Download IFU pdf
Copyright Notice
All rights reserved. Any duplication, adaption or translation without prior written consent is prohibited unless otherwise provided in relevant copyright laws.
Lithotomy Stirrups 800-0049
Replacement Pads
Platinum Stirrup Boot Pads, Set 508-1415
Device Initial Release: 3/10/2007
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
INSTRUCTIONS FOR USE
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.
Attaching Stirrups to Surgical Table
- Attach Schure Socket Clamps (sold separately) onto table side rails.
- Insert Lithotomy Stirrup mounting posts into clamps. Turn Schure Socket handle clockwise to tighten.
- Put patient’s legs into boots and fasten with loop and hook straps.
Adjusting Stirrups
- Turn boot block handles counterclockwise to loosen boot blocks. Adjust up or down to desired position. Turn boot block handle clockwise to tighten.
Detaching Stirrups from Table
- Turn Schure Socket handle counterclockwise to loosen and pull stirrup from socket
INTENDED USE
Intended use is to hold patient’s legs during short or long gynecologic, urological or laparoscopic procedures.
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
- Length 39” +/- 0.5” (99 cm +/- 1 cm)
- Width: 6” +/- 0.5” (15 cm +/- 1 cm)
- Depth: 2.5” +/- 0.5” (6 cm +/- 1 cm) (with pad)
- Device Weight Per Stirrup: 7.5 +/- 0.5 lbs. (3.4 +/- .22 kg)
- Attaches to rail of surgical table at any point on the rail
- Single-person installation
- Push Release Trigger
COMPONENT OVERVIEW
Lithotomy Stirrups are a surgical table accessory that aids in positioning of legs for gynecological, urological, or laparoscopic procedures.
Other required products for use:
800-0006 Schure Socket, 2 each (sold separately)
US: 0.374” x 1.122” (9.5 mm x 28.5 mm) PN# 800-0006
Denyer: 0.236” x 1.496” (6 mm x 38 mm) PN# 800-0006 -DEN
Europe: 0.394” x 0.984” (10 mm x 25 mm ) PN# 800-0006 -EU
Eschmann (UK): 0.236” x 1.260” (6 mm x 32 mm) PN# 800-0006-UK
Japan: 0.354” x 1.260” (9 mm x 32 mm ) PN# 800-0006-JPN
Swiss: 0.394” x 1.181” (10 mm x 30 mm ) PN# 800-0006-SWISS
Replacement Pads
508-1415 Platinum Stirrup Boot Pads, Set
GENERAL INFORMATION
- Product not made with (NRL) Natural Rubber Latex
- Device supports 350 lb. (159 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
- Product is maintenance-free, check product condition before next use
- 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 350 lbs. (159 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 Use with your Operating Table system.
WARNING!
Surgical table load capacities may be less. Never overload a surgical table. Device is intended for mounting on side of surgical table rail 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. 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-800-0049 REV 3.04
Basic UDI-DI: 081001460F0060E2
Latest Revision: 9/15/2021