Contraindications; English - Coapt Endotine Transbleph Bedienungsanleitung

ENDOTINE TransBleph™
Instructions for Use
Available Models
Part Number Tine Length
CFD-080-0177 3.0 mm
CFD-080-0167 3.5 mm
DESCRIPTION
The ENDOTINE TransBleph™ consists of insertion tools and a
bioabsorbable fixation implant. This device and its insertion
tools are for SINGLE USE ONLY and are supplied sterile.
INDICATIONS
The ENDOTINE TransBleph™ is intended for use in subperiosteal
browplasty fixation. The ENDOTINE TransBleph™ is specifically
indicated for use to fixate the subdermis to the frontal bone.

CONTRAINDICATIONS

1. Patients appearing to have an inadequate frontal bone
thickness for the ENDOTINE TransBleph™ bone post
which extends to a depth of 2.65 mm. The drilled hole
extends to a maximum depth of 3.050 mm. In a series of
54 patients, the inferolateral frontal bone thickness was
measured by CT scan. Bone thickness ranged from 4.2
mm to 14.0 mm.
2. Situations where device placement will lead to coverage
by eyelid skin instead of brow/forehead tissue.
3. Any plane of dissection other than subperiosteal.
4. Situations where internal fixation is otherwise
contraindicated (e.g. infection, sinusitis).
5. Thin, atrophic forehead tissue in which the device might be
visible and project excessively.
6. Any known allergy or foreign-body sensitivities to plastic
biomaterial.
PACKAGING, LABELING, and STERILIZATION
The ENDOTINE TransBleph™ and its insertion tools are sterilized
by gamma irradiation. Do NOT resterilize this device or the
tools. Implants and tools should be accepted only if the
factory packaging and labeling arrive intact. Do not use if
packaging shows evidence of puncture(s), tampering, water
contamination or other damage.
STORAGE INSTRUCTIONS
1. Store at room temperature (15 to 24°C or 60 to 75°F) in
a dry place out of direct sunlight. Do not use beyond the
expiration date listed on the outer label.

ENGLISH

Part Name
ENDOTINE
TransBleph™ 3.0
ENDOTINE
TransBleph™ 3.5
INSTRUCTIONS FOR USE
1. Prior to implant usage, verify intraoperatively that the soft
tissue thickness of the forehead is appropriate for the
ENDOTINE TransBleph™ implant.
2. The product consists of an implant preloaded on an
insertion tool and a dedicated drill bit (Figure 1).
3. The supraorbital rim is approached subperiosteally through
a standard upper blepharoplasty incision. Care should be
exercised to protect the supraorbital and supratrochlear
neurovascular bundles. Adequate exposure is required to
align the drill bit and insertion tool perpendicular to the
bone. If necessary, a small, separate incision in the
horizontal lines of expression can be used above the brow
for adequate perpendicular access to the frontal bone.
4. The position of the device anchoring hole is planned at the
junction of the central third and lateral third of the
eyebrow (Figure 2). The position of the hole should be an
adequate distance above the supraorbital rim to prevent
the device from ultimately lying under eyelid skin. Note
that when the device is implanted the tines are superior to
the post.
5. Use the supplied drill bit to create an anchoring hole
perpendicular to the bone surface. The drill bit has
reached an adequate depth when the stop collar on the bit
is flush with the bone (Figure 3). If present, remove any
residual loose bone material in the hole after drilling.
6. Remove the ENDOTINE TransBleph™ device from the
packaging. Prior to inserting the device into the bone hole,
one can pass a double armed suture through the two
platform holes in order to later tack down the tissues onto
the device. Apply moderate, steady pressure to the
insertion tool to seat the implant post in the anchoring
hole (Figure 4). Rotate the insertion tool counterclockwise
to release (Figure 5).
7. Elevate the brow tissue to the desired position over the
frontal bone.
8. Use digital pressure on the outer surface of the brow to
engage brow tissues to the implant tines (Figure 6). If the
fixation appears inadequate, the suture that was previously
passed through the platform holes can be used to fixate
subcutaneous tissue or for temporary transcutaneous
fixation.
9. Apply gentle pressure to the brow area with surgical tape or
elastic fabric to prevent dislodgement in the early post-
operative period (Figure 7).
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