Oakworks Spine Positioning System User Manual
INSTRUCTION MANUAL
SPINE POSITIONING SYSTEM
(1) CresCent
FaCe rest Pad
(1) radioluCent
Frame With
adjustable
FaCe rest
(2) Contoured
torso Wedges
pictured here with
(2) 8” x 16”
reCtangular
adjuster Pads
small wedge
(1) Contoured
torso suPPort Pad
(2) 7” x 12”
reCtangular
adjuster Pads
made in the USA
with US & imported parts
(1) Carry Case
(1) 8” halF
round
bolster
(1) 8” semi
round
bolster
© Copyright 2010
Oakworks® Medical Equipment,
a division of Oakworks®, Inc.
REGULATORY
FDA Listed
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 O
Medical Equipment, a division of
Oakworks®, Inc.
Oakworks® is a registered trademark
of Oakworks®, Inc.
akworks
®
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 ......................................................................... 2
WarnIngs & cautIons .................................................2 - 3
symbol IdentIfIcatIon ........................................................ 4
descrIptIon of components ...................................5 - 7
dIrectIons for use ......................................................8 - 15
maIntenance & servIce........................................17 - 21
• cleaning & disinfecting ...................................17
• maintenance .................................................... 18-19
• list of parts ...........................................................20
• specifications ........................................................ 21
• warranty ................................................................ 21
• contact information ................. back cover
TABLE OF CONTENTS
1
INTRODUCTION / INDICATIONS / WARNINGS
INTRODUCTION
The Spine Positioning System is an integral component of the pain management
uoroscopy 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 efcient 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.
INDICATIONS
The Oakw ork s® 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
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 Oakw ork s® Spine Positioning System 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 is not designed for use with magnetic resonance imaging systems. 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 positioning 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.
2
CAUTION
CAUTIONS
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 Cushion. 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.
The Cervical Support System (see page 5) has metal parts that can cause back scatter of x-rays.
When x-rays are present, wear a suitable radiation barrier.
The Spine Positioning System 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.
CAUTIONS
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.
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.
3
SYMBOL IDENTIFICATION
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 and on product labels, indicates that the
table and components are a Type B Applied Part pursuant to IEC 601.1 and EN
60601-1: 1990.
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 23.
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.
4
DESCRIPTION OF COMPONENTS
(2) 8” x 16”
reCtangular
adjuster Pads
Pn 0552-06
(2) 7” x 12”
reCtangular
adjuster Pads
Pn 4402-06
(1) CresCent
FaCe rest Pad
Pn em2410-sP
(1) radioluCent
Frame With
adjustable
FaCe rest
Pn 64878
(2) Contoured
torso Wedges
Pn 0550-06 (small)
Pn 0554-06 (large)
large not shown
(1) Carry Case
Pn 64705
(1) Contoured
torso suPPort Pad
Pn 0546-06
(1) 8” halF
round
bolster
Pn 1581-06
DESCRIPTION OF COMPONENTS
(1) 8” semi
round
bolster
Pn 5932-06
64878- RADIOLUCENT FRAME
Used to support the Torso
support and Crescent face
rest pad. One cam lock
facilitates cervical flexion
and extension.
Cervical
Support
System
See Caution on page 3.
cam lock
Adequate free
space under see
through face section
for aeration, supplemental O2, jaw/face
contact as necessary; prevents
patient overheating, can more
easily communicate with the
patient without sound mufing.
5
DESCRIPTION OF COMPONENTS - CONTINUED
EM2410-SP - CRESCENT FACE REST PAD
The Crescent Face Rest Pad supports the patient’s face in a prone position without compromising air space for breathing. The face pad can be moved caudad
in situations to prevent imaging of the locking mechanism
when performing upper cervical procedures
that require substantial imaging angulation.
0546-06 CONTOURED TORSO SUPPORT PAD
DESCRIPTION OF COMPONENTS
The Contoured Torso Support is constructed of dense foam in the center,
flanked by softer foam and covered in a fabric designed to withstand today’s
disinfectants. The softer foam accommodates to the patient’s shoulders and/or
breasts to maximize comfort. This helps provide enhanced patient stability while
allowing for the shoulders to decend for optimal cervical and thoracic imaging.
The distal end of the torso support pad is hollowed out under the abdomen to
enhance patient comfort and stability. Additionally, the distal end of the torso
support pad is wider to enhance patient stability by reducing sway while in the device.
0550-06 SMALL CONTOURED TORSO WEDGE
0554-06 LARGE CONTOURED TORSO WEDGE
The Contoured Torso Wedge is constructed of dense foam and covered in a fabric
designed to withstand today’s disinfectants. This provides enhanced patient stability
and conveniently reduces shoulder interference during cervical procedures. For faster
set up, the larger torso wedge can replace the combination of the smaller wedge and
rectangular adjuster pads as shown here.
Large wedge
Small wedge
6
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