BRASSELER Briocut Sterile Carbide Burs Instruction Manual

Briocut Sterile Carbide Burs

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Specifications

• Brand: BRASSELER USA

• Product Name: BRIOCUTTM STERILE CARBIDE BURS

• Material: Stainless steel with tungsten carbide working
  end

• Available Models: Various head diameters, shapes, and working
  lengths

Product Usage Instructions

Description:

The BRIOCUTTM STERILE CARBIDE Dental Bur family includes
Clinical Carbide Burs designed for cutting hard structures in the
mouth.

Intended Use:

BRIOCUTTM STERILE CARBIDE Burs are used in dental handpieces to
cut hard structures like teeth, bone, metals, plastics, and
porcelains.

Warnings and Precautions:

• BRIOCUTTM STERILE CARBIDE BURS are for single use only.

• Follow the recommended RPM range to prevent device failure or
  harm to the patient.

• Proper irrigation is necessary during use to avoid generating
  heat that may harm the patient.

• Avoid applying excessive pressure on the bur to prevent
  injuries.

• Ensure Sterile labeled devices are not opened or damaged before
  use to prevent infection risks.

• Use rubber dental dams and gloves for safety and infection
  control.

Contraindications:

Avoid using BRIOCUTTM STERILE CARBIDE BURS for individuals with
known allergies to nickel and cobalt.

Frequently Asked Questions (FAQ)

Q: Can BRIOCUTTM STERILE CARBIDE BURS be reused?

A: No, these burs are for single use only to maintain cutting
efficiency and prevent risks of device failure or patient harm.

Q: How should I sterilize damaged or opened Sterile labeled

devices?

A: Thoroughly clean and steam sterilize the device before use to
avoid infection risks. Do not use chemical or dry heat
sterilization methods.

Q: What precautions should I take while using BRIOCUTTM STERILE

CARBIDE BURS?

A: Always follow recommended RPM, ensure proper irrigation,
avoid excessive pressure, use rubber dental dams, wear gloves, and
read package labels for correct usage to prevent injuries or
complications.

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BRIOCUTTM STERILE CARBIDE BURS Instructions for Use
BRASSELER USA BRIOCUTTM STERILE CARBIDE BURS
BRIOCUTTM STERILE CARBIDE Burs are available in Sterile models with numerous head diameters, shapes and working lengths.
Description
The BRIOCUTTM STERILE CARBIDE Dental Bur family includes Clinical Carbide Burs. A CARBIDE dental bur is a rotary cutting device designed to fit into a dental handpiece. The device is made of stainless steel with a working end of which is made of tungsten carbide or is made of one piece of tungsten carbide.
Intended Use
BRIOCUTTM STERILE CARBIDE Burs fit into a dental handpiece, which provides the rotation, allowing the user to cut hard structures in the mouth, e.g., teeth or bone. BRIOCUTTM STERILE CARBIDE Burs can also be used to cut hard metals, plastics, porcelains, and similar materials.

Warnings and Precautions
BRIOCUTTM STERILE CARBIDE BURS are Single use. Devices marked as single use are not intended to be used on more than one patient. Use on more than one patient may lead to decreased cutting efficiency which could result in device failure or generation of undesirable heat and cause patient discomfort, tooth or tissue necrosis, or patient burns.
The device is to be used on the instruction of, or by a dentist or other licensed practitioner. Attention should be paid to the speed of work (RPM).
o Always refer to the product packaging for the Maximum RPM. Use of the bur beyond the RPM range may cause the bur to break and result in patient or user harm.
o Operating a bur with too high of an RPM may generate undesirable heat and cause patient discomfort, tooth or tissue necrosis, or patient burns.
Proper irrigation is required while using the device. Inadequate use of irrigation may generate undesirable heat and cause patient discomfort, tooth or tissue necrosis, or patient burns.
Do not apply excessive pressure on the bur as this could cause undesirable heat or may cause the bur to fail and cause patient or user injury. BRIOCUTTM STERILE CARBIDE Burs are labeled “Sterile” and require no further action prior to first use.
o If the packaging for “Sterile” labeled devices is opened or damaged, the device must be thoroughly cleaned and steam sterilized prior to use to prevent the risk of infection or cross-contamination.
o Do not use chemical or dry heat to sterilize BRIOCUTTM STERILE CARBIDE Burs, as these processes have not been validated for use. Use of these processes may be corrosive to the device and could result in premature device failure.
o Use a rubber dental dam while using BRIOCUTTM STERILE CARBIDE Burs to possible aspiration or swallowing of the device. Always wear gloves when handling contaminated instruments to avoid possible infection / cross- contamination. Carefully read package labels to ensure use of the appropriate device Failure to do so may cause patient or user injury. Failure to follow these instructions may cause the following: preparation site damage, injury to the patient or user, or possible aspiration or
swallowing of the BRIOCUTTM STERILE CARBIDE BUR.

Contraindications
BRIOCUTTM STERILE CARBIDE BURS contain nickel and cobalt and should not be used for individuals with known allergic sensitivity to this
metal as it may cause hypersensitivity.

Precautions
Always inspect the burs before use. Use of dull burs could cause undesirable heat or may cause the device to fail. Move the bur continuously when in use to avoid localized heating and/or damage to the bur. Undesirable heat generation can cause patient
discomfort, tooth or tissue necrosis or patient burns.
Avoid removing the bur at too sharp an angle to avoid leverage and breakage and cause patient or user injury. Maintain handpieces in good working condition to ensure maximum effectiveness of the device. Failure to properly maintain handpieces may
lead to injury of the patient or user, aspiration or swallowing of the device or damage to the preparation site due to vibration of a worn chuck or turbine.
Ensure the bur is fully seated and securely gripped in the handpiece collet prior to use. Failure to do so may cause the device to “walk out” of the handpiece and may lead to injury of the patient or user or aspiration or swallowing of the device.
Never force a bur into a handpiece as this could cause damage to the handpiece collet.

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BRIOCUTTM STERILE CARBIDE BURS Instructions for Use
Eye protection must be worn to protect against eject particles. Surgical masks must be worn to avoid inhalation of any aerosol or dust generated BRASSELER USA Bur Blocks used to hold the devices for storage and steam sterilization are not intended to maintain sterility of the device.

General Instructions
1. Clean and sterilize non-sterile burs (only if the packaging for “Sterile” labeled devices is opened or damaged) in accordance with the validated procedures provided below prior to first use.
2. Do not force bur into the handpiece. In case of difficult access, check both handpiece turbine and bur and refer to handpiece instructions for troubleshooting.

Cleaning and Sterilization Instructions

Scope

These instructions are applicable to all BRIOCUTTM STERILE CARBIDE Dental Burs. They are applicable before initial use (only if the packaging

for “Sterile” labeled devices is opened or damaged).

Warnings

1. Cleaning agents with chlorine or chloride as the active ingredient are corrosive to stainless steel and must not be used. Cleaning agents with neutral pH are recommended.

2. Do not use Cold Sterilizing Methods for the sterilization of Carbide Burs. These agents often contain strong oxidizing chemicals that may dull or weaken Carbide Burs.

Reprocessing Limitations

The BRIOCUTTM STERILE CARBIDE BURS are single use medical devices and should not be reprocessed.

Point of Use

BRIOCUTTM STERILE CARBIDE BURS should be immediately used upon opening the primary package (pouch).

Containment/ Transportation

Carbide Burs can be transported wet or dry and should be protected from damage. If transported wet there is an increased chance of staining or corrosion. Prolonged storage in disinfectant solutions may result in degradation of the product and must be avoided.

Manual Cleaning Procedure

If hand cleaning is the only available option, Carbide Burs should be cleaned in a sink reserved for cleaning instruments.

Rinse the Carbide Bur (and dedicated instrument block, if applicable) under cool running water for at least one (1) minute.

Prepare a fresh bath of neutral-pH cleaning solution. Follow the agent’s manufacturer’s instructions. Immerse the Carbide Bur (and instrument block) and soak for at least ten (10) minutes.

After soaking, and keeping it immersed, brush thoroughly away from the body using the neutral cleaning agent for at least one (1) minute. 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 discoloration of stainless steel.

Special care should be taken to clean crevices and other hard-to-reach areas thoroughly. Visually inspect to confirm the removal of debris. Repeat the cycle if needed.

Thoroughly rinse the Carbide Bur (and instrument block) under running warm water for at least one (1) minute and until visibly clean.

Dry the device using a non-shedding wipe or clean compressed air.

Ultrasonic Cleaning Procedure Inspection Testing Page 2 of 3

Prepare a fresh pH-neutral cleaning solution; place the Carbide Bur in the dedicated instrument block (if applicable) and then place in a sonication unit. Follow the agent manufacturers’ instructions for correct concentration, exposure time, temperature, and water quality. Completely submerge the device in the cleaning solution and sonicate for at least fifteen (15) minutes.

Perform a final thorough rinse of the device and instrument block (if applicable) under running warm tap water for at least one (1) minute.

Visually inspect to confirm the removal of debris. Repeat the cycle if needed.

Dry the device using a non-shedding wipe or clean compressed air.

1. Carefully inspect each device to ensure that all debris has been removed.

2. Visually inspect the device for damage/ wear that would prevent proper operation.

a. Do not use if the tip is broken. b. Do not use if there is a broken section of a flute. c. Do not use if there is evidence of corrosion.

IFU-0012 REV D EDCO 24.0127 2024-04-29

BRIOCUTTM STERILE CARBIDE BURS Instructions for Use

Packaging Sterilization

Singly: Pack the Carbide Bur in pouches validated for sterilization In Sets: Place the Carbide Bur in the dedicated instrument block. Use the following cycles for steam sterilization:

Storage Additional Information

Cycle Type
Gravity Pre-vacuum (4 Pulses)

Minimum Sterilization Exposure Time (minutes)
10
3

Minimum Sterilization Exposure Temperature 135°C (275°F)
134°C (273°F)

Minimum Dry Time (minutes) 30
30

Ensure that the sterilizer manufacturer’s maximum load is not exceeded. The minimum dry time has been validated to ensure that the devices will not be left wet. Failure to achieve the minimum dry time may cause moisture to remain on the bur that could result in corrosion.

The Carbide Bur should be stored in the sterilization pouch or instrument block in a sterilization pouch until required.

These processes have been validated as being capable of preparing Carbide Burs for use only if sterile packing was compromised. Any deviation from these instructions should be properly validated for effectiveness and potential adverse results.

Glossary of Symbols: Brasselerusadental.com/resources/

Brasseler U.S.A. Dental, LLC One Brasseler Blvd Savannah, GA 31419 U.S.A Telephone 800-841-4522

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IFU-0012 REV D EDCO 24.0127 2024-04-29

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