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Great White Premium Stirrups 800-0342-PR
Great White Premium Stirrups with Fins 800-0342-PRF
Replacement Pads
Premium Stirrup Boot Pads, Set 508-1354
Platinum Stirrup Boot Pads, Set 508-1415
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. (181 kg) patients in a variety of lithotomy/abduction positions. The intended users of this device are medical professionals within hospitals and surgery centers.
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.
SET-UP
- Attach SpringLoc Clamps P/N 800-0338 on accessory rails in same location on opposite sides of surgical table at patient’s hip joints.
- Prior to placing device into SpringLoc Clamp, identify patient’s left and right side stirrup indicated on boot label.
- Insert stirrup blades into clamps. Tighten clamps by turning handle to the right.
- 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
- 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.
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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.
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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.
TAKE DOWN
- Loosen clamps and remove stirrups by lifting them out of clamps
- Remove accessory clamps from side rails
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
- 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)
- Device Weight: 11 +/- 0.5 lbs. (5 +/- .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
Great White Premium Stirrups and Great White Premium Stirrups with Fins provide a safe system for positioning the legs up to 400 lb. (181 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:
508-1354 Premium Stirrup Boot Pads, Set
508-1415 Platinum Stirrup Boot Pads, Set
GENERAL INFORMATION
- Product not made with (NRL) Natural Rubber Latex
- Device supports 400 lb. (181 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!
Product should not exceed maximum load 400 lb. (181 kg) 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!
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-PR-PRF REV 3.07
Basic UDI-DI: 081001460F0040DU
Latest Revision: 2022-01
eIFU Language Versions
To download and print the Instructions for Use, please click here.
Symbol Glossary
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