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5-2. Reprocessing instruction according to ISO 17664
Take care about clean circumstances before using the probe on the next patients. If processors reprocess this
equipment, refer to these instructions.
Table 1
WARNINGS
Limitations on
reprocessing
Transportation
before using
The level of processing required depends on the type of equipment and its use.
The CDC (Centers for Disease Control and Prevention) in the USA and the RKI (Robert Koch Institute) in
Germany classify medical devices according to their use. For each classification, they specify the level of
disinfection/sterilization processing that is required before use. Table 3 summarizes this information.
Table 2
Classification
Noncritical
Semicritical
Critical
*
1 .
When sterilization is not possible, the FDA in the USA recognize that disinfection (in the USA, high-
level disinfection) and the use of a sterile gel and sterile transducer cover, as described in the instructions
provided with the transducer cover, is an accepted method of infection control for probe.
・ The probe is delivered unsterile. Prior to the first use, reprocess the probe.
・ Do not exceed 60 °C [140 °F].
・ Probe connector has no water resistance.
The probe is not completely submergible (Do not immerse the probe into any liquid
beyond the range of IPX7. The range is indicated in the section 2-2 "specification". ）
Parts which are not submergible can only be disinfected by wipe disinfection.
Sterile pouch or container should be kept between transportation from Central
Sterile Supply Department (CSSD) to operating room. Be careful that no damages
are applied to sterile pouch or container for transportation.
Definition
Application part only contacts
intact and uninjured skin
Application part contacts mucosa
(intracavitary application)
Application part contacts
intracorporeal tissue directly
(intraoperative application)
[in the USA, low-level disinfection]
Disinfection (Disinfectant with bactericidal,
fungicidal and virucidal effect)
[in the USA, high-level disinfection or
-29-
MN1-5752
Processing
Cleaning
↓
Disinfection
Cleaning
↓
sterilization]
Cleaning
↓
Disinfection
↓
Sterilization *
1
Rev.8
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