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.
Candy Cane Stirrups 800-0012
Replacement Accessory:
Candy Cane Stirrup Strap 790-0006
Device Initial Release: 7/11/2004
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 candy cane stirrup mounting post into Schure Socket XL P/N 800-0134 (sold separately), turning handle of Schure Socket XL clockwise to tighten.
- Guide patient’s leg into ankle stirrup
Adjusting Stirrup
- Stainless Steel Candy Cane Stirrups adjust vertically from 28” to 44” (71 cm to 112 cm) with an 8“ (20 cm) leg clearance. Loosen handle to adjust to desired position.
- Lock stirrup height by twisting ergonomic handle
Detaching Stirrup from Table
- Turn handle of Schure Socket XL counter clockwise to loosen and remove 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: 44” +/- .5” (112 cm +/- 1 cm)
- Extended: 28” +/- .5” (71 cm +/- 1 cm) Collapsed
- Width: 17” +/- .5” (43 cm +/- 1 cm)
- Depth: 10.5” +/- .5” (27 cm +/- 1 cm)
- Device Weight Per Stirrup: 5 +/- 0.5 lbs. (2.2 +/- .22 kg) per stirrup
- Connects to side rails of a surgical table
- Single-person installation
- Stirrup has 5/8” (1.6 cm) mounting post which attaches with Schure Socket XL P/N 800-0134 (sold separately)
- Ankle Strap: 18”L x 2”W (46 cm +/- 5 cm)
- Replacement Ankle Strap P/N 790-0006 (sold separately as an each)
COMPONENT OVERVIEW
The Candy Cane Stirrup is an operating room table accessory that aids in the positioning of the legs for gynecological, urological, or laparoscopic procedures.
Replacement Accessory
790-0006 Candy Cane Stirrup Strap
Other required products for use: 800-0134 Schure Socket XL, 2 each (sold separately)
US: 0.374” x 1.122” (9.5 mm x 28.5 mm) PN# 800-0134
Denyer: 0.236” x 1.496” (6 mm x 38 mm) PN# 800-0134-DEN
Europe: 0.394” x 0.984” (10 mm x 25 mm) PN# 800-0134-EU
Eschmann (UK): 0.236” x 1.260” (6 mm x 32 mm) PN# 800-0134-UK
Japan: 0.354” x 1.260” (9 mm x 32 mm) PN# 800-0134-JPN
Swiss: 0.394” x 1.181” (10 mm x 30 mm) PN# 800-0134-SWISS
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 for your Operating Table system.
WARNING!
Surgical table load capacities may be less. Never overload surgical table. Device is intended for mounting on side rail of 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-800-0012 REV 3.05
Basic UDI-DI: 081001460F0031DT
Latest Revision: 9/15/2021