Accucheck go.pdf

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Introduction

The ACCU-CHEK Go blood glucose system is a state-of-the art precision instrument that willenable you to test blood glucose simply and with confidence. The blood glucose meter is designand approved to quantitatively measure the concentration of glucose in capillary whole bloodsamples outside the body (in vitro diagnostics use) by healthcare professionals, or persons withdiabetes, for monitoring glucose in healthcare facilities, or in the home. It should not be used todiagnose diabetes. This users manual contains the complete instructions for using the system.

No matter whether this is your first time using a blood glucose meter or whether you have usothers in the past, please take time to read this manual carefully and completely beforeperforming the first blood glucose measurement. The manual may tell you a lot of what youknow already, but it will also introduce many features that may be new to you. To use the me

correctly and dependably, you need to have a thorough understanding of the way it operateswhat the screen displays mean, and the individual functions.

Should you have any questions, the ACCU-CHEK Customer Care service center is available 24hours a day. Call 1-800-440-3638.

To start testing quickly, you can also refer to the ACCU-CHEK Go Quick Reference Guide.

Last updated user information: January 2006


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ContentsChapter 1: Understanding the ACCU-CHEK Go System..........................................................................

Connecting (or Changing) the Battery .................................................................................................

Setting the Time and Date ..................................................................................................................Setting the Alarm Clock Function........................................................................................................

Setting the Beep Tone.........................................................................................................................

Setting the Hypoglycemic (Hypo) Warning ...........................................................................................

Coding the Meter................................................................................................................................

Chapter 2: Control Testing ......................................................................................................................Why Run Control Tests? ......................................................................................................................

Running a Control Test........................................................................................................................

Understanding Control Test Results.....................................................................................................

Contents 1 ACCU-CHEK Customer Care Service Center 1-800-440-


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Chapter 3: Testing Blood Glucose ..........................................................................................................

Tips for Testing by Healthcare Professionals ......................................................................................

Understanding Blood Glucose Results ................................................................................................

Normal Blood Sugar Ranges .......................................................................................................

Symptoms of High or Low Blood Sugar.......................................................................................Unusual Test Results ...................................................................................................................

Important Information for Healthcare Professionals............................................................................

Storing the Supplies...........................................................................................................................

Sources of Interference......................................................................................................................

Chapter 4: Using the Meters Memory ...................................................................................................Viewing Test Results ..........................................................................................................................

Viewing Trend Information..................................................................................................................

Downloading the Meter to a Computer or PDA ...................................................................................

Chapter 5: Maintenance and Troubleshooting ...............................................................................

Cleaning the Meter ............................................................................................................................

Performing a Full Display Check ........................................................................................................


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Screen Messages and Troubleshooting ...............................................................................................

Possible Sources of Error....................................................................................................................

Chapter 6: Technical Information ...........................................................................................................

Product Limitations.............................................................................................................................

Specifications .....................................................................................................................................

Product Safety Information .................................................................................................................

Warranty.............................................................................................................................................

Patent Information ..............................................................................................................................

Additional Supplies .............................................................................................................................

References .........................................................................................................................................

Alphabetical Index ..............................................................................................................................



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Chapter 1: Understanding the ACCU-CHEK Go System

1 Liquid crystal display (LCD)

2 M button ("memory")

3 S button ("set")

4 Measurement optics cover

5 Test strip guide

6 Test strip ejector

7 Code key slot

8 Code key

9 Battery tray

10 Battery

Chapter 1: Understanding the ACCU-CHEK Go System 4 ACCU-CHEK Customer Care Service Center 1-800-440-

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9 Battery tray

11 Infrared interface


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Connecting (or Changing) the Battery

The ACCU-CHEK Go meter is sold complete with one lithium battery (type CR2430 or DL2430) already inserteA plastic film protects the battery against becoming drained prematurely. Before using the meter, remove the

film covering the battery as follows:

1. Use your thumb to slide the battery tray up and out of the meter.

2. Remove the plastic film and throw it away.

3. Slide the battery tray back into the meter until it locks in place.A new battery provides enough power for about 1,000 testsin a year.

To change the battery, remove the old battery and place the new one in the tray withthe + side facing down.

The battery symbol on the screen means the battery is low and should be changedsoon.

When the battery symbol appears for the first time, it indicates that the battery is wearingdown. You can perform approximately 50 additional tests, however, we recommend thatyou replace the battery as soon as possible.



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NOTE:As long as you change the battery within one minute, the date and time settings will be retained.

NOTE: Healthcare professionals should dispose of used batteries according to their facilitys guidelines.

Setting the Time and Date

1. Briefly press (for less than 3 seconds). The meter is now turned on and in set mode

2. Press to change the time format (12H or 24H). The 24H format is known as militarytime.

3. Press to confirm the setting.S

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4. Press to change the hour, and then press .

5. Repeat step 4 by pressing to choose the function and then entering the setting with until the minuday, and month are set. The date and time are set in the following sequence:

NOTE: If you do not set the date and time, a series of zeros will be displayed when you take a reading.Consequently, statistical evaluations (in the electronic notebook, see Chapter 4) cannot be performed as theyonly use data stored together with the date and time. To distinguish readings in the memory, they are numbeconsecutively.

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Setting the Alarm Clock FunctionOnce you have set the time and date, the alarm function appears. The alarm clock is designed to alert theoperator that it is time to conduct glucose testing.

NOTE: In a multiple resident environment, each resident may require testing at different times. The

recommendation is to not set the alarm clock when using the ACCU-CHEK Go meter in a multiple residentenvironment.

Press to set it to "On" or "Off." Press to confirm your choice.

If you have chosen "Off," the alarm clock function is disabled and youwill automatically move to "Setting the Beep Tone" (see page 10).

When turned "On," you can set up to three separate alarm times. Setthe time for the first alarm call, as follows:

1. Press to select the unit of time you wish to set. The unit will flash, indicating that it is ready to be changed

2. Press to change the time unit.

3. Press to set the second and third alarm times.

NOTE:You do not have to set all three alarm times. Leaving the time as "0:00" deactivates that alarm time.Entering any other time activates that alarm. You can also turn off an alarm that was previously set. Simplychange the time to "0:00." If you wish to set an alarm for 0:00 hrs, be sure to enter 23:59 or 11:59 p.m.

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If you have turned on the alarm clock function, a reminder beeper will sound at the set times with tones at 1second intervals for 20 seconds. You can turn off the alarm within these 20 seconds by pressing either butto

NOTE: If the meter is already turned on at one of the set alarm times, the alarm will not sound.

NOTE: If you turn off the alarm clock function after setting the alarm time(s), they will remain stored in memo

Once you have set the alarm time(s), press to confirm and move on to Setting the Beep Tone.

Setting the Beep ToneOnce you have confirmed the alarm settings, you have the option of turning the beep tone on or off. The beeptone sounds, for instance, after blood has been applied at the start of testing, and when a result is displayed.

1. Press to set the beep to "On" or "Off."2. Press to confirm your choice.

NOTE: The beep tone, as mentioned in this manual, willonly sound if it has been turned "On" as described above.

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Setting the Hypoglycemic (Hypo) WarningOnce you have confirmed the beep tone setting with , you have the option of turning on the hypo warning ansetting a hypo warning threshold (you can program one of three thresholds). This warning appears in the form offlashing hypo? message in the display and is accompanied by five beeps (if the beep tone is turned on).

The hypo warning is delivered whenever a test result is below the threshold that was set onthe meter. This may indicate possible hypoglycemia.

Take caution when using the hypo warning in a multipleresident environment. Each resident may have a differenthypo threshold value. Follow the protocol established by yourhealthcare facility when setting the hypo value. Never maketreatment decisions based on indicators or error messages.

Only take action based on the blood glucose result.

The meter has the hypo indicator turned off by default. To turnon and set the hypo indicator:

1. Press and the lowest threshold value is displayed (60 mg/dL).

Press again to select a higher value (70 or 80 mg/dL).

2. Press to confirm your choice.

3. Press again to exit the set mode and turn the meter off.S

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Coding the MeterChange the code key every time you open a new box of test strips.

1. Slide the new code key from its holder at the bottom of the vial.

2. With the meter off, insert the code key into the code key slot. It should snap into place.

3. When you insert a test strip, make sure the code number on the displaymatches the code on the test strip vial.

NOTE: When you insert a new code key, if the code numberon the display does not match the code on the test strip vial, call the ACCU-CHEK Customer

Care service center at 1-800-440-3638.


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Chapter 2: Control Testing

Why Run Control Tests?Control tests ensure that both the meter and the test strips are working properly and giving reliable results. Yshould run a control test when:

The meter is new

You open a new box of test strips

You insert a new battery

You clean the meter

You drop the meter The test results dont agree with clinical symptoms

You want to make sure youre performing tests correctly

Please contact the ACCU-CHEK Customer Care service center at 1-800-440-3638 for details of where you caobtain ACCU-CHEK Go control solution.

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NOTE: Once the flashing blood drop appears on the screen, you have 90 seconds to apply solution to the stri

Please always wait for this indicator and do not apply control solution prematurely or the meter may gan incorrect reading.

5. Briefly roll the bottle of control solution, open it, squeeze one drop onto a napkin or paper towel, and wipe tip of the bottle clean.

6. Hold the meter so the test strip points down at a slight angle.

7. Gently touch and hold one drop of solution against the black notch on the strip until thehourglass symbol is displayed.

If the beep signal is turned on, the meter will also beep to indicate that the test strip has correct amount of solution.

After approximately 5 seconds, the meter beeps a second time (if the beep signal is turneon) and displays the test result.

Chapter 2: Control Testing 15 ACCU-CHEK Customer Care Service Center 1-800-440-

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8. To remove the test strip, hold the meter so the test strip points straight down and push the test strip ejectorforward as far as it will go. (The meter turns off automatically.) Dispose of the test strip in a proper wastecontainer.

Understanding Control Test ResultsWhen a control test result is within the acceptable range, the test strips and meter are working properly. Thelabel on the test strip vial shows the acceptable ranges for Level 1 and Level 2 control solutions. The control results should be within the listed range. You can compare the result to the range for the level of control soluyou used (Level 1 or Level 2).

Example: Range (mg/dL) Mean (mg/dL)

Level 1 (Lo) 36-66 51Level 2 (Hi) 267-361 314


ACCU-CHEKGo Control

Range (mg/dL)

1 36 - 66

2 267 - 361

Mean (m

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314

The figures are for illustration only.


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When a control test isnt within the acceptable range, there could be several reasons. Follow these steps tofind out why:

Troubleshooting Checks Action

1. Check the expiration dates of the test strips Replace control solution or test strips that haveand control solutions. expired or control solution you opened more thanthree months ago.

2. Make sure the caps were tight on the test strip If either has been open for a while, replace the tesvial and control solution bottles. strips or control solution.

3. Check that the code number on the meter matches If not, recode the meter (see page 12).

the code on the test strip vial.

4. Make sure you followed all the test steps. Reread pages 14 - 15 and test again.

5. Make sure the temperature was between Repeat the test in the appropriate temperature ran50-104F (10-40C) when you did the test.

6. If none of the above apply Repeat the control test with a new test strip. If theresult still isnt within the acceptable range, contacthe ACCU-CHEK Customer Care service center at1-800-440-3638.



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Chapter 3: Testing Blood Glucose

Before running the first blood glucose test, make sure you set up the meter properly and run controltests. See Chapters 1 and 2 for details.

Ensure that the measurement optics cover is in place. For more information, seeChapter 5: Maintenance and Troubleshooting.

1. Remove a test strip from the vial. Be sure to replace thecap tightly.

2. Hold the test strip so the arrows are on top. Insert the teststrip with the arrows pointing toward the meter until it will

go no further. The meter turns on automatically.3. Make sure the code number on the

display matches the code on thetest strip vial.

Do not carry out any tests if the code number on the display is not the same as the code on the test st

vial. Incorrect coding produces incorrect results. Incorrect results can cause the wrong therapeuticdecision to be taken and so produce adverse health effects.

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NOTE: If the symbol (test strip expired) appears at the bottom of the display, it indicates that the test striis past its expiration date. Check the expiration date on the label of the test strip vial. Also check that you havinserted the code key that came with that vial of test strips. The date and time must be set for this functionto work.

Do not carry out any more tests if the test strip has expired . Expired test strips can produceincorrect results. Use a new vial of test strips and the code key that came with it.

4. Wait for the flashing blood drop to appear. You have 90seconds to apply a drop of blood.

Always wait for this indicator and do not apply bloodprematurely or the meter may give an incorrect reading

or display an error message.

5. Use a lancet device to obtain a small drop of blood.

6. Apply the blood drop to the black notch onthe front edge of the test strip. You may applymore blood for up to 15 seconds after applying

the first drop.

Chapter 3: Testing Blood Glucose 19 ACCU-CHEK Customer Care Service Center 1-800-440-

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7. An hourglass symbol will appear on the screen.After 5 seconds the test result will appear.

To help remember specific events that might haveinfluenced a specific blood glucose result, you can adda flagan asteriskto mark those results in the memory.

To flag the result before you begin the test, presstwice when the flashing blood drop appears on the display. To flag the result afterthe test, press twice while the result is still displayed.

If this feature is used in a multiple resident environment, the use of the flag should be predefined and staffshould receive proper training.

NOTE: Do not move the test strip when reading is in progress. If you do, the reading may terminate (see erro

messages "E 4" on page 43 and "E 9" on page 44).8. To remove the test strip, hold the meter so the test strip points straight down and push the test strip ejecto

forward as far as it will go. (The meter turns off automatically.) Dispose of the test strip and lancet in anappropriate biohazard container.

NOTE:Always use the test strip ejector to remove the test strip and turn off the meter after use. If you leave ttest strip in the meter after testing, the meter will begin to beep after 60 seconds. The meter turns off

automatically after another 30 seconds. Leaving the meter on for extended periods of time will shorten thebattery life.

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Tips for Testing by Healthcare Professionals Wear gloves.

Always use the test strip ejector to remove a used test strip.

For each person use a separate lancet and lancing device or a single-use lancet device, which is specially

intended for this type of application.

Discard used lancets and test strips in an appropriate biohazard container or in accordance with your facildisposal procedure.

Be sure to observe all relevant Health and Safety regulations.

A potential infection risk exists. Medical staff and other persons using the ACCU-CHEK Go meter to teblood glucose from more than one resident must be aware that any item coming into contact withhuman blood is a potential source of infection. (Please see "Protection of Laboratory Workers fromInfectious Diseases Transmitted by Blood, Body Fluids, and Tissues"; Second Edition, Tentative Guide1991, Document M29-T2, National Committee for Clinical Laboratory Standards.)

For more information about test results, see page 22.


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Understanding Blood Glucose ResultsNormal Blood Sugar RangesThe fasting adult blood glucose range for a non-diabetic is between 70 mg/dL and less than 110 mg/dL 1.Two hours after meals, the blood glucose range for a non-diabetic is less than 140 mg/dL2.

Symptoms of High or Low Blood SugarBeing aware of the symptoms of high or low blood sugar can help you understand test results and make atreatment decision if the results seem unusual or different from clinical symptoms. Here are the most commosymptoms:

High blood sugar (hyperglycemia): sweating, fatigue, increased appetite or thirst, frequent urination, blurred

vision, headache or general aching.

Low blood sugar (hypoglycemia): sweating, trembling, blurred vision, rapid heartbeat, tingling or numbnessaround mouth or fingertips.


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Unusual Test ResultsIf the displayed result does not reflect clinical symptoms, or seems unusually high or low, follow these steps:

1. Run a control test (see pages 14 - 15)

2. Repeat the blood sugar test (see pages 18 - 20)

If the control test confirms that the meter is working properly, and you have performed another blood glucosetest with a new test strip, and still feel the new result is unusual, call your doctor or take appropriate action pyour healthcare facilitys guidelines.


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Important Information for Healthcare ProfessionalsUsing the ACCU-CHEK Go system in a Multiple Resident Environment

The ACCU-CHEK Go system is not designed to be a data storage device in a multiple resident environment. Tmeans that the use of the meter does not replace the need for documentation that supports the quality contro

and result report functionality required by facility policy or regulatory agencies.Depending on your healthcare facilitys policy, you may be directed to record resident test results in theresidents chart or in a log. The results from each test should be recorded immediately after each resident tesavoid misidentifying results.

Proper resident identification is achieved by ensuring that the glucose result is recorded in the correct residenchart or on a log that prompts the operator to record the resident identification. Be sure to follow your health

facilitys procedures and appropriate regulations.Depending on your facilitys policies, procedures, and compliance standards, information about the meter andperformance may need to be documented and retained for reference. Records could include:

History of meter cleaning

Results from control testing

Results from resident testing


Test strip and control solution lot numbers


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Test strip and control solution lot numbers

Operators trained to perform testing

You may need to develop logs or modify existing templates to document the performance and review of thesrecords. Please call the ACCU-CHEK Customer Care service center at 1-800-440-3638 for a sample template

When reviewing results from these manual logs, keep in mind the following points:

"Missing" results may have been performed but not documented.

It is up to the operator to ensure that the control result is in range.

Meter results cannot be used to reconcile manual log entries. This would be using the meter as a datastorage device which is not recommended in a multiple resident environment.

Reasons for not using meter results to reconcile manual log entries include:

-Multiple meters may have been used to run glucose tests entered on one log

-Meter results have no resident identifiers linked with the results

-Meter results from control samples may not have been flagged as a control test at the time the test wasperformed


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Storing the SuppliesMake sure you close the test strip and control solution bottles tightly after each use. You can keep all the testsupplies in the carrying case. Store the carrying case (and everything in it) where it wont be exposed to heatmoisture.

Never store test strips in areas of high heat and moisture, which can damage them.

Proper Testing Conditions The temperature range must be between 50-104F (10-40C) for accurate results. At temperatures outside

this range, the meter turns off or results are displayed with a thermometer symbol and may not be accuraNever artificially heat or cool the meter.

Humidity must be below 85% so that moisture doesnt condense on or inside the meter. Sudden changes temperature may cause condensation to form within the meter. You may find you are unable to turn on themeter. If this happens, let the meter return to room temperature and thoroughly dry before turning it on.

The meter will display a message if it is too warm or too cold to carry out a blood glucose test (see Chapter

Do not use results obtained at the limits of the permitted temperature range as a basis for makingtherapeutic decisions. Results are displayed with a thermometer symbol under these conditions.


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Sources of Interference


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Sources of InterferenceStrong electromagnetic fields may interfere with the proper operation of the meter. Do not use this meter inclose vicinity 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.


Chapter 4: Using the Meters Memory


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Chapter 4: Using the Meters Memory

The meter automatically stores up to 300 test results, and you can review them at any time. If youve set thedate and time (see pages 7 - 8), this information is stored and displayed with the test results. If you havent s

the date and time, test results are simply stored in order, from newest to oldest. Once all the memory locatioare full, the meter automatically overwrites the oldest entry.

In a multiple resident environment, we recommend that you do not use the memory function, including7, 14, and 30 day average because the results stored in the ACCU-CHEK Go meter memory are not linto specific resident identifications.

In addition to results, the meter also stores all relevant additional information and display messages. For

example, results flagged as control results (see Chapter 2) are displayed together with a bottle symbolincorporating the letter "C." Results obtained at a temperature outside the permitted range are displayedtogether with a thermometer symbol. Please refer to Chapter 5 for a complete list of display messages andsymbols.

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Press and at the same time to display the 7-day average.

Press and at the same time to displaythe 14-day average. By repeating this step, youcan scroll through the 7-, 14-, and 30-day

averages.

Press to exit from the "average" screen and return to normalmemory mode, showing the last result retrieved.

Press to turn off the meter.

NOTE: When averages are being calculated, all results flagged as control readings are ignored.

NOTE: If more than 30 seconds have elapsed since the last button was pressed, the meter turns itself off topreserve battery life.

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Chapter 4: Using the Meters Memory 30 ACCU-CHEK Customer Care Service Center 1-800-440-

Example

Downloading the Meter to a Computer or PDA


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Downloading the Meter to a Computer or PDAYou can transfer the stored results to a computer or PDA to track, identify, and print them out. We offer softwand cables to help you download the results from the meter to a personal computer or PDA. For a list ofsoftware and cables that are compatible with the ACCU-CHEK Go meter, call the ACCU-CHEK Customer Careservice center at 1-800-440-3638.

Transferring Data1. Install the software according to the instructions.

2. Run the software program and follow the instructions about how to download information. Make sure thesoftware is ready to accept data from the meter.

3. Position the meter no more than 4 inches from the infrared adapter. Point the two infrared windows towarone another.

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4. Turn on the meter by keeping pressed until "PC"flashes on the display, indicating that the meter is readyto communicate.

5. After the information has been transferred to your computer,"End" appears in the display.

6. Press to turn off the meter.

NOTE: The computer or PDA may automatically turn off the meterfollowing the transfer. In this case, the "End" message may not be displayed.

NOTE: The meter turns off automatically if the download was unsuccessfulor only part of the data was sent.

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Chapter 5: Maintenance and Troubleshooting


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Chapter 5: Maintenance and Troubleshooting

Cleaning the MeterDuring testing, blood is applied to the test strip and does not enter the meter. This helps reduce the need toclean the meter. Should the measurement optics become dirty, an E4 or E5 error message will display and th

ACCU-CHEK Go meter will not permit glucose testing to occur.

If the display or the outside of the meter is dirty, wipe it off with a slightly damp cotton swab. You may usewater, 70% isopropyl alcohol or a 1:10 dilution of household bleach.

For disinfection, please take note of the contact time it takes for the bleach solution to act. Other cleaning agmay damage the meter or impair its measuring function.

NOTE: Healthcare professionals should observe all relevant health and safety regulations. The meter can becleaned between uses or when the operator notices that the test strip guide has become visibly soiled.

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If there is blood in the test strip opening or the meter displays the E4 or Emessage, follow these steps to clean it:

1. Remove the measurement optics cover by pushing up on theright-hand side (where the arrow is) and lifting it off.

2. Clean the measurement optics with a cotton swab dampenedslightly with water, 1:10 bleach solution or 70% isopropyl alcohol.Make sure no liquid enters the meter. Avoid scratching the measurement optics,as this will impair the measuring function.

3. When the components are thoroughly dry put the measurement optics coverback on by pressing down one side at a time. The cover quietly clicks intoplace.

4. Run a control test (see pages 14 - 15) to make sure the meter is workingproperly.

Always operate the meter with measurement optics cover in place.

Chapter 5: Maintenance and Troubleshooting 34 ACCU-CHEK Customer Care Service Center 1-800-440-

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Some cleaning methods can damage the meter. To protect the meter, DO NOT:

Spray any cleaning solution directly onto the meter.

Put the meter under water (or any liquid).

Pour liquid into the meter.

A potential infection risk exists. Medical staff and other persons using the ACCU-CHEK Go meter to tesblood glucose from more than one resident must be aware that any item coming into contact with humblood is a potential source of infection. (Please see "Protection of Laboratory Workers from InfectiousDiseases Transmitted by Blood, Body Fluids, and Tissues"; Second Edition, Tentative Guideline, 1991,Document M29-T2, National Committee for Clinical Laboratory Standards.)


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Performing a Full Display Check


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Performing a Full Display CheckThe ACCU-CHEK Go meter needs little or no maintenance with normal use. It automaticallytests its own systems every time you turn it on, and lets you know if something is wrong.(See pages 43 - 45 for error messages and what to do about them.)

The standard power-on display test checks the most important display elements. To verify thaall of the elements are functioning correctly, you can carry out a full test.

Press and hold down and together until the display is shown.

All the elements of the liquid crystal display (LCD) are shown on the display at once.

Press any button to terminate the display test and turn off the meter.

If you drop the meter or think its not giving accurate readings, make sure that the test strips and controlsolution havent expired, and then run a control test. (See pages 14 - 15 for more information.)

If you have any questions about whether the meter is working correctly, call the ACCU-CHEK Customer Careservice center at 1-800-440-3638.

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This message appears... and means:


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g pp

in Test Mode

while the result is displayed (Test and Memory) The temperature is/was at the limits of thepermitted range at the time of testing. Do not uthe result as a basis for therapeutic decisions.

in all modes When this symbol first appears, you can perform

approximately 50 additional tests. Replace thebattery as soon as possible.

during testing The test is in progress.




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g pp

during testing, when turned on This is/was a control test.

alongside results in memory

in all modes The expiration date of the test strips you arecurrently using has been exceeded. Change the tstrips and code key. Check the date and time

settings. The date and time must be set for thisfunction to work.

in Memory Mode The respective average value is displayed.




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in Set Mode The beep tone can be turned on or off.

in Set Mode Marks the alarm clock settings.

with the alarm clock call Visual display during the 20 second alarmclock call.

in Test Mode At least one alarm time has been set.

(flashing) in Test Mode Apply blood or control solution now.




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(flashing) in Test Mode The most recent result is below the hypo threshoyou selected.

(flashing) in Memory Mode The stored result was below the hypo thresholdyou selected.


This message means: The blood glucose result is below themeasuring range (< 10 mg/dL)


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The meter is in Memory Mode,but no result has been saved yet.

No 7/14/30 day average can be calculated,because

no results have been saved in the past7, 14, or 30 days

the date and time have not yet been set

or the date has been set to a time in the

past.

Saved result lost.

measuring range (< 10 mg/dL).

The blood glucose result is above the

measuring range (> 600 mg/dL).

The test strip has been inserted incorrectlyor incompletely Gently insert the test strip

The measurement optics are dirty or yohave inserted a used or expired test stri


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ACCU-CHEK Customer Contents 43 Service Center 1-800-440-3

or incompletely. Gently insert the test stripwith the arrows pointing toward the meter,until it will go no further.

The wrong code key is inserted. Insert thecode key that came with the vial of stripsyou are using.

The meter cannot read the code key.Remove the code key and reinsert it.

or

The wrong code key may have beeninserted. Insert the code key that camewith the vial of strips you are using.


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have inserted a used or expired test striClean the measurement optics (Chapterand repeat the test with a new strip.

or

Blood or control solution was applied toearly. Always wait for the test strip symband flashing drop of blood to appear in tdisplay before applying blood or controlsolution.

If you see this error message frequentlyor it is permanent, please contact the

ACCU-CHEK Customer Care servicecenter at 1-800-440-3638.

l l ll

l

llll

ll

l

llllllll

l

Dirty optics. Clean the measurement optics(Chapter 5) The test strip was in the meter

display before applying blood or controlsolution


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(Chapter 5). The test strip was in the meterfor too long (longer than 90 seconds) aftertesting. When you perform the next test,eject the test strip immediately.

If you see this error message frequently

or it is permanent, please contact theACCU-CHEK Customer Care servicecenter at 1-800-440-3638.

The blood volume was insufficient. Repeatthe test with a new test strip.

The test strip was moved during testing.Repeat the test with a new test strip.

or

Blood or control solution was applied tooearly. Always wait for the test strip symbol

and flashing drop of blood to appear in the

l ll

lllllllll

l

l

l

ll

l

llllllll

l

solution.

or

There is electromagnetic interference.Repeat the test. If you get the same

message, move away from sources ofinterference and repeat the test.

The code key was removed after applyinblood, is defective, or is not insertedcorrectly. Remove the code key andreinsert it.

The test strip was moved during testing the blood volume is not sufficient. Repeathe test with a new test strip.

ll

l

llllllll

l

l l ll

l

llll

Turn off the meter and repeat the test.If the error persists please contact the


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If the error persists, please contact theACCU-CHEK Customer Care service centerat 1-800-440-3638.

The code key is missing or is defective.

Replace the code key.

The temperature of the meter is outside thepermitted range. Move the meter to a roomwhere the temperature is between 50-104F

and wait until it has come to roomtemperature and the error message hasdisappeared.


l l ll

l

llll

Possible Sources of Error


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If you receive frequent error messages, or if you often obtain questionable results, please check the following

Are only ACCU-CHEK Go test strips being used with the meter?

Does the code number on the display match the number printed on the test strip vial?

Does the battery still have enough power, and is it properly inserted?

Have you completely removed the protective film from the battery?

Have you carefully read the Users Manual and carried out tests as instructed?

Have you read the package inserts that came with the test strips? Have you stored and used the strips correc

Have you followed all the proper measurement and storage conditions?

Are the test strips and/or control solution still within the stated expiration date?

Are the test strip guide and measurement optics clean? Is the measurement optics cover in place?

If the answer to all these questions is "yes," carry out a control test with a new test strip as described inChapter 2. If this check confirms the meter is working properly, please read the instructions in Chapter 3 agaand perform another blood glucose test with a new test strip.

If you have checked all these points and still are having problems, please contact the ACCU-CHEK Customer

Care service center at 1-800-440-3638.


Chapter 6: Technical Information


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Product LimitationsPlease read the literature packaged with the test strips to find the latest information on product specificationsand limitations.

SpecificationsDisplay 96-segment liquid crystal display

Automatic power-off 1-2 minutes after last button press

Power supply (1) 3-volt lithium battery type CR2430 or DL2430

Meter type ACCU-CHEK Go meter

Measuring range 10 to 600 mg/dL

Sample size 1.5 L

Measuring time approx. 5 seconds

System operating temp. 50F to 104F (10C to 40C)

47

Meter storage conditions -13F to 158F (-25C to 70C)

Test strip storage conditions Refer to the test strip package insert


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Test strip storage conditions Refer to the test strip package insert

Relative humidity operating range Less than 85%

Memory capacity 300 blood glucose results with date and time, 7, 14, and 30 day average

Dimensions (L x W x D) 4.5 x 1.8 x 0.79 inches (113 x 46 x 20 mm)Weight 1.6 oz. (55 g) without battery

Battery life approx. 1000 tests in one year

Interface infrared interface, LED/IRED Class 1

Electromagnetic compatibility This device meets the electromagnetic immunity requirements as per ISO

15197 Annex A. The chosen basis for the immunity tests was basic standIEC 61000-4-2. In addition it meets the electromagnetic emissionsrequirements as per EN61326. Its electromagnetic emission is thus low.Interference from other electrically driven equipment is not to be anticipa

Catalog number/serial number See type plate on the back of the meter

Test principle Determination of glucose in fresh capillary blood by reflectancephotometWhen using different specimen material please refer to the package insethat came with the ACCU-CHEK Go test strips.

Chapter 6: Technical Information 48 ACCU-CHEK Customer Care Service Center 1-800-440-

Product Safety InformationExplanation of Symbols and Notes


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Explanation of Symbols and Notes

ACCU-CHEK Customer Contents 49 Service Center 1-800-440-3Chapter 6: Technical Information 49 ACCU-CHEK Customer Care Service Center 1-800-440-

!CAUTION

Please refer to safety-related notes inaccompanying

documentation.

3-volt battery(CR 2430 or

DL2430)

This product fulfills therequirements of

Directive 98/79/EC onin vitrodiagnosticmedical devices.

The ACCU-CHEK Gmeter has been lis

by UnderwritersLaboratories Inc.

accordance with

UL 3101-1 andCAN/CSA C22.2

No. 1010-1.

Notes - Offer information or helpful hints about the related subject.

Warranty


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ACCU-CHEK Go Limited 3-Year Warranty

Roche Diagnostics warrants to the original purchaser of the meter that the ACCU-CHEK Go meter will be free from defec

in materials and workmanship for three years from the date of purchase. If, during this three-year period, the meter doenot work properly because of a defect in materials or workmanship, Roche Diagnostics will replace it with a new meter

equivalent product free of charge. The warranty of the replacement meter will expire on the date of the original warrantyexpiration or ninety days after shipment of a replacement system, whichever period is longer. The purchasers exclusiveremedy with respect to the ACCU-CHEK Go meter shall be replacement.

This warranty does not apply to the performance of an ACCU-CHEK Go meter that has been damaged by acciden

or has been altered, misused, tampered with or abused in any way. Roche Diagnostics will handle meters that

show damage or abuse according to its Non-Warranty Service Policy, described on the next page.

THE ABOVE WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES, AND ROCHE DIAGNOSTICS MAKES NO OTHERWARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTY OF

MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIAB

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 I

IMPLIED FROM THE SALE OF THE METER, SHALL EXTEND FOR A LONGER DURATION THAN THREE YEARS FROM T

DATE OF PURCHASE.


Some states do not allow limitations on how long an implied warranty will last or the exclusion of incidental orconsequential damages, so the above limitation and exclusion may not apply to you.This warranty gives you specific leg


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rights, which vary from state to state.

Non-Warranty Service Policy

Roche Diagnostics Non-Warranty Service Policy applies to meters where the above warranty has not become effective,become inapplicable, or has expired. Roche Diagnostics will replace at its option meters returned to it for a service char

(not to exceed $100). Replacement will be with like or similar product. Replacement meters will be warranted for a periof 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 Go meters under the above warranty or service policy must be made to the ACCU-CH

Customer Care service center by calling 1-800-440-3638. You will be mailed a return authorization label which must beaffixed to your carton for shipping the system to Roche Diagnostics. Cartons received without this label will be returned

you at your expense. Customers experiencing difficulties should review the Troubleshooting Guide found in this manual.Further inquiries should be directed to the ACCU-CHEK Customer Care service center at 1-800-440-3638.

Be sure to fill out your warranty form that came with your ACCU-CHEK Go system.


CAUTION: A RESTRICTED LICENSE LIMITS USE OF THE ACCU-CHEK GO SYSTEM READCAREFULLY THE LIMITATIONS RECITED BELOW.!


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The ACCU-CHEK Go system (meter, including the code key, and test strips) and its use are protected by USPatent Nos. 5,463,467; 5,206,147; 6,707,554 and 5,366,609. A license to use the ACCU-CHEK Go system is granted when the ACCU-CHEK Go meter is used with the ACCU-CHEK Go test strips and ACCU-CHEK Go codekeys. The ACCU-CHEK Go test strips are provided with a specifically matched ACCU-CHEK Go code key. These

test strips and code keys are specifically manufactured for operation with the ACCU-CHEK Go meter. Use of otest strips with an unmatched code key or even with the matched code key supplied by another manufacturemay prevent or impair the proper function of the ACCU-CHEK Go system.

Using the ACCU-CHEK Go system indicates your acceptance of the restricted license to use the ACCU-CHEK Gsystem only with ACCU-CHEK Go test strips and the ACCU-CHEK Go code key. Further, if you have purchased

ACCU-CHEK Go blood glucose monitoring kit or an ACCU-CHEK Go meter that includes this restricted license,

then this restricted license applies regardless of any additional offers found in ACCU-CHEK Go test strippackages. If you do not agree to the terms and conditions of the restricted license, you may return, at the plaof purchase, the unused ACCU-CHEK Go system for a full refund. If you have any questions, please call the

ACCU-CHEK Customer Care service center at 1-800-440-3638.

Except where prohibited by statute, all warranties covering the ACCU-CHEK Go system are voided by use of tACCU-CHEK Go system with any test strip or code keys other than ACCU-CHEK Go test strips or ACCU-CHEK code keys.


Patent InformationThis product is protected by US Patent Nos 5 463 467; 6 707 554; 5 206 147; 5 240 860; 5 334 508


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This product is protected by US Patent Nos. 5,463,467; 6,707,554; 5,206,147; 5,240,860; 5,334,508,5,382,523; 5,521,060; 6,036,919; 6,696,024; 6,207,000; and 6,455,001.

Additional Supplies

The following supplies and accessories are available from your authorized Roche Diagnostics DiabetesHealthcare Center, pharmacies or your medical/surgical supply dealer:

Test Strips

ACCU-CHEK Go test strips Cat. No. 0 3536351360

Control Solution

ACCU-CHEK Go control solutions Cat. No. 0 3603504160Lancets

ACCU-CHEK Safe-T-Pro lancets Cat. No. 951 Ref No. 0 3136752001

ACCU-CHEK Safe-T-Pro Plus lancets Cat. No. 3448622 Ref. No. 0 3448622001


ReferencesS d Th L h S d M di l Di i h Edi i


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1. Stedman, Thomas Lathrop. Stedmans Medical Dictionary, 27th Edition, 1999, pg. 755.

2. American Diabetes Association, "Clinical Practice Recommendations 2003." Diabetes Care,Vol. 26,Supplement 1, pg. S22.


Alphabetical Index CCleaning


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AAdditional supplies, 53

Alarm clock function

Setting, 910

BBattery

Removing protective film, 6

Replacing, 6

Symbol, 38

Beep tone

Setting, 10

g

Meter, 3335

Coding, 12

Control testing, 1415

Ranges, 16

DDate

Setting, 78

Display check, 36

Display messages, 3742

Error messages, 20, 4345

Disposal of test strip, 21

Downloading data, 3132


EElectromagnetic interference, 27

IInfrared interface 3132


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g ,

Electronic notebook, 2830

Averages, 2930

Retrieving results, 29

Entering settingsAlarm clock function, 910

Basic settings, 711

Beep tone, 10

Hypo indicator, 11

Time and date, 78

Error messages, 4345

HHypo warning, 11

Infrared interface, 31 32

MMeasurement optics cover cleaning, 3335

ModesMemory, 2830

Set, 7-11

NNotebook, electronic, 2830

Averages, 2930Retrieving results, 2930

PParts summary meter, 45

PC (or handheld computer), 3132


QQuality control testing, 1315

SService


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Control readings, 1617

Display check, 36

RRelative humidity, 26, 48Repair service, 5051

Results

Display messages, 3742

Drop symbol, 14, 40

Hypo indicator, 11, 41Memory, 2830

Temperature, 17, 26, 38

Test strip expired, 17, 19

Understanding blood glucose, 2223

Local ACCU-CHEK Customer Care, 51

Sources of error, 46

Sources of interference, 27

Statistics, 2830Software, 31

Storage conditions meter, 48

Symbols (meter)

Alarm clock function, 910, 40

Battery, 6, 38, 49

Beep tone, 10, 40


TTechnical data, 4749

UUnderstanding the meter, 45


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Temperature range storing, 17, 26

Test strip ejector, 20

Testing, 1820

Healthcare professionals, 21Measurement conditions, 48

Memory, 2830

Range (blood glucose), 22

Sources of error, 46

Understanding results, 1617, 2223

Testing procedure, 1415, 1820Time Setting, 78

Turning off, 9, 20, 30

Understanding the meter, 4 5

WWarranty, 5052


Notes


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Notes


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ACCU-CHEKGO


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ACCU-CHEK Customer Care service center 1-800-440-3638

2006 Roche Diagnostics. All rights reserved.

Roche Diagnostics GmbHSandhofer Strasse 116D-68298 Mannheim

Assembled for and distributed in the U.S.A. byRoche Diagnostics9115 Hague RoadIndianapolis, In 46256

Made in Ireland

ACCU-CHEK, ACCU-CHEK GO, and SAFE-T-PRO are trademarks of Roche.

03664414003-

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