DENTSPLY Megalloy EZ Instrucciones De Uso página 4

• In placing and removing amalgam fillings, dentists should use techniques and equipment to
• In placing and removing amalgam fillings, dentists should use techniques and equipment to
minimize the exposure of the patient and the dentist to mercury vapor and to prevent amalgam
minimize the exposure of the patient and the dentist to mercury vapor and to prevent amalgam
waste from being flushed into municipal sewage systems.
waste from being flushed into municipal sewage systems.
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the
use of amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam
use of amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam
restorations should be replaced with another material where this is recommended by a physician.
restorations should be replaced with another material where this is recommended by a physician.
3. Alloy amalgam capsule products contain mercury, which can cause skin sensitization or other allergic
3. Alloy amalgam capsule products contain mercury, which can cause skin sensitization or other allergic
reaction. Although the mercury in this product is bound within the amalgam following trituration,
reaction. Although the mercury in this product is bound within the amalgam following trituration,
proper care should be taken to prevent exposure to mercury.
proper care should be taken to prevent exposure to mercury.
Skin Contact: Before using this product wear protective safety glasses, clothing and gloves. If
Skin Contact: Before using this product wear protective safety glasses, clothing and gloves. If
contact with skin occurs immediately wipe off and flush with generous amounts of water, then wash
contact with skin occurs immediately wipe off and flush with generous amounts of water, then wash
well with soap and water after contact. If skin rash, irritation, sensitization or other allergic reaction
well with soap and water after contact. If skin rash, irritation, sensitization or other allergic reaction
occurs, discontinue use and seek medical attention immediately.
occurs, discontinue use and seek medical attention immediately.
Eye Contact: May be irritating to eyes. Before using this product wear protective glasses as well as
Eye Contact: May be irritating to eyes. Before using this product wear protective glasses as well as
covering the patient's eyes to protect from excess. The use of an enclosed amalgamator is
covering the patient's eyes to protect from excess. The use of an enclosed amalgamator is
recommended. In case of accidental contact with eyes, rinse eyes immediately with plenty of water
recommended. In case of accidental contact with eyes, rinse eyes immediately with plenty of water
and seek medical attention.
and seek medical attention.
Ingestion: Do not swallow or take internally. Whenever possible, the use of protective barriers such
Ingestion: Do not swallow or take internally. Whenever possible, the use of protective barriers such
as rubber dam isolation and protective mask during placement and removal is recommended. If
as rubber dam isolation and protective mask during placement and removal is recommended. If
accidental swallowing occurs, drink lots of water. If nausea or illness develop, seek medical attention
accidental swallowing occurs, drink lots of water. If nausea or illness develop, seek medical attention
immediately. Contact regional Poison Control Center immediately.
immediately. Contact regional Poison Control Center immediately.
Inhalation: Do not breathe vapor. Whenever possible, the use of protective barriers such as rubber
Inhalation: Do not breathe vapor. Whenever possible, the use of protective barriers such as rubber
dam isolation, high-volume evacuation and protective mask during placement and removal is
dam isolation, high-volume evacuation and protective mask during placement and removal is
recommended. Give oxygen or artificial respiration if necessary.
recommended. Give oxygen or artificial respiration if necessary.
4. Do not open capsule prior to trituration. Do not remove or handle mixing pestle or plastic wafer
4. Do not open capsule prior to trituration. Do not remove or handle mixing pestle or plastic wafer
containing mercury.
containing mercury.
5. Do not attempt to clean and/or reuse capsules.
5. Do not attempt to clean and/or reuse capsules.
5. PRECAUTIONS
5. PRECAUTIONS
1. This product is intended to be used only as specifically outlined in the Directions for Use. Any use of
1. This product is intended to be used only as specifically outlined in the Directions for Use. Any use of
this product inconsistent with the Directions for Use is at the discretion and sole responsibility of the
this product inconsistent with the Directions for Use is at the discretion and sole responsibility of the
practitioner.
practitioner.
2. Wear suitable protective eyewear, clothing, mask and gloves. Protective eyewear, and whenever
2. Wear suitable protective eyewear, clothing, mask and gloves. Protective eyewear, and whenever
possible, barrier techniques such as rubber dam is recommended for patients. (See Warnings)
possible, barrier techniques such as rubber dam is recommended for patients. (See Warnings)
3. Mercury corrodes and embrittles particular metals and their alloys. Avoid unnecessary contact
3. Mercury corrodes and embrittles particular metals and their alloys. Avoid unnecessary contact
between mercury and metals.
between mercury and metals.
4. Mercury presents a health hazard if incorrectly handled. Mercury is toxic by vapor inhalation and the
4. Mercury presents a health hazard if incorrectly handled. Mercury is toxic by vapor inhalation and the
effect is cumulative. Spillages of mercury should be removed immediately, including places which are
effect is cumulative. Spillages of mercury should be removed immediately, including places which are
difficult to access. Use a plastic syringe to draw it up. Smaller quantities can be covered by sulfur
difficult to access. Use a plastic syringe to draw it up. Smaller quantities can be covered by sulfur
powder and removed. Avoid inhalation of the vapor.
powder and removed. Avoid inhalation of the vapor.
5. Regulations for disposal must be observed. Adherence to the American Dental Association's current
5. Regulations for disposal must be observed. Adherence to the American Dental Association's current
"Best Management Practices For Amalgam Waste (BMPs)" and "Dental Mercury Hygiene
"Best Management Practices For Amalgam Waste (BMPs)" and "Dental Mercury Hygiene
Recommendations" is strongly recommended. Among these practices:
Recommendations" is strongly recommended. Among these practices:
• Salvage and store non-contact amalgam scrap in well-sealed containers and recycle.
• Salvage and store non-contact amalgam scrap in well-sealed containers and recycle.
• Salvage and store contact amalgam pieces from restorations, traps and filters in well-sealed
• Salvage and store contact amalgam pieces from restorations, traps and filters in well-sealed
containers and recycle.
containers and recycle.
• Do not dispose of amalgam scrap, waste or extracted teeth in regulated infectious waste
• Do not dispose of amalgam scrap, waste or extracted teeth in regulated infectious waste
containers that will be incinerated, or in regular garbage.
containers that will be incinerated, or in regular garbage.
• Recycle used disposable amalgam capsules and plastic wafer (which contained mercury before mixing).
• Recycle used disposable amalgam capsules and plastic wafer (which contained mercury before mixing).
6. Waste material and all primary containers that hold mercury must be disposed of as hazardous waste.
6. Waste material and all primary containers that hold mercury must be disposed of as hazardous waste.
7. If moisture is introduced into the amalgam before it has set, properties such as strength and
7. If moisture is introduced into the amalgam before it has set, properties such as strength and
corrosion resistance may be affected adversely. If the alloy contains zinc, such contamination may
corrosion resistance may be affected adversely. If the alloy contains zinc, such contamination may
result in an excessive expansion (delayed expansion). Whenever it is possible, use a dry field.
result in an excessive expansion (delayed expansion). Whenever it is possible, use a dry field.
8. Manufacturer's variation in amalgamators and differences in local electrical current may necessitate 8. Manufacturer's variation in amalgamators and differences in local electrical current may necessitate
adjusting trituration time to obtain an optimal mix.
adjusting trituration time to obtain an optimal mix.
9. Insufficient data exist to support the use of amalgamators not listed in the chart below. Use of
9. Insufficient data exist to support the use of amalgamators not listed in the chart below. Use of
amalgamators other than those listed may result in less than optimally triturated amalgam. The
amalgamators other than those listed may result in less than optimally triturated amalgam. The
operator must investigate non-listed equipment compatibility and/or consult amalgamator
operator must investigate non-listed equipment compatibility and/or consult amalgamator
manufacturer for recommendations.
manufacturer for recommendations.
10. Do not attempt to place improperly triturated amalgam, or amalgam that has exceeded working
10. Do not attempt to place improperly triturated amalgam, or amalgam that has exceeded working
time (dry, crumbly).
time (dry, crumbly).
11. Drilling, polishing and grinding dental fillings should always be combined with water-cooling and
11. Drilling, polishing and grinding dental fillings should always be combined with water-cooling and
suction under a vacuum.
suction under a vacuum.
12. The following precautions are required by the General Director AFSSAPS (Agence française de
12. The following precautions are required by the General Director AFSSAPS (Agence française de
sécuité sanitaire des produits de santé – French agency for Sanitary Security of Health Products):
sécuité sanitaire des produits de santé – French agency for Sanitary Security of Health Products):