This product fulfills the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.
Welcome Thank you for selecting the Accu-Chek® Sensor System. Designed for ease of use, this system was produced in close association with diabetes healthcare professionals, hospitals and, most importantly, people with diabetes. The Accu-Chek Sensor System is intended for self-testing of glucose in capillary whole blood by persons with diabetes. The lightweight, portable meter provides accurate results in seconds.
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Contents About the Accu-Chek Sensor Meter . . . . . .v Special Features . . . . . . . . . . . . . . . . . . . .vii About the Accu-Chek Sensor Comfort Test Strip . . . . . . . . . . . . . . . . . . . . . . . . .viii Inserting the Battery . . . . . . . . . . . . . . . . . .1 Battery Symbol on the Display . . . . . . . . . .2 Setting the Beeper, Time, Date, Year, and Hypo Flag . . . . . . . . . . . . . . . . . . . . . . .4 Turning the Beeper On or Off . . . . . . . . . . .4 Setting the Time, Date and Year . .
Caring for Your Meter . . . . . . . . . . . . . . . .28 Display Check . . . . . . . . . . . . . . . . . . . . .28 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . .28 Storage and Handling . . . . . . . . . . . . . . .29 Note to Healthcare Professionals . . . . . . .30 Transferring Data . . . . . . . . . . . . . . . . . . .31 Quick Reference Display Guide . . . . . . . . .32 Memory Displays . . . . . . . . . . . . . . . . . . .34 Display Messages . . . . . . . . . . . . . . . . . . .
About the Accu-Chek® Sensor Meter ON/OFF Button Press to turn meter ON or OFF. Serial Port Used to transfer data. Display Shows blood glucose result, messages, and glucose results stored in memory. Right and Left Buttons Used for meter setup and review of memory. Test Strip Slot Insert test strip here.
About the Accu-Chek Sensor Meter Code Key Battery Cover Remove cover to change battery. Code Key Slot Insert code key here. vi 446 731 For coding/ calibrating your meter. New code key comes with every vial of test strips.
Special Features Your meter is designed to store information important to you and your healthcare professional. The memory will store 480 readings. Along with these readings, the meter can store additional important information. The hypo flag allows you to define your hypoglycemic level and receive a reminder whenever you obtain a blood sugar result below this level. See page 8 for additional information.
About the Accu-Chek® Sensor Comfort Test Strip Electrodes Insert strip with silver-coloured bars up and toward the meter. Yellow Window Do not apply blood on the top of the test strip. Before Applying Blood – This window should be completely yellow. After Applying Blood – This window should be completely filled with the blood drop. Note: Any area of the strip can be touched and the glucose reading will not be affected. Comfort Curve Touch drop of blood here, to the edge of the strip.
Inserting the Battery Your meter is shipped with one 3-volt battery type 2032 (CR 2032, DL 2032, or equivalent) that needs to be inserted before testing. The battery that comes with your meter can be found in the mesh pocket of your carrying case. Battery life will vary depending on usage, so always keep a spare on hand. The meter saves battery power by automatically turning off after 90 seconds of non-use or 5 seconds after taking a strip out of the meter following a test.
2. Insert the 3-volt battery (type 2032) into the compartment with “+” side facing you. + 3. Snap battery cover back in place. If time and date feature was set previously, the meter will turn on automatically. Confirm that the time and date are set correctly. If time and date have not been set previously, wait 5 seconds, then turn meter ON. The meter beeps if the beeper is turned on.
I II IIII IIIII If a flashing battery symbol appears on the display, the battery is nearly dead. IIII Battery must be replaced to continue testing. After changing the battery, your meter will prompt you to verify the time and date immediately after the battery is inserted, if time and date had previously been set. See Setting the Time, Date and Year on page 6. Note: To retain the correct time and date settings, you will need to replace the battery before it is completely dead.
Setting the Beeper, Time, Date, Year, and Hypo Flag Turning the Beeper On or Off Does the beeper have to be turned on? No, it is an optional feature. Turning the beeper on or off does not affect the test results. If the beeper is turned off, beeps that occur due to errors will still sound.
3. Press and hold down the ON/OFF button until “set” appears at the bottom of the screen. Release the ON/OFF button. I I I I I I “On,” “set,” and the flashing beeper symbol appear on the display. The beeper is now on. Note: You may leave the set mode at any time by pressing and holding the ON/OFF button. The settings you have entered will be saved. 4. Press and release the right or left arrow button. Sensor I I I I I I “OFF,” “set,” and the beeper symbol appear on the display. The beeper is now off.
5. Press and hold down the ON/OFF button until strip icon is seen flashing or code and “---” appear to leave this function. Sensor I I I I I I I I Setting the Time, Date and Year Do I have to set the time and date? Time and date should be set prior to testing if you plan to download the results into software or if you plan to review your memory to check when a test was done. To set the time, date and year: 1. Press and release the ON/OFF button to turn the meter ON. Sensor 2.
5. Press and release the ON/OFF button. The hour display flashes. 6. Press and release the right or left arrow button until the correct hour is displayed. 7. Press and release the ON/OFF button. The minute display flashes. 8. Press and release the right or left arrow button until the correct minute is displayed. 9. Press and release the ON/OFF button. The month display flashes. 10. Press and release the right or left arrow button until the correct month is displayed. 11. Press and release the ON/OFF button.
Setting the Hypo Flag The hypo flag allows you to define your hypoglycemic level and receive a reminder whenever you obtain a blood sugar result below this level. You can set the hypo indicator level to any number between 60 and 80 mg/dL (3,3 and 4,4 mmol/L). Important Note: Consult with your healthcare professional to set the hypo marker to compliment your therapy. Do not use the hypo marker as the only indicator of hypoglycemia. Rely upon your symptoms and directions from your healthcare professional.
7. Press and release the right or left arrow button to adjust the hypo flag setting. 8. To leave this function, press and hold down the ON/OFF button until the flashing strip symbol or code and “---” are displayed. Coding/Calibrating Your Meter What is coding/calibrating, and when is it necessary? Before you use your meter for the first time and every time you open a new box of test strips, you need to set the meter to “match” the strips. This is called coding/calibrating.
A code key is properly inserted when it snaps into place. You will need to insert a new code key: • Whenever you open a new box of strips. • Whenever either one of these displays appear: I I I I I I I I I 545 1. Make sure meter is turned off. Turn meter over so you are looking at the back. Remove old code key if one is installed. 2. Insert new code key until it snaps into place. 731 3. Turn meter ON. A 3-digit code number appears. This number must match the code number on your vial of test strips.
Testing Gathering Supplies To begin testing, you will need the following items: • Accu-Chek® Sensor Meter • Accu-Chek® Sensor Comfort Test Strips • Accu-Chek® Softclix Lancet • Accu-Chek® Softclix Lancing Device Performing a Test 1. Wash your hands in warm, soapy water. Rinse well and dry completely. Warming fingers can increase blood flow. 2. Load lancet device according to manufacturer’s instructions. To reduce the risk of infection, change lancet with each test.
3. Remove new test strip from vial. Be sure to tightly replace vial cap after removing test strip. 4. Within 3 minutes, insert test strip into test strip slot with silver-coloured bars facing up and toward the meter. The meter turns on automatically. Check that the code number on the meter matches the code on the vial of test strips you are using. Co Sensor When the blood drop symbol flashes, you are ready to perform a test.
5. Let your arm hang down at your side briefly to allow blood to flow to your fingertips. 6. Grasp your finger just below the joint closest to the fingertip, and squeeze for 3 seconds. 7. Obtain blood sample. Use the lancet to obtain a drop on the side of your finger. Do not obtain the drop from the pad of your finger. To perform the test, obtain a small drop of blood resting on your finger. 8. Touch and hold drop of blood to the edge of the strip within the curve.
III III I II I IIIIII III 9. When blood is applied to strip, an hourglass flashes on the display until measurement is completed. Result appears. 10. The blood glucose result is displayed in mg/dL or mmol/L. or RESULTS TIME RESULTS TIME RESULTS TIME S SULT ST RE D TE BLOO TIME Your result is automatically recorded in the meter’s memory. You may also want to record the glucose value in your Record Book or Diary.
11. Remove test strip from meter. Discard the strip and lancet in a puncture-proof container with a lid. If you have completed your testing, turn the meter OFF, or the meter will automatically turn off 5 seconds after removing the strip. If HI is displayed, your blood glucose result may be higher than 600 mg/dL (33,3 mmol/L) (refer to your test strip package insert or the section Understanding Your Test Results on page 17).
Marking a Result with a Flag, Asterisk ( ) This feature allows you to perform a test and mark the result with a flag (asterisk) to be stored in memory. Each result flagged with the asterisk will have special meaning only to you. For your healthcare professional, you should record the meaning along with your reading in your Record Book or Diary. An example includes using the asterisk to mark a result taken immediately after a meal. To mark a result with a flag (asterisk): 1.
Understanding Your Test Results If your blood glucose result seems unusually high, low, or inconsistent with your previous results or glucose trends and does not reflect the way you feel, check the following: • Does the test strip number on the vial match the code number on the meter? • Was the blood sample applied to the test strip within 3 minutes of removing it from the vial? • Was the size of the blood sample sufficient? • Was the test strip vial cap tightly sealed? • Was the test strip used before the
Do’s and Don’ts DO: • TIGHTLY REPLACE VIAL LID IMMEDIATELY AFTER REMOVING A TEST STRIP. • Make sure code number on meter matches code number on strip vial label. • Keep meter clean. • Store strips in the original vial. DON’T: • Store strips outside original vial. • Use expired test strips. • Use code key from another blood glucose system. • Store meter or strips in extreme temperatures. • Store meter in damp or humid areas. • Insert any object other than a test strip into strip slot.
Proper Test Strip Appearance Although only a small amount of blood is needed, it is very important that you put enough blood on your test strip so that the entire yellow window is filled with blood. This ensures that your meter can produce accurate and reliable results. This strip has the correct amount of blood. Notice that the left side of the yellow window is not completely filled with blood. This strip has too little blood and may produce an error message (or an inaccurate result).
Using Memory The meter automatically stores 480 glucose results, letting you review them in order from the most recent to the oldest. If you have set the time/date feature, the time and date of the results are also displayed. If time and date are not set, each result is marked with a number according to how it falls in sequence. If the memory is full and a new result is added, the meter deletes the oldest result. Results stored in memory are not lost when you replace the battery.
followed by the most recent result stored in memory. If no code key is installed, code and “---” appear. Press and release the right or left arrow button again to enter memory recall mode. 2. Once in the memory mode: Press the left arrow button to view individual results in memory, or Or Press the right arrow button to review, in sequence 7, 14, and 30-day averages. or Note: Press and hold down the right or left arrow button to quickly scroll through results. 3. Turn meter OFF.
Quality Control Checks What are quality control checks? They ensure that you are doing a test correctly and that your system is working properly. When should I check my meter? • If you leave the cap off the vial of test strips. • Before using your meter for the first time. • When you open a new vial of test strips. • If you drop the meter. • Whenever your result does not agree with the way you feel. • If you have repeated a test, and the blood glucose result is still lower or higher than expected.
To do a quality control check, you need: • Accu-Chek® Sensor Comfort Glucose Control Solutions (Level 1 and Level 2) • Accu-Chek® Sensor Comfort Test Strips Note: When you open a new bottle of glucose control solution, write the date on the label. Opened bottles of glucose control solution are good for three months or until the expiration date, whichever comes first.
Performing a Quality Control Check 1. Open test strip vial and remove test strip. Replace vial cap. 2. Within 3 minutes, insert test strip (yellow window facing up) into test strip slot. The meter turns on automatically. Check that the code number on the meter matches the code on the vial of test strips you are using. The test strip symbol stops flashing and a blood drop symbol appears on the display. Co Sensor de: 73 1 3.
III III IIIIII 5. Gently squeeze the bottle to form one small drop. 6. Bring the drop to the edge of the strip within the curve, and allow the strip to automatically draw the solution into the yellow window until it is completely filled. An hourglass flashes in the display until the measurement is complete. I II I 7. Tightly replace the cap on control solution. III 8. The control result appears.
Note: Result must be marked with an L1 or L2 for the meter to verify if control result is within range. If result has not been marked with an L1 or L2, refer to your test strip vial label for the glucose control ranges. If result is not within the acceptable range, an icon of the control vial appears on the screen while the control test result, and time and date (if set), alternate with “Err” and “L1” or “L2” on the display. See Understanding Control Results on page 27 for more information.
Understanding Control Results If your glucose control results are within the acceptable range, you can feel confident that your test strips and meter are working correctly. If one or both of your glucose control results are outside of the acceptable range, your system may not be working properly.
Caring For Your Meter Display Check This verifies that all parts of the display are working. Make sure the meter is off. Press and hold down the ON/OFF button. The display should look exactly like the picture at right. If it does not, call Roche Diagnostics.
Storage and Handling Keep your meter free of dust. Protect it from extremes in temperature and humidity, and handle it with care. If meter is dropped, perform a quality control check with the glucose control solutions before doing a blood glucose test. The travel case is designed to let you store a variety of supplies you may need and helps to protect your meter.
Note to Healthcare Professionals: Follow the infection control procedures appropriate for your facility. A drop of fresh, whole blood is required to perform a blood glucose test. Fresh venous, capillary, arterial or neonatal blood may be used. Caution should be taken to clear arterial lines before blood is drawn. Caution should be exercised in the interpretation of neonate blood glucose values below 50 mg/dL (2,8 mmol/L).
Transferring Data The meter allows you to transfer all the data that you have stored in its memory to your computer so this information can be printed. It allows you to transfer data in two different ways: • Directly to your computer using a specialized software and interface cable • Via specialized modems designed for remote transfer Consider the following when using accessory equipment: • DO NOT run a glucose test when the Accu-Chek Sensor Meter is connected to accessory equipment.
Quick Reference Display Guide I I I I I I I I I Meter needs to be coded/ calibrated, or code key is not inserted completely; turn meter OFF and insert code key (see page 9). I I I I I I Meter is in the “set” function, allowing you to set the beeper, time, date, year, and hypo flag (see page 4). Meter is ready to accept a test strip. I I I Blood drop can be applied to test strip (see page 12).
Blood glucose result appears on display (see page 14). or Blood glucose result may be higher than 600 mg/dL (33,3 mmol/L). If this does not confirm the way you feel, review proper testing procedure and perform a quality control check (page 22). Repeat test. If HI still appears, follow your doctor’s instructions. Blood glucose result may be lower than 10 mg/dL (0,6 mmol/L). If this does not confirm the way you feel, review proper testing procedure and perform a quality control check (page 22). Repeat test.
Temperature is above or below the operating range of test strips (14° to 40°C). The result you have obtained may not be accurate. Move to an area between 14° and 40°C, wait 5 minutes, and repeat the test. Do not artificially heat or cool the meter. or Memory Displays The meter is in the “memory” function, allowing you to recall results from memory (see page 20).
If you are reviewing memory and a result appears with a temperature symbol as shown, this result may not be accurate because the test was performed outside the operating range of the test strips (14° to 40°C ). or The meter is in the “memory” function, allowing you to recall 7, 14, and 30-day averages. or This blood glucose result was marked with a result marker flag (asterisk) (see page 16). or Do not use individual values stored in memory to make therapy adjustments.
Display Messages Battery Displays Battery power is low. Change battery soon. (battery symbol not flashing) I II IIII IIIII Battery is dead. Change battery now. Meter will turn off after 3 seconds.
Quality Control Check Displays Meter is ready for a Level 1 or Level 2 glucose control check. Apply a drop of Level 1 or Level 2 glucose control solution.
Example of an acceptable control result. and or and Glucose control result is not acceptable. Repeat test. Refer to Understanding Control Results (see page 27). Example of an unacceptable control result.
Error Messages The meter automatically performs a system check to prevent inaccurate results. If the meter detects a malfunction, it displays the “Err” message and an appropriate symbol. Do not make treatment decisions based on an error message. I I I I I I The code key is faulty, or the code key was removed while the meter was on. Turn meter OFF and re-insert code key. If this error display still appears, contact Roche Diagnostics.
Your blood sugar may be extremely high or a meter or strip error has occurred. If this confirms how you feel, contact your healthcare professional immediately. If it does not confirm how you feel, repeat the test and refer to the section in the manual titled Understanding Your Test Results (see page 17). or If this does not confirm the way you feel, run a quality control check with your glucose control solutions and a new test strip.
I I I I Meter has detected the I I I loss of all results in memory. Turn meter OFF and turn it back ON again. You may not be able to recall the results previously stored in memory, although your meter will store any future test results. I I I I I I I I I I I Temperature is above or below the operating range of the meter. Move to an area between 14° and 40°C, wait 5 minutes, and perform a test. Do not artificially heat or cool the meter. Meter has failed its series of electronic checks.
Technical Data Please read information packaged with test strips regarding up to date product specifications and limitations. Measuring Principle: The glucose dehydrogenase converts the glucose in a blood sample to gluconolactone. This reaction liberates an electron that reacts with a coenzyme electron acceptor, the oxidized form of the mediator hexacyanoferrate (III), forming the reduced form of the mediator, hexacyanoferrate (II). The test strip employs the electromechanical principle of biamperometry.
Product Specifications Meter Storage Conditions -25° to 70°C <85% humidity >53.3 kPa atmospheric pressure System Operating Conditions Refer to your test strip package insert for more information Measuring Range Refer to your test strip package insert for more information Memory Capacity 480 blood glucose results with time and date Display LCD display Blood Volume Refer to your test strip package insert for more information Size 3.3” x 2.2” x .8” (84 mm x 56 mm x 20 mm) Weight 1.
Power Supply One 3-volt lithium battery type 2032 (CR 2032, DL 2032 or equivalent) Data Port 3-wire RS-232C Serial Port Multiplexed TTL UART Test Strip Storage Conditions Refer to your test strip package insert for more information Construction Hand held Protection Class III Rated Operation Continuous operation 44
Product Safety Information Explanation of symbols CAUTION Refer to accompanying documents. 3V type 2032 Listed by Underwriter’s Laboratories, Inc.® in accordance with UL 61010A-1 and CAN/CSA C22.2 No. 1010-1. Laboratory Use Electrical Equipment 8C79 This product fulfills the requirements of Directive 98/79 EC on in vitro diagnostic medical devices. For in vitro diagnostic use Manufactured by This meter is suitable for continuous operation. Meter is not protected against ingress of water.
Warranty and Service Instructions Roche Diagnostics warrants the meter against any material and manufacturing defects that may arise during proper use of the instrument. For precise terms and conditions please see the Warranty Card in the box. This warranty does not affect any statutory or other rights. The warranty ceases to apply if the instrument has been misused or tampered with.
Supplies and Accessories The following supplies and accessories are available from pharmacies or your local surgical supplier.
Index About your Accu-Chek Sensor Meter .........................v Accu-Chek Sensor Comfort Test Strip ....................viii, 11 Batteries ..............................................................1, 2, 3 Battery display .................................................... 2, 3, 36 Battery life..................................................................... 1 Battery cover ............................................................ vi, 1 Battery installation ....................................
Error messages ..........................................................39 Flag (asterisk) ........................................................... 16 Gathering supplies for testing ................................. 11 Getting a good sample .................................................11 Glucose control solutions ............................................ 22 HI display..............................................................15, 33 Hypo flag.....................................................
Specifications, product............................................. 43 Storage conditions ................................................ 29, 43 Storage and handling.................................................. 29 Supplies and accessories.............................................47 Testing, blood glucose.............................................. 11 Testing, quality control ......................................... 22, 27 Test strip slot..........................................................
Any Questions We want to give you the help you need for long and reliable service of your meter. Review your test procedure and make sure that you are performing the steps correctly. If you still have questions, please contact Roche Diagnostics. Please have your AccuChek Sensor Meter, Accu-Chek Comfort Test Strips and Accu-Chek Sensor Comfort Glucose Control Solutions available when you call. IMPORTANT—READ CAREFULLY BEFORE USE.
Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim, Germany www.roche.com ACCU-CHEK and SOFTCLIX are trademarks of a Member of the Roche Group.
