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1

Warning!  ...........................................................  2

Intended use (Europe)  .....................................  2

Training requirements  .....................................  2

Presentation  .....................................................  3

Installation and set-up  ....................................  4

Measurement  ...................................................  5

Enter patient ID (optional) .................................

5

Perform FeNO measurement

 ............................ 6

View stored results  ..........................................  7

Ambient NO measurement  .............................  7

Demonstration mode  .......................................  7

Change settings ...............................................  8

Time and date ...................................................

8

Sound volume ...................................................

8

Top light intensity ..............................................

8

Bluetooth on/off .................................................

8

QC on/off ..........................................................

8

Information menu  ............................................  9

Turn off NIOX MINO

®

   .......................................  9

General care  ...................................................  10

Preventive inspections

 .................................... 10

Change Sensor ............................................... 10
Change NO scrubber ...................................... 10
Disposal of used/expired products .................. 11
Return shipments ........................................... 11
Support ........................................................... 11
Limited warranty ............................................. 11

Troubleshooting  .............................................  11

Alert codes

 ...................................................... 12

Technical data  ................................................  13

Display buttons and symbols

 .......................... 13

Symbols explanation ....................................... 15
Backplate ........................................................ 15
Base label  ...................................................... 15
Dimensions and weight ................................... 15

Electrical data

 ................................................. 15

Noise level (stand by) ..................................... 15
Shelf-life .......................................................... 15
Operating conditions ....................................... 15
Exhaled NO - performance data ..................... 16

Linearity

 .......................................................... 16

Precision

 ......................................................... 16

Accuracy

 ......................................................... 16

Method comparison

 ........................................ 16

Inhalation parameters

 ..................................... 16

Exhalation parameters

 .................................... 16

Memory capacity

 ............................................ 16

Transport and storage ..................................... 16
Patient filter (mouthpiece) ............................... 16
Responsible manufacturer .............................. 16

NIOX MINO

®

 parts  

and accessories  .............................................  17

Connect NIOX MINO

®

 to a PC using USB  ....  18

NIOX

®

 Panel  ....................................................  18

Special 6s FeNO measurement ...................... 19

Nasal measurement

 ........................................ 19

Cautions  .........................................................  19

Clinical documentation  .................................  20

Vigilance  .........................................................  20

Guidance and manufacturer's declaration  ..  21

Electromagnetic emissions ............................. 21

User manual EPM-000110, version 09, April 2017, 

for instruments with software version 20XX, 

22XX and 23XX. X can be any number between 0 

and 9. The version number for your instrument can 

be seen in the Information menu, see page 9.

Information in this document is subject to 

change. Amendments will be made available by 

Circassia AB as they occur.
• NIOX MINO is CE-marked according to In Vitro 

Diagnostic Device Directive 98/79/EC and 

approved for clinical use in EEC countries.

• NIOX MINO is 510(k) cleared, k101034, by FDA.
• NIOX MINO is RoHS compliant.
• Copyright © 2017 Circassia AB, Uppsala, 

Sweden.

• NIOX MINO and NIOX are registered trademarks 

of Circassia AB. 

• Circassia is a registered trademark of Circassia 

Limited.

Table of contents

Содержание 09-1000

Страница 1: ...E N G L I S H NIOX MINO User Manual ...

Страница 2: ... NIOX MINO 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 Always use a NIOX MINO Bag closed for transportation and storage of NIOX MINO when it is disconnected from the power outlet The NIOX MINO Bag is sold separately Shelf life NI...

Страница 3: ...xhalation parameters 16 Memory capacity 16 Transport and storage 16 Patient filter mouthpiece 16 Responsible manufacturer 16 NIOX MINO parts and accessories 17 Connect NIOX MINO to a PC using USB 18 NIOX Panel 18 Special 6s FeNO measurement 19 Nasal measurement 19 Cautions 19 Clinical documentation 20 Vigilance 20 Guidance and manufacturer s declaration 21 Electromagnetic emissions 21 User manual ...

Страница 4: ...property The product warranty does not cover product failure or damage resulting from use with non approved accessories Circassia takes no responsibility for health and safety problems or other problems caused by the use of accessories not ap proved by Circassia No modification of the NIOX MINO instrument or the Sensor is allowed Also see Cautions page 19 Intended use Europe NIOX MINO Airway Infla...

Страница 5: ...ndard measurement mode page 6 Nasal measurement mode page 19 Return Special 6 s measurement mode page 19 Ambient measurement page 7 Demonstration mode page 7 View measurement results page 7 Settings screen Controlled power off page 10 NO scrubber setup page 10 Bluetooth on off page 8 Return QC on off page 8 Light and sound page 8 Time and date page 8 Information page 10 Main screen Number of remai...

Страница 6: ...5 Replace the cover and make sure it snaps in place 6 Attach the power supply unit to the instrument and to a power outlet 7 Wait for the instrument to start up and press the Forward button 8 Reminder to insert a new NO scrubber Press the Forward button 9 Select OTHER on the display Note This screen is only displayed at first start up of the instrument The JAPAN icon is only available for SW 22XX ...

Страница 7: ...let However it is recommended to allow a new NIOX MINO Sensor to be connected for two hours before the first measurement is done Measurement Depending on what is shown on the display proceed as follows Stabilization in progress Wait until ready Instrument in sleep mode Touch the display Ready for use Enter patient ID optional Note If Patient ID is used it has to be entered before each measurement ...

Страница 8: ...ity The cloud on the display is inflated and the top light is turned off while you inhale The sun cloud rises Inhalation time is displayed by buttons if meter is selected 3 Exhale slowly through the filter until the top light and sound turns off Continuous sound and steady light OK Intermittent high frequency sound and flickering light exhalation too hard Intermittent low frequency sound and flick...

Страница 9: ...ement 4 Wait for result approximately 4 minutes Demonstration mode Use this mode for a new patient in order to demonstrate the different steps during a measurement and the corresponding illustrations on the display as well as light and audio feed back Sound volume has to be activated 1 Select Mode 2 Select Demo 3 The inhalation screen is shown and the top light is turned off 4 Use the Forward butt...

Страница 10: ...e sound volume 5 Select OK to accept the changes Top light intensity 1 Select Settings 2 Select Sound and Light 3 Select top light 4 The top light setting is shown 5 Use the plus and minus buttons to set the light intensity 6 Select OK to accept the changes Bluetooth on off 1 Select Settings 2 Select Bluetooth 3 The Bluetooth setting is shown 4 Use the buttons to deactivate or activate Bluetooth 5...

Страница 11: ...est alerts Note The alert codes in the list are only to be used in contact with Customer support Date of the alert Alert code for customer support purpose only 6 Select Return to go back to the Information screen Turn off NIOX MINO Note When within the specified operating conditions see page 15 it is recommended to keep NIOX MINO with installed Sensor connected to a power outlet whenever possible ...

Страница 12: ... is missing or damaged contact your local Circassia representative or Circassia AB Change Sensor Caution Be careful when opening the Sensor can The inside of the opening has sharp edges Do not touch or clean the white Sensor membrane 1 Press and hold the blue button while turning the orange swivel 2 Remove the Sensor 3 Insert the new Sensor 4 Turn back the orange swivel until locked Change NO scru...

Страница 13: ...provides a Limited Warranty for this instrument and original accessories delivered with this instrument Conditions are defined when the items are purchased Do NOT try to repair the instrument It is NOT permitted to open the instrument Any attempt will make the warranty invalid and performance according to the specifications can not be guaranteed Troubleshooting Warning Action The inhalation was to...

Страница 14: ...ter inhalation Code Action A13 Select return and repeat the measurement and do not breathe through the patient filter during analysis A14 Wrong passcode for NO scrubber exchange Instruments alerts A20 Check that the ambient temperature is within specification If necessary shut the instrument down move it to another location and restart the instrument A21 Remove any sources of disturbance such as c...

Страница 15: ...ment research application Stored measurement results Nasal flow 2 ml s research application Nasal flow 5 ml s research application Demonstration mode Clock Information Forward OK Return Previous Next Decrease Increase to Number Backspace Button Description Shift to keypad 0 4 Shift to keypad 5 9 Bluetooth on Bluetooth off US time and date settings ISO time and date settings Alert info Sound and to...

Страница 16: ...Nasal measurement research application Ambient NO measurement Attach nasal olive to nostril research application Insert Sensor NO scrubber NO scrubber General warning Instrument expiration warning Sensor warning Temperature warning NO scrubber warning Symbol Description Wait Wait time Wait for temperature stabilization Wait for Sensor stabilization ...

Страница 17: ...orms to ANSI AAMI ES60601 1 and certified to CAN CSA C22 2 No 60601 1 Base label 2 3 1 1 Instrument expiration date year month 2 Instrument article number 3 Instrument serial number Dimensions and weight Height 230 mm Width 128 mm Depth 96 mm Weight of instrument including Sensor 0 8 kg Electrical data Electrical safety classification The equipment complies with the requirements according to IEC 6...

Страница 18: ...OX instrument from Circassia Inhalation parameters Inhalation to TLC Total Lung Capacity before start of exhalation to secure proper activation Minimum 3 cm H2 O trigger only Exhalation parameters Exhalation time Standard mode 10 s clinical use Special 6 s mode 6 s research use All exhalations are to be performed at an exhalation pressure of 10 20 cm H2 O to maintain a fixed flow rate of 50 5 ml s...

Страница 19: ...3 Parts delivered separately NIOX MINO NO scrubber 09 1300 NIOX MINO User Manual EPM 000110 Accessories NIOX MINO Test Kit 100 03 4000 contains 1 NIOX MINO Sensor for 100 measurements and 100 NIOX Filters NIOX MINO Test Kit 300 03 4001 contains 1 NIOX MINO Sensor for 300 measurements and 300 NIOX Filters NIOX MINO Test Kit 500 03 4007 contains 1 NIOX MINO Sensor for 500 measurements and 500 NIOX F...

Страница 20: ... on the NIOX MINO display to indicate that a USB connection is established Connect NIOX MINO to a PC using Bluetooth 1 Select Settings 2 Select Bluetooth 3 The Bluetooth setting is shown 4 Use the button to activate Bluetooth 5 Select OK to accept the changes 6 Follow the instructions delivered with the PC or from the Bluetooth device manufacturer for how to set up a Blutetooth connection Create a...

Страница 21: ...imum of 30 minutes after that The Special 6 s exhalation and nasal modes are intended for research use only The NIOX MINO Sensor shall be kept in its original unopened package before installation For transportation and storage conditions refer to the corresponding section in this manual The NIOX MINO Sensor is sensitive to changes in ambient temperature and humidity Be careful when opening the Sen...

Страница 22: ...eld device for the measurement of exhaled nitric oxide Allergy 2007 62 1171 1174 5 Menzies D Nair A Lipworth BJ Portable exhaled nitric oxide measurement Comparison with the gold standard technique Chest 2007 131 2 410 4 The Sensor is already calibrated during manufacturing and does not need to be re calibrated Vigilance Circassia as a medical device manufacturer must have a system in place to rep...

Страница 23: ...nments such as base stations for radio cellular 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 device If abnormal performance is observed it may be necessary to reorient or relocate NIOX MINO Warning...

Страница 24: ...AB Uppsala Sweden NIOX MINO and NIOX are registered trademarks of Circassia AB Patents Circassia s NIOX products are protected by a number of patents in the US Europe and a range of other countries A NEW DIMENSION IN ASTHMA CARE Information in this document is subject to change Amendments will be made available by Circassia AB as they occur Copyright 2017 Circassia AB Uppsala Sweden Based on the c...

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