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1. M Acoustic signals Beep with frequency of the cardiac pulse Continuous beep in the case of either 5 gt or cardiac pulse going outside of the programmed levels of alarm Continuous beep during oximetry measurement in the case of a low battery level If the patient s finger is not inserted correctly or the connecter is not properly attached there will be an intermittent beeping sound for 10 seconds If the test has been interrupted due to low battery power an intermittent beeping will be heard for 10 seconds when the device is switched on again The specifications for both the oximetry and for the cardiac pulse are the same regardless of which of the above mentioned oximetry sensors is used spirobank Z7 User Manual cod 980200 Rev 3 3 Page 15 of 43 1 5 3 Other features Memory Display n Interface Power un CMM Weight m Type of electrical protection Type of electrical protection Grade of protection against water ingress Safety level in the presence of inflammable _anaesthetic gas oxygen or nitrogen Conditions OF USE 1 Storage conditions Operating conditions Applied norms 2 FUNCTIONING OF THE SPIROBANK 2 1 Keyboard Memory capacity for over 6000 spirometric tests The precise number depends on the individual configuration s
2. M O O Oo accessories for single use only all other accessories are reusable Before using your spirobank e Read this manual carefully plus all labels and other product information supplied e f not fitted install the operating battery taking care to connect the and battery poles correctly as shown in the battery compartment e Set the device configuration as required date time predicted values device language etc as described in Paragraph 2 4 WARNING A The winspiroPRO PC software supplied with the device MUST be installed correctly to the PC before connecting spirobank JJ to the PC At the end of the installation connect the device to the PC and the hardware will be recognised by the PC The device can then be used with the winspiroPRO software 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 e Return the complete device in the original packaging and e 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
3. 6 1 1 4 Can Or MUSL MaKe the INS 6 1 4 5 Subject effect on the use of the 6 1 1 6 l imitatiorns oPuse Gontrandicatlons 7 1 2 eaae 7 1 2 1 Danaer Of CrOSS COMAMIMAL OM 7 1 2 2 c cc T 1 2 3 IV OULD EC tom Ditta Ier LI uar M EM ED E QUEM 8 1 2 4 OXIME RY SOM va m Tc 8 1 2 5 LJ WIC didi soi sate debs teas shed eet 9 1 3 Dnroreseer el TOES ix o iia sd va 9 1 4 and SV 10 1 4 1 IGERUINIC ATION TAD e V 10 1 4 2 CE mark tormedicaldeViOBS aaa d sh RELE EROA EEKAN 10 1 4 3 sare Dudas cu 10 1 4 4 Waring symbol Tor the RS23
4. m i 2575 5 25 109 The following screens show other values compared to the predicted values 2 8 7 POST test after administration of drug WARNING To carry out a POST test it is necessary to have carried out at least one PRE FVC type test on the patient on the same day it is not possible to do a POST test on the PRE VC or MVV tests it is however possible to do a POST VC or MVV test if the archive already contains at least one PRE test carried out on the same day To carry out a POST test please refer to paragraph 2 5 Before carrying out the test it is necessary to indicate the drug dosage administered in order to have a reference when controlling the results of the parameters measured The results allow the confrontation of the spirometry parameters calculated in the POST test against the best results obtained in the PRE test already present in the patient archive for that session session refers to tests carried out on that day It is not possible therefore to carryout a POST test on a patient if the patient archive only contains PRE tests spirobank Z7 User Manual cod 980200 Rev 3 3 Page 25 of 43 carried out only on previous days When the results are displayed it is possible to see the variation between the PRE and POST values shown in column headed CHG To exit the POST session select a new patient from the archive and press OK the following message is
5. la bee DUAE 32 3 2 2 Setting the Phone NUITIDGI Oeo e HH oleae auch USE utens 32 3 2 3 BIueteotiDala Trans MISSION nen esa 32 3 3 Data Transmission via Bluetooth for 32 3 4 Connection to a PC through USB port 2 1 1 33 3 5 Gonnectiod o a PG Through the RS 232 33 3 6 Upgrade SOMWANGC NC EET EE mmm 33 MAINTENANCE Terr H 33 4 1 Cleaning and controlling the reusable nnne nnne 34 4 2 Gleaning tie oximielby Sen SO iocos 34 4 3 Changing the adhesive tape of the wrap 34 4 4 Changing the Sivas Cosa t e Ce 35 PROBLEM SOLVING eire E 35 5 1 Causes and E a pt t 35 spirobank Z7 User Manual cod 980200 Rev 3 3 Page 4 of 43 LIMITED WARRANTY gio 37 1 TEST REPORT EXAMPLES
6. RR 21 2 6 ING Catal Memory 22 2 7 Online operating mode connected to 22 2 8 re E 23 2 8 1 mu TOSI Me cC 23 2 8 2 ION T cc ETE 24 2 8 3 MNN TOS E 24 2 8 4 FAC ACIIOMMECSS AOS TO DELE UTEM 24 2 8 5 opiromietry Test INLSTOSTATION diea DE 24 2 8 6 Viewing the spirometric 25 2 8 7 POST Test after administration or drug be a ai eee 25 2 9 OXIME IY TESTING m LE 26 2 9 1 LACE cM SUL Ap rr 28 2 9 2 SEEP OMEN RE E T NE 29 2 9 3 DE OZ TOS svi 29 2 9 4 eai PRESS E 29 2 9 5 Adult Single Patient Sensor Instructions for 05 30 DATA TRANSMISSION eve 31 3 1 Wireless Data Transmission via Phone Line esee nenne nennen nenne nennen nennen nnn nnns 31 3 2 Data Transmission via Bluetooth to a cell 32 3 2 1 Preliminary Operati nS
7. Vital Capacity ce Volume expired the 1 second ofthe test AA FEVI FVO FEVTEVO x4100 FEV1 VC FEV1 best between EVC and IVC x 100 DUO RDUM ELI HBBILQO PII PII HEU IUDICO IUBE BI EL DIC IDEE spirobank Z7 User Manual cod 980200 Rev 3 3 Page 12 of 43 SYMBOL DESCRIPTION Units PEF Peak expiratory Us sss FEF2575 Average flow between 25 and 75 ofthe FVC is FEF25 Forced Expiratory Flow at 25 of d LS sss FEFSO Forced Expiratory Flow at 50 of s TIME FEF75 Forced Expiratory Flow at 75 of FVO lS Volume expired the initial seconds of the test 1 Less FEV3 FVO FEV3 FVC 10 de IDs FEV6 Volume expired in the initial 6 seconds of the test FEV6 FEVI FEV6 X100 FET Forced expiratory time Extrapolated volume Ie FIVC Forced inspiratory volume 50 Volume inspired the 1 second ofthe test L Audi m xs MCI MINE Peak inspiratory el S voluntary ventilation calculated on FEV1 vital capacity expratory css EVO Slow espiratory vital capacity IVC Slow inspiratory vital capacity IC Inspiratory capacity max between and IVC ERV Lo EA Expiratory reserve volume IM L
8. The duration of the test is minimum 2 minutes then the screen shows corresponding to the key press this key to pass to the following phase If the phase lasts for more than 6 minutes then spirobank will emit a beep as a reminder to pass to the following walking phase The number of bars cr symbol on the right upper of the screen is proportional to the quality of the oximetry signal the higher the quality of the signal the more bars will be shown maximum 7 Place finger into the sensor in order to obtain the highest quality of the signal Walking Phase At the beginning of the phase the timer is reset to zero to give an accurate control of the duration of each single phase The data on the display is the same as shown before The duration of this phase is minimum 2 minutes then the icon appears corresponding to Press this key for a few seconds to pass to the initial rest phase If this phase lasts for more than 6 minutes then spirobank will emit a beep after which the device passes to the initial phase and the timer is re set to zero Recovery Phase The user can decide freely on the duration of this phase the duration is not suggested at the beginning of the phase the time is re set to zero To end test press ESC and then lt 1 This must be done each time the current test is interrupted At the end of the test the data required for the calculation of the parameters must be inserted more specifically Baseline
9. during the initial phase ofthetest ISS EN IE Predicted standard distance e Fs e Predicted minimum j 96 in variations of the distance covered with respect to predicted standard 96 of variations of distance covered with respect to predicted minimum D CC x Area under SpO2 curve base relative to distance covered 5 Variation in grade of dyspnea during walking iN Variations in level of fatigue during walking 2222 There follows a description of the method for calculating the area below the SpO2 baseline curve spirobank Z7 User Manual cod 980200 Rev 3 3 Page 14 of 43 SpO2 SpO2 baseline time Parameters requested for six minute walk test analysis SYMBOL DESCRIPTION Units Parameters measured with SpO2 Analysis SYMBOL 4 DESCRIPTION Units 2 SpO2 Baseline SpO2 Average first three 5 ss SpO2Min SpO2 Minimum during period of analysis A 5 2 SpO2 Maximum during period of analysis 40 5 2 Mean k 5 2 Average during period of analysis 00600 BPM Baseline Average pulse frequency inthe first 3 minutes BPM BPMMin Minimum pulse frequency during the period of analysis 1 BPM RN BPM Maximum pulse frequency during the period of analysis BPM BPM Average pulse frequency during the period of analysis BPM Recordingtime Totaltime measure
10. NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people spirobank Z7 User Manual cod 980200 Rev 3 3 Page 43 of 43
11. e tI ME 38 ANNEX 2 SPIROME TRY TEST REPORT EXAMPLES iode mue estas ces areca EE 41 ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT 42 spirobank Z7 User Manual cod 980200 Rev 3 3 Page 5 of 43 1 INTRODUCTION 1 1 Intended Use Indications for Use The Spirobank ll spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic The device is intended to test lung function and can make e spirometry testing in people of all ages excluding infants and neonates e oximetry testing in people of all ages It can be used in any setting 1 1 1 User Category The spirobank spirometer oximeter calculates a series of parameters relating to human respiratory function Typically the doctor prescribes a spirometry test and is responsible for analysing and controlling the results obtained 1 1 2 A Ability and experience required The correct use of the device the interpretation of the results and the maintenance of the device all require qualified personnel In the event that the device is operated by the patient then sufficient training must first be given to the patient by the doctor or by the trained paramedic under the supervision of the doctor WARNING A The manufacturer cannot be held responsible for any damage caused by the user of the device failing to follow the instructions and warnings c
12. SpO2 lt 87 0 00 00 00 Total Desaturation Events 1 Total Pulse Rate Variations 5 ODI Desaturation Index 14 3 Pulse Rate Variation Index 71 4 Mean Duration s 50 0 Longest Duration s 50 NOD 4 Baseline 4 00 00 00 Desaturation Peak Nadir 94 NOD 89 lt 89 00 00 00 Mean Desaturation 94 NOD 90 lt 90 Nadir lt 86 00 00 00 Made by spirobank II Signature spirobank User Manual cod 980200 Rev 3 3 Page 38 of 43 Oximetry Walk Test 6MWT Name A B Date 27 03 06 Time 10 17 Age 38 Height cm 182 Wheight kg 70 Sex M SpO2 Graph 1 2 3 4 5 6 7 8 Pulse Rate Graph Minutes 140 100 60 20 d 2 3 4 5 6 7 8 Recording Time 00 05 22 Analysis Time 00 02 18 Baseline Time 00 02 06 Walking Time 00 02 18 Recovery Time 00 00 00 5 2 Mean 96 5 BPM Mean 66 6 Baseline 96 8 End 96 Baseline 65 7 End 72 Minimum 95 Maximum 99 Minimum 63 Maximum 73 T 2 Delta SpO2 gt 2 22 09 03 Bradycardia Events lt 40 BPM 0 T 4 Delta SpO2 gt 4 PP O1 Tachycardia Events gt 120 BPM 0 time hh mm ss time hh mm ss T90 SpO2 lt 90 0 00 00 00 T lt 40 BPM 0 00 00 00 T89 SpO2 lt 89 0 00 00 00 gt 120 0 00 00 00 88 5 02 lt 88 0 00 00 00 T87 SpO2 lt 87 0 00 00 00 Distance Dyspnea Borg scale Walked 0 Baselin 0 End 0 CHG 0 Predicted Standard 754 0 Predicted Minimum 601 0 Fatigue Borg scale AUC Distance 27 0 Baselin 0 End 0 CHG 0 Made by spirobank II Signature
13. USB or battery symbol Current date and time BTPS Body Temperature Pressure Saturated icon Access to the Service Menu e SpO2 BPM icon Press OK to go to the second display Press ESC to go directly to the main screen The second display will show e ATS ERS Standard e Subjects in memory no of registered patients e Spiro no of spirometry tests made e 5 2 of oximetry tests made e Available memory 96 value If there is no information or test data in memory i e the memory is empty all data is shown with O null 2 4 Initial Set up Switch on spirobank by pressing and holding b and wait for the second screen Press lt to access the service menu The following screen Service Menu contains the following menu e Select Language English default e Turbine Calibration e Select Predicted Values e Delete MEMORY e Change Date Time e Date Format e Units Format e Turbine Setup e Standard e Phone Setup e Bluetooth Setup e Firmware Info e Oximetry alarms e SpO2 sampling time Select the required option using lt 1 or and the gt symbol on the left of the screen press OK to access options select the required setup using the X or arrow then press OK to return to the Service Menu Select Language Press OK to access the Menu use lt or to select the required language and then press OK to register the change and return to the Service Menu spirobank Z7 User Manual cod
14. during the first second of a forced expiry the following comment is shown COUGH DETECTED DURING TEST FET error If FET is under the predicted threshold the following message appears EXPIRY TIME INSUFFICENT lt 6s FLOW ERROR If the last flow point of the F V curve is greater than 200 mL s this indicates that the expiration was not complete and thus the following comment is shown BLOW OUT ALL AIR IN LUNGS Between two tests spirobank evaluates the repeatability of the following parameters PEF repeatable when the difference between the two largest PEF is lt 0 67 L s VC repeatable when the difference between the two largest VC is lt 150 mL If FVC is gt 1 0 L then FEV 1 repeatable when the difference between the two largest FEV1 is lt 150 mL FVC repeatable when the difference between the two largest FVC is lt 150 mL if FVC is s 1 0 L then FEV1 repeatable when the difference between the two largest FEV1 is 100 mL FVC repeatable when the difference between the two largest FVC is lt 100 mL 2 8 6 Viewing the spirometric parameters Following an FVC test the spirometry test results are shown The first screen displays the main parameters FVC FEV1 FE1 PEF the percentage of the predicted values the Flow Volume chart plus a traffic light summary of the test interpretation in the upper left part as illustrated below MIR spirobank 5 FEV1 4 5 04 7 1 ine Ju
15. 39 0622754785 Web site www spirometry com Email mir spirometry com MIR has a policy of continuous product development and improvement and the manufacturer therefore reserves the right to modify and to update the information contained in this User s Manual as required Any suggestions and or comments regarding this product should be sent via email to mir spirometry com Thank you MIR accepts no responsibility for any loss or damage caused by the User of the device due to instructions contained in this Manual and or due to an incorrect use of the product spirobank Z7 User Manual cod 980200 Rev 3 3 Page 2 of 43 Note that due to printing limitations the screenshots shown in this manual may differ from the display of the machine and or from the keyboard icons Copying this manual in whole or in part is strictly forbidden FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN spirobank Z7 User Manual cod 980200 Rev 3 3 Page 3 of 43 INDEX 1 4 5 s 6 1 1 insieme 6 1 1 1 C AE EE EEEE EEE E E E 6 1 1 2 6 1 1 3
16. 980200 Rev 3 3 Page 18 of 43 Turbine Calibration Insert the following password to access the calibration function d For the correct use of this function please see Paragraph 2 4 1 Select Predicted Values Adult Paediatric Enter Menu with OK then use lt 1 or gt to select the required value and press OK again nM DER E RS Knudson 52222 Tessa Roe aa USA Knudson Delete Memory ERS Zapletal Enter Menu with OK then enter the password 4 MC Barcelona _ Zapletal qd if the password inserted in correct the following message appears Test data has been cancelled Change Date Time In the date and time setting the 4 arrow shown to the right of the field indicates the field to modify Use or to modify the selected option use gt for the following option Lastly press OK to return to the Service Menu To return to the Service Menu display without entering any changes press ESC Date Format Use lt gt to select the required format and press OK to enter and return to the Service Menu Units Format Access with OK and select imperial or metric as required Press OK again to return to the Service Menu Turbine Setup Access with OK and select the required turbine disposable or reusable Press OK again to return to the Service Menu Standard Access with OK and select the required standard using lt or gt Press OK to re
17. activity Carry out an oximetry test as follows e Connect the sensor to the instrument insert the connector with the arrow printed on the connector face up as shown e Choose a high perfusion site easily adaptable to the sensor e Insert finger into the sensor until the finger touches the end of the probe Ensure that the bottom part of the finger completely covers the detector If the finger is not able to be correctly positioned use another finger Position the sensor so that the cable is underneath the palm of the hand This enables the light source to remain on the fingernail and the detector on the bottom part of the finger e From the main screen press to access the test menu Press gt to access oximetry If this message appears WARNING THE OXIMETRY DEVICE IS NOT AVAILABLE spirobank Z7 User Manual cod 980200 Rev 3 3 Page 26 of 43 your instrument does not include an oximeter Instead If this message appears WARNING THE OXIMETRY DEVICE IS NOT ENABLED your instrument includes an oximeter but the function has not been enabled In this case contact a service centre or the manufacturer WARNING Before starting the test check to see that the battery is fully charged if it is low the following message will be shown Batteries are low and may not be sufficient for an oximetry test In this case select ESC to exit the test by pressing any key you can continue with the test already set up If the t
18. in the presence of inflammable anaesthetic gases oxygen or nitrogen The instrument is not designed to be used in direct air currents e g wind sources of heat or cold direct sun rays or other sources of light or energy dust sand or any other chemical substances The user and or the doctor are responsible for ensuring that the device is stored and used in appropriate environmental conditions in this regard reference is made to the specifics described in paragraph 1 6 3 below WARNING A If the device is exposed to unsuitable environmental conditions this could cause the device to malfunction and to give incorrect results 1 1 4 Who can or must make the installation The device requires installation by qualified personnel Normally the doctor configures the instrument before giving it to the patient for use at home 1 1 5 Subject effect on the use of the device A spirometry test should only be carried out when the subject is at rest and in good health and thus in suitable testing conditions A spirometry test requires the collaboration of the subject since the subject must make a complete forced expiration in order to have a meaningful test result spirobank User Manual cod 980200 Rev 3 3 Page 6 of 43 1 1 6 Limitations of use Contraindications An analysis of the results of a spirometry test is not by itself sufficient to make a correct diagnosis of the subject s clinical condition A detailed clinical history of the su
19. or RS232 Upgrades be downloaded by registering On www spirometry com For further information on upgrading software see the winspiroPro software manual 4 MAINTENANCE spirobank is an instrument that requires very little maintenance The operations to perform periodically are Cleaning and controlling of the reusable turbine Changing the disposable turbine before each test Cleaning of the oximetry sensor for reusable sensors Changing the adhesive tape of the oximetry wrap sensor Changing the battery The maintenance operations described in the User s Manual must be carried out carefully Failing to observe the instructions may cause errors in measurement or in the interpretation of the measured values Modifications adjustments repairs and reconfiguration must be carried out by the manufacturer or by authorised persons In case of problems do not attempt to repair the unit spirobank User Manual cod 980200 Rev 3 3 Page 33 of 43 The setting of configuration parameters must be carried out by qualified personnel In any case the risks pertaining to incorrect configuration settings do not constitute a danger for the patient 4 1 Cleaning and controlling the reusable turbine The turbine utilized by spirobank belongs to one of two categories disposable and reusable These guarantee precise measurements and have the great advantage of requiring no periodic calibration In order to maintain the characteristics of
20. status and correct alignment at least every 4 hours WARNING A Incorrectly applied sensors or damaged cables may cause inaccurate readings Using a damaged sensor may cause inaccurate readings possibly resulting in patient injury or death Inspect each sensor before use If a sensor appears damaged do not use it Use another sensor or contact your authorized repair centre for assistance Use only MIR sensors supplied with or specifically intended for use with the spirobank Use of sensors not intended for use with the spirobank may cause inaccurate readings Oximetry measurements may be inaccurate in the presence of high ambient light Shield the sensor area with a surgical towel for example if necessary WARNING A spirobank Z7 User Manual cod 980200 Rev 3 3 Page 8 of 43 Dyes introduced into the bloodstream such as methylene blue indocyanine green indigo carmine patent blue V PBV and fluorescein may adversely affect the accuracy of the oximetry reading Any condition that restricts blood flow such as the use of a blood pressure cuff or a device for systemic vascular resistance may cause an inability to determine accurate pulse rate and SpO2 readings Remove fingernail polish and or false fingernails before applying SpO2 sensors Both may cause inaccurate oximetry measurement Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin may adversely affect the accuracy of the oxim
21. system enables spirobank to transfer test data directly to a Bluetooth enabled printer The sequence of activities to be followed is e From the main screen select the test to be printed with gt e Onthe next screen press icon e Print either a spirometry or an oximetry test by selecting respectively lt or choosing to print spirometry tests the last test of the patient selected on the main screen will be shown selecting oximetry tests the last test made pertaining to that patient will be printed spirobank Z7 User Manual cod 980200 Rev 3 3 Page 32 of 43 Tests stored on memory can also be printed Use the search method as described in Paragraph 2 6 to print out relevant tests Onthe relevant test screen press lt e spirobank will carry out the connection e At the end of transmission spirobank will show CONNECTION COMPLETED and return automatically to the main screen To interrupt the Bluetooth connection during transmission press ESC to return to the main screen Where no printer has been set up a message will appear to search for devices After the device has been set up it will automatically be enabled for printing data When searching for enabled for Bluetooth devices spirobank will check the address of that device and where previously registered device has changed name it will be automatically updated 3 4 Connection to a PC through USB port WARNING Before conne
22. the turbine a simple cleaning is required prior to each use only for the reusable turbine Cleaning of the disposable turbine is not required as it is supplied clean in a sealed plastic bag It must be disposed of after use WARNING A It is good practice to control from time to time that dirt or foreign bodied are not deposited inside the turbine such as threads or hair Any such deposits could brake or block the rotation of the turbine blade and thus compromise the measurement accuracy Verify the free movement of the turbine e Switch on spirobank as if to make a spirometry test for example FVC Hold spirobank in one hand and move it gently from side to side so that air passes through the turbine e rotor within the turbine is turning correctly then you will hear a beep that indicates that the turbine is moving within the specific low flow range indicated by the beeping e f moving the turbine from side to side at a constant velocity the regular beeps or no beeps at all are heard then proceed with the cleaning of the turbine To clean the reusable turbine first remove it by pulling it gently from the spirobank turning it anti clockwise and pressing lightly It can be helpful to push it gently from underneath with one finger Immerse the turbine in a cold detergent solution and move it within the liquid to remove any impurities which may be deposited inside Leave it to soak for at least the time recommended
23. to select either a POST or PRE test using respectively or ESC Once entered the i icon will appear on the upper right of the main screen for POST testing of the subject For more information about POST test please see paragraph 2 7 8 To access memory From the Patient Data Management screen use gt to directly access the screen with the four memory search methods 2 6 Modifying patient data In the Patient Data Management menu press which corresponds to the icon Modify data in the following screens by using the keys as described for entering new patient data To return to the main screen without changing any data press ESC 2 6 Displaying data in memory T 1 From the main screen press E icon to check patient data choose between spirometry and oximetry or to search for another patient s data the following options are available FUNCTION Display spirometry tests of the selected patient Display oximetry tests of the selected patient _ Access data in memory Press ESC to return to the main screen Access the search menu to display data based on four different methods KEY ICON FUNCTION Display files from beginning to full memory Search by initial letter of surname Search by ID Code enter the ID Code of the patient to be searched for then press OK to access the data Partial Memory enter test date of required file after entering the date press OK to access
24. 00 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 or the user of the spirobank should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment test level guidance 6 kV contact 6 kV contact 8 kV air 8 kV air 1 kV for input output lines 1 kV mode differential Not Applicable 2 kV common mode lt 5 95 UT gt 95 dip in UT for 0 5 cycle Not Applicable 40 UT 60 dip in UT for 5 cycles 70 96 UT 30 96 dip in UT for 25 cycles lt 5 95 UT 95 96 dip in UT for 5 sec 3 Vrms 150 kHz to 80 MHz 3 3 V m 80 MHz to 2 5 GHz Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Portable and mobile RF communications equipment should be used no closer to any part of the spirobank including cables than the recommen
25. 2 senal DOM iaaa 10 1 4 5 Warning symbol for the USB serial 10 1 4 6 Warning symbol for the SpO2 port for 10 1 4 7 Warmng symbol Tor tbe WEEE nho e aga e FOR D Ra EE 10 1 4 8 FDA INAFE C m P T 11 1 4 9 Product 11 1 5 TECHHICAPSDECIICAUOMS PERSM 12 1 51 Features orte Spirometer do Dura EODD v 12 1 5 2 Features or Ine OXIITIO mud E ex ada 13 1 5 3 in MIRI RNC HM 16 FUNCTIONING OF THE spirobank If iae rare dente xe ub nega 16 2 1 FSV pM 16 2 2 Battery 18 2 3 MOANN er EIE 18 2 4 Mual SetU 18 2 4 1 Beide CAID AION cc ETT 20 2 5 ax cui MB
26. 90 600 85 FIVC 2 48 FIV1L 2 41 FIV1 FIVC 97 2 PIF 5 433 HMVV 109 6 104 3 T VOLUME L Best Value Calcolated Value INTERPRETATION Possible Moderate Restriction POST significant Bronchodilatation POST FEF2575 24 CHG QUALITY CONTROL GRADE D REPEATABILITY None Made by spirobank II ver i t Signature spirobank Z7 User Manual cod 980200 Rev 3 3 Page 41 of 43 ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT Guidance and manufacturer s declaration electromagnetic emissions The spirobank is intended for use in the electromagnetic environment specified below The customer or the user of the Spirobank should assure that it is used in such an environment RF emissions CISPR 11 RF emissions CISPR 11 Compliance Group 1 Electromagnetic environment guidance The spirobank uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Class B Harmonic emissions Not applicable IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable Guidance and manufacturer s declaration electromagnetic immunity The spirobank is intended for use in the electromagnetic environment specified below The customer Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 610
27. Check the correct functioning of the spirobank with a new turbine and or Clean the turbine To erase the calibration in use and reset to the factory calibration input 0 in the New FVC and New FIVC fields Then press OK to return to the Service Menu Note Each time a calibration is made the new correction factors are algebraically added to the previous correction factor Therefore before making a new calibration make sure to delete the actual calibration in use as described above spirobank Z7 User Manual cod 980200 Rev 3 3 Page 20 of 43 For an accurate and reliable calibration the syringe volume must be at least 3 L WARNING A In line with the publication Standardised Lung Function Testing of the European Respiratory Society Vol 6 Supplement 16 March 1993 the air expired from the mouth is at a temperature of circa 33 34 C The expired flow and volume to be converted to BTPS conditions 37 C must be increased by 2 6 this is derived from the BTPS factor of 1 026 at a temperature of 33 C which represents a correction of 2 6 In practice the BTPS factor for the expired flow and volumes is therefore constant and equal to 1 026 For the inspired volumes and flows the BTPS factor depends upon the ambient temperature as the air inspired is at ambient temperature For instance at an ambient temperature of 20 C with relative humidity at 50 the BTPS factor is 1 102 a correction of 10 2 The correction of the inspi
28. DYSPNEA Final DYSPNEA Baseline FATIGUE Final FATIGUE Distance m These follow the Borg scale and can have the following values 0 0 5 1 2 3 4 5 6 7 8 9 10 the distance covered is indicated in m The Borg scale coefficients represent the following severity values SCALE SEVERITY spirobank Z7 User Manual cod 980200 Rev 3 3 Page 28 of 43 Use and to enter data use OK to pass to next data Walk test data results are given in the following 6 screens To print data see Paragraph 3 3 The printout version of the test will only show the walk test results an example of a test printout report is attached Press ESC and then lt 1 to end test at any moment WARNING A One of the parameters calculated by the spirobank during an oximetry test is the so called Recovery Time The Recovery Time is defined as the time taken for the SpO2 value to return to at least 99 of the average base value calculated during the initial phase of the test 2 9 2 Sleep Oximetry To activate this type of test press This test records the variations that the parameters of the patient undergo over night After approximately 5 minutes spirobank will on standby i e it stops beeping and the display turns off The led signal remains on To control the correct functioning while on standby press 5 after 1 minute spirobank will return to standby If there is no signal while on standby the device will automaticall
29. L volume ae Lo Ventilation per minute at rest ssi L mn Respiratory frequency Breath min _ cme Average time of inspiration atrest ese Average time of expiration at rest TV t flow of inspiration 0 UTtot d MVV Maximum voluntary ventilation L min ELA Estimated lung age year best values E Flow volume measurement system Bi directional digital turbine Temperature sensor Semiconductor 0 45 C Measurement principle Infrared interruption Volumerange 10422 Flowrange 1605 Volume accuracy 3 3 OF S0 Flow accuracy 5 or 200 mL s Dynamic resistance at 12168 7 lt 5 1 5 2 Features of the oximeter Definitions Desaturation events SpO2 fall gt 496 in a limited period of 8 40 sec and Desaturation Event ee T citing SUCCESSIVE rise gt 2 within a total period of 150 sec amp Total Pulse rate Pulse rate rise gt 10 BPM in limited period of 8 40 sec and successive Variation fall 8 BPM during a total period of 150 sec Parameters measured during sleep oximetry SYMBOL DESCRIPTION 2 7 Units 2 SpO2 Baseline SpO2 Average in first three MINUTES Ds SpO2Min SpO2 Minimum during period of analysis SpO2Max Maximum during period of analysis SpO2 Mean y SpO2 Average during period of ANALYSIS Os BPM Baseline Av
30. TTTITITTETITITITTII s nn ne nn na Cun thet nu uo RR SS RR ERR RR RR RR SER AERE SR RENS SERE SERE SR RENS S RR SERE SR RENS SSRR SERE RSEN SNR itnth unit ienthtnt unt inti iinet ntti nntihuntt nti ient inet nit iinet SER SR SERRE SERE SR nett AR SERE SR SERRE SERR SERE RR SR RR RR a au To transfer data through acoustic coupling WARNING A IF no key is pressed the instrument after 1 minute will beep and if no key is pressed after 10 seconds it will automatically switch off If spirobank is powered by a USB connection to a PC the aforementioned function is disabled and the device is switched off using b spirobank Z7 User Manual cod 980200 Rev 3 3 Page 17 of 43 The instrument can be switched off at any time by pressing and holding the b key for two seconds 2 2 Battery Level The symbol shown in the second screen when the unit is turned on indicates that the battery is charged The following symbol indicates Low Battery c If the battery is discharged the following message appears BATTERY DISCHARGED 2 3 Information Switch on spirobank by pressing b The display will show spirobank 0 1 device name and software revision number Power means
31. When inserting the batteries in the battery slot take care to correctly connect the and as shown inside see figure below The device has an internal lithium battery for RAM memory the average life is approximately 10 years If the display shows the following message Warning change lithium battery Call a service centre or the manufacturer for replacement 5 PROBLEM SOLVING There follows a list of problems that may arise when working with spirobank Diagnostic messages are also shown on the display indicating the type of malfunction 5 1 Causes and Solutions spirobank does not switch on Check that batteries are correctly inserted in the compartment on the back of the instrument If they are correctly positioned then replace them with new ones e During operation the machine switches itself off and on again Change the batteries e At the end of spirometry testing the test data is incorrect Clean the turbine and then control it use a new turbine e All data memory lost due to an unforeseeable event All data in memory has been deleted Contact the technical service centre WARNING A Before contacting the centre for technical assistance please download the archive from the device on to the PC using the Winspiro PRO software This procedure is necessary as the data could be lost whilst repairing the device and could also be of a confidential nature and therefore subject to laws on data privacy sp
32. al after use should turbine adhere to the local regulations and norms in force spirobank Z7 User Manual cod 980200 Rev 3 3 Page 7 of 43 The correct functioning of the re usable turbine can only be guaranteed if it has been cleaned in the correct manner and is free from foreign bodies which could alter its movement If the turbine has not been cleaned sufficiently this could cause cross contamination from one patient to another Periodic cleaning should only be done when the instrument is for personal use and will only be Reusable used by one patient The cleaning of the turbine should be performed according turbine to the instructions contained in the User s Manual The following information applies to both turbine models The turbine must never be held under a jet of water or air and must never come into contact with high temperature fluids Do not allow dust or foreign bodies to enter the turbine sensor in order to avoid incorrect functioning and possible damage The presence of any impurities such as hair sputum threads etc within the body of the turbine sensor may seriously compromise the accuracy of the measurements 1 2 3 Mouthpiece Any disposable mouthpieces included with the device are supplied only as a guide to the correct type and dimensions of the mouthpiece required for this device they are clean but not sterile To purchase appropriate mouthpieces generally either paper or plastic but in any case single use disposa
33. an FVC test for the expired parameters and an FIVC test for the inspired parameters To access the calibration function select the Turbine Calibration option from the Service Menu with the horizontal scroll key and then press OK The following screen appears VOL 300 5 Corr Old FVC 300 0 00 Old FIVC 300 0 00 New FVC 000 lt New FIVC FVC 0 FACTORY CALIBRATION The Old FVC and the Old FIVC values now shown are the ones from the last calibration The values under the 9eCorr column indicate the correction factor These are pre set or 0 by default To make the calibration 1 Insert the volume in cL of the calibration syringe in use e g for a 3L syringe insert 300 cL 2 Insert both the FVC and FIVC values obtained by the measurement made with the calibration syringe in the New FVC and New FIVC field Press gt to select the value to be modified SIRIN New FVC New FIVC Use or to modify the parameter value selected Insert both the FVC and the FIVC values If the calculated correction factors are acceptable 1096 they are displayed beside the New FVC and New FIVC parameters The message ENTER OK TO CONFIRM will appear Press ESC to return to the Service Menu without entering the correction If the FVC and FIVC values produce a correction factor that is gt 10 the FVC and FIVC values will not be accepted This means that the system cannot correct for such a large calibration error In this case
34. and a message informs the user when the battery is discharged Contact Technical Service to have this battery changed In the event of any incident or accident of any kind resulting from the use of the device the user is required to inform the manufacturer without delay this procedure is laid down in Article 9 of the European Regulations No 46 1997 which implemented the EC Directive No 93 42 1 2 1 Danger of cross contamination Two different types of turbine sensors can be used with the device one is reusable and one is single patient disposable A disposable mouthpiece is required in order to connect a subject to the spirometer In order to avoid exposing the subject to the critical danger of cross contamination the reusable flow sensor must always be cleaned before each spirometry test and a new disposable mouthpiece must always be used for each subject The use of an anti bacterial filter is at the discretion of the doctor If a single patient disposable turbine is used then a new one must be used for each patient 1 2 2 Turbine WARNING A If you are going to perform the spirometry test with a disposable turbine it is 2 important to use a new turbine for each new patient The characteristics accuracy and the hygiene of the disposable turbine can only be guaranteed if it 2 ae has been conserved beforehand in its original sealed packaging Disposable The disposable turbine is made of plastic and its dispos
35. apparatus or device such as TV radio appliances cell phones radio phones etc are being used If the instrument is connected to other devices PC printers modem etc to preserve the characteristics of the safety system pursuant to the IEC 601 1 1 Standards it is required that only devices complying with these safety regulations are used spirobank Z7 User Manual cod 980200 Rev 3 3 Page 31 of 43 3 2 Data Transmission via Bluetooth to a cell phone spirobank includes a Bluetooth wireless data transmission system This connection is through radio and allows spirobank JT to be connected to a suitable cell phone The method of data transmission allows the transferring of all the data in spirobank The sequence of operations to follow is described below 3 2 1 Preliminary Operations WARNING A The transmission of data through a Bluetooth connection requires the phone number of the unit where the data shall be transferred the doctor s office telemedicine service etc To enter the telephone number see the main menu when the machine is turned on Refer to Paragraph 2 4 A device must also be set up for the connection refer to Paragraph 2 4 for further details 3 2 2 Setting the Phone Number e Turn on spirobank by pressing b Onthe first screen press lt From the Service Menu select the option phone set up using and F e Press OK e Enter the number by using lt and gt to select digits an
36. bject is also required together with the results of any other test s suggested by a doctor Test comments a test interpretation and suggested courses of treatment must be given by a doctor Any symptoms that the subject has at the time of the test must be carefully considered before a spirometry test is made The user is responsible to assess both the mental and the physical capacity of the subject in order to make a correct test and the user in the evaluation of test results must also assess the degree of collaboration of each test carried out A spirometry test requires the full collaboration of the subject The results depend on the person s capability to inspire and to expire all air completely and as fast as possible If these fundamental conditions are not respected then the results obtained during spirometry testing will not be considered accurate and therefore the test results are not acceptable The acceptability of a test is the responsibility of the user Special attention should be given to testing elderly subjects children and handicapped people The device should never be used when it is possible or probable that the validity of the results may be compromised due to any such external factors WARNING A 1 2 Important safety warnings spirobank has been examined by an independent laboratory which has certified the conformity of the device to the European Safety Standards EN 601 1 and guarantees the EMC Requirements within
37. ble we suggest that you contact your local distributor who supplied the spirometer WARNING A Use a bio compatible mouthpiece to avoid any problems to the patient unsuitable materials could cause a bad functioning of the instrument and therefore the test results could be incorrect The user is responsible for obtaining the correct type of mouthpieces for the device Those required are a standard type with an outside diameter of 30 mm they are commonly used and in general easily procured To avoid environmental contamination caused by the disposal of used mouthpieces the user must follow all the relevant local regulations 1 2 4 Oximetry sensor The oximetry sensors which be used with spirobank are the following MANUFACTURER MANUFACTURER CODE DESCRIPTION 22222 2 BCI adultsensor disposable Wrap around sensor for infants ae s 043 universal Y sensor u 8078 5 6 s 4 pediatric finger sensor reusable 2 o 3444 adult sensor reusable Comfort Clip 3044 adult sensor reusable for finger These sensors require the use of an extension cable cod 919100 to be correctly connected to the device The same sensors are also available with microconnector for the direct connection Prolonged use and or the patient s condition may require changing the sensor site periodically Change sensor site and check skin integrity circulatory
38. by the producer of the cleaning solution as shown in the relevant instructions in general at least one hour To avoid any kind of damage to the reusable turbine please do not use any alcoholic or oily substances do not immerge the turbine in hot water or hot solution Do not put the turbine under a direct jet of water or other liquid If no detergent solution is available clean the turbine in clean water MIR suggest the use of Perasafe manufactured by Dupont which has been tested with positive results on all MIR sensors Rinse the turbine by immerging it in clean water not hot Shake off the excess water from the turbine and leave it to dry standing it vertically on a dry surface Once the turbine has been cleaned insert the turbine tube in its place following the instructions indicated by the closed lock symbol printed on the plastic casing of the spirobank To insert the turbine correctly push it and then turn it clockwise until it reaching the stop which ensures that the tube has been blocked inside the casing To ensure the turbine is functioning correctly repeat the controls described above if it doesn t works correctly replace with an other one If the disposable turbine is used do not clean it but change it after each test 4 2 Cleaning the oximetry sensor Clean the sensor with a soft cloth moistened with water or a mild soap solution To disinfect the sensor rub with isopropylic alcohol Allow the sensor to dry
39. completely after cleaning WARNING A Do not sterilize by irradiation steam or ethylene oxide Do not immerse in liquids Before cleaning or disinfecting the sensor unplug it from the monitor 4 3 Changing the adhesive tape of the wrap sensor The adhesive tape is made with latex free material e Gently remove the used adhesive tape from the sensor and dispose of it spirobank Z7 User Manual cod 980200 Rev 3 3 Page 34 of 43 e The back of the sensor has alignment pins Place the sensor with the alignment pins facing the adhesive part of the tape and align the pins to the holes on the tape e Push the sensor so as to insert the pins into the holes of the tape Lift both the sensor and the tape and check that the pins of the sensor are correctly aligned It is suggested to use a new piece of adhesive tape for each sensor for each patient or as required 4 4 Changing the Batteries If the message BATTERY DISCHARGED appears on spirobank display or if the instrument does not switch on the batteries inside the compartment shown here under must be changed as per the following points e Remove the back cover by pressing and pushing it away from the device e Remove the discharged batteries e Replace with new batteries inserting them properly into the slots e Close the battery compartment by replacing the back cover and sliding it towards the inside of the device WARNING A Use only 1 5 V type AAA batteries or equivalent
40. cting spirobank by USB to a PC winspiroPro must be installed to interface with the device It is important prior to initiating the following procedure to know the version of the operating system installed on the PC used for the connection from control panel click on System where the type of operating system installed on the PC can be checked If winspiroPRO is already installed on the PC then a new installation is not required To make the connection insert the mini USB connector supplied with spirobank as shown in the picture and attach the other connector to the USB port of the PC When initially making a connection the PC will depending on the version of the operating system either make an automatic driver installation or request some information To avoid errors in this phase please read the winspiroPRO User Manual very carefully To check the connection between the device and the PC ensure that the led on the device is illuminated 3 5 Connection to a PC through the RS 232 spirobank can also be connected to a PC through the RS 232 serial port This leaves the USB port free and the device is run directly by the software as a USB 2 connection The picture shows the RS 232 connector attached to spirobank JI For the correct management of the device see the online manual of the software 2 S Vax a 3 6 Upgrade Internal software spirobank software can be upgraded when connected to PC USB
41. d the OK to confirm the selected number e Return to the Service Menu by pressing OK e From the Service Menu access the main screen by pressing ESC 3 2 3 Bluetooth Data Transmission e From the main screen press gt corresponding to the icon e Press lt corresponding to the Es icon e The selected transmission will be shown to confirm press OK to activate the connection with the default device set up e When required by the cell phone enter the PIN code shown on the spirobank display corresponding to the serial number SN of the machine shown on the spirobank ID label e The connection phases then follow e When the connection is completed the data transfer to the default modem starts e The message transmission completed appears at the end of the transfer The following information is now shown on the display e device used for the connection as described in the initial settings e The telephone number as described in the initial settings e The preset PIN corresponding to the serial number of the machine To interrupt the data transmission during the Bluetooth connection press ESC to end the connection and return to the main screen Where no device has been setup for data transmission a message will appear on the display to start searching for enabled devices After setting the device the connection will start automatically 3 3 Data Transmission via Bluetooth for printing The Bluetooth
42. data The data will be shown starting from the date entered up to the last file on memory Full Memory to show data in alphabetical order The last data are marked by a double beep then the data shown begin from the first one recordered Search by Surname enter patient surname or first initial then press OK to access the data Use lt and gt to display relevant patient test data Press ESC to return to the main screen without searching Use from the data screen ie icon to print out data through a Bluetooth connection automatic use to display all test data of relevant file on memory use lt and gt to scroll through data press OK to go back to the memory screen From this screen press OK to make a new test on the subject selected press OK again press ESC to return to the data stored 2 Online operating mode connected to a PC This operating mode is comparable to a laboratory spirometer connected to a PC the device operates in real time Connect the unit to a PC using either the USB cable or the RS 232 serial cable spirobank thus acts as an intelligent sensor for flow and volume measurement while the PC controls functions including the switching on and off of the unit spirobank Z7 User Manual cod 980200 Rev 3 3 Page 22 of 43 Connected to a portable PC spirobank can carry out epidemiologic studies in work environments school settings etc As well as the standard spirometric parameters and F V curves i
43. ded separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 5 NP 3 d 3 5 NP 80 MHz to 800 GHz 3 d 7 1 NP 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 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 spirobank User Manual cod 980200 Rev 3 3 Page 42 of 43 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 is used e
44. e is purchased Due to the materials used in the manufacturing of the device disposing it as a normal waste product could cause harm to the environment and or health Failure to observe these regulations can lead to prosecution 1 4 7 Warning symbol for the WEEE spirobank Z7 User Manual cod 980200 Rev 3 3 Page 10 of 43 1 48 FDA and FCC Warnings FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN FCC ID TUK MIRO20 spirobank complies with Part 15 of the FCC Rules The correct operation is subject to the following conditions 1 this device must not cause harmful interference 2 this device must accept any interference received including interference that may cause undesired operation Any modifications not expressly approved by this company could void the user s authority to operate the equipment NOTE This device has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or televi
45. e out of reach of children and of any person with mental handicap 1 3 Unforeseen errors In case device internal memory data are damaged when the device is switched on the following message appears Error on RAM memory Recovery data Please wait If data have been successfully recovered the device completes the standard switch on process otherwise please contact an authorised technical assistance point or the manufacturer In the case of a problem with the device a message indicating the nature of the problem will appear on the screen together with a warning beep Operation of the device beyond its declared life see 1 6 Technical Specifications could provoke a loss of data in the memory of the device SRAM memory spirobank Z7 User Manual cod 980200 Rev 3 3 Page 9 of 43 Errors in measurement or in interpretation can also be caused by use by non qualified or non trained personnel lacking ability or experience user error use of the instrument outside the guidelines described in this User s Manual use of the instrument even when some operational anomalies are encountered non authorised servicing of the instrument 1 4 Labels and symbols 1 4 1 Identification label SN A23 060 0 0 0 0 1 REF spirobank i MIR Via Maggiolino 125 00155 Roma Italy C C 0476 The label shows e Serial number of the device Product name Name and address of the manufacturer Electrical safety symbol CE mark in compliance wit
46. e reliable will be the data transmission The suggested distance for a reliable transmission is a few centimetres e From the main screen press gt corresponding to the icon Then press F corresponding to the icon e Aconfirmation for the transmission is requested by pressing OK otherwise it is possible to exit the programme by pressing ESC spirobank now emits a series of acoustic signals indicating that the data transmission has started e Wait until spirobank has completed the transmission the instrument ceases to emit an acoustic signal e Atthe end of the transmission the message TRANSMISSION TERMINATED will appear At any time during the transmission the process may be terminated by pressing ESC During this procedure it is strongly suggested to e Eliminate all external noises e Do not touch or move spirobank and the receiver e Be sure to have fully understood the procedure before starting the transmission WARNING A The data transmission is made through the fixed phone line of which the care and proper functioning depends on the national phone operators The manufacturer is not liable for any eventual disservice or dysfunction caused by either the fixed or mobile operators High frequencies emitted by electronic devices can cause interference with the correct functioning of the instrument For this reason a minimum safety distance a few metres must be maintained when in the same room another
47. e to the wrist with a bandage spirobank User Manual cod 980200 Rev 3 3 Page 30 of 43 3 DATA TRANSMISSION WARNING A Read the instructions carefully before starting the data transmission taking due care to ensure that all the information has been properly understood 3 1 Wireless Data Transmission via Phone Line This type of data transmission allows for the transfer of all data in the memory of spirobank ZI Through this method the doctor can control the information sent directly from the patient and assess any changes to the therapy in course from his her PC To transfer the data memorised during various tests to the doctor s PC follow this procedure e Dial the doctor s phone number for example the doctor s office telemedicine services or any other structure directly on the telephone at use e Place spirobank and the phone on a level surface as shown in the figure The suitable distance between spirobank and the phone receiver is between 2 and 5 cm e Place the microphone of the telephone the microphone is near the cable near to the spirobank as shown in the figure with the phone receiver beneath the device s ID label The hole should be close to 2 to 5 cm the microphone s hole positioned on the receiver Where necessary the distance between spirobank and the receiver can be up to 1 metre depending on the environmental noise however the closer the receiver is to the hole of the spirobank J the mor
48. equency gt 120 BPM mmnec e hh mm ss _Bradycardia events during the entire period of Tachycardia events during the entire period of analysis es i Desaturation events during the entire period ofthe analysis V s _Desaturation events by hour of analysis MB Average duration of desaturation Somnus _Longest duration of desaturation events 5 Minimum 5 02 during desaturation events s Os i Average duration of desaturation events o Ds Average SpO2 fall with respect to baseline during the desaturation events Maximum fall of SpO2 with respect of baseline during the desaturation events 96 L Variation of pulse frequency events during the entire period of the analysis Variation of pulse frequency by hour of analysis UU DP T m EREE E EEEE EEEEEEEE EE RRRR R RRR A DELTA Parameters measured for six minute walk test analysis T SYMBOL LLL EBCRIPTION s Units _ SpO2 Baseline SpO2 average before walking e cue SpO2bnd SpO2 after walking cms cise SpO02 Min SpO2 minimum during walking eons scsi SpO2Max ee SpO2 maximu
49. erage pulse frequency in the first 3 minutes BPM BPMMin 2 Minimum pulse frequency during the period of analysis BPM ss BPM Max 2 Maximum pulse frequency during the period of analysis BPM s BPM Mean _Average pulse frequency during the period of analysis ss Recording time Total time measure of 5 2 s T 9096 2 Time passed with Sp02 lt 90 99 hh mm ss 1 lt 89 4 _Time passed with SpO2 lt 89 96 dh hh mm ss lt 886 Us Time passed with SpO2 lt 88 96 hh mm ss Ero Time passed with SpO2 87 hh mm ss Events SpO2 i Fall of SpO2 below 89 for at least 20 seconds spirobank Z7 User Manual cod 980200 Rev 3 3 Page 13 of 43 SYMBOL NOD 90 TX Time passed with 5 2 lt 4 with respect to SpO2 base for continual periods above 5 minutes PE TERT PEA A A AE A TAE PAE HS EE T T A T A A A E T AE E T scant ous sctarssngarataineceneredmsaneecamecaatoanreensecnn sig stacepenecavapancrencnsts scannecensana T A Time passed with SpO2 lt 90 for continued periods above 5 minutes with iminimum value lt 86 Nadir DESCRIPTION 2 Units Index of SpO2 fluctuation calculated in intervals of 12 seconds sss Time passed with pulse frequency lt 40 ll hh mm ss Time passed with pulse fr
50. est is interrupted due to low battery charge the following message will appear on the display when the device is switched on again The last oximetry test was interrupted before being properly completed A beeping sound will be simultaneously heard for 10 seconds After which the device main screen will appear Alternatively the display will show the screen with the oximetry tests that can be performed specifically DESCRIPTION 4 Walk test 6MWT Sleep oximetry gt Oximetry SpO2 BPM WARNING A In order not to compromise the reproducibility of the measurements and the integrity of the sensor avoid twisting the sensor cable and handle with due care when using connecting disconnecting and when placing the finger into it During the first few seconds of the test the device searches for the best signal after which the timer re sets to zero and spirobank starts to memorise the data If the sensor has not been correctly inserted the following message will appear WARNING Sensor unplugged Contemporaneously spirobank emits a beep for 10 seconds If the sensor has been inserted but the finger is not inserted correctly the following message will appear WARNING FINGER not inserted Contemporaneously spirobank emits a beep for 10 seconds If the sensor correctly receives the signal after a few seconds the device starts to beep and the values will be displayed on the screen For all oximtery tests alar
51. etry measurement Optical cross talk can occur when two or more sensors are placed in close proximity Optical cross talk may adversely affect the accuracy of the oximetry readings The danger can be eliminated by covering each site with opaque material Obstructions or dirt on the sensor s emitter and or detector may cause a sensor failure or inaccurate readings Make sure there are no obstructions and the sensor is clean Autoclaving ethylene oxide sterilizing may cause sensor damage Do not attempt to sterilize the sensor Unplug the sensor from spirobank before cleaning or disinfecting to prevent damaging sensor or device and to prevent safety hazards for the user 1 2 5 Device WARNING A The maintenance operations detailed in this manual must be fully and accurately carried out If these instructions are not followed this can cause measurement errors and or an incorrect test interpretation Any modifications adjustments repairs or reconfiguration must be made by the manufacturer or by personnel authorised by the manufacturer Never attempt to make a repair oneself The set up of configurable parameters should only be made by qualified personnel However an incorrect set up of the parameters does not put the patient at risk High frequency emissions from electronic devices may interfere with the correct operation of the instrument For this reason certain minimum clearances a few metres should be observed when high
52. frequency appliances such as a TV radio portable phone etc and other electronic units are operated at the same time in the same room The instrument may give inaccurate readings if operated in the presence of strong electromagnetic sources such as electrosurgical equipment or in the presence of computed tomography CT equipment Do not use the instrument in the presence of magnetic resonance imaging MRI equipment MRI equipment may cause an induced current to the oximetry sensor resulting in patient injury If the PC and or the printer connected to spirobank come into contact with the area containing patient data ref directive EN 60601 1 1 it is necessary that they conform to the directive EN 60601 1 For the recycling of the spirobank the accessories any plastic consumable materials mouthpieces as well as the battery use only the appropriate containers or return all such parts to the dealer or to a recycling centre All applicable local regulations must be followed If any of these rules are not followed then MIR will decline all responsibility for any direct or indirect damages however caused Use only the battery type indicated in the S Technical specifications Remove the battery from the device if the machine is not used for a long period several months The instrument may be powered through a PC by a USB cable By this means the device works both on line with the PC or individually powered by the PC Keep the devic
53. h the Directive 93 42 EEC CCo This product is certified to conform to the Class requirements of the 93 42 EEC medical device directive In accordance with the IEC 60601 1 Standard this product and its component parts are of type BF and therefore protected against the dangers of direct and indirect contact with electricity 1 4 2 mark for medical devices 1 4 3 Electrical safety symbol 1 4 4 Warning symbol for the RS232 serial port RS232 For connection to other devices such as PC or printer Use only the serial cable supplied by the manufacturer and observe the safety regulations of IEC 60601 1 1 1 4 5 Warning symbol for the USB serial port For connection to other devices such as PC or printer Use only the serial cable supplied by the manufacturer and observe the safety regulations of IEC 60601 1 1 1 4 6 Warning symbol for the SpO2 port for oximetry SpO As laid down in the European Directive 2002 96 EEC requirements regarding the disposal of electrical and electronic devices WEEE at the end of its useful life this device must not be thrown away together with normal domestic waste as it contains materials which would cause damage to the environment and or represent a health risk Instead it must be delivered to a WEEE authorised collection centre where the device will then be disposed of correctly An alternative is to return the device without charge to the dealer or distributor when a new equivalent devic
54. he best parameters are always available for review The normal predicted values can be selected from several normal sets For example within the European Union the majority of doctors use the ERS European Respiratory Society predicted values Oximetry function The oximetry sensor has two light emitting diodes LEDs one emits in the visible spectre and one infrared Both lights then pass through the finger and are read by the receiver As these lights pass through the finger a proportion of the light is absorbed by the blood and by the soft tissue in function of the concentration of heamoglobin The quantity of light absorbed at each frequency depends on the degree of oxygenation of the haemoglobin inside the soft tissue This measurement principal ensures accuracy and reproducibility without requiring regular calibration The oximetry sensor can be disinfected with isopropilic alcohol The device has two batteries e Main power AAA 1 5V battery 4 batteries are required e Memory back up lithium battery type CR2032 of 3V The battery life is about 10 years depending on the use of the device 1 5 Technical specifications A comprehensive description of the main features of the device the flow and volume measurement turbine and also of the oximetry sensor follows 1 5 1 Features of the spirometer Measured parameters SYMBOL DESCRIPTION s Units EVO Best Best PEE d LS ss EVC
55. ic alarm will ring to alert the user The cursor at the beginning will rest on the minimum Sp02 value use the or F keys to select the desired value then spirobank Z7 User Manual cod 980200 Rev 3 3 Page 19 of 43 pass to the next value by pressing the OK once the four values have been set up you can then if required activate or disactivate the acoustic alarm by pressing or keys To confirm the selection press OK a service menu will then be displayed SpO2 sampling time Through this function it is possible to define the time that elapses between the values memorised between one oximetry parameter and the next one use o F to select the desired value for 2 seconds P for 4 seconds press OK to set the value selected and then pass to the service menu Having set the parameters from the Service Menu press ESC to access the second screen and then the main screen as follows A Martini Which indicates dd mm yy cm Kg 5 Patient name A Martin Date of birth dd mm yy 04 11 1967 182 70 Height cm ID 0014 e Weight kg E Patient ID code Function icons 2 4 1 Turbine Calibration WARNING A The turbine flow sensor does not require calibration but needs only a regular cleaning If a calibration must be made then the following guidelines should be carefully noted Calibration can be made only on the reusable turbine Calibration of the turbine is performed using a calibration syringe to make
56. irobank User Manual cod 980200 Rev 3 3 Page 35 of 43 ANN MIR srl MEDICAL INTERNATIONAL RESEARCH Via del Maggiolino 125 00155 Roma ITALY Declaration of CE Conformity Quality Management System according to the requirements of Annex Il of the Medical Device Directive 93 42 EEC implemented by the Legislative Decree 46 dated 24 02 97 Notified Body CERMET No 0476 Certificate No MED 9826 MIR srl Medical International Research declares that the Device subject of this declaration together with its standard accessories conforms to the requirements of the Council Directive 93 42 EEC Annex Device Description Spirometer Oximeter Device Name spirobank Classification lla This Device is marked C 0476 Any modifications to the Device which are not authorised by MIR will invalidate this Declaration Rome 01 01 2009 Paolo Sacco Boschetti Chairman Rev 1 Mod PO 10DDC spirobank spirobank User Manual cod 980200 Rev 3 3 Page 36 of 43 LIMITED WARRANTY CONDITIONS spirobank together with its standard accessories is guaranteed for a period of 12 months if intended for professional use doctors hospitals etc e 24 months if the product has been purchased directly by the end user The warranty is effective from the date of purchase shown on the relevant sales invoice or proof of purchase The warranty is effective from date of sale which must be shown on the relevant sales invoice or proof of p
57. istration of a drug PRE POST for a bronchodilator test or for a bronchial challenge test A comparison of data is made between POST after drug and PRE before drug administration The flow and volume measurement sensor is a digital turbine based on the infrared interruption principal This principal ensures the accuracy and the reproducibility of the measurements without requiring a periodic calibration The features of this kind of sensor are listed below e Accurate measurement even at very low flow rates end of expiration e Not influenced by gas humidity nor density e Shockproof and unbreakable e Inexpensive to replace spirobank User Manual cod 980200 Rev 3 3 Page 11 of 43 The turbine flow measurement sensor is available both in reusable and in single patient disposable versions NT t 4 REUSEABLE TURBINE DISPOSABLE TURBINE v The following precautions must be observed to ensure that the characteristics of the turbine remain unaltered over time e for the disposable turbine must always be substituted between patients e for the reusable turbine always clean the turbine between patients to ensure the maximum level of hygiene and safety for the patient For a correct interpretation of a spirometry test the measured values must be compared either to the so called normal or predicted values which are calculated from the anthropometric details of the patient or alternatively to the personal best values from the c
58. linical history of the subject The personal best values can vary considerably from the predicted values which are taken from healthy subjects spirobank is also able to transfer the stored test data through a simple acoustic coupling to a PC so the patient can send test data by phone to the doctor In this way the doctor can check the patient s condition remotely spirobank can also be connected to a PC or to another computerised system to configure the system All spirometric test results plus the related subject details stored inside the device can be transferred from the device to the PC and then viewed on the PC Flow volume curves spirometry parameters plus optional oximetry parameters The connection to the PC can be made in the following ways e through the RS232 port or e through the USB port spirobank gives an automatic interpretation of each spirometry test carried out and assigns a traffic light feedback green yellow or red to each test or series of tests The set up of the traffic light settings is made by the doctor responsible for the system configuration spirobank is able to make FVC VC amp IVC MVV and breathing profile tests and calculates an index of test acceptability quality control plus the reproducibility of the spirometry tests carried out The automatic test interpretation follows the latest 11 level ATS American Thoracic Society classification Each test can be repeated as required T
59. llowed by the measured parameters There follows first a description of these messages and the parameters in the order in which they appear If for 6 seconds no key is pressed then the unit moves automatically to the next message or parameter 2 8 5 Spirometry test interpretation Spirometry test interpretation is based on the Forced Vital Capacity FVC test and is indicated both by a message and a traffic light code green yellow red For each test made an arrow on the upper left part of the screen indicates the interpretation of that test The connection between the traffic light colour and the test interpretation is shown below A AAA very severe severe moderately severe moderate mild normal Through an analysis applied to some of the indices and parameters calculated in the FVC test spirobank produces a variety of quality control comments useful for understanding the reliability of the test made spirobank User Manual cod 980200 Rev 3 3 Page 24 of 43 Where several comments related to the single test are calculated spirobank will only show the most important to facilitate the test interpretation ERROR IN Vext and PEFT If the extrapolated volume Vext is greater than 500 mL or greater than 5 of the FVC or if the PEFT time to peak flow is greater than 300 ms then the following comment is shown FIRST EXPIRATION TOO SLOW FLOW DROP 50 If the flow rate falls and then increases again by over 50
60. m during walking mmm yp NR SpO2Mean SpO2 average during walking BPM Vaseline Average pulse frequency before BPM frequency after walking citing BPM 2222222 BPM Min Pulse frequency minimum during walking 551 BPM BPM Max Pulse frequency maximum during walking 55501 BPM y BPM Mean Pulse frequency average during walking 5 lt 930 ee Time passed with SpO2 lt 90 96 m ll hh mm ss T 8996 4 Time passed with SpO2 lt 89 miss 9876 Time passed with SpO2 lt 88 yn hh mm ss 1 lt 87 2 Time passed with SpO2 87 96 mmiss TA2 ASpO22 276 Time passed during walking test with SpO2 lt 2 with respect to SpO2 base hh mm ss TA4 ASpO2 gt 496 Time passed during SpO2 walking test lt 4 with respect to SpO2 base hh mm ss 0 T 40BPM Time passed with pulse frequency lt 40 mmss 2 I2120BPM Time passed with pulse frequency 120 BPM s N Events lt 40 BPM Bradycardia events during the entire period of analysis N Events gt 120 BPM Tachycardia events during the entire period of analysis cad Mn Recordingtime Total ime medsHre OL SPOS cis octies oce ccn MMI NSS e circus Baseline Time Duration of baseline phase LLL MOEMM SS Walking Time Duration of walking phase hh mm ss Fatigue Borg CHG A DELTA Time for SpO2 value gt 99 of the average base value calculated
61. ms can be set up in the case that the critical values are exceeded as described in paragraph 2 4 If an alarm is activated then the symbol is shown on the display Oximetry Alarms during that test Alarms can be activated or disactivated during a test by SpO2 min 97 max 98 BPM min 80 max 200 pressing gt this brings up a menu showing the preset alarm thresholds Press OK to confirm the disactivate or to activate the alarm function If OK is NOT pressed then the device continues the test without changing Alarm OFF the alarm settings PRESS OK TO ACTIVATE ALARM For further information on the correct set up for this function please refer to paragraph 2 4 WARNING spirobank Z7 User Manual cod 980200 Rev 3 3 Page 27 of 43 A test is archived using the name of last patient visualised If this refers to a patient whose data has already been inserted in the past call up a previous test carried out on the patient in question and proceed as described in the final part of paragraph 2 6 This information is shown as follows 00 02 14 m In SURNAME DXYTEST Spo 97 ALARM 294 Walk Test 6MWT To make a walk test press lt This test is made up of 3 phases e Initial rest e Walking e Recovery Initial Rest In this phase the display will show the following data Test time duration Signal quality indication Current phase SPO2 value and the instant cardiac pulse heart symbol
62. n real time the instrument also calculates more refined indices such as the ventilatory profile and the extrapolated volume Vext The PC software also allows the latest bronchial challenge test protocols with the graph of the FEV1 dose response and time response curves WARNING A If a turbine disposable or reusable is setup while using spirobank the same will remain by default the next time the device is used in the remote mode Attention must be given in the setting of the turbine 2 8 Spirometry Testing To make a correct spirometry test we recommend to follow carefully the following instructions e Insert the mouthpiece into the protruding part of the turbine by at least 0 5 cm e Fit the nose clip onto the nose of the subject to ensure that air cannot escape through the nostrils Hold spirobank JT at either end in two hands or alternatively hold it in one hand as you would a cell phone In either case the display should be facing the user e Insert the mouthpiece well into the mouth beyond the teeth being careful to ensure that air cannot escape from the sides of the mouth e t is suggested to make testing in a standing position and during an expiration to lean forward to help the expiratory action with a compression of the abdomen WARNING Do not touch the keys during a test to avoid switching off the machine or stopping a test too soon TEST On the main screen press corresponding to icon Then the
63. nt To select female patient To carry out a sleep oximetry test To carry out an oximetry test while walking Go to walking phase during test To carry out FVC spirometry test To carry out a VC spirometry test ee ET AT TE T T T E E A T T E L E AT E E E T a T T T E A To carry out MVV spirometry test To access oximetry tests To carry out SpO2 BPM To display previous tests in memory To display next test in memory POOPED ltt henth Sheet uaa uu a ss SR RR hunt RR RR RR GER Rutt RR RE RR SERR SERE SR RES RRS RR iinet inti nine RR SR aud aa uu To print data in memory through Bluetooth connection aa a sun a n To transfer data through a Bluetooth connection nunun nn nenn DETTTE
64. o it COS IY a se _ STN graphic LCD 128x64 Pixel Membrane keyboard with 6 keys 89232 USB Bluetooth Duration of the CR2032 3V lithium battery memory backup 4 _ Circa 10 years under normal conditions use __4x AAA batteries 1 5V DC type AAA or through USB connection 1 60 145 30 mm St Re cea 180 grams including batteries amp 1 as 5 1 d evi e X BF device protected against water drops 1111 Device not suitable jDeviceforconinuoususe l Temperature MIN 20 C MAX 60 C _ Humidity MIN 10 RH MAX 95 RH Temperature MIN 10 C MAX 40 _ Humidity MIN 10 RH MAX 95 RH Electrical Safety M OC M Electro Magnetic Compatibility IEC 60601 1 2 The spirobank keyboard is composed of 7 keys A Martini mi cm 04 11 19 2 78 an i E 30 fs gt 4 Key functions are as followed E E MG Switching on spirobank 0014 On Off To switch on spirobank press and then release Switching off spirobank To switch off spirobank press for at least two
65. of SpO2 MMS T lt 90 lJime passed with SpO2 lt 90 hh mm ss T 8996 7 ime passed with SpO2 lt 89 976 s hh mm ss T lt 88 1 Ime passed with SpO2 lt 88 Ze hhimmess ime passed with SpO2 lt 87 ol hh mm ss N Events SpO2 lt 89 of SpO2 below 89 for atleast 20 seconds 1 A Index 125 Index of SpO2 fluctuation calculated in intervals of 12 seconds T lt 40BPM Time passed with pulse frequency lt 40 BPM hh mm ss T gt 120BPM Time passed with pulse frequency gt 120 BPM i hh mm ss Events lt 40 BPM Bradycardia events during the entire period of analysis N Events gt 120 BPM Tachycardia events during the entire period of analysis NNNM DELTA Measurement method Red and infrared absorption Range of measurement 01006 with 1 increments 9 E SpOs Resolution SpO gt accuracy 2 between 70 100 SpO2 a Average number of heart beats for the SpOz calculation 8beats Range of measurement of cardiac pulse 20 300 with 1 BPM increments E Cardiac pulse relolution EM susp d Accuracy of cardiac pulse 2 2 2 greater 3 Average interval for the calculation of cardiac pulse 8seconds 2 Signal quality indication 0 8 segments on display m 2L eee
66. ontained in this manual If the user of the device is a person considered to be cognitively impaired then the operation of the device must be made under the supervision and responsibility of whoever is legally charged with the supervision of this person The spirobank when used as a pulse oximeter is intended for spot checking overnight sleep screening and or continuous monitoring when attended by a trained healthcare professional 1 1 3 Operating environment spirobank has been designed for use in a doctor s office in a hospital or directly by the patient during day to day activities for the continuous monitoring of physical conditions All information necessary for the proper use of the device in electromagnetic environments as required by the EN 60601 1 2 Standard is available from the manufacturer Used at home at work at school or during sports day by day the device records data and functional respiratory parameters for a period of weeks or months assisting the patient in making a better assessment of his own health The procedures for using the device at home are described according to the type of test to be made the display will show all instructions messages suggestions etc step by step which allows the subject to correctly perform tests and obtain correct results to be analysed by the doctor The instrument is not intended for use in an operating theatre nor in the presence of inflammable liquids or detergents nor
67. red volumes and flows is made automatically as the machine has an internal temperature sensor the BTPS values are thus calculated If a 3L syringe is used to make the calibration and if the spirobank is calibrated correctly then the FVC syringe value will be 3 00 FVC x 1 026 BTPS 3 08 L FVC at BTPS If the ambient temperature is 20 C the FIVC syringe value will be 3 00 FIVC x 1 102 BTPS 3 31 L FIVC at BTPS The user must be aware that the volume of the syringe shown by the machine is converted to BTPS conditions so that the increase of the results with respect to the expected values does not constitute an error For instance if the calibration procedure is carried out with measured data FVC 3 08 L and FIVC 3 31 L at an ambient temperature of 20 C the resulting correction factor becomes EXPIRATION 00 INSPIRATION 00 This does not represent an error but is a logical consequence of the explanation detailed above 2 5 Patient Data Switch on spirobank by pressing b or if already switched on press lt icon to access the PATIENT DATA MANAGEMENT screen the following table describes the functions and displayed icons Key Description To enter new patient data To make a bronchodilator test i e make a test after drug administration with defined dosage to modify patient data already on file gt To access memory To enter new patient data From the Patient Da
68. ring slowly and deeply the following expiration must be made with the maximum effort by expiring all air as fast as possible After 6 seconds of expiration the instrument will emit a continuous beep this helps the user to understand when the minimum expiry time has been reached spirobank Z7 User Manual cod 980200 Rev 3 3 Page 23 of 43 WARNING ZN For accurate spirometry testing it is indispensable that all of the air contained in the lungs is expired The test may be repeated several times by repeating the cycle without taking the mouthpiece out of the mouth in which case spirobank recognises the best test FVC FEV1 and will automatically show the results of this best test To end the test press OK During the test spirobank emits beeps the frequency of which is directly proportional to the inspired and expired air velocity This is useful to the doctor to understand when the velocity of the air is approaching zero and therefore the patient has almost exhausted all of the inspired or expired volume In the maintenance section an explanation is given as to how this feature can also function as a very simple check system for the correct operation of the mobile rotor of the turbine For the FVC test to be judged as acceptable besides breathing as deep as possible it is also required that the forced expiratory time FET is sufficiently long to allow for the complete expiration of all air contained in the lungs Six second
69. s from the start of the forced expiratory test spirobank emits a continuous beep This is useful to the doctor to understand if the patient has reached the minimum expiry time as per the requirements of the major international pneumology associations 2 8 2 VC Test Ventilatory Profile The Slow Vital Capacity test can be started by carrying out several complete breaths at rest After three or four such breaths a beep will sound to confirm that the ventilatory profile has been measured and now you can proceed to carry out the VC or IVC test Expiratory Slow Vital Capacity VC After the beep inspire slowly as much air as possible and then expire slowly as much air as possible Inspiratory Slow Vital Capacity IVC After the beep expire slowly as much air as possible and then inspire slowly as much air as possible To end the test press OK To correctly carry out this test follow the indications as described on the display 2 8 3 MVV Test Start the test by carrying out a series of forced inspirations and expirations with the maximum possible amplitude The suggested frequency is 30 breaths min The test will terminate automatically after 12 seconds The disposable mouthpiece and turbine must be changed at the end of each test 2 8 4 Reading messages A series of measured parameters based on international standards of reference are shown at the conclusion of the test At the end of a test a series of test messages are displayed fo
70. se icons are shown FVC SPO2 Press the key corresponding to the test required FVC Forced Vital Capacity VC Slow Vital Capacity MVV Maximum Voluntary Ventilation SPO Oximetry Heart beat The device displays the information regarding the turbine selected in the initial setting reusable or single patient disposable there follows the necessary information for each screen in order to correctly carry out a test WARNING A test is archived using the name of last patient visualised If this refers to a patient whose data has already been inserted in the past call up a previous test carried out on the patient in question and procede as described in the final part of paragraph 2 6 2 8 1 FVC Test The phases as described on the screen must be followed more specifically INSPIRE slowly EXPIRE quickly INSPIRE slowly It is possible and may be helpful to start the test by breathing at rest for a few moments When ready to start inspire slowly as much air as possible made easier by holding arms wide apart and then make a complete expiration as fast as possible Then with the mouthpiece always held firmly in the mouth complete the cycle by inspiring again as quickly as possible This final inspiration may be left out if the inspiratory parameters FIVC FIV1 FIV1 PIF are not of interest The optional initial inspiration phase can also be performed before inserting the mouthpiece in the mouth After inspi
71. seconds CONFIRM to confirm and pass to the next phase use gt or OK Symbols and Icons The icons used in the various function screens and their meanings are shown in the following table spirobank Z7 User Manual cod 980200 Rev 3 3 Page 16 of 43 DESCRIPTION To access the set up Service Menu of spirobank To manage or enter new patient data from the main screen To enter new patient data To carry out bronchodilator test To modify patient data To carry out a spirometry or oximetry test To access previous tests To access to transmission data area To search for tests made To display oximetry test results of selected subject To display spirometry test results of selected subject To search test by subject ID code e ns ua nn eee ee Cun uu nn uuu eee ee uu eee eee RR SR eee ee ee eee ee ee eee eee ee search test from date and onwards partial memory M EE Geecesnccesccenseansecnsceneseansnecenceceseanseeenseeeseansecesscceseaseeceeceenseanseeceesecescseeeeeseeseaeseceesceeseanseceeecegeseanseceseceeseanseceseseeeseanseces a E A T E E E a E T T E T To scroll through files on memory To select male patie
72. sed for the sensor are subject to biocompatibility tests WARNING A This sensor is contraindicated for use on patients who exhibit allergic reactions to the adhesive tape Do not reuse One use on one patient e Choose an application site on the patient s finger or toe where the light source will be directly over and in line with the detector The preferred sites are the forefinger or smaller thumb e Remove nail polish or artificial fingernails e Place the patient s digit in the sensor nail side up lining up the digits pad over the detector The sensor s positioning line runs across the mid axis of the fingertip e Wrap the bottom adhesive around the digit being careful not to cover the nail e Fold the sensor s top over the digit making sure the light source is directly over and in line with the detector Wrap the adhesive around the finger or toe to secure the sensor Route the cable along the palm or the bottom of the foot and secure with adhesive tape if necessary Connect the sensor to the instrument insert the connector with the arrow on the connector face up and control the correct functioning according to the previous instructions WARNING A Do not twist unnecessarily or use excessive force when using connecting disconnecting or storing the sensor An over tight sensor can produce inaccurate saturation measurements Therefore avoid over tightening the adhesive tape It is recommended to fasten the cabl
73. sion reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Heorient or relocate the receiving antenna e Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for assistance Labels and symbols are displayed on the device like shown in the following images 1 4 9 Product description spirobank is a pocket spirometer with an optional pulse oximetry module It can operate in stand alone mode and it can be connected to a PC or to a printer using any one of several available methods RS232 USB Bluetooth spirobank is specifically designed to measure a range of respiratory parameters and to monitor the saturation of oxygen in the blood and the heart beat A quality control check is carried out internally on the measured parameters and the device has an internal memory sufficient for over 6000 spirometry tests or for 1000 hours or 40 days of oximetry monitoring spirobank is a powerful and compact measurement device intended for use by a respiratory specialist or by a suitably trained generalist The spirometer calculates up to 30 functional respiratory parameters providing the pharmacodynamic effects i e the data comparison after the admin
74. spirobank User Manual KERN ATIO Ng 4 e MEDICAL User Manual Rev 3 3 Issued on 19 12 2008 Approved on 19 12 2008 spirobank User Manual cod 980200 Rev 3 3 Page 1 of 43 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 FUNCTION PRODUCT WITH OXIMETRY Accessories market with spirobank IT CODE Accessories market with spirobank IT CODE spirobank ZI bag 672690 spiroank bag 672690 spirobank device 910575 spirobank device with oximetry function 910570 spirobank User Manual 980205 1 sensor 919010 USB connection cable 532365 spirobankIl User Manul 980205 4 x 1 5V AAA batteries 970080 USB connection cabe 532365 CD winspiroPRO 920100 4 1 5V AAA batteries 970080 i 1 Nose clip A 910320 CDwinsproPRO 920100 E 4 Paper mouthpieces 910300 1Nosecip 1910320 3 disposable turbine sensors 910001 4 Papermouthpieces 22222 910300 1 Reusable turbine sensor 910002 3disposableturbinesensors 910001 Tuc UO gt OPTION CODE OPTION CODE 5232 connection cable 532367 5232 connection cabe 532367 O wM
75. spirobank User Manual cod 980200 Rev 3 3 Page 39 of 43 Oximetry SpO2 BPM Name A B Date 22 03 06 Time 14 48 Age 38 Height cm 182 Wheight kg 70 Sex M SpO2 Graph T 2 3 4 5 6 7 8 Pulse Rate Graph Minutes 140 100 60 20 Recording Time 00 00 00 Analysis Time 00 04 10 5 2 Baseline 0 Mean 97 0 Baseline 0 91 0 Minimum 97 Maximum 97 Minimum 91 Maximum 91 SpO2 Events 89 0 N Bradycardia Events lt 40 BPM 0 Delta Index 12 sec 0 Tachycardia Events 120 BPM 0 time hh mm ss time hh mm ss T90 SpO2 lt 90 0 00 00 00 T 40 BPM 0 00 00 00 T89 SpO2 lt 89 0 00 00 00 gt 120 BPM 0 00 00 00 88 6 2 lt 88 0 00 00 00 T87 SpO2 lt 87 0 00 00 00 Made by spirobank II Signature spirobank Z7 User Manual cod 980200 Rev 3 3 Page 40 of 43 ANNEX 2 SPIROMETRY TEST REPORT EXAMPLES Test Date 21 10 06 11 12 5 1 078 Standard ERS ATS Name Ce 2 IDE 12 Birth Date 04 11 1967 Age 38 Height cm 182 Weight kg 70 Sex M PRE File 13 POST File N 12 Predicted MC BARCELONA FLOW L s th Parameter POST PRE CHG FVC 3 38 dues 10 3 13 2 98 5 PEF 9 74 10 00 3 FVC 3 55 3 22 10 4 24 2 98 5 FEV1 FVC 88 2 92 5 5 PEF 9 74 10 00 8 2575 6 19 5 00 24 FEF25 8 98 8 97 FEF50 6 38 5 60 14 FEF75 Saka 2 12 58 FEV3 3 48 3 22 8 FEV3 FVC 98 0 100 0 FEV6 2 3 3 28 10 FEV1 FEV6 88 2 92 5 S FET 3 40 2 39 42 EVol
76. ta Management menu press lt to access the data input screen First screen name and surname Use lt and gt to select required letters confirm or delete using or F To input surname press OK The letters can also be selected automatically after a few seconds using the cursor Press OK to go to the next screen Second screen date of birth weight height sex Use or to select date of birth use gt to the right to set month repeat to set year continue setting data by entering patient height weight and sex using the same key The arrow lt shown to the right of the field indicates the numerical value that is being changed After this operation use OK to go to the following screen to return to the previous screen press lt or press ESC to exit set up mode and go to the main screen Third screen ethnic group Setting the correction factor this value allows to adapt test data according to the patient ethnic group the no correction option can also be set press OK to complete the setting of parameters the main screen then appears In the event of an error during the setting of patient data press lt to go back to the previous screen WARNING A spirobank Z7 User Manual cod 980200 Rev 3 3 Page 21 of 43 To interrupt data input press ESC which then goes back to the main screen POST BD Test POST Use to set the spirometry test in post mode i e after pharmacological bronchodilation On next screen use
77. ted correctly 2 9 4 SPO2 BPM Test This test allows the control of the oxymetric data plus the cardiac pulse of a patient in real time The test can only be accessed when the device is switched on by pressing gt corresponding to on the first screen To confirm press OK During the test use to activate disactivate the acoustic beep spirobank Z7 User Manual cod 980200 Rev 3 3 Page 29 of 43 Relative data is memorised according to instructions shown on the screen prior to making the test ID 1234 SURNAME OXYTEST This data is required when searching the memory for related test data Test duration SpO2 value and heart beat data are shown To end test see instructions contained in the previous paragraph 2 9 5 Adult Single Patient Sensor Instructions for Use WARNING A The sensor described below is for illustration purposes only spirobank is enabled for the use of any of the sensors described in the previous Paragraph 1 2 4 MIR does not recommend the use of a specific type of senor any decision in made by each individual doctor To perform a non invasive continuous monitoring of arterial oxygen saturation it is recommended to use the reusable wrap sensor The use of this sensor is indicated for patients weighing more than 30 Kg and contraindicated for patients with allergy to adhesive tape WARNING A The materials used for manufacturing the sensor are NATURAL LATEX PROTIEN free The materials u
78. the limits laid down in the European Standard EN 60601 1 2 spirobank is continually controlled during its production and therefore the product conforms to the established security levels and quality standards laid down by the Council Directive 93 42 EEC for MEDICAL DEVICES After removing the device from its packaging check that there is no visible damage In case of damage do not use the device return it to the manufacturer for repair WARNING A The safety and the correct performance of the device can only be assured if the user of the device respects all of the relevant safety rules and regulations The manufacturer cannot be held responsible for damage caused by the failure of the user correctly to follow these instructions The device must be used only and exclusively as a spirometer following the indications given by the manufacturer with particular attention to the paragraph on INTENDED USE and utilizing only original spare parts and accessories Use of non original parts such as the turbine flow sensor and oximetry sensor or other accessories may cause errors in measurement and or compromise the correct functioning of the device and is therefore not permitted The device should not be used beyond the declared life span The life span is strictly related to the life of the internal lithium backup battery CR2032 and in normal conditions this should be around 10 years The device constantly monitors the state of charge of this battery
79. then shown Press OK to make new test on the selected subject Press OK again 2 9 Oximetry testing spirobank can carry out 4 different types of oximetry tests which are described in the following paragraphs WARNING A If spirobank as been purchased without the oximetry option then only spirometry tests can be made If the oximetry option is purchased afterwards then contact the service centre or the manufacturer to enable the function If during the oximetry testing the SpO2 blood pulse rate goes below the bottom threshold or goes over the top threshold spirobank 77 will beep until such situation persists This option can be disenabled during sleep tests The values shown are set by default by spirobank WARNING A The sensor described below is for illustration purposes only spirobank is enabled for the use of any of the sensors described in the previous Paragraph 1 2 4 MIR does not recommend the use of a specific type of senor any decision in regard is made by the individual doctor During the oximetry test spirobank cannot be switched off to switch off the device it is necessary to interrupt the test in progress this avoids unwanted interruptions which could compromise the accuracy of the data obtained For the non invasive measurement of the SpO oxygen saturation and the blood pulse rate utilize the re usable finger sensor This sensor is recommended for patients weighing gt 20 Kg with limited
80. turn to the Service Menu Phone Setup Access with OK and then use the horizontal scroll arrow to select phone number click on number to insert in connect list Having set the option press OK to confirm and to return to the Service Menu Bluetooth Setup Access with OK to search for available devices select Search Device and then press OK spirobank will start to search for Bluetooth devices in the area once one or more devices are found the screen will display profiles press OK to set the device as printer or phone select one of the two options and then press OK On the Bluetooth Setup screen all devices entered on the printer list and on the phone list can be checked A device can be set as default by accessing the lists with OK and then selecting the device to which spirobank will automatically connect or deleted from the list in this case press OK on the bottom to confirm the deletion or press ESC to go back and to not delete the device Firmware Info Access through OK to view information on the revision of the following components where available of spirobank II e spirobank e Bluetooth e Display e Oximetry After approximately 10 seconds spirobank automatically displays the Service Menu otherwise press ESC Oximetry Alarms This function permits the setting up of reference values for Sp02 and BPM if during a test these values go below the minimum or above the maximum values in the set up an acoust
81. urchase The instrument must be checked at the time of purchase or upon delivery and any claims must be made immediately in writing to the manufacturer This warranty covers the repair or the replacement at the discretion of the manufacturer of the product or of the defective parts without charge for the parts or for the labour All batteries and other consumable parts are specifically excluded from the terms of this guarantee This warranty is not valid at the discretion of the manufacturer in the following cases fthe fault is due to an improper installation or operation of the machine or if the installation does not conform to the current safety norms in the country of installation e fthe product is utilised differently from the use described in the User s Manual If any alteration adjustment modification or repair has been carried out by personnel not authorised by the manufacturer If the fault is caused by lack of or incorrect routine maintenance of the machine If the machine has been dropped damaged or subjected to physical or electrical stress If the fault is caused by the mains or by a product to which the instrument has been connected If the serial number of the instrument is missing tampered with and or not clearly legible The repair or replacement described in this warranty is supplied for goods returned at the customers expense to our certified service centres For details of these centres please contact
82. xceeds the applicable RF compliance level above the spirobank should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the spirobank JT b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the spirobank The spirobank is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the spirobank IJ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the spirobank as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of transmitter d 7 NP W 3 3 3 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
83. y exit this phase and a warning message will appear sensor unplugged or finger not detected correctly The data shown are the same as described in the preceding test except for information on this present phase which has not been envisaged for this test After the required time the test can be interrupted as previously described To print data see Paragraph 3 3 an example of a test printout report is attached 2 9 3 SPO2 BPM Oximetry Test To start the test press gt from the oximetry test menu screen The display will show oximeter SpO2 BPM The test duration is unlimited and the aim is to record variations of the oximetry values during a period as decided by the doctor During the test the display will show the information shown here The icons BEEP and ALARM Enable fie user to modify the set up 00 02 14 nmi use to activate disactivate the acoustic heart rate signal DXIMETRY SPDZ BPM amp e ALARM use P to activate disactivate the various alarms as described Spo 97 82 in paragraph 2 8 08 35 As a difference of the sleep oximetry test the display has not the standby function and it always shows test data To end test press ESC and then lt To print data see Paragraph 3 3 an example of a test printout report is attached If the finger is removed from the sensor during the test the following message will appear even if on standby WARNING Searching for signal finger not inser
84. your local supplier of the spirometer or contact the manufacturer directly The customer is responsible for the transportation and for all transport and customs charges as well as for delivery charges of the goods both to and from the service centre Any instrument or accessory returned must be accompanied by a clear and detailed explanation of the defect or problem found If units are to be returned to the manufacturer then written or verbal permission must be received before any instruments are returned to MIR MIR Medical International Research reserves the right to modify the instrument if required and a description of any modification made will be sent along with the returned goods spirobank Z7 User Manual cod 980200 Rev 3 3 Page 37 of 43 ANNEX 1 OXYMETRY TEST REPORT EXAMPLES Oximetry Sleep Test Name A B Date 30 03 06 Time 10 10 Age 38 Height cm 182 Wheight kg 70 Sex M SpO2 Graph 1 2 3 4 5 6 7 8 Pulse Rate Graph Minutes 140 100 60 20 1 2 3 4 5 6 7 8 Recording Time 00 04 10 Analysis Time 00 04 10 SPO2 BPM Baseline 97 Mean 97 5 Baseline 85 Mean 84 9 Minimum 94 Maximum 99 Minimum 75 Maximum 104 N SpO2 Events lt 89 0 N Bradycardia Events 40 BPM 0 Delta Index 12 sec 0 9 N Tachycardia Events gt 120 BPM 0 time hh mm ss time hh mm ss 90 SpO2 lt 90 0 00 00 00 lt 40 BPM 0 00 00 00 T89 SpO2 lt 89 0 00 00 00 gt 120 BPM 0 00 00 00 T88 SpO2 lt 88 0 00 00 00 87

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