Easy Armboard Instructions for Use Ver B March 2020

INSTRUCTIONS FOR USE

ENGLISH ... 3 SUOMI ... 17 FRANÇAIS ... 31 DEUTSCH... 46 ITALIANO ... 61 ROMÂNESC... 75 SRPSKI ... 90 SLOVENSKY ... 105 SLOVENŠČINA ... 118 ESPAÑOL ... 132 SVENSKA ... 148

Document Number: 80028226 Version: B

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Issue Date: 17 MAR 2020 Ref Blank Template: 80025118 Ver. E

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.

•

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.

Document Number: 80028226 Version: B

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Issue Date: 17 MAR 2020 Ref Blank Template: 80025118 Ver. E

INSTRUCTIONS FOR USE

Table of Contents Easy Armboard (I-ABSLFH) 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: ... 7 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: ... 9 1.6 EMC considerations: ... 9 1.7 EC authorized representative: ...10 1.8 Manufacturing Information: ...10

2

System ... 10 2.1 System components Identification: ...10 2.2 List of Accessories and Consumable Components Table: ...11 2.3 Indication for use: ...11 2.4 Intended use: ...11 2.5 Residual risk: ...11

3

Equipment Setup and Use: ... 11 3.1 Prior to use:...11 3.2 Setup: ...12 3.3 Device controls and indicators:...13 3.4 Storage, Handling and Removal Instructions:...13 3.4.1 Storage and Handling: ...13 3.4.2 Removal Instruction: ...13 3.5 Troubleshooting Guide: ...13 3.6 Device Maintenance: ...13

Document Number: 80028226 Version: B

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Issue Date: 17 MAR 2020 Ref Blank Template: 80025118 Ver. E

INSTRUCTIONS FOR USE 4

Safety Precautions and General Information: ... 13 4.1 General Safety Warnings and Cautions: ...13 4.2 Product Specifications: ...14 4.3 Sterilization Instruction: ...14 4.4 Cleaning and Disinfection Instruction: ...15

5

List of Applicable Standards: ... 15

Document Number: 80028226 Version: B

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Issue Date: 17 MAR 2020 Ref Blank Template: 80025118 Ver. E

INSTRUCTIONS FOR USE 1 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.

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 in www.allenmedical.com/pages/termsconditions. Product may be covered by one or more patents. Please consult listing at www.hillrom.com/patents for any patent(s).

Document Number: 80028226 Version: B

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INSTRUCTIONS FOR USE 1.3

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.

1.4

Safety Considerations: 1.4.1

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

1.4.2

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. 1.4.3

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. NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE 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 your supplier for guidance on safe disposal protocols.

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INSTRUCTIONS FOR USE 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 lot code using the Julian Date yyddd, where yy indicates the last two digits of the year and ddd indicates the day of the year, i.e. April 4th, 2019 would be represented as 19094.

EN ISO 15223-1

Indicates the manufacturer’s catalogue number

EN ISO 15223-1

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

Document Number: 80028226 Version: B

Reference

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INSTRUCTIONS FOR USE

1.5.2

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

Intended to show when the IFU should be referenced 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 the safe working load specified in product specification section 4.2” 1.5.3

Compliance with medical device regulations: This product is a non-invasive, Class I Medical Device. This system is CEmarked according to Annex VIII, Rule 1, of the Medical Device Regulations (REGULATION (EU) 2017/745)

1.6

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

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INSTRUCTIONS FOR USE 1.7

EC authorized representative: HILL-ROM SAS B.P. 14 - Z.I. DU TALHOUET 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 USA 800-433-5774 (NORTH AMERICA) 978-266-4200 (INTERNATIONAL)

2

System

2.1

System components Identification:

2.2 Product Code and Description: F-ABSLUK - Armboard, Snaplock, UK rail F-ABSL2EMER - Snaplock AB, Euro, Merivaara F-ABSLDORLP - Snaplock AB, no pad, Dornier F-ABSL - Armboard Snaplock (Extrusion) F-ABSLE - Armboard Snaplock, EURO

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INSTRUCTIONS FOR USE 2.2

List of Accessories and Consumable Components Table: The following list are accessories and components that may be used with this device Name of Accessory

Accessory Cart

Product Number F-30010 (US) F-30010E (EU) F-30010UK (UK)

Name of Consumable

Product Number

Not Applicable

Not Applicable

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

2.3

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

2.4

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

2.5

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

3 3.1

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.

Document Number: 80028226 Version: B

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INSTRUCTIONS FOR USE 3.2

Setup: a. Hold the Armboard in a horizontal position.

b. Tilt the end of the board up approximately 2 to 3" (5 to 7,6 cm). Hook the upper jaw of the mount over the table rail and allow the end of the board to return to horizontal position. The latch should engage the bottom edge of the rail and the Armboard should now be fastened to the table. Lift the end of the board to ensure that it is locked to the rail.

c. To

adjust the Armboards radial angulation SIMPLY LIFT UP ON THE END OF THE BOARD and move it in the desired direction. Lower the end of the Armboard and the weight of the arm will lock the board in position. Do not apply excessive force when lifting the end of the Armboard. Only 2-3lbs (0,91,4kg) of such force should be required to disengage the lock mechanism during repositioning. Extreme upward forces could damage the Armboard.

Be careful not to install the armboard at a tablesection articulation level. the armboard could be damaged in case of movement.

Document Number: 80028226 Version: B

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INSTRUCTIONS FOR USE 3.3

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

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. Grasp the end of the Armboard with one hand. With the other hand lift the latch handle. b. Lift the end of the board up and pull the Armboard away from the rail.

3.5

Troubleshooting Guide: This device does not have a troubleshooting guide. For technical support users of the device shall first contact their supplier

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. To prevent patient and/or user injury and/or equipment damage, verify the device attaching clamps completely touch the table-side rails and are firmly in

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INSTRUCTIONS FOR USE place. Test the locking mechanism to ensure no movement when elevated or pushed.

CAUTION: a. Do not exceed safe working load shown in the product specification table b. 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

Product Dimensions

Description 26" x 5 1⁄2" (66 x 14 cm)

Safe Working Load on the device Overall Weight of Complete Device

 Fiberesin  Vinyl  Aluminum  Stainless Steel 400 lbs. (181 kg) Approx. 5 lbs. (2.3 kg)

Storage Specifications Storage temperature Storage Relative humidity range Operating temperature Operating Relative humidity range Electrical Specifications Not Applicable. Software Specifications Not Applicable. Compatibility Specifications

Description -29ᵒ C to +60ᵒ C 15% to 85% This device is intended to be used in a controlled Operating Room environment. Description Not Applicable. Description Not Applicable. Description

Material

Operating Room Table Compatibility

4.3

Compatible with the following rail styles: 

US, EU, UK based on product Selection

Sterilization Instruction: This device is not intended to be sterilized. Equipment damage may occur.

Document Number: 80028226 Version: B

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INSTRUCTIONS FOR USE 4.4

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

5

List of Applicable Standards:

Sl. no

Standards

Description

1.

EN 62366-1

Medical devices - Part 1: Application of usability engineering to medical devices

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

5.

EN ISO 10993-1

6.

IEC 60601-2-46

7.

ISTA

Document Number: 80028226 Version: B

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables International Safe Transit Association standards for package testing

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