Care &Cleaning of Regular Ophthalmic Instruments 

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 is 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 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 conditions for the next surgical procedure.

CLEANING

Use a mild soap solution with a soft brush to clean the instrument and remove stains. Never use abrasive powders or steel wool to remove stubborn stains - these can damage the superfine finish of an instrument and can help cause corrosion of stainless instruments. Soak instruments in an enzymatic detergent with pH level between 6-9 for 10 min at 40°C/104°F. Disinfection agent should be aldehyde-free. Use distilled or demineralized water to rinse instruments thoroughly. Rinse the instruments minimum 3 times 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 are followed using these instructions as а guideline. Thorough cleaning immediately after use is essential for the durability 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. 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 it. 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 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 abided.

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 to 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 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 (+99°F-117°F)

Exposure time:   3-4 hours

Humidity:     70% RH minimum

Drying Cycle:     1 hour

 

Steam Autoclaving

Sterilizer Type: Gravity Displacement              Prevacuum        

Sample Config.:  wrapped                                 wrapped

Temperature°C :   +132 °C                                  +132º

Temperature°F:   +270 °F                                   +270 °F

Exposure time:  34 minutes                              3 minutes

Drying Cycle:    min.10 minutes                        min.10 minutes

 

‘Flash’ Autoclaving

Sterilizer Type: Gravity Displacement              Prevacuum        

Sample Config.:  unwrapped                             unwrapped

Temperature:       132ºC                                      132ºC  

Temperature°F:   +270 °F                                   +270 °F

Exposure time:    10 minutes                               3 minutes

Drying Cycle:    min.10 minutes                        min.10 minutes

 

Gas plasma sterilization is not recommended as delicate instruments might be physically damaged when exposed to low pressure.

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 International 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 Rumex 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 

APPLICATION

Ophthalmic microsurgical knives with diamond blades are used for cutting and dissection of tissues during ophthalmic, microvascular, neurosurgical, and plastic surgery.

CHARACTERISTICS

The blades are made of natural diamonds and the handles are manufactured from titanium alloy. Blade size: The thickness of the diamond blade cutting edge should not exceed 0.2 μm. The blade points must be edged with no visible chips (visible at 100x power magnification).

DEVICE

The diamond knife consists of a titanium handle and a diamond blade. The handle is fit with a mechanism providing blade installation and its safe fixation in an operative and non-operative position. The construction of the knife can be changed in order to improve its usability.

COMPLETE UNIT

Each complete set must contain:

  • diamond knife - 1 unit
  • label - 1 unit
  • sterilization tray - 1 unit
  • care and cleaning instructions - 1 unit

USAGE INSTRUCTIONS

  1. The diamond blade is very fragile, therefore, each knife must be handled, cleaned, and stored delicately. Avoid blows or vibrations. Any contact 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 retracted into the handles (non-operative position). We recommend the knives to be kept and carried in sterilizing cases or with a teflon shipping clamp to avoid self-movement. When a knife is not in use, its blade must be retracted 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 its operative position. The blade is to be set in the operative position for the surgical operation just prior to usage.
  5. After usage, slightly pull the movable part of the handle downwards and rotate counter clockwise to return the blade into its 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 occur.
  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 the knife varies due to usage and handling. The blade must never be dropped or be in contact with foreign objects. The blade and the spring mechanism need to be handled with care and caution. 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 handle, remove blood, tissue debris and viscoelastic directly after the operation.

Manual Cleaning:

  • use a syringe with distilled water to flush the instrument;
  • dip the knife (blade retracted) into weak alkaline cleaning solution and keep for 60 minutes at a temperature of +22°C (+72°F );
  • the handle of a knife can be cleaned with a soft brush;
  • flush the instrument with flowing water for 30 seconds, then sluice with distilled water for other 30 seconds; the blade should be pointed down for flushing.

We recommend using 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 manufacturer’s instruction.

Ultrasonic Cleaning:

  • The cleaning machine should be filled with warm distilled water +70°C (+152°F).
  • Immerse the knife with the retracted blade into the water. The sterilizing case with finger mats will reduce vibration and protect the blade.
  • 2 to 3 min washing cycle should be enough to clean knife.
  • Rinse the instrument with distilled water before steam sterilization.

STERILIZATION:

The knives should be sterilized before each surgical case by one of these methods:

Sterilization Method

Type of Sterilization

Item

Temperature

Exposure Time

Drying Cycle

Steam

Gravity Displacement

Wrapped

+132ºC (+270ºF)

34 min

Min. 10 minutes

Flash Process

Gravity Displacement

Unwrapped

+132ºC (+270ºF)

10 min

Min. 10 minutes

Steam

Prevacuum

Wrapped

+132ºC (+270ºF)

3 min

Min. 10 minutes

Flash Process

Prevacuum

Unwrapped

+132ºC (+270ºF)

3 min

Min. 10 minutes

 

Make sure the blade is in its non-operative position (retracted) before sterilization; self-movement must be avoided. We recommend sterilizing the knives in trays specially designed for diamond knives as the silicone holders will help stabilize them.

Gas plasma sterilization is not recommended as delicate instruments might be physically damaged when exposed to low pressure.

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 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 and observe the instruction provided by the manufacturer of sterilization and cleaning units.

STORAGE

Diamond knives must be kept at a temperature from +10°C to +35°C (+50°F to +95°F) and relative air humidity 80 % at 25°С. Indoor air must not contain corrosive additive agents. The blade must be fully retracted into the handle (nonoperative position). Self-movement must be avoided and blows or vibrations as well.

MANUFACTURER’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 spring mechanism and titanium parts. The 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);
  • 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 if any defect is noticed. Damaged knives should be sent for resharpening or blade replacement.

Care & Cleaning of Vitreoretinal & Microincision Instruments 

RUMEX Instruments (ophthalmic scissors and forceps for vitreoretinal and microincisional surgery) are designed for various applications in ophthalmic surgery.

It is essential that an instrument is cleaned and sterilized before initial use and after each surgery, following as outlined in this instruction brochure.

Care and handling

The Intraocular tips have a delicate precision mechanism inside. Intraocular fluids will enter this mechanism during a surgery. If these fluids are not promptly and properly cleaned out, it will lead to corrosion or clogs and a possibility of instrument malfunction. Proteins may also accumulate inside of the mechanism.

Ensure the cleaning procedure is implemented after each surgery - warranty shall not extend to instruments that have been improperly handled.

Cleaning

  1. Unscrew the tip from the handle, then attach flushing adapter 12-000T.
  2. Flush the tip with distilled or deionized water by connecting a syringe filled with water to adapter.
  3. Flush the tip with alcohol. This will remove the water and facilitate drying.
  4. 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.
  5. Dry with air.
  6. Handle should be soaked in distilled or deionized water for two minutes.
  7. Dry with surgical sponge.
  8. Lubricate joints in handle with instrument milk and work the mechanism by pressing the key.

CLEANING OF ONE-PIECE MICROINVASIVE AND VITREORETINAL INSTRUMENTS

  1. Put the instrument into PTFE protector.
  2. Soak it in a soap solution at temperature of 50 + 5°C (122 +41°F) and keep it there for (15±1) min.
  3. Wash the handle with brush and cotton/gauze pad.
  4. Take the instrument out of soap bath and wash it under streaming water for (3+1) min.
  5. Rinse the instrument with distilled or deionized water.
  6. After that flush the instrument with alcohol solution. It will remove water and contribute to drying.
  7. Next, adjust the cannula on the luer of the syringe and fill the syringe with distilled or deionized water.
  8. A tube of the cannula then should be inserted into the port, situated at the base of the barrel near the colored wheels.                                 
  9. Flush the tube of the instrument and the tip with distilled or deionized water by forcing syringe plunger. Then repeat the procedure with using an alcohol solution.
  10. Finally, blow the air inside the tube, by forcing the air from the syringe into the port of the instrument.

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. Cleaning guidelines of the solution manufacturer and your institution should be respected.

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 Rumex instruments should be lubricated occasionally with a medical grade instrument lubricant (especially after an ultrasonic bath) to ensure smooth operation of the working mechanism. The recommended directions of the instrument lubricant manufacturer should be observed.

Storage

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 safety protectors made of teflon, which is autoclavable. RUMEX International Co. designed two models of safety protectors. 

  1. Match the nut indicating the gauge with the hub, press the tip gently
  2. Make sure the branches do not touch the protector

Note: the tips should be sterilized in the protector to avoid any contact with other instruments.

Sterilization

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 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 ETO

850±50mg/l

Temperature

+37ºC - 47ºC (+99°F-117°F)

Exposure time

3–4 hours

Humidity

70 % RH minimum

Drying Cycle   

1 hour

 

 

Steam Autoclaving

‘Flash’ Autoclaving

Sterilizer Type

Gravity Displacement

Prevacuum

Gravity Displacement

Prevacuum

Sample Config.

wrapped

wrapped

unwrapped

unwrapped

Temperature

+132 °C

+270 °F

132 °C

+270 °F

132 °C

270 °F

132 °C

270 °F

Exposure time

34 minutes          

3 minutes

10 minutes    

3 minutes

Drying Cycle

min.10 minutes                       

min.10 minutes                       

min.10 minutes                       

min.10 minutes                       

 

Gas plasma sterilization is not recommended as delicate instruments might be physically damaged when exposed to low pressure.

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 International 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 Rumex 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.