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Multi-Axis Arm Positioner 800-0050
Replacement Pad
Multi-Axis Arm Positioner Concave Pad 508-0108
INTENDED USE
Multi-Axis Arm Positioner provides support for non-operative arm during surgical procedures. The intended users of this device are medical professionals within hospitals and surgery centers.
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.
Set Up and Use of Multi-Axis Arm Positioner onto Surgical Table
- Attach Schure Socket XL P/N 800-0134 (sold separately) onto side rail
- Insert mounting post into Schure Socket XL
- Turn handle clockwise to loosely tighten Schure Socket XL
- Loosen Positioning Handle, move to desired position
- Adjust Schure Socket XL to position in lateral, prone, neuro and park bench positions
- Tighten and lock Positioning Handle and Schure Socket XL
Detaching Multi-Axis Arm Positioner from Surgical Table
- Turn clamp handle counterclockwise to loosen
- Remove from clamp
GENERAL SPECIFICATIONS
- Maximum Height: 21” +/- 0.5” (53 cm +/- 1 cm)
- Minimum Height: 7.5” +/- 0.5” (19 cm +/- 1 cm)
- Armboard Length: 16” +/- 0.5” (41 cm +/- 1 cm)
- Armboard Width: 6” +/- 0.5” (15 cm +/- 1 cm)
- Maximum Pad Depth: 2.25" +/- 0.5” (6 cm +/- 1 cm)
- Middle of Pad Depth: 1.5" +/- 0.5” (4 cm +/- 1 cm)
- Net weight: 5.1 lbs. +/- 0.5 lbs. (2.3 +/- .22 kg)
- Gross Weight: 8.2 lbs. +/- 0.5 lbs. (3.7 +/- .22 kg)
- Single-person installation
COMPONENT OVERVIEW
Multi-Axis Arm Positioner is a surgical table accessory providing support for non-operative arm during surgical procedures. Device attaches to surgical table rail with clamp, and used in seated, lateral, prone, neuro and park bench positions. Unique pivoting design allows for infinite positioning.
Replacement Pad
508-0108 Multi-Axis Arm Positioner Concave Pad, 16" x 6" x 2" (41 cm x 15 cm x 5 cm)
Other required products for use:
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
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 500 lbs. (227 kg). Use care with low-maximum load capacity surgical tables that accessory rails are not overloaded.
WARNING!
Hazards result from incorrect use. Strictly follow Instructions for Use with 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 (AORN) Journal Guidelines for proper cleaning and disinfection procedure.
WARNING!
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.
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-800-0050 REV 3.07
Basic UDI-DI: 081001460F0038E9
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