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Spirolab

Rev.1.8

Page 1 of 60

Spirolab

User manual Rev. 1.8

Date issued

04.05.2020

Date approved

04

.05.2020

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Содержание 911080

Страница 1: ...Spirolab Rev 1 8 Page 1 of 60 Spirolab User manual Rev 1 8 Date issued 04 05 2020 Date approved 04 05 2020...

Страница 2: ...ations 20 1 5 3 Other features 22 2 USING THE SPIROLAB 24 2 1 Turning the spirolab on and off 24 2 2 Saving energy 26 2 3 Main screen 27 2 4 Symbols and icons 27 2 5 Service menu 27 2 5 1 Calibrating...

Страница 3: ...Cleaning and checking reusable turbines 52 4 1 1 Checking correct turbine function 53 4 2 Cleaning the oximetry sensor 54 4 3 Recharging the battery pack 54 4 4 Replacing the thermal paper 55 5 TROUBL...

Страница 4: ...cribes the contents of the package and the accessories that can be used with spirolab REF Description 672684 Carrying case 910320 Plastic noseclip 532367 USB cable 910300 cardboard mouthpiece User man...

Страница 5: ...iginal packaging Costs involved in sending the product are at the sender s expense Manufacturer s address MIR SRL Via del Maggiolino 125 00155 ROMA ITALY Tel 39 0622754777 Fax 39 0622754785 Website ww...

Страница 6: ...nd maintaining the device along with the ability to interpret the results provided calls for a qualified health worker WARNING MIR will not be held responsible for any harm or damage of any kind cause...

Страница 7: ...account as well as the results of other tests recommended by the doctor Comments diagnoses and appropriate therapeutic treatments are made by the doctor Any symptoms must be evaluated before spirometr...

Страница 8: ...ne sensors oximetry sensors or other accessories might cause erroneous readings or compromise the correct functioning of the device For this reason the use of such items is not permitted In particular...

Страница 9: ...atient For further details about cleaning refer to the appropriate section in this User Manual The following information is valid for both types of turbine Never expose turbine sensors to jets of wate...

Страница 10: ...able item code 919200 length 1 5 m for connection with the spirolab device Prolonged use of a sensor or the patient s condition may mean that the location of the sensor has to be changed periodically...

Страница 11: ...d free of obstructions Never place the sensor in an autoclave Do not sterilise the sensor Before cleaning the sensor disconnect it from the spirolab unit to prevent damage to the sensor and device and...

Страница 12: ...ntre Local legal requirements in force must be complied with in all cases Failure to comply with the above mentioned regulations will relieve MIR of all responsibility from any direct or indirect clai...

Страница 13: ...ent while so charging the battery WEEE symbol is mandatory to European Directive 2012 19 EEC on Waste Electrical and Electronic Equipment On completion of its useful life this appliance must not be di...

Страница 14: ...ted next to the connector for connecting the battery charger Only use the charger supplied by the manufacturer Features of the battery charger model AC DC 12W N1EFM Temperature limits indicates the te...

Страница 15: ...acts of connectors identified with the ESD warning symbol should not be touched and connections should not be performed before appropriate precautionary electrostatic discharge ESD measures are undert...

Страница 16: ...allow charges to flow to ground more slowly than with conductive materials of equal size Common plastics and glass can act as insulators An insulator retains charges and these cannot be transferred t...

Страница 17: ...ensures accurate reproducible results without needing periodic recalibration The key features of this type of sensor are as follows Accurate readings even with low air flow rates end of exhalation No...

Страница 18: ...imetry function The oximetry sensor features two light emitting diodes LED one emits visible red light and the other infra red Both bands of light pass through the finger to reach a light detector Dur...

Страница 19: ...Volume exhaled in the first 6 seconds of the test L FEV1 FEV6 FEV1 FEV6x100 FEV1 PEF FEV1 PEF empey s index L L s FEV1 FEV0 5 FEV1 FEV0 5 FET Forced exhalation time s EVOL Extrapolated volume mL FIVC...

Страница 20: ...equipment particular requirements for basic safety and essential performance of pulse oximeter equipment Reusable soft sensor for adults Range SpO2 Arms 70 100 1 470 70 80 1 626 80 90 1 667 90 100 0 9...

Страница 21: ...PM Time passed with Pulse rate 120 BPM hh mm ss Method of detection Red and infra red light absorption Measuring range of SpO2 0 99 with 1 increments Resolution of SpO2 1 Accuracy of SpO2 2 between 70...

Страница 22: ...USB Bluetooth Bluetooth interface Frequency range 2402 2480 MHz Output power 0 001W Frequency tolerance 20 ppm Type of antenna permanently attached Antenna gain 0 max dBi Battery pack lifespan About...

Страница 23: ...010 Amd2013 ISO 80601 2 61 2017 IEC 60601 1 8 2006 Key performance in accordance with IEC 60601 1 2005 A1 2012 Error of displayed numeric value Flow measurement percentage error 5 Measurement of oxime...

Страница 24: ...shows the internal software loading progress Only the first time the device will ask the user to protect the access with a PIN According to GDPR General Data Protection Regulation the user can do thi...

Страница 25: ...is moment each time the device is switched on the PIN needs to be inserted If the PIN is incorrect the user can try again the device allows 20 attempts per day After 20 attempts the user needs to wait...

Страница 26: ...ve to allow the device to keep the date and time updated and to be activated remotely if required For this reason the power key s symbol is corresponding to the standby mode 2 2 Saving energy The inte...

Страница 27: ...ormed To save the settings and return to the main screen To exit without save and to return to the previous screen To view the last spirometry session for the current patient To view the last oximetry...

Страница 28: ...ess of the display by tapping the orange cursor vertically The brightness will change in real time The service menu will display the following heading sequence Device Spirometry Calibration Oximetry R...

Страница 29: ...serial number In the Printer section you can set the print header Tap the white space under printout header to bring up the virtual numeric keyboard You can enter characters until the string is compl...

Страница 30: ...tion you can select the values that will be displayed at the end of a test these will be stated on the printout Here too the selection is highlighted by an orange box In the Results section you can ch...

Страница 31: ...this value Calibration For calibration see paragraph 2 5 1 below Oximetry In this section you can configure all alarms related to an oximetry test By setting the desired alarms to ON you will activat...

Страница 32: ...ermanently delete all the tests stored in the device 2 5 1 Calibrating turbines WARNING The turbine does not need calibration just a periodical clean The disposable turbine is inspected before it is s...

Страница 33: ...ection is 10 then the values are shows as in the following screen Tap OK to set the new correction values If the values are 10 then the following message appears on the screen The FVC and FIVC values...

Страница 34: ...TPS factor to be calculated If a 3 litre syringe is used for the test and if the spirolab device is perfectly calibrated the FVC syringe value measured will be 3 00 FVC x 1 026 BTPS 3 08 L FVC at BTPS...

Страница 35: ...lue The icon allows you to delete the last character entered The icon allows you to enter uppercase characters The icon allows you to enter information in the next field The icon allows you to return...

Страница 36: ...rds depending on the ethnic group set different predicted formulae are taken into account in accordance with the reference standard Once the desired ethnic group has been selected the device completes...

Страница 37: ...t the type of test FVC POST VC MVV OXY Each option selected will bring up a box in which you can enter the search data 2 7 2 Viewing archived data The archive displays the list of patients starting wi...

Страница 38: ...he test data to be deleted the data will be selected by two bands on the left and right now tap the icon on the lower right And tap OK in the popup window which appears on the screen At each screen yo...

Страница 39: ...e and printed either together or individually Numbers may appear on the main screen next to the spirometry test icons for example The number inside the red circle represents in this case the FVC tests...

Страница 40: ...e MiniFlowmeter then turn it clockwise until it clicks into place Connect the MiniFlowmeter to spirolab as show in the image on the right Slide the mouthpiece at least 0 5 cm along the groove on the t...

Страница 41: ...ion stage can also be performed before putting the mouthpiece in your mouth Following a slow deep intake of breath the next exhalation should be performed with as much force as possible and as quickly...

Страница 42: ...st After three or four similar consecutive breaths a continuous beep warns the user that the ventilatory profile has been measured and that VC or IVC can now be measured Slow Expiratory Vital Capacity...

Страница 43: ...s enabled below The user is prompted to confirm the move to POST mode tap YES to carry out the test in POST mode or tap NO to go back By POST test we mean a spirometry test performed after administeri...

Страница 44: ...uction restriction The final interpretation level is restriction obstruction where the indicator light indicates the worst parameter between restriction and obstruction Thanks to a mathematical analys...

Страница 45: ...spirolab device will only display the most significant data Vext and PEFT ERROR If the extrapolated volume is For patients with age 6 years 150 mL or 5 of FVC For patients with age 6 years 80 mL or 1...

Страница 46: ...invasive reading of oxygen saturation SpO2 and pulse rate use the reusable finger sensor This sensor is recommended for patients weighing over 20 Kg and with limited mobility or who remain still durin...

Страница 47: ...e last oximetry test was improperly interrupted At the same time the device will beep intermittently for 4 seconds The spirolab will then display the main screen WARNING To avoid compromising the reli...

Страница 48: ...ient displayed if this relates to a patient previously inserted before carrying out the test retrieve a test carried out previously on the subject in question and proceed as described in paragraph 2 7...

Страница 49: ...nsor to the device insert the connector with the arrow stamped on the connector facing up and make sure that everything is working properly as described previously WARNING Do not twist the sensor cabl...

Страница 50: ...onnection via SPP Serial Port Profile protocol For details on using the protocol please contact the manufacturer Similarly spirolab can be connected to a PC on which you have installed winspiroPRO Onc...

Страница 51: ...s the icon If in the service menu it was enabled the direct USB printing then on the screen appears a banner which allows to choose the type of printer to use thermal printer USB direct connection pri...

Страница 52: ...by the manufacturer In the event of problems do not attempt to make repairs The setting of configurable parameters must be performed by qualified staff In no case does the incorrect setting of the dev...

Страница 53: ...urface Before re fitting the turbine check that it is working properly It is good practice to visually check that the blades are moving freely Place the turbine on its side and slowly move the blades...

Страница 54: ...tion steam or ethylene oxide Always disconnect the sensor before cleaning or disinfection Spirolab sensors are latex free 4 3 Recharging the battery pack WARNING To charge the battery pack only use th...

Страница 55: ...scribes the steps to perform in order to replace in the correct way the thermal paper roll 1 Open the lid of the thermal paper compartment and remove it from the device Remove the paper roll holder 2...

Страница 56: ...con 4 Slide the paper through the slot on the lid of the thermal paper compartment Close the lid of the compartment WARNING Operator shall not touch simultaneously the patient and the parts of non med...

Страница 57: ...lled on the PC to comply with privacy policy Problems turning the device on Ram error data recovery Please wait The data in the device memory has been damaged If the data has been correctly restored t...

Страница 58: ...rightness level of the display automatically dims 5 minutes after a test starts This function extends battery life None Problems with charging the battery pack Defective battery The battery pack is da...

Страница 59: ...ases Uses that are incorrect improper or do not conform to the technical or safety standards in force in the country where the product is being used Use of the product for purposes that differ from th...

Страница 60: ...to the manufacturer this must be authorised in writing or by phone beforehand by the manufacturer MIR Medical International Research reserves the right to replace the product or make any changes to i...

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