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

Page 4/40 Version 01.00 • Date 25JAN2018
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.

Page 6/40 Version 01.00 • Date 25JAN2018
Following the ANSI recommendations (American National Standards Institute) for
safety notes, specific 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.

Page 7/40Version 01.00 • Date 25JAN2018
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 AM3 Equipment comprises of:
·AM3
·Power supply
·Bag
Before using the AM3 for the first time, the batteries must be charged for
30 minutes (see chapter "Power Management").
Confirmation
Scroll up
Scroll
down
Off/Cancel
Flow Sensor
(without cap)
Display
OK
ESC
AM
12
1.

Page 8/40 Version 01.00 • Date 25JAN2018
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-inflated chest or ribs
• lips or fingernails 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.

Page 9/40Version 01.00 • Date 25JAN2018
1.1 Display Symbols
Symbol Explanation
12
1.
Assessment
XX
Repeat measurement
Data transfer in progress
Data transfer successful
Data transfer failed
Memory capacity almost full (80%)
Memory capacity full
Battery low

Page 10/40 Version 01.00 • Date 25JAN2018
Prior to starting the measurement, place the flow sensor into the AM3 as shown
below and remove the sealing cap from the flow sensor.
When inserting the flow sensor into the AM3, medical assistants must adhere to the
general hygiene standards valid for hospitals and private practices.
If the flow sensor is inserted into the AM3, the notes on cleaning as described under
the chapter “Cleaning“ must be followed.
2. Lung Function Measurements with the AM3
2.1 Preparing for the Measurement
Sealing cap
Flow sensor
AM3
Flow sensor
The flow sensor can be used multiple times but should only be used by the
same person to prevent contamination.

Page 11/40Version 01.00 • Date 25JAN2018
2.2 Switching on
The AM3 is switched on by pressing OK for at least one second and then releasing
the button.
If the display does not show the faces as below, please contact your doctor!
If you are already assigned to the device, the following display appears:
Please note:
Depending on your device configuration, only a predefined number of
measurements (sessions) can be performed within a preconfigured time window.
Your doctor or study nurse can inform you about the specific settings, for example
number of measurements and any active time window.
An audible reminder may be set for your AM3 to remind you to perform the
measurement.
The Peak Expiratory Flow (PEF) measurement
will start.
OK
ESC
12
1.

Page 12/40 Version 01.00 • Date 25JAN2018
2.3 Measurement
1. The following is displayed:
2. Take the AM3 in your hand.
3. Inhale deeply and hold your breath until you have
positioned the inlet of the flow sensor into your mouth.
It is recommended NOT to perform measurements in direct
sunlight, as the sensor could be damaged.
Please note: The
measurement has to
be performed within
the next 10 seconds.
Do not breathe in through the AM3.
Now you must exhale as hard as possible for at least
2 seconds to obtain a satisfactory measurement.
You should
• pause for about a second and then blow out hard and fast as you can.
• not cough.
• not block the inlet of the flow sensor with your tongue.
• not block the outlet of the flow sensor with your hand.
If you do not follow these instructions, the correctness of the measure-
ment values cannot be guaranteed.
OK
ESC
12
1.

Page 13/40Version 01.00 • Date 25JAN2018
2.3 Measurement 4. Wait until you hear a beep. Your measured
value (here PEF) is displayed. Depending on the
configuration the marker will also point to the
corresponding color code.
OK
ESC
After performing as many measurements as
configured, the highest value measured will be
displayed and automatically saved.
OK
ESC
If the measurement does not qualify as accept-
able the following screen will be shown.
Please press OK and repeat the measurement.
OK
ESC
XX

Page 14/40 Version 01.00 • Date 25JAN2018
2.4 Results
The peak flow value "PEF"** is displayed in liters per minute. If enabled, the
"traffic light function" indicates the relationship between the measured value and
your personal best value and possibly necessary measures. An arrow points to the
respective color.
Arrow points to red: Danger!
Repeat the measurement and follow the instructions of your physician or case
manager.
Arrow points to yellow: Attention!
Repeat the measurement and follow the instructions of your physician or case
manager.
Arrow points to green: OK
Follow the instructions of your physician or case manager.
Press OK to perform another measurement. See "Measurement".
**Depends on the measuring mode set by your physician.
Further available parameters: FEV1 = Forced Expiratory Volume after one second
OK
ESC

Page 15/40Version 01.00 • Date 25JAN2018
3. Data Transfer
Depending on your configuration a data transfer may start automatically after the
measurement sequence is finished or - in case the device is switched off - manually
by pressing
ESC
.
3.1 Data Transfer via Bluetooth
If used in combination with other devices your AM3 comes already configured for
automated data transfer. Please contact your care provider for further information.
The maximum distance between the AM3 and the connecting device
is 5 meters.
If your AM3 is connected via bluetooth to a host device, data of the current
measurement will be automatically transmitted immediately afterwards.
OK
ESC

Page 16/40 Version 01.00 • Date 25JAN2018
Please bring your device to each study visit to avoid reaching full memory
capacity.
4. Memory Capacity
The following message will appear on the screen to indicate that the memory of the
AM3 is almost full (80%) or completely full (no further data can be stored on the
AM3).
OK
ESC
OK
ESC
5. Trend
Depending on your configuration and in addition to the displayed value a graphical
trend of the last seven days may be displayed.
OK
ESC

Page 17/40Version 01.00 • Date 25JAN2018
6. Display Date and Time
When the AM3 is switched off, press ESC and
simultaneously to enter the date and time
menu. Press ESC to exit the date/time display.
Please contact your physician or case manager in
case date and time need to be corrected.
OK
ESC
Battery voltage
Press OK and subsequent displays can be shown. Press
ESC
to abort the program.
OK
ESC
Date and Time
While date/time is displayed, press OK .
7. Display Settings and Information

Page 18/40 Version 01.00 • Date 25JAN2018
OK
ESC
IMEI number (not available for Option BT+)
OK
ESC
Patient-ID
OK
ESC
Memory capacity for measurements
Memory capacity for answers

Page 19/40Version 01.00 • Date 25JAN2018
OK
ESC
Threshold yellow/red (l/min)
Threshold green/yellow (l/min)
OK
ESC
Unique identifier
Version (software)
OK
ESC
Daylight saving date
Indication of measurement mode set for
this device.
PEF = Peak Expiratory Flow
FEV1 = Forced Expiratory Volume after
one second

Page 20/40 Version 01.00 • Date 25JAN2018
OK
ESC
Alarm times to remind the patient to
perform a measurement.
8. Power Management
The AM3 GSM/G+/BT+ has a Li-Ion polymer battery and a power supply to charge
the battery.
Before using the AM3 for the first time, the battery must be charged for
30 minutes.
OK
ESC
BT-Version
BT-Address