Great White Premium Stirrups

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Great White Premium Stirrups   800-0342-PR
Great White Premium Stirrups with Fins   800-0342-PRF
&
Replacement Boot Pads without Fins   508-1354
Replacement Boot Pads with Fins   508-1415

Initial Release: 4/4/14

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

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

1. Attach SpringLoc Clamps P/N 800-0338 on accessory rails in same location on opposite sides of surgical table at patient’s hip joints.
2. Prior to placing device into SpringLoc Clamp, identify patient’s left and right side stirrup indicated on boot label.
   
   
   
3. Insert stirrup blades into clamps. Tighten clamps by turning handle to the right.
   
   
   
4. Ensure patient is positioned on surgical table in accordance with procedure and surgeon requirements.
   WARNING!! To prevent patient or operator injury from inadvertent stirrup movement, securely tighten accessory clamp and boot clamp.
   
   
   (1 & 3) Free Floating Boot Pivot, (2) Boot Clamp, (3) Trigger Handle
   
   
5. Support patient’s leg by grasping heel in one hand and underside of knee with other hand. Gently flex knees and transfer leg into boot, then secure boot straps.

6. To achieve appropriate leg/foot position, loosen boot clamp. Adjust boot to desired position and re-tighten clamp. Ensure patient’s heels are securely seated in boot heels.

7. To achieve appropriate lithotomy and abduction positions, squeeze trigger, adjust to desired position and release to lock.
   
   Note: Free-floating boot is designed to rotate about pivot shown above through-out the full range of motion, reducing risk of superficial nerve injury.

1. Loosen clamps and remove stirrups by lifting them out of clamps
2. Remove accessory clamps from side rails 

INTENDED USE
Great White Premium Stirrups are a patient positioning accessory used in gynecology, urology, and laparoscopic procedures. They provide a safe system for positioning the legs up to 400 lb. patients in a variety of lithotomy/abduction positions.

• Height: 40.25” +/- 0.5”
• Width: 9” +/- 0.5”
• Depth: 14” +/-  0.5”
• Device Weight:  11 +/-  0.5 lbs.  (with pad)
• Range of Motion: -25° to 75° lithotomy range, -9° to 25° adduction to abduction
• Single-person installation
• Connects to seat section of surgical table
• Stirrups store on transport/storage dolly (P/N 800-0074-S sold separately)

COMPONENT OVERVIEW
Great White Premium Stirrups and Great White Premium Stirrups with Fins provide a safe system for positioning the legs up to 400 lb. patients in a variety of lithotomy/abduction positions.

Other required products for use:
800-0338   SpringLoc Clamp (US)
800-0338-EU  SpringLoc Clamp (EU)
800-0338-JPN  SpringLoc Clamp (JPN)
800-0338-SWISS   SpringLoc Clamp (SWISS)

Replacement Pads:
508-1354  Replacement Boot Pads without Fins   
508-1415  Replacement Boot Pads with Fins   

• Product not made with (NRL) Natural Rubber Latex
• Device supports 400 lb. proportional patient load (6'4" 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.
• Life of device is 5 years under normal use
• Store device between  –4°F to +86°F

• 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!
Product should not exceed maximum load 400 lb. patient. Restrictions result from the permissible overall load, among other things, of accessory rails when using operating tables with a low maximum load capacity. Strictly follow instructions for your Operating Table system.

WARNING!
Hazard resulting from incorrect use. Strictly follow instructions for your Operating Table system.

WARNING!
Surgical table load capacities may be less. Never overload a surgical table. The device is intended for mounting on the side of a rail of a surgical table only.

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 the 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 

Symbol Explanation

  Date of Manufacture

  Manufacturer

 Authorized Representative in European Community

  Conformity Mark

  Batch Code/Serial Number

IFU-800-0342-PR-PRF  REV 3.00