related tissue injury in patients at an elevated risk of
pressure ulceration, up to and including those patients at high-risk’ of pressure ulcers. In addition, it is intended to support the management of patients with existing partial thickness (Category 1 and 2) pressure ulcers. SeeIndications’ for further information on use of the Air Overlay.
Intended Environment The OSKA Air Overlay system is intended to be used in the
following environments:-
– Hospital
– Professional Healthcare facilities including care homes, nursing homes and
hospices
– Home Healthcare / Community Healthcare settings
Intended user group This alternating pressure air overlay is intended to
support a single patient between 40Kg and 160Kg in weight. For patients of
very low weight, typically less than 40Kg and / or small stature, OSKA
recommends that the healthcare provider uses clinical judgement to determine
suitability.
It is intended that the system is set up and adjusted by a professional user
who has received product training / instruction on correct set up and use of
the product.
or without existing Category 1 or 2 pressure ulcers. See `NOTE’ below. · The
overlay is to be placed on top of the existing foam bed mattress or a
dedicated foam underlay with a minimum depth of 50mm.
WARNING
Failure to use a suitable mattress or underlay product beneath the OSKA Air
Overlay could increase the risk of pressure related tissue injury for the
patient.
NOTE
Support surfaces represent only one element of a patient’s pressure ulcer
prevention and management care bundle. Other elements of an effective pressure
ulcer care bundle include pressure ulcer risk assessment, regular patient
repositioning, nutritional support, skin care etc.The OSKA Air Overlay system
should only be used once a holistic assessment of the patient’s individual
care needs has been completed by the prescribing clinician / care provider.
Indications The OSKA Air Overlay System is indicated for use as follows:
· Patients at an elevated risk of pressure ulcers, up to and including those
at `high-risk’, with
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04 Safety & Contraindications
Risk Assessment Before using the OSKA Air Overlay, a patientspecific risk
assessment should be performed. As a minimum, this should include the
following:
· Product combination (i.e. bed frame + mattress + overlay + side rails etc.)
to ensure compatibility of products being used for patient care. Specific
consideration should be given to any risk of entrapment and falls. For further
information refer to:
· IEC 60601-2-52:2009 (Medical electrical equipment. Part 2-52: Particular
requirements for the basic safety and essential performance of medical beds)
· MHRA Guidance Bed Rails: management and safe use. Guidance on managing and
using bed rails safely. Published 30 August 2023.
· Pressure ulcer risk assessment to determine the patient’s risk level for
pressure related tissue injury.
· Full body skin check to determine anatomical location and severity of any
existing pressure ulceration.
Contraindications · Do not use the OSKA Air Overlay system for
patients with unstable spinal fractures.
· Do not use the OSKA Air Overlay system for patients where use of an active
therapy support surface could result in any harm or exacerbate their medical
condition.
· Do not use the OSKA Air Overlay system for patients with an intolerance to
motion.
05 General Warnings, Cautions and Information
The following general warnings, cautions and information should be observed
regularly during use of the product and not just upon overlay installation.
GENERAL WARNINGS
· It is the responsibility of the clinician in charge of the patient / care
provider to ensure that the user can use this product safely. NOTE: the Air
Overlay is not typically intended for children. When children are the intended
recipients ensure a full risk assessment is performed which considers the
child’s size in relation to the product and equipment in use.
· The overlay is to be installed and put into service in accordance with the
instructions provided.
· Do not use the overlay without a cover.
· Due to the range of available bed frames, mattresses and bed rails, the
customer / care provider is responsible for performing a risk assessment to
ensure the bed frame, mattress, bed rails and OSKA Air Overlay are compatible,
and that the proposed combination does not impact on patient safety in any
way.The combination of bed frame + mattress + overlay + side rails should not
result in any gap large enough to entrap a patient’s head, body or limb. Care
should be taken to prevent gaps arising as a result of compression or movement
of the mattress / mattress overlay. Death or serious injury may occur.
Air Overlay User Guide
· The combination of products should not permit hazardous ingress or egress
where entanglement with the mains power cord or air hoses may result. Death or
serious injury may occur.
· If the patient is to be left unattended, the decision to use bed side rails
should be based on clinical assessment and in line with local policy. Key
considerations for safe use of side rails are risk of entrapment and risk of
falls. Refer to MHRA guidance and local policy on the safe use of side rails.
· Electrical equipment may be hazardous if misused. No modification of this
equipment is allowed, and only accessories designed and approved for use with
this system are permitted.
· There are no user serviceable parts inside the pump unit.The pump unit case
must only be removed / opened by OSKA engineers or OSKA authorised technical
personnel.
· The mains plug is the disconnect device for the means of isolating the
control unit from the mains supply.The mains power socket / plug must be
accessible at all times.
· Ensure the mains power cord and air hoses are:
· Intact and free from damage. Damaged electrical cables can create a risk of
electrocution and / or fire.
· Positioned to avoid causing an obstruction or injury. Loose or hanging
cables / air hoses can cause a trip hazard or risk of strangulation arising
from baby, child or patient entanglement.
· Clear of moving bed mechanisms such as bed rails or bedframe mattress
platform (or other entrapment areas or crush points) which may result in
damage.
NOTE: Use the overlays cable management feature to minimise potential mains
cable issues.
· DO NOT smoke whilst on or near the Air Overlay Risk of fire. Cigarettes,
lighters, matches and naked flames are all sources of ignition and could
ignite clothing, bed linen, blankets, duvets etc. In the event of a fire, a
breach in the overlay could result in air loss from the product which may act
as a fan effect to assist the flames. It is advised a full fire risk
assessment is carried out prior to using this equipment and for patients at
risk, consider using alternative pressure area care equipment and
fireretardant bedding.
NB. Other external sources of ignition such as exposed heating elements in
electric fires, open fires, lamps/light bulbs, candles and electrical
appliances should also be kept away from the overlay.
· The system is not intended for use in the oxygen rich environment and
presence of flammable anaesthetic mixtures with air, oxygen or nitrous oxide
Risk of fire.
· Do not place blankets, bedding or other items over the pump unit Risk of
fire.
· No servicing or maintenance activities should take place with the patient
in-situ.
· The Air Overlay cover is not freely air permeable and may present a
suffocation risk if used incorrectly.The healthcare professional responsible
for the patient must ensure this product is suitable for the user and that
they can safely use this product.
· Ensure the CPR tag on the overlay is always visible and easily accessible
when
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the system is in use.
· Polythene bags used as part of the product packaging may present a risk of
suffocation. To avoid the risk of suffocation, keep bags away from small
children and babies.
CAUTIONS
· When the OSKA Air Overlay has been kept in conditions close to the minimum /
maximum storage temperatures, a minimum of three hours is required for the
system to adjust to room temperature prior to it being plugged into a mains
electrical supply.
· For optimal pressure area care performance, keep layers of bedding / pads
between the overlay cover and the patient to a minimum. Similarly, secure bed
sheets loosely to prevent areas of `hammocking’ / high pressure.
· Do not allow sharp objects to penetrate the overlay cover.
· Do not use abrasive cleaners, biological or phenolic based cleaners.
· Attach the overlay to the moveable parts of the bed frame only.
· Do not store or use the system in direct sunlight or use in an outdoor
environment.
· Do not store in damp conditions or a moisture rich environment.
· The overlay should be cleaned regularly and always between patients.
· Do not use hot water bottles or electric blankets when using the overlay
system.
Information · Set up the Air Overlay as directed. Once set up,
the Air Overlay does NOT need to be turned or rotated on the bed frame.
· Always supervise children and pets closely when in the vicinity of the
overlay system.
· The overlay is for single person use. Additional weight could damage the
system or affect performance.
· Note to the user and/or patient: any serious incident that has occurred
specifically in relation to this device should be reported to the manufacturer
(or where appropriate, the importer or distributor) and the UK MHRA or the
relevant competent authority of the EU member state in which the user and/or
the patient is established.
Air Overlay User Guide
06 Parts Identification
6.1 Overlay pump unit
4
1
3 2
5
6.2 Pump control panel
4 321
COMFORT SETTING 1 – Soft 8 – Firm
5
UNLOCK MUTE
STATIC
POWER
LOW PRESSURE POWER FAILURE
67
Number 1 2 3 4 5
Overlay Pump Unit Feature / Part Control panel (see 6.2 below) Mains power cable Umbilical attachment point / CPR Bed hooks Fuse (x2)
Number 1 2 3 4 5 6 7
Pump Control Panel Feature / Part ON / OFF power button Static mode button Lock / Unlock button Comfort control Comfort setting display Mute button Indicator lights for low pressure and power failure alarms
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6.3 Overlay
2 1
3
4
5 7
8
6
9
Number 1 2 3 4 5 6 7 8 9
Overlay Feature / Part Removable top cover Static head cells (x3) CPR Alternating air cells (x14) Base cover Fixing straps (x4; 2 each side) Umbilical / Air hose Transport cap Cable management flap (x2; one each side of the overlay)
Air Overlay User Guide
07 Installation
The OSKA Air Overlay system is easy to install, set up and use.To install the
system correctly, follow the steps below.
7.1 System preparation Remove the OSKA Air Overlay system from its
packaging.The unboxed system consists of the following items: · Air Overlay
with integral umbilical (air hose). · Air Overlay Pump · Mains power cord
4. Using the four fixing straps (two on each side of the overlay), attach the
overlay to the bed frame.
NOTE
If the bed frame is a multi-section profiling bed then attach the overlay to
the movable parts of the bedframe only.
7.2 OSKA Air Overlay installation
NOTE
The OSKA Air Overlay is designed to be placed on top of the current mattress
or underlay. DO NOT place the OSKA Air Overlay directly onto the bed base,
always use a mattress or underlay.
5. To prevent air leaking from the overlay, ensure that the CPR cap, attached
to the red CPR tag at the head end of the device, is fully pushed onto the two
air tubes protruding from the
white connector.
1. Check the bed frame / mattress / underlay for sharp objects or edges that
could damage the overlay.
OSKA Air Overlay Mattress or underlay
Bedframe / bed base
2. Unroll the overlay and place it directly onto the mattress, or underlay.
3. Ensure that the white `feet’ symbol on the blue overlay cover is facing
upwards and located at the foot end of the bed.
NOTE
If the CPR cap is not fully in place the overlay may fail to inflate,
resulting in a low-pressure alarm fault.
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4. Once the overlay and pump have been installed correctly and connected, the system is ready for use.
6. Ensure the red CPR tag at the head of the overlay is visible, not covered
by bedding and the `pull’ arrow on the tag is pointing towards the floor.
7. To optimise the pressure area care offered by the overlay, ensure the
overlay cover is loose, and any sheets are loose fitting
7.3 Pump installation 1. Position the air overlay pump either by using
the two brackets on the back of the pump to hang it from the foot board of the
bed or place it upright on the floor at the foot end of the bed.
2. Insert the mains power cable into the overlay pump and insert the plug
into a suitable mains power outlet. Switch the mains socket on.
3. Choose which side of the overlay you wish to run the mains power cable
along.
4. Locate the cable management flap which runs the length of the overlay on
each side.
5. Open the Velcro fastenings, lay the cable into the flap and secure the
Velcro back together, enclosing the mains cable within the material flap.This
will secure the cable and raise it off
the floor to reduce the risk of trips. 6. DO NOT route the mains cable through
or
round any mechanical bed assemblies where the cable could be crushed, trapped
or snagged.
7. The mains cable should not be in tension when the bedframe / platform is
operated throughout its full range of potential movement.
7.4 Connecting / disconnecting the Pump and Overlay
1. To connect the pump and overlay, remove the transport cap’ from the air hose (umbilical) coming from the foot end of the air overlay 2\. Align the plastic connector on the end of the umbilical with the connector on the pump. 3\. Push the two fittings together until you hear aCLICK’.
5. To disconnect the umbilical from the pump unit, use your finger and thumb
to squeeze the tabs on the top and bottom of the umbilical fitting together
(1).
6. Keeping the two tabs squeezed together, pull the umbilical away from the
overlay pump (2) until it fully detaches from the pump.
1
2
1
Air Overlay User Guide
15
08 Pump Functions (Controls, Alarms and Indicators)
Comfort control buttons
2
Lock/unlock button
3
Static mode button
4
ON / OFF power button
1
COMFORT SETTING 1 – Soft 8 – Firm
UNLOCK MUTE
STATIC
POWER
LOW PRESSURE POWER FAILURE
5 Comfort setting
display
6
Mute button
7 Indicator lights for low pressure alarm / power failure alarm.
Under normal operation the OSKA Air Overlay System delivers alternating pressure area care therapy. It does this using an alternating 1 in 2 cell cycle over a 10-minute cycle time.
8.1 Power On/Off
The On/Off power button is located on the right-hand side of the pump control panel see above.
POWER
To power-up the pump, push the On/Off POWER button.You will feel the button click and hear a beep as the unit starts up.The green indicator light immediately below the POWER button will flash while the system reaches the correct pressure. Once it is at the required pressure, the green light will cease to flash and remain constantly illuminated.
To power down the pump (firstly unlock the pump see below) press the POWER button once until you feel a click and hear a beep. All lights will turn off and the system is now OFF.
8.2 Comfort Control buttons The comfort control buttons on the left of the
control panel allow air pressure within the overlay to be adjusted between 1
(Soft) and 8 (Firm), to optimise patient comfort.
NOTE
A firmer comfort setting may offer enhanced support for a heavier patient;
however, the clinician in charge of the patient is responsible for selecting
the most appropriate comfort setting to meet the patient’s needs when using
the overlay.
To adjust the OSKA Air Overlay in response to a change in patient weight,
position, or to meet patients’ individual comfort needs, use the up / down
arrows as required to select the appropriate comfort level for the patient
(this can be done whilst the patient remains on the overlay system).
Air Overlay User Guide
8.3 Unlock (Lock) button
UNLOCK
The UNLOCK button allows the user to `unlock’ the control panel
to adjust the settings on the pump during use.
When the pump is locked the green light under
the UNLOCK button will be permanently illuminated.To unlock the control panel
push
and hold the UNLOCK button for 3 seconds. The system will beep, and the light
will go out to indicate the pump is now unlocked. After adjusting the
settings, the pump can be locked again by pushing and holding the UNLOCK
button (the system will beep, and the light will illuminate again).
Alternatively, the system will lock automatically after five minutes of
inactivity.
8.4 Static Mode button
STATIC
The STATIC mode button can be used to create a static support surface without alternating pressure therapy.
With the pump unlocked (see 8.3 above) push the STATIC button once to select static mode. The button will click, and you will hear a beep.The green indicator light immediately below the STATIC button will illuminate to indicate that STATIC mode has been selected.
Twenty (20) minutes after STATIC mode has been selected the system will automatically return to an active therapy (alternating) support surface and the green light below the STATIC button will go out.
To return to an alternating support surface before the default twenty minutes, unlock the control panel and push the STATIC mode button again. The green light will turn off, and the system will return to its active therapy cycle.
8.6 Mute button
MUTE
The MUTE button will mute the audible element of the pump’s LOW PRESSURE alarm and it will cancel the POWER FAILURE alarm.To mute the LOW PRESSURE alarm, push the MUTE button once. Pushing the button again will unmute the alarm.
8.7 Low Pressure & Power Failure Indicators (Alarms)
The flashing red LOW
LOW PRESSURE
PRESSURE indicator light
will display as a result
POWER FAILURE
of the system operating
at a consistently low pressure for approximately
fifteen minutes. See Section 10.6 (Alarms / Fault
Conditions) for more information.
The flashing red POWER FAILURE indicator light will illuminate as a result of
the mains
power turning off, or the mains power lead being disconnected from the pump
unit.
CAUTION
The power failure alarm will NOT activate as a result of turning the pump unit
off via the POWER (On/Off) button on the control panel.
8.5 Comfort Setting display The comfort setting display will show the comfort
level selected for the patient.This will range from 1 (soft) to 8 (firm). See
Section 8.2 above for more information.
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09 Air Overlay Functions
1 CPR
4
Fixing straps
3
Fixing straps
4
2
Transport cap
9.1 CPR To rapidly deflate the OSKA Air Overlay System, for example during a
cardiac arrest, use the CPR tag at the head of the overlay. Optimise the rate
of deflation by unplugging the umbilical hose from the pump (see Section 7.4).
9.2 Transport Cap (transport mode) The Transport Cap is attached to the end of
the umbilical with a length of webbing to ensure it is available when
required.The transport cap is placed over the end of the umbilical to seal air
within the overlay for an extended period of time.
9.3 Cable Tidy
The Cable Tidy feature runs down each side of the Air Overlay and allows the
mains cable to be neatly positioned off the floor and away from any mechanical
/ moving parts of the bed frame.
9.4 Fixing Straps
There are four overlay fixing straps, two on each side of the overlay.These
allow the overlay to be secured to the moving parts of the bedframe to help
provide a stable support surface during patient ingress/egress from the bed.
Air Overlay User Guide
10 System Operation
The following instructions explain the basic dayto-day operation of the OSKA
Air Overlay system. General maintenance, repair and servicing should be
carried out by suitably qualified personnel. Refer to Sections 7, 8 and 9 of
this User Manual for further information on installation, set up, controls and
functions of the Air Overlay System.
10.1 Overlay inflation
WARNING
Wait until the green POWER’ indicator light is constantly illuminated before placing a patient onto the Air Overlay System. 1\. Set the system up as described in Section 7 and turn the pump on as described in Section 8. 2\. Select the appropriate COMFORT SETTING for the patient. 3\. As the system is inflating the greenPOWER’ indicator light will flash.
4. Once the system reaches the correct pressure, the flashing green `POWER’
indicator light will automatically be replaced by a constant green indicator
light.
5. The system is now ready for use.
2. Pull the CPR tag down towards the floor to remove the bung from the tubes
at the head of the overlay. If the CPR is not disconnected, the 3 static head
cells will remain inflated.
10.3 Static mode To create a static (non-alternating) support surface, follow
steps 1-3 below.To deselect static mode and return to an alternating support
surface, follow steps 4-5 below. 1. With the system set up and operating
normally,
push and hold the UNLOCK button for three seconds until the power unit is
unlocked’. 2. Press theSTATIC’ button on the front of the control panel
once.The button will click, and you will hear a beep.The green indicator light
immediately below the STATIC button will illuminate to indicate that STATIC
mode has been selected and the pump will now inflate all 17 air cells in the
overlay to the same pressure. 3. The system will remain in static mode for a
period of twenty (20) minutes, after which time it will automatically revert
back to an active (alternating) support surface and the green light below the
STATIC button will go out.
NOTE
When static mode is selected, the patient is NOT receiving any alternating
therapy and is exposed to constant unrelieved pressure.
NOTE
It will take approximately 10 minutes for the system to inflate from flat.
10.2 Overlay deflation 1. To deflate the overlay after use, turn off the
pump and disconnect the umbilical from the pump unit.
4. To return the Air Overlay to an alternating pressure support surface
before the twentyminute default period is complete, unlock the pump and push
the static button to deselect the STATIC mode.
5. Once deselected, the green light below the STATIC button will turn off and
the overlay will return to an alternating support surface.
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10.4 Transport mode
`Transport mode’ effectively seals the air within the overlay for an extended
period.This can be useful when disconnecting the pump from the power supply to
move a patient a short distance, during a power cut or when there is a planned
power supply interruption.
WARNING
Patients should be routinely nursed with the system in its normal
(alternating) mode. TRANSPORT mode should only be used when necessary for the
shortest time possible as part of patient transfer, clinical procedures, or
during a power cut. Failure to return the Air Overlay System to active therapy
at the earliest opportunity could increase the risk of pressure related tissue
injury to the patient.
To put the overlay system into Transport mode’: 1. Remove the umbilical air hose from the pump unit (see Section 7.4) 2. Seal the air within the overlay by placing the Transport Cap (attached to the end of the umbilical) over the exposed end of the umbilical air hose.This needs to be done quickly to minimise air loss from the overlay. 3. Push the Transport Cap onto the exposed end of the umbilical until itCLICKS’ into place. 4. Turn the pump off via the On/Off
switch.
To return the overlay system to normal operation: 1. Remove the transport cap
from the end of the
umbilical. 2. Re-attach the overlay to the pump by pushing
the connector at the end of the umbilical onto the pump until it CLICKS into
place. 3. Switch the pump on and wait for it to reach its normal operating
pressure.
CAUTION
When the overlay is in transport mode, the patient is NOT receiving any
alternating therapy and is exposed to constant unrelieved pressure.
Over time (hours), air will gradually leak from the overlay and the patient
will ultimately end up resting on the mattress / underlay. Patient weight,
along with the amount of air in the overlay at the point the Transport Cap was
used, will both affect how long the overlay remains inflated.
Transport mode should be used as a temporary measure and the system returned
to alternating (active) therapy as soon as possible.
10.5 CPR
During a cardiac arrest or other medical emergency, the overlay can be rapidly
deflated by locating the red CPR tag at the head end of the overlay and
pulling it down towards the floor until the bung is detached from the air
hoses.The system will deflate rapidly. To increase the rate of deflation,
disconnect the overlay umbilical from the pump (see Section 7.4)
Air Overlay User Guide
10.6 Alarm Indicators / Fault Conditions Low pressure alarm
LOW PRESSURE
POWER FAILURE
A low pressure’ fault condition will result in the pump simultaneously displaying a flashing redLOW PRESSURE’ indicator light on the control panel
and generating a persistent, beeping audible alarm which continues until it is
muted, or the fault condition is rectified.
See below for a list of possible causes and solutions for a LOW PRESSURE
alarm.
Possible Cause
Solution
Damaged, kinked or disconnected air cells or piping within the overlay.
Unzip the cover and check for damaged, kinked or disconnected overlay air cells and piping.
Damaged or disconnected air pipe / umbilical between the overlay and pump.
Check to ensure the umbilical is intact and the connector is correctly plugged into the pump.
CPR plug not correctly Ensure CPR plug is
pushed onto the air correctly located and
pipes.
in place.
Successfully resolving a low-pressure fault will result in the pump unit returning to normal and the LOW PRESSURE fault will be automatically ended.
NOTE
This will not resolve the fault and the red indicator light will continue to
flash until the fault is resolved.
To unmute the audible alarm simply push the MUTE button again and the low-
pressure alarm will continue to sound. If the alarm cannot be resolved,
contact OSKA for further advice / support.
Power failure alarm
In the event of a power failure (e.g. interruption to mains power or
unplugging the power lead) the overlay pump will simultaneously display a
flashing red `POWER FAILURE’ indicator light on the control panel and generate
a persistent, beeping audible alarm which continues until it is muted
(cancelled) or the fault condition is rectified (i.e. power is returned to the
pump unit).
See below for a list of possible causes and solutions for a POWER FAILURE
alarm.
Possible Cause
Power cut / power outage
Mains power socket switched off or plug removed
Mains lead unplugged from pump
Solution
Wait for power to be restored.
Check switch is on, and lead plugged into socket.
Check mains lead is securely in place at the pump
Muting the Audible LOW PRESSURE Alarm
To mute the audible LOW PRESSURE alarm, press the `MUTE’ button on the front
of the control panel once.
CAUTION
Pushing the MUTE button once will CANCEL the POWER FAILURE alarm. Muting
(cancelling) the power failure alarm DOES NOT rectify the fault. Refer to
above table for possible causes and solutions to a POWER FAILURE alarm.
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11 Care, maintenance, & servicing
WARNING
Always turn the Air Overlay System off and disconnect it from the mains power
supply prior to any product maintenance or servicing.
Wear appropriate Personal Protective Equipment (PPE) and clothing when
performing all maintenance and servicing. Refer to local policies and
guidelines.
Only OSKA engineers or an OSKA approved engineer is to perform system
servicing / repairs.
11.1 Pump care and maintenance OSKA recommends the following actions: · Keep
pump clean. · Regular inspection of pump case for signs of
damage (cracks, chips, dents etc). · Regular inspection of power cord and
plug for
signs of damage / excessive wear. · Check the front panel display is intact,
legible
and in good working order. · Check air connectors are intact and not
damaged. · Check air filter and replace annually as part of
routine annual servicing. * If damaged, remove from use and repair/replace
damaged item before re-use.
· Keep the overlay clean. · Regular visual inspection of the overlay cover
for cuts, needle sticks, tears, scuffing, abrasions, delamination, seams
splitting, zip damage etc. · Regular checks inside the top cover for signs of
staining / strike-through (this will indicate a breach in the cover integrity
and will require a replacement top cover). If strikethrough is apparent, check
air cells / tubing inside overlay for fluid ingress. If present send system
for cleaning/decontamination in line with local guidelines. · Regular
inspection of the umbilical air-line tubing and connector. · Check CPR plug is
firmly in place.
NOTE
Between patients the system should be cleaned / decontaminated, and a full
visual inspection performed to ensure the system is intact prior to re-use.
11.3 Servicing OSKA recommends an annual service of the Air Overlay System
from an OSKA engineer or an OSKA approved service provider. Only OSKA
components or OSKA approved component parts can be used for servicing / repair
of the Air Overlay system.
11.2 Overlay care and maintenance
Check the overlay regularly for signs of wear / damage that could impact on
device performance or compromise the integrity of the cover and pose a
potential risk of infection or cross contamination for the patient or carer.
OSKA recommends the following actions are performed weekly wherever possible:
Air Overlay User Guide
12 Decontamination: Cleaning, disinfection and washing
The following processes are recommended by OSKA as appropriate infection
prevention procedures to reduce the risk of infection / cross infection from
the Air Overlay system during use and re-use of the device.
The following recommendations may need to be adapted to comply with national
or local medical device decontamination guidelines. Seek advice from your
local Infection Prevention & Control specialist where appropriate.
OSKA recommends the Air Overlay System is cleaned and decontaminated at
regular intervals when in use, and always before it is used for a new patient.
After cleaning or disinfection, always check the top cover for signs of
potential damage that may permit the ingress of fluid (strikethrough) into the
internal overlay components. Damage includes pin-prick holes (needle sticks),
scuffing, abrasion, tears, delamination, damaged seams etc.To check for damage
not visible to the naked eye, unzip the cover and examine the white underside
of the cover for staining / discolouration.This is an indication of fluid
strikethrough.
WARNING
Damaged covers present a risk of infection / cross-infection and must be
replaced prior to the product being re-used.
WARNING
Always turn the Air Overlay System off and disconnect it from the mains power
supply prior to any product cleaning, disinfection or maintenance.
DO NOT immerse or soak the pump unit during cleaning / disinfection risk of
electric shock.
DO NOT spray the pump unit directly with any cleaning or disinfection
solutions or chemicals.
Wear appropriate Personal Protective Equipment (PPE) and clothing when
performing all cleaning and disinfection processes. Refer to local policies
and guidelines.
Failure to adhere to these instructions could adversely affect the
performance, safety, efficacy and durability of the Air Overlay System.
CAUTION
DO NOT use abrasive cleaners, biological or Phenol or phenolic-based cleaning
solutions.
DO NOT sterilize, autoclave, boil, mangle or wring the overlay cover or
components.
12.1 General cleaning For general cleaning, OSKA recommends the following
four-step process: 1. Using a clean damp cloth or disposable wipe,
moistened with neutral detergent and clean water, wipe down all external
surfaces of the mattress overlay and pump unit. 2. Ensure all organic matter
has been removed and the pump unit and overlay cover are visibly clean. 3.
Wipe thoroughly with a clean damp cloth or disposable wipe moistened with
clean water. 4. Air dry or use paper towels to dry thoroughly prior to re-use
or storage.
23
12.2 Disinfection / Decontamination Where the overlay is heavily soiled and/or
it has been exposed to body fluids or a patient with a known infection, seek
advice from your local Infection Prevention Specialist, or alternatively refer
to the guidelines below: · OSKA recommends using a concentration of
1,000 parts per million (ppm) available chlorine solution such as sodium
hypochlorite (NaOCl) when disinfecting the Air Overlay system.
NOTE
Concentration of cleaning solution may vary depending on the level of overlay
contamination and local policy / guidelines.
For disinfection / decontamination, OSKA recommends following the following
process: 1. After completing steps 1-3 in the `General
Cleaning’ procedure above, use a clean damp cloth or disposable wipe,
moistened with the disinfectant solution, and wipe down all external surfaces
of the mattress overlay and pump unit. 2. Do not allow water, cleaning or
disinfectant solutions to collect on the pump surface or pool on the overlay.
3. Wipe thoroughly with a clean damp cloth or wipe moistened with clean water.
4. Air dry or use paper towels to dry thoroughly prior to re-use or storage.
12.3 Washing Refer to the Section 14 Technical data for information on the
overlay cover laundry guidelines.
13 Warranty
Your OSKA product comes with a one-year parts and labour warranty. All product
sales are covered by OSKA’s standard terms and conditions, a copy of which is
available from the website (www.oska.uk.com) or on request. The warranty is
based on statutory regulations and does not apply if the goods supplied by
OSKA are processed, handled or modified in any way by other parties without
prior consent from OSKA, or if these Instructions For Use are not followed. If
during inspection it is found that damages are due to wear and tear or are not
subject to warranty, then OSKA is empowered to claim the expenses (inspection,
transport costs etc) from the client.
NOTE
Between patients the system should be cleaned / decontaminated, and a full
visual inspection performed to ensure the system is intact prior to re-use.
Air Overlay User Guide
14 Technical data (specification)
Pump
Model
Power supply
Fuse rating Size Weight Case material Air output Cycle time Pressure range
Noise level Modes
Electrical protection Applied parts Ingress protection Usage Operating
environment
Transport / Storage environment
Air Overlay
OSKA Air Overlay 220-240V 50Hz, 1A T1AL 250V 27.6cm (L) x 16cm (W) x 10cm (H)
2.0 Kg
ABS plastic
8 litres per minute 10 minutes 20mmHg 55mmHg <30dB (within 1.9m) Alternating
mode Static mode Class II Type BF Mattress Overlay IP21 Continuous operation
Ambient Temp range: 5oC 40oC Ambient humidity range: 15% – 90%, non-
condensing Ambient Temp range: -25oC 70oC Ambient humidity range: 10% – 90%,
non-condensing
Size Weight Air cell configuration Air cell material Alternation Cycle Cover
material Top cover properties Flammability / Fire retardancy Machine washing
temperatures
Tumble drying temperatures
203cm (L) x 90cm (W) x 12.5cm (H) 3.8 Kg 17 individual air cells (3 static
head cells; 14 alternating cells) Nylon / PVC 1-in-2 PU coated nylon.
Moisture-vapour permeable; two-way stretch Cover complies with BS 7175
Recommended Temp: 40oC Maximum Temp: 95oC NOTE: Use neutral detergent only no
fabric conditioners / softeners Tumble dry on low heat. Maximum Temp: 60oC
25
15 Troubleshooting
Issue
Possible Cause
Solution
Pump not On’ / running. PumpOn’ and running but overlay not inflating or running at low pressure.
System does not appear to be alternating. Pump is noisy
Low pressure alarm
No mains power to the pump.
POWER button not pushed.
Fuse in plug is blown. Umbilical not connected to pump. Umbilical tubing
kinked. CPR bung unplugged from overlay.
Damaged air cell.
Pressure setting incorrect for patient weight. Umbilical tubing kinked.
Static mode is selected.
Pump placement.
Damaged, kinked or disconnected air cells or piping within the overlay.
Damaged or disconnected umbilical between pump and overlay. CPR plug not
correctly pushed onto the air pipes.
Connect overlay pump to mains power supply and turn on. Push the POWER’ button once to turn the pump on. Green light beneath the POWER button will flash during start up until system reaches pressure, after which it will show a constant green light. Unplug pump from mains supply, replace fuse. Plug pump back into mains and switch pump on. Ensure umbilical connector isclicked’
into place on the side of the pump. Check tubing for kinks. If kinked, unplug
from pump, unkink the tubing and re-attach to pump. Check CPR plug at head end
of overlay is firmly pushed into place and no air is leaking from the
connection. Unzip cover and check air cells for leaking. Replace any damaged
air cells.
Adjust the pressure setting accordingly.
Check tubing for kinks. If kinked, unplug from pump, unkink the tubing and re-
attach to pump. Deselect STATIC mode by `UNLOCKING’ the pump and pushing the
STATIC mode button. The green STATIC mode indicator light will go out when
deselected. Re-position the pump to ensure it is resting against a solid
surface.
Unzip cover, check for damaged, kinked or disconnected overlay air cells and
piping. Repair / replace as required. Replace cover.
Check umbilical is intact, and the connector is correctly plugged into the
pump.
Check CPR plug is correctly located and pushed firmly into place.
If the issue cannot be resolved, contact OSKA for additional support.
Air Overlay User Guide
16. Disposal of parts / End of life disposal
Decontaminate the OSKA Air Overlay system prior to disposal to reduce any risk
of cross infection / contamination during the disposal process. Once clean,
the overlay can be disposed of as general waste in line with local waste
management policies / guidelines which may be landfill or combustion. The OSKA
Air Overlay pump contains electrical components and equipment and should
therefore not be disposed of as general waste. Instead, the pump should be
treated as Waste Electrical and Electronic Equipment (WEEE) and disposed of in
line with local or national policy for WEEE equipment using approved WEEE
recycling facilities.
17. Air Overlay Compatibility
Due to the range of available bed frames, mattresses and bed rails, the
customer / care provider is responsible for performing a risk assessment to
ensure the proposed combination of bed frame, mattress, bed rails and OSKA Air
Overlay are compatible, and the combination of products does not impact on
patient safety in any way.
WARNING
When placing the OSKA Air Overlay on top of a mattress, this will increase the
height of the top surface.When using side rails, a patient risk assessment
must be undertaken to ensure (1) the distance between the top of the side rail
and the top surface of the overlay meets the minimum requirements /
specifications*; (2) the addition of the overlay to the mattress is acceptable
from a risk-management perspective, and (3) this does not introduce an
additional or increased falls hazard to the patient.
Death or serious injury may occur.
- Refer to the following documents for additional information.
· IEC 60601-2-52:2009 Medical electrical equipment. Part 2-52: Particular requirements for the basic safety and essential performance of medical beds.
· National Patient Safety Alert: Medical beds, trolleys, bed rails, bed grab handles and lateral turning devices: risk of death from entrapment or falls (NatPSA/2023/010/MHRA)
· MHRA Guidance. Bed rails: management and safe use. Guidance on managing and using bed rails safely.
WARNING
The combination of bed frame + mattress + overlay + side rails should not
result in any gap large enough to entrap a patient’s head, body, or limb. Care
should be taken to prevent gaps arising as a result of compression or movement
of the mattress / mattress overlay. Death or serious injury may occur.
27
18. Electromagnetic Compatibility (EMC)
With regard to the OSKA Air Overlay system’s capacity to generate / radiate or
be affected by radio frequency (RF) energy, the system has been tested for
compliance with IEC 60601-1-2 and EN 60601-1-2.The OSKA Air Overlay system
complies with the above standards and whilst this device is unlikely to cause
any interference with nearby electronic equipment, it is still a possibility
that interference with sensitive nearby electronic equipment could occur in
some circumstances.
To minimise any potential impact from or to this device, OSKA advises the
following precautions are taken wherever possible:
· The OSKA Air Overlay is used in accordance with the following Warnings and
Declarations.
· Only use the device in the electromagnetic environment specified below and
in line with the Intended Use of the device.
WARNING
The device should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the device should be observed to verify
normal operation in the configuration in which it will be used.
Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
Portable RF communications equipment such as mobile phones, cordless
telephones and base stations etc. (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the [ME EQUIPMENT or ME SYSTEM], including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
18.1 Declaration Electromagnetic Emissions
Guidance and Manufacturer’s Declaration- Electromagnetic Emissions:
The OSKA Air Overlay is intended for use in the electromagnetic environment
specified below.The customer or the user of the OSKA Air Overlay should assure
it is used in such an environment.
Emissions test
RF emissions CISPR 11
Compliance Group 1
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations / Flicker emissions IEC61000-3-3
Class B Class A Complies
Electromagnetic Environment-Guidance
The device uses RF energy only for its internal function.Therefore, its RF
emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
The device is suitable for use in domestic establishment and in establishment
directly connected to a low voltage power supply network which supplies
buildings used for domestic purposes.
Air Overlay User Guide
29
18.2 Declaration Electromagnetic Immunity
Guidance & Declaration: electromagnetic immunity
The OSKA Air Overlay is intended for use in the electromagnetic environment
specified below.The customer or the user of the OSKA Air Overlay should assure
it is used in such an environment.
Immunity Test IEC 60601 test level
Compliance level Electromagnetic environment – guidance
Electrostatic
±8 kV contact
discharge (ESD) ±2 kV, ±4 kV,
IEC61000-4-2 ±8 kV, ±15kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be
at least 30%
Electrical fast transient/burst IEC61000-4-4
±2kV for power supply lines ±1kV for Input/out lines
±2kV for power supply lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC61000-4-5
±1 kV line to line ±2 kV line to earth
±1 kV line to line Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11
<5 % UT (>95% dip in UT.) for 0.5 cycle <5 % UT (>95% dip in UT.) for 1 cycle 70% UT (30 % dip in UT.) for 25/30 cycles <5 % UT (>95 % dip in UT.) for 5/6 sec
<5 % UT (>95% dip in UT.) for 0.5 cycle <5 % UT (>95% dip in UT.) for 1 cycle 70% UT (30 % dip in UT.) for 25 cycles <5 % UT (>95 % dip in UT.) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or battery.
Power frequency
(50/60 Hz) magnetic field IEC61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
NOTE
UT is the a.c. mains voltage prior to application of the test level.
Air Overlay User Guide
Guidance & Declaration: electromagnetic immunity
The OSKA Air Overlay is intended for use in the electromagnetic environment
specified below.The customer or the user of the OSKA Air Overlay should assure
it is used in such an environment.
Immunity Test Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
IEC 60601 test level
3 Vms 150 kHz to 80 MHz 6 Vms in an amateur radio bands
10 V/m 80 MHz to 2.7GHz 385MHz-5785MHz Test specifications for ENCLOSURE PORT
IMMUNITY to RF wireless communication equipment (Refer to table 9 of IEC
60601-1-2:2014)
Compliance level Electromagnetic environment – guidance
3 Vms 150 kHz to 80 MHz
6 Vms in an amateur radio bands
Portable and mobile RF communications equipment should be used no closer to any part of the OSKA Air Overlay, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
10 V/m 80 MHz to 2.7GHz
385MHz5785MHz Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless
communication equipment (Refer to table 9 of IEC 60601-1-2:2014)
Recommended separation distance
d=[3,5/V1]xP1/2
d=1.2xP1/2 80 MHz to 800MHz d=2.3xP1/2 800 MHz to 2.7GHz where P is the
maximum output power rating of the transmitter in Watts (W) according to the
transmitter manufacturer and d is the recommended separation distance in
meters (m). Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, a should be less than the compliance level in
each frequency range.b Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz the higher frequency range applies. NOTE 2:
These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy.To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the OSKA Air Overlay is used
exceeds the applicable RF compliance level above, the OSKA Air Overlay should
be observed to verify normal operation. If abnormal performance is observed,
additional measured may be necessary, such as reorienting or relocating the
device.
b) Over the frequency range 150KHz to 80MHz, field strengths should be less
than 3V/m.
31
Pressure Care Experts
Air Overlay User Guide
Edward House, 5 Penner Road, Havant, PO9 1QZ 02394 318 318 | ask@oska.uk.com oska.uk.com
References
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