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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.