Hillrom O-LPA Easy Irrigation Tower Pole for ORs Instruction Manual

Hillrom O-LPA Easy Irrigation Tower Pole for ORs

Product Information

• Product Name: Easy Irrigation Tower
• Product Number: O-LPA 80028166
• Version: E

Instructions for Use

• 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.
• The symbol on the labels is intended to show when the IFU should be referenced for use.

Storage, Handling, and Removal Instructions

• Storage and Handling: Store the product properly to ensure its integrity and functionality.
• Removal Instruction: Follow the specified instructions to remove the product.

Copyright Notice
No part of this text shall be reproduced or transmitted in any form or by any means, electronic or mechanical, without written permission from Allen Medical Systems, Inc.

Trademarks

• Trademark information can be found at Allenmedical.com/pages/terms-conditions.
• Products may be covered by one or more patents. Please consult the listing at Hill-rom.com/patents for any patent(s).

Contact Details
For ordering information, please refer to the catalog. Contact Allen Customer Service:

• North America: 800-433-5774 or 978-263-8846
• International: +1 978 266 4200 ext.4286 or +1 978 266 4426

Safety Considerations

• Safety hazard symbol notice: Do not use the product if it shows visible damage or material degradation.
• Equipment misuse notice: Do not use the product if the package is damaged or unintentionally opened before use. All modifications, upgrades, or repairs must be performed by an authorized specialist.
• 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.

IMPORTANT NOTICES

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.

• 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.

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).

Contact Details:
For ordering information please see catalog.

Allen Customer Service Contact Information:

ext.4286
   978-263-8846|  +1 978 266 4426

Safety Considerations

Safety hazard symbol notice:

DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL DEGRADATION.

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.

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

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:

Applicable Symbols:

| Indicates the manufacturer’s serial number. The device serial number is encoded as 1YYWWSSSSSSS.

·         YY indicates the year of manufacture.

i.e. 1 18 WWSSSSSSS where 18 represents the year 2018.

·         WW indicates the number of the manufacturing week per a standard shop calendar. (Leading zeros included.)

·         SSSSSSS is a sequential unique number.

| EN ISO 15223-1
| Indicates the medical device Global Trade Item Number| 21 CFR 830 MDR 2017/745
**| Indicates the date when the medical device was manufactured| EN ISO 15223-1
| Indicates the manufacturer’s lot code using the Julian Date yyddd, where yy indicates the last two digits of the year and ddd indicates the day of the year. i.e. April 4th, 2019 would be represented as 19094.| EN ISO 15223-1
**| Indicates the manufacturer’s catalogue number| EN ISO 15223-1
---|---|---
| Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions.| EN ISO 15223-1
| 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

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.

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.

System

System components Identification:

Product Code and Description:
O-LPA – Easy Irrigation Tower

List of Accessories and Consumable Components Table:
The following list are accessories and components that may be used with this device.

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

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.

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.

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.

Equipment Setup and Use

Prior to use:

• Inspect the product looking for any visible damage or sharp edges that could be caused by a drop or impact during storage.
• Make sure product has been properly cleaned and disinfected and wiped dry prior to each use.

Setup

Components identification for assembly

• 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.

• Install washer (C-003293) onto the end of the bar.

• 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.

• 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

• 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.

• 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

• Hang bag on any of the four hooks.

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

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

Device controls and indicators:
The Easy Irrigation Tower provides hanger Height displayed in inches and centimeters as shown below.

Storage, Handling and Removal Instructions:

Storage and Handling:
The product should be stored in a clean and safe environment to prevent product damage.

Removal Instruction:
Not Applicable

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).

Safety Precautions and General Information

General Safety Warnings and Cautions:

WARNING:

• Do not use if product shows visible damage.
• 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.
• 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

Product Specifications

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.| Not Applicable.
Software Specifications| Description
Not Applicable.| Not Applicable.
Compatibility Specifications| Description
The Easy Irrigation Tower is

compatible with:

| The device shall have hook feature to hang the

four fluid bags.

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

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

List of Applicable Standards

| ****

EN 62366-1

| Medical devices – Part 1: Application of usability engineering to medical devices

| ****

EN ISO 14971

| Medical devices- Application of risk management to medical devices.

| ****

EN 1041

| Information supplied by the manufacturer of medical devices

| ****

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

Hillrom Technical Support
hillrom.com/en-us/about-us/locations/

Allen Medical Systems, Inc. is a subsidiary of Hill-Rom, Inc.

References

• allenmedical.com - allenmedical Resources and Information.
• allenmedical.com - allenmedical Resources and Information.
• Patents | Hillrom
• Patents | Hillrom
• Hillrom Locations by Country | Hillrom
• allenmedical.com - allenmedical Resources and Information.
• Patents | Hillrom
• Hillrom Locations by Country | Hillrom

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