Stiegelmeyer Seta pro - Medical Device Classification

6.6.9 Medical device classification
Ambient conditions for
storage
Minimum Maximum
Storage temperature - 10°C + 50°C
Relative humidity 20 % 80 % (non-condensing. At alti-
tude ≤ 3000 m)
Air pressure 700 hPa 1060 hPa
Ambient operating condi-
tions
Minimum Maximum
Ambient temperature + 5°C + 40°C
Relative humidity 20 % 80 % (non-condensing. At alti-
tude ≤ 3000 m)
Air pressure 700 hPa 1060 hPa
This bed fulfils all the requirements of the Medical Device REGULATION (EU) 2017/745
(MDR) and is considered a Class I medical device in accordance with the classification rules.
UMDNS code: 10-347; Bed (electrically adjustable)
For use in the following application groups according to IEC 60601-2-52 / EN 50737:
Group Description
1 Intensive care in a hospital in which 24-hour medical supervision and constant moni-
toring are necessary. The provision of a life support system/device for use in medi-
cal procedures is very important for the support of the patient’s vital functions.
2 Acute care in a hospital or in another medical facility in which medical supervision
and monitoring are required. A medical electrical (ME) device used in medical pro-
cedures is often used to provide support in maintaining or improving the condition of
the patient.
5 Outpatient care facility, which is provided in a hospital or other medical establish-
ment under medical 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.
Product description
Instruction Manual 46