Instruction Manual for Sicuro pesa Hospital Bed
Page
7
2.1
D
EFINITION OF THE
G
ROUPS OF
P
ERSONS
I
NVOLVED
In this instruction manual, the following groups of persons are defined as:
Operator
An operator (e.g. clinic, hospital, hospital administration) is every natural and
legal person with property rights to the Sicura pesa hospital bed. The operator is
responsible for the safe operation of this medical device.
Users
Users (e.g. medical specialists, nursing staff, doctors, carers, care workers) are
persons who, based on their training, experience or briefing, are qualified to
operate the bed on their own authority or to carry out work on it, or have been
instructed how to handle the bed. Furthermore, they can recognise and avoid
potential dangers and assess the clinical condition of the patient.
Patient
A patient is defined as an adult who is in need of care, ill, infirm or disabled, and
occupies this bed.
It is strongly recommended that the operator or user instructs each new patient in
the bed functions that are important for him/her.
Instructions for the Operator:
-
This hospital bed fulfils all the requirements of the 93/42/EEC Medical Device
Directive. It is classified as a Class 1 active medical device in accordance with
the Medical Devices Act (Medizinproduktegesetz,
German abbreviation: MPG
)
§ 13.
-
Please observe your obligations as the operator in accordance with the
Medical Devices Operator Ordinance (Medizinprodukte-Betreiberverordnung,
German abbreviation: MPBetreibV), in order to ensure the permanently safe
operation of this medical product with no risk of danger to patients, users or
third parties.
-
Any item of technical equipment, electrical or otherwise, can prove hazardous
if used improperly.
Instructions for the User:
-
Before using a hospital bed, the user must check that the bed is fully functional
and in perfect working order, and must observe the instructions in the manual
in accordance with the Medical Devices Operator Ordinance (
MPBetreibV
)
§ 2.
-
The same applies for accessories that are attached to the bed.
Before using the hospital bed for the first time:
Remove all transport securing devices and packaging film.
Clean and disinfect the hospital bed prior to first-time use.
