Haemonetics TEG 6S Manual De Instrucciones página 3

EN - English
Proprietary Name and Established Name
Proprietary Name: TEG
(QC) material:
• CaCl (Calcium Chloride) Cartridge and Level 1 QC material
2
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.
The TEG 6s System is used to test the hemostasis properties of blood samples.
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.
Principles of the Procedure
The TEG Hemostasis System whole blood coagulation control Level 1 contains a
preparation of citrated animal plasma. It has been formulated specifically as a quality
control for the TEG analyzer. This control contains no human material. For in vitro
diagnostic use. For professional use only.
Reagents
CaCl (Calcium Chloride) and Level 1 QC Material
2
• Dried Calcium Chloride (adequate to reverse citration in the QC material).
• QC Level 1 Material, consisting of one 1 mL vial of lyophilized citrated bovine plasma
and one 1 mL vial of diluent water for reconstituting the lyophilized material.
Warnings and Precautions
For In-Vitro Diagnostic Use
Hazards
The QC Level 1 material is potentially hazardous in case of ingestion, inhalation, skin
contact and eye contact. It contains animal source material; therefore, it should be
treated as potentially infectious. Use universal precautions for handling potentially
bio-hazardous material. It may cause adverse effects for the environment if discarded
improperly.
6s System and the following cartridge and Quality Control
®
1 / EN