Hillrom O-NTS User manual

Nissen Thigh Strap/Thigh Retractors
Instructions for Use
Product No. O-NTS, O-NTSE
80028136
Version C

INSTRUCTIONS FOR USE
Document Number: 80028136 Page 2 Issue Date: 10 MAR 2020
Version C Ref Blank Template: 80025117 Ver. F
ENGLISH ..........................................................................................................................................4
中文简体 ........................................................................................................................................20
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FRANÇAIS ...................................................................................................................................101
DEUTSCH.....................................................................................................................................118
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日本語版 ......................................................................................................................................188
한국어 ..........................................................................................................................................203
ROMÂNESC................................................................................................................................ 220
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SLOVENSKY.................................................................................................................................252

INSTRUCTIONS FOR USE
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SLOVENŠČINA............................................................................................................................ 268
ESPAÑOL.....................................................................................................................................284
TIẾNG VIỆT....................................................................................................................................301

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.

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Table of Contents
Nissen Thigh Strap (O-NTS, O-NTSE)
1General Information: ...........................................................................................................7
Copyright Notice:.........................................................................................................7
Trademarks:...................................................................................................................7
Contact Details:............................................................................................................8
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:......................................................................................................9
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:...........................................11
EMC considerations: ..................................................................................................11
EC authorized representative:..................................................................................11
Manufacturing Information:......................................................................................11
EU Importer Information:............................................................................................11
Authorised Australian sponsor:..................................................................................11
2System..................................................................................................................................12
System components Identification: .........................................................................12
Product Code and Description:...............................................................................12
List of Accessories and Consumable Components Table:...................................12
Clinical Benefits:..........................................................................................................13
2.4.1 Indication for use: ............................................................................................13
2.4.2 Intended use:....................................................................................................13
3Equipment Setup and Use:...............................................................................................14
Prior to use: ..................................................................................................................14
Setup: ...........................................................................................................................14
Device controls and indicators: ...............................................................................15
Storage, Handling and Removal Instructions:........................................................15

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3.4.1 Storage and Handling:....................................................................................15
3.4.2 Removal Instruction: ........................................................................................15
Troubleshooting Guide: .............................................................................................15
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:............................................................................................17

INSTRUCTIONS FOR USE
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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).

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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
[phone]
[phone] ext.4286
[phone]
[phone]

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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.
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

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Indicates the date when the medical
device was manufactured
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
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

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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: [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:
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

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2System
System components Identification:
Product Code and Description:
O-NTS - Nissen Thigh Strap
O-NTSE - Nissen Strap / Thigh Retractors, EUR
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.
Name of Accessory
Product Number
Accessory Cart
A-30010 (US), A-30010E (EU), A-30010K (UK),
A-30010J (japan)
Name of Consumable
Product Number
Not Applicable
Not Applicable
Pad
Mounts
Strap Section
Buckle Section

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Clinical Benefits:
2.4.1 Indication for use:
The Nissen strap is used in a variety of surgical procedures including, but not limited to
gynecology, urology, laparoscopy, general and robotic surgery during Reverse
Trendelenburg positioning. These devices are capable of being used with a broad
patient population as determined appropriate by the caregiver or institution.
2.4.2 Intended use:
The Nissen strap is designed to position and support the patient’s upper leg in a variety
of surgical procedures including, but not limited to gynecology, urology, laparoscopy,
general and robotic surgery during Reverse Trendelenburg positioning. These devices
are intended to be used by healthcare professionals within the Operating Room
setting.

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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:
a. Position the Strap Mount on the table rail
adjacent to the patient’s thigh. Turn the
locking knob clockwise to secure it to the
rail.
b. Pull the strap under and around the
patient’s thigh. The pad must be between
the thigh and the strap encircling the thigh.
c. Position the buckle mount 150mm (6") from
the strap mount on the table rail toward the
head end of the table. Turn the locking
knob clockwise to secure it.
d. Pull the strap through the buckle until it is
taut, and the patient is held on the
table.
e. Repeat the same steps for the other strap.

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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:
a. Loosen the strap from the buckle.
b. Turn the locking knob anticlockwise and remove the strap mount.
c. Release the patient thigh and remove the buckle section mount.
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).
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

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not use the device if damage is visible, if parts are missing or if it does not function
as expected.
d. To prevent patient and/or user injury and/or equipment damage, verify the
device attaching clamps completely touch the table-side rails and are firmly in
place. Apply device only to U.S. standard side rails. Test the locking mechanism to
ensure no movement when elevated or pushed.
CAUTION:
a. To prevent patient and/or equipment damage, do not over tighten the strap and
buckle.
b. To prevent patient and/or user injury and/or equipment damage: all modifications,
upgrades, or repairs must be performed by an authorized specialist. Failure to
comply may void warranty.
c. Do not exceed safe working load shown in the product specification table.
Product Specifications:
Mechanical Specifications
Description
Product Dimensions
48" x 4.5" x 1" (122 cm x 11.4 cm x 2.5 cm)
(L x W x H)
Pad Length: 20” (50.8 cm)
Material
Aluminum, Stainless Steel, Conductive
Strap, Viscoelastic Foam, Fusion 3, Black,
Lectrolite Duotone, Black, Vinyl-Nitrile
Rubber
Safe Working Load on the device
500 lbs. (226 kg) patient
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

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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 TO CLEAN PAD
5List of Applicable Standards:
Sl. no
Standards
Description
1
EN 62366-1
Medical devices - Part 1: Application of
usability engineering to medical devices
Not Applicable.
Not Applicable.
Software Specifications
Description
Not Applicable.
Not Applicable.
Compatibility Specifications
Description
Operating Room Table Compatibility
The Allen Nissen Thigh Strap is compatible
with the following surgical table rail styles:
US & EU

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Sl. no
Standards
Description
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

Nissen Thigh Strap/Thigh Retractors
使用说明
产品编号 O-NTS、O-NTSE
80028136
Version C

使用说明
Document Number: 80028136 页码 20 Issue Date: 10 MAR 2020
Version C 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。