Skytron F-PTB2SKY User manual

Skytron Patient Transfer Board
Instructions for Use
Product No. F-PTB2SKY
80028209
Version A

INSTRUCTIONS FOR USE
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Version: A Ref Blank Template: 80025118 Ver. E
ENGLISH ......................................................................................................................................... 3
EESTI ............................................................................................................................................. 17
FRANÇAIS .................................................................................................................................... 31
DEUTSCH ...................................................................................................................................... 46
ITALIANO ..................................................................................................................................... 61
LATVISKI ....................................................................................................................................... 75
LIETUVIŲ ....................................................................................................................................... 89
POLSKI ........................................................................................................................................ 103
ROMÂNESC ............................................................................................................................... 117
SRPSKI ........................................................................................................................................ 132
SLOVENSKY ............................................................................................................................... 146
SLOVENŠČINA .......................................................................................................................... 160
ESPAÑOL ................................................................................................................................... 174

INSTRUCTIONS FOR USE
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IMPORTANT NOTICES
•Read and understand all warnings in this manual and on the device itself
prior to use with a patient.
•The symbol is intended to alert the user to important procedures or
safety instructions regarding the use of this device.
The symbol on the labels is intended to show when the IFU should be
referenced for use.
•The techniques detailed in this manual are only manufacturer’s
suggestions. The final responsibility for patient care with respect to this
device remains with the attending physician.
•Device function should be checked prior to each usage.
•This device should only be operated by trained personnel.
•All modifications, upgrades, or repairs must be performed by an authorized
specialist.
•Keep this manual available for future reference.
•Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority listed in this
document.
Prior to using this or any other type of medical apparatus with a
patient, it is recommended that you read the Instructions for Use and
familiarize yourself with the product.

INSTRUCTIONS FOR USE
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Table of Contents
OEM Stryker Patient Transfer Board 2, Skytron (F-PTB2SKY)
1. General Information............................................................................................................ 6
Copyright Notice: ........................................................................................................ 6
Trademarks:................................................................................................................... 6
Contact Details: ........................................................................................................... 6
Safety Considerations:................................................................................................. 6
1.4.1 Safety hazard symbol notice: .......................................................................... 6
1.4.2 Equipment misuse notice: ................................................................................ 6
1.4.3 Notice to users and/or patients:...................................................................... 7
1.4.4 Safe disposal: ..................................................................................................... 7
Operating the system:................................................................................................. 7
1.5.1 Applicable Symbols:.......................................................................................... 7
1.5.2 Intended User and Patient Population:.......................................................... 8
1.5.3 Compliance with medical device regulations: ............................................ 9
EMC considerations:.................................................................................................... 9
EC authorized representative: ................................................................................... 9
Manufacturing Information: ....................................................................................... 9
System ................................................................................................................................. 10
System components Identification:......................................................................... 10
Product Code and Description:............................................................................... 10
List of Accessories and Consumable Components Table:................................... 10
Indication for use: ...................................................................................................... 11
Intended use:.............................................................................................................. 11
Equipment Setup and Use:............................................................................................... 11
Prior to use:.................................................................................................................. 11
Setup:........................................................................................................................... 11
Device controls and indicators:............................................................................... 12
Storage, Handling and Removal Instructions:........................................................ 12
3.4.1 Storage and Handling: ................................................................................... 12
3.4.2 Removal Instruction:........................................................................................ 12
Troubleshooting Guide:............................................................................................. 12

INSTRUCTIONS FOR USE
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Device Maintenance: ............................................................................................... 13
Safety Precautions and General Information:............................................................... 13
General Safety Warnings and Cautions: ................................................................ 13
Product Specifications: ............................................................................................. 13
Sterilization Instruction: .............................................................................................. 14
Cleaning and Disinfection Instruction:.................................................................... 14
List of Applicable Standards: ........................................................................................... 15

INSTRUCTIONS FOR USE
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1. General Information
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 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).
Contact Details:
For ordering information please see catalog.
Customer service Information:
Phone Number: Address:
1-866-841-5663 571 Silveron Blvd
Flower Mound, TX 75028
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.

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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.
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

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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
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.

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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)
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)
[phone] (INTERNATIONAL)

INSTRUCTIONS FOR USE
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System
System components Identification:
Product Code and Description:
FF-PTB2SKY - Patient Transfer Board 2, Skytron
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
Not Applicable
Not Applicable
Note: Consult the corresponding IFU for the products mentioned in the above table.
Name of Consumable
Product Number
Not Applicable
Not Applicable
Board Blades
Board Section

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Indication for use:
The Transfer Board is used in a variety of surgical procedures including, but not limited
to gynecology, urology, laparoscopy, general and robotic surgery. These devices
are capable of being used with a broad patient population as determined
appropriate by the caregiver or institution.
Intended use:
The Transfer Board is designed to support patient legs during transfer to the OR table
in a variety of surgical procedures including, but not limited to gynecology, urology,
laparoscopy, general and robotic surgery. These devices are intended to be used
by healthcare professionals within the Operating Room setting.
Equipment Setup and Use:
Prior to use:
a. Inspect the product looking for any visible damage or sharp edges that could
be caused by a drop or impact during storage.
b. Make sure product has been properly cleaned and disinfected and wiped dry
prior to each use.
Setup:
The side rail type of transfer board can be installed in place of the foot
section of the table or off of the head section. To install the side rail
transfer board, follow the instructions below:
1. Remove the leg section from
the table, if desired.
2. Align the blades on the transfer
board with the rails on surgical
table.
3. Tilt the transfer board.
4. Insert the blades on the transfer
board under the support on the
side rail of the surgical table.
5. Place the hooks over support
rails on the side rails.
Hook

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6. Tilt the transfer board back down to align with the surgical table.
7. Verify that the transfer board is secure on the side rail of the surgical table.
8. Make sure the blades on the transfer board are under the support on the side rail.
Device controls and indicators:
This Device does not have controls and indicators.
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:
Remove Patient Transfer Board from surgical table by unclipping blades from
spacers found between tabletop and rail.
Troubleshooting Guide:
This device does not have a troubleshooting guide. For technical support user of the
device shall first contact his or her supplier.
Hook
Blade

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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).
Safety Precautions and General Information:
General Safety Warnings and Cautions:
WARNING:
a. Do not use if product shows visible damage.
b. Prior to using this device, please read the instructions for equipment set up and
use. Familiarize yourself with the product before application on a patient.
c. To prevent patient and/or user injury and/or equipment damage, examine the
device and surgical-table side rails for potential damage or wear prior to use. Do
not use the device if damage is visible, if parts are missing or if it does not function
as expected.
d. 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
Product Specifications:
Mechanical Specifications
Description
Product Dimensions
Approx. 20 9/16” x 37 ¼” (52 cm x 94,6 cm)
Material
Stainless Steel, Lectrolite Duotone
Safe Working Load on the device
300 lbs (136 kg)
Overall Weight of Complete Device
5.4 lbs (2.4 kg)
Storage Specifications
Description
Storage temperature
-29ᵒC to +60ᵒC

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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.
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
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 Transfer Board is compatible with:
The following Stryker Items: 1602/1700, 3100 A,
3500 Series, 3600 Series, 6000/6001 Series,
6002, 6300 Series, 6500, 6500HD, 6600 Series,
and 6700 Series.

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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.
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 Patient Transfer Board
Kasutusjuhend
Toote nr F-PTB2SKY
80028209
Version A

KASUTUSJUHEND
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OLULISED MÄRKUSED
•Enne seadme patsiendil kasutamist lugege läbi kõik selles 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.
•Selles juhendis toodud tehnikad on üksnes tootja soovitused. Lõplik vastutus
seadme patsientide ravis kasutamise eest on raviarstil.
•Enne igat kasutuskorda tuleb veenduda, et seade oleks töökorras.
•Seadet tohib kasutada ainult asjakohase väljaõppe saanud personal.
•Seadet tohib modifitseerida, täiendada ja remontida ainult volitatud
spetsialist.
•Hoidke juhend alles, et vajaduse korral saaks seda uuesti lugeda.
•Kui seadmega seoses leiab aset tõsine vahejuhtum, tuleb sellest teavitada
tootjat ning selles dokumendis nimetatud pädevat asutust.
Enne selle või muu meditsiiniseadme patsiendil kasutamist on
soovitatav lugeda läbi toote kasutusjuhend ning teha toote
kasutamine endale selgeks.

KASUTUSJUHEND
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Sisukord
OEM Stryker Patient Transfer Board 2, Skytron (F-PTB2SKY)
Üldteave ............................................................................................................................. 20
Autoriõigus .................................................................................................................. 20
Kaubamärgid ............................................................................................................. 20
Kontaktandmed......................................................................................................... 20
Ohutus ......................................................................................................................... 20
1.4.1 Ohusümboli teatis............................................................................................ 20
1.4.2 Seadme väärkasutamise teatis ..................................................................... 20
1.4.3 Teatis kasutajatele ja/või patsientidele........................................................ 21
1.4.4 Ohutu kasutusest kõrvaldamine.................................................................... 21
Süsteemi kasutamine................................................................................................. 21
1.5.1 Olulised sümbolid............................................................................................. 21
1.5.2 Sihtkasutajad ja -patsiendid........................................................................... 22
1.5.3 Vastavus meditsiiniseadmetele kohalduvatele õigusaktidele.................. 23
EMÜ-ga seotud kaalutlused...................................................................................... 23
Tootja volitatud esindaja EÜ-s .................................................................................. 23
Tootja teave................................................................................................................ 23
Süsteem............................................................................................................................... 24
Süsteemi osade tuvastamine ................................................................................... 24
Toote kood ja kirjeldus............................................................................................... 24
Tarvikute ja kuluosade tabel .................................................................................... 24
Näidustused ................................................................................................................ 25
Sihtotstarve.................................................................................................................. 25
Seadme ettevalmistamine ja kasutamine..................................................................... 25
Enne kasutamist.......................................................................................................... 25
Ettevalmistamine........................................................................................................ 25
Seadme juhtseadised ja näidikud........................................................................... 26
Säilitamise, käitlemise ja eemaldamise juhised ..................................................... 26
3.4.1 Säilitamine ja käitlemine................................................................................. 26
3.4.2 Eemaldamisjuhised.......................................................................................... 26
Veaotsingujuhend ..................................................................................................... 26

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Seadme hooldamine ................................................................................................ 27
Ohutusnõuded ja üldteave ............................................................................................. 27
Üldised ohutusega seotud hoiatused ja ettevaatusteated................................. 27
Toote tehnilised andmed.......................................................................................... 27
Steriliseerimisjuhised ................................................................................................... 28
Puhastamise ja desinfitseerimise juhised................................................................. 28
Kohaldatavad standardid ............................................................................................... 29

KASUTUSJUHEND
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Üldteave
Autoriõigus
Redaktsioon
© 2019 Allen Medical Systems Inc. KÕIK ÕIGUSED ON KAITSTUD.
Selle teksti ühtegi osa ei tohi reprodutseerida ega edastada üheski vormis ega
ühelgi viisil, olgu see siis elektrooniline või mehaaniline, sealhulgas fotokopeerimine,
salvestamine, või mis tahes informatsiooni- või otsingusüsteeme kasutades ilma
ettevõtte Allen Medical Systems, Inc. (Allen Medical) kirjaliku loata.
Selles juhendis sisalduv teave on konfidentsiaalne ja seda ei tohi avaldada
kolmandatele osapooltele ettevõtte Allen Medical eelneva kirjaliku nõusolekuta.
Kaubamärgid
Kaubamärgiteabe leiate lehelt www.allenmedical.com/pages/terms-conditions.
Toode võib olla kaitstud ühe või mitme patendiga. Vaadake patentide loendeid
veebisaidilt www.hill-rom.com/patents.
Kontaktandmed
Tellimisteabe leiate kataloogist.
Klienditeeninduste teave
Telefoninumber: Aadress:
1-866-841-5663 571 Silveron Blvd
Flower Mound, TX 75028
Ohutus
1.4.1 Ohusümboli teatis
MITTE KASUTADA, KUI TOODE ON NÄHTAVALT KAHJUSTUNUD VÕI
SELLE SEISUKORD ON HALVENENUD.
1.4.2 Seadme väärkasutamise teatis
Kui toote pakend on kahjustatud või see on eelnevalt kogemata avatud, ei tohi
toodet kasutada.
Seadet tohib modifitseerida, täiendada ja remontida ainult volitatud spetsialist.