NIOX MINO User Manual

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Page 1

ENGLISH

NIOX MINO

External Quality Control

User Manual

Page 2

Note!

This manual is an appendix to the NIOX MINO® User Manual. It describes the optional external Quality Control procedure for NIOX MINO. Please refer to the NIOX MINO User Manual for more information.

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

External Quality Control procedure (QC) ...... 2

Switching QC on/off .......................................... 2

Selection and qualication of QC testers .......... 3

QC measurement ............................................. 3

View stored QC results ..................................... 4

View QC information ......................................... 4

Reset QC tester ................................................ 5

Alerts codes ...................................................... 5

Display buttons and symbols ............................ 5

Table of contents

External Quality Control User manual 000186 (EPM-000158), version 04, December 2016, for

instruments with software version from 2005 to 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 NIOX MINO® User Manual.

Information in this document is subject to change. Amendments will be made available by Aerocrine 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.

• NIOX MINO® and NIOX® are registered trademarks of Circassia AB.

• Circassia is a registered trademark of Circassia Limited

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Warnings!

• Handle the NIOX MINO® instrument as stated in the NIOX MINO User Manual and in this manual. Aerocrine accepts no responsibility for damaged equipment or faulty results, if the equipment is not used according to the manuals mentioned above.

• 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 re. 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 uids 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, re, 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 modication of the NIOX MINO instrument

or the Sensor is allowed.

Please refer to the NIOX MINO User Manual for Cautions.

External Quality Control procedure (QC)

In addition to internal checks and self tests of NIOX MINO, the external Quality Control procedure provides the user with further

condence that the system is operating within its specications.

The external Quality Control consists of two

parts. One positive control from a qualied 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 rst 20 days of

instrument start-up, a maximum of four QC testers

can be qualied without impact to the number of

remaining tests on the Sensor.)

Switching QC on/off

1. Select Settings

2. Select QC settings

3. The QC settings are shown

4. Use the buttons to deactivate or

activate QC measurement

5. Select OK to accept the changes

The main screen shows a twinkling

asterisk to indicate that QC is on and a daily QC measurement has not been performed.

The mode screen shows a QC

measurement mode button for starting a QC measurement

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Selection and qualication 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 qualied over the course of

three days.

Note! If the most recent QC measurement is

older than 30 days, then the qualication

is suspended and the QC tester needs

to re-qualify according to the qualication

procedure.

Perform three 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 calculated from the three measurements that must be between 5-40 ppb

for the QC tester to be qualied. The following

QC measurement on the fourth day must be

within ±10ppb from the mean value and the NO

Scrubber result < 5 ppb. Once the Quality Control has been completed the instrument is ready for clinical use. The next moving mean value is calculated when the QC tester performs a QC measurement following at least 7 days.

Result screens for the QC tester qualication

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 any strenuous exercise at least 1 hour before the measurement.

Preferably do not perform a measurement in case of:

• Ongoing cold.

• Acute seasonal allergy.

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 the NIOX MINO user manual

5. Remove the patient lter

6. Immediately attach the

QC plug

7. Select the Forward icon

on the display

8. Wait for the analysis to be

completed and the test result to be displayed (approximately 5 minutes)

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9. The QC measurement result is displayed

Note!

During the qualication

days of a new QC tester the result is displayed as presented Day 1-3.

Day 1 Day 2 Day 3

A. Positive control result:

FeNO

value and

limits (mean value

+/-10ppb)

B. QC tester number C. Negative control result

(should be < 5 ppb)

After day 3

A B C

10. Remove the QC plug

Repeat the QC measurement if the positive and/ or the negative controls fail. If QC fail persists, discontinue use of NIOX MINO® and contact your local Aerocrine representative or Aerocrine Customer Support.

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

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 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

The qualication results

can also be displayed A. QC tester qualifying

result B QC tester number C. QC sequence number

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

6. Select Return to go back to the Mode screen

View QC information

QC tester information is stored in the instrument.

1. Select Mode

2. Select QC

3. Select QC info

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4. The QC information is displayed:

A. Mean QC

FeNO

value and latest moving mean date for QC testers 1 and 2

B. Ongoing qualication,

position in QC measurement sequence for QC tester 3, and

latest qualication

measurement date

C. The QC tester 4 is not

qualied

B C

Reset QC tester

This procedure will delete the data for the selected individual

1. Select Settings

2. Select QC setup

3. Select Reset QC tester

4. Select the QC tester to be reset

5. Select the crossed-over

number to conrm reset

of desired user ID

Alerts codes

Asterisk shown. The instrument has not been

veried by a daily QC –

Perform a QC measurement.

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 your local Aerocrine representative or Aerocrine Customer Support.

Code Action

QC alerts

A50 The mean value of the three qualication

results does not fall between 5-40 ppb.

Restart the QC tester qualication from qualication day 1.

Code Action

A51 There has been an attempt to perform

several QC measurements on 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 qualication from qualication 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 5 ppb. Restart

measurement with test person who has

FeNO

higher than 5 ppb.

A55 Daily QC result higher than 40 ppb.

Restart measurement with test person who has

FeNO

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.

Display buttons and symbols

Button Description

QC settings

QC measurement

Stored QC measurement results

QC info

External QC on

External QC off

Reset QC tester

Conrm QC tester reset

Symbol Description

The instrument has not been veried

by a daily QC

Insert the QC plug

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000186 (EPM-000157), version 04, December 2016, for instruments with SW from 2005 to 20XX, 22XX and 23XX

Circassia AB, an ISO 13485 certified company

Circassia AB, Råsundavägen 18, SE-169 67 Solna, Sweden

Phone: +46 8 629 07 80, Fax: +46 8 629 07 81, E-mail: [email protected]

www.niox.com.

NIOX MINO® is CE marked according to European In Vitro Diagnostic Device Directive 98/79/EEC

Circassia is a registered trademark of Circassia Limited

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.

Based on the company’s intellectual property, Circassia develops and

commercializes product 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.