SOW - Surgical Helmet Headlamp Systems.pdf

DEPARTMENT OF VETERANS AFFAIRS

660 VA Salt Lake City Health Care System — VISN 19

STATEMENT OF WORK (SOW)

Surgical Helmet Headlamp Systems

SECTION 1 — GENERAL OBJECTIVES AND REQUIREMENTS

1.1 Background

The George E. Wahlen VA Medical Center, Salt Lake City, requires surgical helmet-mounted headlamp systems to enhance intraoperative visualization in the OR. These systems are a critical component of the surgical team's visualization equipment and directly support safe, effective surgical care. Due to the critical uses and integration required, specific salient characteristics for the surgical helmet-mounted headlamps must be met.

1.2 Objective

To acquire medical-grade surgical helmet headlamp systems that provide reliable, hands-free illumination compatible with the OR helmet systems currently in use at the facility, in support of patient safety, surgical efficiency, and high-reliability care.

1.3 Scope of Work

The Contractor shall furnish all materials, equipment, training, and support necessary to provide surgical helmet headlamp systems meeting the salient characteristics in Section 2.1.

SECTION 2 — TASKS AND ASSOCIATED DELIVERABLES

2.1 Task: Supply of Headlamp Systems (Salient Characteristics)

Systems furnished under this contract shall meet or exceed the following characteristics:

Characteristic Requirement

Light output 90,000+ LUX; LED technology

Brightness/focus adjustment Continuously adjustable iris, 3.25 in–5.5 in / 6100° Kelvin

Battery life Minimum 4 hours at highest intensity setting; battery life increases as intensity is lowered

Sterile field compatibility Compatible with Sterile Z patient drapes as currently used at SLC VAMC

Mounting Hands-free; compatible with the existing Stryker Steri- Shield helmet system(s) currently in use at the facility

Electrical safety Compliant with IEC 60601 series (or equivalent recognized medical electrical safety standard)

Weight (including battery), by configuration:

Configuration Definition Max Weight

DRO Disposable, Regular, w/ Optics 10.3 oz

DR Disposable, Regular 9.9 oz

SRO Sterile, Reusable, w/ Optics 8.4 oz

SR Sterile, Reusable 7.9 oz

2.2 Deliverable: Helmet and Component Quantities

Twelve (12) helmets, consisting of:

• 8 Steri-Shield helmets (without integrated lights)

• 4 Steri-Shield helmets with integrated lights

Batteries and chargers (tracked as separate line items from helmet units):

• 16 batteries

• 2 battery chargers

2.3 Location of Deliverable

Delivery shall be within 90 days of award (FOB Destination) to:

George E. Wahlen VA Medical Center 500 Foothill Blvd, Salt Lake City, UT 84148 Building 14, 3rd Floor

Receiving hours: Monday–Friday, 06:30–15:00.

The Contractor shall coordinate delivery date/time in advance with the program's point of contact.

2.4 Task: Training

Deliverable: The Contractor shall provide hands-on training for OR staff and biomedical engineering personnel, covering:

• Device operation

• Cleaning/sterilization procedures

• Battery charging/replacement

• Basic troubleshooting

Training shall consist of four (4) thirty-minute training sessions. All four sessions shall be completed within six (6) weeks following delivery of the new equipment, on a schedule coordinated with the COR to accommodate OR staff shift rotations. Sessions shall cover identical content to accommodate staff scheduling, unless the Contractor proposes a sequential curriculum, in which case content dependencies shall be identified in the training plan. Training shall be conducted on-site at the delivery location within the period of performance.

2.5 Task: Warranty Support

Deliverable: Minimum one-year warranty covering all parts and labor from the date of final acceptance. The Contractor shall:

• Respond to warranty service requests within 2 business days

• Provide loaner unit(s) if repair exceeds 3 business days

2.6 Task: Acceptance Testing

Deliverable: Government inspection and successful functional testing verifying compliance with all Section 2.1 salient characteristics, including but not limited to verification of:

• Light output (LUX) and LED function

• Brightness/focus adjustment range and color temperature

• Battery life at highest intensity setting

• Weight, by configuration (DRO/DR/SRO/SR), against Section 2.1 maximums

• Sterile field compatibility with Sterile Z patient drapes

• Secure, hands-free mounting compatibility with the facility's existing helmet system

• Electrical safety compliance (IEC 60601 series or equivalent) — Contractor shall provide certificate of compliance or test report at delivery

2.7 Task: Regulatory Compliance

The Contractor shall comply with all applicable FAR, VAAR, FDA, and OSHA requirements, including but not limited to:

• FDA 510(k) clearance for intended use as a surgical illumination device

• IEC 60601 series or equivalent electrical safety standard for medical devices

• OSHA workplace safety requirements applicable to OR equipment

2.8 Reporting Requirements

• Invoicing: Contractor shall submit invoices electronically via the Invoice Processing Platform (IPP) upon final acceptance, in accordance with current VA invoicing requirements.

• Packaging and Labeling: All items shall be packaged to prevent damage during shipment and labeled in accordance with manufacturer standards and any applicable VA receiving requirements.

• Security: No PHI access is required under this contract. Contractor personnel shall comply with all applicable VA facility access and security policies while on-site.

SECTION 3 — PERIOD OF PERFORMANCE

Delivery (90 days from award) + acceptance testing within 30 days of delivery (see Section 2.6) + training window (6 weeks post-delivery) + warranty period (1 year from final acceptance).

End of Statement of Work