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user`s manual - Diabetes

1. vial and re cap the vial cap Strip port with indication snaps and stops The meter immediately symbol facing up and turns on automatically aligning the metal point of When you put the strip into the smart code key the strip port you will hear a sound of beep code highlighted on the vial of test strips currently in use 33 Performing a Test in Order Performing a Test in Order 5 While the d symbol flashing you are ready to apply the blood sample The 434 Obtaining blood sample code number will appear on the right up corner of the screen iji 1 Hold the lancing device to the soft side of your fingertip and press the release button to get a tiny blood sample A PRECAUTION KE Before d appearing please don t touch your blood drop to the sample entry on strip because meter is doing a internal test If you do so the meter will show d and Error and you will waste a strip Error Lo PR ECAUTI ON Before you take the blood sample please make sure your fingertip for sampling is dry thoroughly Water or alcohol might affect the accuracy of testing A PRECAUTION To ensure accurate test results make sure the code number on your meter matches the 2 Obtain a small blood drop on your finger code highlighted on the vial of test strips you are using In order to get a more accurate measurement suggest to discard the first If the code number does not match change the Smart Cod
2. cc BIONIME CORPORATION 694 Renhua Road Dali City Taichung County Taiwan 412 Tel 886 4 24951268 Fax http 886 4 24952568 www bionime com E mail info bionime com BIONIME GmbH Tram strasse 16 9442 Berneck Switzerland swissdcesigng Le IA 0197 101 3GM210 060 EN SIONINGe Blood Glucose Monitoring System mg dL iz USER S MANUAL Rightest Gm210 Preface Preface Thank you for selecting the Rightest Blood Glucose Monitoring System Please read this manual thoroughly before you start testing It provides all the information you need to use the product You will get a correct test result by the following instruction of this manual It is quite important for you to monitor blood glucose regularly A derived complication can thus be effectively reduced Through the assistance of Rightest Blood Glucose Monitoring system which provides considerate design and accurate results your diabetes management can become more reliable and ease to use The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use For self testing amp professional use only outside the body The testing result is calibrated to be plasma equivalent for test with fresh capillary whole blood samples from the fingertip You may consult your healthcare professional for instructions on how to use the system correctly Our Customer Support staff is available to assist
3. Blood Glucose Insulin Medication Insu in Medication Dinner Blood Glu cose Lunch Blood Glucose Insulin Medication Insu in Medication Bedtime Blood Glu cose Dinner Blood Glucose Insulin Medication Insu in Medication Other Blood Glu cose Bedtime Blood Glucose Insulin Medication Insu in Medication COMMENTS Other Blood Glucose Insulin Medication 68 COMMENTS 69 Log Book Log Book DATE M T Ww T F S S DATE M T W T F S S Blood Blood Breakfast Glucose Breakfast Glucose Insulin Insulin Medication Medication Blood Blood Lunch Glicose Lunch Glucose Insulin Insulin Medication Medication Blood Blood Dinner Glucose Dinner Slucose Insulin Insulin Medication Medication Blood Blood Bedtime Glucose Bedtime Glucosa Insulin Insulin Medication Medication Blood Blood Other Glucose Other EE Insulin Insulin Medication Medication COMMENTS COMMENTS 70 71 Log Book Log Book DATE Breakfast Blood Glu cose DATE Insu in Medication Lunch Blood Glu cose Breakfast Blood Glucose Insuli
4. CS symbol on the screen You have to do check key test before control solution test If you only use the control solution test without prior check key test the test result will be wrong And the test result will be memorized and calculated for average same as real blood test Please don t touch the control solution by approaching the vial to the sample entry on strip see drawing The reagent might be sucked into the vial of control solution which alteration or degeneration might happen If you approach the control solution vial to the sample entry on strip for 3 5 times you will find that the measurements might lower down for 10 20 Keep your Smart Code Key dry and clean Please clean it up right away if your Smart Code Key gets stain or moisture Refer to page 55 for cleaning When you do the complete quality control test especially the control Solution test make sure the ambient temperature is under 10 40 C If the ambient temperature is O 9 C 32 48 F or 41 50 C 106 122 F the testing result is only for reference 53 Understanding Control Test Results Caring for Your Meter Your control solution test results should fall within the control solution range That means your Rightest System is working correctly Control Soultion Range 90 130 mg dL 5 0 7 2 mmol L Example of control solution range printed on your test strip vial label If control solution test results ar
5. Inaccurate test results may be obtained at high altitude more than about 10000 feet 3048 meters above sea level Hematocrit below 30 may cause higher results and hematocrit above 55 may cause lower results Severe dehydration and excessive water loss may cause inaccurately low results Rightest Blood Glucose Monitoring System has not been validated for use on neonates The glucose test may be interfered under abnormal concentration of Uric acid gt 9 0 mg dL gt 0 54 mmol L L Dopa gt 1 5 mg dL gt 0 076 mmol L Methyldopa gt 1 5 mg dL gt 0 071 mmol L Cholesterol gt 250 mg dL gt 6 5 mmol L 59 Specification Specification Measurement Technology Oxidase Electrochemical Sensor Sample Capillary whole blood Minimum Sample Volume 1 4 microliter Measuring Range 10 600 mg dL 0 6 33 3 mmol L Test Time 8 seconds Memory Capacity 300 blood glucose test results with date and time Power Saving Turn off automatically after 2 Minutes no use Press the Ce button right button for 2 Seconds Operating Temperature 10 40 C 50 104 F Operating Relative Humidity 60 10 90 Hematocrit 30 55 Power Supply Battery Life Two 1 5V AAA batteries About 1000 tests eter Dimension 82 0 mm x 60 0 mm x 20 0 mm Meter Weight 78 0g with batteries Monitor LCD display Display Area 41 8 mm x 36 8
6. NOTE Rotating motion will be easier to move out the strip 2 Put forefinger on the side of strip as shown NOTE This pose is the most force saving way for inserting the test strip 3 Insert the test strip into test strip port until it snaps and firmly stops 3 Take the test strip out of test strip port totally Please follow the local regulation and discard used strip properly NOTE Correct processing way can avoid blood effecting on the code key 28 Getting Ready for Testing Performing a Test in Order Before performing a blood glucose test you have to prepare the items below Rightest Meter with Rightest Smart Code Key installed Rightest Blood Glucose Test Strips Please check the expired date on the vial Don t use the expired test strip Lancing device Sterile lancet Alcohol swab optional PRECAUTION Assembling the Smart Code Key into your meter is necessary before starting your test 30 Depth adjustable cap io button Lancet carrier Safe switch Hub Plunger Each time of using a new box of test strip you have to assemble the Smart Code Key from the new strip package Cleaning your hands Before starting your test use warm soapy water to wash your hands and dry thoroughly Warm water helps to increase the blood flow to your fingertips You can also use alcohol s
7. 2 S E T Meter Serial Number E Smart Code Key Release Button Press down to rele Smart Code Key ase and switch the Battery Cover Slide cover to change batteries The Rightest Test Strip The Rightest Test Strip Sample Entry Apply a drop of blood or control solution here The test request is only 1 4ul of blood N OO Hand Bar e O O G amp Where you can easily hand O O Ooo the strip to do the test Indication Symbol View Window Insert strip with indication symbol This window is originally yellow before applying up and toward meter blood sample It will gradually become red after filled with blood drop rom Sege a 0000 lollo OO oO T OO Electrode Contacts Sensing signal output Contacts 14 The blood sample will be drawn into sample entry by capillarity automatically PRECAUTION Re cap the vial cap immediately and close tightly after taking test strip out from the vial Do not reuse test strips Do not use expired test strips Check the discard date you wrote on the vial label every time you use the strip Store the test strip in a cool dry place and avoid the exposure of direct sunlight and heat For detailed information please refer to the Rightest Test Strip Package Insert Dummy Code Key The Rightest Smart Code Key For package wit
8. About Temperature Error k In order to get accurate testing please do testing between 10 40 C 50 104 F 2 When the ambient temperature is O 9 C 32 48 F or 41 50 C 106 122 F the warning symbol will blinking you still can do the test but the result obtained is only for reference because the test result under these range of temperature might not be correct Repeat the test at an area with temperature between operating range 10 40 C or 50 104 F 3 When you move from the area with temperature outside the operating range of test strip to another area with temperature under operating range of test strip please wait for 30 minutes before you do the test 4 When the temperature is below 0 C 32 F or over 50 C 122 F Meter can not do the test and the Error symbol will blink in this condition Please move the meter to environment with temperature between 10 40 C 50 104 F and redo the test after 30 minutes 56 About Battery Error 1 The lt a symbol is blinking when the battery power is low Please change batteries as soon as you can You can still do the test 2 The a and Error symbol are blinking when the battery is too low Meter can not do the strip test Please change the batteries immediately 3 After changing the batteries you should do the quality control test About Check Key Error When you see Quiz and Error symbols showing on screen please do
9. Medical Device Directive 98 79 EC CE0197 EU Rep BIONIME GmbH Tramstrasse 16 9442 Berneck Switzerland Disposable Sterile Lancets Manufacturer SteriLance Medical SuZhou Inc Product complied with Medical Device Directive 93 42 EEC CE0197 EU Rep EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands 64 NAME ADDRESS HOME PHONE DOCTOR PHARMACY INSULIN PILLS IN CASE OF EMERGENCY CONTACT WORK PHONE DOCTOR S PHONE PHARMACY PHONE LOG BOOK DATE From To 65 Log Book Log Book DATE Breakfast Blood Glu cose DATE Insu in Medication Lunch Blood Glu cose Breakfast Blood Glucose Insulin Medication Insu in Medication Dinner Blood Glu cose Lunch Blood Glucose Insulin Medication Insu in Medication Bedtime Blood Glu cose Dinner Blood Glucose Insulin Medication Insu in Medication Other Blood Glu cose Bedtime Blood Glucose Insulin Medication Insu in Medication COMMENTS Other Blood Glucose Insulin Medication 66 COMMENTS 67 Log Book Log Book DATE Breakfast Blood Glu cose DATE Insu in Medication Lunch Blood Glu cose Breakfast
10. check correct procedure Required items for quality control tests To perform a quality control test you have to prepare the items below Riobtest Meter with Smart Code Key installed Rightest Blood Glucose Test Strips Rightest Control Solution Rightest Check Key 47 About Quality Control Test Performing a Quality Control Test A PRECAUTION When you open a new bottle of Rightest Control Solution please write the discard date on the label Rightest Control Solution is good for 3 months after opening the bottle or until the expiration date printed on the label whichever comes first Example C Exp Date 2010 06 Ne o Replace the vial cap of control solution and close tightly right away after using of control solution sample Check the expiration date before you use the control solution Refer to Control Solution Package Insert 48 Starting with Check Key 1 Insert the Rightest Check Key with Check Key word facing up into test strip port The meter quickly goes through a series of internal checks 2 The check key allows you to make sure your meter is functioning well You can see mra symbol and 0K symbol blinking on the screen The check key also allows your meter proceeding quality control test with control solution NOTE d The check key is only for
11. mm Meter Storage Conditions 10 60 C 14 140 F Test Strip Storage Conditions 4 30 C 39 86 F lt 90 relative humidity 61 Warranty Customer Service Bionime Corporation warrants that your Rightest Meter will be free from defects in materials and workmanship for five years from the date of purchase This warranty does not apply to the performance of a Rightest Meter that has been altered misused tampered with or abused in any way This warranty applies only to the original purchaser of the meter Please complete and return the enclosed warranty card to Bionime authorized representative Different models have different specifications Some of the models are not included with the warranty card 62 We sincerely like to provide complete considerate services to our customers Please review all the instructions to make sure you are performing the steps correctly You are always welcome to contact us by call 886 4 24951268 GMT 08 00 08 30 17 30 or by e mail at info bionime com If you have any question or advice IVD For in vitro diagnostic use tel Manufacturer LOT Lot number z Use by f Temperature limitation Gi Do not reuse Method of sterilization using irradiation 63 Parts of Critical Component Log Book Blood Glucose Meter Test Strip Control Solution and Lancing Device Manufacturer Bionime Corp Product complied with In Vitro Diagnostic
12. the check key test again If this error message appears again it would be Meter or Check Key defect Please return your Meter and Check Key to the store where you bought About Smart Code Key Error The Smart Code Key is faulty or not assembled well to the meter Reinsert the Smart Code Key If the error screen appears again contact Bionime Customer Service Code Se e i CodeError 57 Error Messages and Trouble Shooting Limitations About early applying blood sample or control solution The blood sample or control solution are applied before the meter is ready Repeat the test with a new test strip Add sample after the symbol appears About Strip Error Er Test strip inserted has been used or damaged Please use a new test strip from vial About Meter Error Er2 Meter has malfunctioned Do the quality control test or reinstall the batteries to see if the meter works properly If error screen still appears contact Bionime Customer Service About Signal Error Er3 When you do the test the meter find the signal is unreasonable Please do a new test again 58 Ere _ Error Er 3 Store the strips in the original capped vial at temperatures between 4 C to 30 C 39 F to 86 F and relative humidity below 90 Do not freeze Rightest Blood Glucose Test strips are designed for using with capillary whole blood and venous whole blood samples Do not use serum or plasma samples
13. the local regulation and discard the used strip and lancet properly A PRECAUTION Check the expiration date printed on the package every time you use the strip Do not use Appearance of result 434 expired test strips 1 When blood is applied to the strip you see the countdown mode appearing on Use each test strip immediately after taking it out from the vial your screen This means the meter is measuring your glucose value H Do not reuse test strips Assemble the Smart Code Key into your meter is necessary before starting your test ot gon Be sure to change the Smart Code Key with each new box of Rightest Test Strips 2 Your blood glucose result appears after the measurement is completed The zoe an Do the test at least 30 minutes after while entering another site with different ambient result is displayed in mmol L or mg dL At the same time the result will be II temperature memorized with time and date l U 38 39 Performing a Test in Order Comprehending Test Results and Messages 3 The testing result with time and date is automatically stored in your meter s memory You may also record the glucose value in your Log Book Rotate S 4 Rotate to remove the test strip Please follow the local regulation and discard the used strip properly Wi oO t Pull off the depth adjustable cap Without touching the used disposable lancet stick the lancet tip into the protective cov
14. Card Thank you for purchasing our product Please complete and mail this warranty card within 30 days of purchase of your Rightest Blood Glucose Monitoring System Name Male Female Date of Birth Address City Country Postal Code Phone Number Healthcare Professional Who Recommended Country Store Pharmacy Name Where Purchased Country Date of Purchase Model No Serial Lot No Do you have Type Type Il Gestational Diabetes Have you owned a blood glucose monitor before Yes No Which brand s were you most recently using Will the Rightest meter be your primary monitor Yes No How often do you test your blood glucose Times per day per week Do you use insulin Yes No Oral medication Yes No How did you hear about the Rightest Blood Glucose meter Thank you for answering these questions and for your purchase of the Rightest Blood Glucose Monitoring System 78 BIONINGe EMERGENCY CARD Blood Glucose Monitoring System e User Name e User Phone No e Blood Type e Doctor Hospital BIONING am a diabetes patient If you find me in a coma or stupor please take me to the hospital on left side Or call Please fill this card and carry with you at anytime
15. OTE Fast Settings When you do the settings you can press the J display screen will show setting data i When you keep pressing Ce button right button for 2 seconds the display on screen will turn Ear otis ele button endnolciiirer seconds toadusi asier yOu KSP p mng 3 rig on E ee If you miss the numbers of year date month hour or minute when you off Please don t care it Keep pressing the Ce button right button till entering Setting Mode do the setting adjustment please keep pressing the left button till the end of number The end of year number is 99 The end of date number is 31 The end of month number is 12 The end of hour number is 12 or 24 The end of minute number is 60 And rerun back to the correct number you want 2 Month setting PRECAUTION e E o With the month blinking press the A7 button left button until the current When the display on meter screen shows time memory or average keep pressing Le month appears Then press the 37 button right button to confirm it and button right button for 5 seconds to enter setting mode move to day setting 22 Setting Up Your Meter Setting Up Your Meter 24 Day setting With the day blinking press the Ca button left button until the current day appears Then press the Ce button right button to confirm it and move to time format setting Time Format 12H 24H Selection a on With the
16. Performing a Test in Order Comprehending Test Results and Messages 6 10 wae Ip 17 18 20 22 26 27 28 30 31 41 Review Your Test Memory Recalling Your Test Result Recalling Your Average Test Result Quality Control About Quality Control Test Performing a Quality Control Test Understanding Control Test Results Caring for Your Meter Error Messages and Trouble Shooting Limitations Specification Warranty Customer Service Parts of Critical Component Log Book Warranty Card Emergency Card 43 45 AG 49 54 55 56 59 60 62 63 64 65 76 79 The Rightest Blood Glucose Monitoring System The Rightest Blood Glucose Monitoring System Package of Meter Kit Your Rightest Blood Glucose Monitoring System consists of several items Please identify each item of your system and learn what they re called and how they re used These items are included in your Rightest Blood Glucose Monitoring System 1 Getting Started Guide 2 User s Manual includes Log Book Warranty Card Emergency Card 3 Rightest Blood Glucose Test Strip Package Insert 4 Control Solution Package Insert 5 Rightest Meter 6 Rightest Dummy Code Key for the package without strip or Smart Code Key pre installed for the package with strip 7 Rightest Test strips 0 10 25 50 pcs 8 Rightest Control Solution 9 Rightest Check Key 10 Lancing Device 11 Disposable Sterile La
17. cluding Memory Average and Time in sequence 2 Manual Power Off If you want to turn off the Glucose Meter please keep pressing the 27 button right button for 2 seconds Memory Average Time 2 Under memory function you can keep press J button left button your memorized test data If you want switch the searching direction keep pressing J left button then press Cal right button When the meter screen shows mem you can do searching forward You will see the numerical order of memorized data on the screen like 2 3 4 5 etc When the meter screen shows Mem you can do searching backward You will see the numerical of memorized data on the screen like 10 9 8 7 etc 3 Under Average function press the Ca button left button to search your average data of 1 day 7 days 14 days or 30 days in sequence 3 How to turn on the Power 1 Press the Ce button right button 2 Insert one piece of strip ie d a 9 Mite 26 Hie 7 aS m m m IU I IL iu 26 27 mg dL Easily Handling the Rightest Test Strip Easily Handling the Rightest Test Strip How to easily handle the Rightest test strip Removing the test strip 1 Hold the test strip same as insert it Inserting the test strip 1 Hold the test strip between thumb and middle finger with indication symbol facing up 2 Rotate the test strip counterclockwise and pull up at the same time
18. e Key to the right one and redo drop of blood The first drop of blood from your fingertip might include a test some body liquid which might affect the testing accuracy If the meter turns off before you apply the blood sample take out the unused test strip and reinsert it You have 2 minutes to apply the blood sample before the meter turns off 3 You can start measurement by the second drop of blood automatically Please follow the local regulation and discard the used strips properly 34 35 Performing a Test in Order Performing a Test in Order 4 The minimum blood sample size of Rightest Glucose Monitoring System is 1 4ul ei Applying blood sample to test strip 1 0ul 1 4ul 2 0ul 3 0ul 4 0ul Sample Size Example P P e e J J EI We suggest you to take 1 4 2 5ul to do the test on glucose monitoring system Blood sample size above 4 0ul is too much which will contaminate the Smart Code Key 1 Touch the blood drop 2 Hold your finger on the sample entry until you hear a beep and PRECAUTION to the sample entry of the view window is totally filled with blood If the view window is not Don t take too much blood sample such as 4 0ul please see how much it is in the the strip The blood totally filled with blood and or the test does not start discard the example picture or more to do the test Too much blood might contaminate the Smart will be drawn into the test strip and repeat
19. e out of control solution range your Rightest System may not be working properly Repeat the quality control test If your control solution results outside the range still exist do not use the Rightest System to test your blood glucose And contact Bionime authorized distributor or Bionime Customer Service The reason your control solution results are out of the range Your control solution has expired or after 3 months since opened Your test strip has expired You leave the cap off the vial of test strips or control solution for a long time You didn t perform the test procedure correctly Malfunction of the meter 54 Maintenance Keep your meter and test strip free of dust water or any other liquid Store the meter in the carrying case when not in use If meter is dropped or damaged perform a quality control test with the check key and control solution before doing a blood glucose test Cleaning Meter Clean the outside of the meter with a damp cloth and mild soap detergent Prevent the test strip port and Smart Code Key base from moisture Cleaning Smart Code Key If your Smart Code Key is stained with blood control solution or any liquid please use a dry tissue or alcohol swab to clean it up immediately Do not use any thing wet to clean it Perform a check key and quality control test to ensure the system is working properly 55 Error Messages and Trouble Shooting Error Messages and Trouble Shooting
20. e strip vial and the code number on the bottom of Smart Code Key should be the same If you find they are not the same please return them to the store where you bought from 1 Turn the meter over Remove old Smart Code Key by pressing down Smart Code Key release button if one is installed 2 With the Meter off follow and direction to put the new Smart Code Key into the track on code key base 3 Push down the Smart Code Key until it snaps into the Smart Code Key base A PRECAUTION Assemble the Smart Code Key into your meter is necessary before starting your test Be sure to change the Smart Code Key with each new box of Rightest Test Strips Use only the Smart Code Key that is packaged with the box of strips you are using Please don t remove this Smart Code Key before you run out of these new strips Batteries Installation Batteries Installation Your meter kit comes with two AAA 1 5volt batteries uninstalled New set of batteries will provide 4 Meter will do electronic running test and the whole screen rs P aa DAY rire Di power to perform about 1000 tests under normal use The low battery symbol a will keep will keep blinking as soon as the batteries are installed gogo ave tec appearing on your display if your batteries run low Please keep spares on hand and replace the b DENG CodeError batteries soon when a battery symbol appears 5 Press any button to close the running t
21. er 6 Hold the release button in one hand and pull on the plunger in the other hand will safely eject the used disposable lancet 7 Discard the used disposable lancet into an appropriate puncture proof or biohazard container A A J A is E S 8 Replace the depth adjustable cap after finishing the test PRECAUTION The meter will power off automatically after 3 minutes no use You can also turn off the meter by pressing the main button for 2 seconds 40 If your blood glucose result is unusually high or low or if you question your testing results repeat the test with a new test strip You can also run a QUALITY CONTROL TEST with your Rightest Check Key and Rightest Control Solutions to check your meter and strip Refer to page 46 If the test result still remains unusually high or low contact your healthcare professional immediately If you are experiencing symptoms that are not consistent with your blood glucose test results and you have made sure to follow all instructions of this manual contact your healthcare professional immediately 41 Comprehending Test Results and Messages Recalling Your Test Result The Rightest Meter displays results between 0 6 and 33 3 mmol L or 10 and 600 mg dL If your test result is below 0 6 mmol L 10 mg dL Lo will appear on the screen Please repeat your test again by a new strip If you still get L o result you s
22. est of the meter and CS VB mem gt oK enter setting mode IC WI IC d The meter will automatically turn off after 2 minutes of nonuse to save battery power Your test em em ae io memories are still saved 6 Please set time and date when the batteries are replaced t 3 See Setting the Time Date and Unit on page 23 an ay Semi ZS lt a mmol Lmg dL J d PRECAUTION Danger of explosion might happen if battery is incorrectly replaced replace only with the 1 Turn the meter over 2 Install both batteries at once 3 Slide the battery cover back Press and push battery Be sure to put battery in until it snaps into place same or equivalent type cover to open correct direction Please follow the local regulation and discard used battery properly 20 21 Setting Up Your Meter Setting Up Your Meter Entering Setting Mode Setting the Time Date and Unit 1 Year setting Yi t tting Mod low t ou can enter Setting Mode by below two ways With the year format blinking press the button left button to adjust 1 Reload batteries After removing the battery please press 4 button left button for several it Then press the C67 button right button to confirm the year adjustment times until no signal on screen then follow the steps of page 20 21 to load batteries and move to month setting 2 With batteries Press 2 button right button for 5 seconds till hearing a sound of beep The L N
23. f contro solution well before opening the cap Then open the cap and put it on the table 6 Drip a drop of control solution on the top of the cap L NOTE Don t touch the control solution by approaching the vial to the sample entry on strip Don t let control solution touch anywhere of your body In case please use water to clean down 7 Gently touch sample entry of the strip with the control solution on OD the top of the cap 51 Performing a Quality Control Test Performing a Quality Control Test 8 When you hear a sound of beep leave the meter on the table while waiting the test result The screen will show the countdown mode 9 Tightly recap the cap of control solution 10 The control result appears after the measurement is completed Compare your control test result to the range printed on strip vial label Example CS 434 Your result should fall within the control solution range printed on the label of strip vial If result is not within the control range please refer to Understanding Control Test Results on page 54 Please follow the local regulation and discard the used strip properly Control Solution Range 90 130 mg dL 5 0 7 2mmol L 52 PRECAUTION Your quality control test result by control solution test will not be calculated for average reading but still can be recalled The control solution test result will be shown with
24. functional testing of meter If you want to make sure strip and meter work properly please use control solution for the test see page 50 for detail 3 If both Garey symbol and Error symbol blinking appear remove check key and insert it again If error screen appears again your meter is not working correctly Please contact Bionime authorized distributor or Customer Service Center 49 Performing a Quality Control Test Performing a Quality Control Test Performing test with control solution Please run check key test first After see aurze symbol and OK appear on the screen Remove check key from meter The screen shows the om symbol blinking and CS appears Then you need to put a new strip into the meter 2 Remove test strip from vial and re cap the vial cap immediately 3 Insert the test strip with view window facing up into test strip port The code number will appear 4 The test strip symbol stops blinking You will see blinking d symbol and CS symbol on the screen Then you need to approach your control solution to the meter 50 cs CR WW PRECAUTION Before you do contro solution test you have to do check key test first Before appears please don t touch the control solution to the sample entry on strip because meter is stilling in a internal test If you do so the meter will show Error and 5 Shake the bottle o
25. hould immediately contact your healthcare professional If your test result is above the high end of the system s detective range 33 3 mmol L or 600 mg dL H will appear on the screen Please repeat your test again by a new strip If you still get H result you should immediately contact your healthcare professional 42 Zb BOU D n AM l LU mg dL The Rightest meter is able to store 300 test results with time and date automatically If your test results are up to 300 sets which is the max memory of the meter your newest test results will replace the old ones starting from the oldest one To recall your test memory start with the meter without test strip inserted Press the main button Ce right button to switch the screen to memory function it will show the latest testing result with time and date The latest result is with sequence number 1 2 Under the memory screen press the 4 button left button to review all previous results with date and time You will see results from the most recent Sequence no 1 to the oldest Sequence no 300 at the up right corner of the screen 43 Recalling Your Test Result Recalling Your Average Test Result 3 You can keep pressing button left button for 2 seconds to do fast searching If you want to switch the searching direction keep pressing La left button then press Ce right button When the meter screen sh
26. hout test strip not for package with test strip A Dummy Code Key will be installed on the new Rightest meter in the package without test strip This Dummy Code Key is not intended to be used for testing When you open a new box of test strips you have to replace the Dummy Code Key by new Smart Code Key in the box Do not throw away this Dummy Code Key It can be used to keep the Smart Code Key Base clean while the Smart Code Key is not installed 16 What is Smart Code Key Smart Code Key is designed for calibrating your meter to match the strips of different production lot since each lot of strips owns different parameter Each new box of strips contains its new Smart Code Key The Smart Code Key stores calibrated information that your meter needs to give you accurate blood glucose results You must change your Smart Code Key with each new box of Rightest Test Strips Smart Code Key also contains the test strip port Although you can still review the memory and other settings it s necessary to assemble the Smart Code Key into meter before actually starting your test This procedure makes sure you do calibrate the meter and assures you of getting accurate test results 17 Smart Code Key Installation Smart Code Key Installation How to switch Smart Code Key Every new box of test strips should come with a Smart Code Key inside Before you install the Smart Code Key please check that the code number on th
27. n Medication Insu in Medication Dinner Blood Glu cose Lunch Blood Glucose Insulin Medication Insu in Medication Bedtime Blood Glu cose Dinner Blood Glucose Insulin Medication Insu in Medication Other Blood Glu cose Bedtime Blood Glucose Insulin Medication Insu in Medication COMMENTS Other Blood Glucose Insulin Medication 72 COMMENTS 73 Log Book Log Book DATE Breakfast Blood Glu cose DATE Insu in Medication Lunch Blood Glu cose Breakfast Blood Glucose Insulin Medication Insu in Medication Dinner Blood Glu cose Lunch Blood Glucose Insulin Medication Insu in Medication Bedtime Blood Glu cose Dinner Blood Glucose Insulin Medication Insu in Medication Other Blood Glu cose Bedtime Blood Glucose Insulin Medication Insu in Medication COMMENTS Other Blood Glucose Insulin Medication 74 COMMENTS 75 Warranty Card Warranty Card Please present this card for replacement purpose Distribu
28. ncets 10 pcs 12 Carrying Case not shown 13 Two AAA Batteries not shown 14 Instruction for the lancing device not shown x Different packages have different bundled items Some of packages might not include items ef CONTROL SOLUTION The Rightest Meter The Rightest Meter Display Window Show your test result messages and relative information Smart Code Key For calibrating your meter New one comes with every Oo oxof test strips Refer t 17 BIONING T BIONING pox Supe A ge ae page A i Contain the test strip port for inserting strip Assemble Smart Code Key into code key base f g Test Strip Port Ton Lo Bei Insert test strip here until you hear a click Memory Button 3 Main Button Press to review stored test Press to turn on off meter value in memory and average Select the function mode 10 11 The Rightest Meter Please follow the step and step Smart Code Key Base Assemble Smart Code Key here e The Rightest Meter aT TEE Rightest ewe A f i SN 230GGA0001 S EI aw Bionime Corporation 23
29. on neonates Therefore it s not intended for use of neonates 4 Rightest Blood Glucose Meter hasn t been used for arterial blood testing yet so it is still not suitable to be used for arterial blood testing so far Do the test at least 30 minutes after while entering another site with different ambient temperature Pay attention to the environment protection when disposal of batteries Using appliance in tropical and or temperate climate Not to be exposed dripping or splashing The minimum blood sample size of Rightest Glucose Monitoring System is 1 4ul Sample Size Example 1 0ul 1 4ul 2 0ul 3 0ul 4 0ul e We suggest you to take 1 4 2 5ul to do the test on glucose monitoring system Blood sample size above 4 0ul is too much which will contaminate the Smart Code Key Blood sample size below 1 4ul might cause inaccurate test result or might not start on meter measurement In this case repeat the test with a new test strip Table of Contents Table of Contents About Rightest System The Rightest Blood Glucose Monitoring System The Rightest Meter The Rightest Test Strip Dummy Code Key The Rightest Smart Code Key Being Ready for Test Smart Cade Key installation Batteries Installation Setting Up Your Meter Turning On Off the Meter Function Screens and Button Operations Easily Handling the Rightest Test Strip Testing Procedure Getting Ready for Testing
30. ows mem you can do searching forward You will see the numerical order of memorized data on the screen like 2 3 4 5 etc When the meter screen shows mem you can do searching backward You will see the numerical of memorized data on the screen like 10 9 8 7 etc 4 The quality control solution test result can be recalled from the memorized data When you see data with the C it is testing data with control solution The result will not be used for average calculation 5 If the ambient temperature is OC 9 C or 41 C 50 C 32 F 48 F or 106 F 122 F the test result will show with symbol blinking The test result under these range of temperature will not be used for average calculation because the test result may not be correct It is for reference only 44 The Rightest meter provides you several average test results You can view the 1 day 7 day 14 day and 30 day average of test results for better blood monitoring of your blood glucose D d Ti H ave db Zi ie D W nn W 1 Press the main button Co right button to switch the screen to average function 2 Under the average of screen press the J left button for the option of 1 day 7 day 14 day or 30 day average of test results 3 The number showed on the right up corner means how many test results are calculated 4 The Lo Hi results the control solution results the non average test results and
31. the test result made out of normal temperature range 0 9 Cand 41 50 C are not calculated in the average A PRECAUTION You have to set the time and date to activate the average function 45 About Quality Control Test About Quality Control Test What is quality control test To make sure the monitoring system will work properly It is necessary to do two kinds of quality controls 1 Check Key Test Please check your meter function by check key the detail is shown in Starting with Check Key section on page 49 2 Control Solution Test If you finish the check key test without error that only makes sure the meter is working properly You still have to use control solution to check if the strip and meter work together properly A PRECAUTION The complete quality check should include check key test and control solution test Before you do control solution test you have to do check key test first 46 When should perform a quality control test Before doing a blood glucose test with your meter for the first time When you open and start using a new vial of test strips When you replace a new Smart Code Key please check your meter by CHECK KEY When your meter is dropped or splashed with liquids Whenever you think your test result does not consistent with the way you feel Whenever you want to check if your system is working properly or not Whenever you want to practice testing and
32. the test with a new test strip When you repeat Code Key strip automatically the test you may want to obtain the blood sample from a different Please clean it up right away if your Smart Code Key gets blood stain or moisture finger if the first attempt did not produce enough blood sample Refer to page 55 for cleaning Smart Code Key PRECAUTION Blood sample size below 1 Aul might cause inaccurate test result or might not start on When you do a test please pay attention not to squeeze too much blood to pollute Smart meter measurement In this case repeat the test with a new test strip Code Key 37 Performing a Test in Order Performing a Test in Order View Window Appearance Fr JU WE To ensure accurate test results make sure the code number on your meter matches the Make sure your blood sample covers code number highlighted on the vial of test strips you are using the whole area of the View Window D D Only place the blood drop to the sample entry of the strip to get an accurate test result Keep your Smart Code Key dry and clean Please clean it up right away if your Smart Code Insufficient blood sample might Ki Q O Q Key gets blood stain or moisture Refer to page 55 for cleaning cause inaccurate test result Repeat Pose the finger and the strip to the way you feel most comfortable f f Insufficient blood sample Enough blood sample i 8 i the test with a new test strip Please follow
33. time format blinking press the 4 button left button to adjust it Then press the Ce button right button to confirm it and move to hour setting Hour Setting With the hour blinking press the J button left button until the current hour appears Then press the move to minute setting Ce button right button to confirm it and Minute setting With the minute blinking press the 4 button left button until the current minute appears Then press the Ce button right button to confirm it and move to the setting mode of measurement unit Setting the Unit of Measurement With milligrams per deciliter mg dL or millimol per liter mmol L blinking press the La button left button to switch The Step is only available to the meter which it s unit is adjustable Ending Setting Then press the button right button to complete the setting and go back to time screen The settings you have entered are saved When you do not do any settings of meter for over 2 minutes the meter will leave setting mode and power down automatically weit e mmol L st gog AM 25 Turning On Off the Meter Function Screens and Button Operations 1 Auto Power Off Switching the Function Screens The Meter will power off automatically if you don t operate it for over 2 minutes 1 Press the Ce button right button to switch function screens in
34. tor name and address Name Tel Address Serial No Model Date of purchase Limited warranty ii N wo TF a Bionime corp warrants the original purchaser only that the Rightes Monitor shall be free of any defects in materials or workmanship and provided it is not modified altered or misused will perform in accordance with specifications for a period of five 5 years from the original date of purchase Bionime guarantees the performance of the Rightest Monitor only if used as directed and provided that the failure to perform or misperformance of the Rightest Monitor has not been caused in whole or in part by the use of test strips that are not Rightest Test Strips manufactured by Bionime Use only Rightest Test Strips in your Rightest Monitor The sole obligation of Bionime under this warranty shall be to replace any defective Rightest Monitor No other warranties express or implied are made Bionime shall not be responsible for any incidental or consequential damages Activation of this warranty shall be conditioned upon completion and return of the warranty registration card to your local authorized Bionime distributor You must contact your local authorized Bionime distributor for assistance and or instructions for obtaining a replacement monitor Bi oO N I Ne 76 Distributor name and address PLACE STAMP HERE 77 Warranty Card Emergency
35. wab to clean your finger to get accurate measurement 1 Hold the adjustable cap in one hand and hold the hub in the other hand Bend the cap towards the down side When a gap appears between the cap and hub pull them off in opposite directions 2 Pull off the depth adjustable cap 3 Insert a new disposable lancet firmly into lancet carrier Performing a Test in Order Performing a Test in Order 4 Twist off and set aside the protective cover of the disposable lancet 5 Replace the depth adjustable cap 6 Choose a depth of penetration by rotating the top portion of the depth adjustable cap until the setting depth matches the window Settings are based on skin type qn for soft or thin skin am for average skin om for thick or calloused skin 7 e 7 Hold the hub in one hand and pull on the plunger in the other hand The device will lt i Er be cocked Release the plunger it will automatically move back to its original 2 position near the hub PRECAUTION Load the lancing device Refer to Instruction manual of the lancing device Be careful to load the lancing device to avoid being pierced by the needle 32 4 Check that the code number blinking on your meter matches the Preparing your meter and strip Sr EoD e Bei a 1 Remove new test strip from 2 Insert the test strip into test 3 Push the test strip in until it
36. you as well The Rightest Blood Glucose Monitoring System was manufactured and supported by Bionime Corporation and its authorized representative If you have any questions or concerns please contact your Bionime authorized representative or call us by phone number 886 4 24951268 GMT 08 00 08 30 17 30 We will make every effort to provide assistance and solutions for you Please forward your warranty card to Bionime authorized representative to activate your warranty coverage Precaution Precaution Before using the Rightest System to test your blood glucose please read all the instructions and practice the tests including quality control test Refer to page 46 Please do the quality control test regularly to make sure the test results are accurate The Rightest Blood Glucose Meter can only be used with the Rightest Blood Glucose Test Strips The use of any other brand Strips should not be used under any circumstances The use of other brands of strips may give inaccurate results The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use only The testing result is calibrated to be plasma equivalent for test with fresh capillary whole blood samples by finger stick The Rightest Blood Glucose Monitoring System is intended for self testing It should not be used to diagnose diabetes mellitus Rightest Blood Glucose Monitoring System has not been validated for use

user`s manual - Diabetes

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