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Schure Grip Arthroscopic Leg Holder 800-0065
Replacement Pads
Disposable Premium Pads 508-0103
INTENDED USE
Intended use is to hold leg and immobilize thigh during surgery. The intended users of this device are medical professionals within hospitals and surgery centers.
INSTRUCTIONS FOR USE
Become familiar with patient positioning device’s features before use with patient. Always practice on a nurse, physician or appropriate volunteer prior to using clinically.
Attaching Schure Grip Arthroscopic Leg Holder to Surgical Table
- To install onto surgical table, place 5/8” (1.6 cm) mounting post into Schure Socket XL on either side of table, to desired position. Turn handle right to tighten and left to loosen.
- Dual braces rotate 360° and spread horizontally up to 11”W (28 cm) fitting any size leg
- To adjust braces, undo hook & loop fastener strap, slide braces along support bar to desired position and turn handles to tighten. Spread braces from bottom, not the top
- Wrap pad around patient’s leg. Open braces, place wrapped leg onto the support bar and slide braces right or left for perfect positioning. Pull strap tight and close leg holder.
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
- Length: 12.5” +/- 0.5” (32 cm +/- 1 cm)
- Width: 9.5” +/- 0.5” (24 cm +/- 1 cm)
- Depth: 2” +/- 0.5” (5 cm +/- 1 cm) (rail handle extended)
- Device Weight: 8 +/- 0.5 lbs. (3.6 +/- .22 kg)
- Requires a socket to attach to surgical table
- Single-person installation
- Twist Lock/Release Handle
- Holds accessory equipment up to 5/8” (1.6 cm) diameter mounting post
COMPONENT OVERVIEW
Schure Grip 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” (6mm x 32mm) PN# 800-0134-UK
Japan: 0.354” x 1.260” (9 mm x 32mm) PN# 800-0134-JPN
Swiss: 0.394” x 1.181” (10mm x 30mm) PN# 800-0134-SWISS
Replacement Pads
508-0103 Disposable Premium Pads, 12/cs
GENERAL INFORMATION
- 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)
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 226.7 kg (500 lbs.). 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 for your Operating Table system.
WARNING!
Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.
CLEANING RECOMMENDATION
Follow current Association of periOperative Registered Nurses Journal Guidelines for proper cleaning and disinfection procedures.
WARNING!
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedure.
WARNING!
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.
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-800-0065 REV 3.06
Basic UDI-DI: 081001460F0064EA
Latest Revision: 2022-01
eIFU Language Versions
To download and print the Instructions for Use, please click here.
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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