Accu-Chek Guide Kit

Glucose monitoring system + test strips.

The system includes: Accu-Chek Guide 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.
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, Sample type, Measuring time, Measuring range, Test strip storage conditions, System operating conditions: Refer to the test strip package insert.
Memory capacity: 720 blood glucose results and 30 control results with time and date.
Automatic off: 90 seconds.
Power supply: Two 3‑volt lithium batteries (coin cell type CR2032).
Display: LCD.
Dimensions: 80 x 47 x 20 mm (LWH).
Weight: Approx. 40 g (with batteries).
Construction: Hand-held.
Protection class: III
Meter type: The Accu‑Chek Guide meter is suitable for continuous operation.
Interfaces: USB: micro-B connector; Bluetooth; Continua Certified to a Continua Certified manager.
Radio frequency connectivity: 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).
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 equipment is not anticipated.
Declaration of Conformity: Roche hereby declares that the Accu-Chek Guide blood glucose meter conforms with the basic requirements and other relevant regulations of the European Directives 2014/53/EU. The conformity declaration may be found at the following Internet address: http://declarations.accu-chek.com.
Communication Protocol: The Accu-Chek Guide 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 2014 Continua Design Guidelines which include the Blood Glucose specification for Bluetooth, Bluetooth SIG, Glucose Profile, Version 1.0 and Bluetooth SIG, Glucose Service, Version 1.0.

Performance Analysis: Refer to the test strip package insert.
Test Principle: Refer to the test strip package insert.

The Accu-Chek Guide test strips with the Accu-Chek Guide 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 meter are intended for in vitro diagnostic self-testing by people with diabetes.
The Accu-Chek Guide test strips with the Accu-Chek Guide 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.
The system is not for use in the diagnosis of diabetes mellitus, nor for testing neonate cord blood samples.
Suitable for self-testing.

Choking hazard. Small parts. Keep away from children under the age of 3 years.
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).

Meter Maintenance and Troubleshooting: Meter Maintenance: The meter automatically tests its own systems every time the patient turns it on and letting them know if something is wrong. See the Error Messages as follows.
If the patient drops the meter or thinks the results are not accurate, contact Roche.
Changing the Batteries: 1. 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.
2. Remove the old batteries. Press and hold the meter button for at least 2 seconds.
3. Slide the new batteries under the tabs 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.
Meter data is not lost when replacing the batteries.
Checking the Meter Display: 1. With the meter off, press the meter button to turn the meter on. Press the meter button twice to display the 30-day average screen.
2. Press and hold the meter button until all display segments appear. Check the meter display for missing segments. If any segments are missing from the display, contact Roche, as there may be a problem with the meter.
Cleaning the Meter: Keep the meter free of dust. If needed to clean or disinfect it, follow these guidelines carefully to help in getting the best performance possible.

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Warning: Do not allow liquid to enter any openings in the meter.
Do not spray a cleaning solution directly onto the meter.
Do not immerse the meter in liquid.
1. Make sure the meter is turned off.
2. 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 day.
Error Messages:
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Warning: Never make therapy decisions based on an error message.
If having any concerns or see any other error message, contact Roche.
Note: The error code and Err will alternate on the display for all coded error messages (E-1 through E 14).
The meter will not turn on or the display is blank.
Batteries are dead: Insert new batteries.
Display is damaged/Meter is defective: Contact Roche.
Extreme temperatures: Move the meter to a more temperate area.
USb: 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.
Err: The meter was unable to pair with a mobile device.
Retry the pairing.
E-1: (The error code and Err will alternate on the display.)
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.
E-3: (The error code and Err will alternate on the display.)
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 Control Tests: Understanding Out-of-Range Control Results under Patient Counselling Information.
In rare cases, an E-3 error code may indicate that blood glucose is extremely high and above the system's measuring range. If the patient does not feel that the blood glucose is extremely high, repeat the blood glucose test. See Blood Glucose Tests: Unusual Blood Glucose Results under Patient Counselling Information. If the E-3 code still appears for blood glucose test, contact the healthcare professional immediately.
E-4: (The error code and Err will alternate on the display.)
Not enough blood or control solution was drawn into the test strip for measurement or was applied after the test had started.
Discard the test strip and repeat the blood glucose or control test.
E-6: (The error code and Err will alternate on the display.)
Blood or control solution was applied to the test strip before the flashing drop symbol appeared on the display.
Discard the test strip and repeat the blood glucose or control test.
E-7: (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.
E-8: (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.
E-9: (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 the batteries again, press and hold the meter button for at least 2 seconds, then reinsert the batteries.
E 10: (The error code and Err will alternate on the display.)
The meter's internal clock may need to be reset.
Press the meter button. If the time and date were set, there will be a need to reset them. See Time and Date under Description.
E 11: (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.
E 12: (The error code and Err will alternate on the display.)
The blood sample may contain a high level of ascorbate.
Contact the healthcare professional.
E 13: (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, contact Roche.
E 14: (The error code and Err will alternate on the display.)
An electronic error has occurred.
Contact Roche.
HI: Blood glucose may be higher than the measuring range of the system. See Blood Glucose Tests: Unusual Blood Glucose Results under Patient Counselling Information.
LO: Blood glucose may be higher than the measuring range of the system. See Blood Glucose Tests: Unusual Blood Glucose Results under Patient Counselling Information.
Technical Information: Product Safety Information:
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Warning: 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.
Discarding the Meter:
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Warning: During blood 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 the country. Contact the local council and authority for information about correct disposal.
The meter falls outside the scope of the European Directive 2012/19/EU - Directive on waste electrical and electronic equipment (WEEE).
Discard used batteries according to local environmental regulations.
Information for Healthcare Professionals:
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Warning: Healthcare Professionals: Follow the infection control procedures appropriate for the facility. Refer to the test strip package insert for additional healthcare professional information.
Sample Handling: Always wear gloves when handling blood-contaminated items. Always adhere to the recognised procedures for handling objects that are potentially contaminated with human material. Follow the hygiene and safety policy of the laboratory or institution. Prepare the selected blood collection site per facility policy.
Refer to the test strip package insert for additional information regarding acceptable sample types, anticoagulants, and handling instructions.
Recommending Alternative Site Testing to Patients: Decisions about whether to recommend Alternative Site Testing (AST) should take into account the motivation and knowledge level of the patient and the ability to understand the considerations relative to diabetes and AST. If considering to recommend AST for the patients, the 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 site‑to‑site differences in blood glucose results. These physiological effects vary between individuals and can vary within a single individual based upon the behaviour and relative physical condition.
The studies involving alternative site testing of adults with diabetes show that most persons will find their glucose level changes more quickly in blood from the fingertip or palm than in blood from the forearm or upper arm. This is especially important when blood glucose levels are falling or rising rapidly. If the patient is used to making therapy decisions based upon fingertip or palm test results, they should consider the delay, or lag time, affecting the test results obtained with blood from the forearm or upper arm.

Meter storage conditions: Temperature: -25-70 °C.
Close the test strip container tightly immediately after removing a test strip to protect the test strips from humidity.
Store the unused test strips in their original test strip container with the cap closed.
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.

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Warning: Do not store test strips in high heat and moisture areas (bathroom or kitchen). Heat and moisture can damage test strips.

Accu-Chek Guide Meter: Button Functions: Here are the functions of the back, arrow, and Power/Set/OK buttons on the meter. These functions are used throughout this monograph. See as follows for specific instructions on setting up the meter.
Back Button: Return to previous display. Return to the previous field.
Up Arrow and Down Arrow Buttons: Navigate up and down in a menu. Increase or decrease a number.
Power/Set/OK Button: Press briefly to turn the meter on. Press and hold to turn the meter off. Press to select an option. Press to move to the next field or display. Press to save an option. With the meter off, press and hold to check the meter display.
Setting the Language and Time Format: The meter may prompt you to choose a language and time format (12-hour or 24-hour clock) the first time you turn it on.
Note: If you select the wrong language and cannot correct it, contact Roche.
Target Range: Your healthcare professional can tell you what blood glucose range is appropriate for you. It is very important to stay within your target range.
The target range can be set from a lower limit of 60-100 mg/dL (3.3-5.5 mmol/L) to an upper limit of 101-300 mg/dL (5.6-16.6 mmol/L).
Accu-ChekPerformaM5_MM Warning: This function is no substitute for hypoglycaemia training by your healthcare professional.
Blood Glucose Tests: Accu-ChekPerformaM5_MM Warning: 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 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.
Using the Accu-Chek Guide System: 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 the test strip container tightly immediately after removing a test strip to protect the test strips from humidity.
Store the unused test strips in their original test strip container with the cap closed.
Check the use by date on 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.
Accu-ChekPerformaM5_MM 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 with Blood from the Fingertip: Note: You need the meter, a test strip, and a lancing device with a lancet inserted to perform a blood glucose test.
A blood glucose test cannot be performed while the meter is connected to a PC with a USB cable.
1. Wash your hands with warm soapy water 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 of the test strip into the meter. The meter turns on.
5. When Apply drop appears, perform a finger stick with the lancing device.
6. Gently squeeze your finger to assist the blood flow. This helps you get a blood drop.
7. 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.
8. The test result appears on the display. You have the option of adding a comment to the test result by pressing OK or proceed to Step 11 to complete the test.
9. Add Comment appears. Press Down Arrow Button to highlight a comment. Press OK to set the comment for the test result. See Overview under Review Your Data as follows for details.
10. The final result appears. Press OK or Back Button to set the comment and return to Main Menu. Or to change the comment, press Down Arrow Button to select the comment. Press OK to return to Add Comment.
11. Remove and discard the used test strip by pulling the test strip out of the meter or by pushing the test strip ejector on the side of the meter.
Performing a Blood Glucose Test with Blood from Your Palm, Forearm, or Upper Arm (Alternative Site Testing): Accu-ChekPerformaM5_MM Warning: Do not use alternative site testing to calibrate a continuous glucose monitoring system or to make insulin dosing 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 blood glucose level changes faster in your fingertip 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 following text 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: up to 2 hours following a meal, when blood glucose values can rise quickly; after injecting bolus insulin, when blood glucose values can decrease rapidly; after exercise; if you are sick; if you think your blood glucose is low (hypoglycaemia); 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 Roche.
Unusual Blood Glucose Results: If your blood glucose result does not match how you feel, check the following list of Troubleshooting Checks and Action to help solve the problem.
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 tightly?: Replace the test strips if you think the test strip container was uncapped 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 Blood Glucose Tests and repeat the blood glucose test. Contact Roche if you still have problems.
Are the meter and test strips working properly?: Perform a control test. See Control Tests as follows for instructions.
Are you still unsure of the problem?: Contact Roche.
Symptoms of Low or High Blood Glucose: 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 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.
Accu-ChekPerformaM5_MM
If you are experiencing any of these symptoms, or other unusual symptoms, test your blood glucose from the fingertip or palm. If your blood glucose result is displayed as LO or HI, contact your healthcare professional immediately.
Control Tests: When to Perform a Control Test: Performing a control test lets you know the meter and test strips are working properly. You should perform a control test when: you open a new test strip box; you left the test strip container open; you think the test strips are damaged; you want to check the meter and test strips; the test strips were stored in extreme temperatures, humidity, or both; you dropped the meter; your test result does not match how you feel; 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 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 recognizes the difference between the control solution and blood.
The control solution can stain fabric. Remove stains by washing with soap and water.
Performing a Control Test: You need the meter, a test strip, and control solution Level 1 or Level 2.
1. Check the use by date on the test strip container. Do not use test strips past the use by date.
2. Remove a test strip from the test strip container. Close the cap tightly.
3. Insert the metallic end of the test strip into the meter. The meter turns on.
Preparing to test appears. Apply drop appears.
4. Select the control solution to test. You will enter the level later in the test.
5. Remove the bottle cap. Wipe the tip of the bottle with a tissue. Squeeze the bottle until a tiny drop forms at the tip.
6. Touch the drop to the yellow edge of the test strip. Do not put control solution on top of the test strip.
Analyzing appears when there is enough control solution in the test strip.
7. The control result and control bottle symbol appear. Press the Up or Down Arrow button to select the control level you tested. If you do not select a level, the control result is saved without a control level. Press OK.
8. Within range and tick appear if the control result is within range.
Out of range and a cross appear if the control result is out of range.
9. Wipe the tip of the bottle with a tissue. Cap the bottle tightly.
Remove and discard the used test strip.
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.
Understanding Out‑of‑Range Control Results:
Accu-ChekPerformaM5_MM Warning: The control solution ranges are printed on the test strip container label. If the control result is out of range, check the following list Troubleshooting Checks and Action to help solve the problem.
Were the test strips or control solutions expired?: Discard the test strips or control solution if either is past the use by date. If the control solution was opened more than 3 months ago, discard it. Repeat the control test with an unexpired test strip and an unexpired control solution.
Did you wipe the tip of the control solution bottle before use?: Wipe the tip of the bottle with a tissue. Repeat the control test with a new test strip and a fresh drop of control solution.
Were the caps on the test strip container and the control solution bottle always closed tightly?: Replace the test strips or control solution if you think either was uncapped for some time. Repeat the control test.
Was the test strip used immediately after it was removed from the test strip container?: Repeat the control test with a new test strip and a fresh drop of control solution.
Were the test strips and control solutions stored in a cool, dry place?: Repeat the control test with a properly stored test strip or control solution.
Did you follow the directions?: Read Control Tests and repeat the control test.
Did you choose the correct control solution level, either 1 or 2, when you performed the control test?: If you chose the wrong control solution level, you can still compare the control result to the range printed on the test strip container.
Are you still unsure of the problem?: Contact Roche.
Review Your Data: Overview: Blood glucose results are stored from the newest to the oldest.
The meter automatically stores up to 720 blood glucose results in memory with the time and date of the test and any test result comments.
Once 720 blood glucose results are in memory, adding a new blood glucose result deletes the oldest blood glucose result.
Only test results that have been marked with a fasting, before meal, after meal, or bedtime comment are included in the average for that comment.
All test results are included in the overall 7, 14, 30, and 90‑day averages regardless of what comment is added.
Control results are stored in memory but cannot be reviewed on the meter. To view stored control results, transfer them to a compatible software application.
Control results are not included in the averages or blood glucose reports.
Once 32 control results are in memory, adding a new control result deletes the oldest control result.
Accu-ChekPerformaM5_MM 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: Analyzing your blood glucose results stored in the meter is an effective way for you and your healthcare professional to determine how well you are controlling your diabetes. This analysis is a valuable tool for making improvements to your diabetes management. Use care when adding comments to blood glucose results. Incorrect comments can cause inaccurate patterns to be detected by the meter if Patterns is On.
Low/High Data: Your healthcare professional can tell you what blood glucose range is appropriate for you. It is very important to stay within your target range.
Target Ranges must be set in the meter to track Low/High Data test results (see Target Range under Accu-Chek Guide Meter as previously mentioned for details).
Low BG or High BG Data includes only results that fall above or below the target ranges set in the meter.
Low BG or High BG Data is tracked in the meter for 30 days.
Wireless Communication and Meter Pairing: Overview: You can wirelessly and automatically synchronize your diabetes information with a mobile device. The process of creating a connection between the meter and the other device is called pairing. You need an application on your mobile device that can accept the meter's data.
First‑Time Pairing: The steps as follows are for first‑time pairing. Up to 5 devices can be paired with the meter at any time. Each device must be paired with the meter one at a time. The meter and the device to be paired should be within 1 meter of each other.
1. Prepare the device for pairing. Refer to the device's instructions for information about pairing.
2. Turn the meter on by briefly pressing OK. From Main Menu, press Down Arrow to highlight Settings. Press OK.
3. Press Down Arrow to highlight Wireless. Press OK.
4. Pair Device appears. To pair a device, press Down Arrow to highlight Yes. Press OK.
5. The meter displays its code.
6. 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 5 into the device to be paired.
7. When pairing is complete, Tick and the name of the paired device appear. Press Ok to return to the previous menu.

Other Therapeutic Products

Glucose monitoring system (meter x 1's + test strips x 10's + Accu-Chek Softclix lancing device x 1's + Accu-Chek Softclix lancets x 10's).