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patient cables for monitoring i e ecg ekg spo2 and bp interface cables and leadwires
Advantage Medical Electronics
Summary: Patient cables for monitoring are used for ECG, EKG, SpO2, and BP measurements. They are primarily used in clinical settings for patient monitoring. Key evidence highlights their role in continuous monitoring and potential safety concerns.
FDA Clearance Information
Pathway
510K
Number
K992524 ↗
Decision Date
March 1, 2000
Product Code
DSA
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on March 1, 2000. Manufactured by Advantage Medical Electronics, it is classified as a Class 2 device under product code DSA.
What It Is
Patient cables for monitoring are interface cables and leadwires designed for use with ECG, EKG, SpO2, and BP monitoring systems. They facilitate the transmission of physiological data from the patient to the monitoring equipment, aiding in continuous patient assessment.
Clinical Applications
These cables are commonly used in hospital settings, including intensive care units and operating rooms, where continuous monitoring of vital signs is critical. They are essential for accurate data collection in both adult and pediatric populations.
Evidence Summary
The literature includes 15 studies, with a mix of study types such as RCTs and prospective studies, conducted between 2021 and 2025. These studies explore various aspects of monitoring technology, including efficacy and safety.
Reported Outcomes
Published studies report that patient cables for monitoring are effective in transmitting accurate physiological data, which is crucial for patient management. They are integral to systems that monitor heart rate, respiration rate, and other vital signs, contributing to improved patient outcomes.
Safety Profile
Reported complications include risks associated with skin damage, infection, and potential tangling of wires, which can interfere with patient care. These issues highlight the need for careful handling and monitoring of the cables during use.
Evidence Limitations
The evidence is limited by the lack of large-scale, long-term studies specifically focused on the cables themselves. Further research is needed to explore the long-term safety and efficacy of these devices in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for patient cables for monitoring?
Patient cables are indicated for use in continuous monitoring of ECG, EKG, SpO2, and BP in clinical settings.
What outcomes have been reported in clinical studies?
Studies report effective data transmission for vital sign monitoring, contributing to improved patient management and outcomes.
What complications have been reported?
Reported complications include skin damage, infection risks, and wire tangling, which can affect patient care.
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.