36A77620Q0148-007.docx

VA Nebraska-Western Iowa Healthcare System Initial Outfitting, Transition & Activation Statement of Work Laser, Surgical CO2; Laser, Pulsed Dye; Laser, Dual Wavelength (JSNs: M8525D, M8526 & M8526A)

VA Nebraska-Western Iowa Healthcare System 4101 Woolworth Avenue Omaha, NE 68105 Ambulatory Care Center Project

Introduction Veteran Affairs Nebraska-Western Iowa Healthcare System (VANWIHS) has a requirement to purchase Laser, Surgical CO2; Laser, Pulsed Dye; Laser, Dual Wavelength (JSNs: M8525D, M8526 & M8526A) with an authorized vendor to supply and deliver the item(s) identified in Table 1 below. See salient characteristics below. This requirement is in support of the activation of VA Nebraska-Western Iowa Healthcare System Ambulatory Care Center. The new Ambulatory Care Center has the need for one each Laser, Surgical CO2; Laser, Pulsed Dye; Laser, Dual Wavelength for the Ambulatory Surgery Dermatology Department. The manufacturer Syneron Candela is the basis for design.

Table 1 – Package Items Summary

Additional Item Requirements For the Lasers, the vendor shall provide user manuals that describe proper use, care and cleaning for users of the equipment.

In addition, the vendor will provide service manuals that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA Biomedical Engineering Department.

Date of manufacture must not be greater than 2 years before the purchase order date. The equipment must not be used or refurbished and must have the latest manufacturer’s software/hardware updates installed. Any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.

General Conditions Site Address The address of the VA Nebraska-Western Iowa Healthcare System Ambulatory Care Clinic is provided below.

Delivery Schedule Items shall be delivered no earlier than the estimated delivery start date and no later than the delivery end date listed in Table 2 below.

Table 2 – Anticipated Building Outfitting Schedule

Schedule and Order Management

Delivery and Receiving

2.4.1 Delivery and receipt of the proposed items is anticipated to be directed to the location identified below. Confirmation of delivery location will be provided post-award. To coordinate delivery, contact Government POC Mark Stockstell at (402) 995-5847, mark.stockstell@va.gov, Colin Beal at (402) 930-7775, colin.beal@va.gov , Dan Thompson at (785) 477-2820, dan.thompson@sme-solutions.co , and Derick Lacky at (301) 602-9109, dlackey@hcrmoves.com.

☒ VANWIHS Omaha VA Ambulatory Care Clinic (Direct Delivery to address detailed in paragraph 2.1.1) ☐ IOT&A Contractor-Provided Warehouse Local to the VANWIHS SME Solutions Warehouse: Attn: SME Solutions-VA Project, Gratton Warehouse Co. 11005 E Circle Omaha, NE 68137

If the vendor requires the use of the Government’s activation contractor’s warehouse to meet the requirements of this contract the vendor must provide a certificate of insurance prior to the delivery and offloading of the item(s). This insurance certificate must be completed and presented to the activation contractor prior to delivery.

The vendor shall communicate through the VA and IOT&A POC any required coordination requirements.

Clean Up and Disposal

2.6.1 There are no dumpsters available for vendor use.

2.6.2 The removal of waste and/or excess material shall be conducted through the loading dock area.

Assembly and Installation Required (Yes ☒ No ☐)

2.7.1 The vendor is required to manage and coordinate installation at the VANWIHS Omaha VA Ambulatory Care Clinic with the COR or his representative IOT&A POC.

2.7.2 On-site assembly and installation of items, and performance of services identified in this document shall take place during normal business hours in the new ACC which are defined as: 8:00 AM to 4:30 PM Central Standard Time, Monday through Friday, and excluding Federal Holidays.

2.7.3 The vendor is required to define the need for a staging area to accommodate item assembly and installation, if needed. Post-award, this information will be confirmed with the vendor.

2.7.4 The vendor is required to provide tools, labor and materials to complete assembly and installation of the items detailed in this document.

2.7.5 The vendor shall protect all finished spaces and surfaces as required from delivery and installation damage. The vendor shall use covering and protection to the extent necessary to prevent damage to finished spaces. Any damage occurred during delivery and installation is the responsibility of the vendor. The vendor will be responsible for paying for and repairing any damage or noted deficiencies to finished spaces and surfaces that occur as a result of the vendor’s (or associated sub-contractors) installation.

2.7.6 During the entire duration of assembly and installation, the vendor will have a competent representative on-site as the vendor’s contact, and to serve as the interface between the vendor and VANWIHS. On-site representative can be the installer. All instructions provided from COR to the representative will be binding as if given to the vendor’s main contact. The COR may provide specific instructions, however, only the Contracting Officer may change the terms or conditions of the contract.

Training Clinical Training Training shall include initial setup and user training; onsite training for go-live support, super user training and follow-up training.

Clinical training must take place at the facility. Clinical applications training must be provided for day and night shifts, and must include installation, go-live, and post implementation/super user support.

Scope of Work VA Nebraska-Western Iowa Healthcare System M8526A

Total Quantity: 1 ☐ Finish Sample Required if Checked ☐ Manufacturer Certified Installation Required if Checked ☐ BMET Training Required if Checked ☒ End User Training Required if Checked

JSN Nomenclature: Laser, Dual Wavelength (JSN: M8526A) Description: A laser platform that combines the Alexandrite laser with an Nd:YAG laser. Together, they provide high performance treatment capabilities in terms of speed, efficacy, ease-of-use, and safety.

Salient Characteristics:

· Laser Types / wavelength: Nd:YAG / 1064nm and Alexandrite / 755nm

· Repetition: Up to 10Hz

· Delivered Energy (Max): Nd:YAG is 80 joules (J), Alexandrite is 53J

· Pulse duration: 0.250 – 100ms

· Spot Sizes: 1.5mm, 3mm, 6mm, 8mm, 10mm, 12mm, 15mm, 18mm

· Beam Delivery: Lens-coupled optical fiber w/handpiece(s)

· Pulse Control: Finger switch and/or footswitch

· Electrical: 200-240 VAC, 50/60 Hz, 30A

· Laser Fluence: 0.25ms to 100ms

· Alexandrite Fluence at Spot Size: 3mm – 40 to 400 J/cm2; 6mm – 6 to 150 J/cm2;

8mm – 6 to 100 J/cm2; 10mm – 6 to 60 J/cm2; 12mm – 10 to 40 J/cm2;

15mm – 7 to 30 J/cm2; 18mm – 6 to 20 J/cm2

· Nd:YAG Fluence at Spot Size: 1.5mm – 300 to 520 J/cm2; 3mm – 130 to 400 J/cm2;

6mm – 6 to 200 J/cm2; 8mm – 6 to 150 J/cm2; 10mm – 6 to 100 J/cm2;

12mm – 10 to 70 J/cm2; 15mm – 7 to 44 J/cm2; 18mm – 6 to 30 J/cm2

VA Nebraska-Western Iowa Healthcare System M8525D

Total Quantity: 1

JSN Nomenclature: Laser, Surgical CO2, Mobile, Dermatology (JSN: M8525D) Description: A CO2 laser is a type of gas laser. In this device, electricity is run through a gas-filled tube, producing light. The gas mixture is generally comprised of carbon dioxide, nitrogen, hydrogen and helium. Light produced by CO2 lasers is invisible, falling in the far infrared range of the light spectrum.

Salient Characteristics:

· Laser Type / wavelength: CO2 / 10,600nm

· Laser Emission Mode: Pulsed

· Output Power (max): 60 watts

· Laser Beam Energy (variable): 1 – 90mJ

· Pulse Repetition Rate (max): 16.7kHz

· Pulse Duration: 20 - 3000µsec

· Power Stability: ± 1.5 watts (± 5%)

· Mode Quality (M2): < 1.2

· Beam Size: Ø 1.8 ± 0.5mm

· Beam Divergence (full angle): 7.5 ± 0.5mrad

· Polarization (orthogonal to mounting pads): > 100:1 linear

· Maximum Scan Area: 10mm diameter

· Aiming Laser: 5nW, 650nm (red) diode laser

· Articulated Arm: Lightweight, 7-joint, pneumatically balanced; treatment radius at full extension at least 85cm; 360o Horizontal Rotation

· Lens Assemblies: 120µm spot size, 150µm spot size

· Handpiece: single use and/or multi-use

· User interface: High-resolution color LCD touchscreen

· Laser Emission Control: Footswitch

· Laser Emission Indicators: Solid Amber LED for Standby, Flashing Red LED for Laser in Use

· Electrical: 100 - 240 VAC self-sensing, 50/60 Hz, 7.1 A

· Operating Modes: Light, Mid, Deep, Fusion, Resurfacing and Excision (or similar) VA Nebraska-Western Iowa Healthcare System M8526

Total Quantity: 1

JSN Nomenclature: Laser, Pulsed Dye (JSN: M8526) Description: The pulsed dye lasers emit short bursts of high-intensity yellow light that destroy the targeted tissue. The pulsed dye laser delivers energy at a wavelength and duration that has been optimized for the selective treatment of vascular lesions.

Salient Characteristics:

· Laser Type / wavelength: Pulsed Dye / 595nm

· Pulse: 0.45 – 40ms

· Spot Sizes w/Maximum Energy: 3mm – 40 J/cm2; 5mm – 30J/cm2; 7mm – 20J/cm2;

10mm – 10J/cm2; 12mm – 7J/cm2; 3x10mm – 25J/cm2; 7mm PL – 15J/cm2;

10mm PL – 10J/cm2

· Beam Delivery: Lens-Coupled 3m optical fiber w/handpiece

· Pulse Control: Finger switch and/or footswitch

· Electrical: 230 V 50/60 Hz, single phase, 18A image2.png