Accu-Chek Guide Me User Manual Download Page 63

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Technical Information

Additional Supplies

Test Strips

: Accu-Chek Guide test strips

Control Solutions

: Accu-Chek Guide control solutions

Lancets:

Accu-Chek FastClix 102-ct. lancet drums (17 6-ct. drums)

References

FDA Public Health Notification: “Use of Fingerstick Devices on More than One Person Poses Risk for

Transmitting Bloodborne Pathogens: Initial Communication, (2010). Update 11/29/2010.”

http://wayback.archive-it.org/7993/20161022010458/http://www.fda.gov/MedicalDevices/Safety/

AlertsandNotices/ucm224025.htm. Accessed January 17, 2018.

CDC Clinical Reminder: “Use of Fingerstick Devices on More than One Person Poses Risk for

Transmitting Bloodborne Pathogens, (2010).” http://www.cdc.gov/injectionsafety/Fingerstick-

DevicesBGM.html. Accessed January 17, 2018.

Healthcare Infection Control Practices Advisory Committee (HICPAC), William A. Rutala, Ph.D., M.P.H.,

and David J. Weber, M.D., M.P.H. Centers for Disease Control and Prevention, 2008. “Guideline for

Disinfection and Sterilization in Healthcare Facilities.” Atlanta.

https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf. Accessed Jan 17, 2018.

1080_Guide Me_MANUAL_MASTER.indb 61

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Summary of Contents for Guide Me

Page 1: ...y Blood Glucose Meter This file may not print or view at 100 Die lines and color breaks do not print Holding Area text box and rules do not print Roche USA 1080 V1 1 Guide Me Manual Black 1080_Guide Me_MANUAL_MASTER indb 1 3 5 2018 1 27 39 PM ...

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Page 3: ... New System 7 Chapter 2 The Accu Chek FastClix Lancing Device 13 Chapter 3 Blood Glucose Tests 17 Chapter 4 Control Tests 25 Chapter 5 Review Your Data 31 Chapter 6 Wireless Communication Meter Pairing and Data Transfer 35 Chapter 7 Meter and Lancing Device Cleaning and Disinfecting 41 Chapter 8 Meter Maintenance and Troubleshooting 47 Chapter 9 Technical Information 55 Chapter 10 License and Warr...

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Page 5: ...f diabetes mellitus nor for neonatal use Alternative site testing should be done only during steady state times when glucose is not changing rapidly Accu Chek Guide control solutions are for use with the Accu Chek Guide Me Blood Glucose Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly The system includes Accu Chek Gu...

Page 6: ...hrough Friday between 8 00 am and 8 00 pm eastern standard time EST We offer assistance in many languages You can also visit accu chek com for diabetes management tools and product demonstrations Please register your meter online at accu chek com register so you receive the best customer service possible in addition to product updates About Testing Yourself or Others w WARNING DO NOT CHANGE YOUR T...

Page 7: ...e meter and lancing device should be cleaned and disinfected prior to use by the second person Disinfect the meter and lancing device before allowing anyone else to handle them Do not allow anyone else to test with the meter or lancing device It is important to keep the meter and lancing device clean and disinfected For instructions on how to clean and disinfect the meter and lancing device see th...

Page 8: ...the test strips and control solutions It is very important to follow the instructions in order to avoid an incorrect test result that leads to improper therapy Inspect the test strip container before using the test strips for the first time If you see any damage to the container cap or if anything prevents the cap from closing properly do not use the test strips Contact the Accu Chek Customer Care...

Page 9: ... scroll through test results 4 Right Arrow Button Press to enter memory adjust settings and scroll through averages 5 Test Strip Slot Insert test strip here 6 Battery Door Open to replace batteries 7 Micro USB Port Transfers data from meter to a computer PC The Accu Chek Guide Me Meter Chapter 1 Your New System Front View Back View Side View 1 2 3 5 4 6 7 1080_Guide Me_MANUAL_MASTER indb 7 3 5 201...

Page 10: ...meter 10 Test Strip Yellow Edge Touch blood drop or control solution here 11 Control Solution Bottle 12 Batteries 13 USB Cable Connects the meter to a PC Some items may not be included in the kit They are a separate purchase 8 9 13 12 11 10 1080_Guide Me_MANUAL_MASTER indb 8 3 5 2018 1 27 42 PM ...

Page 11: ...tion depth 3 Penetration Depth Indicator Points to depth setting 4 Lever Advance to a new lancet 5 Lancet Counter Window Shows number of available lancets 6 Release Button Press to prime and prick 7 Lancet Drum Contains 6 lancets 1 2 7 5 6 4 3 NOTE Some items may be sold separately 1080_Guide Me_MANUAL_MASTER indb 9 3 5 2018 1 27 42 PM ...

Page 12: ... set button Turn the meter on or off Navigate to an option or set a selection Check the meter display Press and release With the meter off press and hold to see the complete meter display If one of the segments is missing or looks different from this picture do not use the meter Contact the Accu Chek Customer Care Service Center at 1 800 858 8072 right arrow and left arrow buttons Adjust settings ...

Page 13: ... average of your blood glucose results Bluetooth symbol Control bottle symbol Drop symbol Hourglass symbol Low battery symbol No data to display Pairing symbol A flashing symbol indicates the meter is attempting to pair with a device A solid symbol indicates the meter pairing was successful Temperature warning symbol Test strip symbol A flashing symbol indicates the meter is ready for you to inser...

Page 14: ...ol appears Insert a test strip to perform a test 2 3 Setting the Time and Date The meter prompts you to set the time and date the first time you turn the meter on or if an error occurs NOTE Press and hold at any time until the flashing test strip symbol appears to perform a test The time and date on the meter synchronizes to the time and date on the paired device each time the meter sends data to ...

Page 15: ...e end You cannot reuse a used lancet drum Do not remove the lancet drum until you have used all 6 lancets The penetration depth indicator on the comfort dial shows the current depth setting The higher the number the deeper the penetration The best depth setting is the lowest number that lets you get enough blood for a test Try different depth settings to find the one that is right for you For soft...

Page 16: ...he lancet counter shows a number 6 meaning you have 6 new lancets remaining 3 NOTE Once the lancet drum is inserted into the lancing device do not remove the lancet drum until completely used The lancet drum cannot be reused once it has been removed from the lancing device WARNING You must not insert the lancet drum into the lancing device and simultaneously press the release button or hold the la...

Page 17: ...nnot go back to a used lancet NEVER reuse a lancet NEVER share your lancing device with anyone Using the Accu Chek FastClix Lancing Device Adjust the lancet depth by turning the comfort dial 1 Obtain a blood drop See the chapter Blood Glucose Tests 2 Advance to the next lancet by sliding the lever forward and back all the way The number in the lancet counter decreases by 1 The lancet counter windo...

Page 18: ...en used Throw the old lancet drum away Always discard according to local regulations 1 2 Insert a new lancet drum white end first until it clicks firmly into place Slide the cap back on until it stops by aligning the notch on the cap with the notch on the lancing device 3 Changing the Lancet Drum When you have used the sixth and last lancet change the lancet drum 1080_Guide Me_MANUAL_MASTER indb 1...

Page 19: ...either mg dL or mmol L The back label of the meter shows the unit of measurement If the meter shows the wrong unit contact the Accu Chek Customer Care Service Center at 1 800 858 8072 The correct unit of measure in the US is mg dL If you do not know which unit of measurement is correct for you contact your healthcare professional Using the wrong unit of measurement may cause misinterpretation of y...

Page 20: ...ast the Use By date printed on the test strip container If the Use By date is missing or cannot be read do not use the test strips Contact the Accu Chek Customer Care Service Center at 1 800 858 8072 Refer to the test strip package insert for test strip storage and system operating conditions Do not remove test strips from the test strip container and put them into another container such as a plas...

Page 21: ...at the beginning of this manual NOTE Before you perform your first blood glucose test set the meter time and date You need the meter a test strip and a lancing device with a lancet drum loaded to perform a blood glucose test A blood glucose test cannot be performed while the meter is connected to a PC with a USB cable The meter turns off 90 seconds after a successful test or 15 seconds after the t...

Page 22: ...lashing drop symbol appears obtain a blood drop Press the lancing device firmly against the side of your fingertip Press the release button all the way down to prick your finger 6 7 Remove a test strip from the test strip container Close the cap tightly 4 FPO 1080_Guide Me_MANUAL_MASTER indb 20 3 5 2018 1 27 50 PM ...

Page 23: ...he way Wash hands with soap and water and dry thoroughly 10 11 12 Gently squeeze your finger to assist the blood flow This helps you get a blood drop 8 Touch the yellow edge of the test strip to the blood drop Remove your finger from the test strip when the flashing appears Do not put blood on top of the test strip 9 1080_Guide Me_MANUAL_MASTER indb 21 3 5 2018 1 27 51 PM ...

Page 24: ...ges faster in your fingertip than in the alternative sites These differences may cause you to misinterpret your actual blood glucose level leading to improper therapy and potential adverse health effects Read the next section before you try testing from alternative sites You may perform a palm or upper arm test immediately before a meal while fasting You may NOT perform a palm or upper arm test up...

Page 25: ...ur healthcare professional s instructions or contact your healthcare professional immediately NOTE Always follow your healthcare professional s instructions For example if your healthcare professional has advised you to immediately treat a low blood glucose result such as by eating something then do that first WARNING Do not change your treatment because of one blood glucose result NEVER ignore sy...

Page 26: ...ou feel follow the steps in the Unusual Blood Glucose Results section of this chapter Comparing Your Meter Result to a Laboratory Result A common question is how the blood glucose results on the meter compare to the laboratory results Your blood glucose can change quickly especially after eating taking medication or physical activity If you test yourself in the morning then go to your healthcare p...

Page 27: ...use Write the date you open the control solution bottle on the bottle label The control solution must be discarded 3 months from the date the control solution bottle was opened discard date or on the Use By date on the bottle label whichever comes first Do not use control solution that is past the Use By or discard date Refer to the control solution package insert for control solution storage cond...

Page 28: ...d on the test strip container label The meter turns off 90 seconds after a successful test or 15 seconds after the test strip is removed provided no other action is taken You need the meter a test strip and control solution Level 1 or Level 2 Check the Use By date on the test strip container Do not use test strips past the Use By date Remove a test strip from the test strip container Close the cap...

Page 29: ...ue Squeeze the bottle until a tiny drop forms at the tip 5 Touch the drop to the yellow edge of the test strip Do not put control solution on top of the test strip 6 Insert the metallic end of the test strip into the meter Place the meter on a flat surface 3 The meter turns on A flashing drop symbol appears 1080_Guide Me_MANUAL_MASTER indb 27 3 5 2018 1 27 52 PM ...

Page 30: ... 10 9 or Err appears if the control result is out of range The control result the bottle symbol and the flashing L1 or L2 appear on the display Press to confirm the control level you tested 8 or A flashing appears when there is enough control solution in the test strip 7 Press the or to alternate between L1 and L2 1080_Guide Me_MANUAL_MASTER indb 28 3 5 2018 1 27 53 PM ...

Page 31: ...ip and a fresh drop of control solution Were the caps on the test strip container and the control solution bottle always closed tightly Replace the test strips or control solution if you think either was uncapped for some time Repeat the control test Was the test strip used immediately after it was removed from the test strip container Repeat the control test with a new test strip and a fresh drop...

Page 32: ...30 Control Tests 4 1080_Guide Me_MANUAL_MASTER indb 30 3 5 2018 1 27 53 PM ...

Page 33: ... viewed on the meter To view stored control results transfer them to compatible software Once 30 control results are in memory adding a new control result deletes the oldest control result Control results are not included in the 7 14 30 or 90 day averages w WARNING Do not change your therapy based on an individual test result in memory Talk to your healthcare professional before changing therapy b...

Page 34: ... stored blood glucose result appears on the display Press to view previous test results from newest to oldest 1 2 Reviewing Blood Glucose Results in Memory NOTE scrolls from newest to oldest test result scrolls from oldest to newest test result memory memory 1080_Guide Me_MANUAL_MASTER indb 32 3 5 2018 1 27 54 PM ...

Page 35: ...ay press The 7 day average appears on the display Press to scroll through 7 14 30 and 90 day averages The number of test results in the average n Press to scroll back from 90 30 14 and 7 day averages To return to the most recent blood glucose result press from the 7 day average screen 1 2 3 Viewing 7 14 30 and 90 day Averages memory memory memory 1080_Guide Me_MANUAL_MASTER indb 33 3 5 2018 1 27 5...

Page 36: ...34 Review Your Data 5 1080_Guide Me_MANUAL_MASTER indb 34 3 5 2018 1 27 55 PM ...

Page 37: ...evice Chapter 6 Wireless Communication Meter Pairing and Data Transfer Pairing The meter can only pair with 1 device at a time Pairing with a second device overwrites the first pairing The meter and the device to be paired should be within 3 feet of each other On Your Mobile Device Ensure Bluetooth is on and open the diabetes management app 1 On Your Meter With meter off press and hold and at the ...

Page 38: ...s once you are prompted to enter the PIN 3 NOTE The meter has time and date auto sync capability when paired with a mobile device that will update the meter time and date automatically Even if you use your meter in multiple time zones results are stored from newest to oldest and not by time and date Transferring Data Wirelessly If the meter is paired with a mobile device and Bluetooth is on your t...

Page 39: ...oth off to disable wireless communication flight mode Turning Bluetooth off will not unpair your meter With the meter off press or The last stored test result appears on the display 1 Press and hold until the Bluetooth symbol disappears 2 1080_Guide Me_MANUAL_MASTER indb 37 3 5 2018 1 27 58 PM ...

Page 40: ... off flight mode follow the steps below to turn it back on This will enable wireless communication with your mobile device With the meter off press or The last stored test result appears on the display 1 Press and hold until the Bluetooth symbol appears 2 1080_Guide Me_MANUAL_MASTER indb 38 3 5 2018 1 27 58 PM ...

Page 41: ... the small end of the USB cable into the meter 1 Plug the large end of the USB cable into a USB port on the PC If the meter is off it turns on 2 Start the diabetes management software on the PC and initiate a data transfer 3 The meter transfers the data to the software 4 NOTE The USB cable does not charge the meter s batteries Remove the USB cable after you have finished 1080_Guide Me_MANUAL_MASTE...

Page 42: ...40 Wireless Communication Meter Pairing and Data Transfer 6 1080_Guide Me_MANUAL_MASTER indb 40 3 5 2018 1 27 58 PM ...

Page 43: ... Sani Cloth EPA reg no 9480 4 Super Sani Cloth can be purchased from Amazon com Officedepot com and Walmart com Do not use any other cleaning or disinfecting solutions Using solutions other than the Super Sani Cloth could result in damage to the meter and lancing device The effect of using more than one product interchangeably to clean and disinfect the meter and lancing device has not been tested...

Page 44: ...least once per week and when blood is present on the surface of the meter Clean and disinfect the meter before allowing anyone else to handle the meter Do not allow anyone else to use the meter on themselves for testing purposes NOTE Using cleaning and disinfecting products could result in damage to the meter If you notice any of the following signs of deterioration after cleaning and disinfecting...

Page 45: ...ays use the same product for both cleaning and disinfecting Wash hands with soap and water and dry thoroughly Turn the meter off and wipe the entire meter surface with a Super Sani Cloth Carefully wipe around the test strip slot and other openings Make sure that no liquid enters any slot or opening A separate Super Sani Cloth should be used for cleaning and disinfection For disinfecting the meter ...

Page 46: ...44 Meter and Lancing Device Cleaning and Disinfecting 7 Wash hands with soap and water and dry thoroughly 4 1080_Guide Me_MANUAL_MASTER indb 44 3 5 2018 1 27 59 PM ...

Page 47: ...proved cleaning and disinfecting product on the cap Always remove the lancet drum before cleaning or disinfecting the lancing device Using cleaning and disinfecting products could result in damage to the lancing device If you notice any of the following signs of deterioration after cleaning and disinfecting your lancing device stop using your lancing device and contact the Accu Chek Customer Care ...

Page 48: ...or both cleaning and disinfecting Wash hands with soap and water and dry thoroughly Wash hands with soap and water and dry thoroughly Wipe the entire surface of the lancing device and the inside of the cap with a Super Sani Cloth A separate Super Sani Cloth should be used for cleaning and disinfection For disinfecting the lancing device use a new cloth and repeat step 2 making sure the surface sta...

Page 49: ...ing the tab in the direction of the arrow and pulling the door up 1 SN XXXXXXXXXXX PIN XXXXX xxxxxxx xxxxxxx xxxx x GTIN XXXXXXXXXXXXXX Remove the old batteries 2 Slide the new batteries under the black tabs with the side facing up Put the battery door back in place and snap it closed 3 NOTE If the E 7 or E 9 error code still appears on the display after you have changed the batteries remove the b...

Page 50: ...play is damaged Meter is defective Contact the Accu Chek Customer Care Service Center at 1 800 858 8072 Extreme temperatures Move the meter to a more temperate area Error Messages WARNING Never make therapy decisions based on an error message If you have any concerns or see any other error message contact the Accu Chek Customer Care Service Center at 1 800 858 8072 NOTE The error code and Err will...

Page 51: ...rm a blood glucose or control test OR remove the test strip and start a data transfer Blood glucose may be higher than the measuring range of the system See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests Blood glucose may be lower than the measuring range of the system See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests 1080_Guide Me_MANUA...

Page 52: ...test with a new test strip If the control result is not within the acceptable range see the Understanding Out of Range Control Results section in the chapter Control Tests This error could appear if the cap of the test strip container was not closed tightly The test strips may have been damaged due to improper storage or handling In rare cases an E 3 error code may indicate that your blood glucose...

Page 53: ...e to an area with the appropriate conditions and repeat the blood glucose or control test Do not artificially heat or cool the meter The error code and Err will alternate on the display Not enough blood or control solution was drawn into the test strip for measurement or was applied after the test had started Discard the test strip and repeat the blood glucose or control test The error code and Er...

Page 54: ...time until the flashing test strip symbol appears If time and date sync was not successful the meter prompts you to set them the next time you turn it on See the Setting the Time and Date section in the chapter Your New System The error code and Err will alternate on the display The batteries are almost out of power Change the batteries now If the message reappears after the batteries have been re...

Page 55: ...reinsert the test strip or repeat the blood glucose or control test with a new test strip If the error persists contact the Accu Chek Customer Care Service Center at 1 800 858 8072 The error code and Err will alternate on the display The test strip may be damaged Repeat the blood glucose or control test with a new test strip The error code and Err will alternate on the display Your blood sample ma...

Page 56: ...54 Meter Maintenance and Troubleshooting 8 1080_Guide Me_MANUAL_MASTER indb 54 3 5 2018 1 28 05 PM ...

Page 57: ...o the test strip package insert Meter storage conditions Temperature 13 158 F Memory capacity 720 blood glucose results and 30 control results with time and date Automatic off 90 seconds after performing a test 15 seconds after a test strip is removed Power supply Two 3 volt lithium batteries coin cell type CR2032 Display LCD Dimensions 76 x 48 x 16 mm LWH Weight Approx 40 g with batteries Constru...

Page 58: ...power of 0 dBm 1 mW Bluetooth Wireless Technology The meter uses Bluetooth low energy wireless technology to communicate and transfer information Bluetooth wireless technology is a form of radio frequency RF technology that operates in the unlicensed industrial scientific and medical band at 2 4 to 2 485 GHz The RF channel utilized for communication between the meter and other devices such as a sm...

Page 59: ... with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation Changes or modifications not expressly approved by the party responsible for compliance i e the manufacturer could void the user s authority to operate t...

Page 60: ...lude the Blood Glucose specification for Bluetooth low energy technology Bluetooth SIG Glucose Profile Version 1 0 and Bluetooth SIG Glucose Service Version 1 1 Product Safety Information w WARNING This meter meets IEC 61010 1 IEC61010 2 101 and IEC 609501 1 safety standards Strong electromagnetic fields may interfere with the proper operation of the meter Do not use the meter close to sources of ...

Page 61: ...isposal of sharps and or contaminated products Contact your local health department or other appropriate authorities for proper handling and disposal of used meters used test strips used lancets and used batteries Consider the following points when discarding used testing materials Consider recycling the meters and batteries at an appropriate facility Be aware the meter is potentially hazardous el...

Page 62: ...structions for the Accu Chek Guide Me meter Caution refer to safety related notes in the instructions for use accompanying this product FCC ID WX3 801 This device complies with Part 15 of the FCC Rules Global Trade Item Number Serial number 3 volt coin cell type CR2032 1080_Guide Me_MANUAL_MASTER indb 60 3 5 2018 1 28 06 PM ...

Page 63: ...y AlertsandNotices ucm224025 htm Accessed January 17 2018 2 CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html Accessed January 17 2018 3 Healthcare Infection Control Practices Advisory Committee HICPAC William A Rutala Ph D M P H and David J Weber M D M P H Cent...

Page 64: ...62 Technical Information 9 1080_Guide Me_MANUAL_MASTER indb 62 3 5 2018 1 28 06 PM ...

Page 65: ...rranty on the replacement meter will expire on the date of the original warranty expiration or 90 days after the shipment of a replacement system whichever period is longer The purchaser s exclusive remedy with respect to the Accu Chek Guide Me meter shall be replacement This warranty does not apply to the performance of an Accu Chek Guide Me meter that has been damaged by accident or has been alt...

Page 66: ...ervice Instructions All requests for return of Accu Chek Guide Me meters under the above warranty or service policy must be made to the Accu Chek Customer Care Service Center You will be mailed a return authorization label which must be affixed to your carton for shipping the system to Roche Cartons received without this label will be returned to you at your expense Customers experiencing difficul...

Page 67: ...sed with the Accu Chek Guide test strips Accu Chek Guide test strips are specifically manufactured for operation with the Accu Chek Guide Me meter Use of other test strips supplied by another manufacturer may prevent or impair the proper function of the Accu Chek Guide Me system Using the Accu Chek Guide Me system indicates your acceptance of the restricted license to use the Accu Chek Guide Me sy...

Page 68: ...66 License and Warranty 10 1080_Guide Me_MANUAL_MASTER indb 66 3 5 2018 1 28 06 PM ...

Page 69: ...mia 24 L lancet drum changing 16 lancet drum inserting 14 lancing device cleaning and disinfecting 45 lancing device using 15 low blood glucose 24 M maintenance meter 48 memory 32 meter cleaning and disinfecting 42 P pairing 35 product limitations 55 product specifications 55 S safety information 3 supplies 61 symbols explanation of 60 meter display 11 symptoms hypoglycemia hyperclycemia 24 T tech...

Page 70: ...68 Index 1080_Guide Me_MANUAL_MASTER indb 68 3 5 2018 1 28 06 PM ...

Page 71: ...1080_Guide Me_MANUAL_MASTER indb 69 3 5 2018 1 28 06 PM ...

Page 72: ... marks of the Continua Health Alliance CONTINUA is a registered trademark in some but not all countries in which this product is distributed The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG Inc and any use of such marks by Roche is under license All other product names and trademarks are the property of their respective owners 2018 Roche Diabetes Care 1080_No_PN 1...

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