Human HumaSens2.0plus User manual

HumaSens2.0plus
Starter Pack
User Manual

Table of Contents
Chapter 1 HumaSens2.0plus Multi-Parameter System
1.1 Introduction _________________________________________________________________ 1
1.2 Contents of the Starter Pack _____________________________________________________ 2
1.3 Labelling and Information ______________________________________________________ 3
1.4 HumaSens2.0plus Meter _________________________________________________________ 4
LCD Screen Display and Alert Tones _______________________________________________ 5
Test Strip and Code Strip________________________________________________________ 6
Chapter 2 Setting the Meter
2.1 Installing/Replacing the Batteries_________________________________________________ 7
2.2 Set Date, Time and Units _______________________________________________________ 7
2.3 Code the Meter_______________________________________________________________ 8
Chapter 3 How to Perform a Test
3.1 Before Testing________________________________________________________________ 9
3.2 Perform the Test _________________________________________________________ 10–12
3.3 Care after Testing ________________________________________________________ 13–14

Chapter 4 Meter Memory Function___________________________________________________ 15–16
Chapter 5 Control Solution Test _____________________________________________________ 17–18
Chapter 6 Care and Maintenance
6.1 Care after Testing ____________________________________________________________ 19
6.2 Cleaning and Caring for Your Meter ______________________________________________ 19
Chapter 7 Error Message and Trouble Shooting _________________________________________ 20–21
Chapter 8 Specications _______________________________________________________________ 22
Chapter 9 Limitations
9.1 All Tests ___________________________________________________________________ 23
9.2 Limitations of Blood Glucose Test ________________________________________________ 23
9.3 Limitations of Uric Acid Test ____________________________________________________ 24
9.4 Limitations of Total Cholesterol Test ______________________________________________ 24

1
Chapter 1 HumaSens2.0plus Multi-Parameter System
1.1 Introduction
Thank you for choosing HumaSens2.0plus. HumaSens2.0plus Multi-Parameter System (meter) is based on electrochemi-
cal biosensor technology, which can check your blood glucose (GLU), total cholesterol (CHOL), and uric acid (UA) fast
and convenient. Please read this user’s manual carefully before using this product. If you need any further assis-
tance, please contact your local customer service.
Intended Use
The HumaSens2.0plus Starter Pack contains a hand-held multi-parameter instrument. In combination with the Huma-
Sensplus test strips it is used for the quantitative determination of blood glucose, total cholesterol and uric acid levels in
human capillary whole blood from the nger prick. It is used to monitor the level of glucose, total cholesterol and uric
acid. The HumaSens2.0plus Starter Pack is designed as a semi-automated system. For near patient testing by healthcare
professionals and laboratory testing by laboratory professionals.
The HumaSens2.0plus System is plasma-calibrated by reference instruments which are traceable to the following standard
reference materials and methods:
Test Standard Method
Glucose NIST SRM 917 Glucose Oxidase
Total Cholesterol NIST SRM 911 Abell/Kendall
Uric Acid NIST SRM 913 Uricase/UV
Warning: Please carefully read the instructions and test procedures in this user’s manual before using.
Users should consult a healthcare professional before making any important medical decision.

2
Chapter 1 HumaSens2.0plus Multi-Parameter System
1.2 Contents of the Starter Pack
The items included in the HumaSens2.0plus Starter Pack:
(please check the meter outer box for exact detail)
Description Quantity
HumaSens2.0plus Multi-Parameter Meter (with a CR2032 3V battery)________________________________________ 1
User’s Manual ______________________________________________________________________________ 1
Quick Guide ________________________________________________________________________________ 1
Pouch_____________________________________________________________________________________ 1
Optional (not included in the standard kit package, please contact your local distributor for ordering) REF
Glucose Test Strips Blue HumaSens2.0 /HumaSens2.0plus /HumaSens / HumaSensPlus (50) 2 x 25 pcs. _________17562
Glucose Control HumaSens2.0/HumaSens2.0plus / HumaSens*/ HumaSensPlus* (*BLUE GLU strip) 2 x 2 ml ___ 17562/10
Uric Acid Test Strips HumaSens2.0plus 1 x 25 pcs. ________________________________________________ 17566
Uric Acid Control Solution HumaSens2.0plus 2 x 2 ml___________________________________________ 17566/10
Total Cholesterol Test Strips HumaSens2.0plus 2 x 10 pcs. __________________________________________ 17567
Total Cholesterol Control Solution HumaSens2.0plus 2 x 1,5 ml ___________________________________ 17567/10

3
Chapter 1 HumaSens2.0plus Multi-Parameter System
1.3 Labelling and Information
Use by Recap immidiately
after use
Operation temperature
limitation
Manufacturer Use within 3 months
after initial opening
Storage and transpor-
tation temperature
limitation
Do not reuse Attention
Storage and transpor-
tation relative humidity
limitation
Keep dry In-vitro diagnostic Comply with WEEE
Directive 2012/19/EU
Keep away
from sunlight Lot number
Read instructions Serial number

HumaSens2.0plus
4
Chapter 1 HumaSens2.0plus Multi-Parameter System
1.4 HumaSens2.0plus Meter
Meter (Front Side & Back Side)
LCD Screen:
Display operating
information and
test results
Right “S” Button:
Conrm and set up
Left “M” Button:
Enter memory mode
Press long to turn off
Ejection Button:
Remove test strip
Test Port:
Insert test strip
Serial Number Sticker
Battery:
3V lithium battery (CR2032)
Please remove the plastic
tab before using
Battery Lid:
Slide to open.
Meter Label:
Information about meter

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2
3 4 5 6
7
8
9
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Chapter 1 HumaSens2.0plus Multi-Parameter System
1.4 LCD Screen Display
Information and test result display
1.4 Alert Tones
> Normal Alert: a short “beep”
> Warning Alert: 3 short “beeps”
> Turning On/Off: a long “beep”
1Result Area
2Low Battery
3Temperature Icon
4Average (GLU)
5Unit Icon
6Time
7System Check
8Blood Loading Icon
9Strip Loading Icon
10 Test Mode Icon
11 Memory Mode Icon
12 Code Number Icon

GLU
CHOL
UA
GLU 7142
CHOL 7147
UA 7021
6
Chapter 1 HumaSens2.0plus Multi-Parameter System
1.4 Test Strip
GLU – Glucose
CHOL – Cholesterin
UA – Uric Acid
1.4 Code Strip
The code strip is used to code the meter.
Please do the coding step when you use a new vial of strip.
Electronic Contact Bars:
Insert this end into meter
test port.
Contact Bar:
Insert this end into the
test port of the meter. Code
Test Mode
Sample Inlet:
The whole blood sample and control
solution will be drawn from here.
Note:
Please ll up the round window with
blood sample CHOL test and avoid
disconnecting in the process.

1.
+
CR2032
2. 3.
7
Chapter 2 Setting the Meter
2.1 Installing/Replacing the Batteries
Please remove the plastic tab under the battery before using. This instrument uses a CR2032 3V lithium battery.
Do not use or install different types of battery. It will damage the meter.
Installing Instructions:
Note: Dispose the batteries according to your local environmental regulations.
2.2 Set Date, Time and Units
Press “S” button for over three seconds. You will hear one “beep” for entering the setting mode, then follow the
instruction below to set up.
Setting order: Year/Month/Date/Hour/Minute/Units
>Click “M” button to advance one unit.
>Click “S” button to enter next setting and to end setting mode.
>The meter will turn off automatically after setting.
Slide to remove
the battery lid.
Insert the
battery with
the positive (+)
side up.
Slide back the
battery lid.