NIOX MINO User Manual Ver 9 Dec 2014

Remember • It is important to adhere to the specified operating conditions: Ambient temperature: 60 to 85°F (+16 to 30°C) Humidity: 20 to 60% RH (non-condensing) • Mobile phones and cordless phones might interfere with the instrument and should therefore be kept away from the instrument. Interference could make it impossible to perform a measurement. • When within the specified operating conditions it is recommended to keep NIOX MINO® with installed Sensor connected to a power outlet whenever possible. • It is recommended to allow a Sensor to be connected for two hours before the first measurement is done. • It is recommended not to use 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 - NIOX MINO instrument: Minimum 3 years at time of delivery, or 3,000 measurements. NIOX MINO Sensor: Maximum 12 months when mounted in NIOX MINO or expiration date as stated on the sensor, whichever comes first. Note! This manual is intended for medical care personnel and for use when teaching patients how to use the NIOX MINO instrument. To aid this, a demonstration mode is available in the instrument. Please refer to the "Demonstration mode" section, page 7.

Table of contents Warnings! ... 2 Intended use ... 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 Mode configuration - QC on/off... 8 Information menu ... 9 External Quality Control procedure (QC) ... 10 Selection and qualification of QC testers... 10 QC measurement... 11 View stored QC results... 12 View QC information... 12 Reset QC tester... 12 Turn off NIOX MINO® ... 13 Moving NIOX MINO... 13 General Care ... 13 Preventive inspections... 13 Change Sensor... 13 Change NO scrubber... 14 Disposal of used/expired products... 14 Return shipments... 14 Support... 14 Limited warranty... 14 Troubleshooting ... 15 Alert codes... 16 Technical data ... 17 Display buttons and symbols... 17 Symbols explanation... 19 Backplate... 19 Base label ... 19 Dimensions and weight... 19 Electrical data... 19 Noise level (stand by)... 19 Shelf-life... 19 Operating conditions... 19 Exhaled NO - performance data... 20 Linearity... 20 Precision... 20 Accuracy... 20 Method comparison... 20

Inhalation parameters... 20 Exhalation parameters... 20 Memory capacity... 20 Transport and storage... 20 Patient filter (mouthpiece)... 20 Responsible manufacturer... 20 NIOX MINO® parts and accessories ... 21 Connect NIOX MINO® to a PC using USB ... 21 NIOX® Panel ... 21 Cautions ... 22 NIOX MINO surveillance procedures ... 24 Clinical documentation ... 24 Medical Device Reporting (MDR) ... 25 Guidance and manufacturer's declaration ... 25 Electromagnetic emissions... 25

User manual 000164 (EPM-000109), version 9, December 2014, for instruments with software version from 2005 to 20XX and 22XX to 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 Aerocrine, Inc. as they occur. • NIOX MINO is 510(k) cleared, K101034, by FDA. • 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 RoHS compliant. • Copyright © 2014 Aerocrine AB, Solna, Sweden. • Aerocrine, NIOX MINO and NIOX are registered trademarks of Aerocrine AB. 1

Warnings! • The NIOX MINO® instrument must always be used and handled as stated in this manual. Aerocrine accepts no responsibility for damaged equipment or faulty results, if the equipment is not used according to this manual. • Do not use a damaged NIOX MINO instrument or damaged components. • Use only the power supply unit provided. • Keep the instrument out of water. Ensure that no liquid is spilled or dripped on the instrument. • Do not heat or dispose of the instrument or Sensor in fire. Please refer to the "Handling of used/expired products" section. • Take care not to drop the instrument or subject it to strong impact. • It is recommended not to use 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). • NIOX MINO should not be used adjacent to or stacked with other equipment. • The NIOX MINO Sensor contains chemicals that could be harmful if swallowed. • Touch only the grey cap when exchanging the Sensor. • Do not clean the sensor. Cleaning of the Sensor with ethanol or similar disinfectant might destabilize it for a non-predictable time period. • Keep the Sensor out of water! Ensure that no liquid is spilled or dripped on the Sensor. • The NO scrubber contains potassium permanganate and should be disposed of as hazardous waste in accordance with the local waste disposal regulations. • When selecting an accessory for your NIOX MINO please keep in mind that an accessory not recommended by Aerocrine may result in loss of performance, damage to your NIOX MINO, 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. • No modification of the NIOX MINO instrument or the Sensor is allowed. Also see Cautions page 22.

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Intended use NIOX MINO 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 MINO according to guidelines for NO measurement established by the American Thoracic Society. Measurement of FeNO by NIOX MINO is a quantitative, non-invasive, simple 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 patients with elevated FeNO levels. NIOX MINO is suitable for children approximately 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. NIOX MINO should only be used as directed in the NIOX MINO User Manual and the NIOX MINO Quality Control Test User Manual, by trained physicians, nurses, respiratory therapists and laboratory technicians. NIOX MINO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX MINO should not be used in critical care, emergency care or in anaesthesiology.

Training requirements

NIOX MINO should only be used as directed in this manual, by trained physicians, nurses, respiratory therapists and laboratory technicians. “Trained” status is achieved only after careful reading of this manual.

Presentation

NIOX MINO® instrument NIOX® Filter Disposable patient filter that must be exchanged before each measurement session and patient

Top light Display

NO scrubber, (page 14)

Power supply unit

Optional PC connection. Cable (USB) USB connector NIOX Panel PC based program that allows the patient to follow the measurement on a PC screen, see page 21.

Strap holder for NIOX MINO Hand Strap (optional accessory)

NIOX MINO Sensor, (page 13)

Main screen

Set ID (page 5)

Number of remaining measurements for mounted Sensor, or Patient ID (optional) Perform QC (page 11) USB cable connected Mode status

Settings screen Controlled power off (page 13) NO scrubber setup (page 14) Not available for the US market Return

Mode screen Mode Standard measurement configuration mode (page 6) (page 8) QC measurement Light and sound mode (page 8) (page 11) Time and date (page 8) Information (page 9)

Return

Ambient measurement (page 7) Demonstration mode (page 7) View measurement results (page 7) 3

Installation and set-up 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. Insert the Sensor into the compartment at the base of the instrument

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

2. Turn the orange swivel until locked

9. Select USA on the display Note! This screen is only displayed at first start-up of the instrument.

3. Gently, spread the latches apart, one at a time, (Optionally: Use the red QC plug to spread the latches apart) ... and carefully pull out the cover

10. Select Settings 11. Select Clock

4. Insert the new NO scrubber into the cover

Make sure to use a new NO scrubber, with an unbroken hole 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

4

12. The time and date settings are shown

Unbroken

Broken

13. Use the plus and minus buttons to set the time and date 14. Select the forward button to change between hour, minute, month, day, and year 15. Select OK to accept the changes 16. Select NO scrubber 17. Again select NO scrubber

18. Input the passcode 0000 using the number buttons to confirm that a new NO scrubber is installed

19. Select OK to accept the changes 20. Optional: Connect a USB cable, see page 21 21. Select Return to go back to the Main screen 22. Allow the instrument to stabilize. Note! Stabilization of the instrument normally may take up to 30 minutes following connection of the power supply unit to the power outlet. However, it is recommended to allow the NIOX MINO® Sensor to be connected for two hours before the first measurement is done.

Measurement

Note: A twinkling asterisk on the screen indicates that the external Quality Control (QC) procedure is activated. A daily QC measurement is mandatory for clinical use. You should start the qualification process of at least one staff member for this procedure, see page 11.

Enter patient ID (optional) Note! If Patient ID is used, it has to be entered before each measurement (even if it is the same patient). Input a patient specific ID number, up to 10 digits. 1. Select the ID button on the main screen 2. Input the patient specific ID using the number buttons

to

Use the shift buttons to change between digits 0 to 4 and 5 to 9 3. Select OK to accept the patient ID

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

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Perform FeNO measurement Important! Always attach a new patient filter for each new patient

Make sure that the instrument is ready for measurement (activate by pressing the display if in sleep mode)

Choose one of three options in order to follow the measurement Listen to the sound signals and view the top light.

Look at the display using a mirror.

If the optional PC based NIOX® Panel is used, look at the PC screen. (see page 21)

1. Empty lungs

2. Inhale deeply through the filter to total lung capacity

The cloud on the display is inflated and the top light is turned off while you inhale The sun/cloud is rising Inhalation time is displayed with 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 flickering light = exhalation too weak 4. Wait for result

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FeNO value Patient ID (if entered) Sequence number (each measurement result is given a unique identification number)

View stored results

Demonstration mode

The measurement result is automatically displayed at the end of a measurement. All previous results are stored in the instrument, and can be viewed at any time.

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

1. Select Mode

2. Select Measurement results 3. The latest stored measurement is displayed, showing: A. FeNO value B. Measurement mode C. Patient ID (if entered) D. Sequence number (each measurement result is given a sequence number) E. Time and date of measurement 4. Use the previous and next buttons to step through the stored measurements 5. Select Return to go back to the Mode screen

A B C

3. The inhalation screen is shown and the top light is turned off

D E

Ambient NO measurement Note! A completed ambient NO measurement is counted as one measurement for the Sensor and NIOX MINO®. 1. Attach a new patient filter

2. Select Demo

4. Use the Forward button to advance to the next screen 5. The normal exhalation screen is shown Correct exhalation pressure: The cloud in a steady centered position, the top light is lit, and the audio emits a constant sound 6. Use the Forward button to advance to the next screen 7. The exhalation too weak pressure screen is shown

8. Use the Forward button to advance to the next screen 9. The exhalation too strong pressure screen is shown

2. Select Mode 3. Select Ambient measurement 4. Wait for result (approximately 4 minutes)

10. Use the Forward button to advance to the next screen 11. The wait for result screen is shown (static view)

12. Select Return to go back to the Mode screen

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Change settings Time and date

4. The top light setting is shown

1. Select Settings 2. Select Clock 3. The time and date settings are shown

5. Use the minus and plus buttons to set the light intensity 6. Select OK to accept the changes

4. Select the time format icons to change between US and ISO time and date 5. Use the minus and plus buttons to set the time and date 6. Select the forward button to change between hour, minute, month, day, and year 7. Select OK to accept the changes

Sound volume

Mode configuration - QC on/off Note! For clinical use, the QC must always be on! 1. Select Settings 2. Select Mode Configuration 3. Select QC settings 4. The QC settings are shown

1. Select Settings 2. Select Sound and Light 3. The sound volume setting is shown

5. Use the buttons to deactivate or activate QC measurement 6. Select OK to accept the changes

4. Use the minus and plus buttons to set the sound volume 5. Select OK to accept the changes

Top light intensity 1. Select Settings 2. Select Sound and Light 3. Select top light

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Information menu 1. Select Settings 2. Select Information menu 3. The information screen shows: A. Number of remaining sensor measurements B. Sensor expiration date C. Sensor serial No. D. Number of remaining instrument measurements E. Instrument expiration date F. Instrument serial No. G. Instrument software version 4. Select Return to go back to the Settings screen

A B C D E F G

... alternatively select A to view the alert codes 5. The alert code information screen is shown, showing the 16 latest alerts Note! The alert codes in the list are only to be used in contact with Aerocrine, Inc. Technical Support • Date of the alert • Alert code (for technical support purpose only) 6. Select Return to go back to the Information screen

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External Quality Control procedure (QC) The external Quality Control is one of the procedures that ensures the system is operating within its specifications. For further information regarding NIOX MINO® surveillance procedures, see page 27. Note: The Quality Control function in NIOX MINO must always be activated as a daily QC measurement is mandatory when the instrument is clinically used. 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, generated from ambient air. NIOX MINO will allow for one daily QC measurement that will not affect the number of remaining tests on the NIOX MINO Sensor. (During the first 20 days of instrument start-up, a maximum of four QC testers can be qualified without impact to the number of remaining tests on the Sensor.)

Selection and qualification of QC testers A minimum of one individual (two individuals are recommended) needs to qualify for this procedure. Identify a third individual as a back-up, if possible. Identify the staff members who will perform the Quality Control and meet the following criteria: • Over 18 years of age. • No ongoing cold or known airway disease. • Non-smoker. • Expected stable FeNO values between 5 and 40 ppb. • Preferably no allergies (except seasonal, see below) or asthma. A QC tester will be qualified over the course of three days. Note! 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 three QC measurements, one per day within seven days, according to the QC measurement section. A mean value is calculated from the three measurements that must be between 5-40 ppb. The following QC measurement on the fourth day must be within ± 10 ppb from the mean value and the NO scrubber result < 5ppb. Then the Quality Control has passed and the instrument is ready for clinical use. The next moving mean value is calculated when the QC tester performs a QC measurement following 7 10

days. Result screens for the QC tester qualification Day 1

Day 2

Day 3

After day 3 Positive control result: FeNO value and limits (mean value +/- 10 ppb)

QC measurement The instrument will prompt for a daily QC procedure by showing a twinkling asterisk on the display.

Always consider the following in order to obtain reliable results. Before any measurement: • Avoid nitrate rich food within 3 hrs before the measurement. • Avoid strenuous exercise at least 1 hour before the measurement. Preferably do not perform a measurement in case of: • Ongoing cold. • Acute seasonal allergy.

8. Wait for the analysis to be completed and the test result to be displayed (approximately 5 minutes)

9. The QC measurement result is displayed Note! During the qualification days of a new QC tester the result is displayed as presented Day 1-3. Day 1

Day 2

Day 3

1. Select Mode 2. Select QC mode 3. Select QC tester number (each QC tester must select an individual number) 4. Perform a normal FeNO measurement according to page 6.

5. Remove the patient filter

After day 3 A. Positive control result: FeNO value and limits (mean value +/- 10 ppb) A B. QC tester number B C. Negative control result C (should be < 5 ppb)

10. Remove the QC plug

Repeat the QC test if the positive and/or the negative control fail. If the QC failure persists, discontinue use of NIOX MINO® and contact Aerocrine Inc. Technical Support.

6. Immediately attach the QC plug

7. Select the Forward icon on the display

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6. Select Return to go back to the Mode screen

Note! If the daily Quality Control is not successfully performed, or if the results from the QC are outside limits, an asterisk will be displayed beside every measurement value Note! The prompt to QC the device will remain if the QC measurement was performed by a nonqualified QC candidate. It is not an indication of an unsuccessful (failed) QC measurement.

View QC information QC tester information is stored in the instrument. 1. Select Mode 2. Select QC 3. Select QC info

View stored QC results All previous QC results are stored in the instrument and can be viewed at any time by using the following procedure: 1. Select Mode 2. Select QC 3. Select QC measurement results

4. The QC information is displayed: A. Mean QC FeNO value and latest moving mean date for QC testers 1 and 2 B. Ongoing qualification, position in QC measurement sequence for QC tester 3, and latest qualification measurement date C. The QC tester 4 is not qualified

4. The latest stored measurement is displayed A. Positive control result: FeNO value and limits (mean value +/- 10 ppb) B QC tester number C. Negative control result (should be < 5 ppb) D. QC sequence number E. Time and date of measurement

A

The qualification results can also be displayed A. QC tester qualifying result B QC tester number C. QC sequence number

A

4. Select Reset QC tester

B

5. Select the QC tester to be reset

5. Use the previous and next buttons to step through the results

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B

A B C

Reset QC tester

C

This procedure will delete the data for the selected individual

D

1. Select Settings

E

2. Select Mode Configuration 3. Select QC settings

C

6. Select the crossed-out number to confirm reset of desired user ID

Turn off NIOX MINO® Note! When within the specified operating conditions (see page 16) it is recommended to keep NIOX MINO with installed Sensor connected to a power outlet whenever possible. 1. Pull out the power supply unit connector from NIOX MINO

Moving NIOX MINO The instrument can be moved to another power outlet with optimized initiating startup. Note! The instrument must be connected to the new power outlet within a few minutes. 1. Select Settings 2. Select Controlled power off 3. Select OK to confirm

General Care • Use a new NIOX® Filter (patient filter) for each new patient. • Only clean the instrument with a cloth dampened with 70% ethanol, isopropanol or similar disinfectant. Be careful when using disinfectants as excess alcohol (ethanol) might permanently destroy the Sensor. Do not use spray detergents. Note! Never attempt to open or service the NIOX MINO instrument or Sensor.

Preventive inspections Before each measurement, visually inspect: • that NIOX MINO is not damaged • that the Sensor is in place • that a NIOX Filter is attached • that the power supply cord is undamaged and correctly connected to the instrument and to the power outlet. If any item is missing or damaged contact Aerocrine Inc.

Change Sensor

4. Move the instrument and connect it to a power outlet

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...

5. Wait until the instrument is ready to use

...while turning the orange swivel

2. Remove the Sensor

3. Insert the new Sensor

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4. Turn back the orange swivel until locked

8. Input the passcode 0000 using the number buttons to confirm that a new NO scrubber is installed

Change NO scrubber

9. Select OK

1. Spread the latches apart, one at a time, (Optionally: Use the red QC plug to spread the latches apart)

Disposal of used/expired products • Used or expired NIOX MINO® Sensors should be recycled according to the local recycling program for electronic equipment. Note that there is a LiMnO2 battery inside the Sensor unit*. • An expired NIOX MINO should be recycled, according to the local program for electronic equipment. Note that there is a LiMnO2 backup battery inside the instrument*. • The NO scrubber contains potassium permanganate and should be disposed of as hazardous waste in accordance with the local waste disposal regulations. • NIOX MINO is RoHS compliant. * The batteries are not user-replaceable parts.

... and carefully pull out the cover

2. Remove the used NO scrubber from the cover

3. Insert the new NO scrubber into the cover

Make sure to use a new NO scrubber, with an unbroken hole 4. Replace the cover and make sure it snaps in place

5. Select Settings 6. Select NO scrubber 7. Again select NO scrubber

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Return shipments Contact Aerocrine Inc. before returning any instrument or accessory. See contact information at the end of this User Manual.

Support Unbroken

Broken

Please contact Aerocrine, Inc. Technical Support if you encounter problems, which you can not solve with the actions stated in this manual. For contact details, see back-page of this manual, and provide the following information: • Your name, address and telephone number. • Serial No. (both instrument and Sensor). • Alert description (as thorough as possible). • Alert codes or lists.

Limited warranty Aerocrine Inc. provides a Limited Warranty for this instrument and original accessories delivered with this instrument. Conditions are defined at the time of purchase. Do NOT try to repair the instrument. It is NOT permitted to open the instrument. Any attempt to open the instrument will void the warranty and performance to specifications cannot be guaranteed.

Troubleshooting Warning

Action Asterisk shown. The instrument has not been verified by a daily QC. Perform a QC measurement.

Daily QC measurement outside limits. Restart the daily QC measurement with another QC tester.

The inhalation was too weak to initiate a measurement or an exhalation into the instrument was performed prior to an inhalation. Stop the procedure immediately when this warning appears. Wait until the main menu screen is displayed and repeat the inhalation with a stronger inhalation force. NO scrubber reminder. The symbol is shown at first start-up of the instrument as a reminder to insert and set the software for a new NO scrubber. See Installation and set-up section page 4. NO scrubber almost expired. Order a new NO scrubber. The symbol is shown when 10% of the measurements remain or 2 weeks before expiration date and continue until the NO scrubber has expired. A NO scrubber can be used for 1000 measurements or 1 year. Refer to the Change NO scrubber section on page 14. No Sensor connected. Insert a Sensor.

Warning

Action Sensor almost expired. Order a new Sensor. The symbol is shown when 10% of the measurements remain or 2 weeks before expiration date and will be shown until the Sensor has expired. Refer to the Change Sensor section page 13. Instrument almost expired. Order a new instrument. The symbol is shown 4 months before the instrument expires or when 10% of the measurements remain. The instrument will not work after the indicated date, or after the indicated number of measurements. It is still possible to view measurements stored in the instrument memory and download data to a PC. Make sure that the ambient temperature is between 60 and 85°F (+16 and +30°C). Wait for the Sensor to stabilize.

Remove any sources of disturbance (such as cordless or mobile telephones, or gas emitting appliances). Wait for the Sensor to stabilize.

Wait for the Sensor to stabilize. < 4 minutes (countdown started).

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Alert codes

Code

Alert messages and other information are shown as codes at the top of the instrument display. The table below provides the recommended actions to be taken for an alert code. If alert persists, contact Aerocrine Inc.

QC alerts A50 The mean value of the three qualification results does not fall between 5-40 ppb. Restart the QC tester qualification from qualification day 1. A51 There has been an attempt to perform several QC measurements at the same day with the same test person. Wait one day and perform the next QC measurement. A52 Moving mean value out of range. Restart the QC tester qualification from qualification day 1. A53 NO scrubber result over 5 ppb. Check that the QC Plug was attached when instructed. Restart the QC measurement. If continuously shown replace the NO scrubber. A54 Daily QC result lower than 5ppb. Restart the measurement with a test person who has a FeNO value higher than 5 ppb. A55 Daily QC result higher than 40 ppb. Restart the measurement with a test person who has a FeNO value lower than 40 ppb. A56 Failure to press the QC plug forward button in time (within 1:30 min). Repeat the QC measurement and make sure to press the forward button after the QC plug is inserted.

Code

Action

User alerts A10 Exhalation too strong. Select Return and repeat the measurement with less force. A11 Exhalation too weak. Select Return and repeat the measurement with greater exhalation force and exhale until signal for completed exhalation is heard. A12 No exhalation detected. Select Return and repeat the measurement and exhale into the instrument directly after inhalation. A13 Select Return and repeat the measurement. Do not breathe through the patient filter during analysis. A14 Wrong passcode for NO scrubber exchange. Instruments alerts A20 Check that 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 cordless/mobile telephones, or gas emitting appliances). When the instrument is ready try to repeat the measurement. If the alert persists, unplug and reconnect the power supply unit to restart the instrument. A22 Unplug and connect the power supply unit to restart the instrument. A23 Remove any sources of disturbance (such as cordless/mobile telephones, or gas emitting appliances). When the instrument is ready try to repeat the measurement. If the alert persists, unplug the power supply unit, remove and reinsert the Sensor, reconnect the power supply unit and restart the instrument. A24 Check that the supply voltage is within specification. If necessary replace the power supply unit. Connection alert A31 Check the USB connection to the PC

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Action

Instrument and Sensor expiration alerts A90 Instrument expiration date has passed or all instrument measurements have been used. It is still possible to view measurements stored in the instrument memory and download data to a PC. Contact Aerocrine, Inc. A91 Sensor expiration date has passed or all measurements on the Sensor have been used. Replace the Sensor.

Technical data Display buttons and symbols Button

Button

Description

Description Next

Enter patient ID

Decrease

Mode Configuration Increase Measurement modes Settings

to

Number Backspace

QC settings Standard 10 second exhalation FeNO measurement Not available for the US market, research application

Shift to keypad 0-4 Shift to keypad 5-9 Not available for the US market

QC measurement Ambient NO measurement

Not available for the US market

Not available for the US market, research application

US time and date settings

Stored measurement results

ISO time and date settings

Stored QC measurement results

Alert info

Not available for the US market, research application

External QC on

Not available for the US market, research application

External QC off

Demonstration mode Clock Information QC info Forward

Reset QC tester Confirm QC tester reset Sound and top light Sound Top light

OK

NO scrubber setting

Return

Controlled power off

Previous 17

Symbol

Description

Symbol

Description

Not available for the US market Sensor warning USB cable connected The instrument has not been verified by a daily QC

Temperature warning

Sleep mode Standard FeNO measurement Not available for the US market, research application

NO scrubber expiration warning

Wait

Not available for the US market, research application Ambient NO measurement

Not available for the US market, research application

Wait, time

Wait for temperature stabilization

Wait for Sensor stabilization Insert QC plug

Insert Sensor NO scrubber NO scrubber General warning

Instrument expiration warning

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