|
TECHNICAL
DATA
|
| |
| RINSING/CLEANING |
| ARM-01™ rinses
both the blood and dialysate compartment
with AAMI quality water along with a
cleaning solution such as peracetic
acid / hydrogen peroxide. |
| TOTAL
CELL VOLUME TEST |
| The dialyzer
is tested to determine the total cell
volume Pass/Fail criteria and is based
upon the percent of the original priming
volume according to the clinic's protocol
(>80% minimum). |
| PRESSURE
LEAK TEST |
| The dialyzer
blood side compartment is pressurized
with the dialysate compartment vented
to drain. The rate of leak (mmHg / minute)
is calculated and the appropriate pass
/fail criteria are applied. |
| DISINFECTANT
FILL |
| The dialyzer
under test will be filled with the chemical
germicide to destroy and retard bacterial
growth. |
| DIALYZER
LABELING |
| Each reprocessed
dialyzer will have a unique label that
allows accurate device and patient identification. |
| CHEMICAL
AGENTS |
| The ARM
01™ is currently 510K Cleared
for Peracetic Acid/ Hydrogen Peroxide. |
