TABLE OF CONTENTS
Chapter 1
BeneCheck PLUS Multi-Monitoring System
1.1
Introduction
...............................................................................................................
1-2
1.2
Contents of the Kit
..........................................................................................
3-4
1.3
Labelling and Informations
..........................................................................
5
1.4
System Components
Meter
.........................................................................................................................
6-7
Test Strips
........................................................................................................
8-9
Code Strip
.............................................................................................................
10
Chapter 2
Setting-up the Meter
2.1
Installing/Replacing the Batteries
.................................................
11-12
2.2 Set the Year/Month/Day/Hour/Minute
.................................................
12
Set the Year/Month/Day
..................................................................
13
Set the Hour/Minute
.............................................................................
14
2.3 Coding the Meter
......................................................................................
15-17
2.4 Control Test
.................................................................................................
18-21
Chapter 3
How to Perform a Test
3.1
Before Testing
.............................................................................................
22-24
3.2
Testing procedures for Blood Glucose
...............................................
25
3.3
Testing procedures for Blood Uric Acid
............................................
26
3.4
Testing procedures for Blood Total Cholesterol
.................
26-27
3.5
Care after the Test
..........................................................................................
28
Chapter 4
Meter Memory Function
................................................................................
29-30
Chapter 5
How to Set the Measurement Units
......................................................
31-32
Chapter 6
Storage and Handling of Meter and Strips
..............................................
33
Chapter 7
Icon and Alert Tones
..............................................................................................
34
Chapter 8
Error Message and Trouble Shooting
...................................................
35-36
Chapter 9
Specications
......................................................................................................
37-38
Chapter 10
Limitations
.............................................................................................................
39-46
1
Chapter 1 BeneCheck PLUS Multi-Monitoring System
1.1 Introduction
Thank you for choosing BeneCheck PLUS Multi-Monitoring System. The BeneCheck
PLUS Multi-Monitoring System is designed by General Life Biotechnology Co., Ltd.
and marketed all over the world.
The BeneCheck PLUS Multi-Monitoring System provides you with accurate,
plasma-calibrated results based on electrochemical sensor technology. This
system includes blood glucose, uric acid and total cholesterol level tests, precisely
measured and displayed within 10, 15 and 30-40 seconds respectively.
Intended Use :
The BeneCheck PLUS Multi-Monitoring System is designed to measure the blood
glucose, uric acid or total cholesterol levels in whole blood. The test strips are
for self-testing outside the body (in vitro diagnostic use). It should be used only
for testing glucose, uric acid or total cholesterol with fresh capillary nger blood
samples. The system is suitable for users to monitor their blood glucose, uric
acid or total cholesterol at home by themselves and be used for clinical sites by
healthcare professionals to test the blood glucose, uric acid or total cholesterol
levels of patients.
2
The BeneCheck PLUS Multi-Monitoring System includes glucose, uric acid, and
total cholesterol tests which are all calibrated by J&J DT60 Analyzer (Kodak
EKTACHEM DT60 Analyzer) using venous plasma. The DT60 Analyzer is calibrated
by VITROS DT calibrators which were referenced to the following standard and
method :
Test Standard Method
Glucose NIST SRM 917b AACC/CDC (Hexokinase/G6PDH)
Uric Acid NIST SRM 913a Uricase/UV
Total Cholesterol NIST SRM 911b Abell/Kendall
Please read the entire USER’S MANUAL carefully before using the BeneCheck PLUS
Multi-Monitoring system to test your blood glucose, uric acid or total cholesterol
levels. This USER’S MANUAL guides you through the operation procedures with
illustrated directions and help you nd the required information.
WARNING :
Please carefully read the instructions in this user’s manual and become familiar
with the test procedures before using the system to test blood glucose, uric acid
or total cholesterol levels. Users should consult with a healthcare professional
before going ahead important medical decision.
3
1.2 Contents of the Kit
Please check the whole package for the BeneCheck PLUS Multi-Monitoring System.
The system includes the following items :
Item No. Description Quantity
PD-G001-1 BeneCheck PLUS Meter 1
PD-A041 BeneCheck PLUS Glucose Test Strip x (10pcs/vial) 1
PD-D001 BeneCheck PLUS Uric Acid Test Strip x (10pcs/vial) 1
PD-E001 BeneCheck PLUS Total Cholesterol Test Strip x (5pcs/vial) 1
PD-A020 Code Strip (Glucose x 1, Uric acid x 1, Total Cholesterol x 1) 1
PD-F004 Glucose Control Solution x 1 1
PP-E018 BeneCheck PLUS User’s Manual 1
PP-E019 BeneCheck PLUS Glucose Test Strip Instruction 1
PP-E020 BeneCheck PLUS Uric Acid Test Strip Instruction 1
PP-E021 BeneCheck PLUS Total Cholesterol Test Strip Instruction 1
PP-E023 Glucose Control Solution Instruction 1
PD-A006 Lithium Battery 3V (CR2032) 1
PD-A019 Kit Carrying Bag 1
PD-A015 Lancing Device 1
4
Item No. Description Quantity
PD-A018
Lancets (pack)
(Manufacturers of Lancing Device and Lancet : For detail
information, please refer to inside package. )
1
Optional : ( not included in the standard kit package, please contact your
local distributor for ordering. )
BeneCheck PLUS Glucose Test Strip BKP-G-S001
BeneCheck PLUS Uric Acid Test Strip
BKP-U-S001
BeneCheck PLUS Total Cholesterol Test Strip
BKP-C-S001
5
Caution, consult
accompanying documents
1.3 Labelling and Information
Do not re-use
Keep dry
Operation temperature
limitation
In-vitro diagnostic
Lot number
CE certication
Read instructions
Storage temperature
limitation
Use by
EU Representative
Catalogue number
(Product number)
Manufactured by
Keep away from sunlight
6
1.4 System Components
Meter (Front Side)
Right “Set” Button :
For on/off and setup mode
operation.
LCD Screen :
For display of operating
information and test results.
Test Port :
Where you insert the test strip
for testing.
Left “M” Button :
For memory mode operation.
7
PLUS Multi-Monitoring System
.
Battery : One CR2032
BeneCheck
Battery Cover Lid :
Pull right ward to remove
the cover when replacing
battery
Battery Cover :
For covering the battery.
Battery :
3V lithium battery
(CR2032)
Battery Socket :
For holding a 3V-lithium
battery
Tag :
Display information
about the meter.
Meter (Back Side)
8
Electronic Contact Bar :
Insert Electronic Contact Bar of the
test strip into the Test Port of the
meter to activate it.
Sample Inlet :
The inlet where the whole blood or control solution is drawn
in. Touching a blood sample or control solution will result in
a capillary action automatically
Test Strip
Glucose & Uric Acid Strip
B
en
e
C
h
e
ck
9
Total Cholesterol Strip
Electronic Contact Bar :
Insert Electronic Contact Bar of the
test strip into the Test Port of the
meter to activate it.
Sample Inlet :
The inlet where the whole blood or control solution is
drawn in. When a blood sample or control solution touches
this end, the sample will be sucked into the reaction zone
automatically. The reaction zone of total cholesterol strip
full of control solution or a blood sample at least 10 µL is
essential.
Reaction Zone :
Reaction zone of
Total Cholesterol
10
Code Strip ( Front View )
Contact Bar :
Insert this end into
the Test Port of the
meter.
Code Number
Test Mode :
GLUC - Glucose
UA - Uric Acid
CHOL - Total Cholesterol
Test Mode
11
Chapter 2 Setting-up the Meter
2.1 Installing/Replacing the Battery
Battery is loaded inside the meter. Use only 3V lithium battery. Do not use or
replace the battery with different types of battery which will damage the
electronics of meter.
Instructions :
1.
Hold the meter with one hand, slightly pull right the back
cover to remove the back cover.
2.
Insert a new battery to the battery socket with the “+” side
facing up.
12
3. Place back the battery cover onto the meter.
2.2 Set the Year/Month/Day/Hour/Minute
Press and hold the “Set” button for over two seconds, the meter will sound one
beep and enter the setting mode. Please follow the directions below to set the
meter.
Under the setup mode, the LCD screen of the meter shows all setting items start
from a blinking year “200X” and the rest setting items are listed as follows: