Summary of Contents for Vitalograph Spirotrac 7000
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Vitalograph ® Spirotrac MODEL 7000 Instructions for Use _______________________________________________________________________________________________________________ Page 1 of 78 DT_0006-15...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Vitalograph Ltd, UK Vitalograph Ltd, International Maids Moreton, Buckingham Maids Moreton, Buckingham MK18 1SW MK18 1SW England England Tel: 01280 827110 Tel: +44 1280 827120 Fax: 01280 823302 Fax: +44 1280 823302 E-mail: sales@vitalograph.co.uk...
Six Minute Walk Test ..................48 Blood Pressure Management ............... 49 12-Lead ECG Measurements ............... 50 Maximum Voluntary Ventilation Testing ............55 Inhalation Testing with the Vitalograph Intrac ..........55 Audiometry Testing ..................57 Cleaning & Hygiene ..................... 64 Preventing Cross-Contamination of Subjects ..........64 Fault Finding Guide .....................
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18.4 Install Drivers: Vitalograph In2itive/Alpha USB on PC ........75 18.5 Install Drivers: Nonin Pulse Oximeter on a PC ..........75 18.6 Install Drivers: Supplied by Vitalograph technical support on COMPACT ..75 18.7 Connect Device: Vitalograph Pneumotrac USB to PC ........76 18.8 Connect Device: Serial Vitalograph Pneumotrac to PC ........
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 1 Main Components Figure 1 1. Spirotrac® software and drivers on USB key 2. USB Cable 3. *Pneumotrac™ Base 4. Flowhead Connection Tubing 5. *Pneumotrac Flowhead 6. Bacterial Viral Filter (BVF™) *For other devices see the specific guidance included with the device 1.1 Features of Vitalograph Spirotrac...
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Ability to link external documents to subject info as attachments • Implementation of ATS/ERS 2005 guidelines on Test QA • Pulse Oximetry Testing (SpO • Addition of the Vitalograph 2120 as a device • Addition of the Vitalograph Alpha as a device • PCF (Peak Cough Flow) Test •...
Issue 22 2 Spirotrac Installation Note: Spirotrac must be installed by a User with Administrative privileges on a PC. The Vitalograph COMPACT is supplied with a full installation of Spirotrac including all device drivers and a test station licence Figure 2 To install: 1.
ID. Other user IDs, including technicians, are created by the administrator using Tools > User Management. 7. Enter the Serial Number of the Vitalograph device to be used with Spirotrac, and the user’s email address. Entering a valid Device Serial Number allows Spirotrac to be used as a local test station.
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Refer to the Appendix 18.1 for setup details on a network database after installation. 3 Operating Spirotrac 3.1 Buttons and Icons The following are buttons available on the main toolbar:...
Print current session report Print current session report to PDF Send sessions to over-read Perform an Accuracy Check on the Vitalograph Pneumotrac 3.2 Start-up / Logon Note: In order to use Spirotrac, the user must: • Have full administrative rights on the PC or •...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 3.4.2 Creating a Subject When creating a new subject, the Subject ID is mandatory. All other details are optional. 1. To enter a new subject, select the new subject icon 2.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 3.4.3 Editing a Subject 1. Right click on subject in the subject list on the main screen. Select Edit Subject. Select subject in the subject list on the main screen. Select Edit button in the subject demographics panel.
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 a. Name fields: any/all of last name, first name and/or middle name as part of the subject demographics. b. Unit of Height: height in cm or inches. c. Weight: enter weight or exclude as part of subject demographics. When checkbox is ticked, weight can be entered/displayed/printed for subjects.
2120/2160 • Detect COM Port button – Automatically detects the COM port that the Vitalograph 2120/2160 device is connected to. Displays an error message if device is not connected. • Copy Subjects and Tests - Both Subject and Test data is copied from the 2120/2160 device to Spirotrac and the original data remains stored on the device.
On selecting Upload Subjects, Spirotrac lists all subjects in the Spirotrac database. The user may then select the subject(s) that they wish to send to the Vitalograph device. On selecting Upload these subjects are saved to the Vitalograph device. Test sessions are not saved.
To set: 1. Select Tools > Options > General tab > Perform Accuracy Check Daily Note: It is recommended that the Vitalograph 3 Litre Syringe be used when performing an accuracy check. This has an accuracy of +/-0.5%.
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2. (step 8) Withdraw the syringe while maintaining the flow rate within the highlighted band on screen. 3.8.2 Calibration update NOTE: This should only be conducted by or under the guidance of Vitalograph Service Agents. 1. Select Tools > Calibration Adjustment from the menu.
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 3.9 Institute and Department 3.9.1 Viewing Institution or Department Details 1. Select Institution Details or Current Department in the View menu. 2. The institution or department information displays. 3. Click OK when finished.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 User Activity Grade Activity Description System Annotation Annotation AC06 Department Edit Department Name, Field name modified: From<previous value> To <updated value> AC07 Subject Create Subject Create: Subject ID AC08...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 User Activity Grade Activity Description System Annotation Annotation AC20 Software Update AC22 Test Performed Subject ID=Subject ID, Outside Temp Session=Session Date/Time AC23 Calibration Pneumotrac Device Update Outside ID=device serial number...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 User Activity Grade Activity Description System Annotation Annotation AC37 Alpha Touch Upload # Subject(s) uploaded successfully AC38 Alpha Touch # Subject(s) downloaded. Source = Download Alpha Touch AC39 Alpha Touch...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 User Activity Grade Activity Description System Annotation Annotation AC51 DB Merge - Duplicate Subject Number [subject number] Source [source db information], Subject [destination db information] AC52 DB Merge - Undo...
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 a. Annotation Type – a description of the type of annotation record, e.g. User Logon, etc. b. System Annotation – as above. c. User Annotation – as above. 5. To print current entries click the Report button.
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 3.11.3 Printing a Test Report To print a test report for any test session: 1. Select the Subject to which the test session belongs. 2. Select the session to be printed 3.
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2. Launch Spirotrac. When prompted to logon, click ‘Forgot my password’ link. 3. Enter the reset passcode as provided by Vitalograph. This will be validated by Spirotrac prior to continuing. 4. To reset a user’s password: a.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Search Testing Post Challenge Inhaler ECG-View Audiometry Audiometry-View SpO2 6MWT 6MWT-Post View Delete Reports Print report Report Setup Accuracy Check Perform check Perform update View/Print Log Security User Management...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Site Other Site Other Administrator Administrator operator and Operator and Operator users only users only users only Edit User Delete User Change Password Edit other user's password Display/Print Audit Trail...
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Labels 6MWT Predicteds Challenge Reports Incentives Trending Pulse Oximetry System Configuration Biometrics Automatic Backup (Mirror Configuration Mode COMPACT device only Export/Email Export data Send Email Setup Email 3.13 User Preferences The following preferences may be configured by selecting Tools >...
Select Update button. b. On the Licence Activation wizard, enter the Device Serial Number of a Vitalograph device to be used with Spirotrac. This activates Spirotrac as a local test station. c. To use a network database, enter the Network Licence Key exactly as provided in the ‘If you have purchased an additional Network Licence...
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 3.16 Database Management 3.16.1 Select a new database To create a new database and select it for use through the ‘Database Management’ screen: 1. Select Tools > Database Management.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Note: Performing a database merge is not recommended for larger databases. The merge should be restricted to databases with no more than 1000 subjects/8000 blows. The merge can be performed in one of the following ways: •...
Spirotrac. 3.17 Vitalograph Spirotrac Fusion Vitalograph Spirotrac Fusion is an integrated, easy to use Quality Assured Spirometry System providing expert over-reading of spirometry in primary care, occupational health, or post-training environments. The expert over-readers can be your own experts or provided by Vitalograph as an optional service.
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 On receiving access to the Vitalograph Fusion Quality Assured Spirometry System the user will be provided with the over-read functionality. 3.17.1 Setup mail settings Spirotrac must be setup with a suitable mail server in order to send data to an over- reader.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 3. Click on Options beside the HL7 Enabled checkbox to edit settings for PDF report generation. This displays the HL7 Options window. 4. The location of the PDF file can be changed by editing the PDF File Location field.
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 3.19.6 Transmitting Sessions Automatically Test session data can also be returned automatically without a pending EMR test request. To configure Spirotrac to automatically return unsolicited messages: 1. Select Tools > Options > Advanced. Click on Options beside the HL7 Enabled checkbox to edit settings and enable the Auto Return HL7 Data option.
4.1.1 Checks to make before performing VC, FVC and Post Tests 1. The Vitalograph spirometer device should be connected correctly See relevant device instructions). 2. Check that the correct device is selected: a.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 2. Wait for ‘BLOW NOW’ message to appear on-screen. 3. Select the Volume/Time Graph tab where multi-breath testing is required and use the following guidelines a. Sit upright, fit the nose clip and relax.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 4. Repeat for a minimum of three manoeuvres, usually no more than eight for adults. 5. Check FEV and FVC repeatability and perform more manoeuvres as necessary. NOTE: A single-breath FVC technique may also be performed on the device.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Note: To perform a ‘Post’ VC test session, select ‘Return’ on the Post FVC testing screen to go back to the main screen. This is now in ‘Post Mode’. Select the ‘VC’ icon to perform a ‘Post’...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Ratio Ratio of FEV versus the largest VC from either VC or FVC manoeuvre FEV1/VC Ratio of FEV versus VC FEVn/VC Ratio of Forced Expiratory Volume after n second(s) (L) versus VC...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Tidal Volume (L) Inspiratory Capacity (L) /HT2 Ratio of FEV to Height in meters squared RAWind Airways Resistance Indirect TPEF Time to PEF (ms) TEXT Extrapolated time (ms). EOTV...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 information are displayed - acceptability information for that test and session reproducibility information for the session to date, as follows: Test Acceptability This section contains information on the acceptability of this single blow. The...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Message displayed Reason is not repeatable The largest FEV and the second largest FEV from the acceptable blows in the current session vary by more than 0.15L. 4.1.9 System Acceptability A 'Usable' curve is any curve which passes the 'Start of Test' acceptability criteria and which is artefact free, i.e.
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Quality Grade Criteria At least 3 usable blows with the highest two of the FEV values within 150mL At least 2 usable blows Only one usable blow No usable blows 4.1.12 Incentive Device Setup...
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 1. Connect the Pulse Oximetry device to USB port on the machine. 2. Select a subject by clicking on the Subject in the subject list on the main menu.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 On first use, the default values display for each Challenge Test and will be used unless changed by the operator. Once changed, the new values become the default. 5. The Challenge testing screen displays along with the Challenge test wizard which guides the user through the Challenge test procedure.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 4.3.1.2 ATS 5-breath dosimeter challenge testing The challenge test procedure consists of multiple phases. Baseline Phase: When the challenge session commences, the user may perform an FVC session or select a previously performed FVC session for that subject. The best accepted FEV value from that session becomes the baseline value.
% of the Baseline. 4.4 Six Minute Walk Test Vitalograph Spirotrac includes a Six Minute Walk Test module that measures the distance a subject can walk quickly on a flat, hard surface in 6 minutes and reflects an individual's ability to perform daily physical activities.
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 perform a test (See Pulse Oximetry Testing). Enter test values or perform a test. Select Next. 7. Record baseline fatigue and dyspnoea levels. Blood pressure and rest period are optional entries. Select Next. Record and enter the lap length in metres.
4.6 12-Lead ECG Measurements 4.6.1 Description The Vitalograph ECG software is intended to be used with BT12 12-Lead ECG devices. For further information on the device, refer to the BT12 Instructions For Use. The software offers automated ECG analysis and algorithm-based interpretations using the scientifically recognized Glasgow algorithm.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Start the ECG recording Stop the ECG recording Save the ECG Analysis recording End ECG mode Configuration (for experts only) Allows user to configure Amplitude Gain (mm/mV), Recording Speed(mm/s) and...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 In the analysis view, the software presents an analysis of the QRS complexes of the ECG section over 10 s, which is visible on the monitor. From this data, it calculates an average heart cycle, the so-called representative heart cycle.
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Average beat cycle 4.6.6 Glasgow Interpretation Algorithm The Glasgow Program has been incorporated into the Vitalograph Model 7000 and is intended to provide an interpretation of the resting 12 lead ECG in all situations, whether this be in a hospital or primary care setting. This algorithm has been reviewed against the industry standard, the CSE (Common Standards for Quantitative Electrocardiography) Database.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Malfunction Cause of error Rectification is displayed on the monitor. entered. correct PIN “1111”. The ECG device is not Switch the device on. switched on. Bluetooth dongle is not plugged Insert Bluetooth dongle in a free into USB port on the PC.
10. The next test can be performed once the ‘Start breathing and when stable press the [Spacebar]/[Start Test] to start!’ message re-appears on screen. 4.8 Inhalation Testing with the Vitalograph Intrac Spirotrac includes an Inhalation Test to test the subject's inhalation capacity.
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Issue 22 4.8.1 Configuring the Inhaler Test Before using the Inhaler test: 1. Connect the Vitalograph Intrac to the PC via USB. 2. Select Tools > Spirometer Device > Intrac from the Main Menu. 4.8.2 Performing an Inhaler Test On first use of the Inhaler Test: 1.
Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 Label The name to be given to a new configuration, or the name of the configuration currently selected for editing Inhaler Type Whether the Inhaler is of DPI or MDI type Flow Scale (L/min) The maximum flow axis value at the start of test.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 use – Determining hearing threshold levels, relative to standard reference threshold levels established by means of psychoacoustic test methods. 4.9.2 Performing an audiometry test Note: If ambient noise exceeds 35 dB(A), it is recommended that testing is carried out in a quieter location, in a sound booth or sound proofed room.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 1. Select output transducer: Left, right or binaural 2. Select curve type 3. Select stimuli type: Steady, pulse or warble tone 4. Present tone to subject 5. Frequency down 6.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 1. Toggle common/separated masking – Set masking levels for each frequency. 2. Turn masking on/off. 3. Masking dB level down. 4. Masking dB level up. 5. Turn masking lock on/off – The masking follows the tone attenuator control.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 xx dB Test Only available with Advanced and Diagnostic device Automatic screening test based on the 20 dB test with an adjustable start hearing level. xx dB random test...
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 General settings • Keyboard shortcuts: Set up keyboard shortcuts for pure tone testing via the dropdown menus. • Frequency selection: Enable or disable frequencies. • Set ‘Not heard’ when testing: Enable or disable the not heard symbol. When the setting is enabled a symbol will appear in the audiogram when the subject does not respond.
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Vitalograph Spirotrac Instructions for Use IFU Part No.: 07402 Issue 22 • SISI test o Adjust time intervals and hearing level. 4.9.5 Audiogram and results table options The following buttons within the Audiogram test screen/view screen changes the visual appearance of the audiogram and results table:...
5.1 Preventing Cross-Contamination of Subjects A spirometer is not designed or supplied as a ‘sterile’ device. Vitalograph intends that a new Bacterial Viral Filter (BVF) be used for every subject to prevent cross contamination. Using a new BVF provides a significant level of protection of for the subject, the device and the user against cross contamination during spirometry manoeuvres.
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• Possible Causes: Ensure tubing is connected correctly. Ribbed side (In probable order) of the tubing should be connected to the ribbed half of the connector on the Vitalograph device. • Problem Fault Symptoms: Incorrect or no volume measurements •...
Return to Main Menu and re-enter the test routine. 6.1 Software Check/Technical Support Spirotrac provides a technical support menu function intended to provide information to Vitalograph to help with customer support queries. The log files will be saved as a single zip file. _______________________________________________________________________________________________________________...
Service and repairs should be carried out only by the manufacturer, the approved importer or by Service Agents specifically approved by Vitalograph. For the names and addresses of approved Vitalograph Service Agents or to arrange spirometry workshops, please refer to the contact information at the start of this manual.
Standard, Intrac and asma-1 Spirometry devices. 11.1 Indications for Use Vitalograph Model 7000 Spirotrac is intended for use by, or on the order of, a physician in a hospital or clinic setting. The product is designed for use on both adult and paediatric subjects.
1. No modification of this equipment is allowed. Any unauthorised changes to the Vitalograph device may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported. 2. For the device to be used as intended, there is no requirement to clean the supporting computer.
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Vitalograph. Otherwise, degradation of the performance of this equipment could result. 18. If you connect additional equipment (not produced by Vitalograph) to the USB interface port, it must conform to VDE0750 Part 1-1 regulations and to your EN specifications, e.g.
16 Declaration of Conformity Product: Model 7000, Spirotrac Vitalograph hereby ensures and declares that the above product associated with these instructions for use, is designed and manufactured in accordance with the following QMS regulations and standards: • European Medical Devices Directive {MDD} 93/42/EEC, as amended.
7. To the maximum extent permitted by law, the Company does not accept liability for any consequential damages arising out of the use of, or inability to use any Vitalograph® equipment. _______________________________________________________________________________________________________________...
18.2 Connecting to a network database with Spirotrac on a COMPACT device The Vitalograph COMPACT is supplied with a full installation of Spirotrac, including all device drivers and a test station licence. A network licence key is required (see 2.2).
5. The driver installation completes. Click Finish. 18.6 Install Drivers: Supplied by Vitalograph technical support on COMPACT Note: Any drivers to be installed must be obtained from Vitalograph. To install drivers on a COMPACT device: _______________________________________________________________________________________________________________ Page 75 of 78...
1. Plug one end of USB cable into USB port on PC (usually marked with symbol). 2. Plug other end of USB cable into USB port at side of the Vitalograph Pneumotrac (marked with symbol). 3. Unwrap flowhead connection tubing from its packaging. Connect one end of tubing to the Pneumotrac device.
1. Plug one end of USB cable into USB port on PC/COMPACT (usually marked with symbol). 2. Plug other end of USB cable into USB port at side of the Vitalograph In2itive/Alpha (marked with symbol). 3. The Vitalograph In2itive/Alpha device is ready for use.
Note: Bacterial viral filters must be used to provide maximum protection against the possibility of contamination and inter-subject cross infection during testing. 18.13 Setting up Vitalograph COMPACT for Wireless Networking Note: Please see the manufacturer’s user instructions for more details.
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