User Guide - JNS Biomedical
Contents
1. qCH 4 Gently shake the control solution and apply a drop to the aperture of strip Make sure that the control solution has saturated the Blood Reaction Zone of the test strip 5 Test result will show up in 5 seconds The result should correspond to the range printed on the label of strip vial used NOTE REPEAT TEST IF THE RESULT FALLS OUTSIDE THE CONTROL RANGE IF YOU CONTINUE TO GET THE RESULT FALLING OUTSIDE THE CONTROL RANGE YOUR METER AND STRIP MAY NOT BE WORKING PROPERLY DO NOT USE THE SYSTEM TO TEST YOUR BLOOD UNTIL YOU GET A TEST RESULT FALLS WITHIN THE CONTROL RANGE CON SULT YOUR LOCAL DISTRIBUTOR FOR HELP Check Strip The Check Strip can be used in 2 ways 1 To check that the meter is operating properly Use when performing qual ity control check on your meter 2 To delete all test memories How to check meter by check strip 1 Insert the check strip into strip slot with label side up as above 2 You should obtain an OK reading within 10 seconds which means your meter is working properly 3 Remove the check strip to exit Meter will automatically turn off NOTE IF YOU DO NOT GET OK READING BUT APPEAR OTHER ERROR MESSAGE TURN OFF THE METER BY REMOVE CHECK STRIP FROM THE METER THEN CHECK THE BATTERY AND REPEAT THE TEST IF THE SECOND RESULT PERSISTS CONSULT YOUR LOCAL DISTRIBUTOR FOR HELP How to delete memory 1 Insert check strip into strip slot with label side up 2 A2. GoodLife A User Guide Please read this User Guide pH AC 300 If you have any qu distributor About GoodLife Intended Use The GoodLife Blood Glucose Monitoring System is designed to quantitatively measure the level of glucose in capillary whole blood by people with diabetes or by healthcare pro fessionals for monitoring blood glucose at home or in health care facilities The device is indicated for professional use and over the counter sales g your GoodLife Blood Glucose Meter Or enquiries please contact us or your local Principle of the Test The GoodLife System is an electrochemical biosensor system that measures the amount of electric current pro duced and displays the result as a blood glucose level About the System The GoodLife System is designed to pursuit the accuracy in blood glucose monitoring to provide you with easy and comfortable testing The system requires 0 5uL of blood sample and 5 seconds for the test to complete The GoodLife System consists of GoodLife Blood Glucose Meter GoodLife Blood Glucose Test Strips AC also known as ACH GoodLife Check Strip GoodLife Glucose Control Solution optional Lancing Device optional Lancets optional These products are intended to be used together to get accurate blood glucose test results Do not use other test strips or control solutions with your meter Important Information m The GoodLife System is intended for in vitro diagnost
3. Oe SYMBOL The test can be adjusted and stored into 2 types of test modes BEFORE A MEAL TEST amp and AFTER A MEAL TEST amp Blood Glucose Test Strip oe Aperture apply the blood from the front of strip Blood Reaction Zone It must be filled with blood entirely Black Electrode End insert this end of test strip into meter NIMPORTANT TEST STRIP INFORMATION 1 GoodLife System measures the amount of glucose in capillary whole blood Blood can be applied to the front of the test strip and is automatically drawn to the test strip through capillary action 2 GoodLife Blood Glucose Test Strips are intended for in vitro diagnostic use with capillary whole blood or GoodLife Glucose Control Solution Results will not be accurate if used with plasma or serum samples 3 Do not use test strips beyond the expiration date indi cated on the strip vial label 4 The discard date for test strips is 90 days after first opening the vial Record the discard date on the vial when you open a new vial of test strips 5 Blood Glucose Test Strip can be damaged by heat and light Keep them sealed in the original vial 6 a p Store the vial in a cool dry place below to a 40 C 104 F and above 10 C 50 F Do not refrigerate 7 Do not use damaged test strips in any way Use test strip immediately after taking it out from the vial or foil packet replace the vial cap and close it tightly 8 Do not transfer test
4. depth adjustment re cap Insert a lancet into the lancet holder and push down until it is fully seated Twist off the protective cap until it separates from the lancet Replace the depth adjustment cap and set the puncture depth to the desired number NOTE THE SHORTER THE SCALE THE SHALLOWER THE PUNCTURE Pull back the cocking control until it makes a click press release but lt lt ton for penetration If it does not Ag click the device may have been cocked when the lancet was insert ed Please contact local distributor Performing Blood Test NO UJ D gt 1 Wash your hands throughly with soap and warm water Rinse and dry completely Warm your fingers to increase blood flow 2 Take out new test strip from vial Be sure to tightly replace vial cap after taking out test strips Insert test strip immediately into strip slot as illustrated The meter turns on automatically 3 Check that the code number on the meter matches the code on the vial If the 2 numbers are matched you may begin blood testing otherwise consult your local distributor 4 When the i symbol flashes you are ready to perform a test 5 If the test is done in 2 hours of meal press button to change the setting from eto 4 6 Hold the prepared lancing device firmly against the side of your fin ger Press the release button Gently massage your finger to ob
5. recent latest to the oldest UJ Please press the button for 2 seconds to turn off or put it aside for 3 minutes for auto shut down NOTE ANYTIME IN MEMORY MODE YOU CAN PRESS BUT TON UNTIL YOU HEAR THE BEEP TO EXIT AND TURN OFF THE METER Data Download optional Data can be transfered to the server or pc by RS232 cable line Taking Care of Your Meter To Replace the Battery 1 Make sure the meter is turned off 2 Place the meter face down on a flat surface WW Slide battery compartment door open Remove the old battery and insert new CR2032 battery into the battery compartment Be sure to align the plus and minus signs correctly vI Close the battery compartment door Check to see that your meter is working If it fails to turn on the battery may has been inserted incorrectly Remove the battery and reinsert it correctly NOTE EVERY TIME WHEN YOU REPLACE THE BATTERIES THE METER WILL TURN ON AUTOMATICALLY AND ENTER TO THE TIME DATE SETTING PLEASE SET CORRECT TIME AND DATE BEFORE TESTING CLEANING Clean the outside of the meter with a soft cloth slightly dampened with water Do not get moisture into the strip slot and data port STORAGE AND HANDLING Keep your meter free of dust or water Protect it from extreme temperature and humidity A CAUTION If the product is not used for longer periods of time please remove the inserted battery in order to prevent damage ca
6. 7 o 48 Pi nmo I EE STRIP SLOT Holds a Blood Glucose Test Strip or Check Strip in place when you perform blood glucose test or perform check test DIsPLAY The large easy to read display shows the test re sults messages blood glucose results stored in memory time and date Button Press button to enter date and time setting or enter memory mode to recall the information stored in meter s memory EJECTION BUTTON For a easy ejection of the test strip meter SN Label The label shows the meter serial number BATTERY COMPARTMENT Holds one 3V Lithium battery Battery is not yet installed into meter when new purchas ing Before using the meter please install the battery first Meter LCD Window TEST RESULT BATTERY SYMBOL Appears when battery is low STRIP SYMBOL Appears when the test strip is inserted and meter is ready for blood testing Replace vial cap after re moving test strips Bd BDATE Month Day at the moment of the test cope Code appears to indicate code number when ready to test O Y Year at the moment of the test THERMOMETER SYMBOL Appears when ambient temper ature is above or below the acceptable range needed for testing mmol L Units of measure 888 Memory capacity is 900 entries The display shows to ensure that all digits are working properly TME 12 and 24 hour period format Ou Appears to indicate memory mode when reading pre vious results
7. Check N Caution Rheiner Strasse 172 D 48282 Emsdetten Germany fective by inserting check strip Donot reuse 3K 02 160035 V1 4
8. fter OK displayed press and hold the button for 3 seconds the meter will display dEL then press and hold the button for 2 seconds Meter will display OK before turning off and all the memories have been de leted successfully 3 Remove the check strip from the meter Setting Meter Parameters Setting Time amp Date When you first time installing the battery into the meter or when replacing a battery the meter will automatically enter to the setting mode Please set correct time and date before you begin testing How to set time and date 1 Press button to select the desired year 2 After year is set allow it to flash for 3 times and shift to the next setting 3 Repeat above steps to set the month day hour and minute by Button 4 After minute is set the meter will display OK before turning off Prepare for Blood Sampling Adjustable Lancing Device Depth Selector at San Adjustment Cap Lancet Holder Cocking Control Release Button Ejection Button Lancet en rotective Cap A IMPORTANT TEST STRIP INFORMATION 1 Lancet is for single use only 2 Keep lancing device and lancets clean 3 Be cautious 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 in formation of manufacturer and CE marking Set Lancing Device 1 Remove the
9. ic use with capillary whole blood The system should not be used for diagnosis of diabetes or for testing newborn in fant neonatal testing A CAUTION 1 The user should not take any medical relevance deci sion based on test result without first consulting his or her medical practitioner 2 Call your doctor immediately if you experience symp toms that are not consistent with your blood glucose test results 3 Severe dehydration or excessive water loss may cause false high results Call your doctor right away if you sus pect you are suffering from dehydration 4 A sample with large amount of reducing substances such as triglycerides gt 11 3mmol L ascorbic acid gt 0 13mmol L uric acid gt 0 89mmol L and xylose gt 3 4mmol L 5 A red blood cell count hematocrit that is either very high over 55 or very low under 30 can cause false result 6 High altitudes above than 2 750 meter 8 800 feet may affect the test results 7 Temperatures outside the range of 10 C to 40 C 50 F to 104 F may affect the test results NOTE PLEASE MAKE SURE THAT ALL PRODUCTS LISTED ON THE CONTENTS OF THE BOX ARE CONTAINED IN THE PACKAGE BEFORE USING THIS SYSTEM IF YOU FIND ANY IMPERFECTION IN OUR PRODUCTS PLEASE RETURN THE WHOLE SYSTEM TO THE PLACE OF PURCHASE Blood Glucose Meter Study this diagram and become familiar with all the parts of your GoodLife AutoCode AutoCode Series Blood Glucose Meter
10. me parts of the dis play are not working Contact your local dis tributor for help Review proper testing procedure and perform a quality check with control solution Repeat blood test if HI still ap pears call your doctor immediately Review proper testing Blood glucose procedure and perform result may be a quality check with con lower than 1 1 trol solution Repeat test mmol L if LO still appears call your doctor immediately The result you have obtained may not be accurate Move to an area with temperature between 10 C to 40 C 50 F 104 F Do not ar tificially heat or cool the meter Display check Blood glucose result may be higher than 33 3 mmol L Temperature is above or below the op erating range of test strips Change battery immedi Battery is low ately Test strip un known or may be damaged Perform the test with new test strip Test strip is used or test was not per formed cor rectly Maybe Perform the test with a new test strip and follow the test procedure cor rectly 1 Assay Method Electrochemical biosensor 2 Test Sample Fresh Capillary Whole Blood 3 Calibrated Result Plasma Serum glucose 4 Sample Size 0 5 uL 5 Measuring Time 5 seconds 6 Measuring Range 1 1 33 3 mmol L 7 Acceptable Hematocrit Range 30 55 8 Operating Temp Range 10 C 40 C 50 F 104 F 9 Operating Relative Hu
11. midity 20 80 RH 10 Memory Capacity 900 test results with time and date 11 Result Setting Before a meal After a meal and Con trol solution test setting 12 Average Display 30 days average 13 Power Supply CR2032 Battery x 1 14 Battery Life Approximately 1000 tests 15 Automatic shut off In 3 minutes 16 Meter Dimension 90mm L x 45mm W x 15mm H 17 Weight Approximate 50g without battery Precision Tests were carried by trained technicians in the laboratory setting The venous whole blood from one subject was adjusted to 6 different levels Strips out of a single lot were tested The results are shown in the following table Level No of test Mean Within Run C V mmol L 2 3 46 Accuracy Tests were performed at hospital by healthcare profession als and diabetic patients Fresh capillary finger whole blood samples were tested with the GoodLife System plasma samples from the subjects were tested with YSI Model 2300 Glucose Analyzer as reference The results are shown in the following table Correlation Coefficient R 0 99 Glucose Concentration lt 4 2mmol L Within 0 3mmol L Within 0 6mmol L Within 0 8mmol L 32 38 84 38 38 100 38 38 100 AY my a F BEng e Ez Keep away from sunlight Biological risks Please consult instructions for use In vitro diagnostic medical device Use by Expiry date Serial number Manufacturer Authorised representa
12. r blood glucose result seems unusually high or low or inconsistent with your previous results check the fol lowing 1 Does the code number on the test strip vial match the code number on the meter 2 Was the blood sample applied to the test strip immedi ately after the strip was removed from the vial 3 Was the size of the blood sample sufficient 4 Was the test strip vial cap tightly sealed 5 Was the test strip used before the expiration date 6 Were the test strips stored away from extreme tempera tures or from areas of high humidity Then run a quality control check with your GoodLife Glucose Control Solution and a new test strip If the control test result is within the acceptable range review testing procedure and repeat your blood glucose test with a new test strip If your blood glucose value is still inconsistent with your previous results contact your doctor immediately for help Memory Recall The GoodLife Blood Glucose Meter can automatically store up to 900 results on both before a meal amp and after a meal g When recalling the results each single result appears from the latest to the earliest with time and date To recall Results Stored in Memory 1 Turn meter on by press button till you hear a beep sound The first result displayed on the screen is your 30 days average before a meal test result NO Press button to view 30 days average after a meal and the single test record from the most
13. strips to a new vial Always carry test strips in their original vial 9 iN Do not place in direct heat or sunlight 10 Do not carry loose test strips in your carrying case 11 Test strips are for single use only Glucose Control Solution Optional GoodLife Glucose Control Solution is used to check if the GoodLife Blood Glucose Meter and Test Strip are working correctly as a system It can be used in two ways To practice the test procedure To make sure that the GoodLife Blood Glucose Meter and Test Strips are working together prop erly A IMPORTANT INFORMATION 1 Do not use control solution beyond the expiration date in dicated on the bottle label 2 The discard date for control solution is 90 days after first opening Record the discard date on the bottle when you open a new bottle of control solution 3 ye Store the control solution closed at tempera sila tures between 10 C 50 F and 30 C 86 F 4 Please carefully read the label before use Perform Control Test 1 Insert a new test strip into the strip slot the meter will acti vate 2 The code number will appear on the screen Compare the code number shown on the screen against the code num ber on the test strip vial If the two numbers match you may begin test otherwise consult your local distributor 3 Press button 3 times to choose Level1 control solution test display qCL or 4 times to Level2 control solution test display
14. tain the required blood volume To perform the test you need 0 5uL of blood gt sample resting on your finger Caution To avoid the blood borne pathogen transmission the lancing device is intended only for a single user and should not be shared 7 Apply the blood sample to the front aperture of test strip in a way that is comfortable for you Make sure that the blood drop has satu rated the Blood Reaction Zone When blood is applied to the strip a count down appears on the screen until measurement is com pleted 8 Test result will show up in 5 sec onds O Record your testing result in the log sheet eject the strip from me ter and discard the used strip and lancet safely in a puncture resis tant container 10 The testing range of the meter is from 1 1 to 33 3 mmol L If HI is displayed your blood glucose result may be higher than 33 3 mmol L If LO is displayed your blood glucose result may be lower than 1 1 mmol L H i mmol L TELS Understanding Your Test Result Expected values for people without diabetes Time of Day Expected Range Non diabetes Source American Diabetes Association Position Statement Diabetes Care Vol 35 Suppl 1 P S13 2012 Before Meal Less than 5 6 mmol L After Meal For diabetes patients please consult your healthcare pro fessional to find out your target blood glucose value Less than 7 8 mmol L If you
15. tive in the European com munity This product fulfills the requirement of directive 98 79 EC in vitro diagnostic medical device The symbol indicating seperate collectionfor electrical and electronic equipment consists of the crossed out wheeled bin When the end user wishes to discard this product it must be sent to seperate collection facilities for recovery and recycling By separating this product from other household type waste the volume of waste sent to incinerators or land fills will be reduced and natural resources will thus be conserved Distributed by JNS Biomedical Pty Ltd Paramount Centre Shop 4a 108 Bourke Street No respons 1 Battery is You have to Glucose Concentration gt 4 2mmol L Melbourne Vic 3000 Australia es when strip dead 1 Replace battery Within 5 Within 10 Within 15 Within 20 ABN 79 163 593 833 is inserted 2 Wrong strip 2 Insert the test strip 86 162 53 138 162 85 159 162 98 161 162 99 service jnsbiomedical com au into the me was inserted correctly NOTE THE PRODUCT IS TESTIFIED BY A THIRD PARTY THAT C a nena ee IT DOESN T INTERFACE WITH OTHER POSSIBLE ELECTRO 0537 Maybe You have to ee tal HMD BioMedical Inc 1 Blood sample 1 Repeat test with suf Batch code No 181 Minsheng St Xinpu Township Hsinchu 305 Taiwan is not sufficient ficient sample J Temperature limitation Store at FIA Biomed GmbH 2 Meter is de 2 Perform Meter
16. used by leaking battery Please follow all the instructions on the User Guide while operating GoodLife Blood Glucose Meter HMD BioMedical Inc will not be responsible for any impairment occurred from NOT following the instructions WARRANTY HMD BioMedical Inc warrants to the original purchaser that this instrument will be free of defects in material and workmanship for 5 years from the date of original pur chase During the stated 5 year period HMD shall at no charge replace a unit found to be defective with an equiv alent or current version of the owner s model This warranty is limited to replacement due to defects in parts or workmanship HMD shall not be required to re place any units which malfunction or are damaged due to abuse accidents alteration misuse neglect maintenance by other than HMD or failure to operate the instrument ac cording to instructions POST SALE SERVICE If you have questions or request please contact our service department at Australia Region JNS Biomedical Pty Ltd service jnsbiomedical com au Display Messages and Problem Solving Guide When any of the following messages appears there is a problem with your GoodLife Blood Glucose Meter or the way in which you are performing a test These messages will help you to identify certain problems If error messages appear that are not listed on the following pages contact with your local distributor for help If so
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