TUK-MIR009Portable multipurpose and multifunction spirometer

SpirolabIII – User’s Manual Code MIR 980067 REV 0 Page 1 / 47 Spirolab III
   User’s Manual Rev.0 Issued on 21/06/06 Approved on 21/06/06 SpirolabIII – User’s Manual Code MIR 980067 REV 0 Page 2 / 47 Thank you for choosing a product from MIR Medical International Research The original packaging contains one of the following spirometers, complete with its standard accessories: PRODUCT without oximetry option CODE PRODUCT with oximetry option CODE SpirolabIII bag 672685 SpirolabIII bag 672685 SpirolabIII device 910551 SpirolabIII device plus oxy 910551 MiniFlowmeter sensor 910590 1 oximeter sensor 919010 SpirolabIII User’s Manual 980067 MiniFlowmeter sensor 910590 USB connection cable 532365 SpirolabIII User’s Manual 980067 Connection cable RS 232, 9 pin for PC 671492 USB connection cable 532365 1 power supply (110V) 970080 Connection cable RS 232, 9 pin for PC 671492 CD winspiroPRO 920100 1 power supply (110V) 970080 Roll of thermal paper 910350 CD winspiroPRO 920100 1 nose clip 910320 Roll of thermal paper 910350 2 paper mouthpieces 910300 1 nose clip 910320 2 disposable turbine sensors 910001 2 paper mouthpieces 910300 1 reusable turbine sensor 910000 2 disposable turbine sensors 910001 1 spare fuse (internal) 2A 270464 1 reusable turbine sensor 910000 1 spare fuse (internal) 4A 270468 1 spare fuse (internal) 2A 270464 1 spare fuse (internal) 4A 270468 OPTION CODE OPTION CODE Serial/parallel printer converter 910110 Serial/parallel printer converter 910110 wrap finger sensor for oximetry over a long period 919001 Before using your spirometer ... Please read this manual carefully, plus the labels and all of the information supplied together with the product.



                                                                     Set up the device (date, time, language, predicted values, etc.) to your requirements as described under Configuration Menu in this Manual. Keep the original packaging! In the event that your spirometer has a problem, always use the original packaging to return it to your local distributor or to the manufacturer.                                                 !  "      #  
                        $     %                             &                         '                 &   %      (       '            IMPORTANT NOTE If the instrument is returned for repair it must be accompanied by a clear and detailed explanation of the defect or problem found. ∑ the unit must be returned in its original packaging; ∑ transport costs must be prepaid. SpirolabIII – User’s Manual Code MIR 980067 REV 0 Page 3 / 47 Manufacturer’s address: MIR srl: Via Del Maggiolino, 125 00155 Roma, Italy Tel ++ 39 0622754777 Fax ++ 39 0622754785 e-mail: [email protected] SpirolabIII – User’s Manual Code MIR 980067 REV 0 Page 4 / 47 INDEX INTRODUCTION................................................................................................................................................................. 6 1 GENERAL INFORMATION ......................................................................................................................................... 6 1.1 Intended use ......................................................................................................................................................... 6 1.1.1 User Category ............................................................................................................................................. 6 1.1.2 Ability and experience required ................................................................................................................... 6 1.1.3 Operating environment ............................................................................................................................... 6 1.1.4 Who can or must make the installation ....................................................................................................... 6 1.1.5 Subject effect on the use of the device ....................................................................................................... 6 1.1.6 Limitations of use - Contraindications ......................................................................................................... 6 1.2 Important safety warnings..................................................................................................................................... 7 1.2.1 Danger of cross-contamination ................................................................................................................... 8 1.2.2 Turbine ........................................................................................................................................................ 8 1.2.3 Mouthpiece.................................................................................................................................................. 9 1.2.4 Oximetry sensor .......................................................................................................................................... 9 1.3 problems and unforseen errors........................................................................................................................... 10 1.4 LABELS AND SYMBOLS..............................................................................…

Text truncated - open the document above for the full version.

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 1 of 15 Appendix A. Pictures ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 2 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 3 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 4 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 5 of 15

Medical International Research Spirolab III label location information Pag. 1 of 1

Medical International Research Spirolab III label sample for FCC approval Pag. 1 of 1

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 6 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 7 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 8 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 9 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 10 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 11 of 15

Medical International Research Spirolab III antenna specification Pag. 1 of 4 File: AntSpec Printed and surface mount antennas have certain common properties. Area around and beneath the radiating element must be kept copper free. Ground plane must be provided on one side of the radiating element. Bandwidth >100MHz with VSWR<2.5 and efficiency >60%. The antenna will de-tune if any object is placed close to it (in its near field). This has an effect of pulling the frequency, which must be retuned to 2.45GHz An oscillating or constantly accelerating charge is critical in producing propagating waves, a static or non- accelerating charge will result in a non-propagating electric field. But this is not the only condition for radiation. Consider a printed lg/4 element on microstrip; The fringing field around the microstrip due to the ground plane directly underneath the substrate will be confined to a small area. If a network analyzer is connected to the feed point, it would indicate a high VSWR and narrow bandwidth. This means very little radiation is being emitted from the microstrip element. To increase the radiation emission and achieve a better bandwidth, we have to move the ground plane away from the microstrip element, making the fringing field cover more distance. But it should be noted that if the ground plane is moved too far then the fringing field stops altogether, and there is no radiation. Therefore the position and size of the ground plane is vital in the design of a good radiator. The antenna could be imagined as an impedance transformer, transforming the impedance of a microstrip line (50W) to that of free space (377W) allowing the power to be transferred from guided wave to free space wave. Feed Quarter Wave Fringing field around Microstrip Substrate Ground Medical International Research Spirolab III antenna specification Pag. 2 of 4 File: AntSpec Azimuth Cut Elevation Cut The radiation pattern from such antennas where the physical size is much smaller then wavelength (L<<l) is almost symmetrical in all directions as shown above. Only when L is similar or greater then l, can the pattern be controlled. Input return loss when viewed on a network analyzer looks like as shown here with the full band covered with VSWR<2. This gives very good matching into the antenna, however in real conditions when the antenna is detuned due to handling or placement of components close to it, the VSWR of 3 to 4 is normal. Medical International Research Spirolab III antenna specification Pag. 3 of 4 File: AntSpec For the MIR device, an SMD ceramic chip was chosen, for reasons of dimensions. The following microstrip model can be used to calculate the impedance of the trace which carries the signal to the antenna,: The above diagram shows that the trace must have an impedance of 50
, then the dielectric and also the earthing system. The impedance must be 50
in order to mantain the ROS “stationary waves” as close as possible to 1. Otherwise, there will be losses as the antenna is not suitable. These losses can then only be eliminated by calculating the length of the trace which must be equal to l/2. Dielectric Constant er 4,6 Dielectric Thickness (mils) H 3,9 Trace Width (mils) W 5,4 Finished Copper Weight (mils) T 1,4 RESULTS Impedance Zo (Ohms) 50,03 Inductance/Inch Lo (nH/in) 7,149 Capacitance/Inch Co (pF/in) 2,857 Propogation Delay Tpd (nS/in) 0,1430 These are the formulas used: Zo=(87/(SQRT(Er+1.41)))*LN((5.98*H)/(0.8*W+T)) Lo=0.001*(Co*SUMSQ(Zo)) Co=(0.67*(Er+1.41))/LN((5.98*H)/(0.8*W+T)) Tpd=0.0833*(1.016*(SQRT(0.475*Er+0.67))) In the specific case of our ceramic chip, in order to have the maximum radiation, the antenna mounting specifications are as follows:
e   Medical International Research Spirolab III antenna specification Pag. 4 of 4 File: AntSpec

ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH TEST - REPORT FCC RULES PARTS 15.247 IC RADIO STANDARDS RSS-210 Annex 8 FCC ID: TUK-MIR009 Model Name: Spirolab III Test report no.: G0M20604-0435-P-15 Certificate 1983-01 ELECTRONIC TECHNOLOGY SYSTEMS STORKOWER STRASSE 38C, D-15526 REICHENWALDE B. BERLIN DR. GENZ GMBH PHONE +49-33631-888 00 FAX +49-33631-888 660 ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 1 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH TABLE OF CONTENTS 1 General information 1.1 Notes 1.2 Testing laboratory 1.3 Details of approval holder 1.4 Application details 1.5 Test item 1.6 Test standards 2 Technical test 2.1 Summary of test results 2.2 Test environment 2.3 Test equipment utilized 2.4 General test procedure 2.5 Test results 3 Transmitter parameters 3.1 RF power output conducted 3.2 RF power output radiated (EIRP) 3.3 20 dB bandwidth 3.4 Time of occupancy (dwell time) 3.5 Number of hopping frequencies 3.6 Carrier frequency separation 3.7 Spurious emission conducted 3.8 Spurious emission radiated 3.9 Band-edge compliance 3.10 AC power line conducted emission 4 Receiver parameters 4.1 Radiated emission APPENDIX ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 2 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 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 complexity of the technical specifications, however, means that full and thorough testing is impractical for both technical and economic reasons. Furthermore, there is no guarantee that a test sample which has passed all the relevant tests conforms to a specification. Neither is there any guarantee that such a test sample will interwork with other genuinely open systems. The existence of the tests nevertheless provides the confidence that the test sample possesses the qualities as maintained and that is performance generally conforms to representative cases of communications equipment. The test results of this test report relate exclusively to the item tested as specified in 1.5. The test report may only be reproduced or published in full. Reproduction or publication of extracts from the report requires the prior written approval of the ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH. Tester: 29.06.2006 W. Treffke Date ETS-Lab. Name Signature Technical responsibility for area of testing: 29.06.2006 N. Kaspar Date ETS Name Signature ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 3 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.2 Testing laboratory 1.2.1 Location ELECTRONIC TECHNOLOGY SYSTEM DR. GENZ GMBH (ETS) Storkower Straße 38c D-15526 Reichenwalde b. Berlin Germany Telephone : +49 33631 888 00 Telefax : +49 33631 888 66 1.2.2 Details of accreditation status ACCREDITED TESTING LABORATORY DAR-REGISTRATION NUMBER: DAT-P-201/96 A CCREDITED COMPETENT BODY DAR-REGISTRATION NUMBER: BPT-ZE-026/96 FCC FILED TEST LABORATORY: REG. NO. 96970 INDUSTRY CANADA FILED TEST LABORATORY REG. NO. IC 3470 A2LA ACCREDITED CERTIFICATE NUMBER: 1983-01 B LUETOOTH QUALIFICATION TEST FACILITY (BQTF) A CCREDITED BY: BLUETOOTH QUALIFICATION REVIEW BOARD (BQRF) 1.3 Details of approval holder Name : MIR Medical International Research Street : Via del Maggiolino 125 Town : Roma Country : Italy Telephone : +39 06 22754777 Fax : +39 06 22754785 Contact : Marco Pennacchietti E-Mail : [email protected] ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 4 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.4 Application details Date of receipt of application : 25.04.2006 Date of receipt of test item : 25.04.2006 Date of test : 21.06.2006 – 04.07.2006 1.5 Test item Description of test item : Medical device Type identification : Spirolab III Serial number : without Photos : See annex A. Technical data Frequency band : 2.4 - 2.4835 GHz Frequency Ch A : 2402 MHz Frequency Ch B : 2441 MHz Frequency Ch C : 2480 MHz Transmitter Vnom Power (ch A) : Conducted: -1.58 dBm Power (ch B) : Conducted: -1.59 dBm Power (ch C) : Conducted: -1.74 dBm Antenna Type : Surface-mount ceramic multilayer antennas Antenna Gain : 0 dBi Power supply : 3.7 V DC 120 V AC/DC Adapter Operating mode : duplex Type of modulation : FHSS Host device : none ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 5 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH Classification : Fixed Device Mobile Device (Human Body distance > 20 cm) Portable Device (Human Body distance < 20 cm) Manufacturer: (if applicable) Name : MIR Medical International Research Street : Via del Maggiolino 125 Town : Roma Country : Italy Additional information: The test sample is designed as Bluetooth device. Its pseudorandom hopping scheme, authentication, receiver parameters, synchronization procedure and other parameters are determined by Bluetooth Core Specification. ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 6 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.6 Test standards Technical standard: FCC Parts: 15.247 IC Standards: RSS 210 Issue 6 Annex 8.1 2 Technical test 2.1 Summary of test results No deviations from the technical specification(s) were ascertained in the course : of the tests performed. or The deviations as specified in 2.5 were ascertained in the course of the tests … performed. 2.2 Test environment Temperature : 25 ° C Relative humidity content : 20 ... 75 % Air pressure : 86 ... 103 kPa Details of power supply : 3.7 V DC 120 V AC (AC/DC Adapter) Extreme conditions parameters: : test voltage - extreme min.: 3.0 V (Vnom – 15%) max: 4.1 V (Vnom + 15%) ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 7 of 34 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 2.3 Test equipment utilized No. Test equipment Type Manufacturer ETS 0001 ESD Gun SESD 30000 Schlöder ETS 0002 Test receiver ESVP R & S ETS 0003 Dio…

Text truncated - open the document above for the full version.

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 12 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 13 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 14 of 15 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20604-0435-P-15 Page 15 of 15