ERT AM3 Manuale utente
Instructions for Use
Peak Flow Meter AM3
Option G+
781195
Version 02.01
for Firmware ≥9.40
Page 3/40Version 02.01 • Date 19JAN2017
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. General Handling....................................................................................10
2.1 Turning the Device ON...............................................................................10
2.2 Turning the Device OFF..............................................................................10
3. Performing Assessments and Transferring Data ..................................10
4. Lung Function Measurements with the AM3 .......................................14
4.1 Preparing for the Measurement .................................................................14
4.2 How to Perform Measurements with the AM3...........................................15
4.3 Validity of PEF Measurements ....................................................................17
4.4 Performing Scheduled Sessions ..................................................................17
4.5 Interrupting a Scheduled Session ...............................................................18
4.6 Performing Unscheduled/Optional Measurements......................................18
5. Power Management ...............................................................................19
6. Memory Capacity....................................................................................20
7. Error Checklist .........................................................................................21
8. Cleaning...................................................................................................22
8.1 Cleaning of Sensor ....................................................................................22
8.2 Checking the Sensor..................................................................................22
8.3 Disposal of Sensor and Mouthpiece ..........................................................23
8.4 Cleaning of Housing ..................................................................................23
9. Safety Precautions AM3 .........................................................................24
9.1 Safety Precautions for Lithium Ion Rechargeable Batteries .........................30
9.2 Safety Precautions for Wireless Communication.........................................31
10. Technical Data .........................................................................................36
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 ctitious - any resemblance to living or
deceased persons is purely incidental and not intended.
Subject to technical modications.
This Instructions for Use is for the patient only. For all medical personal, please
use the more detailed MasterScope IFU (article no. 782126).
If you have any questions or problems with your device please contact
your responsible physician.
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Indications for Use
The Asthma Monitor AM3/AM3 BT/AM3 GSM/G+ is an electronic measurement
device to monitor the lung function (determination of the respiratory ows and vol-
ume) with high reproducibility wherever and whenever there is a need of. The AM3
measures the ow 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 trafc
lights, allows an immediate indication of the measurement based on criteria dened
by the patient’s physician.
The device saves the results of a measurement (always with date and time) automati-
cally in an internal database. In addition, 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 then select 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 an ordinary peak ow 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.
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Following the ANSI recommendations (American National Standards Institute) for
safety notes, specic passages of the instruction manual are clearly marked as safety
notes.
Degree of
Danger
Injury to
Persons
Damage
to Property Use in case of:
X
DANGER indicates an imminently
hazardous situation which, if not avoided,
will result in death or serious injury. This
signal word is to be limited to the most
extreme situations.
X
WARNING indicates a potentially
hazardous situation which, if not avoided,
could result in death or serious injury.
X (X)
CAUTION indicates a potentially
hazardous situation which, if not avoided,
may result in minor or moderate injury. It
may also be used to alert against unsafe
practices.
Notes on Safety in Instructions for Use
Declaration of Conformity
Additional icons shown in the instruction manual:
The original document of the Declaration of Conformity can be found in
the Accompanying Documents.
Important and useful information.
Information does not warn of dangerous
or harmful situations.
Hints for use.
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1. The Peak Flow Meter AM3
The AM3 is a medical device that combines a spirometer with a symptom diary. This
device displays questions concerning asthma symptoms to be answered twice a day
and measures and evaluates the Peak Flow (PEF = Peak Expiratory Flow [L/min] and/or
FEV1 (FEV = Forced Expiratory Volume) as well as other expiratory parameters.
The device keeps a diary of measurements by automatically recording in its memory
all answers and measurements with date and time.
The AM3 Equipment comprises of:
·AM3
·Power supply
·Bag
Before using the AM3 for the rst time, the batteries must be charged for
30 minutes (see chapter "Power Management").
Conrmation
Scroll up
Scroll
down
Off/Cancel
Front view: Bottom view:
Flow Sensor
(without cap)
Flow Sensor (with cap)
Display
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Warning
The AM3 can assist in monitoring airway function on a day-to-day basis,
but it is not supposed to provide an entire diagnosis of your state of
health. The use of the AM3 will not replace a medical examination or
other tests if you are not feeling well.
You should call your study doctor immediately if you show any
symptoms of
• severe trouble breathing
• severe cough that will not stop
• trouble talking or walking
• severe chest tightness or wheezing
• over-inated chest or ribs
• lips or ngernails which are bluish rather than pink
or if you
• require treatment with oral or parenteral glucocorticosteroids.
• have been admitted to hospital (including emergency room treatment).
• are concerned about your condition during the study.
Trouble-free operation of the AM3 is guaranteed for temperatures from
+10° to +40°C (50° to +104°F).
It is recommended NOT to perform measurements in direct sunlight, as
the sensor could be damaged.
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1.1 Display symbols
Symbol Explanation
Settings menu
Transfer stored data manually
Display signal strength and provider
Information
Perform test transfer
Activate/Deactivate Airplane mode
Assessment
XX
Repeat measurement
12
Optional measurement
Data transfer in progress
Data transfer successful
Data transfer failed
Memory capacity almost full (80%)
Memory capacity full
Battery low
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2. General Handling
The device is turned OFF by pressing ESC .
2.2 Turning the Device OFF
2.1 Turning the Device ON
Press the ESC and the OK button at the same time and hold both buttons for
approximately 2 seconds. After releasing the buttons the device will switch on.
3. Performing Assessments and Transferring Data
After switching on the AM3, a start screen will
appear. This screen will show the study-ID and
contain two selectable options:
The AM3 has an integrated antenna to transfer the data via SMS. As in
any mobile phone, a sufcient signal strength is needed to transfer data.
If the signal strength is too weak, you should search for a place with
sufcient signal strength. It is important that the device is not shielded by
any objects (particularly metal) or thick walls (e.g. cellar).
OK
ESC
Study-ID
Press arrow keys
to select your choice
By selecting the “Assessment” icon you will be asked to answer the rst question
of the questionnaire or to perform the PEF measurements. After nishing the
assessment, the data transfer will start automatically.
“Settings”
“Assessment”.
Altri manuali per AM3
1
Indice
