Infopia Element Plus Manual de usuario

IMM20-526 Rev. 2012-07-02

Catalog number: INFM21FUS

TEL : 1-888-446-3246

Blood Glucose Monitoring System

Voice Feature in English & Spanish

Dear ElementTM Plus System Owner

Thank you for choosing The ElementTM Plus blood glucose monitoring

system. This manual contains everything you need to know about your

new glucometer and how it works. Please take a moment to read the

instructions carefully.

The unique feature of this system is its voice function, which acts as an

acoustic aid for users. The voice function is optional and can be turned

off in the setup of the meter. Although the ElementTM Plus Glucose Meter

has a voice option it has not been validated for use by the visually

impaired.

Customer Service is available 24 hours a day, 7 days a week, 365 days

a year. Please call customer support toll free: 1-888-446-3246

Intended use

The ElementTM Plus Blood Glucose Monitoring System is for the quantita-

tive measurement of glucose in capillary whole blood taken from the

fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.

ElementTM Plus Blood Glucose Testing System is for in vitro diagnostic

use and is not to be used for the diagnosis of or screening for diabetes or

for neonatal use. ElementTM Plus Blood Glucose Monitoring System is

intended to be used by a single patient and should not be shared. The

ElementTM Plus Blood Glucose Monitoring System is intended for self

testing outside the body (in vitro diagnostic use) by people with diabetes

at home as an aid in the management of diabetes. Alternative site Testing

(ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh) should

be done during steady- state times when glucose is not changing rapidly.

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Warning:

Do not change your medication based on ElementTM Plus meter test results

without contacting your physician or healthcare professional.

Important information

The ElementTM Plus system provides a quick and easy way for patients

with diabetes to measure their blood sugar levels.

It should only be used with fresh capillary whole blood samples. It is

designed for in-vitro diagnostics use only and should not be used for any

purpose other than monitoring blood sugar levels. It should not be used

for the diagnosis of diabetes or for the testing of newborns (neonates).

The ElementTM Plus Test Strips are for use with the Element™ Plus Blood

Glucose Meter to quantitatively measure glucose (sugar) in fresh

capillary whole blood samples drawn from the fingertip, ventral palm,

dorsal hand, upper arm, forearm, calf and/or thigh.

This meter contains some speaking functions but has not been validated

for use by the visually impaired.

Warning:

• Element™ Plus meter and reusable lancing device are for single patient use

only. Do not share them with anyone including other family members! Do

not use on multiple patients!

• All parts of the kit are considered biohazardous and can potentially transmit

infectious diseases, even after you have performed cleaning and disinfec-

tion.

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

• Avoiding getting hands lotions, oil, dirt or debris in or on the lancets and

reusable lancing device.

• Please refer to page 40-45 for cleaning and disinfecting Element™ Plus

system.

“FDA Public Health Notification: Use of Fingerstick Devices on More

than One Person Poses Risk for Transmitting Blood borne Pathogens

:lnitial Communication”(2010) http://www.fda.gov/MedicalDevices/

“CDC Clinical Reminder: Use of Fingerstick Devices on More than One

Person Poses Risk for Transmitting Blood borne Pathogens” (2010)

http://www.cdc.gov/injectionsafey/Fingerstick-DevicesBGM.htm

Important Safety Instructions

The Centers for Disease Control and Prevention(CDC) and the US Food

and Drug Administration (FDA) have become increasingly concerned

about the risks for transmitting hepatitis B virus (HBV) and other blood

borne pathogens to people undergoing finger stick procedures for blood

sample. For instance, people with diabetes who require assistance

monitoring their blood glucose levels.

Reports of HBV infection outbreaks linked to diabetes care have been

increasing. This notice serves as a reminder that finger stick devices

should never be used for more than one person.

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About your new Element™ Plus system:

Element™ Plus KIT contents

Element™ Plus meter

Element™ Brand test strips

Before you test:

Comparing your meter and laboratory results

Setting the meter

Performing a control solution test

Performing your test:

Performing a blood test with your fingertip

Disposing of your test strips and lancets

Reviewing your results:

Reviewing your blood sugar

Reviewing your averages

Alternate site test:

Performing a blood test with an alternate site

Caring for your Element™ Plus meter:

Cleaning and Disinfecting your system

Storage of your system

Transferring your results

Battery installation

Troubleshooting

Warranty

Specifications

Table of contents

About Your New ElementTM Plus System About Your New ElementTM Plus System

The following items are

included:

1. Element

™

Plus meter

2. Owner’s manual

3. Warranty registration card

4. Carrying case

5. Patient logbook

Two 1.5V Alkalin batteries(AAA)

The following items

may be included:

Reusable lancing device

2. Lancet (5)

3. Control solution

4. Test strip (5)

5. Diabetic handbook

6. Quick Reference

Test Strip Port:

Insert the Element™ Brand test strip.

Test Strip Ejector

Releases and discards the test strip.

Display Screen:

Displays your test results, symbols

and messages.

Power / Enter Button:

Powers the meter on/off, prompts

memory data and acts as an enter

button during setup and after tests.

Up / Down Arrow Buttons:

Scroll up or down to adust settings

or retrieve memory.

Serial Number

Battery Cover

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Your Element™ Plus blood glucose monitoring system has been

sealed to protect the contents.

If you find your seal has been broken, please return it to the place

of purchase.

About Your New ElementTM Plus System

Low battery warning

Test strip code

Ready for blood

Alarm clock

Before having a meal (full plate)

After having a meal (empty plate)

After taking medication

After exercise

Temperature / Date

Time

Test result unit

Control solution

Average test result

Voice Feature

Target to apply blood

Confirmation Window

Contact Bar

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1. Store the Element™ Brand test strip vials in a cool, dry place. Keep out

of direct sunlight. Do not freeze.

2. Store test strips in their original vial only. Do not mix the test strips in

new vials or in any other container.

3. Immediately replace the vial cap and close tightly after removing any

test strips from the vial.

4. Make a note of the discard date, which is three months from the date

you first open a new vial of strips. Throw Element™ Brand test strips

and vial away after the discard date.

5. Do not use the test strips after the expiration date printed on the

package or vial since it may cause inaccurate results.

6. Element™ Brand test strips are for single use only. DO NOT RE-USE.

7. Do not test at temperatures below 50°F or above 104°F.

8. Do not test with humidity below 10% or above 90%.

9. Do not bend, cut, or alter the test strip.

10. Avoid getting dirt, food, and water on the test strip. Do not handle test

strips with wet hands.

11. Avoid getting dirt, food, and water on the color-coding label

(backside of test strip).

12. Refer to additional information in the Element™ Brand test strip package.

13. The Element

Plus meter should be used with All Element

Brand

test strips.

12/ 13

Before Testing

Be sure to read this section and the test strip package insert found in the

test strip box carefully. You will need to have all of the necessary items to

begin testing:

If the meter is moved from one temperature to another, allow 30 minutes

for the meter to adjust to the new temperature before testing.

Make sure that the ElementTM Plus meter and test strips have adjusted to

the temperature of the location from where you are testing.

Do not operate the ElementTM Plus system in direct sunlight.

1. ElementTM Plus meter

2. ElementTM Brand test strip

3. Lancing device

4. Sterile lancet

Comparing your meter and laboratory results

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Test results with the ElementTM Plus blood glucose monitor are plasma-

equivalent. This method will help you and your healthcare professional

compare your meter results with laboratory test results. The ElementTM

Plus test result and laboratory test results both are expressed in plasma-

equivalent units. However, your glucose monitor result may differ from

your laboratory result due to normal variation. Your glucose monitor

results can be affected by factors and conditions that do not affect labora-

tory results in the same way.

Your ElementTM Plus monitor value is considered accurate when it is

within ± 20% of the laboratory measurement. There are some specific

situations that could cause a difference of more than ± 20%.

1. You are severely dehydrated.

2. You have eaten recently. The blood glucose level from blood

obtained from a fingertip can be up to 70mg/dL higher than

blood drawn from a vein (venous sample) used for a lab test.1

3. Your hematocrit is above 60% or below 20%.

1Sacks, D.B.: Carbohydrates.: “ Carbohydrates.” Burits, C.A. and Ashwood, E.R. (ed.),Tietz

Textbook of Clinical Chemistry.Philadelphia:W.B.Saunders Company (1994),959

Necessary items:

WARNING!

To reduce the chance of infection:

1. The lancing device and sterile lancets should NOT be shared with others.

2. Always use a new, sterile lancet and a new blood glucose test strip.

3. Practice using the Lancing Device and become accustomed with its use.

4. Lancets and blood glucose test strips are for single use only.

5. Wash your hands with warm clean water and soap before testing.

6. Avoid getting hand lotion, oils, dirt or debris on the lancets or on the

lancing device.

7. Dry your hands completely before testing.

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Setting Your Meter

The Element TM Plus meter has a wide variety of functions to choose from.

From the setup mode you have the ability to turn on the voice feature,

activity/meal flags, set the date/time, designate three unique averages

and set up to five daily alarms.

Press and hold the power button for approximately 3

seconds to enter the setup mode. The word “Voice” will

appear in the lower right corner of the LCD screen indicating

the Voice Feature. Press and release either the Ƈor Ɖ

button to turn the Voice Feature on or off, then press and

release .

If you chose to turn On the voice feature, the next option

is for you to choose your desired language preference.

The letters “L-1” indicating Language-1 and “En”

indicating English will appear.

If English is your desired language then press and

release .

If Spanish is your desired language press ▲ or ▼ for

letters “L-2” indicating Language-2 and “ES” indicating

Español(Spanish), then press .

Select Speaking Function

Select Language(English or Spanish)

Note:

The ElementTM Plus meters language is set to English by default. This

default setting will remain whenever the meter is powered on or after a

battery change.

14/ 15

You tested at a temperature near the low end of the operating range

which could result in a false high blood sugar.

Repeat the test in a warmer environment with a new test strip as soon as

possible.

For additional information on possible limitations for accuracy on

precision, please refer to your test strip insert.

In order to make the most accurate comparison to your laboratory

results. Please follow a few basic guidelines:

Before going to the lab

- Do not eat for at least two hours before you test your blood.

- Perform a control solution test to make sure the meter is

working properly.

- Take your meter with you to the lab.

While at the lab

- Follow all instructions in this owner's booklet for performing a

blood sugar test with your meter.

- Conduct your meter test within 15 minutes of lab test.

- Use only fresh, capillary blood obtained from the fingertip.

You may still experience a difference from the laboratory test results

because blood sugars can change very rapidly over a short period of

time. This can be for a variety of reasons, such as; exercise, medication,

stress or loss of body fluids.

Comparing your meter and laboratory results

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Setting Your Meter

The Element TM Plus meter has a wide variety of functions to choose from.

From the setup mode you have the ability to turn on the voice feature,

activity/meal flags, set the date/time, designate three unique averages

and set up to five daily alarms.

Press and hold the power button for approximately 3

seconds to enter the setup mode. The word “Voice” will

appear in the lower right corner of the LCD screen indicating

the Voice Feature. Press and release either the Ƈor Ɖ

button to turn the Voice Feature on or off, then press and

release .

If you chose to turn On the voice feature, the next option

is for you to choose your desired language preference.

The letters “L-1” indicating Language-1 and “En”

indicating English will appear.

If English is your desired language then press and

release .

If Spanish is your desired language press ▲ or ▼ for

letters “L-2” indicating Language-2 and “ES” indicating

Español(Spanish), then press .

Select Speaking Function

Select Language(English or Spanish)

Note:

The ElementTM Plus meters language is set to English by default. This

default setting will remain whenever the meter is powered on or after a

battery change.

16/ 17

Setting Your Meter

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The year will appear at the bottom of

your screen.

Press and release the ƞor Ơbuttons to

set the year.

By pressing ƞthe number will increase.

By pressing Ơthe number will

decrease. Then press and release .

The month, day, and time will appear on

your screen with the month blinking.

Press and release either the ƞor Ơ

buttons to change the month, then press

and release .

The day will begin blinking.

Press and release either the ƞor Ơ

button to change the day, then press and

release .

The time will be blinking.

Press and release either the ƞor Ơ

button to change the hour and minutes,

then press and release .

Setting Your Meter

Select voice volume

Select activities/meal flag

Select year/month/time

The voice volume will appear on the right

hand side of your screen. This stands for

the volume you can set. Press and release

the ƞor Ơbuttons to set the volume. By

pressing ƞthe number will increase. By

pressingƠthe number will decrease. The

press and release .

Now the activity/meal flags will appear on

the left hand side of your screen. Press

and release either the ƞor Ơbutton to

turn On or Off, then press and release .

Note:

If you did not activate the Voice Feature, language preference and

voice volume setting procedures are not conducted.

18/ 19

Setting Your Meter

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If the alarm is On, press and release

either the ƞor Ơbutton to set the alarm

time, then press and release .

The second alarm will appear.

Press and release either the ƞor Ơ

button to turn additional alarms on/off,

then press and release .

You have the ability to set up to 5

alarms.

Caution:

Make sure that the day and time are set properly to enable your data to be

stored and downloaded properly.

Setting Your Meter

Press and release either the ƞor Ơ

button to set the number of days to be

calculated for that average. That number

will be blinking next to a ‘ ’ at the bottom.

Press and release .

You can set up to 3 averages (from 1-99

days).

A ‘ ’ will appear on the right hand side of

your screen. This stands for the first

average you can set.

The Alarm icon will appear at the bottom

of your screen.

Press and release either the ƞor Ơ

button to turn the alarm ‘On/Off’, then

press and release .

If the alarm is turned off, the set up mode

is now complete. The meter will turn off

automatically.

Set the averages

Set the alarms

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Performing a Control Solution Test

Place a drop of control solution on a clean dry surface

(ex. the lid of the test strip vial).

Dip the test strip into the control solution.

Results will appear in 3 seconds.

Compare the result to the range printed on the test strip

vial, the result should fall within that range.

Caution:

The control solution bottle is at the very bottom left, not to be confused with the

medication bottle. This will allow you to differentiate between a control solution

test and an actual blood test.

Discard the 1st drop of control solution, this will

eliminate any residue.

Gently shake the control solution before use.

Check the expiration date before performing a control

solution test. Do not use if expired. Please note the

expiration date on the control solution bottle.

Performing a Control Solution Test

Firmly insert the test strip into the meter port with the ‘Blue

color’ facing up. Make sure the code number matches the

code on the strip bottle. The Element™ Plus automatically

adjusts the meter accordingly.

Scroll through the icons with the ƞ

or Ơbutton until the control solution

bottle is blinking, press .

Press and release either the ƞor Ơ

button. The control solution bottle will

appear at the bottom left hand corner,

press .

If activity/meal is ON If meal activity/meal is OFF

Element™ Brand control solutions contain a known amount of glucose that

reacts with All Element™ Brand test strips. By comparing your control solution

test results with the expected range printed on the test strip vial, it is able to check

the meter and test strips are working properly. It is very important that you

perform the check routinely to make sure you get accurate results.

The Glucose control solution should be used

•Whenever you suspect the blood glucose test meter or blood glucose test strip

is not functioning properly.

•If your blood glucose test results are not consistent with your symptoms or if you

think they are not accurate.

•If you have dropped the blood glucose test meter.

•For quality control in the point of care usage.

•For teaching or learning the system.

•When using the meter for blood glucose test after any disinfection procedure.

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