There are a number of proprietary technologies that have been combined into the VistaClear™ patent that make it unique. All VistaClear™ models work on the same principles whether as an integrated system or for single or multiple operatories. The control manifold directs the flow of cold domestic water, clean compressed air and filtered water out to the mixing chamber for delivery to the dental unit. The control manifold features an injection port and system pressure gauge. Multiple operatory units also have an upper distribution manifold for directing filtered water to each individual operatory in the building.

The multi-stage, bio-chemical filter element contains a large quantity of high-purity redox media. Water constantly flowing past the alloy in the module allows electrons to flow for a very long time and radically affects the oxidation/reduction potential (ORP) of the water. In general, different types of microbes can only survive and grow within a particular range of redox potential. One function of the filter design is to force a radical change in the ORP creating an environment that is both bacteriostatic and bactericidal depending on the type of organism.

The water continues past the redox media and travels to the ceramic module where any remaining pathogenic and/or opportunistic heterotrophic microorganisms, fungi & yeasts or protozoans that may have survived passage through the first portion of the filter are reduced or removed. The combination filter element contains a proprietary ceramic module design with an absolute rating of 0.90 microns. Although many microorganisms are smaller than 0.90 microns, a torturous pathway through the ceramic module makes locomotion difficult, if not impossible for most. Therefore, most remaining microbes are superficially retained on the surface of the module. Smaller organisms that may enter the pores of the candle more deeply become trapped in the pore network. The ceramic module has also been treated with elemental silver that has been impregnated into the ceramic during manufacture. This agent helps prevent colonization of the filter module by trapped microorganisms and the sole purpose of treatment is to protect the product itself.

The final component of the VistaClear™ system involves the selective and periodic application of chemical agents that may be introduced into the system through the injection port located on the control manifold. Agents (like VistaClean™ Irrigant Solution Concentrate or VistaTab™ Cleaner Tablets) may be easily introduced with a standard syringe without exposing the system to the contaminated atmosphere. The desired agent is loaded into a luer lock-type syringe (less needle) and injected through the injection port on the control manifold. The water inlet valve is then opened and the introduced concentrate is automatically mixed with fresh, filtered water to create a dilution of the desired agent in the mixing chamber. The agent can then be delivered to the dental unit by either filtered water or compressed air as desired.

The VistaClear™ system is intended to provide improved water quality and reduce bacterial contamination in dental unit waterlines used for irrigation, cooling, lubrication and scaling procedures.

Yes. VistaClear™ has been installed on and is designed to work with all types of new or older dental unit configurations including rear delivery, side delivery, cart and over-the-patient systems. The Model 1000 single operatory filter system can be easily mounted in any cabinetry out-of-sight or mounted on a wall, end of a cabinet or post for ease of access. All that is required is a cold water supply and clean compressed air. Although the system has a drain, no formal plumbed drain line is required since a cup or bucket can be used to catch the small amount of water that is discharged during maintenance procedures. The waterline from the mixing chamber is simply connected to the main feeder line running to all handpieces, air/water syringes, ultrasonic scalers and cup filler on the dental unit.

The multiple operatory VistaClear™ is designed to handle your entire clinic, up to seven (7) operatories per zone. It is usually installed in a central location like the equipment room, sterilization center or even in a central hallway area. Normally, the multiple operatory VistaClear&trade is designed into brand new offices or offices that are undergoing a major remodel. However, many existing offices are able to install a model in a central location if there is a basement or crawl space available. All that is required is a cold water supply and clean compressed air. The central systems have a drain that is directly attached to an air gap drain module (included with each system). Individual 1/4" O.D. copper waterlines run from the distribution manifold above the mixing chamber to each operatory dental unit and supply fresh, filtered water to all handpieces, air/water syringes, ultrasonic scalers and cup filler.

Contaminants that exist in the water tubing following the installation point of the VistaClear™ must be removed or they will, in fact, re-contaminate the filtered water produced by the system. Whether dental waterlines have only been used for a few days or many years, they will all have some level of contamination. One of the most unique features of the VistaClear™ system is its ability to accept numerous and varied forms of cleaning agents and medicaments. Upon installation it is recommended that VistaClean™ Irrigant Solution Concentrate or VistaTab™ Cleaner Tablets be injected into the system and delivered throughout the entire network of waterline tubing in the dental unit. Their safe but powerful cleaning action works to free the internal surfaces of tubing, handpiece, air/water syringe, ultrasonic scaler and cup filler lines of preexisting contamination. Virtually any approved or cleared agent for cleaning waterlines can be used with the VistaClear™ system.

The individual Model 1000 system has a rated filter life of one year or 567 liters use and the throughput capacity is about 700 ml/minute. Standard multiple operatory central systems use the same filter element as the Model 1000 but in multiples. For example, the six and seven operatory central models have a throughput capacity of about 3,000 ml/minute. Generally, the filter elements should be changed once per year which only takes a few minutes and no tools are required.

The single operatory Model 1000 system is very small weighing about four pounds and measures about 7" W x 9" H x 5" D. If space is tight, the system is completely modular and components can be installed separately. For example, the filter element and control manifold can be attached in one location and the mixing chamber can be mounted vertically on a post, attached to a cabinet door, etc. The multiple operatory systems come factory-built, tested and mounted on a vinyl-covered white board that measures 16" W x 24" H x 5" D. The entire assembly is typically mounted on a wall or inside a cabinet.

All VistaClear™ models are Class I medical devices, FDA 510(k) Cleared – Exempt K01053 and meet all EPA standards as pesticidal devices, EPA Est.73593-OH- 001. Sub-components are listed under some or all of the following: ANSI/NSF Standard 42, Standard 51, Standard 53, Standard 58, Standard 61 and meet FDA material standards.

Whether a hygienist's suite or operatory, each room where patients are seen should have the water treated. You can select a multiple operatory central system with a treated waterline leading to each operatory or have an individual Model 1000 installed in each operatory.

Although some dentists like to heat the water for patient comfort, it has been found that heaters encourage more rapid growth of organisms in dental waterlines. Most infection control authorities today recommendation removing water heaters from the dental units. However, another benefit of the VistaClear™ is the fact that the large filter element and mixing chamber store a reasonable quantity of filtered water that achieves room temperature increasing patient comfort. Although the temperature increases, the concern for bacterial growth is vastly reduced since the water is contained within the treatment device that, by design, exhibits both bacteriostatic and bactericidal properties.

Since cuspidor bowls can use a high volume of water (compared to handpieces and syringes) and such water is not consumed, they should have a dedicated line from the city water and not be connected to the VistaClear™. This will preserve the useful life of the filter element. The cup filler should, however, receive VistaClear™ water since the water will be consumed or used in a patient's mouth. This is easily accomplished with a "Tee" running to the cup filler feed line. Installation details for dental units with cuspidors are included in the installation instruction manuals.

Yes. There are standard multiple operatory central systems available to handle up to seven (7) operatories per zone from one location. Such a system would be installed in the equipment room or sterilization area for convenient access with a dedicated "clean water" line running to each operatory. There is a single "clean water" valve entering each operatory that would be the source for water delivered to all handpieces, air/water syringes, ultrasonic scalers and cup fillers. Periodic maintenance and/or feeding of selected agents (like VistaClean™ Irrigant Solution Concentrate or VistaTab™ Cleaner Tablets) can be accomplished in just minutes from a central location. The water supply to each operatory can be opened or closed at the discretion of the operator. And, all multiple operatory systems use the same replacement filter element as is used for the single operatory Model 1000 VistaClear™ but in multiples. This multiple operatory central system design is especially appropriate for new construction and remodeling projects. For example, a central system servicing seven operatories would fit into a space measuring as little as 18" W x 36" H x 5" D. However, if access through a ceiling, basement or crawl space is available for running the dedicated "clean water" lines, existing practices can also be accommodated with this type of central system.

Since the amount of particulate vary greatly from one water source to another, predicting the life of the filter module relative to physical filtration capability is not possible. If there is an elevated level of sediment in the water supply to be used, installing a simple sediment pre-filter is strongly recommended since the inlet of the filter element contains a 10 micron pre-filter disk. However, even if the filter element does plug with physical sediment, it can be backwashed by simply reversing the direction of the water flow through the module. Most dental offices today utilize a solenoid shut down system that usually has a filter as part of the product. This sediment filter provides sufficient pre-filtration to help prevent premature plugging of the VistaClear™ filter elements.

Yes. Tests have shown 100% removal of live Giardia lamblia and Cryptosporidium parvum protozoans.

Although removal of heavy metals is not the primary purpose of the system, they are substantially reduced by VistaClear™. The process involves cathodic and anodic activity in the redox media contained in the multi-stage, biochemical filter element. Water-soluble cations of lead, mercury, copper, nickel, chromium, cadmium, arsenic, antimony, cobalt and most other dissolved heavy metals are removed upon direct contact with the redox medium.

This is accomplished in two ways. First, water that contains water treatment residuals or chlorine and chloramines passes through the redox media in the multi-stage filter where the residuals are electrochemically reduced to chloride ions. Should any residuals make it past the redox medium, they are reduced by oxidation/reduction in the carbonized resin found in the pores of the ceramic module.

The redox medium helps prevent the formation and accumulation of mineral hardness scale, primarily calcium carbonate. Normal hardness scale from untreated waters is comprised of large, irregularly shaped crystals of calcium and magnesium mineral salts. As water passes through the filter element, certain ions from the redox medium block the formation of carbonate in preference to aragonite. The morphology of the insoluble calcium and magnesium carbonate and sulfate crystals is altered to form relatively small, rounded particles that won't adhere to metallic surfaces. Some particles are physically filtered from the water stream. This means that dental unit control blocks will be much less prone to plugging by calcium deposits.

On the warranty registration sheet that should be completed and mailed after your systems are installed, simply check the appropriate box and you'll be automatically sent 8" x 10" "Water Treatment System Registry" certificates that can be framed and hung in your operatories. There is also a box on the warranty registration form that lets us know that you want a complimentary supply of our brochure entitled "A Patient's Guide to Understanding Dental Waterline Safety Issues." They will be sent to you along with your Registry certificates. When you run out of brochures simply order additional copies from your distributor.

The multi-stage filter element should be changed at least annually. The filter change can usually be accomplished in less than five minutes.

The only way that we know when you had your systems installed is if you return the warranty registration sheet. You should complete and mail the warranty registration sheet immediately after your system(s) has been installed. When we receive your warranty registration, we'll notify you and your distributor every year so that your filter element can be replaced in a timely manner.

A line cleansing using VistaClean™, VistaTab™ or other suitable cleaner should be done at least quarterly, preferably monthly. Other than that, simply changing the filter element annually is all that should be required for most applications. See the Owner's Manual for specific details and cleaning protocols.

Rigorous tests have been conducted on VistaClear™ at Baylor College of Dentistry in Dallas, Texas. The testing was done under protocol determined by Dr. Raghunath Puttaiah, a known authority on infection control and a veteran dental waterline researcher. Microbial counts in VistaClear™ filtered water consistently produced water quality exceeding the ADA and CDC goals for dental water quality.

No. We are not aware of any system that combines all these features and all VistaClear™ systems are patented.

Probably the most common method for dealing with dental waterline problems is the use of off-line bottle systems. This method uses a plastic bottle with a pick-up tube and compressed air. Water needs to be added manually to the bottle whenever it runs low. This is a relatively simple and "apparently" inexpensive (+/- $200 per operatory) approach but has a number of issues that must be considered. Since water must be added manually, there is substantial staff time required. Also, the water supply can run out during a patient procedure. In addition, bottled water of some type must be purchased, stored and handled which becomes costly and time-consuming. One of the biggest problems with this approach is determining the true microbial quality of the purchased water. It's not easily done unless purchased at a premium price from a laboratory or specialty service. The bulk container and delivery bottle can be contaminated by organisms from the atmosphere and the handler. The more often the bottles are removed and handled the more chance there is of contamination. Once just a few organisms enter the system, colonization begins. Field technicians will attest to the fact that unless bottle systems are aggressively maintained on a very frequent basis line fouling and high bacterial cfu counts will occur. The VistaClear™ systems do not require the purchase of bottled water, staff time is not required for adding water to the system, and the entire system is always protected from human hands and contamination by airborne organisms.

In-line ceramic filter disks are another method being used to address waterline problems. The sub- micron disks do a good job removing bacteria and other organisms but have a number of problems according to dental service technicians and dentists who have used them. The filtration capability is so fine that they often plug with suspended solids in the water supply – often plugging during a procedure that is highly inconvenient. Expensive handpiece, air/water syringe and ultrasonic scaler lines must be cut in order to retrofit the ceramic disk housing. The additional weight on the line and the potential for leaks has also been discussed. Another issue is colonization of the few inches of tubing after the ceramic element. A very big concern is that of cost. The individual disks are rather inexpensive but due to the large number required each year on each line of each operatory, the costs can rise to thousands each year for maintenance costs. The VistaClear™ system uses multiple technologies to address the microbial contamination. Further, no part of the dental unit need be altered and no expensive lines are cut. Finally, the cost of a complete VistaClear&trade system is usually far less than the annual maintenance cost of ceramic disk approaches.

Ozone systems can be efficient at killing organisms (producing zero or near zero cfu/ml counts) but face several problems. The quality of the ozone is greatly affected by the moisture content of the air it uses to produce the ozone and should therefore utilize desiccants and/or electric dryers. Since ozone is very corrosive, there is a concern for long-term use and potential degradation of parts within the dental system. An electrical power source must also be available. The quality of the water used needs to be high since the ozone will readily oxidize certain contaminants in the water causing system fouling and reduced performance. This being the case, systems used for dental waterline applications require the purchase, storing, cost and physical addition of distilled water to the reservoir. Similar to an off-line bottle system, the reservoir can run out of treated water and require filling and a prescribed wait time possibly during a patient procedure. The initial purchase price of the ozone system, cost of electricity and water as well as the cost of annual filter replacements can make this type of system quite costly. The VistaClear™ system requires no electricity, no bottled or distilled water, no desiccants or dryers, no wait time between patients, produces no potentially corrosive substances and is about half the cost of the typical ozone system.

Ultraviolet systems, although not as powerful as ozone systems, can be effective at controlling normal microbial populations. However, they have their own set of problems. An electrical power source must be available. The water used needs to be of high quality since particulate in the water flowing through the U/V chamber can protect an organism from the U/V light and allow it to pass through the system. Additionally, films, organic tannins and oxidized contaminants can build-up on the quartz tube in the U/V chamber preventing sufficient U/V light to make contact with the organisms. By its nature, a U/V bulb begins losing its power (measured in microwatt seconds) immediately after installation and must be monitored and replaced on a regular basis in order to keep sufficient "killing power" within the system. An added concern is that U/V has not been shown to be effective against certain protozoan forms like Giardia and Cryptosporidium unless accompanied by sub-micron filtration. Further, U/V offers no residual protection after the system to help prevent re-contamination. Products exist in the dental market that contain the pesticides of silver and iodine. Such products count on the antimicrobial effects these chemical pesticides to kill microorganisms. These products include tubing, bottles, fittings, filter media and components. Such products may not make any claims relative to the controlling or killing of bacteria or any pest unless they have an EPA establishment number and an EPA product registration number. Certain chemicals can be used in the manufacture of some products to preserve or protect the product itself from colonization by organisms under a treated article exemption but may not make any claims or implications that the additive does anything but protect the article itself. These treated products often make implied or explicit public health pesticidal claims to protect the public against harmful microorganisms. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires the registration of any substance intended to prevent, destroy, repel, or mitigate pests. EPA grants the treated articles exemption for a non-public-health use of a pesticide that is intended to protect only the treated article or substance itself. Consumers may distinguish such products by the absence of the EPA's pesticide registration number (found on the product label) of the registered pesticide used for protecting the article itself. It should be noted here that the EPA registration number would also be absent from an illegal product that should be registered. Products that qualify for this exemption must display appropriate clarifying statements. Articles or products that claim to be effective in controlling microorganisms must be registered as a pesticide. These articles or products make a public health claim that goes beyond the preservation of the treated article itself. EPA requires the submission of chemical data in support of the public health labeling claims and patterns of use of the product. If EPA determines that such a product is exempt from registration as a pesticide, the product may claim only that it contains a pesticidal preservative to protect the product itself. These pesticides are known as materials preservatives. In these cases, the pesticide is registered for the intended use, and the sole purpose of treatment is to protect the product itself. (contact the US EPA Office of Pesticides for more information or to inquire about a specific product or product claim) In summary, there are products in the marketplace that contain pesticides and make certain claims that may be in violation of EPA regulations. All VistaClear&trade systems have been cleared by the FDA for marketing as Class I medical devices. They are also registered with the EPA as pesticidal devices, bear an EPA establishment number as noted on the product label and do not make any claims in violation of the treated article exemption. In discussing the prevention strategies identified by the American Dental Association (ADA) expert panel originally convened in 1995, the Centers for Disease Control (CDC) notes the following conclusion relative to various treatment strategies including independent water supplies, chemical disinfection, draining and air purging regimens, and water line filters: "… In fact, preliminary data suggest that none of the proposed methods appears to permanently eradicate biofilms, thus, a combination of these strategies may be necessary to control biofilm formation and thereby improve water quality." (see www.cdc.gov for complete details) The proprietary design of the VistaClear&trade™ system inherently combines numerous technologies that offer a comprehensive approach for providing improved water quality and reduction of bacterial contamination in dental unit waterlines used for irrigation, cooling, lubrication and scaling procedures. BACKFLOW – Other systems that directly connect to municipal water systems would also be required to install backflow prevention devices (like RPZs and other devices) in most states. This usually involves high additional costs due to the purchase, installation and annual inspection of the devices. VistaClear™ systems have the benefit of backflow prevention due to the inherent design of the systems and the inclusion and use of multiple VistaClear&trade backflow preventer dual check valves with each system.

Most dentists and dental healthcare professionals are both concerned and confused about this whole issue of dental waterline contamination – and rightly so. However, with the preponderance of factual data regarding waterline contamination, warnings and encouragement to take action by government and industry health authorities, dentists should seriously consider some type of corrective measures. In December 2003, the Centers for Disease Control and Prevention (CDC) established a new standard for heterotrophic bacteria counts in dental water which is less than 500 cfu/ml. Inaction may involve unnecessary exposure of patients and staff to potentially concerning levels of contamination and future risk of legitimate or opportunistic legal action as well as probable imposed regulation. The following information may help shed some light on the situation.

The Federal Safe Drinking Water Act (SDWA), the Environmental Protection Agency (EPA), the American Water Works Association (AWWA) and the American Public Health Association (APHA), and now, the Centers for Disease Control and Prevention (CDC), all call for a maximum limit for heterotrophic mesophilic organisms in drinking water at 500 cfu/ml (colony forming units per milliliter). For dialysis equipment, levels should be below 200 cfu/ml. It's been determined that the vast majority of dental operatories have bacterial populations far above these limits. It's not uncommon to see heterotrophic plate counts (HPC's) of 100,000 to 1,000,000+ colonies in dental waterlines and the Centers for Disease Control (CDC) has reported that levels of 10,000,000 cfu/ml have been documented. The biggest fear for using such poor quality water is that patients with especially depressed immune systems (those with cancer, the elderly, the very young, HIV patients, etc.) could be at much greater risk. Procedures for helping reduce colony counts in dental waterlines have been recommended by the American Dental Association (ADA), the Centers for Disease Control (CDC), National Institute for Health (NIH), the Organization for Safety & Asepsis Procedures (OSAP), etc. Even though the connection between poor dental water quality and subsequent infection of patients has not yet been firmly established, it only makes sense that a patient would not want to have microbiologically unsafe water used in their mouth during a healthcare procedure. An article entitled "Dental Unit Waterlines: Approaching the Year 2000" that appeared in the November 1999 Journal of the American Dental Association draws conclusions as to progress as follows:

"The dental profession must continue its awareness of the presence of high levels of opportunistic microorganisms in dental unit water. Despite the lack of evidence of adverse health effects related to these microorganisms, they have the potential to overload the defense systems of immunocompromised patients and occupationally exposed dental staff members. Steps should be taken to improve dental unit water quality; contact of a patient's open wound, mucous membrane or body cavity with water of poor microbiological quality simply is inconsistent with patient expectations of modern dentistry. Efforts should continue to evaluate the health implications of biofilms in dentistry as new technology, research and data become available."

The following comments come from the position paper on dental unit waterlines by the Organization for Safety & Asepsis Procedures (OSAP) following the 1999 OSAP Annual Symposium held June 24-27 in Cincinnati, Ohio:

"Dental practices should immediately take prudent measures to provide quality water for dental treatment and ensure a safe and healthy environment for patients and staff. …The use of water for dental therapeutic procedures that fails to meet established standards for drinking water is inconsistent with recognized standards of infection control and can potentially undermine public confidence in the dental profession. The present lack of epidemiologic evidence of illness or injury among patients or dental healthcare workers does not provide a valid rational for inaction." (see www.osap.org for the complete paper)

The following statement comes from the December 2003 Centers for Disease Control (CDC) statement regarding biofilms and dental unit water quality:

"… exposing patients or DHCP (dental health care personnel) to water of uncertain microbiological quality, despite the lack of documented adverse health effects, is in consistent with accepted infection- control procedures." (see www.cdc.gov for the complete statement)

In a fact sheet called "Backflow Prevention and the Dental Unit" (see www.cdc.gov for more information), the Centers for Disease Control and Prevention (CDC) provides a great deal of information on this subject. A cross-connection is the link through which contaminated materials may enter a potable water supply system when the pressure of the polluted source exceeds the pressure of the potable source (for example, during a water main break). In some locations, local and/or state water system regulators have required dental offices to install backflow prevention devices at the service connection or on individual dental units. These requirements have been based upon the following two assumptions. First, a sudden drop in water pressure would draw oral fluids from a patient's mouth and into the city water supply and second, if such an event would happen, a significant number of blood-borne viruses could be transferred to other users on the same water system. Local regulatory interventions that require expensive and complex equipment are based on the conclusion that a high degree of hazard exists. According to the CDC, however, available science suggests "that there is an extremely low risk of such contamination of public water supplies from cross-connections in dental units."

The American Water Works Association (AWWA) statement of policy clearly recommends that the installation of backflow prevention devices be consistent with the degree of hazard resulting from cross- connections.

In the "ADA Statement on Backflow Prevention and the Dental Office" adopted in April 1996, they state that: "… The risk of backsiphonage from the high-speed handpiece or air/water syringe is virtually nonexistent because: * neither device is intended nor designed to ever be immersed in oral fluids; and * if water flow is disrupted for any reason, such as in the event of backsiphonage, the dental worker would automatically discontinue use of the instrument and attempt to resolve the problem. … The ADA agrees with the American Water Works Association that the installation of backflow prevention devices should be consistent with the degree of hazard. … Although a theoretical possiblilty of contamination resulting from backflow from the dental unit exists, the ADA believes this risk to be nearly zero." (see www.cdc.gov for more information).

With this summary background information from authoritative sources in mind, it is quite apparent that the risk of cross-contamination is virtually zero. However, the VistaClear™ system has a number of safeguards in its design that can lend additional comfort when considering this topic. Every VistaClear™ system includes VistaCheck™ Backflow Preventer Dual Check Valves. For the Model 1000 single operatory systems, these check valves are installed ahead of the air and water inlet valves and one afterthe mixing chamber. For the Model 1000 multiple operatory systems, check valves are installed ahead of the air and water inlet valves and one on each dedicated line after the distribution manifold that protects each operatory. Even in normal air and water pressure conditions they will always close should pressurized air or water attempt to move in the reverse direction. Should the pressure on the inlet side of the check valves be lower than the system-side pressure, such a loss in pressure at that point would only enhance the "closing" force of the valve. In addition to the presence of VistaCheck™ check valves, the system by nature is designed to reduce microbiological contamination as a pesticidal device. Therefore, organisms passing through the system (even if in the reverse direction) would be subject to the bactericidal and bacteriostatic effects of the multi-stage filter thus reducing or removing any theoretical contamination that may have been drawn from a patient. And, finally, inherent in the design of the mixing chamber of the VistaClear™ is the presence of an air-gap in the top of the chamber. Air-gaps are also considered effective backflow prevention devices. For more details, see the FAQ under the VistaCheck™ tab on this website.