Attachment A - Salient Characteristics.docx

SALIENT CHARACTERISTICS ARTHROSCOPY VISION SYSTEM

Camera System Console Must Meet Requirements Camera system must be a three-in-one console (Includes Camera, Image Capture, and Light source) 3 and 1 console must include light source, camera, and image management and not exceed 41 cm W x 13 cm H x 44 cm D Must integrate camera control unit, light source, and image management into a single console/box platform.

Must provide a minimum of 1 TB internal storage Must contain (2) HDMI outputs, (1) DisplayPort output, (4) 12G SDI outputs.

Must have dual-view integration capable of providing two simultaneous, independent views within single system without additional OR integration.

Must support both picture-in-picture and quad-view display modes, with the ability to route at least one external source to the same monitor.

Must have ability for multiple live views intraoperatively during complex orthopedic procedures.

Must have Panoramic Arthroscope Capability Must support an arthroscope featuring:

C-mount scope-to-camera connection Ultra-wide field of view with convex lens design Single Scope must be able to toggle between 30-degree, 70-degree, and 45-degree ultrawide field of view with the press of a button on the camera.

Scope must provide a 140-degree field of view.

Arthroscope minimum length must be no less than 161mm.

Scope must be autoclavable.

Must Include a camera head and console capable of:

Real-time image flattening of the native convex image maintaining 4K resolution at minimum of 60 frames per second during image processing.

Provide a native 45-degree viewing angle without software adjustment Panoramic functionality (ability to change the scope angle) must be software driven (non-mechanical) with no moving parts.

Must include digital drape detection and fire safety prevention measures to include turning the light source off after 30 seconds once it has been removed from cannula and turn light source off in 10 seconds once placed on drapes.

Must have Disposable Micro Camera Capability Must support a fully disposable camera, scope, and light cord system compatible with the same console as the 4K camera system to be displayed on.

Must enable simultaneous use of 4K and micro camera systems on a single monitor with split-screen capability driven from the camera control unit.

Supported disposable scope must:

Have a diameter of ≤ 2.0 mm Maintain image quality when the scope shaft is flexed or bent Console Front Panel Requirements Must include the following controls and connections:

Light standby button Light guide turret compatible with Wolf, Storz, ACMI, and Olympus inputs Minimum of two USB/iPad ports White balance button 4K camera head connection input Micro camera head connection input

Camera Head Requirements The camera system shall include camera heads with the following capabilities:

Must have - 4K resolution with HDR imaging Must have - Minimum of three programmable buttons per camera head, each supporting short and long press functions (total of six customizable commands), with surgeon-specific preference settings Must be Autoclavable design for sterilization Must be compatible with panoramic arthroscope functionality Must have - Ability to visualize fluorescent dye (ICG)

Fluid pump requirements Fluid pump must offer technical innovations that maintain precise joint distention with independent adjustment of inline pressure and flow levels. Must offer technology that maintains constant distention pressure and eliminates pulsing inflow and the autoclavable remote that has an added flush button feature. System must integrate fluid control to maintain optimum visibility during operative procedure. Must maintain precise joint distention with independent adjustment or inline pressure and flow levels. Must coordinate with shaver to maintain visualization. Maximum flow rate ≥150 ml/min. Pressure 12-120 increments of 5. Fluid pump W ≤ 44 cm x H ≤ 20 cm x D ≤3 6 cm. Weight not to exceed 28 lbs.

Resection/Shaver system System must offer Resection/Shaver system that integrates with fluid management system. Resection/Shaver system must have touch panel control with graphic user interface for multiple orthopedic procedures. Must have two fully functional channels to allow optional simultaneous handpiece operation. Must allow single footswitch to control both channels and ability for second footswitch attached to console to operate each channel independently. Must have max speed of 8000 revolutions per minute. Shaver system W ≤ 41cm x H ≤ 14x D ≤ 31cm. Weight ≤7 kg.

Radio Frequency (RF) System System must offer RF console that can be integrated with the imaging system. RF System must offer hand and foot switch controls. RF system must offer metal proximity detection. RF console W ≤ 41cm x H ≤ 14 cm x D ≤ 38 cm. Weight not to exceed 7 kg.

Arthroscopy Video Tower Video Tower with boom footprint width ≤ 28 inches x Depth ≤ 27 inches x Height ≤ 71 inches (excluding monitor). Must have four (4) locking casters. Must include US power cord. Must include fluid bag hanger. Fluid bag holder must hold up to 35 lbs. Must have monitor kit to support 32” monitor minimum weight capacity 27 lbs. Must include transformer 120V with housing. Must have rear door. Must include six shelves including bottom shelf attached to drawer, and must include one shelf that can support up to 27 lbs.

Monitor - Must be 32 inch, 4K, HDR, ≥ 12G, LED medical display.

Required components for vison tower system:

Imaging Vision System 4 EA HDR C-Mount Camera 16 EA 32" LED 4K HDR ≥12G Surgical Monitor 4 EA 4K all in one panoramic Arthroscope,45°, ≥4.2mm x161mm ± 0.5mm 16 EA High Flow Sheath taper arthroscopic 2 stopcock fenestrated 16 EA Panoramic Arthroscope Obturator Sheath taper/fenestrated high flow 16 EA Coupler endoscopic camera 4K C Mount 4 EA Software for imaging system panoramic scope technology 4 EA Video / equipment cart with boom 120 V 4 EA IV bag Hanger, 4 bag f/ video cart 4 EA Color Printer Digital 4 EA Instrument Case mid-size 16 EA Scope Case 16 EA 4K C-Mount Arthroscope, 30°,4mm x 152.5mm ±0.5mm 4 EA 4K C-Mount Arthroscope, 70°, 4mm x 156mm ± 0.5mm 2 EA C Mount Wrench 16 EA Sheath Arthroscopic 4mm scope taper 2 stopcock high flow fenestrated 6 EA Obturator arthroscopic 4mm scope sheath system handle cone 6 EA Resection Shaver Console 4 EA Shaver HP, Handcontrol 16 EA Small Hub Shaver Handpiece 3 APSII Footswitch, Standard 4 EA Arthroscopic RF Console 4 EA RF Footswitch 4 EA Integrated inflow and outflow Arthroscopy Fluid Management System 4 EA