Hillrom O-AHTR Guida utente

Tipo
Guida utente
Basic Rectangular Table,
Basic Hourglass Table & Basic Carpa® Table
Instructions for Use
Product No. O-AHTR, OAHTH, O-AHMPT
80028133
Version C
INSTRUCTIONS FOR USE
Document Number: 80028133 Page 2 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
ENGLISH ........................................................................................................................................... 3
中文简体 ......................................................................................................................................... 19
中文繁體 ......................................................................................................................................... 35
FRANÇAIS ...................................................................................................................................... 52
DEUTSCH ........................................................................................................................................ 68
BAHASA INDONESIA ..................................................................................................................... 84
ITALIANO ...................................................................................................................................... 101
日本語版 ....................................................................................................................................... 117
한국어 ........................................................................................................................................... 133
ROMÂNESC ................................................................................................................................. 149
SRPSKI ........................................................................................................................................... 165
SLOVENSKY .................................................................................................................................. 181
SLOVENŠČINA ............................................................................................................................. 197
ESPAÑOL ...................................................................................................................................... 213
SVENSKA ...................................................................................................................................... 229
TING VIT ..................................................................................................................................... 245
INSTRUCTIONS FOR USE
Document Number: 80028133 Page 3 Issue Date: 27 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: 80028133 Page 4 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
Table of Contents
Basic Rectangular Table, Basic Hourglass Table, Basic Carpa Table (O-AHTR, OAHTH,
O-AHMPT)
1 General Information: ........................................................................................................... 6
Copyright Notice: ......................................................................................................... 6
Trademarks: ................................................................................................................... 6
Contact Details: ............................................................................................................ 7
Safety Considerations: ................................................................................................. 7
1.4.1 Safety hazard symbol notice: ........................................................................... 7
1.4.2 Equipment misuse notice: ................................................................................. 7
1.4.3 Notice to users and/or patients: ...................................................................... 7
1.4.4 Safe disposal: ...................................................................................................... 8
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: ........................................... 10
EMC considerations: .................................................................................................. 10
EC authorized representative: .................................................................................. 10
Manufacturing Information: ...................................................................................... 10
EU Importer Information: ............................................................................................ 10
Authorised Australian sponsor: .................................................................................. 10
2 System .................................................................................................................................. 11
System components Identification: ......................................................................... 11
Product Code and Description: ............................................................................... 11
List of Accessories and Consumable Components Table: ................................... 11
Indication for use: ....................................................................................................... 12
Intended use: .............................................................................................................. 12
Residual Risk:................................................................................................................ 12
3 Equipment Setup and Use: ............................................................................................... 12
Prior to use: .................................................................................................................. 12
Setup: ........................................................................................................................... 13
Device controls and indicators: ............................................................................... 13
INSTRUCTIONS FOR USE
Document Number: 80028133 Page 5 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
Storage, Handling and Removal Instructions: ........................................................ 13
3.4.1 Storage and Handling: .................................................................................... 13
3.4.2 Removal Instruction: ........................................................................................ 14
Troubleshooting Guide: ............................................................................................. 14
Device Maintenance: ................................................................................................ 14
4 Safety Precautions and General Information: ............................................................... 14
General Safety Warnings and Cautions: ................................................................. 14
Product Specifications: .............................................................................................. 15
Sterilization Instruction: ............................................................................................... 16
Cleaning and Disinfection Instruction:..................................................................... 16
5 List of Applicable Standards: ............................................................................................ 16
INSTRUCTIONS FOR USE
Document Number: 80028133 Page 6 Issue Date: 27 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.
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.
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
Document Number: 80028133 Page 7 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
International
North America
Contact Details:
For ordering information please see catalog.
Allen Customer Service Contact Information:
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
Document Number: 80028133 Page 8 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
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.
Operating the system:
1.5.1 Applicable Symbols:
Symbol used
Reference
MDR 2017/745
EN ISO 15223-1
EN ISO 15223-1
21 CFR 830
MDR 2017/745
EN ISO 15223-1
INSTRUCTIONS FOR USE
Document Number: 80028133 Page 9 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
MDR 2017/745
IEC 60601-1
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
Document Number: 80028133 Page 10 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
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).
EMC considerations:
This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.
EC authorized representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: +33 (0)2 97 50 92 12
Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
EU Importer Information:
Baxter Medical Systems GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany
Authorised Australian sponsor:
Welch Allyn Australia Pty. Ltd.
1 Baxter Drive
Old Toongabbie, NSW 2146
Australia
INSTRUCTIONS FOR USE
Document Number: 80028133 Page 11 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
2 System
System components Identification:
Product Code and Description:
O-AHTR - Basic Rectangular Arm and Hand Table
O-AHTH - Basic Hourglass Table
O-AHMPT - Basic Carpa Table
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
Basic Rectangular Table Pad
O-AHTP
Basic Carpa® Table Pad
O-AHMPTP
Basic Hourglass Table Pad
O-AHTHP1.5
Accessory Rail
Frame Brace
Rail Clamp
Leg Lock Handle
Leg Extension Knob
INSTRUCTIONS FOR USE
Document Number: 80028133 Page 12 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
Note: Consult the corresponding IFU for the products mentioned in the above table.
Indication for use:
The Basic Arm / Hand, Hourglass and Capra Tables are used in a variety of surgical
procedures including, but not limited to arthroscopic or open Orthopedic surgery.
These devices are capable of being used with a broad patient population as
determined appropriate by the caregiver or institution.
Intended use:
The Basic Arm / Hand, Hourglass and Capra Tables are designed to position, support
and/or distract the patient’s hand, wrist, forearm and arm in a variety of surgical
procedures including, but not limited to arthroscopic or open Orthopedic surgery.
These devices are intended to be used by healthcare professionals within the
Operating Room setting.
Residual Risk:
This product complies with relevant safety standards. However, Patient harm from
misuse hazards cannot be completely excluded.
3 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.
Name of Consumable
Product Number
Not Applicable
Not Applicable
INSTRUCTIONS FOR USE
Document Number: 80028133 Page 13 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
Setup:
1. Place the two rail clamps on the surgical table’s back
section rail approximately 12”, 30cm, apart on the
patient’s affected side.
2. Hold the table vertically above the rail clamps with
the frame braces outboard of the surgical table and
the Mounting Blades pointing toward the open slots
of the rail clamps.
3. Lower the blades into the clamps & tighten the rail
clamp locking knobs.
4. Fold the table down making sure that the frame
brace ends engage the brace openings in the
mounting blades.
5. To adjust height, loosen the rail clamp knobs. Grasp
the table top adjacent to the rail clamps and raise or
lower the table to the desired height. Securely tighten
the rail clamp knobs.
6. O-AHTR and O-AHTH Only. With the Table set at the
surgeons working height, loosen Leg Lock Handle at
the ball socket near end of table. Swing the leg down
and slide ball socket to position of least interference with surgeon, C-arm, etc.
Loosen Leg Extension Knob and adjust leg length so the foot is securely against
the floor. Firmly lock both handles to stabilize table end.
Note: Support leg may be folded up out of the way for C-arm access only. Care must
be taken not to apply any additional loads beyond the patient’s arm weight while
the support leg is not in contact with the floor. (O-AHMPT do not have a leg).
Device controls and indicators:
Controls and indicators of this device are described within the Setup instructions.
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.
INSTRUCTIONS FOR USE
Document Number: 80028133 Page 14 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
3.4.2 Removal Instruction:
1. Remove both handles to stabilize table end.
2. Remove the mounting blades.
3. Remove the rail clamps.
Troubleshooting Guide:
This device does not have a troubleshooting guide. For technical support user of the
device shall first contact Hill-Rom Technical Support.
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:
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:
Do not exceed safe working load shown in the product specification table
INSTRUCTIONS FOR USE
Document Number: 80028133 Page 15 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
Mechanical Specifications
Description
Product Dimensions
Basic Rectangular Table
14" x 32"(35.5 cm x 81 cm)
Basic Hourglass Table
14" x 31"(35.5 cm x 79 cm)
Basic Carpa Table
14" x 26"(35.5 cm x 66 cm)
Material
Phenolic
Safe Working Load on the device
400 lbs. (181 kg) Patient
Overall Weight of Complete Device
Basic Rectangular Table
8.8 lbs. (4kg)
Basic Hourglass Table
11 lbs. (4.9 kg)
Basic Carpa Table
7.4 lbs. (3.4kg)
Storage Specifications
Description
Storage temperature
-29 C to +60 C
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 Basic Rectangular, Hourglass, and
Carpa Tables are compatible with:
Easy Lock® Blade Clamp
A-40040 (US), A-40041 (EU Rail),
A-40042 (UK Rail), A-40043 (Japan Rail)
INSTRUCTIONS FOR USE
Document Number: 80028133 Page 16 Issue Date: 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
Sterilization Instruction:
This device is not intended to be sterilized. Equipment damage may occur.
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
INSTRUCTIONS FOR USE
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Sl. no
Standards
Description
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
Basic Rectangular Table,
Basic Hourglass Table & Basic Carpa Table
使用说明
产品编号 O-AHTROAHTHO-AHMPT
80028133
Version C
使用说明
Document Number: 80028133 19 Issue Date 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver.F
重要通知
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。
本设备只应由接受过培训的人员操作。
任何修改、升级或维修都必须由经过授权的专业人员执行。
请务必保存好本手册,以备日后参考。
如果出现与设备相关的严重事故,应立即报告制造商和本文档所列的主管机构。
将本设备或其他类型的医疗设备用于患者前,建议阅读
使用说明
并熟悉产品
使用说明
Document Number: 80028133 20 Issue Date 27 MAR 2020
Version C Ref Blank Template: 80025117 Ver.F
目录
Basic Rectangular Table, Basic Hourglass Table, Basic Carpa Table (O-AHTR, OAHTH,
O-AHMPT)
1 一般信息: ............................................................................................................................ 22
版权声明: .................................................................................................................... 22
商标:............................................................................................................................ 22
联系信息: .................................................................................................................... 23
安全注意事项: ............................................................................................................. 23
1.4.1 安全危险符号说明: ........................................................................................... 23
1.4.2 设备误用声明: .................................................................................................. 23
1.4.3 用户和/患者注意事项: .................................................................................. 23
1.4.4 安全处置: .......................................................................................................... 24
操作系统: .................................................................................................................... 24
1.5.1 适用符号: .......................................................................................................... 24
1.5.2 目标用户和患者群体: ....................................................................................... 25
1.5.3 符合医疗设备规定: ........................................................................................... 26
EMC 注意事项: ........................................................................................................... 26
EC 授权代表: .............................................................................................................. 26
制造信息: .................................................................................................................... 26
欧盟进口商信息: ......................................................................................................... 26
授权的澳大利亚赞助商 .............................................................................................. 27
2 系统 ....................................................................................................................................... 28
系统组件标识: ............................................................................................................. 28
产品代码和说明: ......................................................................................................... 28
附件列表和耗材组件表 .............................................................................................. 28
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Hillrom O-AHTR Guida utente

Tipo
Guida utente