Hillrom A-70825 Foam Block Stand Instruction Manual

: October 30, 2023
: Hillrom

Table of Contents

Hillrom A-70825 Foam Block Stand
Product Information
Product Usage Instructions
IMPORTANT NOTICES
General Information
- Operating the system
System
Equipment Setup and Use
Safety Precautions and General Information
- Product Specifications
List of Applicable Standards
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Hillrom A-70825 Foam Block Stand

Hillrom-A-70825-Foam-Block-Stand-product

Product Information

Foam Block Stand

The Foam Block Stand, represented by product number A-70825, is a medical apparatus used in surgical procedures. It is recommendedthat users read the instructions for use and familiarize themselves with the product before use. The product comes with safety hazard symbols that indicate when the Instructions for Use should bereferenced. The product is manufactured by Allen Medical Systems, Inc.

Allen products are known for their reliable service and complimentary onsite product demonstrations. The information in theuser manual is confidential and may not be disclosed to third parties without prior written consent from Allen Medical.

It is important to note that the product may be covered by one or more patents. Customers should consult the listing atHill-rom.com/patents for any patent(s).

For ordering information, please refer to the catalog. AllenCustomer Service Contact Information can be found below:

North America: (800) 433-5774 or (978) 263-8846
International: +1 978 266 4200 ext.4286 or +1 978 266 4426

It is crucial to adhere to all federal, state, regional, and/or local laws and regulations regarding the safe disposal of medicaldevices and accessories. If in doubt, users should first contact Hill-Rom Technical Support for guidance on safe disposal protocols.

Product Usage Instructions

Prior to using the Foam Block Stand, ensure that it shows no visible damage or material degradation. Do not use the product ifthe package is damaged or unintentionally opened before use. All modifications, upgrades, or repairs must be performed by an
authorized specialist.

Refer to the surgical table manufacturer’s user guide for instructions on use, and always refer to the surgical tablemanufacturer’s weight limits. It is essential to never exceed the weight capacity of the operating room table.

Any serious incident that occurs in relation to the device should be reported to the manufacturer and the competent authorityof the Member State in which the user and/or patient is established.

IMPORTANT NOTICES

Prior to using this or any other type of medical apparatus with a patient, it is recommended that you read the Instructions for Use and familiarize yourself with the product.

Read and understand all warnings in this manual and on the device itself prior to use with a patient.
The symbol is intended to alert the user to important procedures or safety instructions regarding the use of this device.
The symbol on the labels is intended to show when the IFU should be referenced for use.
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

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:

North America

(800) 433-5774
(978) 263-8846

International

+1 978 266 4200 ext.4286
+1 978 266 4426

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:

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:

Baxter Medical Systems GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany

Authorised Australian sponsor:

Welch Allyn Australia Pty. Ltd.
1 Baxter Drive
Old Toongabbie, NSW 2146
Australia

System

System components Identification

TOP

BOTTOM

Product Code and Description:
A-70825 – Allen Foam Block Stand

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
Not Applicable	Not Applicable
Name of Consumable	Product Number
---	---
Allen Foam Head Blocks	A-70862

Note: Consult the corresponding IFU for the products mentioned in the above table.
CAUTION: Reuse of disposables will lead to patient cross contamination and/or device failure.

Indication for use:
The Foam Block Stand is used in a variety of surgical procedures including, but not limited to spine surgery and/or surgery that requires prone positioning. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

Intended use:
The Foam Block Stand is designed to position and support the patient’s head in a variety of surgical procedures including, but not limited to spine surgery and/or surgery that requires prone positioning. These devices are intended to be used by healthcare professionals within the Operating Room setting.

Residual Risk:
This product complies with relevant performance, safety standards. However, patient harm from misuse, device or function hazards cannot be completely excluded.

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.
c. Ensure enough room or Foam Block Stand to be fully supported by flat surface.

Shown on OR Table Surface

Setup:

a. Place Foam Block Stand on head end of OR Table.
Note: Ensure face cutout is in correct orientation.
b. Make sure Foam Head Block Stand is centered.
c. Place Foam Head Block onto Foam Head Block Stand.
Note: Ensure cutout on Foam Head Block and Foam Head Block Stand match.
d. Ensure Foam Head Block is fully supported by Foam Block Stand.
Ensure patient’s eyes are free from any contact and chin is adequately supported.
The final responsibility for patient care with respect to this device remains with the attending physician.

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. See storage Specifications under Product Specification section.

Removal Instruction:

a. Gently remove patient’s head from Foam Block.
b. Remove and dispose Foam Block.
c. Pick up Foam Block Stand, and store it as indicated in the Storage instructions.

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

Mechanical Specifications	Description
Product Dimensions	9 ½” [242 mm] W x 10 ½” [267 mm] L

x 3” [76 mm] H

Material| ALUMINUM
Safe Working Load on the device| 500 lbs. (226 kg)
Overall Weight of Complete Device| Approx. 2 lbs. (0.9 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 Allen Foam Block Stand is

compatible with:

| Any flat surface (OR Table, Supine Tops,

etc.) which is rated for patient weight.

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.