Dentsply Sirona AutoMatrix Instrucciones De Uso página 2

AutoMatrix®
Retainerless Matrix System
For use with Automate® III Tightening Device and AutoMatrix® Snippers+
DIRECTIONS FOR USE – ENGLISH
Caution: For dental use only. USA: Rx only.
1. PRODUCT 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 adapta-
tion while protecting against cross-contamination.
1.1 Delivery forms
(Some delivery forms may not be available in all countries)
The AutoMatrix® system matrices are available in four height/width and gauge (thickness) config-
urations (see table below). All AutoMatrix® system matrix sizes fit teeth of any circumference.
Type Medium Thin
a
Height & Gauge 1/4" x .0015
Typical
Bicuspids/molars
Clinical Uses
a Thin-gauge bands identified by notch on auto-lock loop
1.2 Composition
• Matrix Bands: Polished stainless steel
• Automate® III tightening device: Stainless steel
• AutoMatrix® Snippers+: Stainless Steel, with plastic catch-tray
1.3 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).
1.4 Contraindications
None known.
2. GENERAL SAFETY NOTES
Be aware of the following general safety notes and the special safety notes in other chapters of
these directions for use.
Safety alert symbol.
This is the safety alert symbol. It is used to alert you to potential personal injury haz-
ards. Obey all safety messages that follow this symbol to avoid possible injury.
CAUTION
2.1 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 proce-
dures 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 imme-
diately 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 seek medical assistance to lo-
cate swallowed part. If nausea or illness develop, seek medical attention immediately.
Laceration: AutoMatrix® system matrix bands are sharp, and may cut unprotected skin. Han-
dling bands with gloved hands and/or locking college pliers or similar instrument is recom-
mended. In the event a clean band causes a skin laceration, employ usual first aid measures.
Discard and properly dispose of 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. 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 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® III tightening device into tightening coil.
Do not allow rotating coil to contact oral tissues during tightening. When using removal snip-
pers, 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.
2.2 Precautions
• 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 respon-
sibility of the practitioner.
• Devices marked "single use" on the labeling are intended for single use only. Discard after use.
Do not reuse in other patients in order to prevent cross-contamination.
• Always make sure that the plastic-basket is properly connected to the AutoMatrix® Snippers+
before application.
• When clipping AUTO-LOCK LOOP with removal snippers, shield open end with fingers to pre-
vent clipped part from projecting into the oral cavity. Immediately retrieve any loose part and
remove from the mouth. (See Warnings)
• 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)
• Do not use accessory tools other than those designed, supplied, and/or outlined for use with
AutoMatrix® system bands. Injury may result. (See Step-by-Step Instructions)
2.3 Adverse reactions
• Product misuse may cause failure resulting in respiratory, digestive, eye, skin, or mucosa injury.
(See Contraindications, Warnings and Precautions)
• Failure to properly employ accepted handling and disposal techniques may present biohazard.
(See Warnings and Precautions)
Narrow Regular Medium Regular
3/16" x .002 1/4" x .002
Short Bicuspids
Bicuspids/molars
and molars
2.4 Storage
Store AutoMatrix® system bands and accessory AutoMate® III tightening device and AutoMatrix®
Snippers+ at room temperature, away from moisture or excessive humidity. Tightening device and
snippers should be disinfected/sterilized and dried prior to storage.
3. STEP-BY-STEP INSTRUCTIONS
3.1 Pre-operative Sterilization
Matrices are intended for single use. If desired, these components may be steam autoclaved one
time (134 °C, 3 minutes minimum holding time, unwrapped, 12 minutes minimum holding time,
wrapped) prior to clinical use. Tightening device and snippers are not supplied sterile, and should
be steam autoclaved prior to first and each subsequent use (see Hygiene section).
3.2 Cavity Preparation
Complete cavity preparation as usual utilizing rubber dam or other suitable isolation technique.
Technique Tip: Pre-wedging, or placement of a Palodent® Plus ring (available separately, see com-
plete Directions for Use) to achieve slight separation may facilitate matrix placement and accept-
able restoration proximal contact.
3.3 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.
3.3.1 Using protected hands, or suitable instrument (e.g. college pliers), unroll the coil of a clean,
new AutoMatrix® system matrix band slightly.
3.3.2 While securely holding matrix band (with instrument or by side; do not hold by sharp edg-
es) carefully slide the AUTO-LOCK against the coil. If necessary, repeat steps 3.2.1 and 3.2.2
above to further enlarge matrix to the appropriate size.
3.4 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:
Wide Regular
1. To seat matrix in tight interproximal spaces – pre wedging, placement of a Palodent® Plus ring
or use of an Elliot Separator on posteriors may gain temporarily required space.
5/16" x .002
2. To clear debris and facilitate seating – use waxed floss or a soft wedge between tight inter-
proximals.
3. For hard to reach molars – use locking college pliers to grip matrix along the side and facili-
Long molars
tate matrix seating. Release pliers when matrix is securely seated on tooth.
3.5 Tightening the matrix (using the AutoMate® III tightening device)
3.5.1 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.
3.5.2 Insert AutoMate® III tightening device tip into the matrix coil. DO NOT USE FORCE.
3.5.3 Grasp AutoMate® III tightening device with thumb and forefinger on barrel, palm grip in
palm. Rotate knurled barrel clockwise. NOTE: AutoMate® III tightening device has an au-
dible torque indicator, thereby indicating the rotational (tightening) force required. After
2 to 3 "clicks", STOP tightening. The band is properly subgingivally tightened. NOTE: The
AUTO-LOCK LOOP keeps matrix locked tightly until removal is desired.
3.5.4 Remove the tightening device. Rotate AutoMate® III tightening device continuously coun-
terclockwise (backwards) while simultaneously and continuously withdrawing the Auto-
Mate® III tightening device from the coil.
3.6 Placement of restorative
3.6.1 Place wedges as desired (buccal and/or lingual).
3.6.2 Burnish contact areas.
3.6.3 Place desired restorative material as per restorative material manufacturer's directions for
use.
3.7 Removing the matrix
Following appropriate restorative curing/setting, open and remove the matrix using shielded Au-
toMatrix® Snippers+.
3.7.1 Preparation of AutoMatrix® Snippers+
• Align catch-tray with the instrument axis of the snipper.
• Clip Catch-tray straight onto the snippers by sliding the u-shaped cavity into the nut be-
low the bolt head.
• Make sure that the pin on the lower surface of the catch-tray clicks in the hole on the up-
per side of the blade edge.
Displacement of Catch-tray. Small parts-ingestion/inhalation.
• Do not open Snippers+ more than 60° to prevent displacement of Catch-tray, which
may cause leakage of the catch-tray and release of cut pieces.
• Before application, make sure that the catch-tray is properly connected to the snip-
CAUTION
pers: Turn instrument and check that there is no gap between Catch-tray and snip-
pers. Make sure that the catch-tray is empty.
3.7.2 Clip any part of the projecting end of the AUTO-LOCK LOOP.
3.7.3 After clipping immediately retrieve any loose part and remove from the mouth.
3.7.4 Keep snippers closed containing the cut piece during withdrawal from the mouth.
3.7.5 Empty catch-tray and properly discard cut piece.
Small parts-ingestion/inhalation.
• Do not open Snippers+ widely during use. Widest opening is designed to dislodge
the catch-tray.
• After clipping the AUTO-LOCK LOOP into the catch-tray, keep Snippers+ closed
CAUTION during withdrawal from the mouth.
• If tray is dislodged during use, recover any pieces from the mouth immediately.
3.7.6 Insert an explorer, scaler or suitable instrument through the lock-release hole located on
the band near the coil. Gently pull lock-release hole occlusally until the matrix slips open.
NOTE: Locate the gingival segment of the AUTO-LOCK LOOP. This part will usually remain
attached to the band upon removal, but may become dislodged. If segment of AUTO-
LOCK LOOP has separated from band, remove it from the mouth and properly discard.
3.7.7 Support the restoration marginal ridge(s) with a condenser. Slide loosened matrix buccally
or lingually, while removing matrix occlusally. Properly discard matrix.
2