SchureMed 800-0342-M Great White Robotic Stirrups Instructions
- June 11, 2024
- SchureMed
Table of Contents
SchureMed 800-0342-M Great White Robotic Stirrups Instructions
Great White Maxima Stirrups 800-0342-M
Replacement Pads
Bariatric Stirrup Boot Pads, Set 508-1502
INTENDED USE
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.
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)
INTENDED USE
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.
GENERAL INFORMATION
- Product not made with 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
- 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)
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.
TAKE DOWN
- Loosen clamps and remove stirrups by lifting them out of clamps
- Remove accessory clamps from side rails
COMPONENT OVERVIEW
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.
Replacement Pads 508-1502 Bariatric Stirrup Boot Pads, Set
Other required products for use:
- 800-0338 SpringLoc Clamp
- 800-0338-EU SpringLoc Clamp
- 800-0338-JPN SpringLoc Clamp
- 800-0338-SWISS SpringLoc Clamp
DISPOSAL
- General – Prevent infection by cleaning and disinfecting product before disposal
- Packaging – Dispose packaging material via household waste according to national requirements
- Schure Med 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. Device is intended for mounting on side of a rail of a surgical table only.
CLEANING RECOMMENDATION
Follow current Association of peri Operative Registered Nurses Journal
Guidelines for proper cleaning and disinfection procedure.
WARNING!
Adhere to standards for blood-borne pathogens from the Occupational Safety and
Health Administration. 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.
Basic UDI-DI: 081001460F0040DU
Symbol Glossary
Manufacturer
SchureMed (081001460)
IFU-800-0342-M REV 3.03
Latest Revision: 2022-01
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