Hillrom A-70270 Contour Breast Positioners Instructions

Hillrom A-70270 Contour Breast Positioners Instructions & troubleshooting

Hillrom A-70270 Contour Breast Positioners Instructions  & troubleshooting 1

Hillrom A-70270 Contour Breast Positioners

Hillrom A-70270 Contour Breast Positioners Instructions  & troubleshooting 2
INSTRUCTIONS FOR USE

General Information:

Allen Medical Systems, Inc. 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. Allen products are backed by responsive and reliable service and complimentary on-site product demonstrations.

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 at Allenmedical.com/pages/terms-conditions.Products may be covered by one or more patents. Please consult listing at Hill-rom.com/patents for any patent(s).

Contact Details:

  • For ordering information please see catalog.
  • Allen Customer Service Contact Information: Hillrom A-70270 Contour Breast Positioners Instructions  & troubleshooting 3

Safety Considerations:

Safety hazard symbol notice:

DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL DEGRADATION. 

Equipment misuse notice: 

Do not use the 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 to the manufacturer and 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.

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 user of the device shall first contact Hill-Rom Technical Support for guidance on safe disposal protocols.

Operating the system:

Applicable Symbols: Hillrom A-70270 Contour Breast Positioners Instructions  & troubleshooting 4Hillrom A-70270 Contour Breast Positioners Instructions  & troubleshooting 5

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

Compliance with medical device regulations: 

This Product is a non-invasive, Class I Medical Device. This system is CE-marked according to Annex VIII, Rule 1, of the Medical Device Regulations (REGULATION (EU) 2017/745)

EMC considerations:

This is not an electromechanical device. Therefore, EMC Declarations are not applicable.

EC authorized representative:

  • 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)

EU Importer Information:

  • TRUMPF Medizin Systeme GmbH + Co. KG
  • Carl-Zeiss Straße 7-9
  • 07318 Saalfeld/Saale
  • Germany

Australian sponsor Information:

  • Welch Allyn Australia Pty. Ltd.
  • Unit 4.01, 2-4 Lyonpark Road
  • Macquarie Park, NSW 2113
  • Phone 1800 650 083

System

System components Identification:Hillrom A-70270 Contour Breast Positioners Instructions  & troubleshooting 6

Product Code and Description:

A-90002 – LPS Arm Support

List of Accessories and Consumable Components Table:

The following list are accessories and components that may be used with this device.

Name of Accessory Product Number
 

Accessory Cart

A-30010 (US Rail), A-30010E (EU Rail), A-30010UK (UK Rail), A-30010J (Japan

Rail)

Name of Consumable Product Number
Not Applicable Not Applicable

Note: Consult the corresponding IFU for the products mentioned in the above table.

Indication for use:

The Arm Support is used in a variety of surgical procedures including, but not limited to spine and shoulder surgery that requires supine, prone and/or beach chair positioning. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

Intended use:

The Arm Support is designed to position and support the patient’s arm in a variety of surgical procedures including, but not limited to spine and shoulder surgery that requires supine, prone and/or beach chair positioning. These devices are intended to be used by healthcare professionals within the Operating Room setting.

Equipment Setup and Use:

Prior to use:

  • Inspect the product looking for any visible damage or sharp edges that could be caused by a drop or impact during storage.
  • Make sure product has been properly cleaned and disinfected and wiped dry prior to each use.

Setup:

  • Attach device to frame with indicated side forward (towards head of patient). Secure device by firmly pressing on latch as shown.Hillrom A-70270 Contour Breast Positioners Instructions  & troubleshooting 7
  • Adjust Pads by unlocking adjustment levers and moving pads as required. Upper lever locks and unlocks rotational adjustment. Lower lever locks and unlocks width adjustment. Pads should generally be used as shown with all pads centered and touching unless patient anatomy requires different configuration.Hillrom A-70270 Contour Breast Positioners Instructions  & troubleshooting 8

INSTRUCTIONS FOR USE Hillrom A-70270 Contour Breast Positioners Instructions  & troubleshooting 9

  • Attach disposable cover (A-70271) after pads have been positioned and locked. Flaps should face forward, and foam material should be face up. Secure adhesive tabs as indicated. Avoid attaching tabs directly to pads.
  • Transfer patient onto device so that breasts fall over edge of device as shown. Breasts should fall naturally, without being subjected to excessive forces.
  • While supporting breast, wrap outer flap first, then wrap inner flap and secure using adhesive tab. Smaller breasts may not require flap support.

Device controls and indicators:
Controls and indicators of this device are described within the Setup instructions.

 Storage, Handling and Removal Instructions:

Storage and Handling:
The product should be stored in a clean and safe environment to prevent product damage.Hillrom A-70270 Contour Breast Positioners Instructions  & troubleshooting 10

Removal Instruction: 

Removal is the reverse of installation.

DO NOT leave the Hug-U-Vac valve closed with suction still applied in between procedures or in storage. Leaving the suction connected will lead to collapsing and damage of the internal beads and thus, greatly reduce the life of the product.

Troubleshooting Guide:

This device does not have a troubleshooting guide. For technical support user of the device shall first contact Hill-Rom Technical Support.

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: 

  • Do not use if product shows visible damage.
  • 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.
  • 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.
  • It is recommended that this positioner be is used in conjunction with a rigid lateral support in order to prevent patient injury or death in the event the product loses vacuum.
  • Always ensure product is properly and securely fastened to the operating table prior to use.
  • Secure positioners straps only to the operating table’s accessory rails.
  • Never secure positioners straps to table width extenders or any secondary accessory rails.
  • Always ensure the vacuum valves are securely closed and locked, and that the positioner maintains vacuum prior to draping the patient or beginning any surgical procedure.
  • Do not exceed the maximum patient weight limit or width as specified by the manufacturer.
  • Not for use with K-Thermal heating pads or similar.
  • nce the desired form is obtained around the patient, DO NOT leave suction applied to the device. Close the Hug-U-Vac valve and stop suction during the procedure. After the procedure is completed, release the Hug-U-Vac valve and allow air to return into the device.
  • Do not leave the Hug-U-Vac valve closed with suction still applied in between procedures or in storage. Leaving the suction connected will lead to collapsing and damage of the internal beads and thus, greatly reduce the life of he product.
  • Never exceed the weight capacity of the OR table.
  • Always lock valve close and remove suction tube.

CAUTION: 

  • To prevent patient and/or user injury and/or equipment damage: all modifications, upgrades, or repairs must be performed by an Allen authorized specialist. Failure to comply may void warranty.
  • Do not exceed safe working load shown in the product specification table.

Product Specifications:

Mechanical Specifications Description
 

 

 

Product Dimensions

Support Rod (or post):

·         Long section: 50.8 cm (20”)

·         Short Section: 20.3 cm (8”)

·         Smaller post connected to armboard: 18 cm (7”)

Armboard length: 30.5 cm (12”)

Armboard width: 9.2 cm (3.6)

Material Stainless Steel, Nylon, Aluminum, Bronze, Engineering polymers
Safe Working Load on the device 500 lbs. (226 kg)
Overall Weight of Complete Device <44 lbs. (<20 kg)
Storage Specifications Description
Storage temperature -29ᵒ C to +60ᵒ C
Storage Relative humidity range 15% to 85%
Operating temperature This device is intended to be used in a

controlled Operating Room environment.

Operating Relative humidity range
Electrical Specifications Description
Not Applicable. Not Applicable.
Software Specifications Description
Not Applicable. Not Applicable.
Compatibility Specifications Description
The LPS Arm support is compatible with: Easy Lock Socket or equivalent clamp.

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

Sl. no Standards Description
 

1.

 

EN 62366-1

Medical devices – Part 1: Application of usability engineering to medical devices
Sl. no Standards Description
 

2.

 

EN ISO 14971

Medical devices- Application of risk management to medical devices.
 

3.

 

EN 1041

Information supplied by the manufacturer of medical devices
 

4.

 

EN ISO 15223-1

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
 

5.

 

EN ISO 10993-1

Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
 

6.

 

IEC 60601-2-46

Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
 

7.

 

ISTA

International Safe Transit Association standards for package testing

FAQ


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