FAQ

<p>Accu-Chek Instant S was launched in February 2017.</p>

<p>Dimensions: 77.3 × 48.6 × 16.0 mm (LWH)<br><br>Weight: Approx. 43 g (with batteries)</p>

<p>The meter shall operate reliably for a period of five years or 10,000 strip insertions for consumer use.</p>

<p>The Accu‑Chek Instant S meter has a fast test time of less than four seconds.</p>

<p>This system has been tested at altitudes up to 3,094 meters. Do not use this system at altitudes above 3,094 meters.</p>

<p>No, the USB port for any of the Accu‑Chek meters is not water- or dust-resistant.</p>

<p>The enzyme on the test strip, a FAD-dependent glucose dehydrogenase (GDH) expressed in A. oryzae, converts the glucose in the blood sample to gluconolactone. This reaction creates a harmless DC electrical current that the meter interprets for the blood glucose result. The sample and environmental conditions are evaluated using AC and DC signals.</p>

<p>The Accu‑Chek Instant S system provides simple testing with clarity in the results so PwD’s can have confidence in their daily routine. The Accu‑Chek Instant S meter is instantly understood as a result of the color coded Target Range Indicator. The system also provides an easy test experience knowing that you can place a drop of blood anywhere along the test strip.</p>

<p>While smaller, the Accu‑Chek Instant S meter has been proven to include and improve upon the features that are so popular with our current users while maintaining its ease of handling.</p>

<p>This system has been tested at altitudes up to 3,094 meters. Do not use this system at altitudes above 3,094 meters.</p>

<p>No. The meter will retain the date and time settings for up to 40 seconds when the batteries are removed.</p>

<p>No</p>

<p>No</p>

<p>Before starting a test and during testing, the system performs extensive quality checks to ensure accurate results.</p>

<p>Yes they are stored in memory but are not accessible by the user. The memory stores up to 40 error codes. If the user would like to view this in the memory, they would need to call Customer Care at 080076243 (Mon to Fri 09 am to 05 pm) to be walked through steps on how to obtain them</p>

<p>During our human factors testing, we discovered that there could be some confusion in misinterpreting an error with an actual test result if the meter is held upside down while viewing the display. We implemented this approach to showing error codes so as to eliminate any risk of misinterpretation.</p>

<p>Yes. In addition to accuracy with capillary blood, the Accu‑Chek Instant S may be used with venous, arterial and neonate blood.​</p>

<p>The Accu-Chek Instant test strips with the Accu-Chek Instant S meters are intended for in vitro diagnostic use by healthcare professionals in clinical settings. Venous, arterial, and neonatal blood testing are limited to healthcare professional use. The systems are not for diagnosing diabetes mellitus and not for testing neonate cord blood samples.​</p>

<p>Yes, but not explicitly for premature neonates.​</p>

<p>Yes, we have tested at altitudes up to 3,094 meters, anything above that has not been tested.​</p>

<p>Yes. Clean the meter to remove visible dirt or other material. Disinfect the meter between each patient use.​</p>

<p>No. As seen with most products designed for at-home use, the Accu‑Chek Instant system does not have a claim for diagnosis.</p>

<p>No</p>

<p>Battery life may vary due to factors such as temperature and battery manufacturer.​</p>

<p>No, the Accu‑Chek Instant S meter is designed to ensure that the battery power level will not impact results given by the meter.</p>

<p>No, this is not recommended.</p>

<p>No. Memory is retained. Time and date will need to be reset if batteries are out longer than 40 seconds.&nbsp;<br><br>The meter must be connected to the diabetes management software in order to view all of the results stored in the memory and set the time and date.</p>

<p>The meter will retain the date and time settings for up 40 seconds when the batteries are removed.​</p>

<p>No, the USB cable does not charge the meter’s batteries. Remove the USB cable after downloading results. In fact, leaving the USB cable connected to the meter and PC after download could draw power from the meter batteries. A blood glucose test cannot be performed while the Accu‑Chek Instant S meter is connected to a PC with a USB cable.</p>

<p>Yes, any time the meter is on, the battery is being consumed whether searching for a paired device or uploading results.​</p>

<p>Flagging of test results is not possible on the meter itself. However, if a patient chooses to do so, they can add this information via the mySugr app.</p>

<p>Flagging of test results is not possible on the meter itself. However, if a patient chooses to do so, they can add this information via the mySugr app.</p>

<p>Test results may be seen in 7, 30 and 90‑day averages.</p>

<p>Comments cannot be added on the meter, but can be done via the diabetes management software.</p>

<p>Pattern detection cannot be done on the meter, but can be done via the mySugr app. This is a feature that enables the user to look for specific out-of-target BG results that form a pattern.</p>

<p>The target range is set by default at 70–180 mg/dL (3.9–10.0 mmol/L). The target range can be set from a lower limit of 60–140 mg/dL (3.3–7.8 mmol/L) to an upper limit of 90–300 mg/dL (5.0–16.6 mmol/L).​</p>

<p>This feature is no available on the Accu-Chek Instant S meter.​</p>

<p>Yes, the target ranges in the meter can be changed using the device settings on the diabetes management software.</p>

<p>Being too low is life threatening for people with diabetes. Therefore, red has been chosen to be the color indicating “danger”.​</p>

<p>With the Accu‑Chek Instant S meter, it is not necessary to delete stored results. Once 720 blood glucose results are in the memory; adding a new result causes the oldest one to be deleted. Additional editing solutions for results are available with the diabetes management software.</p>

<p>720 readings can be stored in the meter. Only the last result is viewable on the meter.</p>

<p>If desired, data can be transferred by USB cable from the meter to diabetes management software on a PC or on the web.</p>

<p>Yes, at least 720 results will remain in the meter’s memory at all times, despite the transfer of data to the diabetes management software.</p>

<p>Yes. BG results and diabetes data transferred from the meter to the the diabetes management software are stored in the software. You can view this data when the meter is off and not actively connected via USB.</p>

<p>Yes, at least 720 results will remain in the meter’s memory at all times, despite the transfer of data to an app or online portal.​</p>

<p>Yes. BG results and diabetes data transferred from the meter to the app are stored in the app. You can view this data when the meter is off and not actively connected via Bluetooth.​</p>

<p>No, there is no WiFi or NFC connectivity with the meter.</p>

<p>Yes, the Accu‑Chek Instant S meter connects to the Accu‑Chek Smart Pix system using a standard USB cable. There is no need for an extra dongle. Once connected to a computer, the user then can transfer data, set the meter time and date, and set target ranges.</p>

<p>Yes, but the Accu-Chek Connect Online system has been made obsolete. Please contact Customer Care at 080076243 (Mon to Fri 09am to 05pm) to receive guidance.</p>

<p>No</p>

<p>No, the Accu‑Chek Instant test strip utilises the FAD‑GDH chemistry. This system is the most accurate in the history of our organisation. It meets the 10/10 standards for accuracy. The strip is the same one that has been used for the current Accu‑Chek Instant meter.</p>

<p>No, there is no compatibility between the Accu‑Chek Instant test strips and these other Accu‑Chek systems.</p>

<p>There are eight electrodes on the test strip.</p>

<p>A combination of palladium and gold is used for the electrodes. Both of these metals are widely utilised in the electronics and medical industries for surgical instruments and metal contacts.</p>

<p>Yes. The Accu-Chek Instant test strips utilize the FAD-GDH enzyme.</p>

<p>Yes, it is possible to test with all types of blood including capillary, venous, arterial, and neonatal for countries outside the US and Canada.</p>

<p>The Accu‑Chek Instant test strip requires only a small speck of blood (0.6 μL).</p>

<p>The easy‑edge of the Accu‑Chek Instant test strip has the largest dosing window of any major blood glucose test strip. It can be dosed anywhere along the edge and automatically absorbs the blood from the patient’s finger. Regardless of where dosed along the edge, the system provides a fast, accurate result.</p>

<p>No, there is no ability to squeeze extra blood from the finger to dose a strip a second time. However, there is a slight pause in testing that allows for the patient to take full use of the available blood from their finger.</p>

<p>The error code E-4 and Err will alternate on the display. This indicates that not enough blood or control solution was drawn into the test strip for measurement or was applied after the test had started. The user should discard the test strip and repeat the blood glucose or control test.</p>

<p>Blood can be applied anywhere on the wide yellow dosing area on the edge of the test strip.</p>

<p>Yes, as with any test strip, heat, humidity and other environmental conditions can affect strips.</p>

<p>There are many considerations taken into account when determining the opening force for a test strip vial:​&nbsp;<br><br>› Humidity entering the vial—this would affect shelf life​&nbsp;<br><br>› Vials opening during manufacturing​&nbsp;<br><br>› Vials opening during shipping&nbsp;<br><br>There are trade-offs to making a vial take less force to open:​&nbsp;<br><br>› More humidity entering the vial​&nbsp;<br><br>› More scrap in manufacturing​&nbsp;<br><br>› More vials open during shipping (which could result in scrapped or returned product)​&nbsp;<br><br>› Errors when testing​</p>

<p>The Accu‑Chek Instant meters supports the AST claim for testing on the palm, forearm and upper arm.​</p>

<p>Performing a control test lets the user know when the meter and test strips are working properly. A control test should be performed when: ​&nbsp;<br><br>› A new test strip box is opened ​&nbsp;<br><br>› The test strip container has been left open ​&nbsp;<br><br>› The test strips are thought to be damaged ​&nbsp;<br><br>› Checking the meter and test strips ​&nbsp;<br><br>› The test strips were stored in extreme temperatures, humidity, or both ​&nbsp;<br><br>› The meter was dropped ​&nbsp;<br><br>› The test result does not match how the PwD feels ​&nbsp;<br><br>› Checking to see if the PwD is performing the test correctly</p>

<p>By performing a control test.</p>

<p>The control solution contains a known amount of glucose that acts like blood when you apply it to the test strip. Compare the control result to the range on the label of the test strip container. If the control result is within the range, you know that the meter and test strips are working properly.</p>

<p>The numbers in the System Evaluation report are reported in a different way than in the past.​&nbsp;<br><br>​Substances were tested at concentrations described by the Clinical Lab Standard Institute in document EP7-A2—Interference Testing in Clinical Chemistry; Approved Guideline, when available. Testing was conducted according to the ISO 15197:2013 standard. This is a standard used in labs. The way these concentrations are displayed will be changing, as reflected in this report. Concentrations are shown in exponential notation, in order to display values in a uniform manner across the wide range of concentrations.​&nbsp;<br><br>To convert these values:​&nbsp;<br><br>&gt;Positive Exponent: Move the decimal point to the right by the number of places specified by the exponent (number after E). Acarbose Highest Concentration Tested: 6.00E+01 6.00 x 10 = 60 mg/dL​&nbsp;<br><br>&gt;Negative Exponent: Move the decimal point to the left by the number of places specified by the exponent (number after E). Acarbose Upper Therapeutic Concentration: 1.00E–02 1.00 / 100 = 0.01 mg/dL​&nbsp;<br><br>&gt;00 Exponent: Use the stated value with no adjustment. Acetaminophen Upper Therapeutic Concentration: 5.20E+00 = 5.20 mg/dL​</p>

<p>The Accu‑Chek Instant S system fulfills the ISO 15197:2013/EN ISO 15197:2015 standards and delivers even tighter 10/10 accuracy for reliable results you can trust.</p>

<p>10/10 references an ISO‑compliant internal testing protocol. For three different lots of test strips, 95% of results fall within ± 15 mg/dL when &lt;100 mg/dL or ± 15% when ≥ 100 mg/dL.</p>

<p>The Accu‑Chek Instant S meter is one of the most accurate systems our organisation has ever manufactured and meets ISO 15197:2013/EN ISO 15197:2015 standards for accuracy. It has 10/10 analytical accuracy. While this is a highly accurate system, there are other manufacturers that make a similar accuracy claim.</p>

<p>The Accu‑Chek Instant S meter is our latest development in providing accuracy in blood glucose testing technologies. The Accu‑Chek Guide, Accu‑Chek Guide Me, Accu-Chek Instant and Accu‑Chek Instant S meters are very accurate meters.</p>

<p>Yes, the Accu‑Chek Instant S meter complies with the requirements of ISO 15197:2013/ EN ISO 15197:2015 (In vitro diagnostic test systems– Requirements for blood glucose monitoring systems for self‑testing in managing diabetes mellitus).</p>

<p>Yes, we can say the minimum amount is ≥ 10 mg/dL.</p>

<p>No</p>