Hillrom O-LPA Manuale utente

Easy Irrigation Tower

Instructions for Use

Product No. O-LPA

80028166

Version E

 
INSTRUCTIONS FOR USE   
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ENGLISH .......................................................................................................................................... 3 
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BAHASA INDONESIA ................................................................................................................. 110 
ITALIANO .................................................................................................................................... 128 
日本語版 ...................................................................................................................................... 146 
한국어.......................................................................................................................................... 163 
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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® Easy Irrigation Tower (O-LPA)  
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: ............................................ 9 
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:................................... 12 
4 Indication for use: ...................................................................................................... 12 
5 Intended use: .............................................................................................................. 12 
6 Residual Risk: ............................................................................................................... 12 
Equipment Setup and Use: ............................................................................................... 13 
1 Prior to use: .................................................................................................................. 13 
2 Setup: ........................................................................................................................... 13 
3 Device controls and indicators: ............................................................................... 15 

 
INSTRUCTIONS FOR USE   
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4 Storage, Handling and Removal Instructions: ........................................................ 16 
4.1 Storage and Handling: ................................................................................... 16 
4.2 Removal Instruction: ........................................................................................ 16 
5 Troubleshooting Guide: ............................................................................................. 16 
6 Device Maintenance: ............................................................................................... 16 
Safety Precautions and General Information:............................................................... 16 
1 General Safety Warnings and Cautions: ................................................................ 16 
2 Product Specifications: ............................................................................................. 17 
3 Sterilization Instruction: .............................................................................................. 17 
4 Cleaning and Disinfection Instruction: .................................................................... 17 
List of Applicable Standards : .......................................................................................... 18 
 
  

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).

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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 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 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

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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:

Not Applicable.

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)

INSTRUCTIONS FOR USE

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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

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2. System

2.1 System components Identification:

2.2 Product Code and Description:

O-LPA - Easy Irrigation Tower

Tower Hooks

Tower Base Unit

Tower Handles

INSTRUCTIONS FOR USE

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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

Not Applicable

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

2.4 Indication for use:

The Fluid Delivery system devices are used when gravity irrigation is needed for

scope surgery. This device is capable of being used with a broad patient

population as determined appropriate by the caregiver or institution.

2.5 Intended use:

The Fluid Delivery system is designed to hold the fluid bags when gravity irrigation is

needed for scope surgery. These devices are intended to be used by healthcare

professionals within the Operating Room setting.

2.6 Residual Risk:

This product complies with relevant performance, safety standards. However,

patient, user or device harm from misuse, device damage hazards cannot be

completely excluded.

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.

3.2 Setup:

Components identification for assembly

a. Insert bar (C-003292), the end with

the red dot, into the center square

shaped cylinder of the Tower with

the holes facing up. Align holes and

red dots in Tower and bar.

C-003290

C-003293

2X C-003294

C-003292

C-003295

C-003296

C-003300

C-003332

Red Dot

C-001523

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b. Install washer (C-003293) onto the

end of the bar.

c. On the side with the Red Dot,

insert Lock Pin (C-003294)

through the upper hole at the

bottom of the tower and the

corresponding hole in the bar.

Install second pin in lower

hole.

NOTE: Assure that the head of

the Lock Pins are fully installed

and flush with the surface of

the hole in the Tower.

d. Install Base Unit (C-003290)

onto the end of the Tower as

illustrated.

NOTE: The Base Unit may not

fully engage at this

point. Tightening the

screw in Step f will bring

the bottom surface of

the bar flush with the

surface of the larger

washer

INSTRUCTIONS FOR USE

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e. Place smaller washer (C-003296)

onto screw (C-003300) followed

by the larger washer (C-003295).

Apply Loctite 242 (provided) to

the threads of screw (C-001523)

as illustrated.

f. Using the Allen wrench

(C-003332) (provided), thread

washer and screw assembly

onto base of Tower until

washer is flush tightly against

the surface of the bar.

Device Use

g. Hang bag on any of the four hooks.

h. Squeeze handle and move bag up or down to desire height.

i. Release handle and check to ensure that the handle is locked into place.

3.3 Device controls and indicators:

The Easy Irrigation Tower provides hanger Height displayed in inches and

centimeters as shown below.

INSTRUCTIONS FOR USE

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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:

Not Applicable

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).

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:

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

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4.2 Product Specifications:

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.

Mechanical Specifications

Description

Product Dimensions

Height: Range of motion

Trough of hook to floor: 66"-102” (167.6 cm –

259 cm) adjustable in 1" (2.5 cm) increments.

Width: width at base, column and hook.

30" x 5" x 18" (76.2 cm x 12.7 cm x 45.7 cm)

[Diameter at base x Square column x Outside

to outside of hooks]

Material

Nylon, Steel, 6000 Series Aluminum, 300 Series

Stainless Steel, Reid Tool MPB-5 black phenolic.

Safe Working Load on the device

40,000cc (10,000 cc per Hook)

Overall Weight of Complete Device

<50 lbs. (<22.6 kg)

Storage Specifications

Description

Storage temperature

-29ᵒ C to +60ᵒ 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.

Software Specifications

Description

Not Applicable.

Compatibility Specifications

Description

The Easy Irrigation Tower is

compatible with:

The device shall have hook feature to hang the

four fluid bags.

INSTRUCTIONS FOR USE

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• 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

6.

ISTA

International Safe Transit Association standards for

package testing

Easy Irrigation Tower

使用说明

产品编号 O-LPA

80028166

Version E

使用说明

Document Number: 80028166 页码 20 Issue Date: 26 MAR 2020

Version E 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。

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