AMATECH P150830530 Power-Lift Stirrups Instructions

AMATECH P150830530 Power-Lift Stirrups

Product Information

The Power-Lift Stirrups (Product No. P150830530) are a medical apparatus designed for use in surgical procedures. The product is manufactured by Allen Medical Systems, Inc. and is covered by one or more patents. For more information on trademarks and patents, please refer to the websites provided in section 1.2 of the Instructions for Use.

Product Usage Instructions

Before using the Power-Lift Stirrups, it is important to read and familiarize yourself with the Instructions for Use. The manual contains important safety instructions and procedures for using the device.

Safety Precautions

1. Do not use the product if it shows visible damage or material degradation.
2. Do not use the product if the package is damaged or unintentionally opened before use.
3. All modifications, upgrades, or repairs must be performed by an authorized specialist.

Contact Details

If you have any complaints or need ordering information, please contact your supplier and refer to the catalog. For any modifications, upgrades, or repairs, it is important to have them performed by an authorized specialist.

Reporting Incidents

If any serious incidents occur in relation to the device, they should be reported using the contact details provided in section 1.3 of the Instructions for Use. Additionally, incidents should be reported to the competent authority of the Member State in which the user and/or patient is established.

Note: It is recommended to refer to the surgical table manufacturer’s user guide for instructions on use and weight limits. Always follow the guidelines provided by the surgical table manufacturer when using the Power- Lift Stirrups.

IMPORTANT NOTICES

Warning: 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.

• 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.

General Information

AMATECH Corporation is a subsidiary of Allen Medical Systems, Inc. which 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.

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 in www.allenmedical.com/pages/terms-conditions.
• Product may be covered by one or more patents. Please consult listing at www.hill-rom.com/patents for any patent(s).

Contact Details

• For complains or ordering information, please contact your supplier and refer to the catalog.
• All modifications, upgrades, or repairs must be performed by an authorized specialist.

Safety Considerations

Safety hazard symbol notice

• DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE AND MATERIAL DEGRADATION.

Equipment misuse notice

• Do not use 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 using the contact details provided in section 1.3 of this Instruction for Use and to 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

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 users of the device shall first contact their supplier for guidance on safe disposal protocols.

Operating the system

Applicable Symbols

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

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)

System

System components Identification

Product Code and Description

• P150830530 – Power-Lift Stirrups, SET

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.

CAUTION: Reuse of disposables will lead to patient cross contamination and/or device failure.

Indication for use

• The Stirrup is 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

The Stirrup is 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, patient harm from misuse, device, function or mechanical hazards cannot be completely excluded.

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.

Setup

Before Using Power-Lift Stirrup

The Power-Lift Stirrups (see Figure 2-1) are a non-invasive medical device designed to provide safe, comfortable support and independent, secure positioning for the patient’s legs during surgery. The Power-Lift Stirrups attach to U.S. standard side rails only, next to the patient’s hip, using two rail clamps. The patient’s foot and lower leg are secured into the well- cushioned, contoured boot (uniformly supporting the leg weight). By turning the release handle at the distal end of the leg holder, the caregiver is able to align the toe, knee, and opposite shoulder simultaneously adjusting- the lithotomy and abduction angles while keeping both left and right positions in phase. The Power-Lift Stirrups will be used in surgical procedures such as laparoscopic assisted vaginal hysterectomies and Nissen Fundoplication’s. Power-Lift Stirrups are rated for use with patients up to 6’ 7” (2007 mm) tall and weighing up to 500 lbs (226 kg). User must verify patient weight capacity of the surgical table with this accessory applied. Before using stirrups, ensure there are no scratches, dents, or change in appearance. Verify locking handle and clamp work properly.

WARNING:  PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD:

• To prevent patient and/or user injury and/or equipment damage, read and understand all instructions presented in this manual before using the Power-Lift Stirrups. Follow each step in the order presented in these instructions. If you need technical assistance additional instructions, call STERIS.
• To prevent patient and/or user injury and/or equipment damage, apply Power-Lift Stirrups only to U.S. standard side rails like those equipped on the Amsco@ 3080/3085 SP surgical tables. Figure 2-3. Power-Lift Stirrups Release Handle

Attaching PowerLift Stirrups

Complete each step in the order presented below and attach the Power-Lift Stirrups to a surgical table as follows:

1. Review Figure 2-1 through Figure 2-4 and become familiar with product before proceeding.
2. Ensure rail clamp (see Figure 2-1) jaw is fully open by rotating clamp locking handle in a counter-clockwise motion.
3. Position Power-Lift Stirrup onto side rail with locking handle to outside.
4. Move stirrup to desired location on side rail (adjacent to patient’s hip).
5. Tighten rail clamp by rotating clamp locking handle clockwise.
6. Repeat Steps 2 through 5 for other side.
7. With adequate help, place both legs into stirrups simultaneously.
8. To adjust stirrups for patient’s legs, proceed as follows:
   • Loosen boot lock handle or linear adjustment handle.
   • Gently slide boot up or down the bar, slightly flexing patient’s knees to approximately 170 degrees.
   • Maintain ankle, knee, and opposing shoulder in a relatively straight line.
   • NOTE: For a typical patient, the thigh and foot are abducted at approximately the same angle.
   • To reposition stirrups, grasp release handles with palms down and twist your thumbs toward ceiling (see Figure 2-3). When desired degree of lithotomy and/or abduction is obtained, simply release handles.
   • When satisfied with position, tighten boot lock handle.
   • NOTE: Do not use Power-Lift Stirrups in Reverse Trendelenburg unless the Reverse Trendelenburg Restraint Strap accessory is used (see Operator Manual P 150830-523 for more information).
9. Secure boot straps over each boot foot pad.
   • NOTE: Pictorial operating instructions are included on the bottom of each boot (see Figure 2-4).

WARNING:  PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD:

• To prevent patient and/or user injury and/or equipment damage, check the Power-Lift Stirrups and surgical table side rails for possible damage or wear prior to each use. Do not use the Power-Lift Stirrups if any damage is apparent, if parts are missing, or  if it does not operate as expected. Cracked or splintered surfaces may cause injury.
• To prevent patient and/or user injury and/or equipment damage, apply
• Power-Lift Stirrups only to U.S. standard side rails like those equipped on the Amsco 3080/3085 SP surgical tables.
• To prevent patient and/or user injury and/or equipment damage, assure.
• Power-Lift Stirrups attaching clamps fully contact table side rails and are securely tightened in place. Test locking to ensure no extension movement when lifted or pushed.
• Do not use Power-Lift Stirrups in Reverse Trendelenburg position without using the Reverse Trendelenburg Restraint Strap accessory.
• Use Power-Lift Stirrups only with supplied clamps. DO NOT USE STERIS side rail locks (BF13-300).
• WARNING: PERSONAL INJURY HAZARD: Do not hyperextend the patient’s leg using Power-Lift Stirrups.

Device controls and indicators

Storage, Handling and Removal Instructions

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.

Removal Instruction:

Remove the Power-Lift Stirrups (if desired) from the surgical table as follows

NOTE: Refer to Figure 2-1 for component locations. Also, refer to the appropriate surgical table operator manual for specific instructions on operating the surgical table.

1. Position stirrup level with table.
2. Carefully remove boot strap from patient.
3. . With adequate help, carefully remove patient’s legs from stirrups. Place legs in a safe position.
4. After transferring the patient from the surgical table, loosen locking clamps completely by rotating the clamp locking handle counter-clockwise.
5. Gently slide or lift both Power-Lift Stirrups from side rail and away from surgical table.

Troubleshooting Guide:

• This device does not have a troubleshooting guide. For technical support user of the device shall first contact his or her supplier

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 us if you need to repair or replace the device by using the information from the contact details section (1.3).

Safety Precautions and General Information:

General Safety Warnings and Cautions

WARNING

• 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.
• To prevent patient and/or user injury and/or equipment damage, verify the device attaching clamps completely touch the table-side rails and are firmly in place. Test the locking mechanism to ensure no movement when elevated or pushed.
• Additional positioning devices should be used when using the legholder in Trendelenburg or reverse Trendelenburg.
• The handle must be tightened securely before use.
• Additional positioning devices should be used when using the legholder in Trendelenburg or reverse Trendelenburg.
• The patient’s toes may extend beyond the end of the stirrup boot.
• The product must be used with compatible clamps.
• Check for patient contact pressure points and consult the physician before use.
• Ensure the patient’s legs are secure in the boot prior to making adjustments.
• Use only approved padding.

CAUTION

• Do not clean Legholder by immersing it in liquid or using high-pressure spray. Such action may damage product.
• Do not raise thigh closer to torso than 90º as patient may experience nerve damage.
• Do not exceed safe working load shown in the product specification table.

Product Specifications

Engineering Polymer, Bronze

Safe Working Load on the device| 500 lbs. (226 kg)
Overall Weight of Complete Device| 13 lbs. Each (5.9 kg)
Storage Specifications| Description
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 Power-Lift Stirrups is compatible with:

| a.    Clip-On™ Blade Clamp: F-40040 (US), F-40041 (EU), F-40042 (UK), F-40043 (Japan)

b.    Rail Clamp: F-RC2 (US), F-RC29X32MM (Japan), F-RC2XD (Denyer), F-RC2XUK (EU/UK).

Or equivalent clamp.

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.
• 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.
• ipe 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

usability engineering to medical devices

2.| EN ISO 14971| Medical devices- Application of risk

management to medical devices.

3.| EN 1041| 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

| ****

IEC 60601-2-46

| Medical electrical equipment – Part 2-46: Particular requirements for the basic safety

and essential performance of operating tables

7.| ISTA| International Safe Transit Association standards

for package testing

References

• allenmedical.com - allenmedical Resources and Information.
• Patents | Hillrom

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