CholSure Blood Cholesterol Monitoring System User Manual

Thank you for choosing the CholSure Blood Cholesterol Monitoring System.
You have chosen a unique tool which utilizes biosensor technology to help monitor your blood cholesterol level. We have designed the CholSure Blood Cholesterol Monitoring System to be accurate and easy to use. This user manual contains all the information you need to use and maintain your CholSure Blood Cholesterol Monitoring System. Please read it through carefully before using you CholSure Blood Cholesterol Monitoring System. Please contact our authorized dealer for questions and enquiries.. Thank you again for choosing the CholSure Blood Cholesterol Monitoring System.
CholSure
Blood Cholesterol Monitoring System
1
Intended Use
The CholSure Blood Cholesterol Monitoring System is intended to be used for quantitative measurement of cholesterol level in fresh capillary whole blood drawn from the fingertips. It is intended for use outside of body (In Vitro diagnostic use). The CholSure Blood Cholesterol Monitoring System is intended for use as an aid to monitor cholesterol level by users at home or healthcare professionals at clinical settings. IMPORTANT: Hematocrit range -A hematocrit range that is higher than 50% or lower than 35% can cause inaccurate blood cholesterol test result. Fasting - Please fast for at least eight (8) hours before you perform your blood cholesterol test to ensure accurate test result. Measurement Unit - The CholSure Blood Cholesterol Monitoring Systems offers two unit of measurements: mg/dL and mmol/L. Please refer to the section Changing the Unit of Measurement if you wish to change the measurement unit.
CholSure
2
Table of Contents
1. About Your CholSure Blood Cholesterol Monitoring System Contents of Kit .................................................................................................................. 5 The CholSure Meter .......................................................................................................... 6 Screen Display .................................................................................................................. 8 Cholesterol Test Strip ...................................................................................................... 11 Adjustable Lancing Device.............................................................................................. 12 Cholesterol Control Solution (Optional) ........................................................................ 13 2. Meter Setup Inserting (or Changing) the Battery .................................................................................. 14 Coding the Meter ............................................................................................................ 16 Setting Date and Time...................................................................................................... 19 Turn the Buzzer On/Off .................................................................................................. 26 Control Solution Testing .................................................................................................. 28 3. Blood Cholesterol Testing Preparing the Lancing Device .......................................................................................... 37
CholSure
3
Getting a Blood Sample .................................................................................................. 38 Running the Test .............................................................................................................. 40 Disposing Used Strips and Lancets ................................................................................ 43 4. Understanding Your Test Results Your Blood Cholesterol Test Results ................................................................................ 45 5. Viewing Meter Memory Viewing Stored Readings and 7, 14, 30 Days Average from Memory ............................ 46 6. Caring for the Meter Changing the Unit of Measurement ................................................................................ 52 7. Troubleshooting ................................................................................................ 53 8. Specifications.................................................................................................... 57 9. Product Warranty .............................................................................................. 60 10. Symbols Used in the Manual ............................................................................ 61
CholSure
4
1. About Your CholSure Blood Cholesterol Monitoring System

Contents of Kit
The CholSure Blood Cholesterol Monitoring System package includes the following items:
CholSure
Carrying case (1)
User manual (1) log book (1)
Adjustable Lancing Device (1)
CholSure Cholesterol Meter (1)
* The kit contents may vary in some certain areas. Please contact our authorized dealer if you find the contents of your kit are different from the above.
The CholSure Meter
CholSure
6
Display Screen
Large, easy to read LCD screen displays results or messages using simple words or symbols.
Scroll Buttons
Press to scroll up or down stored test values and test averages (see p.46) or numbers when setting up the Meter (see p.19 ) Press to enter control mode with test strip inserted or enter set up mode when not testing
Enter Button
Press and hold to turn on or off the Meter.
Test Strip Port

Insert the test strip here. The Meter will turn on automatically.
CholSure
Code Card Port

Insert the Code Card here. It is located at the side of the Meter. The Code Card programs the meter for a specific lot number of test strips. A new Code Card is packaged with each new package of Test Strips.
Battery Compartment
Holds one 3V Lithium coin cell battery (CR2032)
Screen Display
BUZZER HAPPY/SAD FACE CODE MAIN DISPLAY AREA PC LINK *this function is not availalble yet. CLOCK
CholSure
8
mem
code
TEMPERATURE BLOOD DROP CTL BATTERY
mmgl/dL
ctl
TEST STRIP
DAY AVG AM PM
DAY AVG HOUR/MINUTE
MAIN DISPLAY AREA..............Displays code number, test results, stored test results, result averages, and messages. CODE......................................This icon indicates the current code number. Verify this code number with the code number printed on the test strip bottle every time you test. PC LINK ..................................*this function is not available yet. Indicates the Meter is in data transfer mode to PC. CLOCK ....................................Indicate the Meter is ready to set up time and date. (See Setting Date and Time). BUZZER ..................................Set the buzzer function (See Turn the Buzzer On/Off). BATTERY..................................Appears when the battery is low and you need to change the batteries. (See Changing the Batteries). MEM ......................................This icon indicates the number in the display area is a stored test result. (See Viewing Meter Memory). UNIT........................................Indicates the measurement of unit (mg/dL or mmol/L). CTL..........................................This icon indicates a control solution test. (See Control Solution Testing). TEST STRIP ..............................Indicates the Meter is waiting for the test strip to be inserted.
CholSure
9
BLOOD DROP ........................This icon appears when a Test Strip is inserted into the Meter and the Meter is ready for testing. DAY AVG................................Appears when viewing the day-averages. (See Viewing Meter Memory). HAPPY/SAD FACE ..................These icons indicate if the Meter electronic is working properly. TEMPERATURE ........................Appears when it's either too hot or too cold to test (outside the ranges of 18C~40C or 64F ~ 104F).
18C 40C
CholSure
10
Cholesterol Test Strip

The CholSure Blood Cholesterol Test Strip is colored blue.
Reaction Zone:Apply Blood Here Test Strip Handle
CholSure
Contact Points
Contact Points ........................Insert this end into the Test Strip Port on the Meter Sampling Zone ......................This is where you apply blood sample or control solution
IMPORTANT: Use only the CholSure Blood Cholesterol Test Strips with the CholSure Cholesterol Meter. Other brands of test strips will not work wit the Meter. Store the Test Strips in a cool, dry place at all time and away from sunlight
11
Adjustable Lancing Device

Release Button
3 4
CholSure
12
Adjustable Cap
Sterile Lancet
Protective Cover
The CholSure Blood Cholesterol kit includes an adjustable 5 setting lancing device and sterile lancets. You can adjust the puncture depth of your lancing depth according to the thickness of your skin, from the lightest (1) to the deepest (5). If you are not sure which depth suits you, we recommend you start from depth 2.
Cholesterol Control Solution (Optional)
CholSure
For the GlucoSure Plus and Multisure Meter to be used The Test Strip
CholSure
Suitable for self-testing

15
Storage Temperature
Use within 3 months afte or before the expiration
PN 63105010311
It is the standard cholesterol concentration solution required to perform Cholesterol Control Solution Test (See Cholesterol Control Solution Testing) . Level 1 control solution helps you to validate the performance of your system at normanl range cholesterol reading. Run the control test to make sure the Test Strips and the Meter are working together properly, practice test procedure, and when using a new lot of CholSure Blood Cholesterol Test Strips.
13
2. Meter Setup
Inserting (or Changing) the Battery
Materials you will need: Your CholSure Cholesterol Meter One 3V Lithium coin cell battery (CR2032)
CholSure
14
Step 1. Remove the battery compartment cover.
Step 2. Insert new battery If there is old battery in the compartment, take it out. Insert new battery according to the direction printed on the battery cover.
Step 3. Replace the battery cover.
IMPORTANT: Dispose the used batteries according to your local government regulations. Remove the battery if equipmant is not likely to be used for some time. Note: The code number and the stored results will not be erased when you change the batteries. You may need to reset the date and time. (See Setting Date and Time).
CholSure
15
Coding the Meter

You must code the Meter before you begin testing on the CholSure Cholesterol Meter. Coding is a process of programming the Meter to the new bottle of Test Strips and to ensure accurate test results. A code card is packaged along with each box of the Test Strips. Coding the Meter for Cholesterol Testing Materials you will need: Your CholSure Cholesterol Meter A code card for CholSure Blood Cholesterol Test Strips. A CholSure Blood Cholesterol Test Strip. IMPORTANT: Make sure the Blood Cholesterol Test Strips are not expired. Check the expiration date on the test strip package . Step 1. Obtain the code card Locate the code card in the package of the Blood Cholesterol Test Strips.
CholSure
16
Step 2. Match code number Verify the code number on the code card matches the code number on the test strip package.
100
CholSure
CholSure Blood Cholest
100
Step 3. Code the Meter Firmly and completely insert the code card with the code number facing up into the code card port on the backside of the Meter.
Step 4. Verify code number Obtain a Blood Cholesterol Test Strip (from the test strip bottle. Insert the Strip into the test strip port of the Meter with the contacts points up. The Meter will turn on automatically. The meter will run a series of self tests. will appear on the screen when all tests are complete. If or other error messages (Err 1, Err 2, etc.) appear, see Troubleshooting.
17
The code number will then appear on the display screen. Make sure the code number on the screen is the same as the code number on the test strip bottle.
100
CholSure
18
code
100
PM
Note: Close the cap of the test strip bottle tightly right after taking out a Test Strip. Code number will not be erased when you change batteries. Code number can only be changed when you insert a new code card into the Meter. Remember to change the code card when a new package of Test Strips is opened for use.
Setting Date and Time

Materials you will need: Your CholSure Cholesterol Meter Note: If the date and time on the CholSure Cholesterol Meter are not set, the test results and control results will not be stored in the Meter memory.
CholSure
When you turn the Meter on the first time, or after you change the battery, the Meter will automatically ask you to set the date and time.
Step 1. Turn on the Meter Press and hold the button to turn on the Meter if it's not already on. Step 2. Set year The current year will flash. Press the scroll buttons to select the correct year. Press the button to confirm your choice and advance to set the month.
AM
19
Step 3. Set month The current month will flash. Press the scroll buttons to select the correct month. Press the button to confirm your choice and advance to set the date.
AM
CholSure
20
Step 4. Set date The current date will flash. Press the scroll buttons to select the correct date. Press the button to confirm your choice and advance to set the time format.
AM
Step 5. Set time format to 12-hour or 24-hour The current time format will flash. Press the scroll buttons to select the desired format (12-hour or 24-hour). Press the button to confirm your choice and advance to set the hour.
Step 6. Set hour The current hour will flash. Press the scroll buttons to select the correct hour. Press the button to confirm your choice and advance to set the minute.
AM
CholSure
Step 7. Set minute The current minute will flash. Press the scroll buttons to select the correct minute. Press the button to confirm your choice.
AM
Note: Anytime during setup, inserting a Test Strip will begin testing. Any changes made so far will be stored. You may need to reset the time after you change the battery.
21
Step 8. Exit setup screen Press the scroll buttons until "End' flashes. Press the Meter will exit the setup screen and return to testing mode.
mem
CholSure
22
button. The
Reset the date and time

You may reset the date and time anytime. Step 1. Turn on the Meter Press and hold the button to turn on the Meter.
Step 2. Meter self test The meter will run a series of self tests. will appear on the screen when all tests are complete. If or other error messages (Err 1, Err 2, etc.) appear, see Troubleshooting.
Step 3. Enter setup screen The code number will appear on the display. Press setup screen. Step 4. Enter time setting mode Press the scroll buttons until setup.
mem
CholSure
button to enter
starts to flash. Press the
button to enter time
Step 5. Set year The current year will flash. Press the scroll buttons to select the correct year. Press the button to confirm your choice and advance to set the month.
AM
Step 6. Set month The current month will flash. Press the scroll buttons to select the correct month. Press the button to confirm your choice and advance to set the date.
AM
23
Step 7. Set date The current date will flash. Press the scroll buttons to select the correct date. Press the button to confirm your choice and advance to set the time format.
AM
CholSure
24
Step 8. Set time format to 12-hour or 24-hour The current time format will flash. Press the scroll buttons to select the desired format (12-hour or 24-hour). Press the button to confirm your choice and advance to set the hour.
Step 9. Set hour The current hour will flash. Press the scroll buttons to select the correct hour. Press the button to confirm your choice and advance to set the minute.
AM
Step 10. Set minute The current minute will flash. Press the scroll buttons to select the correct minute. Press the button to confirm your choice.
AM
CholSure
Note: Anytime during setup, inserting a Test Strip will begin testing. Any changes made so far will be stored. You may need to reset the time after you change the battery. Step 11. Exit setup screen Press the scroll buttons until "End' flashes. Press the Meter will exit the setup screen and return to testing mode.
mem
button. The
Begin testing by inserting a Test Strip, or press and hold the off, of see the next section on how to turn the buzzer on/off.
button to turn the Metter
25
Turn the Buzzer On/Off

You can set your Meter to give a beeping sound to alert you about important messages. Step 1. Turn on the Meter Press and hold the button to turn on the Meter. Step 2. Meter self test The meter will run a series of self tests. will appear on the screen when all tests are complete. If or other error messages (Err 1, Err 2, etc.) appear, see Troubleshooting. Step 3. Enter setup screen The code number will appear on the display. Press setup screen. Step 4. Enter buzzer setting mode Press the scroll buttons until setup.
mem
CholSure
26
button to enter
starts to flash. Press the
button to enter buzzer
Step 5. The current setting will flash. Press the scroll buttons to select the desired setting (On or Off). Press the button to confirm your choice.
mg /dL
PM
CholSure
Note: Anytime during setup, inserting a Test Strip will begin testing. Any changes made so far will be stored. Step 6. Exit setup screen Press the scroll buttons until "End' flashes. Press the Meter will exit the setup screen and return to testing mode. Begin testing by inserting a Test Strip, or press and hold the turn the Metter off.
mem
button. The
button to
27
Control Solution Testing

The purpose of the control solution testing is to validate that your CholSure Cholesterol Meter is working properly with the Test Strips. You may purchase the Cholesterol Control Solution as optional items:
For the GlucoSure Plus and Multisure Meter to be used The Test Strip
CholSure
CholSure
28
Suitable for self-testing

15
Storage Temperature
Use within 3 months afte or before the expiration
PN 63105010311
Cholesterol Control Solution: Test solution with a known range of cholesterol concentration. Use this to test if the CholSure Cholesterol Meter is working properly with the blue Cholesterol Test Strips. Level 1 control solution helps you to validate the performance of your system at normal range cholesterol reading.
You should perform Cholesterol control solution test when: You use the Meter for the first time. You open a new package of CholSure Blood Cholesterol Test Strips. You left the test strip bottle open for a while. You dropped the Meter. You suspect your CholSure Cholesterol Meter and Blood Cholesterol Test Strips are not working properly together. You wish to practice the blood cholesterol testing procedure.
CholSure
Cholesterol Control Solution Testing

Materials you will need: Your CholSure Cholesterol Meter CholSure Cholesterol Control Solution (Level 1) A new Blood Cholesterol Test Strip
29
Note: Use only CholSure Blood Cholesterol Control Solution with the Blood Cholesterol Test Strips. Other brands of control solutions will produce inaccurate results. Always check the expiration date of the control solution. DO NOT use the control solution if it is expired. Record the date on the bottle when you open a new bottle of the control solution. Discard any unused control solution three months after the opening date . DO NOT FREEZE. Store the control solutions at room temperature 15C~30C (59F~86F).
15C 30C
CholSure
30
Step 1. Insert Test Strip into the Meter Obtain a Test Strip from the test strip bottle. Insert the Strip into the Meter with the contact points facing up. Make sure to firmly and completely insert the Strip into the Meter. The Meter will turn on automatically.
IMPORTANT: Do not use Test Strips that are expired. Check the expiration date printed on the test strip package . Use each Test Strip immediately after removing it from the test strip bottle. Close the cap of the test strip bottle immediately after you take the Strip out. Do not use wet, bent, scratched, or visibly damaged Test Strips. Keep the Strips away from direct sunlight and heat. Store the Strips in a dry, cool place. Record the date on the bottle when you open a new bottle of the Test Strips. Discard any unused Strips in the test strip bottle three months after the opening date . Make sure you are performing the test in an environment that is between 18C~40C (64F~104F). If the Meter displays a temperature icon , this means that your Meter has been exposed to extreme temperature that is outside the operating temperature range. Move the Meter into an area that is between 18C~40C (64F~104F) and allow 10 to 15 minutes for it to reach the new temperature before use. Your Meter will not begin testing if it detects it is outside the operat18C 40C 18C 40C
CholSure
31
ing temperature range. Step 2. Meter self test and code number verification The meter will run a series of self tests. will appear on the screen when all tests are complete. If or other error messages (Err 1, Err 2, etc.) appear, see Troubleshooting.
100
CholSure
32
A 3-digit code number will then appear on the Meter screen. Verify that the number on the screen is the same as the one printed on the test strip bottle.
code
100
PM
IMPORTANT: If the code number on the screen does not match the one printed on the test strip bottle, you need to replace the code card. See Coding the Meter. If the screen shows " Code----", this means the Meter is not coded. See Coding the Meter. Remember to change the code card every time when you open a new package of Test Strips for use.
Step 3. Switch to control mode Press the up or down button once to switch to control mode. Ctrl will appear on the screen. You may switch back to the normal testing mode by pressing up or down button again.
ctl
CholSure
mg /dL
PM
Step 4. Apply the control solution When the appears on the screen, apply a drop of CholSure Blood Cholesterol Control Solution on the reaction zone of the Test Strip. The Meter will give a beeping sound.
Step 5. Result in 90 seconds The screen will display count down bars ----. The bar will gradually diminish and after 90 seconds, the testing result will appear on the screen.
mg /dL
PM
33
Step 6. Verify test result Compare the reading on the screen to the range printed on the test strip package.
CholSure
34
0170
IMPORTANT: If your control test result does not fall into the range printed on the test strip package, do the following: Make sure you are using Cholesterol Control Solution. Make sure the testing environment is between 18C~40C (64F~104F). Make sure the code number on the Meter and the one on the test strip package match. See Coding the Meter . Make sure your Cholesterol Control Solution and Test Strips are not expired. Repeat the test with a new Test Strip If the problem persists, call our authorized dealer.
18C 40C
Note: Control solution test results will be stored into the Meter memory and indicated by ctl icon. Control solution test results will NOT be used to calculate the averages. Step 7. Discard the used Test Strip into proper waste basket.
CholSure
IMPORTANT: DO NOT reuse test strips.
35
3. Blood Cholesterol Testing

Materials you will need: Your CholSure Cholesterol Meter A new Blood Cholesterol Test Strip Lancing Device with a clean, unused lancet IMPORTANT: Use CholSure Blood Cholesterol Test Strips for Blood Cholesterol Test. Check the expiration date printed on the test strip package . DO NOT use expired Test Strips. When you open a bottle of Test Strips for the first time, record the "open date" on the test strip bottle. Discard the bottle and any remaining Test Strips within three months after the open date. After taking a Test Strip out of the bottle, close the cap of the bottle immediately. Use each Test Strip immediately after taking it out from the bottle. Do not use wet, bent, scratched, or visibly damaged Test Strips. Keep the Test Strips away from direct sunlight and heat. Store the Test Strips in a dry, cool place .
CholSure
36
Preparing the Lancing Device

Caution: The lancets are for single use only. Always use a new, sterile lancet each time you perform the test. DO NOT share your lancing device or lancets with other people.
CholSure
Step 1. Insert lancet Unscrew the adjustable cap of the lancing device. Firmly insert the lancet into the lancet holder of the lancing device. Make sure the lancet is fully seate.
Twist the protective cover off from the lancet. Screw the adjustable cover clockwise back onto the lancing device.
37
Step 2. Adjust the puncture depth Adjust the puncture setting on the lancing device to set the puncture depth to suit your need. 1 being the lightest and 5 the deepest.
CholSure
38
Step 3. Cock the lancing device With one hand holding the adjustable cap, pull back the lancing device with your other hand until you hear a clicking sound. The lancing device is now ready for blood sampling.
Getting a Blood Sample

Step 1. Wash your hands Wash your hands with soap and water. Dry your hands thoroughly.
Step 2. Hold the lancing device in position Hold the lancing device against the side of your fingertip and press the release button to create a puncture.
CholSure
5 3 4
Tips: Gently massage your hand and finger toward the puncture site to form a drop of blood (approximately 15 uL). Do not "milk", or squeeze around the puncture site. Prick the side of your fingertip to avoid soreness. To avoid callusing, choose a different puncture site each time. The lancets are for single use only. Always use a new, sterile lancet each time you perform the test. DO NOT share your lancing device or lancets with other people.
39
Running the Test

Step 1. Firmly insert a CholSure Blood Cholesterol Test Strip with contact points facing up into the Meter.
CholSure
40
IMPORTANT: Use CholSure Blood Cholesterol Test Strips for Blood Cholesterol Test. Check the expiration date printed on the test strip package . DO NOT use expired Test Strips. When you open a bottle of Test Strips for the first time, record the "open date" on the test strip bottle. Discard the bottle and any remaining Test Strips within three months after the open date. After taking a Test Strip out of the bottle, close the cap of the bottle immediately. Use each Test Strip immediately after taking it out from the bottle. Do not use wet, bent, scratched, or visibly damaged Test Strips. Keep the Test Strips away from direct sunlight and heat. Store the Test Strip in a dry, cool place.
Step 2. Meter self test and code number confirmation The meter will run a series of self tests. will appear on the screen when all tests are complete. If or other error messages (Err 1, Err 2, etc.) appear, see Troubleshooting. The 3-digit code number will then appear on the screen of the Meter. Verify the code number is the same as the one printed on the test strip package.
CholSure
100
code
100
PM
IMPORTANT: Make sure the code number on the Meter screen and the code number printed on the test strip bottle are the same. If they do not match, or if the screen shows "Code ----", you need to code the Meter correctly. (See Coding the Meter) Remember to change the code card when you open a new package of Test Strips for use. (See Coding the Meter) Step 3. Obtain blood sample Get a drop of blood using the lancing device.
5 3 4
41
Step 4. Apply the blood sample to the Test Strip When the appears on the screen, apply the drop of blood to the reaction zone of the Test Strip. The Meter will give a beeping sound.
CholSure
42
Note: DO NOT touch the reaction zone of the test strip. DO NOT smear the blood drop onto the reaction zone. DO NOT add or apply a second drop of blood. This may cause false result. Insufficient blood sample may cause inaccurate test result. DO NOT proceed testing if the white window is not filled completely. Discard the Test Strip and retest with a new Test Strip.
Step 5. Result in 90 seconds The screen will display count down bars ----. The bar will gradually diminish and after 90 seconds, the testing result will appear on the screen. The test result will be memorized by the Meter automatically. (See Viewing the Meter Memory) .
mg /dL
PM
Disposing Used Strips and Lancets

Caution: Used lancets and strips are biohazard materials. Dispose them according to local government regulation to avoid injury or contamination. Disposing Used Strips Remove the used Test Strip from the Meter and throw it into the proper waste basket. Disposing Used Lancets Unscrew the adjustable cap of the lancing device. Place the protective cover that you took off from the lancet previously on a hard surface. Push the lance tip into the protective cover. Remove the lancet from the lancing device carefully and discard it into the sharp object container.
CholSure
43
4. Understanding Your Test Results

You've performed the tests and you have your test results. Now you need to understand what the test results mean.
CholSure
44
Your Blood Cholesterol Test Results

High blood cholesterol is one of the major risk factors for heart disease. But high level of blood cholesterol does not cause a symptom - people do not feel ill just by having high blood cholesterol - many people are totally unaware that their cholesterol level is too high. Therefore it is very important to keep a constant monitor of your cholesterol level. Consult your physician about your blood cholesterol level. Total cholesterol levels (1): < 200 mg/dL (5.2 mmol/L) Desirable 200 - 239 mg/dL (5.2 -6.2 mmol/L) Borderline High 240 mg/dL (6.2 mmol/L) High Contact your physician for advice if you keep getting high results.
Reference: 1 "High Blood Cholesterol - What You Need to Know". NHLBI publication No.05-3290, June 2005.
5. Viewing Meter Memory

Your CholSure Cholesterol Meter automatically stores up to 300 cholesterol test results with date and time. The Meter also provides 7, 14, and 30 days averaging to help you track your blood cholesterol trend. You must set the date and time properly to use the memory and day averaging function. See Setting Date and Time. The Meter will not memorize test or control results if the date and time are not set.
CholSure
Viewing Stored Readings and 7, 14, 30 Days Average from Memory

Materials you will need: Your CholSure Cholesterol Meter Note: If the date and time on the CholSure Cholesterol Meter are not set, the test results and control results will not be stored in the Meter memory.
45
Step 1. Turn on the Meter Press and hold the button to turn on the Meter. Step 2. Meter self test The meter will run a series of self tests. will appear on the screen when all tests are complete. If or other error messages (Err 1, Err 2, etc.) appear, see Troubleshooting.
mem
CholSure
46
Step 3. Enter setup screen The code number will appear on the display. Press screen.
button to enter setup
Step 4. Enter memory mode Press the scroll buttons until the mem icon starts to flash. Press the memory mode.
button to enter
Step 5. Viewing stored results of your cholesterol testing mem icon will appear on the display with your most recent cholesterol testing result. Press the up button to see the next result, and the next, and so on. Press and hold the up but-
ton will allow you to flash through the results. "nil" will appear on the display after the last record if less than 300 results are stored. You can press the down button to go back viewing from the oldest to the most recent readings.
mem
CholSure
mg /dL
PM
Step 6. Viewing 7, 14, 30 day averages of your cholesterol testing When you reach the most recent result, continue to press the down button to start viewing day averages. The Meter will display the 7 day average, press down again to see the 14 day average, and press down again to see the 30 day average.
mem mem
mem
mg /dL
DAY AVG
mg /dL
DAY AVG
mg /dL
DAY AVG
47
Step 7. Exit memory mode Press the button to exit memory mode. Press the scroll buttons until "End" flashes and press to return to the testing mode.
CholSure
48
Note: Control testing results are flagged by ctl on the bottom of the display screen. Control results will not be used to calculate the day averages. When the Meter memory is blank, the display will show "nil". When there are no day averages available, the display will show 4 dashed "----". If the Meter memory is full, adding a new test result will cause the oldest one to be deleted. Memorized test results and day averages will not be erased when you change the battery. You can begin testing anytime during viewing the stored results by inserting a Test Strip.
6. Caring for the Meter

Caring for your CholSure Cholesterol Meter is easy. Follow these simple guidelines to keep your CholSure Cholesterol Meter working properly.
CholSure
Cleaning the Meter

If the Meter gets dirty, wipe the surface of the Meter using a lint-free cloth dampened with water and mild detergent. Note: DO NOT get water inside the CholSure Cholesterol Meter. Never immerse the Meter or hold it under running water. DO NOT use glass cleaners or household cleaners on the Meter DO NOT try to clean the test strip holder. DO NOT take the CholSure Cholesterol Meter apart. Do so will void the warranty. If there are technical problems or questions in use of the Meter, contact the authorized dealer. Handle the Meter with care - severe shock, such as dropping the Meter, could damage the electronics.
49
DO NOT contaminate the strip holder with blood or control solution.
CholSure
50
Storage and Precautions

The Meter and the Test Strips are designed to be used within the temperature range between 18C~40C (64F~104F). Avoid leaving the Meter in extremely hot or cold places, such as near a heat source or in an extremely hot or cold car. Do not store or use the Meter or Test Strips in high humidity levels, such as bathroom or kitchen. Always close the cap of the test strip bottle immediately after removing a Test Strip. Make sure the cap is closed tightly. Do not use this meter in a dry environment, especially if synthetic materials are present. Synthetic clothes, carpets, etc., may cause damaging static discharges in a dry environment. Do not use this meter near cellular or cordless telephones, walkie talkies, garage door openers, radio transmitters, or other electrical or electronical equipment that are sources of electromagnetic radiation, as these may interfere with the proper operation of the meter.
18C 40C
Changing the Unit of Measurement

CholSure Cholesterol Meter provides two units of measurement: mg/dL and mmol/L. To change the unit of measure, follow the steps below: Step 1. Remove the battery Flip the Meter to the backside. Open the battery compartment. Take the battery out.
CholSure
Step 2. Change to your desired unit of measurement There is a switch located on the left side in the battery compartment. Switch UP for mg/dL. Switch DOWN for mmol/L. Switch to your desired unit of measurement.
Step 3. Replace the battery cover After changing to the unit of measurement you wish to use, place the battery back in the battery compartment and close the battery compartment.
51
7. Troubleshooting
This section details the significant display screen messages and error codes you will encounter when using your CholSure Cholesterol Meter and Test Strips. What you see What it means
Problem with Meter's electronics.
CholSure
52
What you should do

Replace the battery and turn on the Meter again. If problem persists, contact our authorized dealer or customer service.
"Sad face"
Mismatch of code card and test strips. E.g. using glucose test strip with cholesterol test code card or using cholesterol test strip with glucose test code card.
"Err 1"
Make sure you are using matching code card and test strip. Repeat the test. If the problem persists, call our authorized dealer or customer service.
What you see
What it means
Used or damaged test strip.
What you should do

Repeat the test with a new test strip.
CholSure
"Err 2"
code
The Meter is not coded.
See Coding the Meter section of the user manual . If the problem persists, contact the authorized dealer or customer service.
"code ----"
Battery is low.
Change the battery according to Inserting (or Changing) the Battery section of the user manual .
Battery icon flashes
53
What you see
What it means
Temperature out of range.
What you should do

Move the Meter into an area that is between 18C~40C (64F~104F), and allow 15 minutes for it to reach the new temperature.
18C 40C
CholSure
54
Temperature icon flashes
Your cholesterol test result is higher than 350 mg/dL or 9.1 mmol/L
mg /dL
PM
Wash and dry your hands and repeat the test on your fingertip with a new test strip. If the result is still "HI", inform your physician or healthcare professional in the next visit.
"HI" at testing mode
Your cholesterol test result is lower than 100 mg/dL or 2.6 mmol/L
mg /dL
PM
Wash and dry your hands and repeat the test on your fingertip with a new test strip. If the result is still "Lo", inform your physician or healthcare professional in the next visit.
"Lo" at testing mode
What you see

mem
What it means
There are no results stored in the Meter.
What you should do

Check if the date and time are set up correctly. See Setting Date and Time
CholSure
mg /dL
PM
"nil" at memory recall mode

mem
There are no day averages.
N/A
"----" when viewing day average
55
8. Specifications
Test Strips: Test Range: Calibration: Test Time: Sample Size: Hematocrit Range: Display Type: Memory: Result Averaging: Dimension: Weight: Battery: Automatic Power-off: Operating Temperature: Relative Humidity: Storage Condition: CholSure Blood Cholesterol Test Strip 100~350 mg/dL (2.6-9.1 mmol/L) Lot specific external coding card 90 seconds 15 uL 35-50% Large LCD screen 300 test results 7, 14, and 30 day averaging 105 x 53 x 18.5 mm 65g 1 x 3V Lithium coin cell battery After 2 minutes of non use 18C-40C (64F-104F) 20 % ~ 70 % Meter 4C-50C (39F-122F) Strips 4C-30C (39F-86F)
CholSure
56
For additional information, refer to the CholSure Blood Cholesterol Test Strip inserts. Applied Product Standards: EN 60601-1 EN 60601-1-2 EN 61010-1 EN 61010-2-101 Classification according to IEC/EN 60601-1: IPXO, not evaluated as AP/APG equipment, continuous operation. Electromagnetic Compatibility: This equipment complies wit EMC requirement of EN 60601-1-2.
CholSure
57
Part Number Product Code S70039 S5636007 S5636014 S5636038 S5800039 65235010002 80050000009 80050000008
CholSure
58
Product Name CholSure standard Pack CholSure Blood Cholesterol Test Strips 5's CholSure Blood Cholesterol Test Strips 10's CholSure Blood Cholesterol Test Strips 25's CholSure Cholesterol Control Solution Lancing Device Apex Lancet 50s Apex Lancet 250s
9. Product Warranty
Apex Biotechnology Corporation warrants the CholSure Blood Cholesterol System to be free of defects in workmanship and materials under normal use for a period of five (5) years from the date of purchase to the customer. The liability of Apex Biotechnology Corporation is limited to repair of replacement and in no event shall Apex Biotechnology Corporation be liable for any collateral or consequential damages or loss. Instruments subjected to misuse, abuse, neglect, unauthorized repair or modification will be excluded from this warranty. This guarantee specifically excludes expendables and consumables. All warranty claims must be directed to the Apex Biotechnology Corporation's authorized dealer responsible for the sale of the system. The warranty applies only to the original purchaser of the system.
CholSure
59
10. Symbols Used in the Manual

(EXP) Expiration date (use by last day of month) (LOT) Batch code
15C 30C
CholSure
60
Temperature limitations Consult instructions for use In vitro diagnostic device Caution / warning, consult accompanying documents Product code number Keep away from sunlight/direct light Do not re-use Manufactured by Authorised Representative in the Europ

CholSure Blood Cholesterol Monitoring System User Manual

Загружено:

Сведения о документе

Исходное описание:

Оригинальное название

Авторское право

Доступные форматы

Поделиться этим документом

Поделиться или встроить документ

Параметры публикации

Этот документ был вам полезен?

Это неприемлемый материал?

Авторское право:

Доступные форматы

CholSure Blood Cholesterol Monitoring System User Manual

Загружено:

Авторское право:

Доступные форматы

Thank you for choosing the CholSure Blood Cholesterol Monitoring System.

1. About Your CholSure Blood Cholesterol Monitoring System

Carrying case (1)

User manual (1) log book (1)

Adjustable Lancing Device (1)

CholSure Cholesterol Meter (1)

The CholSure Meter

Test Strip Port

Code Card Port

Blood Cholesterol Monitoring System

TEMPERATURE BLOOD DROP CTL BATTERY

DAY AVG HOUR/MINUTE

Blood Cholesterol Monitoring System

Cholesterol Test Strip

Blood Cholesterol Monitoring System

Adjustable Lancing Device

Blood Cholesterol Monitoring System

Cholesterol Control Solution (Optional)

Suitable for self-testing

Blood Cholesterol Monitoring System

Use within 3 months afte or before the expiration

Blood Cholesterol Monitoring System

Step 1. Remove the battery compartment cover.

Step 3. Replace the battery cover.

Coding the Meter

Blood Cholesterol Monitoring System