FOR-A Diamond Mini Manual de usuario

Blood Glucose Monitoring System

Blutzucker-Überwachungsssystem

Système de contrôle de la glycémie

Sistema per il monitoraggio della glicemia

Σύστημα παρακολούθησης σακχάρου στο αίμα

Sistema de monitorización de glucosa en sangre

Sistema de monitorização de glicose no sangue

MINI

EN-1

Safety Information

Read the following Safety Information thoroughly before using

the device.

• The battery must be charged before using the FORA

Diamond MINI Meter for the rst time.

• Use this device ONLY for the intended use described in this

manual.

• Do NOT use accessories which are not specied by the

manufacturer.

• Do NOT use the device if it is not working properly or

damaged.

• This device does NOT serve as a cure for any symptoms or

diseases. The data measured is for reference only. Always

consult your doctor to have the results interpreted.

• The blood glucose test strip can NOT be used for the

testing of newborns.

• Before using this device to test blood glucose, read all

instructions thoroughly and practice the test. Carry out all

the quality control checks as directed.

• Keep the device and testing supplies away from young

children. Small items such as the battery cover, batteries,

test strips, lancets and vial caps are choking hazards.

• The use of this instrument in a dry environment, especially

if synthetic materials are present (synthetic clothing,

carpets etc.) may cause damaging static discharges that

may cause erroneous results.

• Do NOT use this instrument in close proximity to sources

of strong electromagnetic radiation, as these may interfere

with the correct operation.

• Proper maintenance as well as timely calibration of the

device together with the control solution is essential in

ensuring the longevity of your device. If you are concerned

about the accuracy of the measurement, please contact

the place of purchase or customer service representative

for assistance.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

Important Information

• Severe dehydration and excessive water loss may cause

readings which are lower than actual values. If you believe

you are suering from severe dehydration, consult a

healthcare professional immediately.

• If your blood glucose results are lower or higher than usual,

and you do not have symptoms of illness, rst repeat the

test. If you have symptoms or continue to get results higher

or lower than usual, follow the treatment advice of your

healthcare professional.

• Use only fresh whole blood sample to test your blood

glucose. Using other substances will lead to incorrect

results.

• If you are experiencing symptoms that are inconsistent

with your blood glucose test results and you have followed

all instructions described in this owner’s manual, call your

healthcare professional.

EN-2

Professionals may test with capillary and venous blood

sample. Use only heparin for anticoagulation of whole blood.

Home use is limited to capillary blood from the nger tip.

Test Principle

Your system measures the amount of sugar (glucose)

in whole blood. The glucose testing is based on the

measurement of electrical current generated by the reaction

of glucose with the reagent of the strip. The meter measures

the current, calculates the blood glucose level, and displays

the result. The strength of the current produced by the

reaction depends on the amount of glucose in the blood

sample.

Product Overview

1. SET Button 2. USB Port

3. Display Screen 4. MAIN Button

5. Test Strip Slot

6. Bluetooth Indicator

(for DM30b)

• We do not recommend using this product on severely

hypotensive individuals or patients in shock. Readings

which are lower than actual values may occur for

individuals experiencing a hyperglycaemic-hyperosmolar

state, with or without ketosis. Please consult the healthcare

professional before use.

• The measurement unit used for indicating the

concentration of blood glucose can have mg/dL or mmol/L.

The approximate calculation rule for conversion of mg/dL

in mmol/L is:

mg/dL Divided by 18 = mmol/L

mmol/L Times 18 = mg/dL

For example:

1)120 mg/dL ÷ 18 = 6.6 mmol/L

2)7.2 mmol/L x 18 = 129 mg/dL approximately

Introduction

Intended Use

This system is intended for use outside the body (in vitro

diagnostic use) by people with diabetes at home and by

health- care professionals in clinical settings as an aid to

monitor the eectiveness of diabetes control. It is intended

to be used for the quantitative measurement of glucose

(sugar) in fresh capillary (from the nger, palm, forearm, and

upper arm) and venous blood samples. It should not be used

for the diagnosis of diabetes, or testing on newborns.

EN-3

Screen Display

1.Measurement Unit

2.Blood Drop Symbol

3.Measuring Mode

4.Memory Symbol

5.Test Result

6.Face Low/High Symbol

7.Warning Symbol

8.Low Battery Symbol

9.Date/Time

10. Reminder Alarm

Getting Started

Initial Setup

Please follow the initial setup procedure before using the

device for the rst time or after you have charged the battery.

When the battery power is extremely low and“ & ”

appears on the screen, the meter cannot be turned on.

Step 1: Enter the Setting Mode

Press SET. The display turns on.

Step 2: Conguring the Settings (Date, Time Format,

Time, Universal Tone, Memory Deletion and Reminder

Alarm)

Press MAIN repeatedly to adjust the value or enable/disable

the setting. Then press SET to conrm the setting and switch

to another eld.

Note:

• You may setup Beep On, Universal Tone On and Beep O by

press MAIN to change it.

• When Universal Tone is turned on, the meter guides you

through the blood glucose test using beep tones; it also

outputs the result as a series of beeps.

EN-4

Inserting a Test Strip

Insert the test strip into its slot.

Important!

The front side of test strip should face up when inserting the

test strip. Test results might be wrong if the contact bar is not

fully inserted into the test slot.

Important!

To reduce the chance of infection:

• Never share a lancet or a lancing device.

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

only.

• Avoid getting hand lotion, oils, dirt, or debris in or on the

lancets and the lancing device.

Preparing the Lancing Device

1.Remove the cap.

2.Insert a new lancet rmly into the white lancet holder cup.

3.Remove the protective disk on the lancet.

Hold the lancet rmly in place and twist o the protective

disk.

• When Beep is turned o, the alarm function will remain

eective.

• During memory deletion, select “ ”to keep all saved

results.

• You may set it up to four reminder alarms.

• To turn o an alarm, nd the alarm number by pressing

SET, then press MAIN to toggle On to OFF.

• When the alarm goes o, the device will automatically

turn on. Press MAIN to mute the alarm. If you do not press

MAIN, the device will beep for 2 minutes then switch o.

• If the device is idle for 2 minutes during the setting mode,

it will turn o automatically.

Testing Your Blood Glucose

Test Strip Appearance

Absorbent Hole

Apply a drop of blood

here. The blood will be

automatically absorbed.

Conrmation Window

This is where you conrm

if enough blood has been

applied to the absorbent hole

in the strip.

Test Strip Handle

Hold this part to insert

the test strip into the slot. Contact Bars

Insert this end of the test strip

into the meter. Push it in rmly

until it will go no further.

EN-5

4.Replace the cap until it snaps or clicks into place.

5.Rotate the dial to set the desired lancing depth.

6.Pull the cocking control out until the orange bar appears

on the release button window.

Obtaining the Blood Sample

Please follow the suggestions below before obtaining a drop

of blood:

• Wash and dry your hands before starting.

• Select the puncture site either on your ngertips or other

body parts.

• Rub the puncture site for about 20 seconds before

penetration.

Blood from the ngertip

1.Press the lancing device tip rmly against the lower side of

your ngertip.

2.Press the release button to prick your nger. A click

indicates that the puncture is complete.

Blood from sites other than the ngertip

Alternative site testing (AST) is when individuals check their

blood glucose levels using other areas of the body other

than the ngertips. The FORA test strips allow AST to be

performed on sites other than the ngertips. Please consult

your health care professional before you begin AST.

Alternative site sample results may be dierent from ngertip

sample results when glucose levels are changing rapidly (e.g.,

EN-6

Important!

• Do not use results from alternative site samples to calibrate

continuous glucose monitoring systems (CGMS), or for

insulin dose calculations.

• Choose a dierent spot each time you test. Repeated

punctures at the same spot may cause soreness and

calluses.

• Avoid lancing the areas with obvious veins to avoid

excessive bleeding.

• It is recommended to discard the rst drop of blood as it

might contain tissue uid, which may aect the test result.

Make Blood Glucose Test

1.Insert the test strip into the test slot of the device. Wait for

the device to display the blood drop“ “.

2.Select the appropriate measuring mode by pressing MAIN.

• General Tests - any time of day without regard to time

since the last meal.

• AC ( ) - no food intake for at least 8 hours.

• PC ( ) - 2 hours after a meal.

• QC ( ) - testing with control solution.

3.Obtain a blood sample.

Use the pre-set lancing device to puncture your desired

site. After penetration, discard the rst drop of blood with a

clean tissue or cotton. Gently squeeze the punctured area

to obtain another drop of blood. Be careful NOT to smear

the blood sample. The volume of blood sample must be at

least 0.5 microliter (μL) for blood glucose testing.

after a meal, after taking insulin, or during or after exercise).

We strongly recommend that you perform AST ONLY at the

following times:

• During a pre-meal or fasting state (more than 2 hours since

the last meal).

• Two hours or more after taking insulin.

• Two hours or more after exercise.

Do NOT rely on test results at an alternative sampling site,

but use samples taken from the ngertip, if any of the

following applies:

• You think your blood sugar is low.

• You are not aware of symptoms when you become

hypoglycemic.

• The results do not agree with the way you feel.

• After a meal.

• After exercise.

• During illness.

• During times of stress.

To obtain a blood sample from the alternative sites, please

rub the puncture site for approximately 20 seconds.

1.Replace the lancing device cap with the clear cap.

2.Pull the cocking control out until the orange bar appears

on the release button window.

EN-7

4.Apply the blood sample.

Move your nger to meet the absorbent hole of the test

strip and the drop will be automatically be drawn onto

the test strip. Remove your nger until the conrmation

window is lled. The meter begins to count down. Do not

remove your nger until you hear a beep sound.

5.Read your result.

The results of your blood glucose test will appear after

the meter counts down to 0. The results will be stored

automatically in the meter memory.

(100 mg/dL = 5.5mmol/L)

Announcement of Test Result by Universal

Tone

The blood glucose results will be broken down into individual

digits and each digit represents the corresponding number

of beeps.

The result is announced three times in succession and each

time is preceded by two quick beeps. So you will hear: 2

quick beeps – results – 2 quick beeps – results – 2 quick

beeps – result.

For mg/dL meters, the hundreds are always announced, even

when the result is below 100.

Examples:

80 mg/dL is announced as 1 long beep (0) – 1 single pause –

8 single beeps (8) – 1 single pause – 1 long beep (0)

182 mg/dL is announced as 1 single beep (1) – 1 single pause

– 8 single beeps (8) – 1 single pause – 2 single beeps (2)

For mmol/L meters, the tens are always announced, even

when the result is below 10. The decimal point is represented

by 1 quick beep.

Examples:

6.0 mmol/L is announced as 1 long beep (0) – 1 single pause

– 6 single beeps (6) – 1 single pause – 1 quick beep (.) – 1

single pause – 1 long beep (0)

Note:

Information or warnings in the form of symbols displayed

together with the results are not announced acoustically.

EN-8

1.Insert the test strip into the test slot of the device. Wait for

the device to display the blood drop“ “.

2. Press MAIN to mark this test as a control solution test. With

“QC”displayed, the device will store your test result in the

memory under “QC”. If you press MAIN again, the“QC” will

disappear and this test is no longer a control solution test.

Important!

When doing the control solution test, you have to mark it

so that the test result will NOT mix with the blood glucose

TEST RESULTS stored in the memory. Failure to do so will

mix up the blood glucose test results with the control

solution test results in the memory.

3. Apply the control solution. Shake the control solution vial

thoroughly before use. Squeeze out a drop and wipe it o,

then squeeze another drop and place it on the tip of the

vial cap. Hold the device to move the absorbent hole of the

test strip to touch the drop. Once the conrmation window

is lled completely, the device will begin counting down.

Disposing Used Test Strip and Lancet

The device will automatically turn o after the test strip is

removed. To remove the used lancet, remove the lancet from

the lancing device after you have nished testing. Discard

your used strip and lancet properly in a puncture-resistant

container.

Important!

The used lancet and test strip may be biohazards. Please

consult your health-care provider for proper disposal which

complies with your local regulations.

Control Solution Testing

Our Control Solution contains a known amount of glucose

that reacts with test strips and is used to ensure your device

and test strips are working together correctly.

Test strips, control solutions, or sterile lancets may not

be included in the kit (please check the contents on your

product box). They can be purchased separately.

Do a control solution test when:

9 you suspect the device or test strips are not working

properly.

9 your blood glucose test results are not consistent with

how you feel, or if you think the results are not accurate.

9 you have dropped or think you may have damaged the

device.

To perform the control solution test, do the following:

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