TUK-MIR020Portable multipurpose and mutlifunction spriometer

spirobank II User’s Manual cod. 980200 Rev 2.2 Page 1 of 60 spirobank II User’s Manual



User’s Manual Rev. 2.2 Issued on: 09/05/2006 Approved on: 09/05/2006 spirobank II User’s Manual cod. 980200 Rev 2.2 Page 2 of 60 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 CODE spirobank II with oximeter 910570 spirobank II without oximeter 910575 4 x 1.5V AAA batteries 970080 USB connection cable 532365 This spirobank II User’s Manual 980205 WinSpiro Pro installation CD 920100 Oximeter sensor (optional) 919010 Nose clip 910320 4 Paper mouthpieces 910300 3 Single patient turbine sensors 910001 1 Reusable turbine sensor 910000 Before using your spirobank II ... ∑ Read this manual carefully, plus all labels and other product information supplied. ∑ If not fitted, install the operating battery taking care to connect the “+” and “-” battery poles correctly, as shown in the battery compartment. ∑ Set the device configuration as required (date, time, predicted values, device language etc.) as described in Paragraph 2.4. Keep the original packaging! In the event that your device requires attention then always use the original packaging to return it to the distributor or manufacturer. In this case, please follow these guidelines: ∑ Return the complete device in the original packaging, and ∑ The transport (plus any customs or taxes) costs must be prepaid. Manufacturer’s address: MIR SRL VIA DEL MAGGIOLINO, 125 00155 ROMA (ITALY) Tel ++ 39 0622754777 Fax ++ 39 0622754785 Web site: www.spirometry.com Email: [email protected] spirobank II User’s Manual cod. 980200 Rev 2.2 Page 3 of 60
                           
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 #         $          %              #  "    &     %          FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN spirobank II User’s Manual cod. 980200 Rev 2.2 Page 4 of 60 INDEX 1. INTRODUCTION .................................................................................................................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 ................................................................7 1.1.5 Subject effect on the use of the device ................................................................7 1.1.6 Limitations of use - Contraindications ..................................................................7 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 1.2.5 Device ..................................................................................................................11 1.3 Unforeseen errors.....................................................................................................11 1.4 Labels and symbols..................................................................................................12 1.4.1 Identification label................................................................................................12 1.4.2 CE mark for medical devices ..............................................................................12 1.4.3 Electrical safety symbol.......................................................................................12 1.4.4 Warning symbol for the RS232 serial port .........................................................13 1.4.5 Warning symbol for the USB serial port .............................................................13 1.4.6 Warning symbol for the SpO2 port for oximetry ................................................13 1.4.7 Warning symbol for the WEEE ...........................................................................13 1.4.8 Warning symbol for the FCC...............................................................................13 1.5 Product description...................................................................................................14 1.6 Technical specifications ...........................................................................................16 1.6.1 Features of the spirometer ..................................................................................16 1.6.2 Features of the oximeter .....................................................................................17 1.6.3 Other features ................................................................…

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Medical International Research spirobank II antenna specification Pag. 1 of 4 Fle: 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 spirobank II antenna specification Pag. 2 of 4 Fle: AntSpec 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. Azimut h Cut Elevation Cut Medical International Research spirobank II antenna specification Pag. 3 of 4 Fle: 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 spirobank II antenna specification Pag. 4 of 4 Fle: AntSpec

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 1 of 8 Appendix A. Pictures ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 2 of 8 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 3 of 8

LABEL SAMPLE FOR FCC APPLICATION FCC ID:TUK-MIR020

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 4 of 8 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 5 of 8

ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH TEST - REPORT FCC RULES PART 15 / SUBPART C FCC ID: TUK-MIR020 Test report no.: G0M20504-9446-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: G0M20504-9446-P-15 Page 1 of 35 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 3 Test Results 3.1 Peak output power 3.2 Equivalent isotropic radiated power 3.3 RF exposure radiated emission 3.4 Antenna requirement 3.5 Out of band radiated emission 3.6 Transmitter radiated emissions in restricted bands 3.7 Spurious emissions (tx) 3.8 Carrier frequency separation 3.9 Number of hopping frequency 3.10 Time of occupancy 3.11 20 dB bandwidth 3.12 Band-edge compliance of RF emissions 3.13 Conducted measurement at (AC) power line ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 2 of 35 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: 14.11.2005 D. Hoppe Date ETS-Lab. Name Signature Technical responsibility for area of testing: 14.11.2005 N. Kaspar Date ETS Name Signature ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 3 of 35 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 Telefon : +49 33631 888 00 Telefax : +49 33631 888 66 1.2.2 Details of accreditation status A CCREDITED TESTING LABORATORY DAR- REGISTRATION NUMBER: TTI-P-G 126/96 A CCREDITED COMPETENT BODY DAR- REGISTRATION NUMBER: BPT-ZE-026/96 FCC FILED TEST LABORATORY REG. NO. 96970 B LUETOOTH QUALIFICATION TEST FACILITY (BQTF) A CCREDITED BY BLUETOOTH QUALIFICATION REVIEW BOARD I NDUSTRY CANADA FILED TEST LABORATORY REG. NO. IC 3470 A2LA ACCREDITED Certificate Number 1983-01 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: G0M20504-9446-P-15 Page 4 of 35 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.4 Application details Date of receipt of application : 03.05.2005 Date of receipt of test item : 03.05.2005 Date of test : 03.05.2005 – 14.10.2005 1.5 Test item Description of test item : Medical device Type identification : MIR020 Serial number : without Photos : See Appendix A Technical data Frequency band : 2.4GHz – 2.4835GHz Frequency ( ch A) : 2402 MHz Frequency (ch B) : 2441 MHz Frequency (ch C) : 2480 MHz Transmitter Vnom Vnom Power (ch A) : Conducted: -1.88 dBm Radiated: -3.85 dBm Power (ch B) : Conducted: -1.31 dBm Radiated: -4.66 dBm Power (ch C) : Conducted: -1.39 dBm Radiated: -4.63 dBm Power supply : 6.0 V DC Operating mode : duplex Type of modulation : FHSS Antenna type : internal antenna Antenna gain : 0 dBi ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 5 of 35 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH Host device : none Classification : Fixed Device Mobile Device (Human Body distance > 20cm) Portable Device (Human Body distance < 20cm) 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. According to attached declaration of manufacturer this device don’t work in master inquiry mode. So we have only one frequency hopping system and the hopping sequence of the master inquiry mode is not very fied. ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 6 of 35 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.6 Test standards Technical standard : FCC RULES PART 15 / SUBPART C § 15.247 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 o C Relative humidity content : 20 ... 75 % Air pressure : 86 ... 103 kPa Details of power supply : 6.0 V DC 120 V AC (AC/DC Adapter) Extreme conditions parameters: : test voltage - extreme min.: -- V (Vnom – 15%) max: -- V (Vnom + 15%) ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 7 of …

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Carrier power (Field Strength) FCC RULES PART 15, SUBPART C Approval Holder:MIR Medical International Research EUT:electromedical device Model:MIR 020 / 2402 MHz Test Site / Operator:ETS / Mr. Handrik Temperature/ Voltage:25°C / Unom: 6.0 V DC Test Specification:according to §15.247 Comment 1:Dist.: 3m, Ant.: BBHA9120D Comment 2:Freq: 2.402GHz, Emax: 86.15dBμV/m, RBW: 100kHz 55.58 60.00 65.00 70.00 75.00 80.00 85.00 90.00 Level [dBμV/m] 2.395G2.41G2.42G2.43G2.44G2.45G2.46G2.47G2.488G Frequency [Hz] MES 8. FCC_15247_harm LIM FCC_Tx Page 1/1 14.10.2005 09:33 Overview / Antenna horizontal Spurious emissions Field Strength FCC RULES PART 15, SUBPART C Approval Holder:MIR Medical International Research EUT:electromedical device Model:MIR 020 / 2402 MHz Test Site / Operator:ETS / Mr. Handrik Temperature/ Voltage:25°C / Unom: 6.0 V DC Test Specification:according to §15.247 Comment 1:Dist.: 3m, Ant.: HK 116 Comment 2:Freq: 38.517MHz, Emax: 37.67dBμV/m, RBW: 100kHz 21.16 30.00 40.00 50.00 60.00 70.00 Level [dBμV/m] 30M60M80M100M120M140M160M180M 200M Frequency [Hz] MES 1. FCC_15247 LIM FCC_restricted Page 1/1 14.10.2005 13:34 Overview / Antenna vertical Spurious emissions Field Strength FCC RULES PART 15, SUBPART C Approval Holder:MIR Medical International Research EUT:electromedical device Model:MIR 020 / 2402 MHz Test Site / Operator:ETS / Mr. Handrik Temperature/ Voltage:25°C / Unom: 6.0 V DC Test Specification:according to §15.247 Comment 1:Dist.: 3m, Ant.: HK 116 Comment 2:Freq: 200.000MHz, Emax: 32.69dBμV/m, RBW: 100kHz 20.23 30.00 40.00 50.00 60.00 70.00 Level [dBμV/m] 30M60M80M100M120M140M160M180M 200M Frequency [Hz] MES 1. FCC_15247 LIM FCC_restricted Page 1/1 14.10.2005 13:52 Overview / Antenna horizontal Spurious emissions Field Strength FCC RULES PART 15, SUBPART C Approval Holder:MIR Medical International Research EUT:electromedical device Model:MIR 020 / 2402 MHz Test Site / Operator:ETS / Mr. Handrik Temperature/ Voltage:25°C / Unom: 6.0 V DC Test Specification:according to §15.247 Comment 1:Dist.: 3m, Ant.: HL 223, amplif. Comment 2:Freq: 594.389MHz, Emax: 31.09dBμV/m, RBW: 100kHz 8.16 20.00 30.00 40.00 50.00 60.00 70.00 Level [dBμV/m] 200M 300M400M500M600M700M800M900M1G Frequency [Hz] MES 2. FCC_15247 LIM FCC_restricted Page 1/1 14.10.2005 13:05 Overview / Antenna vertical Spurious emissions Field Strength FCC RULES PART 15, SUBPART C Approval Holder:MIR Medical International Research EUT:electromedical device Model:MIR 020 / 2402 MHz Test Site / Operator:ETS / Mr. Handrik Temperature/ Voltage:25°C / Unom: 6.0 V DC Test Specification:according to §15.247 Comment 1:Dist.: 3m, Ant.: HL 223, amplif. Comment 2:Freq: 594.389MHz, Emax: 34.54dBμV/m, RBW: 100kHz 6.93 20.00 30.00 40.00 50.00 60.00 70.00 Level [dBμV/m] 200M 300M400M500M600M700M800M900M1G Frequency [Hz] MES 2. FCC_15247 LIM FCC_restricted Page 1/1 14.10.2005 13:19 Overview / Antenna horizontal Spurious emissions Field Strength FCC RULES PART 15, SUBPART C Approval Holder:MIR Medical International Research EUT:electromedical device Model:MIR 020 / 2402 MHz Test Site / Operator:ETS / Mr. Handrik Temperature/ Voltage:25°C / Unom: 6.0 V DC Test Specification:according to §15.247, peak detector Comment 1:Dist.: 3m, Ant.: BBHA9120D, amplif. Comment 2:Freq: 3.863GHz, Emax: 42.96dBμV/m, RBW: 1MHz 30.66 35.00 40.00 45.00 50.00 55.00 60.00 65.00 70.00 Level [dBμV/m] 1G1.5G2G2.5G3G3.5G4G Frequency [Hz] MES 3. FCC_15247 LIM FCC_restricted Page 1/1 14.10.2005 10:27 Overview / Antenna vertical Spurious emissions Field Strength FCC RULES PART 15, SUBPART C Approval Holder:MIR Medical International Research EUT:electromedical device Model:MIR 020 / 2402 MHz Test Site / Operator:ETS / Mr. Handrik Temperature/ Voltage:25°C / Unom: 6.0 V DC Test Specification:according to §15.247, peak detector Comment 1:Dist.: 3m, Ant.: BBHA9120D, amplif. Comment 2:Freq: 3.860GHz, Emax: 43.03dBμV/m, RBW: 1MHz 30.57 35.00 40.00 45.00 50.00 55.00 60.00 65.00 70.00 Level [dBμV/m] 1G1.5G2G2.5G3G3.5G4G Frequency [Hz] MES 3. FCC_15247 LIM FCC_restricted Page 1/1 14.10.2005 09:59 Overview / Antenna horizontal Spurious emissions Field Strength FCC RULES PART 15, SUBPART C Approval Holder:MIR Medical International Rescarch EUT:electromedical device Model:MIR 020 / 2402 MHz Test Site / Operator:ETS / Mr. Handrik Temperature/ Voltage:25°C / Unom: 6.0 V DC Test Specification:according to §15.247, peak detector Comment 1:Dist.: 3m, Ant.: BBHA9120D, ampl.+HP. Comment 2:Freq: 4.802GHz, Emax: 56.13dBμV/m, RBW: 1MHz 25.18 30.00 40.00 50.00 60.00 70.00 Level [dBμV/m] 4G5G6G7G8G Frequency [Hz] MES 4. FCC_15247 LIM FCC_restricted Page 1/1 14.10.2005 10:31 Overview / Antenna vertical Spurious emissions Field Strength FCC RULES PART 15, SUBPART C Approval Holder:MIR Medical International Research EUT:electromedical device Model:MIR 020 / 2402 MHz Test Site / Operator:ETS / Mr. Handrik Temperature/ Voltage:25°C / Unom: 6.0 V DC Test Specification:according to §15.247, average detector Comment 1:Dist.: 3m, Ant.: BBHA9120D, ampl.+HP. Comment 2:Freq: 4.802GHz, Emax: 30.00dBμV/m, RBW: 1MHz 15.03 20.00 30.00 40.00 50.00 60.00 70.00 Level [dBμV/m] 4G5G6G7G8G Frequency [Hz] MES 15. FCC_15247_av LIM FCC_restricted Page 1/1 14.10.2005 10:39 Overview / Antenna vertical Spurious emissions Field Strength FCC RULES PART 15, SUBPART C Approval Holder:MIR Medical International Research EUT:electromedical device Model:MIR 020 / 2402 MHz Test Site / Operator:ETS / Mr. Handrik Temperature/ Voltage:25°C / Unom: 6.0 V DC Test Specification:according to §15.247, peak detector Comment 1:Dist.: 3m, Ant.: BBHA9120D, ampl.+HP. Comment 2:Freq: 4.802GHz, Emax: 55.41dBμV/m, RBW: 1MHz 24.81 30.00 40.00 50.00 60.00 70.00 Level [dBμV/m] 4G5G6G7G8G Frequency [Hz] MES 4. FCC_15247 LIM FCC_restricted Page 1/1 14.10.2005 12:46 Overview / Antenna horizontal Spurious emissions Field Strength FCC RULES PART 15, SUBPART C Approval Holder:MIR Medical International Research EUT:electromedical device Model:MIR 020 / 2402 …

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ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 6 of 8 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 7 of 8 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20504-9446-P-15 Page 8 of 8