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Introduction

The Accu-Chek Guide Me System

The Accu-Chek Guide Me blood glucose 

monitoring system is comprised of the 

Accu-Chek Guide Me meter and 

Accu-Chek Guide test strips. 
The Accu-Chek Guide test strips with the 

Accu-Chek Guide Me meter are intended 

to quantitatively measure glucose in fresh 

capillary whole blood from the finger, 

palm, forearm, and upper arm as an aid in 

monitoring the effectiveness of glucose 

control. 
The Accu-Chek Guide test strips with the 

Accu-Chek Guide Me meter are intended 

for in vitro diagnostic self-testing by 

people with diabetes. 
The Accu-Chek Guide test strips with the 

Accu-Chek Guide Me meter are intended 

for in vitro diagnostic use by healthcare 

professionals in clinical settings.  Venous, 

arterial, and neonatal blood testing is 

limited to healthcare professional use.
This system is not for use in diagnosis of 

diabetes mellitus, nor for testing neonate 

cord blood samples.
Suitable for self-testing
The system includes: 
Accu-Chek Guide Me meter with batteries, 

Accu-Chek Guide test strips,* and 

Accu-Chek Guide control solutions*.
* Some items may not be included in the 

kit. They are a separate purchase. 

 

w

WARNING

•  Choking hazard. Small 

parts. Keep away from 

children under the age of 

3 years.

• Keep new and used batteries away 

from children. Ingestion or 

insertion into the body may cause 

chemical burns, perforation of soft 

tissues, and death. Severe burns 

may occur within 2 hours of 

swallowing. If you think a battery 

might have been swallowed or 

placed inside any part of the body, 

seek medical attention 

immediately.

• If the battery compartment does 

not close securely, stop using the 

product and keep it away from 

children. Contact Roche.

• Any object coming into contact 

with human blood is a potential 

source of infection (see: Clinical 

and Laboratory Standards 

Institute: Protection of Laboratory 

Workers from Occupationally 

Acquired Infections; Approved 

Guideline – Fourth Edition; CLSI 

document M29-A4, May 2014).

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Содержание ACCU-Chek Guide Me

Страница 1: ...ew at 100 Die lines and color breaks do not print Holding Area text box and rules do not print Roche USA 81383 V1 1 09241493001 09241493001_01 Black 3_09241493001_09241493001_01 indd 1 3_09241493001_09241493001_01 indd 1 10 13 2020 2 44 01 PM 10 13 2020 2 44 01 PM ...

Страница 2: ... 4 Review Your Data 17 Chapter 5 Wireless Communication Meter Pairing and Data Transfer 19 Chapter 6 Meter Maintenance and Troubleshooting 22 Chapter 7 Technical Information 28 Chapter 8 Guarantee 32 Index 33 3_09241493001_09241493001_01 indd 1 3_09241493001_09241493001_01 indd 1 10 13 2020 2 44 01 PM 10 13 2020 2 44 01 PM ...

Страница 3: ...or self testing The system includes Accu Chek Guide Me meter with batteries Accu Chek Guide test strips and Accu Chek Guide control solutions Some items may not be included in the kit They are a separate purchase w WARNING Choking hazard Small parts Keep away from children under the age of 3 years Keep new and used batteries away from children Ingestion or insertion into the body may cause chemica...

Страница 4: ...ld cause a delay in therapy decisions and lead to a serious medical condition Examples of back up testing methods include a back up meter and test strips Ask your healthcare professional or pharmacist about other possible back up methods The meter prompts you to set the time and date the first time you turn it on Check the time and date on the meter before you begin testing Adjust the time and dat...

Страница 5: ...rrow Button Press to enter memory adjust settings and 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 3_09241493001_09241493001_01 indd 4 3_09241493001_09241493001_01 indd 4 10 13 2020 2 44 0...

Страница 6: ...rip Yellow Edge Touch blood drop or control solution here 11 Control Solution Bottle 12 Batteries 13 USB Cable Connects meter to a PC Some items may not be included in the kit They are a separate purchase 3_09241493001_09241493001_01 indd 5 3_09241493001_09241493001_01 indd 5 10 13 2020 2 44 07 PM 10 13 2020 2 44 07 PM ...

Страница 7: ...urn the meter on or off Navigate to an option or set a selection Press and release Check the meter display memory set up or memory set up 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 Roche right arrow and left arrow buttons Adjust settings for time and date and scroll through ...

Страница 8: ...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 insert a test strip Wireless symbol ...

Страница 9: ...ing test strip symbol appears Insert a test strip to perform a test NOTE The meter prompts you to set the time and date the first time you turn the meter on or if an error occurs Press and hold at any time until the flashing test strip symbol appears to perform a test The time and date on the meter synchronises to the time and date on the paired device each time the meter sends data to the paired ...

Страница 10: ...g properly Then repeat the blood glucose test with a new test strip Do not store test strips in high heat and moisture areas bathroom or kitchen Heat and moisture can damage test strips Use only Accu Chek Guide test strips Use the test strip immediately after removing it from the test strip container Do not apply blood or control solution to the test strip before inserting it into the meter Close ...

Страница 11: ...od glucose test Insert a test strip into the meter Turn the meter on by briefly pressing and insert a test strip 1 Wash your hands with warm soapy water Rinse and dry thoroughly Prepare the lancing device 2 Check the use by date on the test strip container Do not use test strips past the use by date 3 Remove a test strip from the test strip container Close the cap tightly 4 Insert the metallic end...

Страница 12: ...osing calculations You have the option of obtaining a blood sample from other sites on your body besides the fingertip Alternative sites include the palm forearm and upper arm Blood obtained from the fingertip and palm can be used at any time to perform a blood glucose test If blood from the forearm or upper arm is used there are certain times when testing is not appropriate This is because your b...

Страница 13: ...owing list to help solve the problem Troubleshooting Checks Action Did you wash your hands Wash your hands with warm soapy water and dry thoroughly Repeat the blood glucose test with a new test strip Were the test strips expired Discard the test strips if they are past the use by date Repeat the blood glucose test with an unexpired test strip Was the cap on the test strip container always closed t...

Страница 14: ... HI contact your healthcare professional immediately 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 Low blood glucose hypoglycaemia Symptoms of hypoglycaemia may include but are not limited to anxiety shakiness sweating headache increased hunger dizziness pale skin colour sudden change in mood or irritab...

Страница 15: ...on 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 conditions The meter automatically recognises the difference between the control solution and blood The control results are not displayed in memory The control ...

Страница 16: ... enough control solution in the test strip 8 or mmol L or mmol L The control result the bottle symbol and the flashing L1 or L2 appear on the display Press to confirm the control level you tested Press or to alternate between L1 and L2 9 or OK appears if the control result is within range Err appears if the control result is out of range 10 Wipe the tip of the bottle with a tissue Cap the bottle t...

Страница 17: ...f 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 of control solution ...

Страница 18: ... 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 based on test results in memory 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 s...

Страница 19: ...most recent test result on the display press The 7 day average appears on the display 3 memory or memory mmol L 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 3_09241493001_09241493001_01 indd 18 3_09241493001_0...

Страница 20: ...e first pairing The meter and the device to be paired should be within 1 metre of each other 1 On Your Mobile Device Ensure Bluetooth is on and open the diabetes management app 2 On Your Meter With the meter off press and hold and at the same time until appears Both and appear and flash on the display 6 digit PIN Locate the 6 digit PIN on the back of your meter 3 On Your Mobile Device Within the a...

Страница 21: ...s will be automatically sent to the paired device Turning Bluetooth Off Turn Bluetooth off to disable wireless communication flight mode Turning Bluetooth off will not unpair your meter 1 or mmol L With the meter off press or The last stored test result appears on the display 2 or mmol L Press and hold until the Bluetooth symbol disappears Turning Bluetooth On If you have turned Bluetooth off flig...

Страница 22: ...lug the small end of the USB cable into the meter 2 Plug the large end of the USB cable into a USB port on the PC If the meter is off it turns on 3 Start the diabetes management software on the PC and initiate a data transfer 4 The meter transfers the data to the software NOTE The USB cable does not charge the meter batteries Remove the USB cable after you have finished 3_09241493001_09241493001_0...

Страница 23: ...with the side facing up Put the battery door back in place and snap it closed NOTE Always have a spare set of batteries Battery life may vary due to factors such as temperature and battery manufacturer If the E 7 or E 9 error code still appears on the display after you have changed the batteries remove the batteries again press for at least 2 seconds then reinsert the batteries The meter uses two ...

Страница 24: ...ake sure the meter is turned off Gently wipe the meter surface with a soft cloth slightly dampened wring out any excess liquid with one of these solutions To clean the meter Mild dishwashing liquid mixed with water To disinfect the meter 70 isopropyl alcohol Note During disinfection make sure that the meter surface stays wet with isopropyl alcohol for a minimum of 2 minutes Additional wiping of th...

Страница 25: ...ts memory There are no test results in range for the selected data The meter is connected to a PC and a blood glucose or control test cannot be performed EITHER remove the USB cable and perform a blood glucose or control test OR remove the test strip and start a data transfer The meter was unable to pair with a mobile device Retry the pairing Blood glucose may be higher than the measuring range of...

Страница 26: ...ghtly The test strips may have been damaged due to improper storage or handling Never make therapy decisions based on an error message Repeat the blood glucose test If a second E 3 error message appears perform a control test with the control solution and a new test strip See the section Performing a Control Test in the chapter Control Tests If you continue to receive an E 3 error message use an a...

Страница 27: ...d 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 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 The error code and Err will alternate on the dis...

Страница 28: ...chapter Your New System 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 may contain a high level of ascorbate Contact your healthcare professional The error code and Err will alternate on the display Fluid or foreign material may b...

Страница 29: ...rip is removed Power supply Two 3 volt lithium batteries coin cell type CR2032 Display LCD Dimensions 76 48 16 mm LWH Weight Approx 43 g with batteries Construction Hand held Protection class III 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...

Страница 30: ...ant regulations of the European Directive 2014 53 EU The conformity declaration may be found at the following website http declarations accu chek com 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 Cont...

Страница 31: ...ontact 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 Keep new and used batteries away from children See the warning in the Introduction of this User s Manual for additional...

Страница 32: ...a traceable link between the equipment and the manufacturer importer or their agent responsible for compliance and for placing it on the Australian and New Zealand market 2 Temperature limitation store at E Use by M Manufacturer R Catalogue number L Batch code I In vitro diagnostic medical device Q Global Trade Item Number q Serial number A This product fulfils the requirements of the European Dir...

Страница 33: ...ty 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 throughout the body can lead to sample...

Страница 34: ...antee The statutory provisions on rights in consumer goods sales in the country of purchase shall apply 3_09241493001_09241493001_01 indd 33 3_09241493001_09241493001_01 indd 33 10 13 2020 2 45 13 PM 10 13 2020 2 45 13 PM ...

Страница 35: ... G guarantee 33 H healthcare professionals 32 high blood glucose 13 hyperglycaemia 13 hypoglycaemia 13 L low blood glucose 13 M maintenance meter 22 memory 17 P pairing 19 product limitations 28 product safety information 30 product specifications 28 S supplies 31 symbols IVD 31 meter display 7 T technical information 28 test strips 9 time and date setting 8 U USB 21 use by date 9 W wireless commu...

Страница 36: ...ngapore Accu Chek ExtraCare line 6272 9200 www accu chek com sg 대한민국 고객 지원 및 서비스 센터 무료상담전화 080 909 2222 월 금 오전 9시 오후 5시 www accu chek co kr Saudi Arabia United Arab Emirates Jordan Kuwait Lebanon Qatar Roche Diabetes Care Middle East FZCO Tel 971 0 4 816 9165 www rochediabetescareme com or contact Roche local authorized representative in your country Accu Chek Guide Me R C WX3 905 HIDF16000080 3_0...

Страница 37: ... 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 2020 Roche Diabetes Care 09241493001 1020 09241493001 01 1020 Roche Diabetes Care GmbH Sandhofer Strasse 116 68305 Mannheim Germany www accu chek com LAST UPDATE 2020 08 3_09241...

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