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WillowWood LimbLogic Series Instructions Manual

Prosthetist
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LimbLogic®
Prosthetist
Instructions
WHAT'S IN THE BOX
LimbLogic Pump*
Battery Charger*
Fob
Fob Battery (quantity=2)
Fob Key Ring
Diagnostic Disc or Sheet and Sealing Gasket (packaged together)
Exhaust Port Drain Tube
Replacement Exhaust Hose and Muffler*
Patient Instructions
Prosthetist Instructions
Quick-Start Guide
This document provides instruction for the prosthetist in the
installation and use of the system. A separate document,
LimbLogic Patient Instructions, is included with each system
and should be provided to the patient upon delivery of a
prosthesis containing the LimbLogic.
The Vacuum Pump and fob included in this package are
electronically keyed together. They can be used only with
each other unless they are re-keyed with a LImbLogic
Communicator.
*Quantity = 2 for bilateral kit
1

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Summary of Contents for WillowWood LimbLogic Series

  • Page 1 LimbLogic® Prosthetist Instructions WHAT'S IN THE BOX LimbLogic Pump* Battery Charger* Fob Battery (quantity=2) Fob Key Ring Diagnostic Disc or Sheet and Sealing Gasket (packaged together) Exhaust Port Drain Tube Replacement Exhaust Hose and Muffler* Patient Instructions Prosthetist Instructions Quick-Start Guide *Quantity = 2 for bilateral kit This document provides instruction for the prosthetist in the installation and use of the system.
  • Page 2 There are no field-serviceable parts inside the Vacuum Pump. Opening the Vacuum Pump or charger may result in injury or death and will void the warranty. Unauthorized changes or modifications to the LimbLogic pump or accessories may; impair their function resulting in injury or death, will void the warranty, and may prevent their compliance with relevant standards.
  • Page 3 The Side Mount LimbLogic Vacuum Pump has been designed and tested for mounting on transfemoral sockets. Use in other configurations may result in tripping or other hazards. FCC NOTICE Note: This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause...

  • Page 4: Table Of Contents

    TABLE OF CONTENTS Page Installing the Fob Battery ................5 Quick-Start Guide ....................6 Fob Guide .......................6 Keys to Successful Use ..................7 Introduction ......................8 Vacuum System Function ................8 Charging the Vacuum Pump Battery ............9 Charging the Vacuum Pump Battery Outside the U.S....10 Charging the Vacuum Pump Battery in a Vehicle ......10 Turning On the Vacuum Pump ..............10 Turning Off the Vacuum Pump..............11...

  • Page 5: Installing The Fob Battery

    Overview INSTALLING THE FOB BATTERY The fob uses a commercially available CR2032 coin cell battery. The battery that is shipped with the system must be installed prior to using the fob. The battery will normally have to be replaced every 3 months depending upon how much the fob is used.

  • Page 6: Quick-Start Guide

    Overview QUICK-START GUIDE 1. Turn on the Vacuum Pump. Press one time. Pump will beep once. Wait 10 seconds. 2. Turn on the fob. Press and hold center button until the yellow digits flash in a “chasing” pattern and then display the current vacuum level.

  • Page 7: Keys To Successful Use

    • For a transfemoral socket, follow the fabrication instructions provided with the WillowWood One System - Socket Fabrication Instructions booklet. Prior to delivering the prosthesis, you may want to use the Diagnostic Disc or Sheet to confirm that there are no leaks in the system (refer to page 22).

  • Page 8: Introduction

    To obtain medical attention in the even of an open wound on their residual limb. • How to contact you, as WillowWood’s representative to this patient, in the event that they have questions about the configuration, use, or maintenance of their LimbLogic.

  • Page 9: Charging The Vacuum Pump Battery

    Do NOT walk while your LimbLogic is plugged into the charger. Use ONLY a WillowWood Charger. Use of any other charger may result in damage to the Vacuum Pump or the charger or both and may negatively affect EMC performance and/ or compliance and may result in serious injury or death.

  • Page 10: Charging The Vacuum Pump Battery Outside The U.s

    18 hour day of normal usage. It will do so for the life of the product. (Refer to “Service Life” on page 23.) If it is unable to do so, please refer to the troubleshooting section or contact WillowWood. CHARGING THE VACUUM PUMP BATTERY OUTSIDE THE UNITED STATES Chargers sold for use outside the U.S.

  • Page 11: Turning Off The Vacuum Pump

    Overview TURNING OFF THE VACUUM PUMP Press the on/off button on the Vacuum Pump and hold for 1 second. The pump will beep several times to indicate that it has been turned off. Refer to the Quick-Start Guide (page 6) for more information.

  • Page 12: Changing Vacuum Set Point

    Overview CHANGING VACUUM SET POINT Current vacuum level Enter Down Make sure the fob is on and displaying the current vacuum level in the yellow digits. Press the Up or Down button for 1 second until the yellow digits flash to indicate that the Vacuum Set Point is being changed. Adjust the Vacuum Set Point as follows: •...

  • Page 13: Bilateral Indicators

    Overview If the pump detects a leak, the red Leak Indicator will illuminate, the usage mode will change to Standby State, and the pump will beep 10 times rapidly. The pump will repeat this every 30 seconds for 6 minutes unless acknowledged by pressing the on/off button on the pump.

  • Page 14: Changing The Prosthetist Settings

    Overview CHANGING THE PROSTHETIST SETTINGS The system is shipped with the User Maximum set at 20 and the Vacuum Range set at 4. If these settings are not appropriate for your patient, you may adjust them as follows: Make sure the pump and fob are both turned on and are communicating with each other.

  • Page 15: Detecting A Leak

    Overview DETECTING A LEAK Leak Indicator If the Vacuum Pump detects a leak, the red Leak Indicator will illuminate, and the system will enter Standby State. At this time, the pump will make 10 short beeps. This will repeat every 30 seconds for 6 minutes unless acknowledged by pressing the on/off button on the pump.

  • Page 16: Vacuum Plate/Pyramid

    Overview VACUUM PLATE/PYRAMID The Vacuum Plate (LLV-01043) and Vacuum Pyramid (LLV-01044) can be used for attaching the Distal Mount pump in line with other endoskeletal components, instead of attaching the pump directly to the socket. Use the Vacuum Plate and Vacuum Pyramid ONLY in the configurations shown here.

  • Page 17: Exhaust Tube Muffler Cleaning

    Clear the clog in the tube by running water or by gently blowing compressesd air through the tube. If the clog cannot be cleared, purchase a replacement Exhaust Tube from WillowWood (LLV-21080). If the pump must be used before the replacement tube can be installed: 1.

  • Page 18: Troubleshooting Guide

    Verify that the rubber boot is intact the pump. and hasn’t been torn from impact. Contact WillowWood if the switch needs to be replaced. • The pump may have been exposed to a large static charge. Press and hold...
  • Page 19 Charger’s prong using the sliding latch on the back of the adapter. Verify that the metal contacts are springy and are not completely flat against the adapter. Re-install the plug prongs. • If the problem persists, contact WillowWood. continued on next page...
  • Page 20 SUPPORT If you encounter problems that you cannot solve, or encounter unexplained behaviors, contact WillowWood for support. Under normal conditions, you should not need to rinse or sanitize your pump. If a pump starts to smell, or if you suspect...
  • Page 21 “Er” and a two-digit error code. Refer to the chart below for the type of error indicated by each code and the corresponding action. Problem Description Cause Action Contact Pump stall Possibly WillowWood. debris or lubricant stuck in pump Allow pump Temp out of Pump temperature to range...

  • Page 22: Diagnostic Disc Or Sheet

    Overview DIAGNOSTIC DISC OR SHEET The Diagnostic Disc and Sheet are included with LimbLogic Systems. These are used to evaluate the internal seal of the pump. The Disc is used with the distal mounted design, and the Sheet is used with the side mounted design. Do not use the sealing Disc with a Side Mounted pump.

  • Page 23: Service Life

    The sole remedy is replacement of the products or credit for the products. WillowWood’s liability shall not exceed the purchase price of the product. WillowWood shall not be liable for any indirect, incidental, or consequential damage.

  • Page 24: Regulatory Information

    Technical Information REGULATORY INFORMATION Return this product to the factory for proper disposal. Essential performance: The LimbLogic fob, charger, and side mounted pump perform no essential performance. The distally mounted pump is designed to provide structural support when assembled into a prosthesis and complies to ISO 10328 for this function.
  • Page 25 It has not been clinically tested for wound healing or other uses. WillowWood does not currently support the use of the LimbLogic for uses other than suspension. Use only the bolts supplied by WillowWood. All testing for the LimbLogic vacuum system has been tested with the bolts included with the system.
  • Page 26 Technical Information LimbLogic Battery Charger This product is designed to work with WillowWood products specifically designed for its use. Use Willow- Wood charger part number LLV-21011. Use with other products may result in harm to the device, the user, or both, may void the warranty, and may negatively affect EMC performance and/or compliance.
  • Page 27 Technical Information This digital apparatus does not exceed the Class B limits for radio noise emissions from digital apparatus set out in the Radio Interfer- ence Regulations of the Canadian Department of Communications. REMARQUE: Cet équipement a été testé et déclaré conforme aux les règles de ICES-001.
  • Page 28 Technical Information Guidance and Manufacturer’s Declaration - Electromagnetic Immunity LimbLogic is intended for use in the electromagnetic environment specified below. The customer or the user of the LimbLogic should assure it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic test...
  • Page 29 Technical Information Guidance and Manufacturer's Declaration - Electromagnetic Immunity LimbLogic is intended for use in the electromagnetic environment specified below. The customer or the user of the LimbLogic should assure it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic test...
  • Page 30 Technical Information Recommended separation distances between portable and mobile RF communications equipment and the LimbLogic LimbLogic is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of LimbLogic can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LimbLogic as recommended below, according to the maximum...
  • Page 31 Technical Information USER PROFILE Prosthetist user LimbLogic is intended to be used for assembly of prosthetic devices by a certified prosthetist or prosthetic technician. Patient user LimbLogic is intended for use by patients meeting the following conditions. – Age: Any. Determined by clinician’s evaluation of patient competence and health.
  • Page 32 The Ohio Willow Wood Company 15441 Scioto Darby Road Mt. Sterling, OH 43143 phone 740.869.3377 / 800.848.4930 fax 740.869.4374 www.willowwoodco.com Ohio Willow Wood Company B.V Keizersgracht 62/64 1015 CS Amsterdam The Netherlands Patent www.willowwoodco.com/ education-and-resources/patents PN-2025-Y 28 AUG 2015...

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