background image

 

18

 

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19

 

 

The

 

meter

 

for

 

single

patient

 

use

 

and

 

the

 

lancing

 

devices

 

may

 

be

 

cleaned

 

5

6

 

times

 

per

 

day

 

(Test

 

5

6

 

times

 

every

 

day),

 

so

 

the

 

meter

 

will

 

be

 

cleaned

 

and

 

disinfect

 

about

 

11000

 

cycles

 

that

 

include

 

cleanings

 

plus

 

disinfections

 

(1

 

cycle

 

=

 

1

 

cleaning

 

+

 

1

 

disinfection)

 

during

 

its

 

5

 

years

 

life

 

cycle.

 

1.

 

Before

 

the

 

test,

 

the

 

user

 

should

 

clean

 

and

 

wash

 

hands.

 

If

 

you

 

are

 

a

 

caregiver,

 

(not

 

the

 

patient),

 

please

 

use

 

disposable

 

gloves.

 

2.

 

After

 

test,

 

take

 

one

 

wipe

 

to

 

clean

 

the

 

meter’s

 

housing,

 

buttons,

 

lens,

 

mark,

 

usb

 

cover

 

and

 

support

 

block,

 

including

 

its

 

front

 

and

 

back

 

for

 

10

 

seconds

 

for

 

cleaning

 

until

 

there

 

is

 

no

 

soil

 

on

 

the

 

surface.

 

Then

 

disinfect

 

the

 

meter’s

 

housing,

 

buttons,

 

lens,

 

mark,

 

usb

 

cover

 

and

 

support

 

block

 

use

 

another

 

wipe

 

for

 

2

 

min,

 

keep

 

the

 

surface

 

wet

 

for

 

2

 

min.

 

3.

 

Take

 

off

 

the

 

glove;

 

discard

 

carefully

 

according

 

to

 

your

 

health

‐ 

care

 

provider’s

 

instruction.

 

Note:

   

1.

 

Each

 

disinfection

 

step

 

requires

 

a

 

pre

cleaning

 

step.

 

2.

 

If

 

the

 

meter

 

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

 

(excluding

 

batteries)

 

Measuring

 

method

 

Amperometric

 

technology

 

using

 

glucose

 

oxidase

 

Measuring

 

range

 

20

 

mg/dL

 

~600

 

mg/dL

 

Blood

 

Source

 

Fresh

 

capillary

 

whole

 

blood

 

Blood

 

Volume

 

Around

 

1.8uL

 

Memory

 

448

 

blood

 

glucose

 

tests

 

Display

 

LCD

 

display

 

with

 

backlight

 

Power

 

source

 

DC

 

3V

 

(AAA×2

 

alkaline

 

batteries)

 

Battery

 

Life

 

Approx.

 

500

 

normal

 

tests

 

Operating

 

conditions

 

50

~104

,

 

Humidity:25%~80%RH

 

Storage

 

Condition

 

(system

 

:meter

 

and

 

test

 

strips)

 

39.2

~104

and below 85% relative humidity

 

Storage

 

Condition

 

(meter)

 

40

~131

,

 

Humidity

80%RH,

 

700hPa~1060hPa

 

Use

 

life

 

Five

 

years

 

 
 

Limitations

 

of

 

use:

 

 

The

 

blood

 

Monitoring

 

System

 

is

 

not

 

intended

 

for

 

use

 

on

 

neonates.

 

 

The

 

blood

 

Monitoring

 

System

 

is

 

not

 

intended

 

for

 

use

 

on

 

artery

 

blood,

 

neonates’

 

serum

 

and

 

plasma.

 

Summary of Contents for G-427B

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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