Instructions

and cleaning

Instructions for reprocessing

reusable medical devices

Instructions for use

of DenTag instruments

Cleaning

of DenTag instruments

Instructions for reprocessing reusable medical devices

All dental and surgical devices must be disinfected, cleaned and sterilized at every use. Also new, non-sterilized instrument must be cleaned and sterilized before first use and must be treated following the steps hereafter described.


1 – Preconditioning

Immerse all instruments used in the mouth in a detergent and disinfectant solution immediately after use to avoid soiled materials dry onto instruments and to minimize contamination hazard. Use a container with a cap. Adhere strictly to the concentrations and reaction time given by the manufacturer of the cleaning agent and disinfectant.


2 – Cleaning

All operations aimed at removing soiled materials (particles, spots, etc.) from instruments fall within this category. Do not use corrosive detergents or acids (e.g. sodium hypochlorite). 
Rinse abundantly after preconditioning. Disassemble instruments, if applicable.


Manual cleaning:

- Use a soft brush not to damage the instrument.
- Do not use corrosive products.
- Do not use abrasive products.
- Use same detergent and disinfectant used for preconditioning to avoid contamination problems.
Adhere strictly to the concentrations and reaction time given by the manufacturer of the cleaning agent and disinfectant.


Ultrasonic cleaning:

- Use this procedure only on instrumentation that can withstand the process.
- Only use ultrasonic cleaning solutions.
- Only use cleaning agents compatible with the ones used for preconditioning.
Adhere strictly to the concentrations and reaction time given by the manufacturer of the cleaning agent and disinfectant.


Medical washer cleaning.

- Place and safely secure all instruments (machines specifically designed to hold instruments).
- Use suitable cleaning agents.
Adhere strictly to the concentrations and reaction time given by the manufacturer of the cleaning agent and disinfectant.

3 - Rinse

Carefully and abundantly rinse instruments with distilled or demineralized water after cleaning and disinfection.

4 – Drying

Sterilized devices must be first carefully dried with a clean, disposable, non-woven cloth or in a dryer or with filtered compressed air.

5 - Check

Carefully inspect all instruments for effectiveness of cleaning and damages. Damaged instruments must not be reused. Instruments that are still contaminated must be cleaned and disinfected again.

6 – Packing

Only applies to perfectly clean and dry instruments.


Re-usable packing:

Aluminium and stainless-steel watertight cases.
Trays with lid of the same material or thermoresistant plastics.


Disposable packing:

Plastic or coated paper bags and sheaths complying with NF EN 868 regulation.

7 – Sterilization

The effectiveness of sterilization depends on the correct implementation and execution of previous steps. Autoclave steam sterilization is the reference procedure which we recommend. Sterilization usually requires a constant 134°C / 273°F temperature for 18 minutes.


Controls after sterilization.

Medical devices must be inspected for sterilization effectiveness at the end of every cycle. They must be perfectly dry after opening autoclave and remain unaltered at room temperature: wet packages do not guarantee sterility. Each sterilized medical instrument must be labelled with cycle number, sterilization number, date of sterilization and expiration date. Create traceability for each sterilization procedure. Sterilized medical instruments must be also inspected right before use. Integrity of conditioning and expiration date must be verified as well.

8 – Storage

Containers with sterilized devices must be stored in a dry place, a separate room or, if that is not possible, in a closed cabinet or drawers. Labels with date of sterilization and expiration date must be clearly displayed on packages.
Sterilizer cleaning and maintenance
Adhere strictly to the instructions given by the manufacturer for cleaning, routine checks and maintenance of the sterilizing equipment.


Instructions for use of DenTag instruments

(on all packaging)

Intended Use

This DenTag product is intended for medical and dental use only. It must be used exclusively by appropriate trained and licensed professionals.

Contraindications

There are no known contraindications for this device.

Instructions

The device is to be used following a correct and acknowledged medical/dental procedure. The device is provided NON-STERILE, thus it must be thoroughly cleaned and sterilized prior to the first use and each subsequent reuse. Only use disinfectant agents specifically recommended by manufacturer. Do not exceed 175°C - 347°F during heating. Hereabove guidelines for sterilisation do not refer to any validated process. Claims under the warranty are excluded and DenTag srl accepts no liability if damages to devices result from non-observation of these basic rules.

Warnings and precautions

1) Materials non-compatible with surgical instruments may not be used on patients.
2) Dental surgery instruments are packed and sold non-sterile. They must always be thoroughly cleaned and sterilized prior to the first use.
3) The device must first be cleaned and dried and only afterwards sterilized. We recommend ultrasonic cleaner with suitable enzymatic detergents.
In order to preserve the dental instrument’s life span, sterilization temperature and detergents concentration must not exceed recommendations.

Storage

Dental surgery instruments must be stored clean in a clean environment at room temperature.

Disposal and destruction

We recommend accurately cleaning and disinfecting worn items before disposing them, according to legislation in force.

Expiration date

If properly used, the instrument does not expire. The end of life is determined by wear and damage in use.

Cleaning of DenTag instruments

All DenTag surgical instruments for dental clinics are manufactured and controlled with utmost care by highly specialized professionals. To ensure maximum effectiveness and preserve its life span, this device must only be used for its intended use.

Cleaning and sterilization of devices must be carried out with utmost care: only use suitable disinfectants; chemicals concentration must not exceed manufacturer’s recommendations and must be used according to instructions. Temperatures must not exceed 175°C – 347°F.

Some damages (corrosion, rust spots and similar) may be caused by as simple factors as contact. Claims under the warranty are excluded and DenTag srl accepts no liability if damages to devices result from non-observation of these fundamental rules. Warning: instruments are supplied NON-STERILE, thus they must be thoroughly cleaned and sterilized prior to the first use. After each use, instruments must be inspected for corrosion, rust spots, broken, bent or loose parts, damages on blade or elsewhere. Should any instrument be defective, it must be discarded and stored separately. Single use devices must not, under any circumstance, be sterilized and reused. After use they must be discarded and stored separately.

Cleaning and maintenance:

Concise guidelines on cleaning and sterilizing of instruments, that are supplied NON-STERILE, and must be cleaned and sterilized prior to the first use. Immediately after use instruments must be washed with warm, running water and any organic residue must be removed. Instruments must be cleaned immediately afterwards. If that is not possible, immerse instruments in a solution of water and PH-neutral detergent. Devices may be cleaned using a washer, an ultrasonic cleaning system or manually. The following general guidelines should be implemented:

Washer

Follow manufacturer’s instructions. Hinged and articulating items should be lubricated prior to sterilization process.


Ultrasonic cleaning system

Fully immerse instruments in ultrasonic cleaning solution for the time recommended by manufacturer (usually 5-10 minutes). Make sure that hinged and articulating items are in a wide-open position. Carefully position the instruments so they do not contact each other. Items in different materials should never be cleaned together. Do not use same cleaning solution for too many cycles. Follow manufacturer’s instruction and change cleaning solution frequently. When the ultrasonic cleaning cycle is completed, rinse the instruments in water to remove solution residue.

Manual Cleaning

If neither a washer nor an ultrasonic cleaning system– strongly recommended systems – can be used, then manual cleaning can be performed. In this case:

- Use rigid nylon, plastic or similar brushes.
- Never use metal or steel wool brushes.
- Use only PH-neutral detergents.
Carefully scrub devices and, if possible, rinse, clean and sterilize them separately. Closely inspect surface to make sure it is fully clean. Rinse items with running water after scrubbing. Repeatedly open and close hinged and articulating instruments during rinsing to make sure that hinges and joints are also clean. Thoroughly cleaned and rinsed items must be carefully dried. All hinged and articulating instruments must be lubricated using specific products for surgical devices. Never use household or industrial oils or lubricants. Inspect every item to ensure it is clean, functional and in good condition. You may now proceed to sterilization, that can be done individually or in batches.


High temperature sterilization in batches

Place instruments on trays or carriers and load the autoclave. Make sure instrument hinges are open. (A closed instrument will never be sterile, for the steam may not enter overlapping parts).

High temperature sterilization of single items

Insert instrument in disposable pouch (one each). Make sure instrument hinges are open before packaging.

Cold sterilization

Items are immersed in a sterilizing solution for a specific time-span given by the manufacturer of the solution. Adhere strictly to the instructions given by the manufacturer of the sterilizing solution.

Validation error occured. Please enter the fields and submit it again.
Thank You ! Your email has been delivered.