User Manual - Chemglass Life Sciences
Contents
1. vitro diagnostic medical device Tests were carried by trained technicians in the laboratory setting Samples from the subjects were tested with both GlucCell Meter and YSI Model 2300 Glucose Analyzer as reference The results are shown in the following table representative y intercept 5 9 mg dL 0 3 mmol L Correlation Coefficient R Number of tests2. The GlucCell Cell Culture Glucose Meter comes with a battery not yet be installed when new purchasing Please install your battery before started Battery life will vary depending on usage so always keep a spare on hand The battery should last about 12 months when testing 3 times a day When the battery symbol appears on the meter display battery is getting low You will still be able to test with low battery but you should replace it as soon as possible When battery symbol appears flashing on the display the meter will no longer give results and you must replace the battery immediately TO REPLACE THE BATTERY Make sure the meter is turned off Let the front of meter rest in the palm of your hand Slide battery compartment door open Remove the old battery and insert the new 3 volt Lithium battery into the metallic hood of the battery holder with the plus side up Slide battery compartment door closed Check to see that your meter is working If it fails to turn on the battery 12 may have been inserted incorrectly Remove the battery and reinsert it as illustrated NOTE EVERY TIME WHEN YOU REPLACE THE BATTERY 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
3. Use test strip immediately after removing it from the vial replace the vial cap and close it tightly Do not transfer test strips to a new vial Always carry test Strips in their original vial Do not place in direct heat or sunlight Do not carry loose test strips in your carrying case Test strips are for single use only CONTROL SOLUTION Options Control Sol IN vitro diagnostic us be below 30 C 86 F mm 90 days attor fist lOMEDICAL ING diy Sec 1 Chung a GlucCell Control Solution is used to check that GlucCell Cell Culture Glucose Meter and Test Strip are working together as asystem It can be used in two ways 1 To practice the test procedure 2 To make sure that the GlucCell Cell Culture Glucose Meter and Test Strips are working together properly IMPORTANT INFORMATION Do not use control solution beyond the expiration date indicated on the bottle label 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 Store the control solution closed at temperatures below 30 C 86 F PERFORM A CONTROL TEST Insert a new test strip into the strip slot the meter will activate The last code number will appear on the screen Compare the code number shown on the screen against the code number on the test strip vial If the two numbers match you may begin test otherwise consult Section CODIN
4. meter free of dust Protect it from extreme temperature and humidity DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE When any of the following messages appear there is a problem with your GlucCell Cell Culture 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 DISPLAY DESCRIPTION ACTION TO TAKE i moh E Display check lf some parts of the display are not working Contact your local distributor for help Cell Culture Glucose result If this not confirmed by the way you feel review proper may be higher than 600 mg dL testing procedure and perform a quality check with or 33 3 mmol L control solution Repeat test if HI still appears contact your local distributor for help Cell Culture Glucose result If this not confirmed the way you feel review proper may be lower than 20 mg dL on testing procedure and perform a quality check with 1 1 mmol L control solution Repeat test if LO still appears contact your local distributor for help Temperature is above or below The result you have obtained may not be accurate the operating range of test Move to an area with temperature between 10 C to Strips 40 C 50 F 104 F Do not artificially heat or cool the meter Battery is low Change battery soon Battery is dead Test
5. strip may be damaged Test strip is used or test was not performed correctly No responses when Maybe strip is inserted into the 1 Battery is dead meter 2 Wrong strip be inserted 3 Meter is defective No responses when Maybe sample is applied to the Sample is not sufficient Strip Meter is defective Change battery now Perform the test with new test strip Perform the test with a new test strip and follow the test procedure correctly You have to 1 Replace battery 2 Insert the test strip correctly 3 Contact us for help You have to 1 Repeat test with sufficient sample 2 Perform Meter Check by inserting check strip NOTE If there is any error message displayed but not listed here or your meter shut down for no reason you can reset the meter by following two ways 1 Replace the battery 2 Open the battery door and use a needle to prink the reset hole with a reset mark beside the battery component PERFORMANCE EVALUATIONS 3 0 27 2 mmol L PRECISION Tests were carried by trained technicians in the SYMBOL laboratory setting The sample from one subject was adjusted to 3 different levels Strips out of a single lot were tested The results are shown in the following Please consult table instructions for esi mg dL C V Caution consult Low 43 3 4 7 accompanying Normal 96 2 3 4 document High 381 0 2 4 7 ACCURACY 37 Thi i requirements of Directive 98 79 EC in
6. the meter is in the memory mode while recalling 1 7 14 21 28 day test averages DATE Month date TIME The meter is programmed for a 12 hour period format CELL CULTURE GLUCOSE TEST STRIP eo 1 Aperture apply the sample from either side of strip 2 Test Confirmation Window make sure the part is filled up with test sample to ensure the correct result For example X O 3 Gray Electrode End insert this end of test strip into meter A IMPORTANT TEST STRIP INFORMATION GlucCell System measures the amount of glucose in cell culture medium Sample can be applied both to the right or left side of the test strip s apertures and is automatically drawn to the test confirmation window where the reaction takes place GlucCell Cell Culture Glucose Test Strips are intended for in vitro analysis use with cell culture medium Results 3 will not be accurate if used with samples containing no electrolyte Do not use test strips beyond the expiration date indicated on the strip vial label 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 GlucCell Cell Culture Glucose Test Strip can be damaged by heat and light Keep them sealed in the Original vial Store the vial in a cool dry place below to 40 C 104 F and above 10 C 50 F Do not refrigerate Do not use damaged test strips or abnormal test strips
7. E METER GlucCel i T GO kega On uni Y Required Plosse DISPLAY The large easy to read display shows test results messages Cell Culture Glucose results stored in memory time and date S BUTTON Press S button to enter time setting and to decrease values in the setting mode M BUTTON Press M button to enter memory mode to recall the information stored in meter s memory and to increase values in the setting mode STRIP SLOT Holds a GlucCell Cell Culture Glucose Test Strip or Check Strip in place when you perform Cell Culture Glucose test or perform check test DATA PORT Allows you to transfer the information stored in the meter s memory to a computer to view analyze and print BATTERY COMPARTMENT Holds ONE 3v Lithium battery The battery is not yet installed into meter when new purchasing By using the meter please install the battery first 6 O Code M 88 madh ECA ia pal i LI TEST RESULT BATTERY SYMBOL Appears when battery is weak THERMOMETER SYMBOL Appears when ambient temperature is above or below the acceptable range needed for testing DROP SYMBOL Appears when the test strip is inserted and meter is ready for testing STRIP SYMBOL M188 Memory capacity is 180 entries The display shows M188 to ensure that all digits are working properly mg dL mmol L The meter has two units of measurement mg dL or mmol L to choose from DAY AVG Appears when
8. G YOUR METER of this user s manual to code your meter first Gently shake the control solution and apply a drop to the aperture of strip Make sure that the control solution has saturated the test confirmation window When apply sample please allow the sample be absorbed naturally to fill up the confirmation window Never push test sample over the aperture and cause overloading of the sample Test result will show up in 15 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 SAMPLE UNTIL YOU GETA TEST RESULT FALLS WITHIN THE CONTROL RANGE CONSULT YOUR LOCAL DISTRIBUTOR FOR HELP CHECK STRIP The GlucCell Check Strip can be used in 2 ways To check that the meter is operating properly Use when performing quality control check on your meter To change the measuring unit of your meter 1 How to check meter by check strip Step 1 Insert the check strip into strip slot with label side up as above Step 2 You should obtain an acceptable OK reading within 10 seconds which mean your meter is working properly Step 3 Remove the check strip to exit Meter will automatically off NOTE IF YOU DO NOT GET OK READING BUT APPEAR OTHER ERROR MEEAGE
9. GlucCell SYSTEM USER S GUIDE ver 2 0 Intended Use The GlucCell Cell Culture Glucose Monitoring System The GlucCell System is designed to quantitatively measure the concentration of glucose during cell culture It is for use by laboratory researchers or bioreactor professionals to obtain a quantitative measurement of glucose in cell culture About the System The GlucCell System uses the latest technology in Cell Culture Glucose monitoring to provide you with easy and comfortable testing The system requires only a 1 5uL of medium sample to complete the testing in only 15 seconds The GlucCell System consists of 1 the GlucCell Cell Culture Glucose Meter 2 GlucCell Cell Culture Glucose Test Strips and 3 the GlucCell Check Strip These products are intended to be used together to get accurate Cell Culture Glucose test results Do not use other test strips with your meter Important Information The GlucCell System is intended for in vitro analysis use with cell culture medium The system should not be used for diagnosis of diabetes A Caution A sample with large amount of reducing substances such as ascorbic acid and uric acid may cause result slightly higher than the actual glucose level High altitudes above than 2 750 meter 8 800 feet may affect the test results Temperatures outside the range of 10 C to 40 C 50 F to 104F may affect the test results CELL CULTURE GLUCOS
10. PLEASE FOLLOW BELOW PROCEDURES 1 TURN OFF THE METER BY PRESSING M BUTTON FOR 3 SECONDS AND REMOVE THE CHECK STRIP FROM THE METER 2 INSERT CHECK STRIP TO REPEAT TEST IF THE SECOND RESULT PERSISTS CONSULT YOUR 5 LOCAL DISTRIBUTOR FOR HELP 2 How to change measuring unit The meter has two measuring units to choose from mg dL and mmol L The default unit is mg dL if you do not change Step 1 Insert check strip into strip slot with label side up Step 2 After OK displayed press S button until flashing mg dL shows up Step 3 Press S button to switch from mg dL to mmol L Wait until new setting flash for 3 times to validate the setting Meter will display OK before off and the unit is been changed successfully Step 4 Remove the check strip from the meter SETTING METER PARAMETERS SETTING TIME amp DATE When you first time install the battery into the meter or every time when replace 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 Press S BUTTON for 3 seconds to turn on the meter The meter will enter to the setting mode automatically At the beep sound the year will flash for example for the year of 2009 number 09 will appear Press S or M button to obtain the desired year Wait the new setting flash 3 times to confirm and shifts to the next setting Repeat to set the month day hour an
11. d minute After minute is set the meter will display OK before turn off NOTE WHILE SETTING THE TIME AND DATE YOU CAN EXIT THE SETTING MODE ANYTIME BY PRESS M BUTTON FOR 3 SECONDS CODING YOUR METER Before you use your meter for the first time and every time you open a new box of test strips you need to set the meter to match the strips This is called coding Insert the test strip into the strip slot FIG1 the meter will activate The last code number will appear on the screen Compare the code number shown on the meter display against the code number on the test strip vial FIG 2 If the two numbers match you may begin testing Otherwise continue to the next step Press S button until you hear the sound of buzzer and the code value flashes press S or M button to obtain the code number indicated on the new test strip vial FIG 3 Upon obtaining the right code number wait the new setting to flash 3 times to validate the change FIG 4 After screen shows the proper code and a blinking drop symbol shows up your meter is ready to perform a test FIG 5 NOTE THE NEW CODE NUMBER IS DISPLAYED ON THE SCREEN TOO FIG 4 eel casey PERFORMING TEST r mgidL Remove new test strip from vial Be sure to tightly replace TE vial cap after removing test strips Insert test strip Zs immediately into strip slot as illustrated FIG 1 The meter turns on automatically Check that the code number in the meter matches t
12. he code on the vial FIG 2 If the two numbers match you may begin testing Otherwise refer to above section to code your meter first When the drop symbol flashes FIG 3 you are ready to perform atest To perform the test you need only 3 uL of test sample Use a pipette tip to withdraw around 10 ul test sample FIG 4 Code AL mgd Apply the sample to the right or left aperture of test strip in a way that is comfortable for you FIG 5 Please allow the sample be absorbed naturally to fill up the confirmation window Make sure that the sample has saturated the test confirmation window Never push test sample over the aperture and cause overloading of the sample When sample is applied to the strip a line moves on the screen until measurement is completed FIG 6 Test result will show up in 15 seconds FIG 7 After test complete remove the strip from meter FIG 8 and discard the used strip safely The testing range of the meter is from 20 to 600 mg dL 1 1 to 33 3 mmol L If HI is displayed your Cell Culture Glucose result may be higher than 33 3 mmol L or 600 mg dL If LO is displayed your Cell Culture Glucose ar mg d result may be lower than 1 1 mmol L or 20 mg dL FIG 9 m W OD om 8 17 ec GlucCell MEMORY RECALL The GlucCell Cell Culture Glucose Meter automatically stores 180 test results letting you review them in order from the most recent to the oldest If the memory is full and a
13. new result is added the meter deletes the oldest result The meter also calculates and displays the previous 1 14 21 and 28 day averages To recall Results Stored in Memory Turn meter on by press M button till you hear a beep sound The first result displayed on the screen is your latest test result By pressing M button you will see your test record from the most recent to the oldest By pressing S button you will obtain the averages of the last 1 7 14 21 and 28 days NOTE ANYTIME IN MEMORY MODE YOU CAN PRESS M BUTTON UNTIL YOU HEAR THE BEEP TO EXIT AND TURN OFF THE METER To Delete Memory While in the memory mode select the test result you wish to delete and display it on the screen Press S button until you hear a beep sound The blink dEL symbol will appear on the meter Press M button until the OK symbol appears which confirms that the selected test result has been deleted successfully The meter will return to memory mode and display next result after deleting SYSTEM SPECIFICATIONS 1 Assay Method Electrochemical biosensor Test Sample Animal cell culture medium or buffer solution Glucose concentration in mg dL or mmol L Less than 15 seconds 20 600 mg dL 1 1 33 3 mmol L 180 test results with time and date One 3 volt Lithium Battery Approximately 1000 tests Automatic shut off In 3 minutes 1 11 0 2 1 TAKING CARE OF YOUR METER REPLACING THE BATTERY
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