Don’t risk patient safety with Pulse Oximetry imitation sensors

Using imitation SpO₂ sensors may seem cost-effective, but the consequences can be severe. Imitation sensors lack the accuracy and reliability, that genuine Nellcor™ sensors provide, putting patient outcomes at potential risk.1,2†

Pulse Oximeters are more than just a monitor and sensor—they are a system. The performance of each element and how well they work together matter. ISO 80601-2-61 certification ensures that Pulse Oximeters deliver reliable and accurate readings, including under challenging conditions like low perfusion and motion.3

Nellcor™ pulse oximetry technology offers a motion-tolerant pulse oximeter portfolio that is compliant with ISO 80601-2-61:2011. Motion tolerant pulse oximetry is critical for ensuring patient safety because patient movement can thwart accurate readings and delay diagnosis of serious respiratory compromise.2

Why Pulse Oximetry accuracy matters: ISO standards protect your patients

ISO 80601-2-61, the global benchmark for Pulse Oximetry, mandates strict accuracy requirements3. Genuine Nellcor™ sensors not only meet these standards—they exceed them1-3†. Bench testing showed that imitation sensors do not meet the stated requirements of ISO, are often calibrated incorrectly, leading to significant errors in SpO₂ readings1. In some cases, they overestimate oxygen saturation by as much as 18%, which is well beyond the clinically acceptable 4 point error.1

ISO 80601-2-61 outlines the critical aspects of Pulse Oximeter performance:

  • Accuracy: Ensures reliable SpO₂ data for safe patient monitoring. 
  • Response time: Sets the acceptable speed for displaying accurate readings.
  • Safety: Protects patients and users from potential hazards associated with Pulse Oximeters
  • Performance: Establishes how the device should preform under varying conditions. 

The user must ensure that each compnent of the Oximetry system - monitor, sensor, and cable - are validated for compatibility and performance.



Doctors and healthcare organizations that align with ISO standards demonstrate their commitment to providing high quality, safe, and efficient care




Imitation sensors come with risks

In neonatal care, every decision you make can have a life-saving impact. With the increasing presence of imitation SpO₂ sensors on the market, it's easy to be tempted by lower costs. However, these imitation sensors come with serious risks. Unlike ISO-certified Nellcor™ sensors, imitation alternatives can fail to meet stringent standards, putting your most vulnerable patients at risk.1,4,†

Cutting corners with imitation sensors could result in:

  • Provide inaccurate oxygen saturation levels1,4,†
  • Fail to maintain safety under challenging conditions4,†
  • Increased false alarms or missed hypoxic events due to unreliable data4,†
  • Lack of proper shielding against electomagnetic interference, causing inaccurate readings4,† 


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Sensor calibration and quality manufacturing 

Nellcor™ Pulse Oximetry sensors with OxiMax™ technology come with built-in calibration to ensure the correct translation of light absorption data into accurate SpO₂ readings.

In contrast, unvalidated sensors can suffer from mismatched calibration, resulting in significant errors1,4,†. Moreover, proper manufacturing processes ensure consistent and precise performance across different patients and situations1,4,†.


Why choose Nellcor™? Higher quality standard

Nellcor™ sensors deliver highly accurate readings even in challenging conditions like patient motion or low perfusion2,‡, thanks to advanced technology like OxiMax™ and SatSeconds™.

They are ISO 80601-2-61 certified, ensuring safety and reliability2,‡, and help reduce alarm fatigue by up to 40% while providing early detection of respiratory distress2,‡, 5,6,§. These solutions are trusted for improving patient outcomes, particularly in critical care environments


Testimonials



Paul Lee

Bioengineer, Head of Namdet

“Imitation medical devices may seem cost-effective, but they often lack the rigorous testing and standards assurance provided by OEM products, posing a risk to patient care. With modern ISO standards and cost-effective OEM prices, purchasing approved and tested devices like Nellcor™ probes ensures precision, safety, and long-term value for our healthcare services.”.


Request a free demo: experience the difference 

See how genuine Nellcor™ sensors outperform imitations. Request your free demo today for enhanced accuracy, fewer alarms, and better patient care.