User Manual - aculab chile
Contents
1. 2 Obtain a blood rae NOTE If you do not apply a blood sample to the test strip within 2 minutes the test meter will automatically shut down You must remove and reinsert the test strip to restart the test procedure 3 Apply blood onto the test strip Apply your blood to the absorbent hole of the test strip until the confirmation window is full of blood The test meter will begin to count down from 5 seconds and a result will be displayed CAUTION The blood sample should fully fill the confirmation window in order for the countdown to begin If you find that the confirmation window is not fully filled when the test meter is counting DO NOT try to add more blood to the test strip Discard the test strip and retest with a new one 4 Obtain an accurate result in 5 seconds The result of your blood glucose test is shown on the test meter display This reading is automatically stored in the test meter CAUTION Please discard the used test strip immediately after use DO NOT REUSE THE TEST STRIP 10 MEMORY 10 1 Reviewng Results from the memory CE ean store up to 1000 test records Each record includes the test result time and date The meter will also calculate the average values of records from the last 7 14 30days 1 Viewing Stored Records M M With the meter On press one of the Setting but 7 7 tons lt gt to enter memory mode The most re d D cent test result and the memory2. symbol M 0 0 will appear on the display Press the Left arrow aA button lt to go through the stored records First you will see the test number then it will switch to your test results with date and time ont Ber S30 NOTE bt dl If you are using the meter for the first time the meter display will show D three dashed lines and the memory symbol Q This means that no data has been stored in memory D 117 the al Fi Day Avg NOTE If there are already 1 000 records in the memory the oldest record will be erased to make room for a new one Your most recent result will display first 10 2 Clearing the Memory 1 Press and hold both the Setting buttons lt 4 for more than 3 seconds to enter the delete mode from the wo Mma memory mode You will see both displays dEL and D la i Mia ha ALL switching one after another 2 To clear the memory press and hold both the Setting buttons lt p for 3 seconds The display will show memory symbol J and the meter will clear its mem ory and turn itself off after a moment M O NM 3 If you entered the delete mode but want to exit without deleting the stored data press the Power button This will turn the meter off without deleting any data Extreme caution should be used when clearing the memory This is not
3. 2 1 save your choice and move to set the measuremen On OFF unit 8 the Setting buttons lt p to select the measurement mg dL or mmol L With the correct measurement unit on the display press the Power button to save your mg dL sane choice and finish all the settings IMPORTANT Special caution is needed to choose the measurement unit since the test results can be different according to your choice of measurement unit Please consult with your diabetes healthcare professional about the measurement unit NOTE Your test meter displays 7 14 and 30days average which you can access from the test meter memory These averages are calculated from results obtained during 7 14 30days from the current date and time settings When you set a new date and time the 7 14 30day averages may change After 2 minutes of inactivity while the test meter is in the setting mode it will shut down automatically 8 BEFORE TESTING 8 1 Coding the Test Meter Insert the code key completely into the code key port with the code number facing up and the code number will appear on the LCD display Make sure the code numbers on the display match the code key and the test strip vial If all of the numbers match you may begin testing NOTE If the code numbers displayed on the screen do not match the code key and the test strip vial try calibrating again or contact your local distributor 8 2 Glucose Control Solution Test Checking
4. CV 28 amp 4 C 40 C 39 F 104 F error message goes away r 1 Test strip is used Repeat test with a new test strip 1 5 re WARRANTY The manufacturer CERAGEM Medisys Inc guarantees the CERA CHEK 1070 Blood Glucose Monitoring System to be free of defects in material and workmanship for i a period of 3 years This guarantee is valid from the date of purchase The guarantee ro a to operate during Repeat test with a new test strip extends only to the original purchaser and is not transferable ern a test 1 6 SYMBOLS FOR PROPER USAGE row Test strip was removed Repeat test with a new test strip gr during a test Symbol Referent In vitro disgnostic medical device Do not reuse Damaged code key or the Re coding the Test Meter Consulbinstictione Forse l r i code key was removed If the problem still continues 3 during a coding the meter please contact your local service Temperature limitation center U se by z The code is not set Insert the code key that acco Date of manufacture l a H mpanied the box of the test a Batch code strips Manufacturer 1 3 SPECIFICATIONS Serial Number Power Button Authorised representative in the european community Do not dispose the instrument with the urban waste Caution consult accompanying documents gt fe BE aego Direct current This product fulfills the requirements for directive on in vitro disgnostic
5. a reversible operation 1 1 TRANSFERRING STORED DATE x To use the blood glucose management software you should purchase separately the installation CD and the USB data transfer cable 1 Make sure the glucose meter is turned off Data cannot transfer when the device is still on mr 2 After you initiate the software for blood glucose management on the computer you connect the transfer cable from the j la computer to the glucose meter 3 If the connection is properly carried out the glucose meter will display PC on the display screen NOTE When you disable the cable during the transfer of data the data may not be transferring properly Please keep the transfer cable intact until the transfer is completed 4 After the data transfer is completed you can release the transfer cable In case f need more details about the blood glucose monitoring software of CERA lease contact your local distributor 1 2 CARING FOR YOUR TEST METER AND TEST STRIPS To avoid contaminating your test meter and test strips please wash your hands and test site with soap and water Make sure to dry your hands and test site thoroughly 12 1 Maintenance Your test meter does not require special maintenance There is no special cleaning re quired because no blood or control solution comes in contact with the test meter Avoid etting dirt dust blood or water inside the test meter through the test ort
6. the System with Glucose Control Solutions CERA CHEK 1070 Glucose Control Solution contains glucose that reacts to the test strips By comparing the result tested using the control with the expected range printed on the test strip vial label it is able to check that the test meter and the test strips are working together as a system and that you are performing the test correctly It is very important that you do this simple check routinely to make sure you get accurate results Perform a Glucose Control Solution Test if e You would like to test your system without using a blood sample e You are using the test meter for the first time e You suspect the test meter or test strips may not be functioning properly Test results appear to be abnormally high or low or are not consistent with the symptoms you are experiencing The test strip vial was left open You are using a new vial of test strips e You dropped the test meter NOTE The results obtained from your Glucose Control Solution test do not indicate your personal glucose levels IMPORTANT Use CERA CHEK 1070 Blood Glucose Test Meter only with CERA CHEK 1070 Test Strips Glucose control solution is sold separately Do not use the control solution after expiration date as printed on the vial Use the control solution within 4 months after opened It is recommended to record the discard date on the coming 4 months on the glucose control solution vial as a reminder when
7. to dispose the opened control solution For example You open the control solution on January 1st Count forward four months to April 1st This is your discard date Record this date on the side of the control solution vial Always close the cap on the Glucose Control Solution immediately after use 1 Insert the test strip into the insert port of the test meter The blood symbol will start blinking The Indicator will also blink if you have chosen ON for Indicator in the setting mode 2 Prepare the Glucose Control Solution Shake the Glucose Control Solution vial thoroughly Remove the cap squeeze the vial discard the first drop and wipe off the dispenser tip to prevent contamination 3 Apply glucose control solution Aim directly at the absorbent hole of the test strip Squeeze the vial again to get another drop and the drop will be automatically drawn in the test strip Make sure the confirmation window is completely filled The test meter will count down from 5 seconds and then display the Glucose Control Solution test result If the test result is out of the range numbers printed on the test strip vial repeat the test If you continue to have out of range results it means that the system may not be working properly Do not use the product and please contact your local distributor for assistance 9 TESTING YOUR BLOOD 9 1 Getting a Drop of Blood IMPORTANT Please wash and dry your hands prior to starting Lancing De
8. A damp cloth and mid detergent can be used to wipe the outside of the Test meter Your test meter i a precision instrument Please handle it with care 12 2 Storage and Handling 1 Test Meter storage and handling Store test meter at 10 C 60 C 14 F 140 F Do not leave the test meter in very hot or cold places Do not leave it near a heat source or in your vehicle during adverse weather condi tions Always store or carry the test meter in its original storage case e Avoid dropping and strong impact Avoid direct sunlight and humidity 2 Test Strip storage and handing Store test strips at 1 C 32 C 34 F 90 F below 85 relative humidity e Store your test strips in their original vial only e Do not transfer to other containers e Store test strips in a cool and dry place e Keep away from direct sunlight and heat After taking test strips from the vial close the vial cap e Touch the test strips with clean and dry hands e Use each test strips immediately after removing it from the vial Write the disposal date on the test strip vial as a reminder to dispose of the opened vial after 4 months Do not bend cut or alter a test strips in anyway Keep the test strips away from children since the cap and the test strips may be a choking hazard e If swallowed immediately see a doctor for help Follow local governing ordinances and recycling plans for disposal or recycling
9. CERA CHEK 1070 User Manual 1 IMPORTANT SAFETY INSTRUCTIONS READ THIS BEFORE USE The following basic safety precautions should always be taken Close supervision is necessary when the device is used by on or near children or disabled Use the device only for the intended use described in this manual Do not use with accessories which are not supplied by the manufacturer Do not let the device come into contact with hot surfaces Do not use the device where aerosol sprays are being used Do not use the device if it is not working properly or if it has suffered any damage Before using this product read all instructions thoroughly Conduct control solution test as directed in the manual Consult with a diabetes healthcare professional before usage NOTE PLEASE KEEP THE USER S MANUAL NEARBY THE GLUCOSE TEST METER 2 TABLE OF CONTENTS 1 IMPORTANT SAFETY INSTRUCTIONS 9 TESTING YOUR BLOOD 2 TABLE OF CONTENTS 9 1 Getting a Drop of Blood 3 INTRODUCTION 9 2 Alternative Site Testing AST 3 1 Intended Use 9 3 Performing a Blood Glucose Test 3 2 Principle of Measurement 10 MEMORY 4 IMPORTANT INFORMATION 10 1 Reviewing Results from the 5 CONTENTS OF THE SYSTEM memory 6 UNDERSTANDING THE CERA 10 2 Clearing the memory CHEK 1070 BLOOD GLUCOSE 10 3 Blood Glucose Monitoring Chart MONITORING SYSTEM 11 TRANSFERRING STORED DATE 6 1 Appearance and Key Functions of 12 CARING FOR YOUR TEST METER the Test
10. Hold this part to insert or remove the test strip Confirmation Window This is where you confirm if enough blood has been applied to the absorbent hole of the test strip Absorbent Hole Apply a drop of blood here The blood will automatically flow into the reaction zone Absorbent Hole Confirmation h Window l Contact Port 6 4 Code Key Description When the using CERA CHEK 1070 Blood Glucose Contact Monitoring System for the first time or before using a Port new box of test strips you will need to calibrate the test meter There is a code key in every box of test strip Cali gt 1 bration can be easily done by inserting the code key into FRONT the test meter The code key must match the code num 196 bers on the test strip vial and LCD display Please check the right direction to insert the code key Code Number into the test meter 7 PREPARATION BEFORE USE 7 1 Changing the Battery NOTE To save battery power the test meter automatically turns off after 2 minutes of inactivity e When the low battery symbol appears with other displayed data it means the battery is running low but has enough power to run 20 times It is recommended that you should replace the battery as soon as possible The battery symbol will only appear if the bat tery is too low to perform any more blood glucose tests The meter will not function until the battery is replaced e Discard old battery as per local
11. Meter AND TEST STRIPS 6 2 Explanation of the Test Meter 12 1 Maintenance Display 12 2 Storage and Handling 6 3 Test Strips Description 6 4 Code Key Description 7 PREPARATION BEFORE USE 7 1 Changing the Battery 7 2 Test Meter Set up 8 BEFORE TESTING 8 1 Coding the Test Meter 8 2 Glucose Control Solution Test 12 3 Error Message and Trouble shooting 13 SPECIFICATIONS 14 PERFORMANCE CHARACTERISTICS 14 1 Accuracy 14 2 Precision 15 WARRANTY 16 SYMBOLS FOR PROPER USAGE 3 INTRODUCTION Thank you for choosing the CERA CHEK 1070 Blood Glucose Monitoring System The CERA CHEK 1070 is superior in accuracy retest results and portability Stored test results are easily retrievable so that you may compare them to laboratory results with your physician This allows for better management of your diabetes and periodic blood glucose testing Please be sure to read this manual before using the CERA CHEK 1070 Blood Glucose Monitoring System If you have any questions please contact your local healthcare professional 3 1 Intended Use The CERA CHEK 1070 Blood Glucose Monitoring System is intended to help people manage their diabetes with measuring their glucose level with fresh capillary whole blood from the fingertip the palm the forearm the Upper arm the thigh the calf for self testing It also provides professional healthcare personnel with the helpful informa tion with measuring glucose concentration in fre
12. g the battery will not delete test meter settings unless you e Touch the metal wire inside the battery unit with your fingers or with another metal e Exceed 1 minute when replacing the battery e Load the battery incorrectly e Load a used or weak battery e Keep away all batteries from children s reach e If a battery is swallowed please consult a doctor immediately NOTE Recheck and reset the clock setting as necessary after battery replacement to ensure time is set correctly To set the meter clock see Test Meter Set up on the next page 7 2 Test Meter Set up Set up Mode The meter will enter the set up mode when replace the battery With your meter turned on or off press the Power button for 3 seconds to enter the setup mode To exit the set mode in any step of the setting press the Power button for 3 seconds The meter will save the settings and it will turn off IMPORTANT Please always set the date and time before using the CERA CHEK 1070 Blood Glucose Monitoring System for the first time or after replacing the battery Do not perform a blood glucose test until you have set up the test meter 7 Set Indicator Press the Setting buttons lt p to select 4 4 4 to tum On or Off the Indicator light With the indicator a Paa On the indicator light located on the insert port will be g 1 8 1 8 blinking and vice versa After selecting the Indicator On or Off on the display press the Power button to a
13. guidelines 1 Set Year The year will appear at the bottom of the ad Nad display Press the Setting buttons lt p gt until the gt ran la correct year is displayed Once you have selected al la la the correct year press the Power button to save your choice and start setting the month g S y 2 Set Month Press the Setting buttons lt 4 until the correct month is displayed Once you have selected the correct month press the Power button to save your choice and start setting the date 3 Set Date Press the Setting buttons lt p gt until the correct date is displayed Once you have selected the correct date press the Power button to save your choice and start setting the time NOTE Pressing the Setting buttons lt gt continuously will pass the numbers quickly o nt 3 g SET SET e 5 30 4 Set Hour Press the Setting buttons lt until the correct hour is displayed Once you have selected the correct hour press the Power button to save your choice and start setting the minutes 5 Set Minute Press the Setting buttons lt q until the correct w minute is displayed Once you have selected the correct og agen minute press the Power button to save your choice and move to set the alarm 6 SetAlarm You can set up to 5 daily alarms Press the Setting rr r buttons lt gt to choose the number of alarms you would like ry r r Z t
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15. ns lt p Change the date time measurement unit and alarm settings Recall previous test results from the meter memory Battery Cover Data Port Send stored data to a computer via an optional data transfer cable to view 6 2 Explanation of the Test Meter Display i M a cobe ET i Uy Blood Drop Symbol This symbol tells you hal Litt when to apply the sample g fe mg a El Test Strip Symbol Appears when to insert test strip _ CSTR ig H Alarm Symbol Appears when in the alarm setting mol wert mode or when alarm is beeping Be am eld aq E Battery Symbol Appears when the battery is low Hour Minute Month Day rio Code Indicates the code number of the test strip El Memory Symbol Indicates a test result stored in memory Test Result Area Test results code numbers or error messages are displayed here E Measurement Unit Appears with the test result either in mg dL or in mmol L E Temperature Symbol Appears when the temperature is abnomally high or low il Day Average Indicates a test result in average il Set Appears when in the setting mode 6 3 Test Strip Description Your test strip measures the concentration of glucose in whole blood Blood is applied to the absorbent hole of the test strip and is automatically drawn into the reaction zone Contact Port Insert this end of the test strip into the test meter Push it in firmly until it will go no further Grip
16. o set As you press the Setting buttons lt 4 the display with G a OFF message will change to the first alarm reminder 1 If g you continue to press Setting buttons lt p gt it adds the next O ser alarm reminder To save the number of alarm reminder press Power button Following you will move to the hour setting with the hour blinking Press the Setting buttons lt gt until the desired hour appears Press the Power button to save your wy l choice and to move the minute setting with the minute blink ha ing Press the Setting buttons lt 4 until the desired minute appears Press the Power button to save and finalize your w amp alarm setting This will bring you back to the second alarm set o m a o m g gap ggg up mode 2 if you have chosen a second alarm reminder at the first step of alarm set up If not after saving your first alarm reminder it will move to the setting of Indicator light on off NOTE Default alarm times are 6 30 9 30 12 30 18 30 and 21 30 You can choose from these or set your own time To replace the pat Y Make sure the meter is off before removing the battery Pull the buckle on the battery cover and pull the cover forward Remove the old battery and replace with a new 3V lithium battery CR 2032 Make sure that the positive side is facing up Close the battery cover CAUTION Replacin
17. of device components 12 3 Error Message and Troubleshooting 1 4 PERFORMANCE CHARACTERISTICS 14 1 Accurac Message me Possible cause What You Should Do 70 14 20 ved Test result level is over Repeat the test with a new Accuracy results for glucose concentration 2 75 mg dL 4 2 mmol L mae 900mg dL 50 0mmol L test strip If this message shows again please contact your doctor Withine 5 Withine 10 Withing 15 Withins 20 silat Teve 141 180 89 160 180 100 180rt80 100 180 180 i Test result level is less than Repeat the test with a new test LA 10mg dL 0 6mmol L strip If this message shows 14 2 Precision TE again please contact your doc tor immediately ie Prepare to replace the Recommending to replace the aia tet battery battery 45 mgidL 2 5 mmol L STD 2 4 mg dL a Blood average 129 mgldL 7 2 mmol L CV 3 2 The battery power is too Replace the battery at once 228mg dL 12 7 mmol L CV 3 0 Gi 26 malsL18 1mmolt __ OV 22 The operating temperature Allow the test meter and test 43 mg dL 2 4 mmol L STD 2 3 mg dL of the system is not the strips to warm up or cool down Control average 108 mg dL 6 0 mmol L W 32 mentioned range slowly 30 minutes until the 304 mg dL 16 9 mmol L
18. sh capillary whole blood as well as fresh venous blood The CERA CHEK 1070 Blood Glucose Monitoring System is intended for in vitro diagnostic use 3 2 Principle of Measurement The test is based on the measurement of an electrical current generated by the reac tion of glucose with the reagent of the test strip The test meter measures the current and displays the corresponding blood glucose level The strength of the current produced by the reaction depends on the amount of glucose in the blood sample 4 IMPORTANT INFORMATION e Severe dehydration and excessive water loss may cause false low results If you believe you are suffering from severe dehydration please consult your healthcare professional immediately e If your blood glucose results are higher or lower than usual but you do not have any unusual symptoms repeat the test once more for accuracy If you have symptoms or continue to get results higher or lower than usual follow the treatment advice of your healthcare professional Only apply fresh whole blood sample to the absorbent hole Applying other substanc es to the absorbent hole will cause inaccurate results If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all instructions described in this user manual call your healthcare professional Inaccurate results may occur in severely hypotensive individuals or patients in shock Abnormally low resul
19. ts may occur for individuals experiencing a hyperglycemic hy perosmolar state with or without ketosis Critically ill patients should not be tested with test meters Please refer to the insert paper in your test strip package for additional important information 5 CONTENTS OF THE SYSTEM Your test meter has been designed tested and proven to work together as a system to produce accurate blood glucose test results Use only with the manufacturer s compatible test strip and glucose control solution with this test meter Your system includes Test Meter Carrying Case Lancing Device Test Strips including Code Key both optional 3V Lithium Coin Battery Glucose Control Solution sold separately User Manual Sterile Lancet optional a 4 a N fi FOG A bs l C WY NOTE CERA CHEK 1070 Blood Glucose Test Strips including code key and Glucose Control Solution are sold separately UNDERSTANDING THE CERA CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM 6 1 Appearance and Key Functions of the Test Meter Front Indicator Light Insert Port The insert port is where you insert the test strips for testing as well as the code key for calibration CERA CHEK 1070 Power Button Turn the meter ON or OFF Enter the Set mode Save the date time measurement unit and alarm settings Display Your test results are display here Setting Butto
20. vice Ejection System Lancet Holder 5 aT Depth Indicator Adjustable Tip Sliding Barrel Release Button Lancet Protective Cap OS 1 Set the lancing device Screw off the cap of the lancing device Insert a lancet into the lancet holder and push down firmly until it is fully seated 2 Twist the protective cap until it is separated from the lancet 3 To get a drop of blood from a fingertip Hold the lancing device firmly against the side of your fingertip Press the release button You will hear a click indicating that the puncture is complete Then gently squeeze the punctured area to obtain blood sample Do not smear the blood sample 4 Remove the lancet After pulling the sliding barrel out Push the ejection system upwards to remove the lancet Place the protective cap on a hard surface and push the exposed tip into the protective cap es oe aa oe UY v 9 3 Performing a Blood Glucose Test 1 Insert test strip Remove the test strip from the vial and immediately close the cap Insert the test strip into the insert port The blood symbol will blink on the display IMPORTANT Make sure the code number shown on the display matches the code number printed on the test strip vial If the code numbers are different please refer to the section of 8 1 Coding the Test Meter for the procedure of coding i 2009 06 p
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