Directions For Use - Dentsply Sirona SpaceFile Instrucciones De Uso

spaceFile® interproximal reduction system (irs)
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DIRECTIONS FOR USE

caution: U.s. Federal law restricts this device to sale by or on the order of a dentist.
INTRODUCTION
Dentsply sirona hopes that you will benefit greatly from working with your new quality product – spaceFile®
interproximal reduction system. this product has been developed, manufactured and subjected to final inspection
according to legal regulations, quality norms and industry standards. the irs consists of components –
1. air Motor complex aM
2. contra-angle complex its (transmission instrument)
For your safety and the safety of your patients
prior to initial use, please read the Directions For Use. this explains how to use your product and guarantees its
smooth/efficient operation.
INDICaTIONS
Dental system intended for use as a method for achieving interproximal reduction of teeth.
CONTRaINDICaTIONS
the irs is contraindicated for use with patients if it has not been sterilized as recommended in the Directions For Use.
the irs is contraindicated for use in patients who –
• are hypersensitive,
• don't accept stripping,
• have low enamel density (hypoplasia) or a high caries index,
• display poor hygiene,
• have rectangular-shaped teeth, and/or,
• display a high grade of overcrowding.
in these cases, making extractions may be the treatment of choice.
the irs is contraindicated for high-risk patients that need the care and attention of a specialist.
the irs is contraindicated for use by patients in any way or manner even if the spaceFile® strips are used manually
to cause any reduction at home.
the irs is contraindicated for use in patients for any purpose other than the one(s) indicated above.
WaRNINgS
prior to initial use, we advise sterilization of the air Motor complex aM and contra-angle complex its.
as a user, always ensure the correct operating condition, and thus, correct application of the air motor. this motor is
made to be powered by air only. Do not use with electricity.
check on each occasion when fitting a transmission instrument (contra-angle) that it is securely connected on the
air motor by pulling on it lightly. if it does not connect securely, send in the motor for inspection to w&h impex
worldwide, inc.
we strongly advise sterilization prior to each use of the air motor and the contra-angle. the air motor and contra-
angle must be dry when removed from the sterilizer. as part of your infection control procedures, we recommend
sterilization after each use as well before storage of these components on the shelf.
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