ERT AM3 Manual de usuario
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.
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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.
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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-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.
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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
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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.
Otros manuales para AM3
1
Tabla de contenidos
Otros manuales de Equipo médico de ERT
