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NIOX VERO® User Manual

1. S Remaining time until instrument has dried out Gio G2 Oo r A15 Condensation alert A28 Internal hardware error recoverable Reduce frequency of measurements Check that the Sensor battery and lid is in Coni his f its correct position also make sure that the ontinue measuring at this trequency tibe js hol cided causes condensation in the instrument When finished her iv and will make the instrument unusable EAO USNC EEC RAM E EE for 30 minutes lysis fail A22 Memory access failure a toute A Ambient measurement failure E Contact erocrine Customer support as lel COK nian An chicas new measurement G2 o V 000190 04 NIOX VERO User Manual US 31 Chapter 7 Troubleshooting Screen Instrument alerts A30 A31 A31 A40 A41 32 Instrument alerts Bluetooth connection error A50 Check the Bluetooth connection with the PC When finished click the OK button USB connection error A51 Check the USB connection with the PC When finished click the OK button No Sensor inserted Insert Sensor See page 36 replacement of A52 sensor or page 7 initial placement of sensor Sensor error hee Remove any sources of disturbance such as cordless mobile telephones or gas emitting appliances When the Instrument is ready for measurement try to repeat the measurement If alert persists power off the instrument remove and insert the Sensor and restart the instrument Scree
2. Ua The breathing handle status icon appears blinking in the status bar 22 Chapter 8 Preventive care 8 The breathing handle information view opens to confirm the replacement of the breathing handle 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 z Note The Return button returns to settings view without registering change 8 2 2 Exchange of NIOX VERO Sensor 1 Turn off the instrument 2 Open the compartment on the back of the instrument using a screwdriver Turn the swivel to release the Sensor 36 3 Remove the old Sensor 4 Replace with a new Sensor WARNING Make sure to not touch or clean the white Sensor membrane WARNING Be careful when opening the Sensor can The inside of the opening may have sharp edges 5 Turn the swivel to lock 6 Replace the compartment lid CAUTION Make sure there are no foreign material or particles in the Sensor compartment before closing it 000190 04 NIOX VERO User Manual US Chapter 8 Preventive care 8 2 3 Change battery If the rechargeable battery is no longer charging properly malfunctioning or requires charging more frequent than normal then it needs to be re placed Note Only rechargeable batteries supplied by Aerocrine may be used Type No BJ G510039AA Article No 12 1150 The battery is placed in the compart
3. who experience an adverse event related to the product must therefore immediately report this to Aerocrine Inc The report should contain the fol lowing e Description of the incident e When and where did the incident occur e What product accessory was involved serial number batch number e Was the incident related to instructions for use of the product e Was the risk foreseeable and clinically acceptable in view of potential patient benefit e Was the outcome adversely affected by a patient s pre existing condition e Has the event been reported to the FDA only applicable if the use of the device has or may have caused or contributed to injury or death 48 Chapter 14 Guidance and manufacturer s declaration Electromagnetic immunity and electromagnetic emissions The report should be forwarded by e mail fax or telephone to 14 Guidance and manufacturer s declara Aerocrine Inc 5151 McCrimmon Parkway Suite 260 Morrisville NC tion Electromagnetic immunity and 27560 USA electromagnetic emissions Phone 1 866 275 6469 Fax 1 877 329 6469 14 0 1 Electromagnetic immunity Guidance and manufacturer s declaration electromagnetic immunity 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 e mail service us aerocrine com Immunity test Compliance Electromagnetic env
4. 1 Select the Settings button on the main menu 0 2 Select Alert log button 4 amp 000190 04 NIOX VERO User Manual US Chapter 7 Troubleshooting he A A1003 10 16 2013 11 30 01 C A1003 10 17 2013 12 15 20 _ D A2005 10 17 2013 10 32 52 A2005 LO ME7 20tS 1032 22 A2006 10 17 2013 10 17 46 B __ E A Alert code for customer support purpose only B Return returns to previous view C Date and time of alert D Scroll list blue E Download service data only used upon request by Aerocrine 6 7 6 Perform QC measurement There are two options to perform a QC measurement when NIOX Panel is used e Either stand alone like in chapter 5 8 2 QC measurement or e If NIOX Panel is connected to the NIOX database it is possible to create the QC users and store the QC measurements in the database This allows a QC user after qualification to qualify a new instrument with just one QC measurement For instructions how to create QC users in the database see NIOX Patient User Manual 000190 04 NIOX VERO User Manual US 1 Troubleshooting 7 1 Alert codes and actions Alert messages and other information are shown as a code on the instru ment display The tables below provide the alert codes and recommended actions to be taken for an alert code If the alert persists contact your local Aerocrine representative or Aerocrine Customer Support Screen Action User alerts A10 Exhalation
5. 11 43 Exhaled NO performance data The instrument is verified to fulfill the specified performance under the temperature range within 50 to 95 F relative humidity range of 20 80 and pressure range of 700 1060 hPa Measurement range FeNO 5 to 300 ppb Lowest Detection Limit 5 ppb Determination by analyzing gas concentrations around and below the de tection limit 5 ppb was the lowest detectable level 11 5 Linearity Squared correlation coefficient r gt 0 998 slope 0 95 1 05 intercept 3 ppb 11 6 Precision lt 3ppb of measured value for values lt 30 ppb lt 10 of measured value for values gt 30 ppb Expressed as one standard deviation for replicate mea surements with the same instrument using a certified gas concentration of Nitric Oxide reference standard 11 7 Accuracy 5 ppb for measured values lt 50ppb or 10 of measured value for values gt 50 ppb Expressed as the upper 95 confidence limit based on absolute mean of differences from certified gas concentration of Nitric Oxide 11 8 Method comparison lt 10 ppb for values lt 50 ppb lt 20 for values gt 50 ppb Expressed as the difference between a NIOX MINO FeNO value and the corresponding FeNO value measured with NIOX VERO instrument from Aerocrine 11 9 Inhalation parameters Inhale to TLC Total Lung Capacity before start of exhalation Inhalation in instrument is triggered by a pressure of 3 cm H30 44 Chapter 11 Techn
6. Only use the power supply provided Pull the plug when disconnecting NIOX VERO from the power outlet Use only the breathing handle supplied by Aerocrine No modification of NIOX VERO instrument handle or Sensor is allowed Do not drop the instrument or subject it to strong impact Do not use a damaged NIOX VERO instrument or damaged components Keep the instrument and Sensor out of water Ensure that no liquid is spilled or dropped on the instrument or Sensor Do not heat or dispose of the instrument or Sensor in fire Refer to Disposal of instrument and accessories on page 37 NIOX VERO and the NO scrubber in the breathing handle contains potassium permanganate Used or expired instruments and breathing handles should be disposed of as hazardous waste in accordance with local waste disposal regulations The breathing handle must not be used after the expiration date Patient filters should be used immediately after opening NIOX VERO Sensor contains chemicals that could be harmful if swallowed Do not touch or clean the white Sensor membrane Do not clean the sensor Cleaning of the Sensor with ethanol or similar disinfectant might destabilize it for a non predicable time period After inserting a new Sensor it is recommended to wait for three hours with the instrument switched on before performing a measurement Use of substances containing alcohol close to the NIOX VERO instrument may cause erroneous measu
7. with NIOX Panel 7 Follow the instructions and install the program Note Last step of the installation Removing backup files takes a few minutes 8 When the installation is complete click Close 9 The application is now available on the start menu 6 3 Connect to a PC via USB In order for NIOX VERO to be able to communicate with a PC you may use a USB cable An alternative option is Bluetooth communication see how to enable Blue tooth in the next section Note Only USB cables supplied by Aerocrine may be used Article no 12 1002 1 Plug the USB cable into the instrument and connect it to a PC 2 An enabled USB connection is displayed on NIOX VERO with 5 a symbol on the status bar 000190 04 NIOX VERO User Manual US Note Ifthe instrument is in sleep or power saving mode no connection will be established 6 4 Connect to a PC via Bluetooth 6 4 1 Activate Bluetooth functionality 1 Select the Settings button on the main menu 2 Select the Measurement Mode button oy This opens the Configuration modes view 3 To enable Bluetooth check the checkbox 6 7 Unchecking the box disables Bluetooth communication Select OK to confirm change W This returns to the Settings view An enabled Bluetooth function is indicated by a symbol on the status bar provided that the instrument is not connected to a PC via cable Refer to the PC User Manual on how to enable Bluetooth on the
8. 3 Inhale deeply through the patient filter to total lung capacity During inhalation the cloud on the display moves upwards Note The procedure is activated by inhaling air from the handle or by pressing the start measurement button 5 3 2 Measurement 1 Empty the lungs by breathing out thoroughly 000190 04 NIOX VERO User Manual US 13 Chapter 5 Using NIOX VERO 4 Exhale slowly through the filter while keeping the cloud within the limits as indicated on the display the white lines 5 The instrument display and audio signals guide the user to the correct exhalation pressure A continuous sound indicates correct pressure with a frequency proportional to the pressure An intermittent high frequency sound too strong pressure An intermittent low frequency sound too weak pressure Exhalation with Pressure correct Pressure too weak Pressure too strong 14 6 Exhale until the cloud has passed the flag 7 The instrument will analyze the sample and generate a result in approximately one minute Note Do not exhale or inhale through the patient filter during the analysis process 000190 04 NIOX VERO User Manual US Chapter 5 Using NIOX VERO 8 The result is then displayed A Patient ID if applicable B FeNO value in ppb parts per billion C Measurement mode D Measurement sequence number E OK returns to main view A 751203 8933 B 35 C IN 2025 D IY E 5 4
9. Cloud pressure within limits Cloud goal reached ED Cloud warning pressure too high or too low 10 3 Symbol explanation Ni Responsible manufacturer oN N gt 2 5 FO REISS bi The product meets the requirements of applicable European directive Electrical safety Type B applied parts Breathing handle and patient filter The product should be recycled according to the local program for electronic equipment Consult instructions for use Expiration date Transport and storage temperature limitation For single use only In Vitro Diagnostic Device Transport and storage humidity limitation Transport and storage atmospheric pressure limitation Equipment protected throughout by DOUBLE INSULATION or REINFORCED INSULATION The Device includes a Radio Frequency RF transmitter Bluetooth NRTL listed Prescription use only 43 Chapter 11 Technical data 11 Technical data 11 1 Dimensions and weight Height 145 mm Width 185 mm Depth 41 mm Weight of instrument including Sensor 1kg 11 2 Electrical data Electrical safety The equipment complies with the classification i requirements according to IEC 60601 1 Class II ME EQUIPMENT while externally powered and as INTERNALLY POWERED ME EQUIPMENT while powered by battery Mains Voltage 100 240 V 47 63 Hz Secondary voltage 5V external power adapter Power consumption lt 15 VA 11 3 Noise level lt 65 dBA at a distance of 1 m
10. Demonstration mode To help professionals in guiding patients the instrument contains three ani mated demonstrations with visual and audio guides of the different stages of a measurement procedure 1 Select the Animation button on the main menu Li 2 Select which animation to use Cloud Balloon or Meter x DEM Y 3 Select the Demo button DEMO 4 Select the forward button to move to the following sequence Qi 000190 04 NIOX VERO User Manual US select The undo button closes the demonstration and returns the animation Select OK button Y_ to confirm the changes changes Inhalation through the breathing handle Exhalation through the breathing handle with correct pressure Exhalation through the breathing handle with pressure too weak The undo button returns to the main menu without saving N R B E i E eal r Em R O p N 2 A aoc amp O Chapter 5 Using NIOX VERO d Exhalation through the breathing handle with pressure too strong 5 5 Measure ambient NO Note An ambient measurement may be requested by customer support during troubleshooting Note An ambient measurement is counted as one measurement on NIOX VERO Sensor and the instrument 1 Attach a patient filter to the breathing handle until it clicks into place 2 Select the Settings button on the main menu gy 16 3 Select Ambient Measurement button 4 Select the
11. Do not disconnect the USB or power cable during firmware update 1 Connect the instrument via USB Make sure that the power cable is connected 27 Chapter 6 Using NIOX VERO with NIOX Panel 2 Press the update firmware button and wait for the update to be finished ZI NOK Pana Status Serial ID 031100714 MPU FW 1D19 0000 LCD FW 1D06 0000 Graphic 1003 0000 AC Connected USB Connected System Ready l 00 k 20 EC a Update FW IN PROGRESS 3 The instrument will automatically restart and reconnect to NIOX Panel when the update is finished 6 7 Using NIOX Panel Note The buttons symbols and views are similar on NIOX Panel and on NIOX VERO 6 7 1 Measure FeNO See Measure FeNO on page 12 CAUTION Do not disconnect the instrument from the PC during measurement and analyzing process Note Ifthe computer does not fulfill the system requirements it may still be possible to run NIOX Panel To start a measurement select the Win XP animation 28 It is recommended to press the start measurement button to initiate the measurement 6 7 2 Demonstration mode See Demonstration mode on page 15 6 7 3 Change settings See Change settings on page 16 6 7 4 View measurement logs See View measurement logs on page 17 6 7 5 View alert logs Alerts are stored in the instrument and can be viewed at any time The alert codes are for Aerocrine Customer Support use
12. Dy CAS an TN eee DD J o Jo o gnmnm_ 16 wed _am mm 16 Did HOU OAS MTSE EIN eaea nes pe newede ke eo deba b e rena kad A 18 5 8 External Quality Control QC procedure is i uscilsank lkaze 19 6 Using NIOX VERO with NIOX Panel 24 Za r sarees hen ener eee eee _ o og 24 6 2 Installation OF NIOX PANG s ca cumc sy c lkastan tiesias iernat 24 AEE NC TO a TES ey seven atenc n neee eee se ran e heca Sen ort eer 25 64 Connect toa PC via Bluetoot sssseseisiirsserestisirsrasotdssonin idese 25 n2r EEEE E TE A E T 25 P E E EE AASA oom 27 OF IO ae a artesian E E et 28 F TLOUDICSHOOUNE rrr eee e j 29 Tih Aler codes and GOL O TS essiccare k kaye obek nan d n 0 29 Preventive CAR Gp asec sete r AE 34 ARE L e saccsnns ox M Mx z yr _1 34 82 Change disposa Ol nenssas esee iiei tien E ea eoi an disor 35 C Apera ona EE E xoxo x x mm Ir 8 4 Disposal of instrument and accessories sceeeeeeeeeeeeeeeeeeeeeees 2z ava u vr J J JJJ xw 38 9 Salefy IMMOLMATION i 54 5554544545555554n 0i en 3o b e wede ed s n eban b n ek 38 DGD WV AAO rr bb E g ag Ya02m 38 OITA l bar n ae teen nettles ee eas eee eee 320 9 3 Substances disturbing FeNO measurement EEEEEEE 39 94 ECC oma g00 cC UA Y seess enine OE 40 9 5 Emission of electromagnetic energy sssssssssssssssssssrerrrrerese 41 DFO CTA CONOR S seirene E 41 10 Reference inf
13. Start measurement button 5 The progress bar is visible until the measurement is finished and the result is displayed Ambient measurement value in ppb measurement mode and measurement sequence number 5 6 Change settings 5 6 1 Change time and date 1 Select the Settings button on the main menu 2 Select the Time and Date button s Q For more details refer to page 9 5 6 2 Change sound volume 1 Select the Settings button on the main menu Q 2 Select the Sound button 000190 04 NIOX VERO User Manual US Chapter 5 Using NIOX VERO 3 The settings for sound and volume opens A 4 Select increase decrease to adjust volume Y The volume bar indicates the set volume 6 Select the OK button to save settings and return to the Settings view v The Undo button closes the view without saving changes 7 The status bar indicates mute status when the sound volume is af 7 set to zero 5 6 3 View measurement logs All measurement results are stored in the instrument and can be viewed at any time 0 1 Select the Settings button on the main menu 2 Select the Patient measurements log view button 000190 04 NIOX VERO User Manual US 3 The selected log will display the following A 91203 8933 2011 06 05 12 34 mM i CE oct E amp yw F A A Patient ID if defined B FeNO value C Measurement date and time D Measurement mode E Retu
14. Support Note The prompt to QC the device will remain if the QC measurement was performed by a non qualified QC candidate It is not an indication of an unsuccessful failed QC measurement 22 Note Ifthe daily Quality Control is not successfully performed or if the results from the QC are outside limits a warning alert will be displayed beside the measurement value 2025 15 lt QC3 lt 35 454 5 8 3 View QC logs 1 Select the Settings button on the main menu 2 Select the QC log button e The QC log window opens 15 lt QC3 lt 35 32 2011 06 05 12 34 PM 25 ll 3 Browse through the measurement logs using the backward and forward buttons 5 8 4 View QC information After day 3 the QC qualification procedure is complete A qualified tester is displayed in the QC tester view 000190 04 NIOX VERO User Manual US Chapter 5 Using NIOX VERO 1 Select the Settings button on the main menu 1 Select the Settings button on the main menu amp 2 Select QC tester button 45 2 Select QC Settings to which QC IDs are available dp vy The following window is displayed 3 The QC qualifying results are displayed as follows A B C D 4g SVEN JANSSON P 4 QC1 2012 06 05 x15 Di SVEN JANSSON RE E QC2 QC1 2012 06 05 x15 li F 2 QC2 Pe B r 4 v LA C BAR 3 Select the Delete button for the user ID to be reset ii A QC tester number B Last date to
15. for the ranges 4 F to 41 F and 95 F to 140 F e Atmospheric pressure range 700 to 1070 hPa 12 NIOX VERO parts and accessories CAUTION When selecting an accessory for your NIOX VERO product keep in mind that an accessory not recommended by Aerocrine may result in loss of performance damage to your NIOX VERO product fire electric shock injury or damage to other property The product warranty does not cover product failure or damage resulting from use with non approved ac cessories Aerocrine takes no responsibility for health and safety problems or other problems caused by the use of accessories not approved by Aero crine 12 1 Parts included in NIOX VERO package Article No 12 1200 NIOX VERO Instrument 12 1000 NIOX VERO Breathing Handle 12 1010 NIOX VERO Handle Cap 12 1009 NIOX VERO Power Adapter 12 1120 NIOX VERO Power Cord 12 1230 NIOX VERO USB Cable 12 1002 NIOX VERO Battery 12 1150 NIOX VERO Stand 12 1001 NIOX VERO User Manual EPM 000165 NIOX Panel USB Memory stick 12 1003 47 Chapter 13 Medical Device Reporting MDR 12 2 Accessories NIOX VERO Test Kit 100 12 1810 Contains 1 Sensor for 100 tests and 100 NIOX VERO Filters NIOX VERO Test Kit 300 12 1830 Contains 1 Sensor for 300 tests and 300 NIOX VERO Filters NIOX VERO Test Kit 500 12 1850 Contains 1 Sensor for 500 tests and 500 NIOX VERO Filters NIOX VERO Test Kit 1000 1
16. in healthy FeNO levels have been observed In schoolchildren Asian boys could have 6 14 ppb higher FeNO levels than Caucasians boys By contrast Asian girls have elevated FeNO levels to a lesser extent African American children seem to have slightly higher healthy FeNO levels than Caucasians 17ppb versus 12 ppb In African Americans adults slightly higher average healthy FeNO levels than Caucasians 20 ppb versus 17 18 ppb have been observed e Measurement results are to be used as an adjunct to establish clinical and laboratory assessments in asthma 9 4 Electromagnetic immunity NIOX VERO has been tested to comply with the emission and immunity requirements described in the parts of the IEC 61326 series for electrical equipment for measurement control and laboratory use and found to comply with IEC 60601 1 2 2007 General requirements for basic safety and essential performance Collateral standard Electromagnetic compati bility Requirements and tests For more information see Electromagnetic immunity on page 49 CAUTION The test limits are designed to provide protection against harmful interference in a typical medical installation However because of the increased use of radio frequency transmitting equipment and other sources of electrical noise emitters in the healthcare and home 000190 04 NIOX VERO User Manual US Chapter 9 Safety information environments such as base stations for radio cell
17. installation of Sensor and battery Remove the plastic film from the display 1 Carefully place the instrument with the display facing down on a flat and clean surface then unscrew and remove the compartment lid There is a taper on the side of the lid for better grip when opening WARNING Do not touch or clean the white Sensor membrane CAUTION The Sensor should only be stored in its original unopened package or installed in a NIOX VERO instrument 4 Insert the Sensor and turn the swivel clockwise until locked 2 Open the Sensor can 5 Open the battery package 000190 04 NIOX VERO User Manual US Chapter 3 Installation and set up Note Only use the correct rechargeable battery supplied by Aerocrine 7 Take the breathing handle tube and push the end of the tube into the Type No BJ G510039AA Article No 12 1150 breathing handle port slowly until the triangle is no longer visible The breathing handle and the patient filter are Applied parts Type B Note Only attach the breathing handle supplied by Aerocrine Article No 12 1010 Note Use care not to bend the handle tube 6 Insert the rechargeable battery and replace the lid Tighten the screw by using a screwdriver Note The triangle should not be visible when assembled correctly 8 000190 04 NIOX VERO User Manual US Chapter 3 Installation and set up 8 Attach the power adapter to the instrument and then to the power 10 Start the i
18. too strong e 7 Press Return and repeat the measurement with less exhalation force Exhalation too weak BA Press Return and repeat the measurement with greater exhalation force A11 Measurement failed No exhalation detected or the user failed O to exhale within 15 seconds from inhaling D AE Press Return button restart the measurement and exhale into the je _ instrument directly after inhalation A12 29 Chapter 7 Troubleshooting User alerts A13 3 je A21 jo Instrument Screen alerts AO1 A01 fin W IESE 30 Analysis interrupted Repeat the measurement and do not breathe through the handle during analysis Measurement failed Remove any sources of disturbance such as cordless phones mobile phones or gas emitting appliances Then press Return When the instrument is ready for use repeat the measurement If the alert persists unplug and reconnect the power supply unit to restart the instrument Action Unstable temperature Make sure that the ambient temperature is between 50 F and 95 F Wait for the Sensor to stabilize If necessary move the instrument to another location and restart the instrument Instrument alerts A02 Sensor stabilization Remove any sources of disturbances such as cordless phones mobile phones or gas emitting appliances Wait for the Sensor 4 amp to aA A03 Unstable system Remove any sources of disturbances such as cord
19. 2 1900 Contains 1 Sensor for 1000 tests and 1000 NIOX VERO Filters NIOX VERO Sensor Pre calibrated disposable Sensor for 100 300 500 or 1000 measure ments Operational life time Maximum 12 months when installed in NIOX VERO or expiration date as stated on the Sensor whichever comes first NIOX VERO Filter Disposable filter to be changed for every patient Bacterial viral filter according to Medical Device Directive Class I NIOX Apps 12 1004 13 Medical Device Reporting MDR Aerocrine as a medical device manufacturer must have a Medical Device Reporting system in place to report to the FDA any adverse events that have occurred with its medical products The purpose of the Medical De vice Reporting system is to ensure the health and safety of patients users and others using medical products by reducing the likelihood of the same type of adverse event being repeated This is achieved by immediate noti fication of experienced incidents to enable corrective and preventive ac tions Specific guidelines Medical Device Reporting system for user facilities are applicable for users of medical devices An MDR reportable event is an event about which a user facility becomes aware of information that rea sonable suggests that a device has or may have caused or contributed to a death or serious injury Manufacturers of medical devices are obliged to report adverse incidents to the FDA Any user of Aerocrine s products
20. 4 NIOX VERO Breathing handle The breathing handle contains a NO scrubber which can be used for 1000 measurements or one year whichever comes first When there is less than 10 of the number of the measurements left or less than 2 weeks of use remaining a message is shown on the display blinking breathing handle symbol in the status bar 8 4 Disposal of instrument and accessories WARNING NIOX VERO and the NO scrubber in the breathing handle contain potassium permanganate Used or expired instruments and handles should be disposed of as hazardous waste in accordance with local waste disposal regulations 37 Chapter 9 Safety information Used or expired Sensors should be recycled according to local recycling program for electronic equipment Used batteries should be recycled according to the local recycling pro gram for rechargeable batteries Note There is a LiMnO backup battery inside the instrument in addition to the replaceable and rechargeable battery Note There is a silver oxide battery and a LiMnO battery in the Sensor NIOX VERO is RoHS compliant 8 5 Return shipments For return shipments contact your local Aerocrine representative or Aerocrine Customer support 30 9 9 1 Safety information Warnings See Warnings on page 3 9 2 Cautions Mobile phones and cordless phones and gas emitting appliances might interfere with the instrument and could make it impossible to perform a
21. Electromagnetic im munity and electromagnetic EMISSIONS mmm 49 Chapter 1 Important information 1 Important information 1 1 Before using NIOX VERO Airway Inflammation Monitor NIOX VERO may only be operated as directed in this manual by trained healthcare professionals Trained status is achieved only after careful read ing of this manual Read the entire instructions for use and make certain that you fully understand the safety information Symbol Description WARNING Indicates a potentially hazardous situation that if not avoided can result in bodily harm or injury CAUTION Indicates a potentially hazardous situation that if not avoided can damage a product or system cause loss of data or harm to business Note Alerts the reader to important information on the proper use of the product user expectations error situations and actions related to these 1 2 About this manual NIOX VERO User Manual US 000190 EPM 000165 version 04 May 2015 for instruments with software version 1D1x xxxx X can be any number between 0 and 9 or a character For instructions on how to view the software version number installed in the instrument see page 18 Information in this document is subject to change Amendments will be made by Aerocrine AB as they occur 000190 04 NIOX VERO User Manual US The User Manual provides instructions on how to operate NIOX VERO It contains nu
22. NIOX VERO Airway Inflammation Monitor User Manual 510 k 133898 CE Aerocrine 000190 04 EPM 000165 NIOX VERO User Manual US Remember It is important to adhere to the following specified conditions e Ambient temperature 50 F to 95 F e Humidity 20 to 80 RH non condensing e Mobile phones cordless phones and gas emitting appliances might interfere with the instrument and should therefore be kept away from the instrument Interference could make it impossible to perform a measurement e Normally a maximum of 10 measurements can be performed during continuous use However it is possible to perform 20 measurements in one hour if the instrument is paused for a minimum of 30 minutes prior to the next session of measurements e Avoid spilling water or other fluids on the instrument or Sensor e Always use a closed case or bag NIOX VERO bag recommended for transportation and storage of NIOX VERO e It is recommended after inserting a new sensor to wait for three hours with the instrument switched on before performing a measurement e Operational life time NIOX VERO Instrument Minimum 5 years at time of delivery or 15 000 measurements e Operational life time NIOX VERO Sensor Maximum 12 months after opening package and installed in NIOX VERO or expiration date as stated on the Sensor whichever comes first CAUTION Do not use NIOX VERO in the proximity of areas where vol atile substances such a
23. NO Medications and exhaled NO The potential effect of drugs on NO cannot be excluded and so all current medication and time administered should be recorded Exhaled NO falls after treatment with inhaled or oral corticosteroids in subjects with asthma and after inhaled NO synthase inhibitors Leukotrine axis modifiers also reduces FeNO NO donor drugs and oral inhaled and intravenous L arginine increase FeNO and nasal FeNO Even if a certain medication does not effect NO production it might affect the apparent level of NO through other mechanisms such as changes in airway caliber Other factors The manipulation of physiologic parameters has been shown to affect FeNO Changing pulmonary blood flow has no effect in humans but hypoxia decreases exhaled NO and this may occur in subjects at high altitude particularly those prone to high altitude pulmonary oedema The application of positive and expiratory pressure has been shown to increase FeNO in animals but airway pressure in humans does not affect exhaled NO plateau levels according to most reports although one study suggests the opposite Many studies have examined the effect of exercise on FeNO During exercise according to one report FeNO falls whereas NO output increases and this effect may last up to 1 hour Others have reported that FeNO remains stable after exercise It would seem prudent to avoid strenuous exercise for 1 hour before the measurement e Ethnic differences
24. PC 6 4 2 Connect by Bluetooth in NIOX Panel 1 Select in the NIOX Panel window 2 A search view opens select to search for devices 3 Select the instrument and click OK Y Note Ifthe instrument is in power saving mode no connection will be established 6 5 Setup 1 Turn on the PC and monitor 25 Chapter 6 Using NIOX VERO with NIOX Panel Turn on the instrument Select the Start or the Windows button normally found in the left lower hand corner of your monitor Select NIOX Panel from the program list Plug the USB cable into the USB port on the NIOX VERO and conned it to the USB port on the PC or connect by kr C Bluetooth This icon is shown on the display to indicate that a connection is established and NIOX VERO is running remote controlled The NIOX Panel application opens and you can start to operate your NIOX VERO instrument via your PC Note When starting NIOX Panel for the first time the connectivity details 26 dialog opens m e gt QC 200 Gi 02 34 10 pm 4 8 ac amp 6 5 1 NIOX Panel connectivity module The connectivity module in NIOX Panel utilizes Microsoft s secure cloud service Microsoft Azure to automatically transmit technical data from the device via the internet to Aerocrine Technical data such as time stamp alert codes and number of remaining measurements on the device and sensor are received This information will ensure better service and suppo
25. VERO User Manual US To assure correct results when performing FeNO measurement with NIOX VERO the following cautions apply Respiratory maneuvers Because spirometric maneuvers have been shown to transiently reduce exhaled NO levels it is recommended that NO measurement be performed before spirometry The same stipulation applies to other taxing respiratory maneuvers unless these can be shown not to influence exhaled NO The FeNO maneuver itself and body pletysmography do not appear to affect plateau exhaled NO levels Age sex In adults there is no consistent relationship between exhaled NO level and age but it has been reported that in children FeNO increases with age In Adults there are conflicting reports regarding the effects of sex menstrual cycle and pregnancy so theses patient characteristics should be recorded at the time of measurement Airway caliber It has been demonstrated that FeNO levels may vary with the degree of airway obstruction or after bronchodilatation perhaps because of a mechanical effect on NO output Depending on setting it may be prudent to record the time of last bronchodilator administration and some measure of airway caliber such as FEV Food and beverages Patients should refrain from eating and drinking before NO analysis An increase in FeNO has been found after the ingestion of nitrate or nitrate containing foods such as lettuce with a maximum effect 2 hours after ingestion and drinki
26. _ ment on the back of the instrument 1 Turn off the instrument 2 Open the compartment lid see previous section 3 Remove the old battery and insert a new battery 4 Close the compartment lid CAUTION Used batteries should be recycled according to the local recycling program for rechargeable batteries 8 3 Operational life time 8 3 1 NIOX VERO instrument Minimum 5 years at time of delivery or 15 000 measurements whichever comes first The user is prompted for expiry parameters via the device display It is not possible to perform further measurements after expiry although stored measurement data can still be retrieved 000190 04 NIOX VERO User Manual US 8 3 2 NIOX VERO Sensor Maximum 12 months after opening package and installation in NIOX VERO or expiration date as stated on the Sensor whichever comes first The Sensor will expire after the pre programmed number of measurements have been depleted or after one year whichever comes first When there is less than 10 of the number of the measurements left or less than 2 weeks of use remaining a message is shown on the display The expiry date is also shown on the Sensor label 8 3 3 NIOX VERO Patient filter The shelf life of the NIOX VERO Patient Filter in its unopened primary pack age is 2 years from manufacturing date NIOX VERO Patient Filter is for single use and must be replaced for every patient and measurement occasion 8 3
27. a or numeric Select the ABC button to activate a keyboard with the alphabet The 123 button changes view back to the numerical keyboard 4 Select OK button to confirm the registration AY Use the Erase button to erase amp Use the Undo button to undo a registration 5 3 Measure FeNO Verify proper preparations before performing a measurement with NIOX VERO A basic preventive inspection is recommended before each use see page 35 WARNING The patient filter is for single use only 5 3 1 Preparation for measurement 1 Lift the breathing handle from the holder and remove the handle cap 2 Obtain a new patient filter Attach the patient filter to the breathing handle Make sure to twist the patient filter in place until it clicks Note Do NOT use sharp objects to open the packaging for the patient filter Do not touch the filter membrane Note Patient filters should be used immediately after opening Note There is a risk of leakage if the filter is not correctly attached E to the breathing handle and this may result in incorrect measurement values 000190 04 NIOX VERO User Manual US 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 3 Give the breathing handle to the patient and guide the patient to provide a breath sample as described in the next section
28. akes no responsibility for health and safety problems or other problems caused by the use of accessories not approved by Aerocrine If the equipment is used in a manner not specified by Aerocrine the protection provided by the equipment may be impaired Modification of NIOX Panel application is not allowed Do not use damaged components 6 2 Note Installation of NIOX Panel NIOX Panel System requirements e Windows XP 32 bit Windows Vista 32 bit Windows 7 or Windows 8 8 1 Pro RT versions excluded e NET Framework 4 0 e 1 GHz or faster processor e 256 MB RAM 512 MB RAM recommended e 250 MB of video graphics RAM e 250 MB of available hard disc space e 1024x768 screen resolution e Generic Microsoft Bluetooth driver Service Pack 3 Needed for Bluetooth communication If the computer does not fulfill the system requirements see note on page 28 The NIOX Panel software is supplied on a USB storage device Te 2 3 Insert the USB storage device in the computer s USB port Select the file named setup exe If INET Framework VC 2010 XNA or SQL Server Compact is not installed an installation wizard for each of the programs opens one at the time Select to accept license agreement for the program Follow the instructions and wait for the programs to install The Installation wizard for NIOX Panel opens 000190 04 NIOX VERO User Manual US Chapter 6 Using NIOX VERO
29. e see page 35 It is still possible to view measurements stored in the instrument memory 8 Preventive care 8 1 General care In the following sections actions for preventive care and maintenance are described Do NOT try to repair the instrument Any attempt will make the warranty invalid and performance according to the specifications cannot be guaranteed 1 Clean the instrument with a cloth dampened with soap solution If needed use a dampened cloth with 70 ethanol isopropanol or similar disinfectant CAUTION Minimize use of solvents 2 Clean the breathing handle with a cloth dampened with water alcohol or soap solution Note The breathing handle and patient filter are not intended for sterilization WARNING e The breathing handle and the instrument can not be cleaned with an aerosol e Be careful when using disinfectants as excess of alcohol ethanol might permanently damage the Sensor Do not use spray detergents e Exchange the patient filter for each new patient e Never attempt to open the instrument other than the Sensor and battery compartment or to perform service to the instrument or the Sensor e Do not modify the handle tube 000190 04 NIOX VERO User Manual US Chapter 8 Preventive care 8 1 1 Preventive inspections Before each measurement verify that the NIOX VERO working properly is not damaged and that normal operating conditions are fulfilled see page 41 If any item is mis
30. emissions Ca supply network that supplies IEC 61000 3 2 uildings used for domestic purposes Voltage Complies fluctuations flicker emissions IEC 61000 3 3 52 Information in this document is subject to change Amendments will be made available by Aerocrine AB as they occur Copyright 2015 Aerocrine AB Solna Sweden Based on the company s intellectual property Aerocrine develops and commercializes products for the monitoring of nitric oxide NO as a marker of inflammation to improve the management and care of patients with inflammatory disease in the airways Patents For information about patents relating to Aerocrine products see www aerocrine com Aerocrine An ISO 13485 certified company Aerocrine Inc 5151 McCrimmon Parkway Morrisville Suite 260 NC 27560 USA Phone 1 866 275 6469 Fax 1 866 329 6469 E mail service us aerocrine com www aerocrine com Copyright 2015 Aerocrine AB Solna Sweden Aerocrine NIOX and NIOX VERO are registered trademarks of Aerocrine AB
31. enerated from ambient air NIOX VERO will allow for one daily QC measurement that will not affect the number of remaining tests on the NIOX VERO Sensor During the first 20 days of instrument start up a maximum of seven QC testers can be qual ified without impact to the number of remaining tests on the Sensor Note Itis also possible to store the QC users in a database see chapter 6 7 6 Perform QC measurement for information 000190 04 NIOX VERO User Manual US 5 8 1 Selection and qualification of QC testers A minimum of one individual two individuals are recommended needs to qualify for this procedure If possible identify one or two individuals as a back up Identify the staff members who will perform the Quality Control and meet the following criteria e Over 18 years of age e No ongoing cold or known airway disease e Non smoker e Expected stable FeNO values between 5 and 40 ppb e Preferably no allergies except seasonal see below or asthma A QC tester will be qualified over the course of four days within a seven day period Note After a QC tester has been qualified if the most recent QC measurement is older than 30 days then the qualification is suspended and the QC tester needs to re qualify according to the qualification procedure Perform four QC measurements one per day within seven days according to the QC measurement section in order to qualify a QC tester A mean value is calcula
32. iators stoves or open fire in order to avoid unstable conditions e When transporting the unit from one location to another a prolonged stabilization period before measurement might be required Refer to the recommended transportation conditions in the Transport and Storage section on page page 46 Always use a bag for transportation e Make sure that the gas outlet four parallel slots to the left of the lid on the rear side of the device is not covered e The device contains a Lithium ion Battery which may induce an increased risk of heat smoke or fire if handled incorrectly do not open crush heat above 140 F or incinerate e Keep the Sensor out of reach of children e Any person who connects external equipment to signal input and signal output ports of this device has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements of IEC 60601 1 e APC connected to the USB connector has to be certified for one of the standards IEC 60601 1 IEC 61010 1 IEC 60950 or comparable with safety extra low voltage on the USB ports e The connected PC should be placed out of reach from the patient Do not simultaneously touch the connected PC and the patient 9 3 Substances disturbing FeNO measurement Known patient factors that could interfere with FENO measurements are de scribed in the ATS Guidelines Am j Respir Crit Care Med 2005 171 912 930 as follows 000190 04 NIOX
33. ical data 11 10 Exhalation parameters Exhalation time Standard mode 10 s clinical use All exhalations are to be performed at an exhalation pressure of 10 20 cm H O to maintain a fixed flow rate of 50 5 ml s The instrument stops the measurement at pressures outside the interval Warning alerts sounds at 10 12 and 18 20 cm H O 11 11 Memory capacity Up to 15 000 measurements depending on the size of the measurement files 11 12 Patient filter Disposable filter to be changed for each new measurement session and for each patient Bacterial viral filter CE marked according to Medical Device Directive Class 1 11 13 Bluetooth NIOX VERO has a Bluetooth class 2 receiver transmitter with e Frequency band of 2402MHz 2480 MHz e Modulation method e 0 5BT Gaussian Filter 2 FSK modulation index 0 28 0 35 Basic Rate 1Mbps 7 4 DQPSK EDR 2Mbps e 8DPSK EDR 3Mbps e ERP e Power class 2 11 13 1 R amp TTE Directive Hereby Aerocrine AB declares that this NIOX VERO is in compliance with the essential requirements and other relevant provisions of Directive 1999 5 EC 11 13 2 IC This Class B digital apparatus complies with Canadian ICES 003 Cet appareil num rique de la classe B est conforme la norme NMB 003 du Canada This device complies with Industry Canada license exempt RSS stan dard s Operation is subject to the following two conditions 1 this de vice may not cause interference and 2
34. iew without Pa Edit saving changes 6 Enable Bluetooth lt Return a Set configuration gt i Skip ae Reset handle 10 2 Symbols and descriptions ea Erase button 12 Time date active for resetting 10 2 1 Status bar Y Decrease step downwards gt Start measurement Mii Battery fully charged CS Breathing handle about to expire A Increase step upwards gt Start ambient measurement or has expired blinking Check box not active Demo Battery lt 87 charge Instrument about to expire or has DEMO Ul expired blinking v CECR GOR ie Ci Battery lt 62 charge H 100 Sensor status followed by number of measurements eo Radio button off QC not remaining performed O Radio button onOC r TI Battery lt 37 charge ANY Sensor status no Sensor W Z Battery lt 12 charge g Warning temperature is not within operating conditions range 10 1 2 Main menu buttons Bi gt x Audio mute Q Warning humidity is not within operating conditions range D z Setti m Q R k Instrument connected via 02 34pm lime Ji Patient ID c QC USB 42 Chapter 10 Reference information Instrument connected via Bluetooth Connected to Microsoft 2 Not connected to Microsoft Azure Azure Only shown in Only shown in NIOX Panel status NIOX Panel status bar bar 10 2 2 Display Analysis progress bar ee Volume bar A OY Screen code correct x Screen code incorrect a Result screen Ambient measurement General warning
35. ined when measuring continuously at a rate of up to 10 measurements hour Measurement cycle groups of 20 measurements hour with sustained performance for one hour with a minimum of 30 minutes in between each measurement cycle group of 20 measurements hour 9 6 1 Limited warranty Aerocrine provides a Limited Warranty for this instrument and original ac cessories delivered with the instrument Conditions are defined when the items are purchased Do NOT try to repair the instrument Any attempt will make the warranty invalid and performance according to the specifications cannot be guaran teed 9 6 2 Support Contact your local Aerocrine representative or Aerocrine Customer Sup port if you encounter problems which you cannot solve with the informa tion in this manual For contact details see back cover and provide the following information e Your name address and telephone number e Serial number for both the instrument handle and Sensor e Problem description as thorough as possible e Alert codes or lists 41 Chapter 10 Reference information 10 Reference information 10 1 3 Settings view buttons SE Configuration Patient measurements 10 1 Buttons and descriptions Volume e Ambient measurements Alert logs Breathing handle status 10 1 1 Control buttons L U inf p OK accen changeiert ii Delete m nstrument status 4 QC tester information result Time and date QC measurements Undo closes v
36. ironment guidance Electrostatic 6 kV Floors should be wood concrete or discharge contact ceramic tile ESD 8 kV air If floors are covered with synthetic IEC 61000 4 2 material the relative humidity should at least 30 Electrical fast 2 kV for Mains power quality should be that of a transient burst power typical commercial or hospital IEC 61000 4 4 supply lines environment 1 kV for input output lines Surge 1 kV Mains power quality should be that of a IEC 61000 4 5 line s to typical commercial or hospital line s environment 49 Chapter 14 Guidance and manufacturer s declaration Electromagnetic immunity and electromagnetic emissions Voltage dips short Interruptions and voltage variations on power supply Input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Note lt 5V6 L gt 95 dip in U_T for 0 5 cycle 40 U_T 60 dip in U_T for 5 cycles 70 U_T 30 dip in U_T for 25 cycles lt 5 U_T gt 95 dip in U_T for 5 s Mains power quality should be that of a typical commercial or hospital environment If the user of the NIOX VERO requires continued operation during power mains interruptions it is recommended that the NIOX VERO be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical com
37. less phones mobile phones or gas emitting appliances Wait for the system 20 to abi A03 Count down time The remaining time until the instrument is ready to use is displayed A04 Q LEN A05 A05 Lock MMI L When the instrument is connected to a PC the main view buttons will be locked A06 Configuration code error Qx Only provided by Aerocrine upon request The configuration code entered is e incorrect Enter correct configuration code If this error continues to be shown contact Aerocrine Customer support 000190 04 NIOX VERO User Manual US Chapter 7 Troubleshooting Instrument Screen Instrument alerts alerts A07 Lid open warning A25 Temperature or base line failed to Check if the battery or sensor lid is open stabilize within 30 minutes and close if needed Click the OK Check that the ambient temperature and button when finished relative humidity is within specification If necessary move the instrument to another location and restart the instrument A08 Battery problem A26 Self test failure x Low power in battery or other failure A26 The self test of the instrument failed Change the battery and click the OK Restart the instrument l button when finished If alert code persists contact Aerocrine Zv m 2 amp Customer support A09 Condensation countdown A27 Internal hardware error unrecoverable Too frequent use of the instrument Contact Aerocrine Customer support
38. mbered step by step instructions with screens and illustrations Choices within steps are displayed with bullet points For clinical and performance characteristics refer to the NIOX VERO Labeling Summary Package Insert 000249 EPS 000069 1 3 Compliance NIOX VERO is CE marked according to In Vitro Diagnostics Device Direc tive 98 79 EC NIOX VERO is RoHS compliant 1 4 Responsible manufacturer and contacts Mailing address Aerocrine AB P O Box 1024 SE 171 21 Solna Sweden Visiting address Rasundavagen 18 SE 169 67 Solna www aerocrine com WWW nIOx Com 1 5 Warnings e NIOX VERO should only be operated by healthcare professionals e Operate NIOX VERO as stated in this manual Aerocrine accepts no responsibility for damaged equipment or faulty results if the equipment is not handled according to this manual e When selecting an accessory for your NIOX VERO product keep in mind that an accessory not recommended by Aerocrine may result in Chapter 1 Important information loss of performance damage to your NIOX VERO product fire electric shock injury or damage to other property The product warranty does not cover product failure or damage resulting from use with non approved accessories Aerocrine takes no responsibility for health and safety problems or other problems caused by the use of accessories not approved by Aerocrine NIOX VERO should not be used adjacent to or stacked with other equipment
39. measurement Elevated ambient Nitrogen Dioxide NO3 may interfere with FeNO measurement therefore ensure that the patient inhales correctly according to instruction solely through the filter The instrument might produce some heat during normal operation the temperature could increase up to 9 F above the ambient temperature Make sure that the ventilation slots are not blocked Do not place the instrument on a bed sofa carpet or other soft surface Normally a maximum of 10 measurements hour can be performed during continuous use It is possible to perform up to 20 measurements in one hour if the instrument is paused for a minimum of 30 minutes prior to the next session of measurements The system is not designed for continuous use due to the risk of water condensation Typically 30 60 measurements can be made during the course of a working day depending on the surrounding temperature An alert will be issued if there is a high risk of condensation due to high use frequency The Sensor shall be kept in its original unopened package before installation For transportation and storage conditions refer to page 47 The Sensor is sensitive to changes in ambient temperature and 000190 04 NIOX VERO User Manual US Chapter 9 Safety information humidity The best performance is achieved if the ambient conditions are stable Refer to the recommended environmental conditions see page 41 Keep the unit away from windows direct sun rad
40. mercial or hospital environment U is the a c mains voltage prior to application of the test level Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHZ Portable and mobile RF communications equipment should be used not closer to any part of the NIOX VERO including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 5 3 X root P d 3 5 3 Xroot P at80 MHz to 800 MHz d 7 0 3 X root P to 2 5 GHz at 800 MHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol C 50 Chapter 14 Guidance and manufacturer s declaration Electromagnetic immunity and electromagnetic emissions Note At 80 MHz and 800 MHz the higher frequency range applies Rated Separation distance according to frequency of maximum transmitter Note These guidelines may not apply in all situation Electromagnetic output power propagation is affected by absorption a
41. n A51 A52 Measurement failure The measurement value does not fall between 5 50 ppb Restart the QC tester qualification from day one Too many QC attempts In one day the same test person has attempted to perform several QC measurements Wait one day and perform the next QC measurement QC measurement failure Moving mean value out of range Restart the QC tester qualification from qualification day one NO scrubber result out of range NO scrubber result over 10 a Check that the handle cap was attached when instructed Restart the QC measurement If continuously shown replace the NO scrubber 000190 04 NIOX VERO User Manual US Chapter 7 Troubleshooting Instrument Screen Instrument alerts alerts A54 ADD A56 A57 QC daily result too low QC daily result lower than limits from moving mean QC daily result too high QC qaily result higher than limits from moving mean Handle cap time out Failure to press the forward button in time within 2 5 min Repeat the QC measurement and make sure to press the forward button immediately after the Handle Cap is attached NO scrubber analysis error NO scrubber analysis phase error Restart the QC measurement 000190 04 NIOX VERO User Manual US A80 A81 A82 A90 A91 12 Y 2011 06 05 iv X 2011 06 05 if T X 2011 06 05 y The instrument is about to expire Order a new instrumen
42. nd reflection from of transmitter pices awda 150 KHz to 80 80 MHz to 800 800 MHz to 2 5 MHz MHz GHz Field strengths from fixed transmitters such as base stations for radio d 3 5 3 0 x JP d 3 5 3 0 x JP d 3 5 3 0 x JP cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast can not be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitter an electromagnetic site survey should be considered If the measured field strength in the location in which the NIOX VERO is used exceeds the applicable RF compliance level above the NIOX VERO should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or For transmitters rated at a maximum output power not listed above the relocating the NIOX VERO recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where Over the frequency range 150 kHz to 80 MHz field strengths should up ig the maximum output power rating of the transmitter in watts W less than 3 0 V m according to the transmitter manufacturer Note At 80 MHz to 800 MHz the separation distance for the higher frequency range applies Recommended separation distances between portable and mobile RF Note These guidelines may not apply in all situation
43. ng of water and ingestion of caffeine may lead to transiently altered FeNO levels It is possible that a mouthwash may reduce the effect of nitrate containing foods Until more is known it is prudent when possible to refrain from eating and drinking for 1 hour before exhaled NO measurements and to question patients about recent food intake Alcohol ingestions reduces FeNO in patients with asthma and in healthy subjects Circadian rhythm Although FeNO levels are higher in nocturnal 29 Chapter 9 Safety information 40 asthma there was no circadian rhythm in two studies but another study did report a circadian pattern so it is uncertain whether measurements need to be standardized for time of day It is however prudent where possible to perform serial NO measurements in the same period of the day and to always record the time Smoking Chronically reduced levels of FeNO have been demonstrated in cigarette smokers in addition to acute effects immediately after cigarette smoking Despite the depressant effect of smoking smokers with asthma still have raised FeNO Subjects should not smoke in the hour before measurements and short and long term active and passive smoking history should be recorded Infection Upper and lower respiratory tract viral infections may lead to increased levels of exhaled NO in asthma Therefore FeNO measurements should be recorded in the chart HIV infections are associated with reduction in exhaled
44. nstrument by sliding the ON OFF button to ON and allow the outlet When installing the unit either use a socket outlet with a readily instrument to start up and perform the internal check accessible power switch or connect the AC cord plug to an easily accessible socket outlet near the equipment If a fault should occur during operation of the unit use the power switch to cut the power supply or remove the AC cord plug Note Only use the power adapter supplied by Aerocrine with the instrument Article No 12 1120 ON wr CAUTION After inserting a new Sensor it is recommended to wait for three hours with the instrument switched on before performing a 9 Position the instrument with the stand folded out measurement 11 When the internal check is completed the main menu appears m H 100 13 34 gt Ag gt m 2 O 12 Select the Settings button on the main menu Q 13 Select Time and date s 000190 04 NIOX VERO User Manual US 9 Chapter 4 User interface This opens the Time and date setting view 12 12 2010 12 12 12h AO v a G iv 14 Select between 12h US and 24h ISO time and date format 12h 24h O 15 Set time by pressing the button for hour It changes color to blue Change the value to the 12 via current hour by pressing the increase or decrease buttons Repeat this procedure for minute year month and day 16 Select OK V zZ to accept the changes and ret
45. nstrument serial number C Software version number D Instrument expiration date E Return to settings F Numbers of remaining measurements on the Sensor G Sensor serial number H Sensor expiration date I Enter configuration code only used on request from Aerocrine 5 7 Turn off the instrument 1 To turn off the instrument slide the ON OFF button to OFF _ 000190 04 NIOX VERO User Manual US Chapter 5 Using NIOX VERO Note Before transportation remove the used patient filter if still attached and attach the handle cap Note Always use a closed bag or case NIOX VERO bag recommended for transportation and storage of the instrument 5 8 External Quality Control QC procedure The external Quality Control is one of the procedures that ensures the sys tem is operating within the specifications Note The Quality Control function must always be activated as a daily QC measurement is mandatory when the instrument is clinically used A QC icon in the status bar on the screen indicates that a daily exter qc nal QC assessment is needed or that there are not any currently qual ified QC individuals who have completed their initial 4 qualification attempts The external Quality Control consists of two parts One positive control from a qualified staff member with a stable FeNO value providing a normal biological FeNO sample and a negative control consisting of a NO free gas sample automatically g
46. nt generates uses and can radiate radio frequency energy and if not installed and used in accor dance with the instructions may cause harmful interference to radio com munications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful in terference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help Contains FCC ID SQK MBH7BTZXXC2 11 14 Rechargeable battery capacity Only use the power adapter or USB cable supplied by Aerocrine to charge the battery Capacity Approx 30 measurements per day or 36 hours stand by in 77 F environment condition Lifetime At least one year with normal use Charging time lt 8 hours under normal conditions Lowered capacity and or when 8 hours of charging time does not charge the battery fully indicates that the battery should be replaced Battery Type No BJ G510039AA Article No 12 1150 Note To charge the battery by USB cable the instrument needs to be powered off 11 15 Instructions for transpo
47. ormation s sssesssssssssssassssssossssosssssssssssssssssssstsosses 42 10 1 Buttons ANC descriptioNs ccccccrssssssesssseseseenssncceecesecsseccccaananens 42 FOZ Symbol and desci D Ol lS issiran Errn renea a b a 42 10 3 Syml explana ON eseis e E Eeee 43 Table of contents TI Technical dala si enm x5405a0r o k sey n ekl n rne E n Al WAR b Rek RAA WEN 44 PIS Dimensions ana WO B cii s l kya neb kew nda oke a E ke NN Wen ben D rs bt EE A N A l102 DER e e E E E E E E lt i 11 4 Exhaled NO performance data uE EEE 44 nr E E E E en 44 DT EE E A AN A zer a92 uu 44 F A e E E ER 44 11 68 Method COMPAS ON xy si 2yc sik ntayelney niin sines ienen ee ienis 19 WA AO AU AG r r E E E lt 11 10 Exhalatlon D ra IT OLE si yancsnnee yee kadina ny sinara 45 aga rz etsy ce hea ete de 45 EA d o i O OAE A tie 45 e DH E A N E aetna nee 45 11 14 Rechargeable battery capacity LC EEE 46 11 15 Instructions for transport and storage EU E E C LW EEE 46 12 NIOX VERO parts and accessories sssccccccecesssssssssseeees 47 12 1 Parts included in NIOX VERO package Article No 12 1200 eesrcesrreni edar ETE TEE n a y suk b n 47 PZ FCCC SS sarra a oc ote ante neta E ae elkena ke nele ad se y ena va 48 13 Medical Device Reporting MDR ssccccssssssssssseecesssesees 48 14 Guidance and manufacturer s declaration
48. perform a QC measurement without having to re qualify the QC tester C Status buttons green within speci 4 Select W to accept deletion of the selected user ID fications white not within specifications D Mean value in ppb E Edit button F Delete button Note To add or edit a name to a QC tester number press the Edit button X 4 Select the Return button to return to settings IJ 5 8 5 Reset QC tester v This instruction will delete the data for the selected individual 000190 04 NIOX VERO User Manual US Chapter 6 Using NIOX VERO with NIOX Panel 6 Using NIOX VERO with NIOX Panel Your NIOX VERO instrument can be used together with NIOX Panel NIOX Panel is a PC application and visual aid allowing you to operate the instrument from your PC 6 1 24 Warnings NIOX Panel shall professionals only be operated by trained healthcare Operate NIOX Panel as stated in this manual Aerocrine accepts no responsibility for damaged equipment or faulty results if the equipment is not handled according to this manual When selecting an accessory for your NIOX Panel product keep in mind that an accessory not recommended by Aerocrine AB may result in loss of performance damage to your NIOX Panel product fire electric shock injury or damage to other property The product warranty does not cover product failure or damage resulting from use with non approved accessories Aerocrine t
49. rement results Do not reuse the patient filters Do not use NIOX VERO in the proximity of areas where volatile substances such as organic fluids or disinfectants are being used Special attention should be paid to aerosols and disinfection baths either open vessels or ultrasonic baths Do not use the instrument in the presence of flammable anesthetic vapors or liquids 000190 04 NIOX VERO User Manual US Chapter 2 Product description 1 6 Indications for use NIOX VERO measures Nitric Oxide NO in human breath Nitric Oxide is frequently increased in some inflammatory processes such as asthma The fractional NO concentration in expired breath FeNO can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society Measurement of FeNO by NIOX VERO is a quantitative non invasive sim ple and safe method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti inflammatory pharmacological therapy as an indication of the therapeutic effect in pa tients with elevated FeNO levels NIOX VERO is suitable for children ap proximately 7 17 years and adults 18 years and older FeNO measurements provide the physician with means of evaluating an asthma patient s response to anti inflammatory therapy as an adjunct to the established clinical and laboratory assessments in asthma The NIOX VERO is intended for prescription use and
50. rn to settings F Backward G Forward H Measurement sequence number I QC Warning only shown if the daily QC measurement is not performed or if the results from the QC are outside limits 4 Browse through the measurement logs using the backward and forward buttons E TA 5 Select the Return button to return to settings 7 5 6 4 View alert logs Alerts are stored in the instrument and can be viewed at any time The alert codes are for Aerocrine Customer Support use 1 Select the Settings button on the main menu 0 2 Select Alert log button 4 Chapter 5 Using NIOX VERO C a A A1232 12 03 2013 08 35am A1232 12 03 2013 08 35am A1232 12 03 2013 08 35am A1232 12 03 2013 08 35am A1232 12 03 2013 08 35am B lt IN A E F A Alert code for customer support purpose only B Return returns to previous view C Date and time of alert D Scroll list blue E Backward F Forward 3 Select the Return button to return to settings 7 5 6 5 View instrument information Detailed information about the instrument and Sensor can be viewed 1 Select the Settings button on the main menu 2 2 Select the Instrument button 3 This opens the Instrument information view displaying the following a 135 F SENSOR ID 345787843 6026 G SW 1D181D01 X 2015 06 05 Gj 12483 INSTR ID X 2014 08 05 H A Numbers of remaining measurements on the instrument B I
51. rt Aerocrine recommends completion of the details dialog box to allow re ceipt of technical data and provide better service and support functions to its customers 000190 04 NIOX VERO User Manual US Chapter 6 Using NIOX VERO with NIOX Panel Mandatory fields are marked with a Complete these leave the box checked and click OK to continue Please Enter Contact Details nln So Contact Details mandatory text lt is OK that Aerocrine collects technical data to provide better service and support Test connection When connection to Microsoft Azure is established a cloud icon ee is shown in the status bar If the connection to Microsoft Azure is lost or the user has chosen to not send technical data the cloud icon is crossed over FLD 000190 04 NIOX VERO User Manual US To decide at a later stage to allow Aerocrine 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 To reject collecting of Aerocrine technical data not recommended un check the box in the bottom of the window and click OK Note Only technical data and no patient data is collected by Aerocrine Changing contact details To edit contact details click on the cloud icon AD in the status bar to open the contact details dialog box 6 6 Firmware update Note If NIOX VERO firmware is older than 1D 1B xxxx the firmware needs to be updated Note
52. rt and storage CAUTION Always use a closed bag or box for transportation and storage of NIOX VERO 1 Verify that the instrument is turned off and disconnected from the power supply 2 Remove the patient filter and attach the protective cap on the handle Place the instrument and accessories in the bag and close bag 4 Verify that the storage environment conditions are appropriate see recommendations for NIOX VERO including Sensor 11 15 1 NIOX VERO including Sensor transportation and storage e Relative humidity range 20 to 80 non condensing e Temperature range 50 to 95 F 46 Chapter 12 NIOX VERO parts and accessories e Atmospheric pressure range 700 to 1060 hPa When transporting the instrument from one location to another with differ ent ambient conditions a prolonged stabilization period might be required before measurements can be performed 11 15 2 NIOX VERO instrument transport and storage in its unopened original package without Sensor e Relative humidity range 10 to 90 non condensing maximum 1 week when outside relative humidity range 10 to 80 e Temperature range 4 F to 140 F maximum 1 week when outside temperature range 50 F to 95 F e Atmospheric pressure range 500 to 1070 hPa 11 15 3 NIOX VERO Sensor transport and storage in original package e Relative humidity range 10 to 99 non condensing e Recommended temperature range 4 F to 77 F maximum 24h
53. s Electromagnetic communications equipment and the NIOX VERO propagation is affected by absorption and reflection from The NIOX VERO is intended for use in an electromagnetic environment structures objects and people in which radiated RF disturbances are controlled The customer or the user of 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 as recommended below according to the maximum output power of the communications equipment 51 Chapter 14 Guidance and manufacturer s declaration Electromagnetic immunity and electromagnetic emissions 14 0 2 Electromagnetic emissions Guidance and manufacurer s declaration 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 Emission test Compliance Electromagnetic environment guidance RF emissions The NIOX VERO uses RF energy only for CISPR 11 its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The NIOX VERO is suitable for use in all CISPR 11 establishments including domestic establishments and those directly Harmonic Class D connected to the public low voltage
54. s about to expire pie symbol j Sound disabled k Sensor status and number of remaining an ene I Temperature outside of specification m Humidity outside of specification n n Time Settings view A B w rn Q DIR n M 4 amp 4 ean TT e 9 A Modes configuration see page 16 B Volume settings see page 16 C Alert log see page 17 D Instrument amp Sensor info see page 18 E QC log see page 22 F Time and date settings see page 16 G Measurement log see KE 17 H Ambient see page 16 I Breathing hand status ead setings see pape 35 J QC tester Info see page 22 K Return to main view 000190 04 NIOX VERO User Manual US Chapter 5 Using NIOX VERO 5 Using NIOX VERO 5 1 Start the instrument from power save mode If NIOX VERO is in standby or sleep mode simply touch the display to ac tivate it d j 5 2 Register patient ID optional Note If Patient ID is used it must be entered before each measurement even if it is the same patient Local Regulations on Patient information privacy must be considered when using unique patient identifiers 1 Select the Register patient ID button from the main menu A KEZZEEEEEN 1U TT TT 1 2 3 B C D E F 5 JKL J N 8 9 AIRES ET FUNC 0 4 7 a ABC 123 Go a4 G lt 0600 Enter up to 12 characters alph
55. s organic fluids or disinfectants are being used Spe cial attention should be paid to aerosols and disinfection baths either open vessels or ultrasonic baths Table of contents 1important information i i 45y544444444435505454455 iessen 3 1 1 Before using NIOX VERO Airway Inflammation Monitor 3 Vi PROS IAI EE clan obooaaoo E N 3 FD OI NCO E E E E E E E A 3 1 4 Responsible manufacturer and contacts ssseeeeeeeeeeeeeeeeeeeeeees 3 FA ee antec teats age Gad E E E E E 3 RO ONC AOS TOT US Onnee nET r EEE EE EA 5 2 Product descrip hOn cepsssscszecoesvyezsssepszsanstersaxesncacasceopteaannectneiopneveats 5 2 1 NIOX VERO accessories and paris certiwiccemmncrnaantanamewecemss 5 E ll EE I k ey nee E E T y k l dce e k e wene O seed 6 3 Installation and set Up i 4 443544444455 4450445345544044445 4444443 kas R k k ehd N E 7 bz sierosa EE eme a 10 4 1 Main and setings CW ss syus iA es ncany aneneaN desan e N U 08e an banda 10 NL Lb T W dan ue hel wan y xe w eekl ee Re h n neh Kek a kad 10 Ph OMNIS Zl bJ su nicayeeaeeieaneassnecciet sons nx i s Usine NIO VIROS yey end ese en o riyan ete n ee Ea e Nebe b K 12 5 1 Start the instrument from power save mode i 12 5 2 Register patient ID OPUONAL s 4x cu wuladine ier ben el z DD a ND 2gpp anaemic T eae la 2 4 Denona OR MORE 2zarnmnm e m nbogbDmobbPe mm mn 15
56. should only be used as directed in the NIOX VERO User Manual by trained healthcare professionals NIOX VERO cannot be used with infants or by children approximately under the age of 7 as Measurement requires patient cooperation NIOX VERO should not be used in critical care emergency care or in anesthesiology 000190 04 NIOX VERO User Manual US 2 Product description 2 1 NIOX VERO accessories and parts A Breathing handle and handle cap B Sensor supplied separately C Instrument including stand D Rechargeable battery E NIOX Panel USB memory stick F USB cable G Power adapter and power cord H Patient filter supplied separately Note Only accessories and parts supplied by Aerocrine may be used Chapter 2 Product description 2 2 Instrument H ON OFF button I Power adapter port J USB port gt K wy L N Breathing handle holder O Breathing handle port A 4 K Battery LED lit when battery is charging L Standby LED blinking in Standby Sleep mode M Touch panel Display M 6 000190 04 NIOX VERO User Manual US Chapter 3 Installation and set up 3 Installation and set up WARNING Open the Sensor can with care The inside of the opening may have sharp edges Open the package with care Prior to installation check that the package 3 Open the Sensor package contains all the parts See page 5 A screwdriver is required for opening the compartment lid and
57. sing or damaged contact your local Aerocrine representa tive or Aerocrine Inc 8 2 Change disposables 8 2 1 Change breathing handle The breathing handle contains an NO scrubber which can be used for 1000 measurements or one year whichever comes first The breathing handle view is used for viewing the status of the breathing handle and for resetting breathing handle usage parameters A xd 0003 2011 06 05 C E amp A Breathing handle symbol B Remaining number of measurements C Expiration date D Breathing handle reset button E Return button 000190 04 NIOX VERO User Manual US Note two weeks prior to expiration or when 10 of its capacity is left CS Perform the following steps to change the breathing handle Place the device on its side on a level secure surface Remove the used handle from the instrument by pushing the socket into the device and gently pulling out the tube Discard the breathing handle CAUTION The breathing handle contains potassium permanganate and should be disposed of as hazardous waste in accordance with local waste disposal regulations Do not re use an expired breathing handle 4 Attach a new breathing handle to the instrument by pushing the tube into the socket until the triangle is no longer visible Select the Settings button on the main menu Select the Breathing handle button N Select the Reset Breathing handle button on
58. t This alert is visible when less than 500 measurements remain or less than 120 days until expiry date Press OK to acknowledge The Sensor is about to expire Order a new Sensor This alert is visible when less than 10 of the measurements remain or less than 2 weeks until expiry date Press OK to acknowledge The breathing handle is about to expire This alert is visible when less than 100 measurements remain or less than 2 weeks until expiry date Press OK to acknowledge Prepare to change breathing handle All measurements on the instrument have been used It is still possible to view measurements stored in the instrument memory All measurements on the Sensor have been used Replace the Sensor see page 36 33 Chapter 8 Preventive care Instrument alerts A92 A93 A94 A95 34 Screen Hi Z2 A93 E Hi A Q A94 ry man ETE 2011 06 05 lt KA man ETE 2011 06 05 v Instrument expiration date has passed It is still possible to view measurements stored in the instrument memory Sensor expiration date has passed Replace the Sensor see page 36 The breathing handle has expired Press OK Change breathing handle See page 35 CAUTION The breathing handle s NO scrubber contains potassium permanganate and should be disposed of as hazardous waste in accordance with local waste disposal regulations Breathing handle expiration date has passed Replace the handl
59. ted from the three qualifying measurements that must be between 5 40 ppb for the QC tester to be qualified The QC mea surement on the fourth day daily QC must be within 10 ppb from the mean value and the negative control approved If this has been met the Quality Control has passed for that staff member and the instrument is ready for clinical use The moving mean value is recalculated when the QC tester performs a QC measurement after seven days Chapter 5 Using NIOX VERO 5 8 2 QC measurement This procedure applies for qualification and daily QC measurements The instrument will prompt for a daily QC procedure by showing QC in the status bar or when there are no staff who are currently qualified as a tester Always consider the following in order to obtain reliable results Before any measurement e Avoid nitrate rich food for up to 3 hrs before the measurement e Avoid strenuous exercise at least 1 hour before the measurement e Preferably do not perform a measurement in case of e Ongoing cold e Acute seasonal allergy e Always attach a new patient filter for each new QC tester Select QC 0C QC QC1 STEN J QC2 QC3 ANNA G QC 4 OLLE B lt 4 v 2 Select QC Settings to verify which QC IDs are available Note Each QC tester must select an individual number 3 Select an available QC ID 4 Empty the lungs by breathing out thoroughly 20 5 Put the NIOX VERO patient filter to your mouth making s
60. this device must accept any interference including interference that may cause undesired operation of the device Le pr sent appareil est conforme aux CNR d Industrie Canada applicables aux appareils radio exempts de licence L exploitation est autoris e aux deux conditions suivantes 1 l appareil ne doit pas produire de brouillage et 2 l utilisateur de l appareil doit accept er tout brouillage radio lectrique subi m me si le brouillage est suscepti ble d en compromettre le fonctionnement Contains IC 337L MBH7BTZXXC2 11 13 3 FCC FCC CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment 45 Chapter 11 Technical data 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 interfer ence that may cause undesired operation Properly shielded and grounded cables and connectors must be used for connection to host computers and or peripherals in order to meet FCC emission limits Note This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful inter ference in a residential installation This equipme
61. ular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast it is possible that high levels of such interferences due to close proximity or strength of a source may result in disruption of performance of the instrument If abnormal performance is observed it may be necessary to reorient or relocate the NIOX VERO WARNING NIOX VERO should not be used adjacent to or stacked with other equipment 9 5 Emission of electromagnetic energy CAUTION This equipment has been designed and tested to CISPR 11 Class B In a domestic environment it may cause radio interference in which case you may need to take measures to mitigate the interference For more information see Electromagnetic emissions on page 52 9 6 Operating conditions Ensure stable operating conditions by avoiding placement of the instru ment in direct sunlight near sources radiating heat or ventilation NIOX VERO operates during the following conditions e NO in ambient air up to 300 ppb To verify NO in ambient air perform an ambient measurement see page 16 e Exhaled flow during FeNO measurements at 50 ml s 3 L min 10 BTPS during 10 seconds Body Temperature Pressure Saturated 98 6 F 37 C 14 7 psi 1013 hPa 100 RH e Temperature range of 50 F to 95 F e A relative humidity range of 20 to 80 non condensing e An atmospheric pressure range of 700 hPa to 1060 hPa Performance shall be susta
62. ure no air leakage occurs 6 Inhale deeply through the patient filter to total lung capacity During inhalation the cloud on the display moves upwards Exhale slowly through the filter while keeping the cloud within the limits as indicated on the display the white lines 000190 04 NIOX VERO User Manual US Chapter 5 Using NIOX VERO 8 Exhale until the cloud has passed the flag 11 The progress bar is visible until the analysis phase is complete The QC control result is displayed EEE al ns bey cs e Osi 32 ppb 2011 06 05 12 34 PM 25 E 10 Press w to proceed 06 gt A Control result FeNO value limits mean value 10 ppb B Control result in ppb C QC Measurement date and time D Measurement se quence number E QC tester number 12 Remove the handle cap 13 Press to return to main menu 000190 04 NIOX VERO User Manual US 21 Chapter 5 Using NIOX VERO Note During the qualification days of a new QC tester the result is displayed as presented below B A 2012 06 05 32 ppb C 2012 06 06 31 ppb A Date of measurement B Status button green within specifications white not within specifications C Mean value in ppb D QC tester number Press v4 to return to main menu Repeat the QC test if the positive and or the negative control fail If the QC failure persists discontinue use of NIOX VERO and contact Aerocrine Customer
63. urn to the main menu The Undo button closes the view without saving any changes 17 Select the Settings button on the main menu Q 18 Select the Breathing handle button This opens the Breathing handle view N 19 Select the Reset Breathing handle button The breathing handle information view opens to confirm the insertion of Ce the breathing handle 20 Select the OK button to confirm insertion of a new breathing z 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 lt 4 User interface 4 1 Main and settings view This section describes the main view settings view menus and symbols Buttons and symbols are further described on page 42 4 2 Main View gt 1d Bh DR C 751203 8933 QC HH 2 amp A Status bar B Instructive demonstration C Patient ID D Start measurement button 000190 04 NIOX VERO User Manual US Chapter 4 User interface 4 2 1 Main menu 4 3 QC E 2 Q Il T I a b G d a QC Users b Demo c Patient ID entry d Settings 4 2 2 Status bar me QCC lt HO 200 870 10 34 pm e f g h i k m n e Battery status f USB connection y T position a Bluetooth connection may be indicated instead g QC warning h Breathing handle has expired or is about to expire blinking i av i Instrument has expired or i

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