BRASSELER USA Carbide burs User manual

Brasseler USA CARBIDE Burs Instructions for Use
P 1 of 3
IFU-0006 REV A
EDCO 11 0098
BRASSELER USA CARBIDE Burs
BRASSELER USA Carbide Burs are available in Sterile and Non-Sterile models under various trade names with numerous
head diameters and working lengths. The devi es are reusable and are sterilized using steam sterilization in a gravity or
preva uum y le.
Description
The BRASSELER USA CARBIDE Dental Bur family in ludes Clini al Carbides and Laboratory Carbides. A CARBIDE dental
bur is a rotary utting devi e made of stainless steel, the working end of whi h is made from tungsten arbide, and
whi h is designed to fit into a dental handpie e. Alternatively, the devi e may be onstru ted wholly from tungsten
arbide. BRASSELER USA CARBIDE Burs are reusable devi es.
Intended Use
BRASSELER USA CARBIDE Burs fit into a dental handpie e, whi h provides the rotation, allowing the user to ut hard
stru tures in the mouth, e.g., teeth or bone. BRASSELER USA CARBIDE Burs an also be used to ut hard metals, plasti s,
por elains and similar materials.
Warnings and Precautions
Warning
: Attention should be paid to the speed of work (RPM)
o
Always refer to the produ t pa kaging for the Maximum RPM
o
Operating a bur with too high of an RPM may generate undesirable heat
o
Operating a bur with too high of an RPM may ause the bur to fail
•CARBIDE Burs must be thoroughly leaned and steam sterilized prior to the first use and ea h subsequent reuse
•CARBIDE Burs labeled “Sterile” require no further a tion prior to first use but must be thoroughly leaned and
steam sterilized prior to ea h subsequent reuse
oIf the pa kaging for “Sterile” labeled devi es is opened or damaged, the devi e must be thoroughly
leaned and steam sterilized prior to use and ea h subsequent reuse
•Do not use hemi al or dry heat to sterilize BRASSELER USA CARBIDE Burs, as these pro esses have not been
validated for use
•Do not use worn-out or dull burs
•Do not apply ex essive pressure on the bur as this ould ause undesirable heat or may ause the bur to fail
•Avoid removing the bur at too sharp an angle to avoid leverage and breakage
•Carefully read pa kage labels to ensure use of the appropriate devi e
•Ensure the bur is fully seated and se urely gripped in the handpie e ollet prior to use
•Move the bur ontinuously when in use to avoid lo alized heating and/or damage to the bur
•Maintain handpie es in good working ondition to ensure maximum effe tiveness of the devi e
•Use a rubber dental dam while using CARBIDE Burs to avoid possible aspiration or swallowing
•Always wear gloves when handling ontaminated instruments
•Eye prote tion must be worn to prote t against eje t parti les
•Surgi al masks must be worn to avoid inhalation of any aerosol or dust generated
•BRASSELER USA Bur Blo ks used to hold the devi es for storage and steam sterilization are not intended to
maintain sterility of the devi e

Brasseler USA CARBIDE Burs Instructions for Use
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IFU-0006 REV A
EDCO 11 0098
General Instructions
1. The devi e is to be used on the instru tion of, or by a dentist or other li ensed pra titioner.
2. Clean and sterilize non-sterile burs in a ordan e with the validated pro edures provided below prior to first use
and prior to ea h reuse.
3. Do not for e bur into the handpie e. In ase of diffi ult a ess, he k both handpie e turbine and bur and refer
to handpie e instru tions for troubleshooting.
Cleaning and Sterilization Instructions
S ope These instru tions are appli able to all BRASSELER USA Carbide Dental Burs. They are appli able before initial use
and after ea h subsequent use. Carbide Burs are provided me hani ally lean, but are not sterile (unless labeled
“STERILE”). Therefore, Carbide Burs should be sterilized before first use.
Warnings 1. Cleaning agents with hlorine or hloride as the a tive ingredient are orrosive to stainless steel and must not
be used. Cleaning agents with neutral pH are re ommended.
2. Do not use Cold Sterilizing Methods for the sterilization of Carbide Burs. These agents often ontain strong
oxidizing hemi als that may dull or weaken Carbide Burs.
Repro essing Limitations The end of life is determined by wear and damage in use. Carbide Burs should be inspe ted for defe ts (i.e. broken
tips, broken se tions on flutes, et .) during the leaning pro ess.
Point of Use Delay in repro essing must be kept to a minimum to avoid ontaminants drying thereby making leaning more
diffi ult.
Containment/
Transportation
Carbide Burs an be transported wet or dry and should be prote ted from damage. If transported wet there is an
in reased han e of staining or orrosion. Prolonged storage in disinfe tant solutions may result in degradation of
the produ t and must be avoided.
Manual Cleaning
Pro edure
If hand leaning is the only available option, Carbide Burs should be leaned in a sink reserved for leaning
instruments.
Rinse the Carbide Bur (and dedi ated instrument blo k, if appli able) under ool running water for at least one (1)
minute.
Prepare a fresh bath of neutral-pH leaning solution. Follow the agent’s manufa turer’s instru tions. Immerse the
Carbide Bur (and instrument blo k) and soak for at least ten (10) minutes.
After soaking, and keeping it immersed, brush thoroughly away from the body using the neutral leaning agent for
at least one (1) minute. Care should be taken to avoid spreading ontaminants by spraying or splashing during the
brushing pro ess. Use wire brushes with aution as brass parti les may result in galvani orrosion and steel
parti les may ause dis oloration of stainless steel.
Spe ial are should be taken to lean revi es and other hard-to-rea h areas thoroughly. Visually inspe t to
onfirm the removal of debris. Repeat the y le if needed.
Thoroughly rinse the Carbide Bur (and instrument blo k) under running warm water for at least one (1) minute and
until visibly lean.
Dry the devi e using a non-shedding wipe or lean ompressed air.

Brasseler USA CARBIDE Burs Instructions for Use
P 3 of 3
IFU-0006 REV A
EDCO 11 0098
Ultrasoni Cleaning
Pro edure
Prepare a fresh pH-neutral leaning solution; pla e the Carbide Bur in the dedi ated instrument blo k (if
appli able) and then pla e in a soni ation unit. Follow the agent manufa turers' instru tions for orre t
on entration, exposure time, temperature, and water quality. Completely submerge the devi e in the leaning
solution and soni ate for at least fifteen (15) minutes.
Perform a final thorough rinse of the devi e and instrument blo k (if appli able) under running warm tap water for
at least (1) minute.
Visually inspe t to onfirm the removal of debris. Repeat the y le if needed.
Dry the devi e using a non-shedding wipe or lean ompressed air.
Inspe tion Testing 1. Carefully inspe t ea h devi e to ensure that all debris has been removed.
2. Visually inspe t the devi e 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 se tion of a flute.
. Do not use if there is eviden e of orrosion.
Pa kaging Singly: Pa k the Carbide Bur in pou hes validated for sterilization
In Sets: Pla e the Carbide Bur in the dedi ated instrument blo k.
Sterilization Use the following y le for steam sterilization
Cy le Type Minimum
Sterilization
Exposure Time
(minutes)
Minimum
Sterilization
Exposure
Temperature
Minimum Dry Time
(minutes)
Gravity 10 135°C (275°F) 30
Pre-va uum
(4 Pulses)
3 134°C (273°F) 30
Ensure that the sterilizer manufa turer’s maximum load is not ex eeded.
Storage The Carbide Bur should be stored in the sterilization pou h (or instrument blo k) until required.
Additional Information These pro esses have been validated as being apable of preparing Carbide Burs for reuse. Any deviation from
these instru tions should be properly validated for effe tiveness and potential adverse results.
Brasseler USA Dental, L.L.C.
One Brasseler Blvd.
Savannah, GA 31419 USA
Telephone 912-925-8525
This manual suits for next models
2
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