acumed ACU-LOC Series, Руководство пользователя

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PKGI-70-H Effective 03-2019
DESCRIPTION: The Acu-Loc Wrist Spanning plate is designed
to provide temporary fixation for the wrist. The Acu-Loc Wrist
Spanning Plate uses the instruments provided with the Acu-Loc 2
system to facilitate placement of implants.
INDICATIONS: The Acu-Loc Wrist Spanning Plate is indicated
for fixation of fractures, osteotomies, and non-unions of the
radius.
CONTRAINDICATIONS: Contraindications for the system are
active or latent infection; sepsis; osteoporosis, insufficient quantity
or quality of bone or soft tissue and material sensitivity. If material
sensitivity is suspected, tests should be performed prior to
implantation. Patients who are unwilling or incapable of following
postoperative care instructions are contraindicated for these
devices. These devices are not intended for screw attachment or
fixation to the posterior elements (pedicles) of the cervical,
thoracic, or lumbar spine.
IMPLANT MATERIAL SPECIFICATIONS: The implants are
made of titanium alloy per ASTM F136.
ACUMED
®
ACU-LOC
®
WRIST SPANNING PLATE
SURGICAL INSTRUMENT MATERIAL SPECIFICATIONS: The
instruments are made of various grades of stainless steel,
titanium, aluminum, and polymers evaluated for biocompatibility.
IMPLANT INFORMATION FOR USE: Physiological dimensions
limit the sizes of implant appliances. The surgeon must select the
type and size that best meets the patient’s requirements for close
adaptation and firm seating with adequate support. Although the
physician is the learned intermediary between the company and
the patient, the important medical information given in this
document should be conveyed to the patient.
SURGICAL INSTRUMENT INFORMATION FOR USE:
Instruments provided with this system may be single use or
reusable.

The user must refer to the instrument's label to determine
whether the instrument is single use or reusable. Single use
instruments are labeled with a "do not re-use" symbol as
described in the Symbol Legend section, below.

Single use instruments must be discarded after a single use.

Reusable instruments have a limited lifespan. Prior to and
after each use, reusable instruments must be inspected
where applicable for sharpness, wear, damage, proper
cleaning, corrosion and integrity of the connecting
FOR THE PERSONAL ATTENTION OF THE
OPERATING SURGEON
English – US / PAGE 3
US