Blood Glucose - imedisource.com
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1. Blood Glucose InsCire Monitoring System dvance STEP 3 Recalling Individual Test Results After 28 day average the most recent test result with date and time will be shown Press MAIN BUTTON once and the next most recent test result will appear Each time you press and release the MAIN BUTTON the meter will recall up to your last 450 test results in order When the memory is full the oldest result is dropped as the newest is added STEP 4 Exit the Memory Mode After reaching the last set of result the meter will turn Off Anytime in the memory mode you can press and hold MAIN BUTTON for three 3 seconds to turn off the meter NOTE 1 The control solution results are NOT stored in the memory if you preset the control test correctly Please refer to the CONTROL SOLUTION TEST Section for details The list of past results and the result average are for blood glucose results only 2 When using the meter for the first time is displayed When you recall the test results or review the average result it means that there is no test result in memory 3 The averages are calculated from your latest result obtained during the last 7 14 21 and 28 days 4 Anytime in memory mode you can press MAIN BUTTON for 3 seconds to exit the memory mode 5 While in the memory mode if you leave the meter alone without any action for one 1 minute the meter will turn off automatically2. C 45 C 41 F 113 F between 10 85 R H C 40 C 39 F 104 F between 10 85 R H 50 test results with time and date 14 21 and 28 days wo 2 1 5 volt AAA Battery pproximately 1 000 tests n 3 minutes 9 x 50 x 19 6 mm 8g without battery N attery Life Automatic shut off Dimensions Weight Operating Condition fB Power Supply Te Ol Blood Glucose Advance Monitoring System DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE The following is a summary of some display messages and symbols These messages help to identify certain problems but do not appear in all cases when a problem has occurred Improper use may cause an inaccurate result without producing an error message In the event of a problem refer to information under action to take DISPLAY DESCRIPTION ACTION TO TAKE ai 000 kn W OAM EO KOU WWE KOU DOM A If some parts of the display are not working LILI INS Pispiay neck Contact your local distributor for help Display check Meter is in the program check wait to next meter display Blinking Strip Blinking Blood Test result Blood Glucose InsCire Monitoring System dvance The meter is waiting for test strip be insert The meter is ready for blood applying into test strip Appears 5 seconds after applying the blood into test strip Te Offa Blood Glucose aus Monitoring Syste
3. Tr Or Blood Glucose Advance Monitoring System REVIEWING RESULTS ON A PERSONAL COMPUTER Results in memory can be transmitted to a personal computer Inspire Advance meter Diabetes Management Software and an interface cable are required before installation The software and interface cable are optional accessories To learn more about Inspire Advance meter Diabetes Management Software or to obtain an interface cable sold separately please contact your local retailer or distributor STEP 1 Install Software Install the Inspire Advance meter Diabetes Management Software on your computer step by step STEP 2 Connect to Personal Computer Connect the transferring cable to your computer With the meter turned off connect the Interface Cable to the data port of the meter The meter will turn on and PC will appear on the display indicating that the meter is ready to transmit data STEP 3 Transmit Data Follow the instructions provided in the software to transmit data Results transmitted will include date and time Remove the transferring cable and the meter will automatically turn off NOTE While the meter is connected to the PC it is unable to perform a blood glucose test Blood Glucose InsCire Monitoring System dvance REPLACING THE BATTERY The Inspire Advance comes with TWO 1 5v AAA alkaline batteries Battery life will vary depending on usage so always keep a spare battery on hand The battery should las
4. After delete memory the meter will display OFF before shut down The meter setting is now completed Ti Blood Glucose relies Bloo au Monitoring System IMPORTANT 1 2 The time date and unit of measurement can ONLY be changed in the setting mode Therefore when you perform a blood glucose testing it is not possible to change those parameters Your meter displays 7 14 21 and 28 day averages which you can access from the meter memory These averages are calculated from the date of your latest result to 7 14 21 and 28 days before Your meter can display test result in milligram per deciliter mg dL or millimoles per liter mmol L The mg dL unit is standard in the United States The mmol L unit is standard in Canada and European countries We will preset by standard unit of each country When you turn off the meter or replace the battery the unit will not be changed Use of the wrong unit of measure may cause you to misinterpret your blood glucose level and may lead to incorrect treatment Please always consult with your healthcare professionals before you reset the unit of measure While the meter is in the setting mode if no button is pressed for 1 minute the meter will turn off automatically Blood Glucose InsQire Monitoring System dvance CONTROL SOLUTION TEST Inspire Advance meter Control Solution Inspire Advance meter control solutions contain a known amount of g
5. avoid the meter and test strips getting dirt dust or other contaminants please wash and dry your hands thoroughly before use Cleaning Your meter does not require special maintenance As long as no blood or control solution comes in direct contact with the meter there is no special cleaning required Blood Glucose InsOire Monitoring System dvance 1 To clean the meter exterior wipe with a cloth moistened with tap water or a mild cleaning agent then dry the device with a soft and dry cloth Do not flush with water 2 Do not use organic solvents to clean the meter Your meter is a precision instrument Please handle it with care Storage 1 Meter Storage e Storage condition 20 C 50 C 4 F 140 F below 90 relative humidity Always store or transport the meter in its original storage case e Avoid dropping and strong impact e Avoid direct sunlight and humidity 2 Strip Storage e Storage condition 4 C 40 C 39 F 104 F and between 10 85 relative humidity Do not refrigerate e Store your test strips in their original vial only e Do not transfer to other container e Store test strip packages in a cool and dry place Keep away from direct sunlight and heat After removing a test strip from the vial immediately replace the vial cap and close it tightly e Touch the test strip with clean and dry hands e You may touch the test strip anywhere with clean dry hands when removing it from the vial or inserting it
6. equal degree of protection to linspire Medical Corp or your local distributor To get full satisfaction it should be properly used amp maintained as per instructions amp description provided in the user s manual The warranty covers only products purchased The Warranty does not cover the following 1 Transportation costs amp risks of transport 2 Cost of repairs and or defects resulting from repairs carried out by unauthorized persons 3 Periodic check ups maintenance amp repair 4 Breakage of Display Screen and damage of delicate parts viz accidental dropping of the device or that of heavy object on the device Any exposure of device with dampness water spillage of solutions and excessive heat including direct sunlight causing damage to the device body electronic and mechanical parts whether intentionally or otherwise Alteration removal defacing the Serial Number of the device Failure or wear amp tear of accessories besides the main device Meter itself Damages of any kind including personal caused accidentally or by misuse Battery Replacement is not covered during warranty a COON Tr Ol Blood Glucose Advance Monitoring System Costs arising due to non acceptance of a claim those will be charged for Written notice of the specific manufacturing defect in workmanship or malfunction must be intimated Repair or replacement under the warranty does not give rise to any extension or renewal o
7. into the meter Use each test strip immediately after removing it from the vial Do not bend cut or alter a test strip in any way Tr Ol Blood Glucose Advance Monitoring System Keep the strip vial away from children since the cap and the test strip can be a potential choking hazard If swallowed please seek medical assistance immediately 3 Control solution storage Storage condition Store the control solution tightly closed at temperatures below 30 C 86 F Do not refrigerate PERFORMANCE CHARACTERISTIC Accuracy gt 95 in Azone of EGA vs YSI 2300 glucose analyzer Within 12 mg dL at glucose concentration lt 75 mg dL and within 15 glucose concentration 75 mg dl Precision CVs 5 when glucose concentration 75 mg dL The device has been certified to meet the following standards 98 97 EC IEC 60601 1 IEC 61010 1 IEC 60601 1 2 IEC 61326 and ISO 15197 Blood Glucose InsQire Monitoring System dvance SYSTEM SPECIFICATIONS MC 619 Inspire Advance lectrochemical biosensor apillary Whole Blood eferenced to plasma glucose value ES palm forearm upper arm calf or thigh Model Name Assay Method est Sample est Result Alternative Site Testing ample Size Measuring Time Measuring Range Acceptable Hematocrit Range Operating Condition torage Transportation Condition Memory Capacity Average Calculation N E seconds 0 600 mg dL 1 1 33 3 mmol L 0 60
8. is programmed for a 12 hour period format 10 DATE Display month and date METER DISPLAY m T P Hia finia IN AX WX Di ave T vr sham spol Ki mwn W T 5 F 11 THERMOMETER SYMBOL Appears when ambient temperature is above or below the acceptable range needed for testing Blood Glucose InsOire Monitoring System dvance KEY FUNCTIONS OF THE TEST STRIP 1 ABSORBENT CHANNEL apply a drop of blood here the blood will be drawn in automatically 2 CONFIRMATION WINDOW this is where you confirm if enough blood has been drawn into the test strip s absorbent channel 3 TEST STRIP HANDLE hold this part to insert the test strip into the meter slot 3 4 CONTACT BARS Insert this end of the test strip into the a meter until it will go no further n fest strips are for single use only Store the vial in a cool dry place below to 40 C 104 F and above 4 C 39 F Do not refrigerate Store your test strip in their original vial only Do not transfer them to a new vial or any other container With clean dry hands you may touch the test strip anywhere on its surface when removing it from the vial or inserting it into the meter 5 Immediate use a test strip after removing it from the vial replace the vial cap and close it tightly 6 Only apply a blood sample or a control solution sample to the test strip s absorbent channel Applying
9. Cover page Tr Ol Blood Glucose Advance Monitoring System Thank you for selecting Inspire Advance Blood Glucose Monitoring System The system was produced in close association with diabetes healthcare professionals most importantly people with diabetes li This manual contains important information you must know about the system Please read it thoroughly and carefully For short simple instructions a quick reference card is provided for your convenient use If you have any questions or enquiries please contact your local distributor or us for help The Inspire Advance is designed to help you and your healihcare professionals monitor your blood glucose levels All questions about interpreting the results should be directed to your healthcare professionals The Inspire Advance is the latest technology for blood glucose monitoring easy to use and will give you fast and accurate results with a minimal sample of blood The Inspire Advance Meter e Requires no coding allowing you to save time and avoid human error due to coding e Allows you to perform Alternative Site Testing AST Has memory and data management capabilities It gives you and your healthcare professional powerful graphic tools to manage your diabetes Blood Glucose InsCire Monitoring System dvance ZNIMPORTANT SAFETY INSTRUCTIONS READ THIS BEFORE USING The following basic safety precautions should always be taken 1 Close supervision is necessar
10. ERY _ an JO CARING FOR YOUR METER AND TEST STRIP PERFORMANCE CHARACTERISTIC 39 SYSTEM SPECIFICATIONS aavrvrrreresononon 40 SOLVING GUIDE sasona SYMBOLS DESCRIPTION CONTACT INFORMATION UMITED WARRANT Y ciiasan WARRANTY REGISTRATION CARD 91 Blood Glucose Insire Monitoring System dvance NIMPORTANT HEALTH RELATED INFORMATION 1 Apply only capillary whole blood sample to test your blood glucose Applying other substances or plasma serum will cause wrong results 2 Severe dehydration and excessive water loss may cause false low results If you believe you are suffering from severe dehydration consult your healthcare professional immediately 3 If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all instructions described in this user s manual consult your healthcare professional 4 Test results below 60 mg dL 3 3 mmol L 1 may mean low blood glucose hypoglycemia Test results greater than 240 mg dL 13 3 mmol L 2 may mean high blood glucose hyperglycemia If your results are below 60 mg dL 3 3mmol L or above 240 mg dL 13 3 mmol L repeat the test and if the results are still below 60 mg dL 3 3 mmol L or above 240 mg dL 13 3 mmol L follow the treatment advice of your healthcare professional 5 Inaccurate results may occur in severely hypotensive individuals or patients in shock Inac
11. altose 60 mg dL 90 mg dL 500 mg dL 5 0 mg dL 900 mg dl 900 mg dL 3 33 mmol L 1 54 mmol L 12 9 mmol L 0 44 mmol L 50 mmol L 26 3 mmol L 8 Please refer to your test strip package insert for additional important information Blood Glucose InsQire Monitoring System dvance REFERENCE 1 Jabbour Serge Elizabeth A Stephens Irl Bennett Hirsch Type 1 Diabetes in Adults USA CRC Press 2007 2 Unger Jeff Diabetes Management in Primary Care USA Lippincott Williams amp Wilkins 2006 InsQire Blood Glucose Advance Monitoring System ABOUT ALTERNATIVE SITE TESTING AST There are important limitations for doing AST Please consult your healthcare professional before you perform AST What is AST Alternative Site Testing AST means you can use parts of the body other than your fingertips to check your blood glucose levels The Inspire Advance allows you to test your palm forearm upper arm calf or thigh with equivalent results to fingertip testing What is the advantage Fingertips feel pain more readily because they are full of nerve endings receptors At other body sites nerve endings are not so numerous and you will not feel as much pain as you will experience at the fingertip When to use AST Food medication illness stress and exercise can affect blood glucose levels Capillary blood at fingertip reflects these changes faster than capillary blood a
12. ate result wipe off the first drop of blood and gently squeeze another drop of blood STEP 5 Apply Blood Sample Apply the blood sample to the opening of absorbent channel of test strip until the confirmation window is fully covered with blood Then the meter begins to count down and displays test result in 5 seconds STEP 6 Read Your Result The result of your blood glucose test will appear after the meter counts down to 0 This blood glucose result will automatically be stored in the memory This default value is only for your reference please consults your healthcare professional to find out your target blood glucose value Blood Glucose InsQire Monitoring System dvance STEP 7 Remove Strip to Turn Meter Off Your blood glucose result is automatically stored in the meter memory Turn the meter off by removing the test strip Discard the used strip and lancet safely in a puncture resistant container Tr Ol Blood Glucose Advance Monitoring System IMPORTANT The Inspire Advance only requires a tiny sample of blood to perform a test Choose a different spot each time you test Repeat puncture in the same spot may cause soreness and calluses The first drop of blood usually contains tissue and serum which may affect the test result It should be discarded The blood should be completely filled the confirmation window before the meter begins to count down If you find that the confirmation window i
13. curate 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 6 Abnormal red blood cell counts hematocrit levels below 20 or above 60 may cause false results Please consult your healthcare professional if you do not know your hematocrit level 7 Interference Reducing substances occurring in the blood naturally uric acid or from therapeutic treatments ascorbic acid acetaminophen will not significantly affect Inspire Advance test results However elevated concentrations of these substances may affect test Te Ol Blood Glucose Advance Monitoring System results The compounds listed in the tables were found to have no affect at the concentration indicated Compounds Uric Acid Gentisic Acid Acetaminophen Hydroxyurea Ascorbic Acid Lowest concentrations lt lt lt lt lt tectediai Which 8 0 mg dL 5 0 mg dL 8 0 mg dL 3 0 mg dL 5 0 mg dL no interference 0 48 mmol L 0 32 mmol L 0 53 mmol L 0 39 mmol L 0 28 mmol L occured Methyldopa Tolbutamide Triglycerides Lowest concentrations lt lt lt lt lt tested at which 2 0 mg dL 10 mg dL lt 3 0 mg dL 400 mg dL 2000 mg dL no interference 0 11 mmol L 0 51 mmol L 0 13 mmol L 14 8 mmol L 22 6 mmol L occured Compounds Aspirin Bilirubin _ Cholesterol Creatinine Galactose M
14. doctor immediately if you experience symptoms that are not consistent with your blood glucose test results 3 A sample with large amount of reducing substances such as ascorbic acid and uric acid may cause result slightly higher than the actual glucose level 4 High altitudes above 3 402 meters 11 158 feet may affect the test results 5 Temperatures outside the range of 5 C to 45 C 41 F to 113 F may affect the test results Do not test beyond the temperature range TE Ol Blood Glucose Advance Monitoring System CONTENTS OF THE SYSTEM The Inspire Advance complete kit includes Inspire Advance Blood Glucose Meter X 1 Inspire Advance meter Blood Glucose Test Strips X 5 Lancing device X 1 Lancets X 5 Carrying bag X 1 User s manual X 1 Quick reference guide X 1 Strip instruction X 1 Battery AAA x 2 NOTE The Inspire Advance meter is available as a meter only or as a complete kit Contents might vary by different package For meter only products with mark are excluded Please review the contents of your purchase If any items are missing please return your meter to the place of purchase Blood Glucose InsOire Monitoring System dvance KEY FUNCTIONS OF THE METER Study this diagram and become familiar with g all the parts of your Inspire Advance meter STRIP SLOT Insert the test strip here The meter will turn on automatically 2 LCD DISPLAY The large easy to read dis
15. ed for use in the home and in clinical settings It should not be used for the diagnosis of diabetes or for the testing of newborns Test Principle Blood glucose is measured by an electrical current that is produced when a blood samples mixes with the reagent special chemicals of the test strip The electrical current changes with the amount of glucose in the blood sample The Inspire Advance meter measures the strength of the electrical current calculates your blood glucose level and then displays your result in either mg dL or mmol L About the System The Inspire Advance system uses the latest technology to provide you with easy and comfortable testing The system requires only a 0 7uL of blood sample to complete the testing in only 5 seconds The Inspire Advance system consists of 1 Inspire Advance Blood Glucose Meter 2 Inspire Advance meter Blood Glucose Test Strips 3 Inspire Advance meter Control Solution These products have been designed tested and proven to work together as a system to produce accurate blood glucose test results Blood Glucose InsQire Monitoring System dvance Important Use only Inspire Advance test strips and control solutions with your Inspire Advance meter Use other test strips and control solutions with this meter can produce inaccurate results A caution The user should not take any decision of medical relevance without first consulting his or her medical practitioner 2 Call your
16. erly DO NOT use the system to test your blood until you get a test result falls within the control range If you are unable to resolve the problem please contact your local distributor for help Blood Glucose Tr Ol Monitoring System dvance PREPARE FOR BLOOD SAMPLING Adjustable Lancing Device Lancet 1 Lancing Device Cap 2 Depth Selector 1 Protective cap 3 Lancet Holder 4 Cocking Control 5 Release Button Your lancing device and lancets are used for obtainingcapillary blood samples from the puncture site Nmportant Lancing Device and Lancets Information 1 Lancet is for single use only 2 Keep lancing device and lancets clean 3 Use caution when removing the used lancet from the device and when disposing the used lancet 4 The lancing device and lancets are in conformity with MDD 93 42 EEC Refer to product labels for contact information of manufacturer and CE marking Important The meter and lancing devic are for single patient use Do NOT share them with anyone including other family members Do NOT use on multiple patients LEO Blood Glucose aug Monitoring System Set Lancing Device C J 1 Screw off the cap of lancing device Insert a lancet into the lancet holder and push down until it is fully seated 2 Twist off the protective cap until it separates from the lancet 3 Replace the lancing device cap and set the puncture depth to the desired number Note the depth selec
17. f the warranty period This warranty will be applicable only if the complete product amp the warranty card are sent and if the warranty card is completely filled in amp returned within ten 10 days linspire Medical Corp amp its authorized distributor resellers reserve the right to refuse warranty services if any unclear information has been given WARNING This apparatus may or may not suit all users For your own safety and other healthcare reasons you are strongly advised to consult your Doctor Disclaimer of warranty THIS WARRANTY IS EXPRESSLY MADE IN LIEU OF ANY AND ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR USE Limitations of Liability In no event shall linspire Medical Corp amp its distributors resellers be liable for indirect special or consequential damages even if linspire Medical Corp amp its distributors resellers has been advised of the possibility of such damages l InsQire Monitoring System Advance Blood Glucose y InsQire Blood Glucose Advance Monitoring System ARRANTY REGISTRATION CARD The manufacturer warrants to the original retail purchaser that this meter will be free from defects in materials and workmanship for 5 years from the date of the original purchase During the 5 year period we shall at no charge repair or replace a unit found to be defective with an equivalent or current version of the owne
18. l Solution Information 4 1 Use only Inspire Advance meter control solution 2 3 Control solution meter and test strips should come to room temperature 20 30 C 68 86 F Check the expiration date on the control solution bottle Do not use if expired before testing Shake the control solution bottle before use discard the first drop of control solution after squeezing wipes off the dispenser tip to avoid contaminations These steps ensure you will get a good sample and an accurate result Store the control solution closed at temperatures between below 30 C 86 F Do not refrigerate NOTE 1 There are two levels of control solution normal and high available to choose from The control solution supplied with the meter kit is normal range Please contact with your local distributor for other level of control solution The control solution range printed on the test strip vial is for Inspire Advance meter Control Solution only It is used to test meter and strip performance It is not recommended range for your blood glucose level Blood Glucose Insire Monitoring System dvance How to Perform a Control Test OLIN lam AN STEP 1 Insert Test Strip Insert a new test strip into the strip slot the meter will activate STEP 2 Mark as a Control Solution Test After the blood symbol s appears press MAIN BUTTON and CTL appears on the display indicating you are in the Control Solutio
19. lucose that reacts with Inspire Advance meter test strips By testing your control solution and comparing the test results with the expected range printed on the test strip vial label you can make sure that the meter and the test strips are working properly together as a system and that you are performing the test correctly It is very important that you do this simple check routinely to make sure you get accurate results Why perform a control solution test 1 To ensure that your meter and test strip are working properly together 2 To allow you to practice testing without using your own blood When should the control solution test be performed 1 When you first get your Inspire Advance meter Before use this system to test your blood you can practice the procedure by using control solution When you can do three tests in a row that are within the expected range you are ready to test your blood Once a week to make sure that you continue to get accurate results When you begin using a new vial of test strips Whenever you suspect that the meter or test strips are not working properly When your blood glucose test results are not consistent with how you feel or when you think your results are not accurate When test strips are exposed to extreme environmental conditions AUN O TA Blood Glucose Trelis Bloo au Monitoring System G 8 If you drop the meter After changing the batteries Important Contro
20. m Test result is lower than 20 mg dL 1 1 mmol L High or low blood glucose levels can indicate a possibly serious medical condition If this is not confirmed by the way you feel review proper testing procedure and perform a control test Repeat blood test if the display still appears Test result is higher than Please call medical assistance immediately 600 mg dL 33 3 mmol L Deleting memory Deleting is complete Blood Glucose InsOire Monitoring System dvance Battery is dead Replace battery now Maybe 1 Used strip or moistened You have to strip 1 Repeat test with a new test strip 2 Defective meter 2 Contact your local distributor for help The meter is not working Move to an area with Temperature is below the temperature between 5 C to 45 C 41 F 113 F operating range and wait at least 30 minutes Do not artificially heat or cool the meter Te Offa Blood Glucose aug Monitoring System The test strip was removed When meter is counting Repeat test with a new test strip form 05 to 01 Blood sample is not Repeat test with sufficient sample sufficient Maybe No responses when 1 Battery is dead Wrong test strip be into the meter inserted Meter is defective You have to 1 Replace battery 2 Insert the test strip correctly 3 Contact your local distributor for help No res
21. n Mode The meter will not store your test result in the memory when you preset the test as a control solution test If you decide not to perform a control solution test press MAIN BUTTON again and the CTL will disappear STEP 2 Squeeze a drop of Control Solution Shake control solution bottle well Remove the cap Squeeze the bottle discard the first drop and wipe off the dispenser tip with a clean tissue paper or cotton Squeeze the bottle again to get the second drop onto a clean non absorbent surface or on your fingertip first STEP 3 Apply Control Solution Apply the drop to the opening of the strip absorbent channel until the confirmation window is filled The meter begins to count down LEO Blood Glucose aug Monitoring System STEP 4 Check if the test result is in range After the meter counts down form 05 to 01 the test result shows up Compare the test result with the range printed on the test strip vial The result should fall within the printed range NOTE 1 Be sure that you are in Control Solution Mode so that the O test result will not be stored in the meter memory To avoid contaminating the control solution with the content of the test strip DO NOT APPLY THE CONTROL SOLUTION DIRECTLY TO THE mm TEST STRIP If test result falls outside the range printed on the test strip vial repeat test first If you continue to get the result falling outside the range your meter and test strip may not be working prop
22. om a finger stick can be up to 70 mg dL 3 9 mmol L higher than blood drawn from a vein venous sample used for a Blood Glucose InsQire Monitoring System dvance lab test 2 Therefore it is best to fast for eight hours before doing comparison tests Factors such as the amount of red blood cells in the blood a high or low hematocrit or the loss of body fluid severe dehydration may also cause a meter result to be different from a laboratory result REFERENCE 1 Surwit R S and Feinglos M N Diabetes Forecast 1988 April 49 51 2 Sacks D B Carbohydrates Burtis C A and Ashwood E R ed TietzTextbook of Clinical Chemistry Philadelphia W B Saunders Company 1994 959 LEO Blood Glucose Advance Monitoring System MEMORY RECALL The Inspire Advance automatically stores 450 test results letting you review them in order from the most recent to the oldest The meter also calculates and displays 7 14 21 and 28 day averages You can review the individual or average test result by entering the memory mode Recall the Memory JCCs L an mg STEP 1 Enter the Memory Mode While the meter is turned off press MAIN BUTTON for twice to enter memory mode STEP 2 Recalling Average Test Results When entering the memory mode the 7 day average will appear If you continue to press the MAIN BUTTON the 14 day the 21 day and the 28 day averages will display in order
23. other substances to the test strip s absorbent channel will cause inaccurate results Do not use test strips beyond the expiration date indicated on the strip vial label Do not place in direct heat or sunlight Do not carry loose test strips in your carrying case Important Test Strip Information 1 2 3 A ooun Te Offa Blood Glucose aus Monitoring System 10 Do not use damaged test strips or test strips changed in any way Warning Keep the test strips vial away from children the vial cap and the test strips can be a potential choking hazard Never chew or swallow a test strip If this occurs please seek medical assistance immediately Blood Glucose Te Ol Monitoring System dvance SETTING YOUR METER Your Inspire Advance meter comes with the date time and unit of measurement preset However if you change the time or replace the battery you should check and update the time and date STEP 1 Enter Setting Mode Start with the meter off and press SET BUTTON The meter will turn on and enter to the setting mode STEP 2 Set the Year The year appears with the number flashing Press and release the MAIN BUTTON to obtain the desired year Press SET BUTTON to confirm and move to next MONTH setting itr STEP 3 Set the Month The month appears with the number flashing Press and release the MAIN BUTTON to obtain the desired month Press SET BUTTON to confirm and move to ne
24. play shows test results messages test A results stored in memory 3 MAIN BUTTON Press button to turn the meter on or perform other functions described E in this manual 4 SET BUTTON Located in the battery compartment press button to enter meter setting Refer to SETTING YOUR METER section of this user s manual for details 5 BATTERY COMPARTMENT Holds TWO 1 5v AAA alkaline batteries 6 DATA PORT Allows you to transfer the information stored in the meter to a computer to view analyze and print Refer to REVIEWING RESULTS ON A PERSONAL COMPUTER Section of this user s manual for details 7 METER LABEL Each meter has its unique number on it It can be used when you want to obtain warranty service Please do not alter or tear the label off Tr Oe Blood Glucose Advance Monitoring System 1 TEST STRIP SYMBOL Appears when the meter is turned on and waiting for inserting a test strip 2 VOICE SYMBOL Appears while using Inspire Advance talking version 3 BATTERY SYMBOL Appears when battery is weak 4 BLOOD DROP SYMBOL Flashes when it is ready to apply the blood sample 5 MEASUREMENT UNIT Appears with the test result in mg dL or mmol L 6 AVERAGE Appears in the memory mode while recalling 7 14 21 28 day test averages 7 MEMORY SYMBOL Appears when in the memory mode 8 CTL SYMBOL Appears when doing a control sloution test 9 TIME The meter
25. ponses when blood sample is Maybe You have to applied to the test 1 Meter is defective 1 Contact your local distributor for help strip Blood Glucose InsOire Monitoring System dvance SYMBOLS DESCRIPTION IVD For in vitro diagnostic use Temperature limitation Store at Please consult instructions for use mun Use by Expiry date Caution consult accompanying This product fulfils the requirements CE 0123 of Directive 98 79 EC in vitro diagnostic medical device The device has certificated to meet the following standards 98 79 EC IEC 60601 1 IEC 61010 1 IEC 60601 1 2 IEC 61326 and ISO 15197 LEO Blood Glucose aus Monitoring System CONTACT INFORMATION CE 0123 Inspire Medical Corp No 7 Ln 57 Sec 1 Zhiyu Rd Shilin Dist Taipei City 111 Taiwan R O C tel 886 2 838 4177 fax 886 2 838 0392 www imedisource com E mail service imedisource com Blood Glucose InsOire Monitoring System dvance LIMITED WARRANTY linspire Medical Corp warrants that the Inspire Advance meter shall be free of defects in material and workmanship for a period of five 5 years This warranty is valid from the date of purchase The warranty extends only to the original purchaser and is not transferable To obtain warranty service you must take the Product or deliver the Product freight prepaid in either its original packaging or packaging affording an
26. r s model The warranty of the repaired meter or replacement will expire on the date of the original warranty expiration or ninety 90 days after shipment of the repaired or replacement system whichever period is longer This warranty is limited to replacement due to defects in parts or workmanship Failure of the meter due to damage by accident abuse or use not in accordance with the instructions is not covered by this warranty Local distributor Dealer stamp Inspire Medical Corp No 7 Ln 57 Sec 1 Zhiyu Rd Shilin Dist Taipei City 111 Taiwan R O C tel 886 2 838 4177 fax 886 2 838 0392 Email Address Meter Serial Number Purchased From Dealer Name re ee ee eee
27. s not filled with blood when the meter is counting NEVER try to add more blood to the test strip Discard the test strip and retest with a new one If you do not apply a blood sample within four 4 minutes the meter will automatically turn off You must remove the test strip and re insert it again to turn on the meter and restart the test procedure If you have trouble filling the test strip please contact your local distributor for assistance Blood Glucose InsQire Monitoring System dvance UNDERSTANDING YOUR TEST RESULT Normal Blood Glucose Range The normal blood glucose range is 70 to 105 mg dL 3 9 to 5 8 mmol L for a fasting non diabetic adult but less than 140 mg dL 7 8 mmol L two hours after meals Consult your healthcare professional to find out your target blood glucose value If your blood glucose result seems unusually high or low or inconsistent with your previous results check the following Was the blood sample applied immediately to the test strip after removing it from the vial Was the volume of the blood sample sufficient Was the test strip vial cap tightly sealed Was the test strip used before the expiration date Were the test strips stored away from extreme temperatures in very cold or hot weather or from areas of high humidity Or BG Ni Then run a control test with Inspire Advance meter control solution If the control test result is within the acceptable range review testing proced
28. t about 1000 tests or 12 months when testing 3 times a day When the battery symbol appears on the meter display battery is getting low You will still be able to test with low battery but you should replace it as soon as possible When battery symbol and E b shows up in the meter display the meter will no longer give results and you must replace the battery immediately Please always have spare batteries with you to ensure that you can replace the battery anytime How to replace the battery 1 Make sure the meter is turned off Let the front of the meter rest in the palm of your hand Slide battery cover open 2 Remove the old batteries and replace with two 2 new 1 5V AAA size alkaline batteries Te Ol Blood Glucose Advance Monitoring System 4 Close battery cover NOTE 1 Replacing the battery does not affect the test result stored in memory However the time and date may need to re set 2 As with all small objects the battery should be kept away from small children as a safety precaution If the battery is swallowed seek medical assistance immediately 3 Batteries might leak chemicals if not used for a long time Remove the batteries if you are not going to use the device for extended i e 3 months or more 4 bid discard the used or dead batteries properly according to the regulations of your country CARING FOR YOUR METER AND TEST STRIP To
29. t other sites Therefore if you are testing blood glucose level during or immediately after meal physical exercise or stressful event take the blood sample from your fingertip only Blood Glucose InsQire Monitoring System dvance Use AST only 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 e During steady state blood glucose conditions Do NOT use AST if e You have reason to believe you have hypoglycemia or hyperglycemia e Your routine glucose results are often fluctuating e You are pregnant How to increase the accuracy e Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has a significant influence on the glucose value obtained e Blood from the site without rubbing exhibits a measurably different glucose concentration than blood from the fingertip When the puncture site was rubbed prior to blood extraction the difference was significantly reduced Important To increase the accuracy when using AST rub the puncture site more than 20 seconds before extracting blood L ON Blood Glucose Advance Monitoring System ABOUT Inspire Advance SYSTEM Intended Use IVD The system is intended for use outside the body in vitro diagnostic use only It should be used only for testing blood glucose blood sugar and only with fresh capillary whole blood samples The system is intend
30. tor offers 5 levels of skin 1 2 for soft or thin skin 3 for average skin 4 5 for thick or calloused skin 4 Pull back the cocking control until it makes a click and then release If it does not click the device may have been cocked when the lancet was inserted Blood Glucose ON Monitoring System dvance PERFORMING BLOOD TEST STEP 1 Wash Your Hands and the Puncture Site Wash your hands in warm soapy water Rinse and dry completely Warm your fingers to increase blood flow STEP 2 Insert Test Strip Remove a new test strip from vial Be sure to tightly replace vial cap after removing test strips Insert test strip immediately into strip slot as illustrated The meter turns on automatically When the blood symbol blinking you are ready to perform a test STEP 3 Select and Lance a Puncture Site For Fingertip Hold the prepared lancing device firmly against the side of your fingertip Press release button For AST Please refer to the About Alternative Site Testing AST Section Please consult your healthcare professional before obtaining blood from site other than your fingertip tt Blood Glucose ey Bloo au Monitoring System Correct Incorrect STEP 4 Obtain a Blood Sample Gently massage your finger or puncture site to obtain the required blood volume To perform the test you need only O 7pL of blood sample Do not smear the blood sample To obtain best accur
31. ure and repeat your blood glucose test with a new test strip If your blood glucose value is still inconsistent with your previous results glucose trend or how you feel contact your doctor immediately for help Tr Ol Blood Glucose Advance Monitoring System COMPARING WITH LABORATORY RESULTS The result you obtain from your meter may differ somewhat from your laboratory result due to normal variation Meter results can be affected by factors and conditions that do not affect laboratory results in the same way To make an accurate comparison between meter and laboratory results follow the guidelines below Before you go to the lab 1 Perform a control solution test to make sure that the meter is working properly 2 It is best to fast for at least eight 8 hours before doing comparison tests 3 Take your meter with you to the lab While at the lab 1 Make sure that the samples for both tests the meter test and the lab test are taken and tested within 15 minutes of each other 2 Wash your hands before obtaining a blood sample 3 Never use your meter with blood that has been collected in a gray top test tube 4 Use fresh capillary blood only You may still have a variation from the result because blood glucose levels can change significantly over short periods of time especially if you have recently eaten exercised taken medication or experienced stress 1 In addition if you have eaten recently the blood glucose level fr
32. xt DATE setting LEO Blood Glucose aug Monitoring System STEP 4 Set the Date The date appears with the number flashing Press and release the MAIN BUTTON to obtain the desired date Press SET BUTTON to confirm and move to next HOUR setting MEG W STEP 5 Set the Hour The hour appears with the number flashing Press and release the MAIN BUTTON to obtain the desired hour Press SET BUTTON to confirm and move to next minutes setting STEP 6 Set the Minutes The minute appears with the number flashing Press and release the MAIN BUTTON to obtain the desired minute Press SET BUTTON to confirm and the meter will enter to next unit setting STEP 7 Set the Unit of Measurement The existing unit for example mg dL will appear and flashing Press and hold the MAIN BUTTON for 3 seconds to change the unit to mmol L Press SET BUTTON to confirm and the meter will enter to next delete all memory setting Blood Glucose InsOire Monitoring System dvance STEP 8 Delete Memory When the dEL symbol and the flashing memory symbol appear on the display you can choose to clear the memory If you do not want to clear the memory press the SET BUTTON again to skip this step If you want to clear ALL memory press and hold MAIN BUTTON for 3 seconds The image will appear on the LCD screen to indicate that all memory has been deleted STEP 9 Complete Setting
33. y when the device is used near children handicapped persons or invalids Use the device only for the intended use described in this manual Do not use test strips and control solutions which are not supplied by the manufacturer Do not use the device if it is not working properly or if it has suffered any damage Before using any product to test your blood glucose read all instructions thoroughly and practice the test Do all quality control checks as directed and consult with a diabetes healthcare professional akon Warning Keep the test strips vial away from children the vial cap and the test strips can be a potential choking hazard Never chew or swallow a test strip If this occurs please seek medical assistance immediately KEEP THESE INSTRUCTIONS WITH YOU Tr Ol Blood Glucose Advance Monitoring System ABLE OF CONTENTS ABOUT ALTERNATIVE SITE TESTING AST 7 ABOUT INSPIRE ADVANCE SYSTEM 00 sssses 9 CONTENTS OF THE SYSTEM KEY FUNCTIONS OF THE METER METER DISPLAY KEY FUNCTIONS OF THE TEST STRIP 14 SETTING YOUR METER sinrin CONTROL SOLUTION TEST ansuran 20 PREPARE FOR BLOOD SAMPLING csssssssssssssssse24 PERFORMING BLOOD TEST T nsnsi 26 UNDERSTANDING YOUR TEST RESULT 30 COMPARING WITH LABORATORY RESULTS 31 MEMORY RECALIU kikote kosa A 33 REVIEWING RESULTS ON A PERSONAL COMPUTER aie ko isi ket EES OO REPLACING THE BATT
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