Post on 28-May-2020
transcript
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 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.
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: info.US@aerocrine.com
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...
NIOX MINO uses IR communication for easy transfer of patient
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®
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 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.
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: info.US@aerocrine.com
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...
NIOX MINO uses IR communication for easy transfer of patient
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.
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...
NIOX MINO uses IR communication for easy transfer of patient
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®
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 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.
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: info.US@aerocrine.com
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
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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.
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.
NIOX MINO, NIOX and Aerocrine are registered trademarks of Aerocrine AB.
A NE W DIMENSION IN AST H M A CA R E
Asthma In�ammation Monitor
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Tel.: 1-800-361-6991Email: sales@roxon.ca
www.roxon.ca