Medical International Research spirobank G, User Manual

Page 1: ...spirobank G User Manual cod 980026 Rev 2 0 Page 1 of 46 spirobank G User Manual User Manual Rev 2 0 Issued on 15 06 2009 Approved on 15 06 2009...

Page 2: ...n supplied If not fitted install the operating battery taking care to connect the and battery poles correctly as shown in the battery compartment Set the device configuration as required date time pre...

Page 3: ...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...

Page 4: ...port 12 1 4 5 Warning symbol for the WEEE 12 1 4 6 FCC Warnings 12 1 4 7 Product description 13 1 5 Technical specifications 15 1 5 1 Features of the spirometer 15 1 5 2 Other features 16 2 FUNCTIONIN...

Page 5: ...Cleaning and controlling the reusable turbine 36 4 2 Changing the Batteries 38 5 PROBLEM SOLVING 38 5 1 Causes and Solutions 39 LIMITED WARRANTY CONDITIONS 41 ANNEX 1 SPIROMETRY TEST REPORT EXAMPLES...

Page 6: ...ld 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 cognitive...

Page 7: ...ration 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 t...

Page 8: ...rbine 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 d...

Page 9: ...e 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...

Page 10: ...s 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...

Page 11: ...of the device SRAM memory 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...

Page 12: ...ction 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...

Page 13: ...description spirobank G is a pocket spirometer 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 USB Bluetooth spirobank G i...

Page 14: ...tients 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 predic...

Page 15: ...arameters SYMBOL DESCRIPTION Units FVC Best FVC L FEV1 Best FEV1 L PEF Best PEF L s FVC Forced Vital Capacity L FEV1 Volume expired in the 1st second of the test L FEV1 FVC FEV1 FVC x 100 FEV1 VC FEV1...

Page 16: ...0 5 cmH2O L s 1 5 2 Other features Memory Memory capacity for over 6000 spirometric tests The precise number depends on the individual configuration so it cannot be determined more closely Display gr...

Page 17: ...d The spirobank G keyboard is composed of 5 keys Key functions are as followed 1 Off 2 esc ok previous page OSD key 3 Scroll left OSD key 4 Scroll up OSD key 5 On Scroll down OSD key Switching on spir...

Page 18: ...subject To carry out a spirometry test To access to the previous tests To access to transmission data area To search for tests made Visualize tests for current subject To view best test of the curren...

Page 19: ...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...

Page 20: ...is no information or test data in memory i e the memory is empty then all data is shown as 0 null WARNING When the free memory is not sufficient to create a new record the device shows the following...

Page 21: ...ase see Paragraph 2 4 1 Select Predicted Values Enter Menu with then use or to select the required value and press again to return to the Service Menu Delete Memory Enter Menu with then enter the pass...

Page 22: ...press to set the device as printer or PC Online select one of the two options and then press On the Bluetooth Setup screen all devices entered on the printer list and on the PC Online list can be che...

Page 23: ...ine is performed using a calibration syringe to make an FVC test for the expired parameters and an FIVC test for the inspired parameters Before the calibration procedure make a FVC test using a calibr...

Page 24: ...actor 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 volu...

Page 25: ...te of birth weight height sex Use or 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 shown to t...

Page 26: ...h 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 POST BD Test Us...

Page 27: ...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 to r...

Page 28: ...s acts 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...

Page 29: ...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 The tests available w...

Page 30: ...and when the minimum expiry time has been reached WARNING For accurate spirometry testing it is indispensable that all of the air contained in the lungs is expired The test may be repeated several tim...

Page 31: ...e suggested frequency is 30 breaths min The test will terminate automatically after 12 seconds At end of the test press WARNING It is important that the disposable mouthpiece and turbine are changed a...

Page 32: ...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 F...

Page 33: ...largest FVC is 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 FEV...

Page 34: ...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 measured param...

Page 35: ...con Choose one of the tests of the relevant patient using or 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 On th...

Page 36: ...rsons 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 configurati...

Page 37: ...t indicates that the turbine is moving within the specific low flow range indicated by the beeping If moving the turbine from side to side at a constant velocity the regular beeps or no beeps at all a...

Page 38: ...s not switch on then the battery must be changed as follows Remove the battery cover by pressing and pushing it away from the device Disconnect and remove the battery Replace with a new battery ensuri...

Page 39: ...spirometry testing the test data is incorrect Clean the turbine and then control it use a new turbine All data in memory lost due to an unforeseeable event All data in memory has been deleted Contact...

Page 40: ...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...

Page 41: ...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 fau...

Page 42: ...spirobank G User Manual cod 980026 Rev 2 0 Page 42 of 46 ANNEX 1 SPIROMETRY TEST REPORT EXAMPLES G...

Page 43: ...he user of the Spirobank G should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The spirobank G uses RF ene...

Page 44: ...f a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for...

Page 45: ...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...

Page 46: ...transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 3 5 P 3 80 MHz to 800 MHz d 3 5 P 3 800 MHz to 2 5 GHz d 7 P 3 0 01 0 12 0 24 0 24 0 1 0 37 0 37 0 74 1 1...