Accu-Chek 98/79/EC manuale d’uso

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This product fulfills the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.[...]

W elcome Thank you for selecting the Accu-Chek ® Sensor System. Designed for ease of use, this system was produced in close association with diabetes health- care professionals, hospitals and, most importantly , people with diabetes. The Accu-Chek Sensor System is intended for self-testing of glucose in capillar y whole blood by persons with diabe[...]

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Contents About the Accu-Chek Sensor Meter . . . . . . v Special Features . . . . . . . . . . . . . . . . . . . . vii About the Accu-Chek Sensor Comfort T est Strip . . . . . . . . . . . . . . . . . . . . . . . . . viii Inserting the Battery . . . . . . . . . . . . . . . . . . 1 Batter y Symbol on the Display . . . . . . . . . . 2 Setting the Beeper[...]

Caring for Y our Meter . . . . . . . . . . . . . . . . 28 Display Check . . . . . . . . . . . . . . . . . . . . . 28 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . 28 Storage and Handling . . . . . . . . . . . . . . . 29 Note to Healthcare Professionals . . . . . . . 30 T ransferring Data . . . . . . . . . . . . . . . . . . . 31 Quick R[...]

v About the Accu-Chek ® Sensor Meter Display Shows blood glucose result, messages, and glucose results stored in memory . ON/OFF Button Press to turn meter ON or OFF . Right and Left Buttons Used for meter setup and review of memory . Serial Port Used to transfer data. T est Strip Slot Insert test strip here.[...]

vi About the Accu-Chek Sensor Meter 446 731 Code Key F or coding/ calibrating your meter . New code key comes with every vial of test strips. Battery Co ver Remove cover to change battery. Code Key Slot Insert code key here.[...]

Special Features Y our 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 resu[...]

viii About the Accu-Chek ® Sensor Comfort T est Strip Electrodes Insert strip with silver -coloured bars up and toward the meter . Ye llow 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. N[...]

Inserting the Battery Y our meter is shipped with one 3-volt batter y type 2032 (CR 2032, DL 2032, or equivalent) that needs to be inserted before testing. The ba ttery that comes with your meter can be found in the mesh pocket of your carrying case. Batter y life will var y depending on usage, so always keep a spare on hand. The meter saves batter[...]

2. Insert the 3-volt batter y (type 2032) into the compartment with “+” side facing you. 3. Snap batter y 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.[...]

If a flashing batter y symbol a ppears on the display , the batter y is nearly dead. After changing the batter y , your meter will prompt you to verify the time and date immediately after the ba ttery is inserted, if time and date had previously been set. See Setting the Time, Date and Y ear on page 6. Note: To retain the correct time and da te set[...]

Setting the Beeper , Time, Date, Y ear , and Hypo Flag T urning the Beeper On or Off Does the beeper have to be turned on? No, it is an optional feature. T urning 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. The meter is set to beep when: • A strip is inserted[...]

3. Press and hold down the ON/OFF button until “set” a ppears at the bottom of the screen. Release the ON/OFF button. “On, ” “set,” and the flashing beeper symbol a ppear on the display . The beeper is now on. Note: Y ou may leave the set mode at any time by pressing and holding the ON/OFF button. The settings you have entered will be s[...]

5. Press and hold down the ON/OFF button until strip icon is seen flashing or code and “---” a ppear to leave this function. Setting the Time, Date and Y ear Do I have to set the time and date? Ti me 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 tes[...]

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 butt[...]

Setting the Hypo Flag T he hypo flag allows you to define your hypoglycemic level and receive a reminder whenever you obtain a blood sugar result below this level. Y ou 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 comp[...]

7. Press and release the right or left arrow button to adjust the hypo flag setting. 8. T o leave this function, press and hold down the ON/OFF button until the flashing strip symbol or code and “---” are displayed. Coding/Calibrating Y our Meter What is coding/calibrating, and when is it necessary? Before you use your meter for the first time [...]

A code key is properly inserted when it snaps into place. Y ou will need to insert a new code key: • Whenever you open a new box of strips. • Whenever either one of these displays appear: 1. Make sure meter is turned off. T urn meter over so you are looking at the back. Remove old code key if one is installed. 2. Insert new code key until it sn[...]

T esting Gathering Supplies To begin testing, you will need the following items: • Accu-Chek ® Sensor Meter • Accu-Chek ® Sensor Comfort T est Strips • Accu-Chek ® Softclix Lancet • Accu-Chek ® Softclix Lancing Device P erforming a T est 1. Wash your hands in warm, soapy water . Rinse well and dry completely . Warming fingers can increa[...]

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 usin[...]

5. Let your arm hang down at your side briefly to allo w 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 . T o perform the test, obta[...]

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. Y our result is automatically recorded in the meter’ s memory . Y ou may also want to record the glucose value in your Record Book or Diary . Note: F or instructions o[...]

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 s[...]

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 memor y . 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 . [...]

Understanding Y our T est 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 [...]

Do’ s and Don’ts DO: • TIGHTL Y REPLACE VIAL LID IMMEDIA TEL Y 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[...]

Proper T est Strip Appearance Although only a small amount of blood is needed, it is very important tha t you put enough blood on your test strip so that the entire yellow windo w is filled with blood. This ensures tha t your meter can produce accurate and reliable results. Ve ry small amounts of blood may give you an error message or an inaccurate[...]

Using Memory The meter automatically stores 480 glucose results, letting you review them in order from the most recent to the oldest. If you ha ve 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 f[...]

followed by the most recent result stored in memor y . 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 Press the right arrow button to review , in sequence 7, [...]

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 [...]

To do a quality control check, you need: • Accu-Chek ® Sensor Comfort Glucose Control Solutions (Level 1 and Level 2) • Accu-Chek ® Sensor Comfort T est 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 [...]

P erforming 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 [...]

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 dra w the solution into the yellow window until it is completely filled. An hourglass flashes in the display until the measurement is complete. 7. Tightly replace the cap on control solution. 8. The [...]

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[...]

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 . Check the following: • Did you use control solut[...]

Caring For Y our 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. Cleaning Clean the outside of the meter , as needed, using a soft cl oth tha t has been sl[...]

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 pro[...]

Note to Healthcare Professionals: F ollow the infection control procedures a ppropriate for your facility . A drop of fresh, whole blood is required to perform a blood glucose test. Fresh venous, capillar y , arterial or neonatal blood may be used. Caution should be taken to clear arterial lines before blood is drawn. Caution should be exercised in[...]

T ransferring 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[...]

Quick Reference Display Guide Meter needs to be coded/ calibrated, or code key is not inserted completely; turn meter OFF and insert code key (see page 9). Meter is in the “set” function, allowing you to set the beeper , time, date, year , and hypo fla g (see page 4). Meter is ready to accept a test strip. Blood drop can be applied to test stri[...]

Blood glucose result appears on display (see page 14). 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 t[...]

T emperature is above or below the opera ting 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 . Memory Displays The meter is in the “memory” function, allowing you to recall results fro[...]

If you are reviewing memory and a result a ppears 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 ). The meter is in the “memory” function, allowing you to recall 7, 14, and 30-day averages. This blood glucose result was marked with [...]

Display Messages Battery Displays Batter y power is low. Change batter y soon. (battery symbol not flashing) Batter y is dead. Change batter y now . Meter will turn off after 3 seconds. (flashing battery symbol) 36 I I I I I I I I I I I I I I I I[...]

Quality Control Check Displays Meter is ready for a Level 1 or Level 2 glucose control check. A pply a drop of Level 1 or Level 2 glucose control solution. 37 I I I I I I I I I I and I I I I I I I I I I[...]

E xample of an acceptable control result. or Glucose control result is not acceptable. Repeat test. Refer to Understanding Control Results (see page 27). E xample of an unacceptable control result. or 38 and and and and[...]

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 a ppropriate symbol. Do not make treatment decisions based on an error message. The code key is faulty , or the code key was removed while the meter was on. T urn meter OFF and re[...]

Y our 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, repea t the test and refer to the section in the manual titled Understanding Y our T est Results (see page 17). If this does not confirm the way you fe[...]

Meter has detected the loss of all results in memory . T urn meter OFF and turn it back ON again. Y ou may not be able to recall the results previously stored in memory , although your meter will store any future test results. T emperature is above or below the operating range of the meter . Move to an area between 14° and 40°C, wait 5 minutes, a[...]

T echnical 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 gluconolac- tone. This reaction libera tes an electron that reacts with a coenzyme electron acceptor , the oxidized form of the mediat[...]

Product Specifications Meter Storage -25° to 70°C Conditions <85% humidity > 53.3 kP a atmospheric pressure System Operating Refer to your test strip package Conditions insert for more information Measuring Range Refer to your test strip package insert for more information Memory Ca pacity 480 blood glucose results with time and date Displa[...]

Po wer Supply One 3-volt lithium batter y type 2032 (CR 2032, DL 2032 or equivalent) Data Port 3-wire RS-232C Serial Port Multiplexed TTL UART T est Strip Refer to your test strip package Storage Conditions insert for more information Construction Hand held Protection Class III Rated Operation Continuous operation 44[...]

Product Safety Information Explanation of symbols CAUT ION 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. This product fulfills the requirements of Directive 98/79 EC on in vitro diagnostic medical devices. F or in vitro diagnostic use Manuf[...]

W arranty and Ser vice Instructions Roche Diagnostics warrants the meter against an y 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 statutor y or other rights. The warranty ceases to apply if the instr[...]

Supplies and Accessories The following supplies and accessories are available from pharmacies or your local surgical supplier . Accu-Chek Sensor Comfort T est Strips Accu-Chek Sensor Comfort Glucose Control Solutions Accu-Chek Softclix Lancets Accu-Chek Softclix Lancing Device 47[...]

Index About your Accu-Chek Sensor Meter ......................... v Accu-Chek Sensor Comfort T est Strip .................... viii, 11 Batteries .............................................................. 1, 2, 3 Batter y display .................................................... 2, 3, 36 Batter y life .........................................[...]

Error messages .......................................................... 39 Flag (asterisk) ........................................................... 16 Gathering supplies for testing ................................. 11 Getting a good sample ................................................. 11 Glucose control solutions .........................[...]

Specifications, product ............................................. 43 Storage conditions ................................................ 29, 43 Storage and handling .................................................. 29 Supplies and accessories ............................................. 47 T esting, blood glucose .............................[...]

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 Accu- Chek Sensor Meter , Accu-Chek Comfort T est Strips and Accu-Chek Sensor Comfort[...]

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ACCU-CHEK and SOFTCLIX are trademarks of a Member of the Roche Group. 03654117001-0703 2003/06 Roche Diagnostics GmbH Sandhofer Strasse 116 D- 68305 Mannheim, German y www .roche.com[...]