User`s Manual(AST)-P1~79
Contents
1. ce carrier Safe switch Hub ay 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 4 Twist off and set aside the protective cover of the disposable lancet 5 Replace the depth adjustable cap Performing a Blood Test Performing a Blood Test 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 a gt for soft or thin skin amo 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 7 automatically move back to its original position near the hub 8 Wash your hands with warm soapy water and dry thoroughly 9 Take one strip from the vial Re cap the vial cap immediately 10 Insert the strip into the strip port of the meter with the indication symbol facing up The meter confirms the insertion of the strip with a beep Qif volume is turned on L NOTE The meter will automatically detect Code number on strip You don t have to check the Code number on the mete2. Comments Comments 68 69 Log Book Log Book DATE DATE Blood Glucose Breakfast nsulin edication Breakfast Blood Glucose nsulin edicati Blood Glucose Lunch nsulin edication Lunch Blood Glucose nsulin edicati Blood Glucose Dinner nsulin edication Dinner ood B Glucose nsulin edicati Blood Glucose Bedtime nsulin edication Bedtime Blood Glucose Insulin edicati Blood Glucose Other nsulin edication Other Blood Glucose Insulin edicai on Comments Comments 70 71 Log Book Log Book DATE DATE Blood Glucose Breakfast nsulin edication Breakfast Blood Glucose nsulin edicati Blood Glucose Lunch nsulin edication Lunch Blood Glucose nsulin edicati Blood Glucose Dinner nsulin edication Dinner ood B Glucose nsulin edicati Blood Glucose Bedtime nsulin edication Bedtime Blood Glucose Insulin edicati Blood Glucose Other nsulin edication Other Blood Glucose Insu
3. appear The meter is performing an internal test and will display and Error if you apply blood too soon Please repeat the test with a new test strip Record the date of opening a new test strip vial for the first time Discard the vial of test strips after 3 months from opening 30 Discard 4 months aftr first opening Test Strips Discard date _2009 10 01_ Exp Date 2009 11 18 Lot No X10813A Control Solution Range Alternative site testing palm or forearm blood sampling To do the alternative site testing please install the clear cap for your lancing device For detailed information of lancing device please check the instruction manual or the lancing device To increase the blood flow please massage the puncture area of palm or forearm or a few seconds Immediately after massaging the puncture area press and hold the lancing device with the clear cap against palm or forearm Then press the release button Continue holding the lancing device against palm or forearm and gradually increase pressure for a few seconds until the blood sample size is sufficient A eC Pressing for a few seconds HTAR 31 Performing a Test in Order View Window Appearance A PRECAUTION The glucose test results of blood samples taken from different sites might be varied in certain conditions such as your glucose is changing rapidly following a drink a me
4. Log Book Log Book DATE DATE Blood Glucose Breakfast nsulin edication Breakfast Blood Glucose nsulin edicati Blood Glucose Lunch nsulin edication Lunch Blood Glucose nsulin edicati Blood Glucose Dinner nsulin edication Dinner ood B Glucose nsulin edicati Blood Glucose Bedtime nsulin edication Bedtime Blood Glucose Insulin edicati Blood Glucose Other nsulin edication Other Blood Glucose Insulin edicai on Comments Comments 58 59 Log Book Log Book DATE DATE Blood Glucose Breakfast nsulin edication Breakfast Blood Glucose nsulin edicati Blood Glucose Lunch nsulin edication Lunch Blood Glucose nsulin edicati Blood Glucose Dinner nsulin edication Dinner ood B Glucose nsulin edicati Blood Glucose Bedtime nsulin edication Bedtime Blood Glucose Insulin edicati Blood Glucose Other nsulin edication Other Blood Glucose Insulin edicai on Comments Comme
5. items Rightest contRoL SOLUTION pare 25 Test Strips ANON RAR OMN The Rightest Meter The Rightest Meter 5 BIONING GM550 Display Window Show your test result messages and relative information gt Left Button J For operating the meter please check details in following sections 10 Test Strip Port Insert test strip here until you hear a click Main Button For operating the meter please check details in following sections Right Button gt For operating the meter please check details in following sections BIONING Rightest cusso Ze 110 HBA 0021 Battery Cover Slide cover to change batteries Product name Meter Serial Number gt Meter Battery y Backlight Battery 11 The Rightest Meter The Rightest Meter 12 mem No AvG CS OK mmol L OOO Cj CI oO mg dl Kreck Key Code Error Day Honth AM Haia Good ee es mem Indicates a test result stored in memory Tell when to apply the blood sample Indicates a test result not joining into the Average Test stri NO
6. 60 C Test Strip Storage Conditions 39 86 F 4 30 C lt 90 relative humidity 50 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 51 Customer Service Expected glucose values without diabetes 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 If you have any questions or concerns please contact your Bionime authorized representative or call us by toll free at 1 888 481 8485 Monday through Friday 8 00 AM to 5 00 PM PST We will make every effort to provide assistance and solutions for you 52 1 Expected glucose values without diabetes Status Range mg dL Fasting 70 99 References 1 Diabetes Information American Association for Clinical Chemistry AACC Electronic Version Retrieved February 08 2006 from www labtestsonline org understanding analytes glucose test html 53 Parts of Critical Component Log Book Blood Glucose Meter Test Strip and Control Solution Manufacturer Bionime Corporat
7. dL NOTE J Acetaminophen Ascorbic acid Vitamin C Dopamine Ibuprofen L Dopa Methyldopa Salicylic Acid Tetracycline Tolbutamide Bilirubin conjugated Cholesterol Creatinine Triglyceride Maltose Xylose Galactose and Lactose when occurring in normal blood or normal therapeutic concentrations do not significantly affect results However abnormally high concentrations in blood may cause inaccurate results 48 Measurement Technology Oxidase Electrochemical Sensor Measurement Calibration Plasma Sample Capillary whole blood Minimum Sample Volume 1 0 microliters Measuring Range 20 600 mg dL Test Time 5 seconds emory Capacity 500 blood glucose test results with date and time Power Saving Turn off automatically 2 minutes after last user action Press the O button for 4 seconds Operating Temperature 50 104 F 10 40 C Operating Relative Humidity 10 90 49 Specification Warranty f Bionime Corporation warrants that your Rightest Meter will be free from defects in materials and Hematocrit 30 60 workmanship for five years from the date of purchase Power Supply 2 CR2032 batteries Meter Battery Life About 1000 tests Meter Dimension 90 6 mm x 46 mm x 16 5 mm Meter Weight 53 0 5g with batteries Monitor LCD display Display Area 47 mm x 33 5 mm Meter Storage Conditions 14 140 F 10
8. immediately NOTE When meter backlight has no function you cannot see the backilght please change your backlight battery When the backlight battery is runnign out of power your meter still works properly but without backlight function 45 Error messages and Trouble shooting Error messages and Trouble shooting Temperature Error Sampling Error In order to get accurate test result perform testing between 50 104 F 10 40 C Please don t apply the blood drop to the sample entry of the strip before the meter displays If you do so the meter will display Error and accompanied by beeps if volume is turned on Please discard the test strip and repeat the test with a new teststrip 1 When the ambient temperature is 32 48 F 0 9 C or 106 122 F 41 50 C the a warning symbol will be blinking 1a you still can do the test but the test result is only for reference because the test result under these ranges of temperature might not be correct In the memory screen this value will be flagged yi with symbol 1b Repeat the test at an area with temperature between sora Meter Malfunction operating range 50 104 F or 10 40 C If the meter can not be started please follow the steps below 1 Open the battery cover remove the batteries 2 When you move from the area with temperature outside the operating range of 2 Wait for 5 minutes and insert the batteries as described Meter act
9. meter in the carrying case when not in use If meter is dropped or damaged perform a quality control test with the 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 from getting wet Cleaning Test Strip Port If your Test Strip Port 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 quality control test to ensure the system is working properly 43 Error messages and Trouble shooting Error messages and Trouble shooting Er The inserted test strip has been used or damaged Please use a new test strip from vial F r H F F C Er2 Meter has malfunctioned Do the Quality Control Test or reinstall the batteries to check if the meter works properly Er3 Signal transmission is disrupted repeat the test Er4 Applied blood volume is insufficient please repeat the test with a new test strip Erj Er Above if error screen still appears contact your local Bionime Customer Service 44 Battery Error 1 The C3 symbol is blinking when the battery power is low Please change the meter battery as soon as you can You can still do the test 2 The 4 and Error symbols are blinking when the battery is too low Meter can not do the strip test Please change the meter battery
10. will show no figure The Non averaging re averaging function only works in the test mode and when you get the value In the MEM mode you can not perform this action 41 Recalling Test Result and Average Caring for Your Meter 4 Quick Searching If you want to see all values automatically displayed in sequence first enter the memory mode Then keep pressing the right or left button for 2 seconds right button is for searching the tests the latest value to the oldest one by using the left button you can scroll from the oldest to the latest one Anytime you want to stop just release the pressed button It will stop and display the current displayed value You can use this way to find a particular reading you want to check 5 Reading right after test If you just finish the test press the main button to enter the MEM memory screen and review the latest test result NOTE A Your Control Solution results will be automatically non averaged without selecting but still can be recalled The Control Solution Test results will show with CS symbol under memory screen A PRECAUTION You have to set the time and date to activate the average function The g results the Control Solution results and the test result made out of normal temperature range lt 50 F 10 C gt 104 F 40 C are not calculated in the average 42 Maintenance Keep your meter and test strip free of dust water or any other liquid Store the
11. 6 mn l U l ug l mg dL I iu l ULI O g YOg HB g OB wo Non Averaging set and canceled You may select the unwanted or doubtful test results to exclude them from the average calculation after your every test After you finished your test in the test mode you can exclude the unwanted result Keep pressing the right butten until you see the symbol NO AVG in the top right cornetr of the screen By keeping the right button pressed and pressing the main button simultaneously to confirm the value as Non average Now this value is flagged by the symbol NO AVG in the up per right corner of the screen If you want to cancel this non averaging setting you have to stay in the test mode First keep pressing the right button until the NO AVG symbol changes to AVG in the up per right corner of the screen To confirm this original status you again simultaneously press the main button to confirm the AVG status Now the value will be stored as a regular value and included in the average values NOTE L The average function is related to the time setting You must set the time right and have enough time intervals on the basis of current inquiry time to make sure that the average test results will show Use the 14 day average for example if your current inquiry time is 2008 1 30 then that you must check that you have tested blood glucose in the past 14 days before 1 30 including today If not the 14 day average
12. AVG function of this meter w o P Indi ith th Warns when using the strip not suitable for your AVG ndicates with the average result CodeError region test or strip error indicates a control sclutionstest result Day Month Current date under time mode or Testing date cs Af aa under memory mode mmol L A Indicates if the environmental temperature is mg dL Unit of test result exceeded during testing 888 Test result aM Indicates the time in 12H format m Warns when the battery is low or must be replaced Current time under time mode or Testing time under memory mode OK EN Check Key Manufacturing use only The Rightest Test Strip The Rightest Test Strip The Rightest Blood Glucose Meter GM550 can only be used with the Rightest Blood Glucose Test Strips GS550 The application of other Test Strips or control solutions can lead to incorrect results Sample Entry Apply a drop of blood or control solution here The test request is only 1 0 uL of blood J Maca Noble Metal Electrodes reg ee Hand Bar l Electrochemical sensor mac Grip here to insert OJO Doc test strip into meter Indication Symbol View Window Insert strip with indication symbol up and toward meter This window is yellow before applying blood sample It gradually turns red when filled with blood 14 Electrode Contacts Sensing signal output terminals PRECAUTION Re cap the te
13. 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 palm and forearm 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 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 toll free at 1 888 481 8485 Monday through 2 Friday 8 00 AM to 5 00 PM PST We will make every effort to provide assistance and solutions for yo
14. 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 4 Not to be exposed dripping or splashing The minimum blood sample size of Rightest Glucose Monitoring System is 1 0ul e Sample Size Example 1 0uL 1 5uL 2 0uL 3 0uL 4 0uL e Please take a minimum of 1 0ul to do the test on glucose monitoring system Blood sample size above 3 0ul might contaminate the test strip port and the meter Blood sample size below 1 0ul might cause inaccurate test result or might not start on meter measurement In this case repeat the test with a new test strip A PRECAUTOIN The meter will be set to mg dL by default when sold in the United States When your display shows mmol L during setting or test please contact customer service Use of the wrong unit of measure may cause you to incorrect treatment Table of Contents Table of Contents About Rightest System The Rightest Blood Glucose Monitoring System The Rightest Meter The Rightest Test Strip Being Ready for Test Meter activation and Battery change Setting Up Your Meter Setting the Time Volume and Date Turning On Off the Meter Turning On Off the Backlight Easily Handling the Rightest Test Strip Testing Procedure Getting Ready for Testing Performing a Blood Test View Window Appearance Comprehendin
15. al an insulin dose or exercise In these cases only fingertip should be used DO NOT test on the palm or forearm if you are testing for hypoglycemia Low blood glucose Fingertip samples can show the rapid change of glucose faster than palm or forearm samples Consult with your healthcare professionals whenever you want to conduct a sampler from palm or forearm As the blood flow taken from forearm is slower than fingertip or palm we recommend using a special lancing device with Clear Cap for testing sites other than finger If you use normal lancing device for palm or forearm the blood sample might be not enough for meter Please periodically compare the test system to a laboratory test system known to be well maintained and monitored by a healthcare provider 32 Make sure your blood sample covers the whole area of the View Window to get an accurate test result An insufficient blood sample will a result in an error message Er4 If this occurs 5 repeat the test with a new test strip O J O Insufficient blood sample Enough blood sample A PRECAUTION 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 Do the test at least 30 minutes after while entering another site with different ambient temperature 33 Comprehending Test Results and Messages Comp
16. d Type Diabetes l yp Lam a diabetes patient If you Do you have Type Type II Gestational Have you owned a blood glucose monitor before Yes No i find me in a coma or stupor Which brand s were you most recently using MDoctor Hospital please take me to the Will the Rightest meter be your primary monitor Yes No hospital on left side Or call 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 Blood Rightest Glucose Monitoring System BIONING Please fill this card and carry with you at anytime 78 79
17. essing quickly the main button 1 Year setting Dy With the year format blinking press the Left or Right button to adjust it Then P UH press the Main button to confirm it Meantime it will shift to next digit for setting Repeat the above action until the year setting is completed Then it will move to Month setting PAP E HH 2 Month setting 2 r I With the month blinking press the Left or Right button until the current month Cc 4 nN aa 3 Day setting appears Then press the Main button to confirm it and move Day setting With the day blinking press the Left or Right button until the current day appears Then press the Main button to confirm it and move to Time format 3 Day Month Setting Up Your Meter Setting the Time Volume and Date Setting Up Your Meter Setting the Time Volume and Date 4 Time format 12 24H selection 4a 4b With the time format blinking press the Left or Right button _ to adjust it Then press the Main button to confirm it and move to hours setting fo PYH Day Month Day Month 5 Hour setting amp 9 ieii D 9 ied With the hour blinking press the Left or Right button until the current hour appears Then press the Main button to 5 Day Month wy confirm it and move to minute setting 6 Minute setting g nn L amp 9 200 6 With the minute blinking press the Left or Right button to adjust it Then press the Main button to c
18. g Test Results and Messages 10 14 16 18 22 23 24 26 27 33 34 Quality Control Quality Control Test Performing a Quality Control Test Review Your Test Memory Recalling Test Result and Average Caring for Your Meter Error Messages and Trouble Shooting Limitations Specification Warranty Customer Service Expected glucose values without diabetes Parts of Critical Component Log Book Warranty Card Emergency Card 36 38 40 43 44 48 49 51 52 53 54 55 76 79 The Rightest Blood Glucose Monitoring System The Rightest Blood Glucose Monitoring System Package of System Kit 1 2 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 Getting Started Guide User s Manual includes Log Book Warranty Card Emergency Card Rightest Blood Glucose Test Strip Package Insert Control Solution Package Insert Rightest Meter with 2 CR2032 batteries installed Rightest Test strips 0 10 25 pcs Rightest Control Solution Rightest GD500 Lancing Device 9 Clear Cap 10 Disposable Sterile Lancets 10 pcs 11 Carrying Case not shown 12 Instruction for the lancing device not shown x Different packages have different bundled items Some of packages might not include
19. in the Control Solution Range printed on the strip vial label the Rightest Blood Glucose Monitoring System passes Quality Control Test That means your Rightest Blood Glucose Monitoring System is working correctly Control Solution Range Control Solution Range mg dL Example of Control Solution Range a oe printed on your test strip vial label Te When should a Quality Control Test be performed To ensure that your meter and test strips are working together properly To confirm that you are following the correct procedure To prepare for your initial blood glucose test To check the test strips when you open a new vial of strips To check your meter after it has been dropped damaged or exposed to liquids When you suspect that your test results are inaccurate or if your test results are not consistent with the way you feel 36 NOTE If you want to purchase new normal or high level control solutions please contact your authorized Bionime representative The possible reasons your Control Solution results are out of the range Your Control Solution has expired or has been opened 3 months ago Your test strip has expired You left the cap of the tst strip vial opened or the control solution off for a long time You didn t perform the test procedure correctly Malfunction of the meter or the test strip If Control Solution results are out of range you
20. ion N Product complied with In Vitro Diagnostic Medical Device Directive 98 79 EC CE0197 mame EC Rep Bionime GmbH Tramstrasse 16 9442 Berneck Switzerland Address Lancing Device Home Phone Work Phone Manufacturer Bionime Corporation Product complied with Medical Device Directive 93 42 EC Doctor Doctor s Phone EC Rep Bionime GmbH Tramstrasse 16 9442 Berneck Switzerland l Pharmacy Pharmacy Phone Disposable Sterile Lancets Insulin Pills Log book date From a O Manufacturer SteriLance Medical Suzhou Inc Product complied with Medical Device Directive 93 42 EEC CE0197 EC Rep Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands 54 In case of emergency contact 55 Log Book Log Book DATE DATE Blood Glucose Breakfast nsulin edication Breakfast Blood Glucose nsulin edicati Blood Glucose Lunch nsulin edication Lunch Blood Glucose nsulin edicati Blood Glucose Dinner nsulin edication Dinner ood B Glucose nsulin edicati Blood Glucose Bedtime nsulin edication Bedtime Blood Glucose Insulin edicati Blood Glucose Other nsulin edication Other Blood Glucose Insulin edicai on Comments Comments 56 57
21. ivation and Battery change test strip to another area with temperature inside operating range of test strip wm on page 16 17 please wait for 30 minutes before you do the test ILI 5 pag 3 When the temperature is below 32 F 0 C or over 122 F 50 C Meter can not do 2009 The meter should be working normally after finishing above steps If not please contact your local Bionime customer service the test and the Error symbol will blink with thermograph symbol displaying on screen in this condition Please move the meter to environment with temperature 3 between 50 104 F 10 40 C and repeat the test after 30 minutes 46 47 Limitations Specification Store the strips in the original capped vial at temperatures between 39 F to 86 F 4 C to 30 C and relative humidity below 90 Do not freeze Rightest Blood Glucose Test strips are designed for using with capillary whole blood samples Do not use serum or plasma samples 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 60 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 2 10 0 mg
22. lin edicai on Comments Comments 72 73 Log Book Log Book DATE DATE Blood Glucose Breakfast nsulin edication Breakfast Blood Glucose nsulin edicati Blood Glucose Lunch nsulin edication Lunch Blood Glucose nsulin edicati Blood Glucose Dinner nsulin edication Dinner ood B Glucose nsulin edicati Blood Glucose Bedtime nsulin edication Bedtime Blood Glucose Insulin edicati Blood Glucose Other nsulin edication Other Blood Glucose Insulin edicai on Comments Comments 74 75 Warranty Card Warranty Card Name Tel Distributor name and address Address Serial No Model Date of purchase Please present this card for replacement purpose Limited warranty 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 a
23. lly if you don t operate it over 10 seconds 23 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 A Inserting the test strip 1 Hold the test strip between thumb and middle finger with indication symbol facing up 2 Put forefinger on the side of strip as shown 2 Rotate the test strip counterclockwise and pull up at the same time NOTE NOTE This is the easiest way to insert the strip a i Pulling the strip in a counterclockwise direction will make it easier to remove it from the meter 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 Test Strip Port will not be contaminated by blood if you follow the step correctly Bionime _GMss0 C 24 Getting Ready for Testing Performing a Blood Test Before performing a blood glucose test you have to prepare the items below Rightest Blood Glucose Meter 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 26 Depth adjustable cap oe button
24. nd 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 76 N w y a PLACE STAMP Distributor name and address HERE 77 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 EMERGENCY CARD Bl O N l MMe Blood Glucose Monitoring System Phone Number Healthcare Professional Who Recommended City Country i User Name Store Pharmacy Name Where Purchased City Country e User Phone No Date of Purchase Model No Serial Lot No Bloo
25. nts 60 61 Log Book Log Book DATE DATE Blood Glucose Breakfast nsulin edication Breakfast Blood Glucose nsulin edicati Blood Glucose Lunch nsulin edication Lunch Blood Glucose nsulin edicati Blood Glucose Dinner nsulin edication Dinner ood B Glucose nsulin edicati Blood Glucose Bedtime nsulin edication Bedtime Blood Glucose Insulin edicati Blood Glucose Other nsulin edication Other Blood Glucose Insulin edicai on Comments Comments 62 63 Log Book Log Book DATE DATE Blood Glucose Breakfast nsulin edication Breakfast Blood Glucose nsulin edicati Blood Glucose Lunch nsulin edication Lunch Blood Glucose nsulin edicati Blood Glucose Dinner nsulin edication Dinner ood B Glucose nsulin edicati Blood Glucose Bedtime nsulin edication Bedtime Blood Glucose Insulin edicati Blood Glucose Other nsulin edication Other Blood Glucose Insulin edicai on C
26. omments Comments 64 65 Log Book Log Book DATE DATE Blood Glucose Breakfast nsulin edication Breakfast Blood Glucose nsulin edicati Blood Glucose Lunch nsulin edication Lunch Blood Glucose nsulin edicati Blood Glucose Dinner nsulin edication Dinner ood B Glucose nsulin edicati Blood Glucose Bedtime nsulin edication Bedtime Blood Glucose Insulin edicati Blood Glucose Other nsulin edication Other Blood Glucose Insulin edicai on Comments Comments 66 67 Log Book Log Book DATE DATE Blood Glucose Breakfast nsulin edication Breakfast Blood Glucose nsulin edicati Blood Glucose Lunch nsulin edication Lunch Blood Glucose nsulin edicati Blood Glucose Dinner nsulin edication Dinner ood B Glucose nsulin edicati Blood Glucose Bedtime nsulin edication Bedtime Blood Glucose Insulin edicati Blood Glucose Other nsulin edication Other Blood Glucose Insulin edicai on
27. onfirm it eantime it will shift to next digit for setting Repeat the above action until the minute setting is completed Then it will move to volume setting 7 Volume setting With the volume blinking press the Left or Right button to turn it on or off Then press the Main button to confirm and L LI L L L L finish the settings va T cD ca 7a 7 20 8 Ending setting After volume settings for confirmation you will hear a beep if volume is turned on All the settings are saved and completed and will return to time screen If Volume is turned off the display will directly return to time screen without a sound of beep Day Month b 9 cod NOTE When you do not do any settings of meter for over 2 minutes the meter will leave setting mode and power off automatically 21 Turning On Off the Meter Turning on off the Backlight 1 How to turn on the Meter Press the Main button or Insert a test strip 2 Manual Power off If you want to turn off the meter please keep pressing the Main button for 4 seconds 3 Auto Power off The meter will power off automatically if you don t operate it over 2 minutes 22 1 How to turn on the Backlight Keep pressing the Main button for 2 seconds 2 Manual Backlight off If you want to turn off the backlight please keep pressing the Main button for another 2 seconds 3 Auto Backlight off The meter backlight will turn off automatica
28. our meter setting the time volume and date Test results are still stored in the memory PRECAUTION Please follow the local regulation and discard a used battery properly 17 Setting Up Your Meter Setting the Time Volume and Date Setting Up Your Meter Setting the Time Volume and Date You can enter Setting Mode by below two ways 1 Reload battery After removing the battery please press the main button for several times until no signal on screen then follow the battery installation steps to load batteries The meter will do self test Press the main button to exit the self test and enter Setting Mode 2 With Battery inserted Press the main button first to turn on the meter Then press and hold the main button for 7 seconds the meter will first show backlight then be turned off during this period please keep pressing until you hear a beep indicating you have successfully entered Setting Mode The display screen will show setting data L NOTE When you keep pressing the main button for 2 seconds the display on screen will show backlight Keep pressing the main button till display is off When you keep pressing the main button for 4 seconds the display on screen will turn off Please don t care it Keep pressing the main button till entering setting data Quick press the main button allows you to change setting However if you want to return to the time mode you need to go through all the settings first by pr
29. r Rightest Blood Glucose Monitoring 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 Blood Glucose Monitoring System to test your blood glucose and contact your Bionime Customer service i Example of Expiration Date Z PRECAUTION Each time you open a new bottle of Control Solution write the discard date on the label Control Solution is good for 3 months after opening the bottle or until the expiration date printed on the label whichever comes first Exp Date 2010 06 37 Performing a Quality Control Test Performing a Quality Control Test 2 Insert the test strip with view window facing up into test strip port 3 While the blood drop symbol flashing press and hold the main button for over 3 seconds until the CS symbol appears 4 You will see blinking symbol and CS symbol symbol on the screen prompting you to apply Control Solution 5 Shake the bottle of Then open the bott 6 Drip a drop of Control Solution on the top of the cap 7 Gently touch samp top of the cap Take one test strip from vial and Re cap the vial cap immediately Control Solution well before opening the cap e and put the cap on the table e entry of the strip with the Control Solution on the 8 When you hear a beep if volume i
30. r display and strip vial 28 11 12 13 14 A blood drop symbol appears and is accompanied by a further beep if volume is turned on Now you can apply the blood sample within 2 minutes Place the lancing device against your f the release button Touch and hold the drop to the edge o you hear a beep if volume is turned ingertip and sample en on and the press ry until View Window is totally filled with blood If the View Window is not totally filled with blood or the test does not start please discard the test strip and repea test strip the test wit hanew You will see the countdown mode on the screen A seconds the test result appears ter 5 29 Performing a Blood Test Performing a Test in Order 15 Pull off the depth adjustable cap Without touching the used disposable lancet stick the lancet tip into the protective cover 16 Holding the release button in one hand see picture 16 step 1 and pulling on the plunger in the other hand see picture 16 step 2 will safely eject the used disposable lancet 17 Discard the used disposable lancet into an appropriate puncture proof or biohazard container 18 Replace the depth adjustable cap after finishing the test A PRECAUTION Do not apply your blood drop to the sample entry on the strip until you see the ww
31. rehending Test Results and Messages Blood glucose test results are shown on the meter as mg dL 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 Control Solutions to check your meter and strip Refer to page 36 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 34 The Rightest Meter displays results between 20 and 600 mg dL If your test result is below 20 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 600 mg dL Hr will appear on the screen Please repeat your test again by a new strip If you still get Hy result you should immediately contact your healthcare professional LO mg gR 35 Quality Control Test Quality Control Test Please use normal or high level control solutions tested with Rightest Blood Glucose Monitoring System under Control Solution Mode If the test result is with
32. s turned on please wait for the test result The screen will display 38 he countdown number from 5 9 Tightly replace the cap on the Control Solution bottle 10 The Control Solution result appears Compare your Quality Control Test result to the Control Solution Range printed on the test strip vial label Z PRECAUTION Your Control Solution results will not be calculated for average reading but still can be recalled The Control Solution Test result will be shown with CS symbol on the screen Our suggestion environment for Control Solution Test is 59 104 F 15 40 C Before and CS appears please don t touch the Control Solution to the sample entry on strip because the meter is still in an internal check If you do so the meter will show jw and Error Accompanied by beeps if volume is turned on Don t drip the Control Solution to sample entry of the strip directly The reagent on strip might be sucked into the bottle of Control Solution and might cause the degeneration of Control Solution Doing this might contaminate the meter via the test strip port as well Don t touch the tip of the control solution bottle If you have touched it please clean up with water 39 Recalling Test Result and Average Recalling Test Result and Average The Rightest GM550 Meter is able to store 500 test results with time and date automatically If your meter has stored 500 results
33. st strip vial immediately after taking out a test strip Do not reuse test strips Do not use expired test strips Record the date of opening a new test strip vial for the first time Discard the vial of test strips after 3 month from opening Store the test strips in a cool 39 86 F or 4 30 C and dry location lt 90 relative humidity Do not expose to direct sunlight or heat For detailed information please refer to the Rightest Test Strips Package Insert If the Rightest meters and strips are exposed to a high temperature difference please wait 30 minutes before measurement Meter activation and Battery change Meter activation and Battery Change Your meter comes with two CR2032 3volt batteries installed Two new batteries will provide power to perform about 1000 tests under normal use You can press the main button or insert a strip to activate your meter L NOTE When meter backlight has no function you cannot see the backlight please change your backlight battery When the backlight battery is running out of power your meter still works properly but without backlight function 16 3 Slide the battery cover push batteries cover to open put battery in correct direction back until it snaps into place 4 The meter performs a self test 5 Press any button to exit the self test and enter Setting Mode 6 Set the time and date when the batteries are replaced See Chapter Setting up y
34. u Healthcare professional should be contacted when the authorized representatives are not available 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 36 Please do the quality control test regularly to make sure the test results are accurate The Rightest Blood Glucose Meter GM550 can only be used with the Rightest Blood Glucose Test Strips GS550 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 from the fingertip palm and forearm 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 neonates 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
35. which is the maximum memory of the meter the newest test result will replace the oldest one To recall your test memory start the meter without test strip inserted 1 Press the main button to switch from the time mode to the Memory screen First you will see the MEM symbol on the up per left corner of the display When you press the right button the latest result will be displayed By pressing the right button sequentially former test results will be shown in historical order You will see the sequence number on the lower right corner and the year on the lower left corner of the display followed by date and time of the measurement Note The right button is for reviewing the tests with sequence number increasing and the left button is for reviewing tests with sequence number decreasing The sequence no 1 is the latest result while sequence no 500 is the oldest test result 2 To finish reviewing memory tests press main button again and you will enter the Average screen By pressing the right button the display shows AVG on the upper right corner of the display and the average value for the actual day By sequencely pressing the right or left button you will get to the 1 days 14 days 30 days and 90 days average of your blood glucose values You will see the number of the calculated days on the lower left corner and the number of the calculated readings on the lower right corner 40 AVG AVG AVG AVG AVG mn 5 m g mm 6
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