C-Trak Apollo
Disinfection (continued)
Drying
Maintenance, Inspection
and Testing
Packaging
Sterilisation
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a) Take one Rinse Wipe sachet.
b) Remove the Wipe from its sachet and lay it out in the palm of your hand.
c) Wipe the surface of the device that has been decontaminated to remove excess foam.
d) Discard the used Wipe and gloves in accordance with local regulations.
Do not reuse. Keep the empty Wipe sachet for traceability.
For the Tristel Trio Wipes system, upon completion of the decontamination cycle, the device
should be left to air dry. Store the device in accordance with hospital protocols to prevent
damage or recontamination.
See Sections 2.4.7 and 3.0 for System Test information.
Probes and cables should be inspected visually prior to any processing operation
being undertaken for any signs of degradation, surface corrosion or damage.
There are no specific methods for packaging or containing the medical
device during and/or after processing.
All probes in the C-Trak
family of probes are operated while sheathed in a sterile disposable sleeve
®
such as those commonly used with ultrasound probes or laparoscopic cameras.
CAREFULLY FEED PROBE AND CABLE INTO SHEATH.
DO NOT DROP PROBE INTO SHEATH AS THIS PLACES
STRESS ON THE CABLE CONNECTIONS.
Ethylene Oxide
Validated by Nelson Laboratories, Inc., Salt Lake City, UT, USA.
Preconditioning Parameters:
Temperature:
Relative humidity:
Vacuum set point:
Steam partial pressure:
Preconditioning set point:
Preconditioning time:
Sterilisation Parameters:
Temperature:
Relative humidity:
Pressure set point:
Ethylene oxide concentration: 725 ± 25 mg/l
Gas exposure time (full cycle): 2 hours
Aeration time (full cycle):
Aeration temperature:
ASP Sterrad 100S
A full cycle of ASP STERRAD 100S Steriliser (from Advanced Sterilization Products, Inc.).
Validated for 100 cycles by Advanced Sterilization Products, Inc., Irvine, CA, USA.
ASP Sterrad 100NX
A DUO cycle of Sterrad 100NX Steriliser (from Advanced Sterilization Products, Inc.).
Validated for 20 cycles by Advanced Sterilization Products, Inc., Irvine, CA, USA.
STERIS V-PRO® Low Temperature Sterilization Systems
V-PRO® maX, maX 2, 60 s2 Lumen/Non Lumen/Flexible Sterilizer/Cycles (from STERIS
Corporation). Validated for 101 cycles by STERIS R&D, Mentor, OH, USA.
Note: Sterilisation methods other than those described above could damage the probe and cable,
void the warranty and could result in injury to the operator or patient.
54 ± 2°C
70 ± 5%
1.3 psia
2.18 psia
2.8 psia
1 hour
54 ± 2°C
70 ± 5%
9.3 psia
12 hours
51 - 59°C
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