Great White Robotic Stirrups

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  Great White Robotic Stirrups    800-0342-R
  Great White Robotic Stirrups with Fins   800-0342-RF

Replacement Pads
Premium Stirrup Boot Pads, Set   508-1354
Platinum Stirrup Boot Pads, Set    508-1415

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 & 4) 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 

GENERAL SPECIFICATIONS
Device Dimensions (maximum)

• Height: 35.25” +/- 0.5” (90 cm +/- 1 cm)
• Width: 9” +/- 0.5” (23 cm +/- 1 cm)
• Depth: 14” +/-  0.5” (36 cm +/- 1 cm)
• Device Weight Per Stirrup: 10 +/-  0.5 lbs. (4.5 +/- .22 kg) (with pad)
• Range of Motion: 60° to -55° lithotomy range, -9° to 25° adduction to abduction
• Single-person installation
• Connects to seat section of surgical table
• Store stirrups on transport/storage dolly (P/N 800-0074-R sold separately)

COMPONENT OVERVIEW
Great White Robotic Stirrups and Great White Robotic Stirrups with Fins provide a safe system for positioning the legs up to 600 lb. (272 kg) patients in a variety of lithotomy/abduction positions.

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

Replacement Pads
508-1415   Platinum Stirrup Boot Pads, Set
508-1354   Premium Stirrup Boot Pads, Set

• Product not made with (NRL) Natural Rubber Latex
• Device supports 600 lb. (272 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
• Life of device is 5 years under normal use
• Store device between -4°F to +86°F (-20°C to 30°C)

• 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 600 lbs. (272 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 your Operating Table system.

WARNING! 
Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.

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

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-800-0342-R-RF  REV 3.06

  Basic UDI-DI: 081001460F0040DU

Latest Revision: 2022-01

eIFU Language Versions
To download and print the Instructions for Use, please click here.

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