Drive DeVilbiss Healthcare Elite User manual

Elite with Digital Pump
User Manual

Elite Mattress with PUMP1000
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The Elite
The Elite Mattress Replacement System provides a cost effective solution for both the prevention
and treatment of pressure ulcers in any healthcare environment. With a fully encased layer of visco-
elastic foam beneath the cells for added support, the Elite mattress combines a comfortable support
surface and alternating therapy, suitable for patients at Very High Risk of developing pressure ulcers.

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Content
Fire Warning
3
Safeguards
4
Intended Use
5
Contradictions
5
Installation
6
Pump Functions
7
Mattress Functions
8
Storage
8
Damage Prevention
8
Cleaning
9
Maintenance
11
Technical Description
12
Troubleshooting
13
Warranty
14

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Fire Warning
In order to reduce the risk of fire:
DO NOT SMOKE - Smoking will contaminate the product and is NOT permitted around or on the
mattress system. This is a common cause of fatal fires. This system uses room air for circulation
through the mattress. A cigarette could burn a hole in the mattress surface and cause damage to the
mattress system. Patient clothing, bed sheets and other items, may be combustible and could catch
fire. Failure to observe this warning could result in a severe fire, property damage, physical injury or
death.
DO NOT - use candles on or around the mattress system
DO NOT - use electric blankets with this mattress system
DO NOT – use in the presence of flammable anaesthetics, explosions could occur
DO - keep hot equipment off and away from the mattress surface, E.g. Hair dryer, curling tong, etc.
DO - keep matches and lighters away from children
DO - keep heaters away from the mattress system
Follow all manufacturers’ instructions and warning.
It is advised that a full fire risk assessment is carried out prior to using this equipment
In case of fire, exit and call the emergency services.
Please refer to MDA/2013/093 for further guidance

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IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS BEFORE USE
DANGER - To reduce risk of electrocution:
1. Always unplug this product immediately after using.
2. Do not use while bathing.
3. Do not place or store product where it can fall or be pulled into a tub or sink.
4. Do not place in or drop into water or other liquid.
5. Do not reach for a product that has fallen into water. Unplug immediately.
WARNING – To reduce risk of burns, electrocution, fire or injury to person:
1. This product should never be left unattended when plugged in.
2. Close supervision is necessary when this product is used on or near children.
3. Use this product only for its intended use as described in this manual. Do not use attachments not
recommended by the manufacturer.
4. Never operate this product if it has a damaged cord or plug, if it is not working properly, if it has
been dropped or damaged, or dropped in water, return the product to a service centre for
examination and repair.
5. Keep the cord away from heated surfaces.
6. Never block the air opening of this product or place it on a soft surface, such as a bed or couch,
where their openings may be blocked. Keep the air opening free of lint, hair, and other similar
particles.
7. Never drop or insert any object into any opening or hose.
8. Connect this product to a properly grounded outlet only. See grounding instructions.
NOTE, CAUTION AND WARNING STATEMENTS
NOTE -
Indicates some tips
CAUTION -
Indicates correct operating or maintenance procedures in order to prevent damage to or
destruction of the equipment or other property
WARNING -
Calls attention to a potential danger that requires correct procedures or practices in
order to prevent personal injury
SYMBOLS
Class II electrical device
“BF” symbol indicates this product is according to the degree or protecting
against electric shock for type BF equipment.
Attention, instructions should be read
Authorised representative in the European community

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Manufacturer
Disposal of Electrical & Electronic Equipment (WEEE)
Product conforms to all relevant standards (See Declaration of Conformity)
No smoking on or near the mattress
Passive Radio Frequency Identification (RFID) tags maybe in use throughout the
system
Keep dry
Intended Use
The Elite Replacement System is intended to reduce the incidence of pressure ulcers while
optimising patient comfort. It may also be appropriate for the following:
•Individual home care setting and long-term care facilities
•Pain management as prescribed by a healthcare professional
Contraindications
Users with the following condition could experience contraindications if they use this device:
•Cervical or skeletal traction
•Unstable spinal cord injuries
•During some orthopaedic treatments

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Installation
Unpackaging
When unpacking the Elite System, check for any damage which may have occurred during transit. If
found to be damaged remove the system from use and contact Drive DeVilbiss Healthcare Ltd.
Setting up
1. Remove all existing mattress surfaces from the bed frame
2. Ensure the printed surface is placed facing upwards
3. Place the mattress on the bed frame with the image of the feet on the cover placed at the foot
end of the bed
4. Secure the mattress to the moveable platforms of the bed frame using the straps on the base of
the cover
5. Hang the pump at the foot end of the bed; adjust the hangers to secure the pump against the
foot board to reduce vibration. Avoid placing the pump on the floor
6. Join the connectors on the mattress feed pipes to the side of the pump
NOTE:
Ensure the feed pipes on the mattress are not kinked or tucked under the mattress as this
will restrict airflow
7. Plug the pump into the mains electrical outlet
NOTE:
Any extra power cord should be neatly arranged and off the floor to avoid any trips and any
damage to the cable
8. Turn on the pump using the main switch found on the side of the pump and press the standby
button on the front of the pump
9. The pumps low pressure indicator will remain lit until the mattress is inflated to the desired
pressure. The pumps initial set up can take up to 30 minutes
10. Adjust the pressure setting according to the patients weight
11. Place a loosely fitted sheet over the mattress

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Pump Functions
On/Off Standby
Main power rocker switch can be located at the side of the pump. The
standby button is located on the front panel
Lock Out
After 5 minutes of inactivity, the pump will lock out its functions. To
unlock, press and hold the lock out key for 3 seconds
Mute
Press the mute button to silence the alarms
Cushion Mode
Press and hold for 3 seconds to initiate the cushion mode. To return to the
mattress mode, press and hold the cushion mode button for 3 seconds
Static
All cells in the mattress will be inflated by pressing this button. The pump
will automatically revert back to alternating mode after 20 minutes
Alternate
One in two cycle, this function will provide optimum pressure relief
Patient Weight Settings
10 comfort levels are available for a variety of patient weights.
Use the- / + to adjust the weight settings accordingly
Low Pressure Indicator
When low pressure in the mattress is detected, the pump alarm and the
LED will illuminate
Power Failure Indicator
When a power cut is detected, the pump will alarm and the LED will
illuminate
Service Light
This light will illuminate when the pump is due an annual service. The
pump will require recalibrating to deactivate this LED

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Mattress Functions
•High frequency welded cover which reduces the risk of ingress and aids the decontamination
process
•A highly resilient polyurethane covers which can be cleaned down with 10,000ppm sodium
hypochlorite
•50mm deep visco foam to act as a support should there be a power failure
•CPR tag, which when pulled will rapidly deflate the mattress
•Securing straps to keep the mattress in situ during alternation
•Connectors can be joined together to allow for easy transportation
Storage
For the ease of storage, mattresses can be rolled up and stored in a holdall or bag.
To prevent mattresses becoming contaminated and/or damaged during storage:
•Mattresses should be stored within a polythene cover or bag
•Do not store other objects such as side rails or bed ends on top of mattresses
•Allow adequate space for the stored mattresses to be manoeuvred
Damage Prevention
Take extra care not to puncture the cover and cells as this will allow fluid ingress and ultimately
rupture the cells and contaminate the foam base. To prevent the cover from being punctured
and/or damaged:
•Do not place sharp objects such as hypodermic needles, scalpels, etc., on the mattress
•Avoid wearing protruding jewellery i.e. rings with stones
•Take extra care when using medical equipment such as monitors, drip stands, side rails,
transfer boards, etc.

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Cleaning
The following guidelines are suggested by Drive DeVilbiss Healthcare as being suitable infection
control procedures. Further information is available upon request.
Pump Unit
General cleaning may be affected by using a cloth dampened with a mild detergent and water
solution. This approach may be followed either by wiping with a sodium hypochlorite solution to a
dilution of 1000 ppm or by using an alcoholic wipe.
WARNING:
Do not use phenolic or biological based cleaning solutions
Do not use any abrasive compounds or cleaning pads
Do not submerge the pump in to water or any other liquids
Ensure that mains power supply to the pump has been disconnected prior to
cleaning.
Mattress
General Cleaning
During general use, the mattress and tube set may be cleaned using a neutral detergent solution.
Using a single use wipe, clean the mattress cover and/or tube set with a solution of neutral
detergent and hot water. Rinse thoroughly with clean water and a damp single use wipe.
NOTE:
The top, bottom and all four sides of the cover and tube set, including under the zip flaps
MUST be cleaned.
The foam used in this product cannot be decontaminated, therefore, it is recommended
that any contamination must result in the foam being replaced
WARNING:
Do not use phenolic or biological based cleaning solutions
Do not use any abrasive compounds or cleaning pads
Ensure the cover and tube set are completely dried before refitting the cover.
Disinfecting the mattress
If the cover is heavily soiled or has been exposed to bodily fluids such as blood, it will require a
thorough cleaning procedure:
Wipe the cover using a single use wipe with Chlorine Solution (of up to 10,000ppm) and cold water.
Rinse thoroughly with clean water and a damp single use wipe. Make sure the cover is completely
dried before refitting or storing.
Wipe the cells using a single use wipe with Chlorine Solution (1,000ppm) and cold water. Rinse
thoroughly with clean water and a damp single use wipe. Make sure the cells are completely dried
before refitting or storing.
Frequent or prolonged exposure to higher concentration disinfectant solutions may affect the
longevity of the mattress and affect its functionality.
NOTE:
Some surface wrinkling may also occur

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Personal Protective Equipment should be worn during the entire cleaning process
This system must not steam cleaned or used in a autoclave
Laundering
Before laundering the mattress, covers should be completely removed. Where required, mattress
covers can be laundered as follows:
oPre wash: 95°C + 15 minutes
oMain wash: 95°C + 15 minutes
This should be followed by a cold rinse and extraction.
Drying
Mattress inners and tube sets should be wiped with a clean and dry cloth before reinserting.
Mattress covers can be tumble dried on a low heat setting for 90 minutes. Drying temperature must
not exceed 40°C. Exceeding this temperature can cause significant damage to the mattress cover.
NOTE:
Covers must be completely dried before refitting to the mattress inners.
Biocides
This product contains a biocide anti-fungal agent to control microbial deterioration. The active
ingredient is silver phosphate glass CAS number 308069-39-8 which contains 1.5% – 2.6% silver (CAS
number 7440-22-4), glass, oxides, chemicals (CAS number 65997-17-3). The product does not
contain any nanomaterials.
The active ingredient is fully encapsulated within the polymer coating so there are no special
handling requirements.
This product is latex free.

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Maintenance
Pump
The following chart is a guide on how often the pump’s filters should be serviced:
•Ensure that all hoses inside and outside the pump and mattress are kink and split free. If any
splits are found, replace the pipe
•Ensure the filter in the rear of the pump is clean and clear from any debris
•Ensure all indicators are working. If faulty, these should be replaced by a Drive DeVilbiss
Healthcare approved technician
•Ensure the main power cord and plug is free from abrasions and/or excessive wear. Replace if
damaged
•Check the mattress cover for signs of wear and damage. Replace if there are any signs of fluid
ingress
Replacement parts can be purchased from Drive DeVilbiss Healthcare Ltd.
Assessing the condition of the mattress
Mattresses should be checked regularly to ensure they remain ‘fit for purpose’, clinically effective
and pose no risk of infection to either the patient or the carer. Drive DeVilbiss Healthcare Ltd.
recommend that a thorough inspection of both the interior (foam base and cells) and exterior
(cover) of the mattress is carried out on a weekly basis or, each time a new patient is placed on the
mattress. Visual checks should be carried out daily to identify any significant signs of damage or
infection risk.
Weekly checks:
•Check for any signs of staining on the inner substrate
•Check for any signs of tearing and/or punctures marks
•Check all the seams for any signs of splitting
•Check the zip for any signs of damage, also ensure this is fully closed at all times
•Check the foam base for any signs of fluid ingress/staining
•Check the cells for any signs of damage or fluid ingress
Every 12 months
Every 6 months
Every 3 months
Low particle density
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Medium particle density
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High particle density
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Technical Description
Pump
Specification
Power Supply
220-240V 50-60Hz 0.07A 16W
Fuse Rating
T1A / 250v
Cycle Time
10 minutes
Dimensions
291 x 200 x117 (mm)
Weight
2.8kg
Modes
Alternating, Static & Cushion
Air Output
8 litres per minute
Pressure Range
15mmHg – 40mmHg±10%
Environment
Temperature
Operation
10°C to 40°C (50°F to 104°F)
Storage
-15°C to 50°C (5°F to 122°F)
Shipping
-15°C to 70°C (5°F to 158°F)
Humidity
Operation
20% to 90% (non-condensing)
Storage:
10% to 90% (non-condensing)
Shipping:
10% to 90% (non-condensing)
•Not suitable for use in the presence of a flammable anaesthetic mixture (No AP or APG protection)
Noise Level
30 dB
Classification
oClass I medical device
oType BF
Electrical classification
Class II
Ingress Protection
•IP21 (Protection against fingers or other object not greater than 80mm
in length and 12mm in diameter) & (Vertically dripping water shall have
no harmful effect when the enclosure is tilted at an angle of 15° from its
normal position)
Applied Part
•Elite Mattress & Elite Cushion
Usage
•Continuous operation
Mattress
Specification
Dimensions
1880 x 890 x175mm
Weight
6Kg
Max Patient Weight
190kg
Top Cover Material
Xtreme fabric (PU coated fabric substrate)
Cell Material
Nylon / PVC
Cell Configuration
16 single cell formation
Fire Classification
BS5852 / BS7175 composite – (Risk assessment to be carried out)
Risk Factor
Very High Risk with pump
Electromagnetic Interference
•This device has been tested to withstand electromagnetic interference (EMI) from
commonly found electrical equipment.
•EMI can affect some types of electronic medical devices (such as pacemakers, defibrillators,
ECG monitors and infusion pumps). If in any doubt before use, a risk assessment should be
carried out before using this or any other electrical device around sensitive devices.
•Electrical equipment may be susceptible to EMI from sources such as mobile phones, walkie-
talkies, TV broadcast and emergency services’ radio. A risk assessment should also be carried
out before using electronic medical devices in areas close to these sources.
•The addition of components or accessories may affect the EMI susceptibility of the device.
Do not fit accessories other than Drive DeVilbiss Healthcare authorised accessories.

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Problem
Solution
No power to the unit
•Ensure the pump is switched on at the side of the pump and not
on standby
•Ensure the mains lead is connected to the mains and also the
pump
•Ensure there are no blown fuses in the pump or mains lead.
Replace accordingly
Low pressure indicator is
lit
•Ensure the correct comfort setting has been selected
•Ensure the connections between the feed pipe and the pump unit
are secured
•Ensure the CPR tag is engaged
•Ensure all tubing connections along the cells are secure
•Assess the cells for any punctures which maybe causing a leak
Patient is bottoming out
•Pressure setting may be inadequate, adjust comfort range
No air is being produced
from some of the air
outlets of the tube
connectors
•This is normal in alternating mode. Air outlets take turns to
produce air during their cycle time
•If fault still continues, a Drive DeVilbiss Healthcare approved
engineer will be required to repair the fault
Pump is noisy
•Tightly secure the bed hooks to the bed frame as this will reduce
vibration and limit noise
•Ensure pipe work is not kinked
•If fault still continues, a Drive DeVilbiss Healthcare approved
engineer will be required to repair the fault.

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Warranty
Your Drive DeVilbiss Healthcare product is warranted to be free of defects in materials and
workmanship for 5 years on mattresses and 2 year on pumps from date of purchase.
This device was built to exacting standards and carefully inspected prior to shipment. This warranty
is an expression of our confidence in the materials and workmanship of our products and our
assurance to the customer.
In the event of a defect covered by this warranty, we will at our option supply parts or replace the
device.
This warranty does not cover device failure due to owner misuse or negligence, or normal wear and
tear. The warranty does not extend to non-durable components, such as rubber accessories, castors
and grips, which are subject to normal wear and need periodic replacement.
If you have any queries or require full warranty conditions, please contact Drive DeVilbiss Healthcare
Ltd.
This does not affect your statutory rights.

Dealer Stamp
Drive DeVilbiss Healthcare Ltd, Heathfield Lane,
Birkenshaw, West Yorkshire, BD11 2HW
Tel: [phone]
Fax: [phone]
Email: [e-mail]
www.drivedevilbiss.co.uk
The Team at Drive DeVilbiss
develops its products to give
our customers the freedom to live
independently. This encompasses
their daily home life and provides
them with the opportunity to enjoy
an outing with family and friends.
Our goal is to develop a range that
will provide individuals with a
chance to enjoy everyday life.
Leaflet code: 6002990011