Vers.: 20230710ENG
Page 63
12 Appendices
A. Specifications
A.1 Classification
According to the CE classification, the Element HT5+ Hematology Analyzer belongs to in vitro
diagnostic medical devices other than those covered by Annex II and devices for performance
evaluation.
A.2 Reagents
Reagents :
A.3 Application tubes
The following tubes can be used:
• Purple top EDTA collection tubes filled at least halfway.
B. Sampling features
B.1 Sample volumes required for each analysis
Whole blood mode: ≤ 34 µl
Pre-diluted mode: ≤ 20 µl
B.2 Throughput
Open vial-whole blood and open vial-pre-diluted: no less than 40 samples per hour.