Arkray GLUCOCARD Expression User Instruction Manual Download

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User Instruction Manual

Read this User Instruction Manual carefully
before you start testing.

Summary of Contents for GLUCOCARD Expression

Page 1: ...User Instruction Manual Read this User Instruction Manual carefully before you start testing ...

Page 2: ...9 Meter Display Screen 11 The GLUCOCARD Expression Test Strip 13 GLUCOCARD Expression Control Solution required 15 Setting Up Your GLUCOCARD Expression System 16 The Set Up Screen 16 Setting the Clock 18 Setting the Alarms 22 Voice and Beeper Function 24 Voice Function Table 27 Control Solution Testing 33 Performing a Control Solution Test 34 Control Solution Trouble Shooting 39 ...

Page 3: ...e Test Results 54 Viewing the Meter Memory 56 Caring for the Meter 61 Changing the Battery 62 Cleaning and disinfection procedures for GLUCOCARD Expression meter and Lancing Device 63 Purchase information for Dispatch Hosptal Cleaner Disinfectant Towels with Bleach 72 Storage and Precautions 73 Downloading Test Results to a Computer 74 Solving Problems 74 Warranty 78 Specifications 79 ...

Page 4: ...ience of the bilingual voice feature can be used as a verbal aid for using the meter and hearing test results by visually impaired users This manual contains all the information needed to use and maintain your new blood glucose meter Please read carefully before use If you have any questions call Customer Service at 800 566 8558 USA and Canada only Contact your healthcare professional with questio...

Page 5: ...rm or palm Testing is done outside the body In Vitro diagnostic use The meter includes voice functionality to assist visually impaired users It is indicated for lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared It is not indicated for the diagnosis or screening of diabetes or for neonatal use ...

Page 6: ...tact your healthcare professional immediately Hematocrit range A hematocrit range that is higher than 55 or lower than 30 can cause inaccurate blood glucose test results Not intended for use on neonates Alternate site testing should be performed only during steady state when glucose is not changing rapidly Testing is done outside the body ...

Page 7: ...and water after handling the meter lancing device or test strips Links to the public health notification and standard practice guidelines are FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 2010 http www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm CDC Clinical Reminder Use of F...

Page 8: ... GLUCOCARD Expression Meter User Instruction Manual Carrying Case Self testing Log Book May include Test Strips Control Solution and Lancing Device and or Lancets THE GLUCOCARD EXPRESSION SYSTEM INCLUDES ...

Page 9: ...ose test results memory values averages and other messages Enter and buttons Press and hold Enter for 2 seconds to turn on or off the Meter or press Enter to go into setup mode when not testing see page 16 Press or to enter control mode with test strip inserted see page 33 during meter setup see page 16 or to navigate the stored test values and averages see page 56 ...

Page 10: ...10 Data Port Connect an ARKRAY data cable here to send data to a PC Purchased separately Battery Compartment Holds two AAA batteries ...

Page 11: ...er is in data transfer mode to PC MEM Indicates the number in the meter display is a stored test value see page 56 ALARM Indicates alarm has been set see page 22 CTL This icon indicates a control solution test see page 33 or the stored value is a control solution result see page 60 ctl AM DAY AVG PM mg dL mem ...

Page 12: ...set up time and date see page 18 VOICE Indicates the voice feature is turned on see page 24 UNITS Unit of measurement for blood glucose is mg dL BLOOD DROP and ARROW Indicates the meter is ready for testing see page 48 Displays the date time am pm in 24 hours format see page 18 or type of day averages 7 14 or 30 see page 56 ctl AM DAY AVG PM mg dL mem ...

Page 13: ...to lab results however results may be 10 to 15 higher than results obtained from whole blood referenced blood glucose assays The test strip is also equipped with under fill detection to alert you when there is not enough blood to perform a test This ensures that every reading is accurate and meaningful Contact Points Insert this end to the test strip port on the meter Sampling End Apply blood or c...

Page 14: ... after each use Keep the unused test strips in the original bottle DO NOT store any test strips outside the bottle while not in use DO NOT reuse test strips Test strips are for single use only Carefully discard used test strips and lancets in proper waste containers ...

Page 15: ...1 helps you validate the performance of your system for a normal range blood glucose reading Level 2 L2 solution helps you validate your system performance for a high range blood glucose reading Run a control test to make sure the Test Strips and Meter are working together properly to practice testing procedure and after opening a new bottle of GLUCOCARD Expression Test Strips Call your local supp...

Page 16: ...on meter Step 2 Press Enter to enter into the Setup Screen Step 3 Simply use buttons to navigate to the desired function icon and press the Enter button to enter the function when the icon is flashing Step 4 Navigate to End at the display screen to exit the Setup Screen The Meter will also announce each function when the voice feature is turned on Setting Up Your GLUCOCARD expression System mem PM...

Page 17: ...ress Enter to enter PC Link Mode for data transfer onto a PC Press Enter to enter Time and Date Setup see page 18 Press Enter to enter Alarm Setup see page 22 Your meter has 3 alarm settings Press Enter to enter Volume Setup see page 25 mem PM Press Enter to enter Language Selection see page 26 End Exit Setup Screen and return to testing ...

Page 18: ...ession Meter has not been set test or control result will not be stored in memory Step 1 Press and hold Enter to turn on the meter Step 2 Press Enter to go into the setup screen then press or until starts to flash If the voice function is on the meter will say Set date and time Press Enter to enter clock setup ...

Page 19: ...e Month The current month will flash If the voice function is on the meter will say Set Month Press or to select the correct month Press Enter to confirm your choice The screen advances to set the date Step 5 Set the Date The current date will flash Press or to select the correct day If the voice function is on the meter will say Set Day Press Enter to confirm your choice The screen advances to th...

Page 20: ...t the Hour The current hour will flash If the voice function is on the meter will say Set Hour Press or to select the correct hour Press Enter to confirm your choice The screen advances to the minutes setting Step 8 Set the Minute The current minutes will flash If the voice function is on the meter will say Set Minutes Press or to select the correct minute Press Enter to confirm your choice and fi...

Page 21: ...o reset time after changing batteries After date and time has been set the meter will announce the date and time if the voice feature is on Begin testing by inserting a GLUCOCARD Expression Test Strip see page 40 Testing Your Blood Glucose or press and hold Enter to turn the meter off See the next section to set up the alarm feature on your meter ...

Page 22: ...Pressing Enter or inserting a test strip will silence the alarm You can set one two or all three alarms You will need Your GLUCOCARD Expression Meter Step 1 Press and hold Enter to turn on the meter Step 2 Press Enter to enter setup screen Step 3 Press or until starts to flash If the voice function is on the meter will say Set Testing Alarm Press Enter to enter alarm setting screen advances to the...

Page 23: ...e hour Press Enter to confirm your choice and the screen advances to the minute setting Step 6 The current minutes will flash Press or to select the correct minute Press Enter to confirm your choice The screen advances to the alarm 2 setting Step 7 To set alarm 2 and alarm 3 following steps 4 through 6 After you have finished setting up alarm 3 press Enter to exit alarm setup PM PM PM ...

Page 24: ...or press and hold Enter to turn off the meter or see the next section on how to set up the voice feature on your meter Voice and Beeper Function Your meter has a bilingual voice function that can be used as a verbal aid for using the meter and hearing test results The default setting for the voice function is on and can be turned off to conserve battery power When the voice function is off the met...

Page 25: ...en displays the current sound volume default is 2 Press or to adjust the sound volume from 1 lowest to 5 highest A melody will sound according to the sound volume you have selected Setting to 0 will turn off the voice function When the voice is turned off the meter will beep to alert you of important messages Once you have determined the suitable volume press Enter to exit volume setting PM ...

Page 26: ... to flash If the voice function is on the meter will announce Language Selection Step 4 Press Enter to enter the language set up English is the default language 1 on the display screen and is announced Press or to select Spanish 2 on the display screen Press Enter when you have finished selecting the language and exit language selection PM ...

Page 27: ... can be used as an aid for you to hear the test results and use the meter The following table lists WHEN the meter will speak and WHAT the meter will say when voice function is turned on NOTE Any time during set up you can insert a GLUCOCARD Expression Test Strip and begin testing Any changes made so far are stored Your choice of language and volume settings will not be erased when changing batter...

Page 28: ...rip Blood Glucose test is completed and the result is shown on screen Your blood glucose reading is number milligrams per deciliter Blood Glucose test result is BELOW the measurement range of 20 mg dL Your blood glucose reading is below 20 mg dL Blood Glucose test result is ABOVE the measurement range of 600 mg dL Your blood glucose reading is above 600 mg dL Temperature is out of range between 50...

Page 29: ...nd page 40 Testing Your Blood Glucose Insert the test strip and press or ctl appears next to the test strip icon L1 control solution test Please apply control solution onto the test strip L2 control solution test Please apply control solution Blood glucose test Please apply blood onto the test strip ...

Page 30: ...ee page 16 Setting Up Your Glucocard Expression System End Function Mode Set Sound Volume Set Testing Alarm Set Date and Time Pressing Enter to enter setup screen after the meter has been turned on PC Link Memory Recall Language Selection ...

Page 31: ...p setting up the month Set Month During date and time setup setting up the date Set Day During time format setup setting up the time format Set 12 Hour Set 24 Hour During date and time setup setting up the hour Set Hour During date and time setup setting up the minutes Set Minutes After finish setting up date and time The date and time is year month date hour minutes ...

Page 32: ... to PC Sending data to PC Finish sending data to PC Data transmission complete Voice Function Other warning messages See page 74 Solving Problems Meter date and time has not been set Please set date and time Meter failure Error 1 meter failure Used test strip Error 3 used test strip Not enough blood or control solution Error 4 not enough sample ...

Page 33: ... the first time Using a new bottle of GLUCOCARD Expression Test Strips You left the test strip bottle cap open You dropped the meter You suspect your meter and test strips are not working properly The blood glucose test results do not reflect how you feel You want to practice the testing procedure Call your local supplier or pharmacy to order control solution If they do not stock it call ARKRAY Or...

Page 34: ...k the expiration date DO NOT use control solution if it is expired DO NOT FREEZE Store the control solution at room temperature You will need GLUCOCARD Expression Control Solution Level 1 or Level 2 Your GLUCOCARD Expression meter A new GLUCOCARD Expression test strip Step 1 Remove a GLUCOCARD Expression Test Strip from the test strip bottle Close the bottle cap immediately Insert the test strip t...

Page 35: ... sunlight and heat Store the test strip bottle in a dry cool place Record the date opened on the bottle label Discard the bottle and any remaining test strips after 3 months from date of opening Test under the temperature range of 50 F to 104 F Your meter will not work outside of this range Must insert test strip into the test strip port Must see a flashing blood drop icon when the test strip has ...

Page 36: ...trip icon and L1 will appear on the meter display screen The meter will also announce L1 control solution test please apply control solution onto the test strip If you decide not to do a control solution test Press until disappears from the meter display Step 4 Squeeze a drop of control solution onto a clean dry non absorbent surface Do not apply control solution to the test strip directly from th...

Page 37: ...t to count down After 6 seconds the control test result will appear on the meter display screen Step 7 Compare the reading on the screen to the Level 1 range printed on the test strip bottle or its package If the reading falls outside the Level 1 range printed on the test strip bottle or its package see Control Solution Trouble Shooting on page 39 PM Level 1 53 79 Level 2 135 203 ...

Page 38: ...sed for calculating averages Step 8 Remove the used test strip The meter will automatically turn off Discard the used test strip into a proper waste container IMPORTANT Do not re use Test Strips Follow steps 3 through 8 to complete a Level 2 control solution test and compare the result with the Level 2 range printed on the test strip bottle ...

Page 39: ...ration and open bottle date on both the control solution and test strips Repeat test using a new test strip If the result is still out of range use a new bottle of control solution and retest Meter malfunction If problem persists Please call Customer Service at 1 800 566 8558 USA and Canada only Contact your diabetes healthcare professional if you cannot reach Customer Service Control Solution Tro...

Page 40: ...a control test See Setting Up Your GLUCOCARD Expression System on page 16 and Control Solution Testing on page 33 for details Wash your hands and the testing site thoroughly with soap and warm water dry well You are testing in an area between the temperature ranges of 50 F 104 F NOTE Your meter will not test outside of this range and will display a thermometer icon with verbal indication if the vo...

Page 41: ...ed Test Strips When you open a bottle of Test Strips for the first time record the open date on the test strip bottle Discard the bottle and any remaining Test Strips 3 months after the open date After taking a Test Strip out of the bottle close the cap of the bottle immediately Use each Test Strip immediately after taking it out from the bottle Do not use wet bent scratched or visibly damaged Tes...

Page 42: ...adjustable cap by twisting the cap off the lancing device and insert the lancet by pushing down firmly until lancet is fully seated Step 2 Twist the protective cover off the lancet Attach the adjustable cap by twisting clockwise onto the lancing device ...

Page 43: ...stable cap for the puncture depth level 1 is the lightest and 5 is the deepest Step 4 With one hand holding the adjustable cap pull back the lancing device with your other hand until you hear a click The lancing device is now ready for blood sampling ...

Page 44: ...performing a blood glucose test use a new sterile lancet every time If alcohol wipes are used to cleanse the fingers make sure the area is dry before the blood sample is obtained Step 1 Wash hands with soap and warm water and dry thoroughly Warm water stimulates blood flow to the fingers making it easier to obtain a sample Step 2 Hang the arm down at the side for 10 to 15 seconds massage through t...

Page 45: ... on Alternate Site Testing AST The GLUCOCARD Expression Blood Glucose Monitoring System can test blood glucose from areas other than your fingertip such as palm and forearm alternate site testing or AST Alternate site testing can be less painful than fingertip testing because of the physiological differences between your fingertip palm and forearm 1 alternate site test results may be significantly...

Page 46: ...er be used to calibrate continuous glucose monitors CGMs Alternate site measurements should never be used for insulin dosing calculations Alternate Site Testing SHOULD NOT be used when You are experiencing Hypoglycemic unawareness unable to tell if you have low blood sugar Within 2 hours of a meal exercise or medication You will be operating machinery or driving a car You are sick You think your b...

Page 47: ... you feel You are testing for hyperglycemia Your routine glucose results are often fluctuating NOTE Rubbing forearm until warm before lancing will help minimize the difference between fingertip and AST test results The palm at the base of the thumb does not require rubbing before testing If results from alternate site testing do not agree with how you feel use fingertip testing ...

Page 48: ...se expired test strips Use test strip immediately after removing from the bottle Do not use wet or damaged test strips Keep away from direct sunlight and heat Store the test strip bottle in a dry cool place Record the date opened on the bottle label Discard the bottle and any remaining test strips after 3 months from date of opening Must insert test strip into the test strip port Must see a flashi...

Page 49: ... The meter will announce Please apply blood onto the test strip if you have the voice feature turned on Step 3 Obtain blood sample For Fingertip Testing Hold the lancing device use the narrow tip adjustable cap against the side of your fingertip and press the release button mo dL PM ...

Page 50: ...ip to avoid soreness To avoid calluses choose a different lancing site each time For Testing on Palm and Forearm Hold the lancing device use the wide tip adjustable cap against the test site base of palm or forearm Avoid a test site that has veins moles excessive hair or bone Press the lancing device firmly against the test site and press the release button hold lancing device in place ...

Page 51: ... When the blood drop is large enough approximate size lift the lancing device straight up without smearing the blood drop NOTE Rubbing forearm until warm before lancing will help minimize the difference between fingertip and AST test results The palm at the base of the thumb does not require rubbing before testing If results from alternate site testing do not agree with how you feel use fingertip ...

Page 52: ...t down After 6 seconds your glucose test result will appear on the meter display screen and announce verbally if you have the voice feature turned on Your test result will be automatically stored into the meter memory PM CAUTION If you see HI or LO displayed your blood glucose level may be above 600 mg dL or below 20 mg dL Test again using fingertip testing DO NOT test on forearm If you receive th...

Page 53: ...move the used test strip into proper waste container The meter will automatically shut off Step 7 Remove the used lancet from your lancing device and discard into proper waste container Step 7 Remove the used lancet from your lancing device according to instructions and discard into proper waste container IMPORTANT You should consult your healthcare provider for instructions on how to properly dis...

Page 54: ... than 140 mg dL after meals It is important to consult with your physician or healthcare professional to determine an appropriate target range for you High or Low Blood Glucose Readings If the meter displays results that are HI or LO or you get a result that is more than 250 mg dL or below 50 mg dL AND you feel ill Treat your diabetes according to the instruction from your doctor and or consult yo...

Page 55: ... ill Test your meter with a control solution refer to page 33 Control Solution Testing Test again using fingertip testing If you still get a high or low reading contact your healthcare professional NOTE Inaccurate results may occur in severely hypotensive individuals or patients in shock Inaccurate low results may occur for individuals experiencing a hyperglycemic hyperosmolar state with or withou...

Page 56: ...help track your blood glucose trends You must set the date and time on your meter to use the memory and day averaging function see Setting Up Your GLUCOCARD Expression System on page 16 The meter will not store into memory test or control results if the date and time are not set Viewing Stored Readings and 7 14 and 30 Day Average from Memory You will need Your GLUCOCARD Expression meter ...

Page 57: ...ts to flash If the voice function is turned on the meter will say memory recall Press Enter to enter will appear at the upper left corner of the display screen together with your most recent test result Press to see the next result and the next and so on Holding will flash through the test results recent readings mem PM ...

Page 58: ...an press to go back viewing from the oldest to the most recent readings Step 4 When you reach the most recent test result continue to press to start viewing day averages The meter will display the 7 day average press again to see the 14 day average and press again to see the 30 day average mg dL mem PM mg dL mem PM mem ...

Page 59: ...The number of results included in the average is shown right next to the icon Control solution results are not included in the day average calculations mg dL mem DAY AVG mg dL mem DAY AVG mg dL DAY AVG mem ...

Page 60: ...k the display screen will show nil When there is no day average data available the display screen will show 4 dashes If the meter memory is full adding a new test result will cause the oldest to be deleted Stored test results and day averages will not be erased when changing batteries You can begin testing anytime by inserting a test strip ...

Page 61: ...UCOCARD Expression Meter Never immerse the meter or hold it under running water Do not use glass or household cleaners on the meter Do not try to clean the test strip holder Do not contaminate the strip holder with blood or control solution Handle the meter with care severe shock such as dropping the meter could damage the electronics caring for the meter ...

Page 62: ... 1 Press firmly on the battery cover and slide in the direction of the arrow Step 2 Insert new batteries Slide the battery cover back into the meter firmly NOTE Meter will prompt you to reconfirm the date and time when turned on See page 18 for Setting the Clock The date stored results alarm settings volume setting and language choice remain in memory when the batteries are changed ...

Page 63: ...ease For cleaning and disinfecting information see pages 63 72 in this manual You should disinfect areas where there are both high concentrations of dangerous germs and a possibility that they will be spread to others That is because disinfectants have ingredients that destroy bacteria and other germs While surfaces may look clean many infectious germs may be lurking around Given the right conditi...

Page 64: ...d with blood It should be disinfected every day according to the validated cycle of 1825 times The validated cycle of 365 x 5 1825 times is equivalent to one cleaning plus one disinfection per day over 5 years The lancing device cleaning and disinfecting instructions in this manual have only been validated using the lancing device Cleaning and Disinfecting Your Meter Clean and disinfect your meter...

Page 65: ...d from surface and objects before disinfecting Dispense the towel DISPATCH from its package Wipe surface with towel DISPATCH until completely wet You should wipe all external areas of the meter including both front and back surfaces Avoid wetting the test strip holder Allow to remain wet for one minute at room temperature 68 77 F Discard used towel in a sealed container where it will not be touche...

Page 66: ...must wipe all external areas of the meter including both front and back surfaces and allow 1 minute contact at room temperature Avoid wetting the test strip holder Wipe dry or allow to air dry Oily substances must be removed prior to disinfection Discard used towel in a sealed container where it will not be touched by others 6 Wash hands with soap and water ...

Page 67: ...ED read out and amonnia corrodes the metal parts User should wash hands thoroughly with soap and water after handling the meter lancing device and test strip Keep DISPATCH out of reach of children Do not flush towels down toilet Do not get water inside the meter or hold it under running water Do not use glass or household cleaners on the meter Do not try to clean the test strip holder Avoid wettin...

Page 68: ...blood debris dust or lint anywhere on the lancing device 2 Clean or disinfect lancing device 3 To clean the lancing device and endcap blood body fluids must be thoroughly cleaned from surface and objects beore disinfecting Dispense the towel DISPATCH from its package Wipe surface with towel DISPATCH until completely wet Allow to remain wet for one minute at room temperature 68 77 F Discard used to...

Page 69: ...til completely wet You must wipe surface with towel DISPATCH until completely wet and allow 1 minute contact at room temperature Wipe dry or allow to air dry Oily substances must be removed prior to disinfection Discard used towel in a sealed container where it will not be touched by others 5 Wash hand with soap and water ...

Page 70: ...ice is for patient self monitoring by a single person only It must not be used to collect blood from more than one person as this poses an infection risk Keep DISPATCH out of reach of children User should wash hands thoroughly with soap and water after handling the lancing device Only DISPATCH hospital cleaner disinfectant towel should be used to do cleaning and disinfection with the lancing devic...

Page 71: ...tion Control solution out of range Clouding for LCD display Corroding for plastic housing Corroding for buttons Malfunction of any meter buttons If these signs of deterioration are noted you should stop using the device and call customer service at 1 800 566 8558 USA and Canada only ...

Page 72: ...tors and its phone number Medline 800 633 5463 DNR Supplies 763 420 7825 To find a local distributor in your area call Customer Service at 800 234 7700 M F 8 30 5 00 pm EST You can purchase the Dispatch on the web site below www amazon com keyword CLH69150 If you need assistance or have questions about cleaning and disinfection for the meter please contact customer service at 800 566 8558 ...

Page 73: ...ing the meter in extremely hot or cold places such as near a heat source or in an extremely hot or cold car Do not store or use the meter or test strips in high humidity levels such as a bathroom or kitchen Always close the cap of the test strip bottle immediately after removing a test strip and make sure the cap is closed tightly storage and precautions ...

Page 74: ...ou are unable to reach Customer Service If any part of the display screen is missing when the meter is turned on call Customer Service at 800 566 8558 USA and Canada only We offer a diabetes management software system to help you download your test results to a computer For more information on ARKRAY diabetes data management software call ARKRAY Customer Service at 800 566 8558 24 hours a day 7 da...

Page 75: ... test strip If problem persists call us at 1 800 566 8558 USA and Canada only Error 3 used test strip Used or damaged test strip Repeat the test with a new test strip Remember to add sample until you see prompt on the display screen or the meter verbally prompts you to add sample Error 4 not enough sample Not enough sample on the test strip to start Remove the test strip and repeat the test with a...

Page 76: ...is out of range Move the meter into an area that is between 50º 104ºF and allow 10 to 15 minutes to reach the new temperature PM mg dL Your blood glucose reading is above 600 mg dL Test result is higher than 600 mg dL Wash and dry your hands and repeat the test on your fingertip with a new test strip If the result is still HI contact your physician or healthcare professional immediately ...

Page 77: ... dry your hands and repeat the test on your fingertip with a new test strip If the result is still Lo contact your physician or health care professional immediately mem NA There are no stored results in the meter Check if the date and time on your meter is set See Setting Up Your GLUCOCARD Expression System on page 16 and or Testing Your Blood Glucose on page 40 ...

Page 78: ...f a defect in materials or workmanship ARKRAY agrees to replace or repair free of charge any and all parts proven to be defective and subject to warranty This warranty is in lieu of all other warranties expressed or implied including any implied warranty of merchantability or fitness for any purpose other than stated herein This warranty does not apply to the performance of the GLUCOCARD Expressio...

Page 79: ... date and time Result Averaging 7 14 and 30 days averaging Dimension 93L x 58W x 20 5H mm Weight 79g Battery 2 Alkaline AAA Batteries Battery Life 1000 tests of continuous use or 1 year Automatic Power off After 2 minutes of non use Operating Temperature 50 F to 104 F Relative Humidity 20 85 Storage Condition Meter at 39 F 122 F Test Strips at 41 F 86 F For additional information refer to the GLUC...

Page 80: ...TEL 800 566 8558 FAX 952 646 3110 www arkrayusa com 2012 ARKRAY Inc P N 7888 03 Rev 2 14 65070000093 ...

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