Attachment 1 - Statement of Work - Shockwave Therapy System FINAL.docx

STATEMENT OF WORK

EXTRACORPORAL SHOCKWAVE THERAPY SYSTEM

MARTIN ARMY COMMUNITY HOSPITAL

WINN ARMY COMMUNITY HOSPITAL

1. SCOPE

The Contractor shall deliver, install, and provide comprehensive training and technical support for Extracorporeal Shock Wave Therapy (ESWT) systems. This procurement is for the following two military treatment facilities (MTFs):

1. Surgical Clinic, Martin Army Community Hospital (MACH), Fort Benning, Georgia – requiring a complete dual-unit shockwave system setup including radial and focused units with standalone carts.

2. Department of Surgery / Podiatry, Winn Army Community Hospital (WACH), Fort Stewart, Georgia – requiring a complete dual-unit shockwave system including radial and focused units with a standalone cart.

2. APPLICABLE DOCUMENT AND REGULATORY STANDARDS

All equipment provided under this SOW must meet or exceed the following regulatory standards:

· FDA Approval: Devices must be FDA-cleared under 21 CFR Part 878.4820 (Product Code: GZP) for Extracorporeal Shock Wave Therapy Devices.

· Safety Compliance: Built-in safety mechanisms must prevent accidental overexposure to shock waves, ensuring both patient and operator’s safety.

3. PLACE OF PERFORMANCE

Martin Army Community Hospital, Surgical Clinic, 6600 Van Aalst Drive, Fort Benning, GA 31905

Winn Army Community Hospital, Department of Surgery/Podiatry Clinic, 1061 Harmon Avenue, Fort Stewart, GA 31314

4. EQUIPMENT

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

5. TECHNICAL SPECIFICATIONS AND SALIENT CHARACTERISTICS

5.1 Technical Specifications and Salient Characteristics for MACH

5.1.1 Storz Medical MASTERPULS MP100 - Radial Pressure Wave (R-SW) Unit

· Technology: Must generate ballistic radial pressure waves using a compressed air system.

· User Interface: Must feature a primary touchscreen on the control unit and integrated controls on the handpiece.

· Operating Mode: Single and continuous pulse modes with a frequency range of at least 1-21 Hz.

· Pressure Range: Adjustable compressed air output from 1 to 5 bar.

· Included Handpieces: Must include one (1) Falcon R-SW handpiece with two (2) included revisions/overhaul kits.

· Included Transmitters: Must include R15 (15mm), D29-S (20mm) and Di15 (Deep Impact) transmitters.

· Pulse Counter: Must allow pre-setting a pulse count limit for treatment sessions.

· Updates: Software must be updatable via a USB interface.

· Power Requirements: Mains Voltage 100-240 VAC, 50-60 Hz

5.1.2 Storz Medical V-Actor II Handpiece - Vibration Therapy Unit

· Technology: Must provide vibration therapy for the treatment of soft tissues.

· Operating Frequency: 1-35 Hz

· Energy Selection: Adjustable in steps from 1.0 to 5.0 bar.

· Included Transmitters: Must include the following transmitter heads: 10mm spherical (V10), 25mm (V25), and 40mm (V40)

· Service Life: Average expected service life of approximately 5 million pulses.

· Power and Environmental: Operating Temperature: 10 degrees Celsius to 30 degrees Celsius

· Operating Humidity: 5% to 95%, non-condensing

5.1.3 Storz Medical DUOLITH SD1 T-TOP with Sepia F-SW Handpiece

· Technology: Must generate electromagnetically focused shock waves (F-SW).

· User Interface: Must be operable via a Tablet PC with a touchscreen interface for all operations and include integrated controls on the handpiece.

· Operating Mode: Single shock and continuous shock modes with a frequency range of at least 1-8 Hz.

· Energy Range: Adjustable energy flux density from at least 0.01 to 0.55 mJ/mm².

· Included Handpiece: Must include one (1) Sepia F-SW focused shockwave handpiece.

· Penetration Depth: Must be therapeutically effective from 0 to 125mm.

· Focus Size: 5 mm x 5 mm x 30 mm.

· Patient Management: Must include an integrated system to create, manage, export, and report patient data.

· Anatomical Atlas: Must include an integrated 3D anatomy atlas for treatment planning.

· Security: Device access must be controlled via password protection.

· Power Requirements: Mains Voltage 100-240 VAC, 50/60 Hz .

5.1.4 Support Carts and Trolleys

· Remarkable Eco Cart:

· Type: 2-shelf standard configuration.

· Load Capacity: Max Load of 20 kg.

· Compatibility: Capable of carrying the Masterpuls MP100.

· Trolley for Duolith SD1:

· Type: 2-shelf standard configuration.

· Compatibility: Capable of carrying the Duolith SD1.

· Load Capacity: Max Load of 25 kg

· Utility: Interconnects the touchscreen, compressors, diagnostic ultrasound, and therapy modules into a single, cohesive, mobile unit.

5.2 Technical Specifications and Salient Characteristics for WACH

5.2.1 Storz Medical Modular Radial and Focused ESWT System (Duolith SD1 Ultra Modular Tower System)

· Technology and System Architecture: Must offer integrated, modular tower configuration combining both radial pressure wave (R-SW) and focused shock wave (F-SW) therapy modalities, including an integrated Control Module R-SW Module, F-SW Module and Vacu-Actor technology.

· Adjustable Energy Levels and Operating Range:

· Radial therapy output: Adjustable compressed air output from 1.0 to 5.0 bar, operating at frequencies of at least 1-21 Hz.

· Focused therapy output: Adjustable energy flux density ranging from at least 0.01 to 0.55mJ/mm², with a therapeutically effective penetration depth of 0 to 125mm, operating at frequencies of at least 1-8 Hz.

· Design & Portability:

· Modular Design: Compact and ergonomic modular system allowing for easy upgrades and customization based on clinical requirements. Must include the SD1 Control Module, R-SW (Radial) Module, and F-SW (Focused) Module integrated into the system.

· Dedicated Mobile Trolley/Cart: Must include a dedicated Duolith SD1 Ultra Trolley/Tower Cart designed mount, store, interconnect, and transport the Control Module, R-SW Module, F-SW Module, Vacu-Actor, handpieces, and accessories as a single cohesive unit.

· User Interface and Software: Intuitive touchscreen interface preloaded with pre-programmed treatment protocols for common musculoskeletal conditions, integrated 3D anatomical atlas, and patient management capabilities.

· Handpieces and Accessories:

· Radial Handpiece and Kits: Must include (1) Falcon R-SW Handpiece with integrated display/controls and two (2) revision/overhaul kits

· Focus Handpiece: Must include one (1) Sepia F-SW Handpiece with integrated controls

· Transmitters/Applicators: Must include standard radial transmitters (R15, D29-S, Di15 Deep Impact) and focused stand-offs/coupling accessories

· Cooling System: Integrated cooling system to prevent overheating during extended clinical use.

· Connectivity:

· Connectivity: Must provide offline USB interface for software updates and data transfer/export.

· Standalone Utility: Must retain the capability to operate independently as a standalone system without network integration.

6. TRAINING REQUIREMENTS

The Contractor shall provide the following training program upon delivery and installation:

1. Clinical Operator Training: The vendor is required to provide comprehensive, on-site operational training and certification for all clinical operators upon delivery and installation. Training shall focus on safe clinical application, touchscreen navigation, and treatment protocols.

2. Biomedical Engineering Training: The vendor is required to provide on-site technical training for biomedical engineering staff, covering routine maintenance, troubleshooting, and the handpiece repair/overhaul process.

7. WARRANTY, MAINTENANCE AND SUPPORT

7.1 Warranty Support

Main Units: The equipment must include a minimum 2-year warranty covering all main console parts and labor (including generators, touchscreen displays, and support trolleys) to ensure reliability and protection against defects.

Handpieces / Applicators: Non-main unit commercial items (handpieces / applicators) shall be covered under standard commercial warranty practices of one (1) year or their rated commercial pulse life limit (whichever occurs first).

7.2 Preventive Maintenance

The vendor must provide one (1) comprehensive annual preventative maintenance (PM) service visit during the first year (12 months) of ownership to ensure proper device calibration, pressure system inspections, electrical safety testing and overall functioning to reduce initial operational costs.

7.3 Technical Support Availability

The Contractor must provide technical support parameters to include:

· Telephone Technical Support: Response within two (2) business hours.

· On-Site Technical Support: Technician deployment and response on-site within forty-eight (48) business hours if a technical issue cannot be resolved remotely.