Handleiding CareSens N Eco Bloedglucosemeter

Handleiding

Step 3

Shake the bottle well before each test.

Remove the cap and squeeze the

bottle to discard the first drop. Then

wipe the tip with a clean tissue or

cloth. After the

appears on the

display, apply the solution to the

narrow edge of the test strip until the

meter beeps. Make sure the

confirmation window fills completely.

User Manual

INDEX

01 Important Information: Read This First! ---------------------- 2

02 Specifications --------------------------------------------------------- 3

03 CareSens N Eco Blood Glucose Monitoring System ------- 4

04 Inserting or Replacing the Battery ----------------------------- 5

05 Caring for Your System --------------------------------------------- 6

06 CareSens N Eco Blood Glucose Test Strip --------------------- 6

07 CareSens N Eco Blood Glucose Meter ------------------------- 8

08 CareSens N Eco Blood Glucose Meter Display -------------- 9

09 Setting Up Your System -------------------------------------------

10

10 Setting the Strip Expiration Date Indicator -----------------

14

11 Checking the System ----------------------------------------------

15

12 Using the Lancing Device ----------------------------------------

18

13 Alternate Site Testing ----------------------------------------------

23

14 HI and Lo Messages ------------------------------------------------

25

15 Target Blood Glucose Ranges -----------------------------------

26

16 Transferring Test Results ------------------------------------------

26

17 Meter Memory -------------------------------------------------------

27

18 Setting the Alarm Function --------------------------------------

29

19 Understanding Error Messages ---------------------------------

31

20 General Troubleshooting -----------------------------------------

33

21 Performance Characteristics ------------------------------------

33

22 Warranty Information ---------------------------------------------

36

01 Important Information: Read This First!

02 Specifications

03

CareSens N Eco Blood Glucose Monitoring System

04 Inserting or Replacing the Battery

07 CareSens N Eco Blood Glucose Meter

08 CareSens N Eco Blood Glucose Meter Display05 Caring for Your System

06 CareSens N Blood Glucose Test Strip

For optimum safety and benefits, please read the entire manual

contents before using the system.

Intended use:

CareSens N Eco Blood Glucose Monitoring System is used for the

quantitative measurement of the glucose level in capillary whole

blood as an aid in monitoring diabetes management effectively at

home or in clinical settings.

CareSens N Eco Blood Glucose Monitoring System should be used

only for self-testing outside the body (in vitro diagnostic use only).

CareSens N Eco Blood Glucose Monitoring System should not

be used for the diagnosis of diabetes or for testing newborns.

Testing sites include the traditional fingertip testing along with

alternate site testing on forearm and palm.

•

Glucose in blood samples reacts with the chemical in the test strip to

produce a small electrical current. The CareSens N Eco meter detects

this electrical current and measures the amount of glucose in the

blood sample.

•

The CareSens

N Eco Blood Glucose Meter is designed to minimise

code related errors in monitoring by using the no-coding function.

•

The CareSens N Eco Blood Glucose Meter should be used only with

the CareSens N Test Strips.

•

An abnormally high or low red blood cell count (hematocrit level over

65% or below 15%) may produce inaccurate results.

•

If your test result is below 60 mg/dL (3.3 mmol/L) or above 240 mg/dL

(13.3 mmol/L), consult a healthcare professional immediately.

•

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.

•

Inaccurate results may occur in patients undergoing oxygen therapy.

If you need assistance, please contact your authorised i-SENS sales

representative or visit www.i-sens.com for more information.

For in vitro diagnostic use

This product fulfills the

requirements for Directive

98/79/EC on in vitro

diagnostic medical devices

Cautions for safety and

optimum product use

Use by (unopened or

opened test strip vial)

Temperature limitation

Authorised representative

Do not discard this product

with other household-type

waste

Do not reuse

Batch code

Consult instructions for use

Manufacturer

Serial number

Meaning of Symbols Used:

Measurement range 20–600 mg/dL (1.1–33.3 mmol/L)

Sample size Minimum 0.5 μL

Test time 5 seconds

Sample type Fresh capillary whole blood

Calibration Plasma-equivalent

Assay method Electrochemical

Battery life 1,000 tests

Power

One 3.0 V lithium battery

(disposable, type CR2032)

Memory 1,000 test results

Size 95 x 49 x 18(mm)

Weight 49 g (with battery)

Temperature 5–45˚C (41–113˚F)

Relative humidity 10–90%

Hematocrit 15–65%

Glucose meter

(with battery)

0–50˚C (32–122˚F)

Test strip 1–30˚C (34–86˚F)

Product specifications

Operating ranges

Storage Conditions

CareSens N Eco BGM System includes the following items:

* CareSens N Eco Blood Glucose Meter

* Battery

Optional items:

* CareSens N Blood Glucose Test Strips

* User Manual

* Lancets

* Lancing Device

* Quick Reference Guide

* Logbook

* Carrying Case

• Check all the components after opening the CareSens N Eco Blood

Glucose Monitoring System package. The exact contents are listed

on the main box.

• The cable for data management software can be ordered

separately. Please contact your authorised i-SENS sales

representative.

Step 1

Make sure the meter is turned off. Push the

cover in the direction of the arrow to open

the battery compartment.

Step 2

Remove the used battery and your index

finger under the battery to lift and pull out

as shown. Insert a new battery with the +

side facing up and make sure the battery is

inserted firmly.

Step 3

Place the cover on the battery compartment.

Push down until you hear the tab click into

place.

The CareSens N Eco Meter uses one 3.0 V lithium battery.

Before using the meter, check the battery compartment and insert a

battery if empty. When the

symbol appears on the display while

the meter is in use, the battery should be replaced as soon as possible.

The test results may not be saved if the battery runs out.

Press and hold the button for 3 seconds to enter SET mode. After all

settings are finished, press and hold the

button for 3 seconds to turn

off the meter.

Press the

or button to change values. Press and hold the or

button to scroll faster.

Step 8 Setting the Sound On/OFF

On pressing

or

, the screen will display 'On' or 'OFF'. Press the

button to confirm the selection.

Step 1 Entering the Expiration Date Setting

Press and hold the

and

buttons at the same time for 3 seconds to

enter the expiration date settings. After all segments flash across the

screen, 'EP' will show up.

Use a soft cloth or tissue to wipe the meter exterior. If necessary, dip the

soft cloth or tissue in a small amount of alcohol.

Do not use organic solvents such as benzene, acetone, or any household

and industrial cleaners that may cause irreparable damage to the meter.

The CareSens N Eco Blood Glucose Monitoring System measures

blood glucose quickly and accurately. It automatically absorbs

the small blood sample applied to the narrow edge of the strip.

Warning!

• The CareSens N Test Strips should be used only with fresh capillary

whole blood samples.

• Do not reuse test strips.

• Do not use test strips past the expiration date.

• Test strips in new, unopened vials and test strips in vials that have

been opened can be used up until the expiration date printed on the

test strip box and vial label if the test strips are used and stored

according to its storage and handling methods.

• Store test strips in a cool and dry place at a temperature between

1-30 ˚C.

• Keep test strips away from direct sunlight or heat and do not freeze.

• Store test strips only in their original vial.

• Close the vial tightly after taking out a test strip for testing and use

the strip immediately.

• Handle test strips only with clean and dry hands.

• Do not bend, cut, or alter test strips in any way.

• For detailed storage and usage information, refer to the CareSens N

Test Strip package insert.

Caution:

• Do not expose the meter to direct sunlight, heat, or excessive

humidity for an extended period of time.

• Do not let dirt, dust, blood, or water enter into the meter’s test strip

port.

• Do not drop the meter or submit it to strong shocks.

• Do not try to fix or alter the meter in any way.

• Strong electromagnetic radiation may interfere with the proper

operation of this device. Keep the device away from sources of

strong electromagnetic radiation, especially when measuring your

blood glucose.

• Keep the meter in a cool and well ventilated place.

• Store all the meter components in the portable case to prevent loss

and help keep the meter clean.

Disposal of the meter

If you need to throw your meter away, you should follow existing

policies and procedures of your own country or region. For information

about correct disposal, please contact your local council or authority. If

you need assistance, contact your authorised i-SENS sales representative

or visit www.i-sens.com.

Insert

Contact bars

Gently push the test strip, with its

contact bars facing up, into the test

strip port of meter

Edge to apply blood sample

Apply blood sample here for testing

Confirmation window

Check here to see whether sufficient blood

sample has been applied

Caution:

• Keep the meter and testing supplies away from young children.

• Drying agents in the vial cap may be harmful if inhaled or

swallowed and may cause skin or eye irritation.

Note:

• The cable for data management software can be ordered

separately. Please contact your authorised i-SENS sales

representative.

• The unit of measurement is fixed and it cannot be changed by

the user.

Note: The meter may switch off if the control solution is not

applied within 2 minutes of the

appearing on the screen.

If the meter turns off, remove the strip, reinsert, and start from

step 1.

Note: The CareSens Glucose Control Solution can be purchased

separately. Please contact your authorised i-SENS sales

representative.

Note: Removing the meter battery will not affect your stored

results. However, you may need to reset your meter settings. See

pages 10.

Note:

• The

symbol is displayed only when the sound is set to OFF.

• At any stage, press the

button for 3 seconds to exit SET mode

and turn off the meter. Press and hold

to quickly scroll through

the numbers.

Data Port

Used to transfer

data from the

meter to a

computer with a

cable

Display

Shows results

and messages

Button

Turns the meter

on/off, confirms

menu selections,

and changes

information

, Button

Turns the meter

on, selects

or changes

information

Test Strip Port

Insert test strip here

1

Test results : test results displaying panel

2

Memory recall mode : appears when test

results stored in the memory are displayed

3

Setting symbol : appears when in SET mode

4

PP2 alarm : appears when the post-meal alarm

has been set

5

Mute symbol : appears only when the sound is

set to OFF

6

Control Solution flag : appears when the control

solution test results are saved or displayed

7

KET : appears when the test result is greater than 240 mg/dL

(13.3 mmol/L)

8

Hi : appears when the test result is greater than the selected

hyperglycemia level

9

Smile symbol : appears when the test result is within the selected

normal blood glucose range

10

Lo: appears when the test result is lower than the selected

hypoglycemia level

11

alarm: appears when the time alarm has been set

12

mmol/L, mg/dL : unit for measuring blood glucose

13

Pre-meal test flag : used for tests done before eating

14

Post-meal test flag : used for tests done after eating

15

Fasting test flag : used for tests done after fasting for at least 8 hours

16

Battery symbol : indicates meter battery is running low and needs

to be replaced

17

Blood insertion symbol : indicates meter is ready for the

application of a drop of blood or control solution

18

Month/Day/Hour/Minute

09 Setting Up Your System

10 Setting the Strip Expiration Date Indicator

Control Solution Testing

Comparing the Control Solution Test Results

Step 1 Entering the SET Mode

Press and hold the

button for 3

seconds to enter the SET mode.

After all the segments flash across

the screen, ‘SET’ will be displayed

on the screen.

Press the

button again to go to

the next step.

Step 2 Setting the Year

Press and release

or to adjust until the correct year

appears. Press and hold

button to scroll through

the numbers quickly. After setting the year, press the

button to confirm your selection and go to the next

step.

Step 10 Setting the Hypoglycemia (Lo) Indicator

This setting allows you to select the desired level for

the hypoglycemia indicator (possible low blood

sugar). You will be alerted any time your test result is

lower than the selected level. Press the

or button

until the desired hypoglycemia level between 20 and

90 mg/dL (1.1 and 5.0 mmol/L) appears. Then, press

the

button to confirm the level and to go to the

next step.

Step 11 Setting the Hyperglycemia (Hi) Indicator

This setting allows you to select the desired level for

the hyperglycemia indicator (possible high blood

sugar). You will be alerted any time your test result is

higher than the selected level. Press the

or button

until the desired hyperglycemia level between 120

and 349 mg/dL (6.7 and 19.4 mmol/L) appears. Press

and hold the

button to confirm the hyperglycemia

level and turn the meter off.

Step 1

Insert a test strip into the meter’s test strip port,

with the contact bars facing upwards.

Gently push the test strip into the port until the

meter beeps. Be careful not to bend the strip

while pushing it in.

The

will be displayed on the screen.

The test result of each control solution should be within the range

printed on the label of the test strip vial. Repeat the control solution

test if the test result falls outside of this range. Out of range results

may occur in following situations:

Step 5

Compare the result displayed on

the meter to the range printed on

the test strip vial. The result should

fall within the range.

Step 2

You can flag the control solution test result by

pressing the

button for 3 seconds. To undo the

control solution flag, press the

button for 3

seconds again.

Step 4

The display segments will rotate clockwise and a test result will

appear after the meter counts down from 5 to 1.

When flagged, the result is stored in the meter's memory but it is

not included in the averages.

Step 4 Setting the Date

Press

or until the screen displays the correct date.

Press the

button to confirm the date and go to the

next step.

Step 5 Setting the Time Format

The meter can be set in the AM/PM 12-hour or the

24-hour clock format. Press

or to select a format.

The AM/PM is not displayed in the 24-hour format.

After selecting the format, press the

button to go to

the next step.

Step 6 Setting the Hour

Press

or until the correct hour appears. After the

hour is set, press the

button to go to the next step.

Step 2 Setting the Year

A number indicating the year will blink in the left

corner of the screen. Press the

or button until the

correct year appears.

Press the

button to confirm the year and set the

month.

Step 3 Setting the Month

A number indicating the month will blink at the

bottom of the screen. Press the

or button until the

correct month appears. After setting, press and hold

the

button for 3 seconds to turn off the meter.

Step 9 Turning on the Strip Expiration Date Indicator

This setting allows you to turn the strip expiration date indicator on or

off. This setting turns the function on or off only. See page 14 to set the

strip expiration date.

When 'EP' appears on the screen, press the

or button. The screen

will display 'On' or 'OFF'. Press the

button to confirm the setting.

If you do not want to set the indicator, press the

button while the

screen displays 'OFF'.

Step 7 Setting the Minute

Press

or until the correct minute appears. After

setting the minute, press the

button to go to the

next step.

Step 3 Setting the Month

A number indicating the month will blink on the left

corner of the screen. Press

or until the correct

month appears. Press the

button to confirm your

selection and go to the next step.

The meter will beep in the following instances if set to On:

• When you push the

or

to turn on the meter,

• When the test strip is inserted in the meter,

• When the blood sample is absorbed into the test

strip and the test starts,

• When the test result is displayed,

• When you press the

button to set the post-meal

(PP2) alarm,

• When it is time for a preset blood glucose test.

If the sound is set to OFF, none of the sound functions

will work.

After setting the sound, press the

button to go to the

next step.

Caution: The range printed on the test strip vial is for the

CareSens Glucose Control Solution only. It has nothing to do

with your glucose level.

PGUAA-0000047 REV0 12/2018

Test Strip Ejector

Slide down to

discard the used

strips

1

17

16

7

2 3 4 5

6

8

9

10

11

13 14 15

12

18

Control Solution Range

Control A: 101–151 mg/dL (5.6–8.4 mmol/L)

Control B: 184–276 mg/dL (10.2–15.3 mmol/L)

You may check your meter and test strips using the

CareSens Control Solutions(control A and/or B).

The CareSens Control Solution contains a known amount

of glucose and is used to check that the meter and the test

strips are working properly.

The test strip vials have CareSens Control Solution ranges

printed on their labels. Compare the result displayed on the

meter to the CareSens Control Solution range printed on

the test strip vial.

Before using a new meter or a new vial of test strips, you

may conduct a control solution test following the

procedure on pages 16-17.

11 Checking the System

Caution:

Ask your healthcare professional to help you decide what your

hypoglycemia level is before setting your level.

Caution: Ask your healthcare professional to help you decide

what your hyperglycemia level is before setting your level.

Note: If the test result is lower than the pre-set

hypoglycemia level, the meter will display the

following.

Note: If the test result is greater

than the pre-set hyperglycemia

level, the meter will display 'Hi'.

If the test result is greater than

240 mg/dL (13.3 mmol/L), 'KET'

will blink three times on the

screen.

Note: The strip expiration date is printed on the test strip vial.

Notes:

• Use only the CareSens Control Solutions.

• Check the expiration date printed on the bottle. When you first open a

control solution bottle, record the discard date (date opened plus

three (3) months) in the space provided on the label.

• Make sure your meter, test strips, and control solution are at room

temperature before testing. Control solution tests must be done at

room temperature (20-25˚C, 68-77˚F).

• Before using the control solution, shake the bottle, discard the first

drop and wipe the tip clean.

• Close the control solution bottle tightly and store at a temperature

between 8-30˚C(46-86˚F).

You may do a control solution test:

• When you want to practice the test procedure using the control

solution instead of blood,

• When using the meter for the first time,

• Whenever you open a new vial of test strips,

• If the meter or test strips do not function properly,

• If your symptoms are inconsistent with the blood glucose test results

and you feel that the meter or test strips are not working properly,

• If you drop or damage the meter.

Situations

• When the control solution bottle was

not shaken well,

• When the meter, test strip, or the control

solution were exposed to high or low

temperatures,

• When the first drop of the control

solution was not discarded or the tip of

the bottle was not wiped clean,

Do This

Repeat the control

solution test by

referring to the

notes on page 15.

• When the meter is not functioning

properly.

• When the control solution is past the

expiration date printed on the bottle,

• When the control solution is past its

discard date (the date the bottle was

opened plus three (3) months),

•

When the control solution is contaminated.

Discard the used

control solution

and repeat the test

using a new bottle

of control solution.

If results continue to fall outside the range printed on the test strip

vial, the CareSens N test strip and CareSen N Eco meter may not be

working properly. Do not use your system and contact your

authorised i-SENS sales representative.

You will need a lancing device in order to collect a blood sample.

You may use the lancing device included in the CareSens N Eco

Blood Glucose Monitoring System or any other medically approved

lancing device.

12 Using the Lancing Device

• The lancing device is for use by a single user only and should not

be shared with anyone.

• Use a soft cloth or tissue to wipe the lancing device. If necessary,

a small amount of alcohol on a soft cloth or tissue may be

used.

Adjustable Tip

Lancet Holder

Sliding Barrel

Release Button

Load Confirmation

Window

Ejection System

Lancet

Note: It is recommended to check if the display screen on the meter

matches the illustration above every time the meter turns on. Do

not use the meter if the display screen does not exactly match the

illustration as the meter may show incorrect results.

Note: If the pre-set expiration

date expires, the meter will display

EP when the test strip is inserted.

EP shows alternately also when

the test result is displayed right

after the test.

If the expiration date is set to

October of 2020, the meter will

display EP at the beginning of

November, 2020.

74

2

3

8

9

14

15

13

5

6

11

12

10

17

18

16

Meer over deze handleiding

We begrijpen dat het prettig is om een papieren handleiding te hebben voor je CareSens N Eco Bloedglucosemeter. Je kunt de handleiding bij ons altijd downloaden en daarna zelf printen. Indien je graag een originele handleiding wilt hebben, raden we je aan contact op te nemen met CareSens. Zij kunnen wellicht nog voorzien in een originele handleiding. Zoek je de handleiding van CareSens N Eco Bloedglucosemeter in een andere taal? Kies op de homepage je taal naar keuze en zoek daarna op het modelnummer om te zien of we deze beschikbaar hebben.

Specificaties

Alle handleidingen voor CareSens Bloedglucosemeters
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