Hillrom R-734-10 User manual

Wrist Arthroscopy Tower System
Instructions for Use
Product No. R-734-10
80028155
Version D

INSTRUCTIONS FOR USE
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Version D Ref Blank Template: 80025117 Ver. F.
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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
Wrist Arthroscopy Tower System (R-734-10)
1. General Information: ...........................................................................................................6
Copyright Notice:.........................................................................................................6
Trademarks:...................................................................................................................6
Contact Details:............................................................................................................7
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:......................................................................................................8
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:...........................................10
EMC considerations: ..................................................................................................10
EC authorized representative:..................................................................................10
Manufacturing Information:......................................................................................10
EU Importer Information:............................................................................................10
Authorised Australian sponsor:..................................................................................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:..............................................................................................................13
Residual Risk: ...............................................................................................................13
3Equipment Setup and Use:...............................................................................................13
Prior to use: ..................................................................................................................13
Setup: ...........................................................................................................................13
Device controls and indicators: ...............................................................................18
Storage, Handling and Removal Instructions:........................................................18

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3.4.1 Storage and Handling:....................................................................................18
3.4.2 Removal Instruction: ........................................................................................18
Troubleshooting Guide: .............................................................................................18
Device Maintenance:................................................................................................18
4Safety Precautions and General Information:...............................................................19
General Safety Warnings and Cautions: ................................................................19
Product Specifications:..............................................................................................19
Sterilization Instruction:...............................................................................................20
Cleaning and Disinfection Instruction: ....................................................................21
5List of Applicable Standards:............................................................................................21

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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
© 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
(2 digits) and ddd indicates the date of
the year (3 digits)
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.
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:
R-734-10 - Allen Wrist Arthroscopy Tower System
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
Basic Hourglass Table
O-AHTH
The Equalizer
R-734-05
Basic Rectangular Table
O-AHTR
Support Extension
Middle Tower
Section
Swivel Hook
Wrist Stabilizer
Finger Traps
Counter Traction
Device
Lower Tower
Section
Swivel adjustment
Tension Device
Swivel Head
Simple Clamp
Tension Device
Angle Adjustment

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Name of Accessory
Product Number
Basic Carpa Table
O-AHMPT
Pad, Arm/ Hand Tbl, No insert
O-AHTP
Pad, Arm/ Hand Tbl, Hourgl.No Ins 2”
O-AHTHP
Replacement Pad, Carpa Table 1 1/2"
O-AHMPTP
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.
Indication for use:
The Wrist Arthroscopy Tower is used in a variety of surgical procedures including, but
not limited to arthroscopic or open Orthopedic surgery. These devices are capable
of being used with a broad patient population as determined appropriate by the
caregiver or institution.
Name of Consumable
Product Number
Finger Traps (Sterile)
Singles:
A-30522-2 Single, Large
A-30522-4 Single, Medium
A-30522-5 Single, Small
A-30522-8 Single, Extra Large
A-30522-9 Single Pediatric
rap
Doubles:
A- 30522-1 Double, Large
A-30522-3 Double, Medium
A-30522-6 Double, Small
A-30522-7 Double, Extra Large

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Intended use:
The Wrist Arthroscopy Tower is designed to position, support and/or distract the
patient’s hand, wrist, forearm and arm in a variety of surgical procedures including,
but not limited to arthroscopic or open 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 and safety standards. However,
user from misuse, device damage or malfunction hazards cannot be completely
excluded.
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 Simple Clamp over
the table rail at approximately
the patient’s nipple line. Tighten
Securing Knob (A).

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2. Loosen the Power Grip (B) and
insert the first tower upright
making sure that the notched
section at the top of the upright is
positioned as shown here (C).
Tighten the Power Grip (B) on the
Simple Clamp.
3. Insert the next tower section into
the first section. The notched
portion of each tower upright
should engage each other,
locking the sections together.
4. Insert the tension device into the
tower.

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5. The tension device section rotates
freely within the tower and its
position is locked by tightening the
Power Grip (D). The extension arm (E)
of the tension device should point
away from the table, toward the
elbow of the patient’s extended
arm.
6. For greater flexibility, the angle of
the tension device can be adjusted
by pulling down on the pin (F).
Release the pin to lock in the desired
position, making sure the pin
engages the locking slot.
7. The location of the pulley (G) on the
tension device extension arm is
adjustable. Place the pulley directly
over the patient’s elbow, and secure
by tightening the knob.

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8. Extend or retract the cable by
loosening or tightening the tension
wheel (H).
9. Place the patient’s fingers into Allen
finger traps and attach the trap(s) to
the tower cable. Loosen or tighten
cable so that the patient’s upper arm is
level with the top of the operating room
table.
10. Position the tower accessory clamp on
to the lower Tower half. While
supporting the clamp, introduce the
counter traction retractor blade into
the clamp.

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11. Place the counter traction retractor
over the patient’s biceps (I) and secure
its position by tightening the knob on
the accessory clamp (J). Place traction
on the patient’s arm by turning the
wheel on the tension device (K).
12. Place another accessory clamp on the
tower. Position the tower accessory
clamp on to the upper tower half.
13. Insert the wrist stabilizing plate (L) into
the clamp. Adjust the stabilizing plate
so that it supports is secures the hand
and provides a solid working surface.
Tighten both knobs one to secure the
clamp to the upright and one to
secure the stabilizer in the clamp. The
stabilizing plate and adjustable tension
head allow 180-degree hand
positioning capability.

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Device controls and indicators:
Scale on the tension device is to indicate
the traction load (for reference only)
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. Remove the wrist stabilizing plate from the clamp.
2. Remove another accessory clamp from the tower.
3. Remove the counter traction retractor over the patient’s biceps.
4. Remove the tension device from the tower by loosening the power grip.
5. Remove the next tower section from the table.
6. Remove the Simple Clamp from the table rail.
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).

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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.
d. Device function should be checked prior to each usage.
e. 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. Do not reuse the Consumables such as Allen Finger traps.
b. Do not re-sterilize the Consumables such as Allen Finger traps.
c. Do not exceed safe working load shown in the product specification table.
Product Specifications:
Mechanical Specifications
Description
Product Dimensions
1 1/8" X 42 1/2" X 20 1/8" (2.8 cm x 108 cm x 51 cm)
Material
Aluminum, Stainless Steel, and Engineering
Polymers.
Safe Working Load on the device
16 lbs. (7.25 kg)
Overall Weight of Complete
Device
14 lbs. (6.4 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

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Note: Consult the corresponding IFU for the products mentioned in the above table.
Sterilization Instruction:
Following are the parts which will undergo sterilization process:
a. Allen® Wrist Arthroscopy Tower System: Autoclave sterilization.
Pre-Vac Steam Sterilizer - 10 minutes 270 °F or 132 °C @ 28 psig
Note: Device will be supplied as NON-STERILE, but it is the user responsibility
to sterilize the device before use.
Sterilization
Full Cycle Instructions
Cycle Type: Pre-vacuum Sterilization
Temperature: 132.2°C -1°C +3°C
Sterilization Time: 4.0 minutes
Minimum Dry Time: 45 minutes
Packaging: Two (2) layers non-woven CSR wrap
Cool-Down Time: 90 Minutes
Electrical Specifications
Description
Not Applicable.
Not Applicable.
Software Specifications
Description
Not Applicable.
Not Applicable.
Compatibility Specifications
Description
The Allen Wrist Arthroscopy Tower
System is compatible with:
Allen Simple Clamp
•A-40018 (US/ EU Rail)
•A-40018-UK (UK Rail)
R-734-05, The Equalizer
Finger Traps (See the Catalog for Part numbers)
Operating Room Table
Compatibility
The Allen Wrist Arthroscopy Tower System is
compatible with the following surgical table rail
styles: US, UK, EU