eResearchTechnology AM3G02 The Asthma Monitor AM3 is an electronic measurement device to monitor the lung function. User Manual 15 AM3 Gplus UserMan
eResearchTechnology GmbH The Asthma Monitor AM3 is an electronic measurement device to monitor the lung function. 15 AM3 Gplus UserMan
15_AM3 Gplus UserMan
Instructions for Use
Peak Flow Meter AM3
Option G+
781195
Version 02.01
for Firmware ≥ 9.40
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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”.
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Afterwards, the following screens will appear implying whether the data transfer has
been successful or not:
This screen indicates that the data transfer is
in progress. Please wait until the next screen
appears.
By selecting on the start screen the following options will be available:
OK
ESC
OK
ESC
OK
ESC
OK
ESC
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Manual data transfer:
If the automatic data transfer was not possible, you can transfer the stored data
manually any time by selecting .
The device will establish a connection and start the data transfer of stored data
which has not yet been transferred.
Signal and provider:
You can check the signal strength and the
network provider by selecting .
The more black bars are visible, the better the
signal strength. At least one bar is necessary to
successfully transfer data.
Info:
Select to indicate the number of data sets
which have been stored, acknowledged, sent
and failed.
OK
ESC
Telekom.de
OK
ESC
Data sets: 0002
Acknowledged: 0008
Sent: 0014
Failed: 0000
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OK
ESC
Press arrow keys
to select your choice
By conrming the rst information screen with
OK this screen will appear indicating the
transmission type and SIM number.
Test transfer:
To test if the data transfer works correctly, a test
transfer can be performed by selecting .
This test transfer can be performed independent
of study time windows and will not contain any
data.
Airplane mode:
When travelling by airplane, turn “Off” mobile
communication (airplane mode active) to prevent
possible interference with aircraft systems by
selecting .
During activated Airplane mode the Bluetooth
and the mobile communication function are
disabled. As long as the airplane mode is active, a
small airplane icon is displayed in the upper right
corner of the start screen.
OK
ESC
Transmission type:
wireless
SIM no.: 0725340603
OK
ESC
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Prior to starting the measurement, place the ow sensor into the AM3 as shown
below and remove the sealing cap from the ow sensor.
When inserting the ow sensor into the AM3, medical assistants must adhere to the
general hygiene standards valid for hospitals and private practices.
If the ow sensor is inserted into the AM3, the notes on cleaning as described under
the chapter “Cleaning“ must be followed.
4. Lung Function Measurements with the AM3
4.1 Preparing for the Measurement
Sealing cap
Flow sensor
AM3
Flow sensor
The ow sensor can be used multiple times but should only be used by the
same person to prevent contamination.
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Do not breathe in through the AM3.
4.2 How to Perform Measurements with the AM3
To perform a valid PEF measurement with the AM3, the following steps must be
followed:
1. Inhale deeply and hold your breath until you have positioned the inlet of the
ow sensor into your mouth.
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 ow sensor with your tongue.
• not block the outlet of the ow sensor with your hand.
If you do not follow these instructions, the correctness of the measure-
ment values cannot be guaranteed.
2. Now you must exhale as hard as possible for at least 2 seconds to obtain a
satisfactory measurement.
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3. After full exhalation, the AM should be removed from the mouth immediately.
4. The measured PEF is displayed on the AM3.
OK
ESC
OK
ESC
5. The result is conrmed by pressing OK .
After the 1st measurement, you will be asked to perform the 2nd and the 3rd PEFs
(repeat steps 1- 5).
PEF Result
340 L/min
6. At the end of the session, the highest PEF
will be displayed.
Highest PEF
350 L/min
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A PEF measurement performed with the AM3 is valid, if:
• Breathing volume > 0.47 L or < 10 L
• Breathing ow > 50 L/min
• FVC > FEV1
If all efforts are invalid, no measurement data will be stored on the device.
4.3 Validity of PEF Measurements
To store a result in the AM3, at least one adequate maneuver needs to be
performed.
OK
ESC
XX
Otherwise a message will be displayed and you
will be asked to repeat the measurement.
4.4 Performing Scheduled Sessions
Scheduled sessions, including questionnaire and PEF measurements, can only be
performed and stored using programmed devices.
For completing your questionnaire, you can scroll through and select the appropriate
answer by using and buttons and pressing OK .
At the end of the questionnaire you will be asked, if you want to change an answer;
if you select “Yes“, the questionnaire will be displayed again. The answers previously
entered will appear as default, and can be modied as described above.
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4.6 Performing Unscheduled/Optional Measurements
In addition to scheduled measurements, you are able to perform unscheduled/
optional measurements. These are measurements that are:
• performed after having nished the scheduled measurements within the same
time window
• performed outside of the study specic time windows
When performing an unscheduled/optional
measurement, the screen on the left will be
displayed after turning the device ON.
The data from unscheduled/optional measurements is for information only
and will NOT be stored.
OK
ESC
12
4.5 Interrupting a Scheduled Session
If the AM3 is turned OFF before nishing a questionnaire, all questions previously
answered will not be saved.
If the AM3 is turned OFF after completing the questionnaire or between the PEF
measurements, the session can be completed within the remaining time window. In
this case, the AM3 has to be turned ON again and only the missing measurement
may be performed - the questionnaire will not be displayed again.
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5. Power Management
The AM3 GSM/G+ has a Li-Ion polymer battery and a power supply to charge the
battery.
Before using the AM3 for the rst time, the battery must be charged for
30 minutes.
The internal clock will stop after about 5 days when the internal battery is
fully discharged.
When the battery is low (at approx. 5%), the following message will be displayed:
At this point of discharge you have 24 hours to
connect the AM3 to the power supply before the
battery is fully discharged.
How to charge the battery
Plug one end of the wall adapter into the
USB interface of the AM3 and the other
end into a wall socket.
Only the original power supply
delivered with the AM3 must be
used for charging the device.
OK
ESC
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If you switch on the AM3 while the plug-in power supply is connected, the following
message will be displayed:
The battery symbol indicates the state of charge.
Please bring your device to each study visit to avoid reaching full memory
capacity.
6. 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
OK
ESC
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7. Error Checklist
Error Description Reason Action
No response during
power ON A. AM3 battery is empty Charge the AM3
B. Buttons OK and
ESC are not pressed
correctly
• Press and hold the
OK button.
• While holding the
OK button,
press and hold the
ESC button.
• Hold both buttons
for approximately
2 seconds.
Result of
measurements is
questionable
A. Flow Sensor is not
inserted correctly
Insert Flow Sensor
correctly
B. Flow Sensor is dirty Clean Flow Sensor
according to cleaning
instructions
C. Flow Sensor is faulty Replace Flow Sensor
If the proposed actions do not lead to perfect recovery of the AM3´s
normal functionality, please contact your study doctor.
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The sensor is intended for single patient use, only. If the AM3 is passed
on to another patient, the AM surfaces will have to be cleaned and
disinfected with a disinfectant. See 8.4 for cleaning of housing.
See below for informa tion on disposal of a used sensor.
8. Cleaning
8.1 Cleaning of Sensor
To clean the rotary ow sensor, release and remove sensor, rinse it with mild
cleansing agent, e.g. Instruton E by ANTISEPTICA Dr. Hans-Joachim Molitor GmbH
according to instructions of manufacturer, and then rinse with clean distilled water.
Shake off any remaining water on the sensor. Air-dry and reinsert the sensor. Any
minor discoloration in the sensor does not affect the performance of the AM3.
The Cleaning of the sensor should be performed every week or more frequently if
often heavily polluted. Furthermore, it is recommended to exchange the rotary ow
sensory with a new one after one year of use or 2000 measurements. If the sensor
is heavily polluted frequently, the exchange with a new sensor should be performed
every six months or as required. If there are any doubts that the measurement values
are correct, the rotary ow sensor has to be exchanged immediately.
8.2 Checking the Sensor
If your AM3 does not measure accurately, exchange the sensor or contact the
responsible Monitor or ERT Customer Care Helpdesk.
DO NOT use alcohol or any type of household cleaner!
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8.4 Cleaning of Housing
If the device is polluted or passed on to another patient, the AM surfaces have to
be cleaned and disinfected with a disinfectant. We recommend combined cleansing
and disinfecting agents with basic substance quaternary ammonium compound, for
example „Cleanisept Wipes“ by Dr. Schumacher GmbH.
The method of application provided by the disinfectant manufacturer have to be
considered.
8.3 Disposal of Sensor and Mouthpiece
It is absolutely vital to avoid the patient, medical assistant or sensor
becoming contaminated with sputum during disassembly of the
disposable sensor.
Therefore, release and remove the sensor by pulling the disposable sensor
downwards (see picture). Dispose of it immediately.
Releaser
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The Instructions for Use is regarded to be a part of the instrument,
and should always be kept on hand.
9. Safety Precautions AM3
The instruction manual describes the present state of the device/system including
software and accessories with regard to the fundamental requirements of the MDD
93/42/EEC. Exact adherence to the instructions issued is a prerequisite for perfect and
intended functioning of ERT instruments.
Deviation from Intended Use
Any non-observance of the procedures (such as preparing for the measurement and
methods, disinfecting procedures, use of accessories and replacement parts etc.)
described in the Instructions for Use results in a deviation from intended use.
In case of a deviation from intended use the operator/user has to supply proof of
meeting all corresponding fundamental requirements. This is possible by performing
a corresponding conformity assessment procedure within in-house manufacture (see
§ 12, paragraph 1 last sentence of MPG (= Medizinproduktegesetz/ Medical Products
Act).
The operator/user is, however, not only responsible for performing the conformity
assessment correctly but is also completely liable for defective products - i.e. the
operator/user is not only liable for his/her modication of the medical product.
ERT only guarantees for the safety, reliability and functioning of the device if:
- installation, extension, modications, and repairs are exclusively carried out by
personnel authorized for these tasks by ERT.
- the ambient conditions at the place of installation are suitable for the device.
- the device is used according to the Instructions for Use.
- Unpack your medical device. Please check if the unit is damaged. If so, do not use
it and return it for a replacement.
The user has to follow the instructions. If the user doesn’t obey
the safety precautions this can lead to hazardous situations which
can lead to injury or death of the patient and/or destruction of the
device.
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Electrical Safety
The AM3 is powered from an internal Lithium-Ion rechargeable battery, the battery
can be charged over a direct plug-in power supply (unit).
Attention:
- Only the original power supply delivered with the AM3 must be used for charging
the device.
- Do not perform measurements if the AM3 is connected to another device.
- Data transfer is not permitted during measurement.
Patient Safety according to EN 60601-1
The subject has to keep a distance of at least 1,5 m from a connected modem or
notebook to avoid any contact with electrical voltage.
Valid for all ERT Devices
Additional equipment connected to medical electrical equipment must comply with
the respective EN or ISO standards (e.g. EN 60950 for data processing equipment).
Furthermore all congurations shall comply with the requirements for medical
electrical systems. Anybody connecting additional equipment to medical electrical
equipment congures a medical system and is therefore responsible that the system
complies with the requirements for medical electrical systems. Attention is drawn to
the fact that local laws take priority over the above mentioned requirements. If in
doubt, consult your local representative or the ERT Customer Care.
Radiated Interference
The ERT device meets the regulations according to EN 60601-1-2 regarding
interference radiated and received. It is recommended not performing
a measurement with the device directly next to other equipment or in
combination with other devices in a stacked form, as this may result in faulty
operation.
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However, if performing a measurement is required in the manner described above,
the devices should be observed to ensure they work properly.
The device should not be installed in the vicinity of high-frequency devices, X-ray
equipment, motors or transformers with high installed power rating, since electric or
magnetic interference elds may falsify the results of measurements or make taking
measurements impossible. Due to this, the vicinity of power lines is to be avoided as
well.
Existing environmental interferences may cause deviations of the measuring values
without impairing the device’s function.
Therefore, it is recommended to keep a distance of about 2 meters from possible
error sources when using the device.
Use ERT approved accessories or spare parts for this medical device only. Use of
unapproved equipment can result in increased electromagnetic interference or
reduced electromagnetic immunity of the medical device and can lead to faulty
operation.
Other portable RF communication equipment (including their accessories, such as
antenna cables and external antennas) should not be spaced less than 30 cm (or
12 inches) from the parts and leads of the AM3. Failure to do so may result in a
reduction in the performance of the AM3.
Ambient Conditions
AM3 must not be operated in rooms or in the presence of ammable anaesthetic
mixture with air or ammable anaesthetic mixture with oxygen or nitrous oxide.
AM3 has to be effectively protected against moisture. Therefore, it is required that
the AM3 is always stored in the corresponding bag. The device corresponds to IP 22
degree of protection. Measurements in the rain or in the shower are not allowed.
Measuring Mode
As the combination with an IEC 60950-1 proofed PC or modem can lead to a sum-
mation of the leakage current, the AM3 must not be connected to a PC or modem
during the measurement.
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Interfaces
The AM3 must only be connected to a PC that corresponds to EN 60950 standards.
If the connection cable is defective, it has to be replaced by a new one. The operator
must not touch the Interfaces during measurement.
Medical Supervision
A qualied physician has to reassess all AM3 measurements. An interpretation by the
AM3 is only important if it is considered in connection with other clinical ndings.
Contraindications and possible adverse effects:
According to ‘‘ATS/ERS TASK FORCE: STANDARDISATION OF LUNG
FUNCTIONTESTING’’ (ERS Journals Ltd 2005) performing lung function tests can be
physically demanding for a minority of subjects. It is recommended that subjects
should not be tested within 1 month of a myocardial infarction.
In rare cases spirometry testing can lead to syncope due to extensive exhalation.
Furthermore, the following conditions probably lead to suboptimal lung function
results:
- Chest or abdominal pain of any causes,
- Oral or facial pain exacerbated by a mouthpiece,
- Stress incontinence,
- Dementia or disorientation.
According to “German Airway League, German Respiratory Society and German
Society of Occupational and Environmental Medicine, 2015” (S2 guideline
“Spirometry”) forced manoeuvers should not be performed in case of
- acute, life threatening diseases of every description (e.g. acute fulminant
pulmonary embolism, large ascending aortic aneurysm, tension pneumothorax)
Should the measuring values of the AM3 be changed after a longer period of use, a
new sensor should be used.
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Putting the Device into Operation
Temperature changes may give rise to condensation in the device. Consequently, the
device has to adapt to the ambient temperature before putting it into operation.
Cleaning and Hygiene
Prior to every application, all parts which come in contact with the patient and which
are intended for reuse must be cleaned or disinfected (unless otherwise instructions
are available).
During cleaning, the AM3 must not be connected to a PC or modem.
Referring to humidity and water which may get into the device, AM3
corresponds to the safety degree IP 22. This means, the device can be cleaned with
a damp (in no case dripping wet) cloth which does not produce uff. More detailed
information can be found under “Cleaning”. Chemicals required for operation or
care of the unit have to be used in accordance with instructions of the manufacturer
and must always be stored, prepared and made available in specially marked vessels
to prevent any mistakes.
- massive pneumothorax (within the rst weeks)
- abdominal or thoracic surgery (depending on the ndings 1 to 4 weeks
postoperatively)
- surgery of the eyes, brain, or ears (variable, consultation with the surgeon)
- Special care must be taken when dealing with hemoptysis of unknown origin
Maintenance
The device doesn’t require to perform preventive inspection, maintenance and
calibration. No part of the AM3 should be replaced by the subject/doctor.
Use ERT approved accessories and spare parts for this medical device, only.
If the device/applied part has been exposed to extreme mechanical stress, a function
test has to be performed. If function is lost, the defective part is to be replaced.
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Before turning on the device, you should always check whether the device is free
from defects. Immediate maintenance is necessary, if:
- the display glass bursts or breaks: Caution: risk of injury
- the device has been mechanically stressed in the extreme (e.g. impact, damage to
the housing).
- liquid got into the device.
- the connection cable is defective. The connection cable has to be replaced by a
new one.
- coverings have fallen off.
Children should neither get in contact with disposables, accessories and packing
material nor with cleaning and disinfection substances.
Recycling
Adhere to the national law in your country when disposing the medical device and its
accessories. Improper disposal of the device and/or its accessories can result in serious
environmental hazard.
Damaged and frayed plugs, receptacles and housing or the display glass (if available)
should be replaced by an authorized specialist or engineer of the ERT Customer
Care. Device must not be opened. If it is opened without authorization, the
guarantee entitlement expires. In case of service contact ERT.
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9.1 Safety Precautions for Lithium Ion Rechargeable Batteries
The AM3 is powered from an internal Lithium-Ion Polymer battery.
The following safety precautions are valid for Lithium-Ion batteries:
- Do not waste the battery.
- Do not short-circuit the battery.
- Protect the battery against excessive heat!
- Protect the battery against direct sun light!
- Protect the battery against re!
- Do not dismantle or manipulate the battery.
- Do not replace the battery.
- The uid of the battery is toxic and ammable - leaky batteries or batteries with
dents must not be used any longer!
- Do not come in contact with the uid in the battery. If the uid comes in contact
with your skin, immediately rinse the affected part with water and contact a
doctor!
- To charge the AM3, use only the charger specied by ERT and observe the
instructions in the manual!
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For the efcient and safe operation of your AM3, please read the following
information carefully.
Safety and Hazards
Do not operate the AM3 with wireless communication in areas where blasting is in
progress, where explosive atmospheres may be present, near life support equipment,
or any equipment which may be susceptible to any form of radio interference.
In such areas, the wireless communication module MUST BE POWERED OFF. The
AM3 with enabled wireless communication can transmit signals that could interfere
with this equipment. Do not operate the wireless communication module any
aircraft, whether the aircraft is on the ground or in ight. In aircraft, the wireless
communication module MUST BE SWITCHED OFF. When operating, the wireless
communication module can transmit signals that could interfere with various
onboard systems.
Note: Some airlines may permit the use of cellular phones while the aircraft is on the
ground and the door is open. The wireless communication module may be used at
this time.
RF Safety
GENERAL
The AM3 uses a wireless communication module based on the 3G standard for
cellular technology. The 3G standard is spread all over the world and is the most
used telecommunication standard. The wireless communication module is actually a
low power radio transmitter and receiver. It sends out and receives radio frequency
energy. When you use your wireless communication application, the cellular system
which handles your transfers controls both the radio frequency and the power level
of your cellular modem.
9.2 Safety Precautions for Wireless Communication
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EXPOSURE TO RF ENERGY
There has been some public concern about possible health effects from using
wireless communication terminals. Although research on health effects from RF
energy has focused on the current RF technology for many years, scientists have
begun research regarding newer radio technologies, such as 3G. After existing
research had been reviewed, and after compliance to all applicable safety standards
had been tested, it has been concluded that the product was t for use. If you are
concerned about exposure to RF energy there are things you can do to minimize
exposure. Obviously, limiting the duration of your calls will reduce your exposure
to RF energy. In addition, you can reduce RF exposure by operating your cellular
terminal efciently by following the guidelines below.
EFFICIENT TERMINAL OPERATION
For your wireless communication terminal to operate at the lowest power level,
consistent with satisfactory transfer quality:
Do not hold the device when the transfer is in progress. Holding the antenna affects
transfer quality and may cause the wireless communication module to operate at a
higher power level than needed.
General Safety
ELECTRONIC DEVICES
Most electronic equipment, for example in hospitals and motor vehicles, is shielded
from RF energy. However, RF energy may affect some improperly shielded electronic
equipment.
MEDICAL ELECTRICAL EQUIPMENT
Turn your wireless communication module OFF in health care facilities when any
regulations posted in the area instruct you to do so. Hospitals or health care facilities
may be using RF monitoring equipment.
Page 33/40Version 02.01 • Date 19JAN2017
Follow Instructions for Use
Caution!
General warning sign
Switch the device ON and OFF
Year of production
Manufacturer
Applied Part of Type BF
Disposal in compliance with WEEE
Barometric pressure limits
IP 22 Protection against intrusion of solid objects with a diameter ≥
12,5mm; dripping water when tilted up to 15°
Serial Number
CE sign with code number of the Notied Body.
The certied quality management system of eResearchTechnology
GmbH corresponds to the international standard of ISO 13485.
Rx
only
CAUTION:
FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN.
Graphical Symbols
The typeplate can be
found at the rear side of
the device.
Page 34/40 Version 02.01 • Date 19JAN2017
Information to the User related to the optional wireless communication
module:
Changes or modications on the radiator not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed
to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined
by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
Possible source of interference
This device complies with Part 15 of the FCC Rules
The radiation intensity of the bluetooth module is below the SAR
limits which are demanded by the EC Directive 1999/519/EEC.
Approval Notes:
“Approved in accordance to R&TTE directive transmitter module
marked by CE, manufactured by MITSUMI incorporated OEM product,
and by Sierra Wireless incorporated OEM product.“
“This device complies with Part 15 of the FCC Rules. Operation is sub-
jected to the following two conditions: (1) this device may not cause
harmful interference, and (2) this device must accept any interference
received, including that may cause undesired operation.“
This device contains FCC-IDs QOQBT121, 2AAUFAM3G02.
Page 35/40Version 02.01 • Date 19JAN2017
This device complies with Industry Canada licence-exempt RSS standard(s). Operation
is subject to the following two conditions: (1) this device may not cause interference,
and (2) this device must accept any interference, including interference that may
cause undesired operation of the device.
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux
appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions
suivantes : (1) l’appareil ne doit pas produire de brouillage, et (2) l’utilisateur de
l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est
susceptible d’en compromettre le fonctionnement.
IC: 5123A-BGTBT121
IC: 11335A-AM3G02
Frequency
Band
Transmission
Frequency Range
Maximum Output Power Gain
UMTS B1 1922 to 1978 MHz 23 dBm (+/- 2dBm) Class 3bis -1.74 dBi
UMTS B2 1852 to 1908 MHz 23 dBm (+/- 2dBm) Class 3bis -1.1 dBi
UMTS B5 826 to 847 MHz 23 dBm (+/- 2 dBm) Class 3bis
-3.31 dBi
UMTS B6 832 to 838 MHz 23 dBm (+/- 2 dBm) Class 3bis
UMTS B8 882 to 913 MHz 23 dBm (+/- 2 dBm) Class 3bis
UMTS B19 832.4 to 842.6 MHz 23 dBm (+/- 2 dBm) Class 3bis
GSM 850 824 to 849 MHz 2 Watts GSM, GPRS and EDGE
E-GSM 900 880 to 915 MHz 2 Watts GSM, GPRS and EDGE
DCS 1800 1710 to 1785 MHz 1 Watt GSM, GPRS and EDGE -1.1dBi
PCS 1900 1850 to 1910 MHz 1 Watt GSM, GPRS and EDGE
ERT complies with EMC guidelines according to EN60601-1-2.
ERT can provide further information on EMC properties on request.
Page 36/40 Version 02.01 • Date 19JAN2017
10. Technical Data
Principle: Determination of respiratory ow and volume via
exchangeable infrared rotary ow sensor.
Range: Flow
Volume
0 - 840 L/min
0.5 - 8 L
Accuracy: Flow
Volume
± 5 % or ± 20 L/min
± 3 % or ± 0.05 L
Storage capacity: 1200 measurements, 400 sets of questionnaires
(max. 20 questions each)
Power supply: Built-in rechargeable lithium-ion battery 3.7 V, 1700 mAh
Battery will last under standard operating conditions for
about 40 days.
Full charging: 2 h
Cycle life: 80% of rated capacity after 300 cycles
60% of rated capacity after 500 cycles
Dimensions: Length x width x height
Weight
112 x 82 x 37 mm
150 g (battery included)
Ambient conditions: Temperature
Relative humidity
Barometric pressure
+10 °C to +40 °C
15 % to 95 %, not condensing
700 to 1060 hPa
Transport and storage
conditions:
Temperature
Relative humidity
Barometric pressure
-20 °C to +50 °C
15 % to 95 %, not condensing
600 to 1200 hPa
Moisture protection: IP 22
Medical classication: Active Medical Device Class IIa
Page 37/40Version 02.01 • Date 19JAN2017
The expected operational lifetime of the AM3 is 5 years.
AM corresponds to the recommendations of ATS/ERS.
Applied part: Type BF (whole device)
Protection class: Battery Device
Mode of operation: Continuous operation
Max. resistance: 0.002 kPa/L/min at 720 L/min
Interface: USB 2.0
Bluetooth 4.2 Smart Ready
3G
Medical Power supply
(battery charging):
WR9QA1200MUNMRVG2773
Model GTM41134-0605
Input 100-240 Vac, 50/60 Hz, 0.3 A
Output 5 V, 1.2 A
Cable length 1500 mm
Page 38/40 Version 02.01 • Date 19JAN2017
Index
A
Airplane mode ............................. 13
Ambient Conditions .............. 26, 36
Assessment .................................. 10
C
Cleaning ...................................... 22
Conrmation ................................. 7
D
Data transfer ................................ 10
Declaration of Conformity .............. 6
Display ........................................... 7
E
Error ............................................ 21
F
FEV1 ............................................ 17
Flow sensor .................................. 14
FVC ............................................. 17
H
Hazards ....................................... 31
L
Lithium-Ion battery ...................... 30
M
Manual transfer ........................... 12
O
Off .......................................... 7, 10
On ............................................... 10
Optional Measurements ............... 18
P
Patient Safety ............................... 25
PEF Measurements ....................... 17
Power Management .................... 19
Power supply ........................ 19, 36
S
Safety Precautions ...........24, 30, 31
Scheduled Session ........................ 18
Scroll down .................................... 7
Scroll up ........................................ 7
Sealing cap .................................. 14
Symbols ......................................... 9
T
Transfer Menu ............................. 10
U
Unscheduled Measurements ........ 18
V
Validity ........................................ 17
W
Wireless Communication ............. 31
© 2017 eResearchTechnology GmbH or one of its affiliates.
All rights reserved
eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
+49 9305 720-9891 tel
+49 9305 720-7891 fax