Hillrom A-90002 Návod na používanie

Product Name

LPS Arm Support

Instructions for Use

Product No. A-90002

80028197

Version D

INSTRUCTIONS FOR USE         
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Version D    Ref Blank Template: 80025117 Ver. F 
 
ENGLISH .......................................................................................................................................... 3 
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한국어 ............................................................................................................... 149 
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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 
Allen® LPS Arm Support (A-90002)  
General Information: ........................................................................................................... 6 
1 Copyright Notice: ........................................................................................................ 6 
2 Trademarks: ................................................................................................................... 6 
3 Contact Details: ........................................................................................................... 7 
4 Safety Considerations: ................................................................................................. 7 
4.1 Safety hazard symbol notice: .......................................................................... 7 
4.2 Equipment misuse notice: ................................................................................ 7 
4.3 Notice to users and/or patients: ...................................................................... 7 
4.4 Safe disposal: ..................................................................................................... 8 
5 Operating the system: ................................................................................................. 8 
5.1 Applicable Symbols:.......................................................................................... 8 
5.2 Intended User and Patient Population: .......................................................... 9 
5.3 Compliance with medical device regulations: .......................................... 10 
6 EMC considerations: .................................................................................................. 10 
7 EC authorized representative: ................................................................................. 10 
8 Manufacturing Information: ..................................................................................... 10 
9 EU Importer Information: ........................................................................................... 10 
10 Authorised Australian sponsor: ................................................................................. 10 
System ................................................................................................................................. 11 
1 System components Identification: ......................................................................... 11 
2 Product Code and Description:............................................................................... 11 
3 List of Accessories and Consumable Components Table:................................... 11 
4 Indication for use: ...................................................................................................... 12 
5 Intended use: .............................................................................................................. 12 
Equipment Setup and Use: ............................................................................................... 12 
1 Prior to use: .................................................................................................................. 12 
2 Setup: ........................................................................................................................... 13 
3 Device controls and indicators: ............................................................................... 14 
4 Storage, Handling and Removal Instructions: ........................................................ 14 
4.1 Storage and Handling: ................................................................................... 14 

INSTRUCTIONS FOR USE         
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4.2 Removal Instruction: ........................................................................................ 14 
5 Troubleshooting Guide: ............................................................................................. 14 
6 Device Maintenance: ............................................................................................... 14 
Safety Precautions and General Information:............................................................... 15 
1 General Safety Warnings and Cautions: ................................................................ 15 
2 Product Specifications: ............................................................................................. 15 
3 Sterilization Instruction: .............................................................................................. 16 
4 Cleaning and Disinfection Instruction: .................................................................... 16 
List of Applicable Standards: ........................................................................................... 16 
 
  

INSTRUCTIONS FOR USE

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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 on-

site product demonstrations.

1.1 Copyright Notice:

Revision

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).

INSTRUCTIONS FOR USE

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International

North America

1.3 Contact Details:

For ordering information please see catalog.

Allen Customer Service Contact Information:

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 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

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

(800) 433-5774

+1 978 266 4200 ext.4286

(978) 263-8846

+1 978 266 4426

INSTRUCTIONS FOR USE

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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

Reference

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 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

INSTRUCTIONS FOR USE

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Indicates the date when the medical

device was manufactured

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

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

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 the product specification section 4.2

INSTRUCTIONS FOR USE

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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.

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)

1.9 EU Importer Information:

Baxter Medical Systems GmbH + Co. KG

Carl-Zeiss Straße 7-9

07318 Saalfeld/Saale

Germany

1.10 Authorised Australian sponsor:

Welch Allyn Australia Pty. Ltd.

1 Baxter Drive

Old Toongabbie, NSW 2146

Australia

INSTRUCTIONS FOR USE

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2 System

2.1 System components Identification:

2.2 Product Code and Description:

A-90002 - LPS Arm Support

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

A-30010 (US Rail), A-30010E (EU Rail),

A-30010UK (UK Rail), A-30010J (Japan

Rail)

Pivoting Block Handle

Support Rod (post)

INSTRUCTIONS FOR USE

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

2.4 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.

2.5 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.

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.

Name of Consumable

Product Number

Not Applicable

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3.2 Setup:

a. The patient should be safely

positioned on the table and

secured accordingly.

b. Place the arm board post

into a clamp/socket that is

positioned appropriately on

the table siderail.

c. Once the Arm Support is

placed in the clamp and the

desired positioning is

achieved (based on the

position of the arm board

and clamp/socket as it

relates to the orientation of

the patient), you can secure

the clamp/socket to the

table by tightening the knob.

Patient Positioning

a. Once the patient is safely supported in the desired position, place the arm on

the padded Arm Support. Use the straps to secure the patient's arm to the

surface as needed.

b. Fine adjustments of the height of the Arm Support may be made by supporting

the patient's arm while loosening the post in the clamp/socket. When properly

positioned, the patient's arm will rest gently on the Arm Support and the palm of

the hand will “cup” the palm support. The arm is then balanced in a passive,

anatomically correct position. Be sure to re-tighten the clamp/socket.

c. Further adjustments can be performed by repeating the above step in addition

to loosening the Pivoting Block Handle and repositioning the patient's arm

accordingly. Once the desired positioning has been achieved, be sure to re-

tighten all knobs and clamps/sockets.

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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. Safely Remove the Arm of the patient from the LPS Arm Support.

b. Remove the arm board post from the clamp/socket.

c. Remove the clamp/socket from the table by loosening the knob 2.

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).

Knob 2

Knob 1

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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.

CAUTION:

a. 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.

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

4.2 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%

INSTRUCTIONS FOR USE

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

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

Operating temperature

This device is intended to be used in a

controlled Operating Room environment.

Operating Relative humidity range

Electrical Specifications

Description

Not Applicable.

Software Specifications

Description

Not Applicable.

Compatibility Specifications

Description

The LPS Arm support is compatible with:

Easy Lock Socket or equivalent clamp.

INSTRUCTIONS FOR USE

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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

Product Name

LPS Arm Support

使用说明

产品编号 A-90002

80028197

Version D

使用说明

Document Number: 80028197 页码 19 Issue Date: 30 MAR 2020

Version D Ref Blank Template: 80025117 Ver. F

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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Version D    Ref Blank Template: 80025117 Ver. F 
目录 
Allen® LPS Arm Support (A-90002) 
一般信息： ........................................................................................................................... 22 
1 版权声明： .................................................................................................................... 22 
2 商标： ........................................................................................................................... 22 
3 联系信息： .................................................................................................................... 23 
4 安全注意事项： ............................................................................................................ 23 
4.1 安全危险标志说明：........................................................................................... 23 
4.2 设备误用说明： .................................................................................................. 23 
4.3 用户和/或患者通知： ......................................................................................... 23 
4.4 安全弃置： ......................................................................................................... 24 
5 操作系统： .................................................................................................................... 24 
5.1 适用符号： ......................................................................................................... 24 
5.2 适用用户和患者人群： ....................................................................................... 25 
5.3 医疗设备法规符合性： ....................................................................................... 25 
6 EMC 注意事项： .......................................................................................................... 26 
7 EC 授权代表： .............................................................................................................. 26 
8 制造信息： .................................................................................................................... 26 
9 欧盟进口商信息： ......................................................................................................... 26 
10 授权的澳大利亚赞助商： .............................................................................................. 26 
系统 ...................................................................................................................................... 27 
1 系统组件标识： ............................................................................................................ 27 
2 产品代码和描述： ......................................................................................................... 27 
3 附件列表和耗材组件表： .............................................................................................. 27 
4 适用范围： .................................................................................................................... 28 

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