Directions for Use. Veinlite A. TransLite, LLC.

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Directions for Use Veinlite A TransLite, LLC www.veinlite.com IMPORTANT: Veinlite A is a device which allows the medical practitioner to better visualize superficial veins. This information should be incorporated with the patient history, and other examination information, to aid the physician in making a diagnosis. Veinlite* data should not be used as the only basis for making a clinical diagnosis of vein disease. Veinlite is a registered trademark of TransLite, LLC, Sugar Land, Texas, USA *Veinlite uses the same fiber optic light design as the Nevoscope which has US Patent Number 5,146,923. 04 2014 8410, Highway 90A, Suite 150, Sugar Land, TX 77478 Tel: (281) 240-3111, Fax: (281) 240-3122, E-mail: info@veinlite.com

Contents Page 1. Table of Contents 2 2. Introduction 3 3. Operating Instructions 4 4. Care and Maintenance (a) Cleaning Instructions 5 (b) Light Source/Bulb Replacement 5 5. Summary of Veinlite A Operation 6 6. Veinlite A Specifications 7 2

2. Introduction Superficial veins that are less than 3 mm deep can sometimes be seen as bluegreen (often raised) areas of the skin. Visualization of these veins is determined by the type of light used and the properties of the skin, which reflects shorter wavelength light (blue and green) and absorbs longer wavelength light (orange and red). The light reflected by the surface of the skin is intense enough to over power the light transmitted by the skin, thus limiting the visualization of superficial veins to depths of a few millimeters. Transillumination has been used for many years to image subsurface veins and some other structures. It works by eliminating surface reflected light, making the skin translucent. A bright light is directed into the skin and the area of interest is examined by viewing the translucent region around the light. TransLite s Veinlites use the same patented side-transillumination technique as the Nevoscope**, for better visualization of veins. Side-transillumination is a technique whereby a ring of bright light is directed into the skin, at an angle such that the light is focused under the skin. The focused light creates a virtual light source under the skin, illuminating the skin and superficial tissues inside the ring opening. Using this technique, Veinlites are able to uniformly illuminate a small region of the skin, without any shadow, so that much better imaging of veins is achieved than with other transillumination devices. viewer bright light source bright light source skin surface vein virtual light source Figure 1. Side-Transillumination **Veinlite A uses the same patented side-transillumination technique used in the Nevoscope, which has a US Patent Number 5,146,923. 3

3. Operating Instructions The Veinlite A comprises a halogen light source and an autoclavable ring illuminator. The ring illuminator consists of a 6ft flexible fiberoptic cable attached to the autoclavable plastic ring which provides side-transillumination. The light source uses a 150 watt halogen bulb and has a potentiometer for adjustment of the illumination level. Light is channeled through the fiberoptic cable to the specially designed ring light which directs it under the skin. The Veinlite A is designed to operate in two modes: side-transillumination mode and transmission transillumination mode. The side-transillumination mode is achieved by placing the ring light directly in contact with the skin in the area of interest, i.e. above the vein to be visualized. Gentle pressure should be applied to the Veinlite ring to make good skin contact and assure maximum light transfer into the skin. The transmission illumination mode is achieved by placing the ring light against the palm of the hand or the sole of the foot so the light shines through to the dorsum, illuminating the veins in the dorsum. To use the Veinlite A for visualizing veins, first visually locate the approximate region of interest of the skin and then position the ring light over it. Always turn the illumination level down to a minimum before turning on the power to the light source. This minimizes transient power surges that can destroy the filament of the light bulb. Turn off overhead fluorescent lights which interfere with transillumination. Always use the lowest light intensity while positioning the ring light on the skin. Once positioned, the intensity can be adjusted to the desired level. Bright light is useful for visualizing small surface veins in the field of view. Low light level is useful for visualizing deeper veins. For best results in mapping reticular and feeder veins, turn off the overhead lights. Apply gentle pressure to the ring to ensure it is in contact with the skin. Veins can also be viewed by blocking the area inside the ring with a gauze pad and viewing the region outside the ring. Long veins can be visualized using this method. CAUTION: Do not look directly at the ring light when it is illuminated. 4

4. Care and Maintenance 4. (a) Cleaning Instructions CAUTION: Always turn the light source off before cleaning the Veinlite A. The light source box and cable may be decontaminated by using standard medically accepted cleaning solutions. The ring illuminator (which comes into contact with the patient s skin) should be cleaned using 70% isopropyl alcohol or other medically accepted disinfectant. The entire ring illuminator assembly may be autoclaved. Check with the autoclave manufacturer for detailed directions. Use the single use disposable plastic barrier covers provided with the ring illuminator to avoid contaminating the ring illuminator. Wipe the cover with alcohol after the ring illuminator is placed in the cover. Discard the cover after each patient. Use liberal amounts of solution to clean the Veinlite box and cable. Wipe with sterile water or Isopropyl alcohol to remove any residues. The Veinlite ring illuminator is water-resistant but not waterproof. Do not use abrasive material on any part of the equipment or immerse the device in liquid. The entire Veinlite A ring illuminator assembly may be autoclaved. 4. (b) Light Source/Bulb Replacement CAUTION: Do not look directly into the light. The light source contains a bright halogen lamp that has a limited life-time. Use the potentiometer on the light box to control the light level. Always turn the light source off when not in use. Replacement of the light bulb should be carried out with extreme caution. Always disconnect the power from the light source box and allow the unit to cool down for at least an hour before changing the light bulb. When handling the light bulb, wear a glove to avoid getting skin oil onto the bulb surface. Do not touch the inner surface of the bulb. Undo the large screw on top of the light source box and pull the front cover plate forwards. Push the small lever (next to the light bulb) backwards to raise the bulb slightly out the metal clamp which holds it in place. Gently remove the light bulb from the holding clamp and disconnect the plug from the back of the bulb. Position a new light bulb in the clamp and reconnect the plug. Push the lever back to its original position so that the light bulb will be properly seated for illuminating the fiber optic cable. Replace the front cover on the light source box and fasten the screw on the top of the box before reconnecting the unit to the AC power supply. 5

5. Summary of Veinlite A Operation 1. Switch Off Overhead Lights Overhead lights can overpower the transillumination effect. For best results in viewing surface and deeper veins, turn off lights that are directly above patient. Turn overhead lights off and turn room lights low. 2. Positioning the Veinlite Position the Veinlite ring illuminator over the area of interest. Apply a gentle pressure on the ring illuminator so that it is in contact with the skin. Make sure that the light intensity is turned low during positioning. 3. Viewing Veins Bright light is useful for visualizing small surface veins in the field of view. Low light level is useful for visualizing deeper veins. Adjust the light intensity level for optimum imaging. 4. Viewing Veins Outside the Veinlite Ring Veins can also be viewed outside the central area of transillumination by blocking the circular area of illumination with a gauze pad and viewing the region outside the ring illuminator. Long veins can be visualized using this method. 5. Cleaning Always use the disposable, single use barrier covers to prevent contamination of the ring illuminator and discarded the cover after each patient. Clean the Veinlite A ring illuminator before and after use, using 70% isopropyl alcohol or other medically accepted disinfectant. The Veinlite A ring illuminator is designed to be waterproof and liberal amounts of fluids can be used during decontamination but it should not be immersed in any liquid. The ring illuminator can be autoclaved. Always use the disposable, single use barrier covers. Do not immerse the ring illuminator in liquids. 6. Caution Caution is advised in handling the light source and ring illuminator to avoid any possible injury to the eye from the bright light. Always turn the illumination level down to a minimum while handling the Veinlite. CAUTION: Do not look directly at the ring light when it is illuminated. 6

7. Veinlite A Specifications The Veinlite A model comes with an autoclavable large ring illuminator specially designed for mapping larger veins and finding reticular veins. The large ring illuminator has a wide opening to facilitate use with lasers during sclerotherapy treatment. The ring illuminator is supplied with a pack of 50 disposable, plastic, single use barrier covers. The covers are latex free and should be discarded after each patient. Figure 2. Large autoclavable ring illuminator with disposable barrier cover Veinlite A (product code VLA) specifications Input Voltage Light Source Power Power Output Adjust Halogen Bulb Type Color Temperature (approximate) Fiberoptic Cable Length Ring Top Diameter (outer) Ring Top Diameter (inner) Ring Bottom Diameter (inner) Fiber Taper Angle Light Window Width Disposable Plastic Covers One Year Warranty 115V, 60 Hz AC 150 Watts Rheostat continuously variable EJA (EKE type bulb may also be used) 3250 degrees (max intensity with EJA bulb) 6ft 62 mm 51 mm 36 mm 36 degrees 0.5 mm 50 per pack, re-order code VLII-DPC Covers all parts, excluding halogen bulb 8410, Highway 90A, Suite 150, Sugar Land, TX 77478 Tel: (281) 240-3111, Fax: (281) 240-3122, E-mail: info@veinlite.com 7 Phone: (281) 240-3111