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Shoulder Supports 800-0100
Shoulder Supports Pad 508-0117
All rights reserved. Any duplication, adaption or translation without prior written consent is prohibited unless otherwise provided in relevant copyright laws.
Device Initial Release: 3/8/2007
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
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.
- Attach Schure Socket XL clamps (sold separately) on table side rails at top of back/torso section of surgical table (as shown)
**CAUTION Do not place sockets on head section side rails
- Insert mounting rods into clamps and tighten mounting handles
- Shoulder support should be positioned on Acronion Process (boney prominence) of shoulder (away from soft tissue by the Brachial Plexus) and leave 1/2" gap and secure support by tightening locking handle
- Position table in Trendelenburg and allow patient to gently slide into pads
**CHECK TO MAKE SURE PATIENT IS SECURELY HELD
Device Dimensions (maximum)
Intended use is to provide comfortable support for trendelenburg positioning.
- Length: 22” +/- 0.5” (56 cm +/- 1 cm)
- Width: 7” +/- 0.5” (18 cm +/- 1 cm)
- Depth: 8” +/- 0.5” (20 cm +/- 1 cm)
- Device Weight: 4 +/- 0.5 lbs. (1.8 +/- .22 kg)
- Attaches to surgical table anywhere on the rail
- Twist Lock/Release Handle
Shoulder Supports are a surgical table accessory that provides comfortable support for trendelenburg positioning.
Replacement Pad (sold individually)
508-0117 Shoulder Supports Pad, Rectangle 9" x 4" x 2" (23 cm x 10 cm x 5 cm) Deluxe with Velcro Kit
Other required product for use:
(2) 800-0134 Schure Socket XL (sold separately)
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
- 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.
Hazard resulting 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 the Occupational Safety and Health Administration. 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-800-0100 REV 3.04
Basic UDI-DI: 081001460F0067EG
Latest Revision: 9/15/2021