Table of Contents
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Prosthetist's
Guide
This document provides instruction for the prosthetist in
the installation and use of the system. A separate document,
LimbLogic VS Patient Information, is included with each
system and should be provided to the patient upon delivery
of a prosthesis containing the LimbLogic VS.
The Vacuum Pump and fob included in this package are
electronically keyed together and can be used only with
each other.
LimbLogic VS - 1600 Series is now waterproof.
1
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Table of Contents
Summary of Contents for OHIO WILLOW WOOD LimbLogic VS Series
- Page 1 Prosthetist’s Guide This document provides instruction for the prosthetist in the installation and use of the system. A separate document, LimbLogic VS Patient Information, is included with each system and should be provided to the patient upon delivery of a prosthesis containing the LimbLogic VS. The Vacuum Pump and fob included in this package are electronically keyed together and can be used only with each other.
- Page 2 This pump is only designed to move air; use of Vaseline ® or similar lubricating creams inside the socket will clog the pump. Do not allow foreign substances to be pulled through the Vacuum Pump. This may impair function of your vacuum system.
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Page 3: Table Of Contents
Table of Contents Page Quick-Start Guide ..................4 Keys to Successful Use ................5 BK Application ................6 AK Application ................7 Introduction ....................8 Vacuum System Function ..............8 Charging the Vacuum Pump Battery ............9 Charging the Vacuum Pump Battery in a Vehicle ......10 Turning on the Vacuum Pump ..............11 Turning on the Fob ................12 Information Screen ................13 Active Mode ..................13... -
Page 4: Quick-Start Guide
Overview Quick-Start Guide 1. Turn on the Vacuum Pump. Press one time 2. Start regulating the vacuum. Press and hold Press center button one more until LimbLogic VS time logo appears in display 3. Information about the system is displayed. Vacuum Pump current upper battery charge level... -
Page 5: Keys To Successful Use
Overview Keys to Successful Use 1. Fabricate a non-porous Total Surface Weight Bearing socket using a LimbLogic VS 4-Hole Attachment Plate. This is critical to the proper operation of the system. Be sure to follow the fabrication instructions provided with the 4-Hole Attachment Plate. Prior to delivering the prosthesis, you may want to use the Diagnostic Kit (LLV-1300) to confirm that there are no leaks in the system. -
Page 6: Bk Application
Overview BK Application The patient should don an Alpha Liner and Alpha Flex Sleeve as shown below. Fabric side of Gel side of Alpha Liner Alpha Liner Socket Figure 1: Folding over the top Alpha Flex edge of the liner Sleeve Gel side of Alpha Liner... -
Page 7: Ak Application
Overview AK Application The patient should don an Alpha Liner and Alpha AK Sleeve as shown below. Gel side of Alpha Liner Socket Figure 3: Top edge of the liner is folded over the brim of the socket Gel side of Fabric side of Alpha Liner AK Sleeve... -
Page 8: Introduction
Overview Introduction The LimbLogic VS is a remote-controlled vacuum suspension system. The Vacuum Pump is mounted inline on a prosthesis to allow for complete integration without the annoyances of tubes into the socket. LimbLogic VS operates quietly and features “Set and Forget” monitoring, which means that the system monitors the level of vacuum in the socket to maintain a secure and comfortable fit. -
Page 9: Charging The Vacuum Pump Battery
Overview Charging the Vacuum Pump Battery Vacuum Pump Charger outlet charging port charging plug charger node Align the green Green LED mark on the plug SOLID = charging with the green FLASHING = charged mark on the port. reset button 1. -
Page 10: Charging The Vacuum Pump Battery In A Vehicle
Overview 5. Reinstall the cap onto the charging port on the Vacuum Pump. Use ONLY an Ohio Willow Wood charger. For LLV-01042 series Vacuum Pumps use Ohio Willow Wood charger part number LLV-01011. For LLV-01040 series Vacuum Pumps use Ohio Willow Wood charger part number LLV-01010. -
Page 11: Turning On The Vacuum Pump
Overview Turning on the Vacuum Pump on/off button Press the on/off button on the Vacuum Pump one time. The pump will vibrate four times. Note: if the pump has just been unplugged from the charger, the button does not need to be pressed. When you are ready for the pump to begin regulating the vacuum, press the on/off button again (or turn on the fob, as described on the next page). -
Page 12: Turning On The Fob
Overview Turning on the Fob Up/down buttons: adjust vacuum setting button Center button: apply setting left right Right/left buttons: button button toggle between right and left Vacuum Pumps center down (bilateral only) button button Press and hold the center button on the fob until the LimbLogic VS logo appears and the display has reached the desired brightness. -
Page 13: Information Screen
Overview Information Screen The Information Screen indicates important details about the operation of the system. The vertical bars inside the battery symbol on the right side of the screen indicate the amount of charge left in the Vacuum Pump battery. As the battery is discharged, the bars disappear from left to right A) Active Mode When numbers are displayed to the left of the battery symbol, as... -
Page 14: For Bilateral Applications
Overview For bilateral applications: The Information Screen displays right and left indicators to show which pump is currently communicating with the fob. Use the right/left buttons to select the right or left Vacuum Pump, then press the center button to save your selection. The LimbLogic VS logo will appear, followed by the Information Screen for the selected pump. -
Page 15: Configuration Screen
Overview Configuration Screen The system is shipped with the User Maximum set at 20 in-Hg and the Vacuum Control Range set at 6 in-Hg. If these settings are not sufficient for your patient, you may adjust them as follows: With the Information Screen displayed, press the left and right buttons simultaneously. -
Page 16: Detecting A Leak
Overview Detecting a Leak If the leak indicator appears when the patient initially dons the prosthesis, the patient should restart the pump. If the leak indicator appears frequently while the patient is walking, use the Diagnostic Kit (LLV-1300) to determine the source of the leak. -
Page 17: No Radio Connection
• make sure the fob is more than 3 inches away from the Vacuum Pump If the No Radio Connection indicator still appears, contact Ohio Willow Wood. Low-Battery Mode If the Vacuum Pump battery has less than 15% of its capacity remaining, the Vacuum Pump enters a “stutter”... -
Page 18: Cleaning The System
Overview Cleaning the System Once a month, the patient should pour 1/8 cup of distilled water or rubbing alcohol into the socket, place the end of the exhaust port tubing into a cup, and activate the Vacuum Pump. Use ONLY distilled water or rubbing alcohol to clean the system. -
Page 19: Accessories
Overview Accessories Cosmesis Kit The Cosmesis Kit (LLV-01046) extends the Vacuum Pump’s charging port and on/off button so that they are flush with the surface of a cosmetic cover. The kit also includes a hose barb for routing the exhaust tube into the foot shell. -
Page 20: Troubleshooting Guide
Overview Troubleshooting Guide Problem Action • The pump’s internal battery may not be The pump does not charged. Charge the pump with the charger vibrate when the on/ for at least 30 minutes and try again. off button is pressed • The on/off button could be damaged. Verify once and the charger that the rubber boot is intact and hasn’t been is not connected to the torn from impact. Contact Ohio Willow pump. - Page 21 Overview Problem Action • Ensure that the system is properly sealed. Pump battery does not • Ensure that the battery has been charged for maintain charge for a at least 4 hours. full day. • The pump may have ben exposed to a large static discharge. Plug in the charger and press the reset button to reset the pump. The charger does not need to be plugged into an outlet. • Ensure that your socket does not leak excessively. • Make sure the pump is on by pressing the The fob does not on/off button once and verify that the pump communicate with the vibrates in recognition of the button activation.
- Page 22 Problem Action The green LED on • Make sure that the green marks on the the charger node does charging port and the charging plug are not illuminate or blink aligned (page 9). Do not force the when the charger is connection. plugged into vacuum • The pins on the charger plug may be bent. pump and AC outlet. Unplug the charger from the vacuum pump and inspect the pins. Do NOT try to straighten pins while charger is plugged into an AC outlet! If the pins are bent or broken, contact Ohio Willow Wood. • With the charger plugged into an AC outlet and the pump, press and hold the reset button on the charger node for 5 seconds, then release. If the green LED does not blink or turn solid within 5 seconds after the button release, contact Ohio Willow Wood. • If charger plug pins have been bent or the plug has been forced into pump, the internal electronics of the pump can be damaged, or the green LED on the charger could be damaged. Use the fob to check the pump battery level, then charge the pump for 2 hours and re-check the battery level to verify that the level has increased. If the level has not increased, contact Ohio...
- Page 23 Overview Problem Action The fob battery may need to be reset. Pressing the center of the button of the fob Remove the back cover of the fob per the does not display the instructions in the Patient Information LimbLogic VS logo. booklet, then remove and reinstall the battery. If the problem persists, the battery is likely dead and must be replaced per the instructions in the Patient Information booklet. The blue LED light • The AC electricity to the wall outlet may not on the charger does be turned on. Try plugging the charger into not illuminate when a different non-switched wall outlet or in plugged into the wall.
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Page 24: Diagnostic Kit Instructions
Diagnostic Kit Instructions The following process can be used to evaluate the integrity of the system prior to fitting or to iso- late the source of a leak in a system fabricated with the LimbLogic VS 4-Hole Attachment Plate. Start HERE if the leak is found AFTER Start HERE if the leak is found BEFORE the prosthesis has been delivered. -
Page 25: Warranty
The sole remedy is replacement of the products or credit for the products. Ohio Willow Wood’s liability shall not exceed the purchase price of the product. Ohio Willow Wood shall not be liable for any indirect, incidental, or consequential damage. - Page 26 Technical Information Ohio Willow Wood Retention of Rights Ohio Willow Wood retains all intellectual property rights reflected or incorporated in its physical products, regardless of the transfer of the physical products to another party or parties. There are no field-serviceable parts inside the Vacuum Pump. Opening...
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Page 27: Regulatory Information
Technical Information Regulatory Information See www.limblogic.com for detailed WEEE compliance information. LimbLogic VS Fob This product contains a user replaceable lithium battery. Replace only with user replaceable CR2 batteries. Discard of discharged batteries in accordance with local regulations. Observe polarity markings on the battery and the fob housing when replacing the battery. - Page 28 The LLVS vacuum system has been designed for and clinically tested as a suspension aid. It has not been clinically tested for wound healing or other uses. Ohio Willow Wood does not currently support the use of the LLVS for uses other than suspension.
- Page 29 Technical Information LimbLogic VS Battery Charger This product is designed to work with Ohio Willow Wood products specifically designed for its use. For LLV-01042 series Vacuum Pumps use Ohio Willow Wood charger part number LLV-01011. For LLV-01040 series Vacuum Pumps use Ohio Willow Wood charger part number LLV-01010.
- Page 30 Technical Information FCC and IC Compliance Information (for the Fob and the Vacuum Pump) 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.
- Page 31 Technical Information Specifications: IC ..........7475A-6221020 FCC ID ........U3V6221020 Input voltage ......4.5 -12V DC Input current ......37 mA Operating temperature range ..-20ºC to +50ºC Frequency range ......2400 -2483 MHz. Antenna ........Permanently soldered to Module Transmit power ......
- Page 32 Technical Information Electromagnetic Compatibility Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this user manual. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment.
- Page 33 Technical Information Guidance and Manufacturer's Declaration - Electromagnetic Immunity The LLVS is intended for use in the electromagnetic environments specified below. The customer or the user of the LLVS should assure it is used in such an environment. Immunity IEC 60601 Compliance Test Test Level...
- Page 34 Technical Information Guidance and Manufacturer's Declaration - Electromagnetic Immunity The LLVS is intended for use in the electromagnetic environments specified below. The customer or the user of the LLVS should assure it is used in such an environment. Immunity IEC 60601 Compliance Test Test Level...
- Page 35 Technical Information FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the LLVS is used exceeds the applicable RF compliance level above, the LLVS should be observed to verify normal operation.
- Page 36 ® 15441 Scioto Darby Road Mt. Sterling, OH 43143 phone 740.869.3377 / 800.848.4930 fax 740.869.4374 www.owwco.com Ohio Willow Wood Company B.V Keizersgracht 62/64 1015 CS Amsterdam The Netherlands PN-2025-N 28 JULY 2009 US and Foreign Patents Pending...