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spirobank G - DoctorShop

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1. IVC Slow inspiratory vital capacity g IC Inspiratory capacity max between EVC and ING ERV i ERV jExpretoyreservevoume E VE ee Ventilation per minute at rest cain LlMIN RR oos Respiratory frequency us a 4 Breath min t s Average time of inspiration at rest Mw NM tE Average time of expiration atrest amp is EE spirobank G User Manual cod 980026 Rev 1 4 Page 9 of 30 TV ti _ Average flow of inspiration at rest C M Ew SEEE E a a it OO best values Flow volume measurement system 1 5 2 Other features Memory DID NNNM Interface _ memory backup Power supply 1 El Weight Typec of electrical protection Grade of protection against water ingress d Safety level in the presence of inflammable anaesthetic gas oxygen or nitrogen Conditions of A AAA Temperature MIN 20 C MAX 60 C Humidity MIN 10 RH MAX 95 RH o Temperature MIN 10 C MAX 40 C o Electrical Safety Standard IEC 60601 1 Electro Magnetic Compatibility IEC 60601 1 2 Storage co
2. If the battery is discharged the following message appears BATTERY DISCHARGED 2 3 Information owitch on spirobank G by pressing lt I The display will show Ver 1 0 BTPS 1 026 W DATE 19 10 07 14 40 Version 1 0 version of firmware e internal software Power source USB or battery symbol BTPS Body Temperature Pressure Saturated Current date and time icon Access to the Service Menu ESC icon Return to the main screen Press to go to the second screen The second screen will show Standard ATS ERS gt e ATS ERS Standard EIUS emery E e Subjects in memory no of registered patients Spirometry test t e Spiro no of spirometry tests made O 99 e Available memory value of free memory MEMORY AVAILABLE j If there is no information or test data in memory e the memory is empty then all data is shown as 0 null WARNING A When the free memory is not sufficient to create a new record the device shows the following message Archive full It is not possible to create new patients until the archive is cancelled see paragraph 2 4 download the test archive to the PC before proceeding spirobank G User Manual cod 980026 Rev 1 4 Page 12 of 30 2 4 Service menu Switch on spirobank G by pressing and holding Press V to access the service menu The Service Menu screen contains the following fields e Select Language English default e Turbine Calibration e Select Predicted
3. flicker emissions IEC 61000 3 3 Not applicable Guidance and manufacturer s declaration electromagnetic immunity The spirobank G is intended for use in the electromagnetic environment specified below The customer Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 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 G 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 96 UT 95 96 dip in UT for 0 5 cycle Not Applicable 40 UT 60 96 dip in UT for 5 cycles 70 96 UT 30 96 dip in UT for 25 cycles lt 5 96 UT 95 96 dip in UT for 5 sec 3 Vrms 150 kHz to 80 MHz 3 V m 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
4. ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT 29 spirobank G User Manual cod 980026 Rev 1 4 Page 3 of 30 1 INTRODUCTION 1 1 Intended Use Indications for Use The Spirobank G spirometer 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 spirometry testing in people of all ages excluding infants and neonates it can be used in any setting 1 1 1 User Category The spirobank G spirometer 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 contained 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
5. JA A T 15 2 6 Displaying data trom MEMO ista adi da 16 2 7 Online operating mode connected to a PC ooocccccncocnnccccnncnnccconoconcnnnncnnnnnonnnnnononnrcnnnnnnrrnnnnnnnnnnnnrnnnrnncnnnncnnnnnns 17 2 8 eje fue RA METIRI carac noc P DU 18 2 8 1 gie poc E 18 2 8 2 IONS P PEUT 19 2 8 3 WARE C 0 In setae ca ae er lee RSE soon oie dart hetel Ad 19 2 8 4 Reading aio circle PT 19 2 8 5 SPIFOMEILY TESUINIEEDFCLAION md 19 2 8 6 Viewing the spirometric parameters ccccceccccssecceeescecseeeecceseccsescesseeeeeessecsseueeensueeseeseeesseaeeensgesenseeeenies 20 2 8 7 POST test after administration of drug oocccccccccncnnccconcnnncconnnnnnonononononnnnnnnonononnnnnnnnnnnnnnnnnnnnnonennnnnnnnnnnnnns 21 SO O aes tducueinnsc 21 3 1 Data Transmission via Bluetooth to a cell phone cccccocnccnnccnccnnccncnncnncnnncncnnnconnnnnnnonnnenononcnnrnnnnnrnnnrnennncinennns 22 31 1 Preliminary OPENS a aid eee 22 3 1 2 Bluetoot Data Trans misSiO Mar 22 3 2 Data Transmission via Bluetooth for Printings aa ta aaa aA 22 3 3 Gomectionto a Poihroughr USB Do anni induc cade 23 3 4 Upgrade Internal SO MWaTe scans coro iaa 23 4 MAINTENANCE cta 23 4 1 Cleaning and controlling the reusable turbine sessiles nnne 23 4 2 Charging TNE Batres ie baden a O ae 24 5 PROBLEM SOLVING clas 24 5 1 Causes and ouo PIS meei E aE T A RTO 24 EINMITEDWARRANTYCONDIHON Sd ai 27 ANNEX 1 SPIROMETAY TEST REPORT EXAMPLE Sotoca dept vs teres 28
6. and then control it use a new turbine e All data in 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 test memory from the device to the PC using the Winspiro PRO software This procedure is necessary as the test data could be lost whilst repairing the device and could also be of a confidential nature and therefore subject to laws on data privacy spirobank G User Manual cod 980026 Rev 1 4 Page 25 of 30 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 ll 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 l Device Description Spirometer Device Name spirobank G 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 2007 Simon Fowler Carmine Cerullo Sales Manager Quality Manager Rev 0 Mod PO 10DDC_ spirobank G spirobank
7. between the device and the PC ensure that the led on the device is illuminated 3 4 Upgrade Internal software spirobank G software can be upgraded when connected to a PC Upgrades can be downloaded by registering on www spirometry com For further information on upgrading software see the winspiroPro software manual 4 MAINTENANCE spirobank G is an instrument that requires very little maintenance The operations to perform periodically are e Cleaning and controlling of the reusable turbine e Changing the disposable turbine before each test e Changing the battery The maintenance operations described in this User 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 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 G belongs to one of two categories disposable or reusable These both guarantee precise measurements and have the great advantage of requiring no periodic calibration In order to maintain the characteristics of t
8. 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 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 G User Manual cod 980026 Rev 1 4 Page 27 of 30 ANNEX 1 SPIROMETRY TEST REPORT EXAMPLES Test Date 21 10 06 11 12 BTPS 1 078 Name Cc Z Birth Date 04 11 1967 PRE File N E3 Age 38 Height cm 182 POST File N 12 FL
9. 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 1 2 Important safety warnings spirobank G 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 the limits laid down in the European Standard EN 60601 1 2 spirobank G 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
10. providing the pharmacodynamic effects i e the data comparison after the administration 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 The turbine flow measurement sensor is available both in reusable and in single patient disposable versions 4 6 REUSEABLE TURBINE DISPOSABLE TURBINE 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 spirobank G User Manual cod 980026 Rev 1 4 Page 8 of 30 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 d
11. with a compression of the abdomen WARNING A Do not touch the keys during a test to avoid switching off the machine or stopping a test too soon The tests available with spirobank G are FVC Forced Vital Capacity VC Slow Vital Capacity MVV Maximum Voluntary Ventilation On the main screen select as follows FVC VC MVV VC MVV Press lt to access the FVC test Press A to access a new screen and then select either VC or MVV vc MVV VC MVV V ZA The device displays the information regarding the turbine selected in the initial setting reusable or single patient disposable and then the relevant test information follows Or press to turn to the main screen WARNING A With standard NAHNES lll it is not possible to make VC or MVV tests WARNING A A test is always memorised together with the details of the current patient To make a test on a patient previously inserted then you must firstly recall the patient from the memory see the final part of paragraph 2 6 for details 2 8 1 FVC Test The phases as described on the screen must be followed specifically EXPIRE quickly INSPIRE slowly It is possible and may be helpful to start the test by breathing for a few moments at rest 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 spirobank G User Manual cod 980026 Rev 1 4 Page 18 of 30 possible Then with
12. E values if is a POST phase Parameters shown FVC FEV1 FEV1 FVC FEV1 VC PEF FEF2575 FEF25 FEF50 FEF75 FEV3 FEVS FVC FEV6 FEV6 FET EVol FIVC FIV1 FIV1 FIVC PIF MVVcal VC EVC IVC IC ERV TV VE RR ti te TV ti t1 Ttot MVV ELA best values Il case NAHNES lll standard Following an FVC test the spirometry test results are shown The first screen displays the main parameters FEV6 FEV1 FEV1 FEV6 PEF the percentage of the predicted values or to the PRE values in the case of a POST phase the Flow Volume curve plus a traffic light summary of the test interpretation in the upper right as illustrated below PREX 1 Feve H I3 11 revi 3 18 BG revi 3 555 88 PEF SH eli tit best values In case of repeatability a symbol amp is shown in the graphic area The following screens show other values compared to the predicted values or to the PRE values if is a POST phase Parameters shown FEV6 FEV1 FEV1 FEV6 FEF2575 FVC FEV1 FVC best values 2 8 7 POST test after administration of drug WARNING A To carry out a POST test it is necessary to have carried out at least one PRE FVC 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 FVC test carried out on the same day To carry out a POST test pleas
13. G User Manual cod 980026 Rev 1 4 Page 26 of 30 LIMITED WARRANTY CONDITIONS spirobank G together with its standard accessories is guaranteed for a period of e 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 purchase 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 e 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
14. New FVC and New FIVC fields Note Each time a calibration is made the new correction factors are added to the previous correction factor Therefore before making a new calibration make sure to delete the calibration in use as described above 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 2 696 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 5096 the BTPS factor is 1 102 a correction of 10 2956 The correction of the inspired 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 G is calibrated correctly then the FVC syringe value will be 3 00 FVC x 1 026 BTPS 3 08 L FVC at BTP
15. OW L s Parameter FVC FEV1 PEF FVC FEV1 FEV1 FVC PEF F2575 FEF25 FEF50 FEF75 FEV3 FEV3 FVC FEV6 FEV1 FEV6 FIV1 FIVC PIF HMVV VOLUME L n H INTERPRETATION Possible Mo erate Restriction POST No significant Bronchodilatation POST FEF2575 24 CHG QUALITY CONTROL GRADE D REPEATABILITY None spirobank G User Manual cod 980026 Rev 1 4 Standard Weight kg 70 ERS ATS IDH 12 Sex M Predicted MC BARCELONA js H UJ GJ OY COO OY 19 OO GJ WW UJ y a Cs J o A N Best Value PRE duds 10 00 3 22 2 98 92 5 10 00 5 00 8 97 23 1 3 3 22 100 0 3 22 92 5 2 39 600 104 3 Calcolated Value Page 28 of 30 p thet tt b bb tt t ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT Guidance and manufacturer s declaration electromagnetic emissions The spirobank G is intended for use in the electromagnetic environment specified below The customer or the user of the Spirobank G 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 G uses HF 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
16. RRR S RR KR E RR SR RR SR RR RR SE RR au To display next test in memory o m spirobank G User Manual cod 980026 Rev 1 4 Page 11 of 30 To print data in memory through Bluetooth connection To transfer data through a Bluetooth connection E A A A A A A WARNING A IF no key is pressed the instrument after 1 minute will beep and if no key is pressed after a further 10 seconds it will automatically switch off If spirobank G is powered by a USB connection to a PC the aforementioned function is disabled and the device is switched off using O The instrument can be switched off at any time by pressing and holding the b key 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
17. S 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 z 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 Subject Data Switch on spirobank G by pressing a or if already switched on press V 14 icon to access the PATIENT DATA MANAGEMENT screen the following table describes the functions and icons Icon Key Description To enter new patient data RRA mE To make a bronchodilator test i e make a test after drug i administration with defined dosage to carry out this test a base PRE To enter new patient data From the Patient Data Management menu press V to access the data input screen First screen date of birth weight height sex Use V or A to select date of birth use 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 spi
18. The test will terminate automatically after 12 seconds At end of the test press c4 WARNING A It is important that the disposable mouthpiece and turbine are changed at the end of each test 2 8 4 Reading messages A series of measured parameters based on the international reference standards are shown at the end of each test A series of test messages are displayed followed by the measured parameters A description of these messages and the parameters now follow in the order in which they appear If no key is pressed for circa 6 seconds 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 based on the ATS standard For a faster comprehension this interpretation is illustrated by a traffic light code green yellow red For each test made an arrow on the right of the screen indicates the worst level of interpretation of the test session The connection between the traffic light colour and the test interpretation is shown below spirobank G User Manual cod 980026 Rev 1 4 Page 19 of 30 normal mild OT moderate TA aga moderately SEVE e vmm SEVE E rw O Very SeVere nnn Through an analysis applied to some of the indices and parameters calculated in the FVC test spirobank G produces a variety of quality control comments useful to understand the reliability of the test made This control q
19. W 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 G 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 1 0 L then FEV1 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 I case ATS ERS standard Following an FVC test the spirometry test results are shown The first screen displays the main parameters FVC FEV1 PEF FEV1 the percentage of the predicted values or of the PRE values in the case of a POST phase the Flow Volume curve plus a traffic light summary of the test interpretation in the upper right as illustrated below spirobank G User Manual cod 980026 Rev 1 4 Page 20 of 30 best values In case of repeatability a symbol amp is shown in the graphic area The following screens show other values compared to the predicted values or to the PR
20. ations of IEC 60601 1 1 1 4 5 Warning symbol for the WEEE K 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 device 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 6 FCC Warnings 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 spirobank G User Manual cod 980026 Rev 1 4 Page 7 of 30 However there is no guarantee that interference will not occur in a particular insta
21. ay e The 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 device To interrupt the data transmission during the Bluetooth connection press lt to end the connection and to return to the main screen Where no device has been setup for data transmission a message appears on the display to start searching for enabled devices After setting the device the connection will start automatically WARNING A 3 2 Data Transmission via Bluetooth for printing WARNING A Printing is possible only if the printer has a Bluetooth connection alternatively an USB adaptor can be installed on the printer in order to enable a Bluetooth connection The printer used must be in the list of printers accepted by the device To have a copy of the updated list please contact the manufacturer or send an email to the following address mir spirometry com The Bluetooth system enables spirobank G to transfer test data directly to a Bluetooth enabled printer Proceed as follows e From the main screen select the test to be printed with B e Onthe next screen press V M icon e Press A 8 icon e Choose one of the tests of the relevant patient using V PAN or a Tests stored in memory can also be printed Use the search method as described in Paragraph 2 6 to select and print out relevant tests e On the test
22. 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 follows 1 5 1 Features of the spirometer Measured parameters SYMBOL cw DESCRIPTION Units TEVC 1BestFVO at s LI ME CSU AAA EAS PER Best PEF O E FVC Forced Vital Capacity NNNM NP FEVA Volume expired in the 1 secondofthetest n FEVI FVC FEVIFVCx100 0000 FEVI VC FEV1 bestbetween EVC andIVCx100 96 PER X Peak expiratory flow _ zoom E A FEF2575 Average flow between 25 and 75 ofthe FVC Ls FEF25 ForcedExpiratory Flow at 25 of FVC s FEF50 ForcedExpiratory Flow at 50 of FVC ls FEF75 Forced Expiratory Flow at 75 of FVC IO E HR FEV3 Volume expired in the initial 3 seconds of the test L FEV3 FVC FEV3 FVC x 100 TEM EMEN FEV6 Volume expired in the initial 6 seconds of the test L FET iForeedexpiatorytime E EVol X Exrapdatedvoume mM FIVC Forced inspiratory volume _ ee QUNM FIV1 Volumeinspiredinthe 1 second of the test E PIF Peak inspiratory flow ol ES ermara MVVcal Maximum voluntary ventilation calculated on FEVi Us VC Slow vital capacity expiratory iL EVC Slowespirtoryvitalcapacity
23. ce d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people spirobank G User Manual cod 980026 Rev 1 4 Page 30 of 30
24. checked A device can be set as default by accessing the list with c and then selecting the device to which spirobank G will automatically connect or deleted from the list press A on the bottom to confirm the deletion or lt to go back and to not delete the device Info Firmware Access through to view the version number of the following components where available e spirobank G e Bluetooth After approximately 10 seconds spirobank G automatically displays the Service Menu otherwise press 1 Having set the parameters as required from the Service Menu press lt to access the second screen and then the following is shown Which indicates ID 0014 CAUCASIAN e Patient ID code and ethni e Senge ee mum Birth date E bo 7 Height cm 04 11 1967 E Weight kg Sex S 1 PA Function icons PA the ID code is created automatically when new patient data is entered and is progressive the icon VC MVV is not shown when the standard NAHNES III is selected The symbol jl is shown only in the POST phase 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 an FVC test for the expired parameters and an FIVC test for the i
25. cod 980026 Rev 1 4 Page 10 of 30 Switching on spirobank G To switch on spirobank G press c and then release Switching off spirobank G To switch off spirobank G press b for at least two seconds CONFIRM to confirm and pass to the next phase use V Or Symbols and Icons The icons used in the various function screens and their meanings are shown in the following table _ICON DESCRIPTION a eee RRRRRRRR eee eee ee eee eee eee eee ee eee ee ee RR SR SEHR S RR SR RR RR SR R4 a To access the set up Service Menu of spirobank G o S DEPTEETTETTTETETITITTTITo os ue nn uu nn ee ens nana nana uu eee eee RR R RR eee eee eee eee ee ee gNSERS S RR RRERRSENN SERE SRRER RRSRR SERRSRREKRRSRRNSRRRSRRERRRS RR SERE SERE NRSRRR ERR RRRRR SRRR SERE SRRERNRSRRRSERRRRRUR SERRE SRRR KRRERRR SERRE ERR RRERNRSERNSERRKRRENRSRRN SER ERRERRR SERE SERRRRRR RR GERENS RR VR SR RR SE RR SR RR RR sE RR Ru To manage or enter new patient data from the main screen nunnnnnn nennen EEPTTETETETEETE ETT EET In oo e o n ee ee unu nana nana nu ee uu eee eee eee RR RR RR RR RENS SR RR SER RR RE NR SR RR SERE RR SERRE SERE RRERRRZRRRSRRRSRRERRRZRRRSRR RRERRRSRRNSRRRSRRRKSRSRRR S RR SRRENRSRURNSRRRKRRERRRSRR SRRRSRRERRRSRRRSERRSRRERRRS RR SERE SERE RNSRRR SERE SRRRR SNR SERE RRRERRSERNSERRRRRUR SERE SRRR RRRERRSERN SERE RRRRRSERNSERRRRRERRR SERRE SER RR RR RR ERR SERE SERE RRSRRRSRR RR ERR SR RR SR RR RR SE RR au To enter new patient data To carry out a bronchodilat
26. correct operation of the mobile rotor of the turbine For the FVC test to be judged as acceptable besides breathing as deeply 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 seconds from the start of the forced expiratory test spirobank G 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 At end of the test press e as shown in the screen 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 To carry out this test correctly follow the indications shown 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
27. cts as an intelligent sensor for flow and volume measurement while the PC controls its functions including the switching on and off of the unit Connected to a portable PC spirobank G can carry out epidemiologic studies in work environments school settings etc spirobank G User Manual cod 980026 Rev 1 4 Page 17 of 30 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 Note that when using spirobank G in online mode if a turbine disposable or reusable is setup then the same turbine will remain by default the next time the device is used in stand alone mode Thus pay attention to 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 e Hold spirobank G 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
28. d provoke a loss of data in the memory of the device SRAM memory Errors in measurement or in interpretation can also be caused by spirobank G User Manual cod 980026 Rev 1 4 Page 6 of 30 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 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 048 00000 REF spirobankG MIR via del Maggiolino 125 00155 Roma Italy CC al ey 0476 Rx ONLY FCC ID TUKMIR024 The label shows Serial number of the device Product name Name and address of the manufacturer CE mark in compliance with the Directive 93 42 EEC Electrical safety symbol Warning symbol for the WEEE prescription use label indication about FCC 1 4 2 CE mark for medical devices C oaze This product is certified to conform to the Class II 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 43 Electrical safety symbol 1 4 4 Warning symbol for the USB port For connection to other devices such as PC Use only the serial cable supplied by the manufacturer and observe the safety regul
29. e Delete Test Data e Change Date Time e Date Format e Units Format e Select Turbine e Select Standard Insert Phone Number Bluetooth Settings Info Firmware Select the required option using V or ZA and the symbol on the left of the screen press to access options select the required setup using the V Or x then press to return to the Service Menu press N to return without modifications Select Language Press a to access the Menu use V Or ZX to select the required language and press to save the change and return to the Service Menu Turbine Calibration Insert the following password to access the calibration function V AAA For the correct use of this function please see Paragraph 2 4 1 Select Predicted Values Enter Mendwit c1 henis WV B A to select the required value and press c T E EE a A c 0 Ce Knudson i Kmudson com USA Knudson Delete Memory 0000000000000 uuu d ERS Zapletal Enter Menu with then enter the password MC Barcelona Zapletal V WC AAA 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 lt arrow indicates the field to modify Use y or A to modify the selected option use to pass to the the following option Lastly press to return to the Service Menu To return to the Service Menu display without making any changes press N Date Format Use V or A to select the required f
30. e 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 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 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 G User Manual cod 980026 Rev 1 4 Page 2 of 30 INDEX 1 INTRODUC HON sieno
31. e 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 G is used exceeds the applicable RF compliance level above the spirobank G should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the spirobank G 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 G The spirobank G is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the spirobank G can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the spirobank G 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 distan
32. e 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 measured parameters 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 to carry out a POST test on a patient if the patient archive only contains PRE tests carried out 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 insert a new patient or recall a patient from the archive see paragraph 2 6 WARNING A If a new dose is set after a POST test then the device creates a new test session still POST A new test code ID is allocated The interpretation is not based on the previous sessions with different drug doses only the new test is utilized for the interpretation 3 DATA TRANSMISSION WARNING A Read the instructions carefully before starting data transmission taking care to ensure that all the information has been properly understood spirobank G User Manual cod 980026 Rev 1 4 Page 21 of 30 3 1 Data Transmission via Bluetooth to a cell phone spirobank G includes a Bluetooth wireless data transmission system This con
33. essary that they conform to the directive EN 60601 1 For the recycling of the spirobank G 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 it 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 device 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 coul
34. etails of the patient or alternatively to the personal best values from the clinical history of the subject The personal best values can vary considerably from the predicted values which are taken from healthy subjects spirobank G 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 The connection to the PC is made through the USB port spirobank G gives an automatic interpretation of each spirometry test carried out and assigns a traffic light feedback green yellow or red for a rapid reading of the interpretation spirobank G is able to make FVC VC 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 The 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 The device has two batteries e Main power 9V battery 1 battery is required e Memory
35. he 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 G as if to make a spirometry test for example FVC e Hold spirobank G in one hand and move it gently from side to side so that air passes through the turbine e fthe rotor within the turbine is turning correctly then you will hear a regular beep that indicates that the turbine is spirobank G User Manual cod 980026 Rev 1 4 Page 23 of 30 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 G turning it anti clockwise and pulling lightly lt 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
36. hive the following screen appears Patient data 04 11 67 CM182 KG70 C 19 10 07 14 40 FVC VC MW Test made Patient ID code and ID 0016 PRE 0016 test code Y e La A Go back esc Go on Go to the test WARNING A The ID code is automatically associated by the device when are the patient data are entered the test code is like the patient ID for the first test made on the patient The following tests on the same patient are then identified sequentially To show data of the selected test press twice Choosing a test with eA icon the following screen appears 04 11 67 CM 182 KG 70 4 19 10 07 14 40 FVC VC MVV ID 0016 PRE 0016 At this stage it is possible to e Print selected test data via the Bluetooth connection by pressing V 8 icon e Scroll through the list of data in memory pressing lt LE icon e Show all results of the selected test pressing A a icon and then using V and YA or lt to return to the main screen e Make a new test on the selected subject pressing c1 1 icon a new screen is shown with the following message Press OK to make NEW Test on the selected subject Press to confirm otherwise lt to return to the list of data in memory 2 7 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 the USB cable spirobank G thus a
37. inside Leave the turbine immersed for the time specified in the instructions of the solution 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 Never place the turbine under a direct jet of water or any other liquid Where no cleaning solutions are available it is however indispensable to 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 in its place and follow the instructions indicated by the closed lock symbol printed on the plastic casing of the spirobank G To insert the turbine correctly push it and then turn it clockwise until reaching the stop which ensures that the turbine 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 another one If the disposable turbine is used do not clean it but change it after each test 4 2 Changing the Batteries If the message BATTERY DISCHARGED appears on the spirobank G display or if the instrument does not switch on then the battery must be changed as fo
38. llation If this equipment does cause harmful interference to radio or television 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 HReorient 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 help CAUTION ZA Exposure to Radio Frequency Radiation This device must not be co located or operating in conjunction with any other antenna or transmitter Labels and symbols are displayed on the device like shown in the following images FCC ID EDSLMX9838 1 4 7 Product description spirobank G is a pocket spirometer lt 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 USB Bluetooth spirobank G is specifically designed to measure a range of respiratory parameters 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 spirobank G 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
39. llows Remove the battery cover by pressing and pushing it away from the device Disconnect and remove the battery Replace with a new battery ensuring the connector is correctly connected Close the battery compartment by replacing the back cover and sliding it towards the inside of the device WARNING Use only 9 V type PP3 battery or equivalent When inserting the battery in the battery slot take care to connect the and as shown inside see figure below SUPER ALKALINE ie 1604A 9V 9V 6LF bLEZ 6L H61 MNIGUA m UBI 0 MERCURY amp CADMIUM The device also has an internal lithium battery for the RAM memory and 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 A list of problems follow that may arise when working with the spirobank G Diagnostic messages are also shown on the display to indicate the type of malfunction 5 1 Causes and Solutions e spirobank G does not switch on Check that battery is correctly inserted in the compartment on the back of the instrument If it is correctly positioned then replace it with new one spirobank G User Manual cod 980026 Rev 1 4 Page 24 of 30 e During operation the machine switches itself off and on again Change the battery e At the end of spirometry testing the test data is incorrect Clean the turbine
40. ment is for personal use and will only be used by one patient The cleaning of Reusable the turbine should be performed according to the instructions contained in the User s turbine 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 spirobank G User Manual cod 980026 Rev 1 4 Page 5 of 30 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 23 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 disposable 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 diamete
41. n screen without changing any data press N icon Modify data in the following POST BD Test Use lt to set the spirometry test in post mode i e after bronchodilation On the next screen use to select either a PRE or POST test using respectively lt or lt 4 Once entered the ti icon will appear on the upper right of the main screen for POST testing of the subject For more information about the POST test please see paragraph 2 8 7 2 6 Displaying data from memor From the main screen press A a icon to check data of the relevant patient or to search for another patient s data the following options are available FUNCTION Display the last spirometry tests of the selected patient Access data in memory spirobank G User Manual cod 980026 Rev 1 4 Page 16 of 30 lt Esc Return to the main screen Display files from a date onwards partial memory Display files from beginning to end complete memory Search by ID Code enter the ID Code of the patient required then a to access the data Search for date enter test date of the required file then press to access test data The data will be shown starting from the date entered up to the most recent file in memory Full Memory to show test data in alphabetical order The last data are marked by a double beep then the data shown restarts from the first one recordered Press lt to return to the main screen without searching Once in the arc
42. nditions Operating conditions Applied norms 2 FUNCTIONING OF THE SPIROBANK G 2 1 Keyboard The spirobank G keyboard is composed of 5 keys E diste iac E mE A A T RA R TRE A A MEM ED IE cU nsu cd E Ed ELO diols tne TE coset tas cetbana E EE EETA Memory capacity for over 6000 spirometric tests The precise number depends on the individual configuration so it cannot be determined more closely 111 grafic LCD type SFTN 128x48 Pixel nnn Membrane keyboard with 2 keys tos USB Bluetooth Duration of the CR2032 3V lithium battery 1 Circa 10 years Under conditions ona use 1 battery 9V DC type PP3 or through USB connection amp 1 amp 160 grams including battery _Type of electrical protection lt BF IPX1 device protected against water drops C as S 1 i d evi C e meee ne ee ee eee eee ee ee EE EE RR GR EE RR GR RR GR SZ GGR RR GR RR GR RR GR RR GR RR GR RR GR RR GR REGE REGE EE EE EEE EEL Device not suitable spirobankG Key functions are as followed PRE 1 TASA 3 18 Eb 9 55 88 Betis O NON I0 0 0 E 0E00EE spirobank G User Manual
43. nection is through radio and allows spirobank G to be connected to a mobile phone and to transmit data via modem to a telemedicine system This method of data transmission allows all of the data in spirobank G to be transmitted The sequence of operations to follow is described below 3 1 1 Preliminary Operations WARNING A The transmission of data through a Bluetooth connection requires the phone number of the telemedicine system modem where the data shall be transferred This could be the doctor s office a telemedicine service whatever To enter the telephone number see the service menu when the device is switched on see Paragraph 2 4 The device must also have a mobile phone set up see Paragraph 2 4 for further details 3 1 2 Bluetooth Data Transmission e From the main screen press A corresponding to the icon e Press V corresponding to the e Press V corresponding to the Es icon e The selected transmission will be shown to confirm press c1 to activate the connection to the default device set up e When required by the cell phone enter the PIN code shown on the spirobank G display corresponding to the serial number SN of the machine shown on the spirobank G ID label e The connection phases then follow e When the connection is complete then 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 displ
44. nspired parameters Before the calibration procedure make a FVC test using a calibration syringe for example 3 litres and it is vital to make a complete expiratory and inspiratory phase To access the calibration function select Turbine Calibration from the Service Menu with the horizontal scroll key and then press 41 The following screen appears SYRINGE FVC FIVC 300 lt 308 333 0 0 FOR FACTORY CALIBRATION INSERT FVC 0 spirobank G User Manual cod 980026 Rev 1 4 Page 14 of 30 The Old FVC and the Old FIVC values now shown are from the previous calibration The values in indicate the correction factor These are pre set to O by default Use V Or A to set the desired values use c to go to the following value If the difference in percentage between the expected value and the measured value is greater than 10 then it is not possible to continue the calibration procedure this means that the turbine is damaged or requires cleaning To clarify using a 3 litres syringe the expected FVC value is 3 08 L the expected FIVC instead is in function of the ambient temperature Press N to turn to the service menu without applying any calibration factor If 96 FVC and FIVC are more than 10 the device cannot correct such a value in this case Check the correct functioning of the spirobank G with a new turbine and or Clean the turbine To erase the calibration in use and reset to the factory calibration input O in the
45. ntal conditions in this regard reference is made to the specifics described in paragraph 1 6 3 below WARNING 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 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 subject 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 spirobank G User Manual cod 980026 Rev 1 4 Page 4 of 30 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
46. of whoever is legally charged with the supervision of this person 1 13 Operating environment spirobank G 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 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 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 environme
47. or test one ee ee ee ee eecten ee ee eee ene ee ne ee eee eee eee ee eee eee ee N To modify data of the current subject o oe ee ee eee PET To carry out a spirometry test l To access to transmission data area To search for tests made Visualize tests for current subject To search test from date and onwards partial memory briser ri riri Go oe ee ee ee een E E E E E To scroll through files on memory To select male patient bii eene enin n E To select female patient To carry out an FVC test 0 To display previous tests in memory cc RR SER RR SENS SERE SERE RR SERRE SERRRRERRRSRRR SERE SRRERRRRRRR SER ERRRRRSERR SERE SERES gRSRRN S RR SRRENRSRRN SERE RRRERSRSRR hittin net Chit SERE SRRRRRS RR ERR SERE RR SERRSRRRRRRRR RRRSRRRRRRERNRSRRN SERE SRRUN SERRE SERR SERE SR ERN SERERE RR SR SERRE SRRRRRRERRRSRRR SER ER RRRR ERR SERE RRRERRS
48. ormat and A to enter and return to the Service Menu Units Format Access with eA and select imperial or metric as required with V or A Press 41 again to return to the Service Menu Turbine Setup Access with 1 and select the turbine in use disposable or reusable with V Or Zi Press 1 again to return to the Service Menu Select Standard Access with 1 and select the required standard using V or A Press J to return to the Service Menu spirobank G User Manual cod 980026 Rev 1 4 Page 13 of 30 WARNING A With the standard NAHNES lll is not possible to select or to modify the predicted values Insert Phone Number Access with 1 and then use V or A to select phone number scroll through the list of numbers until the number required is in the centre of the display where it is shown enlarged wait one second than the number is automatically inserted as the degault number Then press to confirm and to return to the Service Menu To cancel a wrong number press Bluetooth Setting Access with ct search for available devices select Search Device and then press et spirobank G will start to search for Bluetooth devices in the area when one or more devices are found the screen will display the names of the device s found press to set the device as printer or phone select one of the two options and then press On the Bluetooth Setup screen all devices entered on the printer list and on the phone list can be
49. r 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 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 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 If the PC and or the printer connected to spirobank G come into contact with the area containing patient data ref directive EN 60601 1 1 it is nec
50. return it to the manufacturer for repair WARNING ZA 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 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 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 cro
51. robank G User Manual cod 980026 Rev 1 4 Page 15 of 30 that is being changed After this operation use to go to the following screen or lt to return to the previous data Second screen ethnic group Set an ethnic group this function allows the correction of the predicted values for a subject with the ethnic group to which he or she belongs The function without correction can also be used Group correc Caucasian Hong Kong Chinese 100 Japanese 8 Polynesian 906 Northindian 9096 Souhndan 8 Pakistan 906 p African Descent For ATS ERS standards the correction is applied to the predicted values of the following parameters FVC FEV1 FEV3 FEV6 VC For NAHNES III standards the correction is based on several theoretical formulas as described in the publication press e to complete the setting of the parameters the main screen then appears In the event of an error during the setting of patient data press lt to return to the previous screen To interrupt data input press lt which then goes back to the main screen Once the patient data is set then the ID code appears in the upper left of the main screen this code is associated to the new subject Modifying patient data ma In the Patient Data Management menu press ZA which corresponds to the screens by using the keys as described for entering new patient data To return to the mai
52. screen press ang then V e spirobank G will carry out the connection spirobank G User Manual cod 980026 Rev 1 4 Page 22 of 30 e At the end of transmission spirobank G 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 3 3 Connection to a PC through USB port WARNING A Before connecting spirobank G via 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 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 G as shown in the picture and attach the other connector to the USB port of the PC When making an initial 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
53. spirobank G Y User Manual NATIO e Na AN XS May y35 Ww User Manual Rev 1 4 Issued on 18 05 2009 Approved on 18 05 2009 spirobank G User Manual cod 980026 Rev 1 4 Page 1 of 30 Thank you for choosing a product from MIR MEDICAL INTERNATIONAL RESEARCH The original packaging contains the device with the followings accessories _ Accessories market with spirobank G Code Spirobank EA s 0 2690 Spirobank G device 910575 Spirobank G User Manual 980205 USB connection Cable 232305 _1x 9V battery mod 6LR61 PP3 1 970095 CDwinspiroPRO 5 220100 _3Paper mouthpieces 910300 1 Reusable turbine sensor 910002 T accessories for single use only all other accessories are reusable Before using your spirobank G 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 G to the PC At the end of the installation connect the device to the PC and the hardware will be recognised by the PC Th
54. ss 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 AT If you are going to perform the spirometry test with a disposable turbine it is important yo to use a new turbine for each new patient The characteristics accuracy and the M hygiene of the disposable turbine can only be guaranteed if it has been conserved beforehand in its original sealed packaging Disposable The disposable turbine is made of plastic and its disposal after use should adhere to the turbine local regulations and norms in force 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 instru
55. the mouthpiece still 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 inspiring slowly and deeply the following expiration must be made with the maximum effort by expiring all of the 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 WARNING A 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 G recognises the best test FVC FEV1 and will automatically show the results of this best test At end of the test press as shown on the screen During testing spirobank G 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
56. 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 G including cables than the recommended 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 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 o spirobank G User Manual cod 980026 Rev 1 4 Page 29 of 30 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 mobil
57. uality check assigns a letter for the current session as described below PRE Test A At least two acceptable manoeuvres with the highest two FEV1 values matching to within 100 mL and the largest two FEV6 values within 100 mL B At least two acceptable manoeuvres with the FEV1 values matching to within 101 to 150 mL C At least two acceptable manoeuvres with FEV1 values matching to within 151 to 200 mL D only one acceptable manoeuvres or more than one but the FEV1 values not matching to within 200 mL with no interpretation F No acceptable manoeuvres with no interpretation POST Test A two acceptable 1 FEV1 values matching within 100 mL B two acceptable 1 FEV1 values matching within 200 mL C two acceptable 1 FEV1 values that do not match within 200 mL D only one acceptable 1 FEV1 manoeuvre F No acceptable 1 FEV1 manoeuvres Acceptable manoeuvre means good start and satisfactory exhalation duration and flow Where several comments related to the single test are calculated spirobank G will only show the most important to facilitate the test interpretation ERROR IN Vext and PEF If the extrapolated volume Vext is greater than 500 mL or greater than 596 of the FVC or if the PEFT time to peak flow is greater than 300 ms then the following comment is shown INITIAL EXPIRATION TOO SLOW FET error If FET is under the predicted threshold the following message appears EXPIRY TIME INSUFFICENT 6s FLO
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