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SCHURE FOOT FOR TOTAL KNEE REPLACEMENT,
RADIOLUCENT LEXAN 800-0011
DISPOSABLE FOOT PADS 12/CASE 508-0111
Initial Release 12/29/2004
452 Randolph Street, Abington, MA 02351 USA
Toll Free (888) 724-8763 | Ph (781) 982-7000
Fax (781) 982-7001 | firstname.lastname@example.org
INSTRUCTIONS FOR USE
Authorized Manufacturer: Emergo Europe Prinsessegracht 20
2514 AP The Hague, The Netherlands
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.
Set Up and Use of the Schure Foot
- Attach socket to the operating room table side rail near the end of the torso section, on the side of the operative knee
- Slide black disposable foot pad #508-0111 (sold separately) onto the Schure Foot tube.
- Insert Schure Foot mounting post into the socket
- Once the patient is on the operating room table, slide the Schure Foot along the rail to achieve the desired position for the knee
- Turn the socket handle clockwise to secure the Schure Foot in the desired position.
- Prep and drape in the usual method
- After the procedure is complete, discard the Schure Foot disposable foot pad. Spray the Schure Foot and wipe clean with hospital approved disinfectant.
Device Dimensions (maximum)
The intended use is to hold the patient’s foot firmly in place during knee replacement surgery.
- Length: 16” +/- 0.5”
- Diameter: 2” +/- 0.5” (with pad 2 3/4”)
- Device Weight: 2 +/- 0.5 lbs
- Operates on leg section of the surgical table
- Requires a socket to attach to the surgical table
Overview of Components
The SCHURE FOOT, STAINLESS STEEL is a knee positioning device which is used in knee replacement surgery.
508-0111 Disposable Foot Pads 12/cs
Other required products for use: 800-0134 Schure Socket XL
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 1.118” (10 mm x 30 mm ) PN# 800-0134-SWISS
- Product not made with (NRL) Natural Rubber Latex
- Device supports 500 lb proportional patient load (6'4" 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.
- 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
- 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
The maximum load placed on the product may not exceed the appropriate proportion of a patient weighing 500 lbs. Restrictions result from the permissible overall load, among other things, of accessory rails when using operating tables with a low maximum load capacity. Be absolutely sure to follow the instructions for use for your Operating Table system.
Hazard resulting from incorrect use. Be absolutely sure to follow the instructions for use for your Operating Table system.
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedure.
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.
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