Packaging Symbols - Haemonetics TEG 6S Manual De Instrucciones

Reference Ranges for QC Level 1
Citrated Blood Parameter
R (min)
K (min)
Angle (deg)
MA (mm)
Specific Performance Characteristics
Precision
The precision of the TEG System QC Calcium Chloride cartridge with Level 1 was
evaluated according to CLSI EP5-A2. Testing was performed for within-device (20-day
tests using QC Level 1), and multi-site reproducibility tests were performed across three
sites, three lots, three operators and three analyzers. Results included Coefficient of
Variance (CV) values for all precision tests. The CV of the test results was less than
10% for all parameters.
Legal Notice
Licensed for sale or use only in in-patient hospitals and any laboratories that are primary
providers of such hospitals.

Packaging Symbols

Symbol
EC REP
REF
CONTROL
IVD
4 / EN
Range
0.7 – 1.7
0.4 – 0.6
77 – 86
54 – 67
Description
Manufacturer (address for)
Authorized representative in the European
community (address for)
CE mark
Catalogue number
Batch code
Control
In vitro diagnostic device
Consult instructions for use
Do not reuse
Temperature limitation for storage
(Applies to USA only) USA Federal Law
restricts the sale, distribution or use of this
device to, by or on the order of a physician.