eResearchTechnology AM3G03 The Asthma Monitor AM3 is an electronic measurement device to monitor the lung function. User Manual 2AAUFAM3G03 UserMan

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Instructions for Use
Peak Flow Meter AM3
Option BT+
781199
Version 01.00
for Firmware ≥ 9.40
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 mentioned 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.
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Version 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 volume) 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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Notes on Safety in Instructions for Use
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
Use in case of:
to Property
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.
WARNING indicates a potentially
hazardous situation which, if not avoided,
could result in death or serious injury.
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.
(X)
Additional icons shown in the instruction manual:
Important and useful information.
Information does not warn of dangerous
or harmful situations.
Hints for use.
Declaration of Conformity
The original document of the Declaration of Conformity can be found in
the Accompanying Documents.
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1.
The Peak Flow Meter AM3
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").
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.
Display
AM
1.
ESC
OK
Scroll
down
Off/Cancel
Flow Sensor
(without cap)
Confirmation
Scroll up
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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
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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2.
Lung Function Measurements with the AM3
2.1
Preparing for the Measurement
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.
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.
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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:
1.
ESC
The Peak Expiratory Flow (PEF) measurement
will start.
OK
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.
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2.3
Measurement
It is recommended NOT to perform measurements in direct
sunlight, as the sensor could be damaged.
1.
The following is displayed:
1.
ESC
Please note: The
measurement has to
be performed within
the next 10 seconds.
OK
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.
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 measurement values cannot be guaranteed.
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4.
ESC
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
After performing as many measurements as
configured, the highest value measured will be
displayed and automatically saved.
ESC
OK
If the measurement does not qualify as acceptable the following screen will be shown.
Please press OK and repeat the measurement.
XX
ESC
OK
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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.
ESC
OK
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
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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
ESC
by pressing
ESC
3.1
OK
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.
If your AM3 is connected via bluetooth to a host device, data of the current
measurement will be automatically transmitted immediately afterwards.
The maximum distance between the AM3 and the connecting device
is 5 meters.
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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).
ESC
OK
ESC
OK
Please bring your device to each study visit to avoid reaching full memory
capacity.
5.
Trend
Depending on your configuration and in addition to the displayed value a graphical
trend of the last seven days may be displayed.
ESC
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OK
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6.
Display Date and Time
ESC
When the AM3 is switched off, press
and
simultaneously to enter the date and time
ESC
to exit the date/time display.
menu. Press
Please contact your physician or case manager in
case date and time need to be corrected.
Date and Time
ESC
OK
While date/time is displayed, press
7.
OK
Display Settings and Information
Battery voltage
ESC
Press
OK
OK
and subsequent displays can be shown. Press
Version 01.00 • Date 25JAN2018
ESC
to abort the program.
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IMEI number (not available for Option BT+)
ESC
OK
Patient-ID
ESC
OK
Memory capacity for measurements
Memory capacity for answers
ESC
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OK
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Threshold green/yellow (l/min)
Threshold yellow/red (l/min)
ESC
OK
Unique identifier
Version (software)
ESC
OK
Daylight saving date
ESC
OK
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Indication of measurement mode set for
this device.
PEF = Peak Expiratory Flow
FEV1 = Forced Expiratory Volume after
		 one second
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Alarm times to remind the patient to
perform a measurement.
ESC
OK
BT-Version
BT-Address
ESC
8.
OK
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.
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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.
The internal clock will stop after about
5 days when the internal battery is
fully discharged.
ESC
OK
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.
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.
To perform a session, please
disconnect any cables from the AM3.
ESC
OK
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9.
Error Checklist
Error Description
No response during
power ON
Result of
measurements is
questionable
Reason
Action
A.
AM3 battery is empty
Charge the AM3
B.
The OK button is not
pressed correctly.
Press the OK button
for at least one second
and then release the
button.
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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10. Cleaning
10.1 Cleaning of Sensor
To clean the rotary flow 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 flow
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 flow sensor has to be exchanged immediately.
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 10.4 for cleaning of housing.
See below for informa­tion on disposal of a used sensor.
DO NOT use alcohol or any type of household cleaner!
10.2 Checking the Sensor
If your AM3 does not measure accurately, exchange the sensor or contact the
responsible Monitor or ERT Customer Care Helpdesk.
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10.3 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
10.4 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.
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11. Safety Precautions AM3
The Instructions for Use is regarded to be a part of the instrument,
and should always be kept on hand.
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 modification of the medical product.
ERT only guarantees for the safety, reliability and functioning of the device if:
- installation, extension, modifications, 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 configurations shall comply with the requirements for medical
electrical systems. Anybody connecting additional equipment to medical electrical
equipment configures 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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Version 01.00 • Date 25JAN2018
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 fields 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 flammable anaesthetic
mixture with air or flammable 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 summation of the leakage current, the AM3 must not be connected to a PC or modem
during the measurement.
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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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 qualified physician has to reassess all AM3 measurements. An interpretation by the
AM3 is only important if it is considered in connection with other clinical findings.
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)
- massive pneumothorax (within the first weeks)
- abdominal or thoracic surgery (depending on the findings 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
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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 fluff. 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.
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.
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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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.
11.1 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 fire!
- Do not dismantle or manipulate the battery.
- Do not replace the battery.
- The fluid of the battery is toxic and flammable - leaky batteries or batteries with
dents must not be used any longer!
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- Do not come in contact with the fluid in the battery. If the fluid 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 specified by ERT and observe the
instructions in the manual!
11.2 Safety Precautions for Wireless Communication
For the efficient 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 flight. 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.
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. 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 fit for use. If you are concerned about
exposure to RF energy there are things you can do to minimize exposure.
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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 32/40
Version 01.00 • Date 25JAN2018
Graphical Symbols
Follow Instructions for Use
The typeplate can be
found at the rear side of
the device.
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 Notified Body.
The certified quality management system of eResearchTechnology
GmbH corresponds to the international standard of ISO 13485.
Version 01.00 • Date 25JAN2018
Page 33/40
Rx
only
CAUTION:
FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN.
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 RED directive transmitter module marked
by CE and manufactured by Silicon Labs incorporated OEM.“
“This device complies with Part 15 of the FCC Rules. Operation is subjected 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-ID 2AAUFAM3G03.
Information to the User related to the optional wireless communication
module:
Changes or modifications 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:
Page 34/40
Version 01.00 • Date 25JAN2018
- 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.
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: 11335A-AM3G03
Version 01.00 • Date 25JAN2018
Page 35/40
11.3 Notes on EMC according to EN60601-1-2
The use of accessories not recommended by ERT may result in an increased
electromagentic radiation or a reduced interference immunity of the AM.
Guidance and Manufacturer‘s Declaration –
Electromagnetic Emissions and Immunity
The AM3 uses RF energy for internal function. Therefore, its RF emissions are very low and are
not likely to cause any interference to nearby electronic equipment. The AM3 is suitable for use
in all establishments including domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
IEC 60601 directive
Compliance level
RF emissions CISPR 11
Group 1 Class B
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV indirect contact
± 15 kV direct air
direct contact not possible
Radiated RF
IEC 61000-4-3
10 V/m from 80 MHz to 2700 MHz applied to 4 devices
orientations each with vertical and horizontal antenna
pliarisation
Electrical fast transient/burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
Surge
IEC 61000-4-5
0.5 kV differential mode
1 kV differential mode
Conducted RF
IEC 61000-4-6
3 V(rms) from 150 kHz to 80 MHz
6 V(rms) in ISM bands
Voltage dips
IEC 61000-4-11
tested at 100 and 240 V power supply input lines
< 5% @ 0.5 cycles and 45 degree sync angle steps
< 5% @ 1 cycle
<70% @ 25 cycles and 50 Hz
<70% @ 30 cycles and 60 Hz
Short interruptions and voltage
variations
IEC 61000-4-11
tested at 100 and 240 V power supply input lines
< 5% @ 250 cycles and 50 Hz
< 5% @ 300 cycles and 60 Hz
ERT can provide further information on EMC properties on request.
Page 36/40
Version 01.00 • Date 25JAN2018
12. Technical Data
Principle:
Range:
Accuracy:
Storage capacity:
Power supply:
Dimensions:
Ambient conditions:
Transport and storage
conditions:
Moisture protection:
Medical classification:
Applied part:
Protection class:
Mode of operation:
Max. resistance:
Interface:
Medical Power supply
(battery charging):
Determination of respiratory flow and volume via exchangeable
infrared rotary flow sensor.
Flow
0 - 840 l/min
Volume
0.5 - 8 l
Flow
± 5 % or ± 20 l/min
Volume
± 3 % or ± 0.05 l
1200 measurements, 400 sets of questionnaires
(max. 20 questions each)
Built-in rechargeable lithium-ion battery 3.7 V, 1700 mAh
Battery will last under standard operating conditions for about 40 days.
Full charging:
2h
Cycle life:
80% of rated capacity after 300 cycles
60% of rated capacity after 500 cycles
Length x width x height
112 x 82 x 37 mm
Weight
150 g (battery included)
Temperature
+10 °C to +40 °C
Relative humidity
15 % to 95 %, not condensing
Barometric pressure
700 to 1060 hPa
Temperature
-20 °C to +50 °C
Relative humidity
15 % to 95 %, not condensing
Barometric pressure
600 to 1200 hPa
IP 22
Active Medical Device Class IIa
Type BF (whole device)
Battery Device
Continuous operation
0.002 kPa/l/min at 720 l/min
USB 2.0
Bluetooth 4.2 Smart Ready
WR9QA1200MUNMRVG2773
Model GTM41134-0605
Input
100-240 Vac, 50/60 Hz, 0.3 A
Output
5 V, 1.2 A
Cable length
1500 mm
The expected operational lifetime of the AM3 is 5 years.
AM corresponds to the recommendations of ATS/ERS.
Version 01.00 • Date 25JAN2018
Page 37/40
Index
Ambient Conditions ............... 27, 37
Off .................................................. 7
Cleaning ....................................... 23
Confirmation .................................. 7
Patient Safety ................................ 26
Peak Flow Meter AM3 .................... 7
Power Management ..................... 20
Power supply ......................... 21, 37
Declaration of Conformity ............... 6
Display ............................................ 7
Display Symbols .............................. 9
Error ............................................. 22
Flow sensor ................................... 10
Safety Precautions .....25, 30, 31, 36
Scroll down ..................................... 7
Scroll up ......................................... 7
Sealing cap ................................... 10
Symbols .......................................... 9
Wireless Communication .............. 31
Hazards ........................................ 31
Indications for Use .......................... 5
Lithium-Ion battery ....................... 30
Notes on EMC .............................. 36
Notes on Safety .............................. 6
Page 38/40
Version 01.00 • Date 25JAN2018
© 2018 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

---

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