St. Jude Medical Merlin PSA EX3100, Руководство пользователя

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A-14 Technical Data
• Automated Cleaning and Disinfection
• Manual Cleaning
• Manual Disinfection
• Sterilization
• Storage
• Before Using
Preparation for Cleaning
• Immediately after using the Patient Cable Model EX3150, remove excess soil from the patient cable
with a disposable cloth or paper wipe.
• Do not attempt to disassemble the patient cable.
• Carefully release the clips to separate the three pairs of connectors.
• Within an hour of its last use, soak the patient cable in potable water and Cidezyme™
2
enzymatic
detergent solution for at least one hour according to manufacturer’s instructions.
3
• Rinse the cable thoroughly in potable water after soaking it to remove any residual detergent.
You can clean the cable either through an automated system ( Automated Cleaning and Disinfection )
or manually (see Manual Cleaning ).
Automated Cleaning and Disinfection is recommended over Manual Cleaning for optimal results.
Automated Cleaning and Disinfection
The goal in cleaning the Patient Cable Model EX3150 is to remove any surface contamination on the
product to facilitate the disinfection and sterilization of the cable. Thus, cleaning must be viewed as the
first step in the process that includes disinfection and sterilization for eventual re-use of the cable.
The goal of disinfection is reduce the bioburden to a level so that the sterilization process will reach a
sterility assurance level (SAL) of 10
-6
.
Equipment:
- Washer/disinfector complying with ISO 15883-1
- Detergent and neutralizer: Neodisher™ FA & Neodisher™ Z
4
, or
2. Cidezyme™ is a trademark of Advanced Sterilization Products.
3. St. Jude Medical has validated the following challenge parameters for cleaning efficiency: Cidezyme enzymatic
detergent solution 0.8% v/v, 20°C +/- 2°C, 60 min soak.
Note
Soak for at least 60 minutes in Cidezyme enzymatic detergent solu-
tion. Prolonged exposure to detergent may reduce the expected life
of the product. If soaking for longer periods than two hours, soak in
water until further processing. Do not soak the cable for longer
than 24 hours.
Minimize the time between presoak and cleaning to prevent the
cable from drying.
Do not exceed concentration recommended by the manufacturer of
the detergent.
Follow the detergent’s instruction for use to optimize cleaning effi-
ciency.