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Information |
RECOMMENDED CARE AND CLEANING OF DIAMOND KNIVES |
DIAMOND KNIFE ULTRASONIC CLEANER INSTRUCTIONS |
1- Immediately after surgery rinse lower ¼ of knife under tepid water for one (1) minute while the blade is exposed. (Blade should not be extended beyond footplate for RK knives). Do not use heavy water pressure; a small stream of water is adequate. Point the front of the knife down when flushing. 2 - Place the knife (with blade in the fully retracted position) in an ultrasound unit filled with distilled water and one (1) scoop of enzymatic powder for two (2) to three (3) minutes. The knife may be fully immersed with the blade fully retracted in a small ultrasonic cleaning unit if placed on a rubber mat to preclude severe “chatter” and movement in the chamber. 3 - If the diamond is not clean repeat Steps 1 and 2. It is important not to wipe the diamond with any product. Continue to soak it in ultrasonic cleaner for an extended period of time. 4.After ultrasonic cleaning is complete rinse lower ¼ of knife under distilled water to rinse enzymatic residue from the blade for 30 seconds on each side of the blade while the blade is exposed. (Blade should not be extended beyond footplate for RK knives). Do not use heavy water pressure; a small stream of water is adequate. Point the front of the knife down when flushing. Retract blade and rinse the handle. 5 - Sterilize knife by any normal method. (KNIFE MUST BE STERILIZED WITH THE BLADE IN THE FULLY RETRACTED POSITION.) 275 degrees F (135 degrees C) maximum temperature for 3 minutes unwrapped to 30 minutes wrapped, is an acceptable sterilization method for diamond knives. |
DIAMOND KNIFE STEAM CLEANER INSTRUCTIONS |
1- Immediately after surgery clean your diamond knife. Angle the diamond tip in a downward slant and away from you. The blade should be approximately one inch away from the steamer spout. 2 - Steam each side of the blade for approximately 8 seconds. If there is still debris on the blade repeat the steam process on each side of the blade. 3 - Retract the blade. Hold the knife by the end portion of the handle (the knob) and steam the handle to clean. The handle will become hot from the steamer, be very careful when handling. 4 - After steam cleaning rinse lower ¼ of knife under distilled water to rinse residue from blade for 30 seconds on each side of the blade while the blade is exposed. (Blade should not be extended beyond footplate for RK knives). Do not use heavy water pressure; a small stream of water is adequate. Point the front of the knife down when flushing. Retract blade and rinse the handle. 5 - Dry the knife handle with a paper towel (do not open to dry the blade). 6 - Sterilize knife by any normal method. (KNIFE MUST BE STERILIZED WITH THE BLADE IN THE FULLY RETRACTED) |
POSITION |
275 degrees F (135 degrees C) maximum temperature for 3 minutes unwrapped or 30 minutes wrapped is an acceptable sterilization method for diamond knives. Be sure you and your staff have read and fully understand how to properly use your sterilizer. Follow the manufacturer’s instructions for your sterilization unit. Consult the AAMI ST79 procedures and your institution’s sterilization processes for proper sterilization of your diamond knives.
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Product Info |
“VOLMED Group is serving humanity since 1971 in manufacturing and supplying Quality General Surgical Instruments, Dental Instruments, Hand Tools and Beauty & Salon Scissors. VOLMED is recognised for its finest quality and best craftsmanship of Instruments and Precision Tools, in its advanced manufacturing facility and its controlled process on each stage ensures the best quality and the service of final delivery to our customers” |
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Life cycle of reusable surgical instruments |
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Following purchase, Surgical instruments should follow a strict life cycle, as follows: |
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NHS Estate (2003) Decontamination: |
“Decontamination is the combination of processes (including cleaning, disinfection and sterilization) used to render a reusable item safe for further use on patients and handling by staff. The effective decontamination of reusable surgical instruments is essential in minimising the risk of transmission of infectious agents” (NHS estates 2003). The importance of thorough decontamination and re-processing of instruments is highlighted above and Volmed Group advises that you follow their reprocessing instructions. |
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Instructions for Reprocessing of Reusable Devices |
The following instructions are for all reusable medical devices supplied by Volmed Group, unless stated otherwise with the packaging of the product. These instructions are intended for use only by persons with the required specialist knowledge and training. |
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WARNINGS |
1. Follow instructions and warnings as issued by the manufacturers of any decontaminants, disinfectants and cleaning agents. Wherever possible avoid use of mineral acids and harsh, abrasive agents. No part of the process shall exceed 140ºC. 2. Some sensitive materials (e.g. Aluminium) are damaged by high alkaline solutions (pH>10). 3. Devices with long, narrow cannula, hinges and blind holes require particular attention during cleaning. Note: When reprocessing medical devices, always handle with care, wearing protective clothing, gloves and eyewear in accordance with local Health & Safety procedures.
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LIMITATIONS ON REPROCESSING |
1. Repeated processing has minimal effect on these instruments. 2. End of life is normally determined by wear and damage in use. 3. Any specific limitations on the number of reprocessing cycles shall be made available with the instrument |
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PREPARATION FOR DECONTAMINATION |
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 immediately after use. If they cannot be reprocessed immediately, use an enzymatic foam spray cleaner to help prevent soil from drying. |
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CLEANING: AUTOMATED |
1. Use only either CE marked or validated washer-disinfector machines and low foaming, non-ionising cleaning agents and detergents following the manufacturer’s instructions for use, warnings, concentrations and recommended cycles. 2. Load instruments carefully, with any box joints and hinges open and so that any fenestrations in instruments can drain. 3. Place heavy instruments with care in the bottom of containers, taking care not to overload wash baskets. 4. Place instruments with concave surfaces facing down to prevent pooling of water. 5. Where available, use appropriate attachments to flush inside reamers and devices with lumens or cannula. 6. Ensure that soft, high purity water which is controlled for bacterial endotoxins is used in the final rinse stage. Note: Automated cleaning may not be suitable for all lumens and cannula in which case clean manually with a water jet gun, if available, and an appropriate brush (and stilette if provided) that reaches the depth of the feature. After manually cleaning, pass all devices through an automatic cleaning cycle to achieve disinfection. Note: These instruments have been validated using a washer-disinfector cycle validated to include two cold rinses at <35ºC, a detergent cycle and a rinse cycle both at >50ºC, a disinfection cycle operating at a temperature of between 80ºC and 87ºC for a minimum holding time of 1 minute (actual holding time in excess of 2 minutes 50 seconds) and a 20 minute drying cycle. The detergent used was low foaming, non-ionising spray wash detergent cleaner (max 12pH) and the rinse aid a neutral pH low foaming, non-ionic surfactant with isopropyl alcohol. |
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CLEANING: MANUAL |
Manual cleaning is not advised if an automatic washer-disinfector is available. If the equipment is not available, use the following process: 1. Use a double sink system (wash/rinse) dedicated for instrument cleaning (not used for hand washing). Ensure that the water temperature does not exceed 35ºC. 2. In the first sink, keeping the instrument submerged, with an autoclavable brush, apply CE marked cleaning solution to all surfaces until all soil has been removed. Pay particular attention to serrations, teeth, ratchets and hinges, always brushing away from the body and avoiding splashing. Ensure rangers and hinged instruments are thoroughly cleaned in both open and closed positions. 3. In the second sink, rinse instruments thoroughly with soft, high purity water which is controlled for bacterial endotoxins, so that the water reaches all parts of the instrument, then carefully hand dry or use a drying cabinet. Note: Manual cleaning is NOT a disinfection process: When manual cleaning is used it may not be possible to disinfect the device prior to further handling. |
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CLEANING: INSPECTION |
After cleaning, visually inspect all surfaces, cannulations, ratchets, joints, holes and lumens for complete removal of soil and fluids. If ANY soil or fluid is still visible, return the instrument for repeat decontamination. |
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MAINTENANCE |
Apply surgical grade lubricant to hinges, joints and moving parts as per the lubricant manufacturer’s instructions. |
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INSPECTION AND FUNCTIONAL TESTING |
1. Visually inspect and check:- all instruments for damage and wear; cutting edges are free from nicks and present a continuous edge; jaws and teeth align correctly; all 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; any component parts fit and assemble correctly with mating components. 2. Remove for repair or replacement any blunt, worn out, flaking, fractured or damaged instruments. Note: If an instrument is returned to the manufacturer / supplier, the instrument must be decontaminated and sterilised and be accompanied with the relevant documented evidence. |
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PACKAGING |
All instruments to be packed following local protocol in accordance. |
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STERILISATION |
1. Either CE marked or validated vacuum autoclave operating at 134-137ºC bar for a minimum holding time of 3 minutes – always following the instructions of the machine manufacturer. 2. When sterilising multiple instruments in one autoclave cycle, ensure that the steriliser manufacturers stated maximum load is not exceeded. 3. Ensure instruments are dry before sterilisation.
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STORAGE |
Ensure instruments are dry before storage, and stored in dry, clean conditions at an ambient room temperature. |
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ADDITIONAL INFORMATION |
1. Other forms of cleaning (i.e. ultrasonic) and sterilisation (i.e. Low temperature steam and Formaldehyde, Ethylene Oxide and Gas Plasma) are available. However, always follow the instructions for use as issued by the manufacturer and always consult with them if in any doubt over the suitability of any process used. 2. Cleaning and sterilising guidelines are available in HTM 2030 and HTM 2010. Contact: The NHS Estates Stationers Office Publications Centre for details at www.tso.co.uk. For further information contact: NHS Estates Information Centre, Department of Health, 1 Trevelyan Square, Boar Lane, Leeds, LS1 6AE, UK or visit www.nhsestates.gov.uk.
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Note: It is the responsibility of the reprocesser to ensure that the reprocessing as actually performed using equipment, materials and personnel in the reprocessing facility achieve the desired result. This requires validation and routine monitoring of the process. Likewise any deviation by the reprocessor from the instructions provided must be properly evaluated for effectiveness and potential adverse consequences. |
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Cleaning, Sterilization & Maintenance of Surgical Instruments |
1.RINSING |
Immediately after surgery, rinse instrumentsunder warm (not hot) running water. Rinseshould remove all blood, body fluids and tissue. |
2.CLEANING |
(If not done immediately after rinsing, instruments should be submerged in a solution ofwater and neutral PH(7) detergent.) |
A.Ultrasonic Cleaning |
For micro and delicate instruments, usemanual cleaning (step C). Instruments should be processed in a cleanerfor the full recommended cycle time –usually 5 to 10 minutes. Place instruments in open position into theultrasonic cleaner. Make sure that "Sharp"(scissors, knives osteotomes, etc.) blades donot touch other instruments. All Instruments have to be fullysubmerged. Do not place dissimilar metals (stainless,copper, chrome plated, etc.) in the samecleaning cycle. Change solution frequently – at least asoften as manufacturer recommends. Rinse instruments after ultrasoniccleaning with water to remove ultrasoniccleaning solution. |
B.Automatic Washer Sterilizers |
Follow manufacturers recommendations butmake sure instruments are lubricated afterlast rinse cycle and before sterilization cycle. |
C.Manual Cleaning |
Most instrument manufacturers recommendultrasonic cleaning as the best and mosteffective way to clean surgical instruments,particularly those with hinges, locks andother moving parts. If ultra sonic cleaning isnot available observe the following steps. |
3.AFTER CLEANING |
If instruments are to be stored, let them air dryand store them in a clean and dry environment. |
4.AUTOCLAVING |
If instruments are to be reused or autoclaved: A.Lubricate all instruments which have any"metal to metal" action such as scissors,hemostats, needle holders, self-retainingretractors, etc. Recommend surgical lubricants such asinstrument milk are best. Do not use WD-40, oil or other industrial lubricants. B.Put instruments up for autoclaving eitherindividually or in sets. |
Individual Instruments |
Disposable paper or plastic pouches areideal. Make sure you use a wide enoughpouch (4" or wider) for instruments withratchet locks such as needle holders andhemostats so the instrument can be sterilizedin an open (unlocked) position.
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Instrument Sets |
Unlock all instruments and sterilize them inan open position. Place heavy instrumentson bottom of set (when two layers arerequired). Never lock an instrument during autoclaving. It will not be sterile as steam cannotreach the metal to metal surfaces. Theinstrument will develop cracks in hingeareas because of heat expansion during theautoclave cycle. Do not overload the autoclave chamber aspockets may form that do not permit steampenetration. Place towel on bottom of pan to absorb excess moisture during autoclaving. This will reduce the chances of getting"Wet packs". Make sure the towels used insterilization of instruments have no detergent residue and are neutral – PH(7) ifimmersed in water. This can be a realproblem as laundries frequently use inexpensive but high PH(9-13) detergents and donot properly rinse out or neutralize thosedetergents in the final wash/rinse cycle.Also, some times bleaches such as Cloroxare added and are not neutralized.
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I.Use stiff plastic cleaning brushes (nylon, etc.) Do not use steel wool or wire brushes exceptspecially recommended stainless steel wirebrushes for instruments such as bone files, oron stained areas in knurled handles. II.Use only neutral PH(7) detergents because ifnot rinsed off properly, low PH detergents willcause breakdown of stainless protective surface and black staining. High PH detergent will cause surface depositof brown stain, which will also interfere withsmooth operation of the instrument. III.Brush delicate instruments carefully and, ifpossible, handle them totally separate fromgeneral instruments. IV.Make sure all instrument surfaces are visiblyclean and free from stains and tissue. This is a good time to inspect each instrumentfor proper function and condition. Check and make sure that : Scissors blades glide smoothly all the way(they must not be loose when in closed position). Test scissors by cutting into thin gauze.Three quarters of the length of blade shouldcut all the way to the scissor tips, and not hangup. Forceps (pickups) have properly aligned tips. Hemostats and Needle Holders do not showlight between the jaws, lock and unlock easily,joints are not too loose. Check Needle Holdersfor wear on jaw surfaces. Suction tubes are clean inside. Retractors function properly. Cutting instruments and knives have sharp,undamaged blades. V.After scrubbing, rinse instruments thoroughlyunder running water. While rinsing, open andclose Scissors, Hemostats, Needle Holders andother hinged instruments to make sure thehinge areas are rinsed out, as well as theoutside of the instruments. |
CAUTION |
At the end of the autoclavecycle – before the drying cycle – unlockautoclave door and open it more than a crack(about 3/4"). Then run dry cycle for theperiod recommended by the autoclavemanufacturer. If the autoclave door isopened fully before the drying cycle, coldroom air will rush into the chamber, causingcondensation on the instruments. This willresult in water stains on instruments and alsocause wet packs. If you have any unusual staining on yourinstruments during sterilization, contact yourlocal instrument representative. |
5.COLD STERILIZATION |
Most cold sterilization solutions render instruments sterile only after a 10 hour immersion.This prolonged chemical action can be moredetrimental to the surgical instruments than theusual 20 minute autoclave cycle. If the instruments need to be "disinfected" only, cold sterilization is okay as disinfection will place in only10 minutes. But keep in mind the difference between: |
STERILE |
an absolute term (no living organism survives) |
DISINFECTED |
basically clean. Always use the proper sterilization/cleaningtechnique to render the instrument in requiredcondition for use. For instruments with Tungsten Carbide inserts(Needle Holders, Scissors, Tissue Forceps), wedo not recommend use of solutions containingBenzyl Ammonium Chloride which will destroythe Tungsten Carbide Inserts. |
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RECOMMENDED CARE AND CLEANING OF INSTRUMENTS |
STORAGE |
Surgical instruments should be stored in sterilizing trays of proper size 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, which can melt during autoclaving and cause damage to instruments. |
INSPECTION |
Be sure to inspect every instrument at the end of your surgical day. Please conduct this inspection under a microscope or with magnification lens. |
CLEANING |
Proper cleaning and maintenance will ensure the life of your instruments. All surgical instruments should be disinfected, thoroughly cleaned, inspected and tested after each use. Be sure to pay special attention to inaccessible areas. Clean and rinse instruments immediately after use. Failure to clean foreign matter promptly may cause particles or secretions to adhere to the instrument making cleaning more difficult and sterilization ineffective. |
Manual Cleaning |
Use a mild soap solution approved for surgical instruments with a soft brush or instrument wipe to clean instrument and remove stains. Never use abrasive powders or steel wool to remove stubborn stains—these can damage the super fine finish of an instrument and can actually cause corrosion of stainless instruments. Cleaning solutions at or near neutral pH 7.0 are the best cleaning solutions. Use distilled or de-mineralized water to rinse instruments thoroughly. Carefully dry instruments with a hot air blower or lint-free cloth. |
Ultrasonic Cleaning |
Be sure that you and your staff members are completely familiar with the manufacturer’s ultrasonic cleaner recommended instructions. Use only cleaning solutions approved for surgical instruments. Change the solution frequently, always use de-mineralized or distilled water. Heat water to 150º Fahrenheit (62 º C) using an immersion heater or use a separate stainless container if your unit does not have an automatic built-in water heater. Instruments should never touch each other in the ultrasonic cleaner. After removing instruments from the ultrasonic cleaner, rinse the instruments under running water first then rinse again in clean de-mineralized water. Dry with a lint-free cloth or a hot air blower. |
LUBRICATION |
It is recommended to lubricate all moving parts after each cleaning. Use silicone or Teflon lubricants which can withstand autoclaving. We recommend the use of “Instrument Milk”. Never use ordinary lubricants or cover up even the slightest corrosion with a lubricant.
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STERILIZATION |
Stainless Steel and Titanium instruments can be sterilized via steam autoclaving, chemical disinfectants, ethylene oxide gas, or even dry hot air. The most practical method of sterilization is heat or steam, which require less time. Be sure to separate instruments by material and make sure the instruments do not come into contact with each other when being placed in the sterilization tray |
THE FOLLOWING CYCLES HAVE BEEN VALIDATED |
High speed (flash) autoclave: 270°F (132°C) for 10 minutes, unwrapped. This method should be reserved for emergencies only. Consult AAMI ST79 and your institution’s policy for restrictions regarding the use of flash sterilization Standard gravity autoclave: 250°F (121°C) for 30 minutes, wrapped Pre-vacuum high temperature autoclave: 274°F (134°C) for 3 minutes, wrapped Be sure you and your staff have read and fully understand how to properly use your sterilizer. Follow the manufacturer’s instructions for your sterilization unit. Consult the AAMI ST79 procedures and your institution’s sterilization processes for proper sterilization of your instrumentation
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