in2itive Model 2120 Hand Held Spirometer User Manual Issue 5

Vitalograph Ltd. Maids Moreton Buckingham MK18 1SW England Tel: +44 (0) 1280 827110 Fax: +44 (0) 1280 823302 e- mail: [email protected] Vitalograph Inc. 13310 West 99th Street Lenexa Kansas 66215 USA Tel: (913) 888 4221 Fax: (913) 888 4259 e-mail: [email protected]

Vitalograph GmbH Rellinger Straße 64a D-20257 Hamburg

Germany Tel: (040) 547391-0 Fax: (040) 547391-40 e-mail: [email protected] Vitalograph (Ireland) Ltd. Gort Road Business Park Ennis Co Clare Ireland Tel: (065) 6864100 Fax: (065) 6829289 e-mail: [email protected]

Internet: www.vitalograph.co.uk © Copyright Vitalograph 2009, 2010 & 2011 Current Edition (Issue 5) Cat. No. 07514 Vitalograph is a registered trademark

Page 2 of 45

DT_0006-6

Table of Contents DESCRIPTION OF THE VITALOGRAPH DEVICE

5

FEATURES OF THE VITALOGRAPH DEVICE

7

GETTING THE VITALOGRAPH DEVICE READY FOR USE

7

OPERATING THE DEVICE WITH SPIROTRAC V

8

CONNECTING THE REMOTE FLOWHEAD

8

POWER MANAGEMENT IN THE VITALOGRAPH DEVICE

10

BATTERY PACK BATTERY LOW DETECT OPERATING THE VITALOGRAPH DEVICE ENTERING SUBJECT INFORMATION PERFORMING A TEST SESSION Checks to Make before Performing a Test Session Performing a VC Test Performing an FVC Test SAVING THE TEST SESSION. PERFORMING A POST TEST SESSION PERMANENT STORAGE OF PRE-TEST SESSIONS PRINTING AND VIEWING THE TEST SESSION CLEAR RESULTS CHECKING ACCURACY When to Check Accuracy CONFIGURATION OPTIONS Test Preferences Database Calibration Settings Subject Options Smart Options Report Options CLEANING INSTRUCTIONS CLEANING AND DISINFECTING THE VITALOGRAPH IN2ITIVE REMOVING THE FLEISCH FLOWHEAD REASSEMBLING THE FLEISCH FLOWHEAD Page 3 of 45

11 11 11 11 12 12 12 14 17 17 18 18 19 20 21 21 21 22 22 23 26 27 27 30 30 32 33 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

GUARANTEE

45

Page 4 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

DESCRIPTION OF THE VITALOGRAPH DEVICE The Vitalograph In2itive is a handheld spirometer designed for use by trained professionals in the doctor’s office, clinic, hospital department, etc. for measuring and archiving tests on human subjects. Demographic data are uploaded 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 configuration options. Information about the software can be obtained from the About box. This information can be used if any queries are made to Vitalograph or a service agent. To access the About box: 1. Press the Configuration button from the Main Menu. 2. Press the About button. The main components for the Vitalograph In2itive are shown in Figure 1.

Page 5 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5 PC Software

Flowhead Flowhead Release Button

LCD/Touch panel Display On/Off Button Mini USB ports in cradle and device

Stylus Holder

Cancel Button

Down Button Up Button Enter Button

Figure 1

Page 6 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

FEATURES OF THE VITALOGRAPH DEVICE The Vitalograph In2itive features include: • • • • • • • • • • • • • • • • • • • •

Fleisch pneumotachograph Integral and removable flowhead Touch screen color display or buttons Clear sounds for audio feedback Choice of child incentive displays Fully customizable report format Desktop cradle supplied as standard Optional cradle for connection to A4 USB printers (PCL compatible) Optional communications cradles Automatic download of new subjects 10,000 subject test memory Automatic upload of all test data Pre/post bronchodilator comparison Choice of predicted 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 device

GETTING THE VITALOGRAPH DEVICE READY FOR USE 1. Place the Spirotrac V CD-ROM into the CD drive. The installation program starts automatically after a short period of time and leads you through the installation. The following are the most important points of the installation procedure. 2. If you do not already have Acrobat reader installed then select ‘Install Acrobat Reader’. You will require it to read the User Manual and any Test Reports that you have chosen to ‘Print’ as a PDF document. 3. Spirotrac V can import and export to your practice software, if your practice software supports one of the communications standards in Page 7 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

Spirotrac V. Administration rights on your PC are required. This can also be installed later. 4. For security reasons it is necessary during installation to enter an activation key and licence key. These are available on the CD cover. 5. When installation is complete remove the CD and keep in a safe place. 6. Connect one end of the USB cable into an available USB connection on your computer and the other end into the USB connection on the side of the cradle. The cable can also be connected into the left side of the Vitalograph In2itive device. The device is powered via the USB cable. 7. Place the In2itive device into the cradle. 8. The Vitalograph In2itive device may also be powered using the purpose-built low voltage power supply unit with which it is supplied. Attempted use with other power sources may cause irreparable damage and invalidate the warranty. The output from 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 the On/Off switch on the front face of the instrument and the Vitalograph In2itive is ready for use. 10. For portability the Vitalograph In2itive comes fitted with rechargeable batteries, which allows the device to be used for a period of time without the mains connected.

OPERATING THE DEVICE WITH SPIROTRAC V Refer to the Help Files on Spirotrac V for information on operating the Vitalograph In2itive with Spirotrac V.

CONNECTING THE REMOTE FLOWHEAD The flowhead on the Vitalograph In2itive can be set up to work remotely from the device. This can be done as follows (see figure 2): 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 away from the device from left to right. 4. Attach the device cap in the same position as the flowhead was attached. This is done by sliding the flowhead into the grooves in Page 8 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

the top cover. The Vitalograph font and button on the device cap should be on the same face as the LCD when assembled. Ensure this is fully pushed in. 5. Attach the remote flowhead adaptor to the flowhead. This is done by sliding the flowhead into the grooves in the remote flowhead adaptor. Ensure this is fully pushed in. 6. Open the rubber cover on the left side of 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 recess is provided on the cradle to hold the remote flowhead when not in use. 9. The remote flowhead can be disconnected by removing the device cap from the Vitalograph In2itive, and removing the remote flowhead adaptor from the flowhead. Then slide the flowhead back onto the Vitalograph In2itive. 10. It is recommended that an accuracy check is carried out after the remote flowhead is fitted or removed to verify correct operation and accuracy.

Page 9 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5 Device Cap Release Button Device Cap Rubber Cover

Flowhead Release Button Flowhead

Remote Flowhead Adaptor

Flowhead Connection Tube

Figure 2

POWER MANAGEMENT IN THE VITALOGRAPH DEVICE The Vitalograph In2itive can be powered using the purpose-built low voltage Power Supply 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 will be orange. The LED will be green when the device is powered from the Battery Pack.

Page 10 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

Battery Pack The Vitalograph In2itive is fitted with a rechargeable Battery Pack. This allows the device to be used without the 5V Power Supply connected. The battery pack can be re-charged by plugging in the 5 V Power Supply. To fully re-charge switch off the Vitalograph In2itive and leave it plugged in over-night. The battery pack can also be re-charged by connecting the device or cradle to a PC via the USB cable. The USB connector is located on the left side of the device.

Battery Low Detect The Vitalograph In2itive has 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. It is advised that you plug in the 5V Power Supply or attach the device to a PC to re-charge the batteries and continue testing.

When the Battery Pack is approaching fully discharged the Battery Discharged icon will appear continuously on the Main Menu screen. Plug in the 5V Power Supply or attach to a PC to recharge the batteries and continue testing.

OPERATING THE VITALOGRAPH DEVICE Entering Subject Information After turning on the device, you are presented with the Main Menu screen. Note: In Smart mode you can configure the device to go directly into the Subject Select screen. See Smart Options. Page 11 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

1. Select the Subject button, to bring you into the Select Subject screen. 2. You can list the subjects saved on the device by selecting either the Name or ID tab. 3. To select a subject from the database, hi-light the subject. This will allow you the view the subject details. Select Enter to make the subject current. 4. To create a new subject, select the New tab. Enter the subject details by hi-lighting the required field and typing in the information using the touch panel keypad. Additional subject information may also be entered by selecting the Optional tab. Press the Enter button to save the subject to the database and return to the Home Menu. Note: The current subject surname and forename will be displayed on the bottom left 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 appear in black. If there are no test session results then the subject name and ID will appear in grey.

Performing a Test Session Checks to Make before Performing a Test Session

Before starting a test session, there are a number of checks which should be made: 1. Ensure that the accuracy of the Vitalograph In2itive unit was checked recently. (Refer to the section on Checking Accuracy) 2. Ensure a subject is selected (subject ID or name will appear on the status bar at the bottom of the Main Menu) and the required demographic information is entered for the subject. 3. Fit a disposable BVF or SafeTway mouthpiece. The use of a disposable noseclip is also recommended. Performing a VC Test

Perform the VC test as follows: 1. Select the ‘VC Test’ option from the Main Menu. 2. Wait for the ‘Exhale to Begin’ icon to appear.

Page 12 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

This indicates that the Vitalograph In2itive unit is ready to accept a blow. Note: You can view the results as either a Volume/time graph or a Volume bar graph by selecting the relevant tab. The VC test can be performed using two methods. Read either of the following instructions to the subject so that testing is performed properly: Method 1: a. Sit upright, fit the nose clip and relax. b. Hold the unit, keeping it away from your mouth. c. Inhale as deeply as possible, hold your breath, then insert the mouthpiece carefully into your mouth, not like a trumpet, 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 operator encourages to subject to keep blowing to ensure all air is squeezed out. f. Listen for two beeps. This indicates that Vitalograph In2itive is ready for the next blow. Method 2: Note: Method 2 can only be used when the Volume/Time (V/t) graph is selected as the display option. This method cannot be used when the Volume bar graph is selected as the display. a. Sit 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 tongue down. d. Breathe in and out normally. This is tidal breathing.

Page 13 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

When you are happy that the subject has achieved steady tidal breathing, continue with: e. Blow out as long as possible. Keep blowing until all air is expelled. It is vital that the operator encourages to subject to keep blowing to ensure all air is squeezed out. f. Inhale as deeply as possible (speed is not important) and when fully inhaled. g. Return to tidal breathing, i.e. breathe in and out normally again. The VC values recorded for the blow are tabulated. The best VC value for the current session and the Lower Limit 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 you back to the Main Menu. Performing an FVC Test

1. Select the ‘FVC Test’ option from the Main Menu. 2. Wait for the ‘Exhale to Begin’ icon to appear.

This indicates that the Vitalograph In2itive unit is ready to accept a blow. Note: You can view the results as either a Volume/time (V/t) or a Flow/Volume (F/V) graph by selecting the relevant tab. 3. The FVC test can be performed using 2 methods as follows. Read either of the following instructions to the subject so that testing is performed properly: Method 1: a. Sit upright, fit the noseclip and relax. b. Hold the unit, keeping it away from your mouth. Page 14 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

c. Inhale as deeply as possible, hold your breath, then insert the mouthpiece carefully into your mouth, not like a trumpet, 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 for at least 6 seconds. (From the very beginning of the blow the operator should encourage the subject to keep going in a lively fashion. Keep eye contact with the subject) f. If inspiratory indices are selected, then inhale as quickly as possible. g. Listen for two beeps. This indicates that Vitalograph In2itive is ready for the next blow. Method 2: a. Sit 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 tongue down. d. Breathe in and out normally. This is called tidal breathing. When you are happy that the subject has achieved steady tidal breathing, continue with: e. Inhale as deeply as possible f. Blow out as long as possible. Keep blowing for at least 6 seconds. (From the very beginning of the blow the operator should encourage the subject to keep going in a lively fashion. Keep eye contact with the subject) g. Inhale fully as quickly as possible h. Return to tidal breathing, i.e. breathe in and out normally again. 4. The FVC, FEV1 and PEF values recorded for the blow are tabulated. The best FVC, FEV1 and PEF for the current session are displayed. The test quality (QA) is shown at the bottom of the test screen.

Page 15 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

The best 3 tests performed and the Test Grade are shown in the V/t screen. Each test series is graded in relation to its repeatability between acceptable manoeuvres. The quality Grades are A, B, C, D and F. The repeatability (Within) of FVC and FEV1 are shown in the Information screen. The repeatability information is displayed if at least two tests are performed. I Bars on the F/V graph are shown for FEF25, FEF 50 and FEF75. An I Bar for FVC is also shown on the Volume axis. The upper mark on the I Bars indicates the predicted value for the subject. The lower mark on the I Bar indicates the LLN value for the subject. The I Bars are based on the predicted sets and will be shown if sufficient subject demographics information is 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 right of the screen. If any of the parameters are below the Lower Limit of Normality (LLN), then they will be displayed in red, provided the subject age, height and gender are entered. - To view the graph of the blow select the graph button on the bottom of the screen. - You can choose to manually accept or reject a blow using the drop down list for User Acceptability. - You can view the trend graph by selecting the trend button on the bottom left of the screen. 7. After performing the FVC tests press the Cancel button to exit the FVC Test screen. This brings you back to the Main Menu. Note: The measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and control of chest diseases. Spirometry may support or exclude diagnosis, but it cannot make one.

Page 16 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

Saving the Test Session. The test session is saved to the database by following the on-screen messages. These messages appear when a new subject, an accuracy check or POST mode is selected. Note: If a micro SD card is inserted into the micro SD connector at the right side of the device, then all test blows and not just the best three will be saved to the micro SD card. Results are saved as per the format outlined in the European Respiratory Journal, 2005; 26: Pages 319-338: ATS/ERS Task Force: Standardisation of Lung Function Testing.

Performing a Post Test Session A Post test session can be performed on an FVC test session following the administration of drugs. Post drug delivery performance is measured versus pre 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 return you to the test screen. The text Post Mode will appear on the graph. 3. If you wish to perform a Post Test on a different subject or Pre-test: a. Select ‘Select Subject from List’. b. A message ‘Warning! Current test session will end. Do you want to save the test session?’ will appear. Select Yes and the Select Subject screen will appear. c. Select the subject you wish to perform the Post test on, and the Select Test Session screen will appear. Select the test session. Note: The letters P, V or F or a combination of these will appear after the session ID. If the letter P appears then a POST test session has already been performed on this pre session. If V appears then a VC test has been done as part of the pre-session. If F appears then and FVC test has been performed as part of the pre-session. Page 17 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

d. Press ‘Enter’ to bring you to the test screen. The text Post Mode will appear on the graph. 4. Perform the Post FVC test as outlined in section Performing a Test Session.

Permanent Storage of Pre-Test Sessions The Post Mode screen also gives you the option to save and recall test sessions to and from a permanent storage location on the device. This permanent storage does not get deleted when test sessions are sent to Spirotrac V or printed. To access this option select ‘Permanent Storage’. The Permanent Storage screen gives you four options: 1) Save Test to Permanent Storage: When this option is selected a message will appear informing you of the memory location where the test session will be saved. There are nine permanent memory locations on the Vitalograph In2itive. 2) Load Test from 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 screen. 3) Delete Test from Permanent Storage: When this option is selected the list of permanent pre-test sessions will appear. Select the Test session you wish to delete and press enter. This location will then be marked as ‘Empty’. 4) Delete all Tests from Permanent Storage. When this option is selected a warning message will appear:- ‘Do you want to delete all tests stored in permanent storage?’. Press enter to delete all tests.

Printing and Viewing the Test Session You can print the current test session for the subject by selecting ‘Print’ from the FVC Test screen. The Vitalograph In2itive can be connected through the USB port at the side of the unit or from the cradle to the Vitalograph Reports Utility, so that the report can be written to a PC. By using the optional Print Cradle the Vitalograph In2itive can also be connected to an external PCL compatible printer. Page 18 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

The information printed on the session report and also the reports method (Vitalograph Reports or External Printer) can be configured to suit individual requirements. Refer to section on Report Options. You can also select the Report option from the Main Menu. If you already have a Current Subject selected the following options are available: a) Current Test Session: You can select to print the current test session. To print the current session, select the print icon at the top of the session results screen. b) Select Test Session: You can select a test session for the current subject. To print the session, select the print icon at the top of the session results screen. c) All Test Sessions: You can print all test sessions for the current subject. You can also print Test Session(s) from a different subject in the database. This is done 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 for that subject. To print the selected session, select the print icon at the top of the session results screen. b) All Test Sessions: This will print all test sessions performed on a subject. When you select this option you must first select a subject from the database. c) All Test Sessions Between…: This will print all sessions stored on the device between specified dates. You must first select the dates. The default test parameters on the report will vary according to regional requirements. Test parameters can be configured to suit individual requirements. Refer to section on Parameters.

Clear Results If you wish to delete the current session you can do this as follows: 1. Select the ‘Clear’ option from the Main Menu. 2. A message will appear ‘Warning! Current Test Session Will End. Do you want to save the test session?’ Select ‘Yes’ to save the current test session and return to the Main Menu. Select ‘No’ to not save Page 19 of 45

DT_0006-6

Vitalograph In2itive User Manual Cat. No. 07514 Issue 5

the current test session and return to the Main Menu. Select ‘C’ to cancel the operation and continue with the current test session.

Checking Accuracy All spirometry standards (e.g. ATS/ERS/BTS/ANZRS) recommend checking the accuracy of lung function measuring devices at least daily with a 3-L syringe to validate that the instrument is measuring accurately. The Vitalograph In2itive should never be outside accuracy limits unless damaged or in a fault condition. In this event, see the fault-finding guide. In normal use, calibration traceability certification is recommended as a part of the routine annual service. ATS recommendations require that the difference between the volume measured by the spirometer and the volume pumped into the spirometer from a syringe 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. Depending on how the device is configured you may be prompted to enter the ambient temperature, humidity (0-99%), pressure (25-31 inHg or 850-1060 hPa-mbar) and altitude (18500m). Enter these values using the touch panel keypad. 4. Pump air through the flowhead to bring it to ambient temperature. If the flowhead has very recently been used for testing or has come from a cold environment, its temperature should be equilibrated with ambient by pumping air through it from the syringe several times. 5. Press the ‘Enter’ key to bring you into the Accuracy Check screen and follow the on-screen instructions. Note: Note: Press the ‘C’ key to exit the Accuracy Check screen and return to the Main Menu. The accuracy check will not be logged to the Vitalograph In2itive memory in this case. 6. If an Accuracy Check report is required select the Report option.

Page 20 of 45

DT_0006-6