510(k) cleared for diagnostic/ operative hysteroscopy and · for office hysteroscopy &...

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510(k) cleared for diagnostic/ operative hysteroscopy and cystoscopy Not for sale outside of the United States.

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Page 1: 510(k) cleared for diagnostic/ operative hysteroscopy and · FOR OFFICE HYSTEROSCOPY & CYSTOSCOPY Includes a sterile, single-use RotoSheath that provides a 360° global view, high-definition

510(k) cleared for diagnostic/operative hysteroscopy and cystoscopy

Not for sale outside of the United States.

Page 2: 510(k) cleared for diagnostic/ operative hysteroscopy and · FOR OFFICE HYSTEROSCOPY & CYSTOSCOPY Includes a sterile, single-use RotoSheath that provides a 360° global view, high-definition

LUMINELLE DTx SYSTEM OFFERS THE SIMPLE SOLUTION FOR OFFICE HYSTEROSCOPY & CYSTOSCOPY

Includes a sterile, single-use RotoSheath that provides a 360° global view, high-definition optics giving 50 mm depth, integrated fluid management system and a dedicated 5 Fr.

operative channel that provides you the freedom to perform a multitude of procedures with precision and ease, without leaving the office.

Page 3: 510(k) cleared for diagnostic/ operative hysteroscopy and · FOR OFFICE HYSTEROSCOPY & CYSTOSCOPY Includes a sterile, single-use RotoSheath that provides a 360° global view, high-definition

Spending excessive amounts of time traveling to and from the local hospital to perform hysteroscopies, while always being on the hospital’s schedule—not yours.

Investing tens of thousands of dollars in a piece of equipment that was supposed to make office hysteroscopies more convenient—but didn’t. Or trying a less expensive

disposable device that failed to live up to your expectations. The challenges surrounding hysteroscopies include everything from adversely impacting the patient

experience to impeding your practice workflow.

BUT THERE IS A BETTER PATH. AND YOU’LL FIND IT WITH LUMINELLE.

In Your Office. In Your Control.

• SIMPLE AND FAST ASSEMBLY and disassembly has the potential to reduce the time required for examination room turnover.

• YOU CONTROL YOUR SCHEDULE for hysteroscopy procedures. Not the hospital.

• A best-in-class system—small enough to fit any patient room—ALLOWS YOU TO CUSTOMIZE YOUR WORKFLOW.

Advanced Technology. Smart Focus Optics.

• Leveraging the latest in advanced HD optics, The LUMINELLE DTx Hysteroscopy System provides 120° FIELD OF VIEW, a 50 mm depth, without the “fish eye effect”

• The unique 360° ROTOWINGS ALLOW FOR ONE-HANDED MANEUVERABILITY, providing a complete global view

• The smart focus algorithm AUTOMATICALLY ADJUSTS the focus & lighting during procedures

Managing Costs. Optimizing Workflow.

• COSTS UP TO 75% less than tower systems, the LUMINELLE DTx Hysteroscopy System, delivers a quality, cost-effective solution

• By using the LUMINELLE DTx System in the office, you can potentially INCREASE THE NUMBER OF DAILY PROCEDURES performed

• Based on the 2019 CMS guidelines, office hysteroscopies can offer the opportunity for a HIGHER LEVEL OF REIMBURSEMENT

Page 4: 510(k) cleared for diagnostic/ operative hysteroscopy and · FOR OFFICE HYSTEROSCOPY & CYSTOSCOPY Includes a sterile, single-use RotoSheath that provides a 360° global view, high-definition
Page 5: 510(k) cleared for diagnostic/ operative hysteroscopy and · FOR OFFICE HYSTEROSCOPY & CYSTOSCOPY Includes a sterile, single-use RotoSheath that provides a 360° global view, high-definition

A Better Path to a Better Patient Experience

• Allows the patient to have the procedure in the comfortable setting of your office, surrounded by you and your staff.

• Potentially lowers her out-of-pocket costs by requiring only an in-office copayment instead of additional hospital-charged procedure fees.

• Procedures done in the office lead to shorter wait times and allow you and your patient the freedom to get on with your day.

• The LUMINELLE RotoSheath’s unique graduated tip size and dualinflowfenestrations (front and side) allow for hydrodilation and ease of traversing the cervical canal - providing a more comfortable experience for your patient.

LUMINELLE DTx Hysteroscopy System goes a long way in reducing patient anxiety and improving her experience.