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When a particular paddle need is identified, we start our design
process by reviewing or obtaining information (often via a field
trip) about the target mammography machine. We measure and study
OEM paddle samples and note critical features.
From here our designs come to life on paper with sketches and scale drawings. We consider the paddle's intended use, compliance with the FDA's MQSA standard, compatibility with the mammography machine, fabrication techniques, strength and its effect on the x-ray beam. All of our paddle designs incorporate a minimum radius straight edge at the chest wall side. When we are satisfied that the design will work, we begin production.
The critical " business end" of any compression paddle is the plastic surface exposed to x-ray (bottom); the part that touches and squeezes the breast. For this surface we use polycarbonate plastic because of its strength and radiolucency. In fact, in most cases, all surfaces of our paddle plastics are made from polycarbonate. Except for our unique "flex" paddle, plastics are fabricated by first thermoforming and machining or machining plastic parts which make up the paddle's sides. Using a proprietary bonding technique and specially made tooling, the plastic side parts are bonded together with the bottom.
Paddle frame parts are custom made typically from sheet formed or machined aluminum and machined plastic. Depending on the design, paddle frames are either welded or fastened together with stainless steel hardware. Paddle frame parts are finished by electrostatic powder coating and/or in polished aluminum.
After bonding, our paddle plastics are hand trimmed and machine routed. Biopsy paddle plastics have either a window machined or hole pattern drilled in the bottom. Patient contact edges and corners are rounded by hand sanding with finer and finer grit sandpaper. Afterwards, plastics are polished on a polishing wheel, carefully washed and dried.
OEM sensor markings are hand painted on each paddle plastic with special radiolucent paints. Biopsy paddle coordinates are bonded and coated by hand with a polyurethene finish. Finally, paddle plastics are hand polished and inspected.