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(48 days)
The MedWaves Microwave Coagulation/Ablation System is intended for general surgical use in open procedures for the coagulation and ablation of soft tissues. The system is not intended for use in cardiac procedures.
The MedWaves Microwave Coagulation/Ablation System consists of a microwave generator and accessories used for the surgical ablation of soft tissue. The accessories include two types of sterile, handheld, single use surgical coagulation/ablation probes and required connector cables. The two versions of coagulation/ablation probes are 15-cm in length, 14gauge in diameter, configured into large or small handle. The large handle configuration is the original blue elongated egg-shaped plastic, and the small handle is white plastic handle with 90-degree cable exit (both are made of the same ASB plastic).
The MedWaves microwave generator operates at a frequency of 902 to 928 MHz. For general surgery applications, the generator is set by the manufacturer to deliver a maximum of 32 W and is user selectable up to 28W. The system is capable of being run in two primary modes: power control mode and temperature control mode. A dynamic monitoring system within the generator maintains the set point selected by the user (either a power or temperature control point) in order to provide consistent and expected coagulation/ablation performance.
The system incorporates several monitored parameters that alert the user to potentially unsafe conditions during operation. These parameters and condition alerts include: overtemperature, over-power, inefficient microwave delivery, catheter/probe disconnect and system errors. MedWaves microwave generator utilizes firmware to monitor these processes variables and posts the ablation parameters and progress for the user on an LCD screen.
MedWaves uses proprietary antenna technology coupled with a delivery system that efficiently transmits the microwave energy to the tip of the probe. The microwave antenna is 20 mm long mounted at the distal end. Efficiency of the system relieves the requirement of having high-powered generator in order to create the desired coagulation/ablation results. The efficiency of the system allows the incorporation of monitoring and controls on the microwave energy delivery in order to deliver the most optimal performance available.
The provided text describes the MedWaves Microwave Coagulation/Ablation System. I will extract the requested information based on the content of this document.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Compliance |
|---|---|---|
| Electrical Safety/EMC | EN 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) | Complies with EN 60601-1 |
| EN 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests) | Complies with EN 60601-1-2 | |
| EN 60601-2-2:2006 STD (Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and accessories) | Complies with EN 60601-2-2:2006 STD | |
| IEC CISPR11 Class A Group 3 (Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement) | Conforms to IEC CISPR11 Class A Group 3 | |
| EN61000-3-2 (Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions) | Conforms to EN61000-3-2 | |
| EN61000-3-3 (Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current |
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