R Series Defibrillators - Kansas City VAMC

Statement of Work: R Series Defibrillator

Kansas City VA Medical Center

1. Objective
   1. The Kansas City VA Medical Center intends to procure a replacement fleet of defibrillators. This document highlights the technical specifications and services being requested by the facility for consideration towards purchase of the units. Vendors under this proposal shall provide all equipment and accessories, installation services, and project management support.

1. Scope
   1. The Contractor shall furnish all equipment detailed in Table 1. All products must meet all salient characteristics and functions defined in Section 3.

Table 1

Description

Quantity

30520007201310013

R Series ® Plus Defibrillator includes expansion pack

40

SurePower Rechargeable Lithium lon Battery

Pack

5.8 Ah Capacity

High density lithium ion chemistry

RunTime Indicator

Automatic calibration ready

Stores history of use and maintenance

40

R WiFi Card with Clock Sync and FIPS

40

5-year hospital warranty

n/a

1. 1. The Contractor shall provide all components required to implement all listed hardware and software so the system (including all items in Table 1) is fully operational.
      1. The Contractor shall provide any missing parts, features, software, and/or components not included to fully complete the installation at no additional cost to the Government.
   2. The Contractor shall provide all labor, supervision, and any other resources required to deliver, assemble/install, and test all listed equipment.
   3. All hardware, software, and services must meet the manufacturers and VA specifications.

1. Salient Characteristics[PMC(1] 

1. 1. R Series Defibrillators

Specification/Salient Characteristics:

• Maximum dimensions: Height 10 in; Width 12 in; Depth 13 in
• Maximum weight: 15 lb
• Must be operational with AC or DC
• Includes AC Power Cord
• Guidelines 2020- compatible
• AED w/ manual override 5-year minimum hospital warranty
• Must have the following accessories, capabilities, and ability to operate in the following modes:

Physical features

• • Nellcor Pulse Oximetry Compatibility
  • Order Sensor Separately
  • NIBP

23-33cm reusable cuff 􀀦 3-meter air hose

 RMT motion tolerance

 For use with adult, pedi and neonatal patients

• • Mainstream EtCO2
  • Color LCD screen

Batteries

     SurePower Rechargeable Lithium lon Battery

    Pack 5.8 Ah Capacity High density lithium-ion chemistry Run-Time Indicator

    Automatic calibration ready Stores history of use and maintenance

Operators’ manual

• • 1 per defibrillator
  • Language: English
  • Provided by manufacturer and includes manufacturer’s instructions

Defibrillation

• Biphasic defibrillation
• Provides automatic life support defibrillation when powered on.
• Ability to functions as an AED, but not when initially turned on.
• Manual defibrillator to support pediatrics to adults to include automatic safety feature to eliminate the risk of delivering an adult energy level to a pediatric patient
• Less than 7 seconds of charge time for a new fully charged battery
• Evaluates ECG rhythm to determine if shock delivery is required

Configurations

• Configurable for either CPR or shock-first driven protocols
• Energy sequences can be configured for single or multiple shocks with fixed or escalating energy levels
• The CPR interval length is configurable in 1-minute increments for up to 4 minutes

Wi-Fi connectivity

• • Allows the wireless communication of clinical and test data (no PHI)
  • Synchronizes the time to that of the network to negate “clock drift” and ensures time accuracy of code data.
  • FIPS Compliant

Real CPR Help

• • Numeric display of CPR depth and rate for adult and pediatric patients
  • Visual and audio prompts to coach CPR depth for Adult patients
  • Release bar to ensure adequate release off the chest
  • Metronome to coach rate for Adult and Pediatric patients.
  • Indicates elapsed time since last detected chest compression

CPR artifact filtering

• • Adult and Pediatric AED ECG analysis

See-Thru ® -CPR filter

• OneStep cable manager

Defib Mentor familiarization aid

OneStep Pacing includes:

• OneStep Pacing Cable (also supports CPR)

• ECG leads

1. 1. Contractor shall deliver all equipment to:

Kansas City VA Medical Center

4801 E. Lynwood Blvd

KANSAS CITY, MO 64128

ATTN: Biomedical Engineering

1. 1. 1. Ensure that equipment is sent to the Attention of Biomedical Engineering
      2. Include the PO Number on the shipping label.
   2. Deliver materials to the facility in manufacturer's original sealed boxes or containers with brand name marked thereon. Refurbished products will not be accepted.
   3. Package to prevent damage or deterioration during shipment, handling, and storage.
   4. Maintain protective covering in place and in good repair until delivery is necessary.
   5. Any government requested delayed delivery up to 90 days shall be at no additional cost to the Government.
   6. Contractor shall conduct a pre-delivery meeting at least 3 days prior to initial award delivery date for verification of delivery and installation dates.
   7. Delivery of oversized, palletized orders, or orders that contain a large number of components will be coordinated with the COR who will communicate internally with Warehouse Staff.
   8. Contractor shall adhere to all equipment delivery deadlines outlined in Table 2.
2. ASSEMBLY, INSTALLATION, AND TESTING
   1. Contractor responsible for assembly and installation of systems after notification from COR (or designee) that it has been delivered to station.
      1. Install shall include unboxing and transportation of equipment to final use location.
      2. Installation shall include implementation and testing of all purchased interfaces to VA electronic systems in coordination with Clinical Staff, Biomedical Engineering staff, O&IT staff, and others identified as needed.
   2. Vendor shall provide all necessary accessories, cables, adaptors, etc. to deliver a fully functional clinical device/system.

1. Hours of Operation
   1. Kansas City VA normal hours are Monday through Friday, 7:00 a.m. to 4:30 p.m. Central Standard Time, excluding Federal holidays.
   2. VA follows all Federal holidays that are set by law (USC Title 5 Section 6103).

The Government hereby provides notice and Contractor hereby acknowledges receipt that Government personnel observe the listed days as holidays:

New Year's Day                                  January 1

Martin Luther King's Birthday           Third Monday in January

President's Birthday                            Third Monday in February

Memorial Day                                     Last Monday in May

Juneteenth                                           June 19

Independence Day                              July 4

Labor Day                                           First Monday in September

Columbus Day                                    Second Monday in October

Veterans Day                                      November 11

Thanksgiving Day                              Fourth Thursday in November

Christmas                                            December 25

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

1. Any other day designated by Executive Order.

2. Any other day designated by the President’s Proclamation; and

3. Any other day designated by Federal Statute.

1. 1. All services shall be performed during normal hours unless otherwise scheduled with the COR.
      1. Hardware/software update/upgrade installations, where applicable, may be scheduled and performed outside normal hours at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the COR or designee). 
      2. All agreed-upon work scheduled outside normal business hours shall be at no additional cost to the Government.
2. SITE CONDITIONS & PROTECTION OF PROPERTY
   1. Vendor representatives must check in with Dole VA Biomedical Engineering when they arrive on-site and check out upon completion of work each day.
   2. Vendor on-site visits shall be coordinated with the COR (or designee) before being scheduled or conducted.
   3. There shall be no smoking on Kansas City VA premises at any time.
   4. Eating and drinking are not allowed inside the hospital, except for in the Canteen Dining area.
   5. Vendor staff shall always be professional and shall take all necessary precautions to maintain a safe environment for the occupants. This includes, as necessary, coordinating access and closures for sensitive areas of the Medical Center.
   6. Vendor shall be responsible for cleaning all work areas after completion of tasks. This includes, but is not limited to, removal of packaging and a clean sweep/mop of the area as required by work type.
   7. Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), grounds, and furnishings. The Contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor.
   8. The Contractor shall perform an inspection of the building(s) and grounds with the COR prior to commencing work to ensure that the Contractor shall be able to repair or replace any items, components, building(s) or grounds damaged due to negligence and/or actions taken by the Contractor. The source of all repairs beyond simple surface cleaning is the facility construction contractor (or appropriate subcontractor), so that building warranty is maintained. Concurrence from the VA Facilities Management POC and COR is required before the Contractor may perform any significant repair work. In all cases, repairs shall utilize materials of the same quality, size, texture, grade, and color to match adjacent existing work.
   9. Vendor staff shall minimize noise as much as possible while working in all buildings.
   10. Vendor is responsible for providing all PPE necessary for their work.
   11. The Contractor shall be responsible for security of the areas in which the work is being performed prior to completion.
3. Security Requirements
   1. Network Security
      1. The vendor is required to complete and submit the two attached VA Security Forms, if their equipment can be connected to the VA network. If these forms are not completed and submitted with the bid package, the vendor can be disqualified from the bidding process.
      2. The C&A requirements do not apply, and that a Security Accreditation Package is not required.

1. Warranty & service
   1. The contractor shall provide all manufacturers’ warranty with products upon delivery.
   2. Warranty – The system, all accessories, and all software shall be covered under the manufacturer’s warranty and shall include all parts and labor for at least 5 years following acceptance by the VAMC.
      1. A manufacturer’s factory-trained Field Service Engineer shall perform installation and maintenance during the warranty period.
      2. The warranty period shall not begin until after the Dole VA COR or designee has accepted the products delivery, installation, and functionality.
      3. The warranty shall include all manufacturer recommended Preventive Maintenance procedures for its duration.
      4. All available software updates and security patches will be made available to the Kansas City VA during the warranty period.
      5. Vendor shall provide response to applications and technical calls within 8 hours.
      6. Vendor shall ship replacement parts within 48 hours of identifying necessity by Kansas City VA Biomedical Engineering staff.
2. INVOICING
   1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, Vendor Electronic Invoice Submission Methods. Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:
      1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungstennetwork.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.
      2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org).

 [PMC(1]Mykaela-Need FIPS compliance, TRM approved, and approved ERA language