Certification - Invacare Medley Ergo User Manual

• The Medley Ergo is suitable for refurbishment.
• The estimated product life cycle is 5 years for a Medley Ergo bed.
• The bed is quipped with loose cables, which have to be exchanged if damaged.
• The control unit, external power supply, hand control and motors are protected according to IPX4.
(The IP rating is a measure of protection against ingress of foreign matter into a product)
• Remove the plug from the mains voltage before moving the bed. The cable must be kept clear off the floor and the castors
during transportation.
• The adjustment area of the mattress support is: 40-80 cm or alternatively 33-73 cm for Medley Ergo*.
• The adjustment area of the mattress support is: 28-68 cm or alternatively 21-61 cm for the Medley Ergo Low*.
• The angle between the lower leg section and horizontal is adjustable from 0º to 15º.

1.2 Certification

• The Medley Ergo bed is marked with the CE - mark in accordance with directive 93/42/EEC concerning Medical Apparatus.
• Medley Ergo bed have been approved according to IEC 60601-2-52
(Beds provided with tilt function can not be approved according to IEC 60601-2-52)
• The Medley Ergo bed has been approved and marked with the TÜV mark.
• The Medley Ergo bed has undergone a risk analysis according to EN ISO 14971:2001-03
• The Medley Ergo bed has undergone a usability analysis according to IEC 60601-1-6
Invacare is certified according to DS/EN ISO 9001 and ISO 13485 which ensures that our customers are always supplied with
®
products of uniform quality.
Throughout the entire production process our materials/products are quality controlled by the operators.
Additionally, a final test is carried out prior to packaging and shipping.
If the product does not correspond to the quality demands of Invacare
If, contrary to our expectations, a problem should arise in connection with the delivered product, please contact your Invacare
plier. An address list is shown on the back side at this manual.
Invacare reserves the right to alter product specifications without prior notice.
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