eResearchTechnology AM3G01 The Asthma Monitor AM3 is an electronic measurement device to monitor the lung function. User Manual UserMan

eResearchTechnology GmbH The Asthma Monitor AM3 is an electronic measurement device to monitor the lung function. UserMan

UserMan

782042-xxxxxxUSEN
Version 00.03
Instructions for Use
Peak Flow Meter AM3 for Trial xxxxxx
Logo
· Option AM3 GSM
Page 2/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Product names or services are trademarks of their respective companies.
All rights, including those of translations, are reserved. Written permission of
eResearchTechnology (ERT) shall be obtained for the reproduction of this manual
or any excerpt thereof by any means, including printing, photo static duplication,
microfilms, or any other processes.
eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
Tel: +49 9305 720-9891
Fax: +49 9305 720-7891
www.ert.com
© 2013 eResearchTechnology GmbH. All rights reserved.
782042_TPL_AM3_IFU_FDA_2013-11-04
Page 3/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Table of Contents
Indications for Use ................................................................................................ 4
ERT Customer Care Contacts ................................................................................ 5
ERT Toll-Free Hotline ............................................................................................. 6
Notes on Safety in Instructions for Use .................................................................. 7
Declaration of Conformity ..................................................................................... 7
1. The Ambulatory Monitoring Equipment ............................................. 8
2. The Peak Flow Meter AM3 .................................................................... 8
2.1 Handling.................................................................................................10
2.1.1 Turning the Device ON in Subject Mode .................................................. 10
2.1.2 Turning the Device ON in Investigator Mode ........................................... 10
2.1.3 Turning the Device OFF ........................................................................... 10
2.1.4 TUTORIAL Devices ................................................................................... 10
2.1.5 New Subject Devices ............................................................................... 11
2.1.6 Assigned Subject Devices ........................................................................ 11
2.2 PEF Measurements with the AM ............................................................. 11
2.2.1 Preparing for the Measurement .............................................................. 11
2.2.2 Performing Scheduled Sessions ............................................................... 12
2.2.3 How to Perform PEF Measurements with the AM .................................... 12
2.2.4 Validity of PEF Measurements ................................................................. 13
2.2.5 Interrupting a Scheduled Session ............................................................ 14
2.3 Performing Unscheduled/Optional PEF Measurements ............................. 14
2.4 Device Settings (Service Mode) ................................................................ 15
2.5 Power Management ............................................................................... 17
2.6 Memory Capacity ................................................................................... 18
3. Cleaning................................................................................................ 19
3.1 Disposal of Sensor ................................................................................. 19
3.1.1 Cleaning the Disposable Mouthpiece/Rotary Flow Sensor ........................ 20
3.1.2 Cleaning the Case .................................................................................. 20
3.1.3 Checking the Sensor ............................................................................... 20
4. Error Checklist ...................................................................................... 21
5. General Safety Precautions .................................................................22
5.1 Safety Precautions for Lithium Ion Rechargeable Batteries ...................... 25
5.2 Safety Precautions for GSM Option ......................................................... 26
Literature ............................................................................................................ 30
Notes on EMC according to EN60601-1-2 ........................................................... 31
Return of Goods in Medical Institutions ............................................................... 35
Technical Data .................................................................................................... 39
Index .............................................................................................................. 41
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.
Page 4/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Indications for Use
The Asthma Monitor AM3/AM3 BT/AM3 GSM is an electronic measurement device
to monitor the lung function (determination of the respiratory flows and volume)
with high reproducibility wherever and whenever is a need of. The AM3 measures
the flow during expiration serving far the calculation of further parameters as
FEV1.
The AM3 is used to monitor the respiratory status of human beings in the areas
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 selected parameters
(e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind 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, a 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 select then 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 ordinary peak flow meter, diary and pencil by a
single system. Easy handling, sturdy and handy design allow the Asthma Monitor
AM3 being used almost everywhere: at work, at home, in school, for experts
opinion, research or clinical trial purposes and in occupational medicine.
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN. (Rx only)
The AM can be utilized for subjects from 4 years on and older as long as they can
cooperate in the performance.
The application of this system is restricted to trained subjects who can guarantee
for the correct usage of the device.
The AM is powered with a Lithium-ion battery. No energy is transferred to the
subject.
Page 5/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
ERT Customer Care Contacts
International Support
International telephone technical support is available to all CRAs and Investigators
in English; Monday through Sunday, 24 hours a day (see next page for contact
details).
International Support is responsible for all hardware and software issues and
should be contacted as soon as a problem occurs at a site.
Please have the following information available when you call:
• Studyname
• Sitenumber
• Subject/CRFNumberorSysNumber
• Whetherthisissuehasbeenreportedbytherespectivesitetothe
hotline before
The Technical Hotline Operator will ask you for this information in order to
provide the most efficient service.
International Germany
eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
CustomerCare@ert.com
International US
eResearchTechnology
1818 Market Street, Suite 1000
Philadelphia, PA 19103-3638
CustomerCare@ert.com
Page 6/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
ERT Toll-Free Hotline
Iftheabovenumbersarenotavailableoractive,pleasedial+4993057209891.
Youwillbecalledbackassoonaspossibleifthesupportlineisbusyandyouleaveamessage.
*Before dialing 888 ... please wait until you are prompted by the operator.
Country Toll-FreeNumber
Argentina 0800 6660824
Australia 1800 008184
Austria 0800 293169
Belarus 8820 04910016
Belgium 0800 79185
Brazil 0800 8911518
Bulgaria 00800 1104905
Canada 1866 8415042
Chile 1230 0202398
China (North) 10800 7490031
China (South) 10800 4900031
Colombia 01800 9155750
Costa Rica 0800 0440047
Croatia 0800 222992
Cyprus 800 93295
Czech Republic 800 142391
Denmark 8088 2178
Dom. Rep. 1800 3711741
Ecuador 1800 225 528,,,(3sec)888 680 1981
Egypt 0800 0000366
Estonia 800 0049006
Finland 0800 116605
France 0800 900585
Germany 0800 1015390
Greece 00800 49129105
Guatemala 138126,,,(3sec)888 680 1981
Honduras 800 0123,,,(3sec)888 680 1981
Hong Kong 800 964138
Hungary 0680 015946
Iceland 800 8226
India 000800 4401432
Indonesia 0018 038529591
Ireland 1800 554931
Israel 180 9455201
Italy 800 786498
Japan 00531 121370
Korea 0079814 8006214
Country Toll-FreeNumber
Latvia 8000 0266
Lithuania 8800 30046
Luxembourg 800 26390
Macedonia 0800 98152
Malaysia 1800 808847
Malta 800 62476
Mexico 001866 8415042
Monaco 800 93366
Netherlands 0800 0235262
New Zealand 0800 443629
Norway 800 11592
Panama 001800 5071923
Peru 0800 52161
Philippines 1800 14910008
Poland 00800 1211385
Portugal 800 812743
Puerto Rico 1 888 680 1981
Romania 0800 896647
Russia 8108002 4883011
Serbia 0800 190144
Singapore 800 1204116
Slovakia 0800 004982
Slovenia 0800 80885
South Africa 0800 995609
Spain 900 994964
Sweden 02079 8198
Switzerland 0800 562403
Taiwan 00801 137512
Thailand 001800 120664985
Turkey 0811 2880001,,,(3 sec)888 7922117
Ukraine 0800 503275
United Kingdom 0800 7314027
United States 1800 7049698
Uruguay 000413 5983021
Uzbekistan 8,6417440010,,,(3 sec)888 680 1980
Venezuela 800 1006321
List needs to be updated if Bosnia or Tunesia are
included in the study!!!!!
Page 7/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Declaration of Conformity
The original document of the Declaration of Conformity can be found in the
Accompanying Documents.
Following the ANSIrecommendations (American National Standards Institute)
for safety notes, specific passages of the instruction manual are clearly marked as
safety notes.
Additional icons shown in the instruction manual:
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.
XWARNING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
Important and useful information. Information does not warn
of dangerous or harmful situations.
Hints for use.
Page 8/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
1. The Ambulatory Monitoring Equipment
The Ambulatory Monitoring Equipment comprises of:
· Tutorial Peak Flow Meter AM
· Subject Peak Flow Meter AM
· Power supply
· Mouthpiece
· Bag
With the help of the Peak Flow Meter, the subject records his/her symptoms and
performs peak flow measurements.
Study specic
Display
Releaser
Flow Sensor
Conrmation
Scroll up
Scroll down
Off
Mouthpiece
Front view:
2. The Peak Flow Meter AM3
The AM is an instrument that combines a peak flow meter 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]).
The device keeps a diary of subject measurements by automatically recording in
its memory all answers and PEF measurements with the date and time. Every time
the subject visits the center, the data will be downloaded by using the analogue
modem.
Page 9/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Warning
The AM can assist in monitoring airway function on a day-to-day basis, but it
CANNOTprovide an entire diagnosis of the subject’s state of health. The use of
the AM will not replace a medical examination or other tests if the subject is not
feeling well.
The subject should be instructed to call the study doctor immediately if he/she
shows 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
• Thesubjecthasrequiredtreatmentwithoralorparenteral
glucocorticosteroids.
• Thesubjecthasbeenadmittedtohospital(includingemergencyroom
treatment).
• Thesubjectisconcernedabouthis/herconditionduringthestudy.
Trouble-free operation of the AM 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.
RS232 interface
USB interface (used for charging)
Bottom view:
Page 10/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
2.1 Handling
2.1.1 Turning the Device ON in Subject Mode
Press and hold the button. While holding the button, press and hold the
button. Hold both buttons for approximately 2 seconds.
2.1.2 Turning the Device ON in Investigator Mode
To turn ON the device, press and hold the button. While holding the
button, press and hold the button. Hold both buttons for approximately
2 seconds. After releasing the buttons the investigator password is requested.
The investigator password is distributed during the study training or is available
from the ERT Hotline.
The Investigator Mode needs to be turned ON, whenever there is a need to enter
or change settings on the Peak Flow Meter or the modem.
2.1.3 Turning the Device OFF
The device is turned OFF by pressing .
TUTORIAL devices DO NOT STORE any data. That is why it is not possible to use
them as subject devices.
TUTORIAL devices CANNOTbe changed into subject devices.
2.1.4 TUTORIAL Devices
Each site receives a “TUTORIAL DEVICE“ to train site staff and subjects on how to
operate the device correctly.
In Tutorial Mode, it is possible to have the subject simulate morning and/or
evening sessions. The site staff can also simulate administrative functions such as
dispensing the AM or closing the AM.
Tutorial Device - Tutorial Session
Morning
Press arrow keys
to select your choice
Evening
Page 11/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Study specic
2.2 PEF Measurements with the AM
2.2.1 Preparing for the Measurement
Prior to starting the measurement, place the flow sensor into the AM as shown
below. Remove the sealing cap from the flow sensor and put on the mouthpiece.
When inserting the flow sensor into the AM, medical assistants must adhere to the
general hygiene standards valid for hospitals and private practices.
If the flow sensor is inserted into the AM by the subject, the notes on cleaning as
described under the chapter “Cleaning“ must be followed.
The flow sensor and the mouthpiece are intended for single subject use only.
2.1.5 New Subject Devices
New subject devices are locked, and cannot be used until they are programmed
with a subject number.
2.1.6 Assigned Subject Devices
After programming the AM with the subject’s unique number, the device is ready
to be used by the subject.
Protocol 000.000
NEW DEVICE
Sealing cap
Flow sensor
Mouthpiece
AM3
Flow sensor
Page 12/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
2.2.2 Performing Scheduled Sessions
Scheduled sessions, including questionnaire and PEF measurements, can only be
performed and stored using programmed subject devices. Following the study
protocol, the subject has to carry out two scheduled sessions per day.
The subject can scroll through and select the appropriate answer by using and
buttons and pressing .
At the end of the questionnaire the subject is asked, if he/she wants to change an
answer; if the subject selects “Yes“, the questionnaire will be displayed again.
The answers previously entered will appear as default, and can be modified as
described above. After answering the last question, the subject should complete
the three PEF measurements.
Study specic
2.2.3 How to Perform PEF Measurements with the AM
To perform a valid PEF measurement with the AM, the following steps must be
followed:
1. The subject inhales deeply and holds the breath until he/she has positioned the
mouthpiece of the AM into his/her mouth.
3. After full exhalation, the AM should be removed from the mouth immediately.
The subject should not breathe in through the mouthpiece.
2. Now the subject must exhale as hard as possible for at least 2 seconds to
obtain a satisfactory measurement.
The subject should:
• notcough.
• notblockthemouthpiecewithhis/hertongue.
• notblocktheoutletoftheflowsensorwithhis/herhand.
• beinstructedtopauseforaboutasecondandthenblowouthardandfast
as he/she can.
Page 13/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
2.2.4 Validity of PEF Measurements
A PEF measurement performed with the AM is valid, if:
• Breathingvolume>0.47Lor<10L
• Breathingflow>50L/min
• FVC>FEV1
If a PEF measurement is invalid, a message will be displayed and the subject will
be asked to repeat the measurement.
To store a result in the AM, at least one adequate PEF needs to be performed.
If all efforts are invalid, no PEF data will be stored on the device.
4. The measured PEF is displayed on the AM.
5. The result is confirmed by pressing .
After the 1st measurement, the subject will be asked to perform the 2nd and the 3rd
PEFs (repeat steps 1- 5).
At the end of the session, the highest PEF will be displayed.
Result PEF
220 L/min
Highest PEF
250 L/min
Inadequate effort!
Please try again!
Page 14/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
2.2.5 Interrupting a Scheduled Session
If the device is turned OFF before finishing a questionnaire, all questions
previously answered will not be saved.
If the device 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 device has to be turned ON again and only the missing PEF
measurements may be performed - the questionnaire will not be displayed again.
2.3 Performing Unscheduled/Optional PEF
Measurements
In addition to scheduled PEF measurements, the subject is able to perform
unscheduled/optional PEF measurements. These are measurements that are:
• performedafterhavingfinishedthescheduledmeasurementswithinatime
window
• performedoutsideofthestudyspecifictimewindows
When performing an unscheduled/optional measurement, the screen on the left
will be displayed after turning the device ON.
Study specic
The data from unscheduled/optional measurements will NOT be stored.
Take a very deep breath
and measure your PEF!
optional
Page 15/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
2.4 Device Settings (Service Mode)
The Service Mode must be activated to view the following AM settings:
Study ID, date and time, serial number of the AM, ERT Study ID, Site and Subject
number, battery status, the percentage of stored measurements and answers, the
date of last data transfer and some technical settings.
To turn the AM ON in Service Mode, press and hold the button. While holding
the button, press and hold the button. Hold both buttons for
approximately 2 seconds. The following screen will appear:
After pressing the following screen is displayed:
After pressing the following screen is displayed:
Study ID
Date and time
XXXXXXXXXXX
Date/Time
25.08.09 13.05
Battery status (FULL, OK,
or NOK)
System-generated number
Serial number of AM
Serialno.: E001569
XXXXXX-XXXXXX-145123
Battery: OK
MEMORY STATUS
Measurements: 0%
Answers: 0%
AM storage capacity
ERT Study ID
Page 16/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
After pressing again, further technical AM settings are displayed.
RV1:— RV2:—-
RV3:— RV4:—-
RV5:— RV6:—-
RV7:— RV8:—-
Reference values
Software conguration
Major software version
AM3 Conguration:
XXXXXX-001-GBEN-G
Vers.:9.21..01.00
DLT: 10.07.09
Date of last data transfer
Settings can only be checked, NOT changed.
Contact your CRA or the ERT Hoteline if you have any concerns regarding the
displayed settings.
Pressing will turn the device OFF.
Page 17/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
2.5 Power Management
Before using the AM for the first time, the batteries must be charged for
30 minutes.
When the batteries are low, the following message will be displayed:
Battery low!
Please connect AM3
to charger.
How to charge the batteries:
Plug one end of the wall adapter into the USB interface of the AM3 with GSM
option and the other end into a wall socket.
Only the original power supply delivered with the AM must be used for
charging the device.
The internal clock will stop after about 5 days when the internal battery is
discharged.
Page 18/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
If you switch on the AM3 while the plug-in power supply is connected, the
following message will be displayed:
Please disconnect from
charger or PC to
perform your session.
The battery symbol indicates the state of charge.
As soon as the memory is full, no further data can be stored on the AM.
Please advise subjects to bring their devices to each study visit to avoid
reaching full memory capacity.
2.6 Memory Capacity
The following message will appear on the screen to alert the subject that the
memory of the AM is almost full (80%).
Memory almost full!
Please contact your doctor!
Memory full!
Please contact your doctor!
Page 19/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
The sensor is intended for single-patient use, only. Dispose of used sensors if the
AM is passed on to another patient.
The mouthpiece is intended for single-patient use, only. Dispose of used
mouthpieces if the AM is passed on to another patient.
Sensor Cleaning:
Release and remove sensor, rinse it with distilled water in which a mild cleansing
agent is soluted.
Shake off any remaining water on the sensor. Air-dry and reinsert the sensor.
The sensor is intended for single patient use, only. If the AM is passed
on to another patient, the AM surfaces will have to be cleaned.
See next page for informa tion on disposal of a used sensor.
3.1 Disposal of Sensor
Mouthpiece
Releaser
Flow sensor
3. Cleaning
Page 20/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Disposal:
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 down-
wards (see picture). Dispose of it immediately.
Releaser
3.1.1 Cleaning the Disposable Mouthpiece/Rotary Flow
Sensor
To clean the rotary sensor of the AM3, release the sensor by moving the releaser
sidewards. It is recommended to clean the outer parts of the sensor every 4 weeks
with a damp (not wet) cloth or tissue and letting the sensor air-dry at room
temperature. Place the sensor back in the AM.
The disposable mouthpiece can be cleaned under running water.
Any minor discoloration in the sensor does not affect the performance of the AM.
DONOTuse alcohol or any type of household cleaner!
3.1.2 Cleaning the Case
Wipe off the case with a moist cloth. Then dry the case with a cotton towel.
3.1.3 Checking the Sensor
If the patient’s AM does not measure accurately, clean the sensor as described
above. If there are still doubts that the device is not working correctly, exchange
the sensor or contact the responsible Monitor or ERT Customer Care Helpdesk.
Page 21/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
4. Error Checklist
If the proposed actions do not lead to perfect recovery of the AM´s normal
functionality, please contact the ERT Hotline.
Error Description Reason Action
Noresponseduringpower
ON
A. AM battery is empty Charge the AM3
B. Buttons and are
not pressed correctly
•Pressandholdthe
button.
•Whileholdingthe button,
press and hold the button.
•Holdbothbuttonsfor
approximately 2 seconds.
Clock is not working
correctly
Reprogram AM by connecting it
to the modem. If problem occurs
again replace AM.
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
Page 22/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
5. General Safety Precautions
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 (= Medizinprodukte-
gesetz/ 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 training manual and 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.
Electrical Safety
The AM is powered from an internal lithium Ion rechargable battery, the battery
can be charged over a direct plug-in power supply (unit).
Attention:
- Only the original power supply delievered with the AM must be used for
charging the device.
- Do not perform measurements if PC is connected.
- Data transfer is not permitted during measurement.
General Safety Precautions
Page 23/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
General Safety Precautions
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. Atten-
tion 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. 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.
If available: More detailed information can be found in the EMC tables of the
Instructions for Use of your device.
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 black 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.
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
physician must not touch the patient and live parts at the same time. The operator
must not touch the Interfaces 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. The physician/operator must
not touch any voltage-carrying parts and the subject at the same time.
Page 24/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Contraindicationsandpossibleadverseeffects:
According to ‘‘ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION
TESTING’’ (ERS Journals Ltd 2005) performing lung function tests can be physically
demanding for a minority of patients. It is recommended that patients should not
be tested within 1 month of a myocardial infarction.
In rare cases spirometry testing can lead to syncope due to extensive exhalation.
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).
Prior to measuring a subject, his/her anamnesis is to be checked in order to avoid
a contamination of the device and a resulting cross contamination of the next
subject.
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 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.
General Safety Precautions
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.
Page 25/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
General Safety Precautions
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.
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 shortcut 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!
- Do not come in contact with the fluid in the battery. If the fluid comes in con-
tact with your skin, immediately rinse the affected part with water and contact
a doctor!
- Keep the batteries away from children.
- To charge the AM3, use only the charger specified by the manufacturer and
observes the instructions in the manual!
5.1 Safety Precautions for Lithium Ion
Rechargeable Batteries
Children should not get in contact with disposables, accessories and packing
material and cleaning and disinfection substances.
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.
Page 26/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
5.2 Safety Precautions for GSM Option
For the efficient and safe operation of your AM3 with GSM option, please read the
following information carefully.
Safety and Hazards
Do not operate the AM3 with enabled GSM option 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 GSM modem MUST BE POWERED OFF. The AM3
with enabled GSM option can transmit signals that could interfere with this
equipment. Do not operate the GSM any aircraft, whether the aircraft is on the
ground or in flight. In aircraft, the GSM option MUST BE SWITCHED OFF. When
operating, the GSM modem 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 GSM option may be used at this time.
RFSafety
GENERAL
The AM3 uses a GSM module based on the GSM standard for cellular technology.
The GSM standard is spread all over the world. It covers Europe, Asia and some
parts of America and Africa. This is the most used telecommunication standard.
Your GSM module is actually a low power radio transmitter and receiver. It sends
out and receives radio frequency energy. When you use your GSM application, the
cellular system which handles your transfers controls both the radio frequency and
the power level of your cellular modem.
EXPOSURE TO RF ENERGY
There has been some public concern about possible health effects from using GSM
terminals. Although research on health effects from RF energy has focused on
the current RF technology for many years, scientists have begun research regard-
ing newer radio technologies, such as GSM. 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. Obvi-
ously, 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 efficiently
by following the guidelines below.
EFFICIENT TERMINAL OPERATION
For your GSM terminal to operate at the lowest power level, consistent with satis-
factory transfer quality:
Do not hold the device when the transfer is in progress. Holding the antenna
affects transfer quality and may cause the GSM modem to operate at a higher
power level than needed.
General Safety Precautions
Page 27/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
General Safety Precautions
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 elec-
tronic equipment.
MEDICAL ELECTRICAL EQUIPMENT
Turn your GSM option 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.
AIRCRAFT
Turn your GSM option OFF before boarding any aircraft.
•Useitonthegroundonlywithcrewpermission.
•Donotuseitintheair.
To prevent possible interference with aircraft systems, Federal Aviation Administra-
tion (FAA) regulations require you to have permission from a crew member to use
your terminal while the aircraft is on the ground. To prevent interference with cel-
lular systems, local RF regulations prohibit using your GSM option while airborne.
BLASTING AREAS
To avoid interfering with blasting operations, turn your GSM option OFF when in
a « blasting area » or in areas posted: « turn off two-way radio ». Construction
crews often use remote control RF devices to set off explosives.
POTENTIALLY EXPLOSIVE ATMOSPHERES
Turn your device OFF when in any area with a potentially explosive atmosphere. It
is rare, but your application or its accessories could generate sparks. Sparks in such
areas could cause an explosion or fire resulting in bodily injuries or even death.
Areas with a potentially explosive atmosphere are often, but not always, clearly
marked. They include fuelling areas such as petrol stations; below decks on boats;
fuel or chemical transfer or storage facilities; and areas where the air contains
chemicals or particles, such as grain, dust, or metal powders.
Page 28/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Graphical Symbols
Note 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°
SN 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.
Rx only
CAUTION:
FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN.
Possible source of interference
General Safety Precautions
Page 29/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
The typeplate can be found at the rear side of the device.
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 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-IDs POOWML-C46, 2AAUFAM3G01.
Information to the User related to the optional GSM 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:
- 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). Opera-
tion is subject to the following two conditions: (1) this device may not cause inter-
ference, 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 ap-
pareils 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-AM3G01
General Safety Precautions
Page 30/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Frequency band Transmission frequency
range
Output Gain
GSM 850 824 to 849 MHz 1.70 W -2.9 dBi
E-GSM 900 880 to 915 MHz 0.86 W -8.5 dBi
DCS 1800 1710 to 1785 MHz N/A -2.7 dBi
PCS 1900 1850 to 1910 MHz N/A -3.0 dBi
Literature
Medical Device Directive (Medical Devices Act = Medizinproduktegesetz – MPG,
valid in Germany, only)
EN 60601-1 Medical Electrical Equipment
Part 1: General Requirements for Safety
EN60601-1-2 Medical electrical equipment
Part 1-2: General requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility - Requirements and tests
EN 62353 Medical electrical equipment - Recurrent test and test after repair of
medical electrical equipment
DIN VDE 0100 Part 710 (IEC 60364-7-710) Electrical installations of buildings - Part
7- 710: Requirements for special installations or locations - Medical locations
Reference source:
VDE-Verlag GmbH, Bismarckstr. 33, 10625 Berlin or Merianstrasse 29,
63069 Offenbach, Germany, E-Mail: kundenservice@vde-verlag.de Beuth Verlag
GmbH, Burggrafenstraße 6, 10787 Berlin, E-Mail: info@beuth.de
The safety precautions and operational procedures indicated in this
chapter refer to Germany. Different regulations and standards may
apply in other countries.
General Safety Precautions
Page 31/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
General Safety Precautions
Notes on EMC according to EN60601-1-2
The use of accessories not recommended by ERT may result in an increased elec-
tromagnetic radiation or a reduced interference immunity of the AM3 GSM.
Guidance and Manufacturer‘s Declaration – Electromagnetic Emissions
The AM3 GSM is intended for use in the electromagnetic environment specied below. The customer or the
user of the AM3 GSM should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment -
guidance
RF emissions CISPR 11 Group 1 Class B The AM3 GSM uses RF energy
only for its internal function.
Therefore, its RF emissions are
very low and are not likely to
cause any interference to nearby
electronic equipment.
RF emissions CISPR 11 Group 1 Class B The AM3 GSM 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.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage uctuations/icker
emissions IEC 61000-3-3
Not applicable
Page 32/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Guidance and Manufacturer‘s Declaration – Electromagnetic Immunity
The AM3 GSM is intended for use in the electromagnetic environment specied below. The customer or the
user of the AM3 GSM should ensure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air 6 kV
8 kV
Floors should be wood, concrete
or ceramic tile. If oors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/ burst
IEC 61000-4-4
2 kV for power supply
lines
1 kV for input/output
lines
2 kV
1 kV
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
1 kV differential mode
2 kV common mode
1 kV
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5 % UT (> 95 % dip in
UT) for 0.5 cycle
40 % UT (60 % dip in
UT) for 5 cycles
70 % UT (30 % dip in
UT) for 25 cycles
< 5 % UT (> 95 % dip in
UT) for 5 s
< 5 % UT (> 95 % dip in
UT) for 0.5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
< 5 % UT (> 95 % dip in
UT) for 5 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the AM3
GSM requires continued operation
during power mains interruptions, it
is recommended that the AM3 GSM
be powered from an uninterruptible
power supply or a battery
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
elds should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment.
NOTE UT is the A.C. mains voltage prior to application of the test level.
General Safety Precautions
Page 33/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
General Safety Precautions
Guidance and Manufacturer‘s Declaration – Electromagnetic Immunity
The AM3 GSM is intended for use in the electromagnetic environment specied below. The customer or the
user of the AM3 GSM should ensure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance
level
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the AM3 GSM, including cables,
that the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter:
Recommended protection distance:
Conducted RF
IEC 61000-4-6 3 Vrms
150 kHz to 80 MHz 3 Vrms d = 1.17 1/V * √P
Radiated RF
IEC 61000-4-3 3 V/m
80 MHz to 2,5 GHz 3 V/m d = 1.17 m/V * √P for 80 MHz to 800 MHz
d = 2,33 m/V * √P for 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W) acc.
to the transmitter manufacturer and d is
the recommended separation distance in
meters (m).
Field strengths from xed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the compli-
ance level in each frequency range.b
Interference may occur in the vicinity
of equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reections from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theroretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an
electromagnetic site survey should be considered. If the measured eld strength in the location in which the
AM3 GSM is used exceeds the applicable RF compliance level above, the AM3 GSM should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the AM3 GSM.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Page 34/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Recommended Separation Distance between portable and mobile
RF Communications Equipment and the AM3 GSM
The AM3 GSM is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the AM3 GSM can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF commnucations equipment (transmitters)
and the AM3 GSM as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1.17 1/V * √P
80 MHz to 800 MHz
d = 1.17 m/V * √P
800 MHz to 2,5 GHz
d = 2.33 m/V * √P
0.01 Not applicable 0.12 0.23
0.1 Not applicable 0.37 0.74
1Not applicable 1.17 2.33
10 Not applicable 3.7 7.37
100 Not applicable 11.7 23.3
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not be apply in all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects and people.
General Safety Precautions
Page 35/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Return of Goods in Medical Institutions
Recommendations for action -
forallstaffmembershavingcontactwithpotentiallycontaminated
returns.
Returns or returned goods are all products returned to the producer or the
supplier, irrespective of whether or not they have been used; e.g. due to
complaints, for repair, or for maintenance. Those products might have had contact
with biological substances or highly active pharmaceuticals (e.g. cytostatics,
radioactive medicines) and could be contaminated by them. If in doubt, the goods
to be returned should be treated as contaminated products.
Due to infectious agents, pathogens or pharmaceuticals contaminated goods
pose a potential hygienic risk to all persons having contact with the returns.
This leaflet shall minimize the potential hygienic risk when handling returned
goods. Among other things, this information is based on the legal standards of
the Biostoff-Verordnung (= Biological Substances Regulation) and the Employment
Protection Act (both valid in Germany). A more detailed reference list of applicable
rules and regulations can be obtained from the BVMed (info@bvmed.de).
In order to protect your and our employees who handle contaminated parts and to
optimally examine such parts, you should consider the following:
1. Assessment of returns before reshipment
Irrespectively of whether or not a contamination risk is known, products which had
direct or indirect contact with biological working substances (e.g. blood,
secretions or other body fluids) or with highly active pharmaceuticals (e.g. gloves
of the clinical or surgical staff) should be considered potentially dangerous to
health.
According to the regulation on biological substances, substances of risk group 3
can cause severe illness in humans and pose a serious risk to staff members (e.g.
tuberculosis or hepatitis). Substances of risk group 4 cause severe illness in
humans and pose a serious risk to staff members (e.g. Ebola or smallpox).
Regarding national and international regulations for the transport of potentially
infectious substances (ADR, IATA-DGR) the risk groups 2 (e.g. staphylococcus
aureus) and 3 defined by the Biological Substances Regulation are classified as
Transport Category B.
Products which are potentially contaminated by biological working substances
of risk group 4 according to the regulation on biological substances as well
as products which are potentially contaminated by pharmaceuticals posing a
serious risk to health (e.g. X-ray contrast agents and cytostatics) must not be
returned to the producer.
Page 36/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
The following applies for products which are potentially contaminated by
biological working substances of risk group 3 and 2 according to the regulation on
biological substances and which are thus classified as Transport Category B:
Please contact ERT before returning the goods and refer to the regulations for the
transport of dangerous goods.
2. Cleaning
If the products had contact with biological working substances (for example blood
or other body fluids), they have to be cleaned and disinfected in a combined
cleaning and disinfection procedure, unless a differing agreement has been made
with ERT.
As a rule, the products also have to be cleaned in order to minimize adhesions and
bacterial contamination. Unless body fluids, body tissue or contrast agents etc.
have caused the product defective, deposits and adhesions should be removed
carefully without damaging or altering the product, if possible. For this, refer to
the notes on the preparation of products.
Products which have been contaminated by highly active pharmaceuticals have to
be cleaned appropriately with tap water.
If in doubt, contact ERT for guidance on the further actions!
3.Disinfection/Sterilization
After cleaning, the products have to be disinfected and/or sterilized (only if
permitted for this medical product) in order to avoid endangering of your and our
employees.
If in doubt or in case of suspected material incompatibility, please consult ERT.
4. Packaging
To avoid any contamination, the cleaned and disinfected product has to be packed
as follows:
a) Put it into a sealable primary packing.
Parts with sharp edges need to be packed particularly safely.
b) Put the primary packing in a waterproof secondary packing (if possible use
hard packing material).
c) Pack the secondary packing with a neutral packing material.
For “Packaging and labeling of non-contaminated products“: see point 6.
Page 37/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
5. Labeling
If a concrete risk of infection (e.g. HIV, Hepatitis B or C) is known to be present,
this risk has to be noted on the packing of the returned goods and/or in the
accom-panying documents.
For “Packaging and labeling of non-contaminated products“: see point 6.
6.Packagingandlabelingofnon-contaminatedproducts
If the procedures described under point 2 and 3 are not applied, the contaminated
product has to be returned in a combined packing complying with the packaging
instruction P 650 ADR after contacting ERT, if necessary. Proceed as follows:
a) Put the product into a liquid-tight, sealable packing (e.g. tear-proof plastic
bag) (primary packing)
b) Put the primary packing into a (if possible, liquid-tight) protective packing
(secondary packing); for liquid materials, insert an adequate amount of
absorbing material between the primary and the secondary packing.
c) Pack the secondary packing with an additional outer packaging (padded
envelope or cardboard box).
d) Label the outer packaging with the corresponding UN no. 3373 for
diagnostic or clinical samples and add the note:
“Biologischer Stoff, Kategorie B/Biological Substance, Category B“
7.Dispatch
Please note that non-decontaminated returns with suspected pathogens of risk
group 3 are excluded from mailing. Diagnostic or clinical samples of UN no. 3373
which have been packed according to packing instruction P 650 are not subject
to any further regulations on the transportation of dangerous goods and may be
transported by a forwarding agent or a parcel service.
For this purpose use the accompanying shipping documents of the forwarding
agent/carrier containing the corresponding valid transportation regulations, e.g.
GGVSE (Road and Railway Dangerous Goods Regulation).
The product is then dispatched to the address provided by the manufacturer.
Address:
eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
Tel: +49 9305 720-9891
www.ert.com
Page 38/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Certificate of Hygiene
This certicate must be attached to ANY product complaint, ANY return of medical
products and accessories, ANY repair order and ANY return of studies.
Name of product:
REF (ERT item no.):
LOT (batch no.):
It is herewith conrmed by signature that (please mark appropriate box):
the enclosed medical product had no contact with blood or other body uids so that it is
hygienically safe.
the enclosed medical product had contact with blood or other body uids during its use.
The product has been cleaned and decontaminated as follows:
Disinfection by wiping all accessible surfaces with
Disinfectant:
Concentration:
Reaction time:
Other procedure (please indicate):
Steam sterilization (3 minutes at 134 °C or 15 minutes at 121 °C)
the enclosed medical product could not be decontaminated.
Reason:
Send returns to the following address:
eResearchTechnology GmbH
Abteilung Wareneingang
Sieboldstrasse 3
97230 Estenfeld
Germany
Sender‘s signature and address:
Page 39/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Technical Data
Principle:
Determination of respiratory flow and volume via exchangeable infrared rotary
flow sensor.
Range:
Flow
Volume
0 - 840 liters/minute
0.5 - 8 liters
Accuracy:
Flow
Volume
± 5 % or ± 20 L/min
± 3 % or ± 0.05 liters
Storage capacity: 1200 measurements, 400 sets of questionnaires
(max. 20 questions each)
Power supply: LI-ION Polymer battery 3.7 V, 1700 mAh
Battery will last under standard operating
conditions for about 40 days.
Full charging: 2 h
Dimensions:
Length x width x height
Weight
112 x 82 x 37 mm
120 g (batteries 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 classification: Active Medical Device Class IIa
Applied part: Type BF (whole device)
Protection class: Battery Device
Mode of operation: Continuous operation
Max. resistance: 70 Pa/L/s at 14 L/s
Page 40/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Interface: RS-232 (used in the modem mode and for
production)
USB 2.0
Bluetooth 2.0 (no EDR)
GSM
Medical Power supply
(battery charging):
WR9QA1200MUNMRVG2773
Model GTM41134-0605
Input 100-240 Vac, 47 - 63 Hz, 0.3A
Output 5 V, 1.2 A
The expected operational lifetime of the AM3 is 5 years.
AM corresponds to the recommendations of ATS/ERS.
Page 41/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Index
C
Case 20
Confirmation 8
D
Declaration of Conformity 7
Display 8
Disposable Mouthpiece 20
F
FEV1 13
FVC 13
G
GSM 4, 17, 26, 27, 29, 40
I
Installing 17
International Support 5
Investigator Mode 10
L
Literature 30
N
Notes on EMC 31
O
Off 8
Optional Measurements 14
P
Peak Flow Meter 8
PEF 13
PEF Measurements 13
R
Releaser 8
Return of Goods 35
Rotary Flow Sensor 20
S
Safety Precautions 22
Scheduled Session 14
Scroll down 8
Scroll up 8
Sealing cap 11
Sensor 20
Settings 16
Subject Mode 10
T
Technical Data 39
Toll-free hotline 6
U
Unscheduled/Optional Measurements 14
© 2013 eResearchTechnology GmbH or one of its affiliates.
All rights reserved
eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
Tel: +49 9305 720-9891
Fax: +49 9305 720-7891

Navigation menu