Hillrom O-ABRC User manual

Armboard Cradle
Instructions for Use
Product No. O-ABRC
80028148
Version B

INSTRUCTIONS FOR USE
Document Number: 80028148 Page 2 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
ENGLISH.......................................................................................................................................... 2
ČESKÝ ........................................................................................................................................... 19
DANSK .......................................................................................................................................... 35
NEDERLANDS ............................................................................................................................... 51
SUOMI........................................................................................................................................... 67
FRANÇAIS..................................................................................................................................... 83
DEUTSCH..................................................................................................................................... 100
ΕΛΛΗΝΙΚΑ .................................................................................................................................. 117
MAGYAR .................................................................................................................................... 135
ITALIANO .................................................................................................................................... 152
LATVISKI ...................................................................................................................................... 168
NORSK ........................................................................................................................................ 184
POLSKI......................................................................................................................................... 200
PORTUGUÊS................................................................................................................................ 217
ROMÂNESC................................................................................................................................ 233
SRPSKI ......................................................................................................................................... 250
SLOVENSKY ................................................................................................................................ 267
SLOVENŠČINA ........................................................................................................................... 284
ESPAÑOL .................................................................................................................................... 300
SVENSKA..................................................................................................................................... 317

INSTRUCTIONS FOR USE
Document Number: 80028148 Page 3 Issue Date: 13 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: 80028148 Page 4 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
Table of Contents
Armboard Cradle (O-ABRC)
1. General 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: ............................................ 9
2System ................................................................................................................................. 11
3Equipment Setup and Use:............................................................................................... 13

INSTRUCTIONS FOR USE
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3.4.1 Storage and Handling: ................................................................................... 14
3.4.2 Removal Instruction:........................................................................................ 14
4Safety Precautions and General Information:............................................................... 15
5List of Applicable Standards: ........................................................................................... 17

INSTRUCTIONS FOR USE
Document Number: 80028148 Page 6 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
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).

INSTRUCTIONS FOR USE
Document Number: 80028148 Page 7 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
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 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]

INSTRUCTIONS FOR USE
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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
Indicates the date when the medical
device was manufactured
EN ISO 15223-1

INSTRUCTIONS FOR USE
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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:
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)

INSTRUCTIONS FOR USE
Document Number: 80028148 Page 10 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
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:
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
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2System
System components Identification:
Product Code and Description:
O-ABRC - ARMBOARD RESTRAINT CRADLE
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
Accessory Cart
A-30010
Easy Armboard with Trigger
O-ABSLT
Easy Armboard Lift-to-Position
O-ABSL
Armboard Cradle Strap
Armboard Cradle Pad

INSTRUCTIONS FOR USE
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Note: Consult the corresponding IFU for the products mentioned in the above table.
Indication for use:
The Rotating Spine Positioner devices are used in a variety of surgical procedures
including, but not limited to surgery with supine positioning. These devices are
capable of being used with a broad patient population as determined appropriate
by the caregiver or institution.
Intended use:
The Restraint Cradle is designed to position and support the patient’s arm in a
variety of surgical procedures including, but not limited to surgery with supine
positioning. 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 harm from misuse or device damage hazard 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.
c. As with any unfamiliar patient positioning device, you should always practice its
use on a nurse, physician or other appropriate volunteer prior to using it clinically.
Setup:
1. Place Armboard cradle on
Allen Easy Armboard. Remove
Ease Armboard pad before
placing the Armboard cradle.
2. Secure the Straps around the
Easy Armboard.
3. Place the Easy Armboard Pad

INSTRUCTIONS FOR USE
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4. Place Patient’s arm on the
device at the desired position.
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.
3.4.2 Removal Instruction:
a. Safely remove patient’s arm from the device.
b. Remove Armboard Pad from Armboard Cradle.
c. Release Straps and remove Cradle from Easy Armboard.
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:
Do not exceed safe working load shown in the product specification table
Product Specifications:
Mechanical Specifications
Description
Product Dimensions
Arm Cradle: 18" x 6" (45.7cm x 15.2cm)
Pad: 18 3/16 " X 8" x 3/4"
(46.2cm x 20.3cm x 1.9cm)
Material
Arm Cradle: Smoked Lexan -3/16 Thick
Pad Cover Material: Lectrolite, Duotone
On Bottom and Flap Material

INSTRUCTIONS FOR USE
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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.
Safe Working Load on the device
500 lbs. patient (226.8 kg)
Overall Weight of Complete Device
4 lbs. (1.8 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 Armboard Cradle is compatible
with:
Easy Armboard with Trigger (O-ABSLT)
Easy Armboard Lift-to-Position (O-ABSL)

INSTRUCTIONS FOR USE
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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
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

Armboard Cradle
Návod k použití
Výrobek č. O-ABRC
80028148
Version B

NÁVOD K POUŽITÍ
Document Number: 80028148 Strana 19 Issue Date: 13 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
DŮLEŽITÁ UPOZORNĚNÍ
•Přečtěte si veškerá varování uvedená v tomto návodu a na zařízení dříve,
než ho začnete používat s pacientem.
•Symbol má upozornit uživatele na důležité postupy nebo bezpečnostní
pokyny týkající se používání tohoto zařízení.
Symbol na štítcích upozorňuje na nutnost použití návodu k obsluze.
•Techniky uváděné v této příručce slouží pouze jako doporučení ze strany
výrobce. Odpovědnost za péči o pacienta pokud jde o toto zařízení nese
vždy vyšetřující lékař.
•Funkci zařízení je třeba před každým použitím zkontrolovat.
•Toto zařízení smí obsluhovat pouze vyškolený personál.
•Veškeré jeho úpravy, vylepšení nebo opravy je nutné svěřit
autorizovanému odborníkovi.
•Uchovejte tuto příručku pro budoucí použití.
•Jakákoli závažná událost, která se vyskytla v souvislosti se zařízením, by
měla být nahlášena výrobci a příslušnému orgánu uvedenému v tomto
dokumentu.
Dříve než začnete používat tento nebo jiný typ zdravotnického
přístroje s pacientem, doporučujeme vám prostudovat si Návod
k použití a seznámit se s výrobkem.

NÁVOD K POUŽITÍ
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Version: B Ref Blank Template: 80025117 Ver. F
Obsah
Kryt Armboard Cradle (O-ABRC)
1Obecné informace: .......................................................................................................... 22
1.4.1 Upozornění na bezpečnostním symbolu:..................................................... 23
1.4.2 Upozornění na zneužití zařízení: ..................................................................... 23
1.4.3 Upozornění pro uživatele a/nebo pacienty: ............................................... 23
1.4.4 Bezpečná likvidace:........................................................................................ 24
1.5.1 Platné symboly:................................................................................................ 24
1.5.2 Cílová populace uživatelů a pacientů:....................................................... 25
1.5.3 Dodržování předpisů pro zdravotnické prostředky: ................................... 25
2Systém ................................................................................................................................. 27
3Nastavení a použití zařízení:............................................................................................. 29