6515--Image 1S Saphira- Surgical Service

This is a source sought synopsis only. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (hubzone, 8(a), small, small disadvantage, small veteran owned business or service disabled veteran owned small business) relative to NACIS 339112 (size standard of 1,000 employees). This is not a solicitation. Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought synopsis, a solicitation announcement may be published in the SAM.gov website.

Responses to this sources sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this sources sought announcement. The Department of Veterans Affairs, Network Contracting Office NCO22, is seeking sources for vendors to purchase an Image 1S Saphira for the VA Loma Linda Healthcare System. The anticipated award date shall be 11/20/23.

If you are interested and are capable of providing the required services please provide the requested information as indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Is your business small (2) If small, does your firm qualify as a small, emerging business, or small disadvantaged business? (3) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act? (4) Is your firm a certified Hubzone firm? (5) Is your firm a woman-owned or operated business? (6) Is your firm a certified Service-Disabled Veteran Owned Small Business, (7) Is your firm a Veteran Owned Small Business? Small businesses considering participation in this potential solicitation process under any Small Business Set-aside procedure must do so in a manner consistent with the requirements of the Small Business Act. Responses to this notice shall be e-mailed to Hanan.McCullick@va.gov. Telephone responses will not be accepted. Responses must be received in writing no later than 4:00 p.m. 11/3/23. This notice is to assist the VA in determining sources only. A solicitation is not currently available. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Responses to this sources sought is not a request to be added to a prospective bidders list or to receive a copy of the solicitation.

SCHEDULE OF SUPPLIES:

SALIENT CHARACTERISTICS:

The entire high-definition video cystoscopy system must have the following EXACT characteristics on all items.

Blue Light Cystoscopy Rigid Telescopes:

Telescopes must be Hopkins II 4mm, autoclavable with 30cm working length. They must be 30 degree and 70-degree angle of views with blue light rod lens technology, compatible and interchangeable with all KARL STORZ rigid cystoscope and bipolar resectoscope sets.

Power LED Saphira D-Light PDD Light Source:

Must be Dual LED light source

Must include dual white light and PDD blue light mode ability with excitation filter mounted on the fly wheel

Must include simple switchover between white light and PDD fluorescence excitation light in the selected operating mode via camera head or foot switch

Must include 3 separate operating modes for various photosensitizers and fields of application

Must include operating time of 30,000 hours

Must include Type CF applied part according to IEC 60601-1

Must include integrated SCB (Storz Communication Bus) module for controlling the entire system from camera head

Specifications: Lamp type: LED

Color temperature: 6000 K (white light)

Light intensity adjustment: Continuously adjustable

Dimensions: 305 mm x 120 mm x 370 mm (w x h x d)

Weight: approx. 7.4 kg

Certified to: IEC 601-1, protection class 1/CF

AIDA Bella Image & Video Management System:

Must include Dual Channel Recording for both 4K & 3D

Must include image capture in HDMI 2.0, Video 720p, 1080p and 2160P

Security: Windows LDAP login, disable removable media export function, password-protected procedure cabinet, able to support encrypted USB, military level security.

Must support HL7/DICOM standards for PACS and HER integration.

Must auto-populate patient data, VISTA & Cerner compatible for network access, DICOM export to PACS and vendor neutral storage (VHA approved).

Must export patient images/videos to HER, PACS, StreamConnect, DVD, USB

Must be able to import both patient and procedural information from the HER/VISTA or Cerner.

Must be able to provide advanced surgical feedback

Must be MPEG4 compression

Must have retroactive capture (DVR-like functionality)

Must have customizable surgeon settings

Must have Icon based user interface

Must have Barcode Scanner compatible for patient data entry

Must have configurable mandatory patient fields

Must have Smart touch screen for staff interface

Saphira Image1 S Video Processor CCU s Technology:

Camera Connect Units (CCU) must include 12G / 3G- SDI and HD DVI-D Outputs and be type CF device / defib. resistant

Must be modular architecture design for future expandability and upgradability

Must include Saphira Technology for BLCC

Must include Chroma Enhancement Technology which identifies and brightens up dark areas in real time without overexposing the bright part of the image

Must include Clara Enhancement Technology that allows in real time (no visible lag time) to eliminate dark areas in an image, allowing the surgeon to keep their telescope in the right distance from the surgical target and being able to effectively perceive and discern additional content. which is time consuming during a procedure

Must include Pointer Visualization feature for pointer visualization overlay that facilitates effective verbal communication between the attending surgeon and his assistant

Must include Grid Visualization Feature to facilitate effective verbal communication between the surgical team members minimizing operating time.

Must include Burn-in Screen Saver; if the video system (camera controller, monitor) is not powered down the camera output is permanently displayed on the monitor and, after some time it is burned into the glass. This burnt-in image is overlaid to the surgical image leading to a significant quality reduction.

Saphira BLCC High Definition Camera Head:

Must be compatible with Saphira Image1 S Camera Connect Unit

Must be pendulum in design and high definition

Must have focus knob with 16mm focal length

Must have (3) programmable user control buttons

Must be 16 x 9 image format with 60 Hz image refresh rate

Bipolar & Monopolar Electrosurgical Unit: Generator must meet the following exact specifications. Must have Advanced Tissue Sensing Technology with ARC Control (Advanced Control Response) along with the following technologies:

 Must complement the KARL STORZ True Bipolar Electrodes, which provides less risk of strictures and no de-bulking. AUA Guidelines define True Bipolar as the loop having both the active and return electrodes

 Advanced Response Control (ARC) - Advanced Tissue Sensing Technology, with improved activation, that generates the cutting effect while simultaneously minimizing output power as well as facilities directing cutting and prevents electrode adhesion

 High Resolution Touch Screen Display

 Ergonomic Foot Pedal for both Bipolar and Monopolar Energy. KARL STORZ is the only bipolar manufacturer with a button for preset switchover function on the foot pedal

 ZAP mode - allows the user to switch between two preset power settings through the icon on the touchscreen or the black button on the foot pedal

Insulation type/Classification

EMC : IEC 60601-1-2

Degree of protection provided by the housing: IP 21

Protection class according to EN 60601-1: I

Applied Part type according to EN 60601-1: CF

Classification according to EU Directive 93/42/EEC: IIb

Power Input

Min. power consumption: 3 W / 40 VA

Min. current consumption: 400 mA

Max. power consumption (at 400 W): 700 W / 1150 VA

Max. power consumption (at 400 W): 10 A @100 V, 8 A @127 V

Line Fuse: 2 x 10 AH slow-blow, 250 V

Input voltage range: 90 V to 139.7 V

Power frequency: 50/60 Hz

Power Output

Line frequency: 100-127 V 50/60 Hz

Max. monopolar power: 400 W (at 500 )

Max. bipolar power: 400 W (at 75 )

Output frequency: 350 kHz / 1 MHz

Additional Information

Product dimensions : 177 x 447 x 457 mm

Net weight: 77 x 447 x 457 mm 12.5 kg

Unipolar sockets: 2x (footswitch and finger switch)

Bipolar sockets: 3x (footswitch and finger switch)

Connection for footswitch: 2x