Introduction; Product Use Description; Symbol Identification - OAKWORKS Spine Positioning System II User Manual

InTRODUCTIOn / PRODUCT USe DeSCRIPTIOn / SyMbOl IDenTIfICATIOn

InTRODUCTIOn

The Spine Positioning System II 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 impor-
tantly, the target anatomy 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 II 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 position-
ing combinations for ideal patient comfort and imaging needs for all spinal column procedures.

PRODUCT USe DeSCRIPTIOn

The Oakworks® Spine Positioning System II is a patient cradle device for use in diagnostic and therapeutic pro-
cedures of the spine. It is intended to be used by a healthcare professional in a medical environment 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 II, its secondary components, and optional components are suitable for use in fluoroscopy suites.
No special training is required but a review of the following Safety Instructions is important for the safety of the oper-
ator and patient. The healthcare professional should read and understand this entire manual before use with a patient.

SyMbOl IDenTIfICATIOn

This symbol, when used in this manual and on product labels, represents a caution warning. Be
sure to read and comply with all precautions and warnings.
This symbol, when used in this manual and on product labels, indicates the potential of exposure to
harmful x-rays. Be sure to read and comply with all warnings.
This symbol when used in this manual or on product labels, warns that when stacking containers
during transport and storage, there should be do not stack more than 5 containers high.
This symbol, when used in this manual or on product labels, indicates that the product should be
protected from moisture. The humidity specifications for Transport & Storage are listed on page
21.
This symbol, when used in this manual or on product labels, indicates that information is given
regarding the recommended temperature limits during transport and storing.
This symbol, when used in this manual or on product labels, indicates the date of manufacture of
the device.
This symbol is used to indicate that the operator should consult the user manual.
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