GENERAL INSTRUCTIONS FOR CARE, CLEANING AND STERILIZATION

We at RUMEX guarantee our instruments against manufacturing defects, but the lifespan of reusable instruments lies within proper handling and care. To help your instruments preserve its initial conditions, we strongly recommend you to read the instructions below carefully before use.

A common misconception that "stainless steel" or "titanium" have extreme durability and are indestructible is in need of correction: these metals still might be affected by chemical, mechanical, thermal attacks and etc.

However, if you are aware of metal characteristics and understand how to handle them, the lifespan of the instruments may be enlarged.

A particular care should be taken after microsurgical instruments as they have very delicate working tips.

These instructions being general recommendations, cleaning guidelines of the solutions and equipment manufacturer and your institution, especially those regarding temperature, time of exposure and concentration, should be observed.

 

INSPECTION

It is essential that the instrument is inspected before use. Please conduct this inspection under a microscope or magnification lens. If a problem is detected, notify us immediately. Once the instrument is examined and accepted, IT SHOULD BE CLEANED BEFORE PLACING IT IN THE STERILIZATION TRAY.

 

Stage 1: DESINFECTION               

Soaking

  1. For effective cleaning of instruments it is recommended to start pre-treatment as soon as possible, no later than 30 minutes after surgery is completed. The cleaning/disinfection should be carried out within the next two hours.
  2. Use distilled/demineralized water to prepare the working solution.
  3. Water temperature should be as specified in the manufacturer's instructions. Water layer above the instruments should be no less than 1 cm (.39 inches).
  4. Make sure the disinfectant is free of aldehydes, glutaraldehydes. Stainless steel tools must not be exposed for a long time to media which can promote corrosion (for example, chloride or iodine ions). This also applies to the vapors of the substances mentioned.

Do not immerse stainless steel instruments in an isotonic solution (e.g. physiological saline solution) as stress corrosion cracking and pitting may occur.

  1. Carry out disinfection according to the mode, indicated in the instructions of product manufacturer. Disinfectant solution should not foam.
  2. Instruments with hinges and joints must be handled open

Rinsing

  1. Place the products in a container distilled/demineralized and wash off the remaining solution with thorough rinsing of all lumens for 5 minutes.
  2. Then rinse with distilled water.

 

Stage 2: PRE-STERILIZATION CLEANING              

Never skip this cleaning stage as residues on instruments such as care agents and the ones of package materials may form stains and depositions in course of sterilization.

MANUAL CLEANING

It is imperative to follow the rules:

  1. As much moisture as possible must be eliminated from all instrument's parts since moisture promotes corrosion.
  2. 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.
  3. Thorough cleaning immediately after use is essential for the longevity of the instrument. We recommend that the established surgical instrument cleaning procedures of your institution be followed using these instructions as a guideline.
  4. The cleaning/disinfecting solutions should be exchanged daily.

 

Steps of manual cleaning in solution

  1. Use distilled/demineralized water to prepare the working solution. Use chemicals with non-protein-fixing process, with/without enzymes, and with/without anti-microbial effects. Prepare the solution according to the manufacturer's instructions.
  2. The detachable products should be disassembled prior to be immersed into the solution. Products with locks should be immersed open with preliminary several working movements done inside the solution for its better penetration into hard-to-reach areas of the instruments. Make sure that there are no air bubbles in the cavities and all the inner surfaces are affected.
  3. Soak according to the mode, indicated in the instructions of product manufacturer. We recommend soaking 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.
  4. Wash each product with a brush or a cotton-gauze sponge. Use a syringe to wash the lumens of the instruments. Remove all macroscopically visible dirt.

WARNING! 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.      

  1. Place the products in a container with distilled/demineralized water and wash off the remaining solution with thorough rinsing of all lumens for 5 minutes. Repeat the procedure if necessary.
  2. Then rinse with distilled water to prevent spotting. Instruments with lumens should be flushed out at least five times at the beginning and at the end of the cleaning (10 ml/34 fl. oz) distilled or deionized water to be used each time).
  3. Dry instruments carefully before sterilization with a hot air blower or lint-free cloth. Compressed air is preferred.
  4. The cleaning results must be visually inspected. The instruments must be visibly clean.

 

ULTRASONIC CLEANING

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 into the equipment. A five to ten minutes cycle in the ultrasonic cleaner should be sufficient.

 

The following rules should be followed:

  1. Fill the bath with room temperature water. The temperature higher than 45 °C (113 °F) can lead to encrustation due to denaturation of the protein.
  2. Use enzymatic detergent to soak the instruments. A distilled/demineralized water should be used to prepare the working solution. Make it according to the manufacturer's instructions. Newly prepared cleaning solutions require degassing prior to the first use.
  3. Place instruments next to each other without stacking them.
  4. When carrying out ultrasonic cleaning, all parameters specified by the manufacturer of the cleaning agent, such as exposure time and concentration, must be observed.
  5. The use of ultrasonic baths and strong cleaning fluids (alkaline pH> 9 or acid pH <5) can shorten the lifespan of the products. Make sure the appropriate agents are chosen for performing the procedure.
  6. Place the instruments on silicone fingertip mat, previously put into the ultrasonic bath with the solution. When using deionized water or cleaning solution fully submerge the instruments. Change the ultrasonic solution from ultrasound cleaner after each use.

Instruments with hinges and joints must be handled open to minimize the obscured surface areas. The detachable products should be disassembled prior to be immersed into the solution.

Products with locks should be immersed open with preliminary several working movements done inside the solution for its better penetration into hard-to-reach areas of the instruments.

Large instruments should be placed vertically in order not to create acoustic shadows.

WARNING! Special care should be taken to 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.

  1. Carry out the cleaning procedure. Turn on ultrasonic bath. 3 minutes exposure at frequencies of around 35 kHz would be sufficient. Use soft bristled nylon brush to clean all the parts of the instrument, inside and outside.
  2. Place the products in a container with distilled/demineralized water and wash off the remaining solution with thorough rinsing of all lumens for 5 minutes. Repeat the procedure if necessary.
  3. Then rinse with distilled water to avoid water spots.
  4. Dry the instruments before sterilization. A lint free cloth may be used for manual drying. Sterile compressed air should be used to insufflate cavities of the instruments.

WARNING! DO NOT apply ultrasonic cleaning to diamond knives or instruments with delicate tips (e.g. vitreoretinal and microincisional tips, choppers, hooks, manipulators and etc.)

  

AUTOMATED CLEANING

  1. Baskets in the form of nets with large holes are recommended to be used in special washing equipment. Be sure to use tool holders in the basket. Place instruments inside them without overloading.
  2. Make sure that the large instruments don’t obscure other ones and don’t create spray shadows.
  3. Sort tools by similar metals, avoiding contact between dissimilar ones. This type of contact can cause galvanic corrosion.
  4. Use a solution suitable for washing equipment with low foaming property.
  5. Use a neutralizer, which not only neutralizes alkali, but also reduces surface tension of the liquid during drying, accelerating it, and minimizing stains.
  6. Set the program for the cleaning step. The chosen program must be suitable for the products and include the appropriate number of rinsing cycles.

For automated cleaning and disinfection thermal and chemo-thermal disinfection options are available.

During thermal processes disinfection is carried out at temperatures above 65 °C. A reprocessing program may include the following steps:

  1. Pre-wash with cold water to remove dirt and foaming substances.
  2. Cleaning is performed with use of suitable pH-neutral or alkaline products added to hot or cold distilled water at temperatures of 40-60 °C (104-140 °F) for at least 5 minutes.
  3. Intermediate rinse in hot or cold distilled water with acidic neutralizer added in order to facilitate the removal of remaining alkaline disinfectants.
  4. Second intermediate rinse in hot or cold distilled water without additives should follow.
  5. Thermal disinfection and final rinse is performed at temperatures of 80-95 °C (176-203 °F).
  6. Drying might be carried out in washer/disinfector or in other possible ways.

Chemo-thermal disinfection is suitable for heat-sensitive products. The temperature is limited in all rinsing stages and during the step of drying.

Cleaning is performed normally at < 65 °C (149 °F). A reprocessing program may include the following steps:

  1. Pre-wash with cold water to remove dirt and foaming substances.
  2. Cleaning is performed with use of suitable pH-neutral or alkaline products added to hot or cold distilled water at temperatures of 40-60 °C (104-140 °F) for at least 5 minutes.
  3. Intermediate rinse in hot or cold distilled water followed by chemo-thermal disinfection. Special cleaning agent, compatible with machine-disinfection, is used.
  4. Intermediate rinse in hot or cold distilled water without additives.
  5. Final rinsing with distilled water at higher temperature.
  6. Drying might be carried out in washer/disinfector or in other possible ways.
  7. The cleaning device must be regularly maintained, checked and validated in accordance with internal and manufacturer requirements.
  8. When processing the ophthalmic instruments we recommend using the additional intermediate rinsing with water in the washing programs before the final rinse.

Additional rinsing outside the washing equipment is not required.

A combination of processing stages 1 and 2 is allowed.

WARNING! Tools with blind holes, long narrow tips (e.g. tips, cannulas, handpieces and etc), hinges (3-joint instruments) need more attention during cleaning process. The temperature at all stages of the process should not exceed 170 °C (338 °F).

Aspiration speculums require additional cleaning of silicone tubes prior to be sterilized.

First, soak the instrument in the soap solution at temperature of 50 °C (122 °F) and keep it there for 15 min. After that wash the instrument with brush and cotton/gauze pad. Take the instrument out of soap bath and wash it under streaming water for 3 min. Rinse the instrument with distilled or deionized water. Then attach a syringe filled with warm water into the luer lock and rinse the silicone tubes of the instrument. Finally, blow them with air by forcing one or two syringes full of air through the tubes.

 

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.

 

LUBRICATION

Moving parts and working mechanisms of the Rumex instruments should be lubricated occasionally with a medical grade instrument lubricant (especially after an ultrasonic bath) to ensure the smooth operation of the working mechanism. The lubricant must be biocompatible, suitable for steam sterilization and vapor-permeable. No silicone oil should be applied. The paraffin/white oil based lubricants are allowed to be used.

After cleaning process let the instruments cool down to room temperature prior to their actuation, as otherwise metal abrasion may develop when the details of the tools rub against each other. This may destroy the instruments’ functionality.

The recommended directions of the instrument lubricant manufacturer and your institution should be observed.

 

Stage 3: STERILIZATION

Surgical instruments should be stored at room temperature in dry rooms 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.

WARNING! Never store the instruments close to the chemicals.

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 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.

WARNING! Only clean and disinfected products can be sterilized.

For lumen instruments (e.g. tips, cannulas, handpieces) the gravity procedure is not suitable!            

RUMEX instruments can be sterilized using any of the following methods:

100% ETO cycles

 

Concentration ЕТО:

850±50mg/l

Temperature:   

37-47 °C (99-117 °F)

Exposure time:  

3-4 hours

Humidity:    

70% RH minimum

Drying Cycle:    

1 hour

 

 

WARNING! ETO method is not recommended for diamond knives sterilization.

Steam Autoclaving

 

 

Sterilizer Type:

Gravity Displacement

Prevacuum       

Sample Configuration:  

wrapped   

wrapped

Temperature °C

132 °C

132 °C

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 Configuration:  

unwrapped   

unwrapped

Temperature °C

132 °C

132 °C

Temperature °F:

270 °F

270 °F

Exposure time:    

10 minutes     

3 minutes

Drying Cycle:       

min. 10 minutes

min. 10 minutes

 

WARNING! The sterilization steam must not contain any impurities.

 

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 Co. 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.

WARNING! Follow the guidelines of the processing times. The rapid sterilization process should be reserved for emergency processing only and should not be used for routine instrument sterilization. Longer sterilization period and higher temperatures can lead to premature aging of instruments.

  

RECOMMENDED PRODUCTS FOR CARE AND CLEANING

 

Fully demineralized water for rinsing and correct loading must be used to prevent staining!

The color of titanium instruments may change due to development of different properties of oxide layers. Such discoloration does not bring a safety risk, as well as water stains on the surface of the instruments. They don’t affect the biocompatibility, functionality, and lifetime of the instruments. However, discoloration may affect the visual inspection of the tools (e.g. determining residual dirt).       To prevent the color change of titanium instruments, use only neutral or mild alkaline cleaning agents. While using them, do not exceed a temperature of 70 °C (158 °F).


INSPECTION

Instruments should be washed clean of all residues, dried and inspected after each use. 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. Washing, drying and inspecting the instrument under magnification helps to ensure that the instrument is kept in proper condition for the next surgical procedure.

 

DIAMOND KNIVES HANDLING

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. 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).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.

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 PTFE 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 counterclockwise 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 0.005 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 the knife.

CLEANING

  1. Use a syringe with distilled or demineralized water to flush the instrument.
  2. Dip the knife (blade retracted) into weak alkaline cleaning solution and keep for 60 minutes at a temperature of 22 °C (72 °F).
  3. The handle of a knife can be cleaned with a soft brush.
  4. 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.

WARNING! DO NOT apply ultrasonic cleaning to diamond knives.

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 manufacturer’s instruction.

PLEASE OBSERVE THE GENERAL INSTRUCTIONS FOR CARE, CLEANING AND STERILIZATION BEFORE HANDLING THE TOOL!

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.

WARNING!

ETO method is not recommended for diamond knives sterilization.

The knife must not be treated at more than 140 °C (284°F).

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

STORAGE

Diamond knives must be kept at a temperature from 10 to 25 °C (50 to 77 °F) and relative air humidity at max. 75% at 25 °С (77 °F). Indoor air must not contain corrosive additive agents. The blade must be fully retracted into the handle (non-operative position). Self-movement must be avoided and blows or vibrations should be avoided.

INSPECTION

Incoming inspection is obligatory. It includes:

  1. Visual examination of the package obtained: no mechanical damages are permitted.
  2. 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.
  3. Blade must be set into the operating/non-operating position without jamming; it must be fixed easily.

Please examine the blade before each operation and never use a knife in the event any defect is noticed. Damaged knives should be sent for resharpening or blade replacement.

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.

 

HANDLING OF VITREORETINAL AND MICROINCISIONAL INSTRUMENTS

APPLICATION

RUMEX Instruments (ophthalmic scissors and forceps for vitreoretinal and microincisional surgery) are designed for various applications in ophthalmic surgery. It is essential that the 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 surgery. Proteins may also accumulate inside of the mechanism. If these fluids are not promptly and properly cleaned out, it will lead to corrosion or clogs and the possibility of instrument malfunction. Ensure the cleaning procedure is implemented after each surgery — warranty shall not extend to instruments that have been improperly handled. One-piece and two-piece vitreoretinal instruments are cleaned by use of special adaptor and cannula.

 

CLEANING OF TWO-PIECE VITREORETINAL INSTRUMENTS

  1. Unscrew the tip from the handle, then attach flushing adapter 12-000T.
  2. Flush the tip with distilled or demineralized 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 demineralized 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 VITREORETINAL INSTRUMENTS

  1. Put the instrument into PTFE protector (provided).
  2. Soak it in the soap solution at temperature of 50 °C (122 °F) and keep it there for 15 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 min.
  5. Rinse the instrument with distilled or demineralized water.
  6. After that flush the instrument with alcohol solution. It will remove the water and contribute to drying.
  7. Next, adjust the cannula on the luer of the syringe and fill the syringe with distilled or demineralized 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 demineralized water by forcing syringe plunger. Then repeat the procedure with use of alcohol solution.
  10. Finally, blow the air inside the tube by forcing it from the syringe into the port of the instrument.

WARNING! DO NOT apply ultrasonic cleaning to vitreoretinal and microincisional tips.

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 PTFE, which are autoclavable. RUMEX International Co. designed two models of safety protectors. The photos below illustrate the way to fix a tip in a protector.

Please insert the tips into PTFE protectors as shown in the picture:

  1. Match the nut indicating the gauge with the hub, press the tip gently. Make sure the branches do not touch the protector
  2. The tips in their final position — safely fixed by the protector.

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

PLEASE OBSERVE THE GENERAL INSTRUCTIONS FOR CARE, CLEANING AND STERILIZATION BEFORE HANDLING THE TOOL!

WARNING!

Gravity displacement is not suitable for vitreoretinal and microincisional tips.

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