Lateral Shoulder Holder

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  Lateral Shoulder Holder   800-0169

Required Disposables
Disposable Hand/Forearm Wraps, Sterile, 10/cs   800-0281-F

Sub-Assembly Identification

  
(1) 790-0061  •  (2) 790-0011  •  (3) 790-0013

  
(4) 790-0014  •  (5) 790-0015  •  (6) 800-0281-F

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 Lateral Shoulder Holder to Surgical Table

1. Attach CamLoc Clamp (sold separately) over drape along surgical table side rail where there are no notches. Note: CamLoc locks to rail from the bottom. Clamp cannot be attached where there is a notch on side rail – it will not be secured or locked.
2. Insert 790-0011 into clamp and tighten handle to lock into place
3. Loosen lever and insert 790-0013 into 790-0011. Adjust to desired height and lock lever tight.
4. Loosen handle and pull plunger to slide 790-0014 into 790-0013. Rotate 790-0014 to desired position, lock handle and release plunger.
5. Insert 790-0015 into appropriate slot for desired position, listen for click

Placing and Securing the Patients Arm
With the Disposable Hand/Forearm Wraps, Sterile  (800-0281-F)

1. Place patient arm into Forearm Pad, ensuring patient’s fingers wrap around Forearm Attachment Handle and wrap pad snugly around patient's arm. See Figures 1-2.
2. Using self-adherent wrap, secure patients arm to forearm attachment by wrapping entire assembly. Be sure to secure hands and fingers with wrap. See Figures 3-4.

Instructions for Use of the Lateral Shoulder Holder

1. Insert 790-0061 into appropriate slot of 790-0015. The plunger will pop into place.
2. Loosen handle to allow rotation of arm. Tighten handle when arm has reached desired position.
3. For traction turn knob right to tighten and left to loosen

1. Pull plunger to remove arm from device. Unwrap arm.
2. Release plunger to remove traction system (790-0015)
3. Pull plunger and loosen handle to release (790-0014)
4. Loosen lever to remove pole (790-0013)
5. Loosen clamp and remove (790-0011)
6. Follow cleaning and sterilization instructions below

• Length: 30” +/- 0.5” (76 cm +/- 1 cm) (extended), 9” +/- 0.5” (23 cm +/- 1 cm) (collapsed)
• Range of Motion: 360° Rotation      
• Height: 48” +/-  0.5” (122 cm +/- 1 cm) (extended), 29”+/- 0.5” (74 cm +/- 1 cm) (collapsed) 
• Net Weight with Clamp: 13.8 +/- 0.5 lbs. (6.3 +/- .22 kg)
• Net Weight without Clamp: 12.5 +/- 0.5 lbs. (5.6 +/- .22 kg)
• Gross Weight: 19.5 +/- 0.5 lbs. (8.8 +/- .22 kg)
• Single-person installation

COMPONENT OVERVIEW
Lateral Shoulder Holder is a device used during shoulder surgery. Its function is to provide traction and rotation of the operative shoulder controlled by the surgeons preference, during shoulder surgery.

A CamLoc Rail Clamp (sold separately) is required to attach Lateral Shoulder Holder to surgical table and Disposable Hand/Forearm Wrap that attaches the patient limb to the Lateral Shoulder Holder.

• 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
• 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
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!
Property damage!
Lateral Shoulder Holder is used to support the arm of the patient. No other additional forces, may act on the Lateral Shoulder Holder.

WARNING! 
Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.

• Clean TKR 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 TKR Positioner into separate parts for cleaning:
  - Boot Ball 
  - Mounting Plate with Clamp 
  - Base Plate with Track 
  - Slide Block with Handle

• 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

• Put through washer/decontaminator according to manufacturer’s instruction (Select cycle that does not included lubrication)
• 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.

Pre-Vacuum 
Wrapped Instruments 
Exposure Time at 132°C (270°F): 4 minutes 
Drying Time: 40 minutes

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-800-0169  REV 3.05

  Basic UDI-DI: 081001460F0078EM

Latest Revision: 2022-01

eIFU Language Versions
To download and print the Instructions for Use, please click here.

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