DENTSPLY AutoMatrix Gebrauchsanweisung

utoMatrix
Retainerless Matrix System
For use with AutoMate ® III Tightening Device
DIRECTIONS FOR USE – ENGLISH
Caution: U.S. federal law restricts this device to sale by or on the order of a dentist.
DESCRIPTION
The AutoMatrix ® Retainerless Matrix System is designed to be used as a matrix to contain direct-
placement restorative materials in posterior cavities involving proximal surfaces. The AutoMatrix
system allows matrix placement and retention without the need for bulky retainers, allowing for
ease of placement, better access, clear view of the operating field and greater patient comfort.
Access for wedge placement (where indicated) is not hindered by an external retainer. The single-
use, disposable AutoMatrix ® system bands allow proper subgingival and proximal contact
adaptation while protecting against cross-contamination.
The AutoMatrix ® system matrices are available in four height/width and gauge (thickness)
configurations (see table below). All AutoMatrix
The AutoMate ® III tightening device should be heat/pressure sterilized (autoclaved), removal
snippers disinfected in preparation for re-use.
Type Medium Thin*
Height & Gauge 1/4˝ x .0015
Typical Clinical Uses Bicuspids/
molars
*Thin-gauge bands identified
Thin-Gauge Bands
by notch on auto-lock loop
Identified by Notch
COMPOSITION
Polished stainless steel
INDICATION
AutoMatrix ® Retainerless Matrix System is indicated where placement of a matrix band around a
prepared tooth will facilitate contouring of a direct placement restorative material (e.g., Class II
preparations).
CONTRAINDICATIONS
The AutoMatrix ® Retainerless Matrix System matrix band is intended for single use only. Do not
attempt to sterilize and/or re-use.
WARNINGS
1. AutoMatrix ® System matrix band consists of small, sharp parts. As with all intraoral instruments,
care must be exercised to ensure stable handling and placement. During matrix removal
procedures a segment of the AUTO-LOCK LOOP (retention clip) may separate from the matrix
band. Prevent this segment from being swallowed or aspirated. Remove any separated piece
immediately from the mouth. Placement of rubber dam or other suitable isolation is advised
prior to operative procedures. Wear suitable protective eyewear and gloves.
Aspiration: If aspiration of band or any part occurs seek immediate medical attention.
Ingestion: If accidental swallowing occurs, encourage patient to locate swallowed part when
passed. In most cases, swallowed part will pass uneventfully. If nausea or illness develop, seek
medical attention immediately.
Laceration: AutoMatrix ® system matrix bands are sharp, and may cut unprotected skin. Handling
bands with gloved hands and/or locking college pliers or similar instrument is recommended. In
the event a clean band causes a skin laceration, employ usual first aid measures. Discard and
properly dispose band.
2. Used matrix bands and accessories are contaminated. Follow proper exposure control plans. In
the event of an accidental exposure, follow recommended post-exposure procedures. For
AutoMate ® III tightening device and removal snippers see Disinfection/Sterilization section at the
end of these directions.
Following use of AutoMatrix ® system matrix bands, proper handling and disposal techniques
are required. Used matrix bands are contaminated and sharp. When handling or disposing, use
®
® system matrix sizes fit teeth of any circumference.
Narrow Regular Medium Regular
3/16˝ x .002 1/4˝ x .002
Short Bicuspids Bicuspids/
and molars molars
Auto-Lock Loop
Lock-Release Hole
Coil
1
precautions as when handling or disposing other contaminated sharps.
3. Care should be taken to have good control on any instrument to protect patients from injury. Do
not use excessive force when inserting AutoMate
not allow rotating coil to contact oral tissues during tightening. When using removal snippers,
employ a technique that prevents entrapping soft tissues (skin, gingiva, mucosa) within the
snipper jaws which may result in injury to the tissue. If injury occurs, thoroughly wash the
affected area with water and seek appropriate medical attention.
PRECAUTIONS
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 practitioner.
2. AutoMatrix
reuse. (See Contraindications, Warnings)
3. When clipping AUTO-LOCK LOOP with removal snippers, shield open end with fingers to
prevent clipped part from projecting into the oral cavity. Immediately retrieve any loose part and
remove from the mouth. (See Warnings)
®
4. Avoid placing excessive pressure in an apical direction when placing or on placed bands.
Apical force may result in injury to periodontal tissues. (See Warnings)
5. Do not use accessory tools other than those designed, supplied, and/or outlined for use with
AutoMatrix
6. Storage: Store AutoMatrix
removal snippers at room temperature, away from moisture or excessive humidity. Tightening
device and snippers should be disinfected/sterilized and dried prior to storage.
ADVERSE REACTIONS
1. Product misuse may cause failure resulting in respiratory, digestive, eye, skin, or mucosa injury.
(See Contraindications, Warnings and Precautions)
2. Failure to properly employ accepted handling and disposal techniques may present biohazard.
(See Contraindications, Warnings and Precautions)
Wide Regular
5/16˝ x .002
STEP-BY-STEP INSTRUCTIONS
Long molars
1. Cavity Preparation
Complete cavity preparation as usual utilizing rubber dam or other
suitable isolation technique. Technique Tip: Pre-wedging, or
placement of a Palodent
may facilitate matrix placement and acceptable restoration
proximal contact.
2. Matrix Selection/Preparation-Enlarging Matrix Circumference
Select the appropriate height and gauge matrix band. To properly
fit the tooth, matrix should be slightly larger than the occlusal
circumference.
2.1 Using protected hands, or suitable instrument (e.g. college
pliers), unroll the coil of a clean, new AutoMatrix
matrix band slightly.
2.2 While securely holding matrix band (with instrument or by
side; do not hold by sharp edges) carefully slide the AUTO-
LOCK against the coil. If necessary, repeat steps 2.1 and 2.2
above to further enlarge matrix to the appropriate size.
3. Positioning Matrix
Carefully slide matrix around tooth, through the interproximals.
Position matrix with the AUTO-LOCK LOOP at the center of
buccal or lingual or most secure remaining tooth wall.
Technique Tips:
1. To seat matrix in tight interproximals – Prior wedge or Palodent
BiTine
posteriors may gain temporarily required space.
2. To clear debris and facilitate seating – Use waxed floss or a
soft wedge between tight interproximals.
3. For hard to reach molars-use locking college pliers to grip
matrix along the side and facilitate matrix seating. Release
pliers when matrix is securely seated on tooth.
4. Tightening the Matrix (using the AutoMate
device)
4.1 Stabilize the matrix with gentle finger pressure apically until
the matrix is fully tightened. Check to be sure gingival tissue is
not trapped between band and tooth surface. If so, slightly lift
and reposition band prior to tightening.
4.2 Insert AutoMate
DO NOT USE FORCE.
4.3 Grasp AutoMate
forefinger on barrel, palm grip in palm. Rotate knurled barrel
®
® system matrix bands are designed for one-time use. Discard after use. Do not
® system bands. Injury may result. (See Step-by-Step Instructions)
® system bands and accessory AutoMate
® BiTine ® ring to achieve slight separation
® ring placement or use of an Elliot Separator on
® III tightening
® III tightening device tip into the matrix coil.
® III tightening device with thumb and
2
III tightening device into tightening coil. Do
® III tightening device and
2.1
2.2
® system
3
®
3 3
4.2