Drive DeVilbiss Med Aire FlexWave Instructions For Use Manual
Med Aire FlexWave
Alternating Pressure System
Instructions for use
CONTENTS
Preface ..................................................................... 3
Introduction .............................................................. 3
Declaration of conformity ........................................ 3
Indication/Contraindication ..................................... 3
Scope of delivery ..................................................... 3
Safety instructions ................................................... 4
Electromagnetic compatibility (EMC) ..................... 4
Setting up the system .............................................. 4
Explanation of functions .......................................... 5
Startup ..................................................................... 6
Hand check .............................................................. 6
Alternating pressure function .................................. 6
Static function .......................................................... 6
Autofirm function ..................................................... 6
Seat function ............................................................ 6
Air flow ..................................................................... 7
CPR (cardiopulmonary resuscitation) ..................... 7
Transport function ................................................... 7
Power failure ............................................................ 7
Alarm function.......................................................... 7
Cleaning, disinfection and care .............................. 8
Reuse/patient change ............................................. 8
Maintenance, service and storage .......................... 9
Disposal ................................................................... 9
Warranty ................................................................... 9
Troubleshooting ....................................................... 10
Specifications .......................................................... 10
Type label ................................................................. 11
Service life ............................................................... 11
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Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire FlexWave
Preface
Indication/Contraindication
Thank you for choosing an alternating pressure system
from DRIVE MEDICAL.
Please read these instructions for use carefully prior to
initial use. They contain important safety information
and valuable tips for the proper use and care of the Med
Aire FlexWave alternating pressure system. If you have
questions or need additional information, contact your
DRIVE MEDICAL specialist dealer who supplied your
alternating pressure system.
All repairs as well as some adjustments require special
technical training and must therefore be made by the
medical supplies dealer.
Introduction
The Drive Medical alternating pressure system Med Aire
FlexWave is specially developed for the prophylaxis
and treatment of decubitus, up to and including grade
4 decubitus according to EPUAP. This system replaces
the existing mattress in your bed.
Equipped with a cell-on-cell system and a highperformance unit with an automatic start-stop
mechanism, this system is ideally suited for long-term
therapy and facilitates home care.
Indication:
• Decubitus prophylaxis for patients at high to very high
risk
• Pressure distribution and relief for immobile and
partially mobile patients
• Decubitus therapy up to and including grade 4
according to EPUAP.
Static pressure-relief positioning is suitable for:
• Patients who only occasionally tolerate dynamic
alternating pressure or who do not tolerate it at all.
• Pain patients
Contraindication:
• Body weight less than 20 kg and over 200 kg
• In the case of unstable fractures (particularly of the
back, cervical and lumbar spine)
• In the case of neurological diseases in which dynamic
alternating pressure should not be used, only static
pressure-relief positioning should be used.
To avoid uncertainties regarding the indication and
contraindication, we recommend consulting the
attending physician.
The Med Aire FlexWave can be operated in alternating
pressure mode as well as in static mode. Through an
integrated seat function, the pressure in the cells can be
adapted to a seated position. A special autofirm function
facilitates the mobilization of the patient on this system.
The system is suitable for patients from 20 kg to a max.
of 200 kg.
IMPORTANT! The Med Aire FlexWave does not
replace regular repositioning of the patient!
Declaration of conformity
For the alternating pressure system Med Aire FlexWave,
DRIVE MEDICAL GMBH & Co. KG declares compliance
according to the EC directive 93/42 for medical devices,
taking amending directive 2007/47/EC into account.
Scope of delivery
Please check the contents for damage and completeness.
If one of the parts listed below is missing, please contact
your specialist dealer.
1. Med Aire FlexWave unit
2. Med Aire FlexWave mattress replacement system
(including cell-on-cell system, connection hose)
3. Breathable, water-repellent and quilted cover
4. Instructions for use
Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire FlexWave
3
Safety instructions
Electromagnetic compatibility (EMC)
• Keep the unit away from water and/or other liquids.
• If water or another liquid gets into the device,
disconnect it from the mains immediately.
• Do not allow the system to come into contact with
open flames or smoldering objects.
• Do not operate the unit in the vicinity of flammable
substances or chemicals => Risk of explosion!!!
• The pump housing may only be opened by authorized
technical personnel => Risk of electric shock!!!
• Avoid heavy strain and/or damage to the housing and/
or power cord.
• Avoid pulling, kinking and running over the power
cord.
• If the device fuses are defective, please have the
device checked by an authorized specialist dealer.
• Use this product only for the purpose described in the
instructions for use.
• Operate the device only with the specified voltage
(230 V/50 Hz).
• The unit should not be covered => Risk of overheating!
• Connect the device only to the mattress intended for it.
• This device is safeguarded against electrical shock
according to the specifications for type BF devices!
Product protection class I
• Do not allow the system to come into contact with
sharp objects (knives, scissors, cannulas, etc.).
This product meets the protection requirements listed
in the council directive on the approximation of the laws
of the member states on electromagnetic compatibility
(EMC, IEC 60601-1-2). However, mutual interference
between electrical devices, particularly when mobile
telephones are used, cannot be completely ruled out
under certain conditions.
Setting up the system
The Med Aire FlexWave replaces the existing mattress in
your standard or hospital bed.
It does not impair the functionality of the standard or
hospital bed.
• Take the Med Aire FlexWave out of the packaging.
• Check the contents for completeness and any visible
damage.
• Now remove the existing mattress from the standard
or hospital bed if you have not already done so.
• Place the mattress replacement system in the existing
standard or hospital bed. The foot end is marked with
2 feet.
• Secure the mattress replacement system using the
available straps to the movable parts of the slatted
frame to avoid impairing the functionality of the system
and the adjustable slatted frame.
• Place the unit using the hooks provided at the foot
end, on the floor, or on an even surface.
Do not in any way cover the unit. Risk of overheating!!!
• This device should not be disposed of with household
waste. More information is available from local waste
management companies.
• When using side rails on adjustable beds for
disabled persons, a sufficient distance between
the top edge of the positioning system and the
upper end of the bed rail must be ensured. (220
mm according to DIN 1970:2000). If necessary,
corresponding side rail risers should/must be
attached to protect the patient.
Now attach the connection
hose to the unit.
Important! The connection hose must audibly click into
place in order to prevent an unintentional separation
between the unit and the mattress! Kinking or twisting
the connection hose must be avoided.
Now the Med Aire FlexWave is ready for use.
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Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire FlexWave
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