Care &Cleaning of Regular Ophthalmic Instruments 

INSTRUCTION FOR USE 
Rumex Instruments (ophthalmic scissors, forceps, hooks, choppers, manipulators, spatulas, markersare 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. 
 
CLEANING 
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. 
 
LUBRICATION 
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. 
 
STERILIZATION CYCLES 
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 
Steam Autoclaving 
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 
‘Flash’ Autoclaving 
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. 

INSPECTION 
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. 

Care & Cleaning of Diamond knives 

INSTRUCTION FOR USE 
DIAMOND KNIVES APPLICATION 
Ophthalmic microsurgical knives with diamond blades are used for cutting and dissection of tissues during ophthalmic, microvascular, neurosurgical and plastic surgery. Usage conditions: hospital departments of surgery and ophthalmology at ambient air temperature from + 10° to + 35°С (+50° to +95° F) and relative air humidity at most 98%. 
 
CHARACTERISTICS 
Blades are made from natural diamonds. Handles are manufactured from titanium alloy. Blade size: The width of the diamond blade cutting edge must be at most 0.2 µm. Blade points must be edged. Blade blunting radius must be at most 0.2 µm. No chips (visible at 100x power magnification) on the blade cutting edge are permitted. The average life span of knives is at least 3 years (or 200 cyclic processes). 
 
DEVICE 
Diamond knife consists of a handle and a diamond blade. The handle is fitted with the mechanism providing blade installation and its safe fixation in operative and non-operative position. The construction of a knife can be changed in order to improve its usability. 
 
COMPLETED UNITS 
Each delivery complete set must contain: - diamond knife – 1 unit - a label – 1 unit - care and cleaning instruction – 1 unit 
 
WORKING ORDER 
1.General requirements. Taking into consideration the fragility of the diamond blade, each knife is required to be handled, cleaned and storaged delicately. No blows or vibrations are permitted. Any contacts of the blade with other instruments or materials should be avoided. 
2.Before using a knife make sure there are no chips on the cutting edge. A microscope with at least 100x power magnification should be used for the inspection. 
3.When transporting diamond knives the blades must be fully hidden into the handles (non-operative position). We recommend the knives to be transported in sterilizing cases or special containers to avoid self-movement. Manufacturer provides a shipping clamp to avoid self-movement during transportation. When a knife is not used its blade must be hidden into the handle and protected from mechanical damage. 
4.Please rotate the movable part of the handle clockwise and fix the blade to set the knife in operative position. The blade is to be set in the operative position during surgical operation just before the usage. 
5.After the usage pull slightly the movable part of the handle downwards and rotate it counter clockwise to return the blade into the non-operative position. To avoid accidental movements of the spring please make sure the handle is fixed tightly. When a handle is fixed a slight click will be heard. 
6. To install the knife with a micrometer pull the protective cap down and rotate the bottom part of the handle (with a scale) downwards – the blade will appear. Customize the depth of the blade by screwing the handle – the scale marks will indicate the chosen depth. The scale increment is 0.5 mm. Rotate the handle upwards then put on the protective cap to set the knife in the initial non-operative position. The service life of instruments depends on delicate handling. Do not drop the instruments. The blade must never be in contact with foreign objects. The blade and moving – out spring mechanism need an extremely gentle treatment. Never disassemble the parts of a knife. 
 
PRESTERILIZATION TREATMENT AND STERILIZATION 
Presterilization treatment includes a number of procedures. Please remember to clean the blade and the movable part of the handle, remove blood, tissue debris and viscoelastic directly after the operation (or within 2 hours after it). For Manual Cleaning: 
- dip instruments into weak alkaline cleaning solution and keep for 60 minutes at a temperature of +22°С (+72°F ); 
- the handle of a knife (together with the movable part) can be cleaned with a soft brush; 
- flush the instruments with flowing water for 0.5 minutes, then sluice with distilled water for other 0.5 minutes; 
- we recommend to use a diamond knife cleaning pack (21-602-1) for gentle cleaning of the blade. The pack contains three solutions that eliminate residual debris off the blade and prepare it for sterilization 
 
Diamond knives can be cleaned in an automatic washer designed for micro-surgical instruments. Please follow the instruction of the manufacturer. 
Do not use ultrasonic baths to wash diamond knives – the blade can be damaged. 
 
Sterilization is achieved by means of saturated steam in a steam autoclave. Dry instruments in a drying cabinet by hot air convection at a temperature of +85°С (+185°F ) until complete moisture removal. Sterilization is handled under the pressure up to 0.2 MPa at a temperature of +132°С (+270°F) for 20 minutes. The maximal temperature for sterilization is +141°С (+286°F). Make sure the blade is in the non-operative position before sterilization; self-movement must be avoided. We recommend to sterilize the knives in trays specially designed for diamond knives – silicone holders will fix them safely. 
 
Please always follow the instruction provided by the manufacturer of your sterilizer. 
 
STORAGE 
Diamond knives must be kept at a temperature from +10°C  to +35°С (+50°F  to +95°F) and relative air humidity at most 98%. Indoor air must not contain corrosive additive agents. The blade must be fully hidden into the handle (non-operative position); self-movement must be avoided. No blows or vibrations are permitted. 
 
MANUFACTUR’S WARRANTY 
Manufacturer guarantees knives to be in accordance with the documentation when service and storage instructions are followed by the consumer. We provide a 2 year guarantee for the moving-out spring mechanism and titanium parts. Diamond blade can be resharpened or exchanged according to the after-sale service program. 
 
RECEPTION INSPECTION 
Incoming inspection is obligatory. It includes: - visual examination of the package obtained (no mechanical damages are permitted); - visual inspection of the knife (no mechanical damages such as cracks, chips, oxide scales etc. are permitted; all parts of the knife must be joined smoothly); - a blade must be set into the operating/non-operating position without jamming; it must be fixed easily The knives you purchase are not sterile and should be sterilized before the first surgery. Please examine the blade before each operation and never use a knife in case any defect is noticed – we can always provide you with the resharpening or blade replacement. 

Care & Cleaning of Vitreoretinal & Microincision Instruments 

INSTRUCTION FOR USE 
VITREORETINAL AND MICROINCISION SURGERY 
Rumex Instruments (ophthalmic scissors and forceps for vitreoretinal and microincisional surgery) 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 following the procedures as outlined in this instruction brochure. 
 
CARE AND HANDLING 
Intraocular tips have a delicate precision mechanism inside. Intraocular fluids will enter this mechanism during surgery. If these fluids are not promptly and properly cleaned out, it will lead to corrosion or clogs and the possibility of instrument malfunction. Proteins may also accumulate inside of the mechanism. 
 
CLEANING 
1.Unscrew the tip from the handle, then attach flushing adapter 12-000.
2.Ultrasonically
 clean both parts, if possible. 
3.Flush the tip with distilled or deionized water by connecting syringe filled with water to adapter. 
4.Flush the tip with alcohol. This will remove the water and facilitate drying. 
5.Dry the tip by forcing one or two syringes full of air through tip. Pressurized air is recommended, as it flushes out debris and fluid more efficiently than syringe forced air. Thoroughly dry handle, tip and cup. 
6.Force special thermoresistant instrument milk through the tip, as in No 3 above. 
7.Dry with air as in No 5 above. 
8.Handle should be soaked in distilled or deionized water for two minutes. 
9.Dry with surgical sponge. 
10.Lubricate joints in handle with instrument milk and work the mechanism. 
 
INSTRUMENT DETERGENTS 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. 
 
LUBRICATION 
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 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 they take 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. 
 
STERILIZATION CYCLES 
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 
 
Steam Autoclaving 
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 
 
‘Flash’ Autoclaving 
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. 
 
INSPECTION 
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.