Hillrom O-YFASI Yellofin Stirrups for Hospital
INSTRUCTIONS FOR USE
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.
© 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.
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).
- For ordering information please see catalog.
- Allen Customer Service Contact Information:
Safety hazard symbol notice:
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE OR MATERIAL DEGRADATION.
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.
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
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:
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.
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
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)
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
- 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
Australian sponsor Information:
- Welch Allyn Australia Pty. Ltd.
- Unit 4.01, 2-4 Lyonpark Road
- Macquarie Park, NSW 2113
- Phone 1800 650 083
System components Identification:
Product Code and Description:
A-90002 – LPS Arm Support
List of Accessories and Consumable Components Table:
The following list are accessories and components that may be used with this device.
Note: Consult the corresponding IFU for the products mentioned in the above table.
The Arm Support is used in a variety of surgical procedures including, but not limited to spine and shoulder surgery that requires supine, prone and/or beach chair positioning. These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.Indication for use:
The Arm Support is designed to position and support the patient’s arm in a variety of surgical procedures including, but not limited to spine and shoulder surgery that requires supine, prone and/or beach chair positioning. These devices are intended to be used by healthcare professionals within the Operating Room setting.
Equipment Setup and Use:
Prior to use:
- Inspect the product looking for any visible damage or sharp edges that could be caused by a drop or impact during storage.
- Make sure product has been properly cleaned and disinfected and wiped dry prior to each use.
- 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).
- The Yellofin mount to the table rails using standard rail clamps.
- Position these clamps adjacent to the patient’s hip. The boots are marked on the bottom for the patient’s left and right.
- Insert blade on the Yellofin mount into Easy Lock Blade Clamp A-40040, A-40041, A- 40042, A-40043 or equivalent.
- Once the stirrup is placed in the rail clamp, tighten handle securely.
WARNING: The handle must be tightened securely before use.
- 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.
- Position stirrups to be level with the table by squeezing the release handle and moving stirrup downward.
Positioning Patient in Stirrups
- Ensure the patient is positioned on O.R. table in accordance with procedure and surgeon requirements. 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.
- 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
- Ensure patient’s heels are securely seated in the heels of the boots.
- 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.
- 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.
- 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.
- 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.
- 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
- Attach disposable cover (A-70271) after pads have been positioned and locked. Flaps should face forward, and foam material should be face up. Secure adhesive tabs as indicated. Avoid attaching tabs directly to pads.
- Transfer patient onto device so that breasts fall over edge of device as shown. Breasts should fall naturally, without being subjected to excessive forces.
- While supporting breast, wrap outer flap first, then wrap inner flap and secure using adhesive tab. Smaller breasts may not require flap support.
Device controls and indicators:
This Symbol Represent the Patient’s Right foot
Controls and indicators of this device are described within the Setup instructions.
Storage, Handling and Removal Instructions:
Storage and Handling:
The product should be stored in a clean and safe environment to prevent product damage.
Removal is the reverse of installation.
DO NOT leave the Hug-U-Vac valve closed with suction still applied in between procedures or in storage. Leaving the suction connected will lead to collapsing and damage of the internal beads and thus, greatly reduce the life of the product.
This device does not have a troubleshooting guide. For technical support user of the device shall first contact Hill-Rom Technical Support.
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).
Safety Precautions and General Information:
General Safety Warnings and Cautions
- Do not use if product shows visible damage.
- 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.
- 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.
- It is recommended that this positioner be is used in conjunction with a rigid lateral support in order to prevent patient injury or death in the event the product loses vacuum.
- Always ensure product is properly and securely fastened to the operating table prior to use.
- Secure positioners straps only to the operating table’s accessory rails.
- Never secure positioners straps to table width extenders or any secondary accessory rails.
- Always ensure the vacuum valves are securely closed and locked, and that the positioner maintains vacuum prior to draping the patient or beginning any surgical procedure.
- Do not exceed the maximum patient weight limit or width as specified by the manufacturer.
- Not for use with K-Thermal heating pads or similar.
- nce the desired form is obtained around the patient, DO NOT leave suction applied to the device. Close the Hug-U-Vac valve and stop suction during the procedure. After the procedure is completed, release the Hug-U-Vac valve and allow air to return into the device.
- Do not leave the Hug-U-Vac valve closed with suction still applied in between procedures or in storage. Leaving the suction connected will lead to collapsing and damage of the internal beads and thus, greatly reduce the life of he product.
- Never exceed the weight capacity of the OR table.
- Always lock valve close and remove suction tube.
- 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 warranty.
- Do not exceed safe working load shown in the product specification table.
|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)
O-YFSI: 12 lbs (5 kg) each.
|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|
|Not Applicable.||Not Applicable.|
|Not Applicable.||Not Applicable.|
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.
· 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
Note: Consult the corresponding IFU for the products mentioned in the above table.
This device is not intended to be sterilized. Equipment damage may occur.
Cleaning and Disinfection Instruction
- Do not use bleach or products that contain bleach to clean the device. Injury or equipment damage can occur.
- After each use, clean the device with alcohol-based wipes.
- Do not put the device into water. Equipment damage can occur.
- Use a cloth and a quaternary ammonium disinfecting/cleaning solution to clean and disinfect the device.
- Read and follow the manufacturer’s recommendation for low-level disinfection.
- Read and follow the cleaning product’s instructions. Use caution in areas where liquid can get into the mechanism.
- Wipe the device with a clean, dry cloth.
- Make sure that the device is dry before you store it or use it again.
CAUTION: DO NOT IMMERSE PADS IN ANY LIQUID
CAUTION: DO NOT USE BLEACH OR PHENOLICS ON PADS
List of Applicable Standards
|Medical devices – Part 1: Application of usability engineering to medical devices|
EN ISO 14971
|Medical devices- Application of risk management to medical devices.|
|Information supplied by the manufacturer of medical devices|
EN ISO 15223-1
|Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements|
EN ISO 10993-1
|Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process|
|Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and essential performance of operating tables|
|International Safe Transit Association standards for package testing|