The next generation in POC anticoagulation testing from Roche Diagnostics

CLIA-Waived

The CoaguChek® XS System A smart way to test

The NEW CoaguChek XS SystemThe new CoaguChek XS System uses exclusive smart technology to help ensure accurate results, and offers the flexibility and control that healthcare professionals need to confidently manage a wide range of anticoagulated patients.

Accurate and flexible technology

• Accurate,preciseresultsinoneminute

• Theonlysystemtoperformonboardquality

controlanddeterminepatientresultsinasingle

testchamber1, 2

• Neutralizestherapeuticlevelsofheparin

andLMWH1

• INRcorrectedforhematocritwithinspecifiedrange–

manageabroadarrayofpatientswithonedevice1

Easy and convenient to use

• Smallsamplesize(10µl)foreasydosing

• Stripallowsdosingfromeithertoporsidefor

simplebloodapplication

• 18-monthstripshelflife–norefrigerationneeded

• Outsidemeterbloodapplication–minimizes

potentialforcross-contamination1

• Small,battery-powered,handheldmeterfor

portabilityandefficiency

The NEW CoaguChek XS SystemThe new CoaguChek XS System uses exclusive smart technology to help ensure accurate results, and offers the fl exibility and control that healthcare professionals need to confi dently manage a wide range of anticoagulated patients.

Easy and convenient to use

• Smallsamplesize(10µl)foreasydosing

• Stripallowsdosingfromeithertoporsidefor

simplebloodapplication

• 18-monthstripshelflife–norefrigerationneeded

• Outsidemeterbloodapplication–minimizes

potentialforcross-contamination1

• Small,battery-powered,handheldmeterfor

portabilityandefficiency

Effi cient and cost-effective

• Newonboardcontrols–noexternal

QCnecessary

• Auto-onwithstripinsertionand

auto-offcapabilities

• Testing,treatmentandpotentialrevenue

captureinoneappointment3

• Fingersticktestthatpatientsprefer4

The leader in point-of-care anticoagulation monitoring

Since1994,RocheDiagnosticshashelpedhealthcare

professionalsprovidequalitycaretotheirpatientswith

aPT/INRmetertheytrust.Findoutwhy4outof

5point-of-carePT/INRtestsareperformedwitha

CoaguCheksystem.5ContactyourRocherepresentative

toscheduleanin-officedemonstration.

The CoaguChek XS System combines true innovation with the accuracy, precision, reliability and ease-of-use that physicians demand.

The CoaguChek XS System includes meter, user manual, training DVD, Getting Started guide,The CoaguChek XS System includes meter, user manual, training DVD, Getting Started guide, 5-pack sample lancets, 5-pack sample bleach wipes, and 4 AAA batteries. 5-pack sample lancets, 5-pack sample bleach wipes, and 4 AAA batteries.

DESCRIPTION

Test Principle

Measurement Time

User Interface

Position

Measuring Range

Coding

Sample Application Point

Memory Capacity

Interface

Auto Power

Power Supply

Battery Life

Operating Temperature

Relative Humidity

Maximum Altitude

COAGUCHECK XSCOAGUCHECK XS

Amperometric determination of Amperometric determination of the PT time after activation of the the PT time after activation of the coagulation with hrTFcoagulation with hrTF

Approximately 1 minuteApproximately 1 minute

Simple user interface Simple user interface with icon-based LCD with icon-based LCD

Monitor on a level, Monitor on a level, vibration-free surfacevibration-free surface

0.8 – 8.0 INR0.8 – 8.0 INR

Code Key

Outside the meterOutside the meter

100 test results with 100 test results with date and timedate and time

Infrared interfaceInfrared interface

Auto-on with strip insertion; Auto-on with strip insertion; auto-off in 3 minutesauto-off in 3 minutes

4 x 1.5v AAA batteries4 x 1.5v AAA batteries

Approx. 60 testsApprox. 60 tests

+65°F to +90°F+65°F to +90°F

Up to 85%

14,000 ft.

Product Specifi cations1

Capillary Data from All Sites700 Samples from 357 Patients

Dade Innovin INR

9876543210

Coag

uChe

k XS

INR

9

8

7

6

5

4

3

2

1

0

y = 1.006x + .032Slp CI (0.990,1.023)Int CI (-0.01, 0.06)Correlation = 0.971

Results from the CoaguChek XS monitor show a. .97 correlation coeffi cient with tested lab methods.1

POC anticoagulation testing with the CoaguChek XS System — a smart way to test

1 CoaguChek XS System package insert. Indianapolis, IN. Roche Diagnostics Corporation, 2006.2 INRatio® System package insert. Milpitas, CA. HemoSense Inc., 2003. ProTime® System package insert. Edison, NJ. ITC, 2006.3 Campbell, P., Radensky, P., Denham, C. Economic analysis of systematic anticoagulation management vs. routine medical care

for patients on oral warfarin therapy. Disease Management and Clinical Outcomes, December 2000. 4 Fintel D. and Hoffman C. The physician’s guide to preventing strokes and lowering health risks in patients with atrial fi brillation.

Northwest University Medical School, 1997.5 Third quarter 2006 total market share of projected distributor unit sales of the Point of Care Testing Coagulation Reagents and

Kits product class by HPIS Market Intelligence, a division of GHX Global Healthcare Exchange. Total Market includes all market sectors as defi ned by HPIS: Physician, Long Term Care, Treatment Centers, Clinical Laboratory, Hospital, Home Healthcare and Other/Unspecifi ed. Data on fi le.

Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250

COAGUCHEK is a trademark of Roche. All other trademarks are the property of their respective owners. © 2007 Roche Diagnostics. All rights reserved. 573-33886-1206

www.coaguchek.comwww.roche-diagnostics.us