FAQ

<p>The Accu-Chek Softclix, Accu-Chek Multiclix, Accu-Chek FastClix, and Autoclix products are intended to be used by one person only and shall not be used on multiple users. If someone else uses your lancing device there is an increased risk of cross infections.​</p>

<p>Only the Single-Use Lancing Devices (SULDs) Accu-Chek Safe-T-Pro, Accu-Chek Safe-T-Pro Plus and Accu-Chek Safe-T-Pro Uno are intended for professional use, i.e. in care homes, doctor’s offices, hospitals, etc.</p>

<p>Only our SULDs, Accu-Chek Safe-T-Pro Plus and Accu-Chek Safe-T-Pro Uno, can be used on neonates (children younger than 1 year of age). For Safe-T-Pro Plus, only the two lowest depth settings, both of which have a penetration depth of below 2.0 mm, are suitable for neonatal use.​&nbsp;<br><br>With children younger than 1 year of age (neonates), the capillary blood must be collected from the heel. Blood collection must occur from the lateral areas of the sole. ​&nbsp;<br><br>To collect capillary blood from the heel of children under 1 year, use only the low or medium penetration depth of the Accu-Chek Safe-T-Pro Plus device. If the high penetration depth is used, the calcaneus (heel bone) is at risk of being injured.​</p>

<p>No, currently Roche does not offer any lancing devices especially for use on pets.</p>

<p>Roche Diabetes Care GmbH, as a manufacturer of medical devices, certified to European standards, complies with all applicable European directives.​&nbsp;<br><br>The lancing devices, lancets/lancet drums and SULDs are CE labeled (Conformité Européene), which means that the product meets the safety and normative requirements of those European directives.​&nbsp;<br><br>The European regulations are valid and recognized under mutual recognition agreements with many countries, including Canada, LATAM, APAC and Japan.​&nbsp;<br><br>For more information, please contact the Roche Diabetes Care Registration Desk:​&nbsp;<br><br>[email protected]</p>

<p>For all registration inquiries, please contact the Roche Diabetes Care Registration Desk:&nbsp;<br><br>[email protected]</p>

<p>All Roche lancing systems are produced by external suppliers according to strict Roche quality standards. If you require more information on the production location of a specific lancing product, please contact the International Product Managers for Lancing:​&nbsp;<br>[email protected]&nbsp;<br>[email protected]</p>

<p>No. All Accu-Chek lancing devices, lancets, lancet drums, and SULDs are latex-free..</p>

<p>No. All Accu-Chek lancing devices, lancets, lancet drums, and SULDs are PVC-free and phthalate-free.</p>

<p>All lancets made out of the medical grade steel (type 1.4301, approved for medical purposes) contain nickel in small percentage. This is also the case for all Roche lancets: Accu-Chek FastClix, Accu-Chek Softclix, and Accu-Chek Multiclix, as well as for the Single-Use Lancing Devices for professional use. This stainless steel may contain small amounts of nickel, on average approximately 10%.​&nbsp;<br>However, the same type of steel is also used in surgical knives, blades, cannulas, pen needles, etc. - all of which penetrate the skin deeper and stay within the skin longer than the Accu-Chek lancet needles, which​&nbsp;<br>only stay in the skin for miniscule part of a second.​&nbsp;<br>Nickel is also contained in a lot of items from coins to door handles, or cutlery or even food. A small amount of nickel is essential in the human body. Nickel allergy presents itself as a contact dermatitis which develops 12 to 48 hours after exposure to nickel ions. For a material, it is not relevant how much nickel they contain, but rather how many nickel ions can leak from the material. Therefore, medical grade steel can be used even as prostheses, as not enough nickel ions are released from the material to cause an allergic reaction.​&nbsp;<br>From the Regulatory point of view: All used materials in the Accu-Chek lancets are approved to fulfill the international requirements for biocompatibility and cytotoxicity. They fulfil the requirements according to the European Council Directive 93142lEEC for Medical Devices, and are classified as Class IIa Medical Devices</p>

<p>All lancets made out of the medical grade steel (type 1.4301, approved for medical purposes) contain nickel in small percentage. This is also the case for all Roche lancets: Accu-Chek FastClix, Accu-Chek Softclix, and Accu-Chek Multiclix, as well as for the Single-Use Lancing Devices for professional use. This stainless steel may contain small amounts of nickel, on average approximately 10%.​&nbsp;<br>However, the same type of steel is also used in surgical knives, blades, cannulas, pen needles, etc. - all of which penetrate the skin deeper and stay within the skin longer than the Accu-Chek lancet needles, which only stay in the skin for miniscule part of a second.​&nbsp;<br><br>However, Kobalt is no ingredient of our lancets.​</p>

<p>Please contact the Roche Diabetes Care Registration Desk:&nbsp;<br><br>[email protected]</p>

<p>You need to wash your hands with warm water and soap, and dry them well before lancing. This helps to remove any residues from the skin, e.g. from food and drinks, which can lead to incorrect results, and helps to stimulate the blood flow. Clean and dry fingertips are a must for an optimal glucose measurement with any blood glucose. Any contamination of the fingertip with dirt or liquids (sweat, fruit juice, etc.) may affect glucose readings with any blood glucose meter.</p>

<p>No. As the name states, Accu-Chek Safe-T-Pro Plus, Accu-Chek Safe-T-Pro Uno and Accu-Chek Safe-T-Pro are Single-Use Lancing Devices. They all include a blocking mechanism which prevents re-use. This safety feature is necessary as these devices are used in the professional set up.​</p>

<p>Lancets are for single use only due to hygienic reasons and because the needle will become dull with repeated use. The lancet is only sterile until first time use. Furthermore, the Health Authority regulations (EU, FDA) only allow one-time use of lancets, even for consumer use. Hence a new, sterile lancet should be used each time you perform a test.​</p>

<p>No. For safety and hygienic reasons it is not possible to rotate the lancet drum backwards to a lancet which has been previously used. This applies to all Accu-Chek Multiclix and Accu-Chek FastClix device models which work with a lancet drum.​</p>

<p>No, a lancet drum cannot be reused due to safety and hygienic reasons. A used lancet drum is easily recognized by a red stripe.​</p>

<p>No. You need to advance to a new lancet manually by either​&nbsp;<br><br>Accu-Chek Multiclix: Twisting the plunger back and forth. The number (previously stripes) in the lancet counter window reduces by one (from e.g. 6 to 5).​&nbsp;<br><br>Accu-Chek FastClix: Moving the lancet change lever back and forth. The number (previously stripes) in the lancet counter window reduces by one (from e.g. 6 to 5).​</p>

<p>The single lancets, Accu-Chek Softclix and Autoclix: The single lancets have a protective cap to maintain the sterility of the needle tip. If the cap is missing, the lancet is either used or no longer sterile. Only use lancets with an intact protective cap in place.​&nbsp;<br><br>The lancet drums, Accu-Chek Multiclix, Accu-Chek FastClix: A used lancet drum has a red stripe visible. As an extra safety measure, used lancet drums cannot be re-used in the lancing devices.​</p>

<p>All our lancets/lancet drums and SULDs are sterilized by gamma irradiation.​</p>

<p>Accu-Chek Softclix lancets, Autoclix lancets, SULDs: The sterility of the needle tip is secured by a sterility cap surrounding the needle tip until its’ manual removal. ​&nbsp;<br><br>Accu-Chek Multiclix, Accu-Chek FastClix lancet drums: Each needle tip within the lancet drum has its own sterility cap surrounding the needle tip. During lancing, the needle pushes through this sterility protection.​</p>

<p>The part of the needle tip which is surrounded by the sterility protection maintains sterility throughout the The outer housing as well as further inner parts of a lancet/lancet drum/SULD are not, and are not required to be, sterile.</p>

<p>The expiry date printed on the boxes state 4 years of sterility from production date on. ​&nbsp;<br><br>The expiry date for the sterility can be found either on the outer box of the product, or in case of the Accu-Chek FastClix and Accu-Chek Multiclix lancet drums, also on the drum itself.​</p>

<p>There is no shelf life for a lancing device. It depends on the frequency of stick. There is no official claim of the shelf life for lancing device.&nbsp;</p>

<p>The use of an expired lancet or lancet drum may cause an infection at the puncture site as the lancet may have lost its sterility. We guarantee 4 years of sterility, so the customer has plenty of time to use up your lancets.​</p>

<p>Please check your local regulations concerning disposal of used lancets/lancet drums, as these vary depending on the region and country. ​&nbsp;<br><br>The SULDs should be disposed in accordance with the relevant facility’s disposable procedures and regulations.​</p>

<p>Keep your drums clean and protect them from extreme temperatures. Do not store them in a hot car or in the refrigerator.​</p>

<p>Yes.​&nbsp;<br><br>Accu-Chek FastClix, Accu-Chek Multiclix: 30 G / 0.3mm​&nbsp;<br><br>Accu-Chek Softclix, Autoclix: 28 G / 0.4 mm​&nbsp;<br><br>Accu-Chek Safe-T-Pro Uno: 28 G / 0.36 mm​&nbsp;<br><br>Accu-Chek Safe-T-Pro Plus: 23 G / 0.63 mm&nbsp;<br><br>Accu-Chek Softclix XL: 21 G / 0.8 mm</p>

<p>The needle diameter of each product has been chosen according to the purpose for which a blood sample is required. ​&nbsp;<br><br>For instance, the Accu-Chek FastClix systems are tailored to be suitable for our latest blood glucose meters which require only a very small blood sample.​&nbsp;<br><br>The Accu-Chek Softclix XL lancet thanks to its thicker needle are suitable for people with thicker skin (e.g. due to work), and are also used if a larger blood sample is required, e.g. for coagulation diagnostics.​&nbsp;<br><br>The SULD Accu-Chek Safe-T-Pro Plus has a thicker needle as it is also used for a wider range of blood analyses, e.g. with our Reflotron meter.​&nbsp;<br><br>​</p>

<p>Gauge is a measurement unit often used to declare a needle diameter. Basically it is a measurement of the diameter or cross-sectional area of a wire. The lancet needles are made of a wire which is being stretched until a specific diameter has been reached.​&nbsp;<br><br>The reason why the millimeter declaration of a specific Gauge varies is a result of different calculation methods used. Therefore, e.g. a 28 Gauge needle can be stated as 0.4 mm or 0.36 mm.​</p>

<p>The needles are made of medical grade steel, type 1.4301, approved for medical purposes.</p>

<p>Yes. The Accu-Chek lancets and SULDs have a specially designed 3-bevel cut to enable less friction during skin penetration.​</p>

<p>All our consumer lancing systems, all models of the Accu-Chek FastClix, Accu-Chek Multiclix and Accu-Chek Softclix, offer 11 depths, so that our users can conveniently set the depth according to their individual skin type.​&nbsp;<br><br>The SULD Accu-Chek Safe-T-Pro Plus offers three depths to offer more flexibility concerning the required blood sample size.​&nbsp;<br><br>The Accu-Chek Safe-T-Pro Uno offers one depth, as it is mainly used for blood glucose monitoring in professional set up.​</p>

<p>The penetration depth ranges and depths of each step vary slightly from product to product. Please contact the International Product Managers for more detailed information:​&nbsp;<br><br>[email protected]​&nbsp;<br>[email protected]</p>

<p>The required penetration depth depends on the following:​&nbsp;<br><br>The skin: The softer and thinner your skin is, the shallower the depth setting should be.​&nbsp;<br><br>The required blood sample: The more blood you require, the higher the chosen setting.​&nbsp;<br><br>The optimal depth setting is a combination of both. When using the device for the first time, a low setting should be used. Only if the obtained blood sample is too small, should a higher setting be dialed.​</p>

<p>The lancing device models of the platforms Accu-Chek FastClix and Accu-Chek Softclix can be used for alternative site testing (AST) by using a specially designed AST cap. There are AST kits with instructions for use available to hand out to the customers for each product.​&nbsp;<br><br>The Accu-Chek Softclix AST cap was phased out in 2021 for OUS countries.​</p>

<p>The AST caps of the three Accu-Chek FastClix models consists of 3 components parts. Two of the component parts are identical to the regular cap. In order to align the production process for both caps only the differentiating part is produced with transparent material.​<br><br>This decision was taken because a completely transparent cap is rendered unnecessary with Accu-Chek FastClix as the AST cap needs to be removed from the device in order to produce a blood drop. To obtain a blood sample, the AST cap is pressed against the skin on the punctured site. The bottom of the cap is transparent to enable visibility of puncture site when pressing.​</p>

<p>Background: During the Aviva Universal Coding Project, Phase 3, there is a change to the meter AST Claim by removing thigh and calf areas. This change will be made now to support the upcoming no code meter projects. The history behind this change: Over the past many years Indianapolis bGM groups have relied on historical testing data to retain our AST claims which included the calf and thigh areas. Due to changes in the global regulatory environment, now many additional studies with very difficult recruitment and acceptance criteria that adds significant time and cost to each project just to retain AST claims for the thigh and calf are required for the meters. In addition, there is a highly likely chance that the calf and thigh would not pass the acceptance criteria in the end. The business decision was made by Indianapolis bGM group global stakeholders for APAC, EMEA, Latam, and NA regions that due to the increased demands of testing requirements, high level of risk in obtaining the claims, increased time and cost to projects, and low needs of the customers, the thigh and calf AST claims will no longer be made.​&nbsp;<br><br>Impact on Accu-Chek FastClix, Accu-Chek Multiclix, Accu-Chek Softclix/Plus AST LANCING DEVICE AST Claim:​&nbsp;<br>We will not remove thigh and calf from the alternate site list in the lancing device AST instructions, but will add a generic disclaimer that the customer should refer to their bGM manual or contact Customer Care to check if AST is supported and which alternate sites are supported. This will be implemented during 2013 within the general lancing/AST insert update to also include new cleaning and disinfections instructions.​&nbsp;<br>We will further continue to state the two palm sites as preferred alternate sites.</p>

<p>Clixmotion is the principle of dual-guided lancet motion, meaning that both the forward and return motion of the lancet is controlled. The fast linear motion avoids lateral movement and thus prevents unnecessary skin damage - the key to gentle blood sampling.​</p>

<p>The Accu-Chek FastClix andAccu-Chek Softclix lancing systems all include the Clixmotion Technology. ​</p>

<p>1-Click lancing makes obtaining a blood sample even easier by eliminating one handling step, namely priming. By pressing the release button once the device automatically primes and lances in one step.​</p>

<p>Currently we have two Accu-Chek FastClix lancing device models offering 1-Click lancing: Accu-Chek FastClix and Accu-Chek FastClix M2. The Accu-Chek FastClix device is available with selected blood glucose meter kits and as a stand-alone product. The Accu-Chek FastClix M2 device is available attached to the Accu-Chek Mobile LCM meter.​</p>

<p>Our consumer lancing systems, Accu-Chek FastClix, Accu-Chek Multiclix, Accu-Chek Softclix, facilitate gentle and virtually pain-free blood sampling through their precise lancet cut, customized depth settings and guided lancet motion (Clixmotion). There are additional ways in which blood sampling can be made easy and gentle. For your reference here the most important tips for gentle blood sampling.​&nbsp;<br><br>Clean, dry and warm hands are important​&nbsp;<br>Any contamination of the fingertip with dirt, liquids (even water) or food may affect glucose readings. Clean and dry hands are a prerequisite for optimal self-testing. Warm hands also ensure a good blood flow, and hence a large enough sample size, even with a shallow penetration depth.​&nbsp;<br><br>Once-only use of lancets has perceptible advantages​&nbsp;<br>Only unused lancets are guaranteed sterile and thus hygienic. Also, only unused lancets have the optimal sharpness and a sharp lancet is important because it makes blood sampling less painful.​&nbsp;<br><br>Lancing at the optimal depth setting is a key consideration​&nbsp;<br>A lancet should pierce the skin only to the depth necessary to get an adequate amount of blood. Lancing too deeply increases pain as more nerve endings are encountered by the lancet. In order for the lancet to protrude just far enough into the skin to encounter blood vessels, it is important to adjust the penetration depth according to the individual skin thickness.​&nbsp;<br><br>Sampling is improved by pressing the lancing device firmly against the skin​&nbsp;<br>The intensity with which the lancing device is pressed against the skin has considerable influence on the necessary penetration depth. The more firmly the device is pressed against the skin, the better and more gently the lancet can penetrate the skin with a shallow penetration depth.​&nbsp;<br><br>The side of the fingertip is the optimal puncture site​&nbsp;<br>In general, all fingers are suitable for obtaining blood. Certain fingers can be unsuitable if, for example, a skin or fingernail infection is present. The optimal spot for blood sampling is the side of the fingertip, approximately at the finger nail area. Lancing the finger on the same spot should be avoided. By alternating the fingers with each test, the skin is allowed to regenerate.​ ​&nbsp;<br><br>Massaging the finger gently towards the fingertip does not affect a blood glucose test result​&nbsp;<br>The finger can be massaged (“milking”) in the direction of the fingertip to encourage a blood drop to form. This minimizes lancing pain, as a shallower penetration depth can be selected. Squeezing the fingertip does not significantly dilute capillary blood with “tissue fluid”. However, the finger should not be “milked” if the blood sample is for coagulation measurement.​ ​&nbsp;<br><br>First drop of blood can be used for glucose monitoring​&nbsp;<br>In contrast to former recommendations it is not necessary to discard the first drop of blood for glucose monitoring. There is no significant difference in blood glucose values measured with the first and the second drop. However, any contamination of the fingertip with dirt or liquids (sweat, fruit juice etc.) may affect glucose readings. Clean and dry fingertips are a prerequisite for an optimal glucose measurement.</p>

<p>Here a link to a intranet web tool concerning e.g. Accu-Chek Softclix patent expiry or where patents have been registered:​&nbsp;<br><a href="http://accu-chek.roche.com/portfolio/lancing/Accu-Chek_Multiclix/Pages/Strategicbackground.aspx​">http://accu-chek.roche.com/portfolio/lancing/Accu-Chek_Multiclix/Pages/Strategicbackground.aspx​</a>&nbsp;<br><br>For further information or for information on the patent expiry of other lancing products, please contact the Global Product Manager: :&nbsp;<br><br>[email protected]</p>