FREQUENTLY ASKED QUESTIONS

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1 FREQUENTLY ASKED QUESTIONS How is Genteel Different? With its vibration/vacuum technology, covered by 6 US patents, and multiple international patents, both granted and pending, the Genteel lancing instrument is a brand new concept in painless lancing, completely replacing the pain and discomfort of industry standard springloaded devices. All lancing devices on the market today mainly rely on extracting blood from the fingertips, because they are the primary area where blood capillaries are closest to the surface of the skin. Unfortunately, they also have the most abundant supply of pain nerves. Alternate sites may be an option with other lancing devices, but because they are only spring-loaded slingshots, they have limited ability to control the penetration depth, so they cannot correct for skin thickness, membrane toughness, or blood viscosity. This often results in an incomplete blood draw, and the need to lance multiple times. Genteel, on the other hand, uses a patented Nozzle/Contact Tip Assembly to control the depth of penetration, plus vacuum, so you get reliable blood draw, the first time, from almost any area of the body fingertips or alternate sites even where there are no capillaries close to the skin s surface, and does so quickly, precisely, and without pain. Has Genteel Been Approved by the FDA? The FDA does not approve of any device or invention. However, because Genteel s safety concerns are so minimal, it has been classified as a Class 1 device (the same as a handle, and the same category as a standard spring-loaded device), making it legal for sale in the United States. The fact that Genteel achieves the same results from anywhere on the body without pain does not change its classification as far as the FDA is concerned. Who Should Use Genteel? Genteel is recommended for anyone adult or child where a drop of blood is needed for frequent or occasional testing, such as diabetics, those on blood thinners, or anyone using athome test kits where finger prick sampling has been the industry standard (must be used with physician-approved strips and meters for accurate results). [NOTE: Because Genteel is only designed to draw a drop of blood, it cannot replace, nor is comparable to, testing requiring vials of venous blood.] Genteel s ability to draw blood without pain makes it especially beneficial for those fearful of the usual pain and discomfort of standard lancing devices. What are the Benefits of Using Genteel Instead of the Way I ve Been Testing Before? The benefits of pain-free blood draw cannot be overstated, and because Genteel also excels in its blood drawing reliability from both alternate site and fingertips, this choice of where to test can also allow calloused, fibrotic, numb fingertips a chance to rest and heal. Eliminating the usual pain of sampling can lead to better on-schedule testing, which, in turn, can lead to better control. Even those used to fingertip testing, claiming the pain no longer bothers them, can still experience subliminal avoidance mechanism, where the intention of frequent on-schedule sampling gives way to excuses, and is therefore deterred, delayed, or avoided completely so as not to experience this anxiety.

2 What is the Purpose of Genteel s Contact Tips? Genteel comes with six Contact Tips, of varying colors and thicknesses, each engineered to snap onto the top of either of the two included Nozzles. One Nozzle is for fingertips, and the other for alternate site blood draw. The purpose of the Contact Tip is to precisely control the depth of penetration of the lancet by getting in the way, or blocking, the forward travel. Therefore, the thicker the blocking Contact Tip you snap onto the Nozzle, the more shallow the lancet s skin penetration. The Contact Tips are interchangeable, and the only difference is in their thickness. Because skin thickness varies considerably between our fingertips and the differing parts of our bodies (alternate sites), along with the location of blood capillaries under the skin, some of us require very little penetration to draw up the right amount of blood, whereas others may have thicker skin and deeper capillaries, needing deeper penetration. Genteel s Contact Tips are designed to accommodate those differences, so for most of us, sampling on our fingertips, where skin can be the thinnest and blood capillaries closest to the surface, a shallow penetration (say, using a Blue Contact Tip), may work best, whereas sampling from our stomach or thigh, where skin is usually heavier and capillaries more buried, a thicker Contact Tip may be best (say, Violet). You want to select that Contact Tip that will provide the least penetration but still achieve the quickest, most reliable draw. You determine your personal optimum Contact Tips, one for the fingers and another for alternate site, using an initial trial-and-error period, say, about an hour or less. Once established for your body, the ideal Contact Tip for both fingertips and the one for alternate sites will not change. You only have to determine the right contact tips one time. Can I Use Genteel Without the Contact Tips? It is not recommended, because the Contact Tips help form a vacuum seal with the skin, so if you test without the Contact Tip, you will have trouble maintaining the vacuum. Also, without a Contact Tip to block the lancet s forward travel, skin penetration will be too deep and may hurt. What is the Purpose of the Two Nozzles? Two Nozzles are included in your Genteel package for convenience because it is easier to change Nozzles on Genteel than to change the Contact Tip on the Nozzle. On any person s body, the optimum Contact Tip for all alternate sites stays pretty consistent throughout the body, whereas the optimum Contact Tip for fingers would be very different from that of the alternate site. Therefore, it is recommended that you set up one Nozzle with your optimum Contact Tip for your fingers, and the other Nozzle with the optimum Contact Tip for all your alternate sites. What Makes Genteel Pain-Free? Genteel uses five well-established principles for pain-free sampling: 1. Body sites with less pain nerves. By allowing blood draw from multiple body locations, Genteel eliminates the need to only test from the fingertips, which can contain over 30 times the pain nerve density of other parts of your body. Preferred areas can now be the forearm, calf, thigh, stomach, shoulder and even knee which has the lowest pain nerve density, all of which ensure significantly greater comfort than the fingers and hands. 2. Vibration. Applying vibration to a procedure that would normally be painful, such as lancing, blocks the transmission of that discomfort to the brain. The only sensation is now one of vibration, not pain. As Genteel s Activation Button is pushed, vibration begins immediately before the lancet is even released into the skin, and continues until the lancing process is finished. Because this entire process is so fast, the only sensation may be just a light tap on the skin.

3 3. Speed. Genteel lances up to four times faster than with conventional spring-loaded lancet holders. For the technically inclined, the entire lancing process from start to finish takes 18ms (0.018 sec.), so fast that the body doesn t get a chance to generate pain. 4. Vacuum. When Genteel applies vacuum to the lanced area, in addition to drawing up the test blood, this same vacuum also works to soothe pain nerves, almost like having them take a nap. This prevents any post-lancing discomfort. 5. Less depth of penetration required. With a choice of six Contact Tips to control depth of penetration, and vacuum to assist in the draw process, the lancet doesn t have to penetrate nearly as deeply as with non-vacuum supported conventional lancets. Less penetration depth naturally leads to less pain. 6. Precision control of depth of penetration. The top layer of the capillary blood supply is located just slightly closer to the skin than the pain nerves. Using Genteel s patented Contact Tip technology, the penetration depth is controlled so precisely that the lancet just taps the top side of the capillary blood supply, BUT DOES NOT REACH DEEP ENOUGH TO TOUCH THE PAIN NERVES. When all six of these techniques are applied simultaneously, and in concert, you feel either no pain at all, or so imperceptible as to be non-existent. How Difficult is it to Use Genteel? From adolescents to senior citizens, including those afflicted with vision and dexterity challenges, Genteel is designed for ease of use. However, as with any new product, a short learning curve is important, about the same as with any conventional spring-loaded lancing device. Because the success of pain-free, precise lancing is tied to determining which of Genteel s six Contact Tips work most effectively for both fingertip and alternate site testing, some trial and error testing is imperative. This experimentation usually takes less than an hour. Both the written instructions that come with your product, and instructional videos on this website, will easily guide you through this process. Here s the step-by-step procedure to lancing once the right depth-controlling Contact Tip(s) have been selected: 1. Prime Genteel by pushing in the Plunger. 2. Remove your Nozzle/Contact Tip Assembly with a simple twist. 3. Insert your standard lancet. 4. Reinstall the Nozzle/Contact Tip Assembly (now is a good time to also put the test strip into the meter, which automatically turns it on so it will be ready). NOTE: If you already have your lancet in place, omit steps 2, 3, & 4. Just go from Step I to Step Place the Nozzle/Contact Tip Assembly flat against your preferred body site for sampling. (After a few trials, you will easily learn the most comfortable and easiest to use sites.) 6. Push and hold the Activation Button, while keeping the Nozzle/Contact Tip Assembly flat against the lancing site. Keep your finger on the Activation Button, through step 7 below, until you see enough blood for testing, which usually takes 2-8 seconds. 7. Once you see enough blood, lift your finger off the Activation Button first, allowing air to enter Genteel, causing the vacuum to dissipate. You must do this before going on to Step Lift Genteel off your skin. 9. The test blood is now waiting on your skin, ready for you to use your conventional glucose meter. Always follow the meter manufacturer s instructions. How Difficult is it, and What Is the Best Way, to Press the Activation Button?

4 Pressing the Activation Button starts Genteel s automatic process, and should only takes a slight amount of finger pressure to begin (about as much as pushing a latch to open a cabinet). Hold Genteel as if you were writing with a pen. Have your index finger pressing on the Button for easiest activation. Is Alternate Site Testing as Accurate as Blood From My Fingertips? Yes; both are accurate for normal diabetes testing, which occurs approximately 95% of the time. The mistaken belief that only fingertips offer the most accurate test blood comes from a valid study done several years ago that demonstrated that when test subjects engaged in an activity that would quickly change their blood sugar level, the results would show up 15 minutes sooner on fingertips or hand blood than on other body sites. Example of activities that would quickly change blood sugar are eating a heavy sugar load, or vigorously exercising. However, most prescribed blood sugar testing is scheduled for a considerable time after the patient has eaten, or done anything to change blood sugar levels, so this momentary difference does not affect accuracy. After about 15 to 30 minutes, all blood has the same glucose level, leading to the conclusion that in the long run, there is no difference in test results between finger pricks and alternate site testing. Of course, this makes sense, because your same blood is continually mixing and recirculating. On those rare occasions where you think your blood sugar is changing rapidly, simply use Genteel to test on your fingertips. [NOTE: Always check with your doctor to make certain alternate site testing is right for you.] What are the Recommended Alternate Sites on My Body to Test? The most convenient are best, such as chest, upper arms, thighs, stomach, forearms, hips, calves and knee, all of which have lower pain nerve density than the fingertips, with the knee having the lowest of all. Can I Use the Same Alternate Site Repeatedly? Yes, the same general body area is fine; however, it s recommended that you adjust the body site slightly by, say, at least ½ inch in any direction, to avoid any possible irritation or bruising. Can I Still Draw Blood if My Skin is Cold? To preserve heat when it s cold, the body reduces circulation to the skin. This can make it much harder to draw blood from the extremities, such as the fingertips. To speed up the draw, just vigorously rub and tap the test site first to bring the capillary supply closer to the surface. Also, Genteel s ability to draw blood from almost anywhere on the body allows you to test areas that were covered by clothes, and will significantly reduce the negative effects of cold, so test blood more easily comes to the skin surface even when it s frigid. Because fingertips are much more exposed to, and affected by, the cold, alternate sites not exposed to the weather may be more desirable. If you re consistently testing in the cold, you may wish to change to a more aggressive Contact Tip (see DETERMINING THE RIGHT CONTACT TIP FOR EACH USAGE). How Long Does Genteel Take to Draw the Right Amount of Test Blood? The average amount of time in our tests is between 2-8 seconds, depending on such factors as site location, skin thickness, and body and room temperature. Do I Need a Separate Carrying Case for Genteel? Because Genteel is slightly larger than the industry-standard lancet holder, we provide a customized carrying case with every order, to more comfortably hold Genteel, along with all

5 your usual lancets, test strips, and meters. However, if you prefer to use a case you already have, Genteel s design may make it a tighter fit, and cause the case to bulge out slightly. Do I Have to Change Any Other Diabetes Supplies I m Currently Using? Absolutely not. Genteel can be used with almost any popular FDA-approved popular standard lancets, meters, and test strips currently on the market. Amazingly, because Genteel s technology is not based on any lancet size or configuration, it will work perfectly, regardless of which FDA-approved lancet you select. This is in contrast to the industry-standard lancets on the market today that can only be used with a holder supplied by the same manufacturer. If I Misplace or Lose My Contact Tips or Nozzles, Can I Buy Replacement Parts? Yes; simply click on the PURCHASE link on our website to find exactly what you need. Replacement Contact Tips come six to a package (in your optimum color(s)), and two to a package for the Nozzles. You can place your order on-line, service@mygenteel.com, or call (844-GENTEEL; 7A-5P CST). Will My Health Insurance or Medicare Cover Genteel? Not at this time. Unless a newer way is cheaper, insurers present policy is that if there is an alternate way to accomplish the same result (spring-loaded finger lancers), they will not pay for you to avoid pain. We are working with various insurance companies, including Medicare, but the process is complex and time-consuming. Because Genteel is too new, and insurance/ Medicare coverage is dependent on red tape, doctor referral, prescription drugs, and products they are familiar with, insurers are disposed to see pain-free testing as a patient choice. We encourage you to talk to your physician about the benefits of Genteel.