MIR Medical Research MIR020 Portable multipurpose and mutlifunction spriometer User Manual MANUALE SB II REV 2 2 ENG
MIR Medical International Research Portable multipurpose and mutlifunction spriometer MANUALE SB II REV 2 2 ENG
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![spirobank II User’s Manual cod. 980200 Rev 2.2 Page 18 of 60 analysis BPM Mean Average pulse frequency during the period of analysis BPM Recording time Total time measure of SpO2 hh:mm:ss T < 90% Time passed with SpO2 < 90 % % hh:mm:ss T < 89% Time passed with SpO2 < 89 % % hh:mm:ss T < 88% Time passed with SpO2 < 88 % % hh:mm:ss T < 87% Time passed with SpO2 < 87 % % hh:mm:ss N° Events SpO2 <89% Fall of SpO2 below 89% for at least 20 seconds \ ∆ Index [12s] Index of SpO2 fluctuation calculated in intervals of 12 seconds \ T< 40 BPM Time passed with pulse frequency < 40 BPM % hh:mm:ss T> 120 BPM Time passed with pulse frequency > 120 BPM % hh:mm:ss N° Events < 40 BPM Bradycardia events during the entire period of analysis \ N° Events > 120 BPM Tachycardia events during the entire period of analysis \ Tot. Desat. Events Desaturation events during the entire period of the analysis \ ODI Desaturation events by hour of analysis 1/h Mean Duration Average duration of desaturation events s Longest Duration Longest duration of desaturation events s Desaturation Peak Minimum Sp02 during desaturation events % Mean Desaturation Average duration of desaturation events % Mean Drop SpO2 Average SpO2 fall with respect to baseline during the desaturation events % Max Drop SpO2 Maximum fall of SpO2 with respect of baseline during the desaturation events % N° Pulse Variations Variation of pulse frequency events during the entire period of the analysis \ Pulse Index Variation of pulse frequency by hour of analysis 1/h NOD 4% Time passed with SpO2 < 4 % with respect to SpO2 base for continual periods above 5 minutes \ hh:mm:ss NOD 89% Time passed with SpO2 < 89 % for continued periods above 5 minutes \ hh:mm:ss NOD 90% Time passed with SpO2 < 90 % for continued periods above 5 minutes with minimum value < 86 % (Nadir) \ hh:mm:ss ∆=DELTA Parameters measured for six minute walk test analysis: SYMBOL DESCRIPTION Units SpO2 Baseline SpO2 average before walking % SpO2 End SpO2 after walking % SpO2 Min SpO2 minimum during walking %](https://usermanual.wiki/MIR-Medical-Research/MIR020/User-Guide-671725-Page-18.png)
![spirobank II User’s Manual cod. 980200 Rev 2.2 Page 19 of 60 SpO2 Max SpO2 maximum during walking % SpO2 Mean SpO2 average during walking % BPM Vaseline Average pulse frequency before walking BPM BPM End Pulse frequency after walking BPM BPM Min Pulse frequency minimum during walking BPM BPM Max Pulse frequency maximum during walking BPM BPM Mean Pulse frequency average during walking BPM T < 90% Time passed with SpO2 < 90 % % hh:mm:ss T < 89% Time passed with SpO2 < 89 % % hh:mm:ss T < 88% Time passed with SpO2 < 88 % % hh:mm:ss T < 87% Time passed with SpO2 < 87 % % hh:mm:ss T∆2 [∆SpO2 2%] Time passed during walking test with SpO2 < 2 % with respect to SpO2 base hh:mm:ss T∆4 [∆SpO2 4%] Time passed during SpO2 walking test < 4 % with respect to SpO2 base hh:mm:ss T< 40 BPM Time passed with pulse frequency < 40 BPM hh:mm:ss T> 120 BPM Time passed with pulse frequency > 120 BPM hh:mm:ss N° Events < 40 BPM Bradycardia events during the entire period of analysis \ N° Events > 120 BPM Tachycardia events during the entire period of analysis \ Recording time Total time measure of SpO2 hh:mm:ss Baseline Time Duration of baseline phase hh:mm:ss Walking Time Duration of walking phase hh:mm:ss Recovery Time Duration of recovery phase hh:mm:ss Predicted Predicted standard distance m Pred. Min Predicted minimum distance m % Predicted Standard % in variations of the distance covered with respect to predicted standard distance % % Pred. Min % of variations of distance covered with respect to predicted minimum distance % AUC/Distance Area under SpO2 curve base relative to distance covered \ Dyspnea Borg CHG Variation in grade of dyspnea during walking \ Fatigue Borg CHG Variations in level of fatigue during walking \ ∆=DELTA *There follows a description of the method for calculating the area below the SpO2 baseline curve:](https://usermanual.wiki/MIR-Medical-Research/MIR020/User-Guide-671725-Page-19.png)
![spirobank II User’s Manual cod. 980200 Rev 2.2 Page 20 of 60 Parameters requested for six minute walk test analysis SYMBOL DESCRIPTION Units Dyspnea Borg Baseline Grade of dyspnea before walking \ Dyspnea Borg End Grade of dyspnea after walking \ Fatigue Borg Baseline Level of fatigue before walking \ Fatigue Borg End Level of fatigue after walking \ Walked Distance covered during walking m Parameters measured with SpO2 Analysis: SYMBOL DESCRIPTION Units SpO2 Baseline SpO2 Average in first three minutes % SpO2 Min SpO2 Minimum during period of analysis % SpO2 Max SpO2 Maximum during period of analysis % SpO2 Mean SpO2 Average during period of analysis % BPM Baseline Average pulse frequency in the first 3 minutes BPM BPM Min Minimum pulse frequency during the period of analysis BPM BPM Max Maximum pulse frequency during the period of analysis BPM BPM Mean Average pulse frequency during the period of analysis BPM Recording time Total time measure of SpO2 hh:mm:ss T < 90% Time passed with SpO2 < 90 % % hh:mm:ss T < 89% Time passed with SpO2 < 89 % % hh:mm:ss T < 88% Time passed with SpO2 < 88 % % hh:mm:ss T < 87% Time passed with SpO2 < 87 % % hh:mm:ss N° Events SpO2 < 89% Fall of SpO2 below 89 % for at least 20 seconds \ ∆ Index [12s] Index of SpO2 fluctuation calculated in intervals of 12 seconds \ T< 40 BPM Time passed with pulse frequency < 40 BPM % hh:mm:ss T> 120 BPM Time passed with pulse frequency > 120 BPM % hh:mm:ss N° Events < 40 BPM Bradycardia events during the entire period of analysis \ N° Events > 120 BPM Tachycardia events during the entire period of \](https://usermanual.wiki/MIR-Medical-Research/MIR020/User-Guide-671725-Page-20.png)
![spirobank II User’s Manual cod. 980200 Rev 2.2 Page 57 of 60 Guidance and manufacturer’s declaration – electromagnetic immunity The spirobank II is intended for use in the electromagnetic environment specified below. The customer or the user of the spirobank II should assure 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 contact ±8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst IEC 61000-4-4 ±1 kV for input/output lines 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 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 sec Not Applicable Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz [3 ] V [3 ] V/m Portable and mobile RF communications equipment should be used no closer to any part of the spirobank II, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=[ 3.5 ] P 3 d=[ 3.5 ] P 80 MHz to 800 GHz 3 d=[ 7 ] P 800 MHz to 2,5 GHz 3 where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer](https://usermanual.wiki/MIR-Medical-Research/MIR020/User-Guide-671725-Page-57.png)
![spirobank II User’s Manual cod. 980200 Rev 2.2 Page 58 of 60 and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE UT is the a.c. mains voltage prior to application of the test level. 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 reflection from structures, objects and people. a) Field strengths from fixed 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 theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the spirobank II is used exceeds the applicable RF compliance level above, the spirobank II should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the spirobank II. b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.](https://usermanual.wiki/MIR-Medical-Research/MIR020/User-Guide-671725-Page-58.png)
![spirobank II User’s Manual cod. 980200 Rev 2.2 Page 59 of 60 Recommended separation distances between portable and mobile RF communications equipment and the spirobank II The spirobank II is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the spirobank II can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the spirobank II as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz d=[ 3.5 ] P 3 80 MHz to 800 MHz d=[ 3.5 ] P 3 800 MHz to 2,5 GHz d=[ 7 ] P 3 0.01 0.12 0.24 0.24 0.1 0.37 0.37 0.74 1 1.17 1.17 2.34 10 5.28 5.28 1.056 100 11.66 11.66 23.32 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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 apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.](https://usermanual.wiki/MIR-Medical-Research/MIR020/User-Guide-671725-Page-59.png)
