burmeier Vertica-Homecare, Инструкция по эксплуатации

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Instruction Manual for Vertica-Homecare Bed
Page 7
2 General Information
This instruction manual describes several different models of the Vertica-
Homecare bed.
It is possible that certain functions or features are described which are not
incorporated in your particular bed.
In the following text, the Vertica-Homecare bed will be referred to simply as the
bed.
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 any natural and legal
person with property rights to the Vertica-Homecare 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 a person 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 bed fulfils all the requirements of the 93/42/EEC Medical Devices Directive.
It is classified as a Class I active medical device in accordance with the
Medical Devices Act (
Medizinproduktegesetz , German abbreviation: MPG)
§ 13.
- Any item of technical equipment, electrical or otherwise, can prove hazardous
if used improperly. 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.
Instructions for the User:
- Before using a care 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 Operators of Medical Products Ordinance
(MPBetreibV) § 2.
The same applies for accessories that are attached to the bed.