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Instruction Manual

GB – Sterilization Instruction Hand  Instruments Manufacturer: GDC

  1. Warnings:

     Instruments are not sterile upon receipt and must be sterilized before use in accordance with the following instruction. Instruments can be damaged by alkaline and acidic detergents. Always use a pH(7) neutral detergent or solution. Do not exceed 134°C Remove all. Packaging prior to cleaning and sterilization. contaminated instruments should be handled with gloves and eye protection should be used.

  2. Limitations:

    Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and damage due to use. Never clean color- etched probes or black composite instruments in ultrasonic baths.

  3. Point of use:

     Remove all excess soil with disposable cloth paper wipe.

  4. Containment and Transportation: 

     Protect delicate or fine instruments from damage. Instruments should be reprocessed as soon as is reasonably  practical following use. Instruments left standing wet may stain or corrode.

  5. Preparation for cleaning:

     No  specific requirement. Diassembly  not resuired. Rinsing: Immediately after surgery rinse instruments under warm (not hot) water. It may be helpful to use a nylon toothbrush to rinse the lock boxes and joints of the toothbrush to rinse the lock boxes and joints of the instruments. Be sure  to remove all blood, body fluids, and tissue. Cleaning: If you do not clean your instrument immediately  after rinsing, instruments should be  submerged in a solution of water andneutral  pH(7) detergent. They should never be placed in saline solution, as it may cause corrosion and eventually irreversible damage to the instrument.

  6. Ultrasonic Cleaning:

     For micro and delicate instruments, use manual cleaning (Step C). Instruments should be  processed in a cleaner for the full recommended cycle time– usually 5 to 10 minutes. Place instruments  in open position into the ultrasonic cleaner. Make sure that “Sharp” (Scissor, Knives, osteotomes, etc.) blades do not touch other instruments. All instruments have to be fully submerged. Do not place dissimilar metals (stainless, copper, chrome, plated, etc.) in the same cleaning cycle. Change solution freq.

  7. Automatic Washer Sterilization:

     Follow manufactures recommendations but make sure instruments are lubricated after last rinse cycle and before sterilization cycle.

  8. Manual Cleaning:

     Most instrument manufacturers recommend ultrasonic cleaning as the best and most effective way to clean surgical instruments,particularly those with hinges, locks and other moving parts, if ultrasonic cleaning such as bone files, or on stained area in knurled handles. Use stiff plastic cleaning brushes (nylon, etc.) Do not use steel wool or wire brushes except specially recommended stainless steel wire brushes for instruments such as bone files, or no stained areas in knurled handles. Use only neutral pH(7) detergent because if not rinsed off properly, low pH detergents will cause breakdown of stainless protective surface and black stating, High pH detergent will cause surface deposit of brown stain, which will also interfere with smooth operation of the instrument. Brush delicate instruments carefully and, if possible handle them totally separate from general instruments. Make sure all instruments surfaces are visibly clean and free from stains and tissue. This is good time to inspect each instruments for proper function and condition. Check and make sure that scissor blades glide smoothly all the way (they must not be loose when in closed position). Test scissors by cutting into thin gauge. Three quarters of the length of blade should cut all the way to the scissor tips, and not hang up. Forceps (pickups) have properly aligned tips,. Hemostats and Needle Holders do not show light between the jaws, lock and unlock easily, joints are not too loose. Check Needle Holder for wear on jaw surfaces. Suction tubes are clean inside. Retractors function properly. cutting instruments and Knives have sharp, undamaged blades. After scrubbing rinse instruments thoroughly under running water. While rinsing, open and close Scissor, Hemostats, Needle Holder and other hinged instruments to make sure the hinge areas  are rinsed out, as well as the outside of the instruments. 

  9. After Cleaning:

     If instruments are to be stored, let them, air dry and store them in a clean and dry environment.

  10. Autoclaving:

     If instruments are to be reused or autoclaved Maintenance Lubricate all instruments which have any “metal to metal” action such as scissors, Hemostats, needle holder, self-retaining retractors, etc. Recommend surgical lubricants such as instrument milk are best. Do not use WD- 40, oil or other industrial lubricants. Put instruments up for autoclaving either individually or in sets.

  11. Inspection and Function Testing:

      Visually inspect to ensure all contamination has been removed. Check for distortion, damage and wear. Cutting edges should be free of defects. Discard damaged, worn or corroded instruments. Ensure that detachable tips are secure.

  12. Drying:

     Dry using paper towelling or dsry heat not exceeding 134°C.

  13. Packaging for sterilization:

     Instruments may be loaded into dedicated instruments trays or general purpose sterilization trays. ensure that cutting edges are protected.  Individual Instruments Disposable paper or plastic pouches are ideal. Make sure you use a wide enough pouch (4″ or wider) for instruments with ratchet locks such as needle holders and hemostats so the instruments can be sterilized in an open (unlocked) position.

    • Individual Instruments

      Disposable paper or plastic pouches are ideal. Make sure you use a wide enough pouch (4″ or wider) for instruments with ratchet locks such as needle holders and hemostats so the instruments can be sterilized in an open (unlocked) position.

    • Instrument Sets

      Unlock all instruments and sterilize them in an open position. Place heavy instruments on bottom of set (when two layers are required). Never lock instruments during autoclaving. It will not be sterilize as stream cannot reach the metal to metal surfaces. The instruments will develop cracks in hinge areas because of heat expansion during the autoclave cycle. Do not overload the autoclave chamber as pockets may from that do not permit steam penetration. Place towel on bottom of pan to absorb excess moisture during autroclaving. This will reduce the chances of getting “Wet Packs”. make sure the towels used in sterilization of instruments have no detergent residue and are neutral -pH(7) if immersed in water. This can be a real problem as laundries frequently use inexpensive but high pH(9-13) detergents and do not properly rinse out or neutralize those detergents in the final wash/rinse cycle. Also, sometimes bleaches such as Clorox are added and are not neutralized.

  14. Sterilization:

     14. Parameters such as time, pressure and temperature vary according to the type of sterilizer, materials being being sterilized and individual models within sterilizer brands. The first step in determining the setting for the sterilizer is to refer to the manufacture’s instructions. Sterilizers are medical device, requiring clearance by the Food and Drug Administration before manufactures may offer them for sale. The FDA requires rigorous testing to ensure an adequate margin of safety in each cycle type described in the instructions Failing to follow the instructions of the manufacturer  is ill advised, since it may result in inadequate sterilization of the, Instruments or devices in the sterilizer. It is never appropriate to use a household device, such as a toaster oven, for sterilization of dental instruments, devices, or equipment.     

    • Steam Autoclave

      Steam autoclaves are the most commonly used type of heat sterilizer in dental practices. Two types of process employ steam under pressure. The difference between the two is the manner in which the machine evacuates the air from the sterilization chamber and then introduces the steam. Gravity displacement sterilizer rely on the forces of gravity to force air out of the chamber through air escape vents. The stream entering the chamber from the water reservoir displaces the air as it leaves the chamber, steam and a high temperature for a  prolonged period has the ability to kill virtually all micro organism. This is the most common type of autoclave found in dental offices. A typical cycle for wrapped instruments includes heat-up and pressurization time, followed by a 15 to 30 minutes cycle during which sterilization is taking place (121°C at 15 psi). The sterilization cycle time decreases  as the temperature is increased. It is important to use cycle times and temperatures described in the owner’s manual, and never to interrupt the sterilization cycle to remover or add items  or for any other reason. Interruption of the cycle will result in instruments that are not sterile and therefore not safe for use on patients. After the sterilization cycle the sterilizer must depressurize and the packs remain in the sterilizer for drying. The drying phase may take anywhere from 20-45 minutes. The unit must only be opened after completion of the drying cycle. upon removal from the sterilizer, sterile packs must be stored in a clean , dry area. Packs that become wet, torn, contaminated, or otherwise compromised require re sterilization.  

    • Prevacuum  autoclaves (also called class B or Type B sterilizers) 

      use a variety of technologies to remove air from chamber before the steam enters, thus creating a vacuum to ensure elimination of air from the chamber. This is generally a more efficient means of pressurizing the chamber; therefore the operator may notice some minor time saving in the start-up of the prevacuum sterilizers. Most prevacuum sterilizers use a temperature of 132°-135° for 3-10 minutes to achieve sterilization. This higher temperature may be unacceptable for some items, such as Teflon-coated instruments. Total time for pressurization, sterilization, venting and drying is generally considerably shorter than that for gravity sterilizers-about 45 minutes.

    • Dry-heat sterilization( convection and stack air)

      Dry-heat sterilization employs high temperatures for extended periods to achieve sterilization of instruments. The method of heat circulation in dry-heat sterilizers is usually convection, which helps to ensure that the heat circulates through out the sterilization chamber during the process. Mechanical convection  is more effective, the sterilizer contains a fan or bower that continually circulates the heated air to maintain a uniform temperature throughout the chamber. Most commercially available dry-heat sterilizers on the market today are of this type The higher temperature of a dry-heat sterilizer means that paper will melt. Specialized packaging material is available for dry-heat sterilizers. The manufacture’s instructions should be checked for compatibility of instruments, devices, and materials with the unit.

    • Unsaturated chemical vapor sterilization

      Unsaturated chemical vapor sterilization relies upon the use of a proprietary chemical that contains formaldehyde, alcohol and other inert ingredients, instead of water, to produce a vapor to promote the sterilization. Use of this proprietary chemical also results in the vapor having less humidity and therefore being less corrosive to sensitive instruments than if water were used. 

    • Cold sterilization

      Most cold sterilization solution render instruments sterile only after a 10 hour immersion. This prolonged chemical action can be more detrimental to the surgical instruments than the usual 20 minute autoclave cycle. If the instruments need to be “disinfected” only, cold sterilization is okay as disinfection will place in only 10 minutes. But keep in mind the difference between: STERILE- an absolute term (no living organism survives) and DISINFECTED– basically clean Always use the proper sterilization/ cleaning technique to render the instrument in required condition for use. For instruments with Tungsten Carbide inserts (Needle Holders, Scissors, Tissue Forceps), we do not recommended use of solution containing Benzy| Ammonium Chloride which will destroy the Tungsten Carbide Inserts.

    • Manufacturer contact:

      See brochure for telephone and address of local representative  or telephone GDC TEl: +911882244566 These instruction have been validated by the manufacture as being capable of preparing a device for re-use. It remains the responsibility of the re processor to ensure that the reprocessing has actually achieved the desired result. This normally requires validation and routine monitoring of the process. Any deviation by the re processor from these instruction should be properly evaluated for effectiveness and potential adverse effects
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