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Table Width Extension, 11 x 8 (28 cm x 20 cm) 800-0081
Table Width Extension, 11 x 8 (EU) (28 cm x 20 cm) 800-0081-EU
Table Width Extension Pad, 11 x 8 (28 cm x 20 cm) 508-0132
Intended use is to extend width of surgical table. The intended users of this device are medical professionals within hospitals and surgery centers.
INSTRUCTIONS FOR USE
Attaching 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 from Surgical Table
- Attach Simple Clamp P/N 800-0228 (sold separately) onto side rail
- Insert mounting post into clamp
- Turn handle clockwise to tighten clamp
- Turn clamp handle counterclockwise to loosen
- Remove from clamp
Table Width Extensions are surgical table extensions that attach to surgical table side rails.
Replacement Pad: Table Width Extension Pad, 11 x 8 (28 cm x 20 cm) 508-0132
Other required product for use:
Device Dimensions (maximum)
800-0228 Simple Clamp (sold separately)
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
- Length: 11”+/- 0.5” (28 cm +/- 1 cm)
- Width: 8”+/-0.5” (20 cm +/- 1 cm)
- Depth: 8”+/-0.5” (20 cm +/- 1 cm)
- Device Weight: 4 lbs. +/- 0.5 lbs. (1.8 kg +/- .22 kg)
- Single-person installation
- Product not made with (NRL) Natural Rubber Latex
- Device supports 500 lb. (227 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
WARNING! Maximum load should not exceed appropriate proportion of a patient weighing 500 lbs. (227 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 surgical table system.
Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.
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-800-0077_0079_ 0081 REV 3.08
Basic UDI-DI: 081005737F0003KK
Latest Revision: 2022-01
eIFU Language Versions
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