Warning – Oakworks Spine Positioning System User Manual
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indications
The O
akworks
®
Spine Positioning System is a patient cradle device for use in
diagnostic and therapeutic procedures of the spine. It is intended to be used solely for
the purpose of aiding in patient positioning and comfort during non-surgical
imaging or spinal injection procedures. It may also be used during minimally
invasive surgical procedures such as vertebroplasty or kyphoplasty. The Spine
Positioning System, its secondary components and optional components are
suitable for use in fluoroscopy suites.
t
introduction
The
Spine Positioning System is an integral component of the pain management
fluoroscopy suite. With this system procedural set up time is reduced, patient comfort
is enhanced and unwanted movement is minimized. Most importantly, the target anat-
omy is more readily visualized which allows the physician to perform spine procedures
in a more efficient and secure manner. In collaboration with leading pain management
physicians, Oakworks designed the Spine Positioning System in an effort to achieve the
critical balance between optimal imaging and patient comfort. The radiolucent adjustable
frame and versatile padding system provide a metal free imaging support platform capable
of quickly positioning a wide variety of patient physiques for extended periods of time.
The adjustable face rest position provides individualized positioning for all types of cervical
procedures and anatomy. The contoured torso support pad is complimented by a host of
uniquely shaped and sized adjuster pads and wedges that enable a multitude of positioning
combinations for ideal patient comfort and imaging needs for all spinal column procedures.
Warning
Warnings
A patient safety strap is required during all procedures. Follow normal and required
safety protocol for all procedures where the patient is in an elevated position for the
procedure (straps, attendants, etc.). Always be certain that attending staff is aware of
the patient’s position while the device is in use. Reposition the patient if necessary
to promote stability. Due to the increased distance between the patient and the table
surface, additional safety measues are recommended when the table top is not used
in a level position due to the risk of the patient falling off the table.
The O
akworks
®
Spine Positioning System is not designed for use with diagnos-
tic x-ray systems where the x-ray generator is located above the radiographic table
and the film cassette or image intensifier is located below the radiographic table.
The X-Ray generator
muSt be located below the radiographic table. The Spine
Positioning System is not designed for use with magnetic resonance imaging sys-
tems. The Spine Positioning System is not intended for use in cranial procedures.
Do not overhang the platform frame beyond the warning line on the frame.
Operate the C-arm of the fluoroscopy system with the Spine Positioning System
in place before using the device with a patient for the first time. Make sure there is
adequate clearance to permit free C-arm rotation for both the patient and the posi-
tioning device.
Do not permit the patient to push down on the Crescent Face Cushion in an effort
to lift themselves up while dismounting the platform and/or the
fluoroscopy table.
The Spine Positioning System should generally not be used when a patient is under general
anesthesia, especially when prolonged cases are performed. This will reduce
the risk of ocular or facial nerve injury.