performing a blood glucose test
Contents
1. 187 214 87 209 214 98 2 User Performance Evaluation System Accuracy from layman Diabetes experts have suggested that glucose meters should agree within 15 mg dL of a laboratory method when the glucose concentration is lower than 75 mg dL and within 20 of a laboratory method when the glucose concentration is 75 mg dL or high er The chart below displays how often the SD GlucoNavii meter achieves this goal The chart is based on a study done to see how well the SD GlucoNavii compared to laboratory results Fingertip results For glucose results lower than 75 mg dL the percent and number of meter results that match the laboratory method within 15 mg dL For glucose results at 75 mg dL or higher the percent and number of meter results that match the laboratory method within 20 0 0 0 99 182 184 Alternate site results Pam Forearm Upper Arm For glucose results lower than 75 mg dL the percent and number of meter results that match 0 0 0 the laboratory method within 15 mg dL 0 0 0 0 0 0 For glucose results at 75 mg dL or higher the percent and number of meter results that match 99 99 100 the laboratory method within 20 183 184 183 184 184 184 System Accuracy from healthcare professionals lt 75 mg dl 4 2 mmol L gt 75 mg dl 4 2 mmol L Within 5mo dL Within 10mg dL Within 15mo dl _ _ _ Within 0 28mmol L Within 0 56mmol L Within 0 83mmol L Wi2. Operations amp Procedures Manual Thank you for purchasing the SD Gluco Navii Blood Glucose Monitoring System This manual provides important information to help you to use the system properly Before using this product please read the following contents thoroughly and carefully Please note that the following procedures are provided only as an example to help your facility establish its own policy and procedures Your own policy may differ Please consult with your director of nursing or administrator for further guidance For Questions Regarding Gluco Navii CALL 949 753 0001 or 888 425 1149 CAUTION Please carefully read the User s Manual and all product instructions before using the Gluco Navii Blood Glucose Meter TABLE OF CONTENTS Important Safety Precautions Precautions amp Limitations Interfering Substances Before you begin Intended Use Test Principle Alternative Site Testing Meter Setup Programming Performing a Blood Glucose Test Test Results Using the Meter Memory to Review Results Maintenance ocreen Messages and Troubleshooting Warnings Precautions and Limitations System Specifications Electromagnetic Compatibility Performance Characteristics Training Tools 15 17 18 20 26 28 29 29 29 32 IMPORTANT SAFETY PRECAUTIONS READ BEFORE USE Users need to adhere to Standard Precautions when handling or using this device All parts of the glucose monitorin
3. Monthly 33 If you saw the following massage on the meter s display what action should you take a Replace the battery b Re test with a new strip c Repeat the test when the room temperature is within 50 F to 113 F The test strips should be stored a At 39 2 F to 104 F 4 C to 40 C below 85 humidity b At 4 F to 140 F 20 C to 60 C below 95 humidity c In the freezer d In a different container than the original vial Quiz Completed by 34 Name of Trainee Date Score 1Nsey ebuey 301 2223 ebuey 301 voyoy os m ing Sw Sty Hing a asqa 307 AWA wys aso aa 9A991109 DU S L 4soy JOIN JojJedoddO uonegg w L eq H 46IH IN wnipe Aq pemelAey s jnsey JPe A U uolA JELIOS IJAN Wa SAS HULIOJIUOI BSONN H poojg wi HAPNOONIS GS GYO93e LINSAY TOULNOD ALITVND u9uuuo5e v InNsS y ebuey 301 EZ ebuey 301 uolov jonuoy p d ov du g io uoo padesoy dins oia J dine mi Le ion yx ioe 9A1 991109 dijg ise 4sey JOIN jJjojedgddO _ uonje Ss unl 3q H 46IH IN wnipe Aq pemelAey s insey Je A U uolAj leas IJAN Wa SAS Huoyuow BSOON H poojg w HAPNOON S GS aoad LINSAY TOULNOD ALITWND zjuswy pepy 36 NOTES oF GlucoNavii Distributed by ime Links Medical Products Inc 9247 Research Dr Irvine CA 92618 949 753 0001 888 425 1149 www linksmed com
4. Note each push of the left arrow key will scroll to the next choice 3 After you have set the hypo warning mode OFF or the level to 60 70 or 80 mg dL by pressing the left button press the ON OFF button to confirm your choice STEP 3 Setting the date and time Setting the DATE YEAR 1 After setting the hypo warning the display for setting Date will appear Set the correct year by pressing either the left or the right button left down right up until the correct year is displayed Confirm the correct year by pressing the ON OFF button in center of meter ON OFF button to confirm selection and move to next mode Setting the DATE DISPLAY FORMAT 2 Next will appear the setting to choose the display for month and day format The me ter can display the month and day in either a Month Day m d format or a Day Month d m format Set the preferred format on the display by pressing either the left or the right button Confirm by pressing the ON OFF button in center of meter ON OFF button to confirm selection and move to next mode Setting the DATE MONTH 3 Next set the correct month on the display by pressing either the left or the right button until the correct month appears and confirm by pressing the ON OFF button NOTE In this mode the left button will move the number down and the right button will move ON OFF button to confirm selection the number up and move to next mode
5. Select Month Setting the DATE DAY 4 Next set the correct day on the display by pressing either the left or the right button until the correct date appears and confirm by pressing the ON OFF button NOTE In this mode the left button will move the number down and the right button will move the number up ON OFF button to confirm selection and move to next mode Select Day 10 Setting the TIME FORMAT 1 Next will appear the display for setting clock to the 12 or 24 Hour format The meter can display the time in either the 12h format i e AM PM or the 24h format Set the preferred format on the display by pressing either the left or the right button and confirm your selection by pressing the ON OFF button i E s IC r aw x 8 Left or right button ON OFF button to confirm selection and move to next mode Setting the TIME HOUR 2 Next will appear the setting display to set HOUR Set the correct hour on the display by pressing either the left or the right button and confirm your selection by pressing the ON OFF button phe a2 Left or right button ON OFF button to confirm selection Select Hour and move to next mode NOTE You must scroll through 12 hours to move from AM to PM i e 10am 11am 12pm 1pm etc Be sure the correct AM or PM selection is made before confirming hour and moving to next setup mode Setting the TIME MINUTE 3 Next
6. Obtain a blood sample using a new lancet 7 Hold your finger to the tip of the strip until the yellow window is completely filled with blood Do not place the blood drop on top of the strip 8 The blood will be drawn into the strip automatically If audible sound is turned on meter will beep to let you know the test has begun 9 When blood is applied to the strip the display counts down from 5 to 1 and your result appears on the display in 5 seconds 10 The blood glucose result is displayed in mg dL Caution If your GlucoNavii meter is desplaying results in mmol L please stop usage and contact your supplier 11 When the test is done pull out the used test strip and dispose The meter shuts off automatically 5 seconds after you remove the test strip NOTE e Dispose of the used test strip as per your facility guidelines e Dispose of the used lancet according to facility guidelines e Always use fresh capillary whole blood when performing tests DO NOT USE PLASMA SERUM OR SAVED BLOOD Your Test Results 1 After 5 seconds from applying blood into strip you will receive a result Displayed results using the GlucoNavii range from 20mg dL to 600mg dL DISPLAY FOR NORMAL RESULT 2 If your blood glucose is above 600 mg dL you will receive a HI indication on the display If below 20 mg dL you will receive Lo indication on the display In these cases repeat the test with new test strip If this messag
7. checks as directed 7 Keep the device and testing equipment away from young children Small items such as the battery cover batteries test strips lancets vials and vial caps are choking hazards PRECAUTIONS amp LIMITATIONS INTERFERING SUBSTANCES Interfering substances depend on the concentration The interfering substances listed below may produce elevated glucose test results at or above the concentration levels noted Compound Limitation Acetaminophen gt 6 00 mg dL Ascorbic Acid gt 4 00 mg dL Total Bilirubin Triglycerides Regulatory Requirements The Clinical Laboratory Improvement Amendments CLIA has classified tests of blood glucose as tests that are waived For all entities that conduct one or more tests including waived tests on materials derived from the human body for the purpose of providing information for the diagnosis prevention or treatment of any disease or impairment of or the assessment of the health of human beings CLIA has stated that the entity conducting the tests shall meet certain Federal requirements If any entity conducts tests for the aforementioned purposes then the entity under CLIA is considered to be a laboratory and thus must register with the CLIA Program KEEP THESE INSTRUCTIONS INA SAFE PLACE BEFORE YOU BEGIN Severe dehydration and excessive water loss may cause readings which are lower than actual values If the patient is suffering from severe dehydration consult a
8. emission is thus low Interference from other electrically driven equipment is not to be anticipated PERFORMANCE CHARACTERISTICS The performance data for the SD GlucoNavii system SD GlucoNavii meter with SD GlucoNavii test strips were obtained using capillary blood from diabetic patients method comparison accuracy venous blood repeatability and control solution re producibility Test results are plasma calibrated The reference values are obtained using the YSI method For method comparison the results were compared with 6 higher than the results obtained using YSI method The SD GlucoNavii system meets the EN ISO 15197 2003 requirements The SD GlucoNavii system performance has been evaluated both in laboratory and clinical tests 29 1 Method Comparison The accuracy of the SD GlucoNavii M blood glucose monitoring system was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 STAT Plus glucose analyzer reference a laboratory instrument Slope 1 067 y intercept 1 944 Correlation coefficient R 0 994 Number of sample N 240 Testing range mg dL 33 550 lt 75 mg dl 4 2 mmol L gt 75 mg dl 4 2 mmol L Within Sma dl Within 10mg dL Within 15mg dL 7 _ s Within 0 28mmol L Within 0 56mmol L Within 0 8jmmo Withinz5 Within 10 Within 15 Within 20 14 26 54 17 26 659 26 26 100 30 214 38 155 214 729
9. required Insufficient blood volume will result in inaccurate test results e Store the SD Glucose Control Solution in 36 90 F 2 32 C environment 24 3 Control Solution e Store the SD Glucose Control Solution in 46 86 F 8 30 C environment e Do not refrigerate or freeze Control Solution e Do not use SD Glucose Control Solution that has passed the expiration date e SD Glucose Control Solution can be used for 3 months after opening the bottle Write the opened date on the bottle when first opened e No reconstitution or dilution is necessary 25 SCREEN MESSAGES AND TROUBLESHOOTING Low Battery At this time battery is getting low but you can still perform about 50 tests Replace the battery soon Replace Battery Battery power is very low Replace the battery immediately If you press the ON OFF button the battery icon will flash and after ten seconds the meter will shut off Hi Message Blood glucose may be higher than the measuring range of the system gt 600mg dL 26 Lo Message Blood glucose may be lower than the measuring range of the system lt 20 mg dL Internal Error Message Turn off the meter Then turn on the meter again If there is still an error message please contact your supplier Blood Sample Error An insufficient amount of blood was applied Discard this test strip and test again using new test strip and a larger sample making sure blood is placed to the narrow
10. will appear the setting display for MINUTE Set the correct minute on the dis play by pressing either the left or the right button Confirm your selection by pressing the ON OFF button e x m A to a Left or right button Confirm by pushing ON OFF button Select Minute STEP 4 Post Meal Alarm You can use GlucoNavii s post meal alarm function to remind you to test your blood glucose after meal 1 After day and time setting the display for setting the post meal alarm will appear 2 Set the post meal alarm mode to 2h or OFF by pressing either the left or the right button and then confirm the selection by pressing the ON OFF button Left or right button Confirm by pushing ON OFF button If you select the post meal alarm 2h feature and test with pre meal mark the clock symbol will appear on result display and the beep sound will be heard in 1 minute or until shut off 2 hours after the pre meal test time If you perform the pre meal test while the post meal alarm setting is on then the post meal mark will appear automatically on your LCD when you test within following period from 30min to 130min after your pre meal test If you mark the new test result with a pre meal mark the old alarm setting will be ignored and only the new setting will sound in 2 hours STEP 5 Setting the Test Reminder Alarm GlucoNavii includes an alarm function to remind you to
11. within body natural levels of uric acid ascorbic acid vitamin C bilirubin triglycerides and hemoglobin do not interfere with your blood glucose results obtained e Interferences The following compounds at or above the levels below may affect results Compound Limitation Acetaminophen gt 6 00 mg dL Ascorbic Acid gt 4 00 mg dL Total Bilirubin Triglycerides 28 e Externally taken drugs L dopa dopamine methyl dopa acetaminophen and ibuprofen will not interfere with SD GlucoNavii blood glucose results when taken at therapeutic concentrations e Do not use SD GlucoNavii meter to test neonates or infants It has not been validated for neonatal or infant use e Always insert the test strip into the meter first and then prick the finger SYSTEM SPECIFICATION Meter Test Strip Operation Storage Temperature 50 F 113 F 10 C 45 C Temperature 36 F 90 F 2 C 32 C Humidity 15 RH 90 RH Hematocrit 20 60 Altitude Up to 11 351 feet 3 460 meters Transport and Storage in shipping container Temperature 4 F 140 F 20 C 60 C Humidity 15 RH 90 RH ELECTROMAGNETIC COMPATIBILITY This meter meets the electromagnetic immunity requirements as per ISO 15197 Annex A The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000 4 2 In addition it meets the electro magnetic emissions requirements as per IEC 61326 Its electromagnetic
12. 2 Insert a test strip yellow window printed arrow symbol facing up into test strip slot The meter turns on automatically STEP 2 1 Press the LEFT button for 3 seconds to mark the result as a control solution test and to check the testing system using a control solution in Blood Stand by Display If you dont want the result marked as a control solution check press the left button again 22 2 Shake the control solution bottle and discard the first drop of solution Gently squeeze the bottle to form one small drop Bring the drop to the edge of the strip and allow the strip to automatically draw the control solution into the yellow window When control solution is applied to the test strip the meter counts down from 5 to 1 on the display Tightly replace the cap on control solution 3 The control solution result appears on the display in just 5 seconds 4 Compare the control solution result to the range printed on the test strip vial container If the results are not within the control range printed on the test strip vial then the meter and strips may not be working properly Repeat the control solution test If your results are still out of range contact your supplier The control solution range printed on the test strip container lt lt Example is for SD Glucose Control Solution Only It is not a recommended Control Range range for your blood glucose level ONLY USE SD CONTROL 50 140 mg dl TT SOLUTION WITH THE SD
13. A BLOOD GLUCOSE TEST NOTE e Always wash hands with warm soapy water Rinse and dry them before testing 1 Remove a new test strip from vial Be sure to tightly close vial cap after removing test strip 2 There are two ways to turn the meter on The first method is to press the ON OFF button The second method is to insert the test strip into test strip slot and the meter turns on automatically i Press ON OFF button 3 When the blood drop symbol flashes next to the test strip symbol Blood Stand by Display you are ready to perform a test 4 Before you perform a test you have the option to mark the test as either post meal or pre meal test by pressing the right button Press the RIGHT button once for pre meal or twice for post meal Pushing the RIGHT button again will turn OFF meal mark for that test Pre meal Post meal 15 NOTE You do not have to mark a result If you do not wish to track Pre meal or Post meal results simply perform your test after inserting the test strip and ob serving the flashing blood drop If you perform the pre meal test while the post meal alarm setting is on then the Post meal mark will appear automatically on your LCD when you test within following period from 30 minutes to 130 minutes after your pre meal test 5 Let your arm hang down at your side to allow blood to flow to your fingertips Grasp your finger just below the joint closest to the fingertip 6
14. GlucoNavii BLOOD GLUCOSE METER 5 0 7 8 mmol L 9 4 13 3 mmol L This is an example Refer to the ranges on your test strip container 5 Remove the used test strip from the meter and discard it 23 CAUTIONS 1 Meter e Keep the test strip slot free of dust e Protect the meter from humidity The carrying case is designed to let you store a variety of supplies you may need and helps to protect your meter If you store the meter for extended periods with the battery inserted keep it in a low humidity environment 2 Test Strip The test strips are sensitive to humidity keep them in a dry and cool environment Do not store in direct sunlight Do not store with vial open e After removing a test strip from its vial close the vial cap of the vial immediately The test strip vial closes tightly and can protect the test strips so you should keep the unused test strips in the vial in which they came Keep vial closed when not removing a test strip to test e Each test strip is for single use only Do not reuse strips e A test strip is sensitive to humidity Therefore you should store test strips only in the supplied vial After removing a the test strip from it s vial close the vial cap of the test strip immediately e After removing a test strip from its vial you should use it within 3 minutes e After 6 months from opening a vial of test strips discard any unused test strips e A 9ul blood sample is
15. Glucose Monitoring System Training Checklist Use the following checklist to assess the operators understanding and knowledge of the GlucoNavii Blood Glucose Meter System Task N Area Clinical Use of Device Knows key features of GlucoNavii Blood Glucose Meter _ Understands various test types i e finger AST quality control and understands what sample type and U22722 volume is required Principles of quality testing and QC materials U C f of quality testing and QC materials Understands the features benefits and limitations of the GlucoNavii system Understands the proper disposal of used test strips lancets and exam gloves according to your facility procedures Understands the displayed error messages and corresponding actions to take s Understands the appropriate steps to take for troubleshooting pC Knows the actions to be taken when the results are abnormally high or low po Understands the information required to be documented by law and by your institution Identify the essential parts of the GlucoNavii system pC Able to locate the serial number test strip port test strip ejector and ON OFF buttons on the meter pC Locates the expiration date first opening date lot number and control solution ranges on the test strip vial General Knowledge Locates sample port confi rmation window and contact bars on the test strips Locates the expiration date fi rst opening date and lot n
16. SD Glucose Meter Check Strip 1 Insert the SD Glucose Check Strip Check Strip printed handle facing up into test strip slot The meter turns on automatically 2 If SD Glucose Check Strip is inserted properly the meter will automatically start and will count down from 5 to 1 3 The check result appears on the display in just 5 seconds If there is any problem with the meter EEE message will appear on the display If no problems are detected with the meter OK will appear on the display EEE Error Message ee ISH OK Message 21 2 Performing a Control Solution Test To perform a control solution test you will need the meter a new test strip and control solution Level M and or Level H The expected control level range is printed on the test strip vial label Follow your facilities guidelines to determine if M and or H Lev el controls are to be used NOTE e A set of Level M and H control solutions is available for purchase To order control solutions contact your supplier Your meter is designed to recognize the difference between the SD Control solution and blood Only use SD controls with your GlucoNavii meter e The meter automatically stores the test results using a control solution code letting your review them Control test results are not included in averages STEP 1 1 Remove a new test strip from the vial Be sure to tightly close vial cap after removing test strip
17. atch the way the patient feels You are testing for hyperglycemia You are testing for hypoglycemia e The patient s routine glucose results are often fluctuating METER SET UP PROGRAMMING STEP 1 Setting the Audible Beep 1 With the meter turned on press the ON OFF button for 3 seconds the display for setting the audible beep will appear Note the small gt on the lower right area of screen g Hold ON OFF button for 3 sec Meter turned ON 2 Set the beep mode on or off by pressing the left arrow button to select either ON or OFF If you select the ON feature a beep sound will be heard If you select the OFF feature no sound will be heard Push for sound ON Push again for sound OFF k e aon Push the ON OFF to select confirm sound setting and move to next mode STEP 2 Setting the Hypo Warning NOTE e You can set the GlucoNavii meter to let you know when the result indicates a possible low blood glucose hypoglycemia level You can also select what blood glucose level the warning will be indicated i e 60 70 80 mg dL e If your results are lower than the selected level the hypo symbol will appear on the LCD screen with a beep sound e It is very important to manage your hypoglycemia 1 After confirming the audible sound ON or OFF the display for setting the hypo warning will appear 2 Using the LEFT arrow key select OFF 80 70 or 60 mg dL
18. channel in the top edge of the test strip Communication Error The communication between meter and computer is failed Reonnect the meter to the PC Strip Error Defective test strip used test strip or the test strip is damaged or inserted Improperly Discard this test strip and test again using new test strip Temperature Error lf the environmental temperature is above or below the operating range of a meter a thermometer icon will appear on the display Move to an area between 50 113 F 10 45 C wait for 30 minutes and perform a test Do not artificially heat or cool the meter 2 WARNINGS PRECAUTIONS AND LIMITATIONS e Never make significant changes to your diabetes control program or ignore physical symptom without consulting your healthcare professional e Severe dehydration excessive water loss may cause false low results If you believe you are suffering from dehydration consult your healthcare professional right away e Extremes in hematocrit may affect test results Hematocrit levels less than 20 may cause falsely high readings Hematocrit levels greater than 60 may cause falsely low readings e Inaccurate results may occur in severely hypotensive individuals or patients in shock Inaccurate low results may occur for individuals experiencing a hyperglycemic hyperosmolar state with or without ketosis Critically ill patients should not be tested with blood glucose meters e Normal endogenous
19. e appears again contact your healthcare professional immediately DISPLAY FOR HI amp LO RESULTS 3 If you set the pre meal mark before your test your result will be stored with a pre meal mark If you set the post meal mark before you test your result will be started with a post meal mark C Pre Meal Post Meal USING THE METER MEMORY TO REVIEW RESULTS 1 Turn the meter on press the LEFT button to review in sequence from the most recent test result to the last test result stored mg dL AM THO FEN Normal result Pre meal result Post meal result 2 Turn the meter on press the RIGHT button to review 7 14 and 30 day averages of test result stored GlucoNavii allows you to view your average three ways All results pre meal results and post meal results 3 If there are no stored test results the following display will appear for 1 sec and then the meter will display strip stand by state automatically e METER MEMORY The GlucoNavii has the ability to store 400 results in its memory Once the memory capacity has been reached the oldest result will be deleted NORMAL BLOOD GLUCOSE READINGS The normal fasting blood glucose range for an adult without diabetes is 74 106 mg dL Two hours after meals the blood glucose range for an adult without diabetes is less than 140 mg dL Your results may vary Consult with your healthcare provider if you have any questions about your resul
20. g system should be considered potentially infectious and are capable of transmitting blood borne pathogens between patients and healthcare professionals For more information refer to Guideline for Isolation Precautions Preventing Transmission of Infectious Agents in Healthcare Settings 2007 http lwww cdc govlhicpac 2007ip 2007isolationprecautions html WARNING The GlucoNavii meter should be disinfected after use on each patient The Gluco Navii Blood Glucose Monitoring System may only be used for testing multiple patients when Standard Precautions and the Manufacturer s Disinfection Procedures are followed WHEN USED FOR TESTING MULTIPLE PATIENTS THE METER MUST BE CLEANED DISINFECTED AFTER USE ON EACH PATIENT WARNING Only auto disabling single use lancing devices should be used with this device DO NOT USE REUSABLE LANCING DEVICES WITH THE Gluco Navii PRODUCT 1 Use this device ONLY for the intended use described in this manual 2 DO NOT use accessories which are not specified by the manufacturer 3 DO NOT use the device if it is not working properly or if it is damaged 4 DO NOT under any circumstances use the device on neonates or infants 5 This device does NOT serve as a treatment or a cure for any symptom or disease The data measured is for reference only 6 Before using this device to test blood glucose read all instructions thoroughly and practice performing a test Carry out all the quality control
21. healthcare professional immediately If the patient s blood glucose results are lower or higher than usual and they do not have any symptoms of illness repeat the test If the patient has symptoms or continues to get results which are higher or lower than usual follow the treatment advice of the healthcare professional Use only fresh whole blood samples to test patient s blood glucose Using other substances will lead to incorrect results DO NOT use Gluco Navii to test serum plasma or stored whole blood If the patient has symptoms that are inconsistent with the blood glucose test results and you have followed all the instructions given in this owner s manual contact a healthcare professional We do not recommend using this product on severely hypotensive individuals or patients in shock Readings which are lower than actual values may occur for individuals experiencing a hyperglycaemic hyperosmolar state with or without ketosis Please consult the healthcare professional before use INTENDED USE SD GlucoNavii blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip palm forearm or upper arm SD GlucoNavii meter must be used with SD GlucoNavii blood glucose test strips and SD Control solutions The SD control solutions Level M and Level H are for use with SD GlucoNavii test system as quality controls to verify the accuracy of blood glucose test
22. i Blood Glucose Monitoring System to perform blood glucose tests on residents No Questions Answer The GlucoNavii Blood Glucose Monitoring System uses a GOD glucose oxidase enzyme b GDH glucose dehydrogenase enzyme The GlucoNavii Blood Glucose Monitoring System can test samples from a Finger b AST Alternative Sites Testing c Control solutions d All of the above The GlucoNavii Blood Glucose Monitoring System requires a blood volume of a 0 3uL b 0 9uL d 1 0uL You should perform a control solution test when a You think the meter or test strip may be working incorrectly b You drop the meter c You have repeated a test and the test result is still lower or higher than expected d All of the above After the control solution and test strip vials have been opened when do you discard the remaining materials a 30 days b 90 days c 6 months d 1 year When performing a quality control test how do you apply the control solution onto the test strip a Place a drop directly onto the test strip b Place a drop on a clean surface and then contact the drop with the test strip c Place a drop on your fi nger and then contact the drop with the test strip d Shake the control solution vial and squeeze out a drop onto the tip of the vial cap then touch test strip to drop When do you clean and disinfect the meter T a After each use b Daily c Weekly d
23. perform AST on the patient Measurements from AST should never be used to calibrate a continuous glucose monitoring systems CGMs or entered into insulin dose calculators for insulin dosing recommendations What is AST Alternative site testing AST means that people use parts of the body other than fingertips to check their blood glucose levels The GlucoNavii system allows you to test on the finger palm and forearm What s the advantage of AST Fingertips feel pain more readily because they are full of nerve endings receptors Other body sites since nerve endings are less concentrated patients generally will not feel as much pain compared to the fingertip When to use AST Food medication illness stress and exercise can affect blood glucose levels Capil lary blood at fingertip reflects these changes faster than capillary blood at other sites Therefore when testing blood glucose during or immediately after meal physical exercise or any other event take blood sample from finger only We strongly recommend that you perform AST ONLY at the following times e With you healthcare providers permission e In a pre meal or fasting state more than 2 hours since the last meal Two hours or more after taking insulin Two hours or more after exercise Do NOT use AST if e The healthcare provider has not approved this type of testing Your patient has frequent low blood glucose e The AST results do not m
24. results Testing with Gluco Navii is done outside the body in vitro diagnostic use This system is indicated for home over the counter OTC by persons with diabetes or in clinical settings by healthcare professionals as an aid to monitor the effectiveness of diabetes control This system should not be used for the screening or diagnosis of diabetes or for testing newborns or infants THE PRINCIPAL SD GlucoNavii M test strip is designed with an electrode that measures glucose levels Glucose in the blood sample mixes with reagent on the test strip which causes a small electric current The amount of current that is created depends on how much glucose is in the blood SD GlucoNavii meter measures the current that is created and converts the mea surement to the amount of glucose that is in the blood The blood glucose result is displayed on the meter s screen By touching a drop of blood to the tip of the SD GlucoNavii test strip the strip s reaction chamber automatically draws the blood into the strip through capillary action When the chamber is full SD GlucoNavii meter starts to measure the blood glucose level It is a simple and practical system for the daily monitoring of your blood glucose level ALTERNATIVE SITE TESTING IMPORTANT There are limitations with AST Alternative Site Testing The AST of the system can be used only during steady state blood glucose conditions Please consult the doctor before you
25. test your blood glucose Up to 4 reminder alarms may be set 1 After Post meal alarm setting the display for setting the first alarm will appear 2 Set the first alarm ON or OFF by pressing either the left or the right button and then confirm your selection by pressing the ON OFF button HAG Left or right button Confirm by pushing ON OFF button NOTE e If you select the alarm OFF feature set up is complete e If you select the alarm ON feature you can set the next alarm Up to four alarms per day may be set once OFF is selected set up is complete 3 If you select the alarm ON feature in first alarm mode the clock will begin to blink Set the correct hour and minute you want to be reminded to test for by pressing either the left or the right button Confirm the selection by pressing the ON OFF button aon Confirm by pushing ON OFF button O Left or right button to set hour Confirm by pushing ON OFF button Minute 4 Once you finish setting the first alarm you can set three additional alarms For each alarm set the time as you did for the first alarm Alarm 2 Alarm 3 Alarm 4 5 When you finish setting the last alarm setup is complete NOTE e Once you select OFF for an alarm no further alarms will be set Setup is complete i e if you select OFF for the first alarm setup us complete You will not be prompted to set additional alarms 14 PERFORMING
26. thin 5 Within 10 Within 15 Within 20 0 0 0 0 0 0 73 6 134 184 100 6 184 184 100 184 184 30 System Accuracy Non Professional User Slope 099 0 97 Y intercept 3 5 Correlation coefficient R 0 957 Number of subjects 184 Range tested 83 344 mg dL 3 Precision Precision results indicate that on average you can expect that maximum 3 6 variation from testing across a 50 4 319 8 mg dL glucose range The table shows coefficient of variation CV values for five glucose levels that cover the glucose range typical of persons with diabetes Mean Glucose level mg dL n SD mgdU CV 50 4 3 6 83 4 24 1348 24 201 5 25 319 8 2 0 BIBLIOGRAPHY 1 American Diabetes Association Clinical Practice Recommendation Guidelines 2003 Diabetes care Vol 26 Supplement 1 p 22 2 Stedman TL Stedman s Medical Dictionary 27th Edition 1999 p 2082 3 Ellen T Chen James H Nichols Show Hong Duh Glen Hortin MD Diabetes Tech nology amp Therapeutics Performance Evaluation of Blood Glucose Monitoring Devices Oct 2003 Vol 5 No 5 749 768 Manufactured by 9 BIOSENSOR INC C 4th amp 5th Floor Digital Empire Building 980 3 P S D Yeongtong dong Yeongtong gu Suwon si Kyonggi do Korea www sdbiosensor com Authorized Representative g BIOSENSOR USA INC 12860 Danielson Ct Suite A Poway CA 92064 Toll Free No 855 486 2888 31 Attachment 1 TRAINING CHECKLIST SD GlucoNavii Blood
27. ts or how you feel does not match your results WHAT THIS MEANS FOR YOU Frequent blood glucose testing is the best means to track how well you are doing with your diabetes management It helps you track the effects of medications diet exercise and stress management Blood glucose test results can also tell you if your diabetes is changing This may alert you to adjust your treatment plan Always consult your healthcare professional before making any adjustments DO NOT MAKE ADJUSTMENTS TO YOUR TREATMENT PLAN OR MEDICATIONS WITHOUT YOUR HEALTHCARE PROFESSIONALS APPROVAL FREQUENCY OF TESTING Work with your healthcare professional to decide when and how often to test This will depend on such things as age type of diabetes and medications It is important to make testing part of your daily routine MAINTENANCE QUALITY CONTROL 1 Performing a SD Glucose Check Strip Test When should I check my meter using the SD Glucose Meter Check Strip e Whenever you want to check the performance of the meter e Before using your meter for the first time e Whenever your result does not agree with how you feel If you have repeated a test and the blood glucose result is still lower or higher than expected NOTE e The Check Strip test does not replace a control solution test The Check Strip test is used to check the meter function A Control Solution test is used to test the function of meter strip system 20 How Do I Use the
28. umber on the control solution bottle Knows the proper storage conditions of the meter test strips and control solutions Knows how to maintain the meter Application me gt S O Demonstrates proper safety lancet technique when collecting a blood sample Demonstrates the correct blood testing procedures using the GlucoNavii Blood Glucose Monitoring System Demonstrates the correct test strip insertion technique 4 T the correct test strip insertion Demonstrates the correct test strip insertion technique 4 T Performs quality control tests at specifi c times and determines if the results are acceptable Takes E ree action if there is a problem Practical Application Demonstrates the proper Demonstrates the proper cleaning and disinfecting techniques for the GlucoNavii meter and disinfecting techniques for the GlucoNavii meter Performs meter set up memory retrieval and data transmission operations Demonstrates the proper actions to take for inaccurate results pC Training Certification Name of Trainee Date ee Name of Instructor Signature of Instructor _ j The trainee must complete the training of the GlucoNavii Blood Glucose Monitoring System before performing glucose testing on residents 32 Attachment 2 TRAINING QUIZ SD GlucoNavii Blood Glucose Monitoring System Complete the following questions to assess your understanding about using the SD GlucoNavi
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