13-42 Probes and Biopsy
Hydrogen Peroxide and Peroxyacetic Acid -based sterilant:
DISINFECTANT
(applicable for
Canada region only)
Peroxide
4.5% Peroxyacetic Acid
Please refer to the instructions provided by
the manufacturer of the solution for details.
The plastic bracket can be sterilized using MINNCARE LIQUID DISINFECTANT at least 245
times (11 hours per time) before its safety and performance is affected.
High-pressure steam sterilization
High-pressure steam sterilization is preferred for the metal guided brackets.
1. Wear a pair of gloves to prevent infection.
2. Clean the needle-guided bracket thoroughly in accordance with the cleaning procedure
before sterilization.
3. Package the needle-guided bracket in accordance with the sterilization requirements of
surgical instruments
using the sterilization wrap or pouch cleared by FDA.
4. Place the packaged needle-guided bracket inside a high-temperature steam sterilizer and
perform sterilization. The sterilization parameters are 121°C and 30 minutes for a gravity
displacement steam sterilizer.
5. Take out the sterilization package after sterilization and dry it in an oven at 60°C for 20–
30 minutes.
6. Keep the sterilization package together with other sterilized surgical instruments in a
sterile item storage area.
7. Check whether the needle-guided bracket has defects such as deformation and rusting
before use. If such defects exist, the bracket has reached the end of its service life. In this
case, stop using it and contact the Mindray service department.
1.
Repeated sterilization may degrade the safety and performance of the needle-
guided bracket. Please check the needle-guided bracket’s performance
periodically.
2.
Needle guided brackets are required to verified before each biopsy. If the
verification fails, it indicates that the needle-guided brackets are out of service
life. For details about needle guided bracket verification, please refer to "13.2.5
Verify Biopsy Guide Line".
13.2.9 Storage and Transportation
Don’t use the carrying case for storing the needle-guided bracket. If the carrying case is
used for storage, it may become a source of infection.
Between examinations, keep the needle-guided bracket in a sterile environment.
When the needle-guided bracket is sent to your MINDRAY representative for repair, be
sure to disinfect or sterilize it and keep it in the carrying case to prevent infection.
Sterilize the carrying case as necessary.
Store or transport the needle-guided bracket under the following ambient conditions:
Ambient temperature: -20°C ~ 55°C
Relative humidity: 30% to 95% (no condensation)
13.2.10 Disposal
Be sure to dispose the needle-guided bracket only after sterilizing it.
Contact your MINDRAY representative when disposing of this device.
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