Cera-Chek 1070 - Blood Glucose Monitoring System Manual

IMPORTANT SAFETY INSTRUCTIONS

READ THIS BEFORE USE.
The following basic safety precautions should always be taken.

1. Close supervision is necessary when the device is used by, on, or near children or disabled.
2. Use the device only for the intended use described in this manual.
3. Do not use with accessories which are not supplied by the manufacturer.
4. Do not let the device come into contact with hot surfaces.
5. Do not use the device where aerosol sprays are being used.
6. Do not use the device if it is not working properly, or if it has suffered any damage.
7. Before using this product, read all instructions thoroughly.
   Conduct control solution test as directed in the manual.
   Consult with a diabetes healthcare professional before usage.

NOTE
PLEASE KEEP THE USER'S MANUAL NEARBY THE GLUCOSE TEST METER.

INTRODUCTION

Thank you for choosing the CERA-CHEK 1070 Blood Glucose Monitoring System. The CERA-CHEK 1070 is superior in accuracy, retest results, and portability. Stored test results are easily retrievable so that you may compare them to laboratory results with your physician.
This allows for better management of your diabetes and periodic blood glucose testing. Please be sure to read this manual before using the CERA-CHEK 1070 Blood Glucose Monitoring System. If you have any questions, please contact your local healthcare professional.

Intended Use

The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to help people manage their diabetes with measuring their glucose level with fresh capillary whole blood from the fingertip, the palm, the forearm, the Upper arm, the thigh, the calf for self testing. It also provides professional healthcare personnel with the helpful information with measuring glucose concentration in fresh capillary whole blood as well as fresh venous blood. The CERA-CHEK 1070 Blood Glucose Monitoring System is intended for in vitro diagnostic use.

Principle of Measurement

The test is based on the measurement of an electrical current generated by the reaction of glucose with the reagent of the test strip.
The test meter measures the current and displays the corresponding blood glucose level. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.

IMPORTANT INFORMATION

• Severe dehydration and excessive water loss may cause false, low results. If you believe you are suffering from severe dehydration, please consult your healthcare professional immediately.
• If your blood glucose results are higher or lower than usual but you do not have any unusual symptoms, repeat the test once more for accuracy.
• If you have symptoms or continue to get results higher or lower than usual, follow the treatment advice of your healthcare professional.
• Only apply fresh whole blood sample to the absorbent hole. Applying other substances to the absorbent hole will cause inaccurate results.
• If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all instructions described in this user manual, call your healthcare professional.
• Inaccurate results may occur in severely hypotensive individuals or patients in shock. Abnormally low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with test meters.
• Please refer to the insert paper in your test strip package for additional important information.

CONTENTS OF THE SYSTEM

Your test meter has been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only with the manufacturer's compatible test strip and glucose control solution with this test meter.

Your system includes

1. Test Meter
2. Lancing Device
3. 3V Lithium Coin Battery
4. User Manual
5. Carrying Case
6. Test Strips including Code Key(both optional)
7. Glucose Control Solution(sold separately)
8. Sterile Lancet(optional)

NOTE
CERA-CHEK 1070 Blood Glucose Test Strips(including code key) and Glucose Control Solution are sold separately.

UNDERSTANDING THE DEVICE

Appearance and Key Functions of the Test Meter

Insert Port
The insert port is where you insert the test strips for testing as well as the code key for calibration.

Power Button
Turn the meter ON or OFF Enter the "Set" mode Save the date, time, measurement unit and alarm settings.

Display
Your test results are display here.

Setting Buttons ( )
Change the date, time, measurement unit and alarm settings Recall previous test results from the meter memory.

Data Port
Send stored data to a computer via an optional data transfer cable to view.

Explanation of the Test Meter Display

1. Memory Symbol: Indicates a test result stored in memory.
2. Test Result Area: Test results, code numbers or error messages are displayed here.
3. Blood Drop Symbol: This symbol tells you when to apply the sample.
4. Test Strip Symbol: Appears when to insert test strip.
5. Alarm Symbol: Appears when in the alarm setting mode or when alarm is beeping.
6. Battery Symbol: Appears when the battery is low.
7. Code: Indicates the code number of the test strip.
8. Measurement Unit: Appears with the test result either in mg/dL or in mmol/L.
9. Temperature Symbol: Appears when the temperature is abnomally high or low.
10. Day Average: Indicates a test result in average.
11. Set: Appears when in the setting mode.

Test Strip Description

Your test strip measures the concentration of glucose in whole blood. Blood is applied to the absorbent hole of the test strip and is automatically drawn into the reaction zone.

Contact Port: Insert this end of the test strip into the test meter. Push it in firmly until it will go no further.
Grip: Hold this part to insert or remove the test strip.
Confirmation Window: This is where you confirm if enough blood has been applied to the absorbent hole of the test strip.
Absorbent Hole: Apply a drop of blood here. The blood will automatically flow into the reaction zone.

Code Key Description

When the using CERA-CHEK 1070 Blood Glucose Contact Monitoring System for the first time, or before using a Port new box of test strips, you will need to calibrate the test meter. There is a code key in every box of test strip. Calibration can be easily done by inserting the code key into the test meter. The code key must match the code numbers on the test strip vial and LCD display.
Please check the right direction to insert the code key &RGH1XPEHU into the test meter.

PREPARATION BEFORE USE

Changing the Battery

NOTE

• To save battery power, the test meter automatically turns off after 2 minutes of inactivity.
• When the low battery symbol appears with other displayed data, it means the battery is running low but has enough power to run 20 times. It is recommended that you should replace the battery as soon as possible. The battery symbol will only appear if the battery is too low to perform any more blood glucose tests. The meter will not function until the battery is replaced.
• Discard old battery as per local guidelines.

To replace the battery

1. Make sure the meter is off before removing the battery.
   
2. Pull the buckle on the battery cover and pull the cover forward.
   
3. Remove the old battery and replace with a new 3V lithium battery (CR 2032).
   Make sure that the positive( + ) side is facing up.
   
4. Close the battery cover.
   

Replacing the battery will not delete test meter settings unless you

• Touch the metal wire inside the battery unit with your fingers or with another metal.
• Exceed 1 minute when replacing the battery.
• Load the battery incorrectly.
• Load a used or weak battery.

• Keep away all batteries from children's reach.
• If a battery is swallowed, please consult a doctor immediately.

NOTE
Recheck and reset the clock setting as necessary after battery replacement to ensure time is set correctly. To set the meter clock, see Test Meter Set-up below.

Test Meter Set-up

Set-up Mode: The meter will enter the set-up mode when replace the battery. With your meter turned on or off, press the Power button for 3 seconds to enter the setup mode. To exit the set mode in any step of the setting, press the Power button for 3 seconds. The meter will save the settings and it will turn off.

Please always set the date and time before using the CERA-CHEK 1070 Blood Glucose Monitoring System for the first time or after replacing the battery. Do not perform a blood glucose test until you have set-up the test meter.

1. Set Year: The year will appear at the bottom of the display. Press the Setting buttons ( ) until the correct year is displayed. Once you have selected the correct year, press the Power button to save your choice and start setting the month.
   
2. Set Month: Press the Setting buttons ( ) until the correct month is displayed. Once you have selected the correct month, press the Power button to save your choice and start setting the date.
   
3. Set Date: Press the Setting buttons ( ) until the correct date is displayed. Once you have selected the correct date, press the Power button to save your choice and start setting the time.
   

NOTE
Pressing the Setting buttons ( ) continuously will pass the numbers quickly.

4. Set Hour: Press the Setting buttons( ) until the correct hour is displayed. Once you have selected the correct hour, press the Power button to save your choice and start setting the minutes.
   
5. Set Minute: Press the Setting buttons( ) until the correct minute is displayed. Once you have selected the correct minute, press the Power button to save your choice and move to set the alarm.
   
6. Set Alarm: You can set up to 5 daily alarms. Press the Setting buttons( ) to choose the number of alarms you would like to set. As you press the Setting buttons( ), the display with "OFF" message will change to the first alarm reminder, '1'. If you continue to press Setting buttons( ), it adds the next alarm reminder. To save the number of alarm reminder, press Power button. Following you will move to the hour setting with the hour blinking. Press the Setting buttons( ) until the desired hour appears. Press the Power button to save your choice and to move the minute setting with the minute blinking. Press the Setting buttons( ) until the desired minute appears. Press the Power button to save and finalize your alarm setting. This will bring you back to the second alarm setup mode '2', if you have chosen a second alarm reminder at the first step of alarm set-up. If not, after saving your first alarm reminder, it will move to the setting of Indicator light on/off.
   

NOTE
Default alarm times are 6:30, 9:30, 12:30, 18:30 and 21:30. You can choose from these or set your own time.

7. Set Indicator: Press the Setting buttons( ) to select to turn On or Off the Indicator light. With the indicator On, the indicator light located on the insert port will be blinking and vice versa. After selecting the Indicator On or Off on the display, press the Power button to save your choice and move to set the measuremen unit.
   
8. Press the Setting buttons( ) to select the measurement unit (mg/dL or mmol/L). With the correct measurement unit on the display, press the Power button to save your choice and finish all the settings.
   

Special caution is needed to choose the measurement unit since the test results can be different according to your choice of measurement unit. Please consult with your diabetes healthcare professional about the measurement unit.

NOTE
Your test meter displays 7, 14 and 30days average which you can access from the test meter memory. These averages are calculated from results obtained during 7 14-30days from the current date and time settings. When you set a new date and time, the 7, 14-30day averages may change. After 2 minutes of inactivity while the test meter is in the setting mode, it will shut down automatically.

BEFORE TESTING

Coding the Test Meter

Insert the code key completely into the code key port with the code number facing up and the code number will appear on the LCD display. Make sure the code numbers on the display match the code key and the test strip vial. If all of the numbers match, you may begin testing.

NOTE
If the code numbers displayed on the screen do not match the code key and the test strip vial, try calibrating again or contact your local distributor.

Glucose Control Solution Test

Checking the System with Glucose Control Solutions CERA-CHEK 1070 Glucose Control Solution contains glucose that reacts to the test strips. By comparing the result tested using the control with the expected range printed on the test strip vial label, it is able to check that the test meter and the test strips are working together as a system and that you are performing the test correctly. It is very important that you do this simple check routinely to make sure you get accurate results.

Perform a Glucose Control Solution Test if

• You would like to test your system without using a blood sample.
• You are using the test meter for the first time.
• You suspect the test meter or test strips may not be functioning properly.
• Test results appear to be abnormally high, or low or are not consistent with the symptoms you are experiencing.
• The test strip vial was left open.
• You are using a new vial of test strips.
• You dropped the test meter.

NOTE
The results obtained from your Glucose Control Solution test do not indicate your personal glucose levels.

Use CERA-CHEK 1070 Blood Glucose Test Meter only with CERA-CHEK 1070 Test Strips. Glucose control solution is sold separately. Do not use the control solution after expiration date as printed on the vial. Use the control solution within 4 months after opened. It is recommended to record the discard date on the coming 4 months on the glucose control solution vial as a reminder when to dispose the opened control solution.
[For example: You open the control solution on January 1st. Count forward four months to April 1st. This is your discard date. Record this date on the side of the control solution vial.]

Always close the cap on the Glucose Control Solution immediately after use.

1. Insert the test strip into the insert port of the test meter.
   The blood symbol will start blinking. The Indicator will also blink if you have chosen "ON" for Indicator in the setting mode.
2. Prepare the Glucose Control Solution.
   Shake the Glucose Control Solution vial thoroughly. Remove the cap, squeeze the vial, discard the first drop, and wipe off the dispenser tip to prevent contamination.
3. Apply glucose control solution.
   Aim directly at the absorbent hole of the test strip.
   Squeeze the vial again to get another drop and the drop will be automatically drawn in the test strip. Make sure the confirmation window is completely filled.
   The test meter will count down from 5 seconds and then display the Glucose Control Solution test result.

If the test result is out-of-the range numbers printed on the test strip vial, repeat the test. If you continue to have out-of-range results, it means that the system may not be working properly. Do not use the product and please contact your local distributor for assistance.

TESTING YOUR BLOOD

Getting a Drop of Blood

Please wash and dry your hands prior to starting.

1. Set the lancing device
   Screw off the cap of the lancing device.
   Insert a lancet into the lancet holder and push down firmly until it is fully seated.
   
   
2. Twist the protective cap until it is separated from the lancet.
   Replace the lancing device cap. Insert a lancet into the lancet holder and push down firmly until it is fully seated. Twist the adjustable tip in either direction until the desired number lines up with the arrow: 1~2 for soft of thin skin, 3 for average skin. 4~5 for thick or calloused skin. Pull the sliding barrel until it clicks.
   
3. To get a drop of blood from a fingertip
   Hold the lancing device firmly against the side of your fingertip.
   Press the release button. You will hear a click, indicating that the puncture is complete.
   Then gently squeeze the punctured area to obtain blood sample. Do not smear the blood sample.
   
4. Remove the lancet
   After pulling the sliding barrel out. Push the ejection system upwards to remove the lancet. Place the protective cap on a hard surface and push the exposed tip into the protective cap.

Alternative Site Testing (AST)

You have the option to get a drop of blood from an alternative site (forearm, upper arm, palm, thigh and calf) in addition to blood taken from your fingertip. When blood glucose is changing rapidly, fingertip samples show these changes more quickly than alternative site samples. Please read this section to understand which option is right for you.

Do not use Alternative Site Testing under the following conditions.

• If you think your blood glucose is low (hypoglycemia)
• If you get alternative site blood glucose results that do not agree with how you feel.
• If you have hypoglycemic unawareness (lack of symptoms)
• After a meal, insulin dose or exercise.
• During illness or times of stress.

1. Choose the puncture site. Select a puncture site from a fleshy area on forearm or palm. Avoid veins, hairs, and bones.
   
2. Massage the area. To increase blood flow to the puncture site, massage the area gently. If you have experience difficulty in getting sufficient blood for a test, rub the testing area vigorously until it feels warm.
   
3. Position the lancing device. Press and hold the lancing device against the puncture site for a few seconds. Press the release button.
   
4. Allow blood drop to form. Continue to hold the lancing device firmly against the skin until a blood drop forms.
5. Once a large enough drop of blood has formed, remove the lancing device.

A lancet should only be used once. Please dispose the used lancet in a safe manner in order not to cause accidental injury.
Never share a lancet of the lancing device with another person.
Always use a new lancet.

Performing a Blood Glucose Test

1. Insert test strip
   Remove the test strip from the vial and immediately close the cap.
   Insert the test strip into the insert port.
   The 'blood' symbol ( ) will blink on the display.

Make sure the code number shown on the display matches the code number printed on the test strip vial. If the code numbers are different, please refer to the section of "Coding the Test Meter", for the procedure of coding.

2. Obtain a blood sample
   Please refer to the section of "Getting a drop of blood" or "Alternative Site Testing (AST).

NOTE
If you do not apply a blood sample to the test strip within 2 minutes, the test meter will automatically shut down. You must remove and reinsert the test strip to restart the test procedure.

3. Apply blood onto the test strip
   Apply your blood to the absorbent hole of the test strip until the confirmation window is full of blood. The test meter will begin to count down from 5 seconds and a result will be displayed.
   

The blood sample should fully fill the confirmation window in order for the countdown to begin. If you find that the confirmation window is not fully filled when the test meter is counting, DO NOT try to add more blood to the test strip. Discard the test strip and retest with a new one.

4. Obtain an accurate result in 5 seconds
   The result of your blood glucose test is shown on the test meter display. This reading is automatically stored in the test meter.

Please discard the used test strip immediately after use.
DO NOT REUSE THE TEST STRIP.

MEMORY

Reviewng Results from the memory

CERA-CHEK 1070 can store up to 1000 test records. Each record includes the test result, time and date. The meter will also calculate the average values of records from the last 7, 14, 30days.

1. Viewing Stored Records
   With the meter On, press one of the Setting buttons( ) to enter memory mode. The most recent test result and the 'memory' symbol ( ) will appear on the display. Press the Left arrow button( ◄ ) to go through the stored records. First, you will see the test number then it will switch to your test results with date and time.
   

NOTE
If you are using the meter for the first time, the meter display will show three dashed lines (---) and the 'memory' symbol ( ).This means that no data has been stored in memory.

2. Viewing data averages
   When you press the Right arrow button( ► ) for viewing data, it will display the average value of test results performed during 7 days. Pressing again the Right arrow button ( ► ), it shows the average value of tests during 14 and then 30 days. When you press the Left arrow button ( ◄ ), it will display the latest result.
   * If you press the Power button when viewing memory, the glucose meter will close down.
   

NOTE
If there are already 1,000 records in the memory, the oldest record will be erased to make room for a new one. Your most recent result will display first.

Clearing the Memory

1. Press and hold both the Setting buttons( ) for more than 3 seconds to enter the delete mode from the memory mode. You will see both displays "dEL" and "ALL" switching one after another.
   
2. To clear the memory, press and hold both the Setting buttons( ) for 3 seconds. The display will show 'memory' symbol ( ) and "---", the meter will clear its memory and turn itself off after a moment.
   
3. If you entered the delete mode but want to exit without deleting the stored data, press the Power button. This will turn the meter off without deleting any data.

Extreme caution should be used when clearing the memory. This is not a reversible operation.

Blood Glucose Monitoring Chart

Time of day	Plasma Glucose range (mg/dL) for people without diabetes.	Your target range (mg/dL)/(mmol/L)
Before a meal	Less than 100mg/dL (5.6 mmol/L)
2 hours after a meal	Less than 140mg/dL (7.8 mmol/L)

Source: American Diabetes Association; Diadetes Care, January 2007, Volume 30, Suppl 1 S42~S47

TRANSFERRING STORED DATE

CERA-CHEK 1070 provides a comfortable function to our users; blood glucose management software that can transfer and show analytical interpretation of all the stored data of blood glucose results from your glucose meter into your computer.

※ To use the blood glucose management software, you should purchase separately the installation CD and the USB data transfer cable.

1. Make sure the glucose meter is turned off. (Data cannot transfer when the device is still on).
2. After you initiate the software for blood glucose management on the computer, you connect the transfer cable from the computer to the glucose meter.
3. If the connection is properly carried out, the glucose meter will display "PC" on the display screen.
   

NOTE
When you disable the cable during the transfer of data, the data may not be transferring properly. Please keep the transfer cable intact until the transfer is completed.

4. After the data transfer is completed, you can release the transfer cable.

In case you need more details about the blood glucose monitoring software of CERACHEK 1070, please contact your local distributor.

CARING FOR YOUR DEVICE

To avoid contaminating your test meter and test strips, please wash your hands and test site with soap and water. Make sure to dry your hands and test site thoroughly.

Maintenance

Your test meter does not require special maintenance. There is no special cleaning required because no blood or control solution comes in contact with the test meter. Avoid getting dirt, dust, blood, or water inside the test meter through the test port. A damp cloth and mild detergent can be used to wipe the outside of the test meter. Your test meter is a precision instrument. Please handle it with care.

Storage and Handling

1. Test Meter storage and handling
   • Store test meter at: -10°C ~ 60°C (14°F ~ 140°F).
   • Do not leave the test meter in very hot or cold places.
   • Do not leave it near a heat source or in your vehicle during adverse weather conditions.
   • Always store or carry the test meter in its original storage case.
   • Avoid dropping and strong impact.
   • Avoid direct sunlight and humidity.
2. Test Strip storage and handing
   • Store test strips at 1°C ~ 32°C (34°F ~ 90°F), below 85% relative humidity.
   • Store your test strips in their original vial only.
   • Do not transfer to other containers.
   • Store test strips in a cool and dry place.
   • Keep away from direct sunlight and heat.
   • After taking test strips from the vial, close the vial cap.
   • Touch the test strips with clean and dry hands.
   • Use each test strips immediately after removing it from the vial.
   • Write the disposal date on the test strip vial as a reminder to dispose of the opened vial after 4 months.
   • Do not bend, cut, or alter a test strips in anyway.
   • Keep the test strips away from children since the cap and the test strips may be a choking hazard.
   • If swallowed, immediately see a doctor for help.
   • Follow local governing ordinances and recycling plans for disposal or recycling of device components.

Error Message and Troubleshooting

Message me	Possible cause	What You Should Do
	Test result level is over 900mg/dL. (50.0mmol/L)	Repeat the test with a new test strip. If this message shows again, please contact your doctor immediately.
	Test result level is less than 10mg/dL. (0.6mmol/L)	Repeat the test with a new test strip. If this message shows again, please contact your doctor immediately.
	Prepare to replace the battery.	Recommending to replace the battery.
	The battery power is too low for testing.	Replace the battery at once.
	The operating temperature of the system is not the mentioned range. 4°C ~ 40°C (39°F ~ 104°F).	Allow the test meter and test strips to warm up or cool down slowly (30 minutes) until the error message goes away.
	Test strip is used.	Repeat test with a new test strip.
	Failure to operate during a test.	Repeat test with a new test strip.
	Test strip was removed during a test.	Repeat test with a new test strip.
	Damaged code key or the code key was removed during a coding the meter.	Re-coding the Test Meter If the problem still continues, please contact your local service center.
	The code is not set.	Insert the code key that acco mpanied the box of the test strips.

SPECIFICATIONS

Product Name: CERA-CHEK 1070 Blood Glucose Monitoring System
Model: G 300
Calibration: Plasma (YSI 2300 STAT PLUS)
Sample material: Fresh whole blood from capillary and venous
Sample Size: 0.5
Hematocrit Range: 10% ~ 70 %
Test Time: 5 seconds
Dimensions: 53.6 x 94 x 13.9 (mm)
Weight: 35 g
Power source: One CR2032 3V lithium coin battery
Display: LCD
Memory: 1000 measurement results with date and time
Automatic Turn Off: Shuts down after 2 minutes of inactivity
Measurement Units: Either mg/dL or mmol/L
Operating Condition: 4°C~40°C (39°F~104°F), below 85%, relative humidity
Altitudes up to 4,000m (13,200ft)
Measurement Range: 10~900 mg/dL (0.6~50 mmol/L)
Storage/Transport Condition: -10°C~60°C (14°F~140°F)
(Blood Glucose Test Meter) below 85% relative humidity, 700 to 1,060 hPa

PERFORMANCE CHARACTERISTICS

Accuracy

The accuracy of the CERA-CHEK 1070 Blood Glucose Monitoring System was evaluated by comparing blood glucose results obtained from 100 subjects with replicate measurement. Readings obtained with the CERA-CHEK 1070 Blood Glucose Monitoring System were compared to those obtained using an YSI Model 2300 Glucose Analyzer.

Accuracy results for glucose concentration < 75mg/dL (4.2 mmol/L)
Within ± 5 mg/dL (Within ± 0.28 mmol/L)	Within ± 10 mg/dL (Within ± 0.56 mmol/L)		Within ± 15 mg/dL (Within ± 0.83 mmol/L)
70%(14/20)	95%(19/20)		100%(20/20)
Accuracy results for glucose concentration ≥ 75 mg/dL (4.2 mmol/L)
Within± 5%	Within± 10%	Within± 15%	Within± 20%
78%(141/180)	89%(160/180)	100%(180/180)	100%(180/180)

Precision

The precision of CERA-CHEK 1070 Blood Glucose Monitoring System was estimated with venous blood samples and Glucose Control Solutions in the laboratory.

Within Run Precision
Blood average	45 mg/dL(2.5 mmol/L) 98 mg/dL(5.4 mmol/L) 129 mg/dL(7.2 mmol/L) 228mg/dL(12.7 mmol/L) 326 mg/dL(18.1 mmol/L)	STD= 2.4 mg/dL CV = 3.1 % CV = 3.2 % CV = 3.0 % CV = 2.2%
Day to Day Precision
Control average	43 mg/dL(2.4 mmol/L) 108 mg/dL(6.0 mmol/L) 304 mg/dL(16.9 mmol/L)	STD= 2.3 mg/dL CV = 3.2 % CV = 2.8%

Documents / Resources

Download manual

Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.

Download Cera-Chek 1070 - Blood Glucose Monitoring System Manual