Monitor is only portable oximeter on the market that is indicated for
use in home care settings and is compliant with international standards
for devices used in the home health care environment
DUBLIN, Ireland--(BUSINESS WIRE)--Oct. 9, 2014--
plc (NYSE: COV) today announced U.S. Food and Drug Administration
510(k) clearance for the Nellcor™ Portable SpO2 Patient
Monitoring System (PM10N). The system is the only commercially available
portable oximeter that is equipped with home care and sleep study modes
and complies with IEC 60601-1-11 standards for devices used in the home
health care environment.
Part of a comprehensive Covidien respiratory function monitoring
portfolio, this convenient, handheld patient monitor is simple to use
and ideal for fast, accurate, motion-tolerant monitoring of pulse rate
and blood oxygenation (SpO2). The Nellcor™ Portable SpO2
Patient Monitoring System’s compact design and ability to perform in
challenging conditions make it an ideal tool for multiple critical
clinical screenings including: Six Minute Walk Test, Critical Congenital
Heart Disease Screening and Car Seat Challenge Test.
The lightweight system is user-friendly and features a home care mode
that expands the utility of the monitor beyond the hospital to home-use
environments. With a simplified user interface, patients can clearly
view their vital sign readings, and the settings cannot be easily
altered by the patient, so clinicians can feel confident prescribing the
home-use of this monitor. The system also features a sleep study mode
that enables dimming the LCD display and silencing alarms to prevent
disrupting patients’ sleep.
“Covidien’s new generation of portable monitors is easy to use and
brings our proven pulse oximetry technology to patients inside the
hospital, in health care facilities, and even in their own homes,” said
Matt Anderson, vice president & general manager, Patient Monitoring,
Covidien. “Because our pulse oximetry technology relies on cardiac
signals, it mitigates signal interference, offering caregivers peace of
mind. They can count on Covidien to provide accurate patient data, even
during difficult conditions. The development of this product exemplifies
Covidien’s dedication to enhance patient care, both inside and beyond
The monitoring system includes a vivid three-inch color LCD screen, as
well as connectivity to analytics tools and patient management systems.
It is compatible with the entire line of Nellcor™ sensors with OxiMax™
technology and offers a robust monitoring feature set including SpO2,
pulse rate, SatSeconds alarm management, pleth waveform, blip bar and
tabular trend information. The monitor incorporates Nellcor™ digital
signal processing technology to deliver accurate, reliable SpO2
and pulse rate values even during challenging conditions, such as
patient motion, noise, signal interference and low perfusion, all of
which can interfere with assessing a patient’s respiratory status.
The system can be used as a tool for the following critical clinical
Six Minute Walk Test – This test evaluates the response of all
systems involved during exercise, including the pulmonary and
cardiovascular systems, systemic circulation, peripheral circulation,
blood, neuromuscular units, and muscle metabolism. The Six Minute Walk
Test provides an objective measurement of a patient’s exercise
Critical Congenital Heart Disease (CCHD) Screening – Every
year, about 4,800 (or 11.6 per 10,000) babies in the United States
alone are born with CCHD. These babies are at significant risk if this
condition goes undiagnosed.2 Since 1993, Nellcor™ pulse
oximetry technology has been utilized on more than 33,000 newborns
spanning five separate clinical studies evaluating the use of pulse
oximetry for critical congenital heart disease screening.3-7
Car Seat Challenge Test – According to the American Academy of
Pediatrics guidelines, as part of the discharge process, each preterm
infant born less than 37 weeks gestational age should have a period of
observation in a car safety seat before hospital discharge to monitor
for possible apnea, bradycardia or oxygen desaturation.8-9
More information on the product portfolio is available by visiting Covidien.com/Nellcor.
Covidien is a global health care leader that
understands the challenges faced by providers and their patients and
works to address them with innovative medical technology solutions and
patient care products. Inspired by patients and caregivers, Covidien’s
team of dedicated professionals is privileged to help save and improve
lives around the world. With more than 38,000 employees, Covidien
operates in 150-plus countries and had 2013 revenue of $10.2 billion. To
learn more about our business visit www.covidien.com
or connect with us on Twitter.
1. American Thoracic Society. ATS Statement: Guidelines for the
Six-Minute Walk Test. Available at:
2. Centers for Disease Control and Prevention. Pulse Oximetry Screening
for Critical Congenital Heart Defects. Available at:
3. Hoke, T.R., et al., Oxygen saturation as a screening test for
critical congenital heart disease: a preliminary study. Pediatr Cardiol,
2002 Jul-Aug. 23(4): p. 403-9.
4. Reich, J.D., et al., The use of pulse oximetry to detect congenital
heart disease. J Pediatr, 2003 Mar. 142(3): p. 268-72.
5. Arlettaz, R., et al., The contribution of pulse oximetry to the early
detection of congenital heart disease in newborns. Eur J Pediatr, 2006
Feb. 165(2): p. 94-8.
5. Sendelbach, D.M., et al., Pulse oximetry screening at 4 hours of age
to detect critical congenital heart defects. Pediatrics, 2008 Oct.
122(4): p. e815-20.
6. Walsh, W., Evaluation of pulse oximetry screening in Middle
Tennessee: cases for consideration before universal screening. J
Perinatol, 2011 Feb. 31(2): p. 125-9.
7. Centers for Disease Control and Prevention. Facts about Critical
Congenital Heart Defects. Available at:
9. Davis, N., et al., Car Seat Safety for Preterm Neonates:
Implementation and Testing Parameters of the Infant Car Seat Challenge.
Academic Pediatrics, 2013 May-June 13 (3): p. 272-277.
Rhonda Luniak, 303-406-8743
Lannum, CFA, 508-452-4343