eResearchTechnology GmbH AM3G02 用户手册
Page 24/40
Version 02.01 • Date 19JAN2017
The Instructions for Use is regarded to be a part of the instrument,
and should always be kept on hand.
and should always be kept on hand.
9. Safety Precautions AM3
The instruction manual describes the present state of the device/system including
software and accessories with regard to the fundamental requirements of the MDD
93/42/EEC. Exact adherence to the instructions issued is a prerequisite for perfect and
intended functioning of ERT instruments.
software and accessories with regard to the fundamental requirements of the MDD
93/42/EEC. Exact adherence to the instructions issued is a prerequisite for perfect and
intended functioning of ERT instruments.
Deviation from Intended Use
Any non-observance of the procedures (such as preparing for the measurement and
methods, disinfecting procedures, use of accessories and replacement parts etc.)
described in the Instructions for Use results in a deviation from intended use.
In case of a deviation from intended use the operator/user has to supply proof of
meeting all corresponding fundamental requirements. This is possible by performing
a corresponding conformity assessment procedure within in-house manufacture (see
§ 12, paragraph 1 last sentence of MPG (= Medizinproduktegesetz/ Medical Products
Act).
The operator/user is, however, not only responsible for performing the conformity
assessment correctly but is also completely liable for defective products - i.e. the
operator/user is not only liable for his/her modification of the medical product.
ERT only guarantees for the safety, reliability and functioning of the device if:
- installation, extension, modifications, and repairs are exclusively carried out by
Any non-observance of the procedures (such as preparing for the measurement and
methods, disinfecting procedures, use of accessories and replacement parts etc.)
described in the Instructions for Use results in a deviation from intended use.
In case of a deviation from intended use the operator/user has to supply proof of
meeting all corresponding fundamental requirements. This is possible by performing
a corresponding conformity assessment procedure within in-house manufacture (see
§ 12, paragraph 1 last sentence of MPG (= Medizinproduktegesetz/ Medical Products
Act).
The operator/user is, however, not only responsible for performing the conformity
assessment correctly but is also completely liable for defective products - i.e. the
operator/user is not only liable for his/her modification of the medical product.
ERT only guarantees for the safety, reliability and functioning of the device if:
- installation, extension, modifications, and repairs are exclusively carried out by
personnel authorized for these tasks by ERT.
- the ambient conditions at the place of installation are suitable for the device.
- the device is used according to the Instructions for Use.
- Unpack your medical device. Please check if the unit is damaged. If so, do not use
- the device is used according to the Instructions for Use.
- Unpack your medical device. Please check if the unit is damaged. If so, do not use
it and return it for a replacement.
The user has to follow the instructions. If the user doesn’t obey
the safety precautions this can lead to hazardous situations which
can lead to injury or death of the patient and/or destruction of the
device.
the safety precautions this can lead to hazardous situations which
can lead to injury or death of the patient and/or destruction of the
device.