Diatesse Xper td-4289b User manual

BLOOD GLUCOSE & KETONES MONITORING SYSTEM

USER MANUAL TD- 4289B

Version 1.0 2018/10

DT091018-01F

Blood glucose

Ketones

Certainty in blood glucose monitoring, we care!

Diatesse XPER Bluetooth® (TD-4289B)

Thank you for purchasing the Diatesse XPER

blood glucose & ketones monitoring system,

including software for measuring your

ketone levels.This manual contains

important information on the correct use of

the meter.

Please read all the information carefully

before using the device.

Regularly checking your blood sugar and

ketone levels can help both you and your

doctor to improve the control of your

diabetes. Thanks to the small size and easy-

to-use functions of the Diatesse XPER blood

glucose & ketones monitoring system, you

can use it to easily measure your own levels,

wherever and whenever you want.

Should you have any further queries

after reading this manual, please contact

customer support or your distributor.

Use

This system is intended for exterior use

(in vitro diagnostic use) in a non-clinical

environment by persons with diabetes and

in a clinical environment by healthcare

processionals as an aid for assessing the

effectivity of a person's diabetes treatment.

It is intended to quantitatively measure

blood sugar (glucose) and β-ketones in fresh

capillary whole blood drawn from a nger

and venous whole blood.

This meter is not designed to diagnose and

screen for diabetes mellitus. Healthcare

professionals can use the meter to test both

capillary and venous whole blood samples.

Only capillary whole blood samples can be

tested at home.

IMPORTANT SAFETY INSTRUCTIONS

READ BEFORE USING TABLE OF CONTENTS

KEEP THESE INSTRUCTIONS

IN A SAFE PLACE

• ONLY use the meter for the purposes set

out in this manual.

• Do not use ANY accessories not specied

by the manufacturer.

• Do NOT use the meter if it is

malfunctioning or damaged.

• This meter is not designed to cure given

symptoms or diseases.The measured

data serve solely as reference values.

Always consult your diabetes physician

and/or GP for the proper interpretation of

the results you have measured.

• Read all the instructions carefully and

practice the procedure a number of times

before actually testing your blood sugar

and/or ketone levels. Perform all quality

checks in accordance with the instructions.

• Keep the meter and all its parts out of

reach of young children. Small parts,such

as the battery cover, the batteries, test

strips, lancets and caps are a potential

choking hazard.

• Use the meter in a dry environment,

especially if synthetic materials are

present (such as synthetic clothing or

carpeting), which can cause a static charge

that could mean incorrect results.

BEFORE YOU START ................................... 7

Important information................................ 7

Meter overview ........................................... 8

Display......................................................... 9

Test strip ...................................................... 9

SETTING UP THE METER..........................10

SETUP MODE............................................11

For blood sugar testing............................. 11

For β-ketone testing.................................. 11

QUALITY CONTROL TEST..........................11

When should you test the device using

control solution? ....................................... 11

Performing a test with the control solution

.. 11

TESTING USING BLOOD SAMPLES .........12

Preparing the lancing device for a blood test

.. 12

Preparing the puncture point................... 12

Performing a blood sugar test .................. 13

METER MEMORY .....................................14

Viewing the test results............................. 14

Viewing the average of blood sugar results

over a number of days .............................. 15

DOWNLOADING YOUR RESULTS

TO A COMPUTER...................................... 15

CONNECTING THE METER TO

A SMARTPHONE ......................................16

Maintenance............................................. 17

Battery....................................................... 17

Replacing the batteries............................. 17

Caring for your meter................................ 18

Caring for your test strips.......................... 19

Important information on the

control solution......................................... 19

READING THE RESULTS ..........................20

For blood sugar tests................................. 20

For β-ketone tests...................................... 20

• Do NOT use the meter near sources of

strong electromagnetic currents, as the

accuracy of the measurement could be

affected.

• Proper maintenance is essential to

the operating life of your meter. If you

are worried about the accuracy of your

measurements, contact customer support

or your distributor for support.

REFERENCE VALUES ................................21

For blood sugar tests................................. 21

For β-ketone tests...................................... 21

TROUBLESHOOTING SYSTEM ISSUES....22

Error messages.......................................... 22

Troubleshooting........................................ 23

INFORMATION ON SYMBOLS.................24

SPECIFICATIONS......................................25

4 5

BEFORE YOU START

Important information

• Extreme dehydration and excessive moisture-loss can lead to results being measured that

are below the actual values. If you suspect you are suffering from extreme hydration, contact

your healthcare professional immediately.

• If your blood sugar or β-ketone levels are lower or higher than normal and you are not

displaying any symptoms of being ill, then repeat the test.If you are displaying symptoms

or if you continue to receive results that are lower or higher than normal, then contact your

healthcare professional and follow their advice.

• Only use fresh whole blood samples for testing your blood sugar and β-ketone levels.

Using any other substances will produce incorrect results.

• If you are displaying symptoms that do not match the test results and if you have followed

all the instructions in this manual, then please contact your healthcare professional.

• We do not recommend that this meter be used for persons with very low blood pressure

or those in a state of shock. Always consult your healthcare professional.

6 7

* control solution is not included in the starter pack.

*

Meter overview Display

Test strip slot and strip indicator light

Insert your test strip, the section containing the contact points, into this slot

(so that it is rmly in place) in order to turn the meter on for your test.

Bluetooth® indicator light

(Bluetooth® can be optionally activated).

Ejecting the test strip

Eject the test strip by pushing this button upwards.

Mains button (M)

Open the memory of the meter and turn off the reminder.

Display

Data port

Download the test results to your computer using a USB cable.

SET button (S)

Input the selected meter settings and conrm them.

The SET button is located in the battery compartment.

Battery compartment

Test result

Measuring mode

Gen – at any time

AC – before meals

PC – after meals

Automatic quality

control mode

QC = Quality control test using

the control solution

Average over a number of days

Memory symbol

Date/Time

Error warning

Alarm symbol

Measurement unit

Ketone symbol

Absorbent opening

Test strip grip

PLEASE NOTE: The front of the test strip must be facing

upwards when you insert the test strip.

The test results could be incorrect and/or inaccurate if that part of the test strip containing the

contact points is not fully and correctly inserted into the test slot.

Control window

Contact points

Low battery warning

Test strip symbol

Blood drop symbol

Glucose (blood sugar) symbol

Code

1

2

3

4

5

6

7

8

1 2

11

12

13

14

15

3 4

3

4

5

6

7

8

9

10

NOTE: Only Diatesse XPER test strips may be used with the Diatesse XPER meter.

Using other test strips with this device could produce inaccurate results.

8 9

1

2

SETTING UP THE METER

Before using your meter for the rst time or

whenever replacing its batteries, check and

adjust the following settings:

Open the setup mode (a)

The meter is switched off (a test strip is not

inserted).Press the button marked Sbeside

the batteries.

1. Setting the date

The sequence for setting the date is

YEAR ➞MONTH ➞DAY. When YEAR/

MOTH/DAY are ashing consecutively,

press the button marked Mto select the

correct setting. Next, press S.

2. Setting the date format

Press the main button Mon the front of

the meter to select the required date

format (12 or 24 hour).Then press S.

3. Setting the time

When HOUR/MINUTE are ashing

consecutively, press the button marked M

until the correct time is displayed.Then

press S.

4. Turning sound effects on/off

For sound effects press the button marked

Mon the display to switch between "On"

and "Off" Then press S.

5. To set a reminder

Your meter has four reminder settings.

The meter displays "ON" or "OFF" and .

If you do not want to set a reminder

notication, then press Sto skip this step.

Otherwise press the button marked Mto

select "ON" and then press S.

Measuring methods:

for blood sugar testing

You can measure your blood sugar levels

in three different ways: General,AC (before

meals) and PC (after meals).You can switch

between the different modes as follows:

1. Start with the meter switched off.

Insert a blood sugar test strip into the slot

to turn the meter on.The display shows ,

" " ashing " " and "GLU".

2. Press M to switch between General,

AC and PC.

For β-ketone testing

3. There is only one option for measuring

your β-ketone levels: Gen.Start with the

meter switched off. Insert a β-ketone test

strip into the slot to turn the meter on.The

display shows " ", a ashing" ", "Gen"

and "KET".

When should you test the device

using control solution?

You do not need to perform a test with

the control solution when rst using the

Diatesse XPER.

• When you think that either the meter or

the test strips are defective.

• When your test results do not match the

way you are feeling, or when you believe

the results are not accurate.

• When performing a test.

• If you have dropped the meter or have

reason to believe it is damaged.

When the hour/minute are ashing, press

Mto select the desired hour/minutes.

Then press Sand continue to the next

alarm setup.

PLEASE NOTE: When the reminder

notication goes off, press Mto switch it

off.The reminder will sound for 2 minutes

and then switch off automatically.

6. Turning on Bluetooth

(Bluetooth® is optional)

When "bt" is visible on the display press

Mand select "ON" or "OFF".Then press S.

PLEASE NOTE: This means that data is

transferred using Bluetooth®.

If you select "ON", then the results are

transmitted immediately after the test.

NOTE:

• ALL of these parameters can be changed

in the setup mode.

• If the meter is not used for a period of

3 minutes while in setup mode,

it switches off automatically.

Test strips (c), control solution (d), lancing

device (e) or sterile lancets (f) might not be

included in the kit (please check the list of

contents on your product's packaging).These

articles can be ordered separately. Ensure that

you have a sufcient supply of all the articles

you require for performing tests.

Performing a test with

the control solution.

In order to perform a test with the control

solution, you require (b), (c) and (d).

1. Insert the test strip into the slot to turn

the meter on.

Wait until the meter displays" " and

a ashing " ".

2. Apply the control solution (g)

Shake the bottle of control solution well

before use. Squeeze out the rst droplet

and wipe it off. Squeeze another droplet

onto the point of the bottle's cap. Hold the

meter so that the absorbent opening of

the test strip comes into contact with

the drop and absorbs the control solution.

Once the control window contains

sufcient control solution, the meter starts

an automatic countdown.

QUALITY CONTROL TEST

10 11

3. Read and compare the results

Once the countdown to 0 is completed,

the result of the test using control solution

is shown on the display. Compare the

result with the range stated on the test

strip packaging.The result must be within

this range of values. If that is not the case,

re-read the instructions and repeat the test

with control solution.

We recommend that you perform the

following steps before drawing a drop

of blood:

• Wash and dry your hands before starting.

• Select a puncture point.

• Rub the puncture point for around 20

seconds before inserting the lancet.

• Clean the puncture point with a cotton

swab moistened with a 70% alcohol

solution and allow your skin to air-dry.

• Testing using a ngertip (h)

Firmly press the lancing device against

the underneath part of your ngertip.

Press the release button to puncture your

nger and the device will click when the

procedure is complete.

NOTE:

• Every time you test, use a different

puncture point. Repeatedly puncturing

the same point can cause a sore to

form and callousing.

• We recommend that you wipe away

the rst blood drop, as it could contain

tissue uid that will affect the test results.

Performing a blood sugar test

In order to test your blood sugar levels, you

require the following: (b), (c), (e)

and (f)

1. Insert a test strip into the meter's

test slot to activate it

Wait until ""and "" are displayed

on the meter.

2. Select the required meter mode

by pressing M.

3. Taking a blood sample (i)

Use the pre-set lancing device to puncture

your skin at the selected point. We

recommend that you wipe away the rst

blood drop with a clean tissue/cotton

swab.The size of the blood drop must

be at least as large as (actual size), which

equals around 0.5 microliter (µI) volume

for a blood sugar test and 0.8 microliter

(µl) volume for a β-ketone test. Carefully

squeeze the area around the puncture

point to draw a further blood drop.Take

care NOT to smear out the blood sample.

4. Apply the sample to the test strip (j)

Carefully allow the test strip to come into

contact with the blood drop at an angle.

The control window of the test strip will

be sufciently full once enough blood is

applied. Do NOT take your nger away

before the device beeps.

WARNING:

In order to limit the chance of an infection:

• Never share a lancet or lancing device

with others.

• Always use a new sterile lancet.

Lancets are single-use only.

• Ensure that you do not get any hand

lotion, oil or residual dirt in or on the

lancets or lancing device.

Preparing the lancing device for

a blood test

Follow the instructions on the package

insert of the lancing device for drawing a

blood sample.

Preparing the puncture point

Stimulating blood perfusion by rubbing the

puncture point before taking a sample has

a major impact upon the test results. Blood

extracted from a point that you did not rub

beforehand will return a signicantly different

value than a blood sample extracted from a

point you did rub in advance.

NOTE:

• For blood sugar and ketone tests

the meter will automatically recognise

a test using control solution as

a QC test.

• In order to prevent the control solution

becoming contaminated, never apply

it directly to the strip.

NOTE:

• The range for the control solution that

is stated on the test strip tube is only

valid when control solution is used.

It is not a recommended range for your

blood sugar levels.

• See the section under MAINTENANCE

for important information concerning

the control solution.

TESTING USING

BLOOD SAMPLES

12 13

NOTE:

• Do not press the puncture point

against the test strip and try not to

smear the blood.

• If you do not apply a blood sample to

the test strip within 3 minutes the

device switches off automatically.

Should this happen, remove the test

strip and re-insert it in order to start a

new test.

• The control window must be lled with

blood before the meter automatically

starts to countdown. DO NOT try to

add more blood to the test strip once

the blood drop has lled the control

window. Should that happen,dispose

of the test strip, insert a new test

strip and repeat the test.

• If you struggle to ll the control

window, please contact your healthcare

professional or customer support for

assistance.

5. Reading the test results

Your test results will appear once the meter

reaches 0 in its countdown.The result is

automatically stored in the meter.

6. Eject the used test strip (k)

Eject the test strip by pressing the ejector

button on the side of the device. Use a

specially designated waste container for

disposing of the used test strips. The meter

switches off automatically.

The meter stores the 1,000 most recent test

results together with their dates and times.

In order to access these records, start with

the device turned off.

Viewing the test results

1. Press and release the button marked M.

" " will appear on the display.

Press M again, the rst measurement

displayed is the most recent one, together

with the date, time and meter mode.

2. Press Mto call up the results stored in

the meter.If you keep the Mbutton

depressed, the meter will switch off.

Transmitting data using a cable or

Bluetooth®

You can attach a micro USB cable (Windows

7 and 8) to the meter or activate Bluetooth®

(Windows 10 and up) to view the test results

on a computer using the Health Care Soft-

ware System. For further information on the

Health Care Software System or to acquire a

USB cable, please contact your local customer

support or distributor for assistance.

1. Installing the software

The software can be downloaded from the

website: www.diatesse.nl

2. Connecting the meter to a computer

using a USB cable or (optionally)

wirelessly using Bluetooth®

(Windows 10 and up)

USB cable: Insert the cable in an unused

USB port on your computer.Insert the

other end of the cable in the meter's

data port while the meter is switched

off. "USB" will appear on the meter's

display, indicating that the meter is now in

communication mode. Under the software

options, select the model:TD-4289 (B).

Bluetooth®: Turn the meter on and

immediately switch it off again to activate

Bluetooth® (the indicator light will

ash blue). Next, follow the instructions

contained in the software on your

computer to connect the meter to the

computer using Bluetooth®.

Under the software options, select the

model: TD-4289(B).

Viewing the average of

blood sugar results over

a number of days

1. Press the button marked M(and keep it

depressed for a few seconds) then release

it to open the memory mode and to view

the average results with" "and "DAY

AVG" on the display.

Release the Mbutton and the average

results over 7 days will appear on the

display with the meter in General mode.

2. Press Mto view the average results over

14, 21,28, 60 and 90 days. These results

are stored in each meter mode under Gen,

AC and nally PC.

3. To shut down the meter's memory.

Press the Mbutton repeatedly; the meter

switches off after displaying the most

recent test results.

Always follow the instructions on the

lancing device's package insert for

disposing of the used lancet.

WARNING:

Used test strips and lancets could pose

a biological hazard. Dispose of them

properly in accordance with the local

regulations.

METER MEMORY

NOTE:

• If you want to turn the memory off,

keep the Mbutton depressed for

3 seconds or leave the device alone for

3 minutes, after which it automatically

switches off.

• The results of tests using control

solution are NOT included in the

average daily results.

DOWNLOADING

YOUR RESULTS TO

A COMPUTER

14 15

16 17

1. Transmitting data

Follow the instructions contained in

the software on your computer for

transmitting the data.The results are

transmitted together with their dates and

times. When you disconnect the cable the

meter will switch off automatically.

See also: diatesse.nl/support

Creating a data link using Bluetooth®

(Bluetooth® can be optionally switched

on or off)

Using Bluetooth®, you can create a data

link between your meter and a Bluetooth®-

capable smartphone (iOS or Android).

Download the ProCheck app to your

smartphone from the App Store (iOS) or from

Google Play (Android).The ProCheck app

has been created to assist you simply and

intuitively in monitoring your blood sugar

and ketone levels over an extended period.

For further information,please contact your

local customer support or distributor.You

must link your meter and smartphone using

Bluetooth® before you can transmit data.

Linking your meter and smartphone

(using a security code)

1. Turn on Bluetooth® on your smartphone.

2. Follow the instructions in the ProCheck

app on your smartphone for connecting

to your meter.

3. Use "Search" to nd your meter, which

is called DIATESSE XPER xxxx (xxxx = the

unique four-digit/letter combination of

the Bluetooth® MAC associated with

your meter).

4. Add your meter, press and press "Yes"

to save the settings.

5. Then input your unique code in order to

complete the connection.Your code is the

last 7 digits of the meter's serial number,

excluding the nal digit.

Input these 6 digits then press "Connect".

6. Once the devices are linked,the data in

your meter will be sent via Bluetooth®

to the ProCheck app.

Bluetooth® indicator on your meter:

Battery

Your meter comes with two

1.5 V AAA alkaline batteries.

Low battery warning

The meter will warn you in one of the

following ways when the power is low.

1. The symbol " " appears together

with notications on the display: the meter

is working and the results are still accurate,

but the batteries must be replaced.

2. The symbol " " appears together

with E-b, Error and LOW: There is not

enough power to perform a test.The

batteries must be replaced immediately.

Replacing the batteries

The meter must be switched off when you

replace the batteries.

1. Slide the battery cover to the left to open it.

2. Remove the 2 empty batteries and insert

2 new 1.5 VAAA alkaline batteries.

3. Close the battery cover.

If the batteries are correctly inserted,

the device will beep.

WARNING:

• If your meter and computer are

connected by a USB cable then

your data will be transmitted using

the cable.You can use Bluetooth®

to link the devices without using a

cable, provided that your computer

supports Bluetooth® and Windows

10 or higher is loaded.

• The meter cannot perform a test

while it is transmitting data.

• Ensure that your smartphone or

computer supports Bluetooth® Smart

Technology and that Bluetooth® is

activated before trying to transmit

data. Also make sure that your meter

and the computer or smartphone are

sufciently close together so that they

can link. For the required parameters

for your (mobile) operating system,

check the App Store or Google Play

before downloading and installing

the app.

• Bluetooth® functionality is

implemented in various ways by

different manufacturers.This could

mean that there are compatibility

issues between your meter and the

smartphone.

See, for further information:

diatesse.nl/support

For further information see www.diatesse.nl

WARNING:

You cannot perform tests when the meter

is connected to a computer.

CONNECTING THE METER

TO A SMARTPHONE

MAINTENANCE

BLUETOOTH®

INDICATOR

STATUS

Solid blue light

Flashing

blue light

Bluetooth® is on

and searching for a

connection

Bluetooth® linked

18 19

NOTES

• Replacing the battery will not affect

the test results stored in the device's

memory.

• As with all small parts, the batteries

must be kept out of reach of children.

Alert the emergency services

immediately if a battery is swallowed.

• Batteries can leak chemicals if they are

not used for extended periods.

Remove the batteries if you will not be

using the device of a lengthy period

(i.e. 3 months or more).

• Dispose of used batteries properly,

in accordance with the local

regulations.

Caring for your meter

Cleaning

1. To clean the exterior of the meter, wipe

it off with a cloth that has been lightly

dampened with tap water or a mild

detergent. DO NOT rinse off with water.

2. DO NOT use organic solvents to clean

the meter.

Storing the meter

• Storage conditions: -20 °C to 60 °C

(-4 °F to 140 °F), between 10% and 93%

relative humidity (non-condensing).

• Always store or transport the meter in

its original case.

• Do not drop the meter or subject it

to strong shocks.

• Keep it out of direct sunlight and

high humidity levels.

Disposing of your meter

A used meter must be treated as

contaminated waste that carries a risk of

infection while performing measurements.

The batteries of the meter must be removed

and the meter must be disposed of in

accordance with the local regulations.

The meter does not fall under European

Directive 2012/19EU on waste electrical and

electronic equipment (WEEE).

Caring for your test strips

• Storage conditions: 2 °C to 30 °C and

between 10% and 90% relative humidity

(non-condensing) for blood sugar test

strips and 2 °C to 30 °C and between

10% and 85% relative humidity (non-

condensing) for β-ketone test strips.

DO NOT freeze.

• Keep the tests strips in their original

tube. Do not place in a different tube. For

foil-wrapped test strips: do not unwrap

until required.

• Store the packaging containing the test

strips in a cool and dry place. Keep away

from direct sunlight and heat.

• Reseal the tube immediately after

removing a blood sugar test strip.

• Ensure that your hands are clean and dry

before touching a test strip. Use the test

strip immediately after removing it from

the tube/foil packaging.

• Do not use a test strip after its expiry date,

as the result may be inaccurate.

• Do not bend, cut or alter the blood sugar

test strip.

• Keep tubes and foil packaging containing

test strips out of reach of children.

Immediately alert the emergency services

if one is swallowed.

For further information,see the package

insert for the test strips.

Important information on

the control solution

• Only use TaiDoc (W2) control solution

for your meter.

• Do not use the control solution after its

expiry date or later than 3 months after

opening it. Write the date you opened it

on the control solution bottle and dispose

of any remaining solution after 3 months.

• The recommended room temperature

when performing a test with the control

solution is between 20 °C and 25 °C

(68 °F and 77 °F).

• Ensure that the control solution,

your meter and the test strips are at

the recommended temperature before

conducting a test.

• Shake the control solution well before use

Discard the rst droplet of control solution

and wipe the dispensing tup clean in order

to guarantee a pure sample and accurate

result.

• Keep the control solution properly sealed

at a temperature between 2 °C and 30 °C

(35.6 °F and 86 °F).

DO NOT freeze.

20 21

For blood sugar tests

READING THE RESULTS

< 0.1 mmol/L

0.1 to 8.0 mmol/L

> 8.0 mmol/L

> 44.4 mmol/L (800 mg/dL)

>13.3 mmol/L (240 mg/dL)

< 0,56 mmol/L (10 mg/dL)

Voor β-ketonentesten

Blood Glucose Test

The Blood glucose monitoring plays an important role in diabetes control.A long-term study

showed that maintaining blood glucose levels close to normal can reduce the risk of diabetes

complications by up to 60%.*1 The results provided by this system can help you and your

healthcare professional monitor and adjust your treatment plan to gain better control of your

diabetes.

For blood sugar tests

Your blood sugar measurements are plasma equivalent values and are shown in millimoles of

glucose per litre of blood (mmol/L).

Source: American Diabetes Association. Standards of Medical Care in Diabetes- 2018 Jan;

41(Supplement 1): S1-S2.

For β-ketone tests

Your β-ketone measurements are plasma equivalent values and are shown in millimoles of

ketones per litre of blood (mmol/L).

The β-ketone test measures beta-hydroxybutyrate (βOHB), the most important of the three

β-ketones in your blood.Under normal circumstances, the concentration of βOHB in your blood

should be less than 0.6 mmol/L.1

The βOHB concentration can increase if you are fasting and/or dieting, exercising intensively

or suffer from diabetes and fall ill. If your β-ketone test results in a "Lo", repeat the test using

a new test strip. If you receive the same result or if the result does not match how you are

feeling, then contact your healthcare professional.Always follow the recommendations of

your healthcare professional before making any changes to your diabetes treatment. If the

levels for your β-ketone test are between 0.6 and 1.5 mmol/L, this could be due to an issue

requiring professional medical attention.Carefully follow your healthcare professional's advice.

If your β-ketone test levels are greater than 1.5 mmol/L,immediately contact your healthcare

professional, as this means you could develop diabetic ketoacidosis (DKA).

1: Wiggam Ml, O'Kane MJ, Harper R,Atkinson AB, Hadden Dr, Trimble ER,Bell PM.

Treatment of diabetic ketoacidosis using normalization of blood 3-hydroxybutyrate

concentration as the end point of emergency management.

Diabetes Care 1997; 20:1347-52.

Consult your doctor in order to determine the target range that suits you best.

REFERENCE VALUES

TIME OF DAY NORMAL PLASMA GLUCOSE RANGE

FOR NONDIABETICS

Before meals on an empty stomach

2 hours after meals

< 5.6 m mol/L (100 mg/dL)

< 7.8 m mol/L (140 mg/dL)

MESSAGE WHAT IT MEANS

22 23

If you follow the recommended actions but the problem continues, please contact customer

support or your distributor.

Error messages

Troubleshooting

1. If nothing is displayed on the meter after a test strip is inserted:

2. If the test does not commence after the sample is applied:

3. If the test using the control solution is outside of the specied range:

TROUBLESHOOTING SYSTEM ISSUES

E-b

E-U

E-2

E-t

E-0,

E-A,

E-E,

E-C

E-F

E-8

Displayed when the batteries

are (nearly) drained.

Replace the batteries

immediately.

Displayed when a used test

strip is inserted or incorrectly

used.*

Repeat the test with a new

test strip.

Displayed when the code

chip (ketones) has expired.

Check if the date is

correctly set on the meter

and check the expiry date

on the packaging. If the

issue continues, use a new

code chip.

Displayed when the ambient

temperature is greater than

the operational range of the

device.

The operational range of the

device is between 8 °C and

45 °C (46.4 °F to 113 °F).

Repeat the test when

the meter and the test

strip are within the above

temperature range.

Meter issue. Repeat the test with a new

test strip.

Displayed when the test

strip is removed during

the countdown or where

insufcient blood is present.

Read the instructions

and repeat the test with a

new test strip. If the issue

continues, contact customer

support for assistance.

Displayed when the code

chip is not inserted prior

to testing or if the meter

does not support specic

parameters.

Check that the code chip

has been correctly inserted.

Check that the code

chip used supports the

parameters of your meter.

MESSAGE WHAT IT MEANS WHAT TO DO

Batteries are dead.

Insufcient blood sample.

Test performed incorrectly.

The control solution bottle was not

shaken properly.

The control solution has expired or is

contaminated.

The control solution is too hot or cold.

Defective test strip.

Meter issue.

The meter and test strip are defective.

Sample has been applied after the device

automatically switched off (3 minutes

after the user performed the last action).

Defective test strip.

Defective meter.

Meter or test strips are defective.

The test strip has been inserted upside

down or not full inserted.

Replace the batteries.

Repeat the test using a new test strip.

Use more blood for the sample.

Carefully read the instructions and repeat

the test.

Shake the control solution well and repeat

the test.

Check the expiry date and the date your rst

opened the control solution.

Control solution, meter and test strips must

be at room temperature, 20 °C to 25 °C

(68 °F to 77 °F) when testing.

Repeat the test using a new test strip.

Contact customer support.

Repeat the test using a new test strip.Apply

the blood sample when the" "appears on

the display.

Repeat the test using a new test strip.

Contact customer support.

Insert the part of the strip containing the

contact points in the meter.The part containing

the control window must be pointing upwards.

POSSIBLE CAUSE

SOLUTION

*see the user instructions (video) at diatesse.nl/support or read the procedure.

24 25

In vitro diagnostic

medical device

See the user manual

Use before

Batch code

Serial number

Catalogue number

Temperature limits

Please note, consult the

accompanying documentation

Humidity limit

CE mark

Manufacturer

Authorised representative in

the European Community

This device may not be

disposed of with domestic

waste but must be

surrendered to a recycling

centre for electrical and

electronic devices. Batteries

must be disposed of at a

collection point (such as at a

supermarket).

SYMBOL SYMBOLREFERS TO VERWST NAAR

INFORMATION ON SYMBOLS SPECIFICATIONS

Model no.: TD-4289B

Dimensions and weight: 90.3 (L) x 52.3 (W) x 18 (H) mm, 58 grams.

Power source: Two 1.5 V AAA alkaline batteries

Display: LCD backlight

Memory: 1,000 test results with associated parameters, date and time.

Export options: USB and Bluetooth®

Automatic blood sample detection

Automatic electrode placement detection

Automatic response time countdown

Automatic switch-off after 3 minutes of inactivity

Temperature warning

Operating conditions: Blood sugar: 8 °C to 45 °C (46.4 °F to 113 °F) and 10% to 90% relative

humidity (non-condensing) β-ketones: 10 °C to 40 °C (50 °F to 104 °F) and 10% to 85% relative

humidity (non-condensing)

Storage/transport conditions for the meter: -20 °C to 60 °C (-4 °F to 140 °F), between

10% and 93% relative humidity (non-condensing)

Storage/transport conditions for the test strips:

Blood sugar test strips: 2 °C to 30 °C (35.6 °F to 86 °F), between 10% and

90% relative humidity (non-condensing)

β-ketone test strips: 2 °C to 30 °C (35.6 °F to 86 °F), between 10% and 85% relative

humidity (non-condensing)

Measuring unit:

Blood sugar tests: mmol/L or mg/dL

β-ketone tests: mmol/L or mg/dL

Range:

Blood sugar tests: 0.6 to 44.4 mmol/L (10 to 800 mg/dL)

β-ketone tests: 0.1 to 8.0 mmol/L

Anticipated lifespan: 5 years

Altitude: up to 2000 m, for use indoors

Degree of contamination: contamination rate 2

This device has been tested for compliance with the electrical and safety requirements of

IEC/EN 61010-1, IEC/EN 61010-2- 707,IEC/EN 6 7 326- 7, IEC/EN 6 7 326-2-6, EN 300 328.

RoHS compliance

26 27

NOTES

---------------------------------------------------------------------------------------------------------------------------------------

For self-testing

TD-4289B

TaiDoc Technology Corporation

Bi.7F,No.127,Wugong 2nd Rd.,

Wugu Dist., 24888 NewTaipei City,Taiwan

MedNet EC-REP GmbH

Borkstraße 10, 48163 Münster, Germany

Import Europa: HT Medical BV

Distributor: GD Medical Pharma BV

Hastelweg 224, 5652 CLEindhoven

[email protected]

The Bluetooth® word mark and logos are registered trademarks

owned by Bluetooth SIG, Inc.and any use of such marks by HT Medical BV

is under license.Other trademarks and trade names are those of their

respective owners.

diatesse XPER TD-4289B User manual

Popular Blood Glucose Meter manuals by other brands