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Bionime GM300 Manual

1. Log Book Log Book DATE DATE M T W Y F S Blood Blood Breakfast Glucose Breakfast Glucose Insulin Insulin Medication Medication Blood Blood Lunch Glucose Lunch Glucose Insulin Insulin Medication Medication Dinner Glucose Dinner Glucose Insulin Insulin Medication Medication Blood Blood Bedtime Se Bedtime Glucose Insulin Insulin Medication Medication Blood Blood Glucose Other Glucose Insulin Insulin Medication Medication COMMENTS COMMENTS 70 71 Log Book Log Book DATE DATE M T W Y F S Blood Blood Breakfast Glucose Breakfast Glucose Insulin Insulin Medication Medication Blood Blood Lunch Glucose Lunch Glucose Insulin Insulin Medication Medication Dinner Glucose Dinner Glucose Insulin Insulin Medication Medication Blood Blood Bedtime SUCRE Bedtime Glucose Insulin Insulin Medication Medication Blood Blood Glucose Other Glucose Insulin Insulin Medication Medication COMMENTS COMMENTS 72 73 Log Book Log Book DATE DATE M T Breakfast Blood Glucose Insulin Medication Breakfast Blood Glucose Insulin Medication Lunch Dinner Blood Glucose Insulin Medication Blood Glucose Insulin Medication Lunch Dinner Blood Glucose
2. Pose the finger and the strip to the way you feel most comfortable Please follow the local regulation and discard the used strip and lancet properly Appearance of result n 1 When blood is applied to the strip you see the countdown mode appearing on F your screen This means the meter is measuring your glucose value 2 Your blood glucose result appears after the measurement is completed The result is displayed in mmol L or mg dL At the same time the result will be memorized with time and date Performing a Test in Order 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 4 Rotate to remove the test strip Please follow the local regulation and L discard the used strip properly 5 Pull off the depth adjustable cap Without touching the used disposable lancet stick the lancet tip into the protective cover 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 oroof or biohazard container 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 Comprehending
3. Getting Ready for Testing Before performing a blood glucose test UN 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 Depth adjustable cap puse button Test Strips Discard 3 months after first opening Discard date ze Code ae 063 Control Solution Range Alcohol swab optional ibd carrier Safe switch Hub ind AN PRECAUTION Assembling the Smart Code Key into your meter is necessary before starting your test 30 Performing a Test in Order Each time of using a new box of test strio 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 swab 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 31 Performing a Test in Order 4 Twist off a
4. PILLS LOG BOOK DATE From To NNN No 68 LiTangHe RD XiangCheng SuZhou JiangSu 215133 PR China IN CASE OF EMERGENCY CONTACT Produsteomplsd min Medical Device DirectveOG 42 EEC CEO1O7 Snare etcetera yr EC Rep EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands 64 65 Log Book Log Book DATE DATE M T W Y F S Blood Blood Breakfast Glucose Breakfast Glucose Insulin Insulin Medication Medication Blood Blood Lunch Glucose Lunch Glucose Insulin Insulin Medication Medication Dinner Glucose Dinner Glucose Insulin Insulin Medication Medication Blood Blood Bedtime Se Bedtime Glucose Insulin Insulin Medication Medication Blood Blood Glucose Other Glucose Insulin Insulin Medication Medication COMMENTS COMMENTS 66 67 Log Book Log Book DATE DATE M T W Y F S Blood Blood Breakfast Glucose Breakfast Glucose Insulin Insulin Medication Medication Blood Blood Lunch Glucose Lunch Glucose Insulin Insulin Medication Medication Dinner Glucose Dinner Glucose Insulin Insulin Medication Medication Blood Blood Bedtime Se Bedtime Glucose Insulin Insulin Medication Medication Blood Blood Glucose Other Glucose Insulin Insulin Medication Medication COMMENTS COMMENTS 68 69
5. Please follow the local regulation and discard the used strips properly 34 35 Performing a Test in Order 4 The minimum blood sample size of Rightest Glucose Monitoring System is 1 4ul e 1 0ul 1 4ul 2 0ul 3 0ul 4 0ul Sample Size Example e e Q Q We suggest you to take 1 4 2 5ul to do the test on glucose monitoring system Blood sample size above 4 0ul might contaminate the Smart Code Key PRECAUTION Don t take too much blood sample such as 4 Qul please see how much it is in the example picture or more to do the test Too much blood might contaminate the Smart Code Key Please clean it up right away if your Smart Code Key gets blood stain or moisture Refer to page 55 for cleaning 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 36 Performing a Test in Order Applying blood sample to test strip 1 Touch the blood drop 2 Hold your finger on the sample entry until you hear a beep and to the sample entry of the view window is totally filled with blood If the view window is not the strip The blood totally filled with blood and or the test does not start discard the will be drawn into the test strip and repeat the test with a new test strip When you repeat strip automatically the test you may want to obtain the blood s
6. 76 mmol L gt 1 5 mg dL Methyldopa gt 0 071 mmol L gt 1 5 mg dL Cholesterol gt 6 5 mmol L gt 250 mg dL When you do the test the meter find the signal is unreasonable Please do a new test again mm E 58 59 Specification Measurement Technology Sample Minimum Sample Volume Measuring Range Test Time Memory Capacity Power Saving Operating Temperature Operating Relative Humidity 60 Oxidase Electrochemical Sensor Capillary whole blood 1 4 microliters 10 600 mg dL 0 6 33 3 mmol L 8 seconds 300 blood glucose test results with date and time Turn off automatically after 3 minutes no use Press the button for 2 seconds 10 40 C 50 104 F 10 90 Hematocrit Power Supply Battery Life Meter Dimension Meter Weight Monitor Display Area Meter Storage Conditions Test Strip Storage Conditions Specification 30 5596 Two 1 5V AAA batteries About 1000 tests 85 0 mm x 58 0 mm x 22 0 mm 85 0 g with batteries LCD display 39 0 mm x 38 0 mm 10 60 C 14 140 F 4 30 C 39 86 F 90 relative humidity 61 Warranty 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 warra
7. IL 3 IL I am an vy GB mg dL mg dL di mem N DAY pr 3n 12 4 The quality control solution test result can be recalled from the memorized j n r pala TBI OSEE Gale Mn the TE MISAGO Gale ess i LI l er 1 Press the main button to switch the screen to average function solution The result will not be used for average calculation madl 2 Under the average of screen use either the A or Z for the option of 1 day 7 day 14 day or 7 cu 30 day average of test results 3 The number showed on the down right corner means how many test results are calculated 5 I the ambient temperature S 0c 9 Or ANG SOK PORS ag 4 The Lo Hr results the control solution results the non average test results and the test result 122F the test result will show with o symbol blinking The test mc made out of normal temperature range 0 9 C and 41 50 C are not calculated in the average result under these range of temperature will not be used for average i f 1 calculation because the test result may not be correct It is for reference only ot maid N PRECAUTION L 9 6 du You have to set the time and date to activate the average function 44 45 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 show
8. Insulin Medication Blood Glucose Insulin Medication W T F 5 Bedtime Blood Glucose Insulin Medication Bedtime Blood Glucose Insulin Medication COMMENTS Blood Glucose Insulin Medication Other COMMENTS Blood Glucose Insulin Medication 74 9 Warranty Card Please present this card for replacement purpose Distributor name and address Name Tel Address Serial No Model Date of purchase Limited warranty lk Bionime corp warrants the original purchaser only that the Rightest 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 dam
9. L UV a IL d mg dL 4 DAY D A am 4 i M i l LIPA m j m Y ELT am p om 9 AVG S P Function Screens and Button Operations Time 2 Under Memory function press the A or Y button to search your memorized testing data or Y button to search your average data of 1 day 4 When the display on meter screen shows time memory or average keep pressing button for 5 seconds to enter setting mode e Easily Handling the Rightest Test Strip How to easily handle the Rightest test strip Inserting the test strip 1 Hold the test strip between thumb and middle finger with indication symbol Wy facing up 2 Put forefinger on the side of strip as shown NOTE This is the easiest way to insert the strip 3 Insert the test strip into test strip port until it snaps and firmly stops 28 Easily Handling the Rightest Test Strip Removing the test strip 1 Hold the test strip same as insert it 2 Rotate the test strio counterclockwise and pull up at the same time A NOTE Pull the strip in counterclockwise direction will be easier to remove it from the meter 3 Take the test strip out of test strip port totally Please follow the local regulation and discard used strip properly NOTE Code key will not be contaminated by blood if you follow the step correctly
10. Rightest Test Strip Package Insert I9 Dummy Code Key For package without 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 The Rightest Smart Code Key What is Smart Code Key omart Code Key is designed to calibrate your meter to make each lot of strips have the same performance Each new box of strips contains its new omart 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 omart 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 3 Push down the Smart Code Key until it snaps into the Smart Code Key base Every new b
11. Test Results and Messages Blood glucose test results are shown on the meter as mmol L or mg dL depending on which unit of measurement you have chosen Consult your healthcare professional before making any changes to your diabetes medication program 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 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 Lo result you should 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 Hi result you should immediately contact you
12. ages 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 GBIONING 76 Distributor name and address Warranty Card PLACE STAMP HERE 1 Warranty Card Emergency 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 City Country Store Pharmacy Name Where Purchased City Country Date of Purchase Model No Serial Lot No Do you have Type Type II 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 3 e IN NVC 78 EMERGENCY CARD BIO
13. ample from a different finger if the first attempt did not produce enough blood sample PRECAUTION When you do a test please pay attention not to squeeze too much blood to pollute Smart Code Key 37 Performing a Test in Order View Window Appearance Make sure your blood sample covers the whole area of the View Window to get an accurate test result Insufficient blood sample might Cause inaccurate test result Repeat the test with a new test strip AN PRECAUTION 3 oV o Insufficient blood sample e Q Enough blood sample Check the expiration date printed on the package every time you use the strip Do not use expired test strips Use each test strip immediately after taking it out from the vial Do not reuse test strips 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 Do the test at least 30 minutes after while entering another site with different ambient temperature 38 Performing a Test in Order To ensure accurate test results make sure the code number on your meter matches the code number highlighted on the vial of test strips you are using Only place the blood drop to the sample entry of the strip Keep your Smart Code Key dry and clean Please clean it up right away if your Smart Code Key gets blood stain or moisture Refer to page 55 for cleaning
14. e Monitoring System was manufactured and supported by Bionime Corporation and its authorized representative If you have any questions or concerns please contact Preface 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 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 otrips 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 on neonates Therefore it s not intended for use of neona
15. eodd BIONIME CORPORATION 694 Renhua Road Dali Dist Taichung City 412 Taiwan Tel 886 4 24951268 Fax 886 4 24952568 http www bionime com E mail info bionime com EC REP BIONIME GmbH Tramstrasse 16 9442 Berneck Switzerland swissdesign amp 101 3GM300 702 EN GB OoNING Blood Glucose Monitoring System E3ICOPNIN USER S MANUAL Rightest GM300 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 you as well The Rightest Blood Glucos
16. ert 1 5 Rightest Meter ger 6 Rightest Dummy Code Key for the package without strip or Smart Code Key pre installed MEG for the package with strip 7 Rightest Test strips 0 10 25 pcs 8 Rightest Control Solution x 9 Rightest Check Key 10 Lancing Device 11 Disposable Sterile Lancets 10 pcs 12 Carrying Case not shown The Rightest Meter Up Button A Down Button Y Press to review stored test value in memory and average Select the function mode Display Window Show your test result messages and relative information 10 The Rightest Meter Smart Code Key For calibrating your meter New one comes with every box of test strips Refer to page 17 Contain the test strip port for inserting strip Assemble Smart Code Key into code key base Test Strip Port Insert test strip here until you hear a click Main Button Press to turn on off meter Switch different function screen Press and hold down until enter to the setting mode There will be a power off period during this process 11 The Rightest Meter Please follow the step and step Smart Code Key Base Assemble Smart Code Key here 12 GT BIONING Rightest cM300 Av 5 VG 2 tall Bionime Corporati
17. est Control Solution is good for 3 months after opening the bottle or until the expiration date printed on the label whichever comes first Example Exp Date 2012 06 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 Performing a Quality Control Test Starting with Check Key 1 2 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 The check key allows you to make sure your meter is functioning well You can see Is we symbol and OK symbol blinking on the screen The check key also allows your meter proceeding quality control test with control solution I NOTE The check key is only for 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 If both Ofw 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 If you don t want to conduct the control solution test after the test of check key please press to leave CTL mode first Then start the blood t
18. est procedure Otherwise your test resuit will be recorded as CTL data which will not be counted in average data OK CHECK KEY Error CHECK KEY 49 Performing a Quality Control Test Performing test with control solution CTL 1 Please run check key test first After see Iw symbol and OK appear on the screen Remove check key from meter The screen shows the Tx symbol blinking and CTL 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 symbol and CTL symbol on the screen Then you need to approach your control solution to CTL the meter Os 50 PRECAUTION Before you do control 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 L J meter will show Error and Ww 5 Shake the bottle of control 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 NOTE Dontt drip the control solution to sample entry of strip directly Dontt t
19. etting the Unit of Measurement With milligrams per deciliter mg dL or millimol per liter mmol L blinking press the or Y button on the side to switch mg dl _ mmol L 8 Ending Setting Then press the button to complete the setting and go back to time screen The settings you have entered are saved 9 When you do not do any settings of meter for over 3 minutes the meter will T cut leave setting mode and power down automatically Fast Settings When you do the settings you can press the A or Y buttons and hold them for two seconds to select or adjust faster 25 Turning On Off the Meter 1 Auto Power Off The Meter will power off automatically if you don t operate it for over 3 minutes 2 Manual Power Off If you want to turn off the Glucose Meter please keep pressing the button for 2 seconds 3 How to turn on the Power 1 Press the button 2 Insert one piece of strip 26 3 Under Average function press the 7 days 14 days or 30 days in sequence IL I mg dL PA Y 4 E M Anc A Switching the Function Screens 1 Press the button to switch function screens including Memory Average and Time in EY SEED Ga gt af Memory p ei gt Tw T 5 c d g E 5 E Average r T bas px ct E Asa E
20. hending lest Results and Messages ES RETER 41 6 Table of Contents Review Your Test Memory Recalling Your Test Result 43 Recalling Your Average Test Result 48 Quality Control s e About Quality Control Test 22 Performing a Quality Control Test ss Understanding Control Test Results d 94 Caring for Your Meter 55 EON i a ee eee i Limitations 9 Specification 22 60 EE T AN 62 Customer Service upaniuiiunninnae 63 Parts of Critical Component 64 E AL cu M ENE ETE A N E AT T EAT T a end A MO ee 5 Ec on cud re Tre ree The Rightest Blood Glucose Monitoring System The Rightest Blood Glucose Monitoring System Package of Meter Kit 13 Two AAA Batteries not shown Your Rightest Blood Glucose Monitoring System consists of several items Please identify each 14 Instruction for the lancing device not shown 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 x Different packages have different bundled items Some of packages might not include items 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 Ins
21. n 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 AN 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 About Quality Control Test 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 check correct procedure Required items for quality control tests To perform a quality control test you have to prepare the items below Rightest Meter with Smart Code Key installed Rightest Blood Glucose Test Strips Rightest Control Solution Rightest Check Key About Quality Control Test AN PRECAUTION When you open a new bottle of Rightest Control Solution please write the discard date on the label Right
22. nd set aside the protective cover of the disposable lancet 4 5 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 qr for soft or thin skin aumr for average skin amm for thick or calloused skin 7 Hold the hub in one hand and pull on the plunger in the other hand The device will be cocked Release the plunger it will automatically move back to its original 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 Preparing your meter and strip N 1 Remove new test strip from vial and re cap the vial cap immediately Performing a Test in Order 2 Insert the test strip with indication symbol facing up into test strip port 4 Check that the code number blinking on your meter matches the code highlighted on the vial of test strips currently in use 3 Push the test strip in until it snaps and stops The meter turns on automatically When you put the strip into the strip port you will hear a sound of beep Performing a Test in Order Performing a Test in Order 5 While the
23. ntering Setting Mode 22 Setting Up Your Meter Setting the Time Date and Unit IILI 1 Year setting IL i l With the year format blinking press the A or Y button on the side to i AM adjust it Then press the button to confirm the year adjustment and cuit Bud move to month setting DD Month setting With the month blinking press the A or Y button until the current month appears Then press the button to confirm it and move to day setting 3 Day setting With the day blinking press the A or Y button until the current day i uT appears Then press the button to confirm it and move to time format i C l1 setting tum Setting Up Your Meter 4 Time Format 12H 24H Selection e With the time format blinking press the A or Q Ji button on the side to adjust it Then press the button IL i to confirm it and move to hour setting i i X 5 Hour Setting With the hour blinking press the A or Y button until the current hour appears Then press the 69 button to confirm it and move to minute setting 6 Minute setting With the minute blinking press the A or y button until the current minute appears Then press the button to confirm it and move to the setting mode of measurement unit 24 JULI iC 1 36 800 0 2I IL II C E 0 2I IL II Setting Up Your Meter 7 S
24. nty 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 Customer Service 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 For in vitro diagnostic use Lot number Z Use by p Temperature limitation Method of sterilization using irradiation gd Manufacturer 63 Parts of Critical Component Log Book Blood Glucose Meter Test Strip Control Solution Manufacturer Bionime Corporation 694 Renhua Road Dali Dist Taichung City 412 Taiwan bin m PHM Product complied with In Vitro Diagnostic Medical Device Directive 98 79 EC CE0197 Jor EC Rep Bionime GmbH Tramestrasse 10 9442 Bemeck SE SEE Lancing device EE Manufacturer Bionime Corporation 694 Renhua Road Dali Dist Taichung City 412 Taiwan sk MERRERRPTE Nr Product complied with Medical Device Directive 93 42 EEC EC Rep Bionime GmbH Tramstrasse 16 9442 Berneck Switzerland PHARMACY PHARMACY PHONE Disposable Sterile Lancets INSULIN
25. oNING Blood Glucose Monitoring System e User Name e User Phone No e Blood Type am a diabetes patient If you find me in a coma or Nets ise er stupor please take me to the hospital on left side Or call Please fill this card and carry with you at anytime 79
26. on 0 01 a e gt o The Rightest Meter Smart Code Key Release Button Press down to release and switch the omart Code Key Battery Cover Slide cover to change batteries Model Number Meter Serial Number The Rightest Test Strip Sample Entry Apply a drop of blood or control solution here The test request is only 1 4ul of blood lt Hand Bar Noble Metal Electrodes Where you can easily Electrochemical sensor hand the strip to do the test Indication Symbol View Window Insert strip with indication symbol This window is originally yellow up and toward meter before applying blood sample It will gradually become red after filled with blood drop TT Electrode Contacts O C C O sensing signal output terminals 14 The Rightest Test Strip 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
27. ouch the control solution If you have touched it please clean up with water 7 Gently touch sample entry of the strip with the control solution on the top of the cap Performing a Quality Control Test 7 E I Error EE 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 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 52 Example Control Solution Range 90 130 mg dL 5 0 7 2mmol L Performing a Quality Control Test AN 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 CTL symbol on the screen You have to do check key test before control solution test If you only use the control solution to do the quality control test your test result will be memori
28. ox 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 the 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 g Q m PAN 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 2 With the Meter off follow and Q direction to put the new Smart Code Key into the track on code key base 18 19 Batteries Installation Your meter kit comes with two AAA 1 5volt batteries uninstalled New set of batteries will provide power to perform about 1000 tests under normal use The low battery symbol 61739 will keep appearing on your display if your batteries run low Please keep spares on hand and replace the batteries soon when a battery symbol appears The meter will automatically turn off after 3 minutes of nonuse to save battery power Your test memories are still saved 1 Turn the mete
29. r healthcare professional 42 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 2 Under the memory screen use either the 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 down right corner of the screen or Y button on the side Recalling Your Test Result 1 Press the main 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 43 Recalling Your Test Result Recalling Your Average Test Result 3 If a test result is not yours or you think it is not suitable to be calculated by The Rightest meter provides you several average test results You can view the 1 day 7 day 14 average you can mark it as non average data by pressing and firmly holding day and 30 day average of test results for better blood monitoring of your blood glucose the or Y button for over 2 seconds until the AVG and NO appears on the screen then press the button to confirm it i EE INC INC S
30. r 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 cover to open correct direction 20 Batteries Installation 4 Meter will do the self test and the whole screen will keep blinking as soon as the batteries are installed am mCode ror mem 5 Press any button to close the running test of the meter and N r f ah pei enter setting mode N T LE CTL Em Wmmol Lmg dL vr fe eneck xev S am Hurt nu Hr EIE xD ow 6 Please set time and date when the batteries are replaced See Setting the Time Date and Unit on page 23 ap De pumps DN Sap Ee VAN PRECAUTION Danger of explosion might happen if battery is incorrectly replaced replace only with the same or equivalent type Please follow the local regulation and discard used battery properly 21 Setting Up Your Meter Entering Setting Mode You can enter Setting Mode by below two ways 1 Reload batteries After removing the battery please press button for several times until no signal on screen then follow the steps of page 20 21 to load batteries 2 With batteries Press amp button for 5 seconds till hearing a sound of beep The display screen will show setting data PRECAUTION When you keep pressing button for 2 seconds the display on screen will turn off Please dont care it Keep pressing the amp button till e
31. side 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 O 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 Error Messages and Trouble Shooting About Battery Error 1 The 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 73 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 and Error symbols showing on screen please do 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 _ Error CHECK KEY I Pa N T Code Error 57 Error Messages and Trouble Shoo
32. strips or control solution for a long time You didnt perform the test procedure correctly Malfunction of the meter 54 Caring for Your Meter 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 Keep the test strip port and Smart Code Key base from getting wet 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 About Temperature Error 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 out
33. symbol flashing you are ready to apply the blood sample The Obtaining blood sample code number will appear on the right down corner of the screen mr 1 Hold the lancing device to the soft side of your fingertip and press the I pan release button to get a tiny blood sample AN PRECAUTION i e rror Before appearing please don t touch your blood drop to the sample N PRECAUTION entry on strip because meter is doing a internal test If you do so the Before you take the blood sample please make sure your fingertip for meter will show and Error and you will waste a strip sampling is dry thoroughly Water or alcohol might affect the accuracy of testing PAN PRECAUTION o 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 Code Key to the right one and redo drop of blood The first drop of blood from your fingertip might include a test some bogy 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 three minutes to apply the blood sample before the meter turns off 3 You can start measurement by the second drop of blood automatically
34. tes 4 Precaution 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 e 1 0ul 1 4ul 2 0ul 3 0ul 4 0ul Sample Size Example Rh e o We suggest you to take 1 4 2 5ul to do the test on glucose monitoring system Blood sample size above 4 0ul might 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 About Rightest System The Rightest Blood Glucose Monitoring System 8 The Rightest Meter 10 The Rightest TestStrip s 14 Dummy Code Key mme 16 The Rightest Smart Code Key 17 Being Ready for Test Smart Code Key Installation 18 Batteries Installation d 20 Setting Up Your Meter ss 22 Turning On Off the Meter d 26 Function Screens and Button Operations et 27 Easily Handling the Rightest Test Strip 28 Getting Ready for Testing uses mm 30 JE EEE eee ee 31 Compre
35. ting Limitations About early applying blood sample or control solution Error Store the strips in the original capped vial at temperatures between 4 C to 30 C 39 F to 86 F and The blood sample or contro solution are applied before the meter is ready Repeat relative humidity below 90 Do not freeze the test with a new test strip Add sample after the w symbol appears Rightest Blood Glucose Test strips are designed for using with capillary whole blood and venous I J whole blood samples Do not use serum or plasma samples About Strip Error Er1 N Inaccurate test results may be obtained at high altitude more than about 10000 feet 3048 meters Test strip inserted has been used or damaged Please use a new test strip from vial E above sea level L i i Hematocrit below 30 may cause higher results and hematocrit above 55 may cause lower results About Meter Error Er2 Severe dehydration and excessive water loss may cause inaccurately low results Meter has malfunctioned Do the quality control test or reinstall the batteries to see if Rightest Blood Glucose Monitoring System has not been validated for use on neonates mm 0 EEE I the meter works properly he glucose test may be interfered under abnormal concentration of If error screen still appears contact Bionime Customer Service Uric acid gt 0 54 mmol L gt 9 0 mg dL About Signal Error Er3 L Dopa gt 0 0
36. zed 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 53 Understanding Control Test Results 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 are 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

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