Ama Tech F-ABMT1 User manual

Multi-Task Armboard
Instructions for Use
Product No. F-ABMT1
80028232
Version B

INSTRUCTIONS FOR USE
Document Number: 80028232 Page 2 Issue Date: 17 MAR 2020
Version: BRef Blank Template: 80025118 Ver. E
ENGLISH.......................................................................................................................................... 3
中文简体........................................................................................................................................ 18
DANSK .......................................................................................................................................... 33
NEDERLANDS ............................................................................................................................... 48
SUOMI........................................................................................................................................... 63
FRANÇAIS..................................................................................................................................... 77
DEUTSCH....................................................................................................................................... 93
ΕΛΛΗΝΙΚΑ .................................................................................................................................. 108
ITALIANO .................................................................................................................................... 124
日本語版...................................................................................................................................... 140
한국어.......................................................................................................................................... 154
NORSK ........................................................................................................................................ 168
POLSKI......................................................................................................................................... 182
PORTUGUÊS................................................................................................................................ 197
ROMÂNESC................................................................................................................................ 212
РУССКИЙ .................................................................................................................................. 227
SRPSKI ......................................................................................................................................... 243
SLOVENSKY ................................................................................................................................ 259
SLOVENŠČINA ........................................................................................................................... 274
ESPAÑOL .................................................................................................................................... 289
SVENSKA..................................................................................................................................... 304
TÜRK ............................................................................................................................................ 319

INSTRUCTIONS FOR USE
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IMPORTANT NOTICES
•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.
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.

INSTRUCTIONS FOR USE
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Table of Contents
Multi-Task Armboard (F-ABMT1)
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 Product Code and Description:..................................................................................10
2.3 List of Accessories and Consumable Components Table:.........................................11
2.4 Indication for use:......................................................................................................11
2.5 Intended use:............................................................................................................11
3. Equipment Setup and Use: ........................................................................................... 12
3.1 Prior to use:...............................................................................................................12
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

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4. Safety Precautions and General Information: ............................................................ 13
4.1 General Safety Warnings and Cautions: ...................................................................13
4.2 Product Specifications:..............................................................................................14
4.3 Sterilization Instruction:.............................................................................................15
4.4Cleaning and Disinfection Instruction: .......................................................................15
5. List of Applicable Standards:........................................................................................ 15

INSTRUCTIONS FOR USE
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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/terms-conditions.
Product may be covered by one or more patents. Please consult listing at
www.hill-rom.com/patents for any patent(s).

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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 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 users of the device shall first contact their supplier for guidance on
safe disposal protocols.

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1.5 Operating the system:
1.5.1 Applicable Symbols:
Symbol used
Description
Reference
Indicates the device is a medical
device
MDR 2017/745
Indicates the medical device
manufacturer
EN ISO 15223-1
I 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

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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
ISO 15223
1.5.2 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 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 CE-
marked 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

INSTRUCTIONS FOR USE
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1.7 EC authorized representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: [phone]
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-ABMT1 - LATERAL ARMBOARD W/1" PAD
Armboard
Clamp
Board Clamp
Handle
Support
Rod
Clip-on™
Socket
Armboard with
Extension
Sleeve

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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
Accessory Cart
F-30010 (US), F-30010E (EU), F-30010UK (UK)
Clamp Shell Armboard Pad
O-AMA97X1.0S
Note: Consult the corresponding IFU for the products mentioned in the above table.
2.4 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.
2.5 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.
Name of Consumable
Product Number
Not Applicable

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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. Ensure the patient is safely positioned on the OR table before using the Advanced
Arm Support.
3.2 Setup:
To Install: Insert the Support Rod into an Clip-on™ Socket clamp. Tighten the
Accessory Lock Knob securely to prevent the Support Rod from rotating.
To Adjust Length: Pull the Armboard Extension Sleeve.
To Adjust Radial Angulation: Unlock the Board Clamp Handle and move the
armboard to the desired location. Retighten the Board Clamp Handle to
secure the board in the new position.
To Adjust Height: Vary the amount of the Support Rod that is inserted into the
Clip-on™ Socket clamp.
Equipment Uses
Ensure patient and device are fully supported before adjusting any
joints.
If further device positioning is needed after patient placement,
ensure the arm is fully supported during movement.

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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. Remove patient’s arm from
Armboard.
b. Loosen Power Grip on Clip-on™
Socket and grasp the clamp on
the lower jaw to release.
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
Clamp

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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
place. Test the locking mechanism to ensure no movement when elevated or
pushed.
CAUTION:
a. Damage may result if product is cleaned with bleach.
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.
c. Do not exceed safe working load shown in the product specification table
4.2 Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
Mechanical Specifications
Description
Product Dimensions
Length: 17" (43 cm)
Width: 6" (15.24 cm)
Material
Norplex Fiber Resin Phenolic, Nylon,
Aluminum, Stainless Steal, ABS
Safe Working Load on the device
500 lbs. patient (226 kg)
Overall Weight of Complete Device
10 lbs. (4.5 kg)
Storage Specifications
Description
Storage temperature
-29 ᵒC to +60 ᵒC
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 Advanced Arm Support is
compatible with
Clip-on®Socket: F-ELS (US), F-40023 (EU),
F-40024 (UK), F-40030 (Japan)
Operating Room Table Compatibility
Following rail styles:
US, UK, EU, JP

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

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Sl. no
Standards
Description
8
IEC 60601-2-46
Medical electrical equipment - Part 2-46:
Particular requirements for the basic safety
and essential performance of operating tables
9
ISTA
International Safe Transit Association standards
for package testing

Multi-Task Armboard
使用说明
产品编号 F-ABMT1
80028232
Version B

使用说明
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重要声明
•将设备用于患者之前，请先阅读并了解本手册中以及设备上的所有警告。
•符号用于提醒用户注意有关使用本设备的一些重要操作规程或安全说明。
标签上的 符号旨在提示使用中何时应参考 IFU。
•本手册中详细介绍的技术仅作为制造商的建议。使用本设备进行患者治疗的最终责
任仍由主治医师承担。
•每次使用之前，应检查设备功能。
•本设备仅能由经过培训的人员操作。
•任何修改、升级或维修都必须由经过授权的专业人员执行。
•请保管本手册供日后参考。
•发生与本设备有关的任何严重事故，应报告制造商和此文档所列主管当局。
将本设备或其他类型的医疗仪器用于患者之前，建议您先阅读本
《使用说明》并熟悉该产品。

使用说明
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目录
Multi-Task Armboard (F-ABMT1)
1. 一般信息.......................................................................................................................... 21
1.1 版权声明：................................................................................................................21
1.2 商标：.......................................................................................................................21
1.3 联系信息：................................................................................................................22
1.4 安全注意事项：.........................................................................................................22
1.4.1 安全危险标志说明：........................................................................................22
1.4.2 设备误用说明：...............................................................................................22
1.4.3 用户和/或患者通知：.......................................................................................22
1.4.4 安全弃置：......................................................................................................22
1.5 操作系统：................................................................................................................23
1.5.1 适用符号：......................................................................................................23
1.5.2 适用用户和患者人群： ....................................................................................24
1.5.3 医疗设备法规符合性： ....................................................................................24
1.6 EMC 注意事项： .......................................................................................................24
1.7 EC 授权代表：..........................................................................................................25
1.8 制造信息：................................................................................................................25
2. 系统................................................................................................................................. 25
2.1 系统组件标识：.........................................................................................................25
2.2 产品代码和描述： .....................................................................................................25
2.3 附件列表和耗材组件表：...........................................................................................26
2.4 适用范围：................................................................................................................26
2.5 预期用途：................................................................................................................26
3. 设备设置与使用：............................................................................................................ 26

使用说明
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3.1 使用之前：................................................................................................................26
3.2 设置：.......................................................................................................................27
3.3 设备控制键和指示灯： ..............................................................................................27
3.4 存储、操作处置和拆卸说明：....................................................................................28
3.4.1 存储和操作处置： ...........................................................................................28
3.4.2 拆卸说明：......................................................................................................28
3.5 故障排除指南：.........................................................................................................28
3.6 设备维护：................................................................................................................28
4. 安全注意事项和一般信息： ............................................................................................. 28
4.1 一般安全警告和小心： ..............................................................................................28
4.2 产品规格：................................................................................................................29
4.3 灭菌说明：................................................................................................................30
4.4 清洁与消毒说明： .....................................................................................................30
5. 适用标准列表： ............................................................................................................... 31