Stryker OR Integration SOW - 7.1.25.docx

STATEMENT OF WORK – OR INTEGRATION UPGRADE

BACKGROUND: This acquisition is to provide state of the art operating room equipment to the Rocky Mountain Regional VA Medical Center (RMR) within the Easter Colorado Healthcare System (ECHCS). This upgrade is required to provide quality hospital and surgical care to veterans and to support the mission of the hospital. This is an upgrade to the existing equipment, and the expectation is that the new equipment shares all the same pre-install requirements, Sterile Processing Department (SPD) processes, and space, power, and conduit requirements as the existing equipment. ECHCS is requesting the Stryker Operation Room (OR) Integration system or EQUAL offer to replace the existing integration hardware and accessories.

OBJECTIVES: Replace the existing integration, video equipment, EHR (VistA) connectivity, media management system, and room status system with the equipment listed below.

SCOPE:

Contractor shall provide and install all equipment listed below.

A. IP Integration System B. Device Control C. Camera Control Unit D. 4K Camera Head with Integrated Coupler E. Laparoscopes F. LED Light Source G. Insufflator H. Capture and Record Device I. Miscellaneous Video Equipment J. EHR (VistA) Connectivity K. Media Management System L. Room Status System M. Warranty and Maintenance N. Optional CLIN

The products shall have the following quantities and specifications:

ECHCS is requesting the Stryker OR Integration system or EQUAL offer to replace the existing integration hardware and accessories at RMR. If an offeror is to provide an equal option from the requested brand of Stryker, the offeror shall add any additional CLINs necessary to ensure that their system offered is fully operational. This includes preventative maintenance and licensing. Below outlines the specifications required for any purposed solutions. This includes existing equipment it needs to be compatible with as well as specifications for each room.

A) IP Integration System – Qty 7 ECHCS requires contractor to provide an IP integration system in seven OR’s. Rooms 1-5 have identical requirements. Rooms 6 and 7 have unique attributes. Below, the seven rooms are listed with the required specifications and integrations listed underneath. Contractor shall provide solutions that is compatible with the devices in the listed inputs and outputs at the specified resolution. If not, all components are compatible, the Contractor shall provide optional clin for any equal equipment that meets the specifications with the existing hardware at RMR, the offeror must add replacement parts in optional CLINs to satisfy the needs of RMR as necessary to ensure fully operational rooms.

· ORs 1-5:

· Inputs:

· 4K camera located on Equipment Boom 1

· 1080p DVI signal to existing Stryker In-Light Camera

· SDI and DisplayPort plate on Equipment Boom 1 (plate must handle both 1080p and 4K signals)

· SDI and DisplayPort plate on Equipment Boom 2 (plate must handle both 1080p and 4K signals)

· HDMI and DVI plate on Equipment Boom 1 (plate must handle both 1080p and 4K signals)

· HDMI and DVI plate on Equipment Boom 2 (plate must handle both 1080p and 4K signals)

· HDMI and DVI plate on Anesthesia Boom (plate must handle both 1080p and 4K signals)

· VGA, S-Video, and Composite plate on Equipment Boom 1

· VGA, S-Video, and Composite plate on Equipment Boom 2

· VGA, S-Video, and Composite plate on Anesthesia Boom

· PACS PC (HD DisplayPort) located at nurse desk

· Outputs:

· 4K HDMI signal to existing Stryker 32” OLED monitors in the room (qty 3)

· 4K signal to a 55” wall monitor (also supply the monitor and the wall mount)

· Quad view (ability to show 4 independent inputs on one or more monitors at a given time)

· Other specs:

· Router and capture device must be able to fit in the existing router cabinet in each room (doors have a 23” wide opening).

· 1080p fail-safe signal for MIS camera that directly connects the camera box to one monitor in the field

· Audio input from the PACS PC to the integration system

· Audio input from iPhone at nurse desk to the integration system

· 4 ceiling-mounted speakers for audio output

· 21” 1080p touch panel located at the nurse desk

· No power outlet needed

· USB-C integrated charging port

· USB-A 2.0 and 3.0 ports integrated into the touch panel

· Touch panel can function as a viewable monitor when blowing up an input to the full screen

· Fully sealed keyboard and mouse for the touch panel

· Sterilizable mousepad

· Can control the keyboard, video, and mouse of up to 5 PCs

· OR 6:

· Everything is identical to ORs 1-5 plus:

· Extra inputs:

· HDMI and DVI plate on Perfusion Boom (plate must handle both 1080p and 4K signals)

· Second HDMI and DVI plate on Equipment Boom 1 (plate must handle both 1080p and 4K signals)

· Extra outputs:

· A fourth 4K HDMI signal to existing Stryker 32” OLED monitor in the room

· OR 7:

· Inputs:

· 4K camera located on Equipment Boom 1

· 1080p DVI signal to existing Stryker In-Light Camera

· SDI and DisplayPort plate on Equipment Boom 1 (plate must handle both 1080p and 4K signals)

· SDI and DisplayPort plate on Large Monitor Boom 1 (plate must handle both 1080p and 4K signals)

· SDI and DisplayPort plate on Large Monitor Boom 2 (plate must handle both 1080p and 4K signals)

· HDMI and DVI plate on Equipment Boom 1 (plate must handle both 1080p and 4K signals)

· HDMI and DVI plate on Equipment Boom 2 (plate must handle both 1080p and 4K signals)

· HDMI and DVI plate on Anesthesia Boom (plate must handle both 1080p and 4K signals)

· HDMI and DVI plate on Perfusion Boom (plate must handle both 1080p and 4K signals)

· VGA, S-Video, and Composite plate on Equipment Boom 1

· VGA, S-Video, and Composite plate on Equipment Boom 2

· VGA, S-Video, and Composite plate on Anesthesia Boom

· PACS PC (HD DisplayPort) located at nurse desk

· Control Room PC (HD DisplayPort) located in control room

· Siemens Live (located 60’ from router) (also include DVI 1-in-2-out splitter)

· Siemens Reference (located 60’ from router) (also include DVI 1-in-2-out splitter)

· IVUS (via HDMI PC connection in the control room) (also include DVI 1-in-2-out splitter)

· MacLab (via HDMI PC connection in the control room)

· Outputs:

· 4K HDMI signal to existing Stryker 32” OLED monitors in the room (qty 3)

· 4K signal to a 55” wall monitor (also supply the monitor and the wall mount) (qty 2)

· Quad view (ability to show 4 independent inputs on one or more monitors at a given time)

· Variable 1080p outputs to Siemens (located 60’ from router) (qty 6)

· Variable 1080p output to existing Stryker 26” monitor in the control room

· Other specs:

· Same “other specs” as are listed for ORs 1-5

B) Device Control – Qty 7 ECHCS has a requirement for the control system and it must be able to integrate with current equipment. Contractor shall provide all necessary equipment to be able to control the existing equipment/systems below. If the solution cannot control the existing equipment at RMR, the offeror must provide an optional CLIN to replace or add equipment that will satisfy the requirements of this section.

· System must be able to control and apply surgeon-specific presets that include the following devices:

· Existing Stryker lights

· Existing Stryker in-light cameras

· Existing Stryker 32” monitors

· MIS camera

· Light source for MIS camera

· Insufflator

C) Camera Control Unit – Qty 9 The proposed solution must provide nine units that are able to control the cameras integrated with the system.

D) 4K Camera Head with Integrated Coupler – Qty 14 RMR is requesting 14 additional 4K camera heads to be installed.

E) Laparoscopes:

As part of the procurement, RMR is requesting replacements/upgrades for the laparoscopes on site. The specifications for the scopes to be provided are listed below.

· Fluorescence-capable, autoclavable, 5.4mm diameter, 0 degree, 30cm – qty 10

· Fluorescence-capable, autoclavable, 5.4mm diameter, 30 degree, 30cm – qty 10

· Fluorescence-capable, autoclavable, 10mm diameter, 0 degree, 33cm – qty 10

· Fluorescence-capable, autoclavable, 10mm diameter, 30 degree, 33cm – qty 10

F) LED Light Source – Qty 9 LED light sources must be provided to replace the existing sources. RMR is requesting the specifications below.

· Include light cables that automatically turn off when disconnected from the camera head or light source. Safelight Technology.

G) Insufflator – Qty 9 This requirement includes the need for new insufflators. The offeror should include the adaptors below as part of this(these) CLIN(s).

· Include adapters to connect 6 insufflators to house gas – qty 6

· Include adapters to connect to CO2 tanks on 3 towers – qty 3

H) Capture and Record Device – Qty 10 The offeror must provide ten (seven rooms and three towers) capture and record devices for RMR to document images and videos. These devices should function with the existing OR software at RMR, otherwise the offeror shall provide replacements in option CLIN. The devices should have the capabilities below.

· Needs to handle dual-channel capture in 4K and dual-channel record in 4K

· Needs to export surgical content in 4K

I) Miscellaneous Video Equipment Besides replacing the hardware in the rooms, RMR has towers and other miscellaneous components that will need to be upgraded with compatible hardware. See the specifications below.

· Rolling carts (AKA video towers) with 120V plug and monitor arm to hold existing Stryker 32” monitors – qty 3

· Henke Dyonics Scope Adapter for use with existing scopes – qty 28

J) EHR (VistA) Connectivity The solution provided by the offeror must be able to communicate with RMR’s HER (VistA). If the proposed solution is not compatible with the Stryker Data Mediator system, the offeror must add additional CLIN for whatever software/hardware is needed to fulfill this requirement. The specifications of the need are below.

· Licenses to connect each OR’s capture device to the system – qty 7

· Licenses to connect each tower’s capture device to the system – qty 3

· System must have ability to transmit via the following workflows:

· Capture Device -> EHR Connectivity System -> VistA direct through HL7 as PDF

· Capture Device -> EHR Connectivity System -> VistA through DICOM as full-size images

· Capture Device -> EHR Connectivity System -> Media Management System as images and video

K) Media Management System As described in the specifications above, the offeror must provide a media management system that allows RMR staff to review and manage images and videos transmitted by the capture station. If the offeror’s solution is not compatible with Stryker’s Studio 3, then the offeror shall add optional CLIN for any hardware/software needed to fulfill this requirement. The specific needs are listed below.

· System that is browser-based and resides on the VA’s network but does not communicate outside of the VA’s firewall – qty 1

L) Room Status System This section specifies the need for a room status system. This entails cameras in each of the seven OR’s. See the specification below.

· POE ceiling-mounted “dome” camera for each OR – qty 7

M) Warranty and Maintenance The contractor shall provide details of any warranties and their associated coverage. The contractor shall include or otherwise specify the offeror’s warranty for the system, including all hardware and software components. The warranty shall specify the timeline of the warranty as well as what coverage is provided.

If providing an equal, the offeror shall provide the cost of associated coverage for the system. This includes maintenance, licensing, vendor phone/on-site support, and any other needs to ensure the system is operational at RMR for a base year plus 4 additional option years.

N) Optional CLIN The offeror shall include any hardware, software, or labor required to meet the requirements of this statement of work. If the proposed solution cannot meet the requirements without replacing existing systems, all CLIN required to allow the solution to meet the specifications requested should be included in this section.

The products shall have the following salient characteristics:

This section further expands upon the needs for each solution requested. In this section, specific integrations and existing hardware at RMR will be specified in greater detail. If the offeror’s solution cannot meet the requirements using the existing infrastructure at RMR, the offeror must include additional hardware or software to meet the requirements. These additional needs should be listed as optional CLIN.

IP Integration System

· IP-based system that utilizes an SDVoE backbone

· 3D, 4K, and 8K ready – modular, scalable and future proofed for emerging technologies

· Uncompressed True 4K capability

· 48-Port 10G Switch for scalability. Each 4K signal requires a maximum of 1 port.

· Analog & Digital encoders (no third-party scalers)

· Multiple install options (in-room, adjacent, remote)

· Seamless “Device Control” with an intuitive user interface that adds clinical value: insufflator, light source, pump, camera, annotations, etc. Must include the ability to control existing recently-purchase Stryker devices that are already in the rooms (32” OLED monitors, SLX lights, and HD in-light cameras)

· Intuitive control and routing of audio, video and data sources from a central touch panel monitor

· “One Touch Button” for turning the OR suite On/Off (including all existing Stryker monitors in the room)

· Surgical Checklist (time‐out) Integration which engages team members during surgical time‐outs by broadcasting a pre‐surgical checklist to all monitor screens while automatically muting music in the room.

· High Definition Digital Video Interface Preview

· Picture‐in‐Picture (PIP), Picture‐by‐Picture (PBP), Quad view allowing no more than four video signals to be displayed on one monitor simultaneously

· Presets available to configure for surgeons or case types

· Route any image to any monitor with the touch of a button

· Single Keyboard/Video/Mouse (KVM) solution for up to three (5) PCs (Nurses PC, etc.)

· Connects to multiple room speakers to provide audio from multiple sources (e.g. iPod, Sirius‐Satellite radio, etc.)

Camera Control Unit

· True 4K system with fluorescence technology built into the same camera box

· Scalable to accommodate future advancements in peripheral device integration and control

· Intuitive capacitive touch screen LCD interface for ease of operation

· 10 cross-specialty settings for optimal color resolution and brightness

· Compatible with ureteral stents that, when placed, emits infrared light that can be detected by the camera system.

· Color gamut = 1 billion colors

· 4K Fluorescence and capability to perform real-time endoscopic visualization and near-infrared fluorescence imaging

· Ability to visualize CYTALUX (On-Target Laboratories). Cytalux is the only optical imaging agent FDA approved to help surgeon identify malignant & non-malignant lesions in patients suspected for lung cancer.

· Imaging modes include:

· White light mode

· Overlay mode that integrates white-light image with fluorescence in real time.

· High-contrast fluorescence visualization in Grayscale

· Grayscale with fluorescence overlay

· Fluorescence intensity “heat map”

· Lighted ureteral stents

· Color overlay is 120 frames per second, two times faster than the average image

· CF Rating (electrical safety classification meant for devices that could come in contact with the heart)

4K Camera Head with Integrated Coupler

· CMOS 3-Chip camera technology designed for enhanced light sensitivity and increased patient safety

· Integrated Device Control from the camera head (Control of devices on/off sterile field. Insufflator, light source, CCU, surgical lights, surgical monitors.)

· Programmable camera head to control pictures, video, and light source

· Ergonomic, lightweight design for minimally invasive surgery

· Ability to visualize white light, along with optical agents ICG (Indocyanine green) , CYTALUX

Laparoscopes

· 5.4mm x 30 cm x 30 DEG laparoscope

· 5.4mm x 30cm x 0 DEG laparoscope

· 10mm x 33cm x 30 DEG laparoscope

· 10mm x 33xm x 0 DEG laparoscope

· Ability to visualize white light, along with optical agents ICG (Indocyanine green) , CYTALUX

LED Light Source

· Auto-Light technology. Light source automatically shuts off when the fiber-optic cable disengages from the scope.

· White ring technology. Provides visual confirmation the equipment is connected correctly.

· Auto-Light optimal light distribution

· Visualization of optical imaging agents ICG & CYTALUX.

Insufflator

· 6 unique operating modes dedicated to surgical specialties that utilizes pressure settings and flow rates designed to maintain stable pneumoperitoneum

· Smoke evacuation built in with integrated ULPA filter

· Four controlled levels of smoke evacuation filter out 99.999% of all particles greater than 0.1 micrometer protects patients and staff from the harmful carcinogens found in surgical plume

· Gas heating allows CO2 to warm to core body temperature before entering the patient minimizes laparoscope fogging

· Humidification to 90% relative humidity

· Can be controlled from the sterile field using the camera head, remote control, touch panel, and voice control headset. This includes control over insufflator flow rates, pressure settings, and smoke evacuation levels.

· When activated at the end of the procedure, desufflation automatically pulls CO2 out of the abdomen at a slow and consistent rate to remove the remaining and leftover gas.

· 5 different tubing options with RFID chip technology including heated, humidified, and smoke-evacuation

· Status of the device can be displayed on the existing Stryker 32” monitors in the rooms

· Has a High Flow Rate of 50L/min

Capture and Record Device

· Must be compatible with existing EHR (VistA) Connectivity and media management systems (called DataMediatOR and Studio3, respectively) currently installed on the RMR VAMC's network.

· Displays critical device status on existing, newly-purchased Stryker 32” OLED monitors for insufflator, light source, arthroscopy pump, shaver, and other devices

· Controls clinical devices including the camera, light source, and insufflator through multiple control modalities such as Voice or Device Control

· Captures, records, streams, and prints with 4K or HD

· Standby mode for smart power cycling

· 4K picture-in-picture, picture-by-picture, QUAD

· Includes Surgeon Profiles stores profile settings for:

· Clinical device preferences

· Custom, procedure-specific annotations

· Arthroscopic shaver RPM’s

· Arthroscopic pump critical pressure settings

· Surgical display color preference settings

· Camera system color/light preference settings

· Light source intensity settings

· Print and save settings

· 8” multi-touch capacitive touchscreen

· Integrates surgical media with existing hospital information systems to directly link to patient’s record

· USB 3.0 port

· Integrated Surgical Timeout feature with standard surgical timeout requirements that can also be customized by the facility. All surgical timeout questions are displayed on all monitors and allows for electronic documentation of participation in the patient’s file.

· Barcode scanning imports patient information via a barcode scanner directly from VistA by scanning the patient’s wristband or chart.

EHR (VistA) Connectivity

· Platform designed to securely and seamlessly connect hospital information systems with medical devices

· Ability to archive surgical images, videos and data to the EHR and PACS

· Pulls patient information from the EHR into the capture device and integration system in the OR, which ensures correct patient information is populated on connected devices

· Bi-directional EMR integration automates patient data entry in the OR and sends images and videos back to the EMR

· Can send images to multiple DICOM destinations such as PACS for long term storage.

· Can send video and images to a media management platform to be edited or shared from a secure web browser or mobile device

· Modular system allows addition of more integrated devices as needed

· Open architecture model that accommodates standard communication protocols such as HL7, XML, and DICOM

Media Management System

· Centralized storage solution for archiving and management of surgical videos and images.

· LDAP and LDAPS support

· Microsoft Active Directory integration

· Archive and store surgical images, videos, and documents to a centralized platform with controlled user access

· Edit content in an easy-to-use web browser-based interface

· Share videos and images with patients, referring physicians, and colleagues

· Browser-based solution that resides on the VA’s network but does not communicate outside of the VA’s firewall

Room Status System

· Installed on the VA’s network but does not need to communicate outside of the VA’s firewall

· Stream up to 40 independent video feeds and view up to 12 video feeds at one time

· Privacy mode

· Face-blurring technology

· Viewable on desktop, wall display or tablet

· Unlimited viewers at one time

· Configure an unlimited number of groups

· Digital PTZ control of room camera

· High-definition video signal

· Provides visible image in dark lighting

· H.264 video streaming format

· Microsoft Active Directory integration

INSTALLATION:

Hours: The installation should be completed during normal hour of business, which are Monday through Friday from 7:00am to 5:00pm, excluding the federal holiday listed below. Work performed on holidays or outside of normal business hours can be scheduled in direct coordination with the Contracting Officer’s Representative (COR) granted that it is at no additional cost to the government.

Federal Holidays:

Schedule: All work shall be scheduled in advance with the COR and OR staff. The work should be done in compliance with the allowable interruptions to OR operations as defined by VA staff. Using timeline estimates for the work to be performed in each room, the vendor shall schedule work with the COR and OR staff to ensure that a no point does the OR experience more room closures than expected or scheduled.

LABOR & MATERIALS:

The contractor shall provide all labor and materials necessary for the successful installation of all required components for the solution to be fully functional. If any additional CLINs are added to ensure functionality, the offeror should ensure that any resulting material (cables, mounts, power, etc.) or labor (cable running, data drops, mounting, relocation) needs are included in the offer. Any expected or unexpected labor and materials should be included in the offer or otherwise provided to ensure functionality at no additional cost to the government.

TRAINING:

The offeror shall include options for training in their offer. The offer shall include one option for clinical training for operation and one option for biomed technical training for system support. The trainings should be comprehensive for the solution and other components provided.

SERVICE MANUALS:

The contractor shall provide the VA with any applicable service manuals for the purchased equipment. A reference list of applicable service manuals and their respective locations shall be provided to the Biomedical Engineer upon request.

DOCUMENTATION:

The offeror shall provide reports of the work completed to the COR at least once at the end of the project. The documentation shall include detailed descriptions of the work performed. Each report must, at a minimum, document the following data legibly and in complete detail:

a. Name of contractor and contract number

b. Name of contractor personnel who performed services

c. Date, time (starting and ending), and hours on-site.

d. Work performed

e. Signatures:

-Contractor personnel performing services described.

-Authorized VA Employee who witnessed service described.

NOTE: - Any additional charges claimed must be approved by the COR or Contracting Officer (CO) before work is performed The Contractor shall check in with Biomedical Engineering prior to performing any services. When the service is completed, the contractor shall document the work completed and check out with Biomedical Engineering and submit the documents to the Biomedical Engineer or Point of Contact. All documentation shall be submitted to the equipment user and the Biomedical Engineer for an “acceptance signature”. If the POC’s are unavailable, a signed, authorized copy of the documentation shall be sent to the contractor after the work can be reviewed.

ADDITIONAL CHARGES:

The contractor shall notify the COR of any additional work or equipment/parts required outside of the scope of this contract. If additional charges are required, the contractor must receive approval from the COR and CO before moving forward with the labor or materials. The government will not be responsible for the charges associated with out-of-scope work that was not approved by the CO and COR in advance.