2. Hillrom
  3. A-71404
A-71404

Hillrom A-71404 Manuale utente

  • Ciao, ho letto le istruzioni per l'uso del Cervical Traction Bar Advance A-71404 e sono pronto a rispondere alle tue domande. Questo manuale descrive come installare e utilizzare correttamente la barra di trazione durante le procedure chirurgiche, con particolare attenzione alla sicurezza e alle specifiche tecniche del dispositivo.
  • Qual è il carico massimo per il sistema di trazione?
    Dove viene installata la barra di trazione?
    Il dispositivo deve essere sterilizzato prima dell'uso?
    Cosa devo fare se il dispositivo appare danneggiato?
Advance Cervical Traction Bar
Instructions for Use
Product No. A-71404
80028188
Version C
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 2 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
ENGLISH ........................................................................................................................................ 3
中文简体 ...................................................................................................................................... 18
中文繁體 ...................................................................................................................................... 33
ČESKÝ .......................................................................................................................................... 49
DANSK ......................................................................................................................................... 64
NEDERLANDS .............................................................................................................................. 79
SUOMI ......................................................................................................................................... 94
FRANÇAIS .................................................................................................................................. 109
DEUTSCH ................................................................................................................................... 125
ΕΛΛΗΝΙΚΑ ................................................................................................................................. 141
MAGYAR ................................................................................................................................... 156
BAHASA INDONESIA ................................................................................................................ 171
ITALIANO ................................................................................................................................... 186
日本語版 .................................................................................................................................... 201
한국어 ........................................................................................................................................ 216
LATVISKI ..................................................................................................................................... 231
POLSKI ....................................................................................................................................... 246
PORTUGUÊS .............................................................................................................................. 261
ROMÂNESC .............................................................................................................................. 277
SRPSKI ........................................................................................................................................ 293
SLOVENSKY ................................................................................................................................ 308
SLOVENŠČINA .......................................................................................................................... 323
ESPAÑOL ................................................................................................................................... 338
SVENSKA ................................................................................................................................... 354
TIẾNG VIỆT ................................................................................................................................................ 369
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 3 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
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
Document Number: 80028188 Page 4 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
Table of Contents
Advance Cervical Traction Bar (A-71404)
1 General Information: ....................................................................................................... 6
1.1 Copyright Notice: ......................................................................................................... 6
1.2 Trademarks: ................................................................................................................... 6
1.3 Contact Details: ............................................................................................................ 6
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
1.9 EU Importer Information: ............................................................................................ 10
1.10 Authorised Australian sponsor: .................................................................................. 10
2 System ............................................................................................................................ 11
2.1 System components Identification: ......................................................................... 11
2.2 Product Code and Description: ............................................................................... 11
2.3 List of Accessories and Consumable Components Table: ................................... 11
2.4 Indication for use: ....................................................................................................... 11
2.5 Intended use: .............................................................................................................. 12
3 Equipment Setup and Use: ............................................................................................ 12
3.1 Prior to use: .................................................................................................................. 12
3.2 Setup: ........................................................................................................................... 13
3.3 Device controls and indicators: ............................................................................... 13
3.4 Storage, Handling and Removal Instructions: ........................................................ 13
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 5 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
3.4.1 Storage and Handling: .................................................................................... 13
3.4.2 Removal Instruction: ........................................................................................ 13
3.5 Troubleshooting Guide: ............................................................................................. 13
3.6 Device Maintenance: ................................................................................................ 13
4 Safety Precautions and General Information: ............................................................. 14
4.1 General Safety Warnings and Cautions:................................................................. 14
4.2 Product Specifications: .............................................................................................. 14
4.3 Sterilization Instruction: ............................................................................................... 15
4.4 Cleaning and Disinfection Instruction: .................................................................... 15
5 List of Applicable Standards: ........................................................................................ 15
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 6 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
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
© 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).
1.3 Contact Details:
For ordering information please see catalog.
Allen Customer Service Contact Information:
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 7 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
International
North America
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
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.
(800) 433-5774
+1 978 266 4200 ext.4286
(978) 263-8846
+1 978 266 4426
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 8 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
1.5 Operating the system:
1.5.1 Applicable Symbols:
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
Indicates the date when the medical
device was manufactured
EN ISO 15223-1
Indicates the manufacturer’s
catalogue number
EN ISO 15223-1
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 9 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
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 adults and pediatric patients
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
Document Number: 80028188 Page 10 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
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 US
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
Document Number: 80028188 Page 11 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
2 System
2.1 System components Identification:
2.2 Product Code and Description:
A-71404 - Advance Cervical Traction Bar
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
Not Applicable
Not Applicable
2.4 Indication for use:
The Advance Cervical Traction Bar is used in a variety of surgical procedures
including, but not limited to cervical surgery. These devices are capable of being
used with a broad patient population as determined appropriate by the
caregiver or institution.
Name of Consumable
Product Number
Not Applicable
Not Applicable
Cervical Traction Bar
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 12 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
2.5 Intended use:
The Advance Cervical Traction Bar is designed to be used as a distractor in a
variety of surgical procedures including, but not limited to cervical surgery. 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.
c. Tools required: None
d. Parts required: A-71404 (Advance Cervical Traction Bar)
e. Pre-Use Checks table
Condition
Associated Indicator(s)
The Table power cord is connected to the
Table and to an applicable power outlet.
The Power indicator is on.
The On/Off switch is on.
The Battery Charge Level indicator is on.
The brakes are locked.
Locked indicator is green; Unlocked indicator is
off.
The Table is in Pendant mode.
The Pendant Control indicator is green; the Manual
Flip indicator is off.
The columns are level (at the same height).
Near the bottom on the outside of the columns
there are numbers to help identify height level.
The support top is horizontal (not tilted).
Tilt Level indicator is green; the Tilt indicator is in
the center of the Tilt Indicator Area.
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 13 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
3.2 Setup:
The cervical traction bar gets installed on the support top-side of the head-end H-
bracket (see figure System components Identification section 2.1).
1. Determine the hole location for the cervical traction bar.
2. Put the bar into the H-bracket openings.
3. Make sure the drop locks on each end of the bar moves to the side to hold the bar
in position.
4. For use information, refer to the Allen®1 Advance Table User Manual (D-720686)
and to the warnings on 4.1 General Safety Warnings and Cautions section 4.
3.3 Device controls and indicators:
Refer to the Allen®1 Advance Table User Manual (D-720686)
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. See storage Specifications under Product Specification section.
3.4.2 Removal Instruction:
Pull the bar from the H-bracket openings
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 us if you need to repair or replace the device by using the information
from the contact details section (1.3).
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 14 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
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. The maximum diameter of the traction rope should be 0.25" (6.35 mm). The use of
a traction rope that is greater than 0.25" (6.35 mm) in diameter could cause
binding inside the cervical traction assembly. Patient injury could occur as a result
of inaccurate traction.
e. The maximum weight load for the traction assembly is 50 lb (22.6 kg). To exceed
this weight could cause patient fall, injury, or equipment damage.
f. Make sure the traction weight is in a safe position, free from possible unintended
movement. Failure to do so could cause patient fall, injury, or equipment damage.
g. Do not press the Cervical Traction Release button while traction weight is being
applied. To do so could cause the assembly to retract and the traction weight to
move. Patient fall, injury, or equipment damage could occur.
CAUTION:
Do not exceed safe working load shown in the product specification table
4.2 Product Specifications:
Mechanical Specifications
Description
Product Dimensions
The Cervical Traction Bar is 11.75” long
(29.8 cm)
Material
Stainless Steel
Safe Working Load on the device
The maximum weight load for the traction
assembly is 50 lbs (22.6 kg)
Overall Weight of Complete Device
Approx. 1lbs (0.45 kg)
Storage Specifications
Description
Storage temperature
-29° C to +60° C
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 15 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
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.
5 List of Applicable Standards:
Sl. no
Standards
Description
1.
EN 62366-1
Medical devices - Part 1: Application of usability
engineering to medical devices
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 Advance Cervical Traction Bar is
compatible with:
Allen® Advance Table (A-71100) through the
Advance H-Brackets (A-71402)
INSTRUCTIONS FOR USE
Document Number: 80028188 Page 16 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
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
Advance Cervical Traction Bar
使用说明
产品编号 A-71404
80028188
Version C
使用说明
Document Number: 80028188 第 18 页 Issue Date: 16 MAR 2020
Version C 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
Document Number: 80028188 第 19 页 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
目录
Advance Cervical Traction Bar (A-71404)
1 一般信息： ...................................................................................................................... 21
1.1 版权声明： .................................................................................................................... 21
1.2 商标： ........................................................................................................................... 21
1.3 联系信息： .................................................................................................................... 21
1.4 安全注意事项： ............................................................................................................. 22
1.4.1 安全危险标志说明： ........................................................................................... 22
1.4.2 产品误用说明： .................................................................................................. 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： ........................................................................................................... 25
1.7 EC 授权代表： .............................................................................................................. 25
1.8 制造信息： .................................................................................................................... 25
1.9 欧盟进口商信息： ......................................................................................................... 25
1.10 授权的澳大利亚赞助商： .............................................................................................. 25
2 系统 ................................................................................................................................. 26
2.1 系统组件标识： ............................................................................................................. 26
2.2 产品代码和描述： ......................................................................................................... 26
2.3 附件列表和耗材组件表： .............................................................................................. 26
2.4 适用范围： .................................................................................................................... 26
使用说明
Document Number: 80028188 第 20 页 Issue Date: 16 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
2.5 预期用途： .................................................................................................................... 27
3 设备设置与使用： ............................................................................................................ 27
3.1 使用之前： .................................................................................................................... 27
3.2 设置： ........................................................................................................................... 28
3.3 设备控制键和指示灯： .................................................................................................. 28
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: ................................................................................................ 29
4.1 一般安全警告和小心： .................................................................................................. 29
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
/