Attachment B Salient Characteristics.docx
DOCX document 23 KB Posted
- Attached to
- 6515--Equipment: PEF Ablation System Federal contract opportunity
- Solicitation number
- 36C24825Q0535
About this file
Attachment B Salient Characteristics is a detailed technical specification document for a Pulsed Electric Field (PEF) Ablation System for the Department of Veterans Affairs. The document outlines precise requirements for a medical device used in bronchoscopy settings for lung nodule and cancer interventions, specifying critical technical and functional characteristics including FDA approval, non-thermal tissue ablation capabilities, and precise cardiac synchronization features.
The system must include a generator, cardiac monitor with synchronization capabilities, user manual, and multiple electrode and needle configurations. Key technical specifications include an LCD touchscreen display, power and current output displays, multiple connection ports, and a minimum one-year manufacturer warranty. Additional requirements include on-site staff education and the ability to deliver high-voltage electrical energy that disrupts cellular homeostasis while preserving surrounding tissue and potentially activating immune responses. The solicitation (36C24825Q0535) is issued by the North Florida/South Georgia Veterans Health System to procure this specialized medical equipment.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Attachment C Price Delivery Schedule.docx | DOCX document | |
| Attachment A Combined Synopsis Solicitation Commercial Products and Commercial Services.docx | DOCX document | |
| 36C24825Q0535.docx | DOCX document |
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Text version
36C24825Q0535 Attachment B – Salient Characteristics
The Pulsed Electric Field (PEF) Ablation System shall meet or exceed the following characteristics:
· Shall be able to provide one (1) PEF Ablation System with consumables that supports non-thermal pulmonary soft tissue ablation procedures in the Bronchoscopy suite setting.
· Shall be FDA approved for endoscopic treatment of lung nodules / cancer intervention.
· Deliver high voltage in short duration electrical energy locally that alters the transmembrane potential of a cell by disrupting cellular homeostasis and inducing non-thermal programmed cell death.
· Able to preserve surrounding tissue.
· Provide potential immune activation.
· Provides a constant ablation size for a predictable ablation zone.
· Shall provide a compatible cardiac monitor for synchronization of the delivery of energy with the patient’s cardiac cycle.
· 4-lead configuration that detects the R-wave of the EKG/ECG signal, then sends a trigger signal to the generator for exact synchronization of energy output.
· Generator includes software with algorithm that detects trigger signals from cardiac monitor.
· PEF system shall include:
· Generator
· Cardiac Monitor with Synchronization
· User manual
· Electrodes (system specific, 5 pack)
· Flex Needles (system specific, 5 pack)
· 19G Needles (system specific, 5 pack)
· Display: LCD front panel display with touch screen capable of displaying graphics, messages, activation information, and receiving touch screen input from operator.
· Provide displays of power output and current output.
· Provide connections for:
· AC line power
· Foot switch
· Synchronization input
· Ablation device connector
· Dispersive electrode connections
· Manufacturer warranty: minimum 1 year.
· Provide staff education on-site to all clinical staff utilizing equipment.
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