Drive DeVilbiss Healthcare Med Aire Wave Alternating Pressure System User manual

Instructions for use
Med Aire Wave Alternating
Pressure System

CONTENTS
Preface..................................................................... 3
Introduction.............................................................. 3
Indication/Contraindication..................................... 3
Scope of delivery..................................................... 3
Declaration of conformity........................................ 3
Electromagnetic compatibility (EMC)..................... 3
Safety instructions................................................... 4
Setting up the system.............................................. 4
Explanation of functions.......................................... 4
Startup ..................................................................... 5
Hand check.............................................................. 5
Alternating pressure function.................................. 5
Air flow ..................................................................... 5
CPR (cardiopulmonary resuscitation)..................... 5
Transport function ................................................... 5
Power failure ............................................................ 5
Alarm function.......................................................... 5
Cleaning, disinfection and care .............................. 6
Reuse/patient change ............................................. 6
Maintenance, service and storage.......................... 6
Disposal ................................................................... 7
Specifications .......................................................... 7
Warranty................................................................... 7
Type label................................................................. 8
Service life ............................................................... 8
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Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire Wave

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 Wave alternating pressure system. If you have
questions or need additional information, contact your
DRIVE MEDICAL 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 Wave is a system which is specially developed for
the prophylaxis and treatment of decubitus, up to and
including grade 2 decubitus according to EPUAP. This
system does not replace the mattress already in the bed
but rather should be operated only in connection with a
standard foam mattress or alternatively a foam pad at
least 4 cm thick.
The Med Aire Wave is operated only in alternating
pressure mode.
The system is suitable for patients from 30 to a max. of
140 kg.
IMPORTANT! The Med Aire Wave does not replace
regular repositioning of the patient!
Indication/Contraindication
Indication:
• Decubitus prophylaxis for a low to medium risk of
decubitus
• Pressure distribution and relief for immobile and
partially mobile patients
• Decubitus therapy up to and including grade 2
according to EPUAP.
Contraindication:
• Body weight less than 30 kg and over 140 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.
• Pain patients
To avoid uncertainties regarding the indication and
contraindication, we recommend consulting the
attending physician.
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 Wave unit
2. Med Aire Wave mattress overlay (with connection
hose)
3. Breathable and water-repellent cover
4. Instructions for use
Declaration of conformity
For the alternating pressure system Med Aire Wave,
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.
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.
Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire Wave
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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 specifically
designed 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.
Setting up the system
The Med Aire Wave is placed on the existing mattress.
Alternatively, a foam pad at least 4 cm high can be used.
• Take the Med Aire Wave alternating pressure system
out of the packaging.
• Check the contents for completeness and any visible
damage.
• Place the alternating pressure system on the existing
mattress or on a foam pad at least 4 cm high in the
existing hospital bed or standard bed. The foot end is
marked with 2 feet.
• Secure the overlay system using the available straps
to the mattress or foam pad.
• 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 Wave is ready for use.
Weight setting
User weight setting.
Explanation of functions
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Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire Wave

Startup
Connect the plug to an appropriate power source.
Switch on the unit. The on
and off switch is located
on the side of the device.
(See Fig. 1)
The mattress is now in the
filling phase while the LED
"Low Pressure" is lit.
Adjust the weight* of the
patient using the knob on
the device. When the "Low
Pressure" LED goes out
and the "Normal Pressure" LED comes on, 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
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. 12 minutes. The first 3 air chambers in the head
area remain static.
Air flow
The Med Air Wave 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 Wave 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: No patient should be positioned on the system
when it is in transport mode!
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. Once the set pressure has again
been reached in the cells, the "Low Pressure" LED goes
out and the "Normal Pressure" LED lights up.
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.
Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire Wave
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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 overlay system
The mattress overlay 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 Wave 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
Wave 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.
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
occurs approx. every 12 min.
• Check all hoses and connections for leaks, kinks and
breakage.
• Check all LEDs which must light up in their respective
function.
Please contact your 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 dealer.
Med Air Wave 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 overlay.
• 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 Wave from unrolling.
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Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire Wave

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.
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 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 on the back of the unit); please clean or replace it.
• If the unit continues to generate too little pressure, the unit must be replaced. Contact
your dealer
No alternating
pressure takes place
• Ensure that the air supply hoses are not kinked or twisted.
Unit Mattress overlay Environmental parameters
Power supply 230 V / 50 Hz
Protection class 1; IPX0;
Type BF, AP/APG NO
Dimensions 200 x 88 x 12 cm without
foam pad
Temperatures
Operation 10 – 35°C
Storage -15 – 50°C
Shipment -15 – 70°C
Power consumption Max. 12 watts Cells Nylon/PVC; 17 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 1.1 kg Cell height 12 cm
Dimensions 28 x 13 x 8.5 cm Cover Nylon/polyurethane, breathable,
washable, not suitable for dryer
Pressure range 30 - 80 mbar
Max. load 30 - 140 kg
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.
Specifications
Drive Medical GmbH & Co. KG | Subject to error and change Instructions for use Med Aire Wave
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Your specialist dealer:
1
1
2
2
3
3
5
6
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
4
4
5 6
7
7
8
9
9
10
10
11
12
11
13
8
Type label
Service life
Our company assumes a long service life for this prod-
uct 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.
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]