Stiegelmeyer Evario, Instruction Manual, Page: 22 / 168

Instruction manual for Evario hospital bed
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6 Product Description
This bed fulfils all the requirements of the 93/42/EEC Medical Products Directive. It is classified as
a Class I active medical device in accordance with the Medical Devices Act (Medizinproduk-
tegesetz, German abbreviation: MPG) § 13.
6.1 Designated Use
x
This bed is designed for positioning and transporting patients, as an aid to diagnosing,
monitoring, treating, and alleviating illnesses or compensating for injuries or disabilities.
For detailed instructions for use, see Chapter 9 » 65 .
x
This bed is suitable for accommodating adult patients only (= persons whose height is at
least 146 cm).
x
The bed itself is not life sustaining or life supporting.
x
The bed has no medical indication.
6.2 Use for the Intended Purpose
x
The bed may only be used in hospitals and comparable medical facilities with qualified
personnel within closed rooms.
x
Qualified personnel must be skilled in handling the beds through being thoroughly conver-
sant with the instruction manual.
x
If the owner of the hospital bed changes, the instruction manual must be handed over with
the bed.
x
The bed with its stable, smooth-running castors is designed for being moved within the
room as well as frequently in corridors and across thresholds with a height of up to 2 cm.
x
The safe working load is 260 kg (p accessories).
x
This bed is suitable for repeated use.
x
This bed must not be used in explosive environments caused, for example, by cleaning
agents or anaesthetics.
x
This bed must not be used in combination with high frequency surgical equipment.
x
Before using the safety sides, assess and take into consideration the clinical condition and
particular physical build of the patient: Observe the special safety information in Chapter
9.13 » 94 !
This bed may only be used under the operating conditions described in this instruction manual.
Any other use shall be regarded as contrary to the intended purpose.