Stiegelmeyer Evario, Instruction Manual, Page: 50 / 168

Instruction manual for Evario hospital bed
50
6.7.7 Adjustment Options for Beds with Fixed Headboard
Description 87x200 cm 87x210 cm 100x200 cm
Mattress base height 35 -85 cm 35 -85 cm 35 -85 cm
Mattress base height
Linea castors 32 -82 cm 32 -82 cm 32 -82 cm
Backrest angle by Mattress base
height from 53 cm to 85 cm < 70° < 70° < 70°
6.7.8 Operating Noise
The operating noise of an electrically adjustable bed is not more than 47 dB (A).
6.7.9 Ambient Conditions
The following ambient conditions must be maintained:
Ambient conditions for storage Minimum Maximum
Storage temperature - 10°C + 40°C
Relative humidity 20 % 90% (at 30°C; non-condensing. At
altitude ≤ 2000m)
Air pressure 800 hPa 1060 hPa
Ambient operating conditions Minimum Maximum
Ambient temperature + 5°C + 30°C
Relative humidity 20 % 90% (at 30°C; non-condensing. At
altitude ≤ 2000m)
Air pressure 800 hPa 1060 hPa
6.7.10 Medical Device Classification
This bed fulfils all the requirements of the 93/42/EEC Medical Device Directive.
This bed is considered a Class I medical device in accordance with the classification rules of Di-
rective 93/42/EEC
UMDNS code: Beds, electric 10-347
For use in the following application groups according to IEC 60601-2-52:
Group Description
1 Intensive care in a hospital in which 24-hour medical supervision and constant monitoring are
necessary. The provision of a life support system/device for use in medical procedures is very
important for the support of the patient’s vital functions.
2 Acute care in a hospital or in other medical establishments, in which medical supervision and
monitoring are required. A medical electrical (ME) device for use in medical procedures is often
provided to help maintain or improve the condition of the patient.
5
Outpatient care facility which is provided in a hospital or other medical establishment under medi-
cal supervision. A medical electric device is provided for the needs of persons with an illness,
injury or handicap for the purpose of treatment, diagnosis or monitoring