Roche CoaguChek Vantus User manual

CoaguChek® Vantus
User’s Manual
Manual de usuario

© 2018 Roche Diagnostics GmbH
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Revision History
Version Date Content
1.0 2018-01 New document

3
Introduction
Before you start.....................................................................................................................................................................9
Intended use ...........................................................................................................................................................9
PT time ................................................................................................................................................................... 10
Self-testing ...........................................................................................................................................................10
The CoaguChek Vantus System ...................................................................................................................................12
Test principle ....................................................................................................................................................... 14
Operating conditions ........................................................................................................................................16
Quality control ..................................................................................................................................................... 17
Important Safety Instructions and Additional Information ................................................................................18
The CoaguChek Vantus Meter ..................................................................................................................................... 20
Overview of the meter elements ..................................................................................................................20
Batteries ................................................................................................................................................................ 22
Starting Up
Inserting the batteries ...................................................................................................................................... 26
Initially setting up the meter ..........................................................................................................................29
Code chip .............................................................................................................................................................................34
Inserting the code chip .................................................................................................................................... 35
Testing a Capillary Blood Sample
Important notes ..................................................................................................................................................38
Getting a good capillary blood sample ...................................................................................................... 40
Preparing to test .................................................................................................................................................41
Performing a test ................................................................................................................................................42
Notes concerning the results display .........................................................................................................53
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Reviewing and Handling Data
Reviewing test results ......................................................................................................................................................56
Displaying reports on the meter .................................................................................................................................. 58
Displaying a Trend report ............................................................................................................................... 59
Displaying a Target report .............................................................................................................................. 62
Transferring data ............................................................................................................................................................... 64
Data transfer via USB ....................................................................................................................................... 65
Data transfer via Bluetooth ............................................................................................................................67
Displaying reports on a computer ..............................................................................................................................69
Security settings in the Internet browser .................................................................................................. 71
Virus scanner.......................................................................................................................................................71
Reports overview ................................................................................................................................................ 72
Time period ..........................................................................................................................................................73
Trend graph ..........................................................................................................................................................73
Target range display..........................................................................................................................................74
Target graph ......................................................................................................................................................... 74
List of results .......................................................................................................................................................75
Printing reports ...................................................................................................................................................76
Using data in external applications .............................................................................................................77
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Reminders and Meter Settings
Setting up reminders .......................................................................................................................................................79
New reminder .....................................................................................................................................................80
Editing or deleting a reminder ...................................................................................................................... 84
Meter settings .................................................................................................................................................................... 85
Settings overview .............................................................................................................................................. 86
Language ..............................................................................................................................................................88
Time & Date ......................................................................................................................................................... 89
Result Format ......................................................................................................................................................91
Set Targets ............................................................................................................................................................ 92
Beeper Volume ....................................................................................................................................................95
Display Brightness ............................................................................................................................................. 96
Button Click ......................................................................................................................................................... 97
Data Transfer .......................................................................................................................................................98
Cleaning and Disinfecting the Meter and the Lancing Device
Overview ..............................................................................................................................................................101
What is the difference between cleaning and disinfecting? ...........................................................102
When to clean and disinfect the meter and the lancing device ...................................................102
Approved cleaning and disinfecting product ........................................................................................103
Cleaning the meter housing ........................................................................................................................104
Cleaning the test strip guide and test strip guide cover ...................................................................106
Disinfecting the meter ...................................................................................................................................109
Disinfecting the test strip guide cover and test strip guide .............................................................110
Cleaning and Disinfecting the Lancing Device ...................................................................................................115
When to clean and disinfect the lancing device ..................................................................................115
What to clean and disinfect .........................................................................................................................117
How to clean and disinfect the lancing device ....................................................................................117
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Other Functions and Troubleshooting
Other functions ................................................................................................................................................................119
About (manufacturing information and data encryption key) ........................................................120
Clear Memory ....................................................................................................................................................121
Meter Log ...........................................................................................................................................................123
Display Test ........................................................................................................................................................124
Firmware Update ..............................................................................................................................................125
Troubleshooting ...............................................................................................................................................................127
Errors and unusual behavior without error messages .......................................................................128
Symbols, Icons, Messages
Symbols on packaging and meter ............................................................................................................................129
Icons on the display .......................................................................................................................................................131
Messages ...........................................................................................................................................................................133
Reminders ...........................................................................................................................................................134
Information .........................................................................................................................................................136
Maintenance ......................................................................................................................................................138
Warnings .............................................................................................................................................................142
Error messages .................................................................................................................................................143
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General Product Information
Ordering ..............................................................................................................................................................147
Product limitations ...........................................................................................................................................147
Operating conditions and technical data ...............................................................................................148
Sample material ................................................................................................................................................149
Storage and transport conditions ..............................................................................................................149
Disposal of the CoaguChek Vantus meter .............................................................................................150
For healthcare professionals .......................................................................................................................151
Disposal of used batteries ............................................................................................................................151
Repairs .................................................................................................................................................................151
Information service ..........................................................................................................................................152
Product Safety Information ..........................................................................................................................................153
Bluetooth Wireless Technology ..................................................................................................................153
Radio Frequency Communication .............................................................................................................154
Electromagnetic Compatibility ....................................................................................................................155
Index
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CoaguChek Vantus User’s Manual, version 1.0

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Introduction
Before you start
Intended use
The CoaguChek® Vantus System measures an
INR (International Normalized Ratio) based
on a prothrombin time (PT) response to
monitor the effect of a therapy with vitamin
K antagonists by using the CoaguChek XS®
PT Test strips. The CoaguChek Vantus System
uses fresh capillary whole blood from a nger
stick.
The system is intended for properly selected
and suitable trained users on the prescription
of the treating doctor.
Users should be stabilized on anticoagulation
with vitamin K antagonists for at least 6 weeks
prior to single patient self-testing with the
CoaguChek Vantus System.
The CoaguChek Vantus System is intended
for single patient self-testing only for adults,
age 22 years and older.
Introduction
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PT time
A PT test is often called an INR test. The
International Normalized Ratio (INR) is a way
of standardizing the results of prothrombin
time tests because there are different test
methods. INR enables you and your doctor
to understand your coagulation results even
when they come from different labs using
different test methods.
Self-testing
If you self-test, you need to discuss your
therapy model with your healthcare
professional rst. Self-testing is not a
substitute for regular visits to your doctor.
Depending on the training you have received
and the instructions from your healthcare
professional, you might communicate your
results to a healthcare professional or clinic
toreceive the appropriate dose adjustment.
Introduction
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Self-monitoring of oral anti coagulation
therapy using coagulation values
determined with the CoaguChek Vantus
System may only be undertaken after
consultation with your doctor and
comprehensive instruction by a qualied
healthcare professional.
This manual contains all the information
you need to operate and care for the
CoaguChek Vantus System. Please read
this entire manual carefully before you
use the meter.
Introduction
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The CoaguChek Vantus System
The CoaguChek Vantus System makes
coagulation testing easy. The graphical user
interface of the CoaguChek Vantus meter
guides you through the test step by step.
The code chip accompanying the test strips
contains strip lot-specic information and the
expiry date for the test strips. You only need
to insert the code chip, turn the meter on,
insert the test strip, and apply a blood sample.
The CoaguChek Vantus meter measures your
coagulation time and displays the result. After
the test is completed, the meter automatically
saves the result to memory.
Introduction
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If you have any questions about the CoaguChek
Vantus meter, please contact CoaguChek
Technical Services at 1-800-428-4674. You
will nd further contact details on page 146.
Please note: Before you use the meter
for the rst time (i.e. after you have rst
inserted the batteries), you must set the
date and time correctly to allow you to carry
out measurements properly. Each time you
replace the batteries, you need to check
(and, if necessary, adjust) the date and
time.
Note on screenshots:
The test results and software and hardware
information shown in the screenshots in
this manual are for illustration purposes
only. The information displayed on your
meter may differ.
Introduction
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Test principle
The CoaguChek XS PT Test test strip
contains a lyophilized reagent (reagent
in dried form). The reactive components
of this reagent consist of thromboplastin
and a peptide substrate. When a sample is
applied, thromboplastin activates coagulation,
which leads to the formation of thrombin.
At the same time, the meter starts to
measure the time. The enzyme thrombin
cleaves the peptide substrate, generating an
electrochemical signal. Depending on the
time elapsed when it rst appears, this signal
is then converted by means of an algorithm
into an INR result.
Introduction
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Contents of the pack
• CoaguChek Vantus meter
• 4 alkaline batteries, 1.5 V, type AAA
(LR03)1
• USB cable
• CoaguChek XS Softclix lancing device with
instructions for use
• CoaguChek Softclix Lancet
• System carry-case (not shown here)
• User’s Manual (this document)
• Quick Reference Guide (not shown here)
1 also available as “alkaline-manganese dioxide batteries”
Introduction
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Operating conditions
To ensure that your CoaguChek Vantus
System functions properly, please observe the
following guidelines:
• Only use the meter at a temperature
between 59 °F and 90 °F.
• Only use the meter at a relative humidity
between 10% and 85%.
• When testing, place the meter on a level,
vibration-free surface or hold it so that it is
roughly horizontal.
• If the meter is to remain unused for a
longer period of time, keep it in the carry-
case supplied.
• Use the meter only up to a maximum
altitude of 13120 feet.
Electromagnetic interference
Strong electromagnetic elds may interfere
with the proper operation of the meter. Do not
use the meter near strong electromagnetic
elds.
Introduction
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Quality control
The CoaguChek Vantus System has a number
of built-in quality control functions such as:
A check of the electronic components and
functions every time the meter is turned on.
A check of the test strip temperature while a
test is in progress.
A check of the expiry date and lot information
on the test strip.
A quality control function is incorporated into
the test strip. These on-board quality control
checks verify the test strip integrity.
Introduction
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Important Safety Instructions and Additional Information
This section explains how safety-related
messages and information related to the
proper handling of the system are presented
in the CoaguChek Vantus User’s Manual.
Read these passages carefully.
The safety alert symbol alone (without a
signal word) promotes awareness to hazards
which are generic or directs the reader to
related safety information.
WARNING
Indicates a hazardous situation which, if
not avoided, could result in death or serious
injury.
CAUTION
Indicates a hazardous situation which, if not
avoided, could result in minor or moderate
injury.
Introduction
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NOTICE
Indicates a hazardous situation which, if not
avoided, may result in damage to the system.
Important information that is not safety
relevant is presented against a colored
background (without a symbol). Here you
will nd additional information on correct
use of the meter or useful tips.
Introduction
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The CoaguChek Vantus Meter
Overview of the meter elements
Overview of the meter elements (front)
A Display
Shows menus, results, messages and
results recalled from memory.
B Back button
Exit the currently displayed menu.
C Up/down arrows button
Move or scroll up/down in a screen.
D Enter button (Power on)
Conrm the currently selected option or
perform a function. Also used to power the
meter on and off.
E Test strip guide cover
Remove this cover to clean the test strip
guide.
F Test strip guide
Insert the test strip here.
A
B
E
C
D
F
Introduction
CoaguChek Vantus User’s Manual, version 1.0