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Arthroscopic Leg Holder 800-0023
Disposable Premium Pads 508-0103
Device Initial Release: 2/02/2005
452 Randolph Street, Abington, MA 02351 USA
Toll Free ( 888 ) 724-8763 | Ph (781) 982-7000 | Fax (781) 982-7001 | email@example.com
Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands
NSTRUCTIONS FOR USE
Attaching Arthroscopic Leg Holder to Surgical Table
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.
- Place 5/8” (1.6 cm) mounting post into Schure Socket XL P/N 800-0134 (sold separately) on either side of the table. Turn the handle clockwise to tighten.
- To adjust braces, undo hook and loop fastener straps. Pull spring-loaded pins up and slide braces along support bar to desired position. Release spring-loaded pins and braces lock into place.
- Open braces with pad directly over support bar, placing patient’s leg on pad. Slide braces right or left for perfect positioning. Slip strap through loop, pull back, and close the leg holder.
Device Dimensions (maximum)
Intended use is to hold leg and immobilize thigh during surgery.
- Length: 4 3/4” +/- 0.5” (12 cm +/- 1 cm)
- Width: 5” +/- 0.5” (13 cm +/- 1 cm)
- Depth: 2 1/4” +/- 0.5” (6 cm +/- 1 cm)
- Device Weight: 2 +/- 0.5 lbs. (.9 +/- .22 kg)
- Attaches to rail of a surgical room table anywhere on rail
- Single-person installation
Arthroscopic Leg Holder is a surgical table accessory used in arthroscopic surgery. Schure Socket XL (sold separately) is required to attach arthroscopic leg holder to surgical table.
See side rail dimensions below:
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
Disposable Premium Pads 508-0103
- 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
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.
Hazards result from incorrect use. Strictly follow instructions for use with your Operating Table system.
Strictly read/follow manufacturer’s directions for cleaning fluids. DO NOT use cleaners containing phenolics.
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedures.
Adhere to standards for blood-borne pathogens from Occupational Safety and Health Administration (OSHA). Use recommended protective clothing, gloves, masks and eye protection to clean accessory.
- 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-800-0023 REV 3.04
Basic UDI-DI: 081001460F0047EA
Latest Revision: 9/15/2021