Relion Confirm Owner S Manual

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User

Instruction

Manual

Blood Glucose Monitoring System

CAUTION:

Before using any product to test your blood sugar

(blood glucose), read all instructions and practice

the test. Do all quality control checks as directed and

consult with a diabetes healthcare 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 U.S. Food and Drug Administration, and

the Health Industry Manufacturers Association.

Introduction ...........................................5

Intended Use .......................................6

Understanding the ReliOn® Confirm Blood Glucose Meter ....7

Changing the Battery ...............................10

Meter Set-up .........................................13

Basic Rules ......................................13

Audible Beep ....................................16

Year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Month/Day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Hour/Minute .....................................20

Test Averaging ...................................21

Ending Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Performing a Control Solution Test. . . . . . . . . . . . . . . . . . . . . . . . 23

Troubleshooting Control Solution Test .................30

TABLE OF CONTENTS

3

Blood Glucose Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

The Lancing Device .......................................33

Getting a Drop of Blood ...................................36

Performing a Blood Glucose Test ............................38

Flagging Test Results .......................................42

Alternate Site Testing (AST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

Understanding Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Recalling Results - Entering Memory Mode .......................58

Maintenance ...............................................62

Cleaning ................................................62

Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Display Screen and Error Messages ..........................64

Product Information .........................................69

Product Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Warnings, Precautions & Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Warranty ................................................73

4

Thank you for choosing the ReliOn® Confirm Blood Glucose Monitoring

System. This system measures blood glucose in fresh capillary whole

blood. Results are shown as plasma values. This makes it easy to

compare the ReliOn® Confirm blood glucose meter and lab results.

Please read this manual before using the system. If you have any

questions, call Customer Service at 800.631.0076 (24 hours a day, 7

days a week). Contact your healthcare professional with questions if

you are unable to reach Customer Service.

INTRODUCTION

5

6

Intended Use

The ReliOn® Confirm Blood Glucose Monitoring System meter is

intended for the quantitative measurement of glucose in fresh

capillary whole blood samples drawn from the fingertips or palm.

Testing is done outside the body (In Vitro diagnostic use). It is indicated

for use at home (over the counter [OTC]) by persons with diabetes, or

in clinical settings by healthcare professionals, as an aid to monitor the

effectiveness of diabetes control.

The System Includes:

•Meter

•CarryingCase

•UserInstructionManual

•QuickReferenceGuide

•Self-testingLogbook

•LancingDevice

•Lancets Carrying Case

7

UNDERSTANDING THE ReliOn Confirm BLOOD GLUCOSE METER

Bottom

Battery Compartment

Cover

Display

Connection Terminal

Test Strip

Port

Up

Arrow

Down

Arrow

Top

Tab

®

Memory Mode Symbol

Battery Symbol

Apply Blood Symbol

Temperature Warning

Audible Beep Off

Unit of Measurement

Time Format

Delete Symbol Control Solution

NOTE: Meters in the USA are programmed to show results in mg/dL.

Meters used outside the USA are programmed to show results in either

mg/dL or mmol/L. Results displayed in mmol/L will always have a decimal

point. Results displayed in mg/dL will never have a decimal point.

8

Date

Explanation of the full display screen:

9

ReliOn® Confirm/micro test strips

These test strips need only 0.3 µL (microliter) of blood. Apply blood to the

sample application tip. The strip draws in the blood by capillary action.

The blood glucose reacts with the enzyme on the test strip. This produces

a current proportional to the blood glucose level. The meter detects the

current and converts it into a blood glucose reading.

Code No.

(F-2, 3 or 4)

Expiration date

F- 4

10

0018

F-4

Test Strip Bottle

Front Back

Test Strip

Sample

Application

Tip (Apply blood

to end of test strip.

Capillary draw will

pull blood to

reaction site).

Code No.

(F-2, 3 or 4) Contact Bars

Insert this

way into

meter

10

CAUTION: Replacing the battery will not delete meter settings or test

results stored in the meter unless you:

•Touchthemetalportiononmainunitwithyourngersoranymetal.

•Takeover2minutestoreplacebattery.

•Loadthebatteryincorrectly.

•Loadausedorweakbattery.

Changing the Battery

The ReliOn® Confirm blood glucose meter comes with one lithium battery CR2032

(or DL2032).

WARNING: Keep all batteries out of children’s reach. If a battery is

swallowed, consult a doctor immediately.

NOTE:

•Tosavebatterypower,themeterturnsitselfoff3–5minutesafterlastuse.

•Replacebatterieswhenlowbatterysymbolappears.Otherwise

inaccurate results could be obtained.

•Discardusedbatteriesasperlocalguidelines.

11

To replace battery:

1. Open the battery cover on the back

side of the meter by pushing the tab

in the direction of the arrow and

pulling the cover up.

2. The battery is held in place on the

underside of the cover. Slide the

battery out of the cover.

3. Load a new battery into the battery

cover. Place the “+” side down when

loading the battery into the cover.

4. Make sure the battery is loaded in the

proper position. Otherwise, the

preprogrammed times will be reset.

CAUTION: Do not touch the metal contacts inside the battery

compartment with your finger or any metal.

5. Put the battery cover back into correct position and snap to close.

If the clock setting has been deleted, either “12:00” or “0:00” will blink

when you put a test strip into the meter. The low battery symbol

means you need to replace the battery as soon as possible. Discard

used batteries as per local guidelines.

12

13

Before using the ReliOn® Confirm blood glucose meter for the first

time, set the time and date. Do not perform a blood glucose test until

you have setup the meter.

Meter set-up allows you to adjust the audible

beep volume and to set time, date, and test

averaging.

Basic rules for meter set-up:

Step 1: Enter meter set-up by first

making sure the meter is turned off.

METER SET-UP

Up

Arrow

Down

Arrow

Step 2: Press the Up Arrow and Down Arrow buttons

at the same time for 5 seconds. A beep sounds and

the meter turns on. Next, a second beep sounds and

“SET” shows on the screen.

14

Step 3: Use the Up Arrow to change the set-up screen. When you press

the Up Arrow, the set-up screen changes in the order shown in the dia-

gram on the following page. Press the Down Arrow button to change a

setting within a set-up screen menu.

Note: If you need to go back to a setting, you must scroll through each

set-up option. You cannot go backwards in set-up mode.

In set-up mode, the meter will turn off automatically after 3 minutes of

non-use.

15

<Power OFF>

Gray Arrow

Setting

the

Audible

Beep

1

Ending

Set-up

Setting

the Year

2

8

Up

Arrow

Up

Arrow

Up

Arrow

Up

Arrow

Up

Arrow

Up

Arrow

Return

Setting the

Hour

5

Setting the

Day

4

Setting

the

Minute

6

Setting the

Month

3

Setting

Test

Averaging

7

Up

Arrow

UP

Arrow

UP

Arrow

16

Setting the Audible Beep

If the audible beep is turned “on”, the beep will sound when:

•Youinsertateststripintothemeter.

•Youapplybloodorcontrolsolutiontoateststrip.

•Thetesthasendedandtheresultisdisplayed.

•Themeteristurnedon,butyoudonotuseitforseveralminutes. 

Meter will beep and automatically shut off.

•YougointoMemoryMode.

Make sure the meter is off. Press the Up Arrow

and Down Arrow buttons at the same time for

5 seconds. A beep sounds and the meter

turns on. Next, a second beep sounds and “SET”

shows on the screen.

Press the Up Arrow button. The screen will

display “bUZ” and the current beep setting.

Beep

17

Press the Down Arrow button to

cycle through the volume levels:

“OFF” (no sound)

“on 1” (low)

“on 2”(middle)

“on 3” (high)

“OFF” (no sound) …, etc.

A beep sounds at the set volume

at each step. If “OFF” is set, the

“audible beep mute (Off)” symbol

lights up in the upper right of the

screen. After you select the beep

volume, press the Up Arrow

button to confirm the setting. The

screen changes to the year

set-up screen.

Beep

Beep

Beep

[1]

[1]

[1]

[1]

18

Setting the Year

In the year set-up screen, the last two digits of the

currently set year appear at the top of the screen.

“yER” appears in the middle of the screen. All four

digits of the currently set year appear at the

bottom of the screen. The last two digits will blink.

Press the Down Arrow to change the last

two digits of the year to the correct year. After you

set the year, press the Up Arrow button to confirm

the setting. The screen changes to the

month set-up screen.

[1]

[2]

[3]

19

Setting the Month

Press the Down Arrow button to change the month.

After you set the month, press the Up Arrow button to

confirm the setting. The screen changes to the day

set-up screen.

Setting the Day

Press the Down Arrow button to change the day.

After you set the day, press the Up Arrow button to

confirm the setting. The screen changes to the hour

set-up screen.

[1]

[2]

[3]

[4]

20

Setting the Hour

Press the Down Arrow button to change the hour.

After you set the hour, press the Up Arrow button

to confirm the setting. The screen changes to the

minute set-up screen.

Setting the Minute

Press the Down Arrow button to change the minute.

After you set the minute, press the Up Arrow button

to confirm the setting. The screen changes to the

test averaging set-up screen.

[1]

[2]

[3]

[4]

21

NOTE: “Lo” results are included as 20 mg/dL in the averages. “Hi”

results are included as 600 mg/dL in the averages.

Setting Test Averaging

Press the Down Arrow button to cycle

through the test averaging choices: “oFF”

(not displayed), “14” (14-day average), or“30”

(30-day average).“AVE” appears near the

middle of the screen.

If you select either 14-day or 30-day averaging,

your average test result will appear when you

recall results from memory. See page 58.

After you set test averaging, press the

Up Arrow button to confirm the setting.

22

Ending Set-up

To make further changes to set-up settings, press

the Down Arrow button while “End” is

displayed. This will bring up the Audible Beep

set-up screen. You can then move through the

set-up mode and adjust any settings that you wish.

If you are done with set-up, press the Up

Arrow button while “End” is displayed. This

confirms all settings and turns the meter off.

The meter will turn off automatically 3 minutes after “End” is displayed.

<Power OFF>

Beep

23

Use ReliOn® Confirm/micro CONTROL to check if:

•themeterandteststripsareworkingcorrectlyasasystem.

•youaretestingcorrectly.

To order control solution, call ReliOn® at 800.631.0076.

PERFORM A CONTROL SOLUTION TEST

24

Perform a Control Solution Test:

•BeforetestingwiththeReliOn®Conrmbloodglucosemeterfor 

the first time.

•Wheneveryoususpectthemeterorteststripsmaynotbe  

functioning properly.

•Iftestresultsappeartobeabnormallyhighorloworarenot 

consistent with clinical symptoms.

•Theteststripbottlehasbeenleftopenorhasbeenexposedto 

temperatures below 34°F (1°C) or above 86°F (30°C), or humidity

levels above 80%.

•Tocheckyourtechnique.

•WhentheReliOn®Conrmbloodglucosemeterhasbeen 

dropped or stored below 32°F (0°C) or above 122°F (50°C).

Important:

•UseonlywithReliOn®Conrmbloodglucosemeterand  

ReliOn® Confirm/micro blood glucose test strips.

25

•ReliOn®Conrm/microCONTROLisnotintendedforhuman 

consumption. Do not drink.

•Donotapplytoeye.Contactyourhealthcareprofessional 

immediately if solution is swallowed, injected, or applied to the eye.

•Dyeincontrolsolutionmaystainskin,clothing,orsurfaces.

•Storethecontrolsolutionbetween34-86°F(1-30°C).Keepawayfrom

direct sunlight, flourescent light, and heat. Do not freeze.

•Usebeforetheexpirationdateprintedonbottle.

•Usethecontrolsolutionwithin3monthsofrstopening.Itis 

recommended that you write the date of opening on the control

solution bottle label (OPEN DATE) as a reminder to dispose of the

opened solution after 3 months.

•Alwaysreplacethecapimmediatelyafteruse.

•ReliOn®Conrm/microCONTROLisnotacleaningsolution.Donot

clean your ReliOn® Confirm blood glucose meter with ReliOn®

Confirm/micro CONTROL.

•Donotusethecontrolsolutionwhenthesolutionlevelfallsbelowthe

bottom edge of the label on the bottle.

•UsetheControlSolutionbetween72-82°F(22-28°C).

26

Step 1: Insert a test strip as shown in diagram. Test strip should seat

firmly into meter. The meter will turn on automatically. The full screen

will come on for a moment. Make sure all symbols appear on the

screen (see page 8). The last result will then appear. Then the code

number (F-2, F-3, or F-4) will appear for three seconds followed by the

Apply Blood symbol. Make sure that the code number on the screen

matches the code number on the test strip bottle. If screen code does

not match the test strip code, use a new test strip. If code still does

not match, use a new bottle of test strips or call Customer Service at

800.631.0076 (24 hours a day, 7 days a week).

27

Step 2: Press the

Up Arrow button to

enter the control mode.

You will see “CONT” on

the bottom right of

the screen.

If you do not

enter the control

solution mode,

the control

solution result

will NOT be

valid.

Up

Arrow

Down

Arrow

28

Step 3: Mix control solution by gently

inverting bottle. Remove the cap from the

control solution bottle. While the Apply

Blood symbol is flashing, place a drop of

the control solution on the end of the test

strip. DO NOT put control solution on top of

the test strip. The test strip will draw up the

solution and the meter will beep. The meter

will begin to count down.

Step 4: In 7 seconds the meter will beep

again and display the control solution result.

Compare the result to the range printed

on the test strip bottle. Make sure the result

is within the acceptable range. If the result

falls within this range, the meter and test

strip are working correctly.

29

NOTE: Control solution test results are not included in the averages.

Do not use the system if control solution result is out of range. See

Troubleshooting Control Solution Test (page 30).

Result is automatically stored in memory. See page 42 for additional

information

Step 5: Remove test strip. Dispose of the used test strip.

Control solutions are available in three (3) levels - Low (L), Normal (N),

and High (H).

Repeat Steps 1-5 with other Control Solution levels as per

recommendations of your healthcare professional.

To order control solution, call ReliOn® at 800.631.0076.

Troubleshooting Control Solution Test

If the control solution test result is out-of-range, check the following and repeat the test:

Check Action

Did you do the test in If not, do the test again. Insert a

control solution mode? test strip; press the Up Arrow

Do you see “CONT” on button for control solution mode.

the screen with the result? “CONT” should appear on screen.

Have the test strips and/or Make sure that test strips and control

control solution expired? solutions are not past expiration date.

This date is shown on bottle. Make

sure bottles have not been opened

for more than three months.

Were control solutions at room If not, retest with new bottle

temperature (72-82°F (22-28°C)) of control solution, or warm up/cool

when used? down to room temperature.

Does the code on the test strip bottle If not, obtain a new bottle

match the code on the meter screen? of test strips.

30

31

Check Action

Did you insert test strip Make sure test strip is inserted

firmly into meter? all the way into test strip port.

See diagram on page 26.

Did you follow the Reread “Performing a Control

procedure correctly? Solution Test” (pages 24-29) and retest.

Were test strips stored correctly If not, retest with a

(between 34-86°F (1-30°C))? new bottle of test strips.

Was the bottle cap replaced

immediately after removing

a test strip?

Is the meter damaged? If yes, contact Customer Service at

Does it show an error code? 800.631.0076.

32

Does your Control Solution result still read outside the range

printed on the test strip bottle? If yes, the system may not be

working correctly. DO NOT USE the system to test your blood

glucose until the control solution result is within range. If you

need help, please call Customer Service at 800.631.0076

(24 hours a day, 7 days a week, USA). Contact your diabetes

healthcare professional if you cannot reach Customer Service.

33

The Lancing Device

NOTE: Do not use the lancet if the cap is missing or damaged.

BLOOD GLUCOSE TESTING

Release Button

Deep Depth Setting

(Longest Marker)

Depth

Indicator

Lancet

Medium Depth Setting

Depth Adjustment Cap

Shallow Depth Setting

(Shortest Marker)

Safety Tab

Charge

r

Clear Cap

Step 1: Pry the

depth adjustment cap

sideways to remove it.

34

Step 3: Twist off the safety tab.

Step 4: Attach the depth adjustment cap.

Step 2: Insert a new, unused lancet into the

Holder until it stops.

Holder

35

Step 5: Adjust the depth of puncture setting if necessary. If the

obtained amount of blood is excessive, turn the dial to a lower setting.

If the obtained amount of blood is insufficient, turn the dial to a larger

setting.

1 2 3 4 5

Deeper

Level indications

Lancing Device.

Step 6: Pull the charger to reset the device.

You may hear a click.

36

Getting a Drop of Blood

Step 1: Wash hands with soap and warm water. Dry

hands thoroughly. If you use alcohol wipes to cleanse

fingers, make sure the area is dry before lancing finger.

Residual alcohol may lead to inaccurate readings.

Step 2: Let the arm hang down for 10 to 15 seconds.

(Holding the arm below the heart and massaging

the wrist, palm and finger makes it easier to obtain

a blood drop).

Step 3: Choose a site on the side of a fingertip to minimize pain.

Step 4: Press the depth adjustment cap to the side

of the fingertip. Push the release button.

37

Step 5: Set aside the lancing device and wait a few seconds for a

blood drop to form. Keeping the hand warm, lowering the hand to

waist level and gently massaging your wrist, palm or the base of the

finger helps the flow of blood. Use a different site each time you test to

help prevent soreness and calluses.

NOTE: A lancet should only be used once. Dispose of used lancet in a

safe manner so as not to cause accidental injury.

WARNING: DO NOT share used lancets with another person. To prevent

possible infection, a used lancet should not be touched by another

person.

38

Performing a Blood Glucose Test

Step 1: Remove test strip

from the bottle. Immediately

replace the bottle cap tightly.

Insert test strip as shown in

diagram. A beep will sound

and the meter will turn on

automatically. Verify that

all symbols appear on

the screen.

NOTE: Four and a half minutes after test strip insertion, a beep

sounds every 5 seconds. After 5 minutes, a beep sounds and the

meter turns off. Take out unused test strip and insert it again to turn

meter back on.

39

Step 2: The beep will sound again. The last result will then appear.

Then the code number (F-2, F-3, or F-4) will appear for three seconds

followed by the Apply Blood symbol . Verify that the code number

on the screen matches the code number printed on the bottle.

If the code number does not match, the meter may give a false

reading. If code does not match, use a new strip. If code still does

not match, use a new bottle of test strips or call Customer Service at

800.631.0076 (24 hours a day, 7 days a week). Verify that the date and

time appear on the screen and are correct. If date and time are not

correct, reset them (see Meter Set-up, page 13).

Code No.

(F-2, 3 or 4)

Expiration date

F- 4

10

0018

F-4

40

Step 3: Obtain a blood drop (see pages 36-37).

Apply blood to the end of the test strip. Capillary

action will pull the blood into the strip. The meter will

beep when it detects that blood has been applied.

The meter will begin to count down. Do not add

blood on top of the test strip, as you may receive

an inaccurate result.

Important: Ensure that enough blood is applied

to fill the check window and it turns red. When the

check window is filled with blood and a beep

sounds, remove the tip of the test strip from your

finger. If there is not enough blood, “E-7” or “Lo”

will be displayed.

Filled Not Filled

Filled Not Filled

41

If it takes longer than 20 seconds to obtain a blood

sample and to touch the test strip to the blood drop,

repeat Step 3.

Step 4: The meter will count down, showing a flashing

dash. After 7 seconds, a beep sounds and the test

result and date/time are shown.

Results will be shown in units of mg/dL.

Record result in your logbook.

Step 5: When the test is done, pull out test

strip. Dispose of used test strip. The meter

shuts off automatically when you remove

the test strip.

Remove lancet from lancing device. Dispose

used lancet according to local guidelines.

mg/dL

42

Flagging Test Results

You can mark a test result with either “DEL” or

“CONT” or leave it unmarked.

You must mark the test result after it has been

displayed, but before you remove the test strip

from the meter. You cannot change the marker

after removing the test strip from the meter.

•“DEL ”: Mark a test result with “DEL” if you feel the result is incorrect or

the test procedure was not followed correctly. The result will be store

in memory, but will not be used for Test Averaging. (See page 21).

•“CONT ”: Mark control solution test results with “CONT”.

(See page 23).

Step 1: Wait for test result to be displayed. Be sure test strip is still in

meter. Press the Up Arrow button to cycle through the options: “DEL”—

> “CONT” —> Unmarked —> “DEL”, etc.

mg/dL

43

Step 2: When you have selected the desired

marker, remove the test strip. When you recall

the result from memory, the selected marker

will be displayed (“DEL”, “CONT” or no marker).

NOTE: Results collected in Control Mode automatically show “CONT”

when the result is first displayed and when it is reviewed in Memory.

NOTE: The following are NOT included

in the 14-day or 30-day test averages:

•ResultscollectedinControlSolution

mode (and therefore marked“CONT”).

•Resultsmarked“CONT”or“DEL”

by you.

•Resultsobtainedwhendateand

time have not been set.

[1]

[2]

mg/dL mg/dL

mg/dL

44

Important Information About AST

Sites other than your fingertip may have fewer nerve endings so obtaining

a blood sample from these sites may be less painful. The technique for

alternate site testing is different from fingertip testing. Blood glucose testing

results from sites other than your fingertip could be significantly different.

Physiological differences in circulation between the fingertip and palm may

result in differences in blood glucose measurements between these sites.

Differences in glucose concentrations may be observed after eating, taking

insulin medication, or exercise and are typically shown more quickly in the

fingertip than in the palm.

Consult with your diabetes healthcare professional prior to testing from a site

other than your fingertips.

ALTERNATE SITE TESTING (AST)

45

Consider Alternate Site Testing When:

 •Testingbeforeameal.

 •Youareinafastingstate.

 •Twohourshavepassedsinceameal.

 •Twohourshavepassedsinceinsulindosing.

 •Twohourshavepassedsincephysicalactivity.

Use Fingertip Testing:

 •Withintwohoursafterameal.

 •Withintwohoursafterinsulindosing.

 •Withintwohoursafterphysicalactivity.

 •Ifyouhaveahistoryofhypoglycemia,areexperiencinglow 

blood glucose, or suffer from hypoglycemic unawareness (you

cannot tell when you have low blood glucose).

 •ToconrmyourbloodglucoselevelifyourASTresultisnot 

consistent with how you feel.

 •Duringtimesofstressorillness.

46

Ask your diabetes healthcare professional about recommended

testing procedures when operating machinery or driving a car, as

fingertip testing is usually the preferred method of testing under these

circumstances.

If bruising occurs, you may choose to lance a fingertip instead.

Preparing to Test Your Blood Glucose

From an Alternate Site

Choose a Site: Select a soft, fleshy

area on the palm that is free of visible

veins and moles and away from bone.

Wash the area with warm, soapy water.

Rinse and dry completely. If you use

alcohol wipes to cleanse the site, make

sure the area is dry before lancing the site.

47

Performing a Blood Glucose Test From an Alternate Site

Step 1:

Insert lancet and cock lancing

device.

48

Step 2:

Remove test strip from the bottle.

Immediately replace the bottle cap

tightly. Insert test strip as shown in

diagram. A beep will sound and

the meter will turn on automatically.

Verify that all symbols appear on the

screen (see page 8). The last result

will then appear.

Verify that the

code number

displayed on

the screen

matches the

code number

on the bottle of

test strips used.

Code No.

(F-2, 3 or 4)

Expiration date

F- 4

10

0018

F-4

49

Step 3:

a) PRESS AND VIGOROUSLY

RUB THE SELECTED AREA for

10 seconds until it starts to

feel warm to the touch.

b) Firmly hold the cocked

lancing device against the

clean skin for 5-10 seconds.

50

Step 4:

Pick up the meter and touch the end of the test

strip to the blood sample until the reaction site is

full. Immediately remove the meter and test strip

from the blood drop.

IMPORTANT

Repeat blood draw if fluid is clear. IMPORTANT!

Insert strip

VERTICALLY

into blood sample,

NOT at an angle.

IMPORTANT

If it takes longer than 20 SECONDS to obtain

a blood sample, and any sample has been

applied to the strip, discard strip and use a

new strip before proceeding.

c) Press the release button

on the lancing device to

lance the skin. Continue to

hold the lancing device

firmly against the skin until

a blood drop forms.

d) Once a

large enough

drop of blood

has formed,

remove the

lancing device.

51

IMPORTANT

•Wasthesamplefreeofclearorwateryuid?

•Wasthedroplargeenough(atleast0.3µL)?

•Didthereactionsitellwithenoughbloodallatonce?

Step 5:

The meter will count down, with a flashing dash, and display

result in 7 seconds.

CONSIDER YOUR RESULT. REPEAT ALTERNATE SITE TEST:

•IFthebloodsampleappearedtobedilutedwithclearuid.

•IFyoudidnotvigorouslyrubthetestsite.

•IFtheblooddropwasnotlargeenoughtollthe

reaction site.

•IFthetestwasaccidentallymarkedasa“Control”result.

•IFyourresultwasnotconsistentwithhowyoufeel.

•IFmorethan20secondselapsedfromsample

collection to measurement (evaporation of the

blood sample may cause a test result that is higher

than the actual value).

IF NOT,

REPEAT TEST.

Filled Not Filled

Filled Not Filled

Any of the above situations can lead to an inaccurate test result.

52

If the repeated alternate site result is still not consistent with how you

feel, confirm your blood glucose level with fingertip testing.

Step 6: Always record your results in your self-testing logbook along

with other information such as insulin dosage, diet, and exercise.

The result is automatically stored in memory with the time and date.

Step 7: Remove the test strip and dispose of it in accordance with

local guidelines or as directed by your healthcare professional.

The meter shuts off automatically when the test strip is removed.

53

Understanding Test Results

The ReliOn® confirm blood glucose meter is referenced to a fresh

plasma sample. Your meter results may differ from clinical lab results. This

is due to normal variation. To compare your meter with lab results, follow

the guidelines below.

Before you compare

Perform a control solution test. This makes sure your meter and test strips

are working correctly. Wait at least 2 hours after a meal or drink (other

than water) before doing a comparison. If the lab test needs venous

blood, you must fast before giving a blood sample.

When at the lab

Blood samples for both tests must be taken and tested within 15

minutes of each other. Collect blood for the lab test with an approved

preservative. Heparin samples of blood may be used. See test strip insert

for additional information. ReliOn® Confirm blood glucose meter is

plasma referenced.

54

ALWAYS wash hands with warm soapy water. Rinse and dry them

before testing. ALWAYS use fresh capillary whole blood on meter tests.

You may still see a difference from the lab result. This can be due to

several causes. Blood glucose levels can change over short periods of

time, for example due to food or stress. Test strip results also may vary

due to medications or to low or high hematocrit.

Analyze data with a clinically acceptable method.

Your test results will vary over time. For example, results may vary due to:

1) The time of day the test was done.

2) The food you eat.

3) Activities you do.

4) The insulin and other medications you take.

If your readings do not seem correct, repeat the test. Contact your

healthcare professional immediately if:

 •abnormallyhighorlowreadingspersist.

 •yourtestresultsdonotmatchyoursymptoms.

55

Normal Blood Glucose Readings

Expected blood glucose levels for adults without diabetes¹,²:

Fasting 70 to 110 mg/dL

1 to 2 hours after meals <120 mg/dL

High Blood Glucose Readings

If your blood glucose is above 600 mg/dL, you will receive a “Hi.”

Repeat the test with a new test strip. If this message shows again,

contact your healthcare professional immediately!

Contact your physician for advice if test results are very high³ (above

240 mg/dL) and/or you have symptoms of high blood glucose. These

symptoms include dry mouth, thirst, frequent urination, nausea,

vomiting, blurred vision, sleepiness, or abdominal pain. Symptoms will

vary person to person. You may have one or all of these symptoms.

56

Low Blood Glucose Readings

If your blood glucose is below 20 mg/dL, you will receive a “Lo.”

Repeat the test with a new test strip. If this message shows again,

contact your healthcare professional immediately!

Contact your physician for advice if test results are very low (below 70

mg/dL) and/or you have symptoms of low blood glucose. Symptoms

of low blood glucose include sweating, shakiness, trembling, blurred

vision, hunger, headache, confusion, rapid heartbeat, or tingling or

numbness around the mouth or fingertips. Symptoms will vary person to

person. You may have one or all of these symptoms.

Recent Diabetes Findings

In 1993, the National Institutes of Health reported a study of people

with Type 1 diabetes. This study was called the Diabetes Control and

Complications Trial (DCCT). It found that good blood glucose control

can reduce the risk of complications by about 60%5. This helps protect

the eyes, kidneys, and nervous system from damage due to diabetes.

4

57

What This Means For You

Frequent blood glucose testing is the best means to track how well you

are doing with your diabetes management. It helps you track the

effects of medications, diet, exercise, and stress management. Blood

glucose test results can also tell you if your diabetes is changing. This

may alert you to adjust your treatment plan. Always consult your

healthcare professional before making any adjustments.

Frequency of Testing

Work with your healthcare professional to decide when and how often

to test. This will depend on such things as age, type of diabetes, and

medications. It is important to make testing part of your daily routine.

References

1 Burtis, C.A. Ashwood, E.R.,eds.: Tietz Textbook of Clinical Chemistry. 2nd Edition. Philadelphia: W.B. Saunders. (1994), 2190.

2 Krall, L.P. and Beaser R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Fibiger (1989), 138.

3 Krall, L.P. and Beaser R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Fibiger (1989), 261–263.

4 Kahn, R. and Weir, G.: Joslin’s Diabetes Mellitus. Philadelphia: Lea and Fibiger (1994), 489.

5 American Diabetes Association position statement on the Diabetes Control and Complications Trial (1993).

58

The ReliOn® Confirm blood glucose meter stores up to 360 test results.

When more than 360 test results have been performed, the meter

drops the oldest result each time you add a new result. Before using

the memory, remove test strip from meter and make sure meter is

turned off.

Step 1: Press the Up Arrow button for 2 seconds.

A beep sounds and the test meter turns

on and shows all screen symbols. The meter next

shows the year, date, and time. After 2 seconds,

either the Test Average or the most recent

test result will appear.

RECALLING RESULTS - ENTERING MEMORY MODE

Up

Arrow

Down

Arrow

59

•IfTestAveraginghasbeenturnedon,the

average result will appear first. Either “14d”

or “30d” will show at the bottom of the screen

for either a 14-day or 30-day average. “AVE”

will appear above “14d” or “30d”.

•IfTestAveraginghasbeensetto“Off”,the

display will briefly flash the number “1” at the

bottom of the screen. Then, the most recent

test result appears with the date and time of

the test.

“MEM” will display at the top of the screen.

This shows it is a stored result.

Step 2: Press the Up Arrow button to scroll

through memory. Press and hold the Up

Arrow button to move through the results

quickly. Press the Down Arrow button to

move backwards through results in memory.

[1]

[2]

[3]

mg/dL

mg/dL mg/dL

mg/dL

mg/dL

60

Step 3: After all test results have been reviewed, “End” appears.

•PresstheUpArrowbuttononcetogobacktotherstresult 

in memory. You can then scroll through results in memory again.

•PresstheDownArrowbuttonfor2secondstoexitMemoryand 

turn off the meter. You can exit Memory in this way at any time

when recalling results.

Note:

•Ifnotestshavebeenperformed,oralltestresultshavebeen 

deleted, the current date and time appear first, then “End” appears.

•If3minuteselapsebeforeeithertheupperorlowerbuttonispressed,

a beep sounds and the test meter turns off automatically.

61

Deleting all test results

Step 1: Press both the Up Arrow and Down

Arrow buttons for 5 seconds while “End”

is shown. You will see “dEL” and “ALL”

alternating on the screen.

Step 2: Next press the Down Arrow button

for 5 seconds. “End” appears again. All test

results have now been deleted.

Step 3: Press the Down Arrow button for 2

seconds to turn off test meter.

Note: To get to “End” of memory results quickly, turn off meter, then en-

ter Memory Mode. Next press the Down Arrow button to go backwards

in the memory list to reach “End”.

[1]

[2]

[3]

Note: Deleted test results cannot be recovered.

62

Cleaning

To prevent malfunction of the meter, keep the test strip port free of

blood, moisture, dirt, or dust. Use a lint-free cloth dampened with

water to clean meter. Thoroughly wring out cloth before use. Do not

use an abrasive cloth or antiseptic solution, as these may damage the

display screen. Do not clean inside battery compartment.

MAINTENANCE

63

Storage and Handling

•Storemeterat32°F-122°F(0°C-50°C).

•Donotleavethemeterinveryhotorcoldplaces.Donotleaveit 

near a heat source (radiator) or in a car in hot or cold weather.

•Donotstoreorusemeterorteststrips:

  •inhighhumidity,suchasabathroomorkitchen.

  •nearastrongelectromagneticeldsuchasamicrowaveoven

or cell phone.

•Donotuseameterthathasbeendroppedintowater,orifany 

water has entered the meter. Even if you dry it, correct test results

may not be obtained, and malfunction may result.

•Donotstoremeterorteststripsnearbleachorcleanersthatcontain

bleach.

•Donotdropmeter.Thiscandamagethemeter.Ifyoudodrop 

meter, check it with a control solution test.

•Donottakethemeterapart.

•Donotleaveteststripsoutoftheirbottles.

•Donotholdteststripswithngersforalongperiodoftime.

•Donotholdteststripswithwetordirtyngers.Otherwisecorrecttest

results may not be obtained.

64

Display Screen and Error Messages

Please first read this section. If you still have questions, call Customer

Service at 800.631.0076 (24 hours a day, 7 days a week). Contact your

healthcare professional if you cannot reach Customer Service. Do not

send your meter to ARKRAY or your local dealer without first calling to

get approval to do so.

If any part of the display screen is missing

when the meter is turned on, call

Customer Service at 800.631.0076.

If you have technical problems or questions, please call Customer

Service at 800.631/0076 (24 hours a day, 7 days a week). Contact your

healthcare professional with questions if you cannot reach Customer

Service.

65

Your blood glucose level is less than 20 mg/dL or there

was not enough blood on test strip. Repeat test with new

test strip. Make sure you use enough blood to fill the strip.

If this message shows again, contact your healthcare

professional immediately!

Your blood glucose level is more than 600 mg/dL. Repeat

test with new test strip. If this message shows again,

contact your healthcare professional immediately.

Battery power is too low for testing. Replace batteries

immediately. Results may not be accurate when testing

with low battery symbol on.

Thermometer symbol. The meter temperature is outside

acceptable range of 50˚F-104˚F (10˚C-40˚C). Allow the

meter and test strips to warm up or cool down slowly

(20 minutes) until the temperature warning symbol goes

away.

66

The meter is faulty. Contact Customer Service

at 800.631.0076.

The meter temperature is outside acceptable

range of 50˚F-104˚F (10˚C-40˚C). Allow the meter

and test strips to warm up or cool down slowly

(20 minutes) until the temperature warning

symbol goes away.

The meter is faulty. Contact Customer Service

at 800.631.0076.

The meter is faulty. Contact Customer Service

at 800.631.0076.

67

Test strip problem. Contact bars on test strip may be

dirty. Incorrect test strip used. Used test strip has been

inserted. Repeat test with new test strip.

Not enough blood added to test strip. Or incorrect

blood application technique. Retest with new test strip.

Code Number. This shows the code number currently in

the meter. The number on the screen must match the

number on the test strip bottle. If screen code does not

match the test strip code, use a new test strip. If code still

does not match, use a new bottle of test strips or call

Customer Service at 800.631.0076.

Apply Blood Sample. The Apply Blood symbol flashes

showing that the meter is ready for the blood sample.

68

Apply Control Solution. The Apply Blood symbol flashes

and “CONT” appears at the bottom of the screen.

This shows the meter is ready for you to apply control

solution.

Test Result. The meter shows results between 20

and 600 mg/dL.

Test Average has no results stored. Test Averaging has

been set to 14-day or 30-day but there are no results

stored yet in memory.

mg/dL

For errors not listed, do not attempt to use meter.

Contact Customer Service at 800.631.0076.

69

Product Specifications

Test Strips: ReliOn® Confirm/micro test strips.

Result Range: 20-600 mg/dL .

Calibration: Plasma referenced.

Sample Size: Minimum 0.3 µL.

Blood Source: Fresh capillary whole blood.

Hematocrit Range: 30% - 54%.

Test Time: 7 seconds.

Assay Method: Biosensor, Glucose Oxidase (Aspergillus niger sourced).

Power Source: One 3-volt lithium battery (CR2032 or DL2032)

Battery Life: Approximately 2,000 tests

Screen Type: Liquid Crystal Display (LCD).

Memory: 360 results with time & date stamp.

Average: 14-day or 30-day averaging.

AutomaticShutOff: 3–5minutesafterlastuseraction.

Size: 2" x 3.9" x 0.5".

Weight: 1.6 oz (with battery).

Operating Ranges: 50°F-104°F (10°C-40°C), 20% - 80% relative humidity.

Altitude: 10,000 ft. (3,048 meters).

Unit of Measurement: mg/dL.

PRODUCT INFORMATION

70

Warnings, Precautions & Limitations

•Youmaygettestresultshigherthanyouractualglucoselevel 

if taking PAM (1-Methylpyridine-6-carbaldehyde oxime). Taking

unnecessary measures to lower your blood glucose level may induce

severe low blood glucose symptoms such as coma.

•Nevermakesignicantchangestoyourdiabetescontrolprogram

or ignore physical symptoms without consulting with your healthcare

professional.

•Patientsundergoingoxygentherapymayyieldfalseresults.

•Heparinsamplesofbloodmaybeused.Donotuseother  

preservatives.

•Donotgraspthemeterneartheteststripport.Abuilt-in  

thermosensor used to minimize measurement errors is installed just

inside the port. If you hold this area, it will be warmed by your fingers,

which will adversely affect test results.

•Severedehydration(excessivewaterloss)maycausefalselow 

results. If you believe you are suffering from dehydration, consult your

healthcare professional right away.

71

•Extremesinhematocritmayaffecttestresults.Hematocritlevels 

less than 30% may cause falsely high readings. Hematocrit levels

greater than 54% may cause falsely low readings.

•Inaccurateresultsmayoccurinseverelyhypotensiveindividuals 

or patients in shock. Inaccurate low results may occur for individuals

experiencing a hyperglycemic-hyperosmolar state, with or without

ketosis. Critically ill patients should not be tested with blood glucose

meters.

•Triglyceridesupto3,000mg/dLdonotsignicantlyaffecttestresults.

However, glucose values in specimens beyond this triglycerides level

should be interpreted with caution.

•Normalendogenous(withinbody)naturallevelsofuricacid, 

ascorbate (vitamin C), bilirubin, triglycerides, and hemoglobin do not

interfere with your blood glucose results obtained.

•ExternallytakendrugsL-dopa,dopamine,methyl-dopa,  

acetaminophen, and ibuprofen will not interfere with

ReliOn® Confirm blood glucose results when taken at therapeutic

concentrations.

72

•TheReliOn®ConrmBloodGlucoseMonitoringSystemisnot 

designed to be a substitute for pathology laboratory equipment and

should not be used for the diagnosis of diabetes.

•Useonlyfreshcapillaryblood.Donotuseserumorplasmaorvenous

whole blood.

•DonotusetheReliOn®ConrmBloodGlucoseMonitoringSystem 

to test neonates. It has not been validated for neonatal use.

•Alwaysinserttheteststripintothemeterrst,thenprickthenger. 

Not doing so may result in an“E-6” appearing on the display or a test

result that is higher than the actual value.

•Donotuseataltitudeshigherthan10,000ft(3,048m).

73

Warranty

You are a valued ReliOn® customer. It is important to us that you are

completely satisfied with your ReliOn® Confirm blood glucose meter.

ReliOn® warrants your ReliOn® Confirm blood glucose meter will be free

from defects in materials and workmanship for a period of five years

from the date of the original purchase. If during this time the meter does

not work properly because of a defect in materials or workmanship,

ARKRAY agrees to replace or repair, free of charge any and all parts

proven to be defective and subject to warranty.

This warranty is in lieu of all other warranties, expressed or implied,

including any implied warranty of merchantability or fitness for any

purpose, other than stated herein.

This warranty does not apply to the performance of the ReliOn® Confirm

blood glucose meter that has been damaged by accident or has been

altered, misused, tampered with, or abused in any way. This warranty only

applies to the original purchaser of the meter and/or its agents.

74

Returns

You must contact ReliOn® Customer Service at 800.631.0076 before

returning your meter. You will be instructed how to return the meter

to ARKRAY. Returned meters without this authorization will not be

accepted.

P/N 1857-00

Rev 7/09

TEL 800.566.8558

FAX 952.646.3110

www.arkrayusa.com

©2008 ARKRAY, Inc.