Attachment B - Salient Characteristics - RFQ No.36C26224Q1817.docx

RFQ: 36C26224Q1817

SALIENT CHARACTERISTICS

for

SURGICAL EQUIPMENT LEASE

The following equipment shall be made available for lease in addition to providing procedure manuals for each type of leased equipment supplied:

Digital Capture Device

· Must have device control – Control clinical devices through multiple control modalities. Connect and control camera, light source, insufflator and show critical device updates on the monitor.

· Must have the ability to capture, record, stream, and print with 4K and HD.

· Must have surgeon profiles that allow for customized printing, saving, and clinical device setup/control for each surgeon.

· Must have touchscreen technology.

· Must integrate surgical media with existing hospital information systems.

· Must have an integrated surgical timeout feature that is pre-loaded with standard surgical timeout requirements that can also be customized by the facility.

· Camera Control Unit (CCU)

· Must be 4K.

· Must be able to perform real-time near-infrared fluorescence imaging.

· Must be able to visualize vessels, blood flow and related tissue perfusion, and major extra-hepatic bile ducts via infrared imaging.

· Must be able to integrate while light image with fluorescence to achieve an overlay on the screen.

· Must be able to display an image in high-contrast black and white.

· Must be able to display an image in greyscale with green overlay to provide enhanced visual assessment of blood flow, tissue perfusion, and biliary ducts.

· Must be able to operate in this mode.

Light Source

· Must be able to automatically shut off light source if fiberoptic cable becomes disengaged from the scope.

· Must have auto-light adjusting technology that automatically adjusts the light output for consistent lighting.

· Must have visual check (white-ring) that indicates when the light cable is securely plugged in.

Surgical Camera

· Must have CMOS 3-Chip camera technology.

· Must have integrated device control from the camera head.

· Must be a programmable camera head to control pictures, video, light source, insufflation, and fluorescence.

· Must be ergonomic, with a lightweight design for minimally invasive surgery.

4K Surgical Video Display

· Must have 4X the resolution of a 1080p image.

· Must have 4K pixel density which offers a bright, colorful viewing experience.

· Must be 23.1 lbs. for easy installation in both integrated and cart-based rooms.

· Must have multiple input options for use with a variety of visualization equipment.

· Must have full integration with the digital capture device to control surgeon profiles to include monitor settings and on screen displays for a consistent, seamless OR experience.

· Must have multiple viewing modes.

· Must contain 9 preset surgical specialties.

· Must have integrated device control software compatible with the digital capture device for sterile field control of monitor including picture in picture and picture by picture.

Insufflator

· Must have 6 unique operating modes dedicated to surgical specialties. Each operating mode utilizes pressure settings and flow rates designed to maintain stable pneumoperitoneum.

· Must have integrated smoke evacuation built into the insufflation tubeset to provide consistently clear images through a smart inflow and outflow management system. Designed to maintain stability while actively evacuating smoke.

· Must have four controlled levels of smoke evacuation that filter out 99.999% of all particles greater than 0.1 micrometer.

· Must have integrated heating and humidification: Gas heating allows CO2 to warm to core body temperature before entering the patient, designed to minimize laparoscope fogging.

· Must have the ability to control connected devices, including the insufflator, 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.

· Must include desufflation.

Portable Handheld Imaging System

· Must be 1080p resolution at 60fps.

· Must allow for assessment of perfusion from a wide range of viewing distances.

· Must be able to combine an enhanced fluorescence signal information with vivid white light images in real-time.

· Must have ambient light immunity so the operator can work fluidly without disrupting activities around the surgical table.

Video Processing Illuminator

· Must be able to use the same light source and video processor for both NIR and VIS HD imaging.

· Must be able to handle full HD 1920 x 1080 picture elements with 1080i59.94 signal outputs in HD-SDI and DVI.

· VIS LED (light emitting diode) array and emitted light must be class 3R laser source.

· Must be able to provide real-time HD endoscopic visible and near-infrared fluorescence imaging simultaneously.

· Must have a near infrared laser that operates at805 nm for ICG (indocyanine green) fluorescence excitation.

· Must have fluorescence mode that enables surgeons to visualize the degree of ICG in tissue and anatomical structures.

· Must have an image quality menu where the user can customize configuration of image quality based on sharpness, brightness, red saturation, blue saturation and peak / mean balance.

· Must allow the user to select display options available in the cycle controlled by the display button on the camera head.

· Must be able to restore image quality and display modes selections to default factory settings.

· Must allow user to retrieve a previously saved set of configurable settings for display modes and image quality.

· Must allow user to save a set of configurable settings for future use.

· Must be able to change language setting.

Corded Small Bone/Podiatry Hand Piece

· Must have a dedicated wire driver for small bone orthopedic procedures.

· System must have available hand switch and/or foot petal operation.

· Must require no tools to load burs or blades.

· Must be compatible with existing core console instrument driver.

· Must have a removable hand switch to allow the same hand piece to be used for multiple functions.

· Console must be capable of operating two hand pieces at one time.

· Sagittal saw must feature a rotating, indexing head to increase blade position versatility when cutting.

Cordless Small Bone Power Tool

· Must have a modular small bone power system with a pencil grip and a pistol grip available.

· Must include the following modular motors:

· Sagittal saw

· Oscillating saw

· Reciprocating saw

· Micro drill

· Universal driver

· Battery modules must have a 30-day shelf life without losing power or performance.

· Battery must be insulated to increase resistance thermal damage from sterilization.

· Must include a light to indicate battery status.

· Must be compatible with resurfacing tool burs.

Large Bone Power Tool

· Batteries must have a 30-day shelf life after charging with no loss of performance.

· Batteries, chargers, and hand pieces must be compatible with existing batteries, chargers, and attachments.

· Battery charger must track hand piece performance.

· Rotary hand piece must offer 157 in/lbs. of torque.

· Rotary hand piece must have a drilling and reaming switch.

· Sagittal Saw must offer 12,000 cpm in fast mode, and 10,000 cpm in standard mode.

· Reciprocating Saw must allow for two cut speeds for more versatility. The saw must offer up to 14,000 cpm in fast mode, and up to 11,000 cpm in standard mode.

· Cordless driver must offer a reaming attachment which allows higher torque reaming with a medium bone hand piece.

· Hand pieces must weigh less than 2.5 lbs.

· Must offer dedicated hand pieces for sagittal saw, rotary drill, reciprocating saw, sabo saw, and cordless driver in order to decrease OR staff time spend changing drilling/cutting components.

· Hand pieces must be fully submersible, preventing liquid prevention from normal use.

Instrument Driving Console

· Must be able to power small bone power tools, and high-speed drills.

· Must be compatible with existing power tools, and high-speed drills.

· Must be able to create over 100 user profiles which can be stored and transferred.

· Must have adjustable acceleration and braking.

· Must have software which can adjust torque, tactile feel, and drill precision/performance.

· Must have adjustable irrigation flow rate.

· Must have at least three foot-pedal choices.

· Must have at least three hand piece ports.

· Must run at least 2 heavy duty hand pieces simultaneously.

· Must have colored illumination to match drills and foot pedals.

· Must have distinct, different audio tones to denote different actions and alerts.

High-Speed Surgical Drills

· Drill must be compatible with existing instrument driver.

· Motor construction must utilize flat wiring and triangular shaped magnets to reduce size and increase run time while remaining cool.

· Must spin at least 75,000 rpm.

· Must have at least 5.5 in/lbs. of stall torque.

· Must be less than .7 inches in diameter.

· Must weigh less than .673 lbs. including hose.

· Must include an integrated irrigation attachment.

Ultrasonic Aspirator

· Must redirect the longitudinal stroke into a longitudinal and torsional motion, creating a non-rotational and highly directional motion providing the surgeon with the ability to safely dissect bone in proximity with delicate structures.

· Must be compatible with a tip consisting of two V-shaped notches opposite one another which enables fin, sharp dissection of target tissue.

· Must have a universal hand piece that can operate all tips used with the system.

· Hand piece must not require external cooling by piezoelectric transducer.

· Console must have included irrigation.

· System must use one, dual bore tubing kit for irrigation and suction.

· Suction, irrigation, and ultrasonic functions must be able to be used alone, or simultaneously.

EHR Connectivity

· Must have software that connects to different hospital information systems and medical devices seamless and secure.

· Must act as a central point of integrations between Electronic Medical Record Systems, DICOM destinations, server-based archiving systems, and surgical digital capture devices.

· Must ensure correct patient information is populated on connected devices.

· Capable of archiving surgical images, videos, and data to the EMR and PACS.

· Must have bi-directional EMR integration which automate patient data entry in the OR and send images and videos back to the EMR.

· Must have DICOM support to send images to multiple DICOM destinations such as PACS for long term storage.

· Must be able to send videos and images to archive systems to edit and share media from a secure web browser or mobile device.

· Must have capability to include additional compatible integrated devices as needed.

· Must be integrated into the hospital’s EMR which will allow surgical images to be accessed directly from the patient chart.

· Must be compatible with medical industry communication standards (HL7 and DICOM).

Media Management

· Must be able to share media from a secure web browser or mobile device.

· Must be a centralized storage solution for archiving and management of surgical videos and images.

· Must be integrated into the hospital’s EMR which will allow surgical images to be accessed directly from the patient chart.

· Must be able to archive and store surgical images, videos, and documents to a centralized platform with controlled user access.

· Must be able to edit content in an easy-to-use web browser-based interface.

Other medical requirements as directed by the Government:

· Must be able to provide infrared surgical scopes (cystoscopes, laparoscopes, arthroscopes) as required by the Government to meet its minimum surgical needs.

· Must be able to provide manual instruments (graspers, scissors, obturators) to help with minimally invasive surgery as required by an authorized surgeon.

· Must provide a microcart that meets the minimum of hospital requirements.

· All equipment must be compatible and upgradeable to current hospital systems and technology currently in place.

(End of Salient Characteristics)