background image

 

5

 

/

 

19

 

 

people

 

with

 

diabetes

 

at

 

home

 

as

 

an

 

aid

 

to

 

monitor

 

the

 

effectiveness

 

of

 

diabetes

 

control.

 

Alternative

 

site

 

testing

 

should

 

be

 

done

 

only

 

during

 

steady

 

 

state

 

times

 

(when

 

glucose

 

is

 

not

 

changing

 

rapidly).

 

 

The

 

 

Bioland

 

 

Test

 

Strips

 

are

 

for

 

use

 

with

 

the

 

Blood

 

Glucose

 

Meter

 

to

 

quantitatively

 

measure

 

glucose

 

in

 

fresh

 

capillary

 

whole

 

blood

 

samples

 

drawn

 

from

 

the

 

fingertips,

 

palm,

 

forearm,

 

upper

 

arm,

 

calf

 

and

 

thigh.

 

 

The

 

Bioland

 

control

 

solutions

 

is

 

intended

 

for

 

use

 

with

 

the

 

System,

 

to

 

check

 

that

 

the

 

glucose

 

meter

 

and

 

test

 

strips

 

are

 

working

 

properly

 

and

 

that

 

you

 

are

 

doing

 

the

 

test

 

correctly.

 

These

 

solutions

 

contain

 

a

 

known

 

range

 

of

 

glucose,

 

as

 

indicated

 

on

 

the

 

strips

 

vial

 

bottles.

 

 

This

 

device

 

is

 

not

 

intended

 

for

 

use

 

in

 

healthcare

 

or

 

assisted

use

 

settings

 

such

 

as

 

 

hospitals,

 

physician’s

 

offices,

 

or

 

long

term

 

care

 

facilities

 

because

 

it

 

has

 

not

 

been

 

determined

 

to

 

be

 

safe

 

and

 

effective

 

for

 

use

 

in

 

these

 

settings,

 

including

 

for

 

routine

 

 

assisted

 

testing

 

or

 

as

 

part

 

of

 

glycemic

 

control

 

procedures.

 

 

Use

 

of

 

this

 

device

 

on

 

multiple

 

patients

 

may

 

lead

 

to

 

transmission

 

of

 

Human

 

Immunodeficiency

 

Virus

 

(HIV),

 

Hepatitis

 

C

 

Virus

 

(HCV),

 

Hepatitis

 

B

 

Virus

 

(HBV),

 

or

 

other

 

bloodborne

 

pathogens.

 

AST

 

in

 

this

 

system

 

can

 

be

 

used

 

only

 

during

 

steady

state

 

blood

 

glucose

 

conditions

 

described

 

in

 

the

 

section

 

of

 

“About

 

AST”.

 

 

Test

 

principle

 

The

 

test

 

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

 

and

 

displays

 

the

 

corresponding

 

blood

 

glucose

 

level.

 

The

 

strength

 

of

 

the

 

current

 

produced

 

by

 

the

 

reaction

 

depends

 

on

 

the

 

amount

 

of

 

glucose

 

in

 

the

 

blood

 

sample.

 

 

 

ABOUT

 

ALTERNATIVE

 

SITE

 

TESTING

 

(AST)

 

Important.

 

There

 

are

 

limitations

 

for

 

doing

 

AST.

 

Please

 

consult

 

your

 

healthcare

 

professional

 

before

 

you

 

do

 

AST.

 

What

 

is

 

AST?

 

Alternative

 

site

 

testing

 

(AST)

 

means

 

that

 

people

 

use

 

parts

 

of

 

the

 

body

 

other

 

than

 

the

 

fingertips

 

to

 

check

 

their

 

blood

 

glucose

 

levels.

 

This

 

system

 

allows

 

you

 

to

 

test

 

on

 

the

 

palm,

 

the

 

forearm

the

 

upper

 

arm,

 

the

 

calf

or

 

the

 

thigh

 

with

 

the

 

equivalent

 

results

 

to

 

fingertips

 

testing.

 

 

What’s

 

the

 

advantage?

 

Fingertips

 

feel

 

pain

 

more

 

readily

 

because

 

they

 

are

 

full

 

of

 

nerve

 

endings

 

(receptors).

 

At

 

other

 

body

 

sites,

 

since

 

nerve

 

endings

 

are

 

not

 

so

 

condensed,

 

you

 

will

 

not

 

feel

 

as

 

much

 

pain

 

as

 

at

 

the

 

fingertip.

 

Содержание G-427B

Страница 1: ...Bioland Blood Glucose Monitor Model G 427B OWNER S MANUAL ...

Страница 2: ...ipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful inte...

Страница 3: ...al 4 Do not use adjunct which are not supplied by the producer 5 Do not make the device come into contact with surfaces which are too hot to touch 6 Do not use the device where aerosol sprays are being used 7 Do not use the device if it is not working properly or if it has been damaged 8 Read all the manual and practice the test and then use the product to test your blood glucose Do all quality co...

Страница 4: ...G THE MEMORY 8 THE TWO MEASURING MODES 11 TESTING WITH BLOOD SAMPLE 11 Overview of the Lancing Device 12 Setting Up the Lancing Device 12 Preparing the puncture site 13 Performing a Blood Glucose Test 13 Comparing Meter and Laboratory Results 15 CONTROL SOLUTION TEST 15 VIEWING RESULTS ON THE METER 16 CARE AND STORAGE FOR YOUR SYSTEM 17 Cleaning and Disinfection 17 METER SPECIFICATION 18 Limitatio...

Страница 5: ... intended for self testing outside the body in vitro diagnostic use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control The Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use The Test Strips are for use with the Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips Caut...

Страница 6: ... lead to transmission of Human Immunodeficiency Virus HIV Hepatitis C Virus HCV Hepatitis B Virus HBV or other bloodborne pathogens AST in this system can be used only during steady state blood glucose conditions described in the section of About AST Test principle The test is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip The mete...

Страница 7: ... not be used in insulin doses calculations Do NOT use AST if You think your blood glucose is low You are unaware of hypoglycemia You are testing for hyperglycemia Your AST results do not match the way you feel Your routine glucose results are often fluctuating CONTENTS OF THE KITS A Meter Carry Case Owner s Manual Two AAA Alkaline Batteries Test Strips Optional Lancing Device Sterile Lancet Option...

Страница 8: ...ppears when the meter is turned on 3 LOW BATTERY SYMBOL Appears when the battery power is low 4 MEASUREMENT UNIT Appears with the test result in mg Ml or mmol L 5 CTL SYMBOL Appears when doing a Control test and indicates That the result won t be Stored in the memory 6 MEMORY SYMBOL Appears when you review the memory 7 TEST RESULT AREA Displays glucose results 8 KETONE WARNING Appears when your re...

Страница 9: ...G THE METER AND DELETING THE MEMORY 1 Setting the language and voice volume 1 1 Setting the language Press and Hold S button for 3 seconds until the ENG or ESP is flashing Press M button to select a language you desire Press S 1 2 Setting the Volume With the Volume level number flashing Press M button to select level between 0 7 set 0 to turned off voice Press S 2 Setting the date and time 2 1 Set...

Страница 10: ...ete the memory press the S button to skip this step The meter will automatically turn OFF and the set up will be completed NOTE The date time unit and memory deletion can ONLY be set in the setting mode When the meter is in setting mode if no button is pressed within 3 minutes the meter will turn off No set up necessary meter is pre set Meter is pre set for Eastern Standard Time Please refer to pa...

Страница 11: ...is applied onto the test strip Beep When the test is completed result appears on display Your blood glucose is number milligrams per deciliter When the test result is 20mg dL Your blood glucose is less than 20 milligrams per deciliter When the test result is 600mg dL Your blood glucose is over 600 milligrams per deciliter When selected CTL for control solution testing Control solution mode Recall ...

Страница 12: ...ch mode by 1 Start with the meter turned off Insert a test strip to turn on the meter the screen will display a flashing blood drop 2 Press M to select General or CTL mode TESTING WITH BLOOD SAMPLE CAUTION To reduce the chances of infection Choose a clean dry work surface Never share a lancing device and lancet with another person Always use a new and sterile lancet Lancets are for single use only...

Страница 13: ... are for single use only Avoid ge ng hand lo on oils dirt or debris when handling the lancets Setting Up the Lancing Device 1 Screw the lancing device cap off Insert a needle into the lancet holder and push down firmly until it is fully in place 2 Screw the needle cap and place it in appropriate location to use again after finish blood taking 3 Replace the lancing device cap Turn the cap until it ...

Страница 14: ...fference was significantly reduced Please follow the suggestions below before obtaining a drop of blood Rub the puncture site for about 20 seconds before penetration Select the puncture site either at the fingertips or another body part please see section Alternative Site Testing AST on how to select the appropriate sites Clean the puncture site using cotton moistened with 70 alcohol and let it ai...

Страница 15: ... soon as enough blood has filled the confirmation window of the test strip you will hear a beep letting you know the test has begun A countdown of 5 seconds starts Note make sure the confirmation window of the Test Strip is completely filled with your blood sample Step 7 Your blood glucose level along date and time appears on the display Blood glucose results are automatically stored in the memory...

Страница 16: ... you obtain from your meter may differ somewhat from your laboratory result due to normal variation Meter results can be affected by factors and conditions that do not affect laboratory results in the same way To make an accurate comparison between meter and laboratory results follow the guidelines below Before going to the lab Do a control solu on test to make sure that the meter is working prope...

Страница 17: ...t directly apply control solution onto a strip Step 4 The result of the control solutions test appears on the display The result will not be stored under CTL mode The result of the control solutions test should be within the range printed on the test strip vial label If the test results falls outside the specified range printed on test strip vial label repeat the test Results falling outside the s...

Страница 18: ...he Blood Glucose Monitoring System Test strip and Control Solution to extreme conditions such as high humidity heat freezing cold or dust The storage conditions for the test strips are 39 86 Humidity 80 RH Storage conditions for the meter are 40 131 Humidity 80 RH Always wash your hands with soap and water and rinse and dry completely before handling the Blood Glucose Monitoring system and Test st...

Страница 19: ... is being operated by a second person who is providing testing assistance to the user the meter and lancing device shall be cleaned and disinfected first 3 The users should wash hands thoroughly with soap and water after handling the meter lancing device or test strips METER SPECIFICATION Model G 427B with Bioland test strip and control solution Machine size 90mm L 54mm W 13mm H Weight 50g excludi...

Страница 20: ...mg dL Bilirubin 15mg dL Dopamine 0 03mg dL L dopa 0 45mg dL Methyldopa 0 75mg dL Tolbutamide 24mg dL Triglycerides 2000mg dL Hemoglobin 250mg dL Pa ents undergoing oxygen therapy may yield falsely lower results Not for use for pa ents in a hyperglycemic hyperosmolar state with or without ketosis Not for use on critically ill patients Not to be used for pa ents who are dehydrated hypertensive hypot...

Страница 21: ...be installed improperly 2 Battery power is too low for use 3 Too much time has passed between inserting the Test Strip and perfor ming the test 44 Test Strip has not been fully inserted into the Meter 1 Install the Battery correctly 2 Replace with new Battery 3 Reinsert the Test Strip into the Meter 4 Reinsert the Test Strip into the Meter Test results are incon sistent or Control Solution test re...

Страница 22: ...eter co untdown did not start Test Strip has not been inserted correctly Use a new Test Strip and redo the test Bioland Technology LTD No A6B7 Block G ShangRong Industrial Zone No 5 Baolong Road Baolong Community Longgang District 518116 Shenzhen Guangdong PEOPLE S REPUBLIC OF CHINA Version V1 0 2016 01 by Bioland Technology LTD ...

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