Hillrom O-AHTR User manual

Basic Rectangular Table,
Basic Hourglass Table & Basic Carpa®Table
Instructions for Use
Product No. O-AHTR, OAHTH, O-AHMPT
80028133
Version B

INSTRUCTIONS FOR USE
Document Number: 80028133 Page 2 Issue Date: 27 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
ENGLISH ........................................................................................................................................... 3
FRANÇAIS ...................................................................................................................................... 19
DEUTSCH........................................................................................................................................ 36
ITALIANO........................................................................................................................................ 52
ROMÂNESC ................................................................................................................................... 68
SRPSKI............................................................................................................................................. 84
SLOVENSKY.................................................................................................................................. 100
SLOVENŠČINA............................................................................................................................. 116
ESPAÑOL...................................................................................................................................... 132
SVENSKA ...................................................................................................................................... 149

INSTRUCTIONS FOR USE
Document Number: 80028133 Page 3 Issue Date: 27 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: 80028133 Page 4 Issue Date: 27 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
Table of Contents
Basic Rectangular Table, Basic Hourglass Table, Basic Carpa Table (O-AHTR, OAHTH,
O-AHMPT)
1General 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
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: ...............................................................................................12
Prior to use: ..................................................................................................................12
Setup: ...........................................................................................................................13
Device controls and indicators: ...............................................................................13

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Storage, Handling and Removal Instructions: ........................................................13
3.4.1 Storage and Handling:....................................................................................13
3.4.2 Removal Instruction: ........................................................................................14
Troubleshooting Guide: .............................................................................................14
Device Maintenance:................................................................................................14
4Safety Precautions and General Information:...............................................................14
General Safety Warnings and Cautions:.................................................................14
Product Specifications:..............................................................................................15
Sterilization Instruction:...............................................................................................16
Cleaning and Disinfection Instruction:.....................................................................16
5List of Applicable Standards:............................................................................................16

INSTRUCTIONS FOR USE
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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).

INSTRUCTIONS FOR USE
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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 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]

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

INSTRUCTIONS FOR USE
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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.

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025117 Ver. F
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:
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-AHTR - Basic Rectangular Arm and Hand Table
O-AHTH - Basic Hourglass Table
O-AHMPT - Basic Carpa Table
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 Rectangular Table Pad
O-AHTP
Basic Carpa®Table Pad
O-AHMPTP
Basic Hourglass Table Pad
O-AHTHP1.5
Accessory Rail
Frame Brace
Rail Clamp
Leg Lock Handle
Leg Extension Knob

INSTRUCTIONS FOR USE
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Note: Consult the corresponding IFU for the products mentioned in the above table.
Indication for use:
The Basic Arm / Hand, Hourglass and Capra Tables are 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.
Intended use:
The Basic Arm / Hand, Hourglass and Capra Tables are 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 safety standards. However, Patient harm from
misuse 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.
Name of Consumable
Product Number
Not Applicable
Not Applicable

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Setup:
1. Place the two rail clamps on the surgical table’s back
section rail approximately 12”, 30cm, apart on the
patient’s affected side.
2. Hold the table vertically above the rail clamps with
the frame braces outboard of the surgical table and
the Mounting Blades pointing toward the open slots
of the rail clamps.
3. Lower the blades into the clamps & tighten the rail
clamp locking knobs.
4. Fold the table down making sure that the frame
brace ends engage the brace openings in the
mounting blades.
5. To adjust height, loosen the rail clamp knobs. Grasp
the table top adjacent to the rail clamps and raise or
lower the table to the desired height. Securely tighten
the rail clamp knobs.
6. O-AHTR and O-AHTH Only. With the Table set at the
surgeons working height, loosen Leg Lock Handle at
the ball socket near end of table. Swing the leg down
and slide ball socket to position of least interference with surgeon, C-arm, etc.
Loosen Leg Extension Knob and adjust leg length so the foot is securely against
the floor. Firmly lock both handles to stabilize table end.
Note: Support leg may be folded up out of the way for C-arm access only. Care must
be taken not to apply any additional loads beyond the patient’s arm weight while
the support leg is not in contact with the floor. (O-AHMPT do not have a leg).
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.

INSTRUCTIONS FOR USE
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3.4.2 Removal Instruction:
1. Remove both handles to stabilize table end.
2. Remove the mounting blades.
3. Remove the rail clamps.
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
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

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Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
Mechanical Specifications
Description
Product Dimensions
Basic Rectangular Table
14" x 32"(35.5 cm x 81 cm)
Basic Hourglass Table
14" x 31"(35.5 cm x 79 cm)
Basic Carpa Table
14" x 26"(35.5 cm x 66 cm)
Material
Phenolic
Safe Working Load on the device
400 lbs. (181 kg) Patient
Overall Weight of Complete Device
Basic Rectangular Table
8.8 lbs. (4kg)
Basic Hourglass Table
11 lbs. (4.9 kg)
Basic Carpa Table
7.4 lbs. (3.4kg)
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 Basic Rectangular, Hourglass, and
Carpa Tables are compatible with:
Easy Lock®Blade Clamp
A-40040 (US), A-40041 (EU Rail),
A-40042 (UK Rail), A-40043 (Japan Rail)

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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
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

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Sl. no
Standards
Description
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

Basic Rectangular Table,
Basic Hourglass Table & Basic Carpa®Table
Instructions d'utilisation
N° de produits O-AHTR, OAHTH, O-AHMPT
80028133
Version B

INSTRUCTIONS D'UTILISATION
Document Number: 80028133 Page 19 Issue Date: 27 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
INFORMATIONS IMPORTANTES
•Lisez et assimilez tous les avertissements présents dans ce manuel et sur le
dispositif avant de l'utiliser avec un patient.
•Le symbole sert à alerter l'utilisateur à propos de procédures importantes
ou d'instructions de sécurité concernant l'utilisation de ce dispositif.
Le symbole sur les étiquettes sert à indiquer quand il est nécessaire de
se reporter aux instructions d'utilisation.
•Les techniques détaillées dans ce manuel sont uniquement des suggestions
du fabricant. La responsabilité finale des soins au patient en ce qui
concerne ce dispositif incombe au médecin traitant.
•Le fonctionnement du dispositif doit être contrôlé avant chaque utilisation.
•Le dispositif doit être utilisé uniquement par du personnel qualifié.
•Toutes les modifications, mises à jour ou réparations doivent être effectuées
par un spécialiste agréé.
•Gardez ce manuel pour référence future.
•Tout incident grave qui survient en lien avec le dispositif doit être signalé au
fabricant et à l'autorité compétente figurant dans le présent document.
Avant d'utiliser ce dispositif ou tout autre dispositif médical avec un
patient, il est recommandé de lire les Instructions d'utilisation et de
se familiariser avec le produit.

INSTRUCTIONS D'UTILISATION
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Version: B Ref Blank Template: 80025117 Ver. F
Table des matières
Basic Rectangular Table, Basic Hourglass Table, Basic Carpa Table (O-AHTR, OAHTH,
O-AHMPT)
1Informations générales :....................................................................................................22
Avis de droits d'auteur : .............................................................................................22
Marques de commerce : ..........................................................................................22
Coordonnées :............................................................................................................23
Consignes de sécurité : .............................................................................................23
1.4.1 Avis relatif au symbole de danger pour la sécurité : ..................................23
1.4.2 Avis de mauvaise utilisation de l'équipement : ...........................................23
1.4.3 Avis aux utilisateurs et/ou aux patients :.......................................................23
1.4.4 Mise au rebut en toute sécurité :...................................................................24
Utilisation du système :...............................................................................................24
1.5.1 Symboles applicables : ...................................................................................24
1.5.2 Population de patients et utilisateurs prévus : .............................................25
1.5.3 Conformité au règlement relatif aux dispositifs médicaux : ......................26
Considérations relatives à la CEM :..........................................................................26
Représentant autorisé dans la CE :..........................................................................26
Informations de fabrication : ....................................................................................26
Informations sur l'importateur dans l'UE : .................................................................26
Informations sur le partenaire australien :...............................................................26
2Système ...............................................................................................................................28
Identification des composants du système :..........................................................28
Code produit et description : ...................................................................................28
Liste des accessoires et tableau des consommables :.........................................28
Indication d'utilisation : ..............................................................................................29
Usage prévu :..............................................................................................................29
Risque résiduel : ..........................................................................................................29
3Mise en place et utilisation du dispositif : .......................................................................29
Avant l'emploi :...........................................................................................................29
Mise en place : ...........................................................................................................30
Commandes et indicateurs du dispositif : ..............................................................31