On Call Plus User Manual

Page 1

Page 2

Blood Glucose Monitoring System

Self monitoring of blood glucose (SMBG) is an integral part of diabetes care, but the high cost of testing can make this impossible. At ,

ACON

our goal is to provide high quality glucose monitoring at a price that allows you to test as often as necessary. Together, we can better manage your diabetes and help you live a longer and healthier life.

Welcome, and thank you for choosing the Blood Glucose Monitoring System.

On Call Plus

The Blood Glucose

On Call Plus

Monitoring System will give you accurate blood glucose results in just a few simple steps.

To ensure accurate results from your Blood Glucose

On Call Plus

Monitoring System, please follow these guidelines:

Read instructions before use. Use the code chip that accompanies each box of test strips. Use only Blood Glucose Test Strips with the

Plus

Blood Glucose Meter.

in vitro

For diagnostic use only. Your blood glucose monitoring

®®

On Call Plus On Call

system is to be used only outside the body for testing purposes. For self testing and professional use. Test only whole blood samples with the Blood

On Call Plus

Glucose Test Strips and Meter. For self-testers, consult your physician or diabetes healthcare professional before making any adjustments to your medication, diet or activity routines. Keep out of reach of children. For help with any additional questions or issues, please contact Customer Support at 1-800-838-9502.

By following the instructions outlined in this User's Manual, you will be able to use your Blood Glucose Monitoring System to

On Call Plus

monitor your blood glucose and better manage your diabetes.

Page 3

Table of Contents

Getting Started .................................................................................... 1

Component Descriptions .............................................................. 2

On Call Plus

Blood Glucose Meter ........................................... 3

Meter Display ............................................................................... 4

On Call Plus

Blood Glucose Test Strips .................................... 5

Glucose Control Solution ...................................... 8

Install the Battery .............................................................................. 10

Meter Setup Before Testing .............................................................. 11

Step 1 - Coding the Meter .......................................................... 11

Step 2 - Adjusting the Meter Settings ......................................... 12

Performing a Quality Control Test ................................................... 14

Testing Your Blood ............................................................................ 17

Step 1 - Getting a Drop of Blood ................................................ 17

Step 2 - Testing Blood Glucose .................................................. 22

"HI" and "LO" Messages ............................................................ 24

Using the Meter Memory ................................................................... 26

Viewing Stored Records ............................................................. 26

Clearing the Memory .................................................................. 27

Maintenance ....................................................................................... 28

Replacing the Battery ................................................................. 28

Caring for Your

On Call Plus

Blood Glucose Monitoring System ............................................. 28

Suggested Testing Times and Target Goals ................................... 29

Comparing Meter and Laboratory Results ...................................... 30

Troubleshooting Guide ..................................................................... 31

Specifications .................................................................................... 33

Warranty ............................................................................................. 34

Index ................................................................................................... 35

Page 4

Getting Started

Component DescriptionsComponent Descriptions

Before testing, read the instructions carefully and learn about all the components of your Blood Glucose Monitoring System. Depending on the product you purchase, some of the

On Call Plus

components may need to be purchased separately. Please check the list of contents on the outer box for details on which components are included with your purchase.

Test Strips

135

Blood Glucose Meter

Lancing Device

Sterile Lancet

Code Chip

Clear Cap

ControlSolution

iónde Control

G123-311

diagnosticuse onl

-86F

NLaboratories,Inc.

125MesaRimRoad, Diego,CA92121,USA rSupport:1-800-838-9502

Control Solution

1. Blood Glucose Meter: Reads the test strips and displays the blood glucose concentration.

2. Test Strips: Strips with a chemical reagent system used with the meter to measure glucose concentration in blood.

3. Code Chip: Automatically calibrates the meter with the code number when inserted into the meter.

4. Lancing Device: Used with sterile lancets to prick the fingertip, palm (at the base of the thumb) or forearm for blood sample collection. The packaged lancing device has multiple depth settings, allowing users to adjust the depth of the puncture and minimize discomfort.

5. Clear Cap: Used with the lancing device and sterile lancet to draw blood sample from the forearm and palm.

6. Sterile Lancets: Used with the lancing device to draw a blood sample. Sterile lancets are inserted into the lancing device with each blood draw and discarded after use.

7. Control Solution: Verifies the proper operation of the blood glucose monitoring system by checking the test strips and meter against a precalibrated control solution. Control Solution 1 is all you need most of the time. Control Solution 2 is also available if you want to do a level 2 test. The two levels of control solution, Control 1 and Control 2, are available in the Glucose Control

On Call Plus

Solution package which is sold separately.

8. Carrying Case: Provides portability for blood glucose testing wherever you go.

9. User's Manual: Provides detailed instructions on using the blood glucose monitoring system.

10. Quick Reference Guide: Provides a brief overview of the blood glucose monitoring system and testing procedures. This small guide can be kept in your carrying case.

11. Quick Start Guide: A short set of instructions to get you started testing with your new system.

12. Logbook: Allows users to record their blood glucose data and get a better picture of their broader trends.

13. Warranty Card: Should be completed and returned to the warranty center to qualify for the 5-year meter warranty.

Carrying Case

1 2

Page 5

En En

On Call Plus®Blood Glucose MeterOn Call Plus®Blood Glucose Meter Meter DisplayMeter Display

The meter reads the test strips and displays the blood glucose concentration. Use this diagram to become familiar with all the parts of your meter.

Strip Port

Battery Carrier

Liquid Crystal Display (LCD)

Code Chip

lLlmg

CODE

MEM

M Button

Code Chip Slot

S Button

Data Port

Liquid Crystal Display (LCD):

Shows your test results, and helps you

through the testing process.

M Button:

Recalls previous test results from the meter memory and

performs other menu selection functions.

S Button:

Selects meter settings, performs other menu selection

functions.

Strip Port:

Battery Carrier:

Code Chip Slot:

Code Chip:

Test strips are inserted into this area to perform a test.

The battery carrier is located on the back of the meter.

Insert the code chip here.

For coding the meter. A new code chip comes with every

box of test strips.

Data Port:

Not Currently Available for Use.

Pound Sign (#)

Appears with the control solution test result or when you mark an invalid result to prevent it from being included in the averages.

Month Day Hour Minutes

Test Strip and Blood Drop Symbols

These two symbols appear at the same time to tell you when to apply the sample.

Battery Symbol

Warns when you should replace the battery.

Test Result Area

Indicates code number and test result.

MEM

Shows a test result stored in memory.

Control Solution Symbol

Indicates a control test result. A pound sign (#) will also be displayed when control solution symbol appears.

MEM

lLlmg

CODE

Appears with the code number of the test strips.

Measurement Unit

Only one unit will be displayed on your meter and cannot be adjusted.

3 4

Page 6

Meter Use and Precautions

Blood Glucose Test Strips

Tiras de Examen

G133-114

135

mmol/L mg/dL

CTRL 2

CODE

CTRL 1

mmol/L mg/dL

14.9-19.8 268-356

4.5-6.7 81-121

En En

The meter is pre-set to display blood glucose concentration in either millimoles per liter (mmol/L) or milligrams per deciliter

IMPORTANT: Apply sample only to the sample tip of the test strip. Do not apply blood or control solution to the top of the test strip as this may result in an inaccurate reading.

(mg/dL) depending on which unit of measure is standard in your country. This unit of measure cannot be adjusted. The meter will be set to mg/dL by default when sold in the United States. Do not get water or other liquids inside the meter. Keep the strip port area clean. Keep your meter dry and avoid exposing it to extremes in temperature or humidity. Do not leave it in your car. Do not drop the meter or get it wet. If you do drop the meter or get it wet, check the meter by running a quality control test. Refer to on page 14 for instructions.

Quality Control Test

Do not take the meter apart. Taking the meter apart will void the warranty. Refer to the section on page 28 for

Caring for Your Meter

details on cleaning the meter.

Keep the meter and all associated parts out of reach of children. Note: Follow proper precautions and all local regulations when disposing of the meter and used batteries.

Hold the blood drop to the sample tip of the test strip until the check window is full and until the meter begins to count down. If the check window does not fill, do not add more blood to the test strip. You may get an E-5 message or an inaccurate test result. Discard the strip and retest. Even if the meter begins to countdown but the check window does not fill, discard the strip and begin the test again with a fresh test strip.

Correct Incorrect

On Call Plus®Blood Glucose Test StripsOn Call Plus®Blood Glucose Test Strips

On Call Plus

The Blood Glucose Test Strips are thin strips with a chemical reagent which work with the Blood Glucose Meter to measure the glucose concentration in whole blood. After the strip is inserted into the meter, blood is applied to the sample tip of the test strip, then automatically absorbed into the reaction cell where the reaction takes place. A transient electrical current is formed during the reaction and the blood glucose concentration is calculated based on the electrical current detected by the meter, then the result is shown on the meter display. The meter is calibrated to display plasma equivalent results.

Sample Tip

Apply blood or control solution here.

On Call Plus

Correct Incorrect

Code Number

Contents: 10Test Strips

IMPORTANT: Before using these test strips

carefully read the Package Insert and/or User's Manual for your meter. Each strip contains Glucose oxidase (from ) .

Aspergillus niger

For diagnostic use only.

in vitro

Store at 59-86 F

Lot:

2990001

Exp: 2008/01

ACONLaboratories, Inc.

10125Mesa Rim Road,

SanDiego, CA 92121, USA

CustomerSupport: 1-800-838-9502

Check Window

Check to confirm that sufficient sample has been applied.

Contact Bars

Insert this end of the test strip into the meter until it stops.

Each package of test strips is printed with a code number (CODE), lot number (LOT), unopened expiration date ( ) and control range (CTRL1 and CTRL 2).

Page 7

En En

Storage and Handling

Please review the following storage and handling instructions:

Store test strips in a cool, dry place at room temperature, 59-86 F

(15-30 C). Store them away from heat and direct sunlight.

Do not freeze or refrigerate. Do not store or use test strips in a humid place such as a bathroom. Do not store the meter, the test strips or control solution near bleach or cleaners that contain bleach. Replace the cap on the test strip vial immediately after removing a test strip. The test strip should be used immediately after removing it from container. Do not use your test strips past the unopened expiration date printed on the label. Using test strips past the unopened expiration date may produce incorrect test results. Note: The expiration date is printed in Year-Month format. 2008-01 means January, 2008.

Test Strip Precautions

in vitro

For diagnostic use. Test strips are to be used only outside the body for testing purposes. Do not use test strips that are torn, bent, or damaged in any way. Do not reuse test strips. Before running a blood glucose test, make sure that the code number on the meter display matches the number shown on the test strip vial or on the pouch. Keep the test strip vial or the foil pouch away from children and animals. Consult your physician or healthcare professional before making any changes in your treatment plan based on your blood glucose test results. Not intended for the diagnosis of or screening for diabetes mellitus. Not for use on neonates. When testing alternative sites, test when in steady state only (such as before eating, before taking medication, before exercising, or 2 hours after eating).

Special Instructions for Test Strip in the Vial

Test strips should be stored tightly capped in their protective vial to keep them in good working condition. Do not store test strips outside their protective vial. Test strips must be stored in the original vial with the cap tightly closed. Do not transfer test strips to a new vial or any other container. Replace the cap on the test strip vial immediately after removing a test strip. A new vial of test strips may be used for 3 months after first being opened. The opened expiration date is 3 months after the date the vial was first opened. Write the opened expiration date on the vial label after opening. Discard the vial 3 months after you first open it, usage after this period may result in inaccurate readings.

Special Instructions for Test Strip in Foil Pouch

Tear the pouch carefully starting from the tear gap. Avoid damaging or bending the test strip. Use test strip immediately after removing it from the pouch.

7 8

See the test strip insert for more details.

On Call Plus®Glucose Control SolutionOn Call Plus®Glucose Control Solution

On Call Plus

The Glucose Control Solution contains a known concentration of glucose. It is used to confirm that your Blood Glucose Meter and Test Strips are working together properly and that you are performing the test correctly. It is important to run a quality control test regularly to make sure you are getting correct results. You should run a quality control test:

Before you first use your meter, to familiarize yourself with its operation. Before using a new box of test strips. When you suspect that the meter or test strips are not working properly. When you suspect that your test results are inaccurate, or if they are inconsistent with how you feel. When you suspect your meter is damaged. After cleaning your meter.

At least once a week. Refer to on page 14 for instructions on running a quality control test. Please review the following storage and handling instructions:

On Call Plus

Quality Control Test

Control Solution

ión de Control

G123-311

diagnostic use onl

-86 F

NLaboratories, Inc.

125Mesa Rim Road, Diego,CA 92121, USA rSupport: 1-800-838-9502

Page 8

En En

Storage and Handling

Store the control solution at room temperature, . Do not refrigerate or freeze. If the control solution is cold, do not use until it has warmed to room temperature. Use before the unopened expiration date that is shown on the bottle. Note: The expiration date is printed in Year-Month format. 2008-01 means January, 2008.

59-86 F (15-30 C)

Install the Battery

Battery may not be preinstalled in the meter. One CR 2032 3.0V coin cell battery is required. Please find the battery in your carrying case and install it according to following steps:

1. Pull the battery carrier on the left side of the

meter. The battery carrier should be easily

opened with your finger.

Each bottle of control solution can be used for 3 months after you first open it. The control solution will expire 3 months after the bottle is opened for the first time. Record this opened expiration date on the bottle label.

2. Place a new CR 2032 3.0V coin cell battery.

Make sure it is aligned with the (+) side

Control Solution Precautions

in vitro

For diagnostic use. The control solution is for testing only outside the body. Do not swallow or inject. Shake well before using. Control solution tests are specified to be accurate only when tested between 59 and 104 F (15-40 C). The control ranges shown on the test strip vial (or on the foil pouch) are not recommended ranges for your blood glucose level. Your personal blood glucose target ranges should be

facing up in the battery carrier.

3. Close the battery carrier and make sure that

it snaps shut.

lucose Glucosa

Chip

Codificador

iagnosticuse only.

oratories,Inc.

saRimRoad, CA92121,USA ort:1-800-838-9502

Plus

Meter

enSangre

determined by your diabetes healthcare professional. Do not touch the test strip with the tip of the control solution bottle. Use only the same brand of control solution that was provided with your kit.

Please contact Customer Support at 1-800-838-9502 for more information on obtaining the control solution kit.

See the control solution insert for more details.

9 10

Page 9

En En

Meter Setup Before Testing

Step 2 - Adjusting the Meter SettingsStep 2 - Adjusting the Meter Settings

Before testing, the following steps should be followed:

Step 1 - Coding the MeterStep 1 - Coding the Meter

Simply insert the code chip to code the meter. Every time you change to a new box of test strips, you need to insert the code chip packed with the new box of test strips. You can see the code number appears on the meter. Make sure this number matches the code number printed on the test strip vial label (or on the foil pouch) and the number printed on the code chip.

You can easily find a code chip in your starter kit box. This code chip is used with the test strip packed in your carrying case when you first open the carrying case. If there is already one code chip inserted, remove it and insert the new code chip.

1. Take the code chip from the test strip box. Compare the code number on the code chip with the code number printed on the test strip vial label (or on the foil pouch). If the two numbers are not identical, you may get inaccurate results. If the code number on the code chip does not match the number on the vial or foil pouch of strips with which it was packaged, please contact Customer Support at 1-800-838-9502.

2. With your meter turned off, insert the new code chip into the code chip slot of the meter. It should easily snap into place. The code chip should remain in the meter, do not take it out until you change to another new box of test strips.

Adjust the meter settings to set the clock, ensuring that results stored in the memory are shown with the correct date and time. You can also turn the meter audio feature on or off. You need to adjust the meter settings before you first use your meter. You will need to set the clock settings after replacing the battery.

1. Press the S button to enter the meter setup mode. The meter will automatically enter the setup mode when turned on for the first time by any method.

2. First, set the clock for either 12 or 24 hour mode. Press the M button to switch between the two settings, then press the S button to save your choice and start setting the year, month and date.

3. The year will appear at the top of the display. Press the M button until the correct year is displayed. Once you have selected the correct year, press the S button to save your choice and start setting the month. Press the M button until the correct month is displayed, then press the S button to save your choice and start setting the date. Press the M button until the correct date is displayed, then press the S button to save your choice and start setting the time.

Year Month Date

CODE

135

CODE

135

Note: If a test strip is inserted and no strip code is stored in memory, the display will flash "- - - CODE".

11 12

135

CTRL 2

4. The hour will appear at the top of the display. Adjust the hour with the M button until the correct hour is displayed. Press the S button to save your choice and set the minutes. Press the M button to change to the correct minute. Press the S button to save your choice and move to set the audio feature.

Page 10

En En

Hour Hour

Performing a Quality Control Test

Minutes Minutes

5. Audio Feature The meter comes with the meter audio feature enabled. The meter will give one short beep when it is turned on, after sufficient sample has been applied to the test strip and when the result is ready. The meter will sound three short beeps to sound a warning when an error has occurred. Please check the error number on the display to confirm what kind of error has occurred. Press the M button to switch between turning the meter beep "On" and "Off". Press the S button to confirm your selection. Pressing S at this point will end the setup mode and power off the meter.

The quality control test confirms that the test strips and meter are working together properly, and that you are performing the test correctly. It is important to perform this test:

Before you first use your meter. Before using a new box of test strips. When you suspect that the meter or test strips are not working properly. When you suspect that your test results are inaccurate, or if they are inconsistent with how you feel. When you suspect your meter is damaged. At least once a week.

1. Insert a test strip into the strip port, contact bars end first and facing up, to turn on the meter and display all the display segments. If the audio option is on, the meter will beep, signaling the meter is turned on.

lLlmg

CODE

MEM

2. Check the display to confirm that all the display segments turn on (see display illustration above).

3. Following this display check, the system will enter the test mode. The display will show the date and time and the strip icon with the blood sample icon blinking. The code number will be displayed in the center of the screen. Make sure that the code number that appears on the display matches the code number (CODE) on the test strip vial (or on the foil pouch). If

CODE

not, make sure to locate and insert the code chip that came with the box of strips. If the codes still do not match, do not perform a test. You will need a new package of test strips to perform a test. The blinking test strip and blood drop icon indicates that the test strip is inserted correctly and a drop of control solution can be added. Note: If the test strip has been inserted incorrectly, the meter will not turn on.

13 14

Page 11

4. Press the M button to mark the test as a control solution test. Once

En En

the M button is pressed, the control solution symbol will appear on the display.

7. Remove and discard the test strip. The display should also show a pound sign (#) indicating the test is a control solution test. This shows that the number will not be counted in the 7, 14 and 30-day averages. The pound sign (#) will also be displayed when reviewing the results stored in memory.

CODE

If the result falls outside the indicated control range:

Confirm you are matching the correct range. Control Solution 1 results should be matched to the CTRL 1 range printed on the

CODE

5. Shake the control solution bottle well, then squeeze it gently and discard the first drop. If the tip clogs, tap the tip gently on a clean, hard surface, shake again, and then use. Squeeze out a second small drop on a clean nonabsorbent surface. Touch the sample tip of the test strip to the control solution drop. If the audio option is turned on, the meter will beep to indicate a sufficient sample has been applied. Notes:

Do not apply control solution to the test strip directly from the bottle. If the control solution sample does not fill the check window, do not add a second drop. Discard the test strip and start over with a new test strip.

6. Once sufficient sample has been applied, the meter display will count down from 9 to 1 and then display the result. The control solution test results should be within the control range (CTRL1) printed on the test strip vial (or on the foil pouch). This means that your blood glucose monitoring system is working properly and that you are performing the procedure correctly.

test strip vial (or on the foil pouch). Check the expiration date of the test strip and control solution. Make sure that the test strip vial and control solution bottle have not been opened for more than 3 months. Discard any test strips or control solution that has expired. Confirm the temperature in which you are testing is between.59

and 104 F (15-40 C)

Make sure that the test strip vial and control solution bottle have been tightly capped. Make sure code number on the strip vial label or on the foil pouch matches the code number appears on the meter display. Confirm that you are using the same brand of control solution that was provided with your kit. Make sure that you followed the test procedure correctly.

After checking all of the conditions listed above, repeat the quality control test with a new test strip. If your results still fall outside of the control range shown on the test strip vial (or on the foil pouch), your meter may be defective. Please contact Customer Support at 1-800838-9502 for help.

Two levels of control solution are available labeled Control Solution 1 and Control Solution 2. Control Solution 1 is sufficient for most all selftesting needs. If you think your meter or strips may not be working correctly, you may also want to do a level 2 test. The ranges for both

ControlSolution

ióndeControl

G123-311

diagnosticuseonl

-86F

NLaboratories,Inc.

125MesaRimRoad, Diego,CA92121,USA rSupport:1-800-838-9502

(CTRL 1 and CTRL 2) are displayed on the test strip vial (or on the foil pouch). Simply repeat step 4 through 6, using Control Solution 2. For confirmation of results, Control Solution 1 tests should fall within the CTRL 1 range, and Control Solution 2 tests should fall within the CTRL 2 range. If the control solution test results do not fall within the respective ranges, DO NOT use the system to test blood, as the system

CTRL 2

mg/dL

81-121

mg/dL

81-121

CTRL 2

may not be working properly. If you cannot fix the problem, please contact Customer Support at 1-800-838-9502 for help. Please contact Customer Support at 1-800-838-9502 for more information on obtaining the control solution kit, which

On Call Plus

contains Control Solution 1 and Control Solution 2.

Test results are displayed either in mmol/L or mg/dL depending on the unit of measure most common in your country. The meter will be set to mg/dL by default when sold in the United States.

15 16

Page 12

En En

Testing Your Blood

Fingertip Testing

The following steps show how to use the meter, test strips, lancing device and sterile lancets together to measure your blood glucose concentration.

Step 1 - Getting a Drop of BloodStep 1 - Getting a Drop of Blood

On Call Plus

The Blood Glucose Monitoring System requires a very small sample of blood which may be obtained from the fingertip, palm (at the base of the thumb) or forearm. See page 20 for information on obtaining a blood sample from the palm or forearm. Before testing, choose a clean, dry work surface. Familiarize yourself with the procedure and make sure you have all the items needed to obtain a drop of blood.

IMPORTANT: Prior to testing, wipe the test site with an alcohol swab or soapy water. Use warm water to increase blood flow if necessary. Then dry your hands and the test site thoroughly. Make sure there is no cream or lotion on the test site.

Cocking Barrel

Lancet Holder

Sterile Lancet

Safety Tab

Clear Cap

(for testing on forearm

and palm)

For fingertip sampling, adjust the depth penetration to reduce the discomfort. You do not need the clear cap for fingertip sampling.

1. Unscrew the lancing device cover from the body of the lancing device. Insert a sterile lancet into the lancet holder and push it until

3 4 5

the lancet comes to a complete stop in the lancet holder

2. Hold the lancet firmly in the and

lancet holder twist the safety tab of the lancet until it loosens, then pull the safety tab off the lancet. Save the safety tab for lancet disposal.

3 Carefully screw the cover back onto the

lancing device. Avoid contact with the exposed needle. Make sure the cover is fully

3 4 5

sealed on the lancing device.

Release Button

Puncture Depth

Settings

Lancing Device

Cover

4 Adjust the puncture depth by rotating the

lancing device cover. There are a total of 5 puncture depth settings. To reduce the discomfort, use the lowest setting that still

17 18

Page 13

En En

produces an adequate drop of blood.

Adjustment: 1 and 2 for delicate skin

3 for normal skin 4 and 5 for calloused or thick skin Note: Greater pressure of the lancing device against the finger will also increase the puncture depth.

5. Pull the cocking barrel back to set the lancing

device. You may hear a click. The device is now loaded and ready for obtaining a drop of blood.

Forearm or Palm (at the base of the thumb) Testing

The forearm and palm areas have fewer nerve endings than the fingertip so you may find that obtaining blood from these sites is less painful than from the fingertip. The technique for forearm and palm sampling is different. You need the clear cap to draw blood from these sites. The clear cap is not adjustable for puncture depth.

IMPORTANT: There are important differences between forearm, palm and fingertip samples that you should know. Important information about forearm and palm glucose testing:

You should talk to your healthcare professional before doing forearm or plam glucose testing. When blood levels are changing rapidly such as after a meal, insulin dose or exercise, blood from the fingertips may show these changes more rapidly than blood from other areas. Fingertips should be used if testing is within 2 hours of a meal,

6. Prior to testing, wipe your hand with an alcohol swab or wash your hands with soap. Use warm water to increase blood flow in your fingers if necessary. Then dry your hands thoroughly. Massage the hand from the wrist up to the fingertip a few times to encourage blood flow.

insulin dose or exercise and any time you feel glucose levels are changing rapidly. You should test with the fingertips anytime there is a concern for hypoglycemia or you suffer from hypoglycemia unawareness.

Please refer to to insert the lancet and load the

Fingertip Testing

lancing device.

1. Screw the clear cap onto the lancing device.

7. Hold the lancing device against the side of the finger to be lanced with the cover resting on the finger. Push the release button to prick your fingertip. You should hear a click as the lancing device activates. Gently massage from the base of the finger to the tip of the finger to obtain the required blood volume. Avoid smearing the drop of blood.

For the greatest reduction in pain, lance on the sides of the fingertips. Rotation of sites is recommended. Repeated punctures in the same spot can make your fingers sore and callused.

19 20

2. Choose a puncture site on the forearm or

palm. Select a soft, fleshy area of the forearm that is clean and dry, away from bone, and free of visible veins and hair.

To bring fresh blood to the surface of the puncture site, massage the puncture site vigorously for a few seconds until you feel it getting warm.

Page 14

3. Place the lancing device against the puncture

En En

site. Press and hold the clear cap against the puncture site for a few seconds. Press the release button of the lancing device, but

not immediately lift the lancing device

from the puncture site. Continue to hold the lancing device against the puncture site until you can confirm a sufficient blood sample has formed.

Disposal of the Lancet

1. Unscrew the lancing device cover. Place the safety tab of the lancet on a hard surface and carefully insert the lancet needle into the safety tab.

2. Press the release button to make sure that the lancet is in the extended position. Pull the lancet straight out of the lancet holder and discard it in an appropriate container. Place the lancing device cover back on the lancing device.

Step 2 - Testing Blood GlucoseStep 2 - Testing Blood Glucose

Note: Insertion of a new test strip at any time, except while in the data transfer mode (detailed on page 28) will cause the meter to automatically enter the test mode.

Make sure that the code number that appears on the display matches the code number (CODE) on the test strip vial (or on the foil pouch). If not, make sure to locate and insert the code chip that came with the box of strips. If the codes still do not match, do not perform a test. You will need a new package of test strips to perform a test.

CODE

2. The blinking test strip and blood drop icon will indicate that the test strip is inserted correctly and a drop of blood can be added.

Lancet Precautions

Do not use the lancet if the safety tab is missing or loose when you take the lancet out of the bag. Do not use the lancet if the needle is bent. Use caution whenever the lancet needle is exposed. Never share lancets or the lancing device with other people to prevent possible infections. In order to reduce the risk of infection from prior use of the instrument, always use a new, sterile lancet. Do not reuse lancets. Avoid getting the lancing device or lancets dirty with hand lotion, oils, dirt or debris. For AST testing, if current lancet is not obtaining enough blood due to skin or other conditions, please contact Customer Support at 1-800-838-9502 for information on different lancet options.

Specimen collection and preparation by healthcare professionals

Please refer to test strip insert if applicable.

21 22

3. Touch the blood sample to the sample tip at the end of the test strip. If the audio option is turned on, the meter will also beep to indicate the sample is sufficient and the measurement has started.

DO NOT:

Apply sample to the front or back of the test strip. Smear the blood drop onto the test strip. Press your finger against the test strip. Apply a second drop of blood.

Page 15

4. The meter will count down from 9 to 1 and

En En

then display the measurement results. The

"HI" and "LO" Messages"HI" and "LO" Messages

meter will also beep to indicate that measurement is complete.

To mark invalid results and to prevent them from being included in the 7, 14 and 30 day averages, press the M and S buttons together. A pound sign (#) will appear on the display to show that the result will not be included when calculating the 7, 14 and 30day averages. If a result is marked by accident, press the M and S buttons again to unmark the result. After marking the invalid result, run the test again with a new test strip.

If an error message appears on the display, refer to the on page

Troubleshooting Guide

31. If a "HI" or "LO" error appears on the display, refer to "HI" and "LO" messages below.

5. After inspection, record valid results in your logbook with the date and time, and compare them to the target goals set by your healthcare professional. Refer to

Testing Times and Target Goals

Suggested

on page 29 and your logbook for more details on your target blood glucose concentration goals.

The meter can accurately measure blood glucose concentrations between 1.1 to 33.3 mmol/L (20 to 600 mg/dL). "HI" and "LO" messages indicate results outside of this range.

If "HI" appears on the display, the measured concentration value is above 33.3 mmol/L (600 mg/dL). The test should be retaken to ensure that no mistake was made in the procedure. If you are certain the meter is functioning properly and no mistakes were made in the procedure, and your blood glucose is still consistently measured as "HI", it indicates severe hyperglycemia (high blood glucose). You should contact your healthcare professional immediately.

If "LO" appears on the display, the measured concentration value is below 1.1 mmol/L (20 mg/dL). The test should be retaken to ensure that no mistake was made in the procedure. If you are certain the meter is functioning properly and no mistakes were made in the procedure, and your blood glucose is still consistently measured as "LO", it may indicate severe hypoglycemia (low blood glucose). You should treat yourself for hypoglycemia immediately as recommended by your healthcare professional.

6. Remove and discard the test strip.

Precautions and Limitations

The meter, test strips and other components have been designed, tested and proven to work together effectively to provide accurate blood glucose measurements. Do not use components from other brands. Use only with whole blood. Do not use with serum or plasma samples. Do not use for testing newborns. Do not use the meter in any manner not specified by the manufacturer. Otherwise, the protection provided by the meter may be impaired. Very high (above 55%) and very low (below 30%) hematocrit can cause false results. Talk to your healthcare professional to find out your hematocrit level.

23 24

Page 16

En En

Abnormally high levels of Vitamin C (ascorbic acid), Acetaminophen, Uric Acid, L-Dopa, Tolazamide or other

Using the Meter Memory

reducing substances will produce falsely high blood glucose measurements. Fatty substances (Triglycerides up to 3,000 mg/dL or Cholesterol up to 500 mg/dL) have no major effect on blood glucose test results. The Blood Glucose Monitoring System has been

On Call Plus

The meter automatically stores up to 300 test records. Each record includes the test result, time and date. If there are already 300 records in memory, the oldest record will be erased to make room for a new one. The meter will also calculate the average values of records from the last 7, 14 and 30 days.

tested and shown to work properly up to 8,516 ft (2,595 meters). Severely ill persons should not run the glucose test with the

Call Plus

Blood Glucose Monitoring System. Blood samples from patients in shock, or with severe dehydration or from patients in a hyperosmolar state (with or without ketosis) have not been tested and are not recommended for testing with Blood Glucose Monitoring System.

On Call Plus

Dispose of blood samples and materials carefully. Treat all blood samples as if they are infectious materials. Follow proper

Viewing Stored RecordsViewing Stored Records

To view stored records:

1. Press the M button to turn the meter on and enter memory mode. The most recent value and the word "MEM" will appear on the display.

precautions when disposing of materials.

MEM

If you are using the meter for the very first time, the meter display will show three dashed lines (---), the word "MEM" and the unit of measure. This shows that no data have been stored in memory.

MEM

2. The date and time will be displayed together with the results stored in memory. A pound sign (#) indicates records that will be omitted from the 7, 14 and 30 day averages.

3. Press the M button to go through the stored records.

4. Press the S button to view the data averages. The words "DAY AVG" will appear on the screen. Note: If you do not wish to view your average glucose measurements, you can press the S button again to turn off the display.

25 26

Page 17

5. While in memory mode, press the M button to switch between the 7,

En En

14 and 30 day averages. The meter will calculate the average that

Maintenance

you selected. The number of records used in the DAY AVG will also appear in the display.

Proper maintenance is recommended for best results.

Replacing the BatteryReplacing the Battery

When the battery icon ( ) appears, it means the battery is running low

6. If there are fewer than 7, 14 or 30 days in memory, all the unmarked readings currently stored in memory will be averaged instead.

If you are using the meter for the very first time, no value will appear on the display. This means that no records have been stored in memory.

7. Press the S button to turn off the display. Note: Results from quality control tests will not be included in the averages. When viewing results in memory, these values are marked with a pound sign (#) to show that they will not be included in the 7, 14 and 30 day averages.

Clearing the MemoryClearing the Memory

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

1. With the meter powered off, press and hold the M button for three seconds. This will turn on the meter and enter the delete mode.

2. To clear the memory, press and hold both the M and S buttons for two seconds.

3. The display will show "MEM" and "---", the meter will clear its memory and after a moment turn itself off.

MEM

and you should replace the battery as soon as possible. An "E-6" error message will appear if the battery is too low to perform any more blood glucose tests. The meter will not function until the battery is replaced. Instructions:

1. Make sure the meter is off before removing the battery.

2. Pull the battery carrier on the left side of the meter. The battery carrier should be easily opened with you finger.

3. Remove and discard the old battery. Replace it with a new CR 2032 3.0V coin cell battery.

lucose Glucosa

Chip

Codificador

iagnosticuse only.

oratories,Inc.

saRimRoad, CA92121,USA ort:1-800-838-9502

Plus

Meter

enSangre

Make sure it is aligned with the (+) side facing up in the battery carrier.

4. Close the battery carrier and make sure that it snaps shut.

5. Recheck and reset the clock setting as necessary after battery replacement to ensure time is set correctly. To set the meter clock,

Meter Setup Before Testing

see on page 11.

Caring for Your

Glucose Monitoring System

Blood

Blood Glucose Monitoring System

Call Plus

On Call Plus

Blood Glucose Meter

On Call Plus

Your Blood Glucose Meter does not require special maintenance or cleaning. A cloth dampened with water and a mild detergent solution can be used to wipe the outside of the meter. Take care to avoid getting liquids, dirt, blood or control solution into the meter through the strip or data ports. It is recommended that you store the meter in the carrying case after each use.

On Call Plus

The is a precision electronic instrument. Please handle it with care.

Blood Glucose Meter

4. If you entered the delete mode but want to exit without deleting the recorded data, press the S button. This will turn the meter off without deleting any data.

27 28

Lancing Device

Use mild soap and warm water to clean with a soft cloth as required. Carefully dry the device thoroughly. Do not immerse the lancing device. Please refer to the lancing device insert for more details.

Page 18

Suggested Testing Times

En En

and Target Goals

Tracking your blood glucose concentration through frequent testing is an important part of proper diabetes care. Your diabetes health care professional will help you to decide the normal target range for your glucose levels. They will also help you determine when and how often to test your blood glucose. Some suggested times are:

When you wake up (fasting level) Before breakfast 1-2 hours after breakfast Before lunch 1-2 hours after lunch Before or after exercise Before dinner 1-2 hours after dinner Before bedtime After a snack At 2 or 3 AM, if taking insulin

You may need to test more often whenever :

You add or adjust your medication for diabetes. You think your blood glucose levels may be too low or too high. You are ill, or feeling uncomfortable over long periods of time.

Expected blood glucose levels for people without diabetes:

Fasting and Before Meals

Talk to your diabetes healthcare professional to set your own daily target ranges.

Time of Day

Waking up (Fasting level) Before meals 2 hours after meals Bedtime 2AMto3AM Other

Use the logbook to record your blood glucose measurements and related information. Bring the logbook with you when visiting your physician so that you can determine how well your blood glucose is being controlled. This can help you and your health care professional make the best decisions about your glucose control plan.

1. Jennifer Mayfield and Stephen Havas, "Self-Control: A Physician's Guide to Blood Glucose Monitoring in the Management of Diabetes An American Family Physician Monograph"

2. ADA Clinical Practice Recommendations, 2010.

Time

2 Hours after Meals

Range, mg/dL

Less than 140

(Note: 1 mmol/L = 18 mg/dL)

70 - 100

Your Target Range

29 30

Range, mmol/L

3.9 - 5.6

Less than 7.8

Comparing Meter and Laboratory Results

On Call Plus

Your Blood Glucose Monitoring System and laboratory results both report the glucose concentration in the serum or plasma component of your blood. However, the results may differ somewhat due to normal variation. This is expected, but the difference under normal operating conditions should be no greater than 20%.

Users should make accurate comparisons periodically between meters and laboratory results. Follow the guidelines below.

Before you go to the lab:

Bring your meter, test strip and control solution with you to the lab. Make sure your meter is clean. Perform a quality control test to make sure the meter is working properly. Comparisons will be more accurate if you do not eat for at least four hours (preferably eight hours) before testing.

At the lab:

Wash your hands before obtaining a blood sample. Obtain blood samples for a laboratory test and for your meter within 10 minutes of each other. This will ensure an accurate comparison of results. Never use your meter with blood that has been placed in test tubes containing fluoride or other anticoagulants. This will cause falsely low results.

Page 19

En En

Troubleshooting Guide

Display

Temperature is below the

The meter has built-in messages to alert you of problems. When error messages appear, note the error number, turn off the meter and then follow these instructions.

operating temperature of the system

Battery is discharged but has enough power to run

Display

Meter fails to turn on

Causes Solution

Battery may be damaged or not be charged

Meter is too cold

Replace battery.

If meter has been exposed to or stored in cold conditions, wait 30 minutes to allow meter to reach room temperature then

10 more tests

Battery has discharged and meter does not allow more tests until replacement with a new battery

No code chip in the meter

CODE

repeat test.

Power On self check error

Remove battery for 30 seconds and then put battery back and turn meter on again. If problem persists, contact customer

Damaged code chip or the code chip was removed during a test

support.

If a cell phone, radio frequency

Internal calibration check error

source or a high power electrical source is nearby, place more distance between the meter and any of these sources then retest.

Meter electronics failure

If the problem persists, contact

Test strip was removed during the test

Sample was applied to the test strip too soon

Test strip is contaminated or used

customer support.

Repeat the test and ensure test strip remains in place.

Repeat test and apply sample after blood drop/test strip icon appears.

Repeat test with a new test strip.

Incorrect code chip inserted in the meter

Communications failure

Repeat test and apply enough

Insufficient sample

Temperature has exceeded the operating temperature of the system

sample to fill the test strip check window.

Move to a cooler environment and repeat the test.

For help with any additional questions or issues, please contact Customer Support at 1-800-838-9502.

Causes Solution

Move to a warmer environment and repeat the test.

Test results will still be accurate, but replace the battery as soon as possible.

Replace the battery and repeat the test.

Insert the code chip that accompanied the box of test strips.

If the code chip is damaged, use a new code chip with the correct code number and run the test. If the chip is removed during a test, confirm the code chip matches the test strip code and repeat the test.

If the problem persists, contact customer support.

Indicates an incorrect code chip was inserted in the meter. Please make sure you use the

On Call Plus

with the Blood

brand of test strips

On Call Plus

Glucose Meter. If the problem persists, contact customer support.

There is an error in transferring data to the PC. See the package insert included with the Data Management Kit for troubleshooting.

31 32

Page 20

En En

Specifications

Warranty

Feature

Measurement Range

Result Calibration

Sample

Minimum Sample Size

Test Time

Power Source

Battery Life

Glucose Units of Measure

Memory

Meter Size

Display Size

Specification

20 to 600 mg/dL

Plasma-equivalent

Fresh capillary whole blood

1 µL

10 seconds

One (1) CR 2032 3.0V coin cell battery

12 months or approximately 1,000 tests

The meter is pre-set to either millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL) depending on the standard of your country. The meter will be set to mg/dL by default when sold in the United States.

Up to 300 records with time and date

85mm x 54mm x 20.5mm

35mm x 32.5mm

Please complete the warranty card that came with this product and mail it to the following address:

10125 Mesa Rim Road, San Diego, CA 92121-2915, USA

If the meter fails to work for any reason other than obvious abuse within the first five (5) years from purchase, we will replace it with a new meter free of charge. For your records, also write the purchase date of your product here. Date of purchase:

Note: This warranty applies only to the meter in the original purchase, and does not apply to the battery supplied with the meter.

Warranty CenterOn Call Plus

Weight

Operating Temperature

Operating Relative Humidity

Hematocrit Range

Approximately 49.5 g (with battery installed)

41 - 113 F(

20-90% (non-condensing)

30-55%

5-45 C)

Page 21

Index

Averaging Results...................26

Battery, Replacing the.............28

Carrying Case.............................1

Clearing the Memory...............27

Data Port......................................3

Date Format............................7, 9

Guidelines....................................i

Hematocrit..........................24, 33

Install the Battery.....................10

Lancing Device...............1, 17, 28

Lancets..................................1, 17

Logbook................................2, 29

Maintenance and Disposal..5, 28

Measure, Unit of ..................4, 15

Meter............................................3

Audio feature............................13

Cleaning....................................28

Code chip....................................2

Display.........................................4

Error Messages.........................31

"HI" and "LO" Messages...........24

M Button......................................3

Memory......................................26

Meter code................................11

Meter Setup...............................11

Meter Use and Precautions........5

S Button.......................................3

Set the Clock.............................12

Specifications............................33

Procedure

Precautions and Limitations.....24

Testing Your Blood....................17

Quality Control Test.................14

Control Solution..........................8

How to Run...............................14

Results

Blood Glucose..........................23

Control Solution........................15

Meter vs. Lab Results...............30

Target Goals..............................29

Unit of Measure...................15, 29

Suggested Testing Times........29

Test Strip.....................................5

Code............................................6

Expiration.....................................7

Precautions.................................8

Testing Your Blood..................17

Get a Drop of Blood..................17

Test Blood Glucose...................22

Troubleshooting.......................31

Viewing Stored Records.........26

Warranty..............................2, 34