Ama Tech F-ASLWF User manual

Anesthesia Screen with Wings
Instructions for Use
Product No. F-ASLWF
80028288
Version B

INSTRUCTIONS FOR USE
Document Number: 80028288 Page 2 Issue Date: 27 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
ENGLISH ......................................................................................................................................... 3
FRANÇAIS .................................................................................................................................... 17
DEUTSCH ...................................................................................................................................... 31
ITALIANO ..................................................................................................................................... 46
PORTUGUÊS ................................................................................................................................. 60
ROMÂNESC ................................................................................................................................. 74
SRPSKI .......................................................................................................................................... 88
SLOVENSKY ............................................................................................................................... 103
SLOVENŠČINA .......................................................................................................................... 117
ESPAÑOL ................................................................................................................................... 131

INSTRUCTIONS FOR USE
Document Number: 80028288 Page 3 Issue Date: 27 MAR 2020
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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
Anesthesia Screen with Wings (F-ASLWF)
General Information........................................................................................................ 6
1.1 Copyright Notice: ........................................................................................................ 6
1.2 Trademarks:................................................................................................................... 6
1.3 Contact Details: ........................................................................................................... 7
1.4 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: ..................................................................................................... 7
1.5 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: ............................................ 9
1.6 EMC considerations:.................................................................................................... 9
1.7 EC authorized representative: ................................................................................. 10
1.8 Manufacturing Information: ..................................................................................... 10
System............................................................................................................................ 10
2.1 System components Identification:......................................................................... 10
2.2 Product Code and Description:............................................................................... 10
2.3 List of Accessories and Consumable Components Table:................................... 11
2.4 Indication for use: ...................................................................................................... 11
2.5 Intended use:.............................................................................................................. 11
Equipment Setup and Use: ........................................................................................... 12
3.1 Prior to use:.................................................................................................................. 12
3.2 Setup:........................................................................................................................... 12
3.3 Device controls and indicators:............................................................................... 12
3.4 Storage, Handling and Removal Instructions:........................................................ 12
3.4.1 Storage and Handling: ................................................................................... 12
3.4.2 Removal Instruction:........................................................................................ 12
3.5 Troubleshooting Guide:............................................................................................. 13

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3.6 Device Maintenance: ............................................................................................... 13
Safety Precautions and General Information: ............................................................ 13
4.1 General Safety Warnings and Cautions: ................................................................ 13
4.2 Product Specifications: ............................................................................................. 14
4.3 Sterilization Instruction: .............................................................................................. 14
4.4 Cleaning and Disinfection Instruction:.................................................................... 14
List of Applicable Standards:........................................................................................ 15

INSTRUCTIONS FOR USE
Document Number: 80028288 Page 6 Issue Date: 27 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
General Information
AMATECH Corporation is a subsidiary of Allen Medical Systems, Inc. which 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.
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 in www.allenmedical.com/pages/terms-
conditions.
Product may be covered by one or more patents. Please consult listing at
www.hill-rom.com/patents for any patent(s).

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1.3 Contact Details:
For complains or ordering information, please contact your supplier and refer to the
catalog. All modifications, upgrades, or repairs must be performed by an
authorized specialist.
1.4 Safety Considerations:
1.4.1 Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE AND 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
using the contact details provided in section 1.3 of this Instruction for Use and to 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
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 users of the device shall first contact their supplier for guidance on
safe disposal protocols.

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

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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
Intended to show when the IFU should
be referenced 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.
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.

INSTRUCTIONS FOR USE
Document Number: 80028288 Page 10 Issue Date: 27 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
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)
System
2.1 System components Identification:
2.2 Product Code and Description:
F-ASLWF ANESTHESIA SCREEN,FOLDING
Wing
Knob
Cross
Bar
Angle Adjustment Knob
Post
Crossbar
Knob
Mount Lock
Lever

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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
Accessory Cart
F-30010 (US), F-30010E (EU),
F-30010UK (UK)
Note: Consult the corresponding IFU for the products mentioned in the above table.
2.4 Indication for use:
The Flexible Anesthesia Screen is used in a variety of surgical procedures including,
but not limited to supine, prone, and lateral positioning. This device is capable of
being used with a broad patient population as determined appropriate by the
caregiver or institution.
2.5 Intended use:
The Flexible Anesthesia Screen is designed to holds the drape above the patient's
face to provide visual access to the patient's face for anesthesia. It is used in a variety
of surgical procedures including, but not limited to supine, prone, lateral positioning.
This device is intended to be used by healthcare professionals within the Operating
Room setting.
Name of Consumable
Product Number
Not Applicable
Not Applicable

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Equipment 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:
a. To mount anesthesia screen onto table rail, place the bottom of the mount below
the rail at an angle (illustration A). Next tilt mount into the vertical position. Place
the anesthesia screen next to the patient’s neck opposite the patient transfer side
of the table then turn lock lever clockwise.
b. Unlock by turning the crossbar knob. Rotate the crossbar in the table socket clamp
such as to swing the crossbar away from the table for unobstructed patient
transfer. (Stored position).
c. After the patient has been transferred and placed in the final position the crossbar
can be elevated and rotated into a position above the patient.
d. The angle adjustment knob, found above the mount, may be used to angle the
post over the patient’s shoulder when it is desired to place the crossbar above the
patient’s chest.
e. Adjust the “wings” by loosening the wing knobs and placing in the desired
orientation. Retighten the wing knobs when desired position is achieved.
3.3 Device controls and indicators:
Controls and indicators of this device are described within the Setup instructions.
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:
Removal instructions are the reverse of the installation instructions

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3.5 Troubleshooting Guide:
This device does not have a troubleshooting guide. For technical support users of the
device shall first contact their supplier.
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 us if you need to repair or replace the device by using the information
from the contact details section (1.3).
Safety 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. 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. Test the locking mechanism to ensure no movement when elevated or
pushed.
CAUTION:
Do not exceed safe working load shown in the product specification table

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4.2 Product Specifications:
Note: Consult the corresponding IFU for the products mentioned in the above table.
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.
Mechanical Specifications
Description
Product Dimensions
Adjust vertically from 22” to 30”
(56 cm x 76.2 cm)
Material
Stainless Steel, nylon, Aluminum
Safe Working Load on the device
5 lbs. (2.3 kg)
Overall Weight of Complete Device
Approx. 5 lbs. (2.3 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
Operating Room Table compatibility
This Device is compatible with the following
rail styles: US Rail

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List 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.
ISTA
International Safe Transit Association standards
for package testing

Anesthesia Screen with Wings
Instructions d'utilisation
N° de produit F-ASLWF
80028288
Version B

INSTRUCTIONS D'UTILISATION
Document Number: 80028288 Page 17 Issue Date: 27 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
INFORMATIONS IMPORTANTES
•Lisez et comprenez tous les avertissements dans ce manuel et sur le
dispositif avant de l'utiliser avec un patient.
•Le symbole sert à alerter l'utilisateur 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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Table des matières
Anesthesia Screen with Wings (F-ASLWF)
Informations générales................................................................................................. 20
1.1 Avis de droits d'auteur :............................................................................................. 20
1.2 Marques de commerce :.......................................................................................... 20
1.3 Coordonnées :............................................................................................................ 21
1.4 Consignes de sécurité :............................................................................................. 21
1.4.1 Avis relatif au symbole de danger pour la sécurité :.................................. 21
1.4.2 Avis de mauvaise utilisation de l'équipement :........................................... 21
1.4.3 Avis aux utilisateurs et/ou aux patients : ...................................................... 21
1.4.4 Mise au rebut en toute sécurité : .................................................................. 21
1.5 Utilisation du système :............................................................................................... 22
1.5.1 Symboles applicables :................................................................................... 22
1.5.2 Population de patients et utilisateurs prévus :............................................. 23
1.5.3 Conformité au règlement relatif aux dispositifs médicaux :...................... 23
1.6 Considérations relatives à la CEM :......................................................................... 23
1.7 Représentant autorisé dans la CE : ......................................................................... 24
1.8 Informations de fabrication :.................................................................................... 24
Système ......................................................................................................................... 24
2.1 Identification des composants du système : ......................................................... 24
2.2 Code produit et description :................................................................................... 24
2.3 Tableau de la liste des accessoires et composants consommables : ............... 25
2.4 Indication d'utilisation :.............................................................................................. 25
2.5 Usage prévu :.............................................................................................................. 25
Mise en place et utilisation du dispositif : ................................................................... 26
3.1 Avant l'emploi :........................................................................................................... 26
3.2 Mise en place :........................................................................................................... 26
3.3 Commandes et indicateurs du dispositif :.............................................................. 26
3.4 Instructions de stockage, de manipulation et de retrait :.................................... 26
3.4.1 Stockage et manipulation : ........................................................................... 26
3.4.2 Instructions de retrait :..................................................................................... 27
3.5 Guide de dépannage : ............................................................................................ 27

INSTRUCTIONS D'UTILISATION
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3.6 Entretien du dispositif :............................................................................................... 27
Consignes de sécurité et renseignements généraux : .............................................. 27
4.1 Avertissements et mises en garde de sécurité générale : ................................... 27
4.2 Spécifications du produit :........................................................................................ 28
4.3 Instructions de stérilisation :....................................................................................... 28
4.4 Instructions de nettoyage et de désinfection : ..................................................... 29
Liste des normes applicables :..................................................................................... 29

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Informations générales
AMATECH Corporation est une filiale d'Allen Medical Systems, Inc., elle-même filiale
de Hill-Rom, Inc. (NYSE : HRC), fabricant et fournisseur leader mondial de
technologies médicales et de services connexes pour le secteur des soins de santé.
Nous sommes une entreprise leader dans le domaine du positionnement du patient
et notre passion est d'optimiser la guérison du patient et la sécurité du personnel
soignant, tout en améliorant l'efficience de nos clients. Notre inspiration vient de
notre enthousiasme à développer des solutions innovantes pour répondre aux
besoins les plus pressants de nos clients. Nous nous immergeons dans le monde de
nos clients pour mieux répondre à leurs attentes et aux défis quotidiens de leur
environnement. Qu'il s'agisse de développer une solution pour relever les défis de
positionnement du patient ou de créer un système offrant un accès sûr et efficace
au site chirurgical pour l'équipe chirurgicale, nous nous engageons à fournir des
produits d'une qualité et d'une valeur exceptionnelles.
1.1 Avis de droits d'auteur :
Révision
© 2019 Allen Medical Systems Inc. TOUS DROITS RÉSERVÉS.
Aucune partie du présent document ne doit être reproduite ou transmise sous
quelque forme ou par quelque moyen que ce soit, électronique ou mécanique, y
compris la photocopie, l'enregistrement, ou par tout système d'information ou de
récupération sans l'autorisation écrite d'Allen Medical Systems, Inc. (Allen Medical).
Les informations contenues dans ce manuel sont confidentielles et ne peuvent pas
être divulguées à des tiers sans le consentement écrit préalable d'Allen Medical.
1.2 Marques de commerce :
Les informations sur les marques de commerce sont disponibles à l'adresse
www.allenmedical.com/pages/terms-conditions.
Le produit peut être protégé par un ou plusieurs brevets. Veuillez consulter la liste à
l'adresse www.hill-rom.com/patents pour tout brevet.