Hillrom Allen Yellofins Apex O-YFAX User manual

Allen®
Yellofins Apex™
Instructions for Use
Product Code O-YFAX
80028475 VER C
English

INSTRUCTIONS FOR USE
Page 2
English
Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
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.
IMPORTANT NOTICES
• Read and understand all instructions and warnings in this manual and on the device
itself prior to use with a patient. Keep this manual available to train new users.
• 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 symbol is intended to identify that the user must consult the instructions for
use before 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 authorized Hillrom
personnel. Injury or equipment damage can occur.
• Routine maintenance should be performed by facility-authorized personnel. Injury or
equipment damage can occur.
• 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.
• Product images and labels are for illustrative purposes only. Actual product and label
may vary.
• Device function should be checked when you first receive the device.

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
Yellofins Apex™ (O-YFAX)
1. General Information: .......................................................................................................... 5
1.1 Copyright Notice: .......................................................................................................5
1.2 Trademarks: .................................................................................................................5
1.3 Contact Details:..........................................................................................................6
1.4 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:...................................................................6
1.4.4 Safe disposal: ..................................................................................................7
1.5 Operating the system:................................................................................................7
1.5.1 Applicable Symbols: ......................................................................................7
1.5.2 Intended User and Patient Population........................................................9
1.5.3 Compliance with medical device regulations: .........................................9
1.6 EMC considerations....................................................................................................9
1.7 EC authorized representative: ................................................................................10
1.8 Manufacturing Information:....................................................................................10
1.9 EU Importer Information:..........................................................................................10
1.10 Australian sponsor Information: ............................................................................. 10
2. System................................................................................................................................. 11
2.1 System components Identification: .......................................................................11
2.2 Product Code and Description: .............................................................................12
2.3 List of Accessories and Consumable Components Table: ................................ 12
2.4 Indication for use: .....................................................................................................12
2.5 Intended use: ............................................................................................................13
3. Equipment Setup and Use: ...............................................................................................14
3.1 Prior to use: ............................................................................................................... 14
3.2 Setup: ........................................................................................................................ 14
3.2.1 Device Controls and Components............................................................14
3.2.2 Initial Setup ....................................................................................................15
Table of Contents

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
3.2.3 Pre-Use Function Checks.............................................................................17
3.2.4 Put the Patient in the Stirrups ......................................................................18
3.2.5 Change the Orientation of the Stirrup ......................................................20
3.2.6 Change the Lithotomy Angle or Ab/Ad-duction ....................................21
3.2.7 Begin Sterile Draping....................................................................................23
3.2.8 Remove the Patient from the Stirrup: ........................................................23
3.3 Device controls and indicators:..............................................................................24
3.3.1 Labels and Symbols......................................................................................24
3.3.2 Product Labels..............................................................................................26
3.4 Storage, Handling and Removal Instructions: ......................................................27
3.4.1 Storage and Handling: ................................................................................27
3.4.2 Removal Instruction:.....................................................................................27
3.5 Troubleshooting Guide:............................................................................................27
3.6 Device Maintenance:..............................................................................................27
3.6.1 Labels .............................................................................................................27
3.6.2 Periodic Checks............................................................................................28
3.6.3 Replace the Strap ........................................................................................30
3.6.4 Replace the Stirrup Pad ..............................................................................32
4. Safety Precautions and General Information:...............................................................35
4.1 General Safety Warnings and Cautions:...............................................................35
4.2 Product Specifications:............................................................................................36
4.3 Declarations: .............................................................................................................38
4.4 Sterilization Instruction ..............................................................................................39
4.5 Cleaning and Disinfection Instruction:...................................................................39
4.5.1 Cleaning and Disinfection: .........................................................................40
5. List of Applicable Standards:............................................................................................42

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
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.
1.1 Copyright Notice:
Revision
© 2020 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.
1.2 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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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL DEGRADATION.
NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE
1.3 Contact Details:
For ordering information please see catalog.
Allen Customer Service Contact Information:
North America
International
[phone]
[phone] ext.4286
[phone]
[phone]
1.4 Safety Considerations:
1.4.1 Safety hazard symbol notice:
1.4.2 Equipment misuse notice:
Do not use the product if package is damaged or unintentionally opened before use.
All modifications, upgrades, or repairs must be performed by authorized Hillrom
personnel.
Secure and release straps as directed in section 3.2.4 step 6. and 3.2.8 step 5. of this IFU.
Replace straps as directed in section 3.6.3 of this IFU.
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.

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
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.
1.5 Operating the system:
1.5.1 Applicable Symbols:
Symbol used
Description
Reference
Indicates the device is a medical
device
MDR 2017/745
Indicates the device must not be
submerged in liquid.
IEC 60417
Indicates the maximum patient weight.
Does not identify the maximum safe
working load.
N/A
Indicates that bleach must not be used
on the device.
ISO 7000
Indicates the device do not contain
natural rubber or dry natural rubber
latex
EN ISO 15223-1
Indicates that the user must consult the
instructions for use prior to use.
IEC 60601-1
Indicates the need for the user to
consult the instruction for use
EN ISO 15223-1

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
Symbol used
Description
Reference
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 medical device
manufacturer
EN ISO 15223-1
Indicates the date when the medical
device was manufactured
EN ISO 15223-1
Identifies the country of origin
IEC 60417
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 medical device Global
Trade Item Number
21 CFR 830
MDR 2017/745
Indicates the manufacturer's
description of the device.
N/A

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
Symbol used
Description
Reference
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 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
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).
1.6 EMC considerations:
This is not an electromechanical device. Therefore, EMC Declarations are not applicable.

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
1.7 EC authorized representative:
HILL-ROM SAS
B.P. 14 - Z.I. DU TALHOUET
56330 PLUVIGNER
FRANCE
TEL: [phone]
1.8 Manufacturing Information:
ALLEN MEDICAL SYSTEMS, INC.
100 DISCOVERY WAY
ACTON, MA 01720 USA
800-433-5774 (NORTH AMERICA)
978-266-4200 (INTERNATIONAL)
1.9 EU Importer Information:
TRUMPF Medizin Systeme GmbH + Co. KG
Carl-Zeiss Straße 7-9
07318 Saalfeld/Saale
Germany
1.10 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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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
2. System
2.1 System components Identification:
Item
Feature
A
Lithotomy handle
B
Boot release lever
C
Rail clamp
D
Blade mount
E
Straps
F
Gas piston
G
Stirrup boot
H
Stirrup pad
I
Main support tube

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
2.2 Product Code and Description:
O-YFAX - Yellofins Apex™
2.3 List of Accessories and Consumable Components Table:
WARNING:
Do not use the Yellofins Apex™ with a rail clamp not listed below. Patient or
caregiver injury and equipment damage can occur.
WARNING:
Do not use the Yellofins Apex™ with a pad not listed below. Patient or caregiver
injury and equipment damage can occur.
The following list are accessories and components that may be used with this device.
Name of Accessory
Product Number
Blade Clamp (1” x 0.25”/2.5 cm x 0.6cm)
A-40040
O-RC2
A-40041
O-RC2XD
A-40042
O-RC29X32MM
A-40043
O-RC2XUK
Safety Drape
A-22000
Stirrup Cart
A-30015
Yellofins Apex™ Replacement Pad
O-YFAXPAD
Yellofins Apex™ Replacement Strap
O-YFAXMSR
Note: Consult the corresponding IFU for the products mentioned in the above table.
Contact Allen Medical Systems, Inc. to order accessories. Use the contact information in
“Device Maintenance:” on page 27.

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
2.4 Indication for use:
Used to position adult patients in surgical procedures that utilize stirrups for the lithotomy
position in urology, gynecology, colorectal and robotic surgeries.

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
2.5 Intended use:
The Yellofins Apex™ is a reusable patient positioning stirrup device for safe lithotomy
positioning. Intended to simplify patient positioning in order to gain clinical access before
and after sterile draping.
Designed to be used by health care providers for surgical procedures that involve the
lithotomy position. The Yellofins Apex™ ensures patient and staff safety by providing
stable platform for patient supports and positional control for patient weighing maximum
500 lbs (227 kg).

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
3. Equipment Setup and Use:
3.1 Prior to use:
Pre-Installation Check:
WARNING:
Inspect the product looking for any visible damage or sharp edges that could be
caused by a drop or impact during storage.
WARNING:
Make sure product has been properly cleaned and disinfected and wiped dry
prior to each use.
WARNING:
Before you use the Yellofins Apex™, make sure that the product is appropriate for
the patient's anatomy.
WARNING:
Check for pressure points on the patient before use. Consult the surgeon before
use.
3.2 Setup:
3.2.1 Device Controls and Components
Lithotomy handle

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Boot release lever
Strap
Stirrup pad
3.2.2 Initial Setup
1. Follow facility-approved procedures, or consult the attending surgeon to determine
if the patient has any conditions that contraindicate the use of the Yellofins Apex™
or that limit positioning the patient.
The Yellofins Apex™ is labeled to indicate the patient left and right sides.
2. Place the rail clamps on the rail of the surgical table. Place the rail clamps adjacent
to the patient’s hip joint.
3. Remove the Yellofins Apex™ from the storage cart, cabinet, or table.
4. Grasp and firmly squeeze the lithotomy handle. Make sure that the blade mount is
parallel to the main support tube.
5. Hold the Yellofins Apex™ so that it is oriented vertically with the blade mount towards
the floor.

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
WARNING:
Do not use the Yellofins Apex™ with a rail clamp not
listed in “List of Accessories and Consumable
Components Table:” on page 12. Patient or
caregiver injury and equipment damage can occur.
WARNING:
Make sure that the blade mount is through the rail clamp. Patient fall, injury, or
equipment damage can occur.
6. Insert the blade mount through the rail clamp.
7. Put the rail clamp in the necessary location for the patient. Make sure that the rail
clamp will be secure on the rail when you tighten the rail clamp.
WARNING:
Make sure the rail clamps securely attach the Yellofins Apex™ to the rail. Patient
or caregiver injury or equipment damage can occur.
8. Tighten the rail clamp.
9. Complete the “Pre-Use Function Checks” on page 17.
10. Grasp and firmly squeeze the lithotomy
handle and pull down to lower the
Yellofins Apex™.

INSTRUCTIONS FOR USE
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Version: C
Ref Blank Template: 80025117 Ver. F
11. Grasp the boot release lever and pull up to unlock the stirrup.
12. Move the stirrup along the main support bar until the top end of calf section of the
stirrup is approximately at the patient’s mid-calf.
13. Release the boot release lever to lock the stirrup in place.
14. Do Step 2 through Step 13 on the other side of the table.
3.2.3 Pre-Use Function Checks
Make sure that the Yellofins Apex™ is in good working order. Do the checks that follow:
• Grasp and firmly squeeze the lithotomy handle. Make sure that
the Yellofins Apex™ moves freely through the full range of
lithotomy adjustment, and ab/ad-duction. Release the
lithotomy handle.
• Grasp the boot release lever and pull up to unlock the stirrup.
Make sure that the stirrup does not release before the boot
release lever is fully engaged. Make sure that the stirrup moves
freely through the full range of adjustment. Make sure that the
stirrup moves freely along the main support tube. Release the
boot release lever.
• Apply moderate pressure to the lithotomy handle in all directions. Make sure that the
Yellofins Apex™ does not move.
• Apply moderate pressure to the stirrup boot in all directions. Make sure that the stirrup
boot does not move.
• Make sure that the straps engage securely and do not disengage when light force is
applied.

INSTRUCTIONS FOR USE
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Document Number: 80028475
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Version: C
Ref Blank Template: 80025117 Ver. F
3.2.4 Put the Patient in the Stirrups
1. Make sure that the patient is positioned on the surgical table in accordance with
facility-approved procedures and the guidance of the surgeon.
WARNING:
Patient positioning should be performed by at least two staff members. Both of
the patient’s legs should be put in position at the same time. Patient injury can
occur.
WARNING:
Make sure that the patient’s legs are secure in the stirrup boot before you adjust
the stirrup. Patient injury can occur.
WARNING:
Make sure that there are not limbs or other objects in the path of movement of
the stirrup before you adjust the position of the stirrup. Patient or caregiver injury
and equipment damage can occur.
Do the steps that follow simultaneously to both legs.
2. Put one hand under the patient’s heel and one hand under the patient’s knee to
support the patient’s leg.
3. Gently flex the patient’s knees and put both legs into the stirrups.
• In Low Lithotomy, make sure that you do not hyperextend
the patient’s hip and knee.

INSTRUCTIONS FOR USE
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Document Number: 80028475
Issue Date: 26 November 2020
Version: C
Ref Blank Template: 80025117 Ver. F
• In Medium or High Lithotomy, make sure that the leg
flexion and abduction are minimal.
• The patient’s toe, knee, and opposing shoulder should be
approximately in a straight line.
• The patient’s leg should be centered in the stirrup to
eliminate pressure on the peroneal nerve.
WARNING:
Patient’s toes may extend past the stirrup and pad. Make sure that the patient’s
heels are secure in the heel of the stirrup, and make a note of whether the
patient’s toes extend past the stirrup and pad. Make sure that you do not injure
toes that extend past the stirrup and pad. Patient injury can occur.
WARNING:
Make sure that each strap is properly secured. Make sure that the formed button
is entirely through the slot in the stirrup. Make sure that the formed button faces
away from the pad. Patient or caregiver injury and equipment damage can
occur.