Why Choose Masimo?

Masimo pioneered motion and low perfusion tolerant technology. Masimo SET is the technology proven clinically in over 100 studies since 1994. Masimo Signal Extraction Technology (SET) is a breakthrough technology that represents a new and fundamentally distinct method of acquiring, processing and reporting arterial oxygen saturation and pulse rate. Masimo SET greatly enhances the accuracy of SpO2 monitoring, particularly in the most difficult patient conditions such as motion and low peripheral perfusion.

Numerous clinical studies have demonstrated that the use of Masimo SET, in conjunction with Masimo’s sensors, significantly:

1. Reduce the cost of care
2. Improve patient care
3. Improve patient safety

Clinically Proven:

Over 100 independent and objective studies have shown that Masimo SET is the industry leading technology for pulse oximetry. In addition, two ECRI publications have focused on Masimo SET.

Maximum Accuracy, Lowest Cost, Guaranteed:

Only Masimo SET has the ability to give you accurate pulse oximetry when you need it most with a written guarantee to reduce your annual pulse oximetry costs.

The First and the Best Read-Through-Motion & Low Perfusion Pulse Oximeter:

1. Unprecedented specificity and sensitivity. Essentially eliminates false alarms and detects virtually all true alarms.
2. Accurate during most patient movement, including shivering, combativeness, neonatal movement, and seizures.
3. Effective during helicopter and ambulance transport.
4. Accurate during low perfusion.
5. Designed to be accurate in intense ambient light and with electromagnetic interference, such as electrocautery.
6. Reduces cost of care through reliable monitoring and durable adhesive sensors. Studies have shown that Masimo SET adhesive sensors are replaced less than half as often as other leading brands.
7. Helps reduce neonatal eye damage. Two ground-breaking studies have shown that Masimo SET was an instrumental part of the protocol that dramatically reduced Retinopathy of Prematurity.^1,2
8. Accuracy and reliability of Masimo SET has, for the first time, made pulse oximetry a clinically useful diagnostic tool, helping clinicians determine severity of numerous patient illnesses, including giving them the the ability to accurately diagnose congenital heart disease (CHD) in infants.^3,4,5,6
9. Reduces medical errors. Another ground-breaking study showed that Masimo SET helped reduce unnecessary ABG and excessive or precipitous oxygen use. In addition, it stated that Masimo reduces latent conditions, which have been linked to medical errors.⁷
10. Proven most accurate SpO₂ technology on cyanotic patients.^8,9
11. Masimo SET in FastSat mode tracks rapid changes in arterial O₂ with high fidelity unlike any other pulse oximeter, without false alarms.
12. Masimo SET has won more than twenty prestigious industry awards, including the Society for Technology in Anesthesia Outstanding Technology Award, the Society for Critical Care Medicine Technology Excellence Award, the Medical Device Manufacturing Design Award, the American Electronic Association Breakthrough Technology Award, the Frost & Sullivan New Standard of Care Award, and the Audie Lewis Award for the best technology and service among pulse oximetry vendors.

Signal Extraction Technology

Masimo SET technology enables the power of adaptive filters to be applied to real-time physiologic monitoring by utilizing proprietary techniques to accurately establish a “noise reference” in the detected physiologic signal, thus enabling direct calculation of arterial saturation and pulse rate. While other pulse oximetry technologies employ one, or sometimes two algorithms to attempt to measure a patient’s arterial oxygen saturation, Masimo SET’s unique patented approach employs five algorithms, working in parallel, to ensure continuous, accurate SpO₂ measurement, even under the most challenging conditions.

• ¹ Chow L, Wright K, Sola A. Can changes in clinical practice decrease the incidence of severe retinopathy of prematurity in very low birth weight Infants? Pediatrics 2003; 111(2):339-345.
• ² Sola A, Rogido MR, Deulofeut R. Oxygen as a neonatal health hazard: call for detente in clinical practice. Acta Paediatr. 2007;96:801-12.
• ³ Gianelli A.D., Mellander M, Sunnegardh J, Sandberg K, Ostman-Smith I. Screening for duct-dependent congenital heart disease with pulse oximetry: A critical evaluation of strategies to maximize sensitivity, Acta Paediatrica, 2005; 94: 1590-1596.
• ⁴ Toda Y, Takeuchi M, Iwasaki T, Shimizu K, Morita K. The Accuracy of Masimo SET and Nellcor N-595 in children with cyanotic congenital heart disease. Anesthesiology 2006; 105:A1704.
• ⁵ Whitney GM, Tucker LR, Hall SR, Chang AC. Clinical evaluation of the accuracy of Masimo SET and Nellcor N-595 oximeters in children with cyanotic congenital heart disease. Anesthesiology 2005; 103:A1344.
• ⁶ de-Wahl Granelli A., Östman-Smith I. Noninvasive peripheral perfusion index as a possible tool for screening for critical left heart obstruction. Acta Paediatrica. 2007; 96: 1455-1459.
• ⁷ Durbin CG, Rostow SK. More reliable oximetry reduces the frequency of arterial blood gas analyses and hastens oxygen weaning after cardiac surgery. Crit Care Med. 2002;30(8):1735-1740.
• ⁸ Tsutumi T, Nakashima M, Yasunaga H, Nakao F, Takamatsu J. Clinical evaluation of accuracy of Masimo LNOP Blue sensor in cyanotic infants. Crit Care Med. 2006;34(12):A56.
• ⁹ Whitney GM, Tucker LR, Hall SR, Chang AC. Clinical evaluation of the accuracy of Masimo SET and Nellcor N-595 oximeters in children with cyanotic congenital heart disease. Anesthesiology. 2005;103:A1344.

SIGNAL EXTRACTION TECHNOLOGY^®: WHERE “SOLVING THE UNSOLVABLE” STARTED

Twenty-four years ago, two young engineers asked themselves why pulse oximetry wouldn’t work during patient motion and low perfusion–and by doing so, set a new course that created a revolution in patient monitoring.

OVERCOMING THE LIMITATIONS OF CONVENTIONAL PULSE OXIMETRY

Since its inception, pulse oximetry was plagued by unreliability when it was needed most–during patient motion and low perfusion. The industry had given up and considered the problem “unsolvable.” Clinicians were forced to live with the results–excessive false alarms, delayed notification due to long averaging times, inaccurate data, and an inability to obtain data on the most critical patients.

Conventional pulse oximetry works under the assumption that by looking at only the pulse and normalizing the pulsating signal over the non-pulsating signal, oxygen saturation (SpO2) can be measured without calibration. Although this was a big step forward in the evolution of pulse oximetry, it has one major flaw–it assumes the only pulsating component is arterial blood. Unfortunately for conventional pulse oximetry, venous blood moves every time the patient moves or breathes. This causes conventional pulse oximeters to display false low or high SpO2 and pulse rates–resulting in false alarms as high as 90% in ICUs and recovery rooms.

THE CHOICE OF CLINICIANS IN THE WORLD’S LEADING HOSPITALS

Because of its unmatched reliability during challenging conditions of motion and low perfusion, clinicians at thousands of hospitals around the world count on Masimo SET^® every day to help them care for patients. And while many leading hospitals have already integrated Masimo SET^® pulse oximetry technology, more are converting every day.

These hospitals and clinicians trust Masimo SET^® to help them deliver the most effective and efficient patient care possible. With fewer false alarms,¹ clinicians can focus on the patients who need the most attention. With more trustworthy measurements, clinicians can more tightly control oxygenation levels. And with more timely detection of true events, clinicians can intervene earlier for better patient outcomes and improved patient safety.

Clinical Accuracy

VALIDATED BY INDEPENDENT AND OBJECTIVE RESEARCH

To date, more than 100 independent and objective studies have shown that Masimo SET^® outperforms all other pulse oximetry technologies, providing clinicians with unmatched sensitivity and specificity to make critical patient care decisions.

Unleashing Breakthrough Performance

When Joe Kiani and Mohamed Diab looked at the same pulse oximetry signal differently than anyone had before, they created new possibilities. By employing advanced signal processing techniques–including parallel engines and adaptive filters–they believed they could find the true arterial signal that would allow accurate monitoring of arterial oxygen saturation and pulse rate, even during the most challenging conditions. Signal Extraction Technology, or Masimo SET^®, assumes that both the arterial and venous blood can move and uses parallel signal processing engines–DST^®, FST^®, SST^™, and MST^™–to separate the arterial signal from sources of noise (including the venous signal) to measure SpO2 and pulse rate accurately, even during motion.

After six years of dedicated and focused research and development, Masimo SET^® debuted in 1995 at the Society for Technology in Anesthesia and won the prestigious Excellence in Technology Innovation Award. Thereafter, skeptical clinicians around the world sought actively to compare Masimo SET^® to the best pulse oximetry technologies other companies had to offer. But in study after study, the breakthrough signal processing of Masimo SET^® consistently resulted in significantly fewer false alarms and far superior true alarm detection.

Conventional pulse oximetry uses the standard red over infrared algorithm to provide SpO2, while Masimo SET^® uses that conventional algorithm but has added four other algorithms that all run in parallel. These algorithms allow the distinction between arterial and venous signal during motion and low perfusion by identifying and isolating the non-arterial and venous noise SpO2 (left peak shown in blue) from the true arterial SpO2 components (right peak shown in red) in the signal. The plot peak on the right is then chosen as the SpO2 value, since the physiologically higher SpO2 value within the measuring site will be arterial signal.

With Masimo SET^®, false alarms have been reduced by over 95%, while true alarm detection has increased to over 97%–even during conditions of motion and low perfusion.²

True Alarm Performance During Motion and Low Perfusion

False Alarm Performance During Motion and Low Perfusion

In this hospital-based study, investigators measured SpO2 in 10 subjects during motion and low perfusion conditions and calculated the false alarm rate during 120 full oxygenation events (specificity) and true alarm rate during 40 de-oxygenated events (sensitivity).²

Proven with Children³

This study measured missed true desaturation events out of 75 true events on 5 children undergoing evaluation for sleep-disordered breathing.

Proven with Infants⁴

Performance During Motion and Low Perfusion¹

A total of 70 volunteers were tested with motorized hand motions. Each motion was studied during both room air breathing and hypoxemia. Pulse oximeters on the stationary hand were used to provide control measurements for comparison. Sensitivity was defined as ability to detect a true SpO2 <90%. Specificity was defined as the ability to detect a true SpO2 >90%.

REFERENCES

• ¹ Barker SJ. Anesth Analg. 2002 Oct;95(4):967-72.
• ² Shah N., Ragaswamy H.B., Govindugari K., Estanol L. J Clin Anesth. 2012 Aug;24(5):385-91.
• ³ Brouillette RT, Lavergne J, Leimanis A, Nixon GM, Laden S, McGregor CD. Differences in Pulse Oximetry Technology can Affect Detection of Sleep Disordered Breathing in Children. Anesth Analg. 2002; 94:S47-S53
• ⁴ Hay WW, Rodden DJ, Collins SM, Melara DL, Hale KA, Fashaw LM. Reliability of conventional and new oximetry in neonatal patients. Journal of Perinatology. 2002; 22:360-266

Helping Screen for Congenital Heart Disease and Reduce Eye Damage and Blindness

From the very beginning, infants and children have been the focus of our research development. As a result, Masimo leads the industry in solutions designed exclusively for these most vulnerable patients.

Enabling Critical Congenital Heart Disease Screening

The breakthrough performance of Masimo SET^® is often most appreciated by the clinicians caring for fragile newborns. Up to 30% of all congenital heart disease (CHD) deaths occurring in the first year of life are unrecognized at the time of hospital discharge after birth. Masimo SET^®; pulse oximetry has been shown to reliably assist clinicians in the screening for critical congenital heart disease (CCHD),^1,2 spurring the US Secretary of Health and Human Services to add Measure-through Motion and Low Perfusion^™ pulse oximetry to the recommended Uniform Screening Panel for newborns.³ Masimo SET^® pulse oximeters and sensors meet the recommended criteria for newborn screening, were exclusively used in the two studies that were the basis for the CCHD workgroup decision to recommend newborn screening, and were the first to receive FDA 510(k) clearance with labeling for CCHD screening.

CCHD Detection Screening with Masimo SET^®2

SpO2 screening was conducted on 39,821 newborn babies, preductally (palm of right hand) and postductally (either foot) before routine physical examination. The baby was considered to be screening positive if: 1) either preductal or postductal SpO2 measurement was <90%; 2) if in three repeat measurements, both preductal and postductal SpO2 were <95%, or the difference between the two measurements was >3%.

Helping Clinicians Reduce Retinopathy of Prematurity

Premature infants requiring neonatal intensive care need enough oxygen to preserve vital organ function, but too much oxygen can cause severe eye damage from retinopathy of prematurity (ROP). Masimo SET^® is the only pulse oximetry proven to help clinicians dramatically reduce ROP.⁴

Reduction of ROP with Masimo SET^®4

In period one, the baseline rate for severe ROP in two centers, both using Nellcor pulse oximetry, is established. In period two, the oxygen targeting policies, caregivers, and patient characteristics were the same at both centers, but only Center A switched to Masimo SET^®, which led to a significant reduction in ROP (from 12% to 5%). In period three, Center B switched to Masimo SET^® and experienced a reduction in ROP from period two (from 13% to 6%).

Empowering Care for Cyanotic Patients

In cyanotic infants, Masimo SET^® with the Blue^® Sensor is the only pulse oximeter proven accurate–enabling accurate maintenance of targeted oxygen saturation levels.⁵ And for very low birth weight babies, only the Masimo NeoPt-500™ Sensors are designed for both size and performance in infants as small as 500 grams.

Real-time Newborn Monitoring and Assessment

When each second matters during newborn resuscitation, the Masimo Newborn Sensor ensures the fastest response time at the highest sensitivity–allowing clinicians to focus on real-time patient management instead of the device. In addition, Masimo SET^® is increasingly being used to supplement the standard APGAR score to more reliably assess general newborn health.

Helping Improve Outcomes on the General Floor with Masimo Patient SafetyNet^™

In August 2012, The Joint Commission Sentinel Event Alert on the safe use of opioids in hospitals recommended implementation of better dosing along with continuous oxygenation and ventilation monitoring (instead of spot checks) in post-surgical patients.⁶ Patient SafetyNet^™–combined with Masimo SET^® pulse oximetry and rainbow Acoustic Monitoring^™ or standard capnography–offers a clinically proven, cost-effective approach to continuous post-operative monitoring with high nursing satisfaction and patient compliance.

Reducing Rescues and ICU Transfers

For many years, clinicians have understood the risks of not continuously monitoring patients on the general floor. However, excessive false alarms due to patient motion made improving the safety of these patients an elusive goal. In the last decade, Masimo SET^® has been shown in multiple studies to improve the process of care in neonates and pediatric patients due to its Measure-through Motion and Low Perfusion performance. However, a landmark study in 2010 showed that Masimo SET^® also improves clinical outcomes in adults. After implementing Masimo SET^® and Patient SafetyNet remote monitoring and wireless notification system in a post-surgical floor where only intermittent spot-checking was used before, Dartmouth-Hitchcock Medical Center reduced rapid response activations by 65% and ICU transfers by 48%,⁷ and saved $1.48 million annually. In addition, there were zero brain-damaged patients over a 5-year period.⁸

Just as pulse oximetry has become a standard of care in the OR, PACU, and ICU, we now believe that Measure-through Motion and Low Perfusion pulse oximetry will become a standard of care on the general floor. With Masimo technologies on the general floor, clinicians can be confident their patients are being watched even when they aren’t at the bedside, while families can be assured their loved ones are receiving maximum protection.

Proven Cost-effectiveness

When translated into financial impact, the Dartmouth-Hitchcock study showed that implementing Masimo SET^® and Patient SafetyNet to more safely monitor post-surgical patients could also have a significant impact on the hospital’s bottom line by increasing ICU bed availability and reducing costs associated with emergency rescue events.⁸ With both the clinical and financial rationale now in place, hospitals are increasingly implementing general floor monitoring with Masimo technologies.

Significant reductions in rapid response team activations and ICU transfers were observed in an 11-month evaluation of Patient SafetyNet on a post-surgical unit. Rescue events decreased 65%, from 3.4 to 1.2 per 1,000 patient discharges, and ICU transfers decreased 48%, from 5.6 to 2.9 per 1,000 patient days after implementation. The financial impact resulted in annual opportunity cost savings of $1.48 million. Results drove expansion of the use of Patient SafetyNet to other care areas.^7,8

REFERENCES

• ^† As a result of respiratory depression from opioids.
• * The use of the trademark Patient SafetyNet is under license from University Health System Consortium.
• ¹ Ewer AK et al. Lancet. 2011 Aug 27;378(9793):785-94.
• ² de-Wahl Granelli AD et al. BMJ. 2009;338.
• ³ Secretary of Health & Human Services letter to the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC); dated September 21, 2011.
• ⁴ Castillo A et al. Acta Paediatr. 2011 Feb;100(2):188-92.
• ⁵ Cox PN et al. Anesthesiology. 2007;107:A1540. (abstract)
• ⁶ The Joint Commission Sentinel Event Alert. 2012;49.
• ⁷ Taenzer AH et al. Anesthesiology. 2010;112(2):282-287.
• ⁸ Taenzer AH et al. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

Enhanced Process of Care

The proven accuracy and reliability of Masimo SET pulse oximetry reduces cost by shifting the focus of clinicians from managing equipment to managing patient care.

“The number of ABG’s obtained and the time to wean to a low FiO₂ was nearly half.
This change in practice reduces the costs of oxygen supply and delivery and the associated
risk of morbidity from excessive oxygen exposure.”

Charles G. Durbin
Prof.of Anesthesiology, University of Virginia

	Thomas A, Holmes M, Vogt J, Gangitano E, Stephenson C, Liberman R. Useful life of pulse oximeter sensors in a NICU. Resp Care. 1998;43:860.
	Durbin CG Jr, Rostow SK. More reliable oximetry reduces the frequency of arterial blood gas analyses and hastens oxygen weaning after cardiac surgery: a prospective, randomized trial of the clinical impact of a new technology. Crit Care Med. 2002 Aug;30(8):1735-40.
	Patel DS, Rezkalla R. Weaning protocol possible with pulse oximetry technology. Advance for Respiratory Care Managers. 2000:9(9):86.
	Shah N, Estanol L. Comparison of three new generation pulse oximeters during motion & low perfusion in volunteers. Anesthesiology. 2006;105:A929.
	Erler T, Avenarius S, Wischniewski E, Schmidt K, Kläber HG. Longevity of Masimo and Nellcor pulse oximeter sensors in the care of infants. J Perinatol. 2003 Mar;23(2):133-5. Journal of Perinatology 2003; 23:133-135.

We estimate a typical 250 bed hospital can save more than $300,000 annually using Masimo SET technology. To learn how your institution can lower its costs while improving patient care by converting to Masimo SET pulse oximetry, call 1-877-4-Masimo.

Improve Patient Care

The proven accuracy and reliability of Masimo SET pulse oximetry allows better clinical decision-making, leading to improved patient care.

Masimo SET Technology vs. Other “Next Generation” Pulse Oximetry

• Masimo SET oximeters detect approximately 10 times more true events than any “Next Generation” pulse oximeter.^{1, 2}
• Masimo SET oximeters have one-tenth the false hypoxemia alarms of “Next Generation” pulse oximeters.^1-4
• Accurate tracking of the patient’s true physiology improves outcomes.

A Life Saved with the use of a SET Pulse Oximeter Technology

A dyspneic child with left heart hypoplasia was profoundly pale with circumoral cyanosis as his clinical status worsened…

During ongoing resuscitative efforts, several conventional pulse oximeters failed to read. A Masimo SET pulse oximeter displayed true saturation and pulse rates that correlated with the ECG during the next two hours of resuscitation and stabilization…

The child was placed on mechanical ventilation and stabilized…
Eight days later he received a cardiac transplant and is healthy today.

“Were it not for the steady rise in SpO₂ values, the resuscitative efforts for this baby would have been aborted. This newborn’s life was likely saved by Masimo SET pulse oximetry.”

Mitchell R.Goldstein,MD,FAAP,Neonatal Intensive Care,Vol.12 No.1,Jan/Feb 1998

Case Studies:

	The Impact of Masimo SET Pulse Oximetry on the Reduction of ROP
	Left Heart Hypoplasia: Baby Saved By Masimo SET Pulse Oximetry
	Conventional Pulse Oximetry is Unreliable During Helicopter Transport
	Erroneous SpO2 Values with Conventional Pulse Oximetry in Spite of Matched Heart and Pulse Rates could have Increased the Risk of ROP as well as Cost
	Performance of Masimo SET Pulse Oximetry in a Child with Meningococcemia

• ¹ Hay WW, et al, Reliability of conventional and new oximetry in neonatal patients. Journal of Perinatology, 2002; 22:360-366
• ² Barker SJ, S. Morgan; Department of Anesthesiology, University of Arizona, Tuscon, USA. A Laboratory Comparison of the Newest “Motion Resistant” Pulse Oximeters During Motion and Hypoxemia. Anesthesia and Analgesea 2004; 98: (5S): S2
• ³ Brouillette RT, et al, Anesthesia & Analgeisa 2002; 94:S47 S53
• ⁴ Goldstein MR, et al, Anesthesia & Analgesia 2002; 94:S102

Improve Patient Safety

The proven accuracy and reliability of Masimo SET pulse oximetry allows appropriate clinical intervention.

Clinical/Case Studies

	The Impact of Masimo SET Pulse Oximetry on the Reduction of ROP
	Left Heart Hypoplasia: Baby Saved By Masimo SET Pulse Oximetry
	Conventional Pulse Oximetry is Unreliable During Helicopter Transport
	More Reliable Oximetry Improves Caregiver Efficiency
	Improved Pulse Oximeter Technology Changes Caregiver Practice Patterns: Masimo SET vs. Conventional Pulse Oximetry

Pulse oximetry was developed to monitor patients at risk of heart/lung failure, yet conventional pulse oximetry (CPO) fails on the sickest patients ^1-3 because the patients have poor perfusion and/or are experiencing motion. It is essential that these high acuity patients who represent the highest liability/risk, are reliably monitored for oxygenation and pulse rate.

Masimo SET pulse oximetry provides accurate monitoring for all levels of patient care, including life threatening cases where motion and/or low perfusion is likely. Clinicians can rely on accurate measurements and true alarms from a trustworthy source: Masimo SET pulse oximetry.

Improved Patient Safety

• Studies show excessive false alarms lead to clinical non-response.⁴ Clinician practice patterns change when using accurate and trustworthy Masimo SET pulse oximetry.⁵
• Masimo SET pulse oximetry improves care and reduces medical errors by accurately tracking the patient’s physiology when it is needed most – during motion and low perfusion.^6-8

• ¹ Poets CF, Urschitz MS, Bohnhorst B. Pulse oximetry in the neonatal Intensive care unit (NICU): detection of hyperoxemia and false alarm rates. Anesth Analg 2002; 94;S41-43.
• ² Malviya S, Reynolds PI, Voepel-Lewis T. et al. False alarms and sensitivity of conventional pulse oximetry versus the Masimo SET technology in the pediatric postanesthesia care unit. Anesth Analg 2000; 90 (6): 1336-1339.
• ³ Moller JT, Johannessen NW, Espersen K. et al. Randomized evaluation of pulse oximetry in 20,802 patients II. Perioperative events and oostoperative complications. Anesthesiology 1993; 78(3): 445-53.
• ⁴ Lawless ST. Crying wolf: false alarms in a pediatric intensive care unit. Crit Care Med 1994;22(6): 981-5.
• ⁵ Durbin CG, Rostow SK. More reliable oximetry reduces the frequency of arterial blood gas analysis and hastens oxygen weaning following cardiac surgery; a prospective randomize trial of the clinical impact of a new technology. Crit Care Med 2002; 30(8): 1735-40.
• ⁶ Cox PN. New pulse oximetry sensors with low saturation accuracy claims; a clinical evaluation. Resp Care 2006; 51 (11): 1332.
• ⁷ Murthy TVSP, Goyal R, Singh VP. Masimo-a new reliable non invasive method of detecting oxygen saturation in critically ill. Indian J Anesth 2005:49(2): 133-136.
• ⁸ Baquero H, Alviz R, Sola A. Avoiding hyperoxemia during neonatal resuscitation: time to response to different SpO₂ monitors. presented at the Eastern Society for Pediatric Research annual meeting, Philadelphia, PA 2007