TUKMIR040Portable multipurpose and multifunction spirometer

Spirodoc cod. 980156 Rev 1.3 EN 1/67 ENGLISH Spirodoc User Manual Rev. 1.3 Issued on 27/04/2010 Approved on 27/04/2010 INDEX 1. EQUIPMENT AND ACCESORY LIST ................................................................ 3 2. INTRODUction ................................................................................................... 4 2.1 Intended use ................................................................................................ 4 2.1.1 User category .......................................................................................... 5 2.1.2 Ability and experience required ............................................................... 5 2.1.3 Operating Environment ........................................................................... 5 2.1.4 Who can or must make the installation.................................................... 6 2.1.5 Patient effect on the use of the device .................................................... 6 2.1.6 Limitations of use - Contraindications...................................................... 6 2.2 Important safety warnings............................................................................ 6 2.2.1 Danger of cross-contamination ............................................................... 7 2.2.2 Turbine .................................................................................................... 7 2.2.3 Mouthpiece .............................................................................................. 8 2.2.4 I Oximetry sensor .................................................................................... 8 2.2.5 Device ................................................................................................... 10 2.3 Unforeseen errors ...................................................................................... 11 2.4 Lithium-ion battery pack warning ............................................................... 11 2.5 Labels and symbols ................................................................................... 14 2.5.1 Identification label.................................................................................. 14 2.5.2 CE mark for medical devices ................................................................. 14 2.5.3 Electrical safety symbol ......................................................................... 14 2.5.4 Warning symbol for the RS232 serial port ............................................. 14 2.5.5 Warning symbol for the USB serial port ................................................ 14 2.5.6 Warning symbol for the SpO2 port for oximetry .................................... 15 2.5.7 Warning symbol for the WEEE .............................................................. 15 2.5.8 FDA and FCC Warnings ........................................................................ 15 2.5.9 Product description................................................................................ 16 2.6 Technical specifications ............................................................................. 18 2.6.1 Features of the spirometer .................................................................... 18 2.6.2 Oximeter features .................................................................................. 19 2.6.3 Other features ....................................................................................... 23 3. Functioning of the SPIRODOC .......................................................................... 23 3.1 Display ....................................................................................................... 23 3.2 Accensione e spegnimento di SPIRODOC ................................................ 24 3.3 Symbols and Icons .................................................................................... 24 3.4 Energy saving ............................................................................................ 25 3.5 Information ................................................................................................. 25 3.6 Service menu ............................................................................................. 26 3.6.1 Patient Mode ......................................................................................... 31 3.6.2 Reusable turbine calibration .................................................................. 32 3.7 Patient Data ............................................................................................... 34 3.7.1 Inserting data of a new patient .............................................................. 34 Spirodoc cod. 980156 Rev 1.3 EN 2/67 ENGLISH 3.7.2 Patient data modification ....................................................................... 35 3.8 Visualization of memory data ..................................................................... 36 3.8.1 Database research modality .................................................................. 36 3.8.2 Visualization of database info ................................................................ 36 3.9 Display of last session from current patient. .............................................. 37 3.10 PC On line mode (connected to a PC) ...................................................... 37 3.11 Spirometry testing ...................................................................................... 38 3.11.1 FVC test ................................................................................................ 39 3.11.2 Test VC ................................................................................................. 40 3.11.3 MVV Test .............................................................................................. 40 3.11.4 POST test, after drug administration ..................................................... 40 3.12 Viewing the spirometric results .................................................................. 41 3.12.1 Spirometry Test …

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Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 37 of 44 Annex Pictures EUT Front Side EUT Back Side Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 38 of 44 Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 39 of 44

Medical International Research Pag. 1 of 1 Spirodoc labels sample for FCC approval ID label (MIR code: 451237) Connectors label (MIR code: 500400)

Medical International Research Pag. 1 of 1 Spirodoc labels location information

Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 40 of 44 EUT inside Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 41 of 44 Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 42 of 44 Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 43 of 44

EUROFINS PRODUCT SERVICE GMBH Testing Cert #1983.01 TEST - REPORT FCC RULES PART 15 / SUBPART B IC RSS-GEN ISSUE 2 Medical device spirodoc FCC ID: TUKMIR040 Test report no.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, 15526 Reichenwalde, Phone +49-33631-888 0 Germany Fax +49-33631-888 660 Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 2 of 44 TABLE OF CONTENTS 1 General Information 3 1.1 Notes 3 1.2 Operator: 5 1.3 Testing laboratory 6 1.3.1 Location 6 1.3.2 Details of accreditation status 6 1.3.3 Test location, where different 6 1.4 Details of applicant 7 1.5 Application details 7 1.6 Test item 7 1.6.1 Description of test item 7 1.6.2 Manufacturer (if different from applicant in point 1.4) 8 1.6.3 Frequency behavior 8 1.7 Test standards 8 2 Technical test 9 2.1 Summary of test results 9 2.2 Test environment 9 2.3 Test results 10 2.4 Test equipment utilized 11 2.4.1 Conducted Emission 12 2.4.2 Spurious Emission 13 2.5 Test protocols 14 3 Normative references 36 Annex : Pictures 37 Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 44 1 General Information 1.1 Notes The purpose of conformity testing is to increase the probability of adherence to the essential requirements or conformity specifications, as appropriate. The tests were carried out and passed in accordance to the standards: FCC part 15B IC RSS-Gen Issue 2 The results of this test report relate exclusively to the item tested as specified in chapter “Description of test item” and are not transferable to any other test items. Eurofins Product Service GmbH is not responsible for any generalisations and conclusions drawn from this report. Any modification of the test item can lead to invalidity of test results and this test report may therefore be not applicable to the modified test item. The test report may only be reproduced or published in full. Reproducing or publishing extracts of the report requires the prior written approval of the Eurofins Product Service GmbH. This document is subject to the General Terms and Conditions and the Testing and Certification System of Eurofins Product Service GmbH, available on request or accessible at www.pt.eurofins.com . Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 44 Important Notes: Proper labeling is required for each device. Devices shall be labeled in accordance with labeling requirements pursuant to section 15.19 and section 2.1074 of the FCC rules. Devices subject to a Declaration of Conformity shall be uniquely identified by the responsible party. This identification shall not be of a format which could be confused with the FCC Identifier required on certified, notified type accepted or type approved equipment. The responsible party shall maintain adequate identification records to facilitate positive identification for each device. The user manual or instruction manual shall included also a warning statement that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Reference Section 15.21 Furthermore information to the user regarding to the interference potential of the device and about simple measures that can be taken to correct interference is required. Reference Section 15.105 The responsible party must warrant that each unit of equipment marketed under a Declaration of Conformity is identical to the unit tested and found acceptable with the standards and that the records maintained by the responsible party continue to reflect the equipment being produced under the Declaration of Conformity within the variation that can be expected due to quantity production and testing on a statistical basis. Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 44 1.3 Testing laboratory 1.3.1 Location EUROFINS PRODUCT SERVICE GMBH STORKOWER STR. 38c D- 15526 REICHENWALDE B. BERLIN GERMANY Telephone: + 49 33631 888-00 Telefax: + 49 33631 888-660 1.3.2 Details of accreditation status DAR ACCREDITED TESTING LABORATORY DAR-R EGISTRATION NUMBER: DAT-P-268/08 R ECOGNIZED NOTIFIED BODY EMC R EGISTRATION NUMBER: BNetzA-bS EMV-07/61 R ECOGNIZED NOTIFIED BODY R&TTE R EGISTRATION NUMBER: BNetzA-bS-02/51-53 FCC FILED TEST LABORATORY R EG.-NO. 96970 A2LA ACCREDITED TESTING LABORATORY C ERTIFICATE NO. 1983.01 B LUETOOTH QUALIFICATION TEST FACILITY (BQTF) A CCREDITED BY BLUETOOTH QUALIFICATION REVIEW BOARD I NDUSTRY CANADA FILED TEST LABORATORY R EG. NO. IC 3470A 1.3.3 Test location, where different Name : ./. Street : ./. Town : ./. Country : ./. Telephone : ./. Fax : ./. Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 7 of 44 1.4 Details of applicant Name : MIR Medical International Research Street : Via del Maggiolino 125 Town : Roma Country : Italy Telephone : +39 06 22754777 Contact : Gerda van Houts Telephone : +39 06 22754777 E-mail : [email protected] 1.5 Application details Date of receipt of application : 29.03.2010 Date of receipt of test item : 29.03.2010 Date of test : 15.04.2010 1.6 Test item 1.6.1 Description of test item Type of product : Medical device Type identification : spirodoc Serial number : A23-0W.00005 Hardware Version : 03 Software Version : 0.3 Photos : Please find in Annex. Power supply : 3.7VDC (Battery powered) 5VDC (USB link to Notebook) 120VAC (AC/DC Adapter FW7333SM/05) Antenna type 1 : internal antenna Antenna gain 1 : 0dBi Additional information : ./. Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 8 of 44 1.6.2 Manufacturer (if different from applicant in point 1.4) Name : MIR Medical International Research Street : Vi…

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Test Report No.: G0M21003-3001-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 44 of 44 Test setup radiated measurements Test setup conducted measurements