LimbLogic® Prosthetist Instructions
Contents
1. Interference may occur in the vicinity of equipment marked with the following symbol K NOTE1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromag netic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and 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 LimbLogic is used exceeds the applicable RF compliance level above the LimbLogic should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the LimbLogic b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 25 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 helo prevent electromagnetic interference by maintaining a minimum dista2. VACUUM PLATE PYRAMID The Vacuum Plate LLV 01043 and Vacuum Pyramid LLV 01044 can be used for attaching the Vacuum 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 ik x y se Vacuum Plate gt Hose Barb A Hole Titanium connects Pyramid FND 227014 eee hose on Capscrews pump CUCM TMC LINE NAN A ALAM lt lt Knee Frame or similar Vacuum Pyramid i lt Hose Barb Proximal Sealing Gasket ee a connects to external hose on LimbLogic pump Vacuum Pump A Hole Titanium Pyramid FND 227014 Capscrews dU BDA ceca Ki eC 13 Overview EXHAUST TUBE MUFFLER CLEANING Using a flat blade screwdriver remove the Exhaust Tube Fitting from the pump housing Do not lose the o ring from the fitting Exhaust Tube Fitting 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 Remove the existing tube from the Exhaust Tube Fitting 2 Cut the existing tube just past the Muffler 3 Connect the Exhaust Tube Fitting to the section of tube that does not have the Muffler The pump will function normally but at a sligh
3. s on off button for approximately 12 seconds until you hear a beep If problem persists return to Willow Wood for repair Radio BLE Radio Return to Willow failure Wood for repair O7 Vacuum Vacuum Return to Willow Sensor failure Wood for repair Battery Battery Return to Willow monitoring Wood for repair circuit failure 18 Overview DIAGNOSTIC DISC The Diagnostic Disc included with the LimbLogic System can be used to test the vacuum pump as follows I 2 S 4 Remove the protective tape from the Diagnostic Disc Place the Proximal Gasket in the recess on top of the pump Place the Diagnostic Disc on top of the Proximal Gasket Attach the pump with the Diagnostic Disc and Proximal Gasket to the socket Be sure to tighten the bolts evenly tightening them more on one side than the other may result in a leak Start the pump and watch the display on the fob e f the vacuum level drops the pump has a leak e If the vacuum level holds steady the pump is functioning correctly Remove the Diagnostic Disc for normal operation of the system Diagnostic DISC Proximal Sealing Gasket amp Capscrews LimbLogic Vacuum Pump 19 Technical Information The fob and the Charger are not water resistant SUbmersion of the fob or the Charger will void the warranty WARRANTY The warranty for the LimbLogic is two years from invoice date orovided that the system is selected according to
4. noise emissions from digital apparatus set out in the Radio Interfer ence Regulations of the Canadian Department of Communications REMARQUE Cet quipement a t test et d clar conforme aux les r gles de ICES OO1 Ces limites ont pour objectif de fournir une protection raisonnable contre les interf rences nuisibles dans une installation r sidentielle Cet quipement g n re utilise et rayonne de l nergie de fr quence radio et peut nuire aux communications radio s il n est pas install et utilis en accord avec le mode d emploi Cependant il n est pas garanti que des interf rences survien nent dans une installation particuli re Si l quipement cause des interf rences nuisibles la r ception radio ou t l vision qui peuvent tre localis es en allumant ou en teignant l quipement l utilisateur est encourag corriger les interf rences en employ ant une ou plusieurs des mesures suivantes R orienter ou d placer l antenne de r ception S parer davantage l quipement et le r cepteur Connecter l quipement une prise de courant situ e sur un circuit diff rent de celui du r cepteur Demandez assistance un revendeur o un technicien exp ri ment dans le domaine radio TV ELECTROMAGNETIC COMPATIBILITY Medical electrical equipment needs special precautions regarding electromagnetic compatibility EMC and needs to be installed and out into service according to the EM
5. 3 A m Power frequency frequency magnetic fields 50 60 Hz should be at levels magnetic field characteristic of IEC 61000 4 8 a typical location in a typical com mercial or hospital environment NOTE U is the ac mains voltage prior to application of the test level 24 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 test IEC 60601 Compliance Electromagnetic test level environment guidance Portable and mobile RF communications equip ment should be used no closer to any part of the LimbLogic including cables than the recom mended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vms SV d 14P IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 2VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmit ter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an elec tromagnetic site survey should be less than the compliance level in each frequency range
6. 6 Vacuum System EUN CIOME nn aident 6 Charging the Vacuum Pump Battery unissent 7 Charging the Vacuum Pump Battery in a Vehicle eee 7 Turning On the Vac um PUMP La ane 8 Turning Off the Vacuum PUM P esicenssccccicsstsveccesivcccsseesercvesccbadveterecenneeserdie 8 Resetting the Vacuum PUMP sicisiciveveccccecaase cides tcbsns erence sacsaveertesteedvessnscevens 8 PT FS On the FOD sesiis hennie 8 Changing Vacuum Set POINt s sssssssssrsserrserrnnrrnernnrrnnnrnnnrrnnsrrnnrrrnnrrenne 9 Chanaing Usage Moda osaisin 9 Bilateral MOI Cator arpe nie neaeret ey he rete ent eamentnn 10 Changing the Prosthetist Settings 0 cccceccssseecsseesesseesesseeeeseeeens 11 Detecting a Leak Carretera enters meer en 12 Vacuum Pump Battery Status nr 12 OLIEN Ra aan ae a aovaee 12 VACUUM Plate Pyramid iii eueenrnnrnrrenrneneenennrenrenee 13 Exhaust Tube Muffler Cleaning 14 Flu he Sy SM acc enina REA E 14 Troubleshooting Guide enr 15 DISAIS a uen ame 19 VAR a ae a S aaa 20 Regulatory IN TOMALIQN En tnt 21 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 The fob case can be pried open using a small flat blade screw driver then snapped back together starting at the battery end and working back toward the
7. H ABN 22582837497 i WilowtVood CHARGING 1 Insert the charging plug all the way into the charging port 2 Plug the Charger into a power outlet The Adapter LED will light The battery indicator on the fob will flash alternately between red and green If the battery indicator does not light make sure you have inserted the charging plug all the way into the port If the Node LED is red reset the Charger by unplugging it from the wall and plugging it back in While charging is in progress the Node LED will be solid 3 When charging is complete the Node LED will flash Disconnect the Charger from the Vacuum Pump and from the power outlet When you are ready for the pump to begin regulating the vacuum either turn on the fob refer to page 8 or press the on off button on the Vacuum Pump The pump will operate until the preselected vacuum level is reached Note if the pump has just been unplugged from the Charger it will be in Standby Mode refer to page 9 To resume vacuum regulation press the on off button one time To turn the pump off oress the on off button again Use ONLY a WillowWood Charger Use of any other A charger may result in damage to the Vacuum Pump or the charger or both With normal usage the rechargeable battery should last for the life of the product Do not use the Charger near water The Charger is not waterproof CHARGING THE VACUUM PUMP BATTERY IN A VEHICLE To use a v
8. Pumps one of the two white indicators at the top of the fob will illuminate to show which pump Cleft or right is being controlled To switch the fob from controlling one pump to the other press and hold the Up and Down buttons together for approximately 1 second The chasing pattern will be displayed and the indicator light will switch from one side to the other while communication with the other pump is being established If communication is established the displays and controls are similar to those for a unilateral system If no communication can be established the fob will return to controlling the pump that it controlled prior to the attempted switch Overview CHANGING THE PROSTHETIST SETTINGS The system is shipped with the User Maximum set at 20 and the Vacuum Range set at 6 If these settings are not sufficient 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 Quickly press the Enter button on the fob three times to enable the Prosthetist Settings function The three presses must be within approximately two seconds of each other The display will alternate between two quick flashes of this symbol and the current value for the User Maximum Press the Up or Down buttons to adjust the User Maximum The digits will flash to indicate that the User Maximum is being changed e The user will not be able to increase the Vacuum Set Po
9. comply with United States and international guidelines for low power transceivers If LimbLogic components will be used around safety critical devices such as pacemakers or defibrillators consult the manufacturer for appropriate usage instructions Consult the section on Regulatory Information for more information on safety and compliance LimbLogic is designed for use by a single patient only 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 undesired operation Changes or modifications not approved by The Ohio Willow Wood Company may void the user s authority to operate this equipment Remarque Le pr sent appareil est conforme aux CNR d Industrie Canada applicables aux appareils radio L exploitation est autoris e aux deux conditions suivantes 1 l appareil ne doit pas produire de brouillage et 2 l utilisateur de l appareil doit accepter tout brouillage radio lectrique subi m me si le brouillage est susceptible d en compromettre le fonctionnement TABLE OF CONTENTS Page Installing the Fob Battery iii 4 OVO el nice ue 6 arene ae re mente eee 5 BOB OU a dos 5 Keys to Successful USe acc ccscsssscdectscssuesadeccrascnbinasetnaccusecsstenisbnbezeatecaravncsotees 6 rod OO a
10. received including interference that may cause undesired operation Radio Frequency Interference Statement This is a Class B product In a domestic environment this prod uct may cause radio interference in which case the user may be required to take adequate measures Note This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protec tion against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the in structions may cause harmful interference to radio communica tions However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help 22 Technical Information This digital apparatus does not exceed the Class B limits for radio
11. C 60601 Compliance Electromagnetic test test level level environment guidance Electrostatic 6kVv Pe ky Floors should be discharge contact contact wood concrete or ESD ceramic tile If floors 8 kV air 8 kV Air are covered with synthetic material the relative humidity should be at least 30 IEC 61000 4 2 Electrical fast 2 kV for 2 kV on Mains power quality transient power power should be that of a burst supply lines supply lines typical commercial IEC 61000 4 4 or hospital kVon 1kV on inout Input output lines output lines environment Surge 1kV 1ky Mains power quality IEC 61000 4 5 differential differential should be that of a mode mode typical commercial EOR 9 kV or hospital environment common common mode mode Voltage dips lt 5 U lt 5 UL Mains power quality short interrup 95 dip 95 dip should be that of a tions and volt f typical commercial iations RAA A aid or hospital ONE O 5 cycle O 5 cycle on power environment If supply input 40 U 40 Uz the user of the lines 60 dip in 60 dip LimbLogic requires IEC 61000 4 11 U for in U for continued 5 cycles 5 cycles operation during mains interruptions 70 U 70 U it is recommended 30 dip 30 dip that the LimbLogic in U for in U for be powered from 25 cycles 25 cycles an uninterruptible ower supply or a ay ee ene ou gt 95 dip 95 dip in U_ for in U for 5 sec 5 Sec Power 77m
12. C information provided in this user manual Portable and mobile radio frequency RF commu nications equipment can affect medical electrical equipment Guidance and Manufacturer s Declaration Electromagnetic Emissions LimbLogic is intended for use in the electromagnetic environments specified below The customer or the user of the LimbLogic should assure it is used in such an environment Emissions test Electromagnetic environment guidance RF emissions Group 2 LimbLogic must emit CISPR TI electromagnetic energy in order to perform its in tended function Nearby electronic equipment may be affected RF emissions Class B LimbLogic is suitable CISPR 11 for use in all establish en amines ments including domestic IEC 61000 3 2 establishments and those directly connected to the Voltage fluctuations Complies public low voltage power flicker emissions supply network that sup IEC 61000 3 3 olies buildings used for domestic purposes Emissions from this device comply with the recommendations of the ICNIRP s Guidelines for Limiting Exposure to Time Vary ing Electric and Magnetic Fields 1 Hz 100 kHz Health Physics 99 6 818 836 2010 23 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 IE
13. Road Mt Sterling OH 43143 phone 740 869 3377 800 848 4930 fax 740 869 4374 Wwww willowwoodco com Ohio Willow Wood Company B V C Keizersgracht 62 64 1015 CS Amsterdam The Netherlands ec REP PN 2025 T 1 MAY 2013 Covered by one or more Patents US 8 242 879 8 016 892 7 947 085 7 914 586 Other Patents Pending
14. WillowWood LimbLogic Prosthetist Instructions WHAT S IN THE BOX Vacuum Pump Battery Charger Fob Fob Battery quantity 2 Fob Key Ring Diagnostic Disc and Proximal Gasket packaged together Exhaust Port Drain Tube Replacement Exhaust Hose and Muffler Thermoplastic Fabrication Kit or Lamination Fabrication Kit Patient Instructions Prosthetist Instructions Quick Start Guide C Quantity 2 for bilateral kit 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 and can be used only with each other There are no field serviceable parts inside the Vacuum Pump Opening the Vacuum Pump will void the warranty 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 Do not allow acetone to contact the Vacuum Pump or fob LimbLogic is not intended to be used as the only means of attachment of prosthesis to patient All LimbLogic components have passed safety testing for use as medical devices Radio enabled devices
15. ck in continued on next page 16 Overview The pump runs repeatedly The pump beeps but does not run Using a flat blade screwdriver remove the Exhaust Tube Fitting from the pump housing Do not lose the o ring from the fitting Install the drain tube and flush the system with alcohol The Muffler on the Exhaust Tube may be clogged Clean the Muffler as described on page 14 17 Overview Error Codes If the vacuum pump s controller detects an error from which it cannot recover the fob display will alternate between the letters 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 Pump stall Possibly Reset the pump debris or by pressing and lubricant holding the pump s stuck in on off button for pump approximately 12 seconds until you hear a beep then flush the system with alcohol refer to Flushing the System on page 14 Temp out of Pump tem Allow pump range perature less temperature to than 20 C return to operating or greater range then reset than 70 C the pump by pressing and holding the pump s on off button for approximately 12 seconds until you hear a beep O3 Motion fail Motion Return to Willow sensor failure Wood for repair O4 ADC fail Analog Return to Willow Digital Wood for repair Converter failure O5 Memory Memory Reset ine pump failure by pressing and holding the pump
16. d Press the Enter button to apply the changes The chasing pattern will be displayed while the setting is being applied If the Enter button is not pressed the settings will not be applied and the fob will shut off due to Inactivity in 60 seconds CHANGING USAGE MODE Make sure the fob is on and displaying the current vacuum level When the pump is on it has two usage modes Active Mode Vacuum Pump activates as needed to maintain the vacuum level Standby Mode allows you to temporarily suspend vacuum regulation Press and hold the Enter button to toggle the vacuum pump from one mode to the other The chasing pattern will be displayed while the change in mode is being applied Standby Indicator The white Standby indicator will illuminate when the Vacuum Pump is in Standby Mode The fob will continue to display vacuum levels while in Standby Mode When the white Standby Indicator is not illuminated the pump is in Active Mode Overview If the pump detects a leak the red Leak Indicator will illuminate the usage mode will change to Standby Mode 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 To return to Active Mode press and hold the Enter button Leak Indicator Enter BILATERAL INDICATORS Bilateral Indicators WillowWood If a fob is configured to support bilateral Vacuum
17. e pump may also be required when the fob displays certain error codes refer to page 18 TURNING ON THE FOB Current vacuum level Make sure the pump has been on for at least 10 seconds Press and hold the Enter center button for approximately 2 seconds until the yellow digits flash in a circular chasing pattern The chasing pattern indicates the fob is attempting to communicate with the pump When the fob connects to the pump the current vacuum level will be displayed in the center A connected fob will shut off after one minute of non use If the pump is off or fails to connect to the fob the chasing pattern will end after 6 seconds and all fob LEDs will turn off For bilateral systems if the fob cannot establish communications with the first pump the fob will attempt to connect to the second pump using the same steps as above If communication cannot be established with either pump the fob will shut down 8 Overview CHANGING VACUUM SET POINT Current vacuum level 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 e Press the Up or Down button repeatedly to adjust the Vacuum Set Point by one number at a time or e Press and hold the Up or Down button until the desired Vacuum Set Point is displaye
18. ehicle s power to charge the Vacuum Pump you must purchase a Power Inverter rated at 75 Watts or less to convert the vehicle s 12V DC power to 120V AC Examples of acceptable Power Inverters include the Digital Concepts 75 Watt Portable Power Inverter available from general retailers and the Enercell 75 Watt Power Inverter available from Radio Shack item number 22 133 1 Plug the Power Inverter into the vehicle s 12V DC socket 2 Connect the Charger to the Vacuum Pump 3 Plug the Charger s AC Adapter into the Power Inverter s three pronged receptacle A Do not operate the Charger above 41 C 105 F 7 Overview TURNING ON THE VACUUM PUMP on off button Press the on off button on the Vacuum Pump one time The Vacuum Pump will beep once Before turning on the fob as described below wait 10 seconds for the pump to activate TURNING OFF THE VACUUM PUMP Press the on off button on the Vacuum Pump and hold for 1 second The Vacuum Pump will beep twice Note if the pump has just been unplugged from the Charger it will be in Standby Mode refer to page 9 To resume vacuum regulation press the on off button one time To turn the pump off press the on off button again RESETTING THE VACUUM PUMP It is possible for a large static discharge to interrupt normal operation Should this occur press the on off button on the Vacuum Pump and hold for at least 12 seconds until the unit beeps Resetting th
19. icence GUL LimbLogic Vacuum Pump CE This product contains a rechargeable Lithium lon Battery Use ONLY a Willow Wood Charger Use of other chargers may result in harm to the device the user or both and void the warranty Blocking or plugging the exhaust port of the vacuum control assembly will prevent proper operation of the vacuum pump The LimbLogic Vacuum Pump is intended for use on a single patient Use of the system with multiple patients could lead to cross contamination between patients The LimbLogic 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 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 Use of other bolts could result in mechanical failure This product complies with EN 60601 1 2 2007 IEC 60601 1 2 ED 3 0 IEC 60601 1 2005 CORR1 2006 CORR 2 2007 CEI IEC 605291989 A11999 rating IPX8 3 meters for 8 hours in fresh water and ISO10528 2005 IEC 60601 1 Classifications Internally powered Powered from Class Il Power Supply Degree of protection against electrical shock Type BF Applied Part This product complies with the requirements of ISO 10328 In addition to the above compliances this device com
20. int above the User Maximum e The User Maximum cannot be set higher than 20 Press the Enter button to apply the new User Maximum setting and advance to the next setting The display will alternate between two quick flashes of this symbol and the current value for the Vacuum Range Press the Up or Down buttons to adjust the Vacuum Range The digits will flash to indicate that the Vacuum Range is being changed e The Vacuum Range s how much the current vacuum level can fall below the Vacuum Set Point before the pump activates e The Vacuum Range cannot be set lower than 4 Press the Enter button to apply the new Vacuum Range setting The chasing pattern will be displayed while the setting is be ing applied The fob will then return to displaying the current vacuum level NOTE Adjusting the User Maximum and Vacuum Range Settings can affect the Vacuum Level setting After changing either the User Maximum or Vacuum Range settings please check to ensure the Vacuum Level is set to the desired level Overview DETECTING A LEAK Leak Indicator If the Vacuum Pump detects a leak the red Leak Indicator A will illuminate and the system will enter Standby Mode At this time the pump will make 10 short beeps This will repeat every 30 seconds for 6 minutes unless acknowledged by oressing the on off button on the pump If the Leak Indicator appears when the patient initially dons the prosthesis the patient should
21. is critical to the proper operation of the system Be sure to follow the fabrication instructions provided with the adapter Prior to delivering the prosthesis you may want to use the Diagnostic Disc to confirm that there are no leaks in the system refer to page 19 2 Fully charge the Vacuum Pump Refer to Charging the Vacuum Pump Battery on page 7 3 Properly secure the fully charged Vacuum Pump to the socket Vacuum Plate LLV 01043 or Vacuum Pyramid LLV 01044 with M6 flathead screws If using the socket in a definitive prosthesis apply Loctite 242 Removable Threadlocker or equivalent to the screws and torque the screws to 9 ft lbs 12 Nm 4 Have the patient don an Alpha Liner the prosthesis and a LimbLogic Sleeve Follow the donning instructions provided with the LimbLogic Sleeve INTRODUCTION LimbLogic 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 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 The miniaturized LimbLogic fob provides the user with control and status information for the LimbLogic Vacuum System The fob uses lights or digits to display the vacuum pump s current usage mode the battery level the current vacuu
22. m level and leak indicators The vacuum level and range can be changed using the buttons located on the fob VACUUM SYSTEM FUNCTION The system monitors the vacuum level and draws more vacuum as needed to maintain the level within a designated Vacuum Range The desired vacuum level also known as the Vacuum Set Point is the upper limit of this range and can be adjusted by the patient however the Vacuum Set Point is limited by the User Maximum setting The system is shipped with the Vacuum Range set at 6 and the User Maximum set at 20 but if those settings are not suitable for your patient you may adjust them as desired The User Maximum cannot be set higher than the system maximum of 20 The optimum vacuum setting is different for each amputee Keep in mind that a higher vacuum level is not always better Higher vacuum levels require that the Vacuum Pump use more power and will therefore discharge the battery faster 6 Overview CHARGING THE VACUUM PUMP BATTERY The Vacuum Pump should be charged before it is used for the first time at the end of each day of use and when the Battery Indicator on the fob is red To AC Vacuum Pump Charger outlet AC Adapter Adapter LED indicates that AC outlet is providing power to Charger charging charging plug Node LED port Node LED ndicates Charger function RED fault SOLID charging FLASHING charged LLV 21011 FLASHING CHARGED 13 8 0V AG A
23. ment 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 WILLOW WOOD RETENTION OF RIGHTS WillowWood 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 the Vacuum Pump will void the warranty 20 Technical Information REGULATORY INFORMATION Return this product to the factory for proper dispoal LimbLogic Fob d This product contains a user replaceable lithium battery Replace only with user replaceable CR2032 batteries Discard of discharged batteries in accordance with local regulations Observe polarity markings on the battery and the fob housing when replacing the battery This product complies with EN 60601 1 2 2007 IEC 60601 1 2 ED 3 0 and IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 IEC 60601 1 Classifications Internally powered Degree of protection against electrical shock Type BF Applied Part In addition to the above compliances this device complies with EN55022 1998 A1 2000 A2 2003 Class BITE emissions requirements and all requirements for Low Interference Potential Devices LIPD and compliance with the requirements for a General User L
24. mp until you hear a beep approximately 12 seconds The pump may be partially stalled Refer to the Pump Stall error code information on page 18 Ensure that the system is properly sealed Ensure that the battery has been charged for at least 4 hours The pump may have been exposed to a large static charge Press and hold the on off button on the pump until you hear a beep approximately 12 seconds Ensure that your socket does not leak excessively The system is leaking but not yet ata rate that triggers the Leak Detector light Wash the sealing sleeve of debris around the sealing surface and remove any dirt or debris from the proximal sealing gasket and the pump s sealing surface If the leak is still present use the Diagnostic Disc to determine the source of the leak The battery is likely dead and must be replaced per the instructions on page 4 continued on next page IS Overview problem Aion SOS The fob does not communicate with the pump The chasing pattern of LEDs ends after 6 seconds and the LEDs turn off The Adapter LED on the Charger does not illuminate when plugged into the wall The Node LED on the Charger does not light or blink when the Charger is olugged into vacuum pump and AC outlet The Node LED is red Wait one minute for the fob screen to turn off Make sure the pump is on by oressing the on off button and verify that the pump beeps once Li
25. nce between portable and mobile RF communications equipment transmitters and the LimbLogic as recommended below according to the maximum output power of the communications equipment Separation distance according Rated maximum to frequency of transmitter m output power 150 kHz to 80 MHz to 800 MHz to of transmitter W 80 MHz 800 MHz 2 5 GHz d 1 2VP d 1 2VP d 2 3VP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 Weight Body weight plus any loads normally or routinely carried cannot exceed these weight limits lt 350 lb 160 kg for U S Activity K Level 2 or 3 l
26. opposite end Back Cover Battery Battery Clip After the battery is replaced the system does a quick D check by illuminating all the LED indicators If all of the LEDs do not illuminate then either the battery or the LEDs are not working or the battery has been installed upside down 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 The pump will operate until the preselected EES vacuum level has been reached 3 To enter Standby Mode Press for approximately 2 seconds The chasing pattern will be displayed then the white Standby Indicator will light To resume vacuum regulation Press for approximately 2 seconds The chasing pattern will be displayed as the pump returns to Active Mode 4 Turn off the Vacuum Pump Press one time Pump will beep twice FOB GUIDE Vacuum Pump Battery Indicator E 50 100 EEHEEHE 30 50 E 20 30 EEHEEHE lt 20 Bilateral Indicators Current Vacuum Standby Indicator White Enter Leak Down E Indicator Red Overview KEYS TO SUCCESSFUL USE 1 Fabricate a non porous Total Surface Weight Bearing socket using either a LimbLogic 4 Hole Attachment Plate or LimbLogic Drop In Adapter Fabricating an airtight socket
27. plies with EN55022 1998 A1 2000 A2 2003 Class B ITE emissions requirements and all requirements for Low Interference Potential Devices LIPD and compliance with the require ments for a General User Licence GUL 21 Technical Information LimbLogic Battery Charger This product is designed to work with WillowWood oroducts specifically designed for its use Use WillowWood charger part number LLV 21011 Use with other products may result in harm to the device the user or both and void the warranty Refer to product manuals to verify compatibility with this charger be fore attempting to use this charger with the product Electrical Ratings Rated input 100 240 Vac 0 6 A 47 63 Hz Rated output 13 8 Vdc 2 6 A This product complies with EN 60601 1 2 2007 IEC 60601 1 2 ED 3 0 and IEC 60601 12005 CORR 1 2006 CORR 2 2007 and meets the ICNIRP GUIDELINES FOR LIMITING EXPOSURE TO TIME VARYING ELECTRIC AND MAGNETIC FIELDS 1 HZ 100 KHZ 2010 FCC AND IC COMPLIANCE INFORMATION FOR THE FOB AND THE VACUUM PUMP Note This equipment contains FCC ID XDULE40 S2 IC B456A LE4S2 Contient le module d mission IC 8456A LE4S2 FOR THE CHARGER This equipment contains FCC ID U3V LLV21011 This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions This device may not cause harmful interference and 2 This device must accept any interference
28. restart the pump If the Leak Indicator appears frequently while the patient is walking use the Diagnostic Disc to determine the source of the leak refer to page 19 To resume automatic vacuum regulation after a leak has been detected press the on off button on the Vacuum Pump one time or press the Enter button on the fob VACUUM PUMP BATTERY STATUS Vacuum Pump Battery Indicator The Battery Indicator flashes alternatively between red and green when the Vacuum Pump battery is charging The level of charge is indicated as follows e Solid green Vacuum Pump battery is between 50 and 100 charged e Flashing green Vacuum Pump battery is between 30 and 50 charged e Solid red Vacuum Pump battery is between 20 and 30 charged e Flashing red Vacuum Pump battery is less than 20 charged The battery should be charged when possible The pump will shut down when the battery level reaches O e At 10 the pump will start to beep 3 times every 30 seconds This will repeat for 6 minutes unless acknowledged by pressing the on off button on the pump EXPOSURE TO WATER The Vacuum Pump is waterproof in fresh water up to a depth of 10 feet or 3 meters for up to 12 hours The Vacuum Pump should not be submersed in salt water or any other corrosive liquids Be sure to dry off the Vacuum Pump if it is exposed to rain or other moisture The fob and Charger should not be exposed to water or other liquids 12 Overview
29. sten for about 30 seconds to make sure that the pump doesn t quickly beep twice and turn off which indicates a battery problem Press the fob center button again The fob may be too close or too far from the pump Place the fob about 2 feet away from the pump and press the fob center button again The pump s internal battery may not be charged Charge the pump with the Charger for at least 30 minutes and try again The pump may have been exposed to a large static charge Press and hold the on off button on the pump until you hear a beep approximately 12 seconds Does the patient have the correct fob pump combination The fob and pump are electronically matched during the production process Contact Willow Wood with the serial number of the fob and serial number of the pump to verify that the set is matched The AC electricity to the wall outlet may not be turned on Try plugging the charger into a different non switched wall outlet or in another room The configurable prong may not be seated properly in the back of the Charger s AC Adapter Unplug the Charger from the AC outlet Remove the 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 Contact WillowWood Reset the Charger by unplugging it from the wall and plugging it ba
30. t 300 Ib 136 kg for U S Activity K Level 4 Health Activity Level K2 K4 Nationality Any Mentally competent to operate system as judged by orosthetist PERFORMANCE CHARACTERISTICS Capabilities 2 year warranted service life Vacuum setting up to 68 kPa For ease of use this range has been divided into twenty even steps between 1 and 20 Indoor amp Outdoor usage The LimbLogic Controller pump is waterproof in fresh water to a depth of 3 meters 10 feet for up to 12 hours at a time Operating temperature range O C to 50 C Transportation and storage temperature range 20 C to 50 C Humidity range 10 to 90 RH non condensing Transportation and storage humidity range O to 100 RH non condensing Altitude range O to 5500 feet Transportation and storage altitude range 500 to 20 000 feet Restrictions LimbLogic must not be used in salt water or any other corrosive environment At temperatures below freezing condensation will form and freeze in the pump preventing further operation until warmed The hand held fob communicator and charger should not be exposed to water Frequency of use Daily for 16 hours day or as needed PHYSICAL MEASUREMENTS Module Dimensions mm Welaht ma Fob with Battery 38L x 31W x 8H Pump 36H x 74DIA 23 Charger Wall 86L x 56W x 37H 261 Transformer 27 WillowlVood The Ohio Willow Wood Company 15441 Scioto Darby
31. the following criteria Note The weights listed below are adjusted body weights Adjusted body weight is defined as the weight of the amputee olus any loads normally or routinely carried by the amputee Level 1 Level 2 Level 3 Level 4 350 lbs 350 lbs 350 Ibs 300 Ibs 160 kg 160 kg 160 kg 135 kg Level 4 Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills exhibiting high impact stress or energy levels Typical of the prosthetic demands of the child active adult or athlete Use of LimbLogic for amputees who do not meet the above criteria or who engage in extremely high and abusive activities is against WilowWood s recommendations and will void the two year warranty Extremely high and abusive activities are defined as activities such as skydiving karate and judo activities that could result in injury to an individual s natural limbs and activities that expose the prosthesis to corrosives such as salt water WARRANTY DISCLAIMER WillowWood warrants that each product manufactured will at the time of delivery be of workmanlike quality and substantially free of defects WILLOWWOOD MAKES NO OTHER WARRANTY IMPLIED OR EXPRESSED AND MAKES NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE This warranty shall terminate immediately upon an action to combine our products with other materials or in any manner to change the nature of our products The sole remedy is replace
32. tly higher noise level Exhaust Tube Fitting Muffler Cut here FLUSHING THE SYSTEM In some situations it may become necessary to flush the system Using a flat blade screwdriver remove the Exhaust Tube Fitting from the pump housing Do not lose the o ring from the fitting Install the drain tube and flush the system with alcohol 14 Overview TROUBLESHOOTING GUIDE The pump does not beep when the on off button iS pressed and the Charger is not connected to the pump Pressing the pump button does not start the pump Pump battery does not maintain charge for a full day The pump makes a Zip Zip zip sound as it controls the vacuum Pressing the center button of the fob does not cause the yellow LEDs to light ina chasing pattern The pump s internal battery may not be charged Charge the pump with the Charger for at least 30 minutes and try again The on off button could be damaged Verify that the rubber boot is intact 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 the on off button on the pump until you hear a beep approximately 12 seconds The pump s internal battery may not be charged Charge the pump with the Charger for at least 30 minutes and try again The pump may have been exposed to a large static charge Press and hold the on off button on the pu
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