Siemens Healthcare XPRECIA STRIDE, User Manual, Page: 7 / 59

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Xprecia Stride User Guide 1. Exploring Stride
General warnings and precautions
‒ Always follow the safety procedures and precautions listed throughout this guide when using Stride.
‒ All parts of Stride are potentially infectious and capable of transmitting blood-borne pathogens between patients and
healthcare professionals.
‒ You must disinfect the device after each patient use. You can only use Stride for testing patients when all standard
precautions and the recommended cleaning and disinfection procedures in this guide are followed.
‒ Only use auto-disabling, single-use lancing devices with Stride.
‒ Refer to the following general safety reference materials for further information:
‒ Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007, found
at http://www.cdc.gov/hicpac/2007IP/2007isolationPrecautions.html.
‒ Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline-Third Edition
Clinical and Laboratory Standards Institute (CLSI) M29-A3.
‒ FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial Communication (2010), found at http://www.fda.gov/medicaldevices/safety/
alertsandnotices/ucm224025.html.
‒ CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood-borne
Pathogens (2010), found at http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
‒ Hematocrit range of 22–52% doesn't significantly affect test results.
Intended use
The Xprecia Stride™ Coagulation System, which includes
the Xprecia Stride™ Coagulation Analyzer and the
Xprecia™ System PT/INR Strips, is intended for use
by professional healthcare providers to provide an
INR (International Normalized Ratio) based on a
prothrombin time (PT) response for the monitoring of
oral anticoagulation therapy with warfarin, a vitamin K
antagonist. The Xprecia Stride™ Coagulation Analyzer is
intended to be used with only the Xprecia™ System PT/INR
Strips and the Xprecia™ System PT Controls. The analyzer
uses fresh capillary (fingerstick) whole blood applied to an
Xprecia™ System PT/INR Strip. It is intended
for in vitro diagnostic use at the point-of-care.
Xprecia™ System PT/INR Strips are for use with only
the Xprecia Stride™ Coagulation Analyzer for PT/INR
determinations by professional healthcare providers.
This product is for in vitro diagnostic use.
The Xprecia Stride™ Coagulation System is intended for
use in patients 18 years of age and older. Patients must
be stabilized (> 6 weeks) on warfarin therapy.
The Xprecia Stride™ Coagulation System is not intended
for use in patients who are transitioning from heparin
treatment to warfarin therapy.
Cleaning and disinfecting Stride
You must clean and disinfect the exterior of Stride, and the
test strip port protective cap, after patient and quality control
tests using a Siemens recommended germicidal wipe.
For more information on Cleaning and disinfecting Stride , see
page 70.
Understanding blood-clotting time
Warfarin is prescribed to prevent blood clots from forming
or growing larger in blood or blood vessels. When using
anticoagulation medication, patients have to stay within a
specific therapeutic range, as determined by their doctor.
The doctor needs to monitor the warfarin activity to ensure
that the medication dosage is correct. To monitor the
activity, the doctor orders a PT test. A PT test is a blood test
that measures the time it takes for blood to clot, reporting
results using the International Normalized Ratio (INR).
The INR was developed to standardize the PT results.
About the Xprecia Stride Coagulation Analyzer
Stride is a handheld in vitro diagnostic medical device that
monitors blood-clotting coagulation values in small amounts
of blood applied to test strips. Stride is a device for use in
professional healthcare and point-of-care settings.
Electronic Quality Control (EQC)
When each test strip is inserted, Stride automatically
conducts 2 on-strip quality control checks designed to
help ensure test strip integrity. The first control checks the
presence of adequate
sample reagent on the test strip, and
the second control detects test strip degradation due to
exposure to environmental conditions.