80834 REV ED
13
CyberWand Dual Ultrasonic Lithotripsy System • Instructions for Use
EN
EN
5.4 Steam
Sterilization
Thoroughly clean, rinse, and dry transducers, probes, cleaning stylet, and wrench prior to sterilization.
CyberWand components may be sterilized in a steam sterilizer controlled within the following
parameters:
Probe Sets
Prevacuum
Transducer
Prevacuum
(polypropylene double wrapped)
Temp:
°F
270
270
°C
132
132
Vacuum
20-28 in Hg
20-28 in Hg
Pressure
25-28 psig
25-28 psig
Exposure (minimum)
4 minutes
60 minutes
5.4.1 Caution
Never rinse the CyberWand components with cooled water for speedy cooling after sterilization.
Sudden changes in temperature may damage the components.
NOTE:
• Both sterile (
REF
CW-RBPBX) and non-sterile (
REF
CW-USLRBP) probes are identical.
• All sterile and non-sterile probes are single-use.
• Sterile probes can be steam sterilized with the same method as non-sterile probes if opened and
unused.
• See the Instructions for Use for the sterile probes for more details.
5.5 Ethylene Oxide Sterilization
The transducer, probe, cleaning stylet, and wrench can be sterilized in an ethylene oxide (EO) sterilizer.
1. Thoroughly clean, rinse, and dry prior to sterilization.
2. The devices can be placed in an ethylene oxide (EO) sterilizer controlled within the following
parameters:
EO (100%)
Temp °F (°C):
131 (55)
Rel. Humidity:
> 35%
Vacuum:
2–3 psia (0.14 – 0.20 bar)
Preconditioning Time:
≥
30 minutes
Gas Conc.:
725–750 mg/l
Exposure:
≥
60 minutes
3. After EO exposure, aerate for a minimum of 12 hours at 131°F (55°C) in a mechanical aerator.
5.6 STERRAD™
Sterilization
DO NOT USE STERRAD TO STERILIZE TRANSDUCER.
STERRAD sterilization has not been tested for,
submitted to, or cleared by the FDA for transducer, probe, or component sterilization.
5.7 Caution
CyberWand transducer components can be processed until they exhibit evidence of deterioration, such
as cracking on the transducer or broken insulation on the cable. At such time they must be removed
from use and discarded. Please refer your facility’s procedure for medical waste disposal. Check
carefully for cracking and broken cable after each sterilization.
