niox mino the new niox mino asthma inflammation monitor · the new niox mino ® asthma inflammation...

The New NIOX MINO®

Asthma Inflammation MonitorFrom the company that is revolutionizing the way asthma is managed

A new dimension in AsthmA cAre

Aerocrine is a medical technology company focused on improving the management and care

of patients with inflammatory airway diseases. As the pioneer and leader in eNO technology to

monitor and manage airway inflammation, Aerocrine markets NIOX® Flex and NIOX MINO®.

Both products enable fast and reliable measurement of airway inflammation and may therefore

play a critical role in more effective treatment and follow-up of patients with inflammatory airway

diseases such as asthma.

The founders of Aerocrine emerged from the highly prestigious Karolinska Institute in Sweden where

they were the first to identify Nitric Oxide (NO) as a marker of airway inflammation. Aerocrine has

taken this significant discovery from laboratory to clinical practice and is now established in some of the

world’s largest markets. Over 1 million tests have been successfully performed with NIOX MINO.

NIOX MINO® is 510 (k) cleared by FDA.

CE-marked according to In Vitro Diagnostic Device Directive 98/79/EC and approved for clinical use.

US Patent 5,447,165, US Patent 5,922,610, US Patent 6,038,913, US Patent 6,063,027, US Patent 6,099,480, US Patent 6,149,606,


US Patent 7,014,692, US Patent 7,270,638, US Patent D448,693, US Patent D457,231, US Patent D492,035, US Patent D496,667 and

patents pending.

NIOX MINO, NIOX and Aerocrine are registered trademarks of Aerocrine AB.

www.nioxmino.com, www.aerocrine.com

Aerocrine Inc., 562 Central Avenue, New Providence, NJ 07974Phone: (866) 275-6469, Fax: (866) 630-6469, E-mail: [email protected]

Now it’s even more useful in your clinicTo date, more than 1 million tests have been successfully

completed. The performance is well documented in more than

25 clinical papers in peer reviewed journals making NIOX MINO

a true market leader in monitoring airway inflammation.

Aerocrine posesses an impressive knowledge and competence

within asthma inflammation measurement and is revolution-

izing the way airway inflammation is managed. With the new

version of NIOX MINO, we have taken another leap forward

in measuring exhaled Nitric Oxide (eNO).

NIOX MINO® – The market leader in Asthma Inflammation Monitoring Over 1 million successful tests performed

NIOX MINO Data ManagerFor more efficient management of patient data, Aerocrine has de-

veloped new software – NIOX MINO Data Manager.

NIOX MINO uses IR communication for easy transfer of patient

data to a PC. Historical patient data can be followed over time

and presented graphically.

Nitric oxide (NO) is produced in the

epithelial cells of the bronchial wall as

part of the inflammatory process. Exhaled

NO production increases when there is

eosinophilic airway inflammation.

The presence of endogenous NO in

exhaled air was f irst reported in 1991

by Gustafsson et al. and in 1993 Alving

et al. found that NO in exhaled air was

elevated in patients with asthma. These

researchers are among the founders of

Aerocrine.

There has been a continuous f low of

research and a large body of data (>1,500

publications in peer reviewed medical

journals) to confirm the clinical value of

exhaled NO measurement.

510(k) K072816

Aerocrine - Revolutionizing the way asthma is managed

EMD

-00

0102

-01

Apr

il 20

09

1. Hewitt RS, et al. Supporting the diagnosis of non-specific respiratory symptoms in primary care: the role of exhaled nitric oxide measurement and spirometry. Prim Care Respir J. 2008;17(2):97-103. 2. Smith AD, et al. Exhaled nitric oxide: a predictor of steroid response. Am J Respir Crit Care Med. 2005;172:453-9. 3. Zeiger, RS, et al. Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma. J Allergy Clin Immunol. 2006;117(1):45-52. 4. Sorkness, CA, et al. Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: the Pediatric Asthma Controller Trial. J Allergy Clin Immunol. 2007;119(1):64-72. 5. Szefler, SJ, et al. Significant variability in response to inhaled corticosteroids for persistent asthma. J Allergy Clin Immunol. 2002;109(3):410-8. 6. Little, SA, et al. Non-invasive markers of airway inflammation as predictors of oral steroid responsiveness in asthma. Thorax 2000;55(3):232-4. 7. Knuffman, et al. Phenotypic predictors of long-term response to inhaled corticosteroid and leukotriene modifier therapies in pediatric asthma. J Allergy Clin Immunol. 2009;123(2):411-6. 8. Beck-Ripp J, et al. Changes of exhaled nitric oxide during steroid treatment of childhood asthma. Eur Respir J. 2002;19:1015-9. 9. Delgado-Corcoran C, et al. Exhaled nitric oxide reflects asthma severity and asthma control. Pediatr Crit Care Med. 2004 5(1):48-52. 10. Berg J, Lindgren P. Economic evaluation of FENO measurement in diagnosis and 1-year management of asthma in Germany. Respir Med. 2008;102(2):219-31.11. Price D et al. An economic evaluation of NIOX MINO airway inflammation monitor in the United Kingdom. Allergy 2009 Mar;64(3):431-8.12. Smith AD, et al. Use of Exhaled Nitric Oxide Measurements to Guide Treatment in Chronic Asthma. N Engl J Med. 2005;352:2163-73. 13. Pijnenburg MW, et al. Titrating steroids on exhaled nitric oxide in asthmatic children: a randomized controlled trial. Am J Respir Crit Care Med. 2005;172:831-6. 14. Pijnenburg MW, et al. Exhaled nitric oxide predicts asthma relapse in children with clinical asthma remission. Thorax 2005;60:215-8. 15. Hemmingsson T, et al. Novel Hand-held device for exhaled nitric oxide analysis in research and clinical applications. J Clin Moni Comput. 2004;18:379-87. 16. Sovijärvi A, et al. Accuracy and repeatability of a hand-held nitric oxide analyzer in adults with respiratory symptoms. ERS Annual Congress, Copenhagen 2005, Poster 3670. 17. Alving K, et al. Performance of a new hand-held device for exhaled nitric oxide measurement in adults and children. Respir Res. 2006;7:67. 18. Gill M, et al. Validation study of fractional exhaled nitric oxide measurements using a handheld monitoring device. J Asthma 2006;43(10):731-4. 19. Martins P, et al. Reproducibility of eNO measurements in children using a hand-held analyser. Eur Respir J. 2006; 28, suppl 50: Poster 4528. 20. McGill C, et al. Validation of a hand-held exhaled nitric oxide analyzer for use in children. Pediatr Pulmonol. 2006;41(11):1053-7. 21. Pijnenburg MW, et al. Daily ambulatory exhaled nitric oxide measurements in asthma. Pediatr Allergy Immunol. 2006;17(3):189-93.22. Chen W, et al. Niox and Niox Mino: comparison of exhaled NO in grass pollen allergic adult volunteers. Allergy 2007;62(5):571-2. 23. Khalili B, et al. Reliability of a new hand-held device for the measurement of exhaled nitric oxide. Allergy 2007;62:1171-1174. 24. Menzies D, et al. Portable exhaled nitric oxide measurement: Comparison with the “gold standard” technique. Chest 2007;131(2):410-4. 25. Sardón Prado O, et al. Agreement between two devices for measuring exhaled nitric oxide. An Pediatr (Barc). 2007;67(6):572-7. 26. Kostikas K, et al. Portable exhaled nitric oxide as a screening tool for asthma in young adults during pollen season. Chest 2008 Apr;133(4):906-13. 27. Sardón Prado O, et al. Fractional exhaled nitric oxide: Validation of a 6 second exhalation time with two different analysers. An Pediatr (Barc). 2008;69(3):221-6.28. Torre O, et al. Feasibility and interpretation of FE(NO) measurements in asthmapatients in general practice. Respir Med. 2008;102(10):1417-24. 29. ATS/ERS Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005. Am J Respir Crit Care. 2005;171:912-30. 30. Medical Design Excellence Award 2005. 31. Industrial Excellence Awards 2005.

Procedure

View results on screen

The procedure can be performed us-ing either audio or visual feed-back. Procedure and measurement results are available within two minutes.

Empty lungs

Exhale through filter

Inhale deeply through disposable filter

NIOX MINO® – convenient for you and your patients to useNIOX MINO® – The Asthma Inflammation Monitor for exhaled Nitric Oxide (eNO)

NIOX MINO® – make your practice a center of exellenceNIOX MINO provides immediate measurement of the inflam ma

tion status. This quick, easy and noninvasive tool can make your

practice a center of excellence in the management of asthma.

• Extensive clinical publications15–28

• Awardwinning ergonomic design30, 31

• Collaborate with eNO pioneers and market leaders with the

greatest experience in airway inflammation

Ask Aerocrine – you get help from the world’s most eminent clinical expertsAs a valued user of NIOX MINO, Aerocrine will support you

and answer your questions.

We are in touch with the world’s most eminent clinical experts

and always aim to provide you with the latest information regard

ing the clinical use of inflammation measurement.

Historical patient data can be followed over time and be presented graphically using the new software NIOX MINO Data Manager.

Test Cards make it possible to store individual patient dataover time.

Disposable single use bacterial and viral filter prevents contamination.

Filtering of inhaled air eliminates contami-nation from elevated ambient NO levels.

NIOX MINO Sensor Pre-calibrated disposable sensor for 100 or 300 measurements.

Touch-screen for quick and easy navigation and display of results.

Asthma is defined as a chronic inflammatory process, which

leads to airflow limitation and increased responsiveness to

asthma triggers. Until now, routine assessment of the level of

inflammation has not been possible.

Controlling the inflammation, rather than its consequences, can

dramatically improve the treatment and care of your asthma

patients.

Relying on the patient’s history, subjective evaluation of current

symptoms and lung function test results is considered reactive

symptom control.

Be proactive – measure what really matters – exhaled Nitric

Oxide (eNO) for inflammation status. This means that you can

detect a deterioration in the patient’s asthma before it causes

problems.

NIOX MINO® – allows personalized asthma careInflammation measurement with NIOX MINO offers personal

ized asthma care that can dramatically improve the treatment

and care of your patients.

It takes less than 2 minutes to get an eNO value of the in

flammation. With results in hand, you and your patient get

im mediate feedback on the inflammatory status. The patient’s

understanding of the disease improves, which results in better

adherence to treatment.

The NIOX® Value – the new Gold Standard in Inflammation MonitoringThe value you get from NIOX MINO, the NIOX Value, is always

quality assured. Various factors can influence the measurement

of the patient’s inflammation. An accurate and reliable eNO value

is vitally important for both the physician and the patient.

The NIOX Value together with other diagnostic parameters is the

basis for important decisions concerning the patient’s asthma

management program.

NIOX MINO has a builtin, highly sensitive quality assurance

system that will always guarantee an exact and accurate mea

surement that can be relied upon – The NIOX Value.

• Both low and high NIOX Values are of clinical significance1

• It’s a predictor of steroid response.17

• It improves the patient’s understanding and improves

adherence to treatment8, 9

• It is cost effective10, 11

• It optimizes doseadjustments12, 13

• It predicts asthma relapse.14

Accurate resultsNIOX MINO with its precalibrated NO sensor provides a

NIOX® Value that is immediate, accurate, reproducible and

quality assured.15–28

Infection controlA disposable bacterial and viral filter prevents contamination.

Easy fingertip navigationNIOX MINO has an improved touchscreen for quick and easy

navigation and provides a clear display of results.

Dynamic flow controlThe builtin flow regulator makes it easy, even for young chil

dren, to keep a constant flow rate of 50 mL/sec during the

ex halation.

Quality assuredAn automatic surveillance procedure continually checks for

malfunction of the device and the NO sensor.

Inhalation of NO-free airNIOX MINO removes ambient NO, which ensures accuracy

and follows the recommendations by ATS/ERS.29

Additional features• No calibration or maintenance

• Suitable for adults and children from 7 years

• Designed to comply with the ATS/ERS recommendations for

the standardized procedure for “single breath” measurement

of exhaled NO at a flow rate of 50 mL/sec (Section 2)29

• 510(k) cleared by FDA

• CE marked for clinical use

1

2

3

Demo ModeShows the procedure in order to give the patient an under

standing of how to perform the test.

Data Storage

Test Cards (smart cards) for convenient patient data storage.

Data transfer to a PC...


data to a PC using the new software NIOX MINO Data Manager.

Historical patient data can be followed over time and patient

data can be presented graphically. The software also makes it

possible to create patient reports that can be printed or stored

as a PDF file.

Measurement data can be further exported for statistical

analysis.

...or to a printer

The patient data can be transfered to a printer via the IR port.

The New NIOX MINO®


















patents pending.






























Aerocrine.






510(k) K072816


EMD

-00

0102

-01

Apr

il 20

09


Procedure

View results on screen

The procedure can be performed us-ing either audio or visual feed-back. Procedure and measurement results are available within two minutes.

Empty lungs

Exhale through filter

Inhale deeply through disposable filter

NIOX MINO® – convenient for you and your patients to useNIOX MINO® – The Asthma Inflammation Monitor for exhaled Nitric Oxide (eNO)

NIOX MINO® – make your practice a center of exellenceNIOX MINO provides immediate measurement of the inflam ma

tion status. This quick, easy and noninvasive tool can make your

practice a center of excellence in the management of asthma.

• Extensive clinical publications15–28

• Awardwinning ergonomic design30, 31

• Collaborate with eNO pioneers and market leaders with the

greatest experience in airway inflammation

Ask Aerocrine – you get help from the world’s most eminent clinical expertsAs a valued user of NIOX MINO, Aerocrine will support you

and answer your questions.

We are in touch with the world’s most eminent clinical experts

and always aim to provide you with the latest information regard

ing the clinical use of inflammation measurement.

Historical patient data can be followed over time and be presented graphically using the new software NIOX MINO Data Manager.

Test Cards make it possible to store individual patient dataover time.

Disposable single use bacterial and viral filter prevents contamination.

Filtering of inhaled air eliminates contami-nation from elevated ambient NO levels.

NIOX MINO Sensor Pre-calibrated disposable sensor for 100 or 300 measurements.

Touch-screen for quick and easy navigation and display of results.

Asthma is defined as a chronic inflammatory process, which

leads to airflow limitation and increased responsiveness to

asthma triggers. Until now, routine assessment of the level of

inflammation has not been possible.

Controlling the inflammation, rather than its consequences, can

dramatically improve the treatment and care of your asthma

patients.

Relying on the patient’s history, subjective evaluation of current

symptoms and lung function test results is considered reactive

symptom control.

Be proactive – measure what really matters – exhaled Nitric

Oxide (eNO) for inflammation status. This means that you can

detect a deterioration in the patient’s asthma before it causes

problems.

NIOX MINO® – allows personalized asthma careInflammation measurement with NIOX MINO offers personal

ized asthma care that can dramatically improve the treatment

and care of your patients.

It takes less than 2 minutes to get an eNO value of the in

flammation. With results in hand, you and your patient get

im mediate feedback on the inflammatory status. The patient’s

understanding of the disease improves, which results in better

adherence to treatment.

The NIOX® Value – the new Gold Standard in Inflammation MonitoringThe value you get from NIOX MINO, the NIOX Value, is always

quality assured. Various factors can influence the measurement

of the patient’s inflammation. An accurate and reliable eNO value

is vitally important for both the physician and the patient.

The NIOX Value together with other diagnostic parameters is the

basis for important decisions concerning the patient’s asthma

management program.

NIOX MINO has a builtin, highly sensitive quality assurance

system that will always guarantee an exact and accurate mea

surement that can be relied upon – The NIOX Value.

• Both low and high NIOX Values are of clinical significance1

• It’s a predictor of steroid response.17

• It improves the patient’s understanding and improves

adherence to treatment8, 9

• It is cost effective10, 11

• It optimizes doseadjustments12, 13

• It predicts asthma relapse.14

Accurate resultsNIOX MINO with its precalibrated NO sensor provides a

NIOX® Value that is immediate, accurate, reproducible and

quality assured.15–28

Infection controlA disposable bacterial and viral filter prevents contamination.

Easy fingertip navigationNIOX MINO has an improved touchscreen for quick and easy

navigation and provides a clear display of results.

Dynamic flow controlThe builtin flow regulator makes it easy, even for young chil

dren, to keep a constant flow rate of 50 mL/sec during the

ex halation.

Quality assuredAn automatic surveillance procedure continually checks for

malfunction of the device and the NO sensor.

Inhalation of NO-free airNIOX MINO removes ambient NO, which ensures accuracy

and follows the recommendations by ATS/ERS.29

Additional features• No calibration or maintenance

• Suitable for adults and children from 7 years

• Designed to comply with the ATS/ERS recommendations for

the standardized procedure for “single breath” measurement

of exhaled NO at a flow rate of 50 mL/sec (Section 2)29

• 510(k) cleared by FDA

• CE marked for clinical use

1

2

3

Demo ModeShows the procedure in order to give the patient an under

standing of how to perform the test.

Data Storage

Test Cards (smart cards) for convenient patient data storage.

Data transfer to a PC...


data to a PC using the new software NIOX MINO Data Manager.

Historical patient data can be followed over time and patient

data can be presented graphically. The software also makes it

possible to create patient reports that can be printed or stored

as a PDF file.

Measurement data can be further exported for statistical

analysis.

...or to a printer

The patient data can be transfered to a printer via the IR port.

The New NIOX MINO®


















patents pending.






























Aerocrine.






510(k) K072816


EMD

-00

0102

-01

Apr

il 20

09


Technical Specifications

OperaTing and meaSuremenT cOndiTiOnS

Ambient temperature 60 to 85°F (16 to 30°C)

Atmospheric pressure range 10 to 15 psi (700 to 1060 hPa)

Humidity 20 to 60% RH (non-condensing)

Ambient NO concentration < 300 ppb

Exhaled flow rate during measurement 50 mL/sec ± 10% BTPS Body Temperature Pressure Saturated, 98.7°F (37°C), 14.7 psi (1013 hPa), 100% RH

perfOrmance daTa

Measurement range 5 to 300 ppb

Lowest detection limit 5 ppb

Measurement time < 2 min

Temperature stabilization time ≤ 30 min

Linearity Squared correlation coefficient r2 ≥ 0.998. Determina-tion based on the regression analysis using standard gas reference samples at six different concentration levels covering the operating measurement range.

Precision Analytical precision: < 3 ppb of measured value < 30 ppb, < 10 % of measured value ≥ 30 ppb.

Expressed as one standard deviation for replicate measu-rements with the same instrument, using a certified gas concentration of Nitric Oxide reference standard.

Clinical precision: < 3 ppb of measured value < 30 ppb <10% of measured value ≥ 30 ppb

Determination based on consecutive measurements from the same patient, performed by different operators.

Accuracy Analytical Accuracy: ±5 ppb or max 15 %

Expressed as the upper 95% confidence limit, based on mean of absolute differences from certified gas concentration of Nitric Oxide reference standard.

Method comparison ± 5 ppb for values < 50 ppb ±10 ppb for values 50 – 100 ppb ±25 ppb for values > 100 ppb

Expressed as the difference, using one standard de-viation, between a NIOX MINO measurement value and the corresponding value measured with NIOX instrument from Aerocrine.

exhalaTiOn Time 10 seconds

SOfTware Memory capacity: 1500 measurements (Instrument memory)

dimenSiOnS, weighT and Shelf-life

Height, Width, Depth 9.4” (240 mm), 5.1” (130 mm), 3.9” (100 mm)

Weight including sensor 1.8 lb (0.8 kg)

Shelf-life Minimum 3 years at time of delivery or 1500 measurements, whatever comes first

elecTrical daTa

According to IEC 60601-1 Class II Type B

Main voltage 100 to 240 V ~ 50 to 60 Hz

Secondary voltage 6 V DC (external power adapter)

Asthma Inflammation Monitor

NIOX MINO Item number 03-1000-US

Contains: NIOX MINO device, AC/DC Adapter, Bag, User Manual, QC Test Kit, Test Card and Service Card.

NIOX MINO MONI T O R IN G SY S TEM 100 Item number 03-4500-US

Contains: NIOX MINO, Sensor* and �lters** for 100 measurements.

NIOX MINO MONI T O R IN G SY S TEM 300 Item number 03-4501 -US

Contains: NIOX MINO, Sensor* and �lters** for 300 measurements.

AccessoriesNIOX MINO T E S T K IT 100

Sensor* and �lters** for 100 measurements. Item number 03-4000-US

NIOX MINO T E S T K IT 300

Sensor* and �lters** for 300 measurements. Item number 03-4001-US

* NIOX MINO Sensor

Pre-calibrated disposable sensor for 100 or 300 measurements.

Shelf-life: 15 months from date of manufacture and in unopened primary package. 9 months after mounted in NIOX MINO.

** NIOX Filter

Disposable �lter to be changed for every patient. Bacterial, viral �lter according to Medical Device Directive Class IIa.

NIOX MINO Quality Control Test Kit

Contains: NIOX MINO QC Sensor, QC Filter, QC Card. Item number 03-4099

NIOX MINO Test Card (smart card)

2000 measurements memory capacity.

Standard: for 10 seconds exhalation, clinical use. Item number 03-1301

NIOX MINO Data Manager

For transfer of measurement values to a PC. Item number 03-5000

NIOX MINO is 510(k) cleared (K072816) by FDA. NIOX MINO is CE-marked according to In Vitro Diagnostic Device Directive 98/79/EC and approved for clinical use. US Patent 5,447,165, US Patent 5,922,610, US Pa -tent 6,038,913, US Patent 6,063,027, US Patent 6,099,480, US Patent 6,149,606, US Patent 6,183,416, US Patent 6,511,425, US Patent 6,626,844, US Patent 6,723,056, US Patent 6,733,463, US Patent 6,761,185, US Patent 7,014,692, US Patent 7,270,638, US Patent D448,693, US Patent D457,231, US Patent D492,035,

US Patent D496,667 and patents pending.


A NE W DIMENSION IN AST H M A CA R E

Asthma In�ammation Monitor

EMD

-000

103-

01 A

pril

200

9K072816

Tel.: 1-800-361-6991Email: [email protected]

www.roxon.ca

niox mino the new niox mino asthma inflammation monitor · the new niox mino ® asthma inflammation...

Documents