AMATECH F-63500 Shoulder Supports with Pads Instruction Manual
- June 6, 2024
- AMATECH
Table of Contents
AMATECH F-63500 Shoulder Supports with Pads
INSTRUCTIONS FOR USE
IMPORTANT NOTICES
Read and understand all warnings in this manual and on the device itself prior to use with a patient.
- The techniques detailed in this manual are only manufacturer’s suggestions. The final responsibility for patient care with respect to this device remains with the attending physician.
- Device function should be checked prior to each usage.
- This device should only be operated by trained personnel.
- All modifications, upgrades, or repairs must be performed by an authorized specialist.
- Keep this manual available for future reference.
- Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority listed in this document.
General Information
AMATECH Corporation is a subsidiary of Allen Medical Systems, Inc. which is a subsidiary of Hill-Rom, Inc. (NYSE: HRC), a leading worldwide manufacturer and provider of medical technologies and related services for the health care industry. As an industry leader in patient positioning, our passion is improving patient outcomes and caregiver safety, while enhancing our customers’ efficiency. Our inspiration comes from providing innovative solutions to address our customers’ most pressing needs. We immerse ourselves in our customers’ world, to better address these needs and the daily challenges of their environment. Whether developing a solution to address patient positioning challenges or creating a system to offer safe and effective surgical site access for the surgical team, we are committed to providing products of exceptional value and quality.
Copyright Notice:
Revision
© 2019 Allen Medical Systems Inc. ALL RIGHTS RESERVED.
No part of this text shall be reproduced or transmitted in any form or by any
means, electronic or mechanical, including photocopying, recording, or by any
information or retrieval system without written permission from Allen Medical
Systems, Inc. (Allen Medical).
The information in this manual is confidential and may not be disclosed to
third parties without the prior written consent of Allen Medical.
Trademarks:
Trademark information can be found in www.allenmedical.com/pages/terms-
conditions.
Product may be covered by one or more patents. Please consult listing at www
.hill-rom.com/patents for any patent(s).
Contact Details:
For complains or ordering information, please contact your supplier and refer
to the catalog. All modifications, upgrades, or repairs must be performed by
an authorized specialist.
Safety Considerations:
Safety hazard symbol notice:
WARNING:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE AND MATERIAL DEGRADATION.
Equipment misuse notice:
Do not use product if package is damaged or unintentionally opened before use.
All modifications, upgrades, or repairs must be performed by an authorized
specialist.
Notice to users and/or patients:
Any serious incident that has occurred in relation to the device should be
reported using the contact details provided in section 1.3 of this Instruction
for Use and to the competent authority of the Member State in which the user
and/or patient is established.
Note: Refer to the surgical table manufacturer’s user guide for
instructions on use. Always refer to the surgical table manufacturer’s weight
limits.
WARNING:
NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE
Safe disposal:
Customers should adhere to all federal, state, regional, and/or local laws and regulations as it pertains to the safe disposal of medical devices and accessories. If in doubt, the users of the device shall first contact their supplier for guidance on safe disposal protocols.
Operating the system:
Applicable Symbols:
Intended User and Patient Population:
Intended User:
Surgeons, Nurses, Doctors, Physicians and OR healthcare professionals involved
in the device intended procedure. Not intended for Lay persons.
Intended Populations:
This device is intended to be used with patients that do not exceed the weight
in the safe working load field specified in the product specification section
4.2
EMC considerations:
This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.
EC authorized representative:
EC REP HILL-ROM SAS
B.P. 14 – Z.I. DU TALHOUET 56330 PLUVIGNER FRANCE
TEL: +33 (0)2 97 50 92 12
Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC. 100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
System
System components Identification
Product Code and Description:
F-63500 – SHOULDER SUPPORTS WITH PADS
List of Accessories and Consumable Components Table:
The following list are accessories and components that may be used with this device.
Note:
Consult the corresponding IFU for the products mentioned in the above table.
Indication for use:
The Shoulder Support is used in a variety of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and robotic surgery during steep trendelenburg position. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Intended use:
The Shoulder Support is used in a variety of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and robotic surgery during steep trendelenburg position. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Equipment Setup and Use
Prior to use
- a. Inspect the product looking for any visible damage or sharp edges that could be caused by a drop or impact during storage.
- b. Make sure product has been properly cleaned and disinfected and wiped dry prior to each use.
Setup:
-
Attach each shoulder support to the OR rail and position the patient on the OR table. (Figure 2).
-
Using a combination of the Lateral Adjustment Knob and the Standard Blade Rail Clamp, adjust the supports so that they rest in the lateral aspect of the
shoulder (Figure 3).
The ‘C’ shape of the Pad should contour the anatomy such that it rests on the posterior lateral spine of scapula, the lateral acomion and the anterior lateral clavicle (the acomio-clavicular joint).
-
The “C-Shaped” Shoulder Pad should rest lightly against the patient and there should be no compression of the Pad at this time. This also helps in securing the correct position of the pad on the patient before proceeding to the Trendelenburg position. (Figure 3).
-
Check the placement of the “C-Shaped” Shoulder Pads and then place the patient in Trendelenburg as required. (Figure 7).
TRENDELENBERG POSITIONING:
0° Trendelenburg:
The “C-Shaped” Shoulder Pads are just resting lightly against the patient’s body landmarks as described earlier. (Figure 5)
10° Trendelenburg:
The patient has pressed into the “C-Shaped” Shoulder Pads slightly. The Pads have begun to conform laterally to the patient’s anatomy. (Figure 6) 30° Trendelenburg:
The patient has fully pressed into the “C-Shaped” Shoulder Pads. The Pads have externally rotated, as intended, to conform to the patient’s anatomy and prohibit further sliding. (Figure 7) Device controls and indicators:
Storage, Handling and Removal Instructions:
Storage and Handling:
The product should be stored in a clean and safe environment to prevent product damage. See storage Specifications under Product Specification section.
Removal Instruction:
- a. Safely remove the patient from the OR table
- b. Loosen the blade rail clamp and remove the shoulder support.
Troubleshooting Guide:
This device does not have a troubleshooting guide. For technical support user of the device shall first contact his or her supplier.
Device Maintenance:
Make sure that all labels are installed and can be read. Replace labels as necessary by using a plastic scraper to remove the label. Use an alcohol wipe to remove any adhesive residue.
Contact Allen Medical Systems, Inc. if you need to repair or replace the device contact us using the information from the contact details section (1.3).
Safety Precautions and General Information
General Safety Warnings and Cautions:
WARNING:
- a. Do not use if product shows visible damage.
- b. Prior to using this device, please read the instructions for equipment set up and use. Familiarize yourself with the product before application on a patient.
- c. To prevent patient and/or user injury and/or equipment damage, examine the device and surgical-table side rails for potential damage or wear prior to use. Do not use the device if damage is visible, if parts are missing or if it does not function as expected.
CAUTION:
Do not exceed safe working load shown in the product specification table
Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above
table.
Sterilization Instruction:
This device is not intended to be sterilized. Equipment damage may occur.
Cleaning and Disinfection Instruction:
WARNING:
- Do not use bleach or products that contain bleach to clean the device. Injury or equipment damage can occur.
- After each use, clean the device with alcohol-based wipes.
- Do not put the device into water. Equipment damage can occur.
- Use a cloth and a quaternary ammonium disinfecting/cleaning solution to clean and disinfect the device.
- Read and follow the manufacturer’s recommendation for low-level disinfection.
- Read and follow the cleaning product’s instructions. Use caution in areas where liquid can get into the mechanism.
- Wipe the device with a clean, dry cloth.
- Make sure that the device is dry before you store it or use it again.
CAUTION: DO NOT IMMERSE PADS IN ANY LIQUID
CAUTION: DO NOT USE BLEACH OR PHENOLICS ON PADS
List of Applicable Standards
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