ClearifyTM Visualization System

Introduction

Visualization in Laparoscopic Surgery

A crisp, clear, high-resolution view is essential for laparoscopic and robotic surgery. Challenges include defogging, cleaning, and potential for scope damage. Current solutions can cause procedural delays, scope damage, and hazards like fire or burns from hot water.

Figure 1 shows a fogged view after initial insertion of a cold laparoscope. Figure 2 illustrates a view that remains smeared after the lens is wiped or warmed on a liver surface. Figure 3 displays a clear view after conditioning the lens in ClearifyTM for five seconds and using the "Dip/Wipe/Swipe" technique.

Introducing the ClearifyTM Visualization System, an insightful look at visualization challenges. This highly effective, all-in-one system enables optimal visualization throughout your procedure for smoother case flow. It defogs, cleans, and protects your scope. The ClearifyTM system is multifunctional, intuitively designed, and used right at the surgical site at an affordable price.

System Components

• 1. Warming hub
• 2. Micro pad
• 3. Activation button
• 4. Accommodates scopes up to 12.5mm
• 5. Converter for 3-5mm scopes
• 6. Trocar wipe
• 7. Two microfiber cloths

Features & Benefits

ClearifyTM provides continuous clarity from start to close. It addresses visualization issues with a one-handed Dip/Wipe/Swipe technique.

• Warms in: 5 minutes
• Cleans in: 5 seconds
• Lasts for: 5 hours

ClearifyTM eliminates fogging by combining heat and a powerful anti-fogging solution, working faster than hot water or anti-fogging agents alone. It restores visualization quickly by cleaning the scope in 5 seconds and removing smudges, oils, and debris with the Dip/Wipe/Swipe technique. A microfiber cloth can polish away persistent smudges.

The system removes trocar debris using an integrated trocar wipe inserted into the cannula for quick and thorough cleaning. It protects the lens from damage, as the micro pad and microfiber cloths are softer than cotton and won't scratch delicate lenses like gauze can.

ClearifyTM ensures true white balance, allowing for accurate diagnostics with realistic color, unlike surgical gauze which provides an approximation.

Figure 4 shows a view after the right side of the lens is smudged by contact with viscera. Figure 5 shows the same view restored after using ClearifyTM and the "Dip/Swipe/Wipe" technique. Figure 6 illustrates ClearifyTM checking white balance while the scope warms.

ClearifyTM is rated 4 out of 5 on satisfaction indicators, including lens cleaning, visualization, less fog, and time savings. It is a comprehensive, easy-to-use system that makes defogging and cleaning an intuitive part of case flow, reducing procedural delays.

"I have been doing laparoscopy since 1990 and this is the first effective innovation that reliably eliminates fogging in a simple, cost-effective manner." - Michael Nussbaum, M.D., Shands Jacksonville

Safety

ClearifyTM enhances safety for patients, staff, and scopes. It restores visualization in 5 seconds, with its surfactant solution being more effective than hot water alone. The 5-second cleaning allows immediate reaction to surgical events. It saves time during procedures and potentially reduces patient time under anesthesia.

Ensuring true white balance provides realistic color for accurate diagnostics. The microfiber cloths and trocar wipe do not shed lint or dust, reducing the risk of foreign bodies and incorrect counts. There is no risk of scopes being accidentally discarded in warming sleeves or gauze being left behind.

ClearifyTM lowers scope repair costs by conditioning and protecting delicate scopes. The hub's adhesive backing secures the scope safely at the surgical site, preventing toppling in water baths or drops. It lessens the risk of fire as the fluid reservoir dissipates heat from the fiber-optic light source, avoiding overheating and eliminating the need for standby mode.

It also reduces burn and scalding hazards by eliminating hot water at the surgical site and minimizing risks from high-intensity light sources when the scope is kept in the hub.

"I like the safety that the Advanced Laparoscopic Care Kit* represents. I no longer worry about patient or staff burn injuries, or scope damage from a thermos filled with hot water spilling over into the field." - Robert D. Fanelli, M.D., Berkshire Medical Center

*ClearifyTM was formerly marketed as the D-H.E.L.P. Advanced Laparoscopic Care Kit.

Competitive Cost Analysis

ClearifyTM replaces numerous items: Foam pad with anti-fog, anti-fogging gel or solution, thermal bath, scope warmer, special drapes, sleeve shield, basin, proctology cotton swab, gauze, scope warmer bottle, hot water, humidified CO2, and alcohol wipes.

ClearifyTM is incredibly effective and cost-effective. A survey of 118 general surgeons found 95% use defogging supplies. ClearifyTM replaces warming and defogging methods with no capital costs. It is a multifunctional unit that saves kitting and stocking costs, saves OR time, and may reduce repair costs.

The value comes from eliminating the need for numerous separate components, its unique combination of warming with a powerful surfactant solution, and the added functionality of trocar wipes and microfiber cloths.

Estimated savings per procedure range from $31 to $129, depending on current products used and procedure duration. ClearifyTM can save between 6.3 and 21.7 minutes per procedure.

ClearifyTM vs. Warmer Bottle

Warmer bottles require disposable seals and sterile water, incur sterilization and wrapping costs, risk lens scratching, and can be unstable. Replenishing warm water is needed for longer cases.

*Does not include cost of canister ($100) and base ($60)

ClearifyTM vs. Warming Sleeves

Disposable scope warmer sleeves keep scopes warm for only one hour, may require multiple sleeves per case for long procedures, and risk accidental discarding with the scope inside.

ClearifyTM vs. Electrical Fluid Warming Machines

Fluid warming systems are bulky, have significant capital costs, require additional components, and have time-consuming setup. Water may take minutes to reach temperature, creating clutter, risk of spills, and scalding. Hidden costs include high-wattage heaters.

ClearifyTM vs. FloShieldTM Device

The FloShieldTM device requires different SKUs for each scope size and angle and can be difficult to assemble.

Cleaning and Defogging Time Savings

Other cleaning and defogging methods consume an average of 5.8 minutes per procedure and are often used at the back table. Hot water alone may not be effective at removing fats and tissue.

ClearifyTM reduces defogging/cleaning time by 50% (2.9 minutes). Surgeons save between 6 and 22 minutes per procedure. OR time costs approximately $16 per minute.

*Does not include cost of canister ($100) and base ($60)

When considering the true costs of current visualization systems, ClearifyTM offers significant savings, especially when annualized. It provides clearer visualization, smoother case flow, fewer repairs, fewer delays, and reduced kitting/stocking costs, all for the price of a trocar. This enables better performance and better patient outcomes.

Scope repair costs can range from $10,000 to $75,000 annually for hospitals, with a median of $27,143. A single robotic scope repair can exceed $30,000. Litigation costs from surgical fires, often preventable, can also be substantial.

The Power of Covidien

ClearifyTM offers exceptional stand-alone value. Utilizing complementary products within Covidien's portfolio can further enhance cost-to-value advantages by reducing part numbers and vendors.

How to Order ClearifyTM

To order the ClearifyTM Visualization System, contact Customer Service at 1.800.772.8772 and refer to Reorder Code #21-345. There is no minimum order fee. Each case contains 10 disposable ClearifyTM units, including the warming hub, two microfiber cloths, and one trocar wipe.

Regulatory Clearance

D-H.E.L.P.TM is now ClearifyTM. The system has received 510(k) clearance.

Instructions for Use (IFU)

PREPARING D-HELPTM

1. Activate device: Press the black button at least 5 minutes before use. Ensure the blue light is on, indicating heating has started.
2. Insert Scope into D-HELPTM: Push the scope in firmly and rest it on the back table. Some fluid spillage from D-HELPTM is acceptable. There is no risk of overheating from the light source while the scope is inside. For robotic scopes, turn off the camera light if left in D-HELPTM longer than 5 minutes. Use the attached rubber reducer for 3-5mm scopes. For flexible-tip scopes, open the valve with a rigid instrument first to ease insertion.
3. White balance scope: Activate white balance anytime while the scope is inside D-HELPTM. If light intensity is too high, pull the scope away from the target or reduce light intensity. If necessary, perform white balance with the MicroPad; do not use gauze.
4. Attach device to drapes: Secure to the surgical field by peeling the adhesive backing or using a clamp. Do not hold the scope upright; once secured, it can rest flat.

USING D-HELPTM

Follow these steps anytime the scope is removed from the body:

1. Insert into D-HELPTM for at least 5 seconds. This step is crucial for warming the scope and breaking up debris. Keeping a secondary scope in D-HELP throughout the procedure is acceptable but may reduce battery life.
2. Clean the lens using a MicroPad or the D-HELPTM microfiber surface. Do not use gauze. Under high-fog conditions, do not wipe away all the anti-fog liquid; tap or shake the scope to remove excess fluid without removing the coating.
3. Return scope quickly from D-HELPTM into the body to prevent cooling.

USING THE TROCARWIPETM

1. Use the small foam head for 5mm trocars and the large foam head for trocars >7mm.
2. On certain trocar models with spring-loaded valves, open the valve during insertion or retraction of the TrocarWipe. Ensure the trocar does not have sharp edges that can snag the TrocarWipe. Do not extend the foam head beyond the distal end of the trocar. Not compatible with Snowden-Pencer trocars or other metal trocars.
3. Grasp the blue handle and push the foam head straight into the trocar. Do not release or bend the TrocarWipe.
4. TrocarWipe and MicroPad are radiopaque.

Warnings

Federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Information on the risks of re-using this device is available by contacting New Wave Surgical. ALCK is intended for single use. After use, ALCK should be disposed of in accordance with local guidelines for medical waste that includes batteries. The device is sterile if the package is dry, unopened, and undamaged. Do not use if the pouch is damaged or package seal is broken. Moisture may be present inside the zip-loc bag. Discard the device if mishandling has caused possible damage or contamination, or if the device is past its expiration date.

Indications

D-HELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

Storage

D-HELP should be stored in a clean, dry location at room temperature.

Contact Information

3890 Park Central Blvd. North Pompano Beach, FL 33064, USA

Phone: 866-346-8883 / Fax: 866-586-6793

www.newwavesurgical.com

EC REP: Emergo Europe, Molenstraat 15, 2516 BH, The Hague, The Netherlands

STERILE R LATEX

References

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