| submitted | available | document details (if available) | source link |
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| July 18 2005 | July 18 2005 | Microsoft Word - MedDorna Spirometry User's Manual 003-0004-A.doc Evgueni Bogomolov Acrobat Distiller 6.0.1 (Windows) |
| various | User Manual | Users Manual | 2.29 MiB | July 18 2005 |
CONFIDENTIAL MedDorna Spirometry Users Manual 003-0004 Rev A Initial Release Approvals Document Control Date:
Other Date:
Description Date Revision History REV Engineering Date:
ECO #
MedDorna, LLC CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. CONFIDENTIAL Table of Contents Table of Contents.......................................................................................................................................................... 2 Glossary of Symbols ..................................................................................................................................................... 5 General Cautions & Warnings ...................................................................................................................................... 6 WARNINGS:............................................................................................................................................................ 6 CAUTION: ............................................................................................................................................................... 6 ELECTRICAL SAFETY CLASSIFICATIONS:...................................................................................................... 7 CONTRAINDICATIONS: ....................................................................................................................................... 7 Office Medic Installation .............................................................................................................................................. 8 Installing Office Medic Software From CD-ROM: .................................................................................................. 8 Open Software ............................................................................................................................................................ 10 General Troubleshooting......................................................................................................................................... 10 Navigation................................................................................................................................................................... 11 Navigating the Patient Directory............................................................................................................................. 11 Office Medic Options.................................................................................................................................................. 12 File .............................................................................................................................................................................. 14 Test.............................................................................................................................................................................. 19 Options........................................................................................................................................................................ 20 Tools ........................................................................................................................................................................... 21 MedicSync .............................................................................................................................................................. 21 Main Database..................................................................................................................................................... 21 Remote Database................................................................................................................................................. 21 Notes ................................................................................................................................................................... 22 Steps in the Configuration Process...................................................................................................................... 23 Conflict Resolution ............................................................................................................................................. 25 Scanning for Account Number Conflicts ............................................................................................................ 25 Scanning Main for Missing Account Numbers................................................................................................... 26 Scanning Remote for Missing Account Numbers............................................................................................... 27 Scanning for Conflicts......................................................................................................................................... 27 Help............................................................................................................................................................................. 31 MedDorna Wireless PRN Spirometer Cautions & Warnings ..................................................................................... 32 MedDorna Wireless PRN Spirometer Introduction .................................................................................................... 34 Spirometry............................................................................................................................................................... 34 Getting Started MedDorna Wireless PRN Spirometer................................................................................................ 35 Installation: ............................................................................................................................................................. 35 Connect Mouthpiece ............................................................................................................................................... 35 Performing a Spirometry Test................................................................................................................................. 35 Entering Mouthpiece Number............................................................................................................................. 36 Performing the Maneuver ................................................................................................................................... 36 Menu Buttons on the Test Results Window........................................................................................................ 40 Tabs..................................................................................................................................................................... 40 MedDorna Wireless PRN Spirometer Options ....................................................................................................... 42 FVC............................................................................................................................................................................. 48
(FVC).......................................................................................................................... 48 Proper Procedure:................................................................................................................................................ 48 MVV ........................................................................................................................................................................... 51
(MVV)....................................................................................................... 51 Maximum Voluntary Ventilation SVC............................................................................................................................................................................. 53 Slow Vital Capacity (SVC)..................................................................................................................................... 53 MedDorna Wireless PRN Spirometer Calibration ...................................................................................................... 55 Calibration Check ................................................................................................................................................... 55 Forced Vital Capacity MedDorna Spirometry Users Manual CONFIDENTIAL MedDorna Wireless PRN Spirometer Troubleshooting.............................................................................................. 57 MedDorna Wireless PRN Spirometer Specifications.................................................................................................. 59 MedDorna Wireless PRN Spirometer Export File Field Order................................................................................... 62 Predictor Equations..................................................................................................................................................... 65 Care & Maintenance ................................................................................................................................................... 75 Service ........................................................................................................................................................................ 76 Limited Warranty........................................................................................................................................................ 77 Glossary of Terms....................................................................................................................................................... 78 CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 3 of 81 003-0004 Rev A CONFIDENTIAL Before conducting live tests on patients, read the Caution and Warnings topic that pertains not only to your particular device but the General Caution and Warnings section as well. It is also recommended that you perform some practice sessions on yourself or a colleague before performing live patient testing. Practice the procedures, setting options, setting predicted normals, and saving and deleting patients, sessions and individual maneuvers. This manual has been divided into separate sections to better facilitate the instructional process for users who have purchased more than one PC Card device. Please read the Office Medic Software section to learn how to use and navigate through the Office Medic software. For information on the operation and the mechanics of testing patients with your Spirometer device refer to the appropriate Spirometer section. We at MedDorna, LLC hope that this manual will be of service to you, however if you do need further assistance see Service for information on how to contact MedDornas Technical Support department. Important! Federal (USA) law restricts this device to sale by or on the order of a physician. Note: Office Medic is the trademark of QRS Diagnostic, Inc. Glossary of Symbols BT S/N CONFIDENTIAL Attention: Consult Accompanying Documents Type B Equipment Spirometer Defibrillator proof type CF Applied Part ECG Federal Communication Commission Underwriters Laboratories Do Not Reuse Class II, Electrical Equipment Bluetooth Serial Number General Cautions & Warnings WARNINGS:
CONFIDENTIAL Equipment is not suitable for use in presence of flammable anaesthetic mixture with air or with oxygen or nitrous oxide. The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Proper supervision is necessary when using any MedDorna medical device on children or vulnerable adults. It is recommended that you perform some practice sessions on yourself or a colleague before doing live patient testing. It is recommended to frequently back-up of data to safe guard against data loss should your computer suffer a loss of power or an unrecoverable error. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation. CAUTION:
The MedDorna Wireless PRN Spirometer device does not contain user serviceable components. Necessary repairs must be made at a MedDorna approved service location. Federal (USA) law restricts this device to sale by or on the order of a physician. The MedDorna Wireless PRN Spirometer device used with the Office Medic software are intended for use by a physician or by laboratory personnel under a physician's supervision. It is the physician's responsibility to assure that testing is properly administered, the test data properly evaluated and the patient referred for appropriate treatment. All numerical, graphical and interpretive data should be evaluated with respect to the patient's clinical and historical picture. All printers used with the Office Medic software must be tested and approved per EN60601-1-1 prior to placing the system in service. The MedDorna Wireless PRN Spirometer device has been tested and approved per EN60601-1 and IEC60601-1. All computers used with Office Medic software must be tested and approved per EN60950. If the computer has not been tested and approved per MedDorna Spirometry Users Manual CONFIDENTIAL EN60950, the system must be tested and approved per EN60601-1-1 or IEC60601-1-1 prior to placing it into service. Close all other applications when installing Office Medic software. Battery usage is dependent upon the computer in use. Consult your computer's user manual for battery usage and recharge information. Low battery indication is dependent upon the computer in use. Consult your computer's user manual for battery indicators. ELECTRICAL SAFETY CLASSIFICATIONS:
Note: These classifications apply to the MedDorna Wireless PRN Spirometer device:
Class II Electrical Equipment Protection against Electrical Shock: Type B Equipment Protection against Harmful Ingress of Water: IPX1 Mode of Operation: Continuous Operation Degree of safety in the presence of flammable anesthetics mixture with with air, oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. CONTRAINDICATIONS:
Do not operate in an explosive atmosphere. Do not operate in proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the MedDorna Wireless PRN Spirometer device. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 7 of 81 003-0004 Rev A Office Medic Installation Installing Office Medic Software From CD-ROM:
1. Log out of all other programs running on your computer. CONFIDENTIAL 2. Insert the Office Medic CD-ROM in the CD-ROM drive of your PC 3. If the autorun feature on your computer is disabled go to the next instruction. If not follow the on screen prompts. 4. On the lower Windows toolbar select Start|Run. 5. Type in d:\office\setup.exe in the Open dialog box. Note: substitute the letter of your CD-ROM drive should it be different from d:. 6. Follow the on-screen instructions to complete the software installation. Note that you will be given a choice of whether you wish to use a local database (one that resides only on the PC the software is being installed to) or a network database (see illustration). The network database option requires an additional software purchase. Also during the installation the message below will be displayed. Installing these components will take about four minutes with no outward sign that anything is occurring. Please be patient. MedDorna Spirometry Users Manual CONFIDENTIAL An Office Medic shortcut icon should appear on your Windows desktop when installation is complete. Shortcuts: Shortcut buttons are located just below the main menu. If unsure of the function, hold the mouse arrow over the button and the function's name will pull down. Shortcuts are from left to right, New, Open, Delete, Print, Print Preview, Refresh database, Spirometry, ECG, Oximetry Record Mode, Oximetry Spot Check Mode and Help. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 9 of 81 003-0004 Rev A Open Software The MedDorna Wireless PRN Spirometer device does not have any controls and is operated by the software. Its current status is indicated by two LED on top of the device as follows:
CONFIDENTIAL Red LED OFF ON OFF OFF Blue LED OFF ANY Single blink every 10 sec 3 sec Device Status No battery or battery is fully discharged Low battery Standby mode Dual blink every Device in use by the software Make sure your device is in standby mode. Using your mouse select the Office Medic icon on your computer's desktop to load the software program. General Troubleshooting Question: Can I use the Office Medic software with other medical hardware?
Answer: No. Currently the Office Medic software will work only with MedDorna Wireless PRN Spirometer. Problem: Will not launch program. Solution: Make sure your spirometer device is in standby mode (see above). Check the PC's memory to assure there is enough available memory to launch the Office Medic software. Problem: "Will not print". Solution: Printer is not ready. Office Medic software is designed to print to the default printer you assign through Windows. In Windows go to Start|Settings|Printers to check that the printer you are trying to print to is on-line and selected as the default. Also try to print from a different program such as a word processor. If you cannot print from that program as well as the Office Medic program there is most likely a communication issue between the computer and the printer. Navigation Navigating the Patient Directory CONFIDENTIAL Select the Office Medic icon begins with the directory of patients, sessions and tests. to load the software. The initial screen (illustrated below) The directory is a collapsible directory of patients, sessions and tests. To open a folder click on the "+" icon. To close a folder click on the "-" icon. To navigate you can use the keyboard or mouse. The keyboard commands are:
Up/Down arrow keys move up/down the directory. Left arrow key closes folder. Right arrow key opens folder. The Enter key opens a test session. Tab key moves from field to field. CONFIDENTIAL Office Medic Options Select Options|Office Medic to access the Office Medic options. Select the General tab to change the Measurement Units, Export options or the default path of the Image File Directory. Units - Select US English or Metric. Export File Options - You can create a file that will export your data into tab delimited text files. The export settings must be set prior to running a new test. The only way to export a previously saved session would be to add a new test to that session. To view the files open My Documents\QRS. There are three options for exporting:
Export File Off Overwrite Export File - after activation, this only creates a file for the last patient tested. Append Export File - this will begin creating a text file of all future patient test files from the instance this item is invoked. MedDorna Spirometry Users Manual CONFIDENTIAL to change the default path where your Export Flow/Volume Points - this exports the graph data points for PFT reports. Please note when exporting spirometry tests three text files are created, Session.txt, SpTest.txt and SpCalibr.txt. The Session.txt file will contain patient demographics and a list of the tests performed in that session. The SpTest.txt and SpCalibr.txt files contain test results for tests and calibrations. Selecting the Export Flow/Volume Points feature creates two files called SpGraph.txt and SpCalGr.txt. The SpGraph.txt and SpCalGr.txt files contain the number of graph points and a listing of each graph point separated by a carriage return. See the QRS Export Field Order topic under the Appendix section for additional export file information Image File Directory - Select the browse button image files will be saved. Allow remote handhelds to initiate unattended synchronization sessions - When enabled a remote Pocket PC is able to initiate a MedicSync session. This feature allows for synchronization between PCs and Pocket PCs when the host PC is inaccessible to the user of the remote PC. Several items should be noted:
Important! If the host computer's settings were set to delete data from the remote database during a previous synchronization, data will be deleted from the remote during the current synchronization unless the host computer's settings are changed. Once the automatic session is initiated both the PC and the Pocket PC will display messages indicating that the session has been initiated and will begin in 30 seconds. Any conflict of Account Number or demographics will be resolved using the remote database to overwrite the host database. A user on the host computer is able to cycle through the MedicSync screens and change the options prior to the session's beginning. When changing options the user on the remote PC is notified that the host computer is changing the options. During the session the remote user is kept apprised of the status by a progress bar. When the progress bar is solid (100%) the session is complete, and the remote user is notified. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 13 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL If the host computer does not have a previous synchronization saved with a Pocket PC then the Use the settings from my previous session option is unavailable and the session cannot be initiated. The user on the host computer can cancel the Automatic MedicSync session. If canceled, the remote computer is notified. File The File option displays several choices which provide options for creating and managing patient files, printing, managing the database connection and exiting the program. New (Ctrl+N) - Selecting New will open the Patient Information window. Enter patient information into the provided fields. Move from field to field with the tab key. Required fields are: Last Name, First Name, Height, Sex, Race and Birth Date. The Birth Date may be selected by selecting the arrow key in the field and using the calendar feature. Opening the calendar feature is an easy way to set the desired date. Select the month, then the year desired. Once you have set those parameters, select the date and close out the calendar. When all the information is entered correctly, select OK to save the data. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 14 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Smoking-Pack Years is calculated by multiplying the number of cigarette packs smoked per day by the number of years the patient has smoked. Open (Ctrl+O) - Select a patient and then select Open to open the Patient Information window and modify the patient's demographics. Select OK when finished to save the information. Delete (Ctrl+D) - Select a patient's name and then select Delete to delete that patient and all of his/her test sessions. You can also expand the patient tree and delete an entire test session or an individual test by highlighting the session or test you wish to remove and the choosing Delete. Warning messages will question you to make sure you want to delete the information. Once deleted the information cannot be recovered. Delete All - The Delete All option deletes the entire database stored on the local computer's hard drive. Using this command will delete all patients, sessions and tests including calibration tests. Once deleted the database cannot be recovered. Print to File - Creates an image file of an Office Medic report. Highlight the session or test maneuver you wish to image and select this option. The image file is created in the PDF format. Selecting Print to File prompts you to save the file (see illustration). CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 15 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL The default location for the image file is My Documents\QRS\QRS Image Files. The default file name reflects the patient's account number and the date and time the session or test maneuver is saved. The default file type is *.PDF. You can change the location and file name at the time of creation (to change the default Image File Directory see Office Medic Options). The default file type cannot be changed. The PDF report is an image of the report that would have been printed had you selected File|Print. Multi-page reports create a single file. Batch Print - The Batch Print option allows for the printing of multiple patient reports, assigned by date (see illustration below), or all patient reports within the database. Select the check boxes for the type of reports to be printed, and then set a date range. Select Print All to print the entire database. Spirometry calibration reports within the date range selected will also be printed. Note that the defaults for the Batch Print option is the current date and the last boxes and buttons set from the previous batch print job. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 16 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Finally, if tests do not fall within the date range selected, an error message is displayed. Select OK and you will be returned to the Batch Printing dialog box. Print Preview - Reports for calibration tests, test sessions or individual tests can be previewed on your computer monitor by selecting the desired item in the patient tree and then selecting File|Print Preview. Several options are available when previewing a selected report. Print (Ctrl+P) - Office Medic software is designed to print to the default printer assigned in the Windows settings. Test reports can be printed using this function. Select the test session or individual test and select Print to print a report. Refresh Patient Tree (F5) - This command is most useful when viewing a networked database. This option automatically refreshes the patient database and allows you to observe any new patients, sessions or tests saved since you opened the database or last refreshed it. Database Connection... - This option allows you to switch from the network database (located on the server) to your local database (located on your hard drive). Select this option and the following dialog box is displayed. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 17 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Select database connection type. If connecting to a Network database enter the server name then select OK. Exit - Selecting this option exits the Office Medic program. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 18 of 81 003-0004 Rev A Test Highlight a patient in the patient directory and select Test. Three test types are available:
CONFIDENTIAL Select Spirometry to start spirometric testing. Options Select Options from the main menu and choose Spirometry option. CONFIDENTIAL Tools CONFIDENTIAL MedicSync MedicSync allows you to synchronize data between QRS patient databases. This data includes patients as well as test and session data. When synchronizing between an Office Medic
(workstation or server) database and a Pocket Medic (handheld) database, MedicSync will automatically launch when you dock your handheld to your PC. MedicSync must be manually launched when transferring data between two Office Medic databases. To manually launch MedicSync choose Tools|Office Medic|MedicSync from within Office Medic. For information about unattended remote synchronization with your Pocket PC see Office Medic Options. Important! You should close all other applications on your PC before beginning a MedicSync session. MedicSync is designed to work with Microsoft ActiveSync version 3.5 or higher. Before using MedicSync you should upgrade ActiveSync if necessary. ActiveSync is a free download from the Microsoft website. Main Database When launched MedicSync automatically assigns the Main database to be the currently selected database on your Office Medic workstation software. If your Office Medic workstation has a database connection set to Local Database, the Local Database will be the Main for this session of MedicSync. If your Office Medic workstation has a database connection set to Network Database, the Network Database will be the Main for this session of MedicSync. If you desire to change the Main to a different database, you must exit MedicSync and change the database connection within Office Medic. Select File|Database Connection to accomplish this. Remote Database In order to exchange data with your Main Database, you must specify a Remote database. The Remote database can be either another Office Medic (desktop or server) database or a Pocket Medic (handheld) database. If you dock your handheld to your PC and MedicSync is set to launch automatically (default), the Remote database is automatically set to the Pocket Medic database on that handheld. When MedicSync is launched manually via the Office Medic Tools MedDorna Spirometry Users Manual CONFIDENTIAL menu, all databases available are listed and you must select which one you want to be the Remote database for this session of MedicSync. Notes Before using MedicSync there are several suggestions to make your synchronizations easier. Most customers don't change their settings once they have established a routine for synchronization. The Main database should be the database in which you consistently enter your patient demographic information. This patient data can be sent easily to your Remote database(s). This will establish identical demographic records in both the Main and Remote databases and cut down on potential conflict resolution. Also, if you synchronize often, it will cut down on lengthy synch times and the amount of conflict resolution you will need to perform. For questions about computer compatibility visit www.qrsdiagnostic.com.com/NewFiles/Hardware.html First Time Configuration When used initially MedicSync will walk you through the configuration process. After reading the Welcome Screen the initial choices are Next or Cancel. Choose Next to start the configuration process. Once configured, the Finish button appears as an option and can be used to synchronize the databases using the exact same settings from the previous session, assuming that you are CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 22 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL synchronizing the same database types. For example, the Finish button will not be available if you are synchronizing any new combination of MedDorna databases. Steps in the Configuration Process The first step in the configuration process is to choose a method to resolve conflicts when two records from different databases have the same patient first name, last name and account number, but different demographics. The choices are illustrated below. The second step offers the choice of deleting data from the Remote database. You can choose to delete patients and tests, tests only or to not delete any data from the Remote database. The third step offers the option of sending patient data from the Main to the Remote database. You can choose to not send any patients to the Remote database, to send all the patients or to manually select which patients to send to the Remote database. Whether step four is necessary depends on the choice made in step three. If you choose to export all or none of the patients from the Main to the Remote database, then the synchronization process will begin automatically. If you chose to manually select patients to send to the Remote database, then step four will need to be completed before synchronization can begin. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 23 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Place a check mark in the boxes next to the patients you wish to export and then select Finish to complete step four. At this point the synchronization of data begins and a progress window is displayed. The steps completed during synchronization are checked off, as they are finished. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 24 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Conflict Resolution MedicSync requires unique account numbers in all databases in order to synchronize patient information and tests. The following conflict resolution screens are displayed if any account numbers are missing or are the same as another patient. Scanning for Account Number Conflicts MedicSync scans for patient records that appear in both databases with the same demographic data, but have different account numbers. Should conflicting account numbers be found the following screen is displayed. Choosing to update the Remote database will send the account numbers from the Main database to the Remote database. Choosing to update the Main database will send the account numbers from the Remote database to the Main database. It is important to note that MedicSync will not update the other database with a blank account number, nor can either of the first two choices be used when both account numbers are blank. In cases such as these the conflicts must be manually reconciled. The screen below is a sample of manually reconciling account numbers. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 25 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Highlight a record and select the appropriate account number from the drop down menu. For records in which both account numbers are blank, enter an account number. Select Update to then update both records. Select Continue to proceed to the next step. Scanning Main for Missing Account Numbers MedicSync scans the Main database for duplicate or missing account numbers. The following screen appears if any records meeting those conditions are found. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 26 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL MedicSync can assign unique account numbers to each patient automatically or you can choose to assign account numbers to these patients manually. Highlight the patient's name and enter the account number in the New Number field. Select Update to assign the account number, and select Continue when all patients have been assigned a unique account number. Scanning Remote for Missing Account Numbers The Remote database is also scanned for duplicate or missing account numbers. Should any be found on the Remote database the same type of screen is displayed as above, and the options and procedures are identical to resolve these conflicts. Select Continue when ready to proceed to the next step. Scanning for Conflicts Patients who exist in both databases (identified by having the same account number), but have different demographic data, will display in the Conflict Resolution screen. The differences in the demographics are highlighted. Important! Should you need to change the demographics from within a test session (see Getting Started, MedDorna Wireless PRN Spirometer|Session Demographics). MedicSync will ignore this conflict upon synchronization. Upon synchronization all of the patient data and test data will be synchronized, however the demographics from within the changed test session will be out of sync. Note that the only session information that is continually updated is the Session Comments. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 27 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Conflicts of this type must be resolved manually by choosing the Main or Remote buttons, which will overwrite the demographic information of the record in the database NOT chosen. Selecting Ignore Conflict results in the record not being synchronized. Each time a conflict is resolved, the number of conflicts refreshes to reflect the current number of conflicts remaining and a new record is displayed. Select Continue when all conflicts have been resolved. The data will now be synchronized according to the selections made during configuration. When completed the program will display a completion screen. Select Close to close out the MedicSync program. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 28 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Upon return to the database screen the Main Office Medic database will have automatically been refreshed and the new data will be displayed. If the Remote database was displayed during synchronization you will have to manually refresh this database in order to view the most recent data. Select File|Refresh Patient Tree or press F5 to refresh the Remote database. Select Tools |Spirometry|Perform Calibration Check to open the Calibration Check window of the Office Medic software. The MedDorna Wireless PRN Spirometer device can have its calibration checked. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 29 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Choosing this option for calibration saves the data to the Calibration Data section of the patient directory. See the MedDorna Wireless PRN Spirometer Calibration section for specific information about the calibration testing and the calibration feature. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 30 of 81 003-0004 Rev A Help Selecting the Help option opens a pull down menu with four choices. CONFIDENTIAL Contents - This option opens this on-line help guide with the Contents tab selected as the default. This allows you to view the table of contents and select your choice of chapters to view. Index - This option opens this on-line help guide with the Index tab selected as the default. This allows for the topics to be looked up by index entries. About QRS - Provides information on how to contact QRS by phone, fax and on-line. About Office Medic - This option displays the version of the Office Medic software. CONFIDENTIAL MedDorna Wireless PRN Spirometer Cautions & Warnings WARNING:
Use only MedDorna mouthpieces. These are manufactured to meet the calibration requirements for the MedDorna Wireless PRN Spirometer. Use of other manufacturer's mouthpieces may cause improper Spirometer performance. CAUTION:
Federal (USA) law restricts this device to sale by or on the order of a physician. The MedDorna Wireless PRN Spirometer and the Office Medic/Pocket Medic software are intended for use by a physician or by laboratory personnel under a physician's supervision. It is the physician's responsibility to assure that testing is properly administered, the test data properly evaluated and the patient referred for appropriate treatment. The spirometry test interpretations are intended for the physician's use only. All spirometry numerical and graphical data should be evaluated with respect to the patient's clinical and historical picture. Mouthpieces are single patient use only and MUST be replaced for each patient. Mouthpieces should not be used on a patient with an injured mouth. The opening at the end of the mouthpiece must not be obstructed. Make sure the patient does not obstruct it with his/her fingers. This will result in erroneously high volume and flow results. It is the physician's responsibility to properly train individuals using this product in a non-health care setting. In addition the physician must make patients aware of the risks involved with spirometry testing and inform them of the safety measures to implement to minimize those risks. FVC and MVV testing can cause fatigue and may be dangerous for some patients. Some patients may be at risk for vertigo, arrhythmia or syncope. To reduce the risk of cross contamination the patient should open, handle and dispose of his/her own mouthpiece. Caution should be exercised for patients with a history of COPD when doing spirometry. MedDorna Spirometry Users Manual INDICATIONS FOR USE: Diagnostic Spirometry Patient Population: Male/Female, Pediatric to Adult Device Functionality: Diagnostic Spirometry. Spirometric Parameters: FVC, MVV, SVC, and FEF Environment of Use: Hospital, Clinical and Home Use CONFIDENTIAL 33 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. CONFIDENTIAL MedDorna Wireless PRN Spirometer Introduction Spirometry Spirometry is a primary pulmonary function test (PFT). This test measures the air flow-rate and volume obtained during a patient's maximum forced exhalation/inhalation effort. It is the most commonly ordered PFT procedure and is practical to perform in any health care setting. Spirometry is important because it can:
Identify the presence of lung disease. Help the physician assess the severity of a patient's lung disease. Identify pulmonary disease symptoms and the degree of disability. Assist in the management of patients with lung disease. Provide early detection of pulmonary disease. Assist in convincing patients to quit smoking. Help the physician assess the effects of therapy or medications. Spirometry can help to identify diseases at very early stages. Without spirometry the patient must usually develop physical symptoms before a pulmonary disease is recognized. By then considerable damage may have occurred. CONFIDENTIAL Getting Started MedDorna Wireless PRN Spirometer Installation:
The MedDorna Wireless PRN Spirometer device does not have any controls and is operated by the software. Its current status is indicated by two LED on top of the device as follows:
Red LED OFF ON OFF OFF Blue LED OFF ANY Single blink every 10 sec 3 sec Device Status No battery or battery is fully discharged Low battery Standby mode Dual blink every Device in use by the software Make sure your device is in standby mode. Connect Mouthpiece Connect the pressure tube to the luer fitting on the MedDorna Wireless PRN Spirometer device. The pressure tube is what 'transmits' the pressure produced by the mouthpiece to the MedDorna Wireless PRN Spirometer device. Make sure the pressure tube is not kinked or restricted in any way. Connect the other end of the pressure tube to the disposable mouthpiece. Make sure that the connection is secure. Performing a Spirometry Test Once the patient's demographic data is entered or if the patient already exists, select his/her name from the patient tree. Left select Test|Spirometry or the The Spirometry Test Session screen will appear. Select one of the highlighted buttons to conduct a Pre-test maneuver. The Post-test options are grayed out until a Pre-test maneuver is performed. icon. MedDorna Spirometry Users Manual CONFIDENTIAL Entering Mouthpiece Number Each mouthpiece is individually calibrated. Enter the number on the mouthpiece label following the # sign. Mouthpieces are for single patient use. Performing the Maneuver After the mouthpiece number and the room temperature range is entered (technician name if desired) select OK when ready to test. The software attempts to find the spirometer device and connect to it. During this process the following dialog box is displayed:
CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 36 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL You can click Cancel button to terminate the process of device connection and return to previous mode. If device is successfully found and connected, the software proceeds to testing. If device is not connected, the following message box is displayed:
Click OK button, then the following dialog box is displayed:
CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 37 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Click Cancel button to return to previous mode. Click Retry button to try to connect to the device again. Click Search button to search for any Bluetooth devices around. During the search process the following dialog box is displayed:
Once search is finished the following dialog box is displayed:
Select spirometer device from the list that has the Bluetooth address matching one on the device label, then enter PIN code and click Connect button to complete device connection. Click Cancel to terminate device connection process and return to previous mode. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 38 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Two circles will appear flashing red and yellow alternately. The MedDorna Wireless PRN Spirometer is assuring the pressure measured at the mouthpiece is the same as that in the room. Make sure the mouthpiece is not moving or the patient is not breathing into the mouthpiece while the circles are flashing. When both circles become green and an audible tone is heard, have the patient begin the maneuver. Upon completion of the maneuver, the software will ask whether the maneuver was acceptable. Select YES and the results will be displayed. Select NO and you will be returned to the Spirometry Test Session screen where the maneuver can be repeated. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 39 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL To perform another test select one of the test buttons. The mouthpiece number, the technician name and the room temperature settings will default to that of the last maneuver. Select the Session Comments tab to enter any comments relevant to the session. They will print on the report. You may add comments at any time. When the session is complete, select OK, the session will be saved and you will be returned to the patient database screen. Have the patient discard his/her own mouthpiece after the session is complete. Menu Buttons on the Test Results Window The Prev Test and Next Test buttons allow you to scroll through the tests completed in a single session. These tests appear in the order in which they were completed. To view interpretations select the Interp button on the Spirometry Test Session screen after a test has been conducted. Check for age and height limits in the Predictor Equations section, no interpretation can be given if the patient falls out of the range of predicted equations. Source used for Interpretations:
Office Spirometry: A Practical Guide to the Selection and Use of Spirometers by Paul L..Enright, M.D. Robert E. Hyatt M.D. 1987 Print allows you to print the individual test you are currently viewing. Delete allows you to delete the test you are currently viewing. Tabs Session Comments - Selecting this tab allows you to enter comments regarding the spirometry test session. These comments can be saved and reviewed at a later date. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 40 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Calibration Check - to do a calibration check. Session Demographics - Select this tab to update patient information from within the test window. Enter the changes and select the Update Patient Info button to save the changes to the database, this will affect current and future tests only. Previous test sessions must be individually updated. To have the changes reflected on the current session only, enter the changes and select the Perform Test tab to begin testing. The saved session and reports will reflect the demographic changes. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 41 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL For information on performing specific spirometry maneuvers or to check the calibration of your MedDorna Wireless PRN Spirometer device select one of the buttons below. MedDorna Wireless PRN Spirometer Options Select Options|Spirometry from the main menu to view the spirometry options. The window that opens will feature the spirometry options which can be accessed by selecting one of the five tabs at the top of the window. Select the General tab and you can change or activate the following options. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 42 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Incentives - Using the drop down menu you can change the adult incentive (graph) to one of five pediatric incentives that include a balloon, a ball, a bear, a clown or a pumpkin. Home Use - Checking this option simplifies mouthpiece number entry for patients testing at home by auto entering the previous day's mouthpiece calibration number. The Environmental tab from the Spirometry Options window allows the user to adjust their software based on environmental conditions that may affect test results such as temperature, elevation and barometric pressure. The pull down menu under Select Correction Method allows you to set:
Elevation: Elevation is your altitude above sea level. This is expressed in meters or feet. Use this option if you do not have a barometer. Elevation with Relative Barometric Pressure: In addition to entering the elevation this option allows you to input the relative barometric pressure. The relative barometric pressure is the measured air pressure in your area and varies from day to day. An on site barometer is one way to determine the barometric pressure. Relative barometric pressure is expressed in inches of Mercury ("Hg), millimeters of Mercury (mmHg) or millibars hPa (mb). CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 43 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL The first two options are available for normal office spirometry. Pulmonary laboratories typically utilize the last option. Absolute Barometric Pressure: Absolute barometric pressure is the true barometric pressure observed at a specific elevation and not corrected for altitude above mean sea level. The measurement of absolute barometric pressure is a site-specific reading usually obtained with precise instrumentation. Absolute barometric pressure is expressed in inches of Mercury ("Hg), millimeters of Mercury (mmHg) or millibars hPa (mb). Select Barometric Pressure Units - This pull down menu allows you to select the units of barometric pressure in either inches of Mercury ("Hg), millimeters of Mercury (mmHg) or millibars hPa (mb). Current Settings - Select the Update button to enter current data with regard to temperature, barometric pressure and elevation.
- Selecting the will bring you to this Help information. Other options within the Environmental tab include:
BTPS - The Use BTPS Correction check box should be checked whenever patient testing is performed. When BTPS is selected under the BTPS Options, the selected Room Temperature will be displayed and can be adjusted by selecting the Update button. All values can be entered by selecting the Update button and entering current readings. This brings you to the Current Settings screen allowing you to adjust the current environmental settings. Restore Defaults - The Restore Defaults button returns the settings to their original factory condition. Environmental Correction - During testing the mouthpiece dialog box displays an overview of the current environmental settings. The measurement units selected with the Units option from the Options/General menu (i.e. English vs. Metric) are reflected in the display. To change the settings select the Update button in the dialog box, you are taken to the Change Settings window where you can adjust the settings. When performing a calibration test, the mouthpiece dialog box will display the selected environmental settings. Selecting the Update button allows for changes in the selected settings. BTPS is automatically turned off for the calibration test and Room Temperature cannot be adjusted. Select the Printing tab and you can change or activate the following options:
44 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. MedDorna Spirometry Users Manual CONFIDENTIAL Print Full Page Graphs - Checking this option will put full page graphs into your printed report, usually on the second and third page. Half graphs will still appear at the bottom of the first page. Overlay Pre Tests - Checking this option overlays the graphs of the three best Pre tests on your printed report. If using this option and printing to a color printer the graphs will be overlaid in three different colors. If Post testing is performed in the same session then the best Pre and Post test graphs are overlayed. Custom Report Header - Select Edit Report Header to add a unique heading to your spirometry report. Up to four lines can be added. Check the Custom Report Header box to have the header printed on each report. FVC Reports - Check the box next to the type of graphs you want printed in your reports F(V), V(T) and Predicteds. You can only graph Predicteds if the F(V) box is checked. No graphs will be printed if F(V) and V(T) are unchecked and no Predicteds will be graphed if only the V(T) option is checked. Select the Predictors tab and you can change or activate the following options. 45 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. MedDorna Spirometry Users Manual CONFIDENTIAL Select the predictors to be used in each category (the default predictors are shown above). A first choice and second choice are allowed for adult and pediatric patients. This is useful when a patient falls out of the age or height range of the first choice predictor. The software will use the second choice predictor in this instance. Please note that if the patient falls out of the age or height range of both predictors, no predicted data will be shown. See the Predictor Equations section for predictor equations parameters. Within the Adult FVC Predictors menu you have the option of setting a Minimum Adult Age. The default is 18 years old. The Minimum Adult Age affects the predicted equations and should only be changed on a physician's order. Adult and pediatric predictors are also available for MVV. Race Correction Factors for Predicted Values -- See Predictor Equations. Select the Optional Parameters tab to set the following options. 46 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. MedDorna Spirometry Users Manual CONFIDENTIAL There are 25 different optional parameters that you can select to appear in your spirometry report for an FVC maneuver. Two different options appear for an MVV. All five option tabs have a Restore Default button. Selecting this option will restore the choices to their original factory settings for the active tab only. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 47 of 81 003-0004 Rev A CONFIDENTIAL
(FVC) FVC Forced Vital Capacity The Forced Vital Capacity (FVC) test measures the volume and the airflow a patient can exhale after filling his or her lungs with the maximum amount of air. By comparing the test results with those of a matched healthy population, the degree of obstruction or restriction present can be evaluated. In order to obtain diagnostically reliable results certain testing guidelines should be followed. Patient preparation for the test:
Loosen tight clothing (ties, belts, bras). Remove patient's dentures. Explain the procedure thoroughly to the patient including demonstrating it yourself with your own mouthpiece. Make sure the patient has a tight seal with his/her lips around the disposable mouthpiece. The patient should not bite the tube or use pursed lips against it. Place a disposable nose clip securely on the patient's nose or instruct the patient not to exhale through the nose. Proper Procedure:
Before beginning the test the patient should take several slow, deep inhalations/exhalations to feel comfortable. Have the patient keep the mouthpiece away from his/her mouth. The patient should sit or stand in an upright position during the test. Should you have the patient stand place a chair behind him/her for use should he/she become dizzy. Verbally instruct the patient to take the largest possible inhalation, insert the mouthpiece into his/her mouth and, exhale forcefully and completely. Important! Ensure that the patient does not cover or obstruct the fabric at the end of the mouthpiece with his/her hand. If a Flow/Volume Loop is desired, verbally instruct the patient to inhale back completely following expiration. Enter the mouthpiece number and select OK. When both lights become green and an audible tone is heard the patient can begin testing. Make sure that the patient's mouth is tightly closed around the mouthpiece. The patient should be instructed to exhale (blow out) as hard and as fast as possible. Encourage the patient to keep exhaling as long as possible. It is helpful to coach the patient with verbal commands and physical gestures. A proper expiration should last at least six seconds. Have the patient remove the mouthpiece and breathe normally until they have recovered. If you accept the test your test result screen should look similar to the illustration below. MedDorna Spirometry Users Manual CONFIDENTIAL Unacceptable tests:
Insufficient initial inhalation (lungs not completely filled before the test). Slow or hesitant start of expiration. Leakage around the mouthpiece or nose clip. Mouthpiece obstruction by teeth, tongues, or lips. Coughing during the test. Large variation of FVC or FEV1 between tests. Other problems as indicated by test evaluation messages displayed by the software. Mouthpiece was obstructed during test. Should this occur the reported volume will be unusually high. The Office Medic software will warn you when the volume is 7.0 liters or greater. Ensure that the patient is not covering the fabric on the mouthpiece and then retest. Tidal Breathing:
The MedDorna Wireless PRN Spirometer is able to measure FVC test results with a tidal start. This will enable the patient to breathe normally prior to performing the FVC test. Once the spirometer unit zeros (the software will display a "Perform Test" message), instruct the patient to insert the mouthpiece into his/her mouth and breath normally. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 49 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL When the patient is ready he/she should take a deep breath and exhale forcefully and completely, and (if a Flow/Volume Loop is desired) inhale back completely. The Best FVC test results are calculated using the largest Flow/Volume loop. The FVC test results are calculated using the maneuver that was comprised of the highest sum of FVC and FEV1 from the same test. Click here for information about reproducibility in the FVC results windows. Reproducibility:
The user will be informed if the patient has met the ATS reproducibility criteria if:
1. Three maneuvers have been accepted and 2. The two highest FVC values from any of the maneuvers are within 200 ml and 3. The two highest FEV1 values from any of the maneuvers are within 200 ml. You will receive another ATS warning if you perform more than 8 maneuvers on a patient. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 50 of 81 003-0004 Rev A CONFIDENTIAL MVV Maximum Voluntary Ventilation The Maximum Voluntary Ventilation (MVV) test determines the maximum volume of air a patient can exhale over a 12 to 15 second period. During the test the patient repeatedly exhales and inhales as rapidly and forcefully as possible. The test is often difficult to perform for many patients. The MVV test can be used in:
(MVV) Evaluation of disability due to lung disease. Testing for environmentally induced lung disease. Pneumoconiosis (black lung disease) testing. Proper procedure:
Before beginning the test the patient should take several slow, deep inhalations/exhalations to feel comfortable. Place a disposable nose clip securely on the patient's nose or instruct the patient not to exhale through the nose. The patient should sit or stand in an upright position during the test. Should you have the patient stand place a chair behind him/her for use should he/she become dizzy. Have the patient keep the mouthpiece away from his/her mouth and start the test. Instruct the patient to breathe as deeply and rapidly as possible for 12 to 15 seconds. Watch to make sure that the mouth is tightly closed around the mouthpiece. Important!
Ensure that the patient does not cover or obstruct the fabric at the end of the mouthpiece with his/her hand. Encourage the patient to keep-up maximum effort. It is helpful to coach the patient with verbal commands and physical gestures. At the end of the test the patient should remove the mouthpiece and breathe normally until he or she has recovered. If you accept the test your test result screen should look similar to the illustration below. MedDorna Spirometry Users Manual Unacceptable tests:
Leakage around the mouthpiece or nose clip. Mouthpiece obstructions by teeth, tongue, or lips. Poor patient effort. Coughing during the test. CONFIDENTIAL 52 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. CONFIDENTIAL SVC Slow Vital Capacity (SVC) The Slow Vital Capacity (SVC) test determines the volume that a patient can slowly exhale after filling his/her lungs with the maximum amount of air. Proper procedure:
Before beginning the test the patient should take several slow, deep inhalations/exhalations to feel comfortable. Have the patient keep the mouthpiece away from his/her mouth and start the test. Place a disposable nose clip securely on the patient's nose or instruct the patient not to exhale through the nose. The patient should sit or stand in an upright position during the test. Should you have the patient stand place a chair behind him/her for use should he/she become dizzy. Instruct the patient to take the largest possible inhalation, insert the mouthpiece into his/her mouth, and exhale slowly and completely. Make sure that the patient's mouth is tightly closed around the mouthpiece. Important! Ensure that the patient does not cover or obstruct the fabric at the end of the mouthpiece with his/her hand. Encourage the patient to keep exhaling as long as possible. It is helpful to coach the patient with verbal commands and physical gestures. Have the patient remove the mouthpiece and breathe normally until they have recovered. If you accept the test your test result screen should look similar to the illustration below. MedDorna Spirometry Users Manual CONFIDENTIAL Unacceptable tests:
Insufficient initial inhalation (lungs not completely filled before the test). Leakage around the mouthpiece or nose clip. Mouthpiece obstructions by teeth, tongue, or lips. Coughing during the test. Tidal Breathing:
The MedDorna Wireless PRN Spirometer is able to measure SVC test results with a tidal start. This will enable the patient to breathe normally prior to performing the SVC test. Once the spirometer unit zeros (the software will display a "Perform Test" message), instruct the patient to insert the mouthpiece into his/her mouth and breath normally. When the patient is ready he/she should take a deep breath and exhale slowly and completely. The SVC test results are calculated from the largest difference between maximum inhalation and maximum exhalation. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 54 of 81 003-0004 Rev A CONFIDENTIAL MedDorna Wireless PRN Spirometer Calibration Calibration Check The calibration function can be accessed through the Spirometry Test Session window by selecting the Calibration Check tab. This window is identical to the calibration window that can be accessed from the main menu (see Tools). The MedDorna Wireless PRN Spirometer can have its calibration checked. The calibration check is set up for testing by two different methods:
Standard - A single maneuver test ATS - Designed for testing at three different flow rates to meet the ATS guidelines for calibration. The calibration check is for verification only. There are no user calibration settings. If the MedDorna Wireless PRN Spirometer is found to be out of calibration try again with a different mouthpiece. If the problem persists, see Service. Calibration volume for ATS calibration is set to a 3-liter syringe by default and cannot be changed. MedDorna Spirometry Users Manual CONFIDENTIAL To check calibration:
Select Calibration Check from the test session window. Connect a syringe to the mouthpiece (recommended, 3 liter syringe). Select Begin Stnd to begin a standard calibration check. Enter in the mouthpiece number and the syringe volume (range 1 to 10 liters) and select OK. For an ATS calibration check select ATS, select the flow rate and enter the mouthpiece number in the mouthpiece number window (syringe volume is locked at 3-liters for ATS calibration). When the MedDorna Wireless PRN Spirometer finishes zeroing and the "Perform Test"
message appears, push the syringe in (exhale) fully. If it is a Standard calibration maneuver, the flow rate should attempt to mimic an exhalation. If it is an ATS calibration, you must try to match the flow curve on the display to accurately meet the flow requirements of the test. The MedDorna Wireless PRN Spirometer does not require a calibration check in order to operate!
The calibration report will indicate whether you passed or failed. In addition, Syringe Volume, Recorded Volume, Absolute Variance (the difference from the Syringe Volume and the Recorded Volume), and the Percent Variance (the percentage difference of the Recorded Volume to the Syringe Volume) will be displayed. If the calibration maneuver was acceptable, select OK to complete the calibration check and save the maneuver. To print a copy of the calibration report select Print at the bottom of the Calibration Check window. Choosing this option to check calibration saves the data within the patient's test session. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 56 of 81 003-0004 Rev A CONFIDENTIAL MedDorna Wireless PRN Spirometer Troubleshooting Question: Do I need to replace the spirometer pressure tube after each patient?
A: No. There is a static pressure column created between the end of the mouthpiece and the pressure transducer inside the MedDorna Wireless PRN Spirometer. The patient's exhalation follows the path of least resistance, the vents on the side of the mouthpiece, thereby preventing moisture from entering the pressure tube. To illustrate take a pressure tube that can be discarded. Attach the pressure tube to the mouthpiece and cover the opposite end of the pressure tube with your finger. Breathe through the mouthpiece. Notice the lack of moisture in the pressure tube behind the mouthpiece. Now remove your finger from the end of the pressure tube and repeat. Moisture will be present. This demonstrates that if used properly the pressure tube will not become contaminated. If a patient covers the vents on the mouthpiece or uses the pressure tube when it is not properly connected to the spirometer, the pressure tube must be replaced. Question: Why do I not get predicted values for spirometry with some patients?
A: Predicted values are most often a determined by a combination of the patient's age and height. If you patient falls outside of the parameters for the particular equations used for prediction, no predictors will be printed. Check the Predictor Equations section for the predicted equation sets and set your predictors accordingly. Problem: When I perform a test, the circles keep flashing When zeroing, the MedDorna Wireless PRN Spirometer looks for a constant pressure between the room and the mouthpiece. If one of the two pressures is varying, the MedDorna Wireless PRN Spirometer cannot complete the zeroing process. Situations that may cause these variations are:
Mouthpiece is being moved during zeroing (causes pressure fluctuation) Pressure tube is occluded. A block in the tube will show a constant rising pressure Room air pressure is changing. The MedDorna Wireless PRN Spirometer will detect room pressure changes if the unit is sitting under a heating/air conditioner vent, a door opening or closing or a high traffic area. Problem: "Test will not end after patient has completed maneuver"
A test will not end for the same reasons it will not zero (see above) The MedDorna Wireless PRN Spirometer zeroed at a room pressure that changed during the maneuver and now cannot return to zero. MedDorna Spirometry Users Manual CONFIDENTIAL Problem: Test values are too high (intermittent) End of the mouthpiece tube is being covered by the patients hand causing higher back-pressure and false reading. Problem: Test values are too high (consistently) Pressure tube may be partially occluded. Replace the pressure tube. Problem: Software indicates that no interpretations are available Interpretations require predictor values to do calculations and give an interpretation. If the predictors are set to none for all choices or the patient's height or age falls outside of the predictor equation parameters no predictor values will be given and no interpretation will be available. Problem: Cannot perform maneuvers A Post-test was performed. No more Pre-tests can be performed after a Post-test is conducted. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 58 of 81 003-0004 Rev A CONFIDENTIAL MedDorna Wireless PRN Spirometer Specifications Signal type Number of data channels Sensor type Sensor models Air pressure 2 Air pressure transducer Channel 1 - CPCL10GFN 10 In2 channel 2 - CPC01GFC 30 In2 Air pressure tubing outlet Channel 1 - 6 InH2O Channel 2 - +28 InH2O 0 25 Hz 100 db 16 bit 100 Hz Not more than 3%
Yes Bluetooth Accumulator 1.5 to 8 V Not more than 0.15 W 95 mm 61.5 mm 27.5 mm 100 g Reporting software is stored on the computer
-15 to 50 C (5 to 122 F) 10 to 90% (non-condensing) 700 to 1060 hPa 15 to 40 C (59 to 104 F) 10 to 90% (non-condensing) 700 to 1060 hPa Input connector type Measured signal range Frequency range Common mode rejection ADC resolution Sampling rate Air flow rate measuring error Battery level measurement Interface Power supply Power consumption Device dimensions Device weight Program Environmental Conditions:
Storage Conditions:
Ambient Temperature Relative Humidity Atmospheric Pressure Operating Conditions:
Ambient Temperature Relative Humidity Atmospheric pressure Measurement Method:
FLOW VOLUME Range:
FLOW VOLUME Accuracy:
FLOW VOLUME Precision:
FLOW VOLUME BTPS Conditions:
VOLUME Calibration Predicted Normals Tests Performed Measuring Time Printed Scale:
Flow - Volume Volume - Time MedDorna Spirometry Users Manual CONFIDENTIAL Mouthpiece (US Patent #4,905,709) flow integration
+/-14 liters/second 0-8 liters BTPS Complies with the American Thoracic Society
(ATS) Standards for Spirometry, 1994 Update
+/-5% of indication or +/- 200 ml/sec, whichever is greater for FEF 25-75. +/-10% of indication or +/- 400 ml/s whichever is greater for PEF.
+/-3% of indication or +/- 50 ml, whichever is greater for FVC and FEV1. +/-10% of indication or +/-15 L/min, whichever is greater for MVV. 5% of indication or 200 ml/sec, whichever is greater for PEF and FEF 25-75 3% of indication or 50 ml, whichever is greater for FVC and FEV1
+/- 4.5% of indication or +/- 200 ml, whichever is greater for FVC and FEV1 ATS 3-speed or standard calibration check Crapo, Cherniack, Morris, Knudson 1983, Polgar, HSU, Roberts, Warwick, ECCS, NHANES III, Zapletal FVC, Pre/Post Testing, Flow Volume Loop, MVV, SVC Up to 30 seconds
(vertical) .5cm/1L/S, (horizontal) 1cm/1L
(vertical) 1cm/1L, (horizontal) 1cm/second 60 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. MedDorna Spirometry Users Manual CONFIDENTIAL Resolution:
Flow Rate Volume Limits of Detection:
Flow Rate Volume Parameters measured 2 ml/sec 1 ml 2 ml/sec 1 ml FVC, FEV6, FEV1/FEV6, FEV0.5, FEV1, FEV3, FEV1/FVC, FEV3/FVC, PEFR, FEF25%, FEF50%, FEF75%, FEF25-75%, FIVC, FIV0.5, FIV1, FIV3, FIV1/FIVC, FIV3/FIVC, PIFR, FIF50%, FIF 25-75%, FIF.2-1.2, FVC/FIVC, Extrapolated Volume
(Ext. Vol.) MVV, RR, MTV, SVC CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 61 of 81 003-0004 Rev A CONFIDENTIAL MedDorna Wireless PRN Spirometer Export File Field Order This is the export file field order for the spirometry data saved as a text file. Database: Session.txt Account Last First SessionDate Height Weight Units Race Birthdate Age Sex SessionComments FVCPredVal FVCPred FEV05PredVal FEV05Pred FEV1PredVal FEV1Pred FEV3PredVal FEV3Pred FEV1_FVCPredVal FEV1_FVCPred PEFPredVal PEFPred FEF25PredVal FEF25Pred FEF50PredVal FEF50Pred FEF75PredVal FEF75Pred FEF25_75PredVal FEF25_75Pred FIVCPredVal FIVCPred MVVPredVal MVVPred MedDorna Spirometry Users Manual Database: SpTest.txt Account Last First SessionDate TestType TestSequenceNumber TestDate MouthpieceNumber PhysicianName FVC FEV05 FEV1 FEV3 FEV1_FVC FEV3_FVC PEFR FEF25 FEF50 FEF75 FEF25_75 FIVC FIV05 FIV1 FIV3 FIV1_FIVC FIV3_FIVC PIFR FIF50 FIF25_75 FIF2_1_2 FVC_FIVC ExtVol MVV MTV RR SVC BTPS Degree CONFIDENTIAL 63 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. MedDorna Spirometry Users Manual Database: spGraph.txt PatientInfo Sessiondate TestType TestDate NumberOfGraphPoints Volume- Tab- Flow Database: SpCalibr.txt PatientInfo SessionDate CalibrationType CalibrationDate MouthpieceNumber SyringeVolume RecordedVolume Database: SpCalGr.txt PatientInfo SessionDate CalibrationType CalibrationDate NumberOfGraphPoints Volume-tab-flow CONFIDENTIAL 64 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. CONFIDENTIAL Predictor Equations Race Correction: There is a 15% race correction for Asian and Black patients with the exception of NHANESIII, which utilizes the race corrections for Blacks (African-American) and Hispanics (Mexican American) as referenced in John L. Hankinson, John R. Odencrantz, and Kathleen B. Fedan. 1999. "Spirometric Reference Values from a Sample of the General U.S. Population". Am J Respir Crit Care Med Vol 159. pp 179-187. MORRIS MALE, 20-90 years, 58.0-80.0 in. (147.3-203.2 cm) FVC (L) = 0.148 * H[in] - 0.025 * A[yrs] - 4.241 FEV1 (L) = 0.092 * H[in] - 0.032 * A[yrs] - 1.26 FEV1/FVC% (L/sec) = - 0.31180 * H[in] - 0.2422 * A + 107.12 FEF25-75% (L/sec) = 0.047 * H[in] - 0.045 * A[yrs] + 2.513 FEF0.2 -1.2 (L/sec) = 0.10900 * H[in] - 0.0470 * A + 2.01 FEMALE, 20-90 years, 56.0-72.0 in. (142.2-182.9 cm) FVC = 0.115 * H[in] - 0.024 * A[yrs] - 2.852 FEV1 = 0.089 * H[in] - 0.025 * A[yrs] - 1.932 FEV1/FVC% (L/sec) = - 0.0679 * H[in] - 0.1815 * A + 88.7 FEF25-75 = 0.06 * H[in] - 0.03 * A[yrs] + 0.551 FEF0.2 -1.2 (L/sec) = 0.1450 * H[in] - 0.0360 * A + 2.532 CHERNIACK MALE, 15-79 years, 35.0-85.0 in. (88.9-215.9 cm) FVC (L) = 0.12102 * H[in] - 0.01357 * A[yrs] - 3.18373 FEV1 (L) = 0.09107 * H[in] - 0.0232 * A[yrs] - 1.50723 FEF25% (L/sec) = 0.0903 * H[in] - 0.01987 * A[yrs] + 2.72554 FEF50% (L/sec) = 0.06526 * H[in] - 0.03049 * A[yrs] + 2.40337 FEF75% (L/sec) = 0.03583 * H[in] - 0.04142 * A[yrs] + 1.98361 FEF25-75% (L/sec) = 0.05948 * H[in] - 0.037 * A[yrs] + 2.61187 PEFR = 0.14393 * H[in] - 0.02403 * A[yrs] + 0.22544 MVV = 3.02915 * H[in] - 0.81621 * A[yrs] - 37.94893 FEMALE, 15-79 years, 35.0-85.0 in. (88.9-215.9 cm) FVC (L) = 0.07833 * H[in] - 0.01539 * A[yrs] - 1.04912 FEV1 (L) = 0.06029 * H[in] - 0.01936 * A[yrs] - 0.18693 MedDorna Spirometry Users Manual FEF25% (L/sec) = 0.06876 * H[in] - 0.01926 * A[yrs] + 2.14653 FEF50% (L/sec) = 0.0622 * H[in] - 0.02344 * A[yrs] + 1.4264 FEF75% (L/sec) = 0.02334 * H[in] - 0.0345 * A[yrs] + 2.21596 FEF25-75% (L/sec) = 0.04931 * H[in] - 0.0312 * A[yrs] + 2.2561 PEFR = 0.0913 * H[in] - 0.01776 * A[yrs] + 1.1316 MVV = 2.13844 * H[in] - 0.68503 * A[yrs] - 4.86957 ROBERTS MALE, 18-86 years, 63.4-77.2 in. (161.0-196.0 cm) FVC (L) = 0.06628 * H[cm] - 0.028 * A[yrs] - 5.377 FEV1 (L) = 0.03961 * H[cm] - 0.033 * A[yrs] - 1.558 FEV1/FVC% = (-0.21476 * H[cm] - 0.242 * A[yrs] + 126.252)/100 PEFR = 0.05317 * H[cm] - 0.062 * A[yrs] + 3.884 FEF50% (L/sec) = -0.044 * A[yrs] + 6.456 FEMALE, 18-86 years, 57.5-69.7 in. (146.0 - 177.0 cm) FVC (L) = 0.04321 * H[cm] - 0.023 * A[yrs] - 2.379 FEV1 (L) = 0.03321 * H[cm] - 0.025 * A[yrs] - 1.394 FEV1/FVC% =( -0.172 * A[yrs] + 88.134))/100 PEFR = 0.04087 * H[cm] - 0.05 * A[yrs] + 2.945 FEF50% (L/sec) = -0.038 * A[yrs] + 5.556 KNUDSON (1983) MALE, 6-11 years, 44.0-61.0 in. (111.8-154.9 cm) FVC (L) = 0.0409 * H[cm] - 3.3756 FEV1 (L) = 0.0348 * H[cm] - 2.8142 FEF50% (L/sec) = 0.0378 * H[cm] - 2.5454 FEF75% (L/sec) = 0.0171 * H[cm] - 1.0149 FEF25-75% (L/sec) = 0.0338 * H[cm] - 2.3197 MALE, 12-24 years, 55.0-76.0 in. (139.7-193.0 cm) FVC (L) = 0.059 * H[cm] + 0.0739 * A[yrs] - 6.8865 FEV1 (L) = 0.0519 * H[cm] + 0.0636 * A[yrs] - 6.1181 FEF50% (L/sec) = 0.0543 * H[cm] + 0.115 * A[yrs]-6.3851 FEF75% (L/sec) = 0.0397 * H[cm] - 0.0057 * A[yrs] - 4.2421 FEF25-75% L/sec) = 0.0539 * H[cm] + 0.0749 * A[yrs] - 6.199 CONFIDENTIAL 66 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. MedDorna Spirometry Users Manual CONFIDENTIAL MALE, 25-90 years, 62.0-77.0 in. (157.5-195.6 cm) FVC (L) = 0.0844 * H[cm] - 0.0298 * A[yrs] - 8.7818 FEV1 (L) = 0.0665 * H[cm] - 0.0292 * A[yrs] - 6.5147 FEF50% (L/sec) = 0.0684 * H[cm] - 0.0366 * A[yrs] - 5.5409 FEF75% (L/sec) = 0.031 * H[cm] - 0.023 * A[yrs] - 2.4827 FEF25-75% (L/sec) = 0.0579 * H[cm] - 0.0363 * A[yrs] - 4.5175 FEMALE, 6-10 years, 42.0-58.0 in. (106.7-147.3 cm) FVC (L) = 0.043 * H[cm] - 3.7486 FEV1 (L) = 0.0336 * H[cm] - 2.7578 FEF50% (L/sec) = 0.1846 * A[yrs] + 0.7362 FEF75% (L/sec) = 0.0109 * H[cm] - 0.1657 FEF25-75% (L/sec) = 0.022 * H[cm] - 0.8119 FEMALE, 11-19 years, 52.0-72.0 in. (132.1-182.9 cm) FVC (L) = 0.0416 * H[cm] + 0.0699 * A[yrs] - 4.447 FEV1 (L) = 0.0351 * H[cm] + 0.0694 * A[yrs] - 3.7622 FEF50% (L/sec) = 0.0288 * H[cm] + 0.1111 * A[yrs] - 2.304 FEF75% (L/sec) = 0.0243 * H[cm] + 0.2923 * A[yrs] - 4.4009 - 0.0075 * A[yrs]^2 FEF25-75% (L/sec) = 0.0279 * H[cm] + 0.1275 * A[yrs] - 2.8007 FEMALE, 20-69 years, 58.0-71.0 in. (147.3-180.3 cm) FVC (L) = 0.0444 * H[cm] - 0.0169 * A[yrs] - 3.1947 FEV1 (L) = 0.0332 * H[cm] - 0.019 * A[yrs] - 1.821 FEF50% (L/sec) = 0.0321 * H[cm] - 0.024 * A[yrs] - 0.4371 FEF75% (L/sec) = 0.0174 * H[cm] - 0.0254 * A[yrs] - 0.1822 FEF25-75% (L/sec) = 0.03 * H[cm] - 0.0309 * A[yrs] - 0.4057 FEMALE, 70-90 years, 58.0-66.0 in. (147.3-167.6 cm) FVC (L) = 0.0313 * H[cm] - 0.0296 * A[yrs] - 0.1889 FEV1 (L) = 0.0143 * H[cm] - 0.0397 * A[yrs] + 2.6539 FEF50% (L/sec) = 0.0118 * H[cm] - 0.0755 * A[yrs] + 6.2402 FEF75% (L/sec) = -0.0172 * A[yrs] + 1.8894 FEF25-75% (L/sec) = -0.0615 * A[yrs] + 6.3706 CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 67 of 81 003-0004 Rev A MedDorna Spirometry Users Manual HSU MALE, 7-18 years, 43.3-74.8 in. (111.0-190.0 cm) FVC [ml] = 0.000358 * H[cm]^3.18 FEV1 [ml] = 0.000774 * H[cm]^3 FEV1/FVC = FEV1 pred/FVC pred PEFR [L/sec] = 0.000005583*H[cm]^2.79 FEF25-75% [L/min] = 0.0000133 * H[cm]^2.46 FEMALE, 7-18 years, 43.3-74.8 in. (111.0-190.0 cm) FVC [ml] = 0.00257 * H[cm]^2.78 FEV1 [ml] = 0.00379 * H[cm]^2.68 FEV1/FVC = FEV1 pred/FVC pred PEFR [L/sec] = 0.000043*H[cm]^2.37 FEF25-75% [L/min] = 0.000063167 * H[cm]^2.16 CRAPO MALE, 15-91 years, 61.8-76.4 in. (157.0-194.0 cm) FVC (L) = 0.06 * H[cm] - 0.0214 * A[yrs] - 4.65 FEV05 (L) = 0.0327 * H[cm] - 0.0152 * A[yrs] - 1.914 FEV1 (L) = 0.0414 * H[cm] - 0.0244 * A[yrs] - 2.19 FEV3 (L) = 0.0535 * H[cm] - 0.0271 * A[yrs] - 3.512 FEF25-75% (L/sec) = 0.0204 * H[cm] - 0.038 * A[yrs] + 2.133 FEV1/FVC% = -0.13 * H[cm] - 0.152 * A[yrs] + 110.49 FEV3/FVC% = -0.0627 * H[cm] - 0.145 * A[yrs] + 112.09 FEMALE, 17-84 years, 57.5-70.1 in. (146.0-178.0 cm) FVC (L) = 0.0491 * H[cm] - 0.0216 * A[yrs] - 3.59 FEV05 (L) = 0.0238 * H[cm] - 0.0185 * A[yrs] - 0.809 FEV1 (L) = 0.0342 * H[cm] - 0.0255 * A[yrs] - 1.578 FEV3 (L) = 0.0442 * H[cm] - 0.0257 * A[yrs] - 2.745 FEF25-75% = 0.0154 * H[cm] - 0.046 * A[yrs] + 2.683 FEV1/FVC% = -0.202 * H[cm] - 0.252 * A[yrs] + 126.58 FEV3/FVC% = -0.0937 * H[cm] - 0.163 * A[yrs] + 118.16 CONFIDENTIAL 68 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. MedDorna Spirometry Users Manual WARWICK MALE, 6-18 YEARS, 35.4-74.0 in. (90.0-188.0 cm) FVC (L) = exp(3.0131 * ln(H[cm]) - 14.0535) FEV1 (L) = exp(2.7572 * ln(H[cm]) - 12.9007) FEV1/FVC% = 100 * exp(-0.2679 * ln(H[cm]) + 1.2137) FEF50% (L/sec) = exp(2.1326 * ln(H[cm]) - 9.3589) FEF75% (L/sec) = exp(2.1534 * ln(H[cm]) - 10.2213) PEFR (L/sec)= exp(2.4991 * ln(H[cm]) - 10.7785) FEMALE, 6-18 YEARS, 35.4-70.1 in. (90.0-178.0 cm) FVC (L) = exp(2.9446 * ln(H[cm]) - 13.8007) FEV1 (L) = exp(2.7522 * ln(H[cm]) - 12.921) FEV1/FVC% = 100 * exp(-0.2126 * ln(H[cm]) + 0.9719) FEF50% (L/sec) = exp(2.1958 * ln(H[cm]) - 9.6458) FEF75% (L/sec) = exp(2.2961 * ln(H[cm]) - 10.8666) PEFR (L/sec) = exp(2.4369 * ln(H[cm]) - 10.535) POLGAR MALE, 4-17 years, 43.0-67.0 in. (109.2-170.2 cm) FVC (L) = 0.0000044 * H[cm]^2.67 FEV1 (L) = 0.0000021 * H[cm]^2.8 FEV1/FVC[%] = 47.73 * H[cm] ^0.13 FEF25-75% (L/sec) = - 3.46167 + 0.0436833 * H[cm]
PEFR (L/sec)= -7.0928567 + 0.08738 * H[cm]
FEV3 = FVC pred * 0.98 MVV = 1.276 * H[cm] - 99.507 FEMALE, 4-17 years, 43.0-67.0 in. (109.2-170.2 cm) FVC (L) = 0.0000033 * H[cm]^2.72 FEV1 (L) = 0.0000021 * H[cm]^2.8 FEV1/FVC[%] = 63.63 * H[cm] ^0.08 FEF25-75% (L/sec) = - 3.46167 + 0.0436833* H[cm]
PEFR (L/sec)= - 7.0928567 + 0.0873800 * H[cm]
FEV3 = FVC pred * 0.98 MVV = 1.276 * H[cm] - 99.507 CONFIDENTIAL 69 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. MedDorna Spirometry Users Manual CONFIDENTIAL ECCS MALE, 25-70 years, (155-195 cm) FVC (L) = 0.0576 * H[cm] 0.026*A 4.34 FEV1 (L) = 0.0430*H[cm] 0.029*A 2.49 FEV1/FVC% = (-0.180*A + 87.21)/100 FEF25% (L/sec) = 0.0546 * H[cm] 0.029 * A 0.47 FEF50% (L/sec) = 0.0379*H[cm] 0.031 * A 0.35 FEF75% (L/sec) = 0.0261 * H[cm] 0.026 * A 1.34 FEF25-75% (L/sec) = 0.0194 * H[cm] 0.043 * A + 2.7 PEFR (L/sec) = .0614 * H[cm] 0.043 * A + 0.15 FIVC = 0.0610 * H[cm] 0.028 * A 4.65 FEMALE, 25-70 years, (145-180 cm) FVC (L) = 0.0443 * H[cm] 0.026*A 2.89 FEV1 (L) = 0.0395*H[cm] 0.025*A 2.6 FEV1/FVC% = (-0.190*A + 89.1)/100 FEF25% (L/sec) = 0.0322 * H[cm] 0.025 * A + 1.6 FEF50% (L/sec) = 0.0245 * H[cm] 0.025 * A +1.16 FEF75% (L/sec) = 0.0105 * H[cm] 0.025 * A +1.11 FEF25-75% (L/sec) = 0.0125 * H[cm] 0.034 * A + 2.92 PEFR (L/sec) = .0550 * H[cm] 0.030 * A -1.11 FIVC = 0.0466 * H[cm] 0.024 * A 3.28 NHANES III (John L. Hankinson) John L. Hankinson, John R. Odencrantz, and Kathleen B. Fedan. 1999. "Spirometric Reference Values from a Sample of the General U.S. Population". Am J Respir Crit Care Med Vol 159. pp 179-187. MALE, Caucasian, 8-19 years, 48.0 - 75.6 in. (122 - 192 cm) FVC (L) = - 0.2584 - 0.20415 * A[yrs] + 0.010133 * A[yrs]2 + 0.00018642 * H[cm]2 FEV1 (L) = - 0.7453 - 0.04106 * A[yrs] + 0.004477 * A[yrs]2 + 0.00014098 * H[cm]2 FEV1/FVC% = (88.066 - 0.2066 * A[yrs])/100 FEV6 (L) = - 0.3119 - 0.18612 * A[yrs] + 0.009717 * A[yrs]2 + 0.00018188 * H[cm]2 FEV1/FEV6% = (87.34 - 0.1382 * A[yrs])/100 FEF25-75% (L/Sec) = - 1.0863 + 0.13939 * A[yrs] + 0.00010345 * H[cm]2 PEF (L/Sec) = - 0.5962 - 0.12357 * A[yrs] + 0.013135 * A[yrs]2 + 0.00024962 * H[cm]2 CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 70 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL MALE, Caucasian, 20-80 years, 62.2 - 76.4 in. (158 - 194 cm) FVC (L) = - 0.1933 + 0.00064 * A[yrs] - 0.000269 * A[yrs]2 + 0.00018642 * H[cm]2 FEV1 (L) = 0.5536 - 0.01303 * A[yrs] - 0.000172 * A[yrs]2 + 0.00014098 * H[cm]2 FEV1/FVC% = (88.066 - 0.2066 * A[yrs])/100 FEV6 (L) = 0.1102 - 0.00842 * A[yrs] - 0.000223 * A[yrs]2 + 0.00018188 * H[cm]2 FEV1/FEV6% = (87.34 - 0.1382 * A[yrs])/100 FEF25-75% (L/Sec) = - 1.0863 + 0.13939 * A[yrs] + 0.00010345 * H[cm]2 PEF (L/Sec) = 1.0523 + 0.08272 * A[yrs] - 0.001301 * A[yrs]2 + 0.00024962 * H[cm]2 FEMALE, Caucasian, 8-19 years, 46.5 - 70.1 in. (118 - 178 cm) FVC (L) = - 1.2082 + 0.05916 * A[yrs] + 0.00014815 * H[cm]2 FEV1 (L) = - 0.8710 + 0.06537 * A[yrs] + 0.00011496 * H[cm]2 FEV1/FVC% = (90.809 - 0.2125 * A[yrs])/100 FEV6 (L) = - 1.1925 + 0.06544 * A[yrs] + 0.00014395 * H[cm]2 FEV1/FEV6% = (90.107 - 0.1563 * A[yrs])/100 FEF25-75% (L/Sec) = - 2.5284 + 0.5249 * A[yrs] - 0.015309 * A[yrs]2 + 0.00006982 * H[cm]2 PEF (L/Sec) = - 3.6181 + 0.60644 * A[yrs] - 0.016846 * A[yrs]2 + 0.00018623 * H[cm]2 FEMALE, Caucasian, 20-80 years, 57.1 - 70.9 in. (145 - 180 cm) FVC (L) = - 0.356 + 0.0187 * A[yrs] - 0.000382 * A[yrs]2 + 0.00014815 * H[cm]2 FEV1 (L) = 0.4333 - 0.00361 * A[yrs] - 0.000194 * A[yrs]2 + 0.00011496 * H[cm]2 FEV1/FVC% = (90.809 - 0.2125 * A[yrs])/100 FEV6 (L) = - 0.1373 + 0.01317 * A[yrs] - 0.000352 * A[yrs]2 + 0.00014395 * H[cm]2 FEV1/FEV6% = (90.107 - 0.1563 * A[yrs])/100 FEF25-75% (L/Sec) = 2.367 - 0.01904 * A[yrs] - 0.0002 * A[yrs]2 + 0.00006982 * H[cm]2 PEF (L/Sec) = 0.9267 + 0.06929 * A[yrs] - 0.001031 * A[yrs]2 + 0.00018623 * H[cm]2 MALE, Black (African-American), 8-19 years, 48.0 - 76.4 in. (122 - 194 cm) FVC (L) = - 0.4971 - 0.15497 * A[yrs] + 0.007701 * A[yrs]2 + 0.00016643 * H[cm]2 FEV1 (L) = - 0.7048 - 0.05711 * A[yrs] + 0.004316 * A[yrs]2 + 0.00013194 * H[cm]2 FEV1/FVC% = (89.239 - 0.1828 * A[yrs])/100 FEV6 (L) = - 0.5525 - 0.14107 * A[yrs] + 0.007241 * A[yrs]2 + 0.00016429 * H[cm]2 FEV1/FEV6% = (88.841 - 0.1305 * A[yrs])/100 FEF25-75% (L/Sec) = - 1.1627 + 0.12314 * A[yrs] + 0.00010461 * H[cm]2 PEF (L/Sec) = - 0.2684 - 0.28016 * A[yrs] + 0.018202 * A[yrs]2 + 0.00027333 * H[cm]2 MALE, Black (African-American), 20-80 years, 62.2 - 77.2 in. (158 - 196 cm) FVC (L) = - 0.1517 - 0.01821 * A[yrs] + 0.00016643 * H[cm]2 FEV1 (L) = 0.3411 - 0.022309 * A[yrs] + 0.00013194 * H[cm]2 CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 71 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL FEV1/FVC% = (89.239 - 0.1828 * A[yrs])/100 FEV6 (L) = - 0.0547 - 0.02114 * A[yrs] + 0.00016429 * H[cm]2 FEV1/FEV6% = (88.841 - 0.1305 * A[yrs])/100 FEF25-75% (L/Sec) = 2.1477 - 0.04238 * A[yrs] + 0.00010461 * H[cm]2 PEF (L/Sec) = 2.2257 - 0.04082 * A[yrs] + 0.00027333 * H[cm]2 FEMALE, Black (African-American), 8-19 years, 46.5 - 72.4 in. (118 - 184 cm) FVC (L) = - 0.6166 - 0.04687 * A[yrs] + 0.003602 * A[yrs]2 + 0.00013606 * H[cm]2 FEV1 (L) = - 0.963 + 0.05799 * A[yrs] + 0.00010846 * H[cm]2 FEV1/FVC% =(91.655 - 0.2039 * A[yrs])/100 FEV6 (L) = - 0.637 - 0.04243 * A[yrs] + 0.003508 * A[yrs]2 + 0.00013497 * H[cm]2 FEV1/FEV6% = (91.229 - 0.1558 * A[yrs])/100 FEF25-75% (L/Sec) = - 2.5379 + 0.43755 * A[yrs] - 0.012154 * A[yrs]2 + 0.00008572 *
H[cm]2 PEF (L/Sec) = - 1.2398 + 0.16375 * A[yrs] + 0.00019746 * H[cm]2 FEMALE, Black (African-American), 20-80 years, 53.5 - 70.9 in. (136 - 180 cm) FVC (L) = - 0.3039 + 0.00536 * A[yrs] - 0.000265 * A[yrs]2 + 0.00013606 * H[cm]2 FEV1 (L) = 0.3433 - 0.01283 * A[yrs] - 0.0000974 * A[yrs]2 + 0.00010846 * H[cm]2 FEV1/FVC% = (89.239 - 0.1828 * A[yrs])/100 FEV6 (L) = - 0.1981 + 0.00047 * A[yrs] - 0.00023 * A[yrs]2 + 0.00013497 * H[cm]2 FEV1/FEV6% = (88.841 - 0.1305 * A[yrs])/100 FEF25-75% (L/Sec) = 2.0828 - 0.03793 * A[yrs] + 0.00008572 * H[cm]2 PEF (L/Sec) = 1.3597 + 0.03458 * A[yrs] - 0.000847 * A[yrs]2 + 0.00019746 * H[cm]2 MALE, Hispanic (Mexican-American), 8-19 years, 47.2 - 70.9 in. (120 - 180 cm) FVC (L) = - 0.7571 - 0.0952 * A[yrs] + 0.006619 * A[yrs]2 + 0.00017823 * H[cm]2 FEV1 (L) = - 0.8218 - 0.04248 * A[yrs] + 0.004291 * A[yrs]2 + 0.00015104 * H[cm]2 FEV1/FVC% = (90.024 - 0.2186 * A[yrs])/100 FEV6 (L) = - 0.6646 - 0.1127 * A[yrs] + 0.007306 * A[yrs]2 + 0.0001784 * H[cm]2 FEV1/FEV6% = (89.388 - 0.1534 * A[yrs])/100 FEF25-75% (L/Sec) = - 1.3592 + 0.10529 * A[yrs] + 0.00014473 * H[cm]2 PEF (L/Sec) = - 0.9537 - 0.19602 * A[yrs] + 0.014497 * A[yrs]2 + 0.00030243 * H[cm]2 MALE, Hispanic (Mexican-American), 20-80 years, 61.4 - 75.6 in. (156 - 192 cm) FVC (L) = 0.2376 - 0.00891 * A[yrs] - 0.000182 * A[yrs]2 + 0.00017823 * H[cm]2 FEV1 (L) = 0.6306 - 0.02928 * A[yrs] + 0.00015104 * H[cm]2 FEV1/FVC% = (90.024 - 0.2186 * A[yrs])/100 FEV6 (L) = 0.5757 - 0.0286 * A[yrs] + 0.0001784 * H[cm]2 FEV1/FEV6% = (89.388 - 0.1534 * A[yrs])/100 CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 72 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL FEF25-75% (L/Sec) = 1.7503 - 0.05018 * A[yrs] + 0.00014473 * H[cm]2 PEF (L/Sec) = 0.087 + 0.0658 * A[yrs] - 0.001195 * A[yrs]2 + 0.00030243 * H[cm]2 FEMALE, Hispanic (Mexican-American), 8-19 years, 44.9 - 67.7 in. (114 - 172 cm) FVC (L) = - 1.2507 + 0.07501 * A[yrs] + 0.00014246 * H[cm]2 FEV1 (L) = - 0.9641 + 0.0649 * A[yrs] + 0.00012154 * H[cm]2 FEV1/FVC% = (91.664 - 0.167 * A[yrs])/100 FEV6 (L) = - 1.241 + 0.07625 * A[yrs] + 0.00014106 * H[cm]2 FEV1/FEV6% =(92.36 - 0.2248 * A[yrs])/100 FEF25-75% (L/Sec) = - 2.1825 + 0.42451 * A[yrs] - 0.012415 * A[yrs]2 + 0.0000961 * H[cm]2 PEF (L/Sec) = - 3.2549 + 0.47495 * A[yrs] - 0.013193 * A[yrs]2 + 0.00022203 * H[cm]2 FEMALE, Hispanic (Mexican-American), 20-80 years, 53.5 - 67.7 in. (136 - 172 cm) FVC (L) = 0.121 + 0.00307 * A[yrs] - 0.000237 * A[yrs]2 + 0.00014246 * H[cm]2 FEV1 (L) = 0.4529 - 0.01178 * A[yrs] - 0.000113 * A[yrs]2 + 0.00012154 * H[cm]2 FEV1/FVC% = (92.36 - 0.2248 * A[yrs])/100 FEV6 (L) = 0.2033 + 0.0002 * A[yrs] - 0.000232 * A[yrs]2 + 0.00014106 * H[cm]2 FEV1/FEV6% = (91.664 - 0.167 * A[yrs])/100 FEF25-75% (L/Sec) = 1.7456 - 0.01195 * A[yrs] - 0.000291 * A[yrs]2 + 0.0000961 * H[cm]2 PEF (L/Sec) = 0.2401 + 0.06174 * A[yrs] - 0.001023 * A[yrs]2 + 0.00022203 * H[cm]2 ZAPLETAL Progress of Respiration Research Vol 22 (1987): Lung function in Children and Adolescents;
ISBN: 3-8055-4495-2 MALE, 6-18 years, 42.1 - 71.7 in. (107 - 182 cm) FVC (L) = 10 (-2.9236 + 2.936 * log(H[cm])) / 1000 FEV1 (L) =10 (-2.8652 + 2.8729 * log(H[cm])) / 1000 FEV1/FVC% = (90.6043 - 0.04104 * H[cm])/100 FEF25% (L/Sec) = 10 (-4.0164 + 2.1541 * log(H[cm])) FEF50% (L/Sec) = 10 (-4.2168 + 2.1771 * log(H[cm])) FEF75% (L/Sec) =10 (-4.5808 + 2.2116 * log(H[cm])) FEF25-75% (L/Sec) = 10 (-4.6651 + 2.3588 * log(H[cm])) PEF (L/Sec) = 10 (-4.3722 + 2.3422 * log(H[cm])) SVC (L) = 10 (-2.5768 + 2.7799 * log(H[cm])) / 1000 MVV (L/Min) = 10 (-1.9178 + 3.0388 * log(H[cm])) / 1000 CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 73 of 81 003-0004 Rev A MedDorna Spirometry Users Manual FEMALE, 6-18 years, 42.1 - 71.7 in. (107 - 182 cm) FVC (L) = 10 (-2.704 + 2.8181 * log(H[cm])) / 1000 FEV1 (L) =10 (-2.6056 + 2.7413 * log(H[cm])) / 1000 FEV1/FVC% = (90.6043 - 0.04104 * H[cm])/100 FEF25% (L/Sec) = 10 (-4.0164 + 2.1541 * log(H[cm])) FEF50% (L/Sec) = 10 (-4.2168 + 2.1771 * log(H[cm])) FEF75% (L/Sec) =10 (-4.5808 + 2.2116 * log(H[cm])) FEF25-75% (L/Sec) = 10 (-4.6651 + 2.3588 * log(H[cm])) PEF (L/Sec) = 10 (-4.3722 + 2.3422 * log(H[cm])) SVC (L) = 10 (-2.297 + 2.6361 * log(H[cm])) / 1000 MVV (L/Min) = 10 (-1.9178 + 3.0388 * log(H[cm])) / 1000 CONFIDENTIAL 74 of 81 003-0004 Rev A CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. CONFIDENTIAL Care & Maintenance Care and maintenance is similar for all of MedDorna Wireless devices. Cleaning - If the device becomes dirty, clean surfaces with a damp cloth using water only. Dry thoroughly. AVOID CLEANING AROUND CONNECTORS. Any moisture in luer could affect operation. To help keep luer port clean from dirt and debris, replace vinyl cap when not in use. Handling - Avoid contaminating the luer and connectors of the device. Storage - Store the device in a dry place. Moisture in the device can adversely affect measurements. The card can accept a wide temperature range, but avoid sudden changes in temperature that can cause condensation inside the unit. Physical Shock - Avoid physical shock to the device. A device that has been dropped should have the spirometry calibration verified before use on a patient. EMI - The device is not to be used in the proximity of any piece of equipment that has the potential to generate a significantly large electromagnetic field as to interfere in any manner with the operation of the device. Battery - ????
Disposal - Dispose of the device system components in accordance with the regulations applicable to the country in which it is used. Dispose battery components according to ... CONFIDENTIAL Service For service please contact the MedDorna service department at (000) 000-0000, fax us at (000) 000-0000 or e-mail us at support@MedDorna.com. Service representatives are available Monday through Friday from 7am to 6 pm CST. In the event that your problem cannot be fixed over the telephone you will be issued a Return Merchandise Authorization (RMA) number. Please have the Spirometers serial number and BT address available. Please repackage your device in the original packing materials and ship it to:
MedDorna, LLC 9600 Great Hills Trail, Suite 350W Austin, TX 78759 Normal repairs take three working days and includes static calibration and a stability check. THE INSTRUMENT MUST BE RETURNED FOR REPAIRS AT THE EXPENSE OF THE PURCHASER. IN-WARRANTY REPAIRED UNITS ARE RETURNED AT THE EXPENSE OF MEDDORNA CORPORATION OR ITS AUTHORIZED AGENT. FOR OUT OF WARRANTY WORK THE CUSTOMER IS RESPONSIBLE FOR ALL FREIGHT CHARGES. CONFIDENTIAL Limited Warranty All instruments sold and supplied by MedDorna are guaranteed to be free from defects in material and workmanship for a period of 3 years from date of purchase. All supplies and accessories carry a 90-day limited warranty. If in the judgment of MedDorna, LLC the instrument is proven to be defective during the warranty period it will be repaired or replaced with no charge for parts or labor. An extended hardware warranty is available at additional cost. This warranty does not cover any instrument that has been damaged by accident, misuse, abuse or has been altered or repaired by anyone other than an authorized MedDorna agent. This warranty also does not cover any unit that has had the serial number removed, defaced or rendered illegible. This warranty is in lieu of all other warranties expressed or implied. Including warranties of merchantability and fitness, and is hereby limited to repair or replacement of instruments found defective during the warranty period. ALL REPAIRS MUST BE MADE BY AN AUTHORIZED MEDDORNA, LLCAGENT. THE INSTRUMENT MUST BE RETURNED FOR REPAIRS AT THE EXPENSE OF THE PURCHASER. IN-WARRANTY REPAIRED UNITS WILL BE RETURNED AT THE EXPENSE OF MEDDORNA, LLCOR ITS AUTHORIZED AGENT. INSTRUMENTS SENT BY MAIL OR COMMON CARRIER SHOULD BE INSURED AGAINST LOSS OR DAMAGES, AS THEY ARE NOT COVERED BY THIS WARRANTY. Technical support on software is under warranty for 60 days. A software support package is available after 60 days at an additional cost. CONFIDENTIAL Glossary of Terms
%PRED -- Ratio of patients actual results compared to predicted normal values, expressed as a percentage. Abnormality is defined by using one standard deviation for each variable rather than any specific percentage below the predicted value. Results above 100% are above average. ATS -- American Thoracic Society, a scientific medical organization active in pulmonary research and care of patients with lung diseases. The ATS has recommended standards for spirometers. Back Extrapolation -- A method of determining the start-of-test point as recommended by the ATS. BF Equipment -- Degree of protection against electrical shock. Bronchodilator -- A type of drug (i.e. albuterol), usually administered in an aerosol spray, that is used to dilate air passages to reduce any restrictions to air flow. After bronchodilator administration, the spirometry test is repeated to determine reversibility and therapeutic efficacy in obstructed or asthmatic patients. BTPS -- Body Temperature and Pressure, Saturated: A number, which uniformly expresses all spirometry results at body temperature and pressure, fully saturated with water. Calibration Syringe -- A large syringe which injects a measured amount of air into the mouthpiece. Many syringes have a stop ring on the plunger, which allows injecting various calibrated amounts of air. Class II Equipment -- Double insulated equipment COPD -- Chronic Obstructive Pulmonary Disease. Demographic Data -- Patient information necessary to predict normal values for a patient - age, height, race and sex. Dyspnea -- Shortness of breath, sometimes accompanied by pain. ERS -- European Respiratory Society EX TIME -- Expiratory Time, expressed in seconds - time elapsed between the beginning and completion of expiration. FEF 25-75% -- Forced expiratory flow during the middle half (25-75%) of the FVC (formerly called the maximum middle expiratory flow rate), expressed in liters per second. This is the most sensitive measure of small airways obstruction (typically seen in smokers). MedDorna Spirometry Users Manual CONFIDENTIAL FEFxx% -- Forced Expiratory Flow at xx% point of the FVC, expressed in liters per second. See also: Forced Expiratory Flow. FEV1/FEV6 -- Ratio of FEV6 exhaled in one second. May be used as a surrogate for FEV1/FVC. FEV6 (L) forced expiratory volume -- Measured six seconds after commencement of expiration. May be used as a surrogate for FVC. FEVt -- See: Forced Expiratory Volume (timed) FEVx/FVC% -- The percentage ratio of Forced Expiratory Volume (timed) to Forced Expiratory Vital Capacity, expressed as a percentage. FIF.2-1.2 -- Forced Inspiratory Flow between 200 ml. and 1200 ml. Flow of inspired air measured after the first 200 ml. And during the next 1000 ml. FIF 25-75% -- Forced Inspiratory flow during the middle half (25-75%) of the FIVC expressed in liters per second. FIFxx% -- Forced Inspiratory Flow at xx% point of the FIVC, expressed in liters per second. See also: Forced Inspiratory Flow. FIVt -- See: Forced Inspiratory Volume (timed) FIVx/FIC% -- The percentage ratio of Forced Inspiratory Volume (timed) to Forced Inspiratory Vital capacity, expressed as a percentage. FIVC -- See: Forced Inspiratory Vital Capacity Flow vs. Volume Curve -- Graph obtained by forced exhalation test, Flow is plotted on the vertical axis and volume on the horizontal axis. It allows easier recognition of unacceptable or poorly reproducible tests when compared with the traditional spirogram. Characteristic shapes and subtle airflow changes are more readily apparent than on standard spirograms or numerical presentations. Forced Expiratory Flow -- It is the rate of flow, expressed in liters per second, at various points in the volumetric flow, i.e. FEF25%, FEF50%, FEF75%. May be more sensitive than FEV1 in finding a mild airflow limitation. Forced Expiratory Volume (timed) -- Maximal volume of air, expressed in liters, which can be expelled in specific time in a forced capacity test. For example, FEV1 is the volume of air expelled during the first second of the FVC. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 79 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Forced Inspiratory Vital Capacity -- Total volume of air, expressed in liters, which can be inhaled during a rapid forced inhalation after a maximal expiration. Amount may be decreased because of disorders, which cause volume restriction in the lung or airflow limitation causing air trapping. Forced Inspiratory Flow -- It is the Inspiratory rate of flow, expressed in liters per second, at various points in the volumetric flow, i.e. FIF25%, FIF50%, FIF75%. Forced Vital Capacity -- Total volume of air, expressed in liters, which can be exhaled during a rapid forced exhalation after a maximal inspiration. Amount may be decreased because of disorders which cause volume restriction in the lung or airflow limitation causing air trapping. May also be caused by poor insinuate or expiratory effort on the part of the patient. FVC -- See: Forced Vital Capacity. Lung Age -- Morris JF, Temple W.; Spirometric "lung age" estimation for motivating smoking cessation. Prev Med. 1985 Sep;14(5):655-62. Age Range: 20 - 84 MVV -- Maximum Voluntary Ventilation: The maximum volume of air that can be inhaled and exhaled repeatedly through the lungs over a period of time (usually 12 seconds) and extrapolated to one minute. It is expressed in liters per minute. Note: this is a strenuous test. MTV -- Mean Tidal Volume: see Tidal Volume (TV). Obstruction -- Limitation of airflow. It is shown by the FVC test. Low FEV1/FVC% ratio is the main indication of airways obstruction. Reductions in FEV3/FVC% and FEF25-75% best demonstrate obstruction of small airways (e.g. smokers). PEFR -- Peak Expiratory Flow Rate (FEF max), expressed in liters per second. Maximum instantaneous flow in the FVC test. PFT -- Pulmonary Function Tests: Group of tests including spirometry, lung volume tests, nitrogen washout, helium dilution, body plethysmography, DLCO, and blood gas analysis. PIFR -- Peak Inspiratory Flow Rate, expressed in liters per second. Pred. -- Predicted value according to the "normal" equations used. Pulmonary Functions Tests -- see PFT. RR -- Respiratory Rate: the average number of inhalations/exhalations per minute performed during a test. CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 80 of 81 003-0004 Rev A MedDorna Spirometry Users Manual CONFIDENTIAL Slow Vital Capacity Total volume of air, expressed in liters, which can be exhaled during a slow exhalation after a maximal inspiration. Amount may be decreased because of disorders that cause volume restriction in the lung. SVC See Slow Vital Capacity CONFIDENTIAL: Property of MedDorna, LLC and may not be reproduced without written permission. 81 of 81 003-0004 Rev A
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