In2itive Model 2120 Instructions for Use Issue 1 Nov 2019

A Global Leader in Respiratory Solutions

ENG

Vitalograph Branch Addresses Vitalograph Ltd, UK Vitalograph Inc. Maids Moreton, Buckingham 13310 West 99th Street MK18 1SW Lenexa, Kansas, 66215 England USA Tel: 01280 827110 Toll Free: 800 255 6626 Fax: 01280 823302 Tel: (913) 730 3200 E-mail: [email protected] Fax: (913) 730 3232 www.vitalograph.co.uk E-mail: [email protected] Technical Support www.vitalograph.com Tel: 01280 827177 Technical Support Email: [email protected] Tel: (913) 730-3205 Email: [email protected] Vitalograph Ltd, International Maids Moreton, Buckingham Vitalograph (Ireland) Ltd MK18 1SW Gort Road Business Park England Ennis, Co Clare, V95 HFT4 Tel: +44 1280 827120 Ireland Fax: +44 1280 823302 Tel: +353 65 6864100 E-mail: [email protected] Fax: +353 65 6829289 www.vitalograph.eu E-mail: [email protected] Technical Support www.vitalograph.ie Tel: +353 65 6864111 Technical Support Email: [email protected] Tel: +353 65 6864111 Email: [email protected] Vitalograph GmbH Rellinger Straße 64a Vitalograph Ltd, Hong Kong/China D-20257 Hamburg P.O. Box 812 Germany Shatin Central Post Office Tel: +49 40 547391-40 Hong Kong Fax: +49 40 547391-40 E-mail: [email protected] E-mail: [email protected] www.vitalograph.cn www.vitalograph.de Technical Support Technical Support Tel: +353 65 6864111 Telefon: +49 40 547391-14 Email: [email protected] E-mail: [email protected]

© Copyright Vitalograph 2019 Current Edition (Issue 1, 28-Nov-2019) Cat. No. 09120 Vitalograph is a registered trademark. Page 2 of 44

DT_0006 Issue 15

In2itive - Instructions for Use

09120 Issue 1

1. Main Components of the Vitalograph In2itive... 4 1.1. Features of the Vitalograph In2itive... 5 2. Setting Up the Vitalograph In2itive... 5 2.1. Connecting the Remote Flowhead... 6 3. Operating Instructions... 8 3.1. Entering Subject Data... 8 3.2. Conducting a Test... 8 3.3. Reporting... 12 3.4. Deleting Stored Subjects/Test Results... 13 3.5. Calibration Verification... 14 3.6. Configuration Options... 15 4. Power Management... 23 4.1. Battery Pack... 23 4.2. Battery Low Detect... 24 5. Cleaning & Hygiene... 24 5.1. Preventing Cross-Contamination of Subjects... 24 5.2. Inspection of the Vitalograph In2itive... 25 6. Fault Finding Guide... 26 6.1. Software Check... 28 7. Customer Service... 29 8. Consumables and Accessories... 29 9. Disposal... 30 10. Explanation of Symbols... 30 11. Description of the Vitalograph In2itive... 31 11.1. Indications for Use... 31 12. Technical Specification... 32 13. Contraindications, Warnings, Precautions and Adverse Reactions... 34 14. CE Notice... 36 15. FDA Notice... 38 16. EU Declaration of Conformity... 39 17. Guarantee... 40

Page 3 of 44

ENG

Contents

A Global Leader in Respiratory Solutions

1. Main Components of the Vitalograph In2itive 1

ENG

2

12

3

4

5

6 8

7

9 10

11

Figure 1 Main components of the In2itive

Note: Computer not supplied 1 2 3 4 5 6 7 8 9 10 11 12

PC Software Flowhead Flowhead Release Button LCD/Touch Panel Display Mini USB Ports On/Off Button Stylus Holder in device cradle Cancel Button Enter Button Up Button Down Button BVF™

Page 4 of 44

DT_0006 Issue 15

In2itive - Instructions for Use

09120 Issue 1

• • • • • • • • • • • • •

Fleisch Pneumotachograph Integral flowhead + remote flowhead adaptor kit Colour touch screen with stylus Feedback sounds Real-time curves and quality prompts Incentive display options Single and multi-breath testing 50+ parameter options Bronchodilator responsiveness testing Customizable report format Long battery life 10,000 subject test memory Choice of predicted values and languages

2. Setting Up the Vitalograph In2itive 1. Connect the mini USB connector from the power supply into the USB port on the side of the unit or into the cradle. Plug the mains plug into a suitable socket. Attempted use with other power sources may cause irreparable damage and invalidate the warranty. The In2itive™ may be powered directly via the USB cable or using the purpose-built low voltage power supply unit with which it is supplied. The output from the power supply is 5 volts DC. 2. Place the In2itive device into the cradle. 3. Switch on the In2itive using the On/Off switch on the device. The In2itive is ready for use. 4. The In2itive comes fitted with a rechargeable battery, which allows the device to be used for a time without the mains power supply connected. 5. Install the PC software supplied with the device following the software installation instructions (this may be Spirotrac® or Vitalograph® Reports, either as USB or DVD dependent on the version purchased). Where there is a requirement for data to be imported/exported to primary care practice software, guidance is included in the Spirotrac instructions for use. 6. During software installation the user must enter the activation Page 5 of 44

ENG

1.1. Features of the Vitalograph In2itive

ENG

A Global Leader in Respiratory Solutions

key and licence key which are supplied with the software. 7. For reporting from the In2itive or to use with Spirotrac, connect one end of the USB cable into an available USB port on the PC and the other end into the USB port on the side of the cradle. The cable can also be connected into the port on the left side of the In2itive. If the device has just been unpacked or transported, ensure that it is left sitting, fully powered so that it is at room temperature prior to testing. 2.1. Connecting the Remote Flowhead The In2itive flowhead can be set up to work remotely from the device as follows (see figure 2): 1. Hold the device body firmly in one hand. 2. With the other hand, hold the flowhead. 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 space which was occupied by the flowhead. This is done by sliding the device cap into the grooves in the top cover of the device body. When assembled, the Vitalograph logo and button on the device cap should be on the same face as the LCD screen. Ensure the cap 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 two pressure ports on the device cap. 7. Attach the remote flowhead to the port on the In2itive device cap using the Flowhead Connection Tube as shown in Figure 2. 8. A recess is provided on the cradle to hold the remote flowhead when not in use. 9. The flowhead can be refitted to the In2itive body by removing the device cap from the In2itive, and removing the remote flowhead adaptor from the flowhead, then sliding the flowhead back onto the In2itive. 10. It is recommended that an accuracy check is carried out after the flowhead is used remotely or refitted to verify correct operation and accuracy. Page 6 of 44

DT_0006 Issue 15

In2itive - Instructions for Use

09120 Issue 1

1

7

8

ENG

6

5

2

3 4

Figure 2: Setting up the In2itive remote flowhead

1 2 3 4 5 6 7 8

Device Cap Flowhead Remote Flowhead Adaptor Flowhead Connection Tube Flowhead Release Button Rubber Cover Device Cap Release Button BVF™

Page 7 of 44

A Global Leader in Respiratory Solutions

3. Operating Instructions

ENG

3.1. Entering Subject Data When the device is turned on, the Main Menu screen opens. 1. Select a subject by tapping the Subject button. 2. The subjects saved on the device may be listed using either the Name or ID tab. 3. Select and view the subject details by tapping the subject onscreen. Select ‘Enter’ to make this the current subject. 4. To create a new subject, select the New tab. Touch the required field onscreen to highlight, then enter subject details using the touch panel keypad. Press Enter 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. 3.2. Conducting a Test1 Before starting a test session: 1. Ensure that the device accuracy was checked recently. (Refer to section on Checking Accuracy). 2. Select a subject and ensure the required demographic information is entered. 3. Wash hands (operator and subject). 4. Fit a new Bacterial Viral Filter (BVF) to the flowhead for each test subject. The use of a disposable noseclip is recommended. 5. Instruct and demonstrate the test. 3.2.1. Testing

1

1. Select either ‘VC Test’ or ‘FVC Test’ option from the Main Menu.

Derived from terminology and guidance taken from ATS/ERS Standardisation of Spirometry 2019 Update Am J Respir Crit Care Med 2019 Vol 200, Iss 8 pp e70-e88

Page 8 of 44

DT_0006 Issue 15

09120 Issue 1

2. Select how the results should be presented: • VC Test – Select from Volume/Time (V/T) graph and Volume (Bar Chart). • FVC Test – Select from Volume/Time (V/T) graph and Flow/Volume (F/V) graph. 3. Wait for the ‘Exhale to Begin’ icon to appear. The device is now ready to accept a blow. Example script: • Sit upright, fit the nose clip and relax. • Place BVF in mouth and close lips around the mouthpiece. • Seal your lips around the mouthpiece and keep your tongue down. • Breathe normally. VC test session a. Inhale completely with a brief pause when your lungs are completely full (≤ 2 secs). b. Exhale with no hesitation until no more air can be expelled while maintaining an upright posture. It is vital that the operator encourages the subject to keep exhaling to ensure all air is expelled (when a plateau has been reached or forced expiratory time (FET) reaches 15 seconds). The operator should repeat instructions as necessary, coaching vigorously. c. Listen for two beeps. The device is now ready for the next blow. d. Repeat for a minimum of three manoeuvres, usually no more than eight for adults. e. Check VC repeatability and perform more manoeuvres as necessary. Note: A single-breath VC technique may also be performed on the device. FVC test session: a. Inhale completely and rapidly with a brief pause when your lungs are completely full (≤ 2 secs). b. Exhale with maximal effort until no more air can be Page 9 of 44

ENG

In2itive - Instructions for Use

ENG

A Global Leader in Respiratory Solutions

expelled while maintaining an upright posture. It is vital that the operator encourages the subject to keep exhaling to ensure all air is expelled (when a plateau has been reached or forced expiratory time (FET) reaches 15 seconds). The operator should repeat instructions as necessary, coaching vigorously. c. Breathe in with maximal effort until completely full. The manoeuvre is now complete and the BVF is removed from the mouth. d. Listen for two beeps. The device is now ready for the next blow. e. Repeat for a minimum of three manoeuvres, usually no more than eight for adults. f. Check FEV1 and FVC repeatability and perform more manoeuvres as necessary. Note: A single-breath FVC technique may also be performed on the device. 3.2.2. Saving the Test Session The test session is saved to the database by default, by following the on-screen messages. Note: If a compact flash card is inserted into the compact flash card connector at the right side of the device, then all test blows and not just the best three will be saved to the compact flash 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. The Post Mode screen also offers 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 Vitalograph Reports or Spirotrac. To access this option select ‘Permanent Storage’. The Permanent Storage screen gives you four options: • Save Test to Permanent Storage: An information message will state the memory location where the test session will be saved. There are nine permanent memory locations on the Vitalograph In2itive. Page 10 of 44

DT_0006 Issue 15

09120 Issue 1

• Load Test from Permanent Storage: 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. • Delete Test from Permanent Storage: A list of stored pre-test sessions will appear. Select the Test session to delete and press enter. This location will then be marked as ‘Empty’. • Delete all Tests from Permanent Storage: A warning message will appear:- ‘Do you want to delete all tests stored in permanent storage?’. Select ‘Enter’ to delete all tests. 3.2.3. Bronchodilator Responsiveness Testing A Bronchodilator Responsiveness 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 start bronchodilator responsiveness testing select ‘Post Mode’ from the Main Menu. • To perform a bronchodilator responsiveness test on the Pre-test Session just performed, select ‘Perform Post test on Current Subject’. This will bring up the test screen. The text ‘Post Mode’ will appear on the graph. • To perform a bronchodilator responsiveness test on a different subject or Pre-test: 1. Select ‘Select Subject from List’. 2. 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. 3. Select the subject for bronchodilator responsiveness testing. 4. Select the test session from the Select Test Session screen. Note: The words Pre, VC or FVC or a combination of these will appear after the session ID. If the word Pre appears then a bronchodilator responsiveness test session has already been performed on this pre session. Page 11 of 44

ENG

In2itive - Instructions for Use

ENG

A Global Leader in Respiratory Solutions

If the word VC appears then a VC test has been done as part of the pre-session. If the word FVC appears then an FVC test has been performed as part of the pre-session. 5. Press ‘Enter’ to open the test screen. The text Post Mode will appear on the graph. 6. Perform an FVC test post drug delivery as outlined in section 3.2.1. Testing, to assess bronchodilator responsiveness. 3.2.4. Deleting a Test Session To delete the current session: 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 clear the current test session and return to the Main Menu. • Select ‘C’ to cancel the operation and continue with the current test session. 3.3. Reporting The In2itive can be connected to a PC by USB through the port at the side of the device or from the cradle so that reports can be written to the Vitalograph Reports Application or generated through Spirotrac. By using the optional Print Cradle the In2itive can also be connected to an external PCL compatible printer. The information printed on the session report and also the reports method (Vitalograph Reports or External Printer) can be set to individual requirements. Refer to section on Report Options. To produce a report for the Current Subject via the Report option in the In2itive Main Menu, the options are: • Current Session: Select the print icon on the session results screen. • Saved Test Session for Current Subject: Select the required session then the print icon on the session results screen. Page 12 of 44

DT_0006 Issue 15

In2itive - Instructions for Use

09120 Issue 1

To print Test Session(s) from a different subject in the database. Click the ‘Select’ tab in the View and Report screen. The following options are available: • Select Test Session: 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. • All Test Sessions: To print all test sessions for a selected subject via a PC using Vitalograph Reports software • All Test Sessions Between…: This will print all sessions stored on the device between specified dates using Vitalograph Reports software via a PC. 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. 3.4. Deleting Stored Subjects/Test Results Instructions on deleting subjects/test results that have been stored permanently on the device may be found in section 3.2.2. Saving the Test Session. Instructions on deleting sessions from the device database may be found in section 3.6.2. Database

Page 13 of 44

ENG

• All Test Sessions: It is possible to select to print all test sessions for the current subject via a PC using Vitalograph Reports software.

A Global Leader in Respiratory Solutions

3.5. Calibration Verification

ENG

• Attach flowhead to the syringe with a BVF fitted as per figure 3.

Figure 3: Verifying Calibration

• Select Accuracy Check from the Main Menu using the keypad. • Enter the Syringe volume and reference using the touch panel keypad. • Depending on how the device is configured, follow prompts to enter the ambient temperature, humidity (0-99%), pressure (2531 inHg or 850-1060 hPa-mbar) and altitude (1-8500m). Enter these values using the touch panel or keypad. • 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. • Press the ‘Enter’ key to open Accuracy Check screen and follow on-screen instructions. • If an Accuracy Check report is required, select the Report option. • 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 In2itive memory in this case. Note: If the device is outside calibration, the user is offered the option to update calibration. Selecting to update calibration repeats the accuracy check routine on the device.

Page 14 of 44

DT_0006 Issue 15

In2itive - Instructions for Use

09120 Issue 1

3.6. Configuration Options To access configuration options available on the In2itive, select ‘Configuration’ on the Main Menu. The options are:

3.6.2. Database To manage the available memory on the device, the Management tab tells you how much subject and test session memory has been used up. • Defragment: Device memory may become fragmented through long use. To maximise available memory, select the defragment option. Defragmentation may take several minutes to complete. • Deletion: To delete a session, select the relevant box. The session will be deleted from the device after being printed. (Either print to an internal printer or sent to Vitalograph Reports). It is also possible to ‘Select Test Session(s)’ for Page 15 of 44

ENG

3.6.1. Test Preferences The following options are available to configure the test screen to your requirements: • FVC Display: 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. • VC Display: Select to show the Bar Graph or V/T (VolumeTime) Graph by default in the VC test screen. • Test Acceptance: Select whether to manually accept the tests performed, or allow the device to determine test acceptability (automatic). • Graph Scale: Select the default graph scale. • Posture: Select from ‘no posture selected’, ‘standing’ or ‘sitting’. • Post VC Test: Selecting ‘off’ here means that selecting Post testing brings the user directly to the FVC test screen. Post VC testing is ‘on’ by default where VC testing has been done in a pre-test session. • Temperature: By selecting ‘on’ in the drop down list, the user is offered the option to manually enter the ambient temperature as they go into the VC or FVC test screens.

A Global Leader in Respiratory Solutions

deletion, or ‘Delete Subject(s)’ from the device by pressing the relevant button using the touch panel LCD.

ENG

3.6.3. Calibration The In2itive should never be outside accuracy limits unless damaged or in a faulty condition. In this event, see the faultfinding guide. In normal use, calibration traceability certification is recommended as a part of the routine annual service. The Calibration Options menu offers: • Calibration: To calibrate the device • Precision Syringe: To select the volume of syringe used for calibration • Linearity: To check linearity • Accuracy Log: To view and print the accuracy log Calibration Calibration is not required for normal use. Calibration should only be conducted by, or under the guidance of Vitalograph Service Agents. See contact details on p. 2. 1. Select ‘Calibration’ from the Calibration screen. 2. 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. 3. Press the ‘Enter’ key to bring you into the Calibration screen and follow the on-screen instructions. 4. If a Calibration report is required select the Report option. Press the ‘C’ key to exit the Calibration screen. Note: An Accuracy check must be done on the same day as the device is calibrated. Precision Syringe 1. Select ‘Precision Syringe’ from the Calibration screen. 2. Select the volume of the calibrated syringe from the drop down list. 3. Enter the syringe reference number using the touch panel keypad. Page 16 of 44

DT_0006 Issue 15

09120 Issue 1

4. Press Enter to save the new volume entered and return to the Calibration screen. Press C to cancel the changes made and return to the Calibration screen. Linearity Check 1. Select ‘Linearity’ from the Calibration screen. (Note: Pressing the C key will exit the Linearity Check screen.) 2. Using a 3L calibrated syringe, pump air through the flowhead to bring it to ambient temperature. 3. 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. 4. Enter environmental data if prompted to do so. 5. Press Enter to open the Linearity Check screen. 6. Pump air into the flowhead at a slow rate of < 2L/s. Immediately withdraw the syringe at a slow rate. This manoeuvre should show on the graph between the two red lines. If it is a correct manoeuvre the table on the screen will show ‘Test 1’, and the FVC and FIVC values will be updated. Repeat for the slow rate three times. 7. Repeat the procedure for a medium rate >2L/s and < 6L/s. This manoeuvre should show on the graph between the red and green lines. If it is a correct manoeuvre the test number and the FVC and FIVC values will be updated in the table. Repeat for the medium rate three times. 8. Repeat the procedure for a fast rate >6L/s. This manoeuvre should show on the graph between the outside green lines. If it is a correct manoeuvre the test number and the FVC and FIVC values will be updated in the table. Repeat for the fast rate three times. 9. When all the manoeuvres are complete press Enter for the result. 10. If a Linearity Check report is required select the ‘Report’ option. Accuracy Log 1. Select ‘Accuracy Log’ from the Calibration screen. The accuracy log contains a record of all the accuracy checks done on the device. Page 17 of 44

ENG

In2itive - Instructions for Use

ENG

A Global Leader in Respiratory Solutions

2. There are three options: a. To print the complete accuracy log press ‘Print All’. b. To print a log of the last 30 accuracy tests done, press ‘Print Last 30’. c. To view the accuracy log, press ‘View’. 3. Press C to return to the Calibration screen. 3.6.4. Settings The following options are available in the Device Settings screen: • Date/Time: Update the date and time including format • Units: Metric/Imperial • Sound Options: On/Off/Volume • Power Save Options: Display dulls after 3 minutes • Incentive: Select incentive, % predicted and % best test • Parameters: Select parameters for report/printing Date/Time There are two tabs in this screen for the time and date. 1. Change the time by scrolling the hours and minutes to the required settings by pressing the arrows on the touch panel LCD. 2. Change the time format from 24 hour to 12 hour by switching the ’24 Hour Format’ option off or on. 3. Change the date by scrolling the day, month and year to the required settings by pressing the arrows on the touch panel LCD. Units Modify the units by selecting between Metric and US (Imperial) in the drop down list. Sound Options • Select Off/On options for Key, Flow, Error and Welcome sounds on the device. • Adjust the volume by pressing the ‘-/+’ on the touch panel LCD. Power Save Options In order to improve battery life the device can be configured to dull the display after 3 minutes. This can be switched on or off. Incentive Page 18 of 44

DT_0006 Issue 15

09120 Issue 1

The Incentive Device is used as an aid in testing of children. 4. Select the incentive device to be used in testing using the drop down list. A preview of the incentive will appear on the screen. 5. Modify the % of predicted using the on-screen keyboard. The value entered must be between 80-150. 6. Modify the % of Best Test value using the on-screen keyboard. The value entered must be between 80-150. Parameters The following parameters can be reported and printed for a test session. To select/unselect a parameter check/uncheck the relevant check boxes. Additional parameters are available by selecting the additional index tabs. Parameter

Definition

VC IVC FIVC FVC FEV.5 FEV.75 FEV1 FEV3 FEV6 PEF L/s PEF L/min FEF0.2-1.2 (F02-12)

Vital capacity (L) Inspiratory vital capacity (L) Forced inspiratory vital capacity (L) Forced vital capacity (L) Forced expiratory volume after 0.5 seconds (L) Forced expiratory volume after 0.75 seconds (L) Forced expiratory volume after 1 second (L) Forced expiratory volume after 3 seconds (L) Forced expiratory volume after 6 seconds (L) Peak expiratory flow (L/sec) Peak expiratory flow (L/min) Mean forced expiratory flow in the volume interval between 0.2 and 1.2 L of the test (L/sec) Maximal mid expiratory flow: the mean FEF in the time interval between 25% and 75% of the FVC (L/sec)

FEF 25-75 (F2575)

Page 19 of 44

ENG

In2itive - Instructions for Use

A Global Leader in Respiratory Solutions

ENG

FEF 75-85 (F7585) FEF 25 FEF 50 FEF 75 FIV1 PIF L/s FIF 25 FIF 50 FIF 75 MVVind FMFT FET Vext FRC TV RV TLC IRV ERV IC Rind FIVC/FVC FEV.5/FVC FEV1/FEV6 FEV1/FVC FEV1/VC FEV1/PEF FEV3/VC Page 20 of 44

Forced late expiratory flow: the mean FEF in the time interval between 75% and 85% of the FVC (L/sec) Forced expiratory flow at 25% of the FVC (L/sec) Forced expiratory flow at 50% of the FVC (L/sec) Forced expiratory flow at 75% of the FVC (L/sec) Forced inspiratory volume after 1 second (L) Peak inspiratory flow (L/sec) Forced inspiratory flow at 25% of the FVC (L/sec) Forced inspiratory flow at 50% of the FVC (L/sec) Forced inspiratory flow at 75% of the FVC (L/sec) Maximum voluntary ventilation indirectly calculated from the FEV1 (L/min) Forced mid-expiratory flow time (sec) Forced expiratory time (sec) Extrapolated volume (L) Functional residual capacity (L) Tidal volume (L) Residual volume (L) Total lung capacity (L) Inspiratory reserve volume (L) Expiratory reserve volume (L) Inspiratory capacity (L) Airways Resistance Indirect measurement. Ratio FIVC of FVC Ratio FEV 0.5 of FVC Ratio FEV1 of FEV6 Ratio FEV1 of FVC Ratio FEV1 of VC FEV1 divided by PEF (L/L/s) Ratio FEV3 of VC DT_0006 Issue 15