INSTRUCTION FOR USE
Rumex Instruments (ophthalmic scissors, forceps, hooks, choppers, manipulators, spatulas, markers) are designed for various applications in ophthalmic surgery.
INSTRUCTION FOR INITIAL USE
It is essential that the instrument be cleaned and sterilized before initial use by following the procedures as outlined in this instruction brochure.
CARE AND HANDLING
Instruments should be washed clean of all residues, dried and inspected after each use. It is imperative that as much moisture as possible is eliminated from all of the instrument parts since moisture promotes corrosion оf the instrument. Washing, drying and inspecting the instrument under magnification helps to ensure that the instrument is kept in proper condition for the next surgical procedure.
Use a mild soap solution and with a soft brush to clean the instrument and remove any stains. Never use abrasive powders or steel wool to remove stubborn stains - these can damage the superfine finish of an instrument and can actually help cause corrosion of stainless instruments. Use distilled or demineralized water to rinse instruments thoroughly, and then carefully dry them with a hot air blower or lint-free cloth. We recommend that the established surgical instrument cleaning procedures of your institution be followed using these instructions as а guideline. Thorough cleaning immediately after use is essential for the longevity of the instrument.
INSTRUMENTS DETERGENT AND/OR CLEANERS
Only detergents and cleaners specially designed for use on surgical stainless steel or titanium instruments are acceptable for use in the cleaning process. The cleaning guidelines of the solution manufacturer and your institution should be observed.
ULTRASONIC CLEANING EQUIPMENT
An ultrasonic cleaner could also be used in the instrument cleaning process, but not as the sole cleaning method. The instrument should, at the very least, be flushed with distilled water prior to being placed in the ultrasonic cleaner. А five to ten minutes cycle in the ultrasonic cleaner should be sufficient. The instrument must be secured on а silicone finger mat during the ultrasonic cleaning procedure. Special carе should be taken tо make certain that the tip of the instrument does not come into contact with the sides of the ultrasonic container, as this could damage the instrument.
Moving parts and working mechanisms of the Rumex instruments should be lubricated occasionally with а medical grade instrument lubricant (especially after an ultrasonic bath) tо ensure the smooth operation of the working mechanism. The recommended directions of the instrument lubricant manufacturer and your institution should be observed.
STORAGE AND STERILIZATION
Surgical instruments should be stored in the sterilizing trays of proper size and lined with soft silicone mats. Instruments should not touch each other. We recommend using protective tips made of soft silicone tubing of the proper size and thickness. Do not use rubber or plastic protective tips, as they can melt during autoclaving and cause damage of instruments. Stainless steel and titanium instruments can be sterilized via steam autoclaving, chemical disinfectants, ethylene oxide gas, or even dry hot air. Gas and dry chemical sterilization are the best methods for stainless steel instruments, but it takes a lengthy time period to accomplish the desired result. The most practical method of sterilization is heat or steam, which require less time, however, these methods can be damaging to delicate stainless steel instruments. Please, be sure that you and the members of your staff have read and understood the instructions supplied by the manufacturer of your particular sterilizer.
Finally, the instrument should be sterilized prior to the next surgical procedure. Rumex instruments can be sterilized using any of the following methods:
100% ETO cycles
Concentration ЕТО: 850±50mg/l
Temperature: 37ºC - 47ºC
Exposure time: 3-4 hours
Humidity: 70% RH minimum
Sterilizer Type: Gravity Displacement, Prevacuum
Sample Config.: wrapped, wrapped
Temperature: 121ºC to 123ºC, 132ºC to 135ºC
Exposure time: 15 to 30 minutes, 3 to 4 minutes
Sterilizer Type: Gravity Displacement, Prevacuum
Sample Config.: unwrapped
unwrapped Temperature: 132ºC, 132ºC
Exposure time: 3 minutes, 3 minutes
The above-mentioned sterilization cycles represent the industry standards and should be capable of producing a sterile device. Due to variations in sterilization equipment and device bioburden in clinical use, Rumex Intl. is not able to provide specific cycle parameters. It is the responsibility of each user to perform the validation and verification of the sterilization cycle to ensure an adequate sterility assurance level for our products.
Be sure to inspect every microsurgical instrument at the end of your surgical day. Please conduct this inspection under a microscope or magnification lens. If a damaged instrument is detected, repair or replace it.