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Great White Maxima Stirrups 800-0342-M
Replacement Pads
Bariatric Stirrup Boot Pads, Set 508-1502
INTENDED USE
The Great White Maxima 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 800 lb. (363 kg) patients in a variety of lithotomy/abduction positions. The intended users of this device are medical professionals within hospitals and surgery centers.
INSTRUCTIONS
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.
SET-UP
- 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.
- Prior to placing the device into the SpringLoc Clamp, identify the patient’s left and right side stirrup indicated on the boot label.
- Insert stirrup blades into the clamps. Tighten the clamp by turning the handle to the right.
- 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.
(1 & 4) Free Floating Boot Pivot, (2) Boot Clamp, (3) Trigger Handle
- 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.
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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.
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To achieve the appropriate lithotomy and abduction positions, squeeze the 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 the risk of superficial nerve injury.
TAKE DOWN
- Loosen the clamps and remove the stirrups by lifting them out of the clamps
- Remove the accessory clamps from the side rails.
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
- Height: 40.5” +/- 0.5” (102 cm +/- 1 cm)
- Width: 12” +/- 0.5” (31 cm +/- 1 cm)
- Depth: 18” +/- 0.5” (46 cm +/- 1 cm)
- Device Weight Per Stirrup: 12 +/- 0.5 lbs. (5.4 +/- .22 kg) (with pad)
- Range of Motion: -30° to 75° 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-S sold separately)
COMPONENT OVERVIEW
The Great White Maxima Stirrups provide a safe system for positioning the legs of up to 800 lb. (363 kg) 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
508-1502 Bariatric Stirrup Boot Pads, Set
GENERAL INFORMATION
- Product not made with (NRL) Natural Rubber Latex
- Device supports 800 lb. (363 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)
DISPOSAL
- 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 800 lbs. (363 kg). Use care with low-maximum load capacity surgical tables that accessory rails are not overloaded.
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.
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.
CAUTION
Strictly read/follow manufacturer’s directions for cleaning fluids. DO NOT use cleaners containing phenolics.
- Remove major contaminants from accessory with disposable materials. Follow appropriate bio-hazard waste disposal procedures.
- Apply cleaning fluid liberally to entire accessory and wipe with clean, lint-free cloth until all moisture and cleaning fluid is removed from accessory
- 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-M REV 3.03
Basic UDI-DI: 081001460F0040DU
Latest Revision: 2022-01
eIFU Language Versions
To download and print the Instructions for Use, please click here.
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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