Salient Characteristics.pdf

PDF 63 KB Posted

Attached to
6515--FY25: TEE Automated Probe Cleaner
Solicitation number
36C24825Q1213
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This document is a Salient Characteristics sheet for a specialized medical device designed for Transesophageal Echocardiogram (TEE) probe reprocessing. The device is FDA-cleared and offers an integrated, automated solution for cleaning and high-level disinfection of TEE probes in a single, enclosed unit. Key features include touchscreen controls with pre-programmed cycles, built-in printer and data export capabilities for traceability, secure probe holders, leak detection, and temperature monitoring.

The device addresses multiple healthcare workflow challenges by eliminating manual brushing and soaking, reducing human error and cross-contamination risks, and minimizing staff exposure to contaminated fluids. It is engineered exclusively for TEE probes, ensuring compatibility and safety, and is designed as a standalone unit that can easily integrate into existing medical reprocessing areas. The system utilizes manufacturer-validated cycles that align with TEE probe reprocessing guidelines, providing a comprehensive and efficient solution for medical instrument sterilization.

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Amendment SF-30.pdf PDF
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SOW.pdf PDF
36C24825Q1213_1.docx DOCX document

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36C24825Q1213

SALIENT CHARACTERISTICS

1. Integrates both cleaning and high-level disinfection of Transesophageal Echocardiogram (TEE) probes in a single, enclosed unit.

2. Cleared by the U.S. Food and Drug Agency (FDA) for combined cleaning and disinfection of TEE probes.

3. Engineered exclusively for TEE probes, ensuring compatibility and safety.

4. Removes the need for manual brushing or soaking, reducing human error and risk of cross-contamination.

5. Includes built-in printer and data export functions to support full traceability of reprocessing cycles.

6. Utilizes manufacturer-validated cycles that align with TEE probe reprocessing guidelines.

7. Minimizes staff exposure to contaminated fluids and reduces potential for environmental contamination.

8. Touchscreen controls with pre-programmed cycles and prompts for simplified operation.

9. Standalone unit designed to fit easily into existing reprocessing areas.

10. Includes secure probe holders, leak detection, and temperature monitoring to preserve probe integrity.

SALIENT CHARACTERISTICS

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