Meta SinCrest Gebrauchsanleitung Seite 8

INSTRUCTIONS FOR USE
EN
Intended use
SinCrest is a kit for the maxillary sinus lift with crestal approach in
oral surgery.
The SinCrest system consists of a kit including electric handpiece
drills, depth stops at different levels and a manual osteotome.
The manual osteotome was designed to obtain the controlled frac-
ture of the bone floor near the maxillary sinus membrane without
damaging the membrane itself. Thus dental implants can be inserted
exceeding the initial bone length.
• SinCrest Kit is not sterile when supplied. It must be
washed and sterilised every time before using it.
• The device must be used exclusively by skilled medical
staff.
• The surgeon must assess whether the patient is suitable
for osteotomy surgery and choose the correct surgical
sequence.
• Never use SinCrest without making sure that all its com-
ponents have been assembled correctly (see figure n. 16)
• Before using SinCrest, press the probe onto a sterile field
and check the correct recovery by means of the spring.
(see figure n. 1)
• Make sure that a dental floss is inserted onto the RX Pins
to avoid the risk of accidental ingestion by the patient.
o An incorrect speed (exceeding 850 RPM) of the hand-
piece may overheat the bone tissue leading to bone ne-
crosis.
• Attention, make sure that the Drill Gripper device is not
reassembled during the sterilization stage, but only be-
fore using it (see figure n. 15).
• META does not shoulder any responsibility for the incor-
rect use of the product.
Contraindications
• Do not use the SinCrest technique in case of residual bone shorter
than 5mm and taller than 11mm.
• We recommend not to use the SinCrest device in case of reduced
stability during the screwing stage in the bone hole drilled, due to
the bone tissue softness.
• Do not use the SinCrest device if the vertical distance from the
maxillary sinus floor to the terminal occlusion of the tooth adjacent
to the site to be treated exceeds 23mm (see figure n. 2).
• The Ref 4344 Probe Drill Ø 1.2 is not designed to cut the bone later-
ally and must be used only to drill in depth. An incorrect use may
damage the drill.
• Do not use the SinCrest device without having previously drilled a
hole with the relevant flat SinCrest Drills Ø 3.0 or SinCrest Drill Ø 4.0
(see figure n. 3)
• Do not use tools such as pliers or wrenches to screw the SinCrest
device into the hole in the bone (see figure n. 4)
SINCREST KIT USAGE PROCEDURE
Precautions
Correct X-rays, direct palpation and inspections of the operating site
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are necessary to identify the anatomy of the available bone. The most
suitable surgical sequence is to be assessed according to the avail-
able bone and the size of the dental implant. During the use of the
drills to prepare the bone hole, ensure an abundant external lavage
with sterile saline solution; a good lavage may also be ensured by
means of a sterile syringe.
Surgical procedure
After having proceeded to the full depth incision and elevation of the
soft tissues, the site may be prepared to use the selected SinCrest
device. To handle the drills, we suggest to use the accessory called
"Drill Gripper", which allows preventing the direct contact with the
operator's hands. From the black side the Ref 4338-SinCrest drill Ø 3.2,
Ref 4381-SinCrest drill Ø 4.0 and Ref 4340-SinCrest drill HB Ø 4.2 may
be withdrawn, whereas the brown side contains all the other drills of
the SinCrest Kit (see figure n. 5)
The laser marks reported on the Probe drill Ø 1.2, the SinCrest drills Ø
3.0, 3.2, 4.0 and 4.2 and the RX Pin pins indicate the operating depth at
4-5-6-7-8-9-10 and 11mm. (see figure n. 6)
Ref 4343-Locator drill: use the drill to identify the correct position of
the implant and remove the cortical bone tissue at a 3.5mm depth as
shown by the laser mark.
Ref 4344-Probe drill Ø 1.2: to be used after having positioned the
depth stop selected according to the bone availability (see paragraph
on Stop positioning). Since the osteotomy achieved defines the final
position and angle of the implant, it must be carried out with a view to
the full prosthetic plan. Use the drill with back and forth movements
until the desired depth is achieved. Only the head of the device is
sharp. No lateral cutting strength can be implemented to modify the
osteotomy angle: it must be used only to drill in depth.
Ref 4354-RX pin Ø 1.2: use the pins to check the correct angle and
depth achieved through an x-ray and/or visual examination.
Ref 4379-Sin Probe Ø 1.2: in addition to the tactual check, this device
allows a metric assessment of the operating depth.
Ref 4380-Guide drill Ø 3.0: use the drill to create a coronal recess
in the cortical layer to achieve a 2 mm depth as defined by the stop
on the drill. This drill allows the correct centring of the SinCrest Drill
(see figure n. 7).
Ref 4337-SinCrest drill Ø 3.0: it may be used after having positioned
the depth stop selected according to the available bone (see para-
graph on Stop positioning). To obtain a non-flared hole which may
jeopardize the stabilization of the SinCrest device, operate the motor
only after having placed the SinCrest drill in the guide hole (see figure
n. 7). Prepare the site until the pre-determined depth is achieved. To
obtain a precise hole diameter, use the drill only once until the stop
stroke is achieved. Further uses may lead to a poorer stabilization of
the SinCrest device, in particular if little vertical bone is available. We
recommend to maintain an approximately 2.0 mm distance from the
maxillary sinus floor membrane (see figure n. 3).
Ref 4356-RX pin Ø 3.0: it confirms the correct angle and depth
achieved during the previous osteotomy stages.
Warning:
During this stage the surgeon must decide whether the surgical
sequence should be implemented to use the SinCrest Ø 4.0 so as to
place a dental implant with greater diameter. If necessary, refer to the
Ref 4381 SinCrest Ø 4.0 operating instructions.