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Elbow Surgical Positioner 800-0275
Device Initial Release: 4/15/2018
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
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.
Attaching ELBOW SURGICAL POSITIONER to Table
Instructions for Use of the ELBOW SURGICAL POSITIONER
- Attach clamp over drape
- Insert 790-0011 into clamp and tighten handle to lock into place
- Loosen handle and insert 790-0013 into 790-0011. Adjust to desired height and lock handle tight.
- Loosen the handle (not visible) and pull the plunger to slide 790-0014 into 790-0013. Rotate 790-0014 to desired position, lock handle and release plunger.
- Insert 790-0015 into appropriate slot for desired position, listen for click
Removing ELBOW SURGICAL POSITIONER
- Insert 790-0339 into the appropriate slot of 790-0015. The plunger will pop into place.
- Loosen the handle to allow rotation of the arm. When arm has reached desired position tighten handle.
- For traction turn the knob right to tighten and left to loosen
- Pull plunger to remove arm from device. Unwrap arm.
- Release plunger to remove traction system (790-0015)
- Pull plunger and loosen handle to release (790-0014)
- Loosen handle to remove pole (790-0013)
- Loosen clamp and remove (790-0011)
Device Dimensions (maximum)
Intended use is to provide traction and intra-operative positioning controlled by the surgeons preference, during supine elbow surgery.
- Length: 33” +/- 0.5” (84 cm +/- 1 cm) (extended), 9” +/- 0.5” (23 cm +/- 1 cm) (collapsed)
- Depth: 360° Rotation
- Height: 81” +/- 0.5” (206 cm +/- 1 cm) (extended), 31”+/- 0.5” (79 cm +/- 1 cm) (collapsed)
- Device Weight: 9.50 +/- 0.5 lbs. (4.3 +/- .22 kg)
- Attaches to the rail of a surgical table using the CamLoc Rail Clamp (sold separately) where there are no notches
- Single-person installation
Elbow Surgical Positioner is a device used during supine elbow surgery. Its function is to provide traction and intraoperative positioning controlled by the surgeons preference, during supine elbow surgery. Required CamLoc Rail Clamp (sold separately).
- US: 0.374” x 1.122” (9.5 mm x 28.5 mm) PN# 800-0271
- Denyer: 0.236” x 1.496” (6 mm x 38 mm) PN# 800-0271-DEN
- Europe: 0.394” x 0.984” (10 mm x 25 mm ) PN# 800-0271-EU
- Eschmann (UK): 0.236” x 1.260” (6 mm x 32 mm) PN# 800-0271-UK
- Japan: 0.354” x 1.260” (9 mm x 32 mm ) PN# 800-0271-JPN
- Swiss: 0.394” x 1.181” (10 mm x 30 mm ) PN# 800-0271-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
- 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. Strictly follow instructions for use for your Operating Table system.
Hazards result from incorrect use. Strictly follow instructions for use with your Operating Table system.
ELBOW SURGICAL POSITIONER is used to support the arm of the patient. No other additional forces may act on the Elbow Surgical Positioner.
CLEANING AND STERILIZATION INSTRUCTIONS
- Clean the Elbow Surgical Positioner thoroughly before using (before sterilization) and after each use
- Recommended cleaning products: (All solutions should be used in accordance with manufacturer’s instructions)
- Enzymatic neutral pH detergent solution (Enzymatic cleaners are compatible with metal devices/instruments and are preferred)
- Non-enzyme, hydrogen peroxide based solution
- Coverage Plus NPD One Step Cleaner, Disinfectant & Deodorizer Concentrate
- Disassemble Elbow Surgical Positioner into separate parts for cleaning:
- CamLoc Rail Clamp
- Scrub each piece with a soft, plastic scrub brush and a recommended cleaning solution (see above)
- Rinse all parts thoroughly to remove any chemical residue
- Wipe each part completely dry with a clean, lint-free cloth
- Prepare for sterilization (device must be cleaned before sterilization)
- See sterilization instructions below
*Based on information provided by the Healthcare Infection Control Practices Advisory Committee (HICPAC), the Center for Disease Control (CDC), the National Center for Biotechnology Information (NCBI) and the U.S. National Library of Medicine.
Exposure Time at 132°C (270°F): 4 minutes
Drying Time: 40 minutes
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-800-0275 REV 3.02
To View Available Translations
Go to schuremed.com, select product, scroll down and click on “Instructions for Use”.
Basic UDI-DI: 081005737F0019L2
Latest Revision: 7/28/2021