Sterile Diamonds 

CAUTION:

Rx Only. These instructions, in whole or in part, are not a substitute for formal training in diamond dental burs. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.

 

DESCRIPTION:

Microcopy NeoDiamond burs are manufactured from a single piece of high-quality stainless steel plated at the operational end with a natural diamond grit. The diamond burs are further plated with a unique protective coating formula. 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. These burs are identified as sterile single-use devices and NOT be re-processed and/or re-used. sterile box iconsu icondo not use icon

 

INDICATIONS

Microcopy NeoDiamond diamond burs can be used to cut 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 ceramics and precious and non-precious alloys.

 

CONTRAINDICATIONS TO USE

Use of Microcopy NeoDiamond is contraindicated on any patient who is allergic to any of the components of the product. Do not reuse. Microcopy NeoDiamond are single-use. Attempts to reuse these products will adversely affect their performance.

 

CLINICAL PRECAUTIONS AND WARNINGS:

  1. Carefully read package labels to ensure use of the appropriate device. Failure to do so may cause procedural delays or patient or user injury.
  2. 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 diamond burs.
  3. 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.
  4. 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.
  5. Discard any damaged diamond burs immediately.
  6. Microcopy diamond burs are for SINGLE-PATIENT-USE ONLY. NeoDiamonds are pre-sterilized for single-use and should not be reprocessed or reused.
  7. Do not use chemical or dry heat to sterilize devices, as these processes have not been validated for use
  8. Protect patient’s eyes and vulnerable tissues when using these diamond burs.
  9. Clinicians should wear eye protection and facemask when using diamond burs.
  10. Surgical masks shall be worn to avoid inhalation of aerosol and/or dust generated during the procedure.
  11. Follow the hand piece manufacturer’s instructions for use and maintenance and service all hand pieces appropriately.
  12. Ensure the bur is fully seated and gripped in the handpiece collet.
  13. Before use, run the handpiece to check for any abnormalities including overheating.
  14. Ensure handpieces are maintained in good working order and remain correctly lubricated at all times.
  15. Move the bur continuously when in use so as to avoid localized heating.
  16. Do not apply excessive pressure on the bur as this could cause undesirable heat and/or may cause the bur to failure.
  17. 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.
  18. Avoid removing the bur at too sharp an angle to avoid leverage and breakage which could cause patient or user injury.
  19. 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.
  20. 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.
  21. Never force a bur into a handpiece as this could cause damage to the handpiece collet which could result in procedural delays.
  22. When using short burs (up to 20mm in length) make certain the head/diamonds to not come in contact with the chucking mechanism.
  23. Short burs are recommended to be used with a mini handpiece.
  24. 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.
  25. 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 95,000 25,000 - 75,000
041 - 054 95,000 15,000 - 60,000
055 - 070 60,000 12,000 - 40,000
080 - 100 45,000 10,000 - 20,000

 

CLINICAL USE:

Microcopy NeoDiamond burs can be used to cut a wide variety of materials encountered in dentistry. These include tooth material such as enamel and dentin, dental materials such as composite, glass-ionomer cements, polymer and ceramic and precious and non-precious alloys. Our range of diamond burs provide maximum cutting efficiency and effortless access through tough diamond for both endodontic treatment and crown removal.

 

Holding the bur in the pouch by the operative end, push the stem end through the plastic far enough to insert into the handpiece 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 (PRE-USE):

Store in a dry and clean environment at ambient temperature.
Protect instruments in general against chemicals, acids, heat and extreme temperature variationsIn dry conditions and protected against contaminants.

 

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. do not use icon
  • The products are labeled with their expiry date. Do not use the products after their stated expiration dateuse by icon

 

 TRACEABILITY:

Each package includes Lot number lot icon on its label.

This number must be quoted in any correspondence regarding the product.

 

APPLICABLE SYMBOLS:

manuf icon Manufacturer Indicates the medical device manufacturer.
su icon 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 restiril icon Do not resterilize Indicates a medical device that is not to be re-sterilized.
sterile box icon Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation. 
lot icon Batch Code Indicates the manufacturer's batch code
so that the batch or lot can be identified.
instruction icon Consult instructions for use Indicates the need for the user to consult
the instructions for use. 
use by icon Use by date Indicates the date after which the medical device is not to be used.
do not use icon Do not use if package is damaged Indicates a medical device that should
not be used if the package has been damaged or opened.
ce icon CE marking Indicates European Conformity Mark.
ec rep Authorized European representative Indicates the Authorized representative in the European Community.
keep dry Keep Dry Indicates a medical device that needs to be protected from moisture.
RX ONLY DEVICE for professional use only (ref US FDA CDRH) Indicates device shall only be used by a trained professional.

 

CONTACT INFORMATION, INFORMATIONS DE CONTACT:

 

manuf icon

Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144

   
ec rep

DENTEQ Medical Technologies
Hafenstrasse 12 76344,
Egenstien-Leopoldshafen, Germany
Fax: +49-7247 944843

   
ce icon  0483

 

FRENCH TRANSLATION

Sterile Diamonds

ATTENTION :

Rx uniquement. Ces instructions, dans leur intégralité ou partiellement, ne peuvent remplacer une formation officielle sur les fraises dentaires diamantées. Il est FORTEMENT RECOMMANDÉ de suivre une formation professionnelle appropriée avant d’utiliser cet outil médicalement.

 

DESCRIPTION:

Les fraises NeoDiamond de Microcopy sont fabriquées à partir d’un seul morceau d’acier inoxydable de haute qualité, plaqué de poussière de diamant naturelle au niveau de l’extrémité fonctionnelle. En outre, les fraises diamantées présentent un revêtement de protection à la formule unique. La gamme inclut des modèles conçus pour répondre à toutes les utilisations en chirurgie et en laboratoire. Les fraises sont emballées dans un étui en plastique au sein d’une salle blanche dédiée et stérilisées au stade terminal par irradiation gamma. Ces fraises sont considérées comme des outils stériles à usage unique et ne doivent PAS être retraitées et/ou réutilisées.  

sterile box iconsu icondo not use icon

 

INDICATIONS:

Les fraises NeoDiamond de Microcopy peuvent servir à couper un large éventail de matériaux présents en médecine dentaire. Ceux-ci incluent les matières dentaires, telles que l’émail, la dentine et l’os, des matériaux dentaires comme l’amalgame, le composite, les ciments verre ionomère, les alliages de polymères et de céramique, précieux et non précieux.

 

CONTRE-INDICATIONS D’UTILISATION:

L’utilisation d’une fraise NeoDiamond Microcopy est contre-indiquée pour tout patient allergique à l’un des composants du produit. Ne pas réutiliser. Les fraises NeoDiamond de Microcopy sont à usage unique. Toute tentative de réutilisation de ces produits aura un impact négatif sur leurs performances.

 

PRÉCAUTIONS CLINIQUES ET AVERTISSEMENTS :

  1. Lisez attentivement les étiquettes de l’emballage pour vous assurer que vous utilisez le bon outil. Sinon, vous risquez de provoquer des retards de procédure ou de vous blesser, ainsi que le patient.
  2. Les événements suivants risquent de survenir si vous ne respectez pas ces instructions : site de préparation endommagé, patient ou utilisateur blessé, risque d’aspiration ou d'ingurgitation de la fraise diamantée.
  3. Avant l’utilisation, inspectez soigneusement l’étui afin de détecter tout signe de dommages et/ou de détérioration. Vérifiez également que la date d’expiration n’est pas dépassée. N’ouvrez pas l’étui tant que vous n’êtes pas prêt à utiliser la fraise.
  4. Avant l’utilisation, inspectez la fraise afin de détecter toute cassure et/ou tout dommage au niveau des goujures. Jetez toute fraise potentiellement défectueuse. N’utilisez pas d’outils usés ou émoussés.
  5. Jetez immédiatement toute fraise diamantée endommagée.
  6. Les fraises diamantées Microcopy sont UNIQUEMENT DESTINÉES À UN USAGE SUR UN SEUL PATIENT. Les fraises NeoDiamond sont préstérilisées pour un usage unique et ne doivent être ni retraitées, ni réutilisées.
  7. Ne stérilisez pas les outils à l’aide de chaleur chimique ou sèche, car ces processus n’ont pas été validés les concernant.
  8. Protégez les yeux et les tissus vulnérables du patient lorsque vous utilisez ces fraises diamantées.
  9. Les praticiens doivent porter un masque et des lunettes de protection lorsqu’ils utilisent des fraises diamantées.
  10. Il est nécessaire de porter un masque chirurgical pour éviter d’inhaler de l’aérosol et/ou la poussière au cours de la procédure.
  11. Respectez les instructions d’utilisation et de maintenance du fabricant de l’instrument, et entretenez correctement chaque instrument.
  12. I) Vérifiez que la fraise est bien enfoncée et encastrée dans le col de l’instrument.
  13. Avant l’utilisation, faites fonctionner l’instrument pour détecter toute anomalie, y compris une surchauffe.
  14. Vérifiez que les instruments restent en bon état de fonctionnement et sont toujours correctement lubrifiés.
  15. Déplacez constamment la fraise lors de l’utilisation afin d’éviter l’apparition d’une chaleur localisée.
  16. N’appuyez pas trop sur la fraise : cela risquerait de provoquer une chaleur indésirable et/ou une défaillance de la fraise.
  17. Déplacez constamment la fraise lors de l’utilisation afin d’éviter l’apparition d’une chaleur localisée et/ou d’endommager la fraise. Une chaleur indésirable peut gêner le patient, causer une nécrose dentaire ou tissulaire, ou brûler le patient.
  18. Évitez de retirer la fraise à un angle trop aigu afin de ne pas créer un effet de levier entraînant une cassure, ce qui pourrait vous blesser, ainsi que le patient.
  19. Conservez les instruments en bon état de fonctionnement afin d’assurer une efficacité maximale de l’outil. Si les instruments ne sont pas correctement entretenus, des retards de procédure risquent de survenir, ou le patient tout comme l’utilisateur encourent des blessures, un risque d’aspiration ou d’ingurgitation de l’outil peut apparaître, ainsi qu'un risque de dommages au site de préparation en raison des vibrations d’une turbine ou d’un mandrin usé.
  20. Avant l’utilisation, vérifiez que la fraise est bien enfoncée et correctement encastrée dans le col de l’instrument. Sinon, l’outil risque de se décrocher de l’instrument et de blesser le patient ou l'utilisateur, ou d’être aspiré ou ingurgité.
  21. Ne forcez jamais pour insérer une fraise dans un instrument, car cela risque d’endommager le col de l’instrument et de provoquer des retards de procédure.
  22. Consultez toujours l’emballage du produit pour connaître le régime maximal. Ne dépassez jamais les vitesses maximales figurant dans le tableau, car cela risquerait de provoquer une chaleur indésirable.
  23. Ne dépassez pas les vitesses maximales indiquées dans ce tableau :

 

Diamètre de la tête de l’instrument
01/10 (mm)
Vitesse maximale autorisée (tr/min)

Vitesse de fonctionnement recommandée

(tr/min)
 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 95,000 25,000 - 75,000
041 - 054 95,000 15,000 - 60,000
055 - 070 60,000 12,000 - 40,000
080 - 100 45,000 10,000 - 20,000

 

UTILISATION MÉDICALE:

Les fraises NeoDiamond de Microcopy peuvent servir à couper un large éventail de matériaux présents en médecine dentaire. Ceux-ci incluent les matières dentaires, telles que l’émail et la dentine, des matériaux dentaires comme le composite, les ciments verre ionomère, les alliages de polymères et de céramique, précieux et non précieux. Notre gamme de fraises diamantées offre une efficacité de coupe maximale et un accès sans effort grâce à la dureté du diamant, pour le traitement endodontique et le retrait de couronne.

En tenant la fraise, toujours dans l’étui, par son extrémité fonctionnelle, poussez suffisamment l’extrémité de la tige à travers le plastique pour l’insérer dans le col de l’instrument. Insérez immédiatement la tige dans le col de l’instrument et serrez avant de relâcher l’extrémité fonctionnelle et de jeter l’étui vide.

 

STOCKAGE:

Dans un environnement sec et à l’abri des contaminants. De manière générale, protégez les instruments des produits chimiques, des acides, de la chaleur et des variations brusques de température.

 

DURÉE DE CONSERVATION DU PRODUIT STÉRILE:

  • Dans la mesure où les étuis non ouverts sont correctement stockés et manipulés, la stérilité du produit est maintenue cinq (5) ans, sauf si l’emballage stérile est ouvert ou endommagé. N’utilisez pas le produit si l’emballage est ouvert ou endommagé.do not use icon
  • La date d’expiration des produits figure sur l’emballage. N’utilisez pas les produits après la date d’expiration indiquée.use by icon

 

TRAÇABILITÉ:

Chaque emballage inclut le numéro de lot [LOT] sur son étiquette.lot icon

Ce numéro doit figurer dans toute correspondance au sujet du produit.

 

SYMBOLES APPLICABLES:

manuf icon Fabricant Indique le fabricant de l’outil médical.
su icon Ne pas réutiliser Indique un outil médical destiné à un usage unique, ou pour une utilisation sur un seul patient au cours d’une seule procédure.
do not restiril icon Ne pas restériliser Indique un outil médical ne devant pas être restérilisé.
sterile box icon Stérilisé par irradiation Indique qu’un outil médical a été stérilisé par irradiation.
lot icon Code du lot Indique le code du lot du fabricant permettant d’identifier le lot.
instruction icon

Consulter le mode d'emploi

Indique que l’utilisateur doit consulter le mode d’emploi.
use by icon Utiliser avant le Indique la date après laquelle vous ne devez pas utiliser l’outil médical.
do not use icon Ne pas utiliser si l’emballage est ouvert ou endommagé Indique un outil médical ne devant pas être utilisé si l’emballage a été endommagé ou ouvert.
ce icon Marquage CE Indique la conformité technique européenne.
ec rep

Représentant Européen agréé

Indique le représentant agréé pour la Communauté européenne.
keep dry Garder au sec Indique un dispositif médical qui doit être protégé de l'humidité.
RX ONLY APPAREIL réservé à un usage professionnel (réf US FDA CDRH) Indique que l'appareil ne doit être utilisé que par un professionnel qualifié.

 

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.

NEODIAMOND
IFU for NeoDiamond
IFU for NeoDiamond French

2. Archived (previous) IFU's - obsolete versions of the documents.

NEODIAMOND
IFU for NeoDiamond v.1
IFU for NeoDiamond v.2

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.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at sales@microcopydental.com.

Non-Sterile Diamonds 

CAUTION:
The device is to be used as per the following instructions by physician or licensed practitioner Rx Only. These instructions, in whole or in part, are not a substitute for formal training in diamond dental burs. Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.

DESCRIPTION:
Microcopy NeoDiamond burs are manufactured from a single piece of high-quality stainless steel plated at the operational end with a natural diamond grit. The diamond burs are further plated with a unique protective coating formula. The range includes patterns designed to meet the needs of all surgery and laboratory applications. The burs are packed in a plastic slider.

non sterileThese burs are provided mechanically clean, but non-sterile and must be cleaned and sterilized before first use and can be reused following cleaning and sterilization instructions as following described.

 

INDICATIONS
Microcopy NeoDiamond burs can be used for a wide variety of restorative procedures including but not limited to: removal of caries or old restorations, preparation of cavities for restoration, finishing of restorations, preparation of crowns, orthodontic device procedure and any other dental operation. The bur pattern to be selected for specific application. For best product performance, always match the bur to the task to be performed.

 

CONTRAINDICATIONS TO USE
Use of Microcopy NeoDiamond is contraindicated on any patient who is allergic to any of the components of the product.

  1. Used burs shall be considered as contaminated and as such, appropriate precautions shall be taken during re-processing and disposal. Suitable eye protection, glove and a mask should be worn when re-processing.
  2. In the event of burs being returned to Microcopy, please ensure any contaminated and/or potentially contaminated burs have been effectively cleaned and are appropriately packaged for return.

 

STORAGE (PRE-USE)
Store in a dry and clean environment at ambient temperature.

 

CLINICAL PRECAUTIONS:

  1. Carefully read package labels to ensure use of the appropriate device. Failure to do so may cause procedural delays or patient or user injury.
  2. 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 diamond burs.
  3. Clean and sterilize the burs supplied in a non-sterile condition in accordance with the directions below before first use and before each reuse.
  4. Always wear gloves when handling contaminated instruments.
  5. Protect patient’s eyes and vulnerable tissues when using these diamond burs.
  6. Clinicians should wear eye protection and facemask when using diamond burs.
  7. Surgical masks shall be worn to avoid inhalation of aerosol and/or dust generated during the procedure.
  8. Ensure the bur is fully seated and gripped in the handpiece collet.
  9. 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.
  10. Ensure handpieces are maintained in good working order and remain correctly lubricated at all times.
  11. Discard any damaged diamond burs immediately.
  12. Do not use rusted burs.
  13. Read carefully the labels on the bur package.
  14. Follow the hand piece manufacturer’s instructions for use and maintenance and service all hand pieces appropriately.
  15. Before use, run the handpiece to check for any abnormalities including overheating.
  16. Move the bur continuously when in use so as to avoid localized heating.
  17. Do not apply excessive pressure on the bur as this could cause undesirable heat and/or may cause the bur to fail.
  18. 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.
  19. Avoid removing the bur at too sharp an angle to avoid leverage and breakage which could cause patient or user injury.
  20. 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.
  21. 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.
  22. Never force a bur into a handpiece as this could cause damage to the handpiece collet which could result in procedural delays.
  23. When using short burs (up to 20mm in length) make certain the head/diamonds do not come in contact with the chucking mechanism.
  24. Short burs are recommended to be used with a mini handpiece.
  25. 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.
  26. 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 95,000 25,000 - 75,000
041 - 054 95,000 15,000 - 60,000
055 - 070 60,000 12,000 - 40,000
080 - 100 45,000 10,000 - 20,000


CLINICAL USE:
Microcopy NeoDiamond burs can be used to cut a wide variety of materials encountered in dentistry. These include tooth material such as enamel and dentin, dental materials such as composite, glass-ionomer cements, polymer and ceramic and precious and non-precious alloys. Our range of diamond burs provide maximum cutting efficiency and effortless access through tough diamond for both endodontic treatment and crown removal.

 

REPROCESSING INSTRUCTIONS FOR DENTAL ROTARY INSTRUMENTS

 

SCOPE
The reprocessing instructions detailed below apply only to reusable burs. Burs shall be reprocessed prior to being used.

 

LIMITATIONS OF RE-USE

Reprocessing will have little effect on Microcopy’s dental burs. The end of a bur's life is determined by wear and damage in use and the burs should be inspected for defects during the preliminary cleaning process. Delay between use and reprocessing must be kept to a minimum to avoid contaminants drying, thereby making cleaning more difficult. Therefore, keep the unclean burs immersed in the cleaning/disinfecting agent in accordance with manufacturer instructions, but in any event, do not exceed 12 hours. Prolonged storage in disinfectant solutions may result in corrosion and should therefore be avoided.

Caution: Do not leave burs immersed in disinfectants that have a fixative action (such as aldehyde-based products) unless the burs have been thoroughly cleaned first.

 

WARNINGS

Used burs should be considered as being contaminated and appropriate handling precautions should be taken during reprocessing.  Gloves, eye protection and a mask should be worn.  Other measures may be required if there are specific infection or cross contamination risks from the patient.

Used burs are also considered as bio-hazard and need to be discarded as bio-hazard waste unless reprocessing procedures have been done according to the above instructions.

 

PREPARATIONS FOR CLEANING There are no special requirements unless local infection controls require the use of a disinfectant immediately after use, in which case the selected disinfectant must be validated by the user for cleaning dental burs and the manufacturer’s instructions followed.

MANUAL CLEANING, DRYING, AND

INSPECTION PROCEDURE

If manual cleaning is implemented, the burs should be cleaned in a sink reserved for the purpose.
Pre-clean under running water with a brush directly after use.


1) Rinse the burs under running cold water and, keeping them immersed, brush thoroughly away from the body using a neutral cleaning or cleaning/disinfecting agent labeled for use on dental burs or other similar types of reusable medical instruments, following the agent manufacturer’s instructions.


2) Care should be taken to avoid spreading contaminants by spraying or splashing during the brushing process.
3) Wire brushes must be used with caution, as brass particles may result in galvanic corrosion and steel particles may cause discoloration of stainless steel.


4) After cleaning, inspect the burs, with the aid of magnification if necessary, to ensure that all contamination has been removed. Repeat the cleaning process if necessary.


5) Dry the burs using paper toweling or dry heat not exceeding 140ºC.


6) Inspect the burs, with the aid of magnification if necessary and discard any damaged or corroded instruments.

AUTOMATED CLEANING

PRE-CLEANING –
1) Prepare a 0.1% neutral/mild pH enzymatic detergent, according to manufacturer’s instructions. (in the lowest recommended concentrations).
2) Rinse the bur under running tap water for at least one (1) min.
3) Soak burs immediately into detergent solution, for two (2) minutes.
4) Scrub the burs under running water with soft nylon brush to remove any remaining blood or debris for at least one (1) minute.
5) Place the burs on a clean cloth to avoid any contact between them during the next cleaning procedure.


AUTOMATED CLEANING PROCEDURE -
Place the burs in the washer in a suitable small parts tray or on the load carrier such that all surfaces of the instruments will be cleaned and disinfected.
1) Run the automatic wash cycle – Short cycle parameters
2) Two (2) Minutes prewash at 30±5°C (86±41°F) with tap water.
3) Two (2) Minutes prewash at 30±5°C (86±41°F) with tap water.
4) Ten (10) Minutes main wash with natural pH detergent and tap water at 25±5°C (110±41°F).
5) One (1) Minute rinse with tap water at 30°C (86°F)
6) Ten (10) Minutes distilled water rinse at 30°C (86°F)
7) Twenty (20) Minutes air drying phase at high temperature of 100°C (414°F).


** The cleaning process was validated with short automatic wash cycle. Any cleansing and disinfecting agents used must be compatible with dental burs; otherwise accelerated corrosion or other damage may occur. The washer disinfector and the cleaning agent manufacturers' instructions must be followed.


POST AUTOMATED CLEANING PROCEDURE –
1) Remove the instruments at the end of the washer program.
2) Check that the load is dry and, if necessary, dry with medical compressed air.
3) Visually inspect the burs for cleanliness.
If contamination is still visible, reclean the burs again manually.
4) Subsequently, the recleaned burs must be reprocessed again automatically before sterilization
5) All instruments must be inspected visually for cleanliness, integrity and functionality, if necessary, by using an illuminated magnifying glass
6) All instruments are to be checked for damage and wear. Damaged medical devices may no longer be used and must be sorted out.

 

STERILIZATION – USING STEAM


SCOPE
The sterilization instructions applicable to burs initially provided non-sterile and to non-sterile burs that are being reused. No sterilization before first use is required for burs labeled ‘Sterile.’

 

PACKAGING FOR STERILIZATION

If using an autoclave with a pre-vacuum cycle, pack the burs in appropriate instrument trays or pouches validated for steam sterilization.
If using an autoclave without a pre-vacuum cycle, the burs should not be packed or wrapped but should be contained in appropriate bur stands with perforated lids.


NOTE: Local legislation for sterilization may require that burs are wrapped in pouches for processing in either type of autoclave.

STERILIZATION

Follow the autoclave manufacturer’s instructions to sterilize the burs. In particular, care must be taken not to exceed the maximum recommended load for the autoclave.
The steam sterilization was validated in an autoclave without a pre-vacuum cycle (gravity displacement type) for a holding time of 3 minutes minimum and six minutes maximum at a temperature of 134 ºC and drying time of 30 min.
The holding time is the minimum time for which the minimum temperature is sustained.
1) Place the packaged products in the sterilization chamber
2) Start the program

 

Cycle duration minutes minimum
(Min.)
Cycle duration minutes maximum
(Min.)
Cycle temperature
(0C)
Drying time (Min.)
3 6 134 ºC 30


3) Remove the burs at the end of the program and allow to cool down
4) check the packaging for possible damage and screening effects
5) Faulted packaging must be inspected as being non-sterile. The instruments must be repacked and re-sterilized.
NOTE: Local infection control practice may recommend a different combination of holding time and temperature

STORAGE The burs should be stored in the sterilization container (bur stand or pouch) until required.
Containers or pouches must be dried before opening to avoid recontamination of the contents with water.
Storage should be in dry, clean conditions and at ambient temperature.

 

VALIDATION OF CLEANING AND STEAM STERILIZATION

The above detailed processes have been validated as being capable of preparing Microcopy's dental burs for reuse. It remains the responsibility of the reprocessor to ensure that the reprocessing is actually performed, using the equipment, materials and personnel in the reprocessing facility, to achieve the required results. Any deviation from these instructions should be properly evaluated for effectiveness and potential adverse results.

 

TRACEABILITY:

Each package includes Batch Numberlot icon on its label.

This number must be quoted in any correspondence regarding the product.

 

APPLICABLE SYMBOLS:

manuf icon Manufacturer Indicates the medical device manufacturer.
lot icon Batch Code Indicates the manufacturer's batch code
so that the batch or lot can be identified.
instruction icon Consult instructions for use Indicates the need for the user to consult
the instructions for use. 
ref Catalog Number Indicates the manufacturer’s catalog number so that the medial device can be identified
do not use icon 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 icon CE marking Indicates European Conformity Mark.
ec rep Authorized European representative Indicates the Authorized representative in the European Community.
non sterile Non-Sterile
Indicates a medical device that has not been sterilized.
keep dry Keep Dry Indicates a medical device that needs to be protected from moisture.
RX ONLY DEVICE for professional use only (ref US FDA CDRH) Indicates device shall only be used by a trained professional.

 

CONTACT INFORMATION:

 

manuf icon

Microcopy Dental
3120 Moon Station Rd. NW
Kennesaw, GA 30144

   
ec rep

DENTEQ Medical Technologies
Hafenstrasse 12 76344,
Egenstien-Leopoldshafen, Germany
Fax: +49-7247 944843

   
ce icon  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.

NEODIAMOND
IFU for Sterile NeoDiamond
IFU for Non-Sterile NeoDiamond

 

2. Archived (previous) IFU's - obsolete versions of the documents.

NEODIAMOND
IFU for Sterile NeoDiamond
IFU for Non-Sterile NeoDiamond

 

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.
If you would like to conact our webmaster for any comments or suggestions, please feel free to do so at sales@microcopydental.com.