OneTouch Select PLUS, Owner'S Booklet

Page 1: ...Blood Glucose Monitoring System Owner s Booklet Instructions for Use...

Page 2: ......

Page 3: ...1 Blood Glucose Monitoring System Owner s Booklet...

Page 4: ...test your blood glucose and help you manage your diabetes This Owner s Booklet offers a complete explanation of how to use your new meter and testing supplies It reviews the do s and don ts of testing...

Page 5: ...Glucose Result In Range Note Blood Glucose Result Below Range Note Blood Glucose Result Before Meal Tag After Meal Tag Control Solution Result Blood Glucose Result Above 33 3 mmol L Blood Glucose Resu...

Page 6: ...came with your system for safety related information Direct current Consult Instructions for Use Manufacturer Lot Number Serial Number Storage Temperature Limits In Vitro Diagnostic Device Do Not Re u...

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Page 8: ...display backlight to make it easy to read results 22 First time set up 23 Turn the meter off after setup 31 3 Take a test 32 Test your blood glucose 32 Test with control solution 59 4 Review past res...

Page 9: ...sinfection 102 7 Batteries 108 Replacing the batteries 109 8 Troubleshooting 112 9 Detailed information about your system 126 Comparing meter results to laboratory results 126 Guidelines for obtaining...

Page 10: ...us Control Solutions IMPORTANT SAFETY INSTRUCTIONS This meter and lancing device are for single patient use only Do Not share them with anyone else including family members Do Not use on multiple pati...

Page 11: ...eTouch Select Plus Blood Glucose Monitoring System is intended for self testing outside the body in vitro diagnostic use by people with diabetes at home and with their healthcare professionals in a cl...

Page 12: ...current is produced The strength of this current changes with the amount of glucose in the blood sample Your meter measures the current calculates your blood glucose level displays the blood glucose...

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Page 14: ...The OneTouch Select Plus Blood Glucose Monitoring System Included with your kit OneTouch Select Plus Meter 2 x CR2032 batteries included OneTouch Delica Lancing Device OneTouch Delica Sterile Lancets...

Page 15: ...m 13 A carrying case is included with your system kit NOTE The OneTouch Delica Lancing Device uses ONLY OneTouch Delica Lancets If another type of lancing device was included see the separate instruct...

Page 16: ...old separately Refer to your meter carton for a list of included items OneTouch Select Plus Mid Control Solution OneTouch Select Plus Test Strips OneTouch Select Plus Control Solutions and Test Strips...

Page 17: ...ep the meter and testing supplies away from young children Small items such as the battery door batteries test strips lancets protective covers on the lancets and control solution vial cap are choking...

Page 18: ...1 Getting to know your system 16 Getting to know your OneTouch Select Plus Blood Glucose Monitoring System Meter...

Page 19: ...1 Getting to know your system 17 Test strip...

Page 20: ...ucose result is within below or above your range limits It does this by displaying a Range Indicator Note with your current glucose result The Note also points to a corresponding Range Indicator Colou...

Page 21: ...e Indicator Note will appear with your result after each test depending upon how you set your General low and high range limits in the meter Your meter will use these general settings to decide which...

Page 22: ...f you turn Meal Tagging On you will be asked to set up additional Mealtime low and high range limits Your meter will use these mealtime settings to decide which Range Indicator Note Low In Range or Hi...

Page 23: ...ose tagged results until you turn Meal Tagging On If Meal Tagging is turned on and No Tag is selected the lower before meal limit and upper after meal limit are used as your range to provide a range i...

Page 24: ...neTouch Customer Care on 0800 121 200 UK or 1800 535 676 Ireland during the hours of 8 30am 6pm Monday Friday 9am 1pm Saturday Or visit www LifeScan co uk 800 62253 Malta or 800 9074 Iceland Monday Fr...

Page 25: ...ed to each of your test results Pressing after making your selection confirms each setting and takes you to the next screen When setting up your meter you can press to return to the previous screen to...

Page 26: ...ime date and general range limits 1 Set the time The Set Time screen will be displayed next If the time is correct press to save and continue to Step 2 to set the date If you need to edit the time pre...

Page 27: ...press then repeat Step 1 A Saved screen appears to confirm that the time displayed is now stored in the meter 2 Set the date The Set Date screen will be displayed next If the date is correct press to...

Page 28: ...epeat this step to set the month and year When the date is correct press to save If you need to make an adjustment press or to highlight Edit and press then repeat Step 2 A Saved screen will appear to...

Page 29: ...uring first time set up will apply to all untagged glucose results unless Meal Tagging is turned On CAUTION Be sure to talk to your healthcare professional about the low and high limits that are right...

Page 30: ...ress If the low and high range limits are correct press to save A Saved screen will appear Continue to Setup complete If you need to edit the pre set limits to fit your needs press or to highlight Edi...

Page 31: ...the pre set High Limit to the desired value between 5 0 mmol L and 16 7 mmol L and press When your low and high range limits are correct press to save If you need to make an adjustment press or to hi...

Page 32: ...is now ready for use Press to return to the Main Menu screen See page 62 NOTE If the meter was turned on by inserting a test strip the Apply Blood screen appears instead of the Main Menu A Saved scree...

Page 33: ...e meter off after setup There are three ways to turn your meter off Press and hold for several seconds until the meter turns off Remove the test strip after a test Or Your meter will turn off by itsel...

Page 34: ...d it helpful to practise testing with control solution before testing with blood for the first time See page 59 Preparing for a test Have these things ready when you test OneTouch Select Plus Meter On...

Page 35: ...ore you test Do Not test if there is condensation water build up on your meter Move your meter and test strips to a cool dry spot and wait for the meter surface to dry before testing Keep test strips...

Page 36: ...o Not return the used test strip to the vial after performing a test Do Not re use a test strip that had blood or control solution applied to it Test strips are for single use only Do Not test with a...

Page 37: ...2 NOTE Comparing your blood glucose test results taken with this meter to your results taken from a different meter is not recommended Results may differ between meters and are not a useful measure of...

Page 38: ...are immediately if the test strip vial is damaged Contact OneTouch Customer Care on 0800 121 200 UK or 1800 535 676 Ireland 800 62253 Malta or 800 9074 Iceland If you cannot test due to a problem with...

Page 39: ...ca Lancing Device NOTE The OneTouch Delica Lancing Device uses ONLY OneTouch Delica Lancets If the lancing device shown here is different from the device included in your kit please see the separate i...

Page 40: ...site testing AST Use only fingertips when testing with the system The OneTouch Delica Lancing System does not include the materials needed to perform Alternate site testing AST The OneTouch Delica Lan...

Page 41: ...vice with anyone Always use a new sterile lancet each time you test Always keep your meter and lancing device clean see page 102 The meter and lancing device are for single patient use only Do Not sha...

Page 42: ...time you test Repeated punctures in the same spot may cause soreness and calluses Before testing wash your hands thoroughly with warm soapy water Rinse and dry completely 1 Remove the lancing device...

Page 43: ...n here so that the lancet fits into the lancet holder Push the lancet into the device until it snaps into place and is fully seated in the holder Twist the protective cover one full turn until it sepa...

Page 44: ...3 Take a test 42 3 Replace the lancing device cap Place the cap back onto the device turn clockwise to secure the cap Do Not overtighten...

Page 45: ...adults Deeper punctures work well for people with thick or callused skin Turn the depth wheel to choose the setting NOTE A shallower fingertip puncture may be less painful Try a shallower setting fir...

Page 46: ...urn the meter on Insert a test strip into the test strip port with the contact bars facing you No separate step to code the meter is required When the Apply Blood screen appears on the display you can...

Page 47: ...release button Remove the lancing device from your finger 8 Get a round drop of blood Gently squeeze and or massage your fingertip until a round drop of blood forms on your fingertip If the blood sme...

Page 48: ...r extended and steady move the meter and test strip toward the blood drop Do Not apply blood on the top of the test strip Do Not hold the meter and test strip underneath the blood drop This may cause...

Page 49: ...3 Take a test 47 2 Apply the sample Line up the test strip with the blood drop so that the narrow channel on the edge of the test strip is almost touching the edge of the blood drop...

Page 50: ...from filling properly Do Not smear or scrape the drop of blood with the test strip Do Not apply more blood to the test strip after you have moved the drop of blood away Do Not move the test strip in t...

Page 51: ...e does not fill the confirmation window completely See page 119 Discard the test strip and re start the test process 3 Wait for the confirmation window to fill completely The blood drop will be drawn...

Page 52: ...p away from the blood drop and wait for the meter to count down about 5 seconds Countdown screen CAUTION Do Not make immediate treatment decisions on the Range Indicator Notes that appear with your te...

Page 53: ...or Note The Note tells you if your result is within range below or above your general range limits set in the meter see page 85 The Range Indicator Note will also point to the appropriate Range Indica...

Page 54: ...meter turns off The meter will also automatically turn off if left alone for two minutes Or Remove the test strip and the meter will turn off Removing the used lancet NOTE This lancing device has an...

Page 55: ...h the lancet tip into the cupped side of the cover 3 Eject the lancet Slide the ejection control forward until the lancet comes out of the lancing device Return the ejection control to its back positi...

Page 56: ...lancing device cap Place the cap back onto the device turn clockwise to secure the cap Do Not overtighten It is important to use a new lancet each time you obtain a blood sample This will help prevent...

Page 57: ...unintended lancet stick injuries Used lancets and test strips may be considered biohazardous waste in your area Be sure to follow your healthcare professional s recommendations or local regulations fo...

Page 58: ...the result is less than 1 1 mmol L it may mean hypoglycaemia low blood glucose This may require immediate treatment according to your healthcare professional s recommendations Although this result cou...

Page 59: ...ssional if you are concerned about hyperglycaemia EXTREME HIGH GLUCOSE is displayed when your blood glucose result is over 33 3 mmol L You may have severe hyperglycaemia very high blood glucose Re tes...

Page 60: ...od glucose results and you have followed all instructions in this Owner s Booklet call your healthcare professional Never ignore symptoms or make significant changes to your diabetes management progra...

Page 61: ...test is performing correctly Control solution is available separately NOTE When you first open a new vial of control solution record the discard date on the vial label Refer to the control solution in...

Page 62: ...ution tests must be done at room temperature 20 25 C Make sure your meter test strips and control solutions are at room temperature before testing CAUTION Do Not swallow or ingest control solution Do...

Page 63: ...ntrol solution test Whenever you open a new vial of test strips If you suspect that the meter or test strips are not working properly If you have had repeated unexpected blood glucose results If you d...

Page 64: ...3 Take a test 62 Performing a control solution test 1 Press and hold to turn the meter on and display the Main Menu 2 Highlight Settings on the Main Menu and press 3 Highlight Control Test and press...

Page 65: ...3 Take a test 63 Wait for the Insert Strip screen to appear on the display 4 Insert a test strip Make sure the contact bars are facing you...

Page 66: ...lution screen to appear on the display 5 Prepare the control solution Before removing the cap shake the vial gently Remove the vial cap and place it on a flat surface with the top of the cap pointing...

Page 67: ...65 Wipe both the tip of the control solution vial and the top of the cap with a clean damp tissue or cloth Then squeeze a drop into the small well on the top of the cap or onto another clean non abso...

Page 68: ...Hold the meter so that the narrow channel at the top edge of the test strip is at a slight angle to the drop of control solution Touch the channel on the top edge of the test strip to the control sol...

Page 69: ...se Control Test was selected the meter marks the result as a control solution test CAUTION Make sure you select Control Test from the Settings screen before you begin a control solution test An Error...

Page 70: ...f test strips has the OneTouch Select Plus Mid Control Solution range printed on its label Compare the result displayed on the meter to the range printed on the test strip vial Example range OneTouch...

Page 71: ...ged or expired Meter test strips and or control solution were not all at the same temperature when the control solution test was performed Control solution was not at room temperature 20 25 C A proble...

Page 72: ...ution Contact Customer Care Contact OneTouch Customer Care on 0800 121 200 UK or 1800 535 676 Ireland 800 62253 Malta or 800 9074 Iceland The control solution ranges printed on the test strip vial are...

Page 73: ...3 Take a test 71 This page left blank intentionally...

Page 74: ...hem in several ways 1 Get to the Results Log From the Main Menu press or to highlight Results Log and press Up to four results are displayed on the screen starting with the most recent NOTE The Meal T...

Page 75: ...73 2 Scroll through your results Press to move backward and to move forward through your results Pressing and holding or allows you to move more quickly To display the details of a particular result...

Page 76: ...esult was above 33 3 mmol L if the blood glucose result was below 1 1 mmol L if the result is from a control solution test see page 59 if the glucose result was above the high limit if the glucose res...

Page 77: ...s screen From the Main Menu press or to highlight Averages and press For each of the 7 14 30 and 90 day periods leading up to the current date the meter displays the averages of those results These av...

Page 78: ...you can view your Before Meal and After Meal Averages for the same time periods Press or to display your Before Meal and After Meal Averages Only those results tagged Before Meal or After Meal will be...

Page 79: ...time period being averaged An EXTREME HIGH GLUCOSE result is always counted as 33 3 mmol L and an EXTREME LOW GLUCOSE result is always counted as 1 1 mmol L The meter calculates averages based on the...

Page 80: ...r as it may affect your averages Download results to a computer OneTouch Diabetes Management Software can store all of your records and help you spot patterns for planning meals exercise insulin dosin...

Page 81: ...d a standard micro USB interface cable to connect your OneTouch Select Plus Meter to a computer to download results not included Once the meter has been connected to the computer the meter display wil...

Page 82: ...ngs at any time When you turn your meter on the Main Menu is displayed after the start up screen A shaded bar highlights the current selection on the meter display Select the specific setting you want...

Page 83: ...hlight Time Date on the Settings screen and press Next highlight Time and press The current time set in the meter is displayed Press or to change the hour and press Repeat this step to change the minu...

Page 84: ...e Highlight Date on the Time Date screen and press The current date set in the meter is displayed Press or to change the day and press Repeat this step to change the month and year A Saved screen appe...

Page 85: ...date set in the meter If they are correct press See page 108 for information on changing the batteries If not correct press or to highlight Edit and press Follow steps 1 and 2 to adjust the time and d...

Page 86: ...range limits CAUTION Be sure to talk to your healthcare professional about the low and high limits that are right for you When selecting or changing your limits you should consider factors such as yo...

Page 87: ...85 Edit your general range limits The current general range limits set in the meter are displayed Press or to change the Low Limit to the desired value between 3 3 mmol L and 6 1 mmol L Then press Hi...

Page 88: ...ter first time set up 86 Press or to change the High Limit to the desired value between 5 0 mmol L and 16 7 mmol L Then press A Saved screen will appear to confirm the low and high limits displayed ar...

Page 89: ...On A Before Meal glucose test is taken just before the start of your meal An After Meal glucose test is typically taken one or two hours after the start of your meal We suggest you talk to your health...

Page 90: ...5 Adjust meter settings after first time set up 88 Highlight Meal Tagging on the Settings screen and press A check mark will indicate whether Meal Tagging is currently turned Off or On...

Page 91: ...Before Meal and After Meal Press to continue and make any adjustments to your Before Meal or After Meal limits The pre set Before Meal range limits are 3 9 mmol L and 7 2 mmol L Low and High Limits a...

Page 92: ...fter first time set up 90 Press or to change the Low Limit to the desired value between 3 3 mmol L and 6 1 mmol L Then press Press or to change the High Limit to the desired value between 5 0 mmol L a...

Page 93: ...fter Meal range limits are correct press to save If you need to make adjustments press or to highlight Edit and press Then follow the previous steps above for setting and saving the After Meal range l...

Page 94: ...limits a Saved screen appears to confirm that Meal Tagging is On NOTE If Meal Tagging is turned On and you choose to turn it Off you will be prompted to confirm or edit your general range limits that...

Page 95: ...to be able to edit mealtime range limits See page 87 Highlight Range on the Settings screen and press NOTE If you decide to change your Mealtime range limits your previous Range Indicator Notes in th...

Page 96: ...Before Meal and After Meal range limits Highlight Before Meal on the Range screen and press The current Before Meal range limits set in the meter are displayed Press or to change the Low Limit to the...

Page 97: ...first time set up 95 Press or to change the High Limit to the desired value between 5 0 mmol L and 12 0 mmol L Then press A Saved screen appears to confirm that the Before Meal range limits displayed...

Page 98: ...reen and press Next highlight After Meal on the Range screen and press Follow the previous steps for changing the After Meal range limits NOTE The After Meal Low limit can be set between 5 0 mmol L an...

Page 99: ...tag your glucose results After your glucose result appears on the display after a test your tagging options appear below your result Before Meal After Meal and No Tag Press or to highlight Before Meal...

Page 100: ...result while your result is still displayed see next page Simply press to return to the Meal Tagging screen above and repeat the instructions for tagging your result You can tag an EXTREME HIGH resul...

Page 101: ...r result The Range Indicator feature on your meter automatically displays the appropriate Range Indicator Note and points to the corresponding Range Indicator Colour Bar Your meter applies either Befo...

Page 102: ...meter error The meter serial number software version and information about the last meter error are stored in your meter You can check this information at any time and use it for troubleshooting 1 Pre...

Page 103: ...5 Adjust meter settings after first time set up 101 Press to scroll down and display information about the last error that occurred on the meter...

Page 104: ...away from direct sunlight and heat Cleaning and disinfection Cleaning and disinfection are different and both should be performed Cleaning is part of your normal care and maintenance and should be pe...

Page 105: ...e cleaned whenever they are visibly dirty For cleaning obtain regular strength liquid dish soap and a soft cloth Prepare a mild detergent solution by stirring 2 5 mL of regular strength liquid dish so...

Page 106: ...strip port pointed down use a soft cloth dampened with water and mild detergent to wipe the outside of the meter and lancing device Be sure to squeeze out any excess liquid before you wipe the meter W...

Page 107: ...containing a minimum of 5 5 sodium hypochlorite as the active ingredient Prepare a solution of 1 part household bleach and 9 parts water Follow manufacturer s instruction for handling and storage of...

Page 108: ...dampened with the bleach solution for 1 minute Wash hands thoroughly with soap and water after handling the meter lancing device and cap If you see signs of wear please contact Customer Care Contact O...

Page 109: ...6 Care and maintenance 107 This page left blank intentionally...

Page 110: ...he batteries Do Not change the batteries when connected to a PC IMPORTANT Use only CR2032 lithium batteries with your meter Do Not use rechargeable batteries Use of an incorrect battery type or the re...

Page 111: ...ies Start with the meter turned off Remove the battery cover by sliding it downward Pull up firmly on the plastic battery ribbons The plastic battery ribbon with the symbol is for the meter battery an...

Page 112: ...s into the battery clasp Replace the battery cover by sliding it upwards onto the meter If the meter does not power on after you have replaced the meter battery check that the battery is correctly ins...

Page 113: ...3 Check your meter settings You will be prompted to set the time and date whenever you change the batteries See page 24 4 Dispose of batteries Dispose of batteries according to your local environment...

Page 114: ...eter is on but does not operate locks up contact Customer Care Contact OneTouch Customer Care on 0800 121 200 UK or 1800 535 676 Ireland 800 62253 Malta or 800 9074 Iceland What it means You may have...

Page 115: ...y have a very high blood glucose level severe hyperglycaemia over 33 3 mmol L What to do Re test your blood glucose level If the result is EXTREME HIGH GLUCOSE again obtain and follow instructions fro...

Page 116: ...44 C to work correctly What to do Move the meter and test strips to a cooler area Insert a new test strip when the meter and test strips are within the operating range 10 44 C If you do not get anothe...

Page 117: ...10 C to work correctly What to do Move the meter and test strips to a warmer area Insert a new test strip when the meter and test strips are within the operating range 10 44 C If you do not get anoth...

Page 118: ...76 Ireland 800 62253 Malta or 800 9074 Iceland What it means Error message could be caused either by a used test strip or a problem with the meter What to do Repeat the test with a new test strip see...

Page 119: ...test with a new test strip Apply a blood or control solution sample only after Apply Blood or Apply Control Solution appears on the display If this message continues to appear contact Customer Care Co...

Page 120: ...strip Possible cause is test strip damage What to do Repeat the test with a new test strip see page 32 or page 59 If the error message appears again contact Customer Care Contact OneTouch Customer Ca...

Page 121: ...he test strip may have been damaged or moved during testing The sample was improperly applied There may be a problem with the meter What to do Repeat the test with a new test strip see page 32 or page...

Page 122: ...ble cause is that you did not apply a blood sample to the test strip when prompted by the meter What to do Repeat the test with a new test strip see page 32 If the error message appears again contact...

Page 123: ...u did not apply a control solution sample to the test strip when prompted by the meter What to do Repeat the test with a new test strip see page 59 If the error message appears again contact Customer...

Page 124: ...but there is still enough power to perform a test What to do Once the meter Low Battery icon is displayed it will continue to appear until you replace the meter battery Test results will still be accu...

Page 125: ...is low but there is still enough power to perform a test What to do Press to continue but replace the meter battery as soon as possible What it means There is not enough meter battery power to perform...

Page 126: ...meter What to do Contact Customer Care to report this occurrence unless this is your first use of the meter Contact OneTouch Customer Care on 0800 121 200 UK or 1800 535 676 Ireland 800 62253 Malta o...

Page 127: ...8 Troubleshooting 125 This page left blank intentionally...

Page 128: ...e glucose concentration is lower than 5 5 mmol L and within 15 of a laboratory method when the glucose concentration is 5 5 mmol L or higher Meter results can be affected by factors that do not affect...

Page 129: ...est results taken with this meter to your results taken from a different meter is not recommended Results may differ between meters and are not a useful measure of whether your meter is working proper...

Page 130: ...obtaining accurate meter to lab comparisons Before going to the lab Perform a control solution test to make sure your meter is working properly Do Not eat for at least 8 hours before you test your blo...

Page 131: ...29 Testing with your OneTouch Select Plus Meter at the lab Test within 15 minutes of the lab test Use only a fresh capillary blood sample from your fingertip Follow all instructions in this Owner s Bo...

Page 132: ...lithium batteries or equivalent Biological source Aspergillus Niger Calibration Plasma equivalent Memory 500 test results Operating ranges 10 44 C Relative humidity Non condensing 10 90 Altitude up t...

Page 133: ...f a laboratory method when the glucose concentration is 5 55 mmol L or higher Samples from 100 patients were tested using both the OneTouch Select Plus System and the YSI 2300 Glucose Analyser laborat...

Page 134: ...the laboratory test Within 5 Within 10 Within 15 72 7 314 432 98 6 426 432 100 0 432 432 System Accuracy Results for Glucose Concentrations between 1 2 mmol L and 25 9 mmol L Within 0 83 mmol L or 15...

Page 135: ...plicate on each of three test strip lots Results indicate that the OneTouch Select Plus System compares well with a laboratory method of Subjects of Tests Slope Intercept mmol L 100 600 0 97 0 12 95 C...

Page 136: ...l L Mean Glucose mmol L Standard Deviation mmol L Coefficient of Variation 2 2 2 50 0 09 3 59 3 6 3 90 0 10 2 56 6 7 7 06 0 16 2 25 11 1 11 57 0 29 2 52 19 4 19 55 0 40 2 07 Results show that the grea...

Page 137: ...olution Tests per Glucose Level Data generated using the OneTouch Select Plus Meter Glucose Level Ranges mmol L Mean Glucose mmol L Standard Deviation mmol L Coefficient of Variation Low 1 67 2 78 2 6...

Page 138: ...ions below 5 55 mmol L and 97 7 within 15 of the medical laboratory values at glucose concentrations at or above 5 55 mmol L 98 2 of the total number of samples were within 0 83 mmol L or 15 of the me...

Page 139: ...26 1 or 61326 2 The meter meets the requirements for immunity to electrical interference at the frequency range and test level specified in international standard ISO 15197 Use of this meter near elec...

Page 140: ...ts to laboratory results 126 Control solution discard and expiry dates 59 60 Control solution testing 59 Data port 16 Date setting 81 Dehydration 56 126 Disinfecting your meter lancing device and cap...

Page 141: ...ttery icon 3 123 Main Menu screen 62 72 75 80 Meal tagging setting 87 Mealtime range limits 93 Mealtime range setting 93 mmol L 16 51 130 Plasma calibration 126 130 Range indicator colour bar 16 18 51...

Page 142: ...perature 32 33 60 102 114 115 130 Test strip applying drop of blood 46 Test strip contact bars 18 44 63 Time setting 24 81 Turning meter off 52 Turning meter on 22 44 Unexpected blood glucose results...

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Page 144: ...the following U S patents 6 413 410 6 733 655 7 250 105 7 468 125 8 066 866 and 8 093 903 Purchase of this device does not act to grant a use license under these patents Such a license is granted onl...