Dansk - Coapt Endotine Transbleph Bedienungsanleitung

PRECAUTIONS
1. The ENDOTINE TransBleph™ device is designed to be
seated in the frontal bone. If the frontal sinus or cranial
fossa is entered, appropriate consultation should be
obtained.
2. Inform the patient of possible adverse effects including
palpability and visibility of the device prior to resorption,
discomfort, and surgical risks inherent to the procedure
(including penetration of the frontal sinus or cranium, nerve
injury, facial musculature dysfunction, infection, device
erosion through the skin, scarring, inadequate elevation,
tissue redescent, etc.). These symptoms and/or wound
problems may lead to a decision to remove the device
prior to its full resorption.
3. If the device is placed under eyelid skin or thin forehead
tissue, it may be visible through the skin and
uncomfortable for the patient. Adequate soft tissue
coverage is essential.
4. Local cyst and/or sinus formation may occur and may be
treated by aspiration or device removal.
5. High speed drilling (approximately 1000 rpm and greater)
and repeat drilling may create holes that are wider than
intended for a tight grip of the ENDOTINE TransBleph™
insertion post, resulting in inadequate fixation of the post.
Single pass, low speed drilling reduces the occurrence of
wider holes.
6. The insertion tool is not designed to provide torque and
should not be used to twist an implant into position.
7. If a device is removed after anchoring, discard and replace
with a new device for optimal performance.
WARNINGS
1. DO NOT RESTERILIZE the ENDOTINE TransBleph™ Device or
its insertion tools.
2. Do not cut or reconfigure the ENDOTINE TransBleph™
Device.
3. Do not use if storage temperature exceeds 110°F (43°C)
or the temperature indicator on the outer box has turned
black.
4. Discard open, unused devices.
5. This device and tools are for SINGLE USE ONLY and MUST
NEVER BE REUSED.
6. Inspect all components for damage before use. Do not
attempt to repair damaged components or sharpen the
drill bit.
7. Incomplete insertion of the device in the frontal bone may
result in inadequate anchoring.
8. Contour irregularities of the skin and tenderness may be
noticeable overlying the ENDOTINE TransBleph™ device,
especially in patients with thinner forehead tissue.
2
ADVERSE EFFECTS
Material sensitivity/allergic reactions in patients following
surgery should be reported. Implantation of foreign materials in
tissue can result in histological reactions.
Caution: Federal Law (USA) restricts this device to sale,
distribution, or use by or on the order of a physician.
ENDOTINE TransBleph™
Brugsanvisning
Tilgængelige modeller
Delnummer Spidslængde
CFD-080-0177 3,0 mm
CFD-080-0167 3,5 mm
BESKRIVELSE
ENDOTINE TransBleph™ består af indføringsværktøjer og et
biologisk resorberbart fikseringsimplantat. Denne anordning og
dets indføringsværktøjer er KUN TIL ENGANGSBRUG og leveres
sterile.
INDIKATIONER
ENDOTINE TransBleph™ er beregnet til brug ved subperiostal
plastikkirurgi til fiksering af øjenbryn. ENDOTINE TransBleph™ er
specielt indiceret til brug til fiksering af subdermis til
pandebenet.
KONTRAINDIKATIONER
1. Patienter, hvor der synes at være utilstrækkelig
pandebenstykkelse til ENDOTINE TransBleph™
knoglestang, der går til en dybde på 2,65 mm. Det
borede hul måler i dybde højst 3,050 mm. Tykkelsen på
det inferolaterale pandeben blev målt ved CT-scanning i
en serie på 54 patienter. Knogletykkelsen varierede fra
4,2 mm til 14,0 mm.
2. Situationer, hvor placering af anordningen medfører
dækning af øjenlågshud i stedet for bryn-/pandevæv.
3. Ethvert andet dissektionsplan end subperiostalt.
4. Situationer, hvor intern fiksering er kontraindiceret af andre
årsager (fx infektion, sinusitis).
5. Tyndt, atrofisk pandevæv, hvor anordningen ville være synlig
og rage for meget frem.
6. Alle kendte allergier eller overfølsomheder overfor
fremmedlegemer af biologisk plasticmateriale.
LBL-080-7302 Rev F

DANSK

Delnavn
ENDOTINE
TransBleph™ 3.0
ENDOTINE
TransBleph™ 3.5