Ama Tech F-70820 User manual

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 1
Radiolucent Spine Surgery Frame Replacement
Pad Set
Product No. F-70820
80028574
Version A

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 2
ENGLISH ....................................................................................................................................... 3
БЪЛГАРСКИ............................................................................................................................... 19
中文简体...........................................................................................................................................................35
HRVATSKI.................................................................................................................................... 51
ČESKÝ ......................................................................................................................................... 67
DANSK........................................................................................................................................ 83
NEDERLANDS ............................................................................................................................. 99
EESTI.......................................................................................................................................... 115
SUOMI....................................................................................................................................... 131
FRANÇAIS ................................................................................................................................ 147
DEUTSCH .................................................................................................................................. 163
ΕΛΛΗΝΙΚΑ ................................................................................................................................ 179
MAGYAR.................................................................................................................................. 195
ITALIANO.................................................................................................................................. 211
日本語版........................................................................................................................................................ 227
한국어............................................................................................................................................................................. 243
LATVISKI.................................................................................................................................... 259
LIETUVIŲ.................................................................................................................................... 275
NORSK ...................................................................................................................................... 291
POLSKI ...................................................................................................................................... 307
PORTUGUÊS (PORTUGAL) ....................................................................................................... 323
ROMÂNESC ............................................................................................................................. 339
РУССКИЙ ................................................................................................................................ 355
SLOVENSKY .............................................................................................................................. 371
SLOVENŠČINA ......................................................................................................................... 387
ESPAÑOL.................................................................................................................................. 403
SVENSKA .................................................................................................................................. 419
TÜRK.......................................................................................................................................... 435

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 3
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.
This device is a component of a higher-level medical apparatus.
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
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 4
TABLE OF CONTENTS
1. Contact Details
2. General Safety Warnings and Cautions:
3. Equipment Setup and Use
3.1 Table Compatibility
3.2 Product Specifications
3.3 The Radiolucent Spine Surgery Frame Pad Replacement Set
3.4 Setup
3.5 Loading the patient
4. Cleaning and Maintenance

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 5
1. 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.
2. 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. All modifications, upgrades, or repairs must be performed by an authorized
specialist.
CAUTION: Do not exceed the device safe working load
Wilson is a trademark of Mizuho Orthopaedic Systems, Inc.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 6
31” [788 mm]
3. Equipment Setup and Use
3.1 Table Compatibility
The Radiolucent Spine Surgery Frame Pad Replacement Set is compatible with the
Radiolucent Spine Surgery Frame and OSI Wilson Frame.
Note: Refer to the surgical table manufacturer's user guide for instructions on use.
Always refer to the surgical table manufacturer’s weight limits.
3.2 Product Specifications
•7” [178 mm] W x 31” [788 mm] L x 4.5” [115 mm] H
4,5” [115 mm]

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 7
3.3 The Radiolucent Spine Surgery Frame Pad Replacement Set
Connector Protector Pad-Right
Connector Protector Pad-Left
Radiolucent Spine Surgery Frame Pad
Radiolucent Spine Surgery Frame Pad Fixture

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 8
3.4 Setup
To replace pads:
b. Release rail: press inward at free end of
rail while pulling upward at center of rail
c. Pull rail out from front catch.
a. Ensure pads are at lowest height.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 9
To remove pads:
d. Slide Bow Frame Pad Fixture into
pocket and separate Velcro® between
pad and rail
e. Pull the Pad and Fixture upward and off
the rail
f. Repeat for opposite side.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 10
2” (5 cm) Pieces
1” (2.5 cm) Pieces
To add Velcro®:
a. Remove backing and attach (2x)
1” (2.5 cm ) pieces to top face of
Corner Connectors as shown.
b. Remove backing and attach (2x)
2” (5 cm) pieces to front face of
Corner Connectors as shown.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 11
To add Connector Protector Pad:
a. Place loop of Connector Protector on
Carbon Fiber Band as shown.
Note: Loose leg should be on inside of
frame.
b. Side corner Connector Pad to bottom
of Rail.
c. Repeat for opposite side.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 12
To add Radiolucent Spine Surgery Frame Pads:
a. Slide Radiolucent Spine Surgery Frame Pad Fixture into
pocket of Bow Frame Pad and cover
Velcro ®.
b. Insert the carbon fiber band into the
pocket of the Radiolucent Spine Surgery Frame Pad.
Note: Ensure Velcro ® straps are on
inside of frame.
c. Slide Pad to Bottom of Rail.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 13
To put pads back on:
d. Slide Radiolucent Spine Surgery Frame
Pad over CP Pad.
e. Ensure CP Pad Strap tucks into
Radiolucent Spine Surgery Frame
Pad Pocket
f. Ensure Carbon Fiber Band is sticking
out of top of pad.
g. Pull Bow Frame Pad Fixture out.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 14
To put pads back on:
h. Press pad against carbon fiber, to
secure Velcro in designated area
i. Pull Velcro around and attach to bottom
of pad (3x).
j. Repeat steps a - j on opposite pad.

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 15
Pad Installation Complete

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 16
Check all surfaces exposed to patient to
ensure there is no contact with any hard
or sharp surfaces. Key areas to check are
highlighted below.
3.5 Loading the patient
•Cover Rail Rod Connectors
•Cover Disposable or use
other padding
•Cover Front Catch
•Cover Cross Rod using
Rod Cover

Instructions for Use
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Page 17
4. Cleaning and Maintenance
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.
CAUTION: DO NOT IMMERSE PADS IN ANY LIQUID
CAUTION: DO NOT USE BLEACH OR PHENOLICS TO CLEAN PAD

Инструкции за употреба
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Страница 18
Radiolucent Spine Surgery Frame Replacement
Pad Set
Product No. F-70820
80028574
Version A

Инструкции за употреба
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Страница 19
ВАЖНИ СЪОБЩЕНИЯ
•Прочетете и разберете всички предупреждения в това ръководство и по
самото изделие, преди да го използвате с пациент.
•Символът е предназначен да сигнализира на потребителя за важни
процедури или инструкции за безопасност относно използването на
това изделие.
Символът на етикетите е предназначен да показва кога трябва да
се направи справка с инструкциите за употреба (IFU) за употребата.
•Техниките, описани в това ръководство, са само предложения на
производителя. Окончателната отговорност за грижи за пациента по
отношение на това изделие остава при лекуващия лекар.
•Функцията на изделието трябва да се проверява преди всяка употреба.
•С това изделие трябва да работи единствено обучен персонал.
•Всички модификации, надстройки или ремонти трябва да се
извършват от упълномощен специалист.
•Дръжте това ръководство налично за бъдеща справка.
•Всеки един сериозен инцидент, възникнал във връзка с изделието,
трябва да се докладва на производителя и на компетентния орган,
посочен в този документ.
Това изделие е компонент на медицински апарат от по-високо
ниво. Преди използването на този или друг тип медицински
апарат с пациент се препоръчва да прочетете инструкциите
за употреба и да се запознаете с продукта.

Инструкции за употреба
©2019 Allen Medical Systems, Inc. All Rights Reserved Ref Blank Template: 80026386 Ver. B
Document Number: 80028574 Issue Date: 21 MAY 2020
Version: A Страница 20
СЪДЪРЖАНИЕ
1. Данни за контакт
2. Общи предупреждения за безопасност и сигнали за внимание:
3. Настройване и използване на оборудването
3.1 Съвместимост на масата
3.2 Спецификации на продукта
3.3 Radiolucent Spine Surgery Frame Pad Replacement Set
3.4 Настройване
3.5 Качване на пациента
4. Почистване и поддръжка