eResearchTechnology GmbH AM3G01 User Manual
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Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
5. General
Safety Precautions
The Instructions for Use is regarded to be a part of the instrument, and
should always be kept on hand.
should always be kept on hand.
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 (= Medizinprodukte-
gesetz/ 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.
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 (= Medizinprodukte-
gesetz/ 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 training manual and 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.
- 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 training manual and 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.
safety precautions this can lead to hazardous situations which can lead
to injury or death of the patient and/or destruction of the device.
Electrical Safety
The AM is powered from an internal lithium Ion rechargable battery, the battery
can be charged over a direct plug-in power supply (unit).
Attention:
- Only the original power supply delievered with the AM must be used for
The AM is powered from an internal lithium Ion rechargable battery, the battery
can be charged over a direct plug-in power supply (unit).
Attention:
- Only the original power supply delievered with the AM must be used for
charging the device.
- Do not perform measurements if PC is connected.
- Data transfer is not permitted during measurement.
- Data transfer is not permitted during measurement.
General Safety Precautions