Schure Spine Frame

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Schure Spine Frame   800-0235

Replacement Parts:
Schure Spine Frame Crank Handle   800-0277
Schure Spine Frame Pad Set   508-0472
Disposable Laminetomy Arm Cradles   508-0373 
Disposable Richards Slotted Headrests, Extended   508-1340
Schure Spine Frame Straps   512-0049

Device Initial Release: 5/1/2012

Manufacturer
SchureMed (081001460)
452 Randolph Street, Abington, MA 02351 USA 
Toll Free ( 888 ) 724-8763  |  Ph (781) 982-7000
Fax (781) 982-7001  |  orders@schuremed.com

Authorized Representative
Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands

• Product not made with (NRL) Natural Rubber Latex
• Device supports 500 lb. (227 kg) proportional patient load (6'4" (193 cm) tall patient per 99% human body model)
• Product warranty covers product from manufacturing defects for period of 2 years
• If damaged in shipping, call Customer Service at (888) 724-8763 or (781) 982-7000 to obtain Return Material Authorization (RMA) number. For product warranty issues, contact Customer Service.
• CE marked medical device according to MDR (EU) 2017/745
• Product is maintenance-free, check product condition before next use
• Life of device is 5 years under normal use
• Store device between –4°F to +86°F (-20°C to 30°C)

INSTRUCTIONS FOR USE
Become familiar with features of patient positioning device before use with patient. Always practice use on a nurse, physician or appropriate volunteer prior to using clinically.

1. Buttons
2. Hole for Crank
3. Head End
4. Schure Spine Frame Pad Set  508-0472
5. Disposable Richards Slotted Headrest, Extended  508-1340
6. Schure Spine Frame Straps  508-1340

SET UP FOR THE FLEX FRAME OR JACKSON TABLE

1. Lower head end of Schure Spine Frame onto rails and slide to desired location
2. Ensure Velcro straps are in between rails
3. Lower frame completely onto rails
4. Bring Velcro straps around rails and secure to Schure Spine Frame

SET UP FOR SURGICAL TABLE /FLAT SURFACE

1. Place frame on surgical table with buttons facing head end of surgical table
2. Ensure enough room for head positioner
3. Ensure frame is centered between surgical table table rails
4. Place Velcro straps through surgical table rails
5. Bring Velcro straps around rails and secure back to Schure Spine Frame

DEVICE CONTROLS
To Adjust Pad Height

1. Insert Crank Handle (800-0277) into Schure Spine Frame as shown
2. Press Crank Handle in until fully engaged and line on the shaft is lining up with opening below
3. Support Crank Handle Rod with one hand and grab handle with other

To Release Patient Supports

1. Press inward at free end of support while pulling upward at center
2. Pull support out from front catch
3. Locate button at opposite end of frame
4. Press button firmly
5. Shift support laterally to desired location and release button
6. Lower support to front catch
7. Press firmly inwards and tuck into front catch

•  Note: Techniques detailed in this manual are only manufacturers suggestions. Final responsibility for patient care with respect to this device remains with attending physician.
• Optional Recommended –Place moisture absorbing/friction reducing covers over supports
• Prior to transferring the patient, crank spine frame to highest setting. After transferring patient, lower to desired level.
• Position patient to reduce nerve contact and subsequent injury
• Additional support must be provided to head, arms and legs

REMOVAL AND STORAGE

1. Remove velcro strap from Spine frame and unwrap from rail
2. Remove from table and store

INTENDED USE
Schure Spine Frame is used as a platform to do simple spine surgeries.

• Length: 30”+/- 0.5” (76 cm +/- 1 cm)
• Width: 19”+/- 0.5” (48 cm +/- 1 cm)
• Depth: 7.5”+/- 0.5” (19 cm +/- 1 cm) (Minimum no pad) & 10”+/- 0.5” (25 cm +/- 1 cm) (Maximum no pad)
• Device Weight: 27 +/- 0.5 lbs. (69 +/- .22 kg)
• Range of Motion: 7.5” (19 cm) lateral adjustment
• Attaches to rail of a surgical table anywhere on rail
• Stores on Transport Dolly
• Single-person installation
• Removable hand crank
• Compatible with Jackson table and any other surgical table that has side rails
• 3/4 of the spine frame is radiolucent—just be sure to turn mechanics (where the buttons and crank handle is inserted) are on the opposite end of the surgical procedure

Replacement Parts: 
Schure Spine Frame Crank Handle  800-0277
Schure Spine Frame Pad Set  508-0472
Disposable Laminectomy Arm Cradles, 12 pr/cs  508-0373 
Disposable Richards Slotted Headrests, Extended, 6/cs   508-1340
Schure Spine Frame Straps   512-0049

• General - Prevent infection by cleaning and disinfecting product before disposal
• Packaging - Dispose packaging material via household waste according to national requirements
• SchureMed accepts back used or retired products - or dispose of product in accordance with national requirements

PRODUCT USE WARNINGS
WARNING!
Maximum load should not exceed appropriate proportion of a patient weighing 500 lbs. (227 kg). Use care with low-maximum load capacity surgical tables that accessory rails are not overloaded. 

WARNING!
Hazard resulting from incorrect use. Strictly follow Instructions for Use with your surgical table system.

CLEANING RECOMMENDATION
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedure.


WARNING!
Adhere to standards for blood-borne pathogens from Occupational Safety and Health Administration (OSHA). Use recommended protective clothing, gloves, masks and eye protection to clean accessory.

1. Remove major contaminants from accessory with disposable materials. Follow appropriate bio-hazard waste disposal procedures.
2. Apply cleaning fluid liberally to entire accessory and wipe with clean, lint-free cloth until all moisture and cleaning fluid is removed from accessory
3. Let accessory dry

USER NOTICE
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

IFU-800-0235  REV 3.07

Basic UDI-DI: 081001460F0030DR

Latest Revision: 9/15/2021