Oakworks Spine Positioning System II User Manual
USER MANUAL
OAKWORKS®
Spine Positioning System II
CRESCENT
FACE PAD
RADIOLUCENT
FRAME WITH
ADJUSTABLE
FACE REST
8” X 22” X 2”
(20 x 56 x 5 cm)
LARGE
RECTANGULAR
ADJUSTER PAD
7” X 12” X 1½”
(18 x 30 x 4 cm)
SMALL
RECTANGULAR
ADJUSTER PAD
CONTOURED
TORSO WEDGE
CARRY CASE
CONTOURED TORSO
SUPPORT PAD
8” (20cm)
SEMIROUND
BOLSTER
www.oakworksmed.com · 717.235.6807
made in the USA
with US & imported parts
© Copyright 2013
Oakworks® Medical Equipment,
a division of Oakworks®, Inc.
Printed in U.S.A.
All rights are reserved. No part of
this document may be photocopied,
reproduced or translated to another
language without prior written consent
of Oakworks® Medical Equipment, a
division of Oakworks®, Inc.
Oakworks® is a registered trademark
of Oakworks®, Inc.
Notice
The information contained in this
document is subject to change without
notice and should not be construed as
a commitment by Oakworks®, Inc.
Oakworks®, Inc. assumes no responsibility for any errors that may appear
in this document nor does it make
expressed or implied warranty of
any kind with regard to this material, including, but not limited to, the
implied warranties of merchantability
and fitness for a particular purpose.
Oakworks®, Inc. shall not be liable for
incidental or consequential damages in
connection with or arising out of the
furnishing, performance, or use of this
document and the program material
which it describes.
TABLE OF CONTENTS
Introduction ...........................................................................................................................1
Product Use Description .....................................................................................................1
Important Safety Instructions
Symbol Identification .................................................................................................... 1
Safety Instructions ........................................................................................................ 2
Product Description & Photos
Spine Positioning System II ......................................................................................... 3
Radiolucent Frame ...............................................................................................4
Crescent Face Pad ................................................................................................. 4
Contoured Torso Support Pad ............................................................................4
Contoured Torso Wedge ...................................................................................... 5
Large Adjuster Pad ...............................................................................................5
Small Adjuster Pad ............................................................................................... 5
8” (20 cm.) Semi-Round Bolster ..........................................................................5
Directions for Use
Preparation for Use ...................................................................................................... 6
Face Rest Platform Adjustment ................................................................................... 6
Torso Support Strap ..................................................................................................... 7
Transporting the Spine Positioning System II ........................................................... 7
Imaging Scenarios ........................................................................................................ 8-14
Cleaning & Disinfection ................................................................................................... 15
Inspections & Maintenance ....................................................................................... 15-16
Warranty Information ........................................................................................................ 16
Specifications
Product Specifications ............................................................................................... 16
Environmental Conditions ....................................................................................... 16
Contact Information ......................................................................................... back cover
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 importantly, 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 procedures 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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IMPORTANT SAFETY INSTRUCTIONS
IMPORTANT SAFETY INSTRUCTIONS
CAUTION
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 measures 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 Oakworks® Spine Positioning System II is not designed for use with diagnostic 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 II is not designed for use with magnetic resonance imaging systems. The Spine Positioning System II is not intended for use in cranial procedures.
Do not overhang the radiolucent frame beyond the warning line on the frame.
Operate the C-arm of the fluoroscopy system with the Spine Positioning System II 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 positioning device.
Do not permit the patient to push down on the Crescent Face Pad in an effort to lift themselves up while dismounting the platform
and/or the table.
The Spine Positioning System II 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.
The cushioning foam contained within the Torso Support will lose its ability to spring back to the original position over time and the
amount of foam compression will increase. Therefore, the Torso Support should be replaced periodically to ensure the device functions as intended.
To prevent the potential of cross-contamination, it is strongly advised to use barrier techniques when the device is in use. A disposable or laundered patient gown, or disposable pad are satisfactory for use as a barrier for the Torso Support and other components
and accessories, except when the patient presents with pathology that would indicate otherwise. A disposable face rest cover should
be used to cover the Face Rest Pad. Contact Oakworks for ordering information. Barrier techniques should be used in addition to
disinfection procedures, not in lieu of them.
Be sure to support the weight of the patient’s head while making adjustments to the cervical positioning feature of the Platform
Frame. Make sure all cam locks are secure before relinquishing support of the positioning assembly.
READ AND SAVE THESE INSTRUCTIONS
DANGER
The Cervical Support System has metal parts that can cause back scatter of x-rays, see Product Description for photo.
When x-rays are present, wear a suitable radiation barrier.
The Spine Positioning System II is constructed using metal pins in the Quick Cam Locks and aluminum tubing in the support
structure. These are out of the field of view in most A-P and oblique tilted views. Place the positioning assembly according to the
recommendations in the directions for use to eliminate, or reduce any artifacts. If artifacts still remain to the extent that they would
compromise the efficacy of needle placement, discontinue use of the device during the affected procedure.
The Spine Positioning System II is designed to be a standalone product used with radiographic equipment. It must not be modified
or incorporated into any other equipment.
All materials used in the construction of the device and accessories are safe for temporary and moderately frequent human contact.
The device is not intended for prolonged contact.
Do not use the Face Rest Support Arms as a handle to carry the Spine Positioning System II.
Follow maintenance instructions found near the end of this manual. Mechanical components should be checked periodically to
insure that they are functioning properly to insure the safety of the patient.
SPS II weight limit: 350 lbs. (159 kg.) Crescent Face Pad Support weight limit: 25 lbs. (11 kg.)
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PRODUCT DESCRIPTION
Spine Positioning System II
CRESCENT
FACE PAD
RADIOLUCENT
FRAME WITH
ADJUSTABLE
FACE REST
CONTOURED TORSO
SUPPORT PAD
CONTOURED
TORSO WEDGE
8” X 22” X 2”
(20 x 56 x 5 cm)
LARGE
RECTANGULAR
ADJUSTER PAD
STANDARD SPECIFICATIONS
Weight 16 lbs. (7 kg.)
Frame with Face Rest 12” (30 cm.) Wide x 32.5” (84 cm.) Long
Crescent Face Pad 12” (30 cm.) diameter
Contoured Torso Support Pad 6.5” x 23” x 30” (17 x 58 x 76 cm.)
Contoured Torso Wedge 22” x 29” x 2” (56 x 74 x 5 cm.)
Large Rectangular Adjuster Pad 8” x 22” x 2” (20 x 56 x 5 cm.)
Small Rectangular Adjuster Pad 7” x 12” x 1.5” (18 x 30 x 4 cm.)
8” (20 cm.) Semi-Round Bolster 6” x 8” x 26” (15 x 20 x 66 cm.)
Carry Case Transports the SPS II System
Warranty 2 years - Frame, Fabric and padding
Safety Listings FDA and CE marked
7” X 12” X 1½”
(18 x 30 x 4 cm)
SMALL
RECTANGULAR
ADJUSTER PAD
CARRY CASE
8” (20cm)
SEMIROUND
BOLSTER
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