Intended Use - Haemonetics TEG 6s Manual Del Usuario

EN - English
Proprietary Name and Established Name
Proprietary Name: TEG 6s System Abnormal QC Vial Test Kit
®
containing the following Quality Control (QC) material:
• Abnormal QC material, water vials
Established Name: Whole Blood Hemostasis System

Intended Use

The TEG 6s Hemostasis Analyzer is a non-invasive diagnostic instrument
®
designed to monitor and analyze the coagulation state of a blood sample
in order to assist in the assessment of patient clinical hemostasis
conditions. The TEG 6s analyzer is indicated for use with adult patients
where an evaluation of blood coagulation properties is desired.
Results from the TEG 6s analyzer should not be the sole basis for a
patient diagnosis, but should be evaluated together with the patient's
medical history, the clinical picture and, if necessary, other coagulation
tests.
Summary and Explanation of the Test
The TEG analyzer performs internal QC checks during a pretest when
the cartridge is inserted. This verifies that all electromechanical and
pneumatic functions of the analyzer-cartridge combination are operating
satisfactorily. Laboratories should perform QC testing as required
in accordance with current CLIA Regulations regarding levels and
frequency of control materials. Haemonetics provides QC Level 1 and
Level 2 materials and Calcium Chloride cartridges to be used for this
purpose. For more information, refer to the QC Level 1 and QC Level 2
cartridge package inserts.
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