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Summary of Contents for Circassia NIOX VERO
- Page 1 NIOX VERO Airway Inflammation Monitor ® User Manual 510(k) 133898 ® NIOX VERO User Manual Canada 001504-06 January 2021...
- Page 3 Avoid spilling water or other fluids on the instrument or Sensor. used. Special attention should be paid to aerosols and disinfection • Always use a closed case or bag (NIOX VERO ® bag recommended) baths, either open vessels or ultrasonic baths.
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Page 4: Table Of Contents
6.2 Installation of NIOX Panel ............ 20 6.3 Connect to a PC via USB............21 ® 1.1 Before using NIOX VERO Airway Inflammation Monitor ..3 6.4 Connect to a PC via Bluetooth..........21 1.2 About this manual..............3 6.5 Setup..................21 1.3 Compliance ................ - Page 5 11.16 Instructions for transport and storage......... 40 ® 12 NIOX VERO parts and accessories ........41 ® 12.1 Parts included in NIOX VERO package (Article No. 12-1260/12-1200/12-1100)........41 12.2 Accessories ................41 13 Mandatory problem reporting ..........42 14 Guidance and manufacturer's declaration - Electromagnetic immunity and electromagnetic emissions .......43...
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Page 6: Important Information
Chapter 1 Important information Important information ® The User Manual provides instructions on how to operate NIOX VERO . It contains numbered step-by-step instructions with screens and illustrations. Choices within steps are displayed with bullet points. Before using NIOX VERO ®... -
Page 7: Warnings
• Be careful when opening the Sensor can. The inside of the opening may mind that an accessory not recommended by Circassia may result in have sharp edges. ® loss of performance, damage to your NIOX VERO product, fire, electric •... -
Page 8: Intended Use
FeNO levels. NIOX VERO is suitable for children, 7- 17 years, and adults 18 years and older. NIOX VERO 10 second test mode is for age 7 and up NIOX VERO 6 second test mode is for ages 7- 10 only, who cannot successfully complete a 10 second test. -
Page 9: Instrument
H) ON/OFF button, (I) Power adapter port, (J) USB port (N) Breathing handle holder, (O) Breathing handle port (K) Battery LED - lit when battery is charging, (L) Standby LED - blinking in Standby/Sleep mode, (M) Touch panel Display 001504-06 NIOX VERO ® User Manual Canada... -
Page 10: Installation And Set Up
WARNING! Do not touch or clean the white Sensor membrane. The Sensor should only be stored in its original unopened CAUTION! ® package or installed in a NIOX VERO instrument. 4. Insert the Sensor and turn the swivel clockwise until locked. Open the Sensor can. - Page 11 Take the breathing handle tube and push the end of the tube into the breathing handle port slowly until the triangle is no longer visible. Note: Only use the correct rechargeable battery supplied by Circassia. The breathing handle and the patient filter are Applied parts Type B. (Type No BJ-G510039AA, Article No 12-1150) Note: Only attach the breathing handle supplied by Circassia.
- Page 12 AC cord plug. Note: Only use the power adapter supplied by Circassia with the instrument. Article No 12-1120. CAUTION! After inserting a new Sensor it is recommended to wait for three Position the instrument with the stand folded out.
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Page 13: User Interface
20. Select the OK button to confirm insertion of a new breathing handle. This sets the remaining measurements to 1000 and expiry date one year from the current date. The Return button returns to Settings view without registering change. 001504-06 NIOX VERO ® User Manual Canada... -
Page 14: Settings View
(E) Time and date settings - see page 17, (F) Measurement log - see (k) Humidity outside of specification, (l) Time page 17, (G) Ambient measurement - see page 16, (H) Breathing handle status and settings - see page 29, (I) Return to main view 001504-06 NIOX VERO ® User Manual Canada... -
Page 15: Using Niox Vero
® Chapter 5 Using NIOX VERO Using NIOX VERO ® Enter up to 12 characters (alpha or numeric). Select the ABC-button to activate a keyboard with the alphabet. The 123-button changes view back to the numerical keyboard. Start the instrument from power save mode Select OK button to confirm the registration. - Page 16 ® Chapter 5 Using NIOX VERO Note: Do not switch OFF the instrument during measurement procedure. 2. Close the lips around the mouthpiece on the patient filter so that no air leakage occurs. Give the breathing handle to the patient and guide the patient to provide a breath sample as described in the next section.
- Page 17 ® Chapter 5 Using NIOX VERO Exhale slowly through the filter while keeping the cloud within the limits Exhale until the cloud has passed the flag. as indicated on the display (the white lines). The instrument will analyze the sample and generate a result in approximately one minute.
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Page 18: Demonstration Mode
Perform 6s NO measurement 2. Select which animation to use (Cloud, Balloon or Meter) • The NIOX VERO can be operated with two different exhalation times. 10 seconds and 6 seconds. The 10 second test is the preferred mode for all ages. -
Page 19: Measure Ambient No
® Chapter 5 Using NIOX VERO Measure ambient NO Note: An ambient measurement may be requested by customer support Inhalation during troubleshooting. through the breathing Note: An ambient measurement is counted as one measurement on handle. NIOX VERO ® Sensor and the instrument. -
Page 20: Change Settings
® Chapter 5 Using NIOX VERO The progress bar is visible until the measurement is finished and the 3. The settings for sound and volume opens. result is displayed: Ambient measurement value (in ppb), measurement mode and measurement sequence number. - Page 21 Select the Instrument button. Alerts are stored in the instrument and can be viewed at any time. The alert codes are for Circassia Technical Support use. This opens the Instrument information view displaying the following: Select the Settings button on the main menu.
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Page 22: Turn Off The Instrument
Check the 10s/6s icon to enable using the 6s mode. and attach the handle cap. Uncheck to disable. ® Note: Always use a closed bag or case (NIOX VERO bag recommended) Press OK. for transportation and storage of the instrument. ®... -
Page 23: Using Niox Vero With Niox Panel
Circassia. installed, an installation wizard for each of the programs opens, one at • If the equipment is used in a manner not specified by Circassia, the the time. protection provided by the equipment may be impaired. Select to accept license agreement for the programs. -
Page 24: Connect To A Pc Via Usb
Note: If the instrument is in power saving mode no connection will be established. Setup ® An enabled USB connection is indicated on NIOX VERO by a symbol on the status bar. 1. Turn on the PC and monitor. Note: If the instrument is in power saving mode no connection will be 2. - Page 25 Circassia recommends completion of the details dialog box to allow receipt of technical data and provide better service and support functions to its cus- Plug the USB cable into the USB port on the NIOX VERO ® and connect it to the USB port on the PC. This icon is shown tomers.
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Page 26: Firmware Update
If the connection to Microsoft Azure is lost or the user has chosen to not send technical data, the cloud icon is crossed over To decide at a later stage to allow Circassia to collect data, press cancel and the dialog box will open again next time NIOX Panel is started, or click on the cloud icon in the status bar. -
Page 27: Troubleshooting
6.7.5 View alert logs Circassia representative or Circassia Technical Support. Alerts are stored in the instrument and can be viewed at any time. The alert codes are for Circassia Technical Support use. User alerts Screen Action Select the Settings button on the main menu. - Page 28 Make sure that the ambient PC the main view buttons will be temperature is between +10°C and locked. +35°C. Wait for the Sensor to stabilize. If necessary move the instrument to another location and restart the instrument. 001504-06 NIOX VERO ® User Manual Canada...
- Page 29 Condensation countdown The self test of the instrument failed. Too frequent use of the instrument. Restart the instrument. Remaining time until instrument has If alert code persists contact Circassia dried out. Technical support. ® 001504-06 NIOX VERO User Manual Canada...
- Page 30 Internal hardware error Sensor error unrecoverable Remove any sources of disturbance (such as cordless/mobile telephones or Contact Circassia Technical support. gas emitting appliances). When the instrument is ready for measurement try to repeat the measurement. If alert persists, power off the instrument,...
- Page 31 Replace the handle, see page 29. It is still possible to view measurements stored in the instrument memory. Instrument expiration date has passed It is still possible to view measurements stored in the instrument memory. ® 001504-06 NIOX VERO User Manual Canada...
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Page 32: Preventive Care
This includes sprays or damaged and that normal operating conditions are fulfilled (see page 34). wipes containing alcohol! If any item is missing or damaged, contact your local Circassia representative or Circassia Technical support. WARNING! DO NOT clean area immediately surrounding the ®... - Page 33 Select the OK button to confirm insertion of a new breathing handle and to set the remaining measurements to 1000 and expiration date one year from the current date. Note: The Return button returns to settings view without registering change. 001504-06 NIOX VERO ® User Manual Canada...
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Page 34: Operational Life-Time
Open the compartment on the back of the instrument using a screwdriver. Turn the swivel to release the Sensor. Note: Only rechargeable batteries supplied by Circassia may be used. (Type No BJ-G510039AA, Article No 12-1150) The battery is placed in the compart- ment on the back of the instrument. -
Page 35: Disposal Of Instrument And Accessories
Patient filter ® Circassia Pharmaceuticals Inc. The shelf life of the NIOX VERO Patient Filter in its unopened primary pack- age is three years from manufacturing date. NIOX VERO Patient Filter is for single use and must be replaced for every patient and measurement occasion. -
Page 36: Safety Information
When excessively used in a short period, there is a risk for • A PC connected to the USB connector has to be certified for one of the condensation of water inside NIOX VERO ® standards IEC 60601-1, IEC 60950 or comparable with safety extra low Normally a maximum of 10 exhalations/hour can be performed with NIOX voltage on the USB ports. -
Page 37: Electromagnetic Immunity
Ensure stable operating conditions by avoiding placement of the instrument quirements described in the parts of the IEC 61326 series for electrical in direct sunlight, near sources radiating heat, or ventilation. NIOX VERO ® equipment for measurement, control and laboratory use, and found to com-... - Page 38 Chapter 9 Safety information 9.6.2 Support Contact your local Circassia representative or Circassia Technical Support if you encounter problems which you cannot solve with the information in this manual. For contact details, see back cover, and provide the following information: •...
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Page 39: 10 Reference Information
Warning - temperature is not within operating conditions range Measurements mode 10 Demo Audio - mute Warning - humidity is not within operating conditions range Measurements mode 6s Settings Instrument connected via Time Patient ID 001504-06 NIOX VERO ® User Manual Canada... -
Page 40: Symbol Explanation
Applicable to the US: Prescription use only Responsible manufacturer The product meets the requirements of applicable European Manufacturing date directive Electrical safety Type B applied parts: Medical Device Breathing handle and patient filter 001504-06 NIOX VERO ® User Manual Canada... -
Page 41: 11 Technical Data
NIOX MINO FeNO value and the corresponding The instrument is verified to fulfill the specified performance under a tem- FeNO value measured with NIOX VERO ® instrument from Circassia. perature range of +10 to +35 °C, relative humidity range of 20-80% and pres- sure range of 700-1060 hPa. -
Page 42: Inhalation Parameters
11.14.1 R&TTE Directive Warning alerts sounds at 10 - 12 and 18-20 cm H Hereby, Circassia, declares that this NIOX VERO is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. 11.11... -
Page 43: Rechargeable Battery Capacity
11.15 Rechargeable battery capacity Changes or modifications not expressly approved by the party responsible Only use the power adapter or USB cable supplied by Circassia to charge for compliance could void the user’s authority to operate the equipment. the battery. -
Page 44: Niox Vero
CAUTION! When selecting an accessory for your NIOX VERO keep in mind Temperature Relative humidity Atmospheric that an accessory not recommended by Circassia may result in loss of perfor- (non condensing) pressure ® mance, damage to your NIOX VERO product, fire, electric shock, injury or damage to other property. -
Page 45: 13 Mandatory Problem Reporting
® NIOX VERO Test Kit Refill 500 (12-2850) Any user of Circassia’s products, who experience an incident related to the ® Contains: 1 Sensor* for 500 tests and 500 NIOX VERO Filters** product, must therefore immediately report this to Circassia Pharmaceuticals ®... -
Page 46: Guidance And Manufacturer's Declaration - Electromagnetic Immunity And Electromagnetic Emissions
® The NIOX VERO is intended for use in the electromagnetic environment specified below. ® The customer or the user of the NIOX VERO should assure that it is used in such an environment. Immunity test Compliance Electromagnetic environment - guidance... - Page 47 95% dip in typical commercial or hospital equipment should be used not closer to interruptions U_T) for 0,5 environment. any part of the NIOX VERO, including and voltage cycle cables, than the recommended ® If the user of the NIOX VERO...
- Page 48 ® the NIOX VERO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the NIOX VERO ® recommended below, according to the maximum output power of the communications equipment. 001504-06 NIOX VERO ®...
- Page 49 ® The NIOX VERO is intended for use in the electromagnetic environment specified below. ® The customer or the user of the NIOX VERO should assure that it is used in such an environment Emission test Compliance Electromagnetic environment - guidance ®...
- Page 52 Patents: Circassia’s NIOX products are protected by a number of patents in the US, Europe and a range of other countries. Circassia AB, an ISO 13485 certified company Circassia Pharmaceuticals Inc, 5151 McCrimmon Parkway, Morrisville, Suite 260, NC 27560, USA Phone: +1 (866) 275-6469, Fax: +1 (866) 329-6469, E-mail: service.us@circassia.com...
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