Sterilization; Storage - EDAN Acclarix LX4 User Manual

Acclarix LX4 Diagnostic Ultrasound System User Manual

6.3.3. Sterilization

Intra-operative transducers must be sterilized after each exam.
Sterilizing the transducers:
1. Disconnect the transducer from the system.
2. Wear protective gloves to prevent infection.
3. Clean and dry the transducer according to the methods in section 6.3.1 Cleaning.
4. Prepare the disinfectant solution (Cidex Glutaraldehyde 2.4%). Refer to the instructions
provided by the disinfectant manufacturer for the concentration of the disinfection solution,
method of dilution, method of disinfection, temperature and cautions during use.
5. Place the cleaned and dried transducer in contact with the disinfectant (refers to figure 6-2 for
the contacting area) for 10 hours. Or, follow the time specified by the disinfectant
manufacturer to soak the transducer.
6. Flush the transducer with plenty of sterile water (about 2 gallons) at least one time. Or, follow
the complete rinsing instructions provided by the disinfectant manufacturer to rinse the
transducer.
7. Wipe off the water on the transducer with a dry sterile cloth. Leave the transducer to air dry.
8. Inspect the transducer to ensure that there is no damage.
1. Do not sterilize the transducer using techniques such as autoclave, ultraviolet, gamma
radiation, gas, steam, or heat. Severe damage may result.
2. If L17-7SD transducer is applied to normally sterile tissue without using a sterile
sheath, it must be sterilized. If L17-7SD transducer is applied to normally sterile tissue
using a sterile sheath, it should be sterilized, or disinfected(High-level disinfection).

6.3.4. Storage

1. Dry the transducer after high-level disinfection or sterilization and store it in sterile
environment.
2. Do not use the carrying case for storing the transducer, because the carrying case
may become a source of infection.
1. Ensure the transducer is cleaned, disinfected, sterilized and completely dried before storage.
2. Store the transducer in a sterile environment or in a disposable sterile package.
3. Store the transducer under the following conditions:
a) Atmospheric Temp.: -20℃〜+55℃
b) Relative Humidity: 15%~95% (Non-condensing)
c) Atmospheric Pressure: 70kPa ~ 106kPa.
WARNING
WARNING
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