AB CI-4350-02 HiFocus Electrode Forceps
This document details the recommended care, cleaning, sterilization and maintenance processes for the following reusable surgical tools manufactured by Advanced Bionics:
CI-4350-02 HiFocus Electrode Forceps Kit (includes:)
CI-4350 Lateral Electrode Insertion Forceps (2)
For information on how to use these reusable surgical tools, refer to the surgeon’s manual related to the product/system.
BRĪDINĀJUMI UN BRĪDINĀJUMI
- All tools are supplied unsterilized, therefore, all tools must be thoroughly cleaned and sterilized prior to use.
- Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated materials, devices, equipment, and cleaning agents.
- Process temperatures should not exceed 145 °C (293 °F) to prevent damage to the tools.
REPROCESSING GUIDELINES
Lietošanas vieta:
- At the point of use and after use, submerge tools in water; this will prevent any contaminate drying on the tools.
- It is recommended that tools be reprocessed as soon as possible after use.
Sagatavošanās dekontaminācijai
- Rinse the tools under warm running tap water until visible soil is removed from the tools.
Cleaning: For cleaning, either the manual or automatic method can be used. - Equipment for Cleaning Methods: soft bristle brush or syringe, ultrasonic unit, washer-disinfector, lint-free cloth, alkaline detergent1 with pH≥10 – non-abrasive, low-foaming.
Manual Processing Steps:
- Prepare alkaline detergent per the manufacturer’s recommendation using warm tap water.
- Fully submerge the tools in an alkaline detergent solution and soak for three minutes.
- After three minutes of soaking, brush the tools with the soft bristle brush to remove any debris or soil.
- Remove the tools from the alkaline detergent solution and rinse under warm running tap water for three minutes.
- Prepare alkaline detergent per the manufacturer’s recommendation using warm tap water in an ultrasonic unit.
- Fully submerge the tools in the ultrasonic unit and sonicate for 15 minutes.
IMPORTANT: If using multiple tools, ensure they are not in contact with each other during sonication. - Remove the tools from the ultrasonic unit at the completion of sonication.
- Rinse the tools with Reverse Osmosis (RO) or Deionization (DI) water for one minute.
- Dry the tools with a lint-free cloth and then visually inspect tools for visual soil. If soil is present, repeat the cleaning process.
Automatic Processing Steps
- Rinse the tools under warm running tap water until no visible soil is present.
- A soft bristle brush or syringe may be used to aid in the rinsing.
- Place the tools in the washer according to the following parameters:
Minimum Washer Cycle ParametersFāze Recirkulācija Laiks (Minūtes) Ūdens Temperatūra Mazgāšanas līdzeklis Pirms mazgāšanas 02:00 Aukstais krāna ūdens Nav Mazgāt 02:00 65.5°C (150°F) Alkaline Detergent Noskalo 01:00 65.5°C (150°F) Nav Žāvēšana 15:00 90°C (194°F) Nav - Dry the tools with a lint-free cloth and then visually inspect the tools for visual soil. If soil is present, repeat the cleaning process.
Sterilizācija
Equipment: Pre-vacuum Sterilizer, Gravity Displacement Sterilizer, double barrier sterilization wrap
Processing Steps:
- Wrap tools in a double barrier sterilization wrap using the sequential envelope folding technique, and use the following parameters:
Minimum Sterilization Cycle Parameters
| Sterilizators Tips | Temperatūra | Pakavējies Laiks | Žāvēšana |
| Iepriekšējais vakuums | 132°C (270°F) | 4 minūtes | 15 minūtes |
| Gravitācijas pārvietošanās | 134°C (273°F) | 15 minūtes | 15 minūtes |
IMPORTANT: When sterilizing multiple tools, ensure that the sterilizer’s maximum load is not exceeded.
PĀRBAUDE UN APKOPE
- Carefully examine each instrument(s) to ensure that all visible contamination has been removed. If contamination is noted, repeat the cleaning process.
- Visually inspect the instrument(s) and if any of the following is noted discard the instrument(s) and contact Advanced Bionics as the function or use of the instrument may be compromised:
- Korozija
- Krāsas maiņa
- Pitting or cracks are noted
- Markings are not legible
- Prongs of the forceps are noted to be misaligned
- Guide pin of the forceps is noted to be misaligned with the mating hole feature on the opposing prong
- Examine the instrument to ensure its function. If found as not functional, discard the instrument(s) and contact Advanced Bionics.
UZGLABĀŠANAS IETEIKUMI
It is recommended that you follow the storage process established by the processing facility.
- Advanced Bionics LLC
- 28515 Westinghouse Place
- Valensija, CA 91355, ASV
- Tālr.: +1 661-362-1400
EK/REP
- Advanced Bionics GmbH
- Feodor-Lynen-Strasse 35
- D-30625 Hannover
- Tālr.: +49 511 5248 7522
The instructions provided above have been validated by Advanced Bionics as being capable of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the processing as actually performed using standard equipment, materials, and personnel in the processing facility to achieve the desired result. This requires validation and routine monitoring of the process. Likewise, any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. This guide is provided in fulfillment of ANSI/AAMI ST79, ANSI/AAMI ISO 17664 and ANSI/AAMI ISO 15883.
1For example: Neodisher Mediclean Forte Detergent
Dokumenti / Resursi
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