Roche Diabetes Care 126 blood glucose meter User Manual UserManual newTeil4
Roche Diagnostics Operations, Inc. blood glucose meter UserManual newTeil4
Contents
- 1. UserManual_newTeil1.pdf
- 2. UserManual_newTeil2.pdf
- 3. UserManual_newTeil3.pdf
- 4. UserManual_newTeil4.pdf
UserManual_newTeil4.pdf
Wireless Communication and Meter Pairing Default Device Default Device If more than 1 device is paired, select the default paired device for the Auto‑Send and Sync Time features. Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press . Press Press Press to highlight Default Device. Press . A list of paired devices appears. Press to highlight the device you want as the default device. to highlight Wireless. Press to move Press to set the option and return to the previous menu. to the option. 85 52926_07414587001_EN.indb 85 6/2/16 2:53 PM 7 Wireless Communication and Meter Pairing Auto-Send Auto-Send Select whether data is automatically sent to the default paired device after each test. Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press . Press Press to highlight Wireless. Press to highlight Auto‑Send. Press . to highlight On or Off. Press Press option. or to move Press to set the option and return to the previous menu. to the 86 52926_07414587001_EN.indb 86 6/2/16 2:53 PM Wireless Communication and Meter Pairing Sync Time Sync Time Select whether to synchronize the time and date to the default paired device. Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press . Press Press to highlight Wireless. Press to highlight Sync Time. Press . Press or or Off. Press the option. to highlight On to move to Press to set the option and return to the previous menu. 87 52926_07414587001_EN.indb 87 6/2/16 2:53 PM 7 Wireless Communication and Meter Pairing Pairing Additional Devices Pairing Additional Devices This procedure is to add another paired device (assumes there is already 1 paired device). You can pair 5 devices. If you have 5 paired devices, you must delete a pairing before you can add another device. The device you choose remains the default until you change it. Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press . Press Press to highlight Wireless. Press Press to highlight Pairing. 88 52926_07414587001_EN.indb 88 6/2/16 2:53 PM Wireless Communication and Meter Pairing Pairing Additional Devices Press or to highlight Pair Device. Press . If there are less than 5 paired devices: Pair Device appears. Proceed to Step 5. If there are already 5 paired devices: Maximum paired devices appears. You must delete a paired device before you can proceed to Step 5. Press or to highlight Yes. Press . Prepare the other device for pairing. Refer to the other device’s instructions for information about pairing. The meter displays its code. or to highlight the Press device to delete. Press . Proceed to Step 5. The mobile device displays a list of found devices, including the meter. Select the meter from the list. When prompted, enter the code displayed on the meter from Step 6 into the device to be paired. 89 52926_07414587001_EN.indb 89 6/2/16 2:53 PM 7 Wireless Communication and Meter Pairing Pairing Additional Devices When pairing is complete, and the name of the paired device appear. Press . If there is more than 1 paired device, the meter asks if you want the new device to be the default device. Press or to highlight No or Yes. Press to set the option and return to Pairing. Press to return to the previous menu. 90 52926_07414587001_EN.indb 90 6/2/16 2:53 PM Wireless Communication and Meter Pairing Delete Pairing Delete Pairing This procedure is to delete a paired device (assumes there is at least 1 paired device). You can pair 5 devices. If you have 5 paired devices, you must delete a pairing before you pair to another device. The device you choose remains the default until you change it. Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press . Press Press to highlight Wireless. Press Press to highlight Pairing. 91 52926_07414587001_EN.indb 91 6/2/16 2:53 PM 7 Wireless Communication and Meter Pairing Delete Pairing Press or to highlight Delete Pairing. Press . Press or to highlight the device to delete. Press to set the option. 92 52926_07414587001_EN.indb 92 6/2/16 2:53 PM Wireless Communication and Meter Pairing Delete Pairing If the selected device is not the default device: If the selected device is the default device: The pairing is deleted. The name of the deleted device and appear. The meter prompts you to select a new default device. If there is only 1 device remaining, it becomes the default device. The list of paired devices appears. Highlight the new default device and press .The name of the deleted device and appear, along with the new default device. 93 52926_07414587001_EN.indb 93 6/2/16 2:53 PM 7 Wireless Communication and Meter Pairing 94 52926_07414587001_EN.indb 94 6/2/16 2:53 PM Chapter 8: 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.3 Disinfecting is the removal of most, but not all, disease‑causing and other types of microorganisms (bloodborne pathogens) from the meter or lancing device.3 Approved Cleaning and Disinfecting Product The following product has been approved for cleaning and disinfecting the meter and lancing device: Super 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. Always use Super Sani‑Cloth to clean and disinfect the meter and lancing device. • Roche has demonstrated that the product is good for 5-year use, after testing in a total of 260 disinfection cycles (equal to cleaning and disinfecting once per week for 5 years). *Environmental Protection Agency 95 52926_07414587001_EN.indb 95 6/2/16 2:53 PM 8 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. To clean and disinfect without damaging the meter, follow these procedures carefully. When to Clean and Disinfect the Meter • Clean the meter to remove visible dirt or other material prior to disinfecting. • Clean and disinfect the meter at 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 your meter, stop using your meter and contact the Accu-Chek Customer Care Service Center at 1‑800‑858‑8072: residue around buttons, clouding of display, button malfunction, out‑of‑range control results. What to Clean and Disinfect The following parts of the meter should be cleaned and disinfected: • The area around slots and openings (do not get any moisture in slots or openings) • The meter display • The entire meter surface 96 52926_07414587001_EN.indb 96 6/2/16 2:53 PM 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. • DO NOT get any moisture in slots or openings. • DO NOT spray anything onto the meter. • DO NOT immerse the meter in liquid. • Always use the same product for both cleaning and disinfecting. Wash hands thoroughly with soap and water. 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. A separate Super Sani‑Cloth should be used for cleaning and disinfection. For disinfecting the meter, get a new cloth and repeat step 2, making sure the surface stays wet for 2 minutes. Make sure that no solution is seen in any slot or opening. Make sure that no liquid enters any slot or opening. 97 52926_07414587001_EN.indb 97 6/2/16 2:53 PM 8 Meter and Lancing Device Cleaning and Disinfecting Wash hands thoroughly with soap and water. 98 52926_07414587001_EN.indb 98 6/2/16 2:53 PM Meter and Lancing Device Cleaning and Disinfecting Cleaning and Disinfecting the Lancing Device To clean and disinfect without damaging the lancing device, follow these procedures carefully. When to Clean and Disinfect the Lancing Device • Clean the lancing device to remove visible dirt or other material prior to disinfecting. • Clean and disinfect the lancing device at least once per week to remove visible dirt or other material for safe handling. • Clean and disinfect the lancing device before allowing anyone else to handle the lancing device, for instance, if you have someone assisting you. Do not allow anyone else to use the lancing device. NOTE • Do not throw away the cap after each use. Use the approved 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 Service Center at 1‑800‑858‑8072: residue around buttons, difficulty in priming the device, difficulty in inserting the lancet drum. • You might observe a slight discoloration of the lancing device after multiple cleaning and disinfecting cycles. This does not affect the functionality of the lancing device. What to Clean and Disinfect The following parts of the lancing device should be cleaned and disinfected: • The entire lancing device surface • The cap 99 52926_07414587001_EN.indb 99 6/2/16 2:53 PM 8 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. • Always use the same product for both cleaning and disinfecting. Wash hands thoroughly with soap and water. 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 stays wet for 2 minutes. 100 52926_07414587001_EN.indb 100 6/2/16 2:53 PM Meter and Lancing Device Cleaning and Disinfecting Wash hands thoroughly with soap and water. 101 52926_07414587001_EN.indb 101 6/2/16 2:53 PM 8 Meter and Lancing Device Cleaning and Disinfecting 102 52926_07414587001_EN.indb 102 6/2/16 2:53 PM Chapter 9: Meter Maintenance and Troubleshooting Meter Maintenance and Troubleshooting Meter Maintenance The meter automatically tests its own systems every time you turn it on and lets you know if something is wrong. See the Error Messages section of this chapter. 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 Press Open the battery door on the back of the meter by pushing the tab in the direction of the arrow and pulling the door up. Release the old batteries by pressing the button. Remove the old batteries. Slide the new batteries under the black tabs and button, with the (+) side facing up. Put the battery door back in place and snap it closed. NOTE • The meter uses two 3‑volt lithium batteries, coin cell type CR2032. This type of battery can be found in many stores. It is a good idea to have spare batteries available. • Always replace both batteries at the same time and with the same brand. • The logbook data is saved when you replace the batteries. 103 52926_07414587001_EN.indb 103 6/2/16 2:53 PM Meter Maintenance and Troubleshooting Error Messages w 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. Error Messages The meter will not turn on or the display is blank. • Batteries are dead. Insert new batteries. • Display 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. The meter is connected to a PC and a test cannot be performed. EITHER remove the USB cable and perform a test OR remove the test strip and start a data transfer. The connection between the meter and PC was lost. Disconnect and reconnect the USB cable and retry the connection. Contact the Accu‑Chek Customer Care Service Center at 1-800-858-8072 if the connection is lost again. 104 52926_07414587001_EN.indb 104 6/2/16 2:53 PM Meter Maintenance and Troubleshooting There is no connection between the meter and PC. Connect the USB cable and retry the connection. Blood glucose results were not transferred to a paired device. Make sure the paired device is within range of the meter and turned on. Data could not be transferred from the meter to the PC. Check the PC or USB cable. Data cannot be sent to a paired device because the meter is in Flight Mode. Retry the data transfer when the meter is not in Flight Mode. One or more blood glucose test results are excluded from the selected averages because the results are invalid or outside the system measurement range. One or more blood glucose results are excluded from the selected target % data because the test results are invalid. 105 52926_07414587001_EN.indb 105 6/2/16 2:53 PM 9 Meter Maintenance and Troubleshooting One or more blood glucose results are excluded from the selected low/high data because the test results are invalid. The date entered is not valid. Enter the correct date. A meter setting was changed while in Flight Mode. The setting change will not take effect until Flight Mode is turned off. Pairing to a device cannot be performed while in Flight Mode. Retry pairing when the meter is not in Flight Mode. The blood glucose result has not been sent to the default paired device. The transfer is still pending. Place meter and paired device closer together. The meter was unable to pair with a device. Retry the pairing. 106 52926_07414587001_EN.indb 106 6/2/16 2:53 PM Meter Maintenance and Troubleshooting The test strip may be damaged, not properly inserted, or was previously used. Remove and reinsert the test strip or replace it if damaged or previously used. A meter or test strip error has occurred. Repeat the blood glucose test. If a second E-3 code appears, perform a control test with the control solution and a new test strip. • If the control result is within the acceptable range, review the proper testing procedure and repeat the blood glucose 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. In rare cases, an E-3 error code may indicate that your blood glucose is extremely high and above the system’s reading range. If you do not feel like your blood glucose is extremely high, repeat the blood glucose test. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests. If the E-3 code still appears for your blood glucose test, contact your healthcare professional immediately. 107 52926_07414587001_EN.indb 107 6/2/16 2:53 PM 9 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. Meter Maintenance and Troubleshooting Blood or control solution was applied to the test strip before Apply drop appeared. Discard the test strip and repeat the blood glucose or control test. The temperature is above or below the proper range for the system. Refer to the test strip package insert for system operating conditions. Move to an area with the appropriate conditions and repeat the blood glucose or control test. Do not artificially heat or cool the meter. An electronic error occurred. Remove the batteries, press and hold the Power/Set/OK button for at least 2 seconds, and reinsert the batteries. Perform a blood glucose or control test. The batteries are out of power. Change the batteries now. If the message reappears after the batteries have been replaced, remove the batteries, press and hold the Power/ Set/OK button for at least 2 seconds, then reinsert the batteries. 108 52926_07414587001_EN.indb 108 6/2/16 2:53 PM Meter Maintenance and Troubleshooting The time and date setting may be incorrect. Make sure the time and date are correct and adjust, if necessary. The test strip may be damaged. Retest with a new test strip. Fluid or foreign material may be present in the test strip slot. Remove and reinsert the test strip or repeat the blood glucose or control test with a new test strip. If the problem persists, contact the Accu‑Chek Customer Care Service Center at 1-800-858-8072. An electronic error has occurred. Contact the Accu‑Chek Customer Care Service Center at 1-800-858-8072. Your blood sample may contain a high level of ascorbate. Contact your healthcare professional. 109 52926_07414587001_EN.indb 109 6/2/16 2:53 PM 9 Meter Maintenance and Troubleshooting The meter time and date have been changed to match the paired device. There are no results in the Logbook. There is an invalid result in the Logbook. There are no test results in range for the selected data. 110 52926_07414587001_EN.indb 110 6/2/16 2:53 PM Meter Maintenance and Troubleshooting Target Ranges is Off and there are no results for the Target % data stored in the meter. Target Ranges is Off and there are no results for the low/high data stored in the meter. There are no results stored in the meter for the selected data. 111 52926_07414587001_EN.indb 111 6/2/16 2:53 PM 9 Meter Maintenance and Troubleshooting Patterns is On but there are no active patterns stored in the meter. Patterns is Off. Blood glucose may be higher than the measurement range of the system. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests. Blood glucose may be lower than the measurement range of the system. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests. 112 52926_07414587001_EN.indb 112 6/2/16 2:53 PM Chapter 10: Technical Information Technical Information 10 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 System operating conditions Meter storage conditions Memory capacity Automatic off Power supply Display Dimensions Weight Construction Protection class Meter type Control solution storage conditions Interfaces Radio frequency connectivity Temperature: -13–158 °F 720 blood glucose results and 32 control results with time and date 90 seconds Two 3‑volt lithium batteries (coin cell type CR2032) LCD 80 × 47 × 20 mm (LWH) Approx. 40 g (with batteries) Hand-held III The Accu‑Chek Guide meter is suitable for continuous operation. Refer to the control solution package insert. USB: micro-B connector; Bluetooth; Continua Certified® to a Continua Certified manager. Bluetooth low energy technology operating in the frequency band of 2402 MHz to 2480 MHz with a maximum transmitted power of 0 dBm (1 mW). 113 52926_07414587001_EN.indb 113 6/2/16 2:53 PM 10 Technical Information Bluetooth® Wireless Technology –The meter uses Bluetooth smart class II wireless technology to communicate and transfer information. Bluetooth wireless technology is a form or 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 smartphone, is not an open channel. The meter can only communicate with the device that 1. is Bluetooth smart, 2. it is paired with, and 3. has an application that can accept the meter’s data. This device complies with United States Federal Communication Commission (FCC) standards. The device complies with FCC Part 15 Rules. Operation of the device is subject to the following conditions: 1. This device may not cause harmful interference and 2. must accept any interference received, including interference that may cause undesired operation. Compliance with these guidelines means that under normal, daily circumstances, the device should not affect the operation of other devices. In addition, the device should operate normally in the presence of other devices. In the event there is interference from another device, it is recommended that you increase the distance between the meter and that device. You can also turn off the interfering device. In addition, you can turn off Bluetooth wireless technology on the meter. Changes or modifications to the device not expressly approved by Roche could void the user’s authority to operate the device. The device has been tested and found to comply with the limits for a Class B digital device. The device generates, uses, and can radiate radio frequency energy. 114 52926_07414587001_EN.indb 114 6/2/16 2:53 PM Technical Information 10 Electromagnetic Compatibility – This meter meets the electromagnetic immunity requirements as per EN ISO 15197. The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000-4-2. In addition, the meter meets the electromagnetic emissions requirements as per EN 61326. The meter’s electromagnetic emission is thus low. Interference from the meter to other electrically‑driven equipment is not anticipated. This device complies 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. This equipment complies with FCC and IC radiation exposure limits set forth for an uncontrolled environment. This equipment is in direct contact with the body of the user under normal operating conditions. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. NOTE This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. Changes or modifications not expressly approved by the party responsible for compliance (i.e. the manufacturer) could void the user’s authority to operate the equipment. 115 52926_07414587001_EN.indb 115 6/2/16 2:53 PM 10 Technical Information Performance Analysis – Refer to the test strip package insert. Test Principle – Refer to the test strip package insert. 116 52926_07414587001_EN.indb 116 6/2/16 2:53 PM Technical Information 10 Product Safety Information WARNING • This meter meets IEC 61010-1, IEC 61010-2-101 and IEC 60950-1 safety standards. • Strong electromagnetic fields may interfere with the proper operation of the meter. Do not use the meter close to sources of strong electromagnetic radiation. • To avoid electrostatic discharge, do not use the meter in a very dry environment, especially one in which synthetic materials are present. Travel Documentation If you are traveling on a commercial airline, you may be required to provide documentation certifying that this meter meets environmental conditions and test procedures for Airborne Equipment (RTCA DO‑160 ) section 21 Emission of Radio Frequency Energy. Visit accu‑chek.com or contact the Accu-Chek Customer Care Service Center at 1‑800‑858‑8072 to obtain a copy of the document. 117 52926_07414587001_EN.indb 117 6/2/16 2:53 PM 10 Technical Information Discarding the Meter, Test Strips, Lancing Devices, Lancets, and Batteries 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. • Lancing devices may also be considered sharps. Disposal of sharps is regulated by law in many jurisdictions. Roche is committed to recycling and sustainability. Comply with any laws or ordinances relating to the disposal 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 electronics scrap (e‑scrap) and should be disposed of accordingly. The batteries are potentially hazardous also and should be discarded accordingly. Disinfect the meter before recycling or discarding. *29 CFR 1910.1030 – Bloodborne pathogens 118 52926_07414587001_EN.indb 118 6/2/16 2:53 PM Technical Information 10 Explanation of Symbols Caution, refer to safety‑related notes in the instructions for use accompanying this product. Biological Risks – used meters carry a risk of infection. FCC ID: WX3-126 This device complies with Part 15 of the FCC Rules. Global Trade Item Number Serial number 3‑volt coin cell type CR2032 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://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm. Accessed March 20, 2012. 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 March 20, 2012. 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. 119 52926_07414587001_EN.indb 119 6/2/16 2:53 PM 10 Technical Information 120 52926_07414587001_EN.indb 120 6/2/16 2:53 PM Chapter 11: License and Warranty License and Warranty 11 Warranty Accu‑Chek Guide Meter 30‑day Money‑back Guarantee for Qualifying Consumers Roche offers qualifying consumers that purchase an Accu‑Chek Guide meter, a 30‑day money back guarantee. If you are not fully satisfied with your Accu‑Chek Guide meter, contact the Accu‑Chek Customer Care Service Center toll‑free at 1‑800‑858‑8072 to determine whether you qualify to receive a full refund within 30 days of purchase. If you are covered under Medicare, Medicaid, other federal/state programs, or private insurance you are NOT eligible for this money‑back offer. Consumers affected by this exclusion may instead request a different Accu‑Chek meter/system. The refund will be limited to the amount paid by you net of any rebates. You must have a copy of the dated itemized purchase receipt and the original packaging to obtain this refund. Accu‑Chek Guide Meter Limited 3‑Year Warranty Roche warrants to the original purchaser of the meter that your Accu‑Chek Guide 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 meter or equivalent product free of charge. The warranty 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 meter shall be replacement. This warranty does not apply to the performance of an Accu‑Chek Guide meter that has been damaged by accident or has been altered, misused, tampered with, or abused in any way. Roche will handle meters that show damage or abuse according to its Non‑Warranty Service Policy described on the following page. THE ABOVE WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES, AND ROCHE MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL ROCHE BE LIABLE TO THE PURCHASER OR ANY OTHER PERSON FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL, OR PUNITIVE DAMAGES ARISING FROM OR IN ANY WAY CONNECTED WITH THE PURCHASE OR OPERATION OF THE METER OR ITS PARTS. NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IF ANY IS IMPLIED FROM THE SALE OF THE METER, SHALL EXTEND FOR A LONGER DURATION THAN THREE YEARS FROM THE DATE OF PURCHASE. Some states do not allow limitations on how long an implied warranty will last or the exclusion of incidental or consequential damages, so the above limitation and exclusion may not apply to you. This warranty gives you specific legal rights, which vary from state to state. 121 52926_07414587001_EN.indb 121 6/2/16 2:53 PM 11 License and Warranty Non‑Warranty Service Policy Roche Non‑Warranty Service Policy applies to meters where the above warranty has not become effective, has become inapplicable, or has expired. Roche will replace, at its option, meters returned to it for a service charge (not to exceed $35). Replacement will be with the same or similar product. Replacement meters will be warranted for a period of 90 days from shipment under a limited warranty providing for replacement of parts and labor at no charge. Warranty and Service Instructions All requests for return of Accu‑Chek Guide 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 difficulties should review the troubleshooting information in Meter Maintenance and Troubleshooting of this manual. Further inquiries should be directed to the Accu‑Chek Customer Care Service Center. Be sure to fill out and mail the Warranty Card that comes with the Accu‑Chek Guide system. 122 52926_07414587001_EN.indb 122 6/2/16 2:53 PM License and Warranty 11 Limited License WARNING CAUTION – A RESTRICTED LICENSE LIMITS USE OF THE ACCU-CHEK GUIDE SYSTEM (meter and test strips) IN THE UNITED STATES – READ CAREFULLY THE LIMITATIONS RECITED BELOW. The Accu‑Chek Guide system (meter and test strips) and its use are protected by U.S. Patent Nos. 6,645,368 (expires 22‑December‑2017); 7,276,146 (expires 4‑October‑2022); 7,276,147 (expires 4‑October‑2022); 8,349,168 (expires 4-October-2022); 8,425,759 (expires 4-October-2022); 9,017,543 (expires 4-October-2022); 9,017,544 (expires 4-October-2022); 8,298,401 (expires 4‑October‑2022); 8,303,801 (expires 4‑October‑2022); 8,329,026 (expires 4‑October‑2022); 7,407,811 (expires 9‑May‑2020); 7,452,457 (expires 2‑May‑2026); 7,488,601 (expires 1‑February‑2026); 7,494,816 (expires 29‑December‑2019); 8,377,707 (expires 17-October-2023); 8,859,293 (expires 17-October-2023); 7,569,126 (expires 28‑December‑2026); and 8,361,291 (expires 8-October-2024). A license to use the Accu‑Chek Guide system is required until the expiration of the last-to-expire patent listed above and is only granted when the Accu‑Chek Guide meter is used with the Accu‑Chek Guide test strips. Accu‑Chek Guide test strips are specifically manufactured for operation with the Accu‑Chek Guide meter. Use of other test strips supplied by another manufacturer may prevent or impair the proper function of the Accu‑Chek Guide system. Using the Accu‑Chek Guide system indicates your acceptance of the restricted license to use the Accu‑Chek Guide 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 system for a full refund. If you have any questions, please call the Accu‑Chek Customer Care Services Center at 1‑800‑858‑8072. Except where prohibited by statute, all warranties covering the Accu‑Chek Guide system are voided by use of the Accu‑Chek Guide system with any test strips other than Accu‑Chek Guide test strips. 123 52926_07414587001_EN.indb 123 6/2/16 2:53 PM 11 License and Warranty WARNING A RESTRICTED LICENSE LIMITS USE OF THE ACCU-CHEK FASTCLIX SYSTEM (lancing device and lancet drums) IN THE UNITED STATES. READ CAREFULLY THE LIMITATIONS RECITED BELOW. The Accu‑Chek Fastclix system (device and lancet drums) and its use are protected by U.S. Patent Nos. 7,322,998 (expires 3‑March‑2020); and 7,785,338 (expires 5‑January‑2026). A license to use the Accu‑Chek Fastclix system is required until the expiration of the last‑to‑expire patent listed above and is only granted when Accu‑Chek Fastclix lancet drums are used with the Accu‑Chek Fastclix device. Accu‑Chek Fastclix lancet drums are high precision components that are produced to the close tolerances required for satisfactory operation with the Accu‑Chek Fastclix device. Use of other lancet drums with the Accu‑Chek Fastclix device may prevent or impair proper function of the Accu‑Chek Fastclix device. Using the Accu‑Chek Fastclix device indicates your acceptance of the restricted license to use the Accu‑Chek Fastclix device only with Accu‑Chek Fastclix lancet drums. 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 Fastclix device for a full refund. If you have any questions, please call the Accu‑Chek Customer Care Services Center at 1‑800‑858‑8072. Except where prohibited by statute, all warranties covering the Accu‑Chek Fastclix device are voided by use of the Accu‑Chek Fastclix device with any lancet drums other than Accu‑Chek Fastclix lancet drums. Patent Information U.S. Pat.: http://www.roche-diagnostics.us/patents 124 52926_07414587001_EN.indb 124 6/2/16 2:53 PM Index Index alternate site testing 33 averages 66 battery, changing 103 battery type 113 blood glucose results, unusual 34 blood glucose test, performing 25 blood glucose, warnings 29 button, functions 12 comfort dial 11, 19 comments, adding to results 30 control results, out-of-range 42 control solution 37 control test, performing 38 data transfer 76 USB 78 wireless 76 high blood glucose 35 hyperglycemia 35 hypoglycemia 35 lancet drum, changing 22 lancet drum, inserting 20 lancing device, cleaning and disinfecting 99 lancing device, using 21 logbook 64 low blood glucose 35 low/high data 69 safety information 3 settings, meter 43 beeper 46 language 61 last result 59 patterns 50 post meal 56 reminders 53 target ranges 47 time/date 45 supplies 119 symbols, blood glucose results 31 symbols, explanation of 119 symbols, meter display 15 symptoms, hypoglycemia/hyperglycemia 35 target % data 67 technical information 113 test strips 24 use by date 24, 37 warranty 121 wireless communication auto-send 86 default device 85 delete paired device 91 flight mode 84 overview 81 pairing additional device 88 pairing, first time 82 sync time 87 maintenance, meter 103 meter, cleaning and disinfecting 96 patterns 73 product limitations 113 product safety information 117 product specifications 113 52926_07414587001_EN.indb 125 125 6/2/16 2:53 PM Notes 126 52926_07414587001_EN.indb 126 6/2/16 2:53 PM Notes 127 52926_07414587001_EN.indb 127 6/2/16 2:53 PM Notes 128 52926_07414587001_EN.indb 128 6/2/16 2:53 PM 52926_07414587001_EN.indb 129 6/2/16 2:53 PM Roche Diabetes Care, Inc. 9115 Hague Road Indianapolis, IN 46256 www.accu-chek.com ACCU-CHEK, ACCU-CHEK GUIDE, 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. 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. © 2016 Roche Diabetes Care 07414587001-0316 52926_07414587001_EN.indb 130 6/2/16 2:53 PM
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