Yellofin Stirrups Instructions for Use Ver D March 2020

INSTRUCTIONS FOR USE ENGLISH ... 3 БЪЛГАРСКИ ... 23 中文简体 ... 46 中文繁體 ... 66 HRVATSKI ... 88 ČESKÝ ... 108 DANSK ... 128 NEDERLANDS ... 148 SUOMI ... 169 FRANÇAIS ... 189 DEUTSCH... 209 ΕΛΛΗΝΙΚΑ ... 230 BAHASA INDONESIA ... 250 ITALIANO ... 271 日本語版 ... 291 한국어 ... 311 LATVISKI ... 331 NORSK ... 351 POLSKI ... 371 PORTUGUÊS... 391 ROMÂNESC... 411 SRPSKI ... 433 SLOVENSKY ... 454 SLOVENŠČINA ... 474 ESPAÑOL ... 494 SVENSKA ... 514 TIẾNG VIỆT ... 534

Document Number: 80028160 Version D

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INSTRUCTIONS FOR USE IMPORTANT NOTICES 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.

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Read and understand all warnings in this manual and on the device itself prior to use with a patient.

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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.

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• • • • •

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.

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INSTRUCTIONS FOR USE

Table of Contents Yellofin® Stirrups (O-YFASI, O-YFSI, O-YFES, O-YFESP) 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 Authorised Australian sponsor: ... 10

2

System ... 11 System components Identification: ... 11 Product Code and Description:... 11 List of Accessories and Consumable Components Table:... 12 Indication for use: ... 13 Intended use:... 13 Residual Risk: ... 13

3

Equipment Setup and Use:... 14 Prior to use: ... 14 Setup: ... 14 Device controls and indicators: ... 17 Storage, Handling and Removal Instructions:... 18

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INSTRUCTIONS FOR USE 3.4.1 Storage and Handling:... 18 3.4.2 Removal Instruction: ... 18 Troubleshooting Guide: ... 18 Device Maintenance: ... 18 4

Safety Precautions and General Information:... 18 General Safety Warnings and Cautions: ... 18 Product Specifications: ... 19 Sterilization Instruction: ... 20 Cleaning and Disinfection Instruction: ... 20

5

List of Applicable Standards: ... 21

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INSTRUCTIONS FOR USE 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 onsite 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).

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INSTRUCTIONS FOR USE Contact Details: For ordering information please see catalog. Allen Customer Service Contact Information:

International

North America (800) 433-5774

+1 978 266 4200 ext.4286

(978) 263-8846

+1 978 266 4426

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 the 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

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INSTRUCTIONS FOR USE 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 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 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

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Reference

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INSTRUCTIONS FOR USE

1.5.2

Indicates the date when the medical device was manufactured

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

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.

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INSTRUCTIONS FOR USE 1.5.3

Compliance with medical device regulations: This Product is a non-invasive, Class I Medical Device. This system is CEmarked 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: +33 (0)2 97 50 92 12

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: Baxter Medical Systems GmbH + Co. KG Carl-Zeiss Straße 7-9 07318 Saalfeld/Saale Germany

Authorised Australian sponsor: Welch Allyn Australia Pty. Ltd. 1 Baxter Drive Old Toongabbie, NSW 2146 Australia

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INSTRUCTIONS FOR USE 2

System System components Identification:

Boot

Boot Pad Squeeze Handle

Boot Locking Mechanism

Lift Assist

Rail Clamp

Product Code and Description: O-YFASI - Allen Yellowfins Stirrups with lift-Assist O-YFSI - Allen Yellowfins Stirrups without lift-Assist O-YFES - Allen Yellowfins Elite Stirrups O-YFESP - Allen Pinkfin Elite

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INSTRUCTIONS FOR USE 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

Nissen Thigh Straps

O-NTS

Hug-U-Vac Steep Trend Positioner

A-60001

Allen Steep Trend Secondary Supports

A-63600

Shoulder Supports

A-63500

Uro Catcher® System

O-UC4 (US), O-UC4E (EU), O-UC4UK (UK), O-UC4DEN (Denyer), O-UC4J (Japan)

Shoulder Supports

A-63500

Stirrup cart

A-30015

Name of Consumable

Product Number

Easy Catcher® Disposable System

O-EC51, O-EC52

Uro Catcher Drapes

O-UC31, O-UC32

Brachytherapy Drapes for Uro Catcher System

A-50008

Allen Safety Drape

A-22000

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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INSTRUCTIONS FOR USE Indication for use: These Stirrups are used in a variety of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and robotic surgery. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

Intended use: These Stirrups era designed to position and support the patient’s foot, lower leg and upper leg in a variety of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and robotic 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 harm from misuse, device damage, function or mechanical hazards cannot be completely excluded.

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INSTRUCTIONS FOR USE 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.

Setup: a. Prior to setting up the Yellofin, assess the patient for any pre-existing conditions that might contraindicate the use of leg positioning devices (e.g. recent hip surgery). b. The Yellofin mount to the table rails using standard rail clamps.

c. Position these clamps adjacent to the patient’s hip. The boots are marked on the bottom for the patient’s left and right.

d. Insert blade on the Yellofin mount into Easy Lock Blade Clamp A-40040, A-40041, A-40042, A-40043 or equivalent.

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INSTRUCTIONS FOR USE e. Once the stirrup is placed in the rail clamp, tighten handle securely. WARNING: The handle must be tightened securely before use.

f.

To pre-position stirrup boots, loosen boot-locking mechanism and slide boot along rod until top end (calf portion) of boot is located approximately at patient’s mid-calf. Tighten Boot Locking Mechanism securely. Repeat above procedure for the other stirrup.

g. Position stirrups to be level with the table by squeezing the release handle and moving stirrup downward.

Positioning Patient in Stirrups h. Ensure the patient is positioned on O.R. table in accordance with procedure and surgeon requirements. i. Pre-position stirrup boots. Loosen boot-clamping mechanism and slide boot along rod until top end (calf portion) of boot is approximately at patient’s midcalf. Tighten clamp. NOTE: For larger patients, a padded arm shield can be used to protect the wrist, hand and arm.

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INSTRUCTIONS FOR USE j.

Positioning patient should be performed by two staff members. Support each of the patient’s legs by grasping the heel in one hand and the underside of the knee with the other. Gently flex the knees and simultaneously transfer both legs into the boots

k. Ensure patient’s heels are securely seated in the heels of the boots. l.

Observe following general guidelines regarding proper initial leg flexion: • When using low lithotomy, take care not to hyperextend the leg while achieving desired abduction. •

When using medium or high lithotomy, use minimal initial leg flexion and abduction as both will increase as legs are raised.

m. The ankle, knee and opposing shoulder should be maintained in a relatively straight-line during positioning. Notice that, for a typical patient, the thigh and foot are abducted at approximately the same angle. n. To fine tune boot position and flexion, support boot heel with one hand and, with the other, loosen the boot-clamping mechanism roughly ¼ turn. Use both hands to support and adjust boot to desired position. Tighten clamping mechanism securely. o. Perform a final check to ensure that the patient’s heels are properly seated in the heels of the boots and that there are no pressure points on the calf. The leg must be centered in the boot to eliminate pressure on the peroneal nerve. Close boot pad. p. Place an Allen Safety Drape over each leg to permit continuous monitoring of leg position during the procedure. WARNING: Additional positioning devices should be used when using the stirrup in Trendelenburg or reverse Trendelenburg.

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INSTRUCTIONS FOR USE Device controls and indicators:

Loosen Control Handle to Adjust Flexion, Extension, Abduction, Adduction and Rotation.

Attach Rail Clamp at Patient Hip Joint and Mount Stirrup. Handles Should Mount on the Outside. The Boot Should Cradle the Upper Calf.

Ensure Control Handles Are Tight.

Squeezing the One-Touch Control Handle CounterClockwise Unlocks and Controls the Abduction, Adduction and Lithotomy Controls of the Stirrup.

Ensure Rail Clamp with Stirrup Mounted is Aligned with Patient’s Hip. Toe, Knee and Opposing Shoulder Should Be Aligned.

This Symbol Represent the Patient’s Right foot

This Symbol Represent the Patient’s left Right

This Scale represents Lithotomy angle (For Reference only).

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INSTRUCTIONS FOR USE 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. See storage Specifications under Product Specification section. 3.4.2

Removal Instruction:

a. Lower stirrups by squeezing the release handles, and simultaneously downstage the legs slowly to the desired level. b. Gently remove patient’s legs from stirrups. c. Stirrups should be in a vertical position for removal from sockets. Loosen clamp/socket and remove stirrups.

Troubleshooting Guide: This device does not have a troubleshooting guide. For technical support user of the device shall first contact Hill-Rom Technical Support.

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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Safety 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.

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INSTRUCTIONS FOR USE d. Read and understand all warnings in this manual and on the device itself prior to use for patient. e. Device function should be checked prior to each usage. f. This device should only be operated by medically trained personnel. g. Additional positioning devices should be used when using the stirrup in Trendelenburg or reverse Trendelenburg. h. The patient's toes may extend beyond the end of the stirrup boot. i. The product with specified rail clamps. j. Check for patient contact pressure points and consult the physician before use. k. Warn the user against using non-approved padding. l. To secure the patient's legs in the boots prior to adjusting.

CAUTION:

a. Do not clean stirrup by immersing it in liquid or using high-pressure spray. Such action may damage product. b. Do not raise the thigh closer to torso than 90º as patient may experience nerve damage. c. To prevent patient and/or user injury and/or equipment damage: all modifications, upgrades, or repairs must be performed by an Allen authorized specialist. Failure to comply may void the warranty. d. Keep patient and caregivers away from the area between the gas spring and the main support tube. Possible pinch point hazard when in extreme high lithotomy. e. Do not exceed safe working load shown in the product specification table.

Product Specifications: Mechanical Specifications

Description 35 3/4" x 18" x 11 3/4" (91 cm x 45,7 cm x 30 cm)

Product Dimensions

(l x b x h)

Material

Stainless Steel, Aluminum, and Low temperature Polymers.

Safe Working Load on the device

350 lbs (159 kg) patient

Overall Weight of Complete Device

O-YFASI, O-YFES & O-YFESP: 16.5 lbs (7.4 kg) each O-YFSI: 12 lbs (5 kg) each.

Storage Specifications Document Number: 80028160 Version D

Description

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INSTRUCTIONS FOR USE Storage temperature Storage Relative humidity range Operating temperature Operating Relative humidity range Electrical Specifications

-29ᵒ C to +60ᵒ C 15% to 85% This device is intended to be used in a controlled Operating Room environment. Description

Not Applicable.

Not Applicable.

Software Specifications

Description

Not Applicable.

Not Applicable.

Compatibility Specifications •

The Yellofin stirrups are compatible with:

• • • • •

Description Easy Lock® Blade Clamp: A-40040US, A40041EU, A-40042UK, A-40043Japan Tri-Clamp: A-40016(US, A-40016(EU) Universal Accessory Clamp: A-40015 Universal Clamp: O-RCP2 Rail Clamp: O-RC2 Or equivalent clamps.

Pads: •

Operating Room Table Compatibility

Yellofins Reusable Pad: O-AMA68S0.6S

The Allen Yellofin stirrups are compatible with the following surgical table rail styles: US, UK, EU, DEN, JP, SWISS based on clamp selection.

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.

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