Stryker F-SFFFBER User manual

Spine System
Instructions for Use
Product No. F-SFFFBER
D-720743
Version C

INSTRUCTIONS FOR USE
Document Number: D-720743 Page 2 Issue Date: 15 APR 2020
Version: C Ref Blank Template: 80025118 Ver. E
ENGLISH ........................................................................................................................................ 3
中文简体 ...................................................................................................................................... 34
FRANÇAIS ................................................................................................................................... 65
DEUTSCH ................................................................................................................................... 100
ITALIANO .................................................................................................................................. 131
ESPAÑOL .................................................................................................................................. 163
OTHER LANGUAGES ................................................................................................................ 195

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
Spine System (F-SFFFBER)
1. General 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
2. System ................................................................................................................................. 10
System components Identification:............................................................................10
Product Code and Description:..................................................................................11
List of Accessories and Consumable Components Table:.........................................12
Indication for use:......................................................................................................14
Intended use:............................................................................................................14
Residual risk: ............................................................................................................14
3. Equipment Setup and Use:............................................................................................... 15
Prior to use:...............................................................................................................15
Setup: .......................................................................................................................16
Device controls and indicators:..................................................................................20
Storage, Handling and Removal Instructions:............................................................27
3.4.1 Storage and Handling: ....................................................................................27
3.4.2 Removal Instruction: .......................................................................................27
Troubleshooting Guide:.............................................................................................29

INSTRUCTIONS FOR USE
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Device Maintenance:.................................................................................................29
4. Safety Precautions and General Information:............................................................... 29
General Safety Warnings and Cautions: ...................................................................29
Product Specifications:..............................................................................................30
Sterilization Instruction:.............................................................................................31
Cleaning and Disinfection Instruction: .......................................................................31
5. List of Applicable Standards: ........................................................................................... 32

INSTRUCTIONS FOR USE
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1. General Information
AMATECH Corporation is a subsidiary of Allen Medical Systems, Inc. which is a
subsidiary of Hill-Rom, Inc. (NYSE: HRC), a leading worldwide manufacturer and
provider of medical technologies and related services for the health care industry. As
an industry leader in patient positioning, our passion is improving patient outcomes
and caregiver safety, while enhancing our customers' efficiency. Our inspiration
comes from providing innovative solutions to address our customers' most pressing
needs. We immerse ourselves in our customers' world, to better address these needs
and the daily challenges of their environment. Whether developing a solution to
address patient positioning challenges or creating a system to offer safe and effective
surgical site access for the surgical team, we are committed to providing products of
exceptional value and quality.
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.

INSTRUCTIONS FOR USE
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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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2. System
System components Identification:
Spine System:
Wingsets
Prone Armboard
C-Flex
Easy Lock
Clamp
Armboard Rail
*Patient supports shown here are part of the Allen Spine System.
They are not included with F-SFFFBER but are shown for reference.
C-Prone
Supine Tops

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Product Code and Description:
F-SFFFBER - Spine Frame, Flex Frame, Berchtold
Handle Crank
End Cap
Leg
Rail Clamp
Foot Lock
Floor Lock
Pads
Carbon Fiber
Rails
Handlebar
Corner Connector
Tilt Pin

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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
Spine System OR Table Clamp Set
F-70510
Armboard Rail
F-70500, F-70500-UK, F-70500-EU,
F-70500-DEN, F-70500-JP.
Wing Set System
F-70200
Supine Top
F-70400, F-70403, F-70404
Spine System OR Table Clamps (set)
Left Right
Product Description:
Spine System OR Table Clamps are used to attach the Spine System to the end of a
surgical table.
Arm Board Rail:
Name of Consumable
Product number
Comfort covers
F-70260
Allen Comfort Mask Disposable
F-70310

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Product Description:
This product provides an accessory rail for the Spine System. The accessory rail is used to
install Arm boards onto the Spine System in order to support the patients arm during
surgery.
Wing Set System:
Product Description:
This product is a patient support accessory for the Spine System. It is used to support a
patient’s torso when in the prone position.
Supine Top
Product Description
This product is an attachable top section that is used as an accessory to a spine frame.
It is used to support the patient in the supine position. Typically, four top sections are
needed on a Spine System to create a full operating surface.
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.

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Indication for use:
The Flex Frame is used in a variety of surgical procedures including, but not limited
to spine, cranial, cervical surgery and/or surgery that requires prone, lateral and
supine positioning. These devices are capable of being used with a broad patient
population as determined appropriate by the caregiver or institution.
Intended use:
The Flex frame is designed to position and support the patient’s head, chest, arms,
abdomen and hip in a variety of surgical procedures including, but not limited to
spine, cranial, cervical surgery and/or surgery that requires prone, lateral and
supine positioning. 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 harm from misuse, device damage or mechanical hazards cannot be
completely excluded.

INSTRUCTIONS FOR USE
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3. 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.
c. Position and orient table in the room.
Spine System will extend approximately 5"
(1525 mm) from end of OR table.
d. Remove head section if attaching to back
section.
OR
Remove lower leg section if attaching to
seat section.
e. Place floor lock pads under table, then
engage floor locks. Verify floor locks are
engaged by tugging on floor lock pads.
Ensure OR table is rated for patient weight at connection
(If this information is not available it should be tested prior
to loading a patient).
5’(1525 mm)

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Setup:
1. Position Spine System’s wheels
5"(1525 mm) from end of table
section and remove Rail Clamps
from Handlebar.
2. Attach Rail Clamps to OR table.
Clip on near open area on table rail.
3. Slide to end of rail as shown and
tighten knob securely.
Make sure that the rail clamps are
fully locked onto the accessory
rails prior to loading a patient.
4. Raise leg to its maximum height using the Crank
Handle.
(1525 mm)
5"

INSTRUCTIONS FOR USE
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5. Step on base as shown.
6. Push top of frame forward as shown.
7. "Rock" frame off 1st hook.
8. "Rock" frame off 2nd hook
and lower to ground.
9. Pull End Caps.
10. Lift end of Spine System and place
into table clamps.
Verify OR table’s leg section is clear of
contact with frame if attached to seat
section.

INSTRUCTIONS FOR USE
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11. Push End Caps flush to OR
table clamps. Ensure Flex
Frame is centered on
OR table.
Verify there is a 1” (25 mm) minimum
gap between the OR table and Spine
System.
12. Tighten handles on underside of
frame.
a. Tighten one handle.
b. Verify End Caps are flush and
tighten second side.
1” Min Gap
OR Table
(25 mm)

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13. Verify frame is securely attached
to OR table.
a. Grasp Carbon Fiber Rail as
shown.
b. Push and pull Spine System
to verify it is locked.
14. Lower frame to desired height.
15. Verify leg is vertical and ensure
the base is flush to floor. The
indicator level should be set
to 0° during setup.
Indicator Level

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Device controls and indicators:
Table Attach
Height Adjustment
Lock Location
Base
Lock
Warning
Labels