Hillrom O-YFASI Istruzioni per l'uso

Yellofin® Stirrups

Instructions for Use

Product No.

O-YFASI, O-YFSI, O-YFES, O-YFESP

80028160

Version C

Pinkfin Elite Stirrup

Yellofin Stirrups

Yellofin Stirrups, Without Assist

Yellofin Elite Stirrup

INSTRUCTIONS FOR USE         
 
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ENGLISH  ......................................................................................................................................... 3 
 
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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 
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 
 Australian sponsor Information: ................................................................................ 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 

INSTRUCTIONS FOR USE         
 
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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 
 
   

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

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 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

(800) 433-5774

+1 978 266 4200 ext.4286

(978) 263-8846

+1 978 266 4426

INSTRUCTIONS FOR USE

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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 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

INSTRUCTIONS FOR USE

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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

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: +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:

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 1800 650 083

INSTRUCTIONS FOR USE

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2 System

System components Identification:

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

Boot Pad

Rail Clamp

Lift Assist

Boot Locking

Mechanism

Boot

Squeeze Handle

INSTRUCTIONS FOR USE

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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

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

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.

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

INSTRUCTIONS FOR USE

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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.

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.

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.

INSTRUCTIONS FOR USE

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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 mid-

calf. Tighten clamp.

NOTE: For larger patients, a padded arm shield can be used to protect the wrist,

hand and arm.

INSTRUCTIONS FOR USE

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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.

INSTRUCTIONS FOR USE

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Device controls and indicators:

Attach Rail Clamp at

Patient Hip Joint and

Mount Stirrup. Handles

Should Mount on the

Outside. The Boot Should

Cradle the Upper Calf.

Squeezing the One-Touch

Control Handle Counter-

Clockwise Unlocks and

Controls the Abduction,

Adduction and Lithotomy

Controls of the Stirrup.

Loosen Control

Handle to Adjust

Flexion, Extension,

Abduction,

Adduction and

Rotation.

Ensure Control

Handles Are Tight.

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).

INSTRUCTIONS FOR USE

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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. 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).

4 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.

INSTRUCTIONS FOR USE

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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

Product Dimensions

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

(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

Description

INSTRUCTIONS FOR USE

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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.

Storage temperature

-29ᵒ C to +60ᵒ C

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.

Software Specifications

Description

Not Applicable.

Compatibility Specifications

Description

The Yellofin stirrups are compatible with:

 Easy Lock® Blade Clamp: A-40040US, A-

40041EU, 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:

 Yellofins Reusable Pad: O-AMA68S0.6S

Operating Room Table Compatibility

The Allen Yellofin stirrups are compatible

with the following surgical table rail styles:

US, UK, EU, DEN, JP, SWISS based on clamp

selection.

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