Skytron F-PTB3SKY User manual

Skytron Patient Transfer Board 3
Instructions for Use
Product No. F-PTB3SKY
80028297
Version A

INSTRUCTIONS FOR USE
Document Number: 80028297 Page 2 Issue Date: 23 MAR 2020
Version: A Ref Blank Template: 80025118 Ver. E
ENGLISH.......................................................................................................................................... 3
EESTI .............................................................................................................................................. 16
FRANÇAIS..................................................................................................................................... 29
DEUTSCH....................................................................................................................................... 44
ITALIANO ...................................................................................................................................... 58
LATVISKI ........................................................................................................................................ 72
LIETUVIŲ ........................................................................................................................................ 85
POLSKI........................................................................................................................................... 98
ROMÂNESC................................................................................................................................ 112
SRPSKI ......................................................................................................................................... 126
SLOVENSKY ................................................................................................................................ 140
SLOVENŠČINA ........................................................................................................................... 155
ESPAÑOL .................................................................................................................................... 168

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
Patient Transfer Board 3 (F-PTB3SKY)
1General 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
2System ................................................................................................................................. 10
System components Identification:......................................................................... 10
Product Code and Description:............................................................................... 10
List of Accessories and Consumable Components Table:................................... 10
Indication for use: ...................................................................................................... 10
Intended use:.............................................................................................................. 11
3Equipment Setup and Use:............................................................................................... 11
Prior to use:.................................................................................................................. 11
Setup:........................................................................................................................... 11
Device controls and indicators:............................................................................... 11
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: ............................................................................................... 12
4Safety Precautions and General Information:............................................................... 12
General Safety Warnings and Cautions: ................................................................ 12
Product Specifications: ............................................................................................. 13
Sterilization Instruction: .............................................................................................. 13
Cleaning and Disinfection Instruction:.................................................................... 13
5List of Applicable Standards: ........................................................................................... 14

INSTRUCTIONS FOR USE
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1General 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.

INSTRUCTIONS FOR USE
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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

INSTRUCTIONS FOR USE
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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)
978-266-4200 (INTERNATIONAL)

INSTRUCTIONS FOR USE
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2System
System components Identification:
Product Code and Description:
FF-PTB3SKY - Patient Transfer Board 3, 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.
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.
Name of Consumable
Product Number
Not Applicable
Not Applicable
Board Section
Device Pin (x2)

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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.
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.
Setup:
The pin type of transfer board is used only with the head end of the surgical
table or a KUB accessory. To install the pin transfer board, follow the instructions
below.
1. To remove the head section from the table, loosen the two locking knobs
under the head section of the table.
2. Pull the head section of the table straight off the back section.
3. Set the head section aside.
4. Slide the pins on the transfer board into the holes on the surgical table.
5. Tighten the two knobs on the table to secure the transfer board.
Device controls and indicators:
This Device does not have controls and indicators.
WARNING: DO NOT use the transfer board as a table extension. This
accessory was designed as a temporary support. Injury to the patient may
occur if the transfer board is used incorrectly.

INSTRUCTIONS FOR USE
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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.
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.
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.

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CAUTION:
Do not exceed safe working load shown in the product specification table
Product Specifications:
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.
Mechanical Specifications
Description
Product Dimensions
Approx. 20 9/16” x 37 ¼” (52cm x 94.6cm))
Material
Stainless Steel, Lectrolite Duotone
Safe Working Load on the device
300 lbs. (136 kg)
Overall Weight of Complete Device
Approx. 5.5 lbs. (2.5 kg)
Storage Specifications
Description
Storage temperature
-29ᵒC to +60ᵒC
Storage Relative humidity range
15% to 85%
Operating temperature
This device is intended to be used in a controlled
Operating Room environment.
Operating Relative humidity range
Electrical Specifications
Description
Not Applicable.
Not Applicable.
Software Specifications
Description
Not Applicable.
Not Applicable.
Compatibility Specifications
Description
The Transfer Board is compatible with:
The following Skytron Items: 1602/1700,
6000/6001 Series, 6002, 6300 Series, 6500,
6500HD, 6600 Series, and 6700 Series.

INSTRUCTIONS FOR USE
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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
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 3
Kasutusjuhend
Toote nr F-PTB3SKY
80028297
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.

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Sisukord
Patient Transfer Board 3 (F-PTB3SKY)
1Üldteave ............................................................................................................................. 19
Autoriõigus .................................................................................................................. 19
Kaubamärgid ............................................................................................................. 19
Kontaktandmed......................................................................................................... 19
Ohutus ......................................................................................................................... 19
1.4.1 Ohusümboli teatis............................................................................................ 19
1.4.2 Seadme väärkasutamise teatis ..................................................................... 19
1.4.3 Teatis kasutajatele ja/või patsientidele........................................................ 20
1.4.4 Ohutu kasutusest kõrvaldamine.................................................................... 20
Süsteemi kasutamine................................................................................................. 20
1.5.1 Olulised sümbolid............................................................................................. 20
1.5.2 Sihtkasutajad ja -patsiendid........................................................................... 21
1.5.3 Vastavus meditsiiniseadmetele kohalduvatele õigusaktidele.................. 22
EMÜ-ga seotud kaalutlused...................................................................................... 22
Tootja volitatud esindaja EÜ-s .................................................................................. 22
Tootja teave................................................................................................................ 22
2Süsteem............................................................................................................................... 23
Süsteemi osade tuvastamine ................................................................................... 23
Toote kood ja kirjeldus............................................................................................... 23
Tarvikute ja kuluosade tabel .................................................................................... 23
Näidustused ................................................................................................................ 23
Sihtotstarve.................................................................................................................. 24
3Seadme ettevalmistamine ja kasutamine..................................................................... 24
Enne kasutamist.......................................................................................................... 24
Ettevalmistamine........................................................................................................ 24
Seadme juhtseadised ja näidikud........................................................................... 24
Säilitamise, käitlemise ja eemaldamise juhised ..................................................... 25
3.4.1 Säilitamine ja käitlemine................................................................................. 25
3.4.2 Eemaldamisjuhised.......................................................................................... 25
Veaotsingujuhend ..................................................................................................... 25

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Seadme hooldamine ................................................................................................ 25
4Ohutusnõuded ja üldteave ............................................................................................. 25
Üldised ohutusega seotud hoiatused ja ettevaatusteated................................. 25
Toote tehnilised andmed.......................................................................................... 26
Steriliseerimisjuhised ................................................................................................... 26
Puhastamise ja desinfitseerimise juhised................................................................. 27
5Kohaldatavad standardid ............................................................................................... 27

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1Üldteave
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. Patentide nimekirja leiate lehelt
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.

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1.4.3 Teatis kasutajatele ja/või patsientidele
Kõigist seadmega seoses toimunud tõsistest vahejuhtumitest tuleb teavitada
käesoleva kasutusjuhendi jaotises 1.3 toodud kontaktandmetel ning kasutaja ja/või
patsiendi asukohaks oleva liikmesriigi pädevat asutust.
Märkus. Lugege kasutusjuhiseid operatsioonilaua kasutusjuhendist. Ärge ületage
operatsioonilaua tootja määratud kandevõimet.
OPERATSIOONILAUA KANDEVÕIMET EI TOHI ÜLETADA
1.4.4 Ohutu kasutusest kõrvaldamine
Kliendid peavad järgima kõiki riiklikke, osariigi, piirkondlikke ja/või kohalikke seadusi
ning määrusi meditsiiniseadmete ja -tarvikute jäätmete ohutu kõrvaldamise kohta.
Kahtluse korral peab seadme kasutaja võtma kõigepealt ühendust tarnijaga, et
saada juhised jäätmete ohutu kõrvaldamise eeskirjade kohta.
Süsteemi kasutamine
1.5.1 Olulised sümbolid
Sümbol
Kirjeldus
Viide
Näitab, et tegu on
meditsiiniseadmega.
MDR 2017/745
Näitab, kes on meditsiiniseadme tootja.
EN ISO 15223-1
Tootja määratud seadme
seerianumber. Seadme seerianumber
on vormingus 1AANNSSSSSSS.
AA on valmistamisaasta, nt
118NNSSSSSSS, kus 18 näitab, et
seade valmistati aastal 2018.
NN on valmistamisnädala number
tavakalendri järgi. (Ühekohalisele
numbrile eelneb null.)
SSSSSSS on kordumatu
järjenumber.
EN ISO 15223-1