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sigma pace external pacemaker analyzer model 1000
Dni Nevada
Summary: The Sigma Pace External Pacemaker Analyzer Model 1000 is a diagnostic tool used by cardiologists and electrophysiologists to test and analyze the function of external pacemakers. It ensures the pacemaker's settings are appropriate for patient needs.
FDA Clearance Information
Pathway 510K
Number K011729 ↗
Decision Date August 30, 2001
Product Code DTC
Device Class Class 2
Evidence 0 studies
The Sigma Pace External Pacemaker Analyzer Model 1000 was cleared through the FDA 510(k) pathway on August 30, 2001. Manufactured by Dni Nevada, it is classified as a Class 2 device under product code DTC.
What It Is
The Sigma Pace External Pacemaker Analyzer Model 1000 is a specialized diagnostic device designed to evaluate the performance and settings of external pacemakers. It measures various parameters such as pacing rate, output, and sensitivity to ensure the pacemaker is functioning correctly. This device is crucial for verifying that the pacemaker's settings are tailored to the patient's specific cardiac needs.
Clinical Applications
This device is commonly used in cardiology and electrophysiology departments, particularly in settings where external pacemakers are frequently employed, such as during cardiac surgeries or in intensive care units. It is essential for ensuring the safety and efficacy of temporary pacing in patients with arrhythmias or heart block. The analyzer is used by healthcare professionals to adjust and confirm pacemaker settings in real-time.
Indications for Use
The FDA indications for the Sigma Pace External Pacemaker Analyzer Model 1000 involve its use in testing and verifying the functionality of external pacemakers. It is intended for patients who require temporary cardiac pacing, such as those undergoing certain cardiac procedures or experiencing acute arrhythmias.
Practical Considerations
The Sigma Pace External Pacemaker Analyzer Model 1000 is compatible with a wide range of external pacemakers. Clinicians should ensure proper connection and calibration before use to obtain accurate measurements. Familiarity with the device's interface and settings is recommended for optimal use.
Frequently Asked Questions
What is the Sigma Pace External Pacemaker Analyzer Model 1000 used for?
It is used to test and analyze the function of external pacemakers, ensuring they are set correctly for patient needs.
What specialties typically use this device?
Cardiology and electrophysiology specialists commonly use this device, particularly in surgical and intensive care settings.
What are the FDA-cleared indications?
The device is indicated for testing and verifying the functionality of external pacemakers in patients needing temporary cardiac pacing.
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.