P01 - SOW.pdf

STATEMENT OF WORK (SOW)

Veterans Health Administration (VHA)

Eastern Oklahoma VA Health Care System (EOVAHCS)

Provision of Argon Plasma Electrosurgical Unit

At the new Tulsa VA Medical Center

GENERAL

PURPOSE / OBJECTIVE: The Eastern Oklahoma VA Health Care System (EOVAHCS) requires a contractor to provide (2) new Dual Output Electrosurgical unit with Argon Plasma Coagulation unit for the new Tulsa VA Medical Center, per the Delivery and Location instructions in this

SOW, in a cost-effective, efficient, and safe manner, while contributing to the VA Mission.

BACKGROUND: The Eastern Oklahoma VA Health Care System (EOVAHCS) is renovating a non-medical existing facility to be the new Tulsa VA Medical Center (VAMC).

LOCATION:

Product Delivery: Jack C Montgomery VA Medical Center, 1011 Honor Heights Drive, Muskogee, OK 74401.

DELIVERY TIMES (PERFORMANCE PERIOD): The VA requires the Contractor to deliver the products no earlier than September 30, 2025, and no later than December 01, 2025.

Eastern Oklahoma VA Health Care System (EOVAHCS) requires a contractor to provide ESU with

Dual Output Electrosurgical unit and Argon Plasma Coagulation unit for use in the facility operating rooms for internal precise tissue cutting and coagulation. These devices are used during operative procedures to prevent permanent nerve injuries. The Argon Plasma

Coagulation (APC) units aid in non-contact coagulation of tissue using ionized argon gas. This helps to achieve effective hemostasis, reduce blood loss, and minimize thermal spread to surrounding tissue.

The Purpose, to include provision of products, must be accomplished by the Contractor by the

Delivery Times at the Locations, in accordance with this SOW, in a cost-effective, efficient, and safe manner, while contributing the VA Mission.

The Contractor shall furnish all contract oversight, management, OEM authorizations to support provision of OEM products, materials, supplies, storage, insurances, shipping and delivery costs, and transportations necessary to provide the products, for EOVAHCS in accordance with this

SOW. Any services associated with this product are considered non-personal services. The

Contractor, its employees, agents, and subcontractors shall not be considered VA employees for any purpose of fulfilling the SOW and shall be considered employees of the Contractor.

Contractor must provide products and perform in a professional manner and quality as recognized by commercial industry standards as good to excellent. Contractor must provide to the LOCAL POC and CO, and maintain for the life of the contract, written certification from the

Original Equipment Manufacturer (OEM) that authorizes the Contractor to provide and assemble the products, as detailed in the Contractor’s quote and identified in this SOW.

Brand Name of Products, to include make and model numbers:

All mentions of Brand Name, Make/Model numbers, is provided only for purposes to convey

Basis of Design as a means of providing the minimum requirements.

SCOPE: EOVAHCS requires a contractor to provide products that meet or exceed the physical, functional, and performance of the listed salient characteristics in the following sections. The equipment features are essential to the technical requirements to meet the VA’s needs. The VA’s needs assessment identified the type of products and components listed below as a suitable solution to fill the gap. However, these are only used as a guide and the VA’s basic, salient characteristics and critical minimum requirements define the type of product that is needed to ensure the Purpose of this SOW is satisfied. OEM part numbers/references, in the salient characteristics sections are used as a basis of design and are provided as a means to convey the minimum standard characteristics.

PHYSICAL CHARACTERISTICS: Contractor must provide the equipment in the quantities listed below and associated components that meet or exceed the critical minimum requirements as well as the specifications in this SOW.

CRITICAL MINIMUM REQUIREMENTS

Contractor must provide BRAND NAME OR EQUAL with the following critical minimum requirements.

1) Argon Plasma Coagulation and Electrosurgical Unit, Dual Output -or equivalent

a. Argon Plasma Coagulation Unit and Dual Output (monopolar and bipolar)

Electrosurgical Unit. Used in the operating room as an alternative to the scalpel for cutting tissue.

b. Solid state power source with foot switch jacks, monopolar and bipolar outputs, and four independent modes of operation.

Each Unit consists of:

i. Item# 10135-000 Argon Plasma Coagulation Unit (Erbe Argon Plasma

Coagulation APC 3). Must include equivalent or better of:

1. FORCED Argon Plasma Coagulation (Consistent firing at 30 watts or above with application distance up to 5mm)

2. PULSED Argon Plasma Coagulation (Consistent firing from 10 watts with application distance up to 7mm)

3. PRECISE Argon Plasma Coagulation (Continuous application of energy with intensity of the ionized plasma increasing when the Effect setting in increased)

4. 6 Instrument Sockets

5. Dimensions [Width x Height x Depth]: 415mm x 100mm x 375mm

(16.3“ x 3.9“ x 14.8“)

6. Weight: 5.3 kg (11.7 lbs.)

7. Input pressure: (5 ± 2) x 105 Pa 5 ± 2 bar 72.5 ± 29 psi

8. Max. output pressure: 2 x 105 ± 2 x 104 Pa 2 ± 0.2 bar 29 ± 2.9 psi

9. Adjustable gas flow: 0.1–8 l/min limited by the instrument connected in each case, configurable in 0.1 l/min increments

10. Nominal flow tolerance: ± 20 % [range: 0.1–8 l/min]

11. If you use a compressed gas cylinder, a warning is activated at 7 x 105

Pa 7 bar 101.5 psi

12. Display of remaining quantity: VIO 3 display

13. Display of remaining pressure: Manometer on the gas cylinder

14. The APC 3 switches off at an input pressure of: < 3 x105 Pa < 3 bar <

43.5 psi

ii. Item# 20134-006 APC Pressure reducer with sensor

iii. Item# 1063-2 40cuft Argon Gas Tank-full, 99.998% purity

iv. Item# 10160-000 Erbe VIO3 Electrosurgical Unit

1. Constant Voltage Regulation with Power Dosing automatically delivers lowest effective adjusted power output in all modes, including both CUT and COAG

a. Power Peak SystemTM,PPS, offers optimal support during the initial cutting stage, especially low contact impedance situations, allowing the electrode to start in contact with target tissue without cutting delay

2. Spark Recognition automatically detects the formation of micro-electric arcs (sparks) for controlled and reproducible cuts, e.g. length and quality

a. Spark Regulation (micro-electric arcs) for reproducible, efficient cuts in tissue with high or extremely low impedance

3. Full-color user interface with unique viewing features

a. FocusView: reduces the visual information to the essentials, simplifying the operation of the unit.

b. PreView: graphic depiction of tissue effects with different parameters in real time, shown on the display prior to activation. A power meter displays real time power output during and throughout activation.

4. Maximum CUT output: 300 watt at 500 ohm

5. Safety system: NESSY

6. Frequency: 350 kHz

7. Maximum COAG output: up to 200 watt

8. Rated Supply Voltage: 100 V - 120 V

9. Power frequency: 50 / 60 Hz

10. Power input during stand-by: 40 Watts

11. Power input during max RF output: 500 watt / 920 VA

12. Line Current: 8 A

13. Dimensions: Width x Height x Depth 16.1” x 6.5” x 15.0”

14. Weight: 20 lbs. 17 oz.

v. Item# 20188-350 One-Pedal Foot Switch VIO3; with Remode

vi. Item# 20189-353 Two-Pedal Foot Switch VIO3; with Remode, Bracket, and

Middle Piece

vii. Item# 20192-135 Monopolar Cable MO 3 Pin; OD 3MM socket; L 4.5M

viii. Item# APC3EW - Total 2 Year Parts and Labor Warranty (Manu.Std.Warr. is 1 year on Plasma unit. This line brings a total to 2 years to match the

Electrosurgical Unit)

OTHER REQUIREMENTS:

Contractor is required to provide BRAND NAME OR EQUAL to the following requirements.

SPECIFICATIONS (including SALIENT CHARACTERISTICS)

See below list and attached addendum – “CUTSHEETS” for basis of design

Contractor must provide products that meet or exceed the specifications in this table.

QTY Unit of Issue

Model Numbers are from Erbe brand

Item Description

2 EA 10135-000 Argon Plasma Coagulation Unit (Forced, Pulsed, and Precise)

2 EA 10160-000 Erbe VIO3 Electrosurgical Unit

2 EA 20134-006 APC Pressure reducer with sensor

2 EA 1063-2 40 cuft Argon Gas Tank-full, 99.998% purity

2 EA 20188-350 One-Pedal Foot Switch VIO3; with Remode

2 EA 20189-353

Two-Pedal Foot Switch VIO3; with Remode, Bracket, and Middle Piece

4 EA 20192-135 Monopolar Cable MO 3 Pin; OD 3MM socket; L 4.5M

MANUALS: Contractor shall provide electronic, digital copies of the user manuals and repair manuals for each different product under this order or contract, at no additional cost to the government.

QUALITY

Conformance Standards

Refer to section on Safety and Compliance in this SOW.

DELIVERY:

Delivery and training must be coordinated with the LOCAL POC.

Delivery and receipt of the proposed items are anticipated to be directed to the location identified in this SOW. Confirmation of delivery location will be provided by the VA LOCAL POC post-award. Delivery must be coordinated with VA LOCAL POC before any delivery attempts.

Any item that has not been coordinated will be turned away and any additional charges will be the responsibility of the sender/transportation company. Contractor is required to provide training to 5-7 clinical staff in December 2025 – January 2026. Training must be scheduled and coordinated with the local POC as these dates are subject to change due to onboarding of new staff. Training must be on-site at James Mountain Inhofe VA Medical Center, 440 S. Houston

Ave, Tulsa, OK 74127.

INSPECTION:

Inspection and Acceptance of Products and Services: The Government reserves the right to inspect and test services in accordance with this SOW and the Contract. The only individual authorized to officially accept services is the LOCAL POC. While inspection of services may be delegated by the LOCAL POC and a shared responsibility with departmental management staff, the LOCAL POC is ultimately the only authorized individual to approve and accept services on behalf of the VA.

WARRANTY OF EQUIPMENT: Contractor must provide a warranty per the Specifications in this

SOW. The warranty must meet or exceed standard manufacturer industry warranty terms. The government does not accept an extended warranty, which requires advance payment. Manufacturer’s warranty must begin on day of first use of products i.e. once clinical training begins.

STANDARD BUSINESS HOURS AND FEDERAL HOLIDAYS

Hours: Normal duty hours are 0800 - 1500 CST, Monday through Friday, not including federal holidays. Whenever contact with a facility is required outside of normal duty hours, the

Contractor shall coordinate these times with the designated LOCAL POC.

In accordance with 5 U.S.C. 6103, Executive Order 11582, and Public Law 94-97, the following national holidays are observed and for the purpose of this contract are defined as “Legal

Federal official holidays.”

New Year’s Day January 1st

Martin Luther King’s Birthday Third Monday in January

President’s Day Last Monday in February

Memorial Day Last Monday in May

Juneteenth June 19th

Independence Day July 4th

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran’s Day November 11th

Thanksgiving Day Fourth Thursday in November

Christmas Day December 25th

In addition to the days designated as holidays, the Government observes the following days:

• Any other day designated by Federal Statute

• Any other day designated by Executive Order

• Any other day designated by the President of the United States to be a Federal holiday.

SAFETY AND COMPLIANCE

The Contractor must perform services and ensure equipment functions in accordance with:

a) local, state, and federal Occupational Safety and Health guidelines and legislation, to include Occupational Safety and Health Administration (OSHA), the American National Standards Institute (ANSI) safety guidelines;

b) local, state, and federal Fire and Safety legislation and guidelines, to include VA Health Care System directives and legislation on Fire and Safety, as well as the latest published edition of NFPA-99 (Health Care Facilities Code);

Medical Center Policies Each VA Medical Center has policies that are updated from time to time. The LOCAL POC can provide more detailed information to the contractor of these upon commencement of the contract and throughout the term of the contract, as needed, especially policies regarding, parking, possession of weapons, cell phone use and photography as well as smoking on VA property. Violations of such policies may result in individual fines or citation answerable in the United States (Federal) District Court.

LIABILITIES AND INSURANCES

Protection from Damage Contractor shall provide all labor, materials, and equipment necessary for protection of VAMC personnel, furnishings, equipment and buildings from damage, and shall replace or repair any damage due to work performed under this contract equal to its original construction and finish.

END OF STATEMENT OF WORK