Related Manuals for NIOX VERO
Summary of Contents for NIOX VERO
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Page 1: User Manual
® NIOX VERO Nasal Measurement Mode User Manual ® NIOX VERO Nasal User Manual August 2017 002346-02 English... - Page 2 However, it is possible to perform 20 exhalations in one hour if the instrument is paused for a Refer to the NIOX VERO User Manual for complete review of all minimum of 30 minutes prior to the next session of exhalations.
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Page 3: Table Of Contents
Table of contents ® 6.3 Precision ................19 1 NIOX VERO Nasal measurement mode ........3 6.4 Accuracy ................19 1.1 Before using NIOX VERO ® ............3 6.5 Essential performance ............20 1.2 About this manual..............3 1.3 Compliance ................3 1.4 Responsible manufacturer and contacts ........ -
Page 5: Niox Vero Nasal Measurement Mode
NIOX Panel are CE-marked according to In Vitro Diagnostics Device Directive 98/79/EC. This is an amendment to the NIOX VERO User Manual. Carefully read the NIOX Patient filter is CE marked according to ® NIOX VERO User Manual and the NIOX VERO... -
Page 6: Intended Use
NIOX VERO is suitable for patients age 4 and above for • The breathing handle must not be used after expiration date. -
Page 7: Product Description
Nasal Nitric Oxide has been shown to be decreased in patients with Primary Ciliary Dyskinesia (PCD), and measurement of nNO can assist in the identifi- cation of cases of PCD according to ERS guidelines Measurement of nNO with the NIOX VERO Nasal Measurement Mode is non- ® (A) NIOX VERO... -
Page 8: Main View
® NIOX VERO . A basic preventive inspection is recommended before each use, refer to the NIOX VERO User Manual. Note: Measurements can be performed without NIOX Panel software, however, if done, there is no graph available. Only the value will show on the display screen. -
Page 9: Perform Nasal Measurement
Note: There are two phases of the nasal measurements. A measurement period where the instrument aspirates for 30 seconds, and an analysis period where the instrument analyses the sample for 30 seconds. 002346-02 NIOX VERO ® Nasal User Manual English... - Page 10 Nasal Olive should remain outside the nostril. will not produce a graphical result, it will only give the numerical result of nasal nitric oxide measurement on the NIOX VERO screen. CAUTION! Make sure to use the correct size olives, the seal between the olive and nostril must be airtight to ensure correct measurement result.
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Page 11: Expiration Against Resistance (Er-Nno)
(breathing handle), this generates a pressure that makes sure the velum is closed. The NIOX VERO Breathing Handle with a patient filter and the NIOX VERO restrictor is used as the restrictor in this breathing method. The breathing handle is NOT connected to the NIOX VERO when used in this manner. - Page 12 (B) Note: If measurement is started before patient is ready, there is an option to abort measurement, it is not recorded as a measurement on sensor or instrument. 002346-02 NIOX VERO ® Nasal User Manual English...
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Page 13: Tidal Breathing (Tb-Nno)
When finished restart the instrument. Analysis failure Ambient measurement failure. Click the OK button and obtain a new measurement. For additional alert codes, refer to the NIOX VERO User Manual. ® 002346-02 NIOX VERO Nasal User Manual English... -
Page 14: Nasal Measurements With Niox Panel
250 MB of video graphics RAM • 250 MB of available hard-disc space ® Plug the USB cable into the USB port on the NIOX VERO and connect it to the USB port on the PC or connect by Bluetooth. This icon is shown •... -
Page 15: Perform Nasal Measurements With Niox Panel
® Note: The buttons, symbols and views are similar on NIOX Panel and on the pdf file is chosen, an excel file is saved in the NIOX Nasal ® NIOX VERO Measurements folder on the computers Desktop. To enter patient ID, select patient id button. (A) Select Nasal button. - Page 16 (breathing handle), this generates a pressure that makes sure the velum is closed. The NIOX VERO Breathing Handle with a patient filter and the NIOX VERO restrictor is used as the restrictor in this breathing method. The breathing handle is NOT connected to the NIOX VERO when used in this manner.
- Page 17 ® Chapter 4 Nasal measurements with NIOX Panel Note: If the option “No” is selected the file won’t be saved. When selecting the OK button (B) an option to save the file will be shown. 7. A save dialog will be shown and an option to view the file.
- Page 18 Can change the adjustable calculation area • Output is displayed in ‘red’ text • Orange section of graph • nNO as calculated by NIOX VERO using clinically validated method (F) Patient Information (C) Adjustable Calculation Area • Patient ID •...
- Page 19 ® Chapter 4 Nasal measurements with NIOX Panel 4.3.2 Tidal Breathing (TB-nNO) TB-nNO measurements shall be performed while breathing normally through an open mouth. Before selecting the start measurement button make sure to instruct the patient to slowly inhale and exhale though the mouth.
- Page 20 (B) nNO calculation Range (F) Patient Information • Orange section of graph • Patient ID • nNO as calculated by VERO using clinically validated method • (C) Adjustable Calculation Area • Aspiration time (always 30sec) • Grey section of graph •...
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Page 21: Cleaning Procedure
Linearity • If the any part of the Nasal Kit appears clogged, replace the Nasal Kit • The NIOX Nasal Kit is for single patient use and do not need any Squared correlation coefficient r2 ≥ 0.998 cleaning. Precision < 3ppb of measured value for values < 30 ppb, < 10% of measured value for values ≥... - Page 22 ® Chapter 6 NIOX VERO Nasal Technical Specification For FeNO technical specification refer to the NIOX VERO User Manual. Essential performance Essential performance for NIOX VERO Nasal Measurement Mode consists The measurement of the NO concentration of air aspirated from the...
- Page 24 Patents: Circassia’s NIOX products are protected by a number of patents in the US, Europe and a range of other countries. Circassia AB, Hansellisgatan 13, SE-754 50 Uppsala, Sweden Phone: +46 8 629 07 80, Fax: +46 8 629 07 81, E-mail: nioxtechsupport@circassia.com...