CAUTION:
Rx Only. These instructions, in whole or in part, are not a substitute for formal training in carbide dental burs. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.
DESCRIPTION:
Microcopy NeoBurr tungsten carbide burs are manufactured from either a single piece tungsten carbide or, from a tungsten carbide tip, brazed to a surgical grade stainless steel stem. The range includes patterns designed to meet the needs of all surgery and laboratory applications. The burs are packed in a plastic pouch in a dedicated cleanroom facility and terminally sterilized using Gamma Irradiation 
by a contract sterilizer. These burs are identified as single-use devices and should NOT be re-processed and/or re-used.
INDICATIONS:
Microcopy NeoBurr tungsten carbide burs can be used to cut or finish a wide variety of materials encountered in dentistry. These include tooth material such as enamel, dentin and bone, dental materials such as amalgam, composite, glass-ionomer cements, polymer and ceramic and precious and non-precious alloys.
CONTRAINDICATIONS TO USE:
Use of Microcopy NeoBurr is contraindicated on any patient who is allergic to any of the components of the product.
Do not reuse. Microcopy NeoBurr are single-use. Attempts to reuse these products will adversely affect their performance.
CLINICAL PRECAUTIONS AND WARNINGS:
- Carefully read package labels to ensure use of the appropriate device. Failure to do so may cause procedural delays or 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 carbide burs.
- Prior to use, carefully inspect the pouch for signs of damage and/or deterioration and check that the expiry date has not expired. Refrain from opening the pouch until you are ready to use the bur.
- Prior to use inspect the bur for broken and/or damaged flutes, discard any potentially defective burs. Do not use worn-out or dull devices.
- Discard any damaged carbide burs immediately.
- Microcopy carbide burs are for SINGLE-PATIENT-USE ONLY. Tungsten carbides are pre-sterilized for single-use and should not be reprocessed or reused.
- Do not use chemical or dry heat to sterilize devices, as these processes have not been validated for use
- Protect patient’s eyes and vulnerable tissues when using these carbide burs.
- Clinicians should wear eye protection and facemask when using carbide burs.
- Surgical masks shall be worn to avoid inhalation of aerosol and/or dust generated during the procedure.
- Follow the handpiece manufacturer’s instructions for use and maintenance and service all hand pieces appropriately.
- Ensure the bur is fully seated and gripped in the handpiece collet.
- Before use, run the hand piece to check for any abnormalities including overheating.
- Ensure handpieces are maintained in good working order and remain correctly lubricated at all times.
- Do not apply excessive pressure on the bur as this could cause undesirable heat and/or may cause the bur 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 which could 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 procedural delays or 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 which could result in procedural delays.
- Always refer to the product packaging for the Maximum RPM. Never exceed the maximum speeds as shown in the table, as this may generate undesirable heat.
- Do not exceed the maximum speeds tabulated below:
|
Instrument head diameter
01/10 (mm) - ISO
|
Maximum permissible speed
(RPM)
|
Recommended operational speed
(RPM) |
| 007 - 010 |
450,000 |
100,000 - 220,000 |
| 011 - 014 |
450,000 |
70,000 - 220,000 |
| 015 - 018 |
450,000 |
55,000 - 160,000 |
| 019 - 023 |
300,000 |
40,000 - 120,000 |
| 024 - 027 |
160,000 |
35,000 - 110,000 |
| 028 - 031 |
140,000 |
30,000 - 95,000 |
| 032 - 040 |
120,000 |
25,000 - 75,000 |
041 - 054
|
95,000 |
15,000 - 60,000 |
| 055 - 070 |
60,000 |
12,000 - 40,000 |
| 041 - 054 |
45,000 |
10,000 - 20,000 |
CLINICAL USE:
Microcopy’s tungsten carbide burs can be used to cut or finish a wide variety of materials encountered in dentistry. These include tooth material such as enamel, dentin and bone, dental materials such as amalgam, composite, glass-ionomer cements, polymer and ceramic veneers and precious and non-precious alloys. The bur pattern will be selected to cut a specific material in a specific application.
Holding the bur in the pouch by the operative end, push the stem end through the plastic far enough to insert into the hand piece collet. Immediately insert the stem into the handpiece collet and tighten before releasing the grip on the operative end and discarding the empty pouch.
STORAGE:
In dry conditions and protected against contaminants. Protect instruments, in general, against chemicals, acids, heat and extreme temperature variations.
STERILE PRODUCT SHELF LIFE:
- On the provision that appropriate storage and handling practices are applied to all unopened pouches, product sterility will be maintained for five (5) years unless sterile package is opened or damaged. Do not use the product if the package is opened or damaged.
- Sterile provided products are labeled with their expiry date. Do-not use the products after their stated expiration date
TRACEABILITY:
Each package includes Lot number 
on its label.
This number must be quoted in any correspondence regarding the product.
APPLICABLE SYMBOLS:
 |
Manufacturer |
Indicates the medical device manufacturer. |
|
Do not reuse |
Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. |
|
Do not resterilize |
Indicates a medical device that is not to be re-sterilized. |
|
Sterilized using irradiation |
Indicates a medical device that has been sterilized using irradiation. |
|
Lot Code |
Indicates the manufacturer's batch code
so that the batch or lot can be identified. |
 |
Consult instructions for use |
Indicates the need for the user to consult
the instructions for use. |
|
Use By |
Indicates the date after which the medical device is not to be used. |
|
Do not use if package is open or damaged |
Indicates a medical device that should
not be used if the package has been damaged or opened. |
 |
CE marking |
Signifies European technical conformity. |
 |
Authorized European representative |
Indicates the Authorized representative in the European Community. |
CONTACT INFORMATION:
|
Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144
|
| |
|
|
DENTEQ Medical Technologies
Hafenstrasse 12 76344,
Egenstien-Leopoldshafen, Germany
Fax: +49-7247 944843
|
| |
|
|
0483 |
This section is deivided into 2 sections to allow a quick and practical access to the Instructions For Use (IFU) of Microcopy products. Upon request you can contact Microcopy to order a free of charge copy of any IFU. More details below.
1. Current Valid IFU - section for current valid documents.
NEOBURR
IFU for NeoBurr
2. Archived (previous) IFU's - obsolete versions of the documents.
NEOBURR
IFU for NeoBurr
Upon request, you can contact Microcopy to order a free of charge copy of any IFU. Timetable of receiving the IFU: by Email - 2 working days, by mail - 7 working days.
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