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1 Eurostat. Number of Live Births in 2012 (EU27), http://epp.eurostat.ec.europa.eu/tgm/table.do?tab=table&init=1&plugin=1&language=en&pcode=tps00111; US Department of Health and Human Services. National Vital Statistics Reports, Births Final Data for 2012. December 30, 2013, http://www.cdc.gov/nchs/data/nvsr/ nvsr62/nvsr62_09.pdf#table01. 2 Bhutani VK, Johnson L. A proposal to prevent severe neonatal hyperbilirubinemia and kernicterus. J Perinatol 2009;29 Suppl 1:S61-S67. 3 Kumar RK. Neonatal jaundice: an update for family physicians. Austrian Family Physician Vol. 28 No. 7 July 1999. 4 Kuzniewicz M, Newman TB. Interaction of hemolysis and hyperbilirubinemia on neurodevelopmental outcomes in the collaborative perinatal project. Pediatrics 2009;123:1045-1050. 5 Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics 2004;114:297-316. 6 Herschel M, Karrison T, Wen M, Caldarelli L, Baron B. Isoimmunization is unlikely to be the cause of hemolysis in ABO-incompatible but direct antiglobulin test- negative neonates. Pediatrics 2002;110:127-130. 7 Tidmarsh GF, Wong RJ, Stevenson DK End-tidal carbon monoxide and hemolysis. J Perinatol. 2014 Aug;34(8):577-81. doi: 10.1038/jp.2014.66. Epub 2014 Apr 17. 8 Stevenson DK, Vreman HJ, Oh W et al. Bilirubin production in healthy term infants as measured by carbon monoxide in breath. Clin Chem 1994;40:1934-1939. 9 Vreman HJ, Wong RJ, Harmatz P, Fanaroff AA, Berman B, Stevenson DK. Validation of the Natus CO-Stat End Tidal Breath Analyzer in children and adults. J Clin Monit Comput 1999;15:421-427. 10 Castillo Cuadrado ME, Vreman HJ, Wong RJ, Stevenson DK, Bhutani VK. From bench to bedside: evaluation of a new end-tidal carbon monoxide monitor to identify hemolysis in infants. Poster presentation at Pediatrics Academic Societies Meeting, May 6, 2014. 11 Du L, Zou P, Chen L, and Bhutani V. Exhaled end-tidal carbon monoxide testing for hemolysis in neonates with significant hyperbilirubinemia and postive direct anti-globulin test. Poster presentation at Pediatrics Academic Societies Meeting, May 6, 2014. 12 Lal A, Patterson L, Goldrich A, Marsh A, Yen K, and Bhatnagar A. Detection of Elevated End-Tidal Carbon Monoxide Concentration in Children with Sickle Cell Anemia. Poster presentation at Pediatrics Academic Societies Meeting, May 6, 2014. © 2015 Capnia, Inc. All rights reserved. CoSense is a registered trademark of Capnia, Inc. CoSense ® Key Features: Supports best practices. AAP recommends the use of ETCO. Portable and non-invasive. Test the newborn at the bedside without interruption of bonding. Immediate results. Non-invasively measures ETCO, which allows the physician to determine hemolytic status in less than five minutes. Easy to use. Just three simple steps and no calibration required. MM138 1235 Radio Road, Suite 110 Redwood City, CA 94065 (650) 213-8444 | [email protected] To order, call (866) 432-3788 End-Tidal Carbon Monoxide Monitor

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1 Eurostat. Number of Live Births in 2012 (EU27), http://epp.eurostat.ec.europa.eu/tgm/table.do?tab=table&init=1&plugin=1&language=en&pcode=tps00111; US Department of Health and Human Services. National Vital Statistics Reports, Births Final Data for 2012. December 30, 2013, http://www.cdc.gov/nchs/data/nvsr/nvsr62/nvsr62_09.pdf#table01.

2 Bhutani VK, Johnson L. A proposal to prevent severe neonatal hyperbilirubinemia and kernicterus. J Perinatol 2009;29 Suppl 1:S61-S67.3 Kumar RK. Neonatal jaundice: an update for family physicians. Austrian Family Physician Vol. 28 No. 7 July 1999.4 Kuzniewicz M, Newman TB. Interaction of hemolysis and hyperbilirubinemia on neurodevelopmental outcomes in the collaborative perinatal project. Pediatrics

2009;123:1045-1050.5 Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics 2004;114:297-316.6 Herschel M, Karrison T, Wen M, Caldarelli L, Baron B. Isoimmunization is unlikely to be the cause of hemolysis in ABO-incompatible but direct antiglobulin test-

negative neonates. Pediatrics 2002;110:127-130.7 Tidmarsh GF, Wong RJ, Stevenson DK End-tidal carbon monoxide and hemolysis. J Perinatol. 2014 Aug;34(8):577-81. doi: 10.1038/jp.2014.66. Epub 2014 Apr 17.8 Stevenson DK, Vreman HJ, Oh W et al. Bilirubin production in healthy term infants as measured by carbon monoxide in breath. Clin Chem 1994;40:1934-1939.9 Vreman HJ, Wong RJ, Harmatz P, Fanaroff AA, Berman B, Stevenson DK. Validation of the Natus CO-Stat End Tidal Breath Analyzer in children and adults. J Clin

Monit Comput 1999;15:421-427.10 Castillo Cuadrado ME, Vreman HJ, Wong RJ, Stevenson DK, Bhutani VK. From bench to bedside: evaluation of a new end-tidal carbon monoxide monitor to

identify hemolysis in infants. Poster presentation at Pediatrics Academic Societies Meeting, May 6, 2014.11 Du L, Zou P, Chen L, and Bhutani V. Exhaled end-tidal carbon monoxide testing for hemolysis in neonates with significant hyperbilirubinemia and postive direct

anti-globulin test. Poster presentation at Pediatrics Academic Societies Meeting, May 6, 2014.12 Lal A, Patterson L, Goldrich A, Marsh A, Yen K, and Bhatnagar A. Detection of Elevated End-Tidal Carbon Monoxide Concentration in Children with Sickle Cell

Anemia. Poster presentation at Pediatrics Academic Societies Meeting, May 6, 2014.

© 2015 Capnia, Inc. All rights reserved. CoSense is a registered trademark of Capnia, Inc.

CoSense® Key Features:• Supports best practices. AAP recommends the

use of ETCO.

• Portable and non-invasive. Test the newborn at the bedside without interruption of bonding.

• Immediate results. Non-invasively measures ETCO, which allows the physician to determine hemolytic status in less than five minutes.

• Easy to use. Just three simple steps and no calibration required.

MM138

1235 Radio Road, Suite 110Redwood City, CA 94065(650) 213-8444 | [email protected]

To order, call (866) 432-3788

End-Tidal Carbon Monoxide Monitor

C o S e n s e I S T H E O N LY M O N I T O R

AVA I L A B L E T O D AY F O R T H E

A C C U R A T E D E T E C T I O N O F

E T C O I N N E W B O R N S .

N O N - I N VA S I V E LY D E T E C T S

T H E R A T E O F H E M O LY S I S

I N N E W B O R N S U S I N G E N D - T I D A L

C A R B O N M O N O X I D E ( E T C O )

M E A S U R E M E N T S I N T H E

B A B Y ’ S B R E A T H .

Easy, Rapid & Proven Solution.

BUT, some of these tests aren’t reliable in newborns.5,6

So hemolysis can continue to go undetected, placing the newborn at risk for ADVERSE NEUROLOGICAL OUTCOMES.

• In many babies, this is a normal condition that can be easily treated.

• Babies with both HYPERBILIRUBINEMIA and HEMOLYSIS are at greatest risk for adverse neurodevelopmental outcomes.4

• According to the AAP Guidelines, newborns with a hemolytic condition need to receive phototherapy at lower levels of bilirubin than other newborns.5

60-80%2,3

of these babies will develop jaundice.

How Do You Know if this is Normal

Newborn Jaundice?

Carbon Monoxide Detects Hemolysis

Carbon monoxide and bilirubin are produced in a 1:1 ratio during hemolysis. Carbon

monoxide is eliminated from the body through the lungs as ETCO. The AAP Guidelines

state that ETCO is the ONLY clinical test that measures the rate of bilirubin production

(hemolysis).5 Elevated levels of ETCO indicate the presence of hemolysis in newborns,

and hemolysis in neonates with hyperbilirubinemia confers a higher risk for adverse

neurodevelopmental outcomes.4,7

9 million babies1 are born in the US and EUROPE

each year.

TODAY, physicians order different tests:

Direct Coombs

CBCRetic

CountPeripheral

Smear

ETCO Measurement Detects the Presence of Hemolysis

Published data shows that ETCO measurement is an accurate measure of hemolysis.8,9

Three clinical trials have been conducted to validate the ability of CoSense to detect

the rate of hemolysis.10,11,12 These studies confirm that ETCO values with CoSense accurately

measure bilirubin production and can detect the rate of hemolysis in newborns10,11 and

pediatric patients.12 Preliminary data from Stanford shows that ETCO values with CoSense

closely correlate with carboxyhemoglobin levels in the blood, confirming the ability of

CoSense to measure the rate of hemolysis.10

BILIRUBIN TESTING: Provides the bilirubin

level at a single point in time.

END-TIDAL CARBON MONOXIDE TESTING:

Allows the physician to see the big picture.

Since 2004, the American Academy of Pediatrics has recommended the

use of ETCO.5

AAP Guidelines recommend the

use of ETCO testing in newborns

35 weeks’ gestation or more who:

1 are receiving phototherapy, or

2 have TSB rising rapidly, or

3 have TSB approaching transfusion levels, or

4 have jaundice unexplained by history and physical.

The CoSense End-Tidal Carbon Monoxide Monitor is not intended to screen or diagnose a specific disease or condition. Rather it is a tool intended for the monitoring of carbon monoxide in medical

conditions in which the rate of hemolysis may be relevant.