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User’s Manual

Blood Glucose Meter

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Roche USA – 54461

V1/1 – 07947836001

07947836001(01) – Black

54461_07947836001_07947836001_01_COVER.indb 1

10/3/16 8:02 AM

Содержание WX3-122

Страница 1: ...User s Manual Blood Glucose Meter 54461_07947836001_07947836001_01_COVER indb 1 10 3 16 8 02 AM ...

Страница 2: ...54461_07947836001_07947836001_01_COVER indb 2 10 3 16 8 02 AM ...

Страница 3: ...ests 19 Chapter 4 Review Your Data 25 Chapter 5 Wireless Communication and Meter Pairing 27 Chapter 6 Connecting to a PC 31 Chapter 7 Meter Maintenance and Troubleshooting 33 Chapter 8 Technical Information 41 Chapter 9 Guarantee 47 Index 48 54461_07947836001_07947836001_01_Inside indb 1 10 7 16 10 50 AM ...

Страница 4: ...54461_07947836001_07947836001_01_Inside indb 2 10 7 16 10 50 AM ...

Страница 5: ... blood testing is limited to healthcare professional use This system is not for use in the diagnosis of diabetes mellitus nor for testing neonate cord blood samples Suitable for self testing The system includes Accu Chek Instant meter with batteries Accu Chek Instant test strips and Accu Chek Instant control solutions Some items may not be included in the kit They are a separate purchase w WARNING...

Страница 6: ...4 Introduction 54461_07947836001_07947836001_01_Inside indb 4 10 7 16 10 50 AM ...

Страница 7: ...red in memory 3 Target Range Indicator Indicates whether your blood glucose result falls above within or below a pre set range of values 4 Micro USB Port Transfers data from the meter to a computer PC The Accu Chek Instant Meter Chapter 1 Your New System Right Side View Front View Left Side View 1 3 2 4 54461_07947836001_07947836001_01_Inside indb 5 10 7 16 10 50 AM ...

Страница 8: ...6 Your New System 1 5 Battery Door Open to replace batteries 6 Test Strip Slot Insert test strip here 5 Back View Underside View 6 54461_07947836001_07947836001_01_Inside indb 6 10 7 16 10 50 AM ...

Страница 9: ...Edge Touch blood drop or control solution here 10 Control Solution Bottle 11 Batteries 12 USB Cable Connects the meter to a PC Some items may not be included in the kit They are a separate purchase for example Test Strip 7 8 12 11 9 10 54461_07947836001_07947836001_01_Inside indb 7 10 7 16 10 50 AM ...

Страница 10: ...gement software instructions to set the time and date The meter display will then show the time and date along with your test results Target Range Consult your healthcare professional for the blood glucose range appropriate for you It is very important to stay within your target range The target range is set by default at 70 160 mg dL 3 9 8 9 mmol L The target range can be set from a lower limit o...

Страница 11: ...re viewing the 30 day average of your blood glucose results 90 day average symbol This indicates that you are viewing the 90 day average of your blood glucose results Drop symbol Bluetooth symbol Control bottle symbol Hourglass symbol Low battery symbol No data to display Pairing symbol Target range indicator arrow When flashing your blood glucose result is outside the target range Temperature war...

Страница 12: ...10 Your New System 1 54461_07947836001_07947836001_01_Inside indb 10 10 7 16 10 50 AM ...

Страница 13: ...ement If the meter shows the wrong unit contact Roche 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 your actual blood glucose level and may lead to improper therapy mg dL or mmol L is printed here 54461_07947836001_07947836001_01_Inside indb 11 10 7 16 10 50 AM ...

Страница 14: ...the test strip container Do not use the test strips after that date Store the test strip container and meter in a cool dry place such as a bedroom Refer to the test strip package insert for test strip storage and system operating conditions w WARNING Do not store test strips in high heat and moisture areas bathroom or kitchen Heat and moisture can damage test strips Performing a Blood Glucose Test...

Страница 15: ...ntainer Do not use test strips past the use by date Remove a test strip from the test strip container Close the cap tightly 2 3 Insert the metallic end of the test strip into the meter The meter turns on 4 When a flashing drop symbol appears perform a fingerstick with the lancing device 5 54461_07947836001_07947836001_01_Inside indb 13 10 7 16 10 50 AM ...

Страница 16: ...is helps you get a blood drop 6 Touch the yellow edge of the test strip to the blood drop Remove your finger from the test strip when the flashing hourglass symbol appears Do not put blood on top of the test strip 7 54461_07947836001_07947836001_01_Inside indb 14 10 7 16 10 50 AM ...

Страница 17: ... Remove and discard the used test strip 8 The target range is set by default at 70 160 mg dL 3 9 8 9 mmol L To change the target range pair the meter to a mobile device or connect it to a PC with diabetes management software installed Consult your healthcare professional before changing the target range Blue Test result is above the target range Green Test result is within the target range Red Tes...

Страница 18: ...tip and palm than in the forearm and upper arm 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 the forearm or upper arm You may perform a forearm or upper arm test immediately before a meal while fasting You may NOT perform a forearm or upper arm test u...

Страница 19: ...for some time Repeat the blood glucose test Was the test strip used immediately after it was removed from the test strip container Repeat the blood glucose test with a new test strip Were the test strips stored in a cool dry place Repeat the blood glucose test with a properly stored test strip Did you follow the directions Read the chapter Blood Glucose Tests and repeat the blood glucose test Cont...

Страница 20: ...ge in mood or irritability fatigue difficulty concentrating clumsiness palpitations and or confusion High blood glucose hyperglycaemia Symptoms of hyperglycaemia may include but are not limited to increased thirst frequent urination blurred vision drowsiness and or unexplained weight loss w WARNING If you are experiencing any of these symptoms or other unusual symptoms test your blood glucose from...

Страница 21: ...only Accu Chek Instant 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 date on the bottle label whichever comes first Do not use control solution that is past the use by or di...

Страница 22: ...e 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 tightly 1 2 Insert the metallic end of the test strip into the meter The meter turns on 3 A flashing drop symbol appears 54461_07947836001_07947836001_01_Inside indb 20 10 7 16 10 50 AM ...

Страница 23: ...e bottle with a tissue 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 A flashing hourglass symbol appears when there is enough control solution in the test strip 54461_07947836001_07947836001_01_Inside indb 21 10 7 16 10 50 AM ...

Страница 24: ... 1 control solution The control result appears Press the meter button 7 or 8 or If you tested with Level 2 control solution the L 2 screen appears Press and hold the meter button to confirm that you tested with Level 2 control solution Press the meter button to alternate between L 1 and L 2 54461_07947836001_07947836001_01_Inside indb 22 10 7 16 10 50 AM ...

Страница 25: ...strip 10 NOTE 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 OK appears if the control result is within range 9 or Err appears if the control result is out of range 54461_07947836001_07947836001_01_Inside indb 23 10 7 16 10 50 AM ...

Страница 26: ... 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 of control solution Were the test strips and control soluti...

Страница 27: ...ible software application The meter automatically stores at least 30 control results in memory but only the current control result can be viewed on the meter To view stored control results transfer them to a compatible software application If more than 720 blood glucose tests are performed within a 90 day period only the 720 most recent test results are included in the 90 day average Control resul...

Страница 28: ...rages 1 Reviewing Your Test Result Averages The meter uses all of your blood glucose results from the past 7 30 or 90 days to calculate a single number This number is called the average and helps you to understand your blood glucose results over a given period of time or or or 54461_07947836001_07947836001_01_Inside indb 26 10 7 16 10 50 AM ...

Страница 29: ...ond device overwrites the first pairing The meter and the device to be paired should be within 1 metre of each other Chapter 5 Wireless Communication and Meter Pairing On Your Mobile Device Open the app and select Pair Meter If prompted turn on Bluetooth 1 On Your Meter 2 On Your Mobile Device Within the app select your meter from the list of found meters When prompted enter the 6 digit pin number...

Страница 30: ...ul Err appears if pairing is unsuccessful 4 Transferring Data Wirelessly If the meter is paired with a mobile device and Bluetooth is on your test results will be sent to the paired device automatically On Your Meter 54461_07947836001_07947836001_01_Inside indb 28 10 7 16 10 50 AM ...

Страница 31: ...nication flight mode Turning Bluetooth off will not unpair your meter With the meter off press the meter button to turn the meter on The last test result screen appears 1 Press and hold the meter button until the Bluetooth symbol disappears 2 or or 54461_07947836001_07947836001_01_Inside indb 29 10 7 16 10 50 AM ...

Страница 32: ... to turn it back on This will enable wireless communication with your mobile device With the meter off press the meter button to turn the meter on The last test result screen appears 1 Press and hold the meter button until the Bluetooth symbol appears 2 or or 54461_07947836001_07947836001_01_Inside indb 30 10 7 16 10 50 AM ...

Страница 33: ...e 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 and initiate a data transfer 3 Chapter 6 Connecting to a PC 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 54461_0794...

Страница 34: ...32 Connecting to a PC 6 54461_07947836001_07947836001_01_Inside indb 32 10 7 16 10 50 AM ...

Страница 35: ...ow and pulling the door up 1 SN XXXXXXXXXXX PIN XXXXX xxxxxxx xxxxxxx xxxx x GTIN XXXXXXXXXXXXXX Remove the old batteries Press and hold the meter button for at least 2 seconds 2 Slide the new batteries under the tabs with the side facing up Put the battery door back in place and snap it closed 3 NOTE The meter uses two 3 volt lithium batteries coin cell type CR2032 This type of battery can be fou...

Страница 36: ...screen 1 Press and hold the meter button until all display segments appear Check the meter display for missing segments All segments should look like the picture above If any segments are missing from the display contact Roche as there may be a problem with the meter 2 Checking the Meter Display or or 54461_07947836001_07947836001_01_Inside indb 34 10 7 16 10 50 AM ...

Страница 37: ...r Do not spray a cleaning solution directly onto the meter Do not immerse the meter in liquid Make sure the meter is turned off 1 Gently wipe the meter s surface with a soft cloth slightly dampened wring out any excess liquid with one of these cleaning solutions 70 isopropyl alcohol Mild dishwashing liquid mixed with water 10 household bleach solution 1 part bleach plus 9 parts water made the same...

Страница 38: ...t new batteries Display is damaged Meter is defective Contact Roche Extreme temperatures Move the meter to a more temperate area The meter was unable to pair with a mobile device Retry the pairing 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 Roche Error Messages NOTE The error code and Err will alter...

Страница 39: ...able 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 measuring range If you do not feel like yo...

Страница 40: ...st strip and repeat the blood glucose or control test The error code and Err will alternate on the display An electronic error occurred Remove the batteries press and hold the meter button for at least 2 seconds and reinsert the batteries Perform a blood glucose or control test The error code and Err will alternate on the display The temperature is above or below the proper range for the system Re...

Страница 41: ...ged 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 may contain a high level of ascorbate Contact your healthcare professional 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 replaced remove ...

Страница 42: ...d Glucose Results section in the chapter Blood Glucose Tests The error code and Err will alternate on the display An electronic error has occurred Contact Roche The error code and Err will alternate on the display 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 error persists...

Страница 43: ...city 1 blood glucose result and 7 30 and 90 day test result averages at least 720 blood glucose results and at least 30 control results are also stored and can be viewed with external software Automatic off 90 seconds after performing a test 15 seconds after a test strip is removed or 5 seconds from the last test result screen Power supply Two 3 volt lithium batteries coin cell type CR2032 Display...

Страница 44: ...r to the test strip package insert Declaration of Conformity Roche hereby declares that the Accu Chek Instant blood glucose meter conforms with the basic requirements and other relevant regulations of the European Directives 1999 5 EC and 2014 53 EU once solely applicable The transition period for the European Directive 1999 5 EC ends June 12th 2017 The currently valid conformity declaration may b...

Страница 45: ...lood glucose testing the meter itself may come into contact with blood Used meters therefore carry a risk of infection Before discarding the meter remove the battery or batteries Discard used meters according to the regulations applicable in your country Contact the local council and authority for information about correct disposal The meter falls outside the scope of the European Directive 2012 1...

Страница 46: ...nfection Caution refer to safety related notes in the instructions for use accompanying this product Temperature limitation store at Manufacturer Catalogue number In vitro diagnostic medical device Global Trade Item Number Serial number This product fulfils the requirements of the European Directive 98 79 EC on in vitro diagnostic medical devices 3 volt coin cell type CR2032 54461_07947836001_0794...

Страница 47: ... patient and his or her ability to understand the considerations relative to diabetes and AST If you are considering recommending AST for your patients you need to understand that there is a potential for a significant difference between fingertip or palm test results and test results obtained from the forearm or upper arm The difference in capillary bed concentration and blood perfusion throughou...

Страница 48: ...46 Technical Information 8 54461_07947836001_07947836001_01_Inside indb 46 10 7 16 10 51 AM ...

Страница 49: ...Guarantee 9 Guarantee The statutory provisions on rights in consumer goods sales in the country of purchase shall apply Chapter 9 Guarantee 54461_07947836001_07947836001_01_Inside indb 47 10 7 16 10 51 AM ...

Страница 50: ...5 high blood glucose 18 hyperglycaemia 18 hypoglycaemia 18 L last test result 25 low blood glucose 18 M maintenance meter 33 meter cleaning 35 P product limitations 41 product safety information 43 product specifications 41 S supplies 7 45 symbols IVD 44 meter display 9 T target range 8 15 target range indicator 5 15 technical information 41 test strips 12 time and date 8 U use by date 12 19 W wir...

Страница 51: ...22 www accu chek ir Islamic Republic of Pakistan Hotline number 0800 76243 0800 ROCHE www accu chek com pk Philippines Customer Assist Care Hotline 02 718 7575 02 718 7588 63 917 897 8000 www accu chek com Saudi Arabia United Arab Emirates Master Distributor in the Middle East Accu Chek Enquiry Line 971 0 4 8169 000 www accu chekarabia com arabic Singapore Accu Chek ExtraCare line 6272 9200 www ac...

Страница 52: ...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 APPLE APPLE logo and APP STORE are trademarks of Apple Inc GOOGLE PLAY is a trademark of Google Inc All other product names and trademarks are the property of their respective owners 2016 Roche Diabetes Care 07947836001 0316 07947836...

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