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Chapter 14 Guidance and manufacturer's declaration - Electromagnetic immunity and electromagnetic emissions

000190-09 NIOX VERO

User Manual US

The report should be forwarded, by e-mail, fax or telephone, to:

Circassia Pharmaceuticals

Inc. 5151 McCrimmon Parkway, Suite 260,

Morrisville, NC 27560, USA

Phone: +1 (866) 275-6469,

Fax: +1 (877) 630-6469

e-mail: [email protected]

14 Guidance and manufacturer's declara-

tion - Electromagnetic immunity and
electromagnetic emissions

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.

Immunity test

Compliance

Electromagnetic environment - guidance

Electrostatic
discharge
(ESD)
IEC 61000-4-2

'+/- 6 kV
contact
+/- 8 kV air

Floors should be wood, concrete or
ceramic tile.
If floors are covered with synthetic
material, the relative humidity should at
least 30%.

Electrical fast
transient/burst
IEC 61000-4-4

'+/- 2 kV for
power supply
lines
+/- 1 kV for
input/output
lines

Mains power quality should be that of a
typical commercial or hospital
environment.

Surge
IEC 61000-4-5

'+/- 1 kV
line(s) to
line(s)

Mains power quality should be that of a
typical commercial or hospital
environment.

Содержание NIOX VERO

Страница 1: ...000190 09 EPM 000165 NIOX VERO User Manual US April 2017 NIOX VERO Airway Inflammation Monitor User Manual 510 k 133898 ...

Страница 2: ... for transportation and storage of NIOX VERO It is recommended after inserting a new sensor to wait for three hours with the instrument switched on before performing a measurement Operational life time NIOX VERO Instrument Minimum 5 years at time of delivery or 15 000 measurements Operational life time NIOX VERO Sensor Maximum 12 months after opening package and installed in NIOX VERO or expiratio...

Страница 3: ... Turn off the instrument 17 5 8 External Quality Control QC procedure 18 6 Using NIOX VERO with NIOX Panel 23 6 1 Warnings 23 6 2 Installation of NIOX Panel 23 6 3 Connect to a PC via USB 24 6 4 Connect to a PC via Bluetooth 24 6 5 Setup 24 6 6 Firmware update 26 6 7 Using NIOX Panel 26 7 Troubleshooting 28 7 1 Alert codes and actions 28 8 Preventive care 33 8 1 General care 33 8 2 Change disposab...

Страница 4: ...Exhalation parameters 44 11 11 Essential performance 44 11 12 Memory capacity 44 11 13 Patient filter 44 11 14 Bluetooth 44 11 15 Rechargeable battery capacity 45 11 16 Instructions for transport and storage 45 12 NIOX VERO parts and accessories 46 12 1 Parts included in NIOX VERO package Article No 12 1200 46 12 2 Accessories 46 13 Medical Device Reporting MDR 47 14 Guidance and manufacturer s de...

Страница 5: ...RO 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 Circassia AB P O Box 3006 SE 750 03 Uppsala Sweden Visiting address Hansellisgatan 13 SE 754 50 Uppsala Sweden www circassia com www niox com 1 5 Warnings Do not ...

Страница 6: ...r 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 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...

Страница 7: ...trument including stand D Rechargeable battery E NIOX Apps USB memory stick F USB cable G Power adapter and power cord H Patient filter supplied separately Note Only accessories and parts supplied by Circassia may be used 2 2 Instrument H ON OFF button I Power adapter port J USB port K Battery LED lit when battery is charging L Standby LED blinking in Standby Sleep mode M Touch panel Display ...

Страница 8: ...the package contains all the parts See page 5 A screwdriver is required for opening the compartment lid and 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 2 Open the Se...

Страница 9: ... 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 5 Open the battery package Note Only use the correct rechargeable battery supplied by Circassia Type No BJ G510039AA Article No 12 1150 6 Insert the rechargeable battery and replace the lid Tighten the screw...

Страница 10: ...dle tube Note The triangle should not be visible when assembled correctly 8 Attach the power adapter to the instrument and then to the power outlet When installing the unit either use a socket outlet with a readily 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...

Страница 11: ...ng the button for hour It changes color to blue Change the value to the current hour by pressing the increase or decrease buttons Repeat this procedure for minute year month and day 15 Select OK to accept the changes and return to the main menu The Undo button closes the view without saving any changes 16 Select the Settings button on the main menu 17 Select the Breathing handle button This opens ...

Страница 12: ...Start measurement button 4 2 1 Main menu a QC Users b Demo c Patient ID entry d Settings 4 2 2 Status bar e Battery status f USB connection in this position a Bluetooth connection may be indicated instead g QC warning h Breathing handle has expired or is about to expire blinking symbol i Instrument has expired or is about to expire blinking symbol j Sound disabled k Sensor status and number of rem...

Страница 13: ...hing handle status and settings see page 34 J QC tester info see page 21 K Return to main view 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 activate it 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 Patie...

Страница 14: ...e breathing handle Make sure to twist the patient filter in place until it clicks Note Store the patient filters in the original box prior to use 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 to the breat...

Страница 15: ...de 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 strong Pressure too weak 6 Exhale until the cloud has passed the flag 7 The instrument will analyze the ...

Страница 16: ...t procedure 1 Select the Animation button on the main menu 2 Select which animation to use Cloud Balloon or Meter 3 Select the Demo button 4 Select the forward button to move to the following sequence 5 The undo button closes the demonstration and returns the animation select 6 Select OK button to confirm the changes 7 The undo button returns to the main menu without saving changes a Inhalation th...

Страница 17: ...2 Select the Settings button on the main menu 3 Select Ambient Measurement button 4 Select the 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 ...

Страница 18: ...ton on the main menu 2 Select the Patient measurements log view button 3 The selected log will display the following A Patient ID if defined B FeNO value C Measurement date and time D Measurement mode E Return 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 ...

Страница 19: ...ewed 1 Select the Settings button on the main menu 2 Select the Instrument button 3 This opens the Instrument information view displaying the following A Numbers of remaining measurements on the instrument B Instrument 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 expiratio...

Страница 20: ...lity Control consists of two parts One positive control from a qualified staff member with a stable FeNO value providing a normal biolog ical FeNO sample and a negative control consisting of a NO free gas sample automatically generated 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 da...

Страница 21: ... the instrument is ready for clinical use The moving mean value is recalculated when the QC tester performs a QC mea surement after seven days 5 8 2 QC measurement This procedure applies for qualification and daily QC measurements The in strument will prompt for a daily QC procedure by showing in the status bar or when there are no staff who are currently qualified as a tester Always consider the ...

Страница 22: ...assed the flag 9 Remove the patient filter and immediately attach the handle cap 10 Press to proceed 11 The progress bar is visible until the analysis phase is complete The QC control result is displayed A Control result FeNO value limits mean value 10 ppb B Control result in ppb C QC Measurement date and time D Measurement sequence number E QC tester number 12 Remove the handle cap 13 Press to re...

Страница 23: ...pport 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 Note If the 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 5 8 3 View QC logs 1 Select the Settings...

Страница 24: ...s 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 4 Select the Return button to return to settings 5 8 5 Reset QC tester This instruction will delete the data for the selected individual 1 Select the Settings button on the main menu 2 Select QC Settings to verify which QC IDs are available The ...

Страница 25: ...ircassia If the equipment is used in a manner not specified by Circassia the protection provided by the equipment may be impaired Modification of NIOX Panel application is not allowed Do not use damaged components 6 2 Installation of NIOX Panel The NIOX Panel located in the NIOX Apps software is supplied on a USB storage device 1 Insert the USB storage device in the computer s USB port 2 Select th...

Страница 26: ...t 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 This opens the Configuration modes view 3 To enable Bluetooth check the checkbox Unchecking the box disables Bluetooth communication Select OK to confirm change This returns to the Settings view An enabled Bluetooth function is indicated by a symbol on t...

Страница 27: ...ectivity details dialog opens 6 5 1 NIOX Panel connectivity module The connectivity module in NIOX Panel utilizes Microsoft s secure cloud ser vice Microsoft Azure to automatically transmit technical data from the device via the internet to Circassia Technical data such as time stamp alert codes and number of remaining measurements on the device and sensor are received This information will ensure...

Страница 28: ...by Circassia Changing contact details To edit contact details click on the cloud icon in the status bar to open the contact details dialog box 6 6 Firmware update Note If NIOX VERO firmware is older than 1D1C xxxx the firmware needs to be updated Note 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 2 Press...

Страница 29: ...er 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 Circassia 6 7 6 Perform QC measurement There are two options to perform a QC measurement when NIOX Panel is used Either stand alone like in chapter 5 8 2 QC measurement or If NIOX Panel is connected to the NIOX database it is possible to create the...

Страница 30: ...ess Return button restart the measurement and exhale into the instrument directly after inhalation A13 Analysis interrupted Repeat the measurement and do not breathe through the handle during analysis A21 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...

Страница 31: ...ation code If this error continues to be shown contact Circassia Technical support A07 Lid open warning Check if the battery or sensor lid is open and close if needed Click the OK button when finished Instrument alerts Screen Action A08 Battery problem Low power in battery or other failure Change the battery and click the OK button when finished A09 Condensation countdown Too frequent use of the i...

Страница 32: ...Circassia Technical support A28 Internal hardware error recoverable Check that the Sensor battery and lid is in its correct position also make sure that the tube is not folded When finished restart the instrument Instrument alerts Screen Action A29 Analysis failure Ambient measurement failure Click the OK button and obtain a new measurement A30 Bluetooth connection error Check the Bluetooth connec...

Страница 33: ...een 5 50 ppb Restart the QC tester qualification from day one A51 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 Instrument alerts Screen Action A52 QC measurement failure Moving mean value out of range Restart the QC tester qualification from qualification day one A53 NO scrubber result out of ...

Страница 34: ...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 Instrument alerts Screen Action A82 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 ...

Страница 35: ...e of solvents 2 Clean the breathing handle with a cloth dampened with water or a mild soap solution Note The breathing handle and patient filter are not intended for sterilization WARNING The breathing handle and the instrument can not be cleaned with an aerosol Do not use disinfectants or wipes containing alcohol these might permanently damage the sensor and instrument Do not use spray detergents...

Страница 36: ...d contact your local Circassia representa tive or Circassia Pharmaceuticals 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 Breathing han...

Страница 37: ...athing 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 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 ...

Страница 38: ... 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 ...

Страница 39: ...atient 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 Exhaled breath contains water vapor which can condense inside the ...

Страница 40: ...luence 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 these patient characteristic...

Страница 41: ...ns stable after exercise It would seem prudent to avoid strenuous exercise for 1 hour before the measurement Ethnic differences 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 leve...

Страница 42: ...p to 10 measurements hour Exhaled breath contains water vapor which can condense inside the in strument When excessively used in a short period there is a risk for condensation of water inside NIOX VERO Normally a maximum of 10 exhalations hour can be performed with NIOX VERO during continuous use However it is possible to perform 20 ex halations in one hour if the instrument is paused for a minim...

Страница 43: ...heck box active Radio button off QC not performed Radio button on QC performed Demo Settings Patient ID QC Configuration Patient measurements Volume Ambient measurements Alert logs Breathing handle status Instrument status QC tester information Time and date QC measurements Enable Bluetooth Battery fully charged Breathing handle about to expire or has expired blinking Battery 87 charge Instrument ...

Страница 44: ...o high or too low Responsible manufacturer 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 Diagnost...

Страница 45: ...d as one standard deviation for replicate measure ments with the same instrument using a certified gas concentration of Nitric Oxide reference standard 11 7 Accuracy 5 ppb for measured values 50ppb or 10 of measured value for values 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 10 ppb ...

Страница 46: ...ver transmitter with Frequency band of 2402MHz 2480 MHz Modulation method 0 5BT Gaussian FIlter 2 FSK modulation index 0 28 0 35 Basic Rate 1Mbps π 4 DQPSK EDR 2Mbps 8DPSK EDR 3Mbps ERP Power class 2 11 14 1 R TTE Directive Hereby Circassia AB declares that this NIOX VERO is in compliance with the essential requirements and other relevant provisions of Directive 1999 5 EC 11 14 2 IC This Class B d...

Страница 47: ...ch 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 Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced ...

Страница 48: ...ure range 41 F to 95 F maximum 1 week for the ranges 4 F to 41 F and 95 F to 140 F 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 Circassia may result in loss of performance damage to your NIOX VERO product fire electric shock injury or damage to other pro...

Страница 49: ... type of adverse event being repeated This is achieved by immediate notification of experi enced incidents to enable corrective and preventive actions 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 reasonable sug gests that a device ...

Страница 50: ...unity The NIOX VERO is intended for use in the electromagnetic environment specified below The customer or the user of the NIOX VERO7 should assure that it is used in such an environment Immunity test Compliance Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic mat...

Страница 51: ... a typical commercial or hospital environment Note UT 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...

Страница 52: ...portable and mobile RF communications equipment and the NIOX VERO The NIOX VERO is intended for use in an electromagnetic environment 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 recom...

Страница 53: ...nt Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The NIOX VERO uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The NIOX VERO is suitable for use in all establishments including domestic establishments and those...

Страница 54: ......

Страница 55: ...tory disease in the airways 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 1 877 630 6469 E mail service us circassia com www niox com Copyright 2017 Circassia AB Uppsala ...

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