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INTRODUCTION / PRODUCT USE DESCRIPTION / SYMBOL IDENTIFICATION

SYMBOL IDENTIFICATION

This symbol, when used in this manual and on product labels, represents a caution warn-

ing. 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 con-

tainers 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 and on product labels, indicates the name and 

address of the manufacturer.

This symbol, when used in this manual or on product labels, indicates the country of 

manufacture along with date of manufacture of the device next to it.

This symbol is used to indicate that the operator should consult the user manual.

PRODUCT USE DESCRIPTION

The Oakworks® Spine Positioning System II is a patient cradle device for use in diagnostic and thera-

peutic procedures of the spine. It is intended to be used by a healthcare professional in a medical envi-

ronment 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 operator and patient. The healthcare pro-

fessional should read and understand this entire manual before use with a patient. 

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 move-

ment is minimized.  Most importantly, the target anatomy is more readily visualized which allows the phy-

sician 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 positioning combinations for ideal patient comfort and imaging needs for all spinal column 

procedures.  

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US

Содержание Spine Positioning System II

Страница 1: ...OAKWORKS Imaging and Pain Management Accessory Spine Positioning System II USER MANUAL www oakworksmed com 717 235 6807...

Страница 2: ...within this document is subject to change without notice and should not be construed as a commitment by OAKWORKS Inc OAKWORKS Inc encourages requests for technical specifica tions and the like documen...

Страница 3: ...orso 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 Spin...

Страница 4: ...rpose 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 o...

Страница 5: ...ons 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...

Страница 6: ...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...

Страница 7: ...moved in situations to prevent imaging of the locking mechanism when performing upper cervical procedures that require substantial imaging angulation CONTOURED TORSO SUPPORT PAD The Contoured Torso S...

Страница 8: ...descend out of the plane of the cervical and thoracic spine This pad offers a wide range of flexibility for general patient positioning and stabilization LARGE RECTANGULAR ADJUSTER PAD The wider 8 x 2...

Страница 9: ...STMENT Step 1 Open cam Step 2 Grasp platform and raise to desired position Step 3 Line up the locking pins on the leg with the handle with the corre sponding holes on the center pieces Minor platform...

Страница 10: ...y Case put some pads wedges or bolsters on both sides of the base frame Spine Positioning System Radiolucent Frame Spine Positioning System Pads Spine Positioning System Pads DIRECTIONS FOR USE WARNIN...

Страница 11: ...approach cervical procedures Components used Radiolucent Frame Crescent Face Pad Contoured Torso Support Pad Contoured Torso Wedge Small Adjuster Pad 8 Semi Round Bolster not pictured SPS II set up f...

Страница 12: ...ound Bolster not pictured Don in the SPS II while obtaining an oblique image of the lumbar spine Right oblique image of the lum bar spine Lateral image of the lumbar spine AP image of the lumbar spine...

Страница 13: ...II while obtaining an AP image of the upper thoracic spine Lateral image primarily through the C7 T2 segments AP image visualizing the T1 2 interlaminar space Contralateral oblique showing the upper...

Страница 14: ...s AP image through the C1 2 joints Components used Radiolucent Frame Crescent Face Pad Contoured Torso Support Pad Contoured Torso Wedge 7 x 12 Rectangular Adjuster Pad 8 Semi Round Bolster not pictur...

Страница 15: ...or planning the trajectory for a left thoracic facet injection Right thoracic oblique image to visualize the trajectory for a transfo raminal injection Contralateral oblique showing the trajectory for...

Страница 16: ...set up for Debbie shown here Debbie in the SPS II while obtaining a lateral cervical image AP image of the cervical spine while imaging through the C7 T1 interlaminar space Contralateral oblique of th...

Страница 17: ...er the target interspaces Lateral collimated image of the cervical spine The C6 7 T1 interspaces are appre ciated for all posterior approach cervical procedures such as interlaminar epidural steroid i...

Страница 18: ...procedure Because of possible chemical incompatibilities between various cleaning products and bleach utmost care must be taken by the user to avoid potential exposure to harmful or toxic by prod uct...

Страница 19: ...kly Use the following procedure Step 1 Lock the platform cam Step 2 Rock platform up down Gently rock platform up and down and note any looseness some flexing is normal Look for gaps between the alumi...

Страница 20: ...rso Wedge 70 mm 100 kVp HVL of 3 6 mm 22 x 29 x 2 56 x 74 x 5 cm Small Adjuster Pad 35 mm 100 kVp HVL of 3 6 mm 7 x 12 x 1 5 18 x 30 x 4 cm Large Adjuster Pad 35 mm 100 kVp HVL of 3 6 mm 8 x 22 x 2 20...

Страница 21: ...th the torso pad Model Name Unique Device Information GTIN 14 digit number unique for each variation of a model Manufacture Date Country of manufacture and date the device goes into production in YYYY...

Страница 22: ...THIS PAGE IS INTENTIONALLY LEFT BLANK 19...

Страница 23: ...20 THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 24: ...nt Accessory Spine Positioning System II USER MANUAL CONTACT INFORMATION CoYoMe b v CoMedical Edisonsraat 2 4 3284 WD Oud Beijerland The Netherlands www coyome eu Enrico Cohen Enrico coyome nl info co...

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