Easy Pain Supreme User's Manual
Contents
1. Action Replace the batteries first If Err appears again contact local dealer for repair Supreme System fault Action Replace the batteries first If Err appears again contact local dealer for repair 52 Warning Messages Supreme The Ht and thermometer icon appears Operating temperature is too high Action Relocate the meter to working environment between 10 C 40 C 50 F 104 F It alerts you that an incorrect result may occur if test continues Supreme The Lt and thermometer icon appears Operating temperature is too low Relocate the meter to working environment between 10 C 40 C 50 F 104 F It alerts you that an incorrect result may occur if test continues 53 Test result is higher that 600 mg dL 33 3 mmol L Test again If the result is still the same please contact your healthcare professional immediately The test result is lower than 30 mg dL 1 7 mmol L Action Test again If the result is still the same please contact your healthcare professional immediately First time install batteries and not coding yet Action Coding your meter 54 Device Information Easy Pain Supreme SMBG System Easy Pain Supreme Blood Glucose Test Strips Easy Pain Supreme Blood Glucose Meter Manufacturer EPS BIO TECHNOLOGY CORP 2F No 49 2 Lane 2 Guang Fu Rd Sec 22. E Press A button to adjust the hour If the time is over 12 00AM you need to press A button 12 13 times until symbol AM changes to symbol PM Press B button to confirm E After confirming the blinking area will go to the next 2 digits minute Press A button to adjust the minutes then press B button to confirm the setting Supreme Caution If you want to skip adjusting hours or minutes press B button again then the blinking area will move to next 2 digits C Selecting the Unit of Measurement You will see the unit setting mode after the time setting confirmation The LCD will show the SCL and mg dL message E Press A button to switch to the mmol L unit Press A key again to switch back to the mg dL unit m After selection press B button to confirm the setting and leave the setting mode Supreme Supreme At setting mode the meter will power off after 2 minutes if you don t press any key Caution After the unit setting confirmation the meter will select units automatically Coding Your Meter Caution When you use a new vial of strips you should use the code card to code the device to get the correct reading 1 Check the code number Check that the code on the code card and vial are identical 2 Insert the code card Insert the code card into the slot and the device will turn on E You will see a 3 digit code number on the display a
3. Hsinchu City Taiwan 300 TEL 886 3 5752522 FAX 886 3 5752552 E mail info epsbio com tw http www epsbio com tw Lancing Device Meets the requirement of MDD 93 42 EEC Manufacturer PALCO LAB INC 8030 Soquel Avenue Suite 104 Santa Cruz CA 95062 2032 USA TEL 831 476 3151 800 346 4488 FAX 831 476 1114 E mail info palcolabs com 55 Please read Easy Pain Supreme User s Manual before operation If you have any questions and or need help please contact as follows Within the U S A call Toll Free 1 888 216 5888 Pacific Time Mon Fri 9 00AM 5 00PM E Outside the U S A call your authorized representative or write to E Customer Service E mail info epsbio com tw Warranty EPS warrants the original purchaser for 5 years from the date of purchase EPS will replace your Blood Glucose System with a new one or equivalent product free of charge during the warranty period when it doesn t work for any reason other than obvious abuse 56
4. a bathroom or a refrigerator You should keep the meter strips and lancing device away from children or pets e Please refer to the limitations of the procedure in specifications before testing e Remove batteries when you will not use the meter for one month or more e Store the kits in a dry place with temperature range is below 86 F 30 C Keep away from direct sunlight and heat e Store your test strips in their original vial only Do not transfer them to a new vial or any other container e Indicate the date you open the vial Discard all unused strips after 90 days from open date The strips are for single use only e Warning for potential biohazard Healthcare professionals using this system on multiple patients should handle the all products or objects contact with human blood carefully for fear of transmitting viral disease even after cleaning Caution 1 Do not touch the strip with a wet hand 2 Do not use expired strips the expiration date is shown on the vial 3 Do not bend cut or twist the strip Standard Accessories 1 Wallet 2 User s Manual 3 Self Test Log Book 4 Warranty Card 5 EPS Blood Glucose Meter 6 Instructions 7 Lancing Device 8 Code Card 9 Check Strip 10 Quick Reference Guide 11 EPS Blood Glucose Test Strip x 10 pcs 12 Alkaline Batteries 1 5V AAA x 2 Optional Accessories 1 Glucose Normal Control Solution 2 Glucose High Control Solution Compo
5. check strip into the slot 2 Checking the message on the screen a When you see OK the system is functioning properly b If FAL appears replace the batteries and try again If FAL appears again after replacing batteries please contact your local dealer or manufacturer for further help 3 Removing the check strip 31 Remove the check strip and store in a safe location ll Use control solutions Use control solutions and test strips to check whether the system is working properly 1 You should use control solutions when m Use the Glucose meter for the first time E You open a new vial of test strips E You think the meter or test strips may be working incorrectly E Your results do not reflect how you feel m You drop the meter m You repeat a test and the test results are still lower or higher than expected E You teach or learn how to use the system 32 2 Procedure When you use a new vial of test strips you must code the meter with the new code card packed in the box for an accurate blood glucose test result Please check that the CODE number on the code card matches that on the vial of blood glucose test strips a Insert the code card into the slot of the meter b The meter will automatically turn on and display the code number on the LCD screen c Check the code number to match the one on the code card d Remove the code card and place it in the carrying wallet with your meter
6. the result in 25 seconds and the meter will record results E f there are more than 100 records the device will erase your oldest record stored and replace it with the newest result 4 Remove the strip E After viewing the result or writing the result in the Self Test Log Book remove the strip carefully and discard it according to local regulations E f you do not remove the strip the meter will shut down in 5 minutes The meter will turn off 25 Caution 1 The strip is for single use only Do not reuse it 2 The measuring range is between 1 7 mmol L to 33 3 mmol 30 mg dL to 600 mg dL The display will prompt LO if the reading is lower than 1 7 mmol L 30 mg dL or HI if higher than 33 3 mmol L 600 mg dL Caution The test result may be not correct if the environment temperature of the meter changes violently Please wait 1 hour for temperature balance before testing 26 Note Expected results for non diabetic non pregnant adult a Fasting values 70 mg dL to110 mg dL 3 9 mmol L to 6 1 mmol L b Two hours after meals less than 120 mg dL 6 7 mmol L If your test result is not consistent with your symptoms or if your blood glucose result is less than 60 mg dL 3 3 mmol L or higher than 240 mg dL 13 3 mmol L you should contact your healthcare professional 27 Reviewing Stored Records The device will store 100 sets of records with a time amp date stamp 1 Enteri
7. Easy Pain Supreme Self Monitoring Blood Glucose System User s Manual EPS Bio Technology Corp 2F No 49 2 Lane 2 Guang Fu Rd Sec 2 Hsinchu City Taiwan 300 TEL 886 3 5752522 FAX 886 3 5752552 E mail info epsbio com tw Rev A04 P N 7180002 A Please read this User s Manual thoroughly before use H Table of Contents Introduction Measuring Principle Intended Use Important Information Standard Accessories Optional Accessories Components Before Testing Battery Installation Presetting Coding Your Meter Testing Fingertip Blood Sampling Step by Step Test Procedure Reviewing Stored Records Checking the System Use the check strip Il Use control solutions The Advanced Meter Setting Il N O WwW WwW DO 10 12 16 18 21 23 28 31 31 32 38 Thermometer Setting Il Alarm Setting Ill Beep Setting IV Clock Setting Cleaning and storing the Meter Specifications Limitations of the Procedure Performance Characteristics Accuracy Specifications Displaying Messages Troubleshooting Error Messages Warning Messages Device Information Warranty IV 38 38 40 41 42 43 43 46 47 48 49 49 51 53 55 56 Introduction Thank you for using the Easy Pain Supreme Self Monitoring Blood Glucose System We design his system for medical care on diabetes The test results can help you determine the effects of food exercise and diabetes medications We design this syste
8. an before collecting the blood sample for testing Place the finger to the lancing device tip and press the trigger to sample the blood You may use different fingers for sampling each time When the meter display flashes Place the finger to the lancing device tip to take a blood sample 21 Caution 1 Clean testing area thoroughly for correct reading 2 To avoid infection do not share the lancing device and lancet with other people The sterile lancet is for single use only Do not reuse the lancets 3 You should discard the used strip lancet and alcohol swab 4 Use alcohol or soap and water to clean the outside of the lancing device For more complete cleaning remove the cap wash it in warm water and rinse completely 22 Step by Step Test Procedure 1 Sampling the blood droplet Use the lancing device to get a droplet of blood from fingertip 2 Apply bl he stri 23 m When the display flashes apply the blood droplet to blood collection area on strip E The strip will siphon the blood into the reaction zone E The device will begin to measure Please notice that the blood should fill the reaction zone If the strip has too little blood it may produce an inaccurate result Caution Make sure the blood fills the reaction zone completely Otherwise an incorrect reading may occur 3 Display the reading Supreme E You will see
9. and testing supplies for easy access Coding is now completed e Please follow the test procedures for the Control Solution 33 Step I 1 2 Insert Test Strip Remove a test strip from the vial and recap the vial Insert the test strip into the slot of the meter and the meter will turn on Make sure the code number on the display matches that on the test strip vial If the code number does not match code the meter correctly before proceeding 34 Step 2 1 6 Apply Sample When you see the symbol shake the glucose control solution well Hold the glucose control solution vial discard the first drop of control solution Then squeeze a drop of solution slowly onto a plastic plate remove the solution vial and recap Let the control solution of the plastic plate touch the blood collection area of the test strip The strip will draw the control solution Remove the control solution when the reaction zone is full The meter will begin reading Step 3 Results will appear after 25 seconds Step 4 Check if the reading falls within the range printed on the test strips vial 35 3 Understanding the Reading If the reading of your test falls within the expected range printed on the strips vial labels then the test strip and the glucose meter are working together correctly The results of your blood glucose tests are reliable If the reading falls outsi
10. atalyzes helps the process of aiding the oxidation of glucose to produce gluconic acid During the reaction a mediator transfers electrons to the electrode surface and generates a current The amount of the current is proportional to the amount of glucose present in the blood sample The meter will measure the glucose concentration and display on the screen after 25 seconds Intended Use Easy Pain Supreme Self Monitoring Blood Glucose System is self test IVD medical equipment You may use it for both home testing and for professional use to monitor the blood glucose 6 D glucose value from capillary whole blood You can only use this system outside the body In vitro diagnostic use only You can only use the meter with Easy Pain Supreme Blood Glucose Test Strips Testing is not valid on neonatal blood specimen Important Information e Severe impact may cause the meter not to function correctly Do not disassemble the meter for components damage and incorrect reading You will make the warranty void if you have disassembled the meter e Incorrect results may occur when performing the test When you are not feeling well please contact your healthcare professional e Keep the meter clean and always store it ina safe place Protect from direct sunlight to ensure a longer lifespan e You should keep the strip slot away from dirt dust bloodstains and water stains e You cannot store the meter and test strips ina car
11. be inaccurate when the patient is E Severely dehydrated E Severely hypotensive E In shock or in hypoglycemic hyperosmolar state with or without ketosis 44 You should not test critically ill patients with home use blood glucose meters You should carefully check cholesterol and triglyceride levels for correct meter results Recent studies prove EMI can cause electronic medical device performance degradation and could lead to inappropriate therapy You should carefully check grossly lipemic fatty samples for correct results To understand interferences please check baseline glucose values from a clinical laboratory method before home using 45 Performance Characteristics The measurement range of the Easy Pain Supreme is between 1 7 mmol L to 33 3 mmol L 30 to 600 mg dL The performance of the test strips is validated both in laboratory and in clinical tests Precision We measured Blood Glucose System with both venous blood and control solution in the laboratory The results are shown in the table below Within Run Blood a mmol L mg dL 2 4 43 CV 4 3 Blood a mmol L mg dL 5 3 95 CV 3 5 Blood a mmol L mg dL 8 0 144 CV 3 3 Blood a mmol L mg dL 13 7 246 CV 3 1 Blood a mmol L mg dL 22 1 398 CV 3 3 Total Run Control a mmol L mg dL 3 1 56 CV 5 6 Control a mmol L mg dL 7 2 129 CV 3 5 Control a mmol L mg dL 21 6 388 CV 2 6 46 Accuracy We assessed the Blood Gl
12. de the expected range your meter may not be working properly Check the following Do you use the control solution or test strips before their expiration date Do you use the contaminated control solution Is the code number shown on the meter different from the code number on the test strips vial Did you forget to replace one of either the vials of control solutions or test strips Did you follow the test procedures correctly 36 You may see acceptable control ranges for glucose control tests in the table below el Acceptable Control Ranges Normal Control 5 3 8 0 mmol L 96 144 mg dL High Control 15 6 23 3mmol L 280 420 mg dL 37 The Advanced Meter Setting l Thermometer Setting Press A and B buttons at the same time more than 3 seconds The meter will go into Centigrade Thermometer mode of Press B button the meter will change the temperature reading to Fahrenheit Press B button again the meter will change to the Alarm Setting mode ll Alarm Setting 1 Press A button to switch the On OFF at the left up corner of LCD 38 Supreme Press B button when LCD displays OFF the meter will change alarm mode into Beep Setting Mode Press B button when LCD displays On the first 2 digits of time hour will blank Press A button to adjust the hours If the time is over 12 00AM you need to press A button 12 times for PM Press B but
13. down The code number should face up 4 No display after inserting the check strip e Check the check strip not inserted upside down The side of check strip label should point upward e Check you insert the check strip correctly 49 5 No measuring after faking a blood sample Check the reaction zone window and the blood amount inside The reaction zone should be fully red for correct test result Check you insert the strip correctly LO or HI level You should use the strip in 5 minutes after you take it out of the vial Exposing the strip to open air for a long period of time may occur an incorrect reading If you do not securely tighten the cap of the vial The air will humidify strips inside and lead to incorrect readings Check the code displayed on the meter is the same as that on the test strip s vial and on the label of the code card You can use the check strip to verify the meter s functions and use the control solution to check the performance of the glucose monitoring system Refer to the instructions for using the glucose control solution 50 Error Messages Code transmission failure a T L oei Action Re insert the code card If Err appears consistently contact local dealer for repair ts Humidified strips Action Replace with a new strip Low power Supreme a i Action Replace with new batteries 51 Supreme System fault
14. fter you finish coding E The code number should be the same as the label on the vial Caution 1 Do not discard the code card until you use all strips in the same vial You will see an error message FAL and CODE icon if you did not complete previous coding process Repeat the steps above again to complete the coding process Testing Read the test strip instructions carefully before testing Make sure you have all items needed to test Before blood sampling wash your hands with soap and warm water Rinse and dry thoroughly 1 Unscrew the Lancing Device front cap 2 Insert the lancet Insert the lancet into the lancing device firmly and twist off the protective cover 3 Recap the front cap 4 19 Select 1 2 for soft or thin skin 3 for average skin 4 5 for thick or calloused skin 5 Upper gear 1 Pull on the sliding barrel of the lancing device until it clicks and then release 2 Now the device is ready 3 Do not prick your finger until your meter and strip are prepared 6 Turn the meter on 20 Take one strip out and recap the vial The device will turn on when you insert the strip into the slot You will see the code number briefly Make sure the displayed code is identical to the code on the vial Fingertip Blood Sampling Swab the blood collection area on your finger with an alcohol swab Please wait until the intended area is dry and cle
15. ity less than 90 Please refer to the test strip package for the expiration date 42 Specifications Limitations of the Procedure We design Easy Pain Supreme Blood Glucose Test Strips only for use with fresh capillary whole blood sample 1 2 DO NOT use serum or plasma samples DO NOT use neonatal blood samples Extreme humidity may affect the results A relative humidity over than 90 may cause inaccurate results Use the system between 10 C and 40 C 50 F and 104 F The system only gets correct results within this range DO NOT reuses the test strips The test strips are only for single use DO NOT use iodoacetic acid or sodium fluoride as a preservative for blood specimens Hematocrit A Hematocrit levels less than 30 may cause 43 incorrect high readings B Hematocrit levels greater than 55 may cause incorrect low readings If you do not know your hematocrit level consult your healthcare professional The substances listed below may affect the test results depending on the concentration Acetaminophen 1 0 mmol L or 15 mg dL Gentisic Acid 0 5 mmol L or 8 mg dL Levodopa 0 5 mmol L or 10 mg dL Dopamine 0 7 mmol L or 13 mg dL Methyldopa 0 12 mmol L or 2 5 mg dL Uric Acid 0 4 mmol L or 14 mg dL Patients undergoing oxygen therapy may have inaccurate results Altitudes up to 2000 meters above sea level have no effect on readings Test results may
16. lace until it clicks securely The LCD display will show no CODE when you first time install the batteries Please code your meter correctly Caution 1 The meter will delete earlier records after you replace Batteries 2 You should reset the unit time and date again after you replace the batteries 3 1 5V AAA x 2 batteries is available in shops You may take the old batteries with you for replacement Presetting You need to preset time and date when you install or replace the batteries Please preset your device with the following procedures 1 Entering setting mode Supreme Press B button the meter will enter the setting mode and the display shows the year at the center of LCD display A Setting the Date m After selecting the year press A button to adjust year You will increase year value for one when you press A button less than one second You will increase year value quickly when you press A button more than two seconds m Press B button to confirm 12 m After confirming the first 2 digit month at the left up corner of LCD will blink Press A button to adjust months and press B button to confirm m After confirming the blinking area will go to next 2 digits day Press A button to adjust days and press B button to confirm the setting B Setting the Time After date setting the blinking area will move to the first 2 digits hour of time
17. m to be dependable easy to use compact and lightweight and portable to help you monitor your blood glucose on a regular basis Please read this manual thoroughly before you begin testing It provides you and your diabetes care team with important information and step by step direction to use the Easy Pain Supreme Self Monitoring Blood Glucose System Although the Easy Pain Supreme Self Monitoring Blood Glucose System is easy to use you should consult your healthcare professional this may be your doctor pharmacist or diabetes nurse educator for instructions on how to use the system You should make sure you correctly use the system for accurate results Please forward your warranty card to EPS Bio Technology Corp If you have any concerns please call our EPS Bio Technology Corp office or authorized distributor during business hours Measuring Principle We design The Easy Pain Supreme Self Monitoring Blood Glucose System to allow you to get fast measurement of blood glucose by using an electrochemical biosensor technology This Blood Glucose System uses a disposable dry reagent strip technology based on the glucose oxidase method for glucose determination Each test strip uses an electrode and it contains the glucose oxidase from Aspergillus niger The test strips will apply the capillary blood sample to the collecting area of the strip and automatically draw the sample into the reaction zone The glucose oxidase c
18. nents LCD Display Display information symboland measure result Read buttonA Turn on meter or read memorized result SET Button B Turn on meter or go into setting mode pin i p Strip Slot Insert the strip into this slot blood collection area reaction area through hole hand hold area strip insert direction electrode FRONT BACK Battery Cover Follow the triangle direction to push the battery cover It will pop up automatically Battery slot Install AAA alkaline Battery x2 Tell you when to ali blood y ur Day Sali agi Shows with memorized measuring result he 88 Is x K pat Indicate meter is oh ll transferring x i Y i AL data to PC a with code p Shows with error co Glucose unit Tell you to replace batteries Tell you to insert strip Thermometer mode indicator Before Testing Battery Installation The device uses 1 5V AAA x2 alkaline batteries included You may use the battery power for over 1000 measurements Install the batteries when you want to start to use the meter or replace with new batteries when the L P message and the low battery symbol appear on the LCD display Supreme yo no Slide battery cover from rear side of the meter 2 Replacing the batteries Install the 1 5V AAA x2 alkaline batteries according to the polarity signs 3 Close battery cover Slide the battery cover back in p
19. ng memory mode E Press A button to enter the memory mode if there is no test result in memory LCD will show MEM E You always see the latest records when you look for old records 2 Reviewing the records E Press B button again to view the previous record 100 records maximum E When you are viewing the first record than press B button will return to the latest record 28 3 Delete the record E Press A button for more than 3 seconds the LCD will show dEL instead of the current reviewing record E f you still press A button and do not release you will erase the currently viewed record Supreme 01 01 129 lw MEM mg dL 4 Reviewing the average records on last 7 days Press A button to review the average records for the last 7 days Supreme 29 5 Closing the memory mode 1 Press A button to close the memory mode 2 At memory mode the meter will shut down after minutes if you don t press any key 3 When you don t press any key for operation the meter will shut down in 5 minutes Caution The average last 7 days records result may not fit your expectation if the time and date setting is not correct You should set time and date correctly before testing 30 Checking the System l Use the check strip Use the check strip to check the meter s functions Please store the check strip safely 1 Insert the check strip Insert the
20. ton to confirm After confirmation the blinking area will go to the next 2 digits minute Press A button to adjust the minutes and press B button to confirm the setting 39 lll Beep Setting You will see the Beep Setting Mode after confirming Alarm Setting Press A button to switch the On OFF at the center of LCD Supreme Supreme Press B button to confirm 40 IV Clock Setting You will see the Clock Mode after confirming the beep setting You will see 2 digits second at the center 2 digits month and 2 digits day at the top left corner 2 digits hour and 2 digits minute at the top right corner You activate alarm in this mode when clock time matches the time set in the alarm mode You can stop the alarm by pressing A button or it will stop after 10 seconds Press B button to leave the advanced setting mode 41 Cleaning and storing the Meter I Cleaning the Meter 1 The Blood Glucose Meter does not require special cleaning Keep the strip slot away from dirt dust bloodstains and water stains 2 Clean your meter carefully with moist lint free cloth or dampened cotton swab if the meter gets dirty outside ll Storing the Meter Store or transport the Blood Glucose Meter between 35 6F and 122F 0 C and 50 and relative humidity less than 90 with batteries removed Store test strip vials in a dry place below 86F 30C and relative humid
21. ucose System with the YSI 2300 Analyzer which was for laboratory use We had 213 subjects with diabetes at three independent clinics We designed a plot of the EPS capillary data versus YSI plasma data for the regression statistics The results are listed below Slope 0 97 Intercept 0 64 mmol L 11 452 mg dL Correlation coefficient 0 974 Number of samples 213 Range tested 1 8 28 6 mmol L or 33 514 mg dL 47 Specifications Brand Name Easy Pain Supreme Blood Glucose Meter 30 600 mg dL Range 1 7 33 3 mmol L Response time 25 seconds Memory sets 100 sets Operating rem 10 C 40 C 50 F 104 F condition SS atve RH lt 90 Humidity Blood amount Sample 2 0 uL Capillary whole blood Hematocrit Hct 30 55 Power Alkaline 1 5V AAA x2 Battery life Over 1000 measurements Display dimension LCD 40x32 mm on ee aa 75x54x19 mm Weight 50 grams w o batteries aoe Electrochemical Principles biosensor technology 48 Displaying Messages Troubleshooting 1 If you cannot turn on the meter e Check you install the batteries correctly e Power is low Replace the batteries 2 No display after inserting the strip e Check you insert the strip correctly You should face the graduated blue color side e Check you insert the check strip correctly 3 No display after inserting the code card e Check the code card not inserted upside
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