TABLE OF COnTEnTS - Dex Medical Inc.
Contents
1. PUTTING IN OR REPLACING THE BATTERIES The Bravo Meter comes with two 3 0 V lithium batteries Before using the meter check the battery compartment and insert batteries if empty When the icon appears on the display for the first time the battery should be replaced as soon as possible The test results might not be saved if the battery runs out Make sure the meter is turned off Push the cover in the direction of the arrow to open the battery compartment Remove the old batteries one by one by lifting with the index finger and pulling with your thumb and index fingers as shown in the figure on the right Insert two new batteries with the side facing up and make sure the batteries are inserted firmly Place the cover on the battery compartment Push down until you hear the tab click into place Removing the meter batteries will not affect your stored result However you may need to reset your meter settings See pages 12 15 38 Bra VO BLOOD GLUCOSE MONITORING SYSTEM WHAT TO DO Repeat the test after inserting a new test strip Repeat test after Inserting a Bravo test strip Do not use the meter Contact your authorized Endomedical sales representative WHAT IT MEANS The blood sample has abnormally high viscosity or insufficient volume This error message may appear when the wrong blood glucose test strip is used instead of Bravo blood glucose tes2. 0 sar a Boag m ave ESTE E p mmol L mg dL are 5 aye Month real unit for measuring Alarm icon Hour Minute blood glucose appears when the post meal alarm has been set Blood insertion icon indicates meter is ready for the application of a drop of blood or control solution Your meter has been preset and locked to display results in mmol L millimoles of glucose per liter In some countries the meters are preset to display unit in mg dL milligrams of glucose per deciliter Check your display to ensure that results are being displayed in mmol L If they are not contact Endomedical at 1 800 282 6542 www endomedical ca 11 BRAVO GLUCOSE METER Data Port Used to transfer data from the meter to a computer with a cable Display Shows results alarm mem 04 check messages ouo Selects or changes information mmol L mg dL at lt CHEE QC Turns the meter on off 1211 1 121121 ave 2000 001 Pm and confirms menu selections v Button Selects or changes information Test Strip Port Insert test strip here The cable for data transmission to PC can be ordered separately Please contact your authorized Endomedical sales representative or visit www endomedical ca 10 Bra VO BLOOD GLUCOSE MONITORING SYSTEM SETTING UP YOUR SYSTEM Press and hold the S button for 3 seconds to enter the SET amp Set
3. 24 Applying Blood Sample 0000000 25 Discarding Used Lances 27 Alternative nn 28 HI and Lo IMGSSA0 eneen 31 Target Blood Glucose Ranges 6 0 32 Additional Functions Meter 00 esse 33 Viewing Test Results Stored in the Meter s 33 Setting the Alarm 35 Setting the Post meal Alarm PP2 alarm 35 Setting the Time Alarm alarm 1 3 0000 36 Maintenance Putting in or Replacing the Batteries ccsssssesseeeeeeeeeeeeeeeeeeeaes 38 Caring 39 Understanding Error and Other Messages ssceeeeeeeeeeeeeeeeeeaes 40 General Troubleshooting 00060000006006 02 Performance Characteristics 03 0 0 47 www endomedical ca 3 IMPORTANT INFORMATION e The Bravo Blood Glucose Monitoring System is intended for self testing outside the body in vitro diagnostic use e The glucose in th
4. On pressing A or Y the screen will display On or OFF Press the S button to confirm the selection The meter will beep in the following instances if set to On e When the test strip is inserted in the meter e When the blood sample is absorbed into the test strip and the test starts e When the test result is displayed When you push the 5 button or A button to turn on the meter e When you push the A button to set the post meal PP2 alarm e When it is time for a preset blood glucose test If the sound is set to OFF none of the sound functions will work Only when the sound is set to OFF icon appears on the display www endomedical ca 15 O Setting the Hour Press A or V until the correct hour appears After the hour is set press the S button to enter the minute setting mode Setting the Minute Press A or W until the correct minute appears After setting the minute press the S button to enter the sound setting mode 14 Bra VO BLOOD GLUCOSE MONITORING SYSTEM You may check your meter and test strips using the Bravo Control Solution control A and or B The Bravo Control Solution contains a known amount of glucose and is used to check that the meter and the test strips are working properly The test strip vials have Bravo Control Solution ranges printed on their labels Compare the result displayed on the meter to the Bravo Control Solution range printed on the test s
5. after the meter counts down from 5 to 1 The result will be automatically stored in the meter s memory If the test strip is removed after the test result is displayed the meter will automatically switch off after 3 seconds Discard used test strips safely in disposable containers E Place protective cover on lancet Push the lancet ejector forward with the thumb and simultaneously pull out the sliding barrel to dispose of the used lancet in a proper biohazard container The lancet is for single use only Never share or reuse a lancet Always dispose of lancets properly 26 Bra 76 BLOOD GLUCOSE MONITORING SYSTEM www endomedical ca 27 THINGS TO KNOW WHEN USING AST Please understand the following things before testing outside of the fingertip arms palm thighs calves The capillary blood of the fingertip shows the change in glucose more rapidly than AST Therefore the test results from the fingertip test and AST may differ This is because things such as lifestyle and ingested food have an effect on glucose levels Vacuum assisted lancing devices are useful in collecting blood from alternative sites It is possible to use regular lancing devices for alternative sites by piercing deeper than when sampling from fingertips and pressing slightly against the skin ACCEPTABLE SITUATIONS FOR AST e Fasting period e Before a meal SITUATIONS REQUIRING FINGERTIP TEST e When the glucose levels are rapidly
6. changing during the two hours after a meal insulin dose or exercise e When sick or when glucose levels seem quite lower than test value e When hypoglycemia is not well recognized hypoglycemic unawareness e When insulin has the biggest effect e 2 hours after an insulin injection e If you think your blood glucose is low e If you think you will be driving a car or operating machinery www endomedical ca 29 ALTERNATIVE SITE TESTING What is Alternative Site Testing AST Usually when someone tests their glucose they take the blood sample from the tip of the finger However since there are many nerve endings distributed there it can be quite painful When doing a glucose test using different parts of the body such as the arms palms thighs and calves can reduce the pain during testing This method of testing with different parts of the body other than the fingertips is called Alternative Site Testing While AST may reduce the pain during testing it may not be simple for everyone and the following precautions should be observed during testing Alternative Site Blood Sampling forearm palm thigh calf Select a clean soft and fleshy sample site area free of visible veins and hair and away from bones Gently massage the sample site to help blood circulation to minimize result differences between fingertip and alternative site sampling Firmly press and hold the lancing device against site Wait until the skin surface
7. on the meter to the range printed on the test strip vial The result should fall within that range Used strips should be discarded safely in disposable containers CONTROL SOLUTION RANGE SOLUTIONS DE CONTROLE Control A Contr le A 5 8 8 4 mmol L Control B Contr le B 10 2 15 3 mmol L c ard 6 months after first opening Jeter 6 mois apr s o card Date te se rej 182144 The range printed on the test strip vial is for the Bravo Control Solution only It does not have any connection to your blood glucose level The Bravo Control Solution can be purchased separately Please contact your authorized Endomedical sales representative www endomedical ca 19 e f the meter or test strips do not function properly If your symptoms are inconsistent with the blood glucose test results and you feel that the meter or test strips are not working properly e If you drop or damage the meter CONTROL SOLUTION TESTING Insert a test strip into the meter s 6 test strip port with the contact bars facing upwards Gently push the test strip into the port until the meter beeps Be careful not to break the strip while pushing it in The cmm symbol will be displayed on the screen Shake the Bravo Control Solution bottle before each test Remove the cap and squeeze the bottle to discard the first drop Then wipe the tip with a clean tissue or cloth After the gt symbol
8. seconds 1 1 to set the post meal alarm The ae an PP character the bell a icon eee and then the On character will A OS Dw Hari On be displayed The screen will then automatically change to the memory check mode At this time the bell a icon indicating that the PP2 alarm has been set will be displayed on the screen Setting the PP2 alarm OFF r r To turn off the PP2 alarm press and hold A for 3 seconds The al al PP2 character the bell a icon mmol and then the OFF character 200 On pressing Y the latest test result saved in the will appear on the screen meter s memory will be displayed on the screen Then the screen will change A Icon vanishes along with the date and time Press and hold to automatically to the memory scroll through the test results check mode without the bell a icon being displayed 34 Bra VL BLOOD GLUCOSE MONITORING SYSTEM www endomedical ca 35 On pressing A the number indicating the minute will start blinking Press W to set the accurate minute Press the S button to finish and to enter the alarm 2 mode Repeat steps 2 to 5 to set the remaining time alarms alarm 2 3 Press the S button for 3 seconds to finish and turn the meter off www endomedical ca 37 SETTING THE TIME ALARMS ALARM 1 3 ihour inserting a test strip press A and the S button simultaneously for 3 seconds to
9. under the lancing device changes color Then press the release button while continuing to apply pressure Keep holding the lancing device against your skin until sufficient at least 0 5 uL actual size blood is drawn Carefully lift the lancing device away from your skin 28 Bra 76 BLOOD GLUCOSE MONITORING SYSTEM AST PRECAUTIONS HI AND LO MESSAGES e Do not ignore the symptoms of hyperglycemia or HI Message hypoglycemia The meter displays results between 1 1 e When the results of the test do not reflect your opinion 33 3 mmol L HI appears when the retest using the fingertip test If the test results do not blood glucose level is more than 33 3 reflect your opinion please consult your healthcare mmol L and indicates hyperglycemia professional e Do not rely on the AST results for changing your If the HI is displayed again on treatment method retesting please contact your e The amount of glucose in alternative sites differs from healthcare professional immediately person to person Before using AST please consult your healthcare professional Lo Message Lo appears when the result is less than 1 1 mmol L and indicates hypoglycemia If the Lo is displayed again on retesting please contact your healthcare professional immediately Results from alternative site and fingertip samples may differ from each other as there is a time lag for the glucose levels to reach the same value Use a fingertip for drawing i
10. TABLE OF CONTENTS Information Important Information 4 1 1212 1 1 14 0000 6 Bravo Blood Glucose Monitoring 51 7 Bravo Blood Glucose Test Strip 66 66000066666 8 Bravo Blood Glucose Meter 10 Bravo Blood Glucose Meter Display 0 11 Preparation Setting UP Your SV pueis indadari EN 12 Adjusting the Date and TIME 12 Setimg the Sound Ol OPP 15 Setting the Test Result Reset 01010 16 Checking the Syste css nos cadsaicesaceencatetaon rain akaa Rin ARANEA 17 Control Solution Tes UM sessar enee Ees aree 18 Comparing the Control Solution Test ReESUItS ccscceceeeeeeeeeeeeeeeeeseeaneas 20 Testing Using the Lancing 6 21 Preparing the Lancing DEviCE sonici 22 Preparing the Meter and Test 518 00 66 66 0 6666 24 Flagging Post inGal Test Results
11. UCOSE MONITORING SYSTEM www endomedical ca 43 PRECISION Precision The precision studies were performed in a laboratory using Bravo BGM Systems Within Run Precision Blood avg 2 8 mmol L SD 0 1 mmo L Blood avg 5 1 mmol L SD 0 2 mmo L Blood avg 7 8 mmol L CV 2 4 Blood avg 11 3 mmol L CV 2 9 Blood avg 19 2 mmol L CV 2 9 Total Precision Control avg 2 6 mmol L SD 0 1 mmol L Control avg 7 6 mmol L CV 3 1 Control avg 18 7 mmol L CV 3 5 This study shows that there could be variation of up to 3 5 44 Bra VL BLOOD GLUCOSE MONITORING SYSTEM www endomedical ca 45 46 Brav BLOOD GLUCOSE MONITORING SYSTEM
12. appears on the display apply the solution to the narrow edge of the test strip until the meter beeps Make sure the confirmation window fills completely The meter may switch off if the control solution sample is not applied within 2 minutes of the lt CHEF symbol appearing on the screen If the meter turns off remove the strip reinsert and start from step 1 18 Bra 76 BLOOD GLUCOSE MONITORING SYSTEM USING THE LANCING DEVICE Comparing the Control Solution Test Results You will need a lancing device in order to collect a blood The test result of each control solution should be within the sample range printed on the label of the test strip vial Repeat the You may use the lancing device contained in the Bravo Blood control solution test if the test result falls outside of this range Glucose Monitoring System or any other medically approved Out of range results may occur due to the following factors lancing device Situations Actions When the control solution bottle was Repeat the control Adjustable Tip Ejection System not shaken well solution test by Lancet Holder e When the meter test strip or the referring to the control solution were exposed to high Notes on page or low temperatures 17 e When the first drop of the control Lancet Sliding Barrel solution was not discarded or the tip Release Button of the bottle was not wiped clean e When the meter is not functioning l 0 l properly e The lan
13. cing device is intended for self testing by a single patient It must not be used on more than one person due to risk of infection e Use a soft cloth or tissue to wipe the lancing device If necessary a small amount of alcohol on a soft cloth or tissue may be used e When the control solution is past the Discard the used expiration date printed on the bottle control solution e When the control solution is past its and repeat the test discard date the date the bottle was using a new bottle opened plus three 3 months of control solution e When the control solution is To avoid infection when drawing a sample use contaminated a lancet only one time and e Do not use a lancet that has been used by others e Always use a new sterile lancet Keep the lancing device clean If results continue to fall outside the range printed on the test strip vial the Bravo Test Strip and Meter may not be working properly Do not use your system and contact Endomedical sales representative Repeated puncturing at the same sample site may cause pain or skin calluses thick hard skin Choose a different site each time you test 20 Bra VO BLOOD GLUCOSE MONITORING SYSTEM www endomedical ca 21 PREPARING THE LANCING DEVICE 4 Select a desired depth of one to five 1 5 on lancing device s adjustable tip Rotate ring to align desired number with arrow A beginning setting of three 3 is recommended Wash
14. e blood sample mixes with special chemicals on the test strip to produce a small electrical current The Bravo Meter detects this electrical current and measures the amount of glucose in the blood sample e The Bravo Blood Glucose Meter is designed to minimize code related errors in monitoring by using the no coding function e The Bravo Blood Glucose Meter should be used only with the Bravo Test Strip e An abnormally high or low red blood cell count hematocrit level over 60 or below 20 may produce inaccurate results e If your test result is below 3 3 mmol L or above 13 3 mmol L consult a healthcare professional immediately e The Bravo Meter and lancing device are for single patient use Do not share them with anyone including other family members e Inaccurate results may occur in severely hypotensive having low blood pressure individuals or patients in shock Inaccurate low results may occur for individuals experiencing a hyperglycemic high blood sugar or hyperosmolar state with or without ketosis Critically ill patients should not be tested with blood glucose meters If you need assistance please contact your authorized Endomedical sales representative or visit www endomedical ca for more information www endomedical ca 5 IMPORTANT INFORMATION READ THIS FIRST To receive safe and optimum system benefits please read the entire manual contents before using the system Please note the f
15. e of 0 5 uL Flagging Post meal Test Results The meter allows you to flag a result of a post meal test with ff icon The post meal test flag ff can be attached just before applying the blood sample Once you attach the post meal flag ff to the test results it cannot be deleted D If you want to attach a post meal flag f to a test result press and hold for 3 seconds after inserting the test strip The post meal flag ff and the CHEZ symbol will appear on the screen The test result will also be filled before the meter finishes o Ee OE AA counting down then discard A i insert a n If you do not want to save the the test strip and insert a new 4 N one result as a post meal test move 5 After the aE symbol appears on the screen apply the blood sample to the narrow end of the test strip till the meter beeps If the confirmation window is not If confirmation window is on to the step 8 after the step 6 wat dled ine me becie of abnormal viscosity or Coon insufficient volume Er4 Sample Sample message will appear 24 Bra VO BLOOD GLUCOSE MONITORING SYSTEM www endomedical ca 25 DISCARDING USED LANCETS Unscrew lancing device tip The meter may switch off if the blood sample is not applied within 2 minutes of the cmm symbol appearing on the screen If the meter turns off remove the strip reinsert it and start from step 6 0 The test result will appear
16. enter the time alarm mode The alarm1 will be displayed while the OFF blinks on the screen 6 On pressing the alarm1 is set and the On is displayed on the screen Press W again to cancel the alarm1 The OFF will blink on the screen Press A to adjust the time of the alarm1 A number representing the time will blink on the screen Press W to set the time Press A to end 36 Bra VL BLOOD GLUCOSE MONITORING SYSTEM CARING FOR YOUR SYSTEM Use a soft cloth or tissue to wipe the meter exterior If necessary the soft cloth or tissue might be dipped in a small amount of alcohol Do not use organic solvents such as benzene or acetone or household and industrial cleaners that may cause irreparable damage to the meter Store all the meter components in the portable case to prevent loss Caution e Do not expose the meter to direct sunlight or heat for an extended period of time e Do not let dirt dust blood or water enter into the meter s test strip port e Do not drop the meter or submit it to strong shocks e Do not try to fix or alter the meter in any way Keep the meter in a cool and well ventilated place Keep the meter away from strong electromagnetic fields such as cell phones and microwave ovens e Bravo Meter should be used only with Bravo strips e Store all the meter components in the portable case to prevent loss www endomedical ca 39
17. f you suffer from hypoglycemia or have experienced hypoglycemic shock or symptoms If the sample drop of blood runs or spreads due to Please contact your authorized Endomedical contact with hair or with a line in you palm do sales representative if such messages are displayed not use that sample Try puncturing again in a even if you do not have hyperglycemia or smoother area hypoglycemia 30 Bra VL BLOOD GLUCOSE MONITORING SYSTEM www endomedical ca 31 TARGET BLOOD GLUCOSE RANGES METER MEMORY The meter can save up to 250 glucose test results with time and date If the memory is full the oldest test result will be deleted and the latest test result will be stored Reminders Your target ranges from Time of day your healthcare professional Before breakfast Before lunch or dinner The meter calculates and displays the averages of total test results pre meal test results and post meal ff test results from the last 14 days VIEWING TEST RESULTS STORED IN THE METER S MEMORY 2 hours after meals Between 2 a m and 4 a m Blood Glucose Targets for Most People with Diabetes Press the A or S button mem A recommended target for fasting blood glucose or glucose to turn the meter on The 1 1 before meals is 4 0 7 0 mmol L A recommended target for current date and time will blood glucose 2 hours after eating is 5 0 to 10 0 mmol L be displayed on the bottom e of the screen for 2 seconds Reference
18. fficient r 0 993 Number of Sample 114 Range tested 2 5 32 5 mmol L Accuracy results for glucose concentration lt 4 2 mmol L Within 0 28 mmol L Within 0 56 mmol L Within 0 83 mmol L 8 8 100 8 8 100 8 8 100 Accuracy results for glucose concentration 4 2 mmol L Within 5 Within 10 Within 15 Within 20 49 106 46 82 106 77 101 106 95 106 106 100 TROUBLESHOOTING e Check whether the test strip is inserted with the contact bars facing up Check if the strip has been inserted completely into the test strip port Check if the appropriate test strip was used e Check whether the batteries are inserted with the side facing up e Replace the batteries e Check if the confirmation window is filled completely e Repeat the test after inserting a new test strip e Repeat the test after inserting a new test strip e Check the expiration date of the test strip e Check if the strip has passed the discard date date of opening the test strip vial plus 6 months e Check the meter GENERAL TROUBLESHOOTING PERFORMANCE CHARACTERISTICS PROBLEM The display is blank even after inserting a test strip The test does not start even after apply ing the blood sample on the strip The test result does not match the way you feel If the problem is not resolved please contact your authorized Endomedical sales representative A2 Bra VO BLOOD GL
19. followed by the average Canadian Diabetes Association 2008 Clinical Practice value and the number of the pe number of Guidelines for the Prevention and Management of Diabetes test results saved within the tests in Canada last 14 days These targets are intended to be a guide Please discuss your blood glucose targets with your healthcare professional 2 Press to view the average a value and the number of _ E tests performed before eating a meal for the last 14 days On pressing again the average value and the alal mmol L number of tests performed The number of The number of post meals for the same pre meal tests post meal tests period will appear on the screen 32 Bra VO BLOOD GLUCOSE MONITORING SYSTEM a a e 3 SETTING THE ALARM FUNCTION Use the W button to scroll through the test results starting Four types of alarms can be set in the meter one post meal from the most recent and ending with the oldest Press A alarm PP2 alarm and three time set alarms alarm1 3 to return to the result seen previously The PP2 alarm goes off 2 hours after setting the alarm The alarms ring for 15 seconds and can be silenced by After checking the stored test result press the S button to pressing Y A or the S button or by inserting a test strip turn off the meter SETTING THE POST MEAL ALARM PP2 ALARM Setting the PP2 alarm On m Without inserting a test strip press and hold A for 3
20. hands and fingertip sample site with soap and warm water Rinse and dry thoroughly Unscrew and remove the lancing device tip amp To cock the lancing device hold the body in one hand Pull the sliding barrel on with the other hand The lancing device is cocked when you feel a click Firmly insert a new lancet into the lancet holder Hold the lancet firmly Gently twist to pull off protective disk Save disk to recap lancet after use Replace lancing device tip The skin depth to get blood samples will vary for various people at different sample sites The lancing device s adjustable tip allows the best depth of skin penetration for an adequate sample size A beginning setting of three 3 is recommended 22 Bra VO BLOOD GLUCOSE MONITORING SYSTEM www endomedical ca 23 PREPARING THE METER AND TEST STRIP APPLYING BLOOD SAMPLE Insert a test strip with the contact bars facing upwards into the meter s test strip port Push the strip in gently until the meter beeps Be obtain a blood sample using the lancing device Place the device against the pad of the finger The best puncture sites are on the middle or careful not to bend the test ring fingers Press the release strip The CHEZ symbol button Remove the device will appear on the screen from the finger Wait a few seconds for a blood drop to form A minimum volume of 0 5 microliter is needed to fill the confirmation window Actual siz
21. ndomedical ca 17 seconds setting mode will finish and the meter Setting the Test Result Reset Deleting all the saved test results In this mode all the test results stored in the meter can be deleted Please note that if you select YES all the stored test results will be deleted and cannot be restored After the beeper mode is set press the S button to enter the Test Result Reset mode The dEL character will blink on the screen Press A or W to alternate between YES or no To delete all the stored test results press the S button while the screen displays YES Then all the test results stored in the meter will be deleted and the screen will be similar to the picture on the right If you do not want to delete the results press the S button while the screen displays no Then the screen will return to step 2 See page 12 At any stage if the S button is pressed for 3 will be turned off Press and hold to scroll through numbers quickly CHECKING THE SYSTEM 16 Bra VO BLOOD GLUCOSE MONITORING SYSTEM A test result will appear after the meter counts down from 5 to 1 After your control solution result appears on the display press W for 3 seconds till the check appears on the display When the check is displayed MOJ ea the result is not stored in the meter s memory and is not included in the 14 day averages Compare the result displayed
22. ollowing instructions Intended use Bravo Blood Glucose Monitoring System is used for the quantitative measurement of the glucose level in capillary whole blood as an aid in monitoring diabetes management of individual user effectively Bravo Blood Glucose Monitoring System should be used only for self testing outside the body in vitro diagnostic use only Bravo Blood Glucose Monitoring System should not be used for the diagnosis of diabetes or for testing newborns Testing sites include the traditional fingertip testing along with alternate sites testing on forearm palm thigh and calf The following chart explains the symbols you ll find in the Bravo User Manual product packaging and product inserts For in vitro diagnostic use Cox This product fulfills the requirements for Directive 98 79 EC on in vitro diagnostic medical devices Cautions for safety and optimum product use X Do not discard this product with other household type waste Consult instruction for use aie Manufacturer Authorized representative Q Do not reuse Serial number Use by y Temperature limitations LOT Batch code rd VO BLOOD GLUCOSE MONITORING SYSTEM 2 Bravo Blood Glucose Meter Logbook P Lancing Device EJ Carrying Case Lancets 10 gt Bravo Blood Glucose f Owner s Booklet Test Strips 10 Quick Reference Guide d Batteries 2 9 Warranty Card The components of the prod
23. t in mg dL milligrams of glucose per deciliter Check your display to ensure that results are being displayed in mmol L If they are not contact Endomedical at 1 800 282 6542 Keep the meter and testing supplies away from young children www endomedical ca 9 BRAVO BLOOD GLUCOSE TEST STRIP The Bravo blood glucose monitoring system measures blood glucose quickly and accurately It automatically absorbs the small blood sample applied to the narrow edge of the strip Contact bars Gently push the test Eeng l strip with its contact ite a bars facing up into the test strip port of meter Confirmation window Check here to see whether sufficient blood sample has been applied Insert Edge to apply blood sample Apply blood sample here for testing 8 Bra 76 BLOOD GLUCOSE MONITORING SYSTEM BRAVO BLOOD GLUCOSE METER DISPLAY mem Sound icon appears when test results appears only when the stored in the memory are sound is set to OFF displayed check alarm appears when appears when the time test results have alarm has been set not been saved Battery icon darm mem m check Test results indicates meter test results battery is running 11 N 1 displaying panel low and needs to Decimal point i appears when oo ne het mg dL the blood glucose be replaced measuring unit is A CH appears during post meal testing and when post Post meal test flag set to mmol L
24. t strip There is a problem with the meter MESSAGE If the error messages persist contact your authorized Endomedical sales representative www endomedical ca 41 UNDERSTANDING ERROR AND OTHER MESSAGES WHAT TO DO Repeat the test with a new test strip Repeat the test with a new test strip and wait until the 2 symbol appears before applying the blood or control solution sample Move to an area where the temperature is within the operating range 10 40 C 50 104 F and repeat the test after the meter and test strips have reached a temperature within the operating range WHAT IT MEANS A used test strip was inserted The blood or control solution sample was applied before the symbol appeared The temperature during the test was above or below the operating range 40 Bra VL BLOOD GLUCOSE MONITORING SYSTEM MESSAGE The performance of Bravo Blood Glucose Monitoring System has been evaluated in laboratory and in clinical tests Accuracy The accuracy of the Bravo BGM System Model GM505MA GM505MB GM505MC GM505MD GM505ME was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer a laboratory instrument The following results were obtained by diabetic patients at clinic centers Slope 0 97 Y intercept 0 13 mmol L Correlation coe
25. ting the Month mode After all settings are finished press and hold the 5 A number indicating the month will be button for 3 seconds to turn off the meter blinking on the left corner of the screen Press A or W until the correct month appears Press the 5 button to confirm your selection and enter the date setting mode Press A or W to reach the accurate value Press and hold to scroll faster ADJUSTING THE DATE AND TIME 0 Setting the Date 6 Entering the SET Mode Press A or W until the screen displays the Press and hold the 5 button for 3 seconds correct date Press the S button to confirm to enter the SET mode After all the the date and enter the time setting mode segments flash across the screen the SET character will be displayed on the screen Press the S button again to enter the year setting mode Setting the Time The meter can be set in the AM PM 12 hour or the 24 hour clock format Press A or W to select a format The AM PM icon is not displayed in the 24 hour format After selecting the format press the 5 button to enter the hour setting mode Setting the Year Press and release A or W to adjust until the correct year appears Press and hold V button to scroll through the numbers quickly After setting the year press the S button to confirm your selection and enter the month setting mode 12 Bra VO BLOOD GLUCOSE MONITORING SYSTEM www endomedical ca 13 Setting the Sound On OFF
26. trip vial Before using a new meter or a new vial of test strips you may conduct a control solution test following the procedure on pages 18 19 Encomedical ravo GLUCOSE CONTROL SOLUTION OLUTION DE CONTROLE Use with Bravo Glucose Meters Utiliser avec les lecteurs de glyc nsh Discard 3 months after first opening eter 3 mois apr s overture lose the vial immediately after wy Refermer le flacon immediatementaf Forin vitro diagnostic use only Usage te in vitro uniquement hake well before use Agiter avant chaque utilisation Forself testing Pour auto test Notes e Use only the Bravo Control Solution Check the expiration dates printed on the bottle When you first open a control solution bottle record the discard date date opened plus 3 months in the space provided on the label e Make sure your meter test strips and control solution are at room temperature before testing Control solution tests must be done at room temperature 20 25 C 68 77 F Before using the control solution shake the bottle discard the first few drops and wipe the tip clean e Close the control solution bottle tightly and store at a temperature of 8 30 C 46 86 F You may do a control solution test e When you want to practice the test procedure using the control solution instead of blood e When using the meter for the first time e Whenever you open a new vial of test strips www e
27. uct are identical to what s listed in the meter manual however you need to check the meter box for the quantity of strips e Please contact your authorized Endomedical sales representative if any component is missing or damaged e The cable for data transmission can be ordered separately Please contact your authorized Endomedical sales representative or visit www endomedical ca WARNING e The Bravo test strip should be used only with fresh capillary whole blood samples e Do not reuse test strips e Do not use test strips past the expiration or discard date e Check the expiration date printed on the vial When you first open a test strip vial you must record the discard date date opened plus six months in the space provided on the label e Store test strips in a cool and dry place at a temperature of 1 30 C 34 86 F e Keep test strips away from direct sunlight or heat and do not freeze e Store test strips only in their original vial e Close the vial tightly after taking out a test strip for testing and use the strip immediately e Handle test strips only with clean and dry hands e Do not bend cut or alter test strips in any way For detailed storage and usage information refer to the Bravo test strip package insert IMPORTANT NOTE Your meter has been preset and locked to display results in mmol L millimoles of glucose per liter In some countries the meters are preset to display uni
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