Hillrom O-PRSLH Manual de utilizare

Patient Restraint Strap &

Deluxe Maximum Restraint Strap

Instructions for Use

Product No. O-PRSLH, O-PRSH & O-RSX2

80028144

Version C

INSTRUCTIONS FOR USE         
 Document Number: 80028144 Page 2  Issue Date: 30 MAR 2020 
                              
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ENGLISH .......................................................................................................................................... 4 
中文简体 ........................................................................................................................................ 21 
中文繁體 ........................................................................................................................................ 38 
NEDERLANDS ................................................................................................................................ 56 
FRANÇAIS ..................................................................................................................................... 73 
DEUTSCH ....................................................................................................................................... 90 
ΕΛΛΗΝΙΚΑ ................................................................................................................................... 107 
BAHASA INDONESIA .................................................................................................................. 124 
ITALIANO ..................................................................................................................................... 142 
日本語版 ...................................................................................................................................... 159 
한국어 .......................................................................................................................................... 176 
LATVISKI ....................................................................................................................................... 193 
NORSK ......................................................................................................................................... 210 
POLSKI ......................................................................................................................................... 227 
PORTUGUÊS ................................................................................................................................ 244 
ROMÂNESC ................................................................................................................................ 261 
SRPSKI .......................................................................................................................................... 278 
SLOVENSKY ................................................................................................................................. 295 
SLOVENŠČINA ............................................................................................................................ 312 

INSTRUCTIONS FOR USE

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ESPAÑOL ..................................................................................................................................... 329

SVENSKA ..................................................................................................................................... 346

TIẾNG VIỆT .................................................................................................................................... 363

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 
Patient Restraint Strap and Deluxe Maximum Restraint Strap (O-PRSLH, O-RSX2)  
1 General Information: ....................................................................................................... 7 
 Copyright Notice: ......................................................................................................... 7 
 Trademarks: ................................................................................................................... 7 
 Contact Details: ............................................................................................................ 7 
 Safety Considerations: ................................................................................................. 8 
1.4.1 Safety hazard symbol notice: ........................................................................... 8 
1.4.2 Equipment misuse notice: ................................................................................. 8 
1.4.3 Notice to users and/or patients: ...................................................................... 8 
1.4.4 Safe disposal: ...................................................................................................... 8 
 Operating the system: ................................................................................................. 9 
1.5.1 Applicable Symbols: .......................................................................................... 9 
1.5.2 Intended User and Patient Population: ........................................................ 10 
1.5.3 Compliance with medical device regulations: ........................................... 10 
 EMC considerations: .................................................................................................. 10 
 EC authorized representative: .................................................................................. 11 
 Manufacturing Information: ...................................................................................... 11 
 EU Importer Information: ............................................................................................ 11 
 Authorised Australian sponsor: .................................................................................. 11 
2 System ............................................................................................................................ 12 
 System components Identification: ......................................................................... 12 
 Product Code and Description: ............................................................................... 12 
 List of Accessories and Consumable Components Table: ................................... 12 
 Indication for use: ....................................................................................................... 13 
 Intended use: .............................................................................................................. 13 
 Residual risk: ................................................................................................................. 13 
3 Equipment Setup and Use: ............................................................................................ 14 
 Prior to use: .................................................................................................................. 14 
 Setup: ........................................................................................................................... 14 
 Device controls and indicators: ............................................................................... 15 

INSTRUCTIONS FOR USE         
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 Storage, Handling and Removal Instructions: ........................................................ 15 
3.4.1 Storage and Handling: .................................................................................... 15 
3.4.2 Removal Instruction: ........................................................................................ 15 
 Troubleshooting Guide: ............................................................................................. 15 
 Device Maintenance: ................................................................................................ 16 
4 Safety Precautions and General Information: ............................................................. 16 
 General Safety Warnings and Cautions:................................................................. 16 
 Product Specifications: .............................................................................................. 17 
 Sterilization Instruction: ............................................................................................... 18 
 Cleaning and Disinfection Instruction: .................................................................... 18 
5 List of Applicable Standards: ........................................................................................ 19 
 
  

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.

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.

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:

INSTRUCTIONS FOR USE

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International

North America

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

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Operating the system:

1.5.1 Applicable Symbols:

Symbol used

Description

Reference

Indicates the device is a medical

device

MDR 2017/745

Indicates the medical device

manufacturer

EN ISO 15223-1

Indicates the manufacturer’s serial

number. The device serial number

is encoded as 1YYWWSSSSSSS.

• YY indicates the year of

manufacture. i.e.: 118WWSSSSSSS

where 18 represents the year 2018.

• WW indicates the number of

the manufacturing week per a

standard shop calendar.

(Leading zeros included.)

• SSSSSSS is a sequential unique

number.

EN ISO 15223-1

Indicates the medical device Global

Trade Item Number

21 CFR 830

MDR 2017/745

Indicates the manufacturer’s lot code

using the Julian Date yyddd, where yy

indicates the last two digits of the year

and ddd indicates the day of the year.

i.e. April 4th, 2019 would be represented

as 19094.

EN ISO 15223-1

Indicates the date when the medical

device was manufactured

EN ISO 15223-1

Indicates the manufacturer’s

catalogue number

EN ISO 15223-1

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Indicates the need for the user to

consult the instructions for use for

important cautionary information such

as warnings and precautions.

EN ISO 15223-1

Indicates the device do not contain

natural rubber or dry natural rubber

latex

EN ISO 15223-1

Indicates the authorized representative

in the European Community

EN ISO 15223-1

Indicates the Medical Device complies

to REGULATION (EU) 2017/745

MDR 2017/745

Indicates a Warning

IEC 60601-1

Indicates the need for the user to

consult the instruction for use

EN ISO 15223-1

1.5.2 Intended User and Patient Population:

Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare

professionals involved in the device intended procedure. Not intended for Lay

persons.

Intended Populations:

This device is intended to be used with patients that do not exceed the weight in the

safe working load field specified in the product specification section 4.2

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.

INSTRUCTIONS FOR USE

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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

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2 System

System components Identification:

Product Code and Description:

O-PRSH - Patient Security Strap Hooks (P/N 59008)

O-PRSLH - Deluxe Patient Restraint Strap

O-RSX2 - Deluxe Maximum Restraint Strap

List of Accessories and Consumable Components Table:

The following list are accessories and components that may be used with this

device.

Strap Buckle

Strap

Padded

section

Hook

INSTRUCTIONS FOR USE

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Name of Accessory

Product Number

Accessory Cart

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

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

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

Indication for use:

The Restraint Strap is used in a variety of surgical procedures including, but not

limited to spine and 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 Restraint Strap is designed to safely hold the patient in a variety of surgical

procedures including, but not limited to spine and orthopedic 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, device

or patient harm from misuse or device damage hazards cannot be completely

excluded.

Name of Consumable

Product Number

Not Applicable

INSTRUCTIONS FOR USE

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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.

Setup:

1. Place the padded area of the Restraint Strap at

the desired location on the patient. Drape the

Restraint Strap on both sides of the patient.

2. Loop the end of the Strap down between the

Surgical Table and the Accessory Rail, then back

up on the outside of the Accessory Rail.

3. Lift up on Cam Buckle and thread the Strap

through. Pull Strap to adjust tension.

Installation and use of Rail Hooks (Optional)

1. Thread one end of the Strap through one of the Hooks.

Lift up on Cam Buckle and thread the free end of the

Strap through. Note the orientation of the Clip to the

Buckle. This orientation is the same on both ends.

Repeat for the other end of the Strap.

INSTRUCTIONS FOR USE

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2. Clip the Hook under the Accessory Rail.

3. Secure the Hook by sliding the Lock Plate over

the top of the Accessory Rail.

4. Confirm that the Lock Plate and Hook is

securely attached to the Accessory Rail.

5. Adjust strap tension as previously described.

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.

3.4.2 Removal Instruction:

Remove Strap

Lift up on the Cam Buckle and pull the Strap out from the Buckle. Remove the Strap from

the Accessory Rail.

Remove Hooks

To remove the Hooks from the Accessory Rail, reverse the previous steps.

Troubleshooting Guide:

This device does not have a troubleshooting guide. For technical support user of the

device shall first contact Hill-Rom Technical Support.

INSTRUCTIONS FOR USE

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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:

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

b. To prevent patient and/or user injury and/or equipment damage: all modifications,

upgrades, or repairs must be performed by an Allen authorized specialist. Failure

to comply may void warranty.

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Product Specifications:

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

Mechanical Specifications

Description

Product Dimensions

• O-PRSLH

⎯ Soft Padded Section:

0.5” (1.3 cm) thick

5” (12.7cm) wide

18” (45.7cm long)

⎯ Strap Adjustable from 18” to 45”

(45.7cm to 114 cm)

• O-RSX2

⎯ Soft Padded Section:

0.5” (1.3 cm) thick

6” (15.25 cm) wide

24” (61cm) long

⎯ Strap Adjustable from 24” to 80”

(61cm to 203 cm)

Material

• Stainless Steel

• Fusion 3

Nylon

Safe Working Load on the device

500 lbs. patient (226 kg)

Overall Weight of Complete Device

2 lbs. (0.9 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 Patient Restraint Strap and Deluxe

Maximum Restraint Strap are

compatible with:

Any rail style

INSTRUCTIONS FOR USE

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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

INSTRUCTIONS FOR USE

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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.

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

Patient Restraint Strap &

Deluxe Maximum Restraint Strap

使用说明

产品编号 O-PRSLH、O-PRSH 和 O-RSX2

80028144

Version C

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