Final Approval
In August the FDA gave final approval to allow us to market the new APPAIS™ HEPA filtration system to the medical market. The APPAIS unit is a modified version of the HPS Portable HEPA unit that is designed to eliminate the need for any tools to change any of the three filters that are included with each unit.
The APPAIS unit is designed to provide a Class 100 environment 20″ from the discharge of the HEPA unit. This washed area will be used to administer injections. The syringe will be opened and pulled to clear in this sterile area and the patients arm will also be set approximately 10″ to 12″ from the HEPA discharge face. This will ensure that any puncture area will be in a very clean environment thus minimizing the possibility for any airborne particulates or pathogens to enter the patients blood stream thus reducing the possibility for infection.
The APPAIS unit has two slots on the top ends that allow for the placement of either the Polyester Ring Panel prefilter, located on the air inlet end of the unit, keeps the blower/motor and electrical harness clean and protects the HEPA filter from getting loaded too quickly with large dust and dirt particles. The other slot holds the Splash filter that keeps any human fluids from penetrating the HEPA filter which is located just behind the Splash filter.
The slots have snap in covers that keep the two filters in place. To eliminate any confusion we have different size slots so the prefilter and Splash filter can only go into their respective openings. The snap in covers are also mated to the openings so again no confusion on location.
In order to maintain a tight seal for the HEPA gasket we included a knife edge seat section against which the HEPA filter sits in the unit. Compressing the HEPA against the seal used to require a complicated device that required four screws and a tool to remove and replace the HEPA. The new APPAIS unit has a simple compression bar that is placed between the HEPA aluminum face and the first internal mounting frame. By simply twisting the flat compression bar the HEPA body moves back and compresses the gasket onto the knife edge seal creating a very tight seal. Again, no tools are required.
The APPAIS unit is mounted to a five star wheel rolling base stand that is much like a business chair unit with a pneumatic actuator that allows for height adjustment to accommodate for patient sizes and proper arm location. The base also supports the syringe holder so the Doctor or Pharmacists will always have the proper materials right at the APPAIS unit.
Our initial market will be Pharmacies as they are now doing more injections than Doctors offices especially with Flu and Shingle shots. We hope to have some of our first units in the market by the first quarter of 2015 if not sooner. Look for the all white APPAIS unit at your favorite Pharmacy the next time you go for your annual flu shot.
You can find out more information on the APPAIS unit at: http://pureairsytems.com or call us at: 800-869-8025.