User Manual - nu-beca
Contents
1. 5 Read your result The result of your blood glucose test will appear after the meter counts down to O This blood glucose result will automatically be stored in the memory 100 mg dL 5 6 mmol L 6 Eject the used test strip and remove the lancet To eject the test strip point the strip ata disposal container for sharp items The meter will switch itself off automatically after the test strip is ejected Always follow the instructions in the lancing device insert when removing the lancet The used lancet and test strip may be biohazardous Please discard them carefully according to your local regulations 23 METER MEMORY The meter stores the 450 most recent blood glucose test results along with respective dates and times in its memory To enter the meter memory start with the meter switched off Reviewing Test Results 1 Press and release M Mm will appear on the display Press M again and the first reading you see is the last blood glucose result along with date time and the measurement mode 300 mg dL 16 7 mmol L 2 Press the M to recall the test results stored in the meter each time you press After the last test result press M button again and the meter will be turned off 200 mg dL 11 1 mmol L gt N 24 Reviewing Blood Glucose Day Average Results 1 Press and release M When m appears on the display keep pressing M button for2. The measurement range of this meter is 20 600 mg dL 1 1 33 3 mmol L Reference values Time of day Normal plasma glucose range for people without diabetes Fasting and before meal Less than 100 mg dL 5 6 mmol L 2 hours after meals Less than 140 mg dL 7 8 mmol L Source American Diabetes Association 2010 Clinical Practice Recommendations Diabetes Care 33 Supplement 1 S1 100 Please consult your doctor to determine a target range that works best for you Questionable or inconsistent results If your test results are unusual or inconsistent with how you are feeling m Make sure the confirmation window of the test strip is completely filled with blood m Check the expiration date of the test strips m Check the performance of your meter and test strip with the control solutions PLEASE NOTE Unusually high or low blood glucose levels may be symptoms of a serious medical condition If most of your results are unusually high or low please contact your healthcare professional Quality Control Testing Our control solutions contain a known amount of glucose that can react with test strips You can check the performance of the meter test strip and your technique by comparing the control solution results with the range printed on the label of test strip vial Checking regularly can ensure your test results are accurate Please refer to the Owner s Manual for complete testing instructions IMPORTANT The referenc
3. 3 seconds until the flashing DAY AVG appears Release M button and then your 7 day average result measured in general mode will appear on the display S 4 DAY AVG 4 gt 2 Press M to review 14 21 28 60 and 90 day average results stored in each measuring mode in the order of Gen AC then PC 3 Exit the meter memory Keep pressing the M button and the meter will turn off after displaying the last test result NOTE e Any time you wish to exit the memory keep pressing Main button for 5 seconds or leave it without any action for 3 minutes The meter will switch off automatically e Control solution results are NOT included in the day average e If using the meter for the first time displays when you recall the test results or review the average result It indicates that there is no test result in the memory 25 Downloading Results onto a Computer Data Transmission Via Cable You can use the meter with an USB cable and the Health Care Software System to view test results on your personal computer To learn more about the Health Care Software System or to obtain an USB cable separately please contact local customer services or the place of purchase for assistance 1 Obtaining the required cable and installing the software To download the Health Care Software System please visit the nu beca s website www nu beca com 2 Connecting to a personal computer Connect the cable to a USB port on
4. Hole Apply a drop of blood here The blood will be automatically absorbed Confirmation Window This is where you confirm if enough blood has been applied to the absorbent hole in the strip Test Strip Handle Hold this part to insert the test strip into the slot Contact Bars Insert this end of the test strip into the meter Push it in firmly until it will go no further ATTENTION The front side of test strip should face up when inserting test strip Test results might be wrong if the contact bar is not fully inserted into the test slot Front NOTE The SMOQZE itis monitor should only be used with SNOOZE series Test Strips Using other test strips with this meter can produce inaccurate results 10 Setting the Meter Before using your meter for the first time or if you change the meter battery you should check and update these settings Make sure you complete the steps below and have your desired settings saved Entering the Setting Mode Start with the meter off no test strip inserted Press SET 1 Setting the date With the year flashing press M button until the correct year appears Press SET With the month flashing press M button until the correct month appears Press SET With the day flashing press M button until the correct day appears Press SET 2 Setting the time format Press and release M button to select the desired time format 12h or 24h Press SET 11 3
5. IEC EN 61010 1 IEC EN 61010 2 101 EN 61326 1 IEC EN 61326 2 6 35 PNPOI siy ISN O AUJIGeU JO ISN y JO INO Sulsue sasewep PRJU2PIDU JO JEMUSNDISUOD 12 lIIp AUC 104 J GE 9G 1OU eUS M ONPOI silu JO ISN y 0 P dS I UUM sod nd JeinoiWed p 10 SS ullJ JO ALJIGEJUCUDOW JO SINUPIJPEM y GUIPNIDU Passaldxa JO padu S I JUPIIPAA 19410 je wepsip m SUdeJGeIed DAOGE 241 UI Paes sp d 2x3 JOJJUOD UBLUNY PUOAD SL JOYIO AUP JO SIL Qed qpuOSp l JO ype GULIdWe 1u pioop asnge ASNSILW AG PISNed SJP 19402 JOU SBOP AULEM SIUL UOSIOA PIZWOUINEUN Aq P S 10 p led u q sey Pnpod sy JI PIOA SI AJUCLIEM styl aseyoind JO Jp y WO SAPP pL ULY 197 JOU 91440 INO O 1U S SI PIPI UONPIISISIN AULEM y JI pue duels s Joyesp pue JOQUUNU seas aseyoINd JO 3p YUM D duuo2 Ajnp Y De pL UONPIISISIN AULEM PUPR JVD AULEM SUI JI AJUO PIJPA SI AULEM SIU E ponad AJUPHEM Uu JO JOPUSELWSJ IY 0 dN 104 PIJUCLEM 20 JIM ONpOId y BGBUCYDX9 JO JUDWIIE Gad ed YONS JOY JUMO CUIGHO SY 0 IGJEYUD OU Je BSOOUD Aew 9M se 9npO1d BJOUM y GUIGUEBUDXa JO Sed SAIPa2Jap 2e d 1 JO ed Uu U JIM IM ADIAJAS AJUBLEM JOJ SINOY SSOUISNG ewou GUUNDP 221440 INO O SISPQ ULANE p UO SWI AJUPIIPAA pue 1491292991 SpUDInd y YUM JOYIBGO JI GUNG ACW NOA Al193J p q 0 PUNO s Pnpod siy JI ponad AJUCEM y GULING IJL AJUPHEM U U
6. beca SMOQZE itis Blood Glucose Meter Model BG4117 m o IML JA Apu Owner s Manual Dear SMOQZE itis System Owner Thank you for purchasing theS SMOQZE itis Blood Glucose Meter 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 Regular monitoring of your blood glucose levels can help you and your doctor gain better control of your diabetes Due to its compact size and easy operation you can use the SMOQZE itis Blood Glucose Meter to easily monitor your blood glucose levels by yourself anywhere any time If you have other questions regarding this product please contact the place of purchase or call the Customer Care Line Version 1 0 2012 08 311 4116100 001 2 10 IMPORTANT SAFTY INSTRUCTIONS READ BEFORE USE Use this device ONLY for the intended use described in this manual Do NOT use accessories which are not specified by the manufacturer Do NOT use the device if it is not working properly or if it is damaged Do NOT use the equipment in places where aerosol sprays are being used or where oxygen is being administered Do NOT under any circumstances use the device on newborns or infants This device does NOT serve as a cure for any symptoms or diseases The data measured is for reference only Before using this device to test blood glucose read all instructions thoroughly a
7. e you suspect the meter or test strips are not working properly e your blood glucose test results are not consistent with how you feel or if you think the results are not accurate e practicing the testing process or e you have dropped or think you may have damaged the meter Performing a Control Solution Test You will need 1 Meter 2 Test Strip 3 Control Solution NIE We 15 1 Insert the test strip to turn on the meter Insert the test strip into the meter Wait for the meter to display the ambient temperature EB and 8 2 Press M to mark this test as a control solution test With QC displayed the meter will not store your test result in memory If you press the M button again the QC will disappear and this test is no longer a control solution test WARNING When doing the control solution test you have to mark it so that the test result will NOT be stored in the memory Failure to do so will mix up the blood glucose test results with the control solution test results in memory 16 3 Apply control solution Shake the control solution vial thoroughly before use Squeeze out a drop and wipe it off then squeeze out another drop and place it on the tip of the vial cap Hold the meter to move the absorbent hole of the test strip to touch the drop Once the confirmation window fills completely the meter will begin counting down
8. for the diagnosis of diabetes or testing on newborns Professionals may test with capillary and venous blood sample home use is limited to capillary whole blood testing Test Principle Your system measures the amount of sugar glucose in whole blood The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip The meter measures the current calculates the blood glucose level and displays the result The strength of the current produced by the reaction depends on the amount of glucose in the blood sample Meter Overview 1 Display Screen 2 Test Strip Ejector Eject the used strip by pushing this button up 3 Test Slot Insert test strip here to turn the meter on for testing 4 SET Button Enter and confirm the meter settings 5 Data Port Download test results with a cable connection 6 Main Button Enter the meter memory and silence a reminder alarm Display Screen 5 KETONE ra A HIGH LOW gt a 7 Mlnce mg dL 15 ge 8 QC PCX DAY AVG 2 9 IO I AAM 10 kal LA KANA Dah Dal KN LI PM 1 Low battery symbol 9 2 Test strip symbol 10 3 Blood drop symbol aa 4 Test result 12 5 Ketone warning 13 6 Error Message 14 7 Memory symbol 15 s Control solution mode Measuring mode Date Time Day average Reminder alarm Face Low High symbol Measurement unit Test Strip Absorbent
9. time press M button to switch off the meter Congratulations You have completed all settings NOTE e These parameters can ONLY be changed in the setting mode e f the meter is idle for 3 minutes during the setting mode it will switch off automatically 13 THE FOUR MEASURING MODES The meter provides you with four modes for measuring General AC PC and QC General any time of day without regard to time since last displays as Gen meal no food intake for at least 8 hours 2 hours after a meal testing with the control solution You can switch between each mode by 1 Start with the meter switched off Insert a test strip to turn on the meter The screen will display a flashing blood drop and Gen 2 Press M button to switch between General AC PC and QC mode 14 TESTING WITH BLOOD SAMPLE Our Control Solution contains a known amount of glucose that reacts with test strips and is used to ensure your meter and test strips are working together correctly Test strips control solutions or sterile lancets may not be included in the kit please check the contents on your product box They can be purchased separately Please make sure you have those items needed for a blood glucose test beforehand Do a control solution test when e you first receive the meter e at least once a week to routinely check the meter and test strips e you begin using a new vial of test strips
10. your computer With the meter switched off connect the other end of the USB cable to the meter data port PE will appear on the meter display indicating that the meter is in communication mode 3 Data transmission To transmit data follow the instructions provided with the software Results will be transmitted with date and time Remove the cable and the meter will automatically switch off WARNING While the meter is connecting to the PC it will be unable to perform a blood glucose test 26 MAINTENANCE Your meter comes with two 3V CR2032 lithium batteries Low Battery Signal The meter will display one of the messages below to alert you when the meter power is getting low 1 The a appears along with display messages The meter is functional and the result remains accurate but it is time to change the batteries ac IMA MIN AM LA Lhah LALI The C3 appears with E b Error and low The power is not enough to do a test Please change the batteries immediately Replacing the Battery To replace the batteries make sure that the meter is turned off 1 Press the edge of the battery cover and lift it up to remove 2 Remove the old batteries and replace with one 1 5V AAA size alkaline battery 3 Close the battery cover If the batteries are inserted correctly you will hear a beep afterwards 27 NOTE e Replacing the batteries does not affect the test results stored in the m
11. F 2 Select the appropriate measuring mode by pressing M For selecting the measurement mode please refer to the FOUR MEASURING MODES 3 Obtaining a blood sample PA Use the pre set lancing device to puncture the desired site After penetration discard the first drop of blood with a clean cotton swab Gently squeeze the punctured area to obtain another x drop of blood Be careful NOT to smear the blood sample The volume of blood sample must be at least 0 5 microliter UL of volume o actual size 4 Apply the sample Gently apply the drop of blood to the absorbent hole of the test strip at a titled angle Confirmation window should be completely filled if enough blood sample has been applied Do NOT remove your finger until you hear a beep sound NOTE e Do not press the punctured site against the test strip or try to smear the blood If you do not apply a blood sample to the test strip within 3 minutes the meter will automatically turn off You must remove and reinsert the test strip to start a new test e The confirmation window should be filled with blood before the meter begins to count down NEVER try to add more blood to the test strip after the drop of blood has moved away Discard the used test strip and retest with a new one e If you have trouble filling the confirmation window please contact your health care professional or the local customer service for assistance 22
12. O pod AULEM ples y UUM sen PUL dIUSUPULNIOAA UI SPIJOP JO 3314 q 0 NPOJ SIU JUCLEM M ALNVdavM JO SNOILIGNOD 8 SWIL Owner s portion WARRANTY CERTIFICATE Name of product Name of owner Address Tel No Mobile HH OP _ Email CA Gender OM LiF Date of Purchase J Jl Dealer s Stamp day month year Serial No NOTE Please produce this card together with the purchase receipt for warranty service dWYI1S XlddV JSV31d Dealer s portion WARRANTY REGISTRATION CARD Name of product Name of owner Address Tel No Mobile HY C O Email CA Gender OM ma Date of Purchase ER Jl Dealer s Stamp day month year Serial No IMPORTANT To qualify for the warranty please fill in this card and mail to us within 14 days from the date of purchase Mbeca 312 4117000 001 Blood Glucose Test Strips smooze Series gt For in vitro diagnostic use for use outside of the body only gt For single use only gt Healthcare professionals and other users testing multiple patients with this system should handle everything that has comes into contact with human blood carefully to prevent transmitting infectious diseases including sanitized objects gt Please read this sheet and your Blood Glucose Monitoring System Owner s Manual before you use this est strip Use only smooze series Test Strips with smooze series Blood Glucose Monitoring System to
13. Setting the time With the hour flashing press M button until the correct hour appears Press SET With the minute flashing press M button until the correct minute appears Press SET 4 Deleting the memory With dEL and a flashing M symbol on the display press M button and select No to keep the results in memory then press SET to skip To delete all the results press M button and select YES to delete all the memory records 5 Setting the reminder alarm You may set up any or all of the reminder alarms 1 4 The meter displays On or OFF and 6 press M to turn on or turn off to set the first reminder alarm Press M button to select On then press SET to set the hour When the hour is flashing press M button to add an hour Press SET to confirm and go to minutes press M button to add one minute Hold M button longer to add faster Press SET to confirm and go to the next alarm setting 12 If you do not want to set an alarm press SET to skip this step If you want to turn off an alarm find the alarm number by pressing SET in the setting mode press M button to change from ON to OFF At the time of your alarm the meter will beep and automatically turn on You can press M button to silence the alarm and insert a test strip to begin testing If you do not press M button the meter will beep for 2 minutes then switch off If you do not want to test at this
14. To avoid contaminating the control solution do not directly apply control solution onto a strip 4 Read and compare the result After counting down to O the control solution test result will appear on the display Compare this result with the range printed on the test strip vial and it should fall within this range If not please read the instructions again and repeat the control solution test 158 mg dL 8 8 mmol L 109 165 mg dL 6 1 9 2 mmol L Out of range results If you continue to have test results fall outside the range printed on the test strip vial the meter and strips may not be working properly Do NOT test your blood Contact the local customer service or place of purchase for help NOTE e The control solution range printed on the test strip vial is for control solution use only It is not a recommended range for your blood glucose level e See the Meter Maintenance section for important information about your control solutions 17 TESTING WITH BLOOD SAMPLE WARNING To reduce the chance of infection e Never share a lancet or the lancing device e Always use a new sterile lancet Lancets are for single use only e Avoid getting hand lotion oils dirt or debris in or on the lancets and the lancing device Preparing the Lancing Device for Blood Testing Please follow the instructions in the lancing device insert for collecting a blood sample Preparing the Puncture Site Stimulat
15. dehydration and excessive water loss may cause readings which are lower than actual values If you believe you are suffering from severe dehydration consult a healthcare professional immediately elf your blood glucose results are lower or higher than usual and you do not have any symptoms of illness first repeat the test If you have symptoms or continue to get results which are higher or lower than usual follow the treatment advice of your healthcare professional e Use only fresh whole blood samples to test your blood glucose Using other substances will lead to incorrect results e The measurement unit used for indicating the concentration of blood or plasma glucose can either have a weight dimension mg dL or a molarity mmol L The approximate calculation rule for conversion of mg dL in mmol L is Divided by 18 For example 1 120 mg dL 18 6 6 mmol L 2 7 2 mmol L x 18 129 mg dL approximately Intended Use This system is intended for use outside the body in vitro diagnostic use by people with diabetes at home and by health care professionals in clinical settings as an aid to monitoring the effectiveness of diabetes control It is intended to be used for the quantitative measurement of glucose Sugar in fresh whole blood samples from the finger palm forearm and upper arm Professionals may test with capillary and venous blood sample home use is limited to capillary whole blood testing It should not be used
16. e performed on sites other than the fingertip We strongly recommend that you perform AST ONLY at the following times m During a pre meal or fasting state more than 2 hours since the last meal m Two hours or more after taking insulin m Two hours or more after exercise Do NOT use AST if m You think your blood glucose is low m You may not notice if you are hypoglycemic m Your AST results are inconsistent with the way you feel m You are testing for hyperglycemia m Your routine glucose results often fluctuate To obtain a blood sample from the alternative sites please rub the puncture site for approximately 20 seconds before following the procedures of Testing Your Blood Glucose gt Xylose Do not test blood glucose during or soon after a xylose absorption test Xylose in the blood can give falsely elevated results gt Hematocrit The hematocrit level is limited to between 20 and 60 Please ask your healthcare professional if you do not know your hematocrit level gt Neonatal Use This test strip must not be used for the testing of newborns gt This test strip is used for testing fresh capillary and venous whole blood gt Uric acid ascorbic acid and acetaminophen at normal blood concentration do not significantly affect blood glucose test results P There are no significant interference in the presence of galactose maltose or fructose observed in blood glucose tests gt Lipemic Effects Blood triglyce
17. e range of the control solutions may vary with each new vial of test strips Make sure you check the range on the label of your current vial Chemical Components gt Glucose dehydrogenase E Coli 8 gt Electron shuttle 55 gt Enzyme protector 8 gt Non reactive ingredients 29 Additional Information for Healthcare Professionals Always wear gloves and follow your facility s biohazard control policy and procedures when performing tests involving patient blood samples Use fresh whole blood samples only Professionals may use test strips to test capillary and venous whole blood Sample Size 0 5 uL Reaction Time 5 seconds System Measurement Range 20 mg dL to 600 mg dL Hematocrit Range 20 to 60 Accuracy smooze series Test Strips were tested on 120 capillary blood samples and each sample was tested twice which had 240 test results The results were compared to the YSI 2300 reference method The table below show how well the two methods compared N test results 240 Y 0 9939 2 0908 R 0 9845 Range 35 406 mg dL The following tables show differences in glucose values between this system and YSI 2300 Table 1 represents samples for glucose results lower than lt 75mg dL Table 2 represents samples for glucose results greater than 2 75 mg dL Table 1 Difference distribution for glucose concentration lt 75 mg dL Difference range in values between Within Within Within the reference va
18. emory e As with all small batteries these batteries should be kept away from children If swallowed promptly seek medical assistance e Batteries might leak chemicals if unused for a long time Remove the batteries if you are not going to use the device for an extended period i e 3 months or more Properly dispose of the batteries according to your local environmental regulations Caring for Your Meter To avoid the meter and test strips attracting dirt dust or other contaminants please wash and dry your hands thoroughly before use Cleaning e To clean the meter exterior wipe it with a cloth moistened with tap water or a mild cleaning agent then dry the device with a soft dry cloth Do NOT rinse with water e Do NOT use organic solvents to clean the meter Meter Storage e Storage conditions 20 C to 60 C 4 F to 140 F below 95 relative humidity e Always store or transport the meter in its original storage case e Avoid dropping and heavy impact e Avoid direct sunlight and high humidity Caring for Your Test Strips e Storage conditions 2 C to 32 C 35 6 F to 89 6 F below 85 relative humidity Do NOT freeze e Store your test strips in their original vial only Do not transfer to another container 28 e Store test strip packages in a cool dry place Keep away from direct sunlight and heat e After removing a test strip from the vial immediately close the vial cap tightly e Touch the te
19. g dL Fasting and before meal lt 100 mg dL 5 6 mmol L 2 hours after meals lt 140 mg dL 7 8 mmol L Source American Diabetes Association 2010 Clinical Practice Recommendations Diabetes Care 33 Supplement 1 S1 S100 Please consult your doctor to determine a target range that works best for you SYMBOL INFORMATION IVD In vitro diagnostic medical L Use within 3 months after device first opening NG u Keep away from sunlight Serial number lt Caution consult jai Keep dry accompanying documents Temperature limitation Sterilized using irradiation E Do not use if package is Use by Expiry date Authorized representative in the European Community 34 SPECIFICATIONS Model No SMOQZE itis Dimension amp Weight 96 5 L x 54 3 W x 20 5 H mm 55 4 g Power Source two CR2032 lithium batteries Display LCD Memory 450 measurement results with respective date and time External Output USB Auto electrode insertion detection Auto sample loading detection Auto reaction time count down Auto switch off after 3 minutes without action Temperature Warning Operating Condition 10 C to 40 C 50 F to 104 F below 85 R H non condensing Storage Transportation Conditions 20 C to 60 C 4 F to 140 F below 95 R H Measurement Units Fixed mg dL Measurement Range 20 to 600 mg dL 1 1 to 33 3 mmol L This device has been tested to meet the electrical and safety requirements of
20. ing blood perfusion by rubbing the puncture site before blood extraction has a significant influence on the glucose value obtained Blood from a site that has not been rubbed exhibits a measurably different glucose concentration than blood from the finger When the puncture site was rubbed prior to blood extraction the difference was significantly reduced Please follow the suggestions below before obtaining a drop of blood e Wash and dry your hands before starting e Select the puncture site either at fingertips or another body parts please see section Alternative Site Testing AST on how to select the appropriate sites e Clean the puncture site using cotton moistened with 70 alcohol and let it air dry e Rub the puncture site for about 20 seconds before penetration e Use a clear cap included in the kit while setting up the lancing device 18 e Fingertip testing Press the lancing device s tip firmly against the lower side of your fingertip Press the release button to prick your finger then a click indicates that the puncture is complete e Blood from sites other than the fingertip Replace the lancing device cap with the clear cap for AST Pull the cocking J control back until it clicks When lancing the forearm upper arm or hand avoid lancing the areas with obvious veins because of excessive bleeding NOTE e Choose a different spot each time you test Repeated punctures at the same spot may cause sore
21. lue and smooze 5mg di 10mg dL 15 mg dL series s value The percentage and number of samples for which the difference between smooze series s and 71 90 reference value were within the 90 42 38 42 difference range shown in the top row Table 2 Difference distribution for glucose concentration gt 75 mg dL Difference range in values between Within Within Within Within the reference value and BG 4117 s 5 10 15 20 value The percentage and number of samples for which the difference 51 82 95 between smoaze series san 100 198 162 198 189 198 reference value were within the difference range shown in the top row Acceptance criteria in ISO 15197 95 of all differences should be within 15 mg dL 0 83 mmol L for glucose concentration lt 75 mg dL 4 2 mmol L and within 20 for glucose concentration gt 75 mg dL 4 2 mmol L Note When meter results are compared to the laboratory results results below 75 mg dL are compared in mg dL Precision The CV is less than 5 both in intermediate precision and repeatability precision Symbol Information T ramon wl owe r _ i Authorised tative i Keep away from sunlight Aona keran CE Temperature limitation re if package is oC Use within 3 months after first R o O FR opening om eoo For self testing Use Only With smooze series C 32 C Blood Glucose Monitoring System 0123 ver 1 0 2012 06
22. nd practice the test Carry out all the quality control checks as directed Keep the device and testing equipment away from young children Small items such as the battery cover batteries test strips lancets and vial caps are choking hazards Use of this instrument in a dry environment especially if synthetic materials are present synthetic clothing carpets etc may cause damaging static discharges that may cause erroneous results Do NOT use this instrument in close proximity to sources of strong electromagnetic radiation as these may interfere with the accurate operation KEEP THESE INSTRUCTIONS IN A SAFE PLACE TABLE OF CONTENTS BEFORE YOU BEGIN 06 Important Information 06 Intended Use 07 Test Principle 07 Meter Overview 08 Display Screen 09 Test Strip 10 Setting the Meter 11 TESTING WITH BLOOD SAMPLE 15 Control Solution Testing 15 Performing a Control Solution Test 15 TESTING WITH BLOOD SAMPLE 18 Preparing the Puncture Site 18 Alternative Site Testing 20 Performing a Blood Glucose Test 21 METER MEMORY 24 Reviewing test results 24 Reviewing Blood Glucose Day Average Results 25 Downloading Results Onto A Computer 26 MAINTENANCE 27 Battery 27 Caring for Your Meter 28 Caring for Your Test Strips 28 Important Control Solution Information 29 SYSTEM TROUBLESHOOTING 30 Result Readings 30 Error Messages 31 Troubleshooting 33 DETAILED INFORMATION SYMBOL INFORMATION SPECIFICATIONS BEFORE YOU BEGIN e Severe
23. ness and calluses e Please consult your health care professional before you begin AST e It is recommended that you discard the first drop of blood as it might contain tissue fluid which may affect the test result 19 Alternative Site Testing You can test on a variety of locations on your body Upper Arm Forearm Suggested Test Areas for the Hand Important There are limitations with AST Alternative Site Testing Please consult your health care professional before you perform AST When to use AST Capillary blood at the fingertip reflects these changes faster than capillary blood at other sites Thus when testing blood glucose during or immediately after a meal physical exercise or any other event take a blood sample from your finger only We strongly recommend that you perform AST ONLY at the following times e In a pre meal or fasting state more than 2 hours since the last meal e Two hours or more after taking insulin e Two hours or more after exercise Do NOT use AST if e You think your blood glucose is low e You are unaware of hypoglycemia e You are testing for hyperglycemia e Your AST results do not match the way you feel e Your routine glucose results often fluctuate 20 Performing a Blood Glucose Test You will need 1 Meter 2 Test Strip 3 Lancing Device 4 Lancet n 1 Insert the test strip to turn on the meter Wait for the meter to display B and 66
24. obtain accurate results and be covered by the manufacturer s warranty gt Results may be inaccurate when testing on patients with abnormally low blood pressure or those who are in shock gt Low results may be inaccurate when testing on patients in hyperglycemic hyperosmolar state with or without ketosis gt Please do not use this Blood Glucose Monitoring System on critically ill patients gt Keep test strips and lancets away from small children If swallowed consult a doctor immediately for advice Intended Use smooze series test strips when used together with smooze series Blood Glucose Monitoring System allow your blood glucose levels to be measured by yourself at home or by healthcare professionals It uses fresh whole blood samples from the finger and the following areas the palm forearm upper arm calf and thigh This system is not intended for use in the diagnosis or screening of diabetes mellitus Professionals may use test strips to test capillary and venous whole blood home use is limited to capillary whole blood testing About Alternative Site Testing AS IMPORTANT There are limitations for performing AST Please read the smooze series Blood Glucose Monitoring System Owner s Manual and consult your doctor before you perform AST Alternative site testing AST is when individuals check their blood glucose levels using areas of the body other than the fingertip The smooze series test strips allow AST to b
25. rides up to 2000 mg dL 22 8 mmol L do not affect the results significantly but may affect results at higher levels gt Altitude Effects Altitudes up to 10 742 feet 3 275m do not affect test results gt Use only heparin or EDTA for anticoagulation of fresh capillary or venous whole blood Storage and Handling IMPORTANT Do not use the test strips if they have expired gt Test strips expire 3 months after first opening Write the first opening date on the test strip vial when you first opened it gt Store the test strips in a cool dry place between 2 C and 32 C 35 6 F and 89 6 F and below 85 relative humidity b Keep the test strips away from direct sunlight Do not store the test strips in high humidity gt Store the test strips in their original vial ONLY Do not transfer them to a new vial or any other containers b Do not touch the test strips with wet hands gt Use each test strip immediately after taking it out of the vial Close the vial immediately after taking out a strip b Keep the vial closed at all times b Do not bend cut or alter the test strip Strip Appearance 4 1 Absorbent Hole Apply a drop of blood here The blood will automatically be absorbed 2 Confirmation Window This is where you confirm if enough blood has been drawn into the absorbent hole of the strip 3 Test Strip Handle Hold this part to insert the test strip into the slot 4 Contact Bars Insert this end of the test
26. s other than the ones below appear please call your local customer service Do not attempt to repair yourself and never try to disassemble the meter under any circumstances Result Readings messas WTM to lt 20 mg dL 1 1 mmol L EON aes sow 20 69 mg dL 1 1 3 8 mmol L 129 mg dL __ 179 mg dL sen 119 mg dL 3 9 7 2 3 9 3 9 Rone mao 2 240 mg dL 13 3 mmol L Fe gt 600 mg dL 33 3 mmol L ii 239 mg dL 239 mg dL 239 mg dL 7 2 13 3 mmol L 9 9 13 3 mmol L 6 7 13 3 mmol L 30 Error Messages coe WHAT IT MEANS WHAT TO DO Appears when the batteries cannot provide enough power for a test Appears when a used test strip is inserted Appears when ambient temperature is below system operation range Appears when ambient temperature is above system operation range Replace the batteries immediately Repeat with a new test strip System operation range is 10 C to 40 C 50 F to 104 F Repeat the test after the meter and test strip are in the above temperature range 31 MESSAGE WHAT IT MEANS WHAT TO DO Repeat the test with a new test strip If the meter still does not work please contact the customer service for Problem with the meter assistance 32 Troubleshooting 1 If the meter does not display a message after inserting a test strip POSSIBLE CAUSE WHAT TO DO Battery exhausted Replace the battery Tes
27. st strip with clean and dry hands e Use each test strip immediately after removing it from the vial e Write the opening date on the vial label when you first opened it Discard remaining test strips after 6 months e Do not use test strips beyond the expiry date This may cause inaccurate results e Do not bend cut or alter a test strip in any way e Keep the strip vial away from children since the cap and the test strip may be a choking hazard If swallowed promptly see a doctor for help For further information please refer to the test strip package insert Important Control Solution Information e Use only our control solutions with your meter e Do not use the control solution beyond the expiry date or 3 months after first opening Write the opening date on the control solution vial and discard the remaining solution after 3 months e t is recommended that the control solution test be done at room temperature 20 C to 25 C 68 F to 77 F Make sure your control solution meter and test strips are at this specified temperature range before testing e Shake the vial before use discard the first drop of control solution and wipe off the dispenser tip to ensure a pure sample and an accurate result e Store the control solution tightly closed at temperatures between 2 C to 30 C 35 6 F to 86 F Do NOT freeze 29 SYSTEM TROUBLESHOOTING If you follow the recommended action but the problem persists or error message
28. strip into the meter Push it in firmly until it will go no further ATTENTION Test results might be wrong if The front side of the test strip the contact bar is not fully y should face up when inserting l inserted into the test slot kil x the test strip 1 Front Back Testing Your Blood Glucose PLEASE WASH AND DRY YOUR HANDS BEFORE PERFORMING ANY TESTING STEP 1 Insert the test strip fully into the slot of the meter until it will go no further When the strip is fully inserted the meter will do several self checks Z STEP 2 WA Collect a blood sample with the test strip A sufficient guantity of blood is required for the test to provide accurate results Touch the blood drop with the absorbent hole of the test strip and wait until the confirmation window is fully covered Do NOT apply a smeared blood sample The meter will start counting down m K STEP 3 m After a few seconds the meter will display your blood glucose level The last a reading will be automatically saved in the meter Turn it off by removing the mg dL test strip and throw away the used test strip Please refer to your Owner s Manual for more information The used lancet and test strip are potentially biohazardous Please dispose of them carefully according to your local regulations Reading Your Result Your blood glucose readings deliver plasma equivalent results and are displayed in milligrams of glucose per deciliter of blood mg dL
29. t strip inserted upside down or Insert the test strip with contact incompletely bars end first and facing up Defective meter or test strips Please contact customer services 2 If the test does not start after applying the sample Insufficient blood sample Repeat the test using a new test strip with larger volume of blood sample Defective test strip Repeat the test with a new test strip Sample applied after automatic Repeat the test with a new test strip switch off 2 minutes after last user Apply sample only when flashing 6 action appears on the display Defective meter Please contact customer services 3 If the control solution testing result is out of range POSSIBLE CAUSE WHAT TO DO Error in performing the test Read instructions thoroughly and repeat the test again Control solution vial was poorly shaken Shake the control solution vigorously and repeat the test again Expired or contaminated control Check the expiry date of the control solution solution Control solution that is too warm or Control solution meter and test strips too cold should be at room temperature 20 C to 25 C 68 F to 77 F before testing Defective test strip Repeat the test with a new test strip Meter malfunction Please contact customer services 33 DETAILED INFORMATION The meter provides you with whole blood equivalent results Time of day Normal plasma glucose range for people without diabetes m
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