B.Braun Aesculap DX646T Mode D'emploi page 2

®
Aesculap
Aesculap Bone Fixation
Legend
1 Screw magazine
1a Locked position of the screw magazine (closed)
1b Operation of screw magazine
1c Unlocked position of the screw magazine (open)
2 Screwdriver handle
3 Silver-colored steel end
4 Screw holding sleeve
4a Screw not secured
4b Screw secured
5 Screwdriver bit
6 Screw
Symbols on product and packages
Follow the instructions for use
Not for reuse in intended applications as defined by the manufacturer
Non-sterile medical product
Manufacturer's article number
REF
Delivery quantity
Manufacturer's batch designation
LOT
Manufacturer
Date of manufacture
CE-approved in accordance with Directive 93/42/EWG
Intended use
The Aesculap Bone Fixation screws are used for fixing a bone fragment to the jaw bone in implantological dentistry.
The Bone Fixation spiral drill and the Bone Fixation screwdriver with bit and screw securing sleeve are provided for
implantation of the Bone Fixation screws.
Operating principle
Traction hole-slide hole principle: the functionality of Bone Fixation uses traction screw technology to fix bone
blocks.
To this end, a slide hole with a large diameter is created in the bone piece, opposite a traction hole in the transplant
mounting with a small diameter. The insertion of a screw ensures the secure adaptation of the transplant on the
mounting required for osseointegration.
Available sizes
Set
Art. no. Designation
DX715 Bone Fixation Set
Unscrew screws
Art. no. Designation
DX608T Magazine with 8 Bone Fixation screws/1.5 mm, L = 8 mm, Phil-
lips head
DX610T Magazine with 8 Bone Fixation screws/1.5 mm, L = 10 mm,
Phillips head
DX612T Magazine with 8 Bone Fixation screws/1.5 mm, L = 12 mm,
Phillips head
DX614T Magazine with 8 Bone Fixation screws/1.5 mm, L = 14 mm,
Phillips head
Slide hole Traction hole
drill drill
DX631R DX630R
Art. no. Designation
DX646T Magazine with 8 Bone Fixation micro-screws/1.2 mm,
L = 6 mm, Phillips head
DX648T Magazine with 8 Bone Fixation micro-screws/1.2 mm,
L = 8 mm, Phillips head
DX650T Magazine with 8 Bone Fixation micro-screws/1.2 mm,
L = 10 mm, Phillips head
Drill
Art. no. Designation
Spiral drill, ∅ 1.0 mm, L= 31/12 mm, with tool holder diameter 2.35 mm
DX629R
Dental
Spiral drill, ∅ 1.25 mm, L= 31/16 mm, with tool holder diameter 2.35 mm
DX630R
Dental
Spiral drill, ∅ 1.5 mm, L= 27/12 mm, with tool holder diameter 2.35 mm
DX631R
Dental
Screwdriver and accessories
Art. no. Designation
DX604R Screw holding sleeve for DX604R
DX605R Screwdriver handle
DX606R Screwdriver blade
Materials
The materials used in the implant are listed on the label:
■
Titanium forged alloy Ti6Al4V acc. to ISO5832-3
The titanium implants are coated with a colored oxide. Slight changes in coloration may occur, but do not affect the
implant quality.
Indications
Use for:
■
Bone augmentation in the jaw region
Absolute contraindications
■
Foreign body sensitivity to the implant materials
■
Acute or chronic infections in the region of the implant anchoring
■
Severe damaged bone structures that could prevent stable implantation of implant components
■
Bone tumors in the region of implant fixation
Relative contraindications
Do not use if the patient has:
■
Fever
■
Systemic diseases and metabolic disorders
■
Acute osteoporosis or osteomalacia
■
Medical or surgical conditions that could negatively affect the outcome of the implantation
■
Dependency on pharmaceutical drugs, drug abuse, or alcoholism
■
Degenerative bone diseases
■
Inadequate patient compliance
■
Anticipated overload on the implant
■
Cases not listed under indications
Side effects and interactions
■
Changes in position, loosening, wear and tear on, or fracture of implant components
■
Primary and secondary infections
■
Tissue reaction to implant materials
■
Injury to blood vessels and nerves
■
Haematosis and wound healing disorders
The application or improper use of this system may result in:
■
Implant failure resulting from excessive load
– Warping or bending
– Loosening
– Breakage
■
Inadequate fixation
■
Failed or delayed fusion
Safety notes
■
It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly.
■
General risk factors associated with surgical procedures are not described in this documentation.
■
The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the
established operating techniques.
■
The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood ves-
sels, muscles, and tendons.
■
Aesculap is not responsible for any complications arising from, wrong choice of implant, incorrect combination
of implant components and operating technique, the limitations of the treatment method, or inadequate asepsis.
■
Aesculap Bone Fixation screws may only be combined with spiral drills DX629R to DX631R and screwdriver han-
dle DX605R incl. screwdriver bit DX606R.
■
Do not, under any circumstances, use damaged or surgically removed components.
■
Implants already used must not be reused.
■
The forces to be transferred by the implant must be kept to the achievable minimum.
Slide hole Traction hole
drill drill
DX630R DX629R