Ultrasonic Aspirator System Salient Characteristics.pdf
PDF 75 KB Posted
- Attached to
- Ultrasonic Aspirator System Federal contract opportunity
- Solicitation number
- PANHCA-25-P-6680
- Issued by
- Department of the Army Medical Command
About this file
The document is a Salient Characteristics specification for an Ultrasonic Aspirator System, detailing technical and operational requirements for medical equipment intended for use at Landstuhl Regional Medical Center in Germany. The system must operate at an ultrasonic frequency of 23-36 kHz, provide precise tissue fragmentation while preserving vessels and nerves, and include multi-functional capabilities like integrated fragmentation, irrigation, and aspiration in a single handpiece. Key technical specifications include an ergonomic, lightweight handpiece with interchangeable tips, a digital console with safety alarms, compatibility with U.S. Army sterilization protocols, and compliance with IEC and FDA standards.
The specification outlines comprehensive logistical and support requirements, including a minimum 1-year warranty, on-site installation and training, long-term supply assurance for consumables for 5+ years, and vendor-provided accessories such as a device cart, sterilization case, user adjustment tools, and necessary software. The system must be compatible with 110-240V power, have a European plug, feature an English-language interface, and include vendor-provided documentation. This Sources Sought Notice is issued by the Department of the Army Medical Command, with responses due by 2 July 2025 at 12 PM local Germany time, aimed at identifying potential qualified vendors for this medical equipment.
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Text version
SALIENT CHARACTERISTIC Ultrasonic Aspirator System
1. Clinical Performance
• Ultrasonic Frequency Range: 23–36 kHz or as required for optimal tissue selectivity.
• Tissue Specificity: Capable of fragmenting soft tissues while preserving vessels and nerves.
• Multi-functionality: Integrated fragmentation, irrigation, and aspiration in one handpiece.
• Customizable Power Settings: Adjustable frequency and amplitude for different tissue types.
• Minimal Collateral Damage: Designed to minimize heat generation and protect adjacent structures.
2. System Components
• Main Console/Control Unit: Digital interface with intuitive controls, safety alarms, and diagnostics.
• Ergonomic Handpiece: Lightweight, low vibration, with easy tip interchangeability.
• Interchangeable Tips: Various lengths, curvatures, and lumen diameters; preferably reusable and autoclavable.
o Disposable irrigation suction cassettes.
• Foot Pedal Control: Multifunctional footswitch for hands-free operation
3. Safety & Infection Control
• Single-use and Sterilizable Options: Compatible with U.S. Army sterilization protocols, Include dedicated sterilization tray for safe and efficient reprocessing
• Integrated Safety Alarms: For overheating, low irrigation, and system malfunction.
• Backflow Prevention: In-line filter or mechanism to prevent fluid contamination.
4. Compatibility & Standards
• U.S. Voltage & Frequency: 110–240V, 50/60 Hz compatible. (Dual voltage or Single 220V) o Requires European plug
• IEC & FDA Compliant:
• CE Marking: Certified for use in the EU, including Germany.
5. Logistics & Support
• Portability: Compact, mobile unit with locking wheels or rack-mount capability.
• Maintenance Support: On-site service availability o On-site installation and training
• Warranty and Service Contract: Minimum 1-year warranty with optional extended service contract.
• Language Interface: User interface available in English
• Training & Documentation: Vendor-provided training, manuals, and safety documentation in English.
• Long-Term Supply Assurance: Vendor must ensure availability of consumables (tips, tubing) for ≥5 years.
• Cart for the Device: Vendor must supply a cart for the device to rest on
• Tools for user adjustments: Any tools required for user adjustments must be supplied by the vendor
• Case for Sterilization: Vendor must supply a case to sterilize any pieces requiring sterilization
• Software: Vendor must supply any additional software required for full functionality of the device.
*No Service Contract required at time of procurement*
File details come from the government source that posted it. Updated .