Ama Tech F-70801 User manual

Radiolucent Spine Surgery Frame
Instructions for Use
Product No. F-70801
80028263
Version B

INSTRUCTIONS FOR USE
Document Number: 80028263 Page 2 Issue Date: 25 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
ENGLISH.......................................................................................................................................... 3
БЪЛГАРСКИ................................................................................................................................. 23
中文简体........................................................................................................................................ 43
HRVATSKI ...................................................................................................................................... 65
ČESKÝ ........................................................................................................................................... 88
DANSK ........................................................................................................................................ 108
NEDERLANDS ............................................................................................................................. 128
EESTI ............................................................................................................................................ 148
SUOMI......................................................................................................................................... 168
FRANÇAIS................................................................................................................................... 188
DEUTSCH..................................................................................................................................... 208
ΕΛΛΗΝΙΚΑ .................................................................................................................................. 228
MAGYAR .................................................................................................................................... 248
ITALIANO .................................................................................................................................... 268
日本語版...................................................................................................................................... 288
한국어.......................................................................................................................................... 308
LATVISKI ...................................................................................................................................... 329
LIETUVIŲ ...................................................................................................................................... 349
NORSK ........................................................................................................................................ 369
POLSKI......................................................................................................................................... 389
PORTUGUÊS................................................................................................................................ 409
ROMÂNESC................................................................................................................................ 429
РУССКИЙ .................................................................................................................................. 450
SRPSKI ......................................................................................................................................... 470
SLOVENSKY ................................................................................................................................ 491
SLOVENŠČINA ........................................................................................................................... 512
ESPAÑOL .................................................................................................................................... 534
SVENSKA..................................................................................................................................... 554
TÜRK ............................................................................................................................................ 574

INSTRUCTIONS FOR USE
Document Number: 80028263 Page 3 Issue Date: 25 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: 80028263 Page 4 Issue Date: 25 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
Table of Contents
Radiolucent Spine Surgery Frame (F-70801)
1General Information............................................................................................................ 6
Copyright Notice:........................................................................................................ 6
Trademarks:............................................................................................................... 6
Contact Details:.......................................................................................................... 7
Safety Considerations:............................................................................................... 7
1.4.1 Safety hazard symbol notice:........................................................................... 7
1.4.2 Equipment misuse notice:................................................................................ 7
1.4.3 Notice to users and/or patients:........................................................................ 7
1.4.4 Safe disposal: .................................................................................................. 7
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
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:.........................................11
Indication for use:......................................................................................................11
Intended use:............................................................................................................11
Residual risk: ............................................................................................................11
3Equipment Setup and Use:............................................................................................... 12
Prior to use:...............................................................................................................12
Setup: .......................................................................................................................12
Device controls and indicators:..................................................................................13
Storage, Handling and Removal Instructions:............................................................18
3.4.1 Storage and Handling: ....................................................................................18
3.4.2 Removal Instruction: .......................................................................................18
Troubleshooting Guide:.............................................................................................18

INSTRUCTIONS FOR USE
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Version: B Ref Blank Template: 80025118 Ver. E
Device Maintenance:.................................................................................................18
4Safety Precautions and General Information:............................................................... 19
General Safety Warnings and Cautions: ...................................................................19
Product Specifications:..............................................................................................20
Sterilization Instruction:.............................................................................................20
Cleaning and Disinfection Instruction: .......................................................................20
5List of Applicable Standards: ........................................................................................... 21

INSTRUCTIONS FOR USE
Document Number: 80028263 Page 6 Issue Date: 25 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
1General 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.
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).

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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.
Safety Considerations:
1.4.1 Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE AND MATERIAL
DEGRADATION.
1.4.2 Equipment misuse notice:
Do not use product if package is damaged or unintentionally opened before use.
All modifications, upgrades, or repairs must be performed by an authorized specialist.
1.4.3 Notice to users and/or patients:
Any serious incident that has occurred in relation to the device should be reported
using the contact details provided in section 1.3 of this Instruction for Use and to the
competent authority of the Member State in which the user and/or patient is
established.
Note: Refer to the surgical table manufacturer's user guide for instructions on use.
Always refer to the surgical table manufacturer’s weight limits.
NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE
1.4.4 Safe disposal:
Customers should adhere to all federal, state, regional, and/or local laws and
regulations as it pertains to the safe disposal of medical devices and accessories. If
in doubt, the user of the device shall first contact your supplier for guidance on safe
disposal protocols.

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Operating the system:
1.5.1 Applicable Symbols:
Symbol used
Description
Reference
Indicates the device is a medical device
MDR 2017/745
Indicates the medical device manufacturer
EN ISO 15223-1
Indicates the manufacturer’s serial number.
The device serial number is encoded as
1YYWWSSSSSSS.
YY indicates the year of manufacture. i.e.
118WWSSSSSSS where 18 represents the
year 2018.
WW indicates the number of the
manufacturing week per a standard shop
calendar. (Leading zeros included.)
SSSSSSS is a sequential unique number.
EN ISO 15223-1
Indicates the medical device Global Trade
Item Number
21 CFR 830
MDR 2017/745
Indicates the date when the medical device
was manufactured
EN ISO 15223-1
Indicates the manufacturer’s lot code using
the Julian Date yyddd, where yy indicates the
last two digits of the year and ddd indicates
the day of the year. i.e. April 4th, 2019 would
be represented as 19094.
EN ISO 15223-1
Indicates the manufacturer’s catalogue
number
EN ISO 15223-1
Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions
EN ISO 15223-1
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

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Indicates the Medical Device complies to
REGULATION (EU) 2017/745
MDR 2017/745
Indicates a Warning
IEC 60601-1
Intended to show when the IFU should be
referenced for use
EN ISO 15223-1
1.5.2 Intended User and Patient Population:
Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare professionals
involved in the device intended procedure. Not intended for Lay persons.
Intended Populations: This device is intended to be used with patients that do not
exceed the weight in the safe working load field specified in the product
specification section 4.2.
1.5.3 Compliance with medical device regulations:
This product is a non-invasive, Class I Medical Device. This system is CE-
marked according to Annex VIII, Rule 1, of the Medical Device
Regulations (REGULATION (EU) 2017/745)
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:
Radiolucent Spine Surgery Frame:
Product Code and Description:
F-70801 - Radiolucent Spine Surgery Frame
Crank Handle
Pads
Front Catch
Buttons
Rail Rod
Connectors
Velcro Straps

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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
Foam Head Block Stand
F-70825
Radiolucent Spine Surgery Frame Cart
F-70815
Note: Consult the corresponding IFU for the products mentioned in the above table.
CAUTION: Reuse of disposables will lead to patient cross contamination and/or
device failure.
Indication for use:
The Spine Surgery Frame 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.
Intended use:
The Spine Surgery Frame is designed to position and support the patient’s chest
and abdomen 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
Residual risk:
This product complies with relevant performance, safety standards. However,
device or patient harm from misuse, device, functional, device damage or
mechanical hazards cannot be completely excluded.
Name of Consumable
Product number
Spine Surgery Frame Skin Care Covers
F-70810
Spine Surgery Frame Standard Covers
F-70805
Foam Head Block
F-70862

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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.
c. Verify Hook/Loop Straps are in good condition
d. Verify table under Radiolucent Spine Surgery Frame is rated for patient
weight. (If this information is not available confirm rating with table
manufacturer prior to loading a patient).
e. Verify Velcro Straps are in good condition.
Setup:
1. Hold Radiolucent Spine Surgery
Frame above table and verify
there is enough room to lower
the frame.
2. Place Frame on OR table with
Buttons facing head end of OR
table.
3. Ensure enough room for head
positioner.
4. Ensure frame is centered
between OR table rails.

INSTRUCTIONS FOR USE
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5. Place Velcro straps through OR
Table Rails.
6. Bring Velcro straps around rails
and secure back to Radiolucent
Spine Surgery Frame.
Device controls and indicators:
To Adjust Pad Height:
1. Insert Crank Handle into
Radiolucent Spine Surgery
Frame as shown.
2. Press Crank Handle in until fully
engaged.

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3. Support Crank Handle Rod with
one hand and grab handle with
other.
To Adjust Pad height:
•To raise Radiolucent Spine Surgery
Frame pads, turn the handle
counterclockwise.
•To lower Radiolucent Spine Surgery
Frame pads, turn the handle
clockwise.
To adjust pad width:
1. Ensure pads are at lowest height.

INSTRUCTIONS FOR USE
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2. To release band, press inward at
free end of band while pulling
upward at center of band.
3. Pull band out from Pad Band
Catch.
To adjust pad width:
4. Locate Pad Width Adjustment
Button at opposite end of
frame.
5. Press button firmly.

INSTRUCTIONS FOR USE
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6. Shift rail laterally to desired
location and release button.
To adjust pad width:
7. Lower rail to front catch.
8. Press firmly inwards and tuck into
Pad Band Catch.
Loading the Patient:
Note: 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.

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(Optional/Recommended) Place
moisture absorbing / friction
reducing covers over the
supports.
Prior to transferring the patient, crank frame to highest setting. After
transferring the patient, lower to desired level.
Position the patient to reduce nerve contact and subsequent injury.
Additional support must be provided to the head, arms and legs.
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.
Cover Cross Rod
using Cross Rod
Cover Disposable
or use other
padding
Cover Rail Rod Connectors
Cover Front Catch

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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.
3.4.2 Removal Instruction:
To remove from table
1. Remove Velcro strap from
Radiolucent Spine Surgery
Frame and unwrap from rail.
2. Remove from table and store.
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).

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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.
e. All modifications, upgrades, or repairs must be performed by an authorized
specialist.
f. To reduce the chances of patient tissue damage, care should be taken to ensure
proper orientation and location of supports.
g. To reduce the chances of skin maceration and shear, it is required that a
disposable cover be used between the patient and the pads.
h. To avoid serious injury to patient, additional restraints must be used to securely
restrain the patient to the OR table prior to tilting the system.
i. Do not tilt or flex the OR table while Bow Frame is on it.
CAUTION:
Do not exceed safe working load shown in the product specification table.

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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
28 ½” X 21” X 9 ¼”
(724 mm × 533 mm × 235 mm) (L×W×H)
Material
ABS Plastic, UHMW –PE, Stainless Steel,
Engineering Composites, High Density
Foam, Low Density, Foam, Garolite
Safe Working Load on the device
500 lbs. (226 kg)
Overall Weight of Complete Device
29 lbs. (13,2 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 Radiolucent Spine Surgery Frame is
compatible with:
a. Spine System
b. Jackson Table or Mizuho Modular Table
c. Most competitor tables with 1 ¼” (3.2
cm) W x 1 ½” (3.8 cm) H x 17” (43 cm)
spaced rails.