6515--Melling Lumenis Pulse 2.0

DEPARTMENT OF VETERANS AFFAIRS VETERANS INTEGRATED SERVICE NETWORK (VISN) 16 REQUEST FOR INFORMATION 36C25622Q1318 REQUESTED RESPONSES: The intent of this Request for Information is to establish sources in order to define the procurement strategy. Interested contractors are requested to respond in accordance with the following Please respond to this RFI if you are capable of providing the brand name or equal products listed in the Performance Work Statement found in the background section below. In the response, please cite business size status. POTENTIAL SOURCES SHALL PROVIDE THE FOLLOWING INFORMATION IN THEIR RESPONSE: 1) Company name, address, phone number, primary contact(s), e-mail address, NAICS code(s), business size (i.e., small/large), proof that supplies are domestically made, proof that supplies are from a domestic small business if offeror is not the manufacturer, and unique entity identifier used in SAM.gov. 2) Provide a Statement of Capability that demonstrates the offeror's past performance in providing these types of supplies. Please include the following: (a) Proof of OEM or OEM distributor of brand name supplies. (b) examples of prior completed Government contracts, references, and other related information. Please include contract number of previous contract(s). CONTACT INFORMATION AND RESPONSE DUE DATE: Please email all responses to contact@example.gov. Please respond to this RFI no later than 16:00 Central Standard Time on Friday, July 29, 2022. DISCLAIMER: This RFI is issued solely for informational and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and cannot be accepted by the Department of Veterans Affairs to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this RFI. BACKGROUND: Performance Work Statement Title of Project: Lumenis MOSES 2.0 Pulse 120H Scope of Work: The vendor shall provide one Lumenis MOSES 2.0 Pulse 120H that meets the salient characteristics listed below to include shipping. Background: Lumenis MOSES 2.0 Pulse 120H is needed at G.V. Sonny Montgomery VAMC provides surgical services in support of Veteran care. Lumenis MOSES 2.0 Pulse 120H is a groundbreaking, patent-protected pulse delivery technology, that remarkably improves energy transmission, resulting in more efficient lithotripsy and BPH treatments compared to the regular Holmium pulse1. Performance Period: The contractor shall complete the work required under this SOW in 90 calendar days or less from date of award, unless otherwise directed by the Contracting Officer. GENERAL REQUIREMENTS All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms. SALIENT CHARACTERISTICS AND REQUIREMENTS Unique Salient Characteristics (MOSES 2.0) System gives surgeons/physicians the ability to address several of the most common urological problems tied to prostatic enlargement, stone disease, tumors and strictures. System is uniquely capable of accommodating situation where multiple issues present in a single case, for example when stones are encountered during a prostate vaporization case. Laser includes procedure presets and allows surgeons to input their own custom presets allowing staff and surgeon to quickly navigate to their preferred settings. The laser utilizes a foot pedal capable of switching between two settings without technician assistance intraoperatively for both stone and BPH cases giving the surgeon full control freeing nurse to manage other OR duties during procedure. Foot pedal integrates a button where surgeon can independently move from ready to stand by. This simple addition dramatically speeds up procedure as surgeon is able to start lazing as soon as they are ready. The laser incorporates a platform to integrate suction for percutaneous lithotripsy. No other holmium laser on the market has this capability. System has the unique ability to generate the combination of joules and repetition rates required to achieve StoneDusting settings of 0.2 Joules and 80 Hz (potentially 120Hz with Moses 2.0) that have been tied to superior stone free and staged procedure rates. System employs unique and patented Moses Technology that reduces retropulsion / migration allowing more time in contact with stone and a more efficient procedure. System employs unique and patented Moses Technology that extends the distance at which energy can be efficiently delivered, reducing the time spent repositioning fiber. In most cases, the laser will help us eliminate the complete stone burden in the kidney, ureter or bladder which is associated with reduce readmissions for stone disease. System is uniquely capable of Vaporization & Enucleation settings of 2.0 Joules and 60Hz that are tied to best in class reduction in reoperation rates, complication rates, PSA and an increase in flow rate, plus improvement in globally recognized symptom & quality of life scores. System has integrated options to alter pulse width (different from repetition rate). A wider pulse duration allows quick and effective hemostasis. For BPH patients, the holmium wavelength vaporizes prostatic tissue without thermally damaging and necrosing surrounding tissue enabling reduced readmission rates. A reduction in readmission not only benefits the patient, but also reduces the overall patient load, enabling patients to experience shorter wait times. The laser enables the department to attract and retain surgeons who intend to perform vaporization, enucleation, bridge and advanced lithotripsy treatments. The laser allows compatibility with the Xpeeda side firing fiber which has been proven effective in soft tissue and prostate cases. DELIVERABLES Item QTY Lumenis Pulse 120H Moses 2.0 1 EA Shipping 1 EA Warranty 1 EA SHIPPING G.V. Sonny Montgomery VAMC 1500 Woodrow Wilson Avenue Jackson, MS 39216 CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor. GOVERNMENT RESPONSIBILITIES The Government is responsible for communicating with the contractor promptly if assistance is needed in any matter related to this contract and for allowing reasonable time for contractor response and follow through. Unique Qualifications - Lumenis Pulse 120H with Moses 2.0 Holmium Laser System Qualifications System gives surgeons/physicians the ability to address several of the most common urological problems tied to prostatic enlargement, stone disease, tumors and strictures. System is uniquely capable of accommodating situation where multiple issues present in a single case, for example when stones are encountered during a prostate vaporization case. Laser includes procedure presents and allows surgeons to input their own custom presets allowing staff and surgeon to quickly navigate to their preferred settings. The laser utilizes a foot pedal capable of switching between two settings without technician assistance intraoperatively for both stone and BPH cases giving the surgeon full control freeing nurse to manage other OR duties during procedure. Foot pedal integrates a button where surgeon can independently move from ready to stand by. This simple addition dramatically speeds up procedure as surgeon is able to start lazing as soon as they are ready. The laser incorporates a platform to integrate suction for percutaneous lithotripsy. No other holmium laser on the market has this capability. System has the unique ability to generate the combination of joules and repetition rates required to achieve StoneDusting settings of 0.2 Joules and 120 Hz that have been tied to superior stone free and staged procedure rates. System employs unique Moses Technology that reduces retropulsion / migration allowing more time in contact with stone and a more efficient procedure. System employs unique Moses Technology that extends the distance at which energy can be efficiently delivered, reducing the time spent repositioning fiber. In most cases, the laser will help us eliminate the complete stone burden in the kidney, ureter or bladder which is associated with reduce readmissions for stone disease. System is uniquely capable of Vaporization & Enucleation settings of 2.0 Joules and 60 Hz that are tied to best in class reduction in reoperation rates, complication rates, PSA and an increase in flow rate, plus improvement in globally recognized symptom & quality of life scores. System has integrated options to alter pulse width (different from repetition rate). A wider pulse duration allows quick and effective hemostasis. For BPH patients, the holmium wavelength vaporizes prostatic tissue without thermally damaging and necrosing surrounding tissue enabling reduced readmission rates. A reduction in readmission not only benefits the patient, but also reduces the overall patient load, enabling patients to experience shorter wait times. The laser enables the department to attract and retain surgeons who intend to perform vaporization, enucleation, bridge and advanced lithotripsy treatments. Company or General Qualifications Lumenis has been a leader in this market for 50 years and has a long track record of service and quality. Systems are designed with an eye towards future improvements and modifications which will allow for simple replacement of a bad component vs. replacement of an entire combined unit as in some other systems. Lumenis Case-Saver Mode is unique to Lumenis systems. If the unit is unable to provide full power, the system will deliver a lower power setting allowing the surgeon to finish the case until a technician can arrive. This feature will save time and money by allowing cases scheduled to be finished. The Lumenis system is user friendly and simple to understand by surgeons and staff. This enables the laser to be used with minimal disruption and improved safety. The warranty includes parts and labor for repairs due to manufacturing defects caused by workmanship and/or materials for a period of one year. Typical time required to return unit to service while under warranty is 48 hours from first report of problem; however, time required to return unit to service may be less if a Lumenis service representative is located near the facility. Lumenis provides a unique Field Service capability with service representatives deployed locally. Servicing activities are performed on-site, including scheduled preventative maintenance, saving time and cost of logistics. Lumenis US Field Service Team has historically resolved any and all issues on the first Service visit 89% of the time. Lumenis offers maintenance programs which include all recommended preventative maintenance and comprehensive coverage for all repairs (both parts and labor) with the exception of customer misuse and software updates. Maintenance programs may provide discounts on feature upgrades and other accessories. Lumenis offers a Premium or Standard priority package with 2-day or 5-day response times respectively. Lumenis provides clinical staff training as soon as can be scheduled after installation. This training consists of device set up and usage, laser safety, simple system troubleshooting and clinical procedure training. FDA clearances: System is multi-specialty, multi-application laser system intended for use in the following surgical specialties: Gastroenterological surgery: Open and endoscopic vaporization, ablation, incision, excision, and coagulator of soft tissue and endoscopic fragmentation of biliary, file duct, and gall bladder calculi Urology: Open and endoscopic vaporization, ablation, incision, excision, and coagulation of soft tissue and endoscopic fragmentation of urethral, ureteral, renal, bladder and biliary calculi. Arthroscopy: Ablation, excision and coagulation of soft tissues in all joints of the body excluding the spine. Endonasal Surgery: Endoscopic vaporization, ablation, incision, and coagulation of soft tissue and cartilage. Gynecology: Endoscopic and open applications ablation, vaporization incision, excision, and coagulation of soft tissues. General Surgery: Open laparoscopic and endoscopic vaporization, ablation, incision, and coagulation of soft tissue. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. End of Document