eResearchTechnology GmbH AM3G03 User Manual
Page 5/40
Version 01.00 • Date 25JAN2018
Indications for Use
The Asthma Monitor AM3/AM3 BT/AM3 GSM/G+/BT+ is an electronic measurement
device to monitor the lung function (determination of the respiratory flows and vol-
ume) with high reproducibility wherever and whenever there is a need of. The AM3
measures the flow during expiration serving for the calculation of further parameters
as FEV1.
The AM3 is used to monitor the respiratory status of adult human beings in the areas
of 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 the selected parameters
(e.g. PEF, FEV1). Furthermore, a visual control unit, displayed in the form 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, questionnaire functionality can be
called up by the use of a software (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 then select from a couple of different answers. This information is
also stored in the internal database and can be transmitted for evaluation using the
software AMOS.
The AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a
single system. Easy handling, sturdy and handy design allow the Asthma Monitor
AM3 to be used in healthcare, clinical and home use environments/settings.
device to monitor the lung function (determination of the respiratory flows and vol-
ume) with high reproducibility wherever and whenever there is a need of. The AM3
measures the flow during expiration serving for the calculation of further parameters
as FEV1.
The AM3 is used to monitor the respiratory status of adult human beings in the areas
of 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 the selected parameters
(e.g. PEF, FEV1). Furthermore, a visual control unit, displayed in the form 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, questionnaire functionality can be
called up by the use of a software (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 then select from a couple of different answers. This information is
also stored in the internal database and can be transmitted for evaluation using the
software AMOS.
The AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a
single system. Easy handling, sturdy and handy design allow the Asthma Monitor
AM3 to be used in healthcare, clinical and home use environments/settings.
US FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN. (Rx only)
ORDER OF A PHYSICIAN. (Rx only)
The application of this system is restricted to trained users who can guarantee for the
correct usage of the device.
The AM3 is powered with a Lithium-ion battery. No energy is transferred to the users.
correct usage of the device.
The AM3 is powered with a Lithium-ion battery. No energy is transferred to the users.