Vitalograph In2itive 2120 User Manual Download Page 1

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Page 1 of 45 DT_0006-6

Model 2120 Hand Held

Spirometer

Vitalograph

In2itive™

User Manual

Summary of Contents for In2itive 2120

Page 1: ...Page 1 of 45 DT_0006 6 Model 2120 Hand Held Spirometer Vitalograph Vitalograph Vitalograph Vitalograph In2itive User Manual l...

Page 2: ...0 547391 40 e mail info vitalograph de Vitalograph Inc 13310 West 99th Street Lenexa Kansas 66215 USA Tel 913 888 4221 Fax 913 888 4259 e mail vitcs vitalograph com Vitalograph Ireland Ltd Gort Road B...

Page 3: ...SESSION 12 Checks to Make before Performing a Test Session 12 Performing a VC Test 12 Performing an FVC Test 14 SAVING THE TEST SESSION 17 PERFORMING A POST TEST SESSION 17 PERMANENT STORAGE OF PRE T...

Page 4: ...45 DT_0006 6 FAULT FINDING GUIDE 33 CUSTOMER SERVICE 35 CONSUMABLES AND ACCESSORIES 36 EXPLANATION OF SYMBOLS 36 TECHNICAL SPECIFICATIONS 37 CE NOTICE 38 FDA NOTICE 43 DECLARATION OF CONFORMITY 44 GUA...

Page 5: ...ded or entered via a keypad and stored together with spirometry test data Current test data can be viewed on the LCD and printed and downloaded to a PC There are a variety of backup and other configur...

Page 6: ...at No 07514 Issue 5 Page 6 of 45 DT_0006 6 Figure 1 PC Software Mini USB ports in cradle and device Enter Button Up Button Down Button Cancel Button Stylus Holder On Off Button LCD Touch panel Display...

Page 7: ...edicted values and languages Diagnostic interpretation options Lung age for adults and adolescents Real time test quality prompts Vitalograph PC software included Stylus Can enter subject details on d...

Page 8: ...the power supply is 5 volts DC Connect the mini USB connector from the power supply into the USB socket on the side of the unit or into the cradle Plug the mains plug into a suitable socket 9 Operate...

Page 9: ...the device cap This will expose the two pressure ports on the device cap 7 Attach the remote flowhead to the Vitalograph In2itive device cap by the dual silicone tubing Flowhead Connection Tube 8 A re...

Page 10: ...ly unit with which it is supplied or from the PC via the USB cable or from the internal Battery Pack When powered from the low voltage Power Supply or the PC the LED on the front face on the device wi...

Page 11: ...s a number of battery power detect messages When the Battery Pack starts to run low the Battery Low icon will flash on and off on the Main Menu screen You will be allowed to continue to use the device...

Page 12: ...eft hand corner of the screen If the subject name is not entered then the subject ID will be displayed If the subject has test session results associated with it then the subject name and ID will appe...

Page 13: ...but clamping it gently between your teeth d Seal your lips around the mouthpiece and keep your tongue down e Blow out as long as possible Keep blowing until all air is expelled It is vital that the o...

Page 14: ...mit of Normality LLN are also displayed 4 Repeat the blow three times or more to obtain good test quality 5 After performing the VC tests press the Cancel button to exit the VC Test screen This brings...

Page 15: ...upright fit the noseclip and relax b Insert the mouthpiece carefully into your mouth not like a trumpet but clamping it gently between your teeth c Seal your lips around the mouthpiece and keep your t...

Page 16: ...entered 5 Repeat the blow three times or more to obtain good test quality 6 To view results select the results tab You can view the results for each blow by selecting the up down arrows on the top rig...

Page 17: ...delivery To perform a Post test 1 Select Post Mode from the Main Menu 2 If you want to perform a Post Test on the Pre test Session just performed select Perform Post test on Current Subject This will...

Page 18: ...Permanent Storage When this option is selected the list of permanent pre test sessions will appear Select the required pre test session from the list and select enter to bring you into the Post Mode...

Page 19: ...e by selecting the Select tab in the View and Report screen The following options are available a Select Test Session You must first select a subject from the database and then select a test session f...

Page 20: ...ge is within 3 Follow these steps to check the accuracy of the unit 1 Select Accuracy Check from the Main Menu using the keypad 2 Enter the Syringe volume and reference using the touch panel keypad 3...

Page 21: ...wing options are available d FVC Display You can select to show F V Flow Volume or V T Volume Time Graph by default in the FVC test screen Select the required option from the drop down menu e VC Displ...

Page 22: ...Select Test Session s for deletion or Delete Subject s from the device by pressing the relevant button using the touch panel LCD Calibration The Vitalograph In2itive should never be outside accuracy...

Page 23: ...ngs This allows you to adjust the settings of the device The following options are available in the Device Settings screen Date Time Sound Options Incentive Units Power Save Options Parameters Volume...

Page 24: ...using the on screen keyboard The value entered must be between 80 150 Units The units used can be modified by selecting the alternative option available on the drop down list Metric US Imperial Power...

Page 25: ...atory flow the mean FEF in the time interval between 25 and 75 of the FVC L sec FEF 75 85 F7585 Forced late expiratory flow the mean FEF in the time interval between 75 and 85 of the FVC L sec FEF 25...

Page 26: ...V1 divided by the largest VC from the VC or FVC manoeuvre Vext FVC Ratio extrapolated volume of FVC PIF L min Peak inspiratory flow L min Lung Age Lung age will be displayed if the date of birth heigh...

Page 27: ...nu after selecting a subject Select the required option from the drop down list c After VC You can configure the device to go to FVC or the Main Menu after performing a VC test Select the required opt...

Page 28: ...m the drop down list h F V Size The Flow Volume graph can be changed from standard to ATS ERS 2005 ATS requirements Select the required option from the drop down list i V T Graph The session report ca...

Page 29: ...tout can be set to Colour or Black White Select on for a colour printout and off for black white Note In order to send the report to the Vitalograph Reports Utility it is necessary to have the Vitalog...

Page 30: ...leaned according to the guidelines of the user s facility In the event of visible contamination of the flowhead cones or flowhead element they should be cleaned or disinfected as described in the acco...

Page 31: ...No White Flowhead Tube Silicone Rubber Clean Viable Remote Flowhead Attachments PC ABS Silicone Rubber Clean No Cradle Case Exterior PC ABS Clean No Stylus PC ABS Clean No Screen Electrode with Anti...

Page 32: ...ad 1 Hold the device body firmly in your left hand 2 Hold the flowhead with your right hand at the same time press and hold the button firmly on the front of the fleisch flowhead 3 Slide the flowhead...

Page 33: ...oblem Fault Symptoms Accuracy check variations 3 False readings suspected Possible Causes In probable order Recheck Calibration with reference to section Checking Accuracy Was the correct syringe volu...

Page 34: ...hat external printer is selected in the Report Options screen Check USB cable is connected between In2itive Cradle and printer Check printer as per manufacturers instructions Check printer compatibili...

Page 35: ...m Fault Symptoms Cannot read screen Possible Causes In probable order The battery may be low Plug in the USB cable or mains power supply and switch on the device LCD failure contact support Main PCB f...

Page 36: ...ule Spare Set 79191 Flowhead Complete 79192 Flowhead Connection Tube 79163 Remote Flowhead Adaptor Kit 79164 CD with User Manual 79165 Test Data Storage Card 65030SPR Vitalograph Reports Application 7...

Page 37: ...s Min flow rate 0 02 L s Operating temperature range ATS ERS limits 17 37 C Design limits 10 40 C Performance standards the Vitalograph In2itive meets or exceeds ATS ERS 2005 ISO 23747 2007 ISO 26782...

Page 38: ...Model 2120 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Model 2120 uses RF energy only for its...

Page 39: ...EC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electr...

Page 40: ...the Model 2120 should assure that it is used in such an environment Immunity test IEC 60601 Test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC...

Page 41: ...put 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 determin...

Page 42: ...0 1m 0 1m 0 2m 0 1 0 4m 0 4m 0 7m 1 1 2m 1 2m 2 3m 10 3 7m 3 7m 7 4m 100 11 7m 11 7m 23 3m For transmitters rated at a maximum output power not listed above the recommended separation distance d in me...

Page 43: ...and needs to be installed and put into service according to the EMC information provided Portable and mobile RF communications equipment can affect medical electrical equipment WARNINGS 1 No modificat...

Page 44: ...ards European Medical Devices Directive MDD 93 42 EEC This device classified as 2a as per Annex IX of MDD 93 42 EEC meets the following provisions of Annex II of the Medical Devices Directive as per A...

Page 45: ...eriod stated above provided that the failure can be recreated and the software has been installed and used in accordance with the user manual Notwithstanding this clause the software is not warranted...

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