L011-68
Rev.
E0
2018-70-18
Page
5
of
11
Warnings and Cautions:
WARNING: Do not drill or install anchors in bone that is less than 4.5mm thick, or in bone that is weakened or diseased.
WARNING: Do not use anchors that exhibit any sign of looseness. Replace anchors and rescan if necessary.
WARNING: Do not allow WayPoint™ Anchors to remain implanted for more than 28 days.
WARNING: Do not overtighten screws or anchors as this could result in targeting errors.
WARNING: Complete kit is labeled MR Unsafe because it contains some MR Unsafe components. Refer to inventory
section for MRI status of individual components.
WARNING: Avoid trajectories close to parallel to the ground as this can cause accuracy errors due to flexing of the
plastic hubs and positioners.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
CAUTION: Sterilized by ethylene oxide
CAUTION: Sterile Medical Device - Do NOT resterilize
CAUTION: Do not use the contents if there is any evidence of damage to the package or package seal that could
compromise sterility.
CAUTION: WayPoint™ Implant and Surgical Kits are for single use only. Do not reuse. Cleaning or reuse may affect the
structural integrity and/or function of the device.These devices are difficult to clean after exposure to biological
materials and may cause adverse patient reactions if reused.
CAUTION: For the most secure fit of the WayPoint™ Anchors, advance drill and driver tools as perpendicular to the skull
as possible, and do not permit them to ‘wobble’ during advancement.
CAUTION: Avoid over tightening anchors as this can strip bone, or otherwise damage components.
CAUTION: Instruct the patient to avoid situations that could affect or disrupt the implanted anchors and to be cautious
about infection.
Содержание WayPoint 66-WP-BKS
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