Bayer Healthcare Blood Glucose Meter Ascensia Elite Users Manual — (#21296)

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2015-02-02

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THE NEW FACE

of Glucometer

Diabetes Care System

SER

UIDE

For Use With Ascensia

LITE

™

Blood Glucose Meter

Need Help With Reimbursement? Call Our Bayer Care Help Line: 1-877-787-1912.

If You Have Any Questions, Comments or Need Help With Reimbursement For

Your Testing Supplies, Please Call 1-800-348-8100.

Introduction

What it is:

The Ascensia ELITE™ Diabetes Care System is a blood glucose monitoring

system. The system is made up of the Ascensia ELITE™ Meter, Test Strip,

and Code Strip. For quality control of the system, the Ascensia ELITE™

Check Strip and Normal, Low and High Controls are also available.

How it works:

The Ascensia ELITE blood glucose testing process is based on an electrode sensor

technology. Capillary action at the end of the Test Strip draws a small amount

of blood into the reaction chamber and a reading is displayed in 30 seconds.

No timing, wiping or blotting is required.

What is new and different:

Ascensia ELITE™ Test Strips are calibrated to give plasma/serum equivalent

glucose results. Plasma/serum results are used by doctors and laboratories as

the most accurate method for reading blood glucose levels. The Ascensia ELITE

System provides you with readings that correspond directly to those of your

doctor or clinic. Compare Ascensia ELITE Test Strip results only to systems which

use a plasma/serum calibration.

6 75

TESTING MATERIALS

Test Slot – provides an opening for inserting strip into the Meter.

Icon – shows proper orientation and direction for inserting the Test Strip, Code Strip

or Check Strip into the Meter.

Display – displays test results, current Code (Function) Number (F– #), or low battery

indicator.

Batteries – provide power for the Meter.

Check Strip – conﬁrms that the Meter electronics are working properly, and acti-

vates the memory recall and the delete option.

Code Strip – codes (calibrates) the Meter.

Test Strip – tests for glucose in blood and control solutions, and can be used to

“mark” a control test or to delete a test result from the memory.

Test end – draws sample into the reaction chamber of the Test Strip.

Meter end – inserted into the Meter to activate power.

MICROLET®Adjustable Lancing Device and lancet – for skin puncture.

Normal Control Solution – a solution with a known amount of glucose used to

conﬁrm that the system is working properly (Low and High Control Solutions are

also available).

Introduction (continued)

What you do:

1. Insert the Test Strip into the Test Slot located at the top,

center of the Meter.

2. Touch the test end (tip) of the Test Strip to a drop of blood.

A “beep” sounds after the Test Strip reaction chamber is

ﬁlled with blood. The test result is displayed in 30 seconds.

The Meter turns on when the Test Strip is inserted and turns off

when the Test Strip is removed, therefore, no operating buttons are required. The Meter auto-

matically stores the last 20 test results, including both blood glucose and control test results.

The Ascensia ELITE System provides blood glucose results ranging from 20–600 mg/dL

(1.1–33.3 mmol/L). The Meter is battery operated and approximately 1000 tests may be

performed before replacing batteries.

CAUTION: Before using any product to test your blood glucose (sugar),

read all instructions and practice the test. Do all quality control checks

as directed and consult with a diabetes health professional. These

recommendations apply to all blood glucose monitoring systems and

are supported by the American Association of Diabetes Educators,* the

American Diabetes Association, the Food and Drug Administration and

the Health Industry Manufacturers Association.

*You may call the American Association of Diabetes Educators for the

location of a Certiﬁed Diabetes Educator (CDE) near you 1-800-338-DMED.

iii

Special Feature

1. WHAT IS DIFFERENT?

The part of the Test Strip that touches the sample.

2. HOW IS IT DIFFERENT?

The blood sample is drawn into the Test Strip and

is not put on the Test Strip.

3. WHEN DOES THIS HAPPEN?

The test end (tip) of the Test Strip draws (pulls) the

blood sample into the Test Strip when the tip touches

the blood sample.

IN OTHER WORDS:

Think of the Test Strip as

a straw used for drink-

ing. You put the straw

into the liquid.

The liquid

is drawn into

the straw

at one end...

SO the

blood sample

is drawn

into the Test Strip at one

end when you put the

tip of the Test Strip into

the sample. We call this

“Sip-in Sampling.”

RIGHT

WRONG

Contents

SECTION 1 – The Ascensia ELITE™Diabetes Care System

• Learn About the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

• Install/Replace Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

• Check the Meter Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

• The Check Strip Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

SECTION 2 – Prepare for the Blood Glucose Test

• Code (Calibrate) the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

• The Control Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

SECTION 3 – The Blood Glucose Test

• Get Ready for the Blood Glucose Test . . . . . . . . . . . . . . . . . . . . . . . . . . 14

• Perform the Blood Glucose Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Contents (continued)

SECTION 4 – Learn About the Memory Feature

• Introduction to Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

• Recall Test Results from the Memory . . . . . . . . . . . . . . . . . . . . . . . . . . 23

• Delete All Test Results from the Memory . . . . . . . . . . . . . . . . . . . . . . . 24

• Delete a Single Test Result from the Memory . . . . . . . . . . . . . . . . . . . 25

• Mark a Control Test Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

• Things to Remember . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

SECTION 5 – Care of the Meter and Strips . . . . . . . . . . . . . . . . . . . . . . . . . 29

SECTION 6 – Solve Problems

• Meter and Test Strip Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

• Test Result Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

SECTION 7– Service the System

• Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

• Check List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

• Limitations of the Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

• Speciﬁcations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

• Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

• Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Learn About the System SECTION 1

This booklet is designed to guide you through

the operation of the Ascensia ELITE™ Diabetes

Care System with detailed directions and

illustrations. A Quick Reference Guide is

provided, and can be carried in your Meter

Carrying Case.

Please read the entire User Guide before you

begin testing.

Before reading the User Guide, you will need

to unpack and set up your testing materials.

See the “Testing Materials” foldout, attached to the

ﬁrst page of this User Guide, to identify testing

materials needed.

CUSTOMER SERVICE1-800-348-8100

Bayer Corporation

Mishawaka, IN 46544 USA

Quick Reference Guide

Always refer to your USER GUIDE for detailed instructions

wash

insert on

dry

remove off

stick

wait

30 sec.

result record result

stroke

touch

THENEWFACE

of Glucometer

Diabetes Care System

SER

UIDE

For Use With Ascensia

LITE

™

Blood Glucose Meter

Need Help With Reimbursement? Call Our Bayer Care Help Line: 1-877-787-1912. If

You Have Any Questions, Comments or Need Help With Reimbursement For

Your Testing Supplies, Please Call 1-800-348-8100.

Diagnostics Division

Install / Replace Batteries SECTION 1

THE BATTERIES: The Meter uses two (3-volt lithium) batteries. These are furnished with

the Meter.

WHEN TO REPLACE: When the battery voltage becomes weak (after approximately

1000 readings), the Meter will show a battery display ( ). When this display appears, it is

time to replace the batteries (see page 40 for battery types). The Meter will continue to pro-

vide accurate results for a period of time until the batteries are exhausted. At this time, the

Meter will “lock you out” from further testing.

DIRECTIONS:

1. With the tip of a ﬁnger, press the battery compartment

lid latch toward the word “open.” Lift the lid.

2. Place the two new batteries into the battery compartment with

the “+” side up and close the lid. NOTE: If replacing batteries,

remove the old batteries from the compartment and discard.

Things to remember:

• WARNING: Keep batteries away from children. Lithium

batteries are poisonous. If swallowed, immediately

contact your physician.

• Discard batteries according to your local

environmental regulations.

• The Meter memory will not be erased when

batteries are changed.

Check the Meter Performance SECTION 1

WHEN: When your Meter is new and anytime you want to check that

your Meter is functioning properly.

WHAT TO EXPECT:

A Check Strip test result that falls within the Check Strip

Range tells you that the Meter electronics are working properly.

Note the Check Strip Range printed on the

check strip package insert.

A Check Strip test result that falls outside the Check

Strip Range tells you the Meter may not be functioning

properly. If this occurs, refer to Section 6 – page 31.

OTHER:The Check Strip can also be used to activate the Meter’s memory recall

function, or memory deletion option (see Section 4).

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

Insert the Check Strip

fully into the Meter as

shown (with tab pointing

right). A beep sounds and a

full display* appears.

Another beep sounds and the

Check Strip test result is dis-

played. A check mark (✔)

shows on the display when

the Check Strip test is done.

MATERIALS

REQUIRED:

•Ascensia ELITE™Meter

•Ascensia ELITE™

Check Strip

CHECK THE METER:

Remove the Check

Strip from its package.

The Check Strip Test SECTION 1

1 2

*A full display, as shown here, indicates that

all characters in the display are working

properly. If ever all the display segments do

not appear, see Section 6, page 32.

If the Check Strip test

result is within the range

listed on the package insert

found inside the Check Strip

package, the Meter is

functioning properly. If not,

refer to the Problem Solving

Chart in Section 6.

Carefully remove the Check

Strip from the Meter, and

replace it in its package.

Things to remember:

• It is important to insert

the Check Strip with a

ﬁrm motion until it comes

to a full stop. When

inserted fully, the tab on

the top portion of the

strip should be completely

hidden within the Meter.

• Always keep the Check

Strip stored in its package

when not in use.

• Do not bend the Check

Strip.

• You can also use the

Check Strip to recall the

Meter’s memory, or to

delete all of the stored

test results from the

memory (see Section 4).

The Check Strip Test (continued) SECTION 1

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

Code (Calibrate) the Meter SECTION 2

WHY CODE THE METER?

To match the Meter to the reactivity of the Test Strip, you must

ﬁrst code (calibrate) the Meter using the Code Strip provided in

the carton of Ascensia ELITE™ Test Strips now in use.

Each lot of Test Strips is tested extensively and assigned a Function

Number (0 through 12) identiﬁed on the Code Strip.

WHEN TO CODE THE METER

Reset the code for each new carton of Ascensia ELITE™ Blood Glucose Test Strips used,

unless the new carton of Test Strips has the same Function Number as the previous

one.

MATERIALS

REQUIRED:

•Ascensia ELITE™Meter

•Ascensia ELITE™Code

Strip

CODE THE METER:

1Open your new carton of

Test Strips and ﬁnd the

clear plastic packet contain-

ing the Code Strip.

2Carefully tear open the

packet, and remove the

Code Strip. Save the packet

to store the Code Strip.

Code the Meter (continued) SECTION 2

3Insert the Code Strip

into the Test Slot (as

shown). A beep sounds and a

full display appears brieﬂy.

Another beep sounds and the

Function Number (for exam-

ple, F-4) appears in the

Display.

Things to remember:

• It is important to insert the Code Strip with a ﬁrm motion

until it comes to a full stop. When inserted fully, the tab

on the top portion of the strip should be completely hid-

den within the Meter.

• The Function Number appearing in the Display must match

the number appearing:

– on the Code Strip.

– on the front of the Code

Strip packet (see #2).

– on the back of the Test Strip

packet.

• If the Function Numbers match as indicated above, the

Meter may now be used to run a control test or blood

glucose test.

• The Meter must be coded again when a new carton of

Test Strips is used unless the F# of the new carton is the

same as the old carton. Use the new Code Strip found in

the new carton of strips.

• Store the Code Strip in the clear plastic packet until all the

strips are used (in case you ever need to recode the meter).

Throw away the old Code Strip when Test Strips are all used.

Code the Meter (continued) SECTION 2

The Control Test SECTION 2

To make sure your Ascensia ELITE™ Diabetes Care System is performing properly, a Control

Test is performed using the Ascensia ELITE™ Normal Control solution.

WHY? A Control Test conﬁrms that the system is functioning properly and you are using

proper technique. When running a Control Test, the system is deﬁned as: the Meter and

the Test Strips. In addition to the Normal Control, an Ascensia ELITE Low and High Control

are also available for use with this system.

WHEN TO RUN A CONTROL TEST:

• Any time you want to conﬁrm that the Meter system is working properly, and that your

testing technique is correct.

• Any time you question your blood glucose test results.

• On the advice of your physician or healthcare professional.

WHAT TO EXPECT:

• When the Control Test is done properly, the Control Test result should fall within the

range listed on the end ﬂap of your Test Strip Carton.

• A Control Test result that falls outside of the speciﬁed range means the system may not be

functioning properly or your testing technique may not be correct. If this occurs, refer to

Section 6 of this User Guide or the Ascensia ELITE Control package insert for assistance.

MARK THE CONTROL TEST RESULT (if using the memory feature):

You should always “mark” a Control Test result with a “C” as described in the following

procedure. Marking with a “C” keeps a Control Test result from being included in the

average of your blood glucose tests.

MATERIALS

REQUIRED:

•

Ascensia E

LITE

™

Meter

•

Ascensia E

LITE

™

Normal

Control Solution

•

Ascensia E

LITE

™

Test

Strip and Code Strip

•CLINILOG

Diary

PREPARE FOR TEST:

If not already done, code

your Meter using the Code

Strip (see page 7). Also check

to make sure the Test Strips

and the Normal Control

Solution have not passed

their expiration date.

1Remove foil packets from

the Test Strip carton and

tear off a single packet.

The Control Test (continued) SECTION 2

2To open the Test Strip

packet, carefully PEEL the

foil until the Test Strip is

completely exposed (as

shown).

NOTE: The numbers printed

on each Test Strip are manu-

facturing numbers and

should not be confused with

a Function Number.

1. 2. 3

For Use With Ascensia™

“

1. 2. 3.

Made In Japan

Blood Glucose Test Strip

For Use With Ascensia™ ELITE®/ELITE® XL Meters

“

2. 3.

Made In Japan

od Glucose Test Strip

For Use With Ascensia™ ELITE®/ELITE® XL Meters

“

For Use With Ascensia™ ELITE®/ELITE® XL Meters

3Remove the Test Strip

from packet. Holding the

round end, insert the strip

fully into the Meter.

NOTE: Save the empty foil

packet for use in Step 6.

4A beep sounds and a full

display appears, followed

by the Function Number (F#)

and the previous test result.

The Function Number and

the previous test result begin

ﬂashing alternately.

If you are not using the

memory feature, go directly

to Step 6.

5Mark your Control Test

result by pulling out the

Test Strip, and quickly insert-

ing it back into the Meter

(within 2 seconds). A C- and

the Function Number F#

begin ﬂashing in the Display.

Marking a Control Test

excludes the Control Test

result from the average of

stored Blood Glucose Test

results.

The Control Test (continued) SECTION 2

6Gently squeeze a small

drop of Control solution

onto the inside of the foil

you saved in Step 3.

7Touch and hold the TEST

END of the Test Strip in

the drop until after the

Meter beeps. A small amount

of Control solution is auto-

matically drawn into the Test

Strip. The timer begins count-

ing down from 29 seconds.

The Control Test (continued) SECTION 2

8After 29 seconds, the

Control Test result

appears in the Display.

Compare the result to the

range listed on the end ﬂap

of your Test Strip carton.

Using a tissue, remove

the Test Strip and discard.

The Meter will turn off

automatically.

FOLLOW UP:

Record and date all Control

Test results in your CLINILOG

Diary.

CAUTION: If the Control Test

result does not fall within

the stated range, the system

may not be operating prop-

erly. See Section 6 of this

User Guide and the Ascensia

ELITE™ Control package

insert for help.

Things to remember:

• Run a Control Test frequently to make sure that you are

using good technique and that your system is working

properly.

• Always check the EXPIRATION DATE on the Test Strip foil

packet or carton before using. Throw away expired Test

Strips. Use only unexpired Test Strips.

• Use the Test Strip immediately after removing from the foil

packet.

• Insert the Test Strip until it comes to a full stop. When

inserted fully, the tab on the top portion of the strip should

be completely hidden within the Meter.

• If using the memory feature, be sure to “mark” the Control

Test before running the test (see Section 4).

• Remove the Test Strip immediately after use to turn off the

Meter and preserve battery life.

• The Meter turns off automatically after 3 minutes if the

strip is left in the Meter.

• Test Strips cannot be reused.

• The end ﬂap of your Test Strip carton lists speciﬁc Control

Ranges for that carton of strips. Please keep this end ﬂap

until all the Test Strips in the carton are used.

The Control Test (continued) SECTION 2

MATERIALS

REQUIRED:

•Ascensia ELITE™

Meter

•Ascensia ELITE™Test

Strip and Code Strip

•MICROLET®Adjustable

Lancing Device/Lancet

- Tissue or cotton ball

for wiping

ﬁnger

after testing

•

CLINILOG

Diary

PREPARE FOR TEST:

If not already done, code

your Meter using the Code

Strip (see page 7). Also check

to make sure the Test Strips

have not passed their expira-

tion date.

Load the MICROLET Adjustable Lancing Device:

See the MICROLET Adjustable Lancing Device package

insert for complete instructions. Place the MICROLET

Adjustable Lancing Device on a clean surface while

preparing for your blood glucose test.

Get Ready for the Blood Glucose Test

SECTION 3

2Wash your hands. Use

warm soapy water. Rinse

and dry thoroughly. 3Remove foil packets from

carton and tear off single

packet. 4To open the Test Strip

packet, carefully peel the

foil until the Test Strip is

completely exposed (as

shown).

NOTE: The numbers printed

on each Test Strip are manu-

facturing numbers and

should not be confused with

a Function Number.

Get Ready for the Blood Glucose Test (continued)

SECTION 3

1. 2. 3

For Use With Ascensia™

“

1. 2. 3.

Made In Japan

Blood Glucose Test Strip

For Use With Ascensia™ ELITE®/ELITE® XL Meters

“

2. 3.

Made In Japan

od Glucose Test Strip

For Use With Ascensia™ ELITE®/ELITE® XL Meters

“

For Use With Ascensia™ ELITE®/ELITE® XL Meters

5Remove Test Strip from

packet. Holding the round

end, insert the strip fully into

the Meter.

NOTE: Be sure to save the foil

to use when disposing of the

Test Strip.

6A beep sounds and a full

display appears, followed

by the Function Number (F#)

and the previous test result.

The Function Number and

the previous test result begin

ﬂashing alternately.

Get Ready for the Blood Glucose Test (continued)

SECTION 3

Proceed immediately (within

3 minutes) to

Step 1 on the next page…

1Stick your ﬁnger with the

MICROLET Adjustable

Lancing Device and form a

small drop of blood.

Perform the Blood Glucose Test SECTION 3

Note: Multiple Site Testing

Consult with your healthcare professional prior to testing from a

site other than your ﬁngertips.

Blood glucose testing results from sites other than your ﬁngertip

could be signiﬁcantly different. These differences may vary from

individual to individual, and are physiological differences caused

by factors such as food intake, health state and medication

being used.

If you perform testing other than from a ﬁngertip:

A. Select a soft, ﬂeshy area of skin that is free from hair and

visible veins.

B. Wash the puncture site with soap and warm water. Rinse and

dry thoroughly. This ensures cleanliness and increases blood

ﬂow to the puncture site.

C. After you have determined the

proper depth of your selected site,

set the lancing device for that

depth of puncture. Firmly press the

lancing device against the skin at

the selected lancing site, then

press the button to lance the skin.

When a drop of blood forms on

the surface of your skin, bring the meter and test strip up to

touch the drop.

4If you want to store the

test result, remove the

Test Strip from the Meter as

shown. The Meter turns off

automatically and the test

result is now stored in the

memory. You may wish to use

a tissue or the foil wrapper

from the strip to remove the

used strip.

CAUTION: Dispose of the used Test

Strip and lancet carefully to pre-

vent injury or contamination to

others. You may use the empty foil

packet to dispose of the Test Strip.

Perform the Blood Glucose Test (continued)

SECTION 3

2Touch and hold the test

end (tip) of the Test Strip

to the drop of blood until

after the Meter beeps. See

page iv for the right method.

Blood is auto-

matically

drawn into

the Test Strip.

The timer

begins count-

ing down

from 29 seconds.

3After 29 seconds, your

blood glucose result

appears in the display. The test

result remains in the display.

NOTE: If Lo appears in the display, your

blood glucose value may be below

20 mg/dL (1.1 mmol/L). If Hı appears,

your result may be above 600 mg/dL

(33.3 mmol/L). See page 33 for other

reasons Lo or Hı could occur. Follow the

advice of your medical team for hypogly-

cemia (low blood sugar) if your blood

glucose is below 50 mg/dL (2.8 mmol/L)

or hyperglycemia (high blood sugar) if

your blood glucose is above 250 mg/dL

(13.9 mmol/L).

5If you do not want to

store the test result in the

memory, pull out the Test

Strip and quickly insert it

back into the Meter (within 2

seconds).

dEL appears in the Display,

and the test result will not be

stored in the memory. Do not

pull the Test Strip out of the

Meter until the Display goes

blank, or the test result will

not be deleted.

Perform the Blood Glucose Test (continued)

SECTION 3

FOLLOW UP:

Record the result in your

CLINILOG Diary.

NOTE:

If you do not remove the

Test Strip, the test result

remains in the Display

for 3 minutes.

Perform the Blood Glucose Test (continued)

SECTION 3

Things to remember:

• Never use a Test Strip beyond the printed expiration date (on the foil packet).

• Use the Test Strip immediately after removing from the foil packet.

• It is important to insert the Test Strip until it comes to a full stop. When inserted fully, the tab

on the top portion of the strip should be completely hidden within the Meter.

• After inserting Test Strip, wait until the F# and previous test result begin ﬂashing before apply-

ing sample to strip.

• Always make sure the Function Number printed on the Code Strip, Code Strip Packet and the

Test Strip Foil matches the Function Number displayed in the Display.

• To be sure your Test Strip ﬁlls completely, hold the test end of the Test Strip in the blood drop

until after the “beep” sounds.

• Remove the Test Strip immediately after use to turn off the Meter and preserve battery life.

The Meter turns off automatically after 3 minutes if the strip is left in the Meter.

• You can recall stored test results from the Meter memory by inserting a new Test Strip (before

applying blood), and waiting 3 minutes. The memory recall function will then begin automati-

cally. Do not recall results with a used Test Strip.

• Teach another person to use the system so you will have someone to help should you ever

need assistance.

• If a problem occurs, refer to Section 6 or the Test Strip package insert.

Introduction to Memory SECTION 4

This section will instruct you on the use of the Ascensia ELITE™Meter’s memory

feature. The following questions and answers should help you learn about this

feature.

How many test results does the memory store?

The memory stores up to 20 test results, and also provides the “average” of the

Blood Glucose Test results currently stored in the memory. Both Blood Glucose Test

results and Control Test results can be stored in the memory. If 20 test results are

stored and a new one is added, the oldest test result is automatically deleted. The

newest one stored will now be #1 in memory recall.

How do I recall the stored test results?

By inserting an Ascensia ELITE™Check Strip into the Meter and waiting 10 seconds.

After the 10 second period, an A- appears in the display followed by the average of

all the stored test results. If a Check Strip is not available, you may use a new Test

Strip to access the memory. When you use a Test Strip, you must wait 3 minutes

after inserting the Test Strip to access the memory.

Introduction to Memory (continued) SECTION 4

Can I delete test results?

Yes, you can delete either all of the test results stored in the memory, or a single

test result before it goes into the memory.

How will I know the difference between a stored Blood Glucose Test and a

Control Test?

A Control Test result in memory is preceded by a C- display.

Since Control Test results should not be a part of the average blood glucose result,

marking the Control Test result with a C- tells the Meter not to use that result when

calculating the average. The C- is entered at the beginning of the Control Test.

The following pages will instruct you on performing each one of these features.

1Insert the Check

Strip fully into the

Meter as shown.

NOTE: If your Check

Strip is not available,

you can use a new

Test Strip for this

procedure. However,

you have to wait 3

minutes for the

memory sequence

to begin.

2A beep sounds

and a full display

appears brieﬂy.

Another beep sounds

and the Check Strip

result is displayed.

Recall Test Results from the Memory SECTION 4

3After 10 seconds,

the memory

sequence begins

automatically. An A-

(for average) appears

for 2 seconds, fol-

lowed by the average

test result value (for

4 seconds).

4The memory

recall sequence

continues. The most

recent result is pre-

ceded by a 1- fol-

lowed by all other

stored results. The

last result displayed is

the oldest test result.

NOTE: If no values

are stored, three bars

––– appear after the

average A-.

1Insert the Check Strip fully

into the Meter. Wait 10

seconds for the memory

sequence to begin.

NOTE: You may also use a

Test Strip to delete all test

results from memory.

However, you must wait 3

minutes for the memory

sequence to begin. When you

see the memory sequence

begin, proceed to Steps 2

and 3.

2Pull out the Check Strip,

and quickly insert it

back into the Meter (within

2 seconds).

3The Display begins ﬂash-

ing dEL and ALL every

second for 5 times, and then

the Display goes blank.

Do not pull the Check Strip

out of the Meter until the

Display goes blank, or the

stored test results will not be

deleted.

Delete ALL Test Results from the Memory

SECTION 4

1A test result may be

deleted at the end of a

test during the 3 minutes it is

displayed. Use a tissue to pull

out the Test Strip and quickly

insert it back into the Meter

(within 2 seconds).

NOTE: Single test results can

only be deleted at the end of

a test.

2dEL appears in the Display

for 2 seconds and then

the Meter turns off.

NOTE: Do not pull the Test

Strip out of the Meter until

the Display goes blank, or

the test result will not be

deleted.

Delete a SINGLE Test Result from the Memory

SECTION 4

3After the Meter turns off,

remove and discard the

used Test Strip.

1To prevent the Control

results from being

included in the average, you

should mark each Control

Test with a “C.” This must

be done before performing

the Control Test.

First, insert the Test Strip fully

into the Meter.

2A beep sounds and a full

display appears brieﬂy.

The Function Number and

the previous test result begin

ﬂashing alternately.

3Pull out the Test Strip,

and immediately insert it

back into the Meter (within 2

seconds). A C- and the F#

begin ﬂashing alternately in

the Display.

You can now run the Control

Test (see page 9).

Mark a Control Test Result SECTION 4

Things to Remember About the Memory

SECTION 4

Recall Test Results from the Memory (see page 23)

• Low (below 20 mg/dL [1.1 mmol/L]) and high (above 600 mg/dL [33.3 mmol/L]) test

results are displayed and stored in memory as Lo and Hı. In calculating the aver-

age, Lo is entered as 20 mg/dL (1.1 mmol/L), and Hı is entered as 600 mg/dL

(33.3 mmol/L).

•A C- display preceding a test result display indicates that the test result is a

Control Test result.

Delete Test Results from the Memory (see pages 24 and 25)

• The only time you can delete a single test result (i.e., keep it from being stored in

the memory) is at the end of a Control or Blood Glucose Test.

• A test result is automatically stored in the memory if it is not deleted at the end

of the test.

• If you decide not to delete the test result after beginning the delete process, pull

out the strip while dEL is still displayed.

Things to Remember About the Memory (continued)

SECTION 4

Mark a Control Test Result (see page 26)

1. You should “mark” your Control Test results with a “C” before storing them in the

memory. This prevents the Meter from averaging your Control Test results in with

your blood glucose results.

2. Each Control Test result stored in memory will take up one of the 20 memory spaces

that are available. Therefore, if you have 3 Control Test results and 17 blood glucose

test results stored in the current memory, the memory sequence might look like this:

3. When the Meter calculates the average, the Control Test results in the memory

will not be a part of the average. In the above example, the average is ﬁgured

using only the 17 blood glucose test results listed.

When the

memory is

full, new test

results are

entered into

position #1

and the old-

est result dis-

appears from

the memory.

A - 139

1 - 116

2 - 154

3 - 102

C - 95

4 - 92

5 - 200

6 - 189

907 -

C - 102

8 -

9 -

184

115

10 - 103

11 - 153

12 - 195

13 - 94

14 - 207

15 - 190

16 - 89

17 - 92

99C -













Care of the Meter and Strips SECTION 5

1. To help keep the Meter and Test Strips free of oils and other

contaminants, wash hands and dry thoroughly before using.

2. Handle the Meter carefully. Dropping may damage the electronics or

cause other malfunctions.

3. Do not expose the Meter, Test Strip, Code Strip or Check Strip to

excessive humidity, heat, cold, dust or dirt.

4. If the Meter exterior needs cleaning, dampen a facial tissue with fresh

water and wipe the Meter and Display carefully. Avoid spilling any

liquids on the Meter. Liquids may damage the Meter’s electronics.

5. Store Meter in the case provided or a replacement case of your

choosing whenever possible.

Care of the Meter and Strips (continued)

SECTION 5

WARNING: Potential Biohazard: Healthcare professionals or persons using this

system on multiple patients should be aware of the following and should follow

the infection control procedure approved by their facility.

All products or objects which come in contact with human blood, even after clean-

ing, should be handled as if capable of transmitting viral diseases.

The user should follow the recommendations for prevention of blood-borne trans-

missible diseases in healthcare settings, as recommended for potentially infectious

human blood specimens in National Committee for Clinical Laboratory Standards,

Protection of Laboratory Workers from Instrument Biohazards and Infectious

Disease Transmitted by Blood, Body Fluids and Tissue: Approved Guideline. NCCLS

document M29-A [ISBN 1-56238-339-6] NCCLS, 940 West Valley Road, Suite 1400,

Wayne, Pennsylvania 19087-1898, USA, 1997. This document has complete informa-

tion on the area of user protection and can be used as background material for

instruction.

Meter and Test Strip Problems SECTION 6

E-1

E-2 display

E-4

Display goes blank

after Test, Code or

Check Strip is inserted

into the Meter.

The Function Number

displayed is different

from the number print-

ed on the Test Strip foil

packet or carton.

Check Strip test result

out-of-range.

Meter electronics failure.

1. Batteries are not installed

correctly.

2. Strip is not fully inserted

into the Meter.

Batteries are dead

4. Too much time has passed

since inserting the strip and

the Meter has turned off.

1. Wrong Code Strip used.

2. Code Strip not inserted

properly.

1. Check Strip (Meter end)

dirty or damaged.

2. Meter electronics failure.

Immediately, contact the

Customer Service Dept.

1-800-348-8100. The meter will no

longer function.

1. Install batteries correctly.

2. Insert Strip until tab is inside

Meter.

3. Replace with new batteries.

4. Remove and reinsert the strip.

1. Use correct Code Strip. Discard

incorrect one.

2. Reinsert Code Strip carefully,

but ﬁrmly.

1. Wipe Check Strip thoroughly

with clean dry tissue, and

retest.

2. Contact Customer Service

Department.

PROBLEM CAUSE SOLUTION







Meter and Test Strip Problems (continued)

SECTION 6

Meter fails to start

countdown.

Some display seg-

ments do not appear.

Battery display.

1. Blood applied wrong;

see pp. iii, iv.

2. Test Strip inserted

incorrectly.

3. Sample is applied while

full display is showing

Meter electronics or

battery failure.

1. Battery voltage low.

1. Form a larger drop of blood or

control solution and rerun test

using a new Test Strip. Hold

test end to sample until after

the “beep.”

2. Insert Test Strip correctly

(Meter

end ﬁrst).

3. Wait for F# and last test

result to begin ﬂashing before

applying sample to strip.

Replace batteries and if Display is

still incorrect, contact Customer

Service Department.

1. Replace batteries.

See Section 1, page 2.

PROBLEM CAUSE SOLUTION

Test Result Problems

SECTION 6

“Lo” display.

“Hı” display.

1. The blood glucose value

may be below 20 mg/dL

(1.1 mmol/L).

2. Test Strip not ﬁlled

completely.

3. Test Strip is defective or

has deteriorated.

4. Wrong Function Number

used.

1. The blood glucose value

may be above 600 mg/dL

(33.3 mmol/L).

2. Same as #3 above.

3. Same as #4 above.

1. Possible hypoglycemic condition

(low blood sugar). Contact your

physician or diabetes counselor

about your condition.

2. Rerun test with new strip and

apply sufﬁcient sample to ﬁll

Test Strip. Hold test end to

sample until after the “beep.”

3. Rerun test using a new, unex-

pired Test Strip.

4. Use correct Code Strip

provided with carton of Test

Strips being used.

1. Possible hyperglycemic

condition (high blood sugar).

Contact your physician or

diabetes counselor about

your condition.

2. Same as #3 above.

3. Same as #4 above.

PROBLEM CAUSE SOLUTION

CAUTION: Glucose

levels below 50 mg/dL

(2.8 mmol/L) may indi-

cate a potentially serious

medical condition.

CAUTION: Glucose

levels above 250 mg/dL

(13.9 mmol/L) may indi-

cate a potentially serious

medical condition.

Test Result Problems (continued) SECTION 6

IMPORTANT:

To have accurate

test results, sufﬁcient sample to

ﬁll the reaction chamber is

needed. The following drawings

show how a Test Strip looks

when ﬁlled and not ﬁlled.

1. Rerun test with new Test Strip

and apply sufﬁcient sample to

ﬁll Test Strip. Hold TEST END to

sample until after the “beep.”

2. Obtain new Test Strips and/or

Control Solution that are with-

in their expiration date.

3. Run a Control Test using a new

Test Strip. If results are still out

of range, replace carton of Test

Strips. See carton for proper

storage instructions.

4. Allow time for Meter, Control

Solution and/or Test Strips to

come to room temperature

before use.

Blood glucose or con-

trol test results are

inconsistent, or control

test results are not

within the speciﬁed

range.

1. Not enough blood or

control solution is drawn

into the Test Strip.

2. Test Strips or control

solution have passed

their expiration date.

3. Deteriorated Test Strip

caused by heat or

humidity.

4. Meter, Control Solution and/

or Test Strip are not at room

temperature when used.

PROBLEM CAUSE SOLUTION

RIGHT

(ﬁlled) WRONG

(not ﬁlled)







Service SECTION 7

If attempts to correct a problem fail, please call our Customer Service

Department. We have trained specialists to assist you.

In the U.S.A., call toll free at:

1-800-348-8100

IMPORTANT:

• Speak to a Customer Service Representative before returning your Meter

for any reason. He/she will give you the information needed to get your

problem handled correctly and efﬁciently.

• Have your Ascensia ELITE™Meter, Ascensia ELITE™Check Strip, and a

box of Ascensia ELITE™Test Strips (including the Code Strip) nearby

when you phone. It would also be helpful to have a bottle of Ascensia

ELITE™Normal Control available.

• Fill out the check list on the following page before calling!

Check List SECTION 7

1. The Meter serial number is:

2. The date and time the problem occurred was:

3. I tested with both the Check Strip and with

the Ascensia ELITE™Normal control:

•The Check Strip result was:

•The Normal Control result was:

4. The Normal Control Range listed on the end ﬂap

of the Test Strip carton is:

5. The Function Number being displayed on the

Meter is: F-

The Function Number on the Code Strip

and on the Test Strip foil packet

currently being used is: F-

6. Please include the lot number and expiration date

of the Test Strips and Controls currently being used.

For the Test Strips, this information is printed on the

carton as well as on the back of each foil packet.

For the Controls, this information is

printed on the bottle.

NoYes

Lot Number:

Expiration Date:

Test Strips Control

Limitations of the Procedure SECTION 7

1. PRESERVATIVES:

•Fluoride – Do not use ﬂuoride as a preservative for blood specimens.

•Iodoacetic acid – Do not use iodoacetic acid as a preservative for blood specimens.

2. ARTERIAL SPECIMEN: Arterial specimens with pO2of >200 mmHg had a small bias

(average of –6%) on the Ascensia ELITE™in comparison to the laboratory method

glucose results. The reference range for arterial pO2is 80 to 110 mmHg (11.04 to

14.36 kPa).

3. NEONATAL USE: This Ascensia ELITE™Blood Glucose Meter is not qualiﬁed for testing

neonatal blood specimens.

4. METABOLITES: Reducing substances such as ascorbic acid and uric acid at normal blood

concentrations do not signiﬁcantly affect Ascensia ELITE Blood Glucose Test results.

5. HEMATOCRIT: At normal glucose levels, Ascensia ELITE Test Strip results are not

signiﬁcantly affected by hematocrits in the range of 20% to 60%. At glucose levels

above 300 mg/dL (16.7 mmol/L), hematocrit levels above 55% will cause lowered results.

6. LIPEMIC SPECIMEN: Cholesterol up to 500 mg/dL (13.0 mmol/L) or triglycerides

up to 3000 mg/dL (33.9 mmol/L) do not signiﬁcantly affect the results. Glucose val-

ues however, in specimens beyond these levels should be interpreted with caution.

CONTRAINDICATION: Fingerstick blood glucose testing may not be clinically appropriate when

peripheral blood ﬂow is decreased. Shock, severe hypotension, hyperosmolar hyperglycemia

and occurrence of severe dehydration are examples of clinical conditions which may adversely

affect the measurement of glucose in peripheral blood.1

Atkin S, Jaker MA, Chorost MI, Reddy S, Fingerstick Glucose Determination in Shock. Annals of Internal Medicine 1991, 114: 1020–24.

Speciﬁcations SECTION 7

Test Sample: Whole blood

Test Result: Plasma/Serum glucose

Reaction Chamber

Sample Volume: 2 µL

Measuring Range: 20–600 mg/dL (1.1–33.3 mmol/L)

Measuring Time: 30 Seconds

Calibration Curve: Selected by use of the Code Strip

Memory Feature: Stores last 20 test results

Temperature Compensation: Automatic compensation with

built-in thermistor

Battery Type: 3-volt lithium batteries (DL or CR2032) – 2

Battery Life: Approximately 1000 Tests (1 year of average use)

Operating Temperature Range:

50°–104° F (10°–40° C)

Humidity: 20–80% RH

Dimensions: 81 x 51 x 14 mm (311⁄32 x 2 x 9⁄16 in.)

Weight: Approximately 50g (1.75 ounces)

Alarm: “Beeps” whenever a Check Strip, Code Strip or Test

Strip is inserted into the Meter, when the Test Strip

is completely ﬁlled with blood or Control Solution,

and when a test result appears in the Display.

3Then quickly turn the Meter

back over (display is blank),

remove and reinsert strip within

10 seconds. on is displayed.

Immediately pull the strip out

within 2 seconds. off is dis-

played. The alarm is now off.

To turn the alarm back on,

repeat this procedure (#1-2-3).

The Display sequence is

reversed, off appears ﬁrst and

then on.

Speciﬁcations (continued) SECTION 7

2Turn the Meter over and

open and shut the battery

door.

TURNING OFF THE

ALARM:

We strongly advise you to

leave the alarm on, as it

helps tell you when the

Test Strip is adequately

ﬁlled with blood or con-

trol solution. However,

you can operate your

Meter discreetly by turn-

ing off the alarm.

MATERIALS REQUIRED:

Ascensia ELITE™Check

Strip or Test Strip (both

strips will work).

1Insert Check or Test Strip

fully into Meter.

Supplies SECTION 7

When calling or writing for supplies

be sure to include the number with the

name of the replacement part

or accessory item.

REPLACEMENT PARTS

ACCESSORY ITEMS

Part Number*

40030030

Item

3-volt Lithium Battery

(DL or CR2032) – 2

(Available at most

Camera Stores)

99M39019

50184221

Ascensia ELITE™User Guide

Quick Reference Card

These parts are available in the

United States from:

Bayer Corporation

Customer Service Department

Order Entry P. O. Box 2004

Mishawaka, Indiana 46546

*Part numbers are subject to change without notice

Product

Number Item

3911A Ascensia ELITE™

Test Strips – 25’s in foil

3918A Ascensia ELITE™

Test Strips – 50’s in foil

3942A Ascensia ELITE™

Test Strips – 100’s in foil

3940A Ascensia ELITE™Low and High Controls

3972A Ascensia ELITE™Normal Control

5509A Ames Gluco SystemTM Lancets (100’s)

5702M GLUCOLET®Automatic Lancing Device

5700G GLUCOLET®Endcaps – Regular

5701G GLUCOLET®Endcaps – Super

6540B MICROLET®Adjustable Lancing Device

3416 MICROLET Vaculance®Lancing Device

6546B MICROLET®Lancets (100’s)

6550B MICROLET®Lancets (200’s)

Accessory items may be obtained from Diabetes Care

Centers, retail drug chains or other home healthcare

distributors.

Limited Warranty SECTION 7

Manufacturer’s Warranty: Bayer

Corporation (“Bayer”) warrants to the origi-

nal purchaser that this instrument will be

free from defects in materials and work-

manship for 5 years from the date of origi-

nal purchase (except as noted below).

During the stated 5-year period, Bayer shall,

at no charge, replace a unit found to be

defective with an equivalent or current ver-

sion of the owner’s model.

Limitations of Warranty: This warranty is

subject to the following exceptions and

limitations:

1. A 90-day warranty only will be extended

for consumable parts and/or accessories.

2. This warranty is limited to replacement

due to defects in parts or workmanship.

Bayer shall not be required to replace

any units which malfunction or are dam-

aged due to abuse, accidents, alteration,

misuse, neglect, maintenance by other

than Bayer, or failure to operate the

instrument in accordance with instruc-

tions. Further, Bayer assumes no liability

for malfunction or damage to Bayer

instruments caused by the use of

reagents other than reagents (i.e.,

Ascensia ELITE™Test Strips) manufac-

tured or recommended by Bayer.

3. Bayer reserves the right to make

changes in design of this instrument

without obligation to incorporate such

changes into previously manufactured

instruments.

4. Important: Bayer has no knowledge of

the performance of the Ascensia ELITE™

Blood Glucose Meter when used with

any Test Strips other than Ascensia ELITE

Test Strips, and therefore makes no war-

ranty of the performance of the Ascensia

ELITE Meter when used with any Test

Strips other than Ascensia ELITE Test Strips

or when the Ascensia ELITE Test Strip is

altered or modiﬁed in any manner.

Warranty (continued) SECTION 7

BAYER MAKES NO OTHER EXPRESS WAR-

RANTY FOR THIS PRODUCT. THE OPTION

OF REPLACEMENT, DESCRIBED ABOVE, IS

BAYER’S ONLY OBLIGATION UNDER THIS

WARRANTY.

IN NO EVENT SHALL BAYER BE LIABLE

FOR INDIRECT, SPECIAL OR CONSEQUEN-

TIAL DAMAGES, EVEN IF BAYER HAS BEEN

ADVISED OF THE POSSIBILITY OF SUCH

DAMAGES.

Some states do not allow the exclusion or

limitation of incidental or consequential

damages, so the above limitation or exclu-

sion may not apply to you. This warranty

gives you speciﬁc legal rights and you may

also have other rights which vary from state

to state.

For warranty service: Purchaser must

contact the Customer Service Department

of Bayer Corporation, by calling toll free

1-800-348-8100, for assistance and/or

instructions for obtaining service of this

instrument.

Bayer Corporation

Elkhart, IN 46515 USA

Ascensia ELITE™is a trademark of Bayer Corp. CLINILOG®

, GLUCOLET®and MICROLET

Vaculance®are registered trademarks of Bayer Corporation, Elkhart, Indiana.

Bayer Corporation

Mishawaka, IN 46544 USA

www.bayercarediabetes.com

www.ascensia.com

Bayer Healthcare Blood Glucose Meter Ascensia Elite Users Manual — (#21296)

bloodglucosemeterascensiael 0e6708ca-3e74-02e4-9d91-4e0f02d00fa8 Bayer HealthCare Blood Glucose Meter Blood Glucose Meter Ascensia Elite User Guide |

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