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Pediatric Lithotomy Stirrups - PUPS 800-0233
Pediatric Lithotomy Stirrups - KIDS 800-0234
Replacement Pads
PUPS Boot Pads 508-1295
KIDS Boot Pads 508-1296
Device Initial Release: 5/1/2013
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 features of patient positioning device before use with patient. Always practice use on a nurse, physician or appropriate volunteer prior to using clinically.
(Schure Socket XL shown incorrectly in photo – Schure Socket is correct clamp)
Attaching PUPS and KIDS Pediatric Lithotomy Stirrups to Surgical Table
- Put PUPS and KIDS Pediatric Lithotomy Stirrups mounting posts into Schure Sockets (sold separately) and turn Schure Socket handles clockwise to tighten.
- Put patient’s legs into boots and fasten with hook and loop fastener straps.
Adjusting PUPS and KIDS Pediatric Lithotomy Stirrups
- Turn boot block handles counterclockwise to loosen and adjust up or down to desired position. Turn boot block handles clockwise to tighten.
Detaching PUPS and KIDS Pediatric Lithotomy Stirrups from Surgical Table
- Turn Schure Socket handles counterclockwise to loosen and pull stirrups from sockets.
INTENDED USE
Intended use is to hold patient’s legs during short or long gynecologic, urological and laparoscopic procedures.
GENERAL SPECIFICATIONS:
Device Dimensions (maximum)
- Length: 26.5” +/- 0.5” (67 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: 5.25 +/- 0.5 lbs. (2.3 +/- .22 kg)
- Attaches to surgical table rail at any point on rail
- Single-person installation
COMPONENT OVERVIEW
PUPS and KIDS Pediatric Lithotomy Stirrups are a surgical table accessory that aids in positioning of legs for gynecological, urological and laparoscopic procedures.
Other required products for use:
800-0006 Schure Socket, 2 each (sold separately)
See side rail dimensions below:
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 1.118” (10 mm x 30 mm) PN# 800-0006-SWISS
Replacement Pads
508-1295 PUPS Boot Pads
508-1296 KIDS Boot Pads
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!
Hazards result from incorrect use. Strictly follow Instructions for Use with your Operating Table system.
CLEANING RECOMMENDATION
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedures.
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-800-0233_0234 REV 3.04
Basic UDI-DI: 081001460F0013DR
Latest Revision: 9/15/2021