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Bariatric Foot Extension, 36 x 18 800-0326
Bariatric Foot Extension Pad 508-1371
All rights reserved. Any duplication, adaption or translation without prior written consent is prohibited unless otherwise provided in relevant copyright laws.
Device Initial Release: 2/15/2021
452 Randolph Street, Abington, MA 02351 USA
Toll Free ( 888 ) 724-8763 | Ph (781) 982-7000 | Fax (781) 982-7001 | firstname.lastname@example.org
Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands
INSTRUCTIONS FOR USE
Attaching Bariatric Foot Extension to Surgical Table
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.
Detaching Bariatric Foot Extension from Surgical Table
- Attach Simple Clamps P/N 800-0228 (sold separately) onto side rails
- Insert mounting posts into Simple Clamps on both sides of tables
- Turn handle clockwise to tighten clamps
- Turn simple clamp handle counterclockwise to loosen foot extension
- Lift foot extension from operating room table and store properly
Bariatric Foot Extension mounts horizontally as table extension or vertically as foot support when using reverse Trendelenburg.
Device Dimensions (maximum)
- Length: 18” +/- 0.5” (46 cm +/- 1 cm)
- Width: 36” +/- 0.5” (91 cm +/- 1 cm)
- Depth: 3.75” +/- 0.5” (10 cm +/- 1 cm) (with pad)
- Device Weight: 15.25 +/- 0.5 lbs. (6.9 kg +/- .22 kg)
- Attaches to rail of surgical table at foot section
- Single-person installation
Bariatric Foot Extension is operating room table extension or used as foot support. Simple Clamp (sold separately) required for proper use of Foot Extension.
See side rail dimensions below:
US: 0.374” x 1.122” (9.5 mm x 28.5 mm) PN# 800-0228
Denyer: 0.236” x 1.496” (6 mm x 38 mm) PN# 800-0228-DEN
Europe: 0.394” x 0.984” (10 mm x 25 mm ) PN# 800-0228-EU
Eschmann (UK): 0.236” x 1.260” (6 mm x 32 mm) PN# 800-0228-UK
Japan: 0.354” x 1.260” (9 mm x 32 mm ) PN# 800-0228-JPN
Swiss: 0.394” x 1.181” (10 mm x 30 mm ) PN# 800-0228-SWISS
- Product not made with (NRL) 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
- 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)
- 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
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.
Hazards result from incorrect use. Strictly follow Instructions for Use with your Operating Table system.
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedures.
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
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-800-0326 REV 3.02
Basic UDI-DI: 081001460F0074ED
Latest Revision: 9/15/2021