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Mabs N Ortho: Nous sommes certifiés ISO 9001: 2000 ISO 13485: 2003, s'est qualifié pour Good Manufacturing Practice approuvé par la FDA - Etats-Unis et la marque CE a approuvé ...
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Scope
These instructions are applicable to the www.popwatch.org processing of mekasomed enterprises dental hand instruments including hinged instruments (forceps, scissors, and tweezers), reusable syringes, implant tools, matrix retainers, mirrors and impression trays. They are applicable before first use and each reuse. Mekasomed enterprises dental hand instruments are supplied mechanically clean but are not sterile. They should therefore be sterilized before first use.

Warnings
Never expose stainless steel instruments to products that are not specifically formulated for use with dental instruments or for the purpose of cleaning and sterilizing dental instruments. Do not expose stainless steel dental instruments to the following chemicals. These chemicals will cause an adverse reaction and may destroy your instruments: chlorine or chlorinated products, household bleach, tarter and stain remover, aluminum chloride, aqua regia, barium chloride, bichloride of mercury, calcium chloride, carbolic acid, chlorinated lime, citric acid, dakin’s solution, ferric chloride, ferrous chloride, hydrochloric acid, iodine, lysol®, mercury chloride, mercury salts, phenol, potassium permanganate, potassium thiocyanate, sodium hypochlorite (bleach), stannous chloride, sulfuric acid and tartaric acid (tarter & stain remover)

Used instruments should be considered as contaminated and appropriate handling precautions should be taken during reprocessing. Gloves, eye protection and a mask should be worn. Other measures may be required if there are specific infection or cross-contamination risks from the patient.

Particular attention is required when cleaning instruments with hinges, blind holes, lumens or long cannulae.

Limitations Of Processing
Reprocessing will have little effect on mekasomed enterprises dental hand instruments. The end of life is determined by wear and damage in use and the instruments should be inspected for defects during the preliminary cleaning process.

Containment at the Poing of Use
Unless there is specific infection or cross-contamination risks, there are no special requirements for containment. The instruments can be transported wet or dry and should be protected from damage to the cutting edges. If transported wet there is an increased chance of staining or corrosion. Prolonged storage in disinfectant solutions may result in corrosion and should be avoided.

Delay in reprocessing must be kept to a minimum to avoid contaminants drying thereby making cleaning more difficult. If the delay is excessive instruments must be manually cleaned before auto cleaning (see manual cleaning method detailed below).

Preparation For Cleaning
There are no special requirements unless infection controls require the use of a disinfectant, in which case a disinfectant agent validated for processing of dental hand instruments must be used and the disinfectant manufacturers‿instructions must be followed.

Auto Cleaning
Auto cleaning is the only recommended method and should use only validated washer disinfectors and appropriate agents validated for use on dental instruments with the selected machine. Follow the washer disinfector and the cleaning agent manufacturers‿instructions. The minimum water temperature shall be 80◦c.

After cleaning inspect the instruments, with the aid of magnification if necessary, to ensure that all contamination has been removed. Repeat the cleaning process if necessary, cleaning by hand and re-inspecting before repeating the auto-cleaning phase.

Manual Cleaning
If hand cleaning is the only available option, the instruments should be cleaned in a sink reserved for the purpose. Rinse the instrument under running cold water and, keeping the instrument immersed, brush thoroughly away from the body using a cleaning or cleaning/disinfecting agent validated for use on dental instruments. Follow the agent manufacturers‿instructions. Care should be taken to avoid spreading contaminants by spraying or splashing during the brushing process. Use wire brushes with caution as brass particles may result in galvanic corrosion and steel particles may cause discolouration of stainless steel. Particular attention is required when cleaning instruments with hinges, blind holes, lumens or long cannulae. The use of a water jet, appropriate brush or stilette may be required.

Drying And Maintenance
Dry the instruments using paper towelling or dry heat not exceeding 140ºc. If required apply a small amount of a recommended lubricant to the moving parts of hinged instruments.

Inspection
Inspect the instruments, with the aid of magnification if necessary, and discard any damaged or corroded instruments.

Packaging for sterilization
If using a vacuum autoclave pack the instruments in dedicated instrument trays or pouches validated for sterilization. Hinged instruments should be packed in the open position.

If using a non-vacuum autoclave the instruments must not be packed or wrapped but placed on open trays to obviate the need for unnecessary handling. Hinged instruments should be packed in the open position.

Note: national legislation may require that instruments are wrapped in pouches for processing in either type of autoclave

Sterilization
Autoclave the instruments for a holding time not less than three minutes at a temperature of between 155 and 170ºc. Other validated time/temperature regimes may be used. The holding time is the minimum time for which the minimum temperature is sustained.

Be sure to only use solutions and chemicals that are compatible with stainless steel hand instruments.

Mekasomed stainless steel instruments can be sterilized by any recognized acceptable method of sterilization including:
‿steam autoclave
‿chemical vapor
‿dry heat
‿ethylene oxide
Never exceed temperatures 350º f / 177º c as this will have an adverse effect on the temper of the steelThe autoclave should bear the ce mark and the manufacturer’s instructions must be followed. In particular care must be taken not to exceed the maximum recommended load for the autoclave

Storage
The instruments should be stored in the sterilization container (instrument tray or pouch) until required. Containers or pouches must be dry before opening to avoid recontamination of the contents with water. Storage should be in dry, clean conditions and at ambient temperature

We prefer Advance Payment but L/C is also acceptable but it must be Irrevocable Letter of Credit at Sight. If you have any question please contact us.

Validation
These processes have been validated as being capable of preparing mekasomed enterprises dental hand instruments including hinged instruments (forceps, scissors, and tweezers), reusable syringes, implant tools, matrix retainers, mirrors and impression trays for reuse.

Note: it remains the responsibility of the reprocessor to ensure that the reprocessing as actually performed using the equipment, materials and personnel in the reprocessing facility achieve the required results. This may require validation and monitoring of the process. Any deviation from these instructions should be properly evaluated for effectiveness and potential adverse results.

 
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