Description

The Masimo RD SET SpO2 series offers advanced pulse oximetry sensors designed for precise, noninvasive monitoring of oxygen saturation and pulse rate. These single-patient-use, disposable sensors are equipped with Masimo's renowned Signal Extraction Technology (SET®), ensuring accurate readings even in challenging conditions such as patient motion and low perfusion. This makes them highly reliable across diverse patient populations, including adults, pediatrics, infants, neonates, and preterm infants.

Compatibility and Application

• Compatible Devices: Designed for use with Masimo SET pulse oximeters and licensed third-party monitors.
• Intended Environments: Suitable for hospitals, mobile settings, and home environments, intended for professional use with a prescription requirement.

Sensor Models and Features

The RD SET sensors are available in multiple models tailored to different patient weight ranges and application sites, including fingers, toes, hands, and feet. The sensors feature:

• Secure Application: Fold-over and wrap-around styles for secure attachment and easy removal.
• Comfort Design: Lightweight with a flat, soft cable to enhance patient comfort and minimize pressure.
• Adhesive Options: Available in adhesive and non-adhesive forms, not made with natural rubber latex.

Environmental Considerations

These sensors contribute to environmental sustainability by generating up to 84% less waste compared to traditional sensors. Their packaging is designed to reduce storage space and waste.

Performance Specifications

• SpO2 Accuracy: Maintains high accuracy across various conditions, with specific ARMS values tailored to patient types and models.
• Pulse Rate Accuracy: Reliable across a broad range of conditions, including motion and low perfusion.

Advanced Technology

The sensors incorporate LED technology and X-Cal® technology to enhance measurement reliability and extend monitoring duration. They also feature shielding against electromagnetic and ambient light interference, ensuring dependable performance.

Clinical Validation

Supported by extensive clinical evidence, Masimo RD SET SpO2 sensors have demonstrated high accuracy across all skin pigmentations and clinical settings. They are associated with reduced false alarms and improved clinical outcomes, such as fewer unplanned ICU transfers and neonatal complications.

Safety and Usage Guidelines

• Contraindications: Not suitable for patients with foam rubber or adhesive tape allergies.
• Precautions: Not to be used during MRI scans or in high ambient light without precautions.
• Application: Proper site selection and frequent checks are essential to prevent skin injury and ensure accurate readings.

Regulatory Compliance

These sensors comply with the European Medical Device Directive and are marked with the CE label. They are non-sterile and should be discarded after single-patient use. Proper storage and transport conditions must be observed, with specific temperature and humidity limits.

The Masimo RD SET SpO2 sensors represent a sophisticated solution for healthcare professionals seeking reliable and accurate patient monitoring across a wide range of clinical environments.