Ultra Comfort Prone Supports Instructions for Use Ver C March 2020

INSTRUCTIONS FOR USE ENGLISH ... 3 中文简体 ... 24 ČESKÝ ... 45 DANSK ... 66 NEDERLANDS ... 87 SUOMI ... 108 FRANÇAIS ... 131 DEUTSCH... 154 ΕΛΛΗΝΙΚΑ ... 175 MAGYAR ... 197 ITALIANO ... 219 LATVISKI ... 240 NORSK ... 261 POLSKI ... 282 PORTUGUÊS... 303 ROMÂNESC... 324 SRPSKI ... 346 SLOVENSKY ... 368 SLOVENŠČINA ... 390 ESPAÑOL ... 412 SVENSKA ... 434

Document Number: 80028187 Version: C

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Issue Date: 16 MAR 2020 Ref Blank Template: 80025117 Ver. F

INSTRUCTIONS FOR USE 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.

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Read and understand all warnings in this manual and on the device itself prior to use with a patient.

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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.

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• • • • •

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.

Document Number: 80028187 Version: C

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INSTRUCTIONS FOR USE

Table of Contents Allen Ultra Comfort Prone Supports (A-71301, A- 71303, A-71305, A-71307, A-71309, A-71311, A-71312, A-71316) 1

General Information: ... 6 1.1 Copyright Notice: ... 6 1.2 Trademarks:... 6 1.3 Contact Details: ... 7 1.4 Safety Considerations:... 7 1.4.1 Safety hazard symbol notice: ... 7 1.4.2 Equipment misuse notice:... 7 1.4.3 Notice to users and/or patients: ... 7 1.4.4 Safe disposal: ... 8 1.5 Operating the system: ... 8 1.5.1 Applicable Symbols: ... 8 1.5.2 Intended User and Patient Population: ... 9 1.5.3 Compliance with medical device regulations: . Error! Bookmark not defined. 1.6 EMC considerations: ... 9 1.7 EC authorized representative: ... 9 1.8 Manufacturing Information: ... 10 1.9 EU Importer Information: ... 10 1.10 Australian sponsor Information: ... 10

2

System ... 11 2.1 System components Identification: ... 11 2.2 Product Code and Description:... 13 2.3 List of Accessories and Consumable Components Table:... 13 2.4 Indication for use: ... 14 2.5 Intended use:... 14 2.6 Residual Risk: ... 14

3

Equipment Setup and Use:... 14 3.1 Prior to use: ... 14 3.2 Setup: ... 15 3.3 Device controls and indicators: ... 17

Document Number: 80028187 Version: C

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INSTRUCTIONS FOR USE 3.4 Storage, Handling and Removal Instructions:... 19 3.4.1 Storage and Handling: ...19 3.4.2 Removal Instruction:...19 3.5 Troubleshooting Guide: ... 19 3.6 Device Maintenance: ... 19 4

Safety Precautions and General Information:... 19 4.1 General Safety Warnings and Cautions: ... 19 4.2 Product Specifications: ... 20 4.3 Sterilization Instruction: ... 21 4.4 Cleaning and Disinfection Instruction: ... 21

5

List of Applicable Standards: ... 22

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INSTRUCTIONS FOR USE 1

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 onsite product demonstrations.

1.1 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.

1.2 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).

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INSTRUCTIONS FOR USE 1.3 Contact Details: For ordering information please see catalog. Allen Customer Service Contact Information:

International

North America (800) 433-5774

+1 978 266 4200 ext.4286

(978) 263-8846

+1 978 266 4426

1.4 Safety Considerations: 1.4.1

Safety hazard symbol notice: DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL DEGRADATION.

1.4.2

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. 1.4.3

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

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INSTRUCTIONS FOR USE 1.4.4

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.

1.5 Operating the system: 1.5.1

Applicable Symbols:

Symbol used

Description Indicates the device is a medical device

MDR 2017/745

Indicates the medical device manufacturer

EN ISO 15223-1

Indicates the manufacturer’s serial number. The device serial number is encoded as 1YYWWSSSSSSS.  YY indicates the year of manufacture. i.e. 118WWSSSSSSS where 18 represents the year 2018.  WW indicates the number of the manufacturing week per a standard shop calendar. (Leading zeros included.)  SSSSSSS is a sequential unique number.

EN ISO 15223-1

Indicates the medical device Global Trade Item Number

21 CFR 830 MDR 2017/745

Indicates the date when the medical device was manufactured

EN ISO 15223-1

Indicates the manufacturer’s catalogue number

EN ISO 15223-1

Document Number: 80028187 Version: C

Reference

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INSTRUCTIONS FOR USE

1.5.2

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions.

EN ISO 15223-1

Indicates the device do not contain natural rubber or dry natural rubber latex

EN ISO 15223-1

Indicates the authorized representative in the European Community

EN ISO 15223-1

Indicates the Medical Device complies to REGULATION (EU) 2017/745

MDR 2017/745

Indicates a Warning

IEC 60601-1

Indicates the need for the user to consult the instruction for use

EN ISO 15223-1

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

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

1.7 EC authorized representative: HILL-ROM SAS B.P. 14 - Z.I. DU TALHOUET Document Number: 80028187 Version: C

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INSTRUCTIONS FOR USE 56330 PLUVIGNER FRANCE TEL: +33 (0)2 97 50 92 12

1.8 Manufacturing Information: ALLEN MEDICAL SYSTEMS, INC. 100 DISCOVERY WAY ACTON, MA 01720 US 800-433-5774 (NORTH AMERICA) 978-266-4200 (INTERNATIONAL) 1.9

EU Importer Information: TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss Straße 7-9 07318 Saalfeld/Saale Germany

1.10 Australian sponsor Information: Welch Allyn Australia Pty. Ltd. Unit 4.01, 2-4 Lyonpark Road Macquarie Park, NSW 2113 Phone 1800 650 083

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INSTRUCTIONS FOR USE 2 2.1

System System components Identification: Advance Chest Support Chest

Pad

Support Base Label & Serial Number (Underside of Support)

Straps (2 Per Side)

Rubber strips are optional. If removed chest pad will slide more freely along carbon fiber rails.

Head Plate Support Base

Serial Number (Underside of Support)

Straps (1 Each Side)

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INSTRUCTIONS FOR USE Advance Hip and Thigh Supports Pad

Pad Vent

Support Base

Product Label

Lock Indicator Lock Lever

Leg Sling Leg Sling

Product Number

Straps & Buckles

Document Number: 80028187 Version: C

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INSTRUCTIONS FOR USE 2.2 Product Code and Description: A-71301 - Allen Advance Chest Support w/pad A- 71303 - Allen Advance Hip Support-SM w/pad A-71305 - Allen Advance Hip Support – MED w/pad A-71307 - Allen Advance Hip Support – LG w/pad A-71309 - Advance Thigh Support w/pad – left A-71311 - Allen Advance Thigh Support w/pad – right A-71312 - Allen Advance Sling Support A-71316 - Advance Head Plate

2.3 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

Advance Pillow - Queen

A-71313

Advance Pillow - Standard

A-71314

Name of Consumable

Product number

Foam Head Block

A-70862

Small Ultra Comfort Covers

A-71261

Large Ultra Comfort Covers

A-71263

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.

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INSTRUCTIONS FOR USE 2.4 Indication for use: The Advance Support is used in a variety of surgical procedures including, but not limited to spine surgery in prone position. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

2.5 Intended use: The Advance Support is designed to position and support the patient’s chest in a variety of surgical procedures including, but not limited to spine surgery in prone position. These devices are intended to be used by healthcare professionals within the Operating Room setting.

2.6 Residual Risk: This product complies with relevant performance, safety standards. However, patient harm from misuse hazard cannot be completely excluded.

3

Equipment Setup and Use:

3.1 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. Select the proper sized hip pad for the patient. d. Ensure both a left and right thigh pad are available for use.

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INSTRUCTIONS FOR USE 3.2 Setup:

1. Place the Allen Ultra Comfort™ hip and thigh pads on the rail top in the orientation shown. Product labels denote proper location of the pads. 2. Place the Allen Ultra Comfort™ chest pad on the rail top and secure hook and loop straps. Be sure the pad is installed in the correct orientation (as shown). 3. Place Allen Head Plate on rails ahead of chest pad and secure with supplied hook and loop. 4. Adjust the supports up or down the table to the desired location of the patient.

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INSTRUCTIONS FOR USE 5. On hip and thigh pads: Rotate the lock lever towards the inside of the rails and slide from red to green to lock. Be sure to lock both hip and both thigh pads.

6. Place the leg sling over the rails and attach the male and female ends of each of the corresponding straps. a. Pull the free end of the strap to adjust (tighten) the sling to the desired location. b. Lift up on the male end of the buckle and pull to adjust (loosen) the sling to the desired location. c. Secure Velcro loop around the strap to keep the end from hanging free.

NEVER EXCEED THE WEIGHT CAPACITY OF THE O.R. TABLE

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INSTRUCTIONS FOR USE 7. Install Allen Ultra Comfort Covers over prone support pads to reduce shear and friction and to absorb moisture. 8. Transfer the patient onto the Ultra Comfort Prone Supports. Position the patient to reduce nerve contact and subsequent injury. Additional support must be provided to the head and arms. a. If desired, supine tops may be used in place of the leg sling to support the patient’s legs. b. b) After transferring the patient, check that the covers did not shift and the patient is not lying directly on a seam.

3.3 Device controls and indicators: Product Labels

Green indicates Product Location

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INSTRUCTIONS FOR USE Lock Lever Operation – Hip and Thigh Pads:

LOCKED

UNLOCKED

NEVER EXCEED THE WEIGHT CAPACITY OF THE O.R. TABLE

Buckle Operation – Leg Sling

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INSTRUCTIONS FOR USE 3.4 Storage, Handling and Removal Instructions: 3.4.1

Storage and Handling:

The product should be stored in a clean and safe environment to prevent product damage. 3.4.2

Removal Instruction:

a. Release all locks on hip and thigh pads (red stripe visible) b. Detach hook and loop straps from chest pad and head plate c. Separate buckle ends on all four straps of leg sling. d. Lift supports straight upward to remove from table. e. Store pads on Allen Advance Table cart or alternate storage location.

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

3.6 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).

4

Safety Precautions and General Information:

4.1 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. d. Do not exceed 600 lbs. (272 kg) patient weight limit e. To reduce the chances of patient tissue damage, care should be taken to ensure proper orientation and location of all supports. Document Number: 80028187 Version: C

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INSTRUCTIONS FOR USE f.

To reduce the chances of patient tissue damage, ensure that patient does not come in direct contact with hard surfaces. g. To reduce the chances of skin maceration and shear, it is recommended that Allen Ultra Comfort™ Covers be used between the patient and the pads. h. To avoid injury to patient, ensure all supports are properly secured and locked prior to loading a patient. i. To avoid serious injury to patient, additional restraints must be used to securely restrain the patient to the OR table prior to tilting the system. j. To avoid serious injury to patient, before operating the table ensure the area beneath/around the table is clear of objects that could obstruct or come in contact with the patient or support platforms.

CAUTION: a. Do not exceed safe working load shown in the product specification table b. Damage may result if product is cleaned with bleach. c. 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.

4.2 Product Specifications: Mechanical Specifications

Description A-71301 Chest Support w/ Pad: 17.4ʺ X 7.7ʺ X 4.1ʺ (44 cm x 19.5 cm x 10.4 cm) A-71312 Sling Support: 37.7ʺ X 26.25ʺ (95.7 cm x 66.6 cm) A-71303 Small Hip w/ Pad: 8.5ʺ X 5.25ʺ X 9.2ʺ (21.5 cm x 13.3 cm x 23.4 cm)

Product Dimensions

A-71305 Medium Hip Support w/ Pad: 7.5ʺ X 5.25ʺ X 9.7ʺ (19 cm x 13.3 cm x 24.6 cm) A-71307 Large Hip support w/ Pad: 10ʺ X 5.25ʺ X 11.7ʺ (25.5 cm x 13.3 cm x 29.7 cm) A-71309 and A-71311 Left and Right Thigh Supports w/ Pads: 4.7ʺ X 5.2ʺ X 8.9ʺ (12 cm x 13.5 cm x 22.6 cm)

Document Number: 80028187 Version: C

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