LifeScan 512 User Manual

Blood Glucose Monitoring System

Welcome to the OneTouch®family!

OneTouch®is committed to creating a world without limits for people with diabetes.

The OneTouch®UltraLink™Meter, developed by LifeScan and Medtronic Diabetes, makes it simple to get a blood glucose test result and review past results. We designed this product to make testing easy and to help you manage your diabetes.

A special wireless communication feature lets the meter automatically transmit glucose test results to Medtronic Diabetes devices with MWT1* technology.

Automatically transmits glucose test results to

Medtronic Diabetes devices with MWT1 technology

Owner’s Booklet

For Investigational Use Only. The performance characteristics of this product have not been established.

This owner’s booklet will help you learn how to use your meter properly. Please read it carefully.

If you need assistance, please contact Customer Service at 999-999-999 or visit www.LifeScan.com for more information.

If you have questions about any partner device* from Medtronic Diabetes, you may contact the manufacturer at 888-888-8888 or visit their Web site at www.medtronicdiabetes.com.

* Throughout this owner’s booklet, references to Medtronic Diabetes devices with MWT1 technology will be referred to as simply “partner devices”.

Table of contents

Setting up pg. 2 your system

• Getting to know your OneTouch Glucose Meter and Test Strips

• Turning your meter on and off

• Setting up your meter

• Turning the PUMP COMM

(partner device communication) feature on and off.

Your meter comes pre-set to automatically transmit glucose test results to your partner device. You will also need to program your meter ID into your partner device for results to be transmitted. See page 10 for instructions on where to find your meter ID and how to program it into your partner device.

UltraLink™Blood

Starting the test process pg. 12

NOTE: Before testing, read this owner’s booklet carefully.

Insert a test strip

Check the code on the test strip vial before inserting the test strip. Make sure the three contact bars are facing you. Push the test strip in as far as it will go. Do Not bend the test strip.

The meter will turn on, show a black start-up screen and then a code number. The first time you use the meter, the CAL CODE screen will display “––” instead of a number.

Match the code displayed on the meter with the code on the test strip vial

If the code on the meter does not match the code on the vial, press or to change the code. If the display changes to the

APPLY BLOOD screen before

you are ready, remove the teststrip and re-start the test process.

Press when the numbers match.

The meter is ready for testing when the

APPLY BLOOD screen

appears.

Getting a blood sample pg. 16

Prepare the OneTouch®Lancing Device

Remove the blue cap and put a new lancet in the lancing device. Twist off the protective disk. Replace the cap and cock the lancing device.

Get a drop of blood

Hold the OneTouch Device firmly against your finger. Press the release button.

Gently squeeze and/or massage your fingertip until a round drop of blood of at least one microliter ( actual size) forms on your fingertip.

Lancing

Applying blood pg. 28 and reading results

Touch and hold the drop of blood to the narrow channel in the top edge of the test strip

Blood will be drawn into the test strip. Keep holding the drop of blood to the top edge of the test strip until the confirmation window is full. The meter will begin to count down from 5 to 1. Then, your blood glucose level appears on the display along with the unit of measure, and the date and time of the test.

Your glucose test result will flash on the display to indicate that it is being transmitted to your partner device. The result will stop flashing after it has been received. After about 60 seconds, if the result has not been received by the partner device, the transmit feature will turn off and the result will stop flashing.

If the test results are lower than, higher than, or not what you expect, see pages 34–36.

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OKOKOK

Attaching flags or comments to your results pg. 38

Add a meal flag to track different types of averages

While viewing your test result, (or after it stops flashing if the PUMP COMM feature is turned on), press to get to the

FLAG

screen.

MEAL

Add a comment

While viewing your test result (or after it stops flashing if the PUMP COMM feature is turned on), press to get to the

COMMENT screen.

Reviewing past pg. 42 results and averages

• Last result

• All results

• Result averages

• Downloading results

Press or to highlight

BEFORE MEAL or AFTER MEAL.

To confirm your selection, press .

The meal flag you chose will appear above the result.

If you do not wish to add a meal flag, select NO FLAG and press . This will return you to the glucose result screen.

Press or to highlight an appropriate comment.

To confirm your selection, press .

The comment you chose appears below the result.

Meal flag

Comment

Control solution pg. 48 testing

Caring for your pg. 54 system

Troubleshooting pg. 60

Detailed information pg. 68 about your system

Index pg. 73

 WARNING: Failure to carefully follow the directions in this owner’s booklet can

lead to inaccurate test results.

Before you begin

Before using this product to test your blood glucose, carefully read this booklet and the inserts that come with the OneTouch®Ultra®Test Strips and OneTouch®Ultra Control Solution. Take note of warnings and cautions throughout this booklet, which are identified with . Many people find it helpful to practice the test with control solution before testing with blood for the first time. See page 48 in the Control solution testing section.

Intended use

• The OneTouch®UltraLink™Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm.

• The OneTouch®UltraLink™System is intended for use by people with diabetes in a home setting and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. When used with the partner device, the OneTouch®UltraLink™System can automatically transmit glucose values to the partner device using radio frequency (RF) communication.

• Not for the diagnosis of diabetes

• Not for use with neonates

• Test strips for single use only

• Test strips are specific to D-glucose and do not react to other sugars that may be present in the blood

• Not for use with serum or plasma The OneTouch®UltraLink™Blood Glucose Monitoring System may also be used with

designated partner devices. OneTouch®UltraLink™is set up to automatically transmit each glucose result to the partner device.

See your partner device manual for instructions for setting up, using, and troubleshooting problems with your partner device.

Test principle

Glucose in the blood sample mixes with special chemicals in the test strip and a small electric current is produced. The strength of this current changes with the amount of glucose in the blood sample. Your meter measures the current, calculates your blood glucose level, displays the result, and stores it in its memory.

viv

About RF

Radio frequency (RF) is a type of wireless communication. Cell phones use RF technology,

as do many other devices. RF is how your OneTouch

UltraLink™Blood Glucose Meter

transmits glucose test results to your partner device. Your OneTouch

UltraLink™Meter comes from the factory pre-set to automatically transmit glucose test results to the partner device. You must also program the partner device to recognize the unique meter ID stored in your meter for test results to be received. This will help ensure that only results from your OneTouch

UltraLink™Meter will be received by

your partner device. Your meter is subject to and complies with U.S. federal guidelines, Part 15 of the FCC rules

for devices with RF capability. These rules state two conditions specific to the operation of the device. They are:

• This device may not cause harmful interference.

• This device must accept any interference received, including interference that may cause undesirable operation.

These guidelines help ensure that your meter will not affect the operation of other nearby devices. Additionally, other devices should not affect the use of your meter.

Other wireless devices that are in use nearby, such as a cell or mobile phone, or a wireless network, may prevent or delay the transmission of data from your meter to your partner device. Moving away from or turning off these devices may allow communication.

The meter has been tested and found to be appropriate for use at home. In most cases, it should not interfere with other home electronic devices if used as instructed. However, this meter gives off RF energy when the RF feature is turned on and in use; so, if not used correctly, your meter may interfere with your TV, radio, or other similar electronic devices that receive or transmit RF signals. If you experience meter interference problems, you should try moving your meter away from the source of the interference, or relocate the electronic device or its antenna to another location to resolve the problem.

If you continue to experience interference problems, contact Customer Service at 999-999-9999, or contact support service for the manufactuer of the device causing the interference.

In locations where cell phone use is not permitted, such as hospitals, some health care professional offices, and airplanes, you should turn the meter RF feature off.

If you plan to travel to another country, be familiar with local regulations regarding the use of RF devices. You may contact 888 888-8888 for more information about local regulations.

 WARNING: If you plan to use the RF feature on your meter to automatically

transmit test results to your partner device, Do Not let anyone else use your meter to test their blood glucose. This will prevent other people’s results from being transmitted to your partner device or being included in your past results and averages. If you must lend your meter to anyone else, be sure to turn the RF (PUMP COMM) feature off.

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The OneTouch®UltraLink™Blood Glucose Monitoring System

Your new OneTouch®UltraLink™System Kit includes: a OneTouch®UltraLink™Meter (batteries included) b OneTouch®Ultra®Control Solution c OneTouch®Lancing Device

If another type of lancing device was included, see the separate instructions

that came with that lancing device.

d OneTouch®AST™Clear Cap e OneTouch®UltraSoft®Sterile Lancets f Carrying Case

g OneTouch®Ultra®Test Strips

Documents in your kit include this owner’s booklet, a quick reference guide,

a control solution insert and a warranty registration card.

If any items are missing from your kit, call Customer Service.

 WARNING: Keep the meter and testing supplies away from young children.

Small items such as the battery door, batteries, test strips, lancets, protective

disks on the lancets, and control solution vial cap are choking hazards.

Setting up your system

Turning your meter on

There are two ways to turn your meter on:

Getting to know your OneTouch®UltraLink™Blood Glucose Meter and test strips

To perform a test, insert a test strip as far as it will go. The meter will briefly perform system checks, then the display will turn on.

Front

Display

Test port

Insert test strip here to turn meter on for testing

mg/dL is the pre-set unit of measure

Back

Battery compartment cover

Test strip

Edge to apply sample

Meter ID

Confirmation window

or,

With the meter turned off, press and hold for two seconds to access MAIN MENU.

Check that the screen shows solid black for two seconds. If it does, the display is working properly. If the meter does not power on, try changing the meter batteries. See pages 56–59.

 CAUTION: If you see any light areas within the black start-up screen, there

Meter ID

Data port

Contact bars

Insert into test port

selection available using up or down button

OK button

Turns the meter on/off

Confirms menu selections

Up and down buttons

Select or change information

Indicates

Serial number

2 3

may be a problem with the meter. Call Customer Service.

Setting up your system

OKOKOK

OKOKOKOKOK

Turning your meter off

There are several ways to turn your meter off:

• Press and hold for five seconds.

• Your meter will turn off by itself if left alone for two minutes.

• Go to MAIN MENU and press or to highlight METER OFF, then press .

• Before or after completing a test, remove the test strip. If you advance from the test result screen to the MAIN MENU by pressing , removing the test strip will not turn the meter off. Use one of the three methods above.

In other cases, from the

MAIN MENU, press or

to select SET UP. To confirm your selection, press . Then, press or to select METER

SETTINGS.

To confirm your

selection, press .

The display now shows the LANGUAGE screen.

3. Choose a language

Setting up your system

Setting the meter language, date and time

You can change many of the settings that came pre-set with your meter. Before using your meter for the first time or if you change the meter batteies, you should check and update these settings. Make sure you complete steps 1 through 8 below to ensure your desired settings are saved.

1. Turn the meter on, see page 3

2. Get to the LANGUAGE screen

When using the meter for the first time, or after changing the meter batteries,

you will automatically start in the LANGUAGE screen.

Now press or to highlight the language of your choice. To confirm your selection, press .

The display now shows the DATE FORMAT screen.

NOTE: If you select the wrong language, press and hold for five seconds to turn the meter off. Then, turn the meter back on and re-start from step 1.

4. Set the date format

Press or to highlight the date format—choose month first (MM-DD-YYYY) or day first (DD-MM-YYYY). To confirm your selection, press .

The display now shows the DATE SET UP screen.

4 5

Setting up your system

5. Set the date

OKOKOK

In the DATE SET UP screen, press or to change the first value. To confirm your selection, press .

Press or to change the second value. To confirm your selection, press .

Press or to change the year. To confirm your selection, press .

The display now shows the TIME FORMAT screen.

Setting up your system

6. Set the time format

Press or to select the time format you prefer—AM/PM or 24 HR. To confirm your selection, press .

The display now shows the TIME SET UP screen.

7. Set the time

Press or to set the hour.

To confirm your selection,

press .

Press or to set the minutes.

To confirm your

selection, press .

If you have selected the AM/PM time format, AM or PM will be displayed next to the minutes.

Setting up your system

Press or to set AM or PM.

To confirm your selection,

press .

The display now shows the SETTINGS screen.

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OKOKOK

8. Confirm your settings

The choice YES will be highlighted at the bottom of the screen. If your settings are correct, press to confirm and save the settings and return to the MAIN MENU.

If you do not wish to track separate result averages for before and after meals, nor attach comments to any test result, you may turn this feature off.

If you turn off the flags/comments feature, you will not see on the test result screen after you complete a blood glucose test. You will be able to review the

ALL RESULTS AVG screen, but not before- or after-meal averages. See page 44 for

more information about result averages.

Setting up your system

 WARNING: The unit of measure mg/dL must be displayed here.

If your display shows mmol/L rather than mg/dL, contact Customer

Setting up your system

Service. You cannot change the unit of measure. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment.

If you want to cancel your settings and start the settings process over again, press or to highlight NO and press . You will be returned to the

LANGUAGE screen. Note that none of the settings you entered will be saved.

Turning the flags/comments feature off or on

Your OneTouch®UltraLink™Meter allows you to attach optional notes to any blood glucose test result. See pages 38–41 for the types of meal flags and comments you can attach to a result, and the reasons for using this feature. We suggest you talk to your health care professional to see how meal flags and comments may help you manage your diabetes.

8 9

To turn the flags/comments feature off or on:

1. From MAIN MENU, press or to select SET UP

To confirm your selection, press .

2. From the SET UP screen, select FLAGS/COMMENTS

To confirm your selection, press .

3. Press or to highlight your response

Select YES if you wish to change the setting, or NO if you wish to leave it as it is.

Press to confirm your selection and return to MAIN

OKOKOK

Turning the PUMP COMM (partner device communication) feature off or on

The PUMP COMM feature allows your meter to automatically transmit glucose test results to your partner device using a wireless (RF) link.

The meter comes pre-set with the PUMP COMM feature turned on. This means once you program the meter ID into your partner device, glucose test results will automatically be transmitted to your partner device every time you do a test.

If you turn the PUMP COMM feature off, your glucose test results will not be transmitted to your partner device.

Setting up your system

Your unique meter ID is stored in the meter memory. To display the ID on your meter, you must complete step 1 below. The ID also appears on both labels on the back side of the meter.

IMPORTANT: See your partner device manual for instructions for programming your meter ID into your partner device.

Meter ID

To turn the PUMP COMM feature off or on:

1. From MAIN MENU, press or to select PUMP

COMM

To confirm your selection, press .

2. Press or to highlight your response

Your unique meter ID will be displayed on the top line of the screen. The current PUMP COMM setting will be displayed underneath.

Select YES if you wish to change the setting, or NO if you wish to leave it as it is.

Press to confirm your selection and return to MAIN MENU.

To confirm the PUMP COMM feature is set the way you want, select PUMP COMM from the MAIN MENU and press .

Setting up your system

1110

Starting the test process

Have these things ready when you test your blood glucose level:

• OneTouch®UltraLink™Meter

• OneTouch®Ultra®Test Strips

• Lancing device

• Sterile lancets with protective disks

• OneTouch®Ultra®Control Solution

NOTE:

• Use only OneTouch®Ultra®Test Strips with your OneTouch®UltraLink™Meter.

• Make sure your meter and test strips are about the same temperature before you test.

• Testing must be done within the operating temperature range (43–111°F). For the most accurate results, try to test as close to room temperature (68–77°F) as you can.

• OneTouch®Ultra®Test Strips are for single use only. Never re-use a test strip that had either blood or control solution applied to it.

12 13

 CAUTION: If you

cannot test due to a problem with your testing supplies, contact your health care professional or Customer Service. Failure to test could delay treatment decisions and lead to a serious medical condition.

 CAUTION: The test

strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation.

1. Check the code on the test strip vial before inserting the test strip

Code numbers are used to calibrate your meter with the test strips you are using.

2. Insert a test strip to turn on the meter

Start with the meter off. If you have turned the meter on to change settings or review past results, turn it off. Remove a test strip from its vial and immediately replace the vial cap and close it tightly. With clean, dry hands, you may touch the test strip anywhere on its surface. Do Not bend, cut or modify the test strips in any way. Use each test strip immediately after removing it from the vial.

Insert the test strip into the test port as shown. Make sure the three contact bars are facing you. Push the test strip in as far as it will go. Do Not bend the test strip.

Starting the test process

After the black start-up screen appears, the meter will

display the code from your last test. If a flashing “––” appears instead of a code number, such as when you are first using the meter, follow the instructions in step 3 to change to a numerical code.

If the codes already match, press to go to the APPLY

BLOOD

screen. When you do not make a change after

five seconds, the display will advance to the APPLY

BLOOD

screen.

The meter is now ready to perform a blood glucose test.

Starting the test process

3. Match the code on the meter with the code on the test strip vial

If the code on the meter does not match the code on the test strip vial, press or to match the code number on the test strip vial. The new code number will flash on

Starting the test process

the display for three seconds, then briefly stop flashing, after which the display will advance to the APPLY BLOOD screen.

 CAUTION: Matching the code on the meter and the code on the test strip

vial is essential to obtaining accurate results. Each time you test, check to make sure the code numbers match.

NOTE:

• If the APPLY BLOOD screen appears before you are sure the codes match,

remove the test strip, and re-start from step 1, see page 13.

• If you change APPLY BLOOD to APPLY CONTROL by mistake, press to change it back to APPLY BLOOD.

14 15

Getting a blood sample

Overview of the OneTouch®Lancing Device

Cocking control

Release button

Depth indicator

OneTouch (for alternate site sampling)

AST™Clear Cap*

Choosing the right sampling site at the right time

The OneTouch®UltraLink™Meter allows you to sample blood from your fingertip, forearm or palm. At times, results obtained at the forearm or palm may be different from a fingertip measurement. Talk to your health care professional before you begin using your forearm or palm for sampling.

Use blood

If you are testing: sample from your:

Routinely before meals

Fingertip, forearm, or palm

Protective disk

Blue cap* (for fingertip sampling)

OneTouch®UltraSoft®Sterile Lancet

*The blue cap and OneTouch

CAUTION: To reduce the chance of infection:



AST™Clear Cap are also used for depth adjustment.

Lancet point

• Make sure to wash the puncture site with soap and water before sampling.

• Never share a lancet or a lancing device with anyone.

• Always use a new, sterile lancet—lancets are for single use only.

• Keep your meter and lancing device clean. See pages 54–56.

NOTE: If you do not have a OneTouch

Lancing Device, please refer to the

instructions that came with your lancing device.

16 17

Prior to or more than two hours after:

• a meal

• a rapid-acting insulin injection or insulin pump bolus

• exercise

When your blood glucose is changing rapidly, such as:

• within two hours after a meal

• within two hours after a rapid-acting insulin injection or insulin pump bolus, or

• during or within two hours after exercise

When you are concerned about the possibility of hypoglycemia (low blood sugar)

When the AST site results do not agree with the way you feel, during illness or during times of stress

Fingertip, forearm, or palm

Fingertip

Getting a blood sample

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