Skytron F-ABSS User manual

Skytron Easy Armboard
Instructions for Use
Product No. F-ABSS
80028234
Version B

INSTRUCTIONS FOR USE
Document Number: 80028234 Page 2 Issue Date: 18 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
ENGLISH ........................................................................................................................................ 3
EESTI ........................................................................................................................................... 18
FRANÇAIS..................................................................................................................................... 33
DEUTSCH....................................................................................................................................... 49
ITALIANO ...................................................................................................................................... 66
LATVISKI ..................................................................................................................................... 81
LIETUVIŲ ..................................................................................................................................... 96
POLSKI ........................................................................................................................................ 111
ROMÂNESC................................................................................................................................ 126
SRPSKI ......................................................................................................................................... 141
SLOVENSKY ................................................................................................................................ 157
SLOVENŠČINA ........................................................................................................................... 173
ESPAÑOL .................................................................................................................................. 188

INSTRUCTIONS FOR USE
Document Number: 80028234 Page 3 Issue Date: 18 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
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: 80028234 Page 4 Issue Date: 18 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
Table of Contents
Easy Armboard (F-ABSS)
1. 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: .................................................................................................. 8
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:.................................................................................................10
1.7 EC authorized representative:...................................................................................10
1.8 Manufacturing Information:........................................................................................10
2System............................................................................................................................ 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
2.6 Residual risk: ............................................................................................................11
3Equipment Setup and Use: ........................................................................................... 12
3.1 Prior to use:...............................................................................................................12
3.2 Setup: .......................................................................................................................12
3.3 Device controls and indicators:..................................................................................13
3.4 Storage, Handling and Removal Instructions:............................................................13
3.4.1 Storage and Handling: ....................................................................................13
3.4.2 Removal Instruction: .......................................................................................13
3.5 Troubleshooting Guide:.............................................................................................13

INSTRUCTIONS FOR USE
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3.6 Device Maintenance:.................................................................................................14
4Safety Precautions and General Information: ............................................................ 14
4.1 General Safety Warnings and Cautions: ...................................................................14
4.2 Product Specifications:..............................................................................................14
4.3 Sterilization Instruction:.............................................................................................15
4.4 Cleaning and Disinfection Instruction: .......................................................................15
5List of Applicable Standards:........................................................................................ 16

INSTRUCTIONS FOR USE
Document Number: 80028234 Page 6 Issue Date: 18 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
1. 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 ordering information please see catalog.
customer service Information:
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 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
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
1-800-759-8766
Address: 5000 36th Street SE
Grand Rapids, MI 49512
North America

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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 your supplier for guidance on safe
disposal protocols.
1.5 Operating the system:
1.5.1 Applicable Symbols:
Symbol used
Description
Reference
Indicates the device is a medical
device
MDR 2017/745
Indicates the medical device
manufacturer
EN ISO 15223-1
Indicates the manufacturer’s serial
number. The device serial number is
encoded as 1YYWWSSSSSSS.
YY indicates the year of
manufacture. i.e. 118WWSSSSSSS
where 18 represents the year
2018.
WW indicates the number of the
manufacturing week per a
standard shop calendar.
(Leading zeros included.)
SSSSSSS is a sequential unique
number.
EN ISO 15223-1
Indicates the medical device Global
Trade Item Number
21 CFR 830
MDR 2017/745
Indicates the 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

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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
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 the
safe working load specified in 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
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1.6 EMC considerations:
This is not an electromechanical device. Therefore, EMC Declarations are not
applicable.
1.7 EC authorized representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: [phone]
1.8 Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
2System
2.1 System components Identification:
2.2 Product Code and Description:
F-ABSS - Armboard, Surgical Skytron

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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 Armboard is used in a variety of surgical procedures including, but not limited
to spine surgery. These devices are capable of being used with a broad patient
population as determined appropriate by the caregiver or institution.
2.5 Intended use:
The Armboard is designed to position and support the patient’s non operative
arm in a variety of surgical procedures including, but not limited to spine surgery.
These devices are intended to be used by healthcare professionals within the
Operating Room setting.
2.6 Residual risk:
This product complies with relevant performance, safety standards. However,
device, patient harm from misuse, device damage or functional hazards cannot
be completely excluded.
Name of Consumable
Product Number
Not Applicable
Not Applicable

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3Equipment Setup and Use:
3.1 Prior to use:
a. Inspect the product looking for any visible damage or sharp edges that could
be caused by a drop or impact during storage.
b. Make sure product has been properly cleaned and disinfected and wiped dry
prior to each use.
3.2 Setup:
a. Hold the Armboard in a horizontal
position.
b. Tilt the end of the board up
approximately 2 to 3" (5 to 7,6cm). Hook
the upper jaw of the mount over the
table rail and allow the end of the
board to return to horizontal position.
The latch should engage the bottom
edge of the rail and the Armboard
should now be fastened to the table.
Lift the end of the board to ensure that
it is locked to the rail.

INSTRUCTIONS FOR USE
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c. To adjust the Armboards radial
angulation SIMPLY LIFT UP ON THE END
OF THE BOARD and move it in the
desired direction. Lower the end of the
Armboard and the weight of the arm
will lock the board in position. Do not
apply excessive force when lifting the
end of the Armboard. Only 2–3lbs
(0,9–1,4kg) of such force should be
required to disengage the lock
mechanism during repositioning.
Extreme upward forces could damage
the Armboard.
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.
3.4.2 Removal Instruction:
a. Grasp the end of the Armboard with one hand. With the other hand lift the
latch handle.
b. Lift the end of the board up and pull the Armboard away from the rail.
3.5 Troubleshooting Guide:
This device does not have a troubleshooting guide. For technical support users of
the device shall first contact their supplier.
Be careful not to install the armboard at a table section articulation level. the
armboard could be damaged in case of movement.

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3.6 Device Maintenance:
Make sure that all labels are installed and can be read. Replace labels as
necessary by using a plastic scraper to remove the label. Use an alcohol wipe to
remove any adhesive residue.
Contact Allen Medical Systems, Inc. if you need to repair or replace the device
contact us using the information from the contact details section (1.3).
4Safety Precautions and General Information:
4.1 General Safety Warnings and Cautions:
WARNING:
a. Do not use if product shows visible damage.
b. Prior to using this device, please read the instructions for equipment set up and
use. Familiarize yourself with the product before application on a patient.
c. To prevent patient and/or user injury and/or equipment damage, examine the
device and surgical-table side rails for potential damage or wear prior to use. Do
not use the device if damage is visible, if parts are missing or if it does not function
as expected.
d. 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:
a. Do not exceed safe working load shown in the product specification table
b. To prevent patient and/or user injury and/or equipment damage: all
modifications, upgrades, or repairs must be performed by an Allen authorized
specialist. Failure to comply may void warranty.
4.2 Product Specifications:
Mechanical Specifications
Description
Product Dimensions
26" x 5 1⁄2" (66 x 14 cm)
Material
Fiberesin
Vinyl
Aluminum
Stainless Steel

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4.3 Sterilization Instruction:
This device is not intended to be sterilized. Equipment damage may occur.
4.4 Cleaning and Disinfection Instruction:
WARNING:
Do not use bleach or products that contain bleach to clean the device. Injury or
equipment damage can occur.
After each use, clean the device with alcohol-based wipes.
Do not put the device into water. Equipment damage can occur.
Use a cloth and a quaternary ammonium disinfecting/cleaning solution to clean and
disinfect the device.
Read and follow the manufacturer’s recommendation for low-level disinfection.
Read and follow the cleaning product’s instructions. Use caution in areas where
liquid can get into the mechanism.
Wipe the device with a clean, dry cloth.
Make sure that the device is dry before you store it or use it again.
CAUTION: DO NOT IMMERSE PADS IN ANY LIQUID
CAUTION: DO NOT USE BLEACH OR PHENOLICS ON PADS
CAUTION: DO NOT USE BLEACH OR PHENOLICS
Safe Working Load on the device
400 lbs. (181 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
Following rail styles:
US

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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

Skytron Easy Armboard
Kasutusjuhend
Toote nr F-ABSS
80028234
Version B

KASUTUSJUHEND
Document Number: 80028234 Lehekülg 18 Issue Date: 18 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
OLULISED MÄRKUSED
•Enne seadme patsiendil kasutamist lugege läbi kõik käesolevas juhendis ja
seadmel endal olevad hoiatused ning tehke need endale selgeks.
•Sümbol teavitab kasutajat tähtsatest seadme kasutamisega seotud
tööjuhistest või ohutusjuhistest.
Märgistusel olev sümbol tuletab kasutajale meelde, et enne kasutamist
tuleb lugeda kasutusjuhendit.
•Käesoleva juhendi juhised on tootja soovitused. Lõplik vastutus seadme
patsientide ravis kasutamise eest on raviarstil.
•Enne igat kasutuskorda tuleb kontrollida, et seade oleks töökorras.
•Seadet tohib kasutada ainult asjakohase väljaõppe saanud personal.
•Modifitseerida, täiendada ja remontida tohib ainult volitatud spetsialist.
•Hoidke juhend alles, et vajaduse korral saaks seda uuesti lugeda.
•Kui seadmega seoses leiab aset tõsine vahejuhtum, tuleb sellest teatada
tootjale ning käesolevas dokumendis nimetatud pädevale asutusele.
Enne selle või muu meditsiiniseadme patsiendil kasutamist on
soovitatav lugeda läbi toote kasutusjuhend ning teha selle kasutamine
endale selgeks.

KASUTUSJUHEND
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Version: B Ref Blank Template: 80025118 Ver. E
Sisukord
Easy Armboard (F-ABSS)
1Üldteave ........................................................................................................................ 21
1.1 Autoriõigus................................................................................................................21
1.2 Kaubamärgid.............................................................................................................21
1.3 Kontaktandmed.........................................................................................................22
1.4 Ohutus......................................................................................................................22
1.4.1 Ohusümboli teatis: ..........................................................................................22
1.4.2 Seadme väärkasutamise teatis: ......................................................................22
1.4.3 Teatis kasutajatele ja/või patsientidele:...........................................................22
1.4.4 Ohutu kasutusest kõrvaldamine:.....................................................................23
1.5 Süsteemi kasutamine................................................................................................23
1.5.1 Olulised sümbolid:...........................................................................................23
1.5.2 Sihtkasutajad ja -patsiendid ............................................................................24
1.5.3 Vastavus meditsiiniseadmetele kohaldatavatele õigusaktidele........................24
1.6 EMÜ-ga seotud kaalutlused: .....................................................................................25
1.7Tootja volitatud esindaja EÜ-s:..................................................................................25
1.8 Tootja teave:.............................................................................................................25
2Süsteem ......................................................................................................................... 25
2.1 Süsteemi osade tuvastamine: ...................................................................................25
2.2 Toote kood ja kirjeldus: .............................................................................................25
2.3 Tarvikute ja kuluosade tabel:.....................................................................................26
2.4 Näidustused:.............................................................................................................26
2.5 Sihtotstarve:..............................................................................................................26
2.6 Jääkrisk:....................................................................................................................26
3Seadme ettevalmistamine ja kasutamine.................................................................. 27
3.1 Enne kasutamist........................................................................................................27
3.2 Ettevalmistamine.......................................................................................................27
3.3 Seadme juhtseadised ja näidikud:.............................................................................28
3.4 Säilitamise, käitlemise ja eemaldamise juhised:........................................................28
3.4.1 Säilitamine ja käitlemine:.................................................................................28
3.4.2 Eemaldamisjuhised.........................................................................................28
3.5 Veaotsingujuhend: ....................................................................................................28

KASUTUSJUHEND
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3.6 Seadme hooldamine: ................................................................................................29
4Ohutusnõuded ja üldteave .......................................................................................... 29
4.1 Üldised ohutusega seotud hoiatused ja ettevaatusteated:.........................................29
4.2 Toote tehnilised andmed:..........................................................................................29
4.3 Steriliseerimisjuhised: ...............................................................................................30
4.4 Puhastamise ja desinfitseerimise juhised:.................................................................30
5Kohaldatavad standardid: ........................................................................................... 31