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SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM

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6. Warnings, Precautions and Limitations

•

Never make significant changes to your

diabetes control program or ignore

physical symptom without consulting

with your healthcare professional.

•

Severe dehydration (excessive water loss)

may cause false low results. If you believe

you are suffering from dehydration,

consult your healthcare professional right

away.

•

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.

•

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.

•

Normal endogenous (within body) natural

levels of uric acid, ascorbic acid (vitamin

C), bilirubin, triglycerides, and hemoglobin

do not interfere with your blood glucose

results obtained.

Содержание CodeFree

Страница 1: ...L21CF1ENR2 Issue date 2012 08 on User Instruction Guide BLOOD GLUCOSE MONITORING SYSTEM No Coding...

Страница 2: ...isit www sdbiosensor com for diabetes management tools and product demonstrations Please refer to the instructions with following symbols in this User Instruction Guide To identify conditions or pract...

Страница 3: ...Monitoring System 6 The SD CodeFree Meter 7 The SD CodeFree Test Strip 8 SD CodeFree Accessories 9 Changing the Battery 10 Meter Set up 11 Using SD CodeFree Test Strips Chapter 2 Control Solution Test...

Страница 4: ...D Check Strip Test 2 Cleaning the meter 3 Maintenance Testing and Transportation 4 Cleaning the Lancing Device 5 Screen Messages and Troubleshooting 6 Warnings Precautions and Limitations Chapter 6 Pr...

Страница 5: ...e only for use outside the body in vitro Your new meter is designed for testing fresh capillary whole blood samples for example blood from your fingertip palm upper arm or forearm Only use SD CodeFree...

Страница 6: ...on Dehydration Severe dehydration resulting from excessive water loss may cause false low results If you believe you are suffering from severe dehydration consult a healthcare pro fessional immediatel...

Страница 7: ...y you should take if you continue to get results higher than 180 mg dL 10 mmol L or if you have symptoms Repeated unexpected results If you continuetoget unexpectedresults checkyour system with contro...

Страница 8: ...our blood Your SD CodeFree blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip palm forearm or upper arm Your SD CodeFre...

Страница 9: ...mixes with reagent on the test strip that cause a small electric current The amount of current that is created depends on how much glucose is in the blood SD CodeFree meter measures the current that i...

Страница 10: ...em includes SD CodeFree Meter SD CodeFree Test strips SD Glucose Check strip 3V battery type CR2032 User Instruction Guide Quick Guide Self test Diary Strip Insert Carrying Case Lancing device with a...

Страница 11: ...sult stored in memory 6 The SD CodeFree Meter Arrow Buttons Used for meter setup and review of memory moving to the right and left ON OFF Button Press to turn meter ON or OFF Test Strip Slot Insert te...

Страница 12: ...e Indicates during the meter setting Indicates beep setting Warns when the battery is low or must be replaced Indicates if environmental temperature is exceeded during testing Indicates post meal or p...

Страница 13: ...New System Indicates the average result Test strip Tells you when to apply the sample and indicates if you select whole blood for blood reference type Indicates a control solution test result Indicate...

Страница 14: ...test strip is inserted into the meter in either Strip Stand by Display or turning off the below will be displayed automatically to show the appropriate test result after applying blood sample And if...

Страница 15: ...eal or post meal mark its icon will be displayed by pressing the right button one or two times Pre meal Post meal If you perform the pre meal test while the post meal alarm setting is on then the Post...

Страница 16: ...ystem 7 The SD CodeFree Test Strip The SD CodeFree System measures the amount of glucose in whole blood Blood is applied in the Yellow Window TOP EDGE of the SD CodeFree Test Strip and is automaticall...

Страница 17: ...New System SD Glucose Control Solution 8 SD CodeFree Accessories 1 2 AST Cap Cap Comfort dial with puncture depth selection 1 2 Lancing Device Cap Comfort dial with puncture depth selection Arming Kno...

Страница 18: ...ur meter can be found in the mesh pocket of your carrying case Battery life will vary depending on usage so always keep a spare on hand The meter saves battery power by automatically turning off after...

Страница 19: ...nt with side facing you STEP 3 Snap battery cover back in place STEP 4 Push the ON OFF button or insert a strip to start testing After inserting or replacing the battery confirm that the time and date...

Страница 20: ...isplay for setting the beep will appear the first step of the setting mode 2 Set the beep mode on or off by pressing either the left or the right button and then selecting the preferred feature by pre...

Страница 21: ...4 mmol L by pressing either the left or the right button and then selecting the preferred feature by pressing the ON OFF button You can set the meter to let you know when your result indicates a possi...

Страница 22: ...e Time will appear the third step of the setting mode Set the correct year by pressing either the left or the right button and then select the correct year by pressing the ON OFF button Your new meter...

Страница 23: ...nth 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 and select by pressing the ON OFF button...

Страница 24: ...the 12h format or the 24h format Set the preferred format on the display by pressing either the left or the right button and select by pressing the ON OFF button 2 Next will appear the setting display...

Страница 25: ...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 the fourth of setting mode 2 Set the post meal alarm mode 2h or of...

Страница 26: ...hours to remind you to test your blood glucose after meal for 1mimute If you perform the pre meal test while the post meal alarm setting is on then the post meal mark will appear automatically on you...

Страница 27: ...rm You can use the meter s alarm function to remind you to test your blood glucose 1 After Post meal alarm setting the display for setting the alarm will appear the fifth of setting mode 2 Set the fir...

Страница 28: ...you select the alarm off feature next will appear the Strip Stand by Display If you select the alarm on feature you can set the alarm up to four times a day at any time you want NOTE 3 If you select t...

Страница 29: ...u finish setting the first alarm next will appear the second alarm setting mode Set the alarm with the same way as above 2 3 5 You can set the third and fourth alarm mode with the same way as above 2...

Страница 30: ...t and heat Do Not refrigerate test strips Do Not expose strips to heat moisture or humidity Temperatures outside the required range as well as moisture and humidity e g bathroom kitchen laundry room c...

Страница 31: ...control solution applied to it Avoid getting dirt food or liquids on the test strip With clean dry hands you may touch the test strip anywhere on its surface Do Not bend cut or alter a SD CodeFree Tes...

Страница 32: ...l solution You open a new box test strips You left the test strip container open or you think your test strips have been damaged Your test strips were stored in extreme temperatures and or humidity Yo...

Страница 33: ...lution Shake the container discard the first drop of control solution and wipe off the tip to ensure a proper sample and an accurate result Store control solution tightly closed at temperatures betwee...

Страница 34: ...htly replace container cap after removing test strip 2 Insert a test strip yellow window printed arrow symbol facing up into test strip slot The meter turns on automatically A set of Level M and H con...

Страница 35: ...ontrol solution container and discard the first drop of solution Gently squeeze the container to form one small drop Bring the drop to the edge of the strip and allow the strip to automatically draw t...

Страница 36: ...g properly Repeat the control solution test 5 Remove the used test strip for control solution from the meter and discard it mg dL mmol L NOTE The control solution range printed on the test strip conta...

Страница 37: ...ds in Blood Stand by Display to display a control solution container icon Have the test strips and or control solution expired Make sure that test strips and control solutions are not past expiration...

Страница 38: ...en 2 32 C 36 90 F Was the bottle cap replaced immediately after removing a test strip If not retest with a new container of test strips Is the meter damaged Does it show an error code If yes contact S...

Страница 39: ...nterclockwise to remove it insert the lancet into the lancing device holder and push down firmly until it is fully seated Twist the lancet protective disk until it separates from the lancet 3 Replace...

Страница 40: ...ng device back hold the lancing device firmly against the side of finger and then press the release button 1 2 1 2 1 2 1 2 1 2 1 2 1 2 A lancet should only be used once DO NOT share used lancets with...

Страница 41: ...by two methods First method is that press the ON OFF button and second method is that insert the test strip into test strip slot in power off state the meter turns on automatically In second case you...

Страница 42: ...elow the joint closest to the fingertip 6 Obtain a drop of blood sample using the lancet and lancing device 7 Hold your finger to the tip of the strip until the yellow window is completely filled with...

Страница 43: ...cond and your result appears on the display in just 5 seconds 10 The blood glucose result is displayed in mg dL or mmol L 11 When the test is done pull out the used test strip The meter shuts off auto...

Страница 44: ...ur Blood Sugar Narrow Channel STEP 1 STEP 2 STEP 3 Line up the blood drop with the yellow window channel on test strip Gently touch test strip to the blood drop Proper test strip appearance Do not pre...

Страница 45: ...anging rapidly after a meal insulin or exercise Consult with your diabetes healthcare professional prior to testing from a site other than your fingertips Results obtained from sites other than the fi...

Страница 46: ...ycemia are experiencing low blood glucose or suffer from hypoglycemic unawareness you cannot tell when you have low blood glucose During times of stress or illness Ask your diabetes healthcare profess...

Страница 47: ...y area on the palm forearm or upper arm that is free of visible veins moles and hair and away from bone Prepare Your Lancing Device We recommend using the SD Lancing device with the clear end cap when...

Страница 48: ...p of lancing device And then insert lancet and cock lancing device Step 2 The meter turns on by two methods First method is that press the ON OFF button and second method is that insert the test strip...

Страница 49: ...cted area for 10 seconds until it starts to feel warm to the touch 2 Wash the area with warm soapy water Rinse and dry completely If you use alcohol wipes to cleanse the site make sure that the area i...

Страница 50: ...firmly against the skin until a blood drop forms 5 Once a large enough drop of blood has formed remove the lancing device Step 4 Pick up the meter and touch the end of the test strip to the blood samp...

Страница 51: ...ection to measurement evaporation of the blood sample may cause a test result that is higher than the accurate value Any of the above situations can lead to an inaccurate test result If the repeated A...

Страница 52: ...s testing time from applying a blood into strip you will receive a normal result 10mg dL to 600mg dL 2 If your blood glucose is above 600 mg dL you will receive a HI and is below 10 mg dL you will rec...

Страница 53: ...lt with pre meal mark 4 If you set the post meal mark before test you will receive a result with post meal mark If you perform the pre meal test while the post meal alarm setting is on then the post m...

Страница 54: ...sting 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 a...

Страница 55: ...of the results are also displayed If the memory is full and a new result is added the meter deletes the oldest result The meter also calculates three kinds of 7 14 and 30 day averages of test results...

Страница 56: ...the Meter Memory 1 Searching Test Results 1 In Strip Stand by Display press the left arrow button to review in sequence from the most recent test result to the last test results stored in memory Norma...

Страница 57: ...result 3 If there aren t the stored test results the following display appears for 1 sec and then the meter will display Strip Stand by Display automatically 2 After the result with date and time disp...

Страница 58: ...rages of test result stored in memory in sequence normal pre meal and post meal state You can also review the number of results at each average in the right bottom of the LCD window If you press the r...

Страница 59: ...lowing display will appear on the LCD You cannot search the stored test results and average of results in the meter if a test strip is inserted in the meter Blood Stand by Display After removing the t...

Страница 60: ...the software on a personal computer Please refer to Software Product Manual While the meter is connected to the PC it is unable to perform a blood glucose test For downloading SD Diabetes Management...

Страница 61: ...meter for the first time Whenever your result does not agree with the level you feel If you have repeated a test and the blood glucose result is still lower or higher than expected How to Use the SD G...

Страница 62: ...Cleaning the meter Caring for the SD CodeFree meter is easy Just keep it free of dust If you need to clean it follow these guideline carefully to help you get the best performance possible To prevent...

Страница 63: ...ansportation 1 Meter Keep the test strip slot free of dust Protect the internal meter from humidity The carrying case is designed to let you store a variety of supplies you may need and helps to prote...

Страница 64: ...ces manufactured by other company But if at all possible use the lancing device manufactured by SD Biosensor Inc Before using check a packaging condition if there is any problem you should not use it...

Страница 65: ...he container tightly after each use 4 Cleaning the Lancing Device Clean the outside of the SD lancing device regularly with 70 isopropyl rubbing alcohol Do not place the entire device under water Do n...

Страница 66: ...5 Screen Messages and Troubleshooting Message Description The meter turns on normally Strip Stand by Display The meter is ready for you to insert a test strip Blood Stand by Display The meter is ready...

Страница 67: ...TEM 66 Maintenance and Troubleshooting The meter is ready for a drop of blood with post meal mark The meter shows the result of blood glucose The meter shows three kinds of average of results Normal R...

Страница 68: ...CodeFree BLOOD GLUCOSE MONITORING SYSTEM 67 Maintenance and Troubleshooting The meter shows the saved results of blood glucose The meter is ready for a drop of control solution Post meal Results Avera...

Страница 69: ...9 Changing the Battery Replace battery Battery power is low Replace the battery immediately See Chapter 1 9 Changing the Battery If you press the ON OFF button after discharging of the battery the bat...

Страница 70: ...tanding Test Results Internal Error Message for a meter Turn off a meter Then turn on the meter again If there is still error massage please contact SD Biosensor Inc TEL 82 31 300 0400 Strip Error Def...

Страница 71: ...of the test strip See Chapter 3 2 Performing a Blood Glucose Test Temperature Error If the environmental temperature is above or below the operating range of a meter a thermometer icon will appear on...

Страница 72: ...tremes 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 Inaccurate results may occu...

Страница 73: ...be used for the diagnosis of diabetes Use only fresh capillary blood Do not use serum or plasma or venous whole blood Do not use the SD CodeFree meter to test neonates It has not been validated for n...

Страница 74: ...inimum 0 9 microliter Test Time 5 seconds Assay Method Glucose Oxidase Biosensor ON OFF Source One replaceable 3 V Lithium Battery type CR2032 Battery Life Around 1 000 tests Glucose Unit mg dL mmol L...

Страница 75: ...feet 3 776 meters Storage Temperature 2 C 32 C 36 F 90 F Memory 500 blood glucose tests Function Hypowarning 60 70 80mg dL 3 3 3 9 4 4 mmol L Pre meal and post meal mark Alarm setting up to 4 times Po...

Страница 76: ...mmunity requirements as per EN 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 requ...

Страница 77: ...and blood perfusion throughout the body can lead to sample site to site differences in glucose results These physiological effects vary between individuals and can vary within a single individual bas...

Страница 78: ...the meter Symbol Description Caution consult accompanying documents Battery type used in this meter Crossed out wheeled bin To discard it separately from other household waste Consult instructions fo...

Страница 79: ...c use BATCH CODE To indicate the lot number for this system DATE OF MANUFACTURE To indicate the date of manufacture for this system USE BY This system should be used by the given date To indicate the...

Страница 80: ...is system should be used by the given date To indicate the temperature limitations in which the transport package has to be kept and handled BATCH CODE To indicate the lot number for this system CATAL...

Страница 81: ...SDCodeFree BloodGlucosemeter SDCodeFree BloodGlucoseteststrip 10Tx1vial Lancet 10ea Lancingdevice SDGlucoseCheckStrip 01GC111 SDCodeFree BloodGlucosemeter SDCodeFree Blood Glucose test strip 10T x 1v...

Страница 82: ...l Level M and Level H Lancet 01GL10 Lancets 100ea x 1 box Software 01SCC10 SD Communication Cable ITEM Cat No System 01GC115 SD CodeFree Blood Glucose meter Lancet 10ea 01GC116 SD CodeFree Blood Gluco...

Страница 83: ...OOD GLUCOSE MONITORING SYSTEM 83 Product Technical Information Manufactured by SD BIOSENSOR Inc C 4th 5th Floor Digital Empire Building 980 3 Yeongtong dong Yeongtong gu Suwon si Kyonggi do Korea EC R...

Страница 84: ...r Digital Empire Building 980 3 Yeongtong dong Yeongtong gu Suwon si Kyonggi do Korea 01GM11 01GC11 series TEL 82 31 300 0400 FAX 82 31 300 0499 For further information on please contact your SD BIOSE...

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