Hillrom A-70115 User manual

AP-Vantage Table Adaptor
Instructions for Use
Product No. A-70115
80028171
Version B
Allen® C-Flex AP- Vantage Table Adaptor (A-70115)

INSTRUCTIONS FOR USE
Document Number: 80028171 Page 2 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
ENGLISH ........................................................................................................................................ 3
DANSK ........................................................................................................................................ 20
FRANÇAIS ................................................................................................................................... 37
DEUTSCH ..................................................................................................................................... 54
ITALIANO .................................................................................................................................... 72
ROMÂNESC ................................................................................................................................ 89
SRPSKI ....................................................................................................................................... 108
SLOVENSKY .............................................................................................................................. 125
SLOVENŠČINA ......................................................................................................................... 142
ESPAÑOL .................................................................................................................................. 159
SVENSKA ................................................................................................................................... 177

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
Allen®AP- Vantage Table Adaptor (A-70115)
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: ..................................................................................................... 8
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: .......................................... 10
EMC considerations:.................................................................................................. 10
EC authorized representative: ................................................................................. 10
Manufacturing Information: ..................................................................................... 10
EU Importer Information: ........................................................................................... 10
Australian sponsor Information:................................................................................ 10
2System ................................................................................................................................. 11
System components Identification:......................................................................... 11
Product Code and Description:............................................................................... 11
List of Accessories and Consumable Components Table:................................... 11
Indication for use: ...................................................................................................... 12
Intended use:.............................................................................................................. 12
3Equipment Setup and Use:............................................................................................... 12
Prior to use:.................................................................................................................. 12
Setup:........................................................................................................................... 12
Device controls and indicators:............................................................................... 15
Storage, Handling and Removal Instructions:........................................................ 15
3.4.1 Storage and Handling: ................................................................................... 15

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3.4.2 Removal Instruction:........................................................................................ 15
Troubleshooting Guide:............................................................................................. 15
Device Maintenance: ............................................................................................... 16
4Safety Precautions and General Information:............................................................... 16
General Safety Warnings and Cautions: ................................................................ 16
Product Specifications: ............................................................................................. 16
Sterilization Instruction: .............................................................................................. 17
Cleaning and Disinfection Instruction:.................................................................... 17
5List of Applicable Standards: ........................................................................................... 18

INSTRUCTIONS FOR USE
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1. General Information:
Allen Medical Systems, Inc. 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.
Allen products are backed by responsive and reliable service and complimentary on-
site product demonstrations.
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 at Allenmedical.com/pages/terms-
conditions.
Products may be covered by one or more patents. Please consult listing at
Hill-rom.com/patents for any patent(s).

INSTRUCTIONS FOR USE
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International
North America
Contact Details:
For ordering information please see catalog.
Allen Customer Service Contact Information:
Safety Considerations:
1.4.1 Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR 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
to the manufacturer and 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
[phone]
[phone] ext.4286
[phone]
[phone]

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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 Hill-Rom Technical Support 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
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

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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
Indicates the need for the user to
consult the instruction 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

INSTRUCTIONS FOR USE
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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)
EU Importer Information:
TRUMPF Medizin Systeme GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany
Australian sponsor Information:
Welch Allyn Australia Pty. Ltd.
Unit 4.01, 2-4 Lyonpark Road
Macquarie Park, NSW 2113 - Phone [phone]

INSTRUCTIONS FOR USE
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2System
System components Identification:
Product Code and Description:
A-70115 –AP-Vantage Table Adaptor
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
C-Flex Head Positioner System
A-70701
Note: Consult the corresponding IFU for the products mentioned in the above table.
Name of Consumable
Product number
Comfort Mask Disposable
A-70310
Rail Clamp
Lateral Lock
Knob
Long Rail
Rail Clamp Knob
Lateral Lock Knob
Long Rail
Rail Clamp Knob
Rail
Clamp
Cross Brace

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Indication for use:
The AP-Vantage Table Adaptor 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 AP-Vantage Table Adaptor is designed to use in combination with the C-Flex
head positioner to position and support the patient’s head 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.
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. Remove any plug-in or ratcheted sections from the end of the OR table where
the table adaptor will be mounted. The table adaptor should only be mounted
to powered table sections.
d. The AP-Vantage is rated to support a 500lb (227kg) patient. This device does
extend the operating table. Review the OR table users guide to verify that the
OR table's weight capacity will not be exceeded.
e. Refer to the C-Flex owner’s manual for instructions on using C-Flex and head
modules.
Setup:
a. Completely unscrew the rail clamp
knobs and lateral locking knobs.

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b. Set the rail clamp width to fit the
accessory rails. The table adaptor
should be centered on the OR table.
c. Slide the table adaptor onto the
accessory rails. The rail clamps must clear
any stops and be completely engaged
on the accessory rail. The table adaptor
may be slid further down the accessory
rails if desired.
Make sure that the accessory rails sit
properly in the clamp.
Make sure the rail clamps are not
mounted across two accessory rails at
a hinge point.

INSTRUCTIONS FOR USE
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d. Tighten the rail clamp knobs while
applying light upward pressure to the
table adaptor.
e. Tighten the lateral locking knobs.
f. Test that the device is properly
mounted by the following procedure:
Verify that both rail clamps
are tight by lifting and
lowering the table adaptor
to look for play in each rail
clamp.
Verify the lateral knobs are
tight by pulling and pushing
the table adaptor side to
side.

INSTRUCTIONS FOR USE
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g. Attach C-Flex to the end of the table adaptor. The C-Flex may be
mounted anywhere along the table adaptor rails.
Device controls and indicators:
Controls and indicators of this device are described within the Setup instructions.
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:
a. Remove the C-Flex from the table adaptor. Remove the leg and/or traction bar
if they were used.
b. Completely loosen the knobs on the rail clamps.
c. Slide the table adaptor off the accessory rails.
Troubleshooting Guide:
This device does not have a troubleshooting guide. For technical support user of
the device shall first contact Hill-Rom Technical Support.

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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).
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. Do not exceed OR table weight capacity.
e. Do not apply weight until rail clamps are fully tightened.
f. Do not adjust table position while using leg.
g. Do not hang traction weight directly off C-Flex, the traction bar must be used.
CAUTION:
Do not exceed safe working load shown in the product specification table.
Product Specifications:
Mechanical Specifications
Description
Product Dimensions
32½” (82.5 cm), 17” (43 cm),
20 -25½” (50.8-64.8 cm) (L X B X H)
Material
Steel, Stainless Steel, Aluminum, Delrin,
Carbon Fiber, Rubber
Safe Working Load on the device
500 lbs. (226 kg) Patient
Overall Weight of Complete Device
14 lbs. (6.4 kg)

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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.
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 Allen C-Flex AP-Vantage Table
Adaptor is compatible with:
Standard OR table rails.

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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:
Requirements for the basic safety and essential
performance of operating tables
7
ISTA
International Safe Transit Association standards for
package testing

AP-Vantage Table Adaptor
Brugsanvisning
varenr. A-70115
80028171
Version B
Allen® C-Flex AP- Vantage Table Adaptor (A-70115)

BRUGSANVISNING
Document Number: 80028171 Side 20 Issue Date: 26 MAR 2020
Version: B Ref Blank Template: 80025117 Ver. F
VIGTIGE BEMÆRKNINGER
•Læs og forstå alle advarsler i denne manual og på selve enheden, før
denne anvendes til en patient.
•Symbolet er beregnet til at advare brugeren om vigtige procedurer
eller sikkerhedsanvisninger vedr. brugen af denne enhed.
Symbolet på mærkater er beregnet til at vise, når brugsanvisningen
skal anvendes.
•De teknikker, der beskrives i manualen, er udelukkende producentens
anbefalinger. Det endelige ansvar for patientplejen med hensyn til
enheden ligger hos den behandlende læge.
•Før hver anvendelse skal det kontrolleres, at enheden fungerer.
•Enheden skal altid betjenes af uddannet personale.
•Alle ændringer, opgraderinger og reparationer skal udføres af en
autoriseret specialist.
•Sørg for, at denne manual er til rådighed til fremtidig reference.
Enhver alvorlig hændelse, der er opstået i forhold til enheden, skal
meddeles til fabrikanten og den ansvarlige myndighed, der er angivet i
dette dokument.
Inden brug af dette og andre former for medicinsk udstyr med en
patient anbefales det, at man læser brugsanvisningen og sætter sig
ind i produktet.