PRODUKTINFORMATION
GEBRAUCHSANWEISUNG
PRODUCT INFORMATION
OPERATING INSTRUCTIONS
Hergestellt von / Manufactured by:
Wolff Kunststoffe GmbH
Industriestraße 28
69509 Mörlenbach - Germany
Steuernummer 007 248 13204
VAT No. DE 144458680
CE-Erklärung:
Der Hersteller erklärt hiermit, dass CONFORM
®
–
Med.
Luftkissen Systeme mit den Bestimmungen der Richtlinien für
Medizinprodukte 93/42/EWG übereinstimmen
CE-Declaration:
CONFORM
®
Air Cushion Systems are in accordance with all
requirements for medical products as set out in 93/42/EWG,
made in the EC.
CONFORM
®
Med. Luftpolsterkissen sind Medizinprodukte
der Klasse I (DE/CA/23/051603NA001.01)
CONFORM
®
Air Cushions are Medical Products
class I (DE/CA/23/051603NA001.01)
Product Information
C
ONFORM
®
Med. Air Cushions are made of natural rubber. Natural
Rubber is a renewable resource which requires only low energy
expenditure processes for its treatment. C
ONFORM
®
Products are fully
biodegradable and require no special disposal measure.
Only the purest rubber (24-015 NR green) is used for the production
of C
ONFORM
®
products. This particular quality is free of allergens and
fulfils all current demands for a medical product.
C
ONFORM
®
cushions are available in 3 different heights (5, 7.5 and 10
cm) and a wide range of sizes. Our cushions offer the very highest
seating comfort, limiting the danger of pressure sores, and can be
used therapeutically with existing skin problems. The high elasticity
results in pressure relief - allowing the blood flow in the capillaries.
The cushions are used from stage of prophylaxis up to pressure ulcer
(Grade IV).
There are no usage restrictions either in terms of the material or the
cushion form. The choice of 2- or 4-valve cushions allows the seating
comfort to be optimized when necessary.
Inaccuracy in the application and use of the product and consequent
risks remain those of the "user". No contraindications have been
reported till date.
Maximum users weight - no limitation. For patients (weight above
190 kg) we recommend at least 7.5 or 10 cm height cushion.
The cushion is equipped with a flame retardant cotton/lycra-stretch
cover with non-slip base. The cushion corners are designed with
integrated metal eyelets to allow for fixing strips etc.
Cushion weights vary depending on size e.g.:
Code
Measurement/Height Weight
SKN4040 (1valve)
38 x 38 x 5 cm
850 g
SKN4045 (1valve)
38 x 43 x 5 cm 1020 g
SKD4540 (2valve)
43 x 38 x 7.5 cm 1040 g
SKD5045 (2valve)
47 x 43 x 7.5 cm 1600 g
SKH3540 (4valve)
33 x 38 x 10 cm 1090 g
SKH5055 (4valve)
47 x 52 x 10 cm 2230 g
Version DTSCH/ENGL 04/2017
Zertifiziert nach/Certified according to:
DIN EN ISO 9001:2008
DIN EN ISO 13485:2012