OAKWORKS Spine Positioning System II User Manual

OAKWORKS Spine Positioning System II User Manual

Imaging and pain management accessory
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USER MANUAL
OAKWORKS
®
Imaging and Pain Management
Accessory - Spine Positioning
System II
www.oakworksmed.com · 717.235.6807

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Summary of Contents for OAKWORKS Spine Positioning System II

  • Page 1 USER MANUAL OAKWORKS ® Imaging and Pain Management Accessory - Spine Positioning System II www.oakworksmed.com · 717.235.6807...
  • Page 2 OAKWORKS , Inc. tial damages in connection with or ® arising out of the furnishing, per- formance, or use of this document OAKWORKS is a registered and the program material which it ® trademark of OAKWORKS , Inc. describes. ®...
  • Page 3: Table Of Contents

    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 .....................16 Warranty Information ......................17 Specifications Product Specifications ....................
  • Page 4: Introduction

    P R O D U C T U S E D E S C R I P T I O N 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.
  • Page 5: Safety Instructions

    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.
  • Page 6: Product Description & Photos

    PRODUCT DESCRIPTION Spine Positioning System II CONTOURED TORSO SUPPORT PAD CRESCENT FACE PAD RADIOLUCENT FRAME WITH ADJUSTABLE FACE REST CONTOURED TORSO WEDGE 8” X 22” X 2” 7” X 12” X 1½” (20 x 56 x 5 cm) (18 x 30 x 4 cm)
  • Page 7 PRODUCT DESCRIPTION R A D I O L U C E N T F R A M E Used to support the Torso Support and Crescent Face Pad. One cam lock facilitates cervical flexion and extension. Cervical Support Adequate free space System under see through face sec- tion for aeration, supplemental...
  • Page 8 PRODUCT DESCRIPTION C O N T O U R E D T O R S O W E D G E The Contoured Torso Wedge is constructed of dense foam This provides enhanced patient stability and conveniently reduces shoulder interference during cervical procedures. S M A L L R E C T A N G U L A R A D J U S T E R P A D The 7”...
  • Page 9: Directions For Use

    All components are shipped in a clean but not sterile condition. If the Spine Positioning System II will be used for an indicated surgical proce- dure, be sure to disinfect the components prior to use. F A C E R E S T P L A T F O R M A D J U S T M E N T Step 3 - Line up the locking pins on Step 1 - Open cam.
  • Page 10: Transporting The Spine Positioning System Ii

    DIRECTIONS FOR USE T O R S O P A D S T R A P WARNING A patient safety strap must be used during all procedures. To secure the Torso Pad to the table, wrap the Velcro® strap under the table top and attach securely. T R A N S P O R T I N G T H E S P I N E P O S I T I O N I N G S Y S T E M I I Spine Positioning System Pads...
  • Page 11: Imaging Scenarios

    A patient safety strap must be used during all procedures. The following imaging scenarios of patients will demonstrate: 1. Various body types using the Spine Positioning System II (SPS II) 2. Their positioning and specific configurations of the SPS II used in particular clinical situations 3.
  • Page 12 IMAGING SCENARIOS WARNING A patient safety strap must be used during all procedures. PATIENT - DON Components used: Radiolucent Frame, Crescent Face Pad, Contoured Torso Support Pad, Large Adjuster Pad, 8” Semi-Round Bolster (not pictured) SPS II set up for Don shown here Don in the SPS II while obtaining an Lateral image of the lumbar oblique image of the lumbar spine...
  • Page 13 IMAGING SCENARIOS WARNING A patient safety strap must be used during all procedures. PATIENT - LIZ Components used: Radiolucent Frame, Crescent Face Pad, Contoured Torso Support Pad, Contoured Torso Wedge, 8” Semi-Round Bolster (not pictured) SPS II set up for Liz shown here Liz in the SPS II while obtaining an Liz in the SPS II while obtaining a AP image of the upper thoracic spine.
  • Page 14 IMAGING SCENARIOS WARNING A patient safety strap must be used during all procedures. PATIENT - MARY 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 pictured) SPS II set up for Mary shown here Mary in the SPS II while obtaining an AP image through the C1-2 segment...
  • Page 15 IMAGING SCENARIOS WARNING A patient safety strap must be used during all procedures. PATIENT - CARL Components used: Radiolucent Frame, Crescent Face Pad, Contoured Torso Support Pad, Contoured Torso Wedge, 8” Semi-Round Bolster (not pictured) SPS II set up for Carl shown here Carl in the SPS II while obtaining an Right thoracic oblique image to AP image of the mid-thoracic spine...
  • Page 16 IMAGING SCENARIOS WARNING A patient safety strap must be used during all procedures. PATIENT - DEBBIE 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 for Debbie shown here Debbie in the SPS II while obtaining AP image of the cervical spine a lateral cervical image.
  • Page 17 IMAGING SCENARIOS WARNING A patient safety strap must be used during all procedures. PATIENT - JANE Components used: Radiolucent Frame, Crescent Face Pad, Contoured Torso Support Pad, Contoured Torso Wedge, 8” Semi-Round Bolster (not pictured) SPS II set up for Jane shown here Jane in the SPS II while obtaining a The lower cervical interlami- lateral image of the cervical spine.
  • Page 18: Cleaning & Disinfection

    Follow the cleaners/disinfectant manufacturers’ directions for use. Please note that cleaning and dis- infecting an OAKWORKS ® product is a two part process. First it must be cleaned of any visible soil, then it can be disinfected. Please follow this procedure for best results: 1.
  • Page 19: Inspections & Maintenance

    INSPECTIONS & MAINTENANCE I N S P E C T I O N S & M A I N T E N A N C E Inspect Torso Support Pad monthly to be sure that the foam has not lost shape or firmness to the extent that patient support would be compromised.
  • Page 20: Specifications

    WARRANTY / SPECIFICATIONS W A R R A N T Y View complete warranty details at www.oakworks.com PRODUCT SPECIFICATIONS Component Aluminum Equivalence Dimensions Radiolucent Frame 1.20 mm @ 100 kVp, HVL of 3.6 mm 1/4” x 12” x 32.5” (.6 x 30 x 84 cm.) Crescent Face Pad .72 mm @ 100 kVp, HVL of 3.6 mm...
  • Page 21: Unique Device Identification (Udi) Information

    UNIQUE DEVICE IDENTIFICATION (UDI) INFORMATION U N I Q U E D E V I C E I D E N T I F I C A T I O N (U D I) I N F O R M A T I O N The UDI Label is located on the top side of the frame underneath the torso pad...
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  • Page 24: Contact Information

    USER MANUAL OAKWORKS ® Imaging and Pain Management Accessory - Spine Positioning System II C O N T A C T I N F O R M A T I O N: CoYoMe b.v. - CoMedical Oakworks Inc. ® Edisonsraat 2 - 4...

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