Human HumaSens User Manual

Headline

HumaSens

Glucose Meter

User Manual

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Table of Contents

Chapter 1 HumaSens Glucose Meter 3

1.1 Introduction 3

1.2 Contents of the Kit 3

1.3 Symbols 4

1.4 System Components 5

Chapter 2 Meter Setup 6

2.1 Replacing the Battery 6

2.2 Set Date, Time and Units 6

2.3 Coding the Meter 8

2.4 Control Te st 9

Chapter 3 Performing a Test 11

3.1 Before Tes t in g 11

3.2 Te st Procedures for Blood Glucose 13

3.3 Safety 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 To n es 16

Chapter 7 Error Messages and Troubleshooting 17

Chapter 8 Specif ications 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

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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]

HumaSens Glucose test strips (2x25 strips/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

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Before first use, remove the transparent

protective foil from the battery.

2.1 Replacing the Battery

The battery is located inside the meter.

Use only 3V lithium batteries (CR2032).

Do not use with different types of

batteries, as this may damage the

electronics of the meter.

Instructions

1. Remove the back cover by pulling it to

the side.

2. Insert a new battery into the battery

socket with the “+” side facing up.

3. Replace the battery cover.

2.2 Set Date, Time and Units

The setup has to be completed before

first use or after a battery change. Press

and hold the “Set” button for at least

two seconds. The meter will beep once

and enter the setup mode.

In setup mode, the LCD screen of the

meter shows all setting options conse-

cutively, starting with a flashing year

number:

1. Set the Year

A. When the meter enters setup mode,

the year will flash on the screen.

B. Click the “M” button to advance in

one-year increments to set the correct

year.

C. After setting the desired year, click

the “Set” button again, and the meter

advances to the month setting.

2. Set the Month

A. Click the “M” button until the correct

month appears.

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Chapter 2 Meter Setup