S02 SOW Stryker Endoscopic Tower.docx

Statement of Work (SOW) Stryker Endoscopic Video System James J. Peters Va Medical Center 130 West Kingsbridge Road Bronx, NY 10468

1. Background The James J. Peters VA Medical Center is requesting the purchase of Brand Name Only Stryker Endoscopy System needed for laparoscopic and video-assisted thoracoscopic surgical procedures for use in the Surgical Department.

2. Project Scope The vendor will provide the 1688 Stryker Endoscopic Surgical System and required accessories listed in Price/Cost Schedule. The Stryker 1688 AIM 4K Platform must enable minimally invasive real-time imaging of anatomy during surgery, with automated light control for a seamless workflow across multiple specialties. The Stryker Endoscopic System shall provide reduce ureteral injuries through use of IRIS or bile duct injuries and anastomotic leaks through NIR imaging. As well as accurately distinguishing anatomical variances and overcoming poor vision through 4K resolution for Urology. The Orthopedic modality will provide superior lighting in posterior compartments and improve fluid management and resection through use of Autolight. Gynecology to improve deep pelvic lighting and expected to reduce the risk of ureteral injury through use of IRIS. The ENT modality shall provide color reproduction and posterior lighting in cavernous sinus. Colorectal modality will mitigate ureteral injuries and anastomotic leaks.

The Stryker Endoscopy Surgical System will include SPY Portable Handheld Imager which utilizes SPY Fluorescence Imaging Technology, and allows surgeons to visualize blood flow in vessels and related tissue perfusion during plastic, microsurgical, reconstructive and gastrointestinal procedures. SPY-PHI's modalities include: white light, SPY Fluorescence Mode, Overlay Fluorescence Mode and Color-Segmented Fluorescence Mode.

Technical Specifications Equipment Information Size

· Control Unit: 13” W × 17” D × 6” H

· Total Weight: 19.4 lbs (8.8 kg)

· Display: 8” TFT LCD, with digital touchscreen Power Consumption

· 100-240VAC ~ 50/60Hz (± 10%), 4A/2A maximum Recommended Security — Authentication and Encryption (when connecting to Hospital network)

· WPA2-Enterprise (PEAPv0/EAP-MSCHAP v2) Authentication Wireless Transmission

· 2.4GHz wifi: Operating frequency range: 2400MHz-2483.5MHz

· Maximum EIRP level: 16.89 dBm

· 5GHz wifi: Operating frequency range: 5150MHz-5350MHz & 5470MHz - 5725MHz

· Maximum EIRP level: 10.59 dBm Electrical Safety Classification

· Class I Equipment

· No Applied Part

· Water Ingress Protection, IPX0

· Continuous Operation Environmental Specifications

· Operating Temperature: 10 – 40°C

· Operating Humidity: 25 – 75% RH

· Operating Atmospheric Pressure: 700–1060 hPa

· Transport and Storage Temperature: -18° – 60°C

· Transport and Storage Humidity: 15 – 90% RH FCC Compliance

· Contains FCC ID: 2ACWK76X2

· This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) This device must accept any interference received, including interference that may cause undesired operation.

Battery Recycling

· The Batteries Directive 2006/66/EC introduces new requirements from September 2008 on removability of batteries from waste equipment in EU Member States. To comply with this Directive, this device has been designed for safe removal of the batteries at end-of life by a waste treatment facility. Infected units should be decontaminated before they are sent for recycling. In the case that it is not possible to decontaminate the unit for recycling, the hospital should not attempt to remove the batteries from waste equipment.

· Continued disposal of small amounts of portable batteries to landfill and incineration is allowed under the Batteries Directive 2006/66/EC and Member State regulations.

Image Resolution

· XGA: 1024 × 768

· SXGA: 1280 × 1024

· High Definition 720: 1280 × 720

· High Definition 1080: 1920 × 1080

· Ultra High Definition 4K: 3840 × 2160 Formats

· Bitmap (BMP), Joint Photographic Experts Group (JPG, JPEG), JPEG2000, Tagged Image File Format (TIFF), Truevision Targa (TGA) and Portable Network Graphics (PNG) Audio Input/Output

· Stereo Line and Microphone Input/Output

· 1 Speaker Output Network Type

· 10/100/1000 Mbps ethernet Video Input

· DVI

· RGBHV (via DVI-I connectors)

· HDMI

Video Outputs

· DVI, (via DVI-I connectors)

· HDMI

Encoding Format/Resolution

· MPEG2: 720 × 480, 720 x 576

· H.264: (NTSC) 720 × 480, (PAL) 720 × 576, (XGA) 1024 × 768, (SXGA) 1280 × 1024, (720p) 1280 × 720, (1080p) 1920 × 1080, (UHD) 3840 × 2160 Auto Printing

· 1, 2, 4L, 4S, 6, 8, 12, or 18 images per page for portrait orientation

· 1, 2, 4L, 4S, 6, 9, 12, or 16 images per page for landscape orientation Printers Supported

· SDP1000

Storage Devices USB

· Format: NTFS and FAT32 format supported (read/write), MAC users will only have read capabilities

3. Delivery Location:

James J. Peters VAMC 130 West Kingsbridge Road Bronx, NY 10468

4. Warranty and Support

Standard warranty of the equipment will be provided for one year upon receipt and acceptance of the equipment. The Chief Biomedical Engineer, or designee, must sign off on acceptance before the warranty cycle begins. The warranty must be provided in the quote to cover all components of the patient monitoring equipment.

Key Terms for warranty support:

· One year of warranty upon initial receipt and acceptance signature

· 4 hours call back response during normal business hours of 7AM to 6PM

· 24 hours on site response for repairs

· Service reports sent to all appropriate points of contact with quarterly aggregate reports

HTM will have full access to the hardware and software that constitute the system, including any diagnostic software features and general administration rights. The HTM point of contact must be briefed, by the vendor, on all software upgrades and changes and agrees to each prior to installation. The vendor shall provide and install manufacturer recommended software upgrades and changes at no additional charge during warranty/contract period. The vendor will provide two (2) sets of user manuals and technical manuals to HTM.

For any repairs or services that will be performed during normal working hours, the vendor’s service representative will report upon arrival to the HTM Point of Contact (POC) or his/her designee. Upon completion of the work, the vendor’s service representative must report in person to the Point of Contact and must present a copy of his/her field service report signed by the service using the equipment. This report must reflect date and time of service, name of company, and the name of the vendor’s service representative. At a minimum, this report must contain a detailed description of any services or repairs performed and identification of the units serviced. It must include a listing of replacement parts, when applicable. The report will also include the vendor’s recommendations necessary to maintain the equipment in best operating condition. Preventive maintenance procedures followed should be thoroughly documented (step-by-step) on the service report.

A copy of the service report shall be provided to the HTM POC for documentation.

5. Installation the contractor Stryker or certified subsidiary is responsible to install all 1688 Stryker Endoscopic Surgical Systems to be 100% functional and set with the VA infrastructures as necessary. All work and installation will be coordinated with the identified VA Point of Contact (POC) and the Nursing and HTM groups. Work schedule will be provided and coordinated with the VA POC. A detailed installation schedule will be provided during the project implementation kick-off meeting. The installation will occur at the discretion of the VA POC and be coordinated with the VA. The full deployment shall have a 60-day deployment window.

The James J. Peters VA Medical Center is a fully operational hospital. The Contractor must schedule his work around VA operations and specifically for the convenience of the hospital. Contractor must note work at times other than normal operating hours.

The vendor will confine operations (including storage of materials) on Government premises to areas authorized and approved by the Contracting Officer. Working space and space available shall be as determined by the VA POC.

Contractor will have no access to VA sensitive information during installation.

6. Testing

The contractor shall verify to HTM and Nursing staff that the system meets all requirements stated on this contract through demonstration and validation. Contractor will have no access to VA sensitive information during testing.

7. Training

The Contractor will be responsible for providing on-site user training for the patient monitoring equipment. The James J. Peters VAMC will have six days of onsite user training included to be used at their discretion. Training shall have a 1 year window to be used. Contractor will have no access to VA sensitive information during training.

8. VA Information Security Policies:

The contractor will not remove any medical system components from the facility without authorization from Chief Biomedical Engineer or designee. Any medical system hard drives will remain in the possession of the James J. Peters VAMC.

The C&A requirements do not apply, and that a Security Accreditation Package is not required

9. Work Hours:

Normal business hours are 8:00AM to 4:30PM Monday through Friday excluding Federal Holidays. Work completed outside this time must be requested through the VA POC.

Requests for after-hours work must be submitted in writing to the VA POC two (2) weeks prior to work. The VA requires that information submitted must contain extent of work, workers involved, the affected areas, and the estimated times of operation.

10. Price/Cost Schedule:

TOTAL