Great White HD 1000 Stirrup Boot System

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  Great White HD 1000 Stirrup Boot System    800-0364

Replacement Boots & Pads
Premium Stirrup Boots & Pads    800-0364-BS
Platinum Stirrup Boots & Pads    800-0364-BM
Bariatric Stirrup Boots & Pads    800-0364-BL

Replacement Pads Only
Premium Stirrup Boot Pads, Set   508-1354
Platinum Stirrup Boot Pads, Set   508-1415
Bariatric Stirrup Boot Pads, Set   508-1502

INTENDED USE
The Great White HD 1000 Stirrups are a patient positioning accessory used in gynecology, urology, and laparoscopic  procedures. They provide a safe system for positioning the legs of up to 1,000 lb. (454 kg) patients in a variety of lithotomy/abduction positions. The interchangeable boots allow the user to perform different procedures without switching the stirrup. The intended users of this device are medical professionals within hospitals and surgery centers.

INSTRUCTIONS: SET-UP
Become familiar with the features of patient positioning device before use with a patient. Always practice use on a nurse, physician or appropriate volunteer prior to using clinically.

1. Attach SpringLoc Clamps P/N 800-0338 on the accessory rails in the same location on opposite sides of the surgical table at the patient’s hip joints
   
2. Prior to placing the device into the SpringLoc Clamp, identify the patient’s left and right side of the stirrup indicated on the shaft of the boot connector
   
   
   
   
3. Insert stirrup blades into the clamps. Tighten the clamp by turning the handle to the right.
   
   
   
   
4. Ensure the patient is positioned on the surgical table in accordance with the procedure and surgeon requirements
   
   
   WARNING!! To prevent patient or operator injury from inadvertent stirrup movement, securely tighten the accessory clamp and the boot clamp.
   
   
5. Select the appropriate boot for the procedures. The label on the boot will identify the left or right boot, insert the boot into the connector (label on Step 2 will identify the appropriate connector) 
   
     
   
   
6. Support the patient’s leg by grasping the heel in one hand and the underside of the knee with the other hand. Gently flex the knees and transfer the leg into the boot, then secure boot straps.
   
   
   
   
7. To achieve the appropriate leg/foot position, loosen the boot clamp. Adjust the boot to desired position and re-tighten this clamp. Ensure the patient’s heels are securely seated in the heels of the boots.
8.  To achieve the appropriate lithotomy and abduction positions, squeeze the trigger, adjust to desired position and release to lock

1. Boot Clamp – 2. Trigger Handle – 3. Free-Floating Boot Pivot

Note: Free-floating boot is designed to rotate about pivot shown above through-out the full range of motion, reducing the risk of superficial nerve injury.

1.  Remove boot by pulling and holding the plunger with one hand, using your  other hand support the bottom of the boot once supported lift the boot until the plug is free from the connection. Repeat procedure to remove the other boot.
2. Loosen the SpringLoc Clamp and remove the stirrups by lifting them out of the clamps
3. Remove the accessory clamps from the side rails 

• Height: 40.25” +/- 0.5” (102 cm +/- 1 cm)
• Width: 9” +/- 0.5” (23 cm +/- 1 cm)
• Depth: 14” +/-  0.5” (36 cm +/- 1 cm)
• Connects to the seat section of the surgical table 
• Range of Motion: -25° to 75° lithotomy range, -9° to 25° adduction to abduction
• Single-person installation 
• Device Weight Per Stirrup:
  14.7 +/-  0.5 lbs. (6.7 +/- .22 kg) (with Maxima pads) 
  14 +/-  0.5 lbs.  (6 +/- .22 kg) (with Platinum pads) 
  13.7 +/-  0.5 lbs.  (6.2 +/- .22 kg) (with Premium pads) 
  10.5 +/-  0.5 lbs.  (5 +/- .22 kg) (without Boot) 
• Store stirrups on transport/storage dolly (P/N 800-0074-S sold separately) 

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 Boots & Pads
Premium Stirrup Boots & Pads    800-0364-BS
Platinum Stirrup Boots & Pads    800-0364-BM
Bariatric Stirrup Boots & Pads    800-0364-BL

Replacement Pads Only
Premium Stirrup Boot Pads, Set   508-1354
Platinum Stirrup Boot Pads, Set   508-1415
Bariatric Stirrup Boot Pads, Set   508-1502

• This product is not made with (NRL) Natural Rubber Latex   
• This device supports a 1,000 lb. (454 kg) proportional patient load (6'4" (193 cm) tall patient per 99% human body model)
• Product warranty covers the product from manufacturing defects for a period of 2 years
• If damaged in shipping, please call Customer Service at (888) 724-8763 or (781) 982-7000 to obtain a Return Material Authorization (RMA) number. For product warranty issues also contact Customer Service.
• CE marked medical device according to MDR (EU) 2017/745
• Life of device is 5 years under normal use
• Storage of device shall be between -4°F to +86°F (-20°C to 30°C)

• General - Used products or parts may be contaminated. To prevent potential infection, please clean and disinfect the product prior to disposing
• Packaging - Packaging material can be disposed of via household waste in accordance with national requirement
• SchureMed will take back used product or no longer in service. Product can also be disposed in accordance with national requirement

WARNING! Maximum load should not exceed appropriate proportion of a patient weighing 1,000 lbs. (454 kg). Use care with low-maximum load capacity surgical tables that accessory rails are not overloaded. Strictly follow instructions for use for your Operating Table system.

WARNING! Hazards result from incorrect use. Strictly follow instructions for use with 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.

WARNING! You should always practice on a nurse, physician or a volunteer prior to use clinically.

WARNING!
Improper cleaning and disinfection can cause property damage! Perform visual and functional inspections after each cleaning and disinfection process.

MAINTENANCE
There is no specific maintenance required. Please check stirrups before every procedures to ensure it is operating as designed. 

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-800-0364  REV 3.06

 Basic UDI-DI: 081001460F0075EF

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