ERT AM3 User manual

Instructions for Use
Peak Flow Meter AM3
Option BT+
781199
Version 01.00
for Firmware ≥ 9.40

Page 3/40Version 01.00 • Date 25JAN2018
Table of Contents
Indications for Use ....................................................................................................5
Notes on Safety in Instructions for Use......................................................................6
Declaration of Conformity.........................................................................................6
1. The Peak Flow Meter AM3 ......................................................................7
1.1 Display Symbols ...........................................................................................9
2. Lung Function Measurements with the AM3 .......................................10
2.1 Preparing for the Measurement .................................................................10
2.2 Switching on .............................................................................................11
2.3 Measurement ............................................................................................12
2.4 Results.......................................................................................................14
3. Data Transfer...........................................................................................15
3.1 Data Transfer via Bluetooth ........................................................................15
4. Memory Capacity....................................................................................16
5. Trend ........................................................................................................16
6. Display Date and Time ...........................................................................17
7. Display Settings and Information..........................................................17
8. Power Management ...............................................................................20
9. Error Checklist .........................................................................................22
10. Cleaning...................................................................................................23
10.1 Cleaning of Sensor ....................................................................................23
10.2 Checking the Sensor..................................................................................23
10.3 Disposal of Sensor and Mouthpiece ..........................................................24
10.4 Cleaning of Housing ..................................................................................24
11. Safety Precautions AM3 .........................................................................25
11.1 Safety Precautions for Lithium Ion Rechargeable Batteries .........................30
11.2 Safety Precautions for Wireless Communication.........................................31
11.3 Notes on EMC according to EN60601-1-2..................................................36
12. Technical Data .........................................................................................37
Index .................................................................................................................38

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This document contains copyright information. All rights are reserved. It is not
allowed to copy, duplicate or translate this manual in any other language without
having the written approval of ERT before. ERT reserves the right to alter the
information included in this document without notice. Names of persons men-
tioned in the context of this manual are fictitious - any resemblance to living or
deceased persons is purely incidental and not intended.
Subject to technical modifications.
If you have any questions or problems with your device please contact
your responsible physician.

Page 5/40Version 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.
US FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
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.