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Instruction Manual for Sicuro pesa Hospital Bed
Page
83
9.6
C
LASSIFICATION
This hospital bed fulfils all the requirements of the 93/42/EEC Medical Device
Directive.
This bed is classified as a class I medical product (in accordance with the
Medical Devices Act § 13).
For use in the following application groups according to IEC 60601-2-52:
1: Intensive care in a hospital, whereby 24-hour medical supervision and
constant monitoring are required. 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 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.
Active, class 1 medical product
Equipment with type B application component.
UMDNS Code:
Bed (electrically adjustable)
10-347
Protective cover
16-492