Hillrom R-644-36 User manual

Weightless Shoulder
Suspension System
Instructions for Use
Product No. R-644-36
80028154
Version B

INSTRUCTIONS FOR USE
Document Number: 80028154 Page 2 Issue Date: 27 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
ENGLISH ..........................................................................................................................................3
中文简体........................................................................................................................................21
FRANÇAIS .....................................................................................................................................39
DEUTSCH.......................................................................................................................................57
ΕΛΛΗΝΙΚΑ.....................................................................................................................................75
ITALIANO.......................................................................................................................................93
LATVISKI.......................................................................................................................................111
POLSKI .........................................................................................................................................129
PORTUGUÊS ................................................................................................................................147
ROMÂNESC ................................................................................................................................165
SRPSKI..........................................................................................................................................183
SLOVENSKY.................................................................................................................................201
SLOVENŠČINA............................................................................................................................219
ESPAÑOL.....................................................................................................................................237

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
Weightless Shoulder Suspension System (R-644-36)
1General Information: ...........................................................................................................6
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:......................................................................................................8
1.5.1 Applicable Symbols:..........................................................................................8
1.5.2 Intended User and Patient Population: ..........................................................9
1.5.3 Compliance with medical device regulations:...........................................10
2System..................................................................................................................................11
3Equipment Setup and Use:...............................................................................................13

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3.4.1 Storage and Handling:....................................................................................16
3.4.2 Removal Instruction: ........................................................................................16
4Safety Precautions and General Information:...............................................................16
5List of Applicable Standards:............................................................................................18

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.
1.1 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.
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 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.
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 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
Acronym indicating “For Reference
Only”
Allen Medical Systems
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.

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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)
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: [phone]
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:
TRUMPF Medizin Systeme GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany
1.10 Australian sponsor Information:
Welch Allyn Australia Pty. Ltd.
Unit 4.01, 2-4 Lyonpark Road
Macquarie Park, NSW 2113 Phone [phone]

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2System
2.1 System components Identification:
2.2 Product Code and Description:
R-644-36 - Weightless Shoulder Suspension System
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
Lateral Brace (3-piece set)
O-UPBL3S, O-UPBLC, O-UPBLR
Hug-U -Vac Large Lateral Positioner
A-60002
Hug-U -Vac Standard Lateral Positioner
A-60003
Boom Adjustment
Tension Adjustment
Main Post
Arm Trap
Swivel Hook

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Note: Consult the corresponding IFU for the products mentioned in the above table.
CAUTION: Reuse of disposables will lead to patient cross contamination and/or
device failure.
2.4 Indication for use:
The Weightless Shoulder Suspension System is used in a variety of surgical procedures
including, but not limited to lateral arthroscopic and mini-open shoulder surgery.
These devices are capable of being used with a broad patient population as
determined appropriate by the caregiver or institution.
2.5 Intended use:
The Weightless Shoulder Suspension System is designed to position, support and/or
distract the patient’s shoulder in a variety of surgical procedures including, but not
limited to lateral arthroscopic and mini-open shoulder 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 harm from biological hazards cannot be completely excluded.
Name of Consumable
Product Number
Allen Arm Trap Disposal
A-21200
Hug-U-Vac Large Lateral Disposable
A-60102
Hug-U-Vac Standard Lateral Disposable
A-60103

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3Equipment 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:
1. Place the rail clamp over the table rail on either side of the bed below the
patient’s knee (approximate location, placement will vary based on patient
size). Tilt the clamp so the upper jaw engages the rail first, and then lower the
clamp down. Tighten the securing knob (A).
A

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2. Insert the shoulder system’s upright post into the rail clamp.
Note: Do not tighten the power grip handle (B) until the system’s boom has been
properly positioned in Step 3.
3. Knob (C) on the boom section allows you to adjust the boom length. Loosen
the knob by turning counter clockwise. Lock the desired length by tightening
the knob. The boom may also be adjusted up and down by applying a
downward force at lever (D). The locking of the clamp to the device.
Note: Lever (D) is spring loaded to automatically lock into the next available
position.
B

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4. The wheel on the tension device (E) allows you to extend and retract the cable.
Once the patient’s arm has been secured to the cable you can apply traction
to the joint by turn
5. ing the wheel clockwise
3.3 Device controls and indicators:
Tension wheel clockwise rotation increases
the traction load, and anticlockwise
rotation reduces the traction load.
The scale in Tension device is
to indicate the traction load
(for reference only).

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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. See storage Specifications under Product Specification section.
3.4.2 Removal Instruction:
1. Release the rail clamp Power grip handle, to remove the shoulder system.
2. Release the rail clamp securing knob (A) and tilt the rail clamp upwards to remove
the rail clamp from the table rail.
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).
4Safety 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.
d. Read and understand all warnings in this manual and on the device itself prior to
use for patient.
e. Device function should be checked prior to each usage.
f. This device should only be operated by medically trained personnel.

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CAUTION:
Do not exceed safe working load shown in the product specification table
4.2 Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
Mechanical Specifications
Description
Product Dimensions
68" x 15" x 15" (172.7 cm x 38 cm x 38 cm)
Material
Constructed from traditional engineering
materials including stainless steel,
aluminum, and high and low temperature
polymers.
Safe Working Load on the device
16 lbs. (7.25 kg)
Overall Weight of Complete Device
20 lbs. (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 Allen Weightless Shoulder
Suspension System is compatible with:
Allen Simple Clamp
A-40018 (US/ EU Rail)
A-40018-UK (UK Rail)
A-20200, Arm Trap
Operating Room Table Compatibility
The Allen Weightless Shoulder Suspension
System is compatible with the following
surgical table rail styles: US, UK, EU.

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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.
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.
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

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Sl. no
Standards
Description
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

Weightless Shoulder
Suspension System
使用说明
产品编号 R-644-36
80028154
Version B