SYMBOLS DESCRIPTIONS Titanium or titanium alloy available lengths Available number of holes Available versions: left/right Torx drive Number of threaded holes in the shaft part of the plate Torx drive cannulated Number of locking holes in the plate Hexagonal drive Variable angle Hexagonal drive cannulated Cancellous Ster Non Ster Available in sterile/ non- sterile condition Refer to surgery technique Caution - pay attention to the particular proceeding. Perform the activity with X-Ray control. Information about the next stages of the proceeding. Proceed to the next stage. Return to the specified...

This surgical technique applies to transpalatal distractors. The presented range of implants is made of materials in accordance with ISO 5832 standards. Compliance with the requirements of quality management systems and the requirements of Directive 93/42/EEC concerning medical devices guarantee high quality of the offered implants. The system includes: • implants (distractor and microscrews), • instrument set used in the surgery, • surgical technique. Indications • Correction of the deformities of the maxilla in surgically assisted rapid palatal expansion (SARPE) procedures, especially in skeletally...

HEX shape of the microplate body: • facilitated activation with a wrench. Blocking screw: • blocks the distraction screw, • design of the blocking screw prevents the screw from being completely removed from the microplate body (eliminated swallowing or choking possibility). Articulated mechanism: • ensures solid attachment of the fixing plate to the bone. Holes for microscrews: • for microscrews of 2.0ChMP system. Spikes: • secure anchoring of the fixing plate in the bone, • ensure stable position of the distra

Markings on the transpalatal distractor An additional patient-side identification system has been introduced in the transpalatal distractors: R - right side of the patient, L - left side of the patient. In addition, the fixing plates were colour-coded: right plate - green colour; left - blue. • R - right side of • L - left side of • green colour • arrows indicating the direction of distraction • blue colour Diagram of subsequent rotation sequences Distraction is performed by rotating the distractor body in the direction indicated by the arrows. Schematic description of subsequent rotation sequences:...

ChM3. SURGICAL TECHNIQUE Perform planned osteotomies of the maxilla. NOTE: It is recommended to place a gauze in the mouth to retain any small element in the event it is dropped in the mouth. 3.1. SURGICAL APPROACH Perform an L-shaped or cross-incision of the palate between premolars and molars or between premolars. The length of the horizontal incision should be about 10mm parallel to the teeth, while the vertical one - about 3mm perpendicular to the teeth. Use trials [43.4499] and forceps [30.3303] to choose the distractor of an adequate length.

3.3. IMPLANT INSERTION Use dissecting forceps STANDARD 14.5cm [30.3303] to position the implant on the bone. Set the fixing plates in horizontal position. NOTE: Make sure the plate is positioned correctly: the left (L) side of the plate (blue) should be placed on the left side of the patient. 3.4. MICROSCREW INSERTION Use the quick coupling handle [40.6405] and a screwdriver tip X [40.6449] to insert the microscrews, of the appropriate length, in the fixing plate holes.

If need be, use the 1.25/15 drill [40.6422] to drill a hard bone. 3.5. ACTIVATION Use the flat wrench [40.8402] to activate the transpalatal distractor until diastema of about 1mm is observed. Activate the distractor in accordance with the direction indicated by the arrows - refer to point 2 IMPLANT DESCRIPTION.

3.6. LATENCY PERIOD Use the quick-coupling handle [40.6405] and screwdriver tip X [40.6449] to tighten up the blocking screw and block the distractor during the latency period. NOTE: Tighten clockwise. Do not overtighten the blocking screw to avoid damage to the thread. The latency period lasts about 1 week. The doctor decides on the length of the latency period. 3.7. DISTRACTION Following the latency period, begin the distraction. a) se the quick-coupling handle [40.6405] and screwdriver tip X [40.6449] U to unlock the blocking screw. NOTE: Do not apply excessive force while unlocking since...

b) Use the flat wrench [40.8402] to rotate the implant body until resistance is felt. c) Make one or two rotations of the microplate body d) In the distraction period, the patient performs 1/3 of the rotation twice a day using the flat wrench [40.8402]. Detailed diagram of the rotation sequences - refer to point 2 IMPLANT DESCRIPTION. The doctor determines the size of the entire and daily distraction. Depending on the size of the intended distraction, this period last from 1 to 4 weeks. The doctor provides the patient with a distraction calendar for recording the sequence of rotations performed....

3.8. CONSOLIDATION PERIOD Once the planned expansion is accomplished, the new bone must be given time to consolidate. Block the distractor with blocking screw using screwdriver tip X [40.6449] and quick-coupling handle [40.6405]. NOTE: Tighten clockwise. Do not overtighten the blocking screw to avoid damage to the thread. The consolidation period lasts about 3÷6 months. The doctor decides on the length of the consolidation period. 4. IMPLANT REMOVAL The doctor decides to remove the implant. To remove the implant: a) unlock the blocking screw, b) loosen the microscrews (do not remove them completely),...

5. CATALOGUE PAGES5a. INSTRUMENT SET Instrument set for 2.0ChMP 40.8409.000 Quick coupling handle Dissecting forceps STANDARD 14.5cm Flat wrench

5b. DISTRACTORS Transpalatal distractors 13.5 20_3.4499.020

5c. SCREWS I ChM Micro Plates

processing area in a closed container or covered with a damp cloth. 3) In order to avoid contamination during transportation, the dirty instruments should be separated from the clean ones. 3.Preparation for washing and disinfection (for all methods). 1) The used instruments should be reprocessed as soon as possible. 2) If the instrument can be disassembled, it must be done before cleaning processes. 3) Rinse under running water and remove surface debris using a disposable cloth, paper towel or plastic brushes (nylon brushes are recommended). Particular attention should be paid to openings and...