User manual

0 4625706001(01)
R1 (black)
The following U.S. patents have been granted or are pending for the CoaguChek XS
System (meter and test strips): 6,662,439; 7,073,246; 2005/0103624; 6,881,378; 6,207,000;
2005/0214171; 2005/0123441; 6,645,368; 2004/0157339; 2005/0129574; 2005/0135968
COAGUCHEK is a trademark of Roche.
©2006 Roche Diagnostics. All rights reserved.
Made in Germany
Manufactured by:
Roche Diagnostics GmbH
D-68298 Mannheim
www.roche.com
www.coaguchek.com
Distributed in the U.S.A. by:
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46256
Accuracy: 700 capillary samples were collected from 357 outpatients at three ex-
ternal sites. Capillary blood samples were assayed on the CoaguChek XS meter with
the CoaguChek XS PT Test and venous plasma samples were measured on a Sysmex
Analyzer with Dade Innovin (ISI = 1.02) The results comparison is as follows:
Capillary Data:
N Slope Intercept Correlation
Site 1 230 1.111 -0.10 0.973
Site 2 229 1.081 -0.068 0.979
Site 3 241 0.952 0.02 0.985
All 700 1.006 0.032 0.971
Whole Blood Precision for Venous Blood
Mean of Replicates
0 1 2 3 4 5 6 7 8
Difference Between Replicates
1.0
.8
.6
.4
.2
.0
-.2
-.4
-.6
-.8
-1.0
Built-In Controls and Diagnostics
The CoaguChek XS System has quality control functions integrated into the meter
and test strips, so you never have to run quality control tests with liquid quality
controls. The meter automatically runs its own quality control test as part of every
blood test. For more information about the built-in quality control functions, see the
CoaguChek XS System User Manual.
References
1. Moll, S and Ortel, TL. “Metering Warfarin Therapy in Patients with Lupus Anticoagu-
lants.” Annals of Internal Medicine 1997; 127: 177-185.
2. Loeliger EA, van den Besselaar AMHP and Lewis SM., “Reliability and Clinical
Impact of the Normalization of the Prothrombin Times in Oral Anticoagulant Control.”
Thromb Haemostas, 1985; 53: 148-154.
Return Policy
If there is a problem with the CoaguChek XS PT Test Strips, you may be asked to
return them, along with the Test Strip Code Chip, to Roche Diagnostics. Before return-
ing, call Roche Diagnostics Technical Service Center at 1-800-428-4674. You will be
mailed a return authorization label which must be put on the shipping carton.
Additional Information
The CoaguChek XS System User Manual contains more information. If you still have
questions, call Roche Diagnostics Technical Service Center at 1-800-428-4674,
24 hours a day, 7 days a week.
Limited Warranty
Roche Diagnostics warrants that your CoaguChek XS PT test strips will be free from
defects in materials and workmanship until the product expiration date printed on the
label if the test strips are used and stored in the manner described in this package
insert and in your CoaguChek XS System User’s Manual. If, prior to the expiration date
of the test strips, there is a defect in materials or workmanship, Roche Diagnostics will
replace the test strips free of charge. Your sole and exclusive remedy with respect to
the strips shall be replacement. Any warranty claim should be directed to the Roche
Diagnostics Technical Service Center at 1-800-428-4674.
THE ABOVE WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES, AND
ROCHE DIAGNOSTICS MAKES NO OTHER WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT
Capillary Data from All Sites
700 Samples from 357 Patients
Dade Innovin INR
CoaguChek XS INR
9
8
7
6
5
4
3
2
1
0
0 1 2 3 4 5 6 7 8 9
y = 1.006x + .032
Slp Cl (0.990, 1.023)
Int Cl (-0.01, 0.06)
Correlation = 0.971
Precision: Whole blood precision was determined for venous and capillary blood
from sample duplicates collected at three sites. The following charts represent whole
blood precision for venous and capillary blood.
Whole Blood Precision for Capillary Blood
Mean of Replicates
Difference Between Replicates
0 1 2 3 4 5 6 7 8
1.0
.8
.6
.4
.2
.0
-.2
-.4
-.6
-.8
-1.0
SHALL ROCHE DIAGNOSTICS BE LIABLE TO THE PURCHASER OR ANY OTHER
PERSON FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL OR
PUNITIVE DAMAGES ARISING FROM OR IN ANY WAY CONNECTED WITH THE
PURCHASE OR USE OF THE TEST STRIPS. NO WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE, IF ANY IS IMPLIED FOR THE SALE
OF THE TEST STRIPS, SHALL EXTEND FOR A LONGER DURATION THAN THE
EXPIRATION DATE OF THE TEST STRIPS.
"