Introduction; Getting Your System Ready For Testing; Contacting Hemosense - HemoSense INRatio2 PT Benutzerhandbuch

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1. Introduction


Before You Begin
Before using this system to test your Prothrombin Time (PT), read this entire User Guide and
the inserts that came with the INRatio Test Strips and the Lancet device.
Take special note of CAUTIONS
training on the INRatio2 PT Monitoring system and practice the test with a health care
provider before you begin using the system.
Intended Use
The INRatio2 PT Monitoring system is used for the quantitative measurement of Prothrombin
Time (PT) in fresh, capillary whole blood. The INRatio2 PT Monitoring system is intended
for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral
anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood.
The INRatio2 PT Monitoring System is not intended to be used for screening purposes.
The INRatio2 PT Monitoring system should only be used with a prescription from your physician.
Test Principle
A drop of blood is applied to the test strip, where it is drawn into the test area. The blood
mixes with reagents that start the clotting reaction. As the blood clots, there is a change in
the impedance in the sample. The monitor detects the change and then calculates the PT for
the sample and reports the result on the screen.
The reagents used in performing PT tests can vary substantially between testing methods.
This may cause differences in test results depending on the method used. For this reason,
the International Normalized Ratio (INR) unit was developed. The INR is a mathematical
correction of the PT result that adjusts for sensitivity differences in reagents. The INRatio2 PT
Monitoring system provides both a PT and INR result with every test.

2. Getting your System ready for Testing

Your INRatio2 PT Monitoring system comes with:
• INRatio2 PT Monitor
• Self Test User Guide
• Quick Reference Guide
• Reusable Lancet Device
• Disposable Sterile Blood Lancets
throughout this User Guide. You must complete proper
• Gauze and alcohol pads (USA only)
• 4 x AA Alkaline Batteries
(not installed)
• Carrying Case
• Training Video
NOTE: The INRatio2 PT monitor uses standard AA alkaline batteries.
You will also need:
• INRatio Test Strips
• Puncture resistant (Sharps) container
Optional accessories not provided with this system kit:
• Power Supply (available from HemoSense). Power from a standard wall outlet
can be used to power the monitor instead of using battery power. DO NOT use
any other Power Supply with the INRatio2 PT Monitoring system or you may
damage the system.
The Power Supply, additional INRatio Test Strips, the Lancet Device and Sterile Blood Lancets
may be ordered through an authorized INRatio2 distributor.

. Contacting HemoSense

Contact HemoSense Customer Service if you have questions about your system kit contents.
Customer Service
1-877-436-6444 (toll free) or 1-408-719-1393
Customer Service available 7am – 5pm (PST), Monday – Friday
To re-order supplies, contact the distributor who provided you with the INRatio2 system kit.
Product Part Number
INRatio Test Strips 0100071
(Box of 12)
INRatio2 PT Monitor Power Supply 0100011
USA
INRatio2 PT Monitor Power Supply 0100260
with Worldwide Plugset
Autolet Impression Device 0200497
Unilet GP 21g Lancets 0200122
(Box of 12)
Unilet GP 21g Lancets 0200138
(Box of 100)
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Description
12 single-use test strips for use
with the INRatio2 PT Monitor
USA Power supply for use
with the INRatio2 PT Monitor
Worldwide Power supply for use
with the INRatio2 PT Monitor
Reusable Lancet Pen
Disposable sterile blood lancets for
use with the Autolet Impression
Disposable sterile blood lancets for
use with the Autolet Impression