Roche CoaguChek XS Pro Installation guide

CoaguChek®Professional Monitoring Systems
Training Manual

CoaguChek Professional Training folder v1.0
Information obtained from:
CoaguChek XS Plus Operators Manual version 4.0
CoaguChek XS Pro Operators Manual version 5.0
CoaguChek XS PT Test strip pack insert #580 (2010)-RPD-B 322-Frau Frank
© Copyright 2015. Roche Diagnostics Limited. All rights reserved.
COAGUCHEK and ‘BECAUSE IT’S MY LIFE’ are registered trademarks of Roche.
Roche Diagnostics Ltd. Charles Avenue, Burgess Hill, RH15 9RY United Kingdom
www.coaguchek.co.uk
Company registration no: 571546
07572735001

CONTACT AND ORDER DETAILS
Page 7
SYSTEM INTRODUCTION
Page 11
INTERFERENCES
Page 19
TRAINING
Page 25
CLEANING
Page 39
TROUBLESHOOTING
Page 47
APPENDIX 1
Page 51
APPENDIX 2
Page 67

CONTACT AND
ORDER DETAILS

CoaguChek Professional Monitoring Systems Training Manual 7
Roche Diagnostics Contact Information
UK Main Switchboard: 01444 256000
Freephone UK Customer Services:
0808 100 9998
UK Technical Support: 0808 100 1920
Ireland Main Switchboard:
[phone]
Freephone Ireland Customer Services:
1 800 509 586
Ireland Technical Support: 1 800 409 564
Roche Diagnostics
Charles Avenue
Burgess Hill
West Sussex
RH15 9RY
England
CoaguChek XS Professional Monitors Consumables
Cat. No’s for CoaguChek Consumables:
CoaguChek XS Test Strips x 24 04625358019
CoaguChek XS Test Strips x 48 04625315019
CoaguChek XS PT Controls x 4 04696522190
Safe-T-Pro Plus Single Use Device x 200 03603539195
Battery Pack 04687345001
QC Logbook 05520517001
There is a handling fee for orders under £100
Enter your CoaguChek XS Professional Monitors
serial number here:
Account Specialist Name and Number:
Local Contacts:

SYSTEM
INTRODUCTION

CoaguChek Professional Monitoring Systems Training Manual 11
CoaguChek XS Professional Monitors
System Introduction
The CoaguChek XS Professional Monitors (CoaguChek XS Plus and CoaguChek XS Pro)
quantitatively determine prothrombin time (“PT”), using capillary blood or whole blood from a
vein (non-anticoagulated venous whole blood). It is indicated for use by healthcare
professionals. The system is ideally suited to monitor coagulation values in people who are
taking oral anticoagulation medication (vitamin K antagonists, VKAs).
The CoaguChek XS Plus and XS Pro meters have the ability to connect to a data
management system (DMS) through the Handheld Base Unit from Roche. The meters
support data exchange via POCT1A standard. Data management systems may have the
ability to expand the security features of the meter, such as enabling operator lockouts. Data
management systems may also enable data transfer to a LIS or HIS.
CoaguChek XS Professional Monitors
System Introduction
The CoaguChek XS Professional Monitors (CoaguChek XS Plus and CoaguChek XS Pro)
quantitatively determine prothrombin time (“PT”), using capillary blood or whole blood from a
vein (non-anticoagulated venous whole blood). It is indicated for use by healthcare professionals.
The system is ideally suited to monitor coagulation values in people who are taking oral
anticoagulation medication (vitamin K antagonists, VKAs).
The CoaguChek XS Plus and XS Pro meters have the ability to connect to a data management
system (DMS) through the Handheld Base Unit from Roche. The meters support data exchange
via POCT1A standard. Data management systems may have the ability to expand the security
features of the meter, such as enabling operator lockouts. Data management systems may also
enable data transfer to a LIS or HIS.

12 CoaguChek Professional Monitoring Systems Training Manual
CoaguChek XS Plus
Pictorial Guide
ATouchscreen
Shows test results, information, icons and
results recalled from memory. To select an
option, simply touch the button lightly.
BOn/Off button
Press and hold this button to power the
meter on or off.
CTest strip guide cover
Remove this cover to clean the test strip
guide (if it has become soiled, e.g., with
blood).
DTest strip guide
Insert the test strip here.
ETab for battery compartment cover
FBattery compartment cover
Covers the battery compartment (4 standard
AA alkali-manganese batteries or the
rechargeable battery pack).
GCharging terminals
Used for power supply and/or charging the
battery pack, when the meter is docked in
the (optional) Handheld Base Unit.
HCode chip slot
Insert the code chip here.
IConnection socket for power adapter
Plug in the power adapter here.
JInfrared interface
(Covered by the semi-transparent panel)
Supports data communication.
KReset button
Use this button to reset the meter in case of
software or power-up errors.
CoaguChek XS Plus
Pictorial Guide
CoaguChek XS Pro
ATouchscreen
Shows test results, information, icons and
results recalled from memory. To select an
option, simply touch the button lightly.
BOn/Off button
Press and hold this button to power the
meter on or off.
CTest strip guide cover
Remove this cover to clean the test strip
guide (if it has become soiled, e.g., with
blood).
DTest strip guide
Insert the test strip here.
ETab for battery compartment
cover
FBattery compartment cover
Covers the battery compartment (4
standard AA alkali-manganese batteries or
the rechargeable battery pack).
GCharging terminals
Used for power supply and/or charging the
battery pack, when the meter is docked in the
(optional) Handheld Base Unit.
HCode chip slot
Insert the code chip here.
IConnection socket for power adapter
Plug in the power adapter here.
JInfrared interface
(Covered by the semi-transparent panel)
Supports data communication.
KReset button
Use this button to reset the meter in case of
software or power-up errors

CoaguChek Professional Monitoring Systems Training Manual 13
CoaguChek XS Pro
Pictorial Guide
ATouchscreen
Shows test results, information, icons and
results recalled from memory. To select an
option, simply touch the button lightly.
BOn/Off button
Press and hold this button to power the
meter on or off.
CTest strip guide cover
Remove this cover to clean the test strip
guide (if it has become soiled, e.g., with
blood).
DTest strip guide
Insert the test strip here.
EBarcode scanner (Laser)
The integrated barcode scanner can read
operator and patient IDs into the meter
FTab for battery compartment cover
GBattery compartment cover
Covers the battery compartment (4 standard
AA alkali-manganese batteries or the
rechargeable battery pack).
HCharging terminals
Used for power supply and/or charging the
battery pack, when the meter is docked in
the (optional) Handheld Base Unit.
ICode chip slot
Insert the code chip here.
JConnection socket for power adapter
Plug in the power adapter here.
KInfrared interface
(Covered by the semi-transparent panel)
Supports data communication.
LReset button
Use this button to reset the meter in case of
software or power-up errors
Pictorial Guide
CoaguChek
Test Principle
ATouchscreen
Shows test results, information, icons and
results recalled from memory. To select an
option, simply touch the button lightly.
BOn/Off button
Press and hold this button to power the
meter on or off.
CTest strip guide cover
Remove this cover to clean the test strip
guide (if it has become soiled, e.g., with
blood).
DTest strip guide
Insert the test strip here.
EBarcode scanner (Laser)
The integrated barcode scanner can read
operator and patient IDs into the meter
FTab for battery compartment
cover
GBattery compartment cover
Covers the battery compartment (4 standard
AA alkali-manganese batteries or the
rechargeable battery pack).
HCharging terminals
Used for power supply and/or charging the
battery pack, when the meter is docked in the
(optional) Handheld Base Unit.
ICode chip slot
Insert the code chip here.
JConnection socket for power adapter
Plug in the power adapter here.
KInfrared interface
(Covered by the semi-transparent panel)
Supports data communication.
LReset button
Use this button to reset the meter in case of
software or power-up errors

14 CoaguChek Professional Monitoring Systems Training Manual
CoaguChek
Test Principle
Instead of detecting the clot by mechanical or optical methods, the activity
of thrombin, a final stage of the clotting cascade, is monitored using
an electrochemical detection. The CoaguChek XS PT test strip contains,
in the blue area behind the strip, a reagent in dried form. The reactive
components of this reagent are human recombinant Tissue Factor (hrTF),
also known as thromboplastin and a peptide substrate Electrocyme TH.
Electrozyme TH can be used for the determination of thrombin activity.
When a sample is applied, thromboplastin activates the coagulation
cascade leading to the formation of thrombin.
The enzyme thrombin cleaves Electrocyme TH, into a residual peptide
and electrochemically active phenylenediamine thereby generating an
electrochemical signal.
Depending on the time elapsed when it first appears, this signal is then
converted by means of an algorithm (encoded in the code chip) into the
INR reading which is displayed on screen.
Instead of detecting the clot by mechanical or optical methods, the
activity of thrombin, a final stage of the clotting cascade, is
monitored using an electrochemical detection.
The CoaguChek XS PT test strip contains, in the blue area behind
the strip, a reagent in dried form. The reactive components of this
reagent are human recombinant Tissue Factor (hrTF), also known
as thromboplastin and a peptide substrate Electrocyme TH.
Electrozyme TH can be used for the determination of thrombin
activity.
When a sample is applied, thromboplastin activates the coagulation
cascade leading to the formation of thrombin.
The enzyme thrombin cleaves Electrocyme TH, into a residual
peptide and electrochemically active phenylenediamine thereby
generating an electrochemical signal.
Depending on the time elapsed when it first appears, this signal is
then converted by means of an algorithm (encoded in the code chip)
into the INR reading which is displayed on screen.
Figure - Position of electrodes and reagent on the test strip:
CoaguChek
Measurement terms
Instead of detecting the clot by mechanical or optical methods, the
activity of thrombin, a final stage of the clotting cascade, is
monitored using an electrochemical detection.
The CoaguChek XS PT test strip contains, in the blue area behind
the strip, a reagent in dried form. The reactive components of this
reagent are human recombinant Tissue Factor (hrTF), also known
as thromboplastin and a peptide substrate Electrocyme TH.
Electrozyme TH can be used for the determination of thrombin
activity.
When a sample is applied, thromboplastin activates the coagulation
cascade leading to the formation of thrombin.
The enzyme thrombin cleaves Electrocyme TH, into a residual
peptide and electrochemically active phenylenediamine thereby
generating an electrochemical signal.
Depending on the time elapsed when it first appears, this signal is
then converted by means of an algorithm (encoded in the code chip)
into the INR reading which is displayed on screen.
Figure - Position of electrodes and reagent on the test strip:
CoaguChek
Measurement terms
Figure - Position of electrodes and reagent on the test strip:

CoaguChek Professional Monitoring Systems Training Manual 15
CoaguChek
Measurement terms
Prothrombin time (PT) and International Normalised Ratio (INR) are parameters used to measure
the activity of oral anticoagulation therapy on the clotting ability of patient blood. Below is a short
explanation of the terms most frequently used in the training session.
Prothrombin Time (PT)
Thromboplastin is added to blood to activate coagulation; this causes a blood clot to form. The time
taken to produce the clot is measured in seconds (secs) and is known as the Prothrombin Time.
Either venous or capillary blood samples can be used to monitor anticoagulation therapy.
International Sensitivity Index (ISI)
As not all laboratories use the same reagents and equipment, differences in results were
observed. In 1983 the World Health Organisation (WHO) launched a scheme where all
thromboplastins used are compared against a known WHO standard preparation.
Every manufacturer of Thromboplastin must calibrate it against the WHO standard and the
deviation from this standard is measured. The value obtained is known as the International
Sensitivity Index.
The ISI is obtained by comparison of the log PT results of 20 normals and 60 patients stabilized on
anticoagulant therapy tested with the local PT against the manual PT tests with the same plasmas
using the WHO international reference preparation.
The ideal thromboplastin has an ISI of 1.
International Normalised Ratio (INR)
INR is the globally recommended unit for the measurement of Prothrombin time. INR makes the
comparison of results possible, despite the difference in thromboplastins and equipment used.
An INR value is calculated from the clotting time of the patient blood sample, divided by the
clotting time of a normal, healthy patient. This is known as the Prothrombin Ratio (PTR). To
neutralize the affects of the different thromboplastins, the PTR is multiplied by the power of the ISI
of the thromboplastin used.
INR = (Patients PT / Mean Normal PT)ISI

INTERFERENCES

CoaguChek Professional Monitoring Systems Training Manual 19
CoaguChek
Limitations - Interferences
Important Note – The test interferences below are subject to change therefore always
refer to the test strip pack insert for full details and up to date information
The blood drop must be a minimum of 8ml in volume. Low sample volume will cause an error
message.
Testing performed with the following in vitro spiked samples or native blood samples
(Triglycerides) indicated no significant effect on test results.
• Bilirubin up to 513 mmol/L (30 mg/dL)
• Hemolysis up to 0.62 mmol/L (1000 mg/dL)
• Hematocrit ranges between 25 % and 55 %
• Triglycerides up to 5.7 mmol/L (500 mg/dL)
• Heparin concentrations up to 0.8 U/ml
• The CoaguChek XS PT Test is insensitive to low molecular weight heparins (LMWH) up to 2 IU/
mL antifactor Xa activity
CoaguChek and Anti-phospholipid antibodies (APA)
The presence of Lupus antibodies (antiphospholipid antibodies: APA) may lead to an increase in
INR that leads to false high INR values. The extent and the frequency of such false and high INR
measurements depend on the type and amount of APA. This varies between Lupus patients. Some
patients do not show an influence on their INR, others have a prolonged INR, and again others only
get error messages. This may vary over time in an individual as the amount of APA increases or
decreases over time.
Clinical investigations to prove effects are hard to perform, therefore even when a study provides
us with some information on the influence of Lupus antibodies on the CoaguChek XS system, it
will not allow us to predict the effect for an individual patient or population.
It is recommended to measure with the CoaguChek XS system and an APA insensitive lab reagent
several times in parallel to see if the values are reliable. If the difference is acceptable, the
patient could potentially use the CoaguChek XS system to monitor INR levels. If the difference is
unacceptable, we do not recommend using the XS system, even when the difference is acceptable
at some but not all time points. Please keep in mind that APA may vary in concentration over
time, therefore, a control measurement with a lab reagent is recommended to be done at regular
intervals to guarantee the reliability of the CoaguChek system values.

20 CoaguChek Professional Monitoring Systems Training Manual
The Hughes Syndrome Foundation are a registered UK charity aiming to provide information
about Hughes Syndrome (antiphospholipid syndrome: APS). Their website provides information
about the charity and all aspects of Hughes Syndrome for patients, doctors and supporters. They
have a section on treatment and monitoring of INR by patients themselves with self-testing INR
machines, and we would recommend contacting them for any advice on this subject.
www.hughes-syndrome.org