2AAUFAM3G01The Asthma Monitor AM3 is an electronic measurement device to monitor the lung function.

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 …

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Product Service External Photo page 1 Model No.: AM3 FCC ID: 2AAUFAM3G01 IC: 11335A-AM3G01 Eurofins Product Service GmbH Storkower Str. 38C, D-15526 Reichenwalde, Germany Product Service External Photo page 2 Model No.: AM3 FCC ID: 2AAUFAM3G01 IC: 11335A-AM3G01 Eurofins Product Service GmbH Storkower Str. 38C, D-15526 Reichenwalde, Germany

www.ert.com eResearchTechnology GmbH Wuerzburg HRB 10688 General Manager: Werner Buerk, Jeffrey Litwin, Waqar Nasim, Achim Schuelke Sieboldstrasse 3 D-97230 Estenfeld Germany Tel: +49 (0)9305 720 60 Fax: +49 (0)9305 720 70 HypoVereinsbank Wuerzburg Account Nr.: 616057294 BLZ: 790 200 76 IBAN: DE57 790200760616057294 S.W.I.F.T. (BIC): HYVEDEMM455 TAX ID Nr.: DE270 853 733 Exhibit: Label Sample

Product Service Internal Photo page 1 Model No.: AM3 FCC ID: 2AAUFAM3G01 IC: 11335A-AM3G01 Eurofins Product Service GmbH Storkower Str. 38C, D-15526 Reichenwalde, Germany

Test Report No.: G0M-1303-2685-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 21 EMC TEST REPORT FCC 47 CFR Part 15B Industry Canada RSS-Gen Electromagnetic compatibility - Unintentional radiators Report Reference No. .................... : G0M-1303-2685-EF01-V01 Testing Laboratory ........................ : Eurofins Product Service GmbH Address ............................................ : Storkower Str. 38c 15526 Reichenwalde Germany Accreditation .................................... : A2LA Accredited Testing Laboratory, Certificate No.: 1983.01 FCC Filed Test Laboratory, Reg.-No.: 96970 IC OATS Filing assigned code: 3470A Applicant’s name ........................... : eResearch Technology GmbH Address ............................................ : Sieboldstrasse 3 97230 Estenfeld Germany Test specification: Standard ........................................... : 47 CFR Part 15 Subpart B RSS-Gen, Issue 3, 2010-12 ANSI C63.4:2009 Equipment under test (EUT): Product description Asthma Monitor AM3 Model No. AM3 GSM Additional Models None Hardware version 01 Firmware / Software version 01 FCC-ID: 2AAUFAM3G01 IC: 11335A-AM3G01 Contains FCC-ID: POOWML-C46 IC: None Test result Passed Test Report No.: G0M-1303-2685-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 21 REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION 4 1.1 Photos – Equipment external 6 1.2 Photos – Equipment internal 7 1.3 Photos – Test setup 8 1.4 Supporting Equipment Used During Testing 9 1.5 Operating Modes 10 1.6 Test Equipment Used During Testing 11 1.7 Sample emission level calculation 12 2 RESULT SUMMARY 13 3 TEST CONDITIONS AND RESULTS 14 3.1 Test Conditions and Results – Radiated emissions 14 3.2 Test Conditions and Results – AC power line conducted emissions 19 Test Report No.: G0M-1303-2685-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 21 1 Equipment (Test item) Description Description Asthma Monitor AM3 Model AM3 GSM Additional Models None Serial number None Hardware version 01 Software / Firmware version 01 FCC-ID 2AAUFAM3G01 IC 11335A-AM3G01 FCC-ID BT Module POOWML-C46 IC BT Module None Power supply 100 – 240 VAC AC/DC-Adaptor Model : GTM41134-0605 Manufacturer : GlobTek Input : 100-240VAC / 50-60Hz Output : 5 VDC Radio module GSM Type GSM Module Model WISMO228 Manufacturer Sierra Wireless HW Version 111 SW Version L23a00gg.wismo0228 121211 FCC-ID N7NWISMO2228 IC 2417C-WISMO228 IMEI 355457051769662 Radio module Bluetooth Type Bluetooth Module Model WML-C46N Manufacturer Mitsumi HW Version 26 SW Version 2626 FCC-ID FCC-ID POOWM IC None Test Report No.: G0M-1303-2685-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 21 Manufacturer eResearch Technology GmbH Sieboldstrasse 3 97230 Estenfeld Germany Highest emission frequency 4MHz Device classification Class B Equipment type Tabletop Number of tested samples 1 Test Report No.: G0M-1303-2685-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 9 of 21 1.4 Supporting Equipment Used During Testing Product Type* Device Manufacturer Model No. Comments AE Radio Communication Tester R&S CMU 200 - None *Note: Use the following abbreviations: AE : Auxiliary/Associated Equipment, or SIM : Simulator (Not Subjected to Test) CABL : Connecting cables Test Report No.: G0M-1303-2685-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 10 of 21 1.5 Operating Modes Mode # Description 1 GPRS link to Radio Communication Tester + charging Test Report No.: G0M-1303-2685-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 11 of 21 1.6 Test Equipment Used During Testing Radiated emissions Description Manufacturer Model Identifier Cal. Date Cal. Due Biconical Antenna R&S HK 116 EF00012 2013-02 2016-02 LPD-Antenne R&S HL 223 EF00187 2011-02 2014-02 LPD-Antenna R&S HL 025 EF00327 2013-02 2016-02 EMI Test Receiver R&S ESU8 EF00379 2013-03 2014-03 EMI Test Receiver R&S ESCS30 EF00295 2013-10 2014-10 Conducted emissions Description Manufacturer Model Identifier Cal. Date Cal. Due AMN R&S ESH2-Z5 EF00182 2012-10 2014-10 AMN R&S ESH3-Z5 EF00036 2012-11 2014-11 EMI Test Receiver R&S ESCS 30 EF00295 2013-10 2014-10 Test Report No.: G0M-1303-2685-EF01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 12 of 21 1.7 Sample emission level calculation The following is a description of terms and a sample calculation, as appears in the radiated emissions data table. The numbers used in the calculation are for example only. There is no direct correlation to the specific data taken for the product described in this document: Reading: This is the reading obtained on the spectrum analyzer in dBμV. Any external preamplifiers used are taken into account through internal analyzer settings. A.F.: This is the antenna factor for the receiving antenna. It is a conversion factor, which converts electric fields strengths to voltages, which can be measured directly on the spectrum analyzer. It is treated as a loss in dB. Cable losses have been included with the A.F. to simplify the calculations. The antenna factor is used in calculations as follows: Reading on Analyzer (dBμV) + A.F. (dB) = Net field strength (dBμV/m) Net: This is the net field strength measurement (as shown above). Limit: This is the FCC Class B radiated emission limit (in units of dBμV/m). The FCC limits are given in units of μV/m. The following formula is used to convert the units of μV/m to dBμV/m: Limit (dBμV/m) = 20*log (μV/m) Margin: This is the margin of compliance below the FCC limit. The units are given in dB. A negative margin indicates the emission was below the limit. A positive margin indicates that the emission exceeds the limit. Example only: Reading + AF = Net Reading : Net reading …

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Product Service Test set up Photo page 1 Model No.: AM3 FCC ID: 2AAUFAM3G01 IC: 11335A-AM3G01 Eurofins Product Service GmbH Storkower Str. 38C, D-15526 Reichenwalde, Germany