Hill-Rom A-10052 Pal Pro Stirrups Instruction Manual

Hill-Rom A-10052 Pal Pro Stirrups

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).

Contact Details

For ordering information please see catalog.
Allen Customer Service Contact Information:

North America
Tel: 800-433-5774
Fax: 978-263-8846

International
Tel: +1 978 266 4200 ext.4286
Fax: +1 978 266 4426

Safety Considerations

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.

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

Applicable Symbols

encoded as 1YYWWSSSSSSS.

• YY indicates the year of manufacture. i.e. 1 18 WWSSSSSSS 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
| 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.

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 StraBe 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

System

System Components Identification

Product Code and Description

A-10052 – PAL PRO STIRRUPS (w/o integral clamp)

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, device harm from misuse, device damage, function or mechanical hazards cannot be completely excluded.

Equipment Setup and Use

Prior to Use

1. Inspect the product looking for any visible damage or sharp edges that could be caused by a drop or impact during storage.
2. Make sure product has been properly cleaned and disinfected and wiped dry prior to each use.
3. The patient for any pre-existing conditions that might contraindicate the use of leg positioning devices (e.g. recent hip surgery).

Setup

1. Squeeze the Release Handle. This action rotates the attachment blade for easy set-up on the surgical table rail.

2. Position clamps adjacent to the patients’ hip.

3. Attach stirrup to the table rail.
   CAUTION: Avoid pinching fingers between rail and clamp body.
   WARNING:

   • A-10052: Slide Blade into the slot on the top of the rail clamp.
     
     WARNING: Once the stirrup is placed on the rail, the clamp/socket must be tightened securely before use.

4. Pre-position the stirrup boots, by loosening the Boot-Locking Mechanism and sliding the Boot along the rod until the top end (calf portion) of the Boot is located approximately at the patient’s mid-calf. Tighten the Boot Locking Mechanism securely.

5. Pre-position the stirrup boots, by loosening the Boot-Locking Mechanism and sliding the Boot along the rod until the top end (calf portion) of the Boot is located approximately at the patient’s mid-calf. Tighten the Boot Locking Mechanism securely. Repeat above procedure for the other stirrup.

6. Position stirrups to be level with the table by squeezing the Release Handle and moving stirrup downward.
   

Positioning Patients in Stirrups

7. Ensure the patient is positioned on the table in accordance with procedure & surgeon requirements.
   NOTE: For larger patients a padded arm shield can be used to protect the wrist, hand and arm.

8. Positioning 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.

9. Ensure patient’s heels are securely seated in the heels of the Boots.

10. 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 Boot-Locking 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 procedure.

    • Grasp and squeeze release handles and simultaneously move legs slowly to desired height, maintaining leg symmetry.

    • Once lithotomy level has been achieved, check for pressure points and, if necessary, make appropriate adjustments. Boot clamping mechanism can be manipulated through the drape. Patient leg position (symmetry) can be documented using markings on ratcheting mechanism as guideline.

Note: Patient leg position symmetry can be documented using the leg length indicator markings on the tube. The degree of lithotomy can be documented by using the lithotomy Angle Indicator located on both sides of the release handle.
WARNING: Additional positioning devices should be used when using the stirrup in Trendelenburg or reverse Trendelenburg.

Device Controls and Indicators

Left Side Degree scale indicator. For Reference only

Right Side Degree scale indicator. For Reference only

This Symbol Represent the Patient’s Right foot

This Symbol Represent the Patient’s left Right

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

1. Lower stirrups by squeezing the release handles, and simultaneously downstage the legs slowly to the desired level. A.O.R.N. recommends the lowering and staging process take two full minutes. Gently remove patient’s legs from stirrups.
2. Stirrups should be in horizontal 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.

Safety Precautions and General Information

General Safety Warnings and Cautions

1. Do not use if product shows visible damage.
2. 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.
3. 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.
4. Read and understand all warnings in this manual and on the device itself prior to use for patient.
5. Device function should be checked prior to each usage.
6. This device should only be operated by medically trained personnel.
7. The patient’s toes may extend beyond the end of the stirrup boot.
8. The product with specified rail clamps.
9. Check for patient contact pressure points and consult the physician before use.
10. Ensure the patient’s legs are secure in the boot prior to making adjustments.
11. Use only approved padding.

CAUTION:

1. Do not use product if the sterile package is damaged or unintentionally opened before use.
2. Do not exceed safe working load shown in the product specification table.
3. Do not raise thigh closer to torso than 90º as patient may experience nerve damage.
4. 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.

Product Specifications

Product Dimensions

|

38″ x 16 1/4″ x 13 1/4″ (96.5 x cm 41.2 cm x 33.6 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| 16.5 lbs (7.4 kg) each (33 lbs (14.9 kg) set)
Storage Specifications| Description
Storage temperature| -29°C to +60°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 Pal Pro Stirrups are compatible with:|

1. Easy Lock® Blade Clamp: A-40040 (US), A-40041 (EU), A-40041 (UK), A-40043 (JP)
2. Tri Clamp: A-40016 (US)
3. Universal Accessory Clamp: A-40015
4. Rail Clamp: O-RC2, O-RC2XUK, (EU/UK) O-RC29X32MM(JP), O-RC2XD(DEN)
5. Or equivalent clamps.

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.
• 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

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
4| EN ISO 15223-1| Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied

• Part 1: General requirements

5| EN ISO 10993-1| Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
6| 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

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