Hillrom O-PRSLH User manual

Patient Restraint Strap &
Deluxe Maximum Restraint Strap
Instructions for Use
Product No. O-PRSLH, O-PRSH & O-RSX2
80028144
Version B

INSTRUCTIONS FOR USE
Document Number: 80028144 Page 2 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
ENGLISH ..........................................................................................................................................3
中文简体 ........................................................................................................................................20
NEDERLANDS................................................................................................................................37
FRANÇAIS .....................................................................................................................................54
DEUTSCH.......................................................................................................................................71
ΕΛΛΗΝΙΚΑ.....................................................................................................................................88
ITALIANO.....................................................................................................................................105
LATVISKI.......................................................................................................................................122
NORSK.........................................................................................................................................139
POLSKI .........................................................................................................................................156
PORTUGUÊS................................................................................................................................173
ROMÂNESC................................................................................................................................190
SRPSKI..........................................................................................................................................207
SLOVENSKY.................................................................................................................................224
SLOVENŠČINA............................................................................................................................241
ESPAÑOL.....................................................................................................................................258
SVENSKA .....................................................................................................................................275

INSTRUCTIONS FOR USE
Document Number: 80028144 Page 3 Issue Date: 30 MAR 2020
Version: B 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: 80028144 Page 4 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
Table of Contents
Patient Restraint Strap and Deluxe Maximum Restraint Strap (O-PRSLH, O-RSX2)
1General Information:....................................................................................................... 6
Copyright Notice:.........................................................................................................6
Trademarks: ...................................................................................................................6
Contact Details:............................................................................................................6
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
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
EMC considerations: ....................................................................................................9
EC authorized representative:..................................................................................10
Manufacturing Information:......................................................................................10
EU Importer Information:............................................................................................10
Australian sponsor Information: ................................................................................10
2System ............................................................................................................................ 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
3Equipment Setup and Use:............................................................................................ 13
Prior to use: ..................................................................................................................13
Setup: ...........................................................................................................................13
Device controls and indicators: ...............................................................................14

INSTRUCTIONS FOR USE
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Storage, Handling and Removal Instructions: ........................................................14
3.4.1 Storage and Handling:....................................................................................14
3.4.2 Removal Instruction: ........................................................................................14
Troubleshooting Guide: .............................................................................................14
Device Maintenance:................................................................................................15
4Safety Precautions and General Information:............................................................. 15
General Safety Warnings and Cautions:.................................................................15
Product Specifications:..............................................................................................16
Sterilization Instruction:...............................................................................................17
Cleaning and Disinfection Instruction: ....................................................................17
5List of Applicable Standards: ........................................................................................ 18

INSTRUCTIONS FOR USE
Document Number: 80028144 Page 6 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
1General 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:

INSTRUCTIONS FOR USE
Document Number: 80028144 Page 7 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
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.
[phone]
[phone] ext.4286
[phone]
[phone]

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025117 Ver. F
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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Version: B 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 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
Document Number: 80028144 Page 10 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
EC authorized representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: [phone]
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:
TRUMPF Medizin Systeme GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany
Australian sponsor Information:
Welch Allyn Australia Pty. Ltd.
Unit 4.01, 2-4 Lyonpark Road
Macquarie Park, NSW 2113
Phone [phone]

INSTRUCTIONS FOR USE
Document Number: 80028144 Page 11 Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
2System
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
Not Applicable

INSTRUCTIONS FOR USE
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3Equipment 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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Version: B Ref Blank Template: 80025117 Ver. F
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).
4Safety 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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Version: B 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
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
-29ᵒC to +60ᵒC
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 Patient Restraint Strap and Deluxe
Maximum Restraint Strap are
compatible with:
Any rail style

INSTRUCTIONS FOR USE
Document Number: 80028144 Page 17 Issue Date: 30 MAR 2020
Version: B 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

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025117 Ver. F
5List 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 B

使用说明
Document Number: 80028144 页码 20 Issue Date: 30 MAR 2020
Version: B 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。