eResearchTechnology GmbH AM3G01 User Manual
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Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Indications for Use
The Asthma Monitor AM3/AM3 BT/AM3 GSM is an electronic measurement device
to monitor the lung function (determination of the respiratory flows and volume)
with high reproducibility wherever and whenever is a need of. The AM3 measures
the flow during expiration serving far the calculation of further parameters as
FEV1.
The AM3 is used to monitor the respiratory status of human beings in the areas
asthma, chronic obstructive pulmonary disorder and in areas like occupational
medicine, clinical trials and disease management.
The patient is informed of the results by numeric values for selected parameters
(e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic
lights, allows an immediate indication of the measurement based on criteria
defined by the patient’s physician.
The device saves the results of a measurement (always with date and time)
automatically in an internal database. In addition, a questionnaire functionality can
be called up by the use of a software package (AMOS) to record e.g. the “Quality
of Life” status. When enabled, the AM3 can be programmed with a couple of
questions, where the patient can select then from a couple of different answers.
This information is also stored in the internal database and can be transmitted for
evaluation to a standard PC using the software package AMOS.
The AM3 is designed to replace ordinary peak flow meter, diary and pencil by a
single system. Easy handling, sturdy and handy design allow the Asthma Monitor
AM3 being used almost everywhere: at work, at home, in school, for experts
opinion, research or clinical trial purposes and in occupational medicine.
to monitor the lung function (determination of the respiratory flows and volume)
with high reproducibility wherever and whenever is a need of. The AM3 measures
the flow during expiration serving far the calculation of further parameters as
FEV1.
The AM3 is used to monitor the respiratory status of human beings in the areas
asthma, chronic obstructive pulmonary disorder and in areas like occupational
medicine, clinical trials and disease management.
The patient is informed of the results by numeric values for selected parameters
(e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic
lights, allows an immediate indication of the measurement based on criteria
defined by the patient’s physician.
The device saves the results of a measurement (always with date and time)
automatically in an internal database. In addition, a questionnaire functionality can
be called up by the use of a software package (AMOS) to record e.g. the “Quality
of Life” status. When enabled, the AM3 can be programmed with a couple of
questions, where the patient can select then from a couple of different answers.
This information is also stored in the internal database and can be transmitted for
evaluation to a standard PC using the software package AMOS.
The AM3 is designed to replace ordinary peak flow meter, diary and pencil by a
single system. Easy handling, sturdy and handy design allow the Asthma Monitor
AM3 being used almost everywhere: at work, at home, in school, for experts
opinion, research or clinical trial purposes and in occupational medicine.
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN. (Rx only)
PHYSICIAN. (Rx only)
The AM can be utilized for subjects from 4 years on and older as long as they can
cooperate in the performance.
The application of this system is restricted to trained subjects who can guarantee
for the correct usage of the device.
cooperate in the performance.
The application of this system is restricted to trained subjects who can guarantee
for the correct usage of the device.
The AM is powered with a Lithium-ion battery. No energy is transferred to the
subject.
subject.