Accu-Chek Guide Me User Manual
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Accu-Chek Guide Me User Manual

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User's Manual
for Single Patient Use Only
Blood Glucose Meter
1080_Guide Me_MANUAL_MASTER.indb 1
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.
3/5/2018 1:27:39 PM
Roche USA – 1080
V1/1 – Guide Me Manual –
Black

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Summary of Contents for Accu-Chek Guide Me

  • Page 1 Die lines and color breaks do not print. “Holding Area” text, box and rules do not print. User’s Manual for Single Patient Use Only Roche USA – 1080 Blood Glucose Meter V1/1 – Guide Me Manual – Black 1080_Guide Me_MANUAL_MASTER.indb 1 3/5/2018 1:27:39 PM...
  • Page 2 1080_Guide Me_MANUAL_MASTER.indb 2 3/5/2018 1:27:39 PM...

  • Page 3: Table Of Contents

    Contents Important Safety Information ....................3 Roche USA – 1080 Chapter 1: Your New System ....................7 V2/1 – Guide Me Manual – Black Chapter 2: The Accu-Chek FastClix Lancing Device ..............13 Chapter 3: Blood Glucose Tests .....................17 Roche USA – 1080 Chapter 4: Control Tests ......................25...
  • Page 4 1080_Guide Me_MANUAL_MASTER.indb 4 3/5/2018 1:27:39 PM...

  • Page 5: Important Safety Information

    The Accu-Chek Guide Me Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
  • Page 6 For questions, contact the Accu-Chek Customer Care Service Center toll-free at 1-800-858-8072. Hours of operation are Monday through 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.
  • Page 7 Important Safety Information w WARNING • During normal testing, any blood glucose meter or lancing device may come in contact with blood. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from bloodborne pathogens, even after you have performed cleaning and disinfecting.
  • Page 8 Contact the Accu-Chek Customer Care Service Center. Damaged test strips can cause inaccurate results, which could lead to improper therapy.

  • Page 9: Chapter 1: Your New System

    Chapter 1: Your New System Your New System The Accu-Chek Guide Me Meter Front View Back View Side View 1. Power/Set Button 5. Test Strip Slot Turns the meter on or off and sets Insert test strip here. options. 6. Battery Door 2.
  • Page 10 Your New System 8. Test Strip Container* 12. Batteries 9. Test Strip* – Metallic End 13. USB Cable* Insert this end into the meter. Connects the meter to a PC. 10. Test Strip* – Yellow Edge * Some items may not be included in the kit. Touch blood drop or control solution here.
  • Page 11 Your New System The Accu-Chek FastClix Lancing Device 1. Cap 4. Lever For fingertip testing. Advance to a new lancet. 2. Comfort Dial with Depth Selection 5. Lancet Counter Window Select penetration depth. Shows number of available lancets. 3. Penetration Depth Indicator 6.
  • Page 12 If one of the segments is missing or looks set-up different from this picture, do not use the meter. Contact the Accu-Chek Customer Care Service Center at 1-800-858-8072. memory Adjust settings for time and date, scroll Press and release or press and hold to through test results in memory.
  • Page 13 Your New System Symbols Symbol Description 7-day average symbol. This indicates that you are viewing the 7-day average of your blood glucose results. 14-day average symbol. This indicates that you are viewing the 14-day average of your blood glucose results. 30-day average symbol.
  • Page 14 Your New System 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. set-up set-up Set-up appears on the display Repeat steps 1 and 2 to set Press to set the hour and with the hour flashing.

  • Page 15: Chapter 2: The Accu-Chek Fastclix Lancing Device

    Chapter 2: The Accu-Chek FastClix Lancing Device The Accu-Chek FastClix Lancing Device Using the Accu-Chek FastClix Lancing Device • The black cap is for fingertip testing only. • Remember that the opening where the lancet comes out is not in the center of the cap.
  • Page 16 The Accu-Chek FastClix Lancing Device Inserting a Lancet Drum You must first load the lancet drum into the lancing device to get it ready for use. Remove the cap. Slide the cap on until it stops by You are now ready to use the aligning the notch on the cap first lancet.
  • Page 17 The Accu-Chek FastClix Lancing Device Using the Accu-Chek FastClix Lancing Device Using the Accu-Chek FastClix Lancing Device Obtain a blood drop. See the Obtain a blood drop. See the chapter Blood Glucose Tests. chapter Blood Glucose Tests. Adjust the lancet depth by Adjust the lancet depth by turning the comfort dial.
  • Page 18 The Accu-Chek FastClix Lancing Device Changing the Lancet Drum When you have used the sixth and last lancet, change the lancet drum. Remove the cap. Hold the lancet drum between your thumb and index finger and pull it straight out.

  • Page 19: Chapter 3: Blood Glucose Tests

    • Blood glucose results can be displayed in 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.
  • Page 20 • Discard the test strips if they are past 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.
  • Page 21 Blood Glucose Tests Performing a Blood Glucose Test with Blood from Your Fingertip Refer to the Important Safety Information section at the beginning of this manual. NOTE • Before you perform your first blood glucose test, set the meter time and date. •...
  • Page 22 Blood Glucose Tests Remove a test strip from the Insert the metallic end of the test strip container. test strip into the meter. The meter turns on. Close the cap tightly. When the flashing drop symbol Press the lancing device firmly appears, obtain a blood drop.
  • Page 23 Blood Glucose Tests Gently squeeze your finger to Touch the yellow edge of the test strip to the blood drop. Remove assist the blood flow. This helps your finger from the test strip when the flashing appears. Do not you get a blood drop. put blood on top of the test strip.
  • Page 24 • if you sometimes do not notice when your blood glucose is low. If you are interested in AST, talk to your healthcare professional first. To obtain an AST cap and detailed AST instructions, contact the Accu-Chek Customer Care Service Center at 1-800-858-8072.

  • Page 25: Unusual Blood Glucose Results

    Blood Glucose Tests Unusual Blood Glucose Results If your blood glucose result does not match how you feel, follow these steps: 1. Perform a control test. See the chapter Control Tests. 2. Repeat the blood glucose test. If your blood glucose result still does not match how you feel, follow your healthcare professional’s instructions or contact your healthcare professional immediately.
  • Page 26 Blood Glucose Tests Symptoms of Low or High Blood Glucose WARNING The meter is designed to provide a numerical value for blood glucose in the range of 20–600 mg/dL. Being aware of the symptoms of low or high blood glucose can help you understand your test results and decide what to do if they seem unusual.

  • Page 27: Chapter 4: Control Tests

    • you want to check if you are performing the test correctly. About the Control Solutions • Use only Accu-Chek Guide control solutions. • Close the control solution bottle tightly after 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...
  • Page 28 Control Tests Performing a Control Test NOTE • Most people just test the Level 1 control. If you wish, you can also test a Level 2 control. A set of Level 1 and Level 2 control solutions is available for purchase. • The ranges for Level 1 and Level 2 controls are printed on the test strip container label. •...
  • Page 29 Control Tests Insert the metallic end of The meter turns on. the test strip into the meter. A flashing drop symbol Place the meter on a flat appears. surface. Select the control solution to Remove the bottle cap. Wipe Touch the drop to the yellow edge of the test strip.
  • Page 30 Control Tests The control result, the bottle symbol, and the flashing L1 or L2 A flashing appears when appear on the display. Press to confirm the control level you there is enough control tested. solution in the test strip. Press the to alternate between L1 and L2.
  • Page 31 1 or 2, when you performed the compare the control result to the range printed on the test test? strip container. Are you still unsure of the problem? Contact the Accu-Chek Customer Care Service Center at 1-800-858-8072. 1080_Guide Me_MANUAL_MASTER.indb 29 3/5/2018 1:27:53 PM...
  • Page 32 Control Tests 1080_Guide Me_MANUAL_MASTER.indb 30 3/5/2018 1:27:53 PM...

  • Page 33: Chapter 5: Review Your Data

    Chapter 5: Review Your Data Review Your Data Overview • The meter automatically stores up to 720 blood glucose results in memory with the time and date of the test. • Once 720 blood glucose results are in memory, adding a new blood glucose result deletes the oldest blood glucose result.
  • Page 34 Review Your Data Reviewing Blood Glucose Results in Memory memory memory With the meter off, press Press to view previous to view blood glucose test results from newest to results stored in memory. oldest. The most recent stored blood glucose result appears on the display.
  • Page 35 Review Your Data Viewing 7, 14, 30, and 90-day Averages memory memory memory With the most recent test With the meter off, press Press to scroll through 7, result on the display, to view blood glucose 14, 30, and 90-day averages. press ...
  • Page 36 Review Your Data 1080_Guide Me_MANUAL_MASTER.indb 34 3/5/2018 1:27:55 PM...

  • Page 37: Chapter 6: Wireless Communication, Meter Pairing, And Data Transfer

    Chapter 6: Wireless Communication, Meter Pairing, and Data Transfer Wireless Communication, Meter Pairing, and Data Transfer Overview The process of creating a connection between the meter and the mobile device is called pairing. You will need an application on your mobile device that can accept the meter’s data. You can use this application to wirelessly and automatically synchronize your diabetes information between the meter and the mobile device.
  • Page 38 Wireless Communication, Meter Pairing, and Data Transfer On Your Meter On Your Mobile Device Within the app, follow the instructions and select your meter. When prompted, enter the meter’s 6-digit PIN. The meter times out after 30 seconds once you are prompted to enter the PIN.
  • Page 39 Wireless Communication, Meter Pairing, and Data Transfer Turning Bluetooth Off Turn Bluetooth off to disable wireless communication (flight mode). Turning Bluetooth off will not unpair your meter. With the meter off, press Press and hold until the   or  . The last stored Bluetooth symbol disappears.
  • Page 40 Wireless Communication, Meter Pairing, and Data Transfer Turning Bluetooth On If you have turned Bluetooth 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 Press and hold until the  ...
  • Page 41 Wireless Communication, Meter Pairing, and Data Transfer Transferring Data Using a USB Cable This feature allows you to transfer data from your meter to special software for diabetes management on a PC using a USB cable. Start the diabetes management software on the PC and initiate a data transfer.
  • Page 42 Wireless Communication, Meter Pairing, and Data Transfer 1080_Guide Me_MANUAL_MASTER.indb 40 3/5/2018 1:27:58 PM...

  • Page 43: Chapter 7: Meter And Lancing Device Cleaning And Disinfecting

    Chapter 7: Meter and Lancing Device Cleaning and Disinfecting Meter and Lancing Device Cleaning and Disinfecting What is the difference between cleaning and disinfecting? Cleaning is the removal of dirt from the meter or lancing device. Disinfecting is the removal of most, but not all, disease-causing and other types of microorganisms (bloodborne pathogens) from the meter or lancing device.

  • Page 44: Cleaning And Disinfecting The Meter

    Meter and Lancing Device Cleaning and Disinfecting NOTE For technical assistance or questions on cleaning and disinfecting, contact the Accu-Chek Customer Care Service Center at 1-800-858-8072. Cleaning and Disinfecting the Meter WARNING If the meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be cleaned and disinfected prior to use by the second person.
  • Page 45 Meter and Lancing Device Cleaning and Disinfecting How to Clean and Disinfect the Meter WARNING Failure to follow these instructions will damage the meter and stop it from working properly. • DO NOT clean or disinfect the meter while performing a blood glucose or control test.
  • Page 46 Meter and Lancing Device Cleaning and Disinfecting Wash hands with soap and water and dry thoroughly. 1080_Guide Me_MANUAL_MASTER.indb 44 3/5/2018 1:27:59 PM...

  • Page 47: Cleaning And Disinfecting The Lancing Device

    Accu-Chek Customer Care Service Center at 1-800-858-8072: residue around buttons, difficulty in priming the device, difficulty in inserting the lancet drum.
  • Page 48 Meter and Lancing Device Cleaning and Disinfecting How to Clean and Disinfect the Lancing Device WARNING Failure to follow these instructions may damage the lancing device and stop it from working properly. • DO NOT get any moisture into any openings. •...

  • Page 49: Chapter 8: Meter Maintenance And Troubleshooting

    If you have problems with the meter or think the results are not accurate, perform a control test with an unexpired test strip and control solution. If the control result is not within the acceptable range, contact the Accu-Chek Customer Care Service Center at 1-800-858-8072. Changing the Batteries...
  • Page 50 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 alternate on the display for all coded error messages (E-1 through E 14).
  • Page 51 Meter Maintenance and Troubleshooting The meter is connected to a PC The meter was unable to pair and a blood glucose or control with a mobile device. test cannot be performed. Retry the pairing. EITHER remove the USB cable and perform a blood glucose or control test OR remove the test strip and start a data transfer.
  • Page 52 Meter Maintenance and Troubleshooting (The error code and Err will alternate on the display.) (The error code and Err will alternate on the display.) A meter or test strip error has occurred. The test strip may be damaged, Repeat the blood glucose test. If a second E-3 code appears, not properly inserted, or was perform a control test with the control solution and a new previously used.
  • Page 53 Meter Maintenance and Troubleshooting (The error code and Err will alternate on the display.) (The error code and Err will alternate on the display.) Not enough blood or control solution was drawn Blood or control solution was applied to the test into the test strip for measurement or was strip before the flashing drop symbol appeared applied after the test had started.
  • Page 54 Meter Maintenance and Troubleshooting (The error code and Err will alternate on the display.) (The error code and Err will alternate on the display.) The batteries are almost out of power. The time and date setting may be incorrect. A flashing wave symbol appears while the meter Change the batteries now.
  • Page 55 Fluid or foreign material may be present in the An electronic error has occurred. test strip slot. Contact the Accu-Chek Customer Care Service Remove and reinsert the test strip or repeat Center at 1-800-858-8072. the blood glucose or control test with a new test strip.
  • Page 56 Meter Maintenance and Troubleshooting 1080_Guide Me_MANUAL_MASTER.indb 54 3/5/2018 1:28:05 PM...

  • Page 57: Chapter 9: Technical Information

    Chapter 9: Technical Information Technical Information Product Limitations See the literature packaged with the test strips and control solutions for the latest information on product specifications and limitations. Specifications Blood volume Refer to the test strip package insert. Sample type Measuring time Measuring range Test strip storage conditions...

  • Page 58: Technical Information

    Technical Information Specifications Meter type The Accu-Chek Guide Me meter is suitable for continuous operation. Control solution storage conditions Refer to the control solution package insert. Interfaces USB: micro-B connector; Bluetooth low energy; Continua Certified to a Continua Certified manager.
  • Page 59 Technical Information Electromagnetic Compatibility – The meter meets the electromagnetic emission requirements as per EN 61326-2-6. Its electromagnetic emission is thus low. Interference on other electrically-driven EN ISO 15197. The chosen basis for electrostatic discharge immunity testing was basic standard equipment is not anticipated.
  • Page 60 Performance Analysis – Refer to the test strip package insert. Test Principle – Refer to the test strip package insert. Communication Protocol – The Accu-Chek Guide Me blood glucose meter is Continua Certified. Continua Certified signifies that this product complies with applicable IEEE 11073-10417 standards and that it has been tested and certified against the 2016 Continua Design Guidelines which include the Blood Glucose specification for Bluetooth low energy technology, Bluetooth SIG, Glucose Profile Version 1.0 and...
  • Page 61 Technical Information Discarding the Meter, Test Strips, Lancing Devices, Lancets, and Batteries w WARNING • Any product coming in contact with blood is considered contaminated (potentially infectious).* • During normal testing, any blood glucose meter may come in contact with blood. •...
  • Page 62 Technical Information Explanation of Symbols These symbols may appear on the packaging, on the type plate, and in the instructions for the Accu-Chek Guide Me meter. Caution, refer to safety-related notes in the instructions for use accompanying this product. This device complies with Part 15 of the FCC Rules.
  • Page 63 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).
  • Page 64 Technical Information 1080_Guide Me_MANUAL_MASTER.indb 62 3/5/2018 1:28:06 PM...

  • Page 65: Chapter 10: License And Warranty

    Accu-Chek Guide Me Meter Limited 3-Year Warranty Roche warrants to the original purchaser of the meter that your Accu-Chek Guide Me meter will be free from defects in materials and workmanship for three years from the date of purchase. If, during this 3-year period, the meter does not work properly because of a defect in materials or workmanship, Roche will replace it with a new Accu-Chek Guide Me meter or equivalent product free of charge.
  • Page 66 Warranty and Service 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.

  • Page 67: Limited License

    Using the Accu-Chek Guide Me system indicates your acceptance of the restricted license to use the Accu-Chek Guide Me system only with Accu-Chek Guide test strips. If you do not agree to the terms and conditions of the restricted license, you may return, at the place of purchase, the unused Accu-Chek Guide Me system for a full refund.
  • Page 68 License and Warranty 1080_Guide Me_MANUAL_MASTER.indb 66 3/5/2018 1:28:06 PM...

  • Page 69: Index

    Index Index alternative site testing 22 maintenance, meter 48 averages, reviewing 33 memory 32 meter, cleaning and disinfecting 42 batteries, changing 47 battery type 47, 55 pairing 35 blood glucose results, unusual 23 product limitations 55 blood glucose test, performing 19 product specifications 55 blood glucose, warning 24, 49 button, functions 7, 10...
  • Page 70 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 Indianapolis, IN 46256 www.accu-chek.com ACCU-CHEK, ACCU-CHEK GUIDE, ACCU-CHEK GUIDE ME, and FASTCLIX are trademarks of Roche. CONTINUA, the CONTINUA logos and CONTINUA CERTIFIED are trademarks, service marks, or certification marks of the Continua Health Alliance. CONTINUA is a registered trademark in some, but not all, countries in which this product is distributed.

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