2. Hillrom
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O-YFASI

Hillrom O-YFASI Návod na používanie

  • Prečítal som si návod na použitie Yellofin chirurgických stremien od spoločnosti Hill-Rom. Som pripravený odpovedať na vaše otázky týkajúce sa ich používania, funkcií a bezpečnostných opatrení. Návod popisuje rôzne modely stremien, ich inštaláciu, používanie a údržbu. Môžem vám pomôcť s akýmikoľvek otázkami, ktoré máte.
  • Aké sú bezpečnostné opatrenia pri používaní Yellofin stremien?
    Ako sa čistia a dezinfikujú Yellofin stremená?
    Aká je nosnosť Yellofin stremien?
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
Document Number: 80028160 Page 2 Issue Date: 18 MAR 2020
Version: C Ref Blank Template: 80025117 Ver. F
ENGLISH ......................................................................................................................................... 3
БЪЛГАРСКИ ................................................................................................................................ 23
中文简体 ....................................................................................................................................... 46
HRVATSKI ..................................................................................................................................... 66
ČESKÝ ........................................................................................................................................... 86
DANSK ....................................................................................................................................... 106
NEDERLANDS ............................................................................................................................ 126
SUOMI ......................................................................................................................................... 147
FRANÇAIS ................................................................................................................................... 167
DEUTSCH ..................................................................................................................................... 187
ΕΛΛΗΝΙΚΑ ................................................................................................................................. 208
ITALIANO ................................................................................................................................... 228
LATVISKI ..................................................................................................................................... 248
NORSK ....................................................................................................................................... 268
POLSKI ......................................................................................................................................... 288
PORTUGUÊS ................................................................................................................................ 308
ROMÂNESC................................................................................................................................ 328
SRPSKI ......................................................................................................................................... 350
SLOVENSKY ................................................................................................................................ 371
SLOVENŠČINA ........................................................................................................................... 391
ESPAÑOL ................................................................................................................................... 411
SVENSKA ..................................................................................................................................... 431
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
© 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 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
+1 978 266 4200 ext.4286
+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.
Not Applicable.
Software Specifications
Description
Not Applicable.
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.
/