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Yes. The Accu-Chek® 360° Diabetes Management system is unique in that it allows users to print out a report or graph in any of the 10 languages supported by the application. Providing information for print in multiple languages is another way the Accu-Chek® 360° Diabetes Management system may help improve the communication between the patient and the healthcare team.
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Yes. The Accu-Chek® 360° Diabetes Management system is designed to meet the personalized needs of users by employing a setup wizard to automatically run the first time the application is used. This “intelligent” wizard customizes the application to meet the needs of the specific user. Users will only see those features that they want to use, thus providing an improved out-of-the-box experience.
In addition, if users have future needs, they can be addressed by simply using the Show / Hide function within the system application to activate the features to meet these new needs.
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Yes. The Accu-Chek® 360° Diabetes Management system provides a variety of advanced reporting options with the intended purpose of making the user’s experience more positive and efficient. These options include:
Favorite reports – The Accu-Chek® 360° Diabetes Management system offers the ability to define favorite reports. This is much like creating a list of your favorite Web sites in your Web browser. Once these are created, the user can return to these at the click of a button.
Batch reports – This option is designed to allow the user to output several different reports at the same time. For example, the user may want to always print the Trend graph and the Logbook report when his or her supported Accu-Chek® device is downloaded. In this case, the goal of the Accu-Chek® 360° Diabetes Management system is to make it as simple as identifying what reports should be printed together, and it does the rest.
Custom reports – This option is designed to allow users to create or lay out their own reports. It is intended for those users who may want the information presented in a manner different from the standard reports.
This is a simple drag-and-drop feature.
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Yes. The Accu-Chek® 360° Diabetes Management system is uniquely designed in that it offers the ability to print, email and fax reports directly from the application. In fact, its technology allows a user to perform all 3 actions consecutively, which may shorten the user’s wait time.
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The Accu-Chek® 360° Diabetes Management system offers a newly created feature that is designed to download supported Accu-Chek® devices automatically. With the application closed, the user simply puts the supported Accu-Chek® device in communication mode and places it in front of the Accu-Chek® cable. The Accu-Chek® 360° Diabetes Management system does the rest and even auto-prints a report.
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The goal of population management is to focus on a group of patients rather than an individual patient. The population-management tool is designed to offer the healthcare professional the ability to identify which therapies are working and which ones are not for a group of patients. This information can help the healthcare professional make informed treatment decisions and potentially provide the proof needed for reimbursement. For example, if a healthcare professional believes that he or she should be reimbursed for certain programs that are being conducted but has been unable to show evidence in the past, the Accu-Chek® 360° Diabetes Management system may be able to help with the evaluation of a program and could potentially provide the necessary proof to gain reimbursement.
Not only does the population-management tool’s design offer the ability to prove outcomes, its intended purpose is to do it more efficiently when compared to traditional methods.
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Yes, it can be used for alternative site testing (AST) by using the specially designed AST cap. We recommend using Accu- Chek Multiclix at the palm of the hand when performing AST.
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Accu-Chek® Multiclix is intended to be used by only one person. If someone else uses your lancing device there is an increased risk of infection. To avoid exposure to contaminants, do not use it on multiple users.
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No, Accu-Chek® Multiclix is designed so that a new lancet cannot be selected if the device is primed. Nonetheless, by applying force you may be able to change to the new lancet while the device is primed. This can cause damage to internal parts of the device.
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No, for safety and hygienic reasons this is not possible.
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No, without manipulation this is not possible. Safety hooks prevent accidental reuse of a used drum. A used drum is easy recognized by the red stripes.
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We highly recommend the use of a new, sterile lancet every time you test. This is based on hygienic considerations and to help avoid infection. Additionally, the tip of a new needle is sharp, with optimal form and cut and therefore ensures gentle lancing. This is diminished with multiple use.
However, a lancet may be used more than once.
Never use a lancet that has been used by someone else.
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No, Accu-Chek® Multiclix does not contain latex.
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The drum can simply be disposed of in the household waste. Since all lancets are concealed safely in the drum, you no longer have to reapply any safety caps.
(Please note: If a lancet drum containing used lancets is dropped on the hard surface (either on its own or in the lancing device), lancets may in rare cases protrude from the front of the drum. These lancets could cause injury. Therefore take great care not to touch the front of the used drum.
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The use of an expired 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 you have plenty of time to use up your lancets.
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Please proceed in the following manner:
1. Check whether the lancet display is visible. If not, turn the priming button until the lancet display becomes visible.
2. Check whether the yellow area in the transparent release button is visible. If this is the case, the device is already primed and ready for use.
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To keep your lancing device in tip-top condition, clean it regularly and wipe off any blood from it immediately. Clean your lancing device from the outside only. Follow a weekly cleaning regime using a cloth moistened with 70% isopropanol or 70% ethanol (available from your pharmacy/ chemist).
In addition, thoroughly wipe the inside of the cap using a cotton bud moistened with 70% isopropanol.
Allow your Accu-Chek® Multiclix lancing device time to dry thoroughly.
Never dip Accu-Chek® Multiclix in water, isopropanol or any other liquid. This may damage internal parts, so impairing operation of the lancing device.
Use only 70% isopropanol or 70% ethanol to clean the lancing device. Other substances used for cleaning may attack the plastic and stop the lancing device from operating properly.
Do not clean the Accu-Chek® Multiclix drum.
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Keep your drums clean and protect them from extremes of temperature. Do not store them in a hot car or in the refrigerator. Always store the lancing device unprimed.
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The required penetration depth depends on the following:
• Your skin: The softer and thinner your skin is, the shallower the depth setting should be.
• The required blood sample: The more blood you require, the higher the chosen setting.
The optimal penetration depth is a combination of both. Always start with a low setting when using the device for the first time. Dial to a higher setting until blood volume is right.
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Yes, it can be used for alternate site testing (AST) by using the specially designed AST cap. When performing AST we recommend using Accu-Chek® Softclix Plus lancing device at the:
• Base of the little finger
• Base of the thumb
• Inside of the forearm
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No. Accu-Chek® Softclix Plus lancing device is intended to be used by only one person. If someone else uses your lancing device there is an increased risk of infection.
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No, Accu-Chek® Softclix Plus lancing device lancing device is not designed for use with pets.
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Yes, Accu-Chek® Softclix Plus lancing device gives you the flexibility of choice: You can leave the lancing device attached to the meter to collect blood or, if you prefer, you can detach it and use it as a single lancing device. Just as you wish.
When on the go, most people prefer to have the lancing device docked to the meter because of easy handling and packing.
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Yes, the device can be used attached to or detached from the meter, including lancet exchange.
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Dropping the lancing device with a lancet inserted may loosen the lancet in its holder. In that case the lancet is no longer properly lodged and cannot be used to obtain blood. In rare cases the lancet may even protrude from the cap. In a case such as this you might injure yourself on the lancet. Therefore, take great care not to touch the front of the cap.
Should you drop the lancing device, please pick it up with care. Remove the cap from the lancing device. Take care to avoid the lancet so as not to injure yourself. Always eject and dispose of the lancet if the lancing device has been dropped. Afterwards reattach the cap without inserting a lancet. Press the plunger all the way down twice. Only after this should a lancet be inserted.
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If no lancet has been left in the device, a new lancet can be inserted in the primed device. Nevertheless, for safety reasons we highly recommend not to exchange the lancet while the device is primed.
If a lancet has been left in the primed device, please press the plunger (without pressing the device against the skin) to trigger the device. Then remove the cap and press the plunger a second time, holding the device upright above a waste bin. The lancet will be ejected and a new lancet can be inserted.
Note: Keeping the lancing device in a primed state can cause parts to become misshapen through tension and impair its operation.
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You should use a new, sterile lancet every time you test. This is based on hygienic considerations. In order to reduce risk of infection, the medical device directive (93/42/EEC) in the EU requires sterile one-time use for products such as lancets.
In addition to the hygienic considerations, there are also other reasons which support once-only use: the tip of an unused needle is sharp, with optimal form and cut and therefore ensures gentle, virtually pain-free lancing. The single use of lancets also helps prevent skin changes.
Furthermore, never use a lancet that has been used by someone else!
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No, Accu-Chek® Softclix Plus lancing device and the Accu-Chek® Softclix lancets do not contain latex.
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The lancet should be disposed of in a waste bin carefully, so it cannot cause injury.
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Wash your hands with warm water and soap, and dry them carefully. This will improve circulation and ensures a clean penetration site.
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No!
In contrast to former recommendations, it is not necessary to discard the first drop of blood and to use only the second one 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.
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The lancet should be disposed of in a waste bin carefully, so it cannot cause injury.
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Yes!
Blood should be sampled by gently squeezing the fingertip (the tissue is pressed together and blood is forced out of the incision), since it minimizes lancing pain (shallower penetration) and reduces the risk of scarring and residual. Squeezing the fingertip does not significantly dilute capillary blood with ‘tissue water’.
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Take the following preparatory actions:
•Run warm water over your hands before testing to increase blood flow. Be sure to dry hands completely before testing.
•Improve blood flow to the fingers by warming them.
•Lower hands below your waist level and gently massage the selected finger before lancing.
•Press the lancing device firmly against your finger.
•After lancing, massage your finger towards the tip.
Only if all of the above are insufficient, increase the penetration depth of the lancet device by rotating the black dial one step at a time.
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The use of an expired lancet may cause an infection at the puncture site as the lancet may have lost its sterility. We guarantee 4 years of sterility, so you have plenty of time to use up your lancets.
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This can be caused by several reasons:
•The penetration depth is too shallow for your skin. Please select a higher penetration depth setting.
•The device needs to be pressed firmly against the skin Check, if a lancet is inserted in the device.
•Sometimes the blood does not appear immediately after lancing. Massaging the finger by gently squeezing it towards the fingertip helps to form a drop of blood.
Please also check the preceding question about drawing too little blood.
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Make sure that the cap of the lancing device has been removed. Hold the lancing device upright above a waste bin and press the plunger until it clicks. The lancet should drop out now.
If, in rare cases, the lancet does not drop out, keep the plunger pressed down. Use the white “collar” of the cap to pull the lancet out by hooking the edge of the collar behind the platform of the lancet. A cut-out area on the inside of the lancet holder makes it easy to hook the lancet platform.
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To keep your lancing device in tip-top condition, clean it regularly and wipe off any blood from it immediately. Clean your lancing device from the outside only. Follow a weekly cleaning regimen using a cloth moistened with 70% isopropanol or 70% ethanol (available from your pharmacy / chemist).
In addition, thoroughly wipe the inside of the cap using a cotton bud moistened with 70% isopropanol. Allow your Accu-Chek® Softclix Plus lancing device lancing device time to dry thoroughly.
Never dip Accu-Chek® Softclix Plus lancing device in water, isopropanol or any other liquid. This may damage internal parts, and impair operation of the lancing device. Use only 70% isopropanol or 70% ethanol to clean the lancing device. Other substances used for cleaning may attack the plastic and stop the lancing device from operating properly.
Do not clean the Accu-Chek® Softclix lancets.
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Keep your lancets clean and protect them from extreme temperatures. Do not store them in a hot car or in the refrigerator.
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Accu-Chek® Softclix Plus lancing device is sold only as a kit together with Accu-Chek® Compact Plus system. The kit is available at many retail and online pharmacies. Please view list of retailers for more details.
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Due to its unique mechanism (Clixmotion technology) only the Accu-Chek® Softclix and Accu-Chek® Softclix XL lancets are to be used with Accu-Chek® Softclix Plus lancing device lancing device. Using any other lancets may damage the lancing device or impair its function.
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The required penetration depth depends on the following:
• Your skin
• The softer and thinner your skin is, the shallower the depth setting should be.
• The required blood sample
• The more blood you require, the higher the chosen setting.
• The optimal penetration depth is a combination of both.
Accu-Chek® Compact Plus meter only requires 1.5 μl of blood for determining the blood glucose level. Always start with a low setting when using the lancing device for the first time. Should you not obtain enough blood, dial to a higher setting until blood volume is right.
Please also refer to the following questions for further details on how to draw sufficient blood.
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The plunger is a multifunctional button used to prime, trigger and eject the lancet.
This allows you to operate the device with just one hand, easy and convenient!
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No. Accu-Chek® Performa meters are designed exclusively for use with Accu-Chek® Performa test strips.
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For your safety, the Accu-Chek® Performa system is designed to prevent biased results caused by expired test strips.
During the last month before the code key expires, the meter continues to provide a result, along with the warning ‘code exp’ at the bottom of the display.
After the code key expires, the meter displays an ‘E-5’ error and ‘code exp’will flash.
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No. Although you can insert a code key from another meter into the Accu-Chek® Performa meter, you will get an ‘E-2’ error, and ‘code’ will flash.
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Yes. Simply go into setup mode and turn the beeper off.
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Yes. The user can redose the test strip within 5 seconds of adding the first drop of blood.
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Only 3 other substances in the bloodstream (galactose, xylose, and lipids) can interfere with the Accu-Chek® Performa test strip. No other leading system has fewer interfering substances.
Patients who take a xylose tolerance (D-xylose absorption) test should not use an Accu-Chek® Performa meter to test their blood glucose for 24 hours after the test—and should discuss alternative testing options with their doctor.
Some interfering substances that affected the Accu-Chek® Advantage/Sensor system are no longer a concern (e.g., bilirubin, ascorbic acid, and acetaminophen).
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Control test values will not be in the user-accessible memory. However, they will be stored in the downloadable memory, so they can be viewed through software programs, such as Accu-Chek® Compass and Accu-Chek® CAMIT Pro programs.
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No, the control ranges are fixed.
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High levels of maltose in blood can result in falsely high test results. Blood maltose levels can be high in any patient who is:
* Undergoing peritoneal dialysis with solutions containing icodextrin (e.g., Extraneal®) because icodextrin is metabolized to maltose
* Receiving certain types of IV immunoglobulin therapies that contain maltose (e.g., Octagam® or Gamimune®)
* Receiving IV solutions containing maltose as a substitute for glucose or as a means of hydration
Patients on these therapies should not use Accu-Chek® Performa Nano meters to test their blood glucose for as long as therapy continues and should discuss alternative testing options with their healthcare professional.
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In market research that compared different test strip shapes and sizes, users considered the final end-dose design optimal.
Consumers found it easiest to perform alternative site testing with an end-dose strip.
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You can transfer stored results to a computer simply by pointing the infrared (IR) window on the top of the meter toward the IR window of the Accu-Chek® download cable. The 2 windows should be 3 to 10 cm (1 to 4 in) apart.
To enter download mode:
* Turn off the meter.
* Press and hold and until 2 arrows in the display flash alternately.
* Initiate the data download by following the instructions provided with the supported software.
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The Accu-Chek® Performa meter automatically recognizes Accu-Chek® Performa control solutions, so running a control test is easier than ever.
First, wipe the tip of the control bottle with a tissue. Then put the meter on a flat surface, insert the test strip, and squeeze a drop of control solution onto the front edge of the strip. A result appears with a flashing ‘L-.’ Press once to mark the result as a Level 1 control, or twice for a Level 2 control. Press to set the level in the meter. The control result and ‘OK’ alternate in the display if the result is in range.
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You can set up to 4 test reminders per day, in 15-minute increments. At the set reminder time(s), a series of beeps will sound every 2 minutes, up to 3 times per reminder. The reminder beep will not occur if the meter is on at the set time, or if the user runs a test 30 minutes or less before the set reminder time. If the user turns on the meter while the reminder is sounding, the series of beeps for that reminder will stop.
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The Accu-Chek® Performa system checks for more potential issues than any previous Accu-Chek® system. It achieves this by combining the power of technologies in the testing system (the meter), the code key, and test strips with 6 gold electrodes to perform extensive quality checks during each test.
These include:
* Sample checks
o Verify the correct amount of blood is applied
o Show user if more sample is needed
o Permit redosing within 5 seconds
o Detect whether sample is blood or control solution
* Strip checks
o Check test strips and reagent for potential damage/abuse
o Exposure to high humidity
o Scratches on strip electrodes
o System is designed to compensate for humidity or temperature or to produce an error message if unable to compensate
*System checks
o Check for variations in:
o Hematocrit
o Humidity
o Temperature
These checks start when the meter is turned on and are complete when a blood glucose result is shown.
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The control range data is stored in the code key.
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During the last month before the code key expires, the meter will continue to provide a result, along with the warning “Code exp” at the bottom of the display. After the code key has expired, the user will no longer be able to get a result, but will see the error reading “Err. Code exp” on the display.
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If the initial blood sample applied to the test strip window is not sufficient, the blood drop display will continue to flash on the meter. If sufficient blood is not applied within another 5 seconds, the meter will indicate the error ‘E-4’.
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Press and hold the ON/OFF button until the flashing strip symbol appears.
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With the meter turned on and the flashing strip symbol on the display, press and hold the ON/OFF button for about 4 seconds until "Set" and the hour are flashing on the display.
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The target expiration date is 18 months from the date of manufacture.
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The target expiration date is 18 months from the date of manufacture.
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The Accu-Chek® Performa system will test blood samples from 4 alternative sites (called Alternative Site Testing): forearm, upper arm, thigh, or calf.
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Yes. Although the Accu-Chek® Performa system adheres to the same high standards of clinical accuracy as other Accu-Chek® systems, no blood glucose monitoring system is 100% accurate.
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When troubleshooting a meter, it may be necessary to recall errors. To view the last 10 errors stored in memory:
* Press or to enter memory mode.
* Press and hold and for approximately 4 seconds. The most recent error code will appear on the screen.
* Scroll through the memory to view the 10 most recent errors.
This information is not contained in the Owner’s Booklet.
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Yes. Because the Accu-Chek® Performa system is cleared to test capillary, venous, arterial, and neonatal blood samples, it is appropriate for use in clinical settings.
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Before the user actually doses the test strip, the meter runs quality checks of the strip chemistry to make sure the strip will give a valid test result. This ensures that the strip has not been exposed to outside environmental factors, such as humidity.
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The test strip uses glucose dehydrogenase chemistry, which prevents oxygen from interfering with test results.
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Err and the control result will alternate on the display.
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The test strip container being introduced with the Accu-Chek® Performa system features a flip-top lid with the Accu-Chek® logo molded on it. The new design makes it significantly easier to open the container and to make sure it’s closed properly, which may help increase testing compliance and decrease strip exposure. The container is also shorter – making it more convenient for customers to carry – and has the desiccant inside (instead of on top, as in prior designs). This helps ensure increased strip stability and additional protection from environmental factors.
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An additional internal battery supports the clock when the main battery is removed. You can leave the battery out of the meter for 72 hours and still retain the time and date. If you replace the battery within that time, the meter will ask you to verify the time and date. The internal battery will automatically recharge. If you do not replace the battery within 72 hours, the meter will retain the time and date that was stored before the 72 hours.
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The Accu-Chek® Performa system uses an electrochemical test principle instead of the photometric principle used in the Accu-Chek® Active system, Accu-Chek® Compact system, and Accu-Chek® Go system.
Electrochemical biosensors such as those in the Accu-Chek® Performa system provide high levels of sensitivity and specificity:
In an electrochemical test principle, glucose dehydrogenase enzymatically reacts with glucose in a sample causing the release of an electron that then reacts with a mediator. The modified mediator is subsequently electrochemically converted to its initial state upon application of a voltage difference between the electrodes, resulting in a small electric current that is detected by the system.
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The Accu-Chek® Performa test strip has 6 gold electrodes that work together with the rest of the system to perform extensive quality checks.
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The Accu-Chek® Performa test strip container provides several important advantages over previous designs:
* Flip-top lid:
o Makes opening the container easier
o Helps ensure proper closing to protect test strips from environmental exposure
* Smaller design helps make it more convenient to carry.
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The system will work on the 5 main AST areas: forearm, palm, upper arm, thigh, and calf.
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The system differentiates between control solution and blood because controls have a higher salt concentration. However, if the control solution evaporates or concentrates on the tip of the bottle, it could cause the meter to display an incorrect control reading.
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Roche Diagnostics retained the code key for 4 reasons:
* It can provide feature upgrades (such as faster test times and smaller sample sizes) without the need to buy a new meter.
* It is designed to prevent the use of expired test strips.
* It helps ensure more accurate results by reducing the inherent variability in all test strips.
* It is easy to use. Unlike some systems, which require you to scroll through multiple numbers to code the meter manually, the code key for the Accu-Chek® Performa system just snaps in place.
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In the same way that fresh blood should always be used for testing, fresh control solution should be used to prevent a contaminated control drop. Old control solution should always be wiped from the tip of the bottle so that only what is in the bottle itself is used for the test.
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As soon as a sufficient amount of blood is applied to the strip, the system automatically detects it and begins the test, even if some yellow is still visible in the window. The only time the user needs to apply more blood is when the blood drop symbol continues to flash in the display.
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A backlight would substantially increase the meter’s size and cost, and decrease battery life. Affordability, small size, and long battery life outweighed the benefit of a backlight.
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In market research that looked at different strip shapes and sizes, users considered the final end-dose design and size optimal, particularly when considering AST testing. Consumers find it difficult to do an alternative site test with a curved strip. Finally, it is easier for left-handed and right-handed people to use an end-dose strip.
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The Accu-Chek® Performa meter automatically recognizes Accu-Chek® Performa Control Solutions, so running a control test is easier than ever. First, wipe the tip of the control bottle. Then put the meter on a flat surface, insert the strip, and squeeze a drop of the control solution onto the front edge of the test strip. A result appears with a flashing “L”. Press one of the arrow keys once to indicate a Level 1 control test or twice to indicate Level 2. Press the ON/OFF button to set the level in the meter. The control result and “OK” alternate in the display if the result is in range.
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We recommend regular cleaning of the test strip guide and the optical component underneath it as described in the manual. In the professional area, regular cleaning is even more important in order to minimize the risk of cross-contamination.
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