Catheter Tipping Equipment Manufacturing & RF Tipping - FAQ's

Product & Technical Questions

 

Product Questions

How does your name change affect me?

How reliable is the equipment?

Can you do multiple up?

How can you validate a Vante catheter manufacturing system?

What kind of chiller do you use?

Is the system easy to use and safe for my operators?

Why is the capital investment the highest among the options; more than double the second highest option, which is also RF heating technology.

Vante uses RF - so what materials can you process?

Why is the cost of molds high and the lead times long?

What support does Vante provide for helping me through my validation?


Technical Questions

Why does my sealer “spark” if there is no heat in an RF sealer?

 


Answers

How does your name change affect me?

We're changing our name, but we're not changing the outstanding products, services and support we've provided our customers for over 30 years. All existing warranties and contracts still apply.

How reliable is the equipment?

Data from the last 2 years shows Vante's "Full Field - Full Life" failure rates for all catheter manufacturing systems at less than 1%.

Can you do multiple up?

Depending on the application, yes. However, over the past 20 years Vante has developed Catheter Manufacturing Systems that focus on process control to improve yield, reduce scrap and provide highly reliable and consistent results. Our customers experience on average 96% - 100% first pass yields. Our goal is to provide a process that will meet and exceed your overall annual volume requirements. While other companies may offer 2 or more ups, their yield and process/equipment reliability result in lower overall throughput. We believe that the true metric of success is the number of good parts a system is able to produce over the period of time a company chooses to measure.

How can you validate a Vante catheter manufacturing system?

Vante's systems are the only systems which provide quantifiable, validatable process parameter inputs and outputs useful toward ISO/GMP documentation and validation. Vante is an ISO 13485:2003 certified company, as well as, FDA Registered. Our systems were designed specifically for catheter manufacturing and to support process validation. VANTE's Catheter Manufacturing Systems are the only RF systems on the market to offer Patented Closed-Loop Temperature Control. We provide precise control of all process parameters including : Heat Time, Cool Time, and Pressure. We control temperature to +/- 1 Degree C on PIRF II and +/- 1% of target temperature on PIRF III and Saffire.

What kind of chiller do you use?

Vante's systems do not require chillers of any type thus reducing overall maintenance cost and eliminating the potential for contamination of a clean room environment.

Is the system easy to use and safe for my operators?

Vante's systems are completely operator safe as certified by UL/TUV/CSA and CE. We have NO exposed RF coils, NO hot spots and NO pinch points. The units are extremely easy to use and the output is not dependent upon the operator's skilled input.

Why is the capital investment the highest among the options; more than double the second highest option, which is also RF heating technology.

Vante's technology offerings, depending on configuration, are at times more expensive than the competition. We provide significantly more value and an overall lower total cost of ownership (TCO).

Vante uses RF - so what materials can you process?

While Vante uses RF to heat our dies, it's employed indirectly. RF is a source of power that creates an inductive field used to heat our dies which then conductively heat the material, as a result we are able to effectively process all thermoplastics for all your current and potential future needs.

Why is the cost of molds high and the lead times long?

Vante's dies are typically manufactured from 440 Stainless Steel using various machining methods. Vante's die's, properly maintained, are expected to last between 3 million and 5 million cycles. This robust life cycle contributes to: lowering overall TCO, production stability and consistent results. VANTE takes a relatively conservative approach when quoting timelines. We have the ability to deliver systems to customers within 48 hours and tooling in as little as 3 weeks. Our timelines realistically run from 3 – 12 weeks depending on complexity of application and speed of response from our customers. Vante utilizes a 16 step project plan which is communicated to our customers on a weekly basis ensuring expectations are always aligned. At the end of tooling development, you will be in a position to begin making quality products right away and with the ease our equipment can be validated, your time to production is actually shorter than some competition.

What support does Vante provide for helping me through my validation?

Vante provides software certification with our systems at no additional charge. Most of our customers have used solely this documentation to support their validation process. Moreover, each mold purchased from Vante comes with a set of process parameters for you to begin DOE's and process qualification based upon.

Why does my sealer “spark” if there is no heat in an RF sealer?

RF signals take the path of least resistance; therefore, if there are any biologics like carbon or other carbon based items, the RF signal prefers that path vs. other reactive materials. When carbon molecules get excited or begin to vibrate, the carbon can spark. You can avoid a carbon spark by cleaning your sealing head often. Follow the directions in the sealer Instruction manual and clean with a cotton swab and alcohol.

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