These instruments are for minimal invasive surgery. They are shipped non-sterile and must be sterilized before use. ASTRA SURGICAL, as manufacturer and seller of the product, accepts no liability for indirect damage or preparation, sterilization or maintenance. Instruments are only to be used as designated in their specialized medical fields by the respective trained and qualified personnel. They are not intended to be used on the central circulatory or central nervous system.
MAINTENANCE AND CARE
Every instrument must be cleaned and sterilized before being used for the first time and after every subsequent use. • Appropriate cleaning, inspection and maintenance help to ensure the serviceability of surgical instruments and prolong service life. • Clean, inspect and test all instruments thoroughly, and sterilize before use. • Cleaning and rinsing should be done promptly after every use. Otherwise tissue particles or dried secretions may adhere to it, which may make subsequent cleaning and sterilization difficult, if not impossible. Instruments must be entirely free of any foreign bodies.
HANDLING, STORAGE AND STERILIZATION
Extreme care must be exercised while using, transporting, cleaning, sterilizing, and storing. Damage to the function and safety of the instrument may occur if the instrument is handled roughly or improperly or used for something other than its intended purpose.
DISASSEMBLING & CLEANING
- Take apart the biopsy needles so all the pieces are separate (A, B, C & D)
- Check the condition of the sealing cap. Replace if broken or in hard, brittle condition
The instruments can be sterilized fully assembled (recommended) or it can be sterilized disassembled and then reassembled in a sterile field in the operating room.
1- When using the wrap method, make certain that all complete instruments and all parts are individually wrapped or sealed in a sterile pack.
|Cycle||Sterilizing Temp||Sterilizing Time||Drying Time|
|Prevaccum / Wrapped||270°F (132°C)||4 minutes||30 minutes|
|Gravity / Wrapped||250°F (121°C)||30 minutes||45 minutes|
|Gravity / Wrapped||270°F (132°C)||15 minutes||45 minutes|
2- ETO Sterilization:
Instruments can be sterilized by ethylene oxide in any standard cycle. Pressure reading should not exceed 12 PSI. Temperature should not exceed 68.3°C (155°F). It is recommended to follow the manufacturer’s instructions for the ETO sterilization unit concerning humidity, vacuum, cycle time, gas concentration and temperature.
3- Sterrad Sterilization Process: Uses low temperature plasma. Adhere to the sterilization instructions provided by the manufacturer (e.g. Johnson & Johnson).
4- Flash Autoclaving (fast heating/cooling cycle): Flash autoclaving will reduce the useful life of the instrument, particularly when it is constructed of various materials, encom-passing different expansion rates. Caution: Continued use of this process will cause premature failure of instruments, especially the insulation.
5- Chemiclaving – Soaking: Not Recommended This is destructive to the insulating and silicone materials and can cause rapid deterioration and failure.
Warning: If this device is/was used in a patient with or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross-contamination!