eResearchTechnology GmbH AM3G01 Benutzerhandbuch
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Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Contraindications and possible adverse effects:
According to ‘‘ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION
TESTING’’ (ERS Journals Ltd 2005) performing lung function tests can be physically
demanding for a minority of patients. It is recommended that patients should not
be tested within 1 month of a myocardial infarction.
In rare cases spirometry testing can lead to syncope due to extensive exhalation.
According to ‘‘ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION
TESTING’’ (ERS Journals Ltd 2005) performing lung function tests can be physically
demanding for a minority of patients. It is recommended that patients should not
be tested within 1 month of a myocardial infarction.
In rare cases spirometry testing can lead to syncope due to extensive exhalation.
Putting the Device into Operation
Temperature changes may give rise to condensation in the device. Consequently,
the device has to adapt to the ambient temperature before putting it into
operation.
Temperature changes may give rise to condensation in the device. Consequently,
the device has to adapt to the ambient temperature before putting it into
operation.
Cleaning and Hygiene
Prior to every application, all parts which come in contact with the patient and
which are intended for reuse must be cleaned or disinfected (unless otherwise
instructions are available).
Prior to measuring a subject, his/her anamnesis is to be checked in order to avoid
a contamination of the device and a resulting cross contamination of the next
subject.
During cleaning, the AM3 must not be connected to a PC or modem.
Referring to humidity and water which may get into the device, AM3 corresponds
to the safety degree IP 22. This means, the device can be cleaned with a damp
(in no case dripping wet) cloth which does not produce fluff. More detailed
information can be found under “Cleaning”. Chemicals required for operation or
care of the unit must always be stored, prepared, and made available in specially
marked vessels to prevent any mistakes.
Prior to every application, all parts which come in contact with the patient and
which are intended for reuse must be cleaned or disinfected (unless otherwise
instructions are available).
Prior to measuring a subject, his/her anamnesis is to be checked in order to avoid
a contamination of the device and a resulting cross contamination of the next
subject.
During cleaning, the AM3 must not be connected to a PC or modem.
Referring to humidity and water which may get into the device, AM3 corresponds
to the safety degree IP 22. This means, the device can be cleaned with a damp
(in no case dripping wet) cloth which does not produce fluff. More detailed
information can be found under “Cleaning”. Chemicals required for operation or
care of the unit must always be stored, prepared, and made available in specially
marked vessels to prevent any mistakes.
Maintenance
The device doesn’t require to perform preventive inspection, maintenance and
calibration. No part of the AM3 should be replaced by the subject/doctor.
Use ERT approved accessories and spare parts for this medical device, only.
If the device/applied part has been exposed to extreme mechanical stress, a
function test has to be performed. If function is lost, the defective part is to be
replaced.
Damaged and frayed plugs, receptacles and housing or the display glass (if
available) should be replaced by an authorized specialist or engineer of the ERT
Customer Care. Device must not be opened. If it is opened without authorization,
the guarantee entitlement expires. In case of service contact ERT.
The device doesn’t require to perform preventive inspection, maintenance and
calibration. No part of the AM3 should be replaced by the subject/doctor.
Use ERT approved accessories and spare parts for this medical device, only.
If the device/applied part has been exposed to extreme mechanical stress, a
function test has to be performed. If function is lost, the defective part is to be
replaced.
Damaged and frayed plugs, receptacles and housing or the display glass (if
available) should be replaced by an authorized specialist or engineer of the ERT
Customer Care. Device must not be opened. If it is opened without authorization,
the guarantee entitlement expires. In case of service contact ERT.
General Safety Precautions
Medical Supervision
A qualified physician has to reassess all AM3 measurements. An interpretation
by the AM3 is only important if it is considered in connection with other clinical
findings.
A qualified physician has to reassess all AM3 measurements. An interpretation
by the AM3 is only important if it is considered in connection with other clinical
findings.