Human HumaSens User manual

Headline
HumaSens
Glucose Meter
User Manual

2
Table of Contents
Chapter 1 HumaSens Glucose Meter 3
1.1 Introduction 3
1.2Contents of the Kit 3
1.3Symbols 4
1.4System Components 5
Chapter 2 Meter Setup 6
2.1Replacing the Battery 6
2.2Set Date, Time and Units 6
2.3Coding the Meter 8
2.4Control Test 9
Chapter 3 Performing a Test 11
3.1Before Testing 11
3.2Test Procedures for Blood Glucose 13
3.3Safety Instructions 14
Chapter 4 Meter Memory Function 14
Chapter 5 Storage and Handling 15
Chapter 6 Icons and Alert Tones 16
6.1 Screen Icons 16
6.2 Alert Tones 16
Chapter 7 Error Messages and Troubleshooting 17
Chapter 8 Specifications 18
Chapter 9 Limitations of Blood Glucose Tests 19

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1.1 Introduction
The HumaSens Glucose Meter by HUMAN provides you
with accurate, plasma-calibrated results based on elec-
trochemical sensor technology. This system measures
blood glucose levels precisely and displays results within
10 seconds.
Intended Use:
The HumaSens Glucose Meter is designed to measure
the blood glucose levels in whole blood and must only
be used with HumaSens Glucose test strips. The test
strips are for self-testing outside the body (in vitro
diagnostic use). The system is also suitable for use by
healthcare professionals. It should be used only for
testing glucose with fresh capillary blood samples taken
from a fingertip.
The HumaSens Glucose test strips are calibrated against
the Kodak EKTACHEM DT60 analyzer using venous
plasma. Calibration can be referenced to the NIST SRM
917b standard.
Please read the entire user manual carefully before
using the HumaSens Glucose Meter to test your blood
glucose level. This user manual guides you through the
operating procedures with illustrated directions and
helps you find the required information.
1.2 Contents of the Kit
Please check the HumaSens Glucose Meter package for
the following items:
Description Qty.
HumaSens Glucose Meter 1
HumaSens Glucose test strips (10 pcs/vial)
Code Strip (glucose) 1
Chapter 1 HumaSens Glucose Meter

4
Headline
HumaSens Glucose control solution (4 ml)
HumaSens user manual 1
HumaSens quick guide 1
Lithium battery 3V (CR2032) 1
Pouch 1
Lancets (10 pcs/bag)
Lancing device 1
Lancing device user instructions 1
Glucose test strip user instructions 1
Glucose control solution user instructions 1
Patient diary 1
Optional: (not included in the standard kit package,
please contact your authorized distributor for ordering.)
[REF]
HumaSensGlucose test strips (2x25strips/box) 17542/25
Lancets (100 pcs) 17543
HumaSens Glucose control solution (2x4 ml) 17545
PC connector cable 17549
PC software 17550
Battery pack 17548
1.3 Symbols
EC
representative
Catalogue
number
In vitro
diagnostic
device
Lot number
[EC¤REP]
[REF]
[IVD]
[LOT]
Do not re-use
Keep dry
Storage temperature
Product conforms to
directive 98/79/EC
Manufacturer
Expiry date
Consult manual
Attention
Recap immediately
after use
Use within 3 months
after initial opening
½
¼
Š
Chapter 1 HumaSens Glucose Meter

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1.4 System Components
Glucose Meter (Front View) Glucose Meter (Back View)
Glucose test strip
Code strip
M button
Strip port
Set button
Screen
Battery cover
Type plate
PC connection
port
Electrodes
Sample entry zone
Electrodes
Code number