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4

PRECAUTIONS & 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).

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

IN A SAFE PLACE

Содержание SD Gluco Navii

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Страница 3: ...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...

Страница 4: ...ve Site Testing Meter Setup Programming Performing a Blood Glucose Test Test Results Using the Meter Memory to Review Results Maintenance Screen Messages and Troubleshooting Warnings Precautions and L...

Страница 5: ...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 LA...

Страница 6: ...ll 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 dis...

Страница 7: ...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...

Страница 8: ...ose 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...

Страница 9: ...rtip 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...

Страница 10: ...3 seconds the display for setting the audible beep will appear Note the small on the lower right area of screen 2 Set the beep mode on or off by pressing the left arrow button to select either ON or...

Страница 11: ...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 If your results are lower than t...

Страница 12: ...utton 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 M...

Страница 13: ...t button and confirm your selection by pressing the ON OFF button 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 befor...

Страница 14: ...th a pre meal mark the old alarm setting will be ignored and only the new setting will sound in 2 hours STEP 4 Post Meal Alarm You can use GlucoNavii s post meal alarm function to remind you to test y...

Страница 15: ...e 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 NOTE If...

Страница 16: ...t 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...

Страница 17: ...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...

Страница 18: ...eter 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...

Страница 19: ...hcare professional immediately 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 DISPLA...

Страница 20: ...review in sequence from the most recent test result to the last test result stored 2 Turn the meter on press the RIGHT button to review 7 14 and 30 day averages of test result stored GlucoNavii allow...

Страница 21: ...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 WIT...

Страница 22: ...en should I check my meter using the SD Glucose Meter Check Strip Whenever you want to check the performance of the meter Before using your meter for the first time Whenever your result does not agree...

Страница 23: ...lems are detected with the meter OK will appear on the display How Do I Use the SD Glucose Meter Check Strip 1 Insert the SD Glucose Check Strip Check Strip printed handle facing up into test strip sl...

Страница 24: ...ol solution and blood Only use SD controls with your GlucoNavii meter The meter automatically stores the test results using a control solution code letting your review them Control test results are no...

Страница 25: ...wn 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 prin...

Страница 26: ...ip 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 Each test strip...

Страница 27: ...not refrigerate or freeze Control Solution Do not use SD Glucose Control Solution that has passed the expiration date SD Glucose Control Solution can be used for 3 months after opening the bottle Writ...

Страница 28: ...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 glu...

Страница 29: ...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 Communication Error The communication between mete...

Страница 30: ...e falsely high readings Hematocrit levels greater than 60 may cause falsely low readings Inaccurate results may occur in severely hypotensive individuals or patients in shock Inaccurate low results ma...

Страница 31: ...on it meets the electro magnetic emissions requirements as per IEC 61326 Its electromagnetic emission is thus low Interference from other electrically driven equipment is not to be anticipated PERFORM...

Страница 32: ...ormance 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 m...

Страница 33: ...n 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 no...

Страница 34: ...TRAINING CHECKLIST SD GlucoNavii Blood Glucose Monitoring System Training Checklist Use the following checklist to assess the operators understanding and knowledge of the GlucoNavii Blood Glucose Met...

Страница 35: ...QUIZ SD GlucoNavii Blood Glucose Monitoring System Complete the following questions to assess your understanding about using the SD GlucoNavii Blood Glucose Monitoring System to perform blood glucose...

Страница 36: ...34...

Страница 37: ...35 Attachment 3 QUALITY CONTROL RESULT RECORD SD GlucoNavii Blood Glucose Monitoring System...

Страница 38: ...36 Attachment 3 QUALITY CONTROL RESULT RECORD SD GlucoNavii Blood Glucose Monitoring System...

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Страница 40: ...GlucoNavii Distributed by MAXPERT Medical Expert Products for Expert Care...

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