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oc-100 oximeter interface calibrator
Telediagnostic Systems
Summary: The oc-100 oximeter interface calibrator by Telediagnostic Systems is a device used to ensure the accuracy of oximeter readings. It is primarily used by clinicians and technicians in settings where precise oxygen saturation measurements are critical.
FDA Clearance Information
Pathway
510K
Number
K884891 ↗
Decision Date
December 28, 1988
Product Code
DQA
Device Class
Class 2
Evidence
0 studies
The oc-100 oximeter interface calibrator was cleared through the FDA 510(k) pathway on December 28, 1988. Manufactured by Telediagnostic Systems, it is classified as a Class 2 device under product code DQA.
What It Is
The oc-100 is a calibrator designed to verify and adjust the accuracy of oximeters, which are devices used to measure oxygen saturation in the blood. It works by simulating various oxygen saturation levels, allowing healthcare providers to ensure their oximeters are providing accurate readings. This is crucial in clinical settings where precise monitoring of a patient's oxygen levels is necessary, such as in critical care or during surgical procedures.
Clinical Applications
The oc-100 is commonly used in hospitals, clinics, and other healthcare settings where oximeters are employed. It is particularly important in specialties such as anesthesiology, pulmonology, and critical care medicine, where accurate oxygen saturation readings are vital for patient management. The device is used by biomedical technicians and clinical engineers to maintain the reliability of oximeters across various patient populations, including those with respiratory or cardiovascular conditions.
Indications for Use
The FDA indications for the oc-100 involve its use in calibrating oximeters to ensure their accuracy. This is important for patients who require precise monitoring of blood oxygen levels, such as those with chronic respiratory diseases or during perioperative care.
Practical Considerations
The oc-100 is typically compatible with a wide range of oximeters, making it a versatile tool in clinical settings. It is important for users to follow the manufacturer's guidelines for calibration procedures to ensure optimal performance. Regular calibration using the oc-100 can help prevent erroneous readings that could impact patient care.
Frequently Asked Questions
What is the oc-100 oximeter interface calibrator used for?
It is used to calibrate oximeters, ensuring their accuracy in measuring blood oxygen saturation levels.
What specialties typically use this device?
Specialties such as anesthesiology, pulmonology, and critical care medicine commonly use this device.
What are the FDA-cleared indications?
The device is indicated for calibrating oximeters to ensure accurate oxygen saturation readings in clinical settings.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.