Sibelmed DATOSPIR TOUCH User Manual
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Sibelmed DATOSPIR TOUCH User Manual

Sibelmed DATOSPIR TOUCH User Manual

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DATOSPIR TOUCH
SPIROMETER
Bronchoconstriction
test
USER'S MANUAL
511-BH0-MU2 • REV. 1.03 • 2017-04

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Summary of Contents for Sibelmed DATOSPIR TOUCH

  • Page 1 DATOSPIR TOUCH SPIROMETER Bronchoconstriction test USER’S MANUAL 511-BH0-MU2 • REV. 1.03 • 2017-04...
  • Page 2 SIBEL S.A.U., Rosellón 500 bajos,08026 BARCELONA (Spain) National Sales: Tel. 93 436 00 08 e-mail: comercial@sibelmed.com International Sales: Tel. +34 93 436 00 07 e-mail: export@sibelmed.com Technical service: Tel. +34 93 433 54 50 e-mail: sat@sibelmed.com Fax: +34 93 436 16 11, Website: www.sibelmed.com...

  • Page 3: Table Of Contents

    Bronchoconstriction test user’s manual TABLE OF CONTENTS INSTRUCTIONS FOR USE AND INSTALLATION …. 1.1. INTRODUCTION AND SAFETY 1.2 DESCRIPTION OF THE TEST 1.3. BRONCHOCONSTRICTION TEST CUSTOMIZATION 1.4. BRONCHOCONSTRICTION TEST PROCEDURE 2. TECHNICAL SPECIFICATIONS ………………………… COMPLIANT PRODUCT 93/42/EEC Medical Device Directive. Class II a Revised Approved...

  • Page 4: Instructions For Use And Installation

    DATOSPIR TOUCH spirometer. This manual is an addendum to the manual of the Spirometer DATOSPIR TOUCH, dedicated exclusively to the operation of this module, and it is designed for use alongside the general manual. We suggest consulting some bibliography on the usual procedure required to perform correctly bronchoconstriction tests.
  • Page 5 The DATOSPIR TOUCH spirometer has the possibility to perform the test according to two different methods: - Normal or continuous method: Consists of administering to the patient a certain concentration of an allergen for a specified time.

  • Page 6: Bronchoconstriction Test Customization

    Bronchoconstriction test user’s manual made. Then, subsequent Bronchoconstriction tests may be done, allowing the patient to rest between them. CONSTRIC. (BC2) Apply the patient the second drug-dose. CONSTRIC. (BC3) Apply the patient the third drug-dose. The process can be repeated until it is convenient. The system allows applying a maximum of 10 drug-doses (BC10).
  • Page 7 Bronchoconstriction test user’s manual  Select the method or operating mode Normal Short  Select whether to use dissolution or not  Set the time between Bronchoconstriction drug application and the start of the maneuvers.  Set the time between drug application and initiation of bronchodilator maneuvers.

  • Page 8: Bronchoconstriction Test Procedure

    Enter the patient’s data. The procedure is the same as the one described in the section 4.1.1 ENTERING PATIENT DATA of the DATOSPIR TOUCH general user’s manual. The Bronchoconstriction customization screen will appear. See section 1.3. BRONCHOCONSTRICTION TEST CUSTOMIZATION. Then, the following screen will appear: 511-BH0-MU2 •...
  • Page 9 Bronchoconstriction test user’s manual Goes back or exits the test screen Presents a summary with the data of the performed steps Deletes the selected maneuver Saves the best maneuver and goes to the next step (NORMAL mode) Saves the best maneuver and goes to the next step (SHORT mode) Presents the graphic dose/response graph of the performed steps...
  • Page 10 Bronchoconstriction test user’s manual Maneuvers are ordered best to worst according to ATS/ERS criteria, M1 being the best. Press the Parameters area and the data of all maneuvers performed will be displayed: The maneuvers are compared with predicted values of the patient. Once the adequate maneuvers are performed, press to save 511-BH0-MU2...
  • Page 11 Bronchoconstriction test user’s manual the best maneuver as BASAL and go to the next step. DILUENT (DIL) Apply the diluent with neutral PH to the patient, if you have selected this option. Start a new set of forced maneuvers, once the normalized time has passed.
  • Page 12 Bronchoconstriction test user’s manual Presents a summary with the data of the performed steps CONSTRIC. (BC1) Normal mode: 511-BH0-MU2 • REV. 1.03...
  • Page 13 Bronchoconstriction test user’s manual Short Mode: Modify the data if necessary and press . Apply the first dose of bronchoconstrictor drug and start another series of maneuvers again, when the timer reaches 00:00 and an audible alarm sounds. Press to save the best maneuver carried out, and goes to the next stage.
  • Page 14 Bronchoconstriction test user’s manual Presents the dose/response graph of the performed steps. Allows you to view or change the dose of drug. CONSTRIC. (BC2, BC3, ... BC10) Follow the same procedure as in the previous steps, for the subsequent drug-doses. 511-BH0-MU2 •...
  • Page 15 Bronchoconstriction test user’s manual When the value of FEV1 falls below the user-configure limit (x %) compared to the diluent or the basal, the system warns it and the PDx value will appear on the dose-response graph. The dose-response graph is presented mathematically adjusted through a process of logarithmic adjustment (y = C1 + C2 log (x)) if the coefficient of determination is better than (100-x) % and to calculate...
  • Page 16 Bronchoconstriction test user’s manual CONSTRICTION + DILATATION (BDx) If you wish provide to the patient a bronchodilator drug to reverse induced Bronchoconstriction, press save last Bronchoconstriction carried out and pass to the Bronchodilation stage. Enter bronchodilator drug’s data and press 511-BH0-MU2 •...
  • Page 17 Bronchoconstriction test user’s manual Apply the bronchodilator drug to the patient. After standardized time, perform a set of maneuvers. Save the best maneuver by pressing and, if necessary, repeat the process above. Press to view the dose/response graph of the Bronchodilation test: 511-BH0-MU2 •...
  • Page 18 Bronchoconstriction test user’s manual 1.4.1. TEST SUMMARY The summary of the Bronchoconstriction test is presented in a graphic way (graphic dose/response shown before) or numerically (summary of the data shown next). Press the key to access the summary of the data screen: Take into account that the observed values are compared according to: ...

  • Page 19: Technical Specifications

    Bronchoconstriction test user’s manual Presents the graphic dose/response Allows you to scroll through the data 1.4.2. PRINTING AND/OR DATABASE STORAGING Once a test has been saved on the Database, by pressing , it can be retrieved in the same manner as any spirometric test from the database menu , print it and /or transfer it to a computer.
  • Page 20 Bronchoconstriction test user’s manual  Environmental data of temperature, pressure and relative humidity  Continuous or shorter methods  Deviation Percentage between Basal and dissolution  Superposition of graphics in Flow/Volume or Volume/Time  Timer for control of the steps ...

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