Chapter 9. Probes 9 – 13
9.1.5. Cleaning and Disinfecting the Probe
All probes must be cleaned and disinfected after each use. Cleaning is an important procedure
that must be carried out before disinfecting the probe. For cleaning the probe please refer to the
appropriate chapter. Using an inappropriate disinfectant may damage the probe.
Always use protective eyewear and gloves when cleaning and disinfecting
probes.
Inspect the housing, strain relief, lens and seal for damage, and check for
any functional problem after cleaning and disinfecting the probe.
Using an inappropriate cleaning or sterilizing agent may damage the product.
9.1.5.1. Information of Detergent, Disinfectant, and Ultrasound Gel
■ Classification of Disinfectants
To maintain the performance of ultrasound probes, proper maintenance is required.
As ultrasound probes are classified into critical, semi-critical or non-critical devices based on
the standards of FDA guidance* and the Hygiene Requirements for the Reprocessing of
Medical Devices from Germany guideline of Robert Koch Institute(RKI), proper cleaning and
disinfection or sterilization methods for that classification should be used.
Classification
Criteria
Contact Area Application Probe Level Selection
Non-critical
device
Intact skin
Convex, Linear array, and
sector transducers
Low level disinfectant
Semi-critical
device
Mucous membrane and
damaged skin
Endocavity High level disinfectant
Critical device Blood, sterile tissue, etc. Intraoperative, TEE
High level disinfectant or
sterilization
* Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and Transducers - Appendix D
* It is recommended that only high level disinfectants are used for Endocavity probes.
An appropriate detergent, disinfectant or ultrasound gel should be selected for all probes.
Please use an appropriate detergent, disinfectant or ultrasound gel by referring to Samsung
Medison website and the user guide. All probes are tested under IPX 7 Criteria.
• User guide: provided as a booklet when the product is purchased.
• Website: http://samsungmedicalsolution.com
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