Care, Handling and Reprocessing of Swann-Morton Skin Graft Knife Handles / Hand-operated Dermatome
Surgical instruments are designed to perform many specific functions. The use of any instrument for tasks other than those for which they are intended may result in damage or breakage. The proper cleaning, handling and sterilisation procedures will ensure that your surgical instrument will perform as intended and extend its useful life.
The instrument is supplied non sterile and must be cleaned and sterilised prior to use according to the procedures outlined in this document, unless stated otherwise with the packaging of the product.
Inspection & Function Testing
Visually inspect and check the instrument for damage and wear after each cleaning and disinfecting cycle; articulated instruments have a smooth movement without excess play; locking mechanisms (such as ratchets) fasten securely and close easily; long slender instruments are not distorted. Do not use and remove for repair or replacement any worn out, fractured or damaged instruments.
Delicate surgical instruments require special handling to prevent damaging. Use caution during cleaning and sterilisation. A non fibrous sponge should be used to wipe off all blood and surgical debris. Do not apply excessive stress or strain to the joints, misuse will result in damage. Do not apply excessive stress during use. Instruments manufactured of different metals should be processed separately to avoid electrolytic action between the different metals.
Care & Handling
The procedures outlined below are recommended to ensure safe handling of biologically contaminated surgical instruments. All instruments must be sterilised before use. NOTE: When reprocessing medical devices always follow local Health & Safety procedures.
Follow instructions and warnings as issued by manufacturers of any decontaminants, disinfectants and cleaning agents used. Wherever possible, avoid use of mineral acids and harsh, abrasive agents. No part of the process shall exceed 140 degrees C. Some sensitive materials can be damaged by higher alkaline solutions, (pH >10). Devices with long hinges and blind holes require particular attention during cleaning. Note: Single use devices must not be reprocessed and reused.
Limitations on Reprocessing
Repeated processing has minimal effect on stainless steel surgical instruments. End of life is normally determined by wear and damage in use.
Pre - Cleaning
Wherever possible, do not allow blood, debris or bodily fluids to dry on instruments. For best results and to prolong the life of the medical device reprocess as soon as it is reasonably practical following use. If they cannot be reprocessed immediately, use an enzymatic cleaner to help prevent soil from drying.
Cleaning (Cleaning Precautions)
Do not soak instruments in hot water, alcohol, disinfectants or antiseptics to avoid coagulation of mucus, blood or other bodily fluids. Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents.
The hand-operated dermatome/skin graft knife is intended to hold a dermatome/skin graft blade that removes skin transplants that are used to treat burns or other skin injuries.
|Handle Ref||Name||Description||Blade Ref|
|9901||BRAITHWAITE||With a rotating,oscillating and adjustable guide rod.||9940|
|9902||COBBETT||With an oscillating and adjustable guide rod.||9940|
|WATSON||With a rigid and adjustable guide rod.||9940|
|SILVER||With a rotating and adjustable guide rod.||9942|
WARNING Risk of injury from sharp blade!
- Insert the dermatome/skin graft blade carefully.
- Do not scratch or otherwise damage the adjustable guide rod with other instruments.
- Make certain that the adjustable guide rod is not bent or damaged by heavy objects or instruments.
- Avoid moving the instrument forcefully or vibrating.
- Make certain that the guide rod is firmly fixed in place during the entire application.
BRAITHWAITE AND COBBETT MODELS
The guide rod is mounted in two support arms and is held in place by screws.
- Make certain that the support arms are screwed securely in place and that there is no play between the guide rod and support arms.
The guide rod is mounted in two support arms and is stopped with a nut.
- Make certain that the nut is absolutely flush with its counterpiece and that there is no play between the guide rod and support arms.
Implant thickness is adjusted with the aid of two screws each of which is mounted in a bearing support.
- Make certain that there is no play between bearing supports and screws.
In order for the hand-operated dermatome/skin graft knife to function properly, pressure must be evenly distributed over the entire length of the blade. This can be achieved only if the procedure described below is applied:
- In order to avoid damaging the blade, set the guide rod so that it is as far away as possible from the blade.
- Insert the blade precisely in the mounting that is provided for it.
- Fix the blade in place with the tensioning plate.
WARNING: Risk of injury from sharp blade!
- Remove blade carefully.
- Avoid damaging the edges of either the base plate or tensioning plate.
- Do not use hard or metallic objects to remove the blade.
- Discard Blade in used sharps container.
Care and Handling
After each use
- Clean contaminated instrument as soon as possible.
- For mechanical cleaning, place the instrument in a suitable wire basket, and avoid watermarks.
- Preferably put away the instrument when it is dry.
- If put away while wet, use an active cleaning disinfectant. Prior to mechanical cleaning and disinfecting, rinse the instrument thoroughly in clear running water.
- If ultrasound is needed, carry out the procedure according to the instructions provided by the manufacturer of the apparatus:
As an effective mechanical supplement to manual cleaning.
for initial cleaning of instruments with dried debris on them prior to mechanical cleaning.
Perform manual or mechanical cleaning. Follow the manufacturer’s instructions.
Manual Cleaning, Disinfecting
- Place the instruments in a suitable active cleaning disinfectant solution in such a way that all surfaces, interior surfaces, lumina, and openings are immersed. Follow the disinfectant manufacturer’s instructions.
- After disinfecting chemically, always rinse the items thoroughly in plenty of clear running water. Follow the disinfectant manufacturer’s instructions.
- Remove encrusted material with a soft nylon brush. Do not use harsh cleaning agents or metal brushes.
- Dry lumina and channels with a soft round nylon brush of the appropriate diameter.
- Carry out the final rinse in distilled or fully demineralized water.
- Dry the instrument with a soft, absorbent, lint-free cloth.
- Dry lumina and channels with compressed air.
Mechanical Cleaning, Disinfecting
- When choosing a program, take into consideration the type of material (e.g. stainless instrument-grade steel, aluminum) the instruments being cleaned are made of.
- Follow the instructions provided by the manufacturer of the cleaning device.
- Carry out the final rinse in fully demineralized water.
- Be sure the drying phase is sufficiently long.
- Remove the instrument from the apparatus as soon as the program is completed.
- Allow the instrument to cool down to room temperature.
- Spray moving parts such as hinges and latches with a sterilizable and moisture-permeable lightweight machine oil.
- Inspect the instrument after each cleaning and disinfecting cycle to be sure it is clean, functioning properly, not damaged and does not have e.g. any loose, bent, broken, cracked, worn, or fractured components.
- Set aside and replace the instrument if it is damaged or defective.
Sterilization Method and Parameters
Sterilize using steam sterilization, taking note of the following:
- The sterilization has to be done according to a validated steam sterilization procedure (e.g. in a sterilizer according to EN 285/BS EN ISO 17665-1). In case of application of the fractionated vacuum procedure the sterilization has to be carried out for a minimum of 5 minutes at 134°C and at 2 bar pressure.
Sterilization for the U.S market
CAUTION: U.S Federal law restricts this device to sale by or on order of a physician!
- Read the instructions for use and keep them in a safe place.
- Use the instrument only in accordance with professional standards and practices, see Intended use.
- Clean new instruments either manually or mechanically prior to the initial sterilization.
- Store any new or unused instrument in a dry, clean and safe place.
- Inspect the instrument after each cleaning and disinfecting cycle to be sure it is clean, functioning properly, e.g. not damaged, has intact insulation and does not have any loose, bent, broken, cracked, worn, or fractured components.
- Do not use the instrument if it is damaged or defective. Replace any damaged parts immediately with original spare parts.
- Set aside the instrument immediately if it is damaged.
- Prior to each use, inspect the instrument for loose, bent, broken, cracked, worn, or fractured components.
Sterilization of the device may be accomplished by steam or ethylene oxide (EtO) gas.
SWANN-MORTON does not recommend the device be sterilized by “Flash” or chemical sterilization.
Surgical instruments may also be placed with-in a rigid sterilization container (sterile – container) for processing under generally accepted hospital in-house conditions.
The recommended sterilization parameters are as follows:
Minimum Exposure Time
|Wrapped||In Sterile Container System|
|Pre-vacuum||270 – 275 °F||4 min||4 min|
|Gravity||250 – 254 °F||15 Min||40 Min|
|270 – 275 °F||10 Min||30 Min|
|Ethylene Oxide (EtO)||125 – 130 °F||105 min with 12 % EO,
88 % FREON;
45-75 % chamber humidity, reaction of
Ensure instruments are dry before storage, and stored in dry, clean conditions at an ambient room temperature.
Returning handles to the Manufacturer
Products returned to Swann-Morton must have a decontamination certificate, which testifies that each instrument has been thoroughly cleaned and disinfected. Failure to supply evidence of cleaning and disinfection will result in the delay of your enquiry being processed.