Drive DeVilbiss Med Aire FlexWave User manual

Instructions for use
Med Aire FlexWave
Alternating Pressure System

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
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 high-
performance unit with an automatic start-stop
mechanism, this system is ideally suited for long-term
therapy and facilitates home care.
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.
Indication/Contraindication
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.
Scope of delivery
Pleasecheckthecontentsfordamageandcompleteness.
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
• 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 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.
Electromagnetic compatibility (EMC)
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!!!
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

Weight setting
User weight setting
Seat
Increase in the cell pressure in a seated position
Static and alternating pressure
Adjustment of static pressure-relief positioning and
dynamic alternating pressure.
Autofirm
Maximum increase of cell pressure in all cells
Cycle time
Adjustable: 10/15/20/25 minutes
Lock
Automatically enabled after 30 seconds of inactivity or
by pressing the "Tastensperre/Lock" button.
Mute
Acoustic alarm signal can be muted and remains muted
until the button is pressed once again!
Explanation of functions
Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire FlexWave
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Startup
Connect the plug to the unit and an appropriate power
source. (See Fig. 1).
Switch on the unit. The on and off switch is located
on the side of the device, above the power cord. (See
Fig. 2).
Alternating pressure function
All air chambers are evenly inflated and deflated in a
1:1 ratio. An alternating cycle involves in each case
the inflating and deflating of an air chamber and takes
approx. 10/15/20/25 minutes, depending on the setting.
The first 3 air chambers in the head area remain static.
The "Alternating Pressure" LED indicates that the
alternating pressure function is enabled.
Static function
The Med Aire FlexWave has a static function as a
standard feature.
This is switched on using the button. The "Static"
LED indicates that the static function is enabled.
The air chambers all maintain the same pressure and
ensure adjustable pressure-relief positioning.
In static pressure-relief mode, the deepest point on the
patient (buttock/hip area) should sink into the system
to approximately halfway down the upper cell system
(approx. 3-4 cm).
Note: Perform a hand check to verify; see hand check
section.
Autofirm function
This function facilitates the positioning and mobilization
of the patient through a firm and stable surface. The
pressure within the cells is increased to a maximum
level. For reasons of safety, this function automatically
switches off after 30 minutes!
Seat function
In this case, the pressure in the air chambers is increased
and adapted to the short-term seated position. The
objective is to prevent the patient from "bottoming out."
The seat function can be manually switched on and off.
This function may only be used for short periods of
time.
For safety reasons, this function automatically switches
off after 90 minutes.
Important!: The system is not suitable for long
periods of sitting in bed!
The mattress is now in the filling phase while the LED
"Low Pressure" is lit. (See Fig. 3).
Adjust the weight of the patient using the (+) and (–)
button on the weight adjustment scale*; if the "Low
Pressure" LED goes out and the "Normal Pressure" LED
is lit, the patient can be placed on the system.
*The weight adjustment scale indicated is a guideline
and does not reflect the actual pressure in the air
chambers.
Hand check
After each change in pressure and position, use your
hand to check the proper pressure setting at the
buttocks/hips. When correctly adjusted, a hand should
be able to be easily inserted between the patient and a
deflated cell.
A A A A AB B B B B
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Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire FlexWave

Air flow
The Med Aire FlexWave has nine air flow cells. This
group of air chambers is microperforated at the edge
and in this way, it ensures that the Med Aire FlexWave is
actively supplied with air.
CPR (cardiopulmonary resuscitation)
Before resuscitation can/may be performed on the
system, the system must be fully deflated.
For rapid deflation, pull down on the red tab printed
with "CPR" at the head end (see fig.). The tab is on the
same side as the hose system. The valves open and air
escapes from all of the cells.
To supply the system with air once again, close the CPR
valve again by pressing it firmly and securely fasten the
tab marked "CPR" once again.
Transport function
Remove the hose system from the unit and promptly
close it with the attached cap. Now the mattress is in
transport mode. To return to normal operation, remove
the cap on the connection hose and connect it back to
the unit and start the unit.
Note: When the Med Aire FlexWave is in transport
mode, it is possible to leave patients on the system for
up to 12 hours. However, at this time, we recommend
regularly monitoring the patient and the mattress
replacement system.
Power failure
In the event of a power failure, set the system to transport
mode. See section on transport function.
Alarm function
Low pressure
The "Low Pressure" LED is lit whenever the unit detects
too little air in the cells. An acoustic signal sounds at the
same time if it has not been switched off beforehand by
pressing the "Mute" button.
Once the set pressure has been reached in the cells
again, the display goes out and the acoustic signal
stops. The "Normal Pressure" LED is lit.
Important: During the filling phase, the "Low Pressure"
LED is lit; once the pressure in the air chambers has
reached the set user weight, the "Low Pressure" LED
goes out.
System failure/service display
If the unit detects an internal error, the "System Failure"
LED is continuously lit and an acoustic signal additionally
sounds. This can be muted using the "Mute" button. The
"System Failure" LED will still be lit. Please notify your
specialist dealer.
Power failure
If there is a power failure or if the unit is disconnected
from the power supply, the "Power Failure" LED begins
to blink and an acoustic signal sounds.
This alarm stays on until the unit is reconnected to the
mains or the On/Off switch is operated.
Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire FlexWave
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Cleaning, disinfection and care
Unit
Before cleaning, disconnect the unit from the power supply. During cleaning, please ensure that no fluids/cleaning
solutions come into contact with the plug.
The unit should not be saturated or soaked.
The unit may be cleaned by hand. To do this, use a moist (not wet) cloth and a mild household cleaning and
disinfectant solution.
Do not use any solutions which contain phenol or abrasive cleaners. This can corrode the surface of the unit.
Allow the unit to dry thoroughly.
Perform a function test after the device is thoroughly dry.
Mattress replacement system
The mattress replacement system should not be saturated or soaked*, however it can be cleaned by hand. To do
this, use a moist (not wet) cloth and a mild standard cleaning and disinfectant solution.
* There is a risk of liquid getting into the cell chambers and hoses.
Cover
The cover can be cleaned by hand. To do this, use a moist (not wet) cloth and a mild cleaning solution.
You can detach the cover using the zipper and wash it at a max. temperature of 60° using a household detergent.
Do not dry the mattress cover in the dryer.
Note! If the Med Aire FlexWave is machine-washed and -disinfected, a validated and automated method
according to the Robert Koch Institute (RKI) and/or the Association for Applied Hygiene (VAH) is necessary.
Reuse/patient change
In the case of reuse/patient change, the Med Aire FlexWave must be disinfected and cleaned according to
a validated method recognized by the Robert Koch Institute.
During processing, take note of the medical device law, the "Guidelines for the Processing of Medical
Devices" as well as the "Guidelines for Hospital Hygiene and Infection Prevention" of the Robert Koch
Institute.
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Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire FlexWave

Maintenance, service and storage
Maintenance
This product is subject to the Medical Device Law
(MPG) and the Medical Devices Operator Ordinance
(MPBetreibV). Internationally, the respective valid
national regulations apply.
The functionality and proper condition must be checked
before each use.
The following points must be regularly checked:
• Check power cord and plug for wear and damage.
• Check the housing of the unit for damage.
• Check the alternation between air supply and
ventilation in each air chamber circuit. This alternation
must take place according to the cycle time of
10/25/20/25 minutes set.
• Check all hoses and connections for leaks, kinks and
breakage.
• Check all LEDs which must light up in their respective
function.
Please contact your specialist dealer if you identify any
damage or defects.
During all visual inspections and maintenance, the unit
must be disconnected from the power supply.
Testing and assessments must be performed and
documented by suitable technical staff in accordance
with DIN EN 62353.
Service
Only original replacement parts and accessories from
Drive Medical may be used. If the system develops a
defect or fault, please contact a trusted specialist dealer.
Med Aire FlexWave can be checked and repaired by an
authorized specialist dealer or via your specialist dealer
from Drive Medical.
Drive Medical recommends performing a technical
safety check at least every 2 years.
Storage
• Remove the hose system from the compressor.
• Fully deflate the mattress.
• After you have fully deflated the overlay, roll up the
overlay, starting at the foot end. You can use the
fastening strap to secure the rolled-up overlay to
prevent the Med Aire FlexWave from unrolling.
Disposal
Please contact your local waste management company
regarding professional disposal.
Please be aware that the alternating pressure overlay
and the mattress cover may be carrying microbes. This
can lead to transmission of infection. Please dispose of
the overlay and mattress cover such that there is no risk
to you and third parties.
Warranty
Drive Medical grants a 2-year warranty for the product
against material and manufacturing errors.
Damage due to natural wear and/or improper handling
remain excluded from the warranty.
Damage due to material and/or manufacturing errors
will be corrected free of charge through a replacement
or repair.
Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire FlexWave
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Unit Mattress replacement system Environmental parameters
Power supply 230 V / 50 Hz
Protection class 1; IPX0;
Type BF, AP/APG NO
Dimensions 200 x 88 x 20 cm Temperatures
Operation 10 – 35°C
Storage -15 – 50°C
Shipment -15 – 70°C
Power consumption Max. 25 watts Cells Nylon/PU; 20 cells of which 9
are air flow cells, 3 are static
head cells
Relative humidity
Operation 20 – 80% => non-condensing
Storage 10 – 90% => non-condensing
Weight 3.9 kg Cell height 20 cm
Dimensions 36.9 x 13.5 x 25 cm Cover Nylon/PU, breathable, washable
Pressure range 10- 50 mbar
Cycle time 10/15/20/25 min.
Max. load 20 - 200 kg
Troubleshooting
Symptom Remedy
Unit does not work • Check whether the plug is correctly inserted. Switch on the unit again.
• If the LED on the On/Off switch does not light up, check the voltage of the outlet or
insert the plug into another outlet.
• If the LED on the On/Off switch lights up but the unit does not work, please contact
your specialist dealer.
"Low Pressure" alarm • Check whether the connection hose on the unit is correctly inserted.
• The CPR valve must be closed.
Mattress does not
pump up
• Ensure that all cells are correctly connected to each other and that the connection
hoses are not twisted or kinked.
Patient bottoms out • This indicates excessively low pressure in the air chambers. Increase the user weight
and perform a hand check to check whether the patient is sinking down.
• Check air filter (located above the on/off switch on the side of the unit); please clean
or replace it.
• If the unit continues to generate too little pressure, the unit must be replaced. Contact
your specialist dealer
No alternating
pressure takes place
• Ensure that the air supply hoses are not kinked or twisted.
• The static function must be switched off. When the static function is switched on, no
alternating pressure takes place.
• Ensure that the autofirm and seat functions are switched off.
Specifications
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Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire FlexWave

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1. Product name
2. Article number
3. Serial number
4. Production date year/month
5. Do not dispose of in
household waste
6. Follow the instructions for use
7. CE marking
8. Do not dry in dryer
9. Do not iron
10. Wash in a normal wash cycle
up to a temperature of 60°C
11. Do not bleach
1. Product name
2. Article number
3. Serial number
4. Production date year/month
5. Voltage
6. DIN standard
7. Follow the instructions for use
8. CE marking
9. Type BF
10. Protection type
11. Protection class 1 and 2
12. Do not dispose of in
household waste
13. Important
Type label
Service life
Our company assumes a long service life for this
product as long as the product is used as intended and
all maintenance and service requirements are observed.
This service life can be significantly prolonged if the
product is carefully handled, maintained, cared for and
used.
The service life may also be significantly shortened
through extreme and improper use, however.
Determination of the service life by our company does
not represent any additional guarantee.
Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire FlexWave
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Your specialist dealer:
Subject to error and change
Last updated: 01.07.2019
Manufacturer: Drive Medical GmbH & Co. KG • Leutkircher Straße 44 • D-88316 Isny/Allgäu • Germany • [email protected] •
www.drivemedical.de • Tel.: [phone] • Fax: [phone]
Distributor: DeVilbiss Healthcare GmbH • Kamenzer Straße 3 • D-68309 Mannheim • Germany • [email protected] •
www.drivedevilbiss-int.com • Tel: [phone] • Fax: [phone]