Communicator User`s Guide
Contents
1. D WCU SOG ING Sismsastei iai aaa nai a o d Baii ea i ai a it a lg a 8 e o CEI Se E CNC c TENERO mem 1 Seal Quality Diagnostics eat tea 15 Par FO With vacuum E BER mmm ivecie Ss ET n tts ai ai a a til ant E 2 SSS Sis GLU ene 22 Eiaa Wes agha ai EAEE E mm 24 S9 ju 44 ie E N je Le a SNNT RN RI RR RN RN N N TIN N INN A NI INI 24 6 10 je c PPP 25 ADOT ECITO NC e ata ace i iata ea RS 26 Regulatory Information eee cana 28 INTRODUCTION The LimbLogic Communicator provides a variety of functions to help you optimize your use of the LimbLogic System With the Communicator you can easily e configure and confirm a patient s LimbLogic settings e record data while a patient is in your office e review data collected during usage between visits e evaluate the integrity of the socket s vacuum seal e configure adaptive vacuum e access advanced features using the Assistant e monitor patient usage between visits Note it is recommended that you download usage statistics with the Communicator refer to page 11 during a patient s initial fitting to establish a baseline that can be used to allow tracking of usage between future visits The Communicator s functions are grouped onto eight main software screens Getting Started Vacuum Settings Usage Seal Quality Pair Fob Adaptive Vacuum Assistant and G2. Before Adaptive Mode can be activated you must configure this function for the patient Configuration involves capturing data from the system while the patient is walking and again while the patient is resting If Adaptive Mode has not yet been configured you will see the 3 icon on the Adaptive Vacuum tab To begin ask the patient to start walking After a few seconds click the Moving button on the left side of the Adaptive Vacuum screen Getting Started Vacuum Settings Usage Seal Quality Pair Fob Adaptive Vacuum e Adaptive Vacuum 6 55 Activitv Capture 5 45 44 25 Resting 4 Time Secs Connected to Jane Doe c Copyright amp 2013 2015 The Ohio Willow Wood Company All rights reserved 1 LimbLogic Vacuum Systems Protected by one or more patents For details see www owwco com patent Ask the patient to continue to walk around for approximately 15 seconds The patient should remain within 30 feet of the Communicator with no walls or other obstructions between the Communicator and the pump As the patient walks a graph of the patient s motion level will be displayed on the screen Note the units disolayed on the activity axis are arbitrary units that simply indicate the relative difference between moving and resting activity They are not an indicator of the vacuum level they are an indicator of the magnitude of the patient s movement LimbLogic Communicator Getting
3. 2013 2015 The Ohio Willow Wood Company All rights reserved C3 ConnectedtoJaneDoe 1 LimbLogic Vacuum Systems iii Adel egale ese The Seal Quality Rating gauges how frequently the current socket system may activate the LimbLogic System A rating of Good indicates that the system was well sealed so during normal use it should last for a full day s use on a full charge A rating of Marginal indicates that the system is likely to provide a full day of Operation but is activating more than might be expected A rating of Poor means that the system is activating frequently The Good Marginal and Poor ratings are historical and may not indicate future performance Note regarding the ability to measure seal quality Many factors contribute to the seal quality of a given socket including but not limited to leak rate socket size fit and the use of fabric sleeves The resulting system can take minutes to stabilize sufficiently to get a reasonable measure of the seal quality While the Seal Quality Rating will provide a reasonable estimate of the seal quality for most sockets this process may not work well for small or leaky sockets where vacuum levels may drop too quickly for the socket pressure to equilibrate Note Systems with very good seals in the range of 10 may not leak enough to detect a drop in vacuum With these sockets small changes in posture may be detected as motion during the measurement If the vacuum
4. The Assistant function allows you to view information about socket conditions that have been found to correlate with socket motion This function collects and processes gait data to detect several of these features and then combines them to create a single indication of motion This function works well with patients with strong symmetrical gait Use with patients with highly compensatory gait will have less accurate results A qualified professional should always confirm indications from the Assistant Before data can be collected the software needs to understand the placement of the vacuum pump mounting location button orientation etc If this information has not yet been entered you will see the 3 icon on the Assistant tab STEP 1 Vacuum System Style STEP 2 Mounting Location STEP 3 Affected Side After you are prompted to set up the orientation of the E CECI ME pump the window shown at right will appear on the STEP 5 Button Orientation Assistant screen Select the appropriate option from each of the five drop down menus then click Set Orientation Note that the only options for pump placement are medial lateral anterior or posterior if the pump is located in one of the quadrants for example medial posterior or anterior lateral instead of on one of the axes then the sensors in the pump will not work properly If the orientation of the pump is changed at some point after the initial setup click the Change
5. 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 output power of the communica tions equipment Separation distance according to frequency of transmitter m Rated maximum output power of 150 kHz 80 MHz 800 MHz transmitter W to 80 MHz to 800 MHz to 2 5 GHz d 1 2VP d 1 2VP d 2 3VP For transmitters rated at a maximum output power not listed above the recom mended 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 NOTEI At80 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 52 USER PROFILE Prosthetist user The LimbLogic Communicator is intended to be used for monitoring of prosthetic devices by a certified prosthetist or pros
6. the Communicator User s Guide Click the Additional Guides tab on the left side of the screen to select a different guide to view LimbLogic Communicator Getting Started Vacuum Settings Usage Seal Quality Pair Fob Adaptive Vacuum Assistant Updates Additional Guides LimbLogic 4 Hole Adapter Instructions g LimbLogic Quick Start Guide z A x Overview LimbLogic Communicator User s Guide LimbLogic Components 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 LimbLogic Diagnostic Flow Chart LimbLogic Drop In Adapter Instructions The battery will normally have to be replaced every 3 months LimbLogic Patient Instructions depending upon how much the fob is used The fob case can be pried open using a small flat blade screw LimbLogic Prosthetist Instructions driver then snapped back together starting at the battery end and working back toward the opposite end Copyright amp 2013 2015 The Ohio Willow Wood Company All rights reserved CI Connected to Jane Doe 2 LimbLogic Vacuum Systems Protected by one or more patents For details see www owwco com patent ABOUT LIMBLOGIC When contacting WillowWood for technical support on a device you may be asked to provide the firmware revision level for that device This information can be found by accessing the About LimbLogic window To do th
7. Communicator software interface components LimbLogic Technical Support may be contacted by phone at 1 800 848 4930 or by email at limblogicsupportQ owwco com Your LimbLogic Communicator is running version 1 2 1 3 1 0 software Jane Doe s LimbLogic device is at firmware revision 0 43 BATTERY 9896 SET POINT 17 5 USER MAXIMUM 19 CY Ex nnected to Derek Nixon _ 11 LimbLoaic Vacuum Systems Copyright The Ohio Willow Wood Company 2013 LimbLogic Communicator Getting Started Pair Fob Guides LimbLogic Vacuum Systems New Vacuum Vacuum System X System Detect d Serial 000000126 Register Niv Unilateral LimbLogict fansDos Search About LimbLogic x LimbLogic Communicator ht 2013 2015 The Ohio Willow Wood Company All rights reserved Protected by one or more patents For details see Name Version Description LimbLogic AdverseConditions 2015 2 1 8 LimbLogic adverse conditions support LimbLogic Bootloading 2015 2 1 8 LimbLogic bootloading support LimbLogic Communicator 2015 2 1 8 LimbLogic Communicator LimbLogic Communicator 2015 2 1 8 LimbLogic Communicator LimbLogic Communicator Data 2015 2 1 8 LimbLogic Communicator data access components LimbLogic Communicator Framework 2015 2 18 LimbLogic amp Communicator software interface components LimbLogic Technical Support may be contacted by phone at 1 800 848 4930 or by email at limblogicsupport o
8. Started Vacuum Settings Usage Adaptive Vacuum Activity Capture e Movin g act ivity MOVING ood Company All rights reserved more patents For details see www owwco com patent CI Connected to Jane Doe 1 LimbLogic Vacuum Systems Copyright 2013 2015 The Ohio Willow W Protected by one or 20 After the moving data has been captured ask the patient to sit After a few seconds press the Resting button on the left side of the screen A graph of the patient s resting motion level will be displayed on the screen Activity Capture Resting activity i 0 2 3 4 2 6 rd 8 9 RESTING Time Secs NL r After the moving and resting data have been captured you will see a prompt asking if you want to adjust the mobility setting If you click Yes you may use the slider bar to adjust the threshold between the Moving level and the Resting level As you adjust the slider you will see the straight green line move up or down on the graph ic Vacuum Systems Ur 3 IF you move the green line up closer to the Moving graph you will make the system less sensitive in other words a higher amount of activity will be required before the vacuum setting switches from Resting to Moving IF you move the green line down closer to the Resting graph you will make the system more sensitive in other words a lower amount of activity will be required
9. green on the dial The current Vacuum Set Point is displayed in the Resting Set Point field and is the number at the upper end of the green range on the dial Adaptive Mode Disabled When Adaptive Mode is disabled refer to page 20 the Standard Mode Settings control vacuum activation regardless of the user s activity level The Resting Settings are not applicable and will not be displayed Note if Standard Mode is enabled when communication between the Communicator and the pump is shut down the patient will only have access to the Standard Mode until the next time the pump is configured by a Communicator Note the Vacuum Range Vacuum Set Point and User Maximum Settings are described in the LimbLogic Prosthetist Instructions Refer to the Guides section of this document for information on accessing the LimbLogic Prosthetist Instructions 8 If desired you may adjust the Vacuum Set Point VACUUM SETTINGS Range and User Maximum by entering the new setting s in place of the existing setting s Changes to the vacuum settings are confirmed by a beep from the pump unless the pump is currently running or performing some other critical task In the example at right the Moving Set Point has been RESTING SETTINGS MOVING SETTINGS changed to 17 the Moving Range has been changed ioan ae nu Fee ser pont Gz to 5 and the User Maximum has been changed iaca LM Lx LOIS Notice that corresponding indicators on the dial have mov
10. or a lack of full charge cycles at night remind the patient of the importance of charging the battery each night until the Node LED on the charger starts flashing Refer to the LimbLogic Prosthetist Instructions for details Refer to the Guides section of this document for information on accessing the LimbLogic Prosthetist Instructions A red X indicates that a full charge was prevented by something other than unplugging the charger too soon If the problem persists contact WillowWood LimbLogic Communicator Getting Started Vacuum Settings Seal Quality Pair Fob START DATE END DATE Get Latest Statistics June 11 2014 12 38 PM Summary from June 11 2014 12 38 PM to March 30 2015 8 33 AM Seal Battery CHARGING HISTORY The Charging History graph shows the lannth fin hours of each charging session during ime frame the selected tim m rge at the Refer to this area ibus Er of the screen for I P descriptions of the Charging History amp statistics Completed end of Charging Cycle Usage I Copyright 2013 2015 The Ohio Willow Wood Company All rights reserved e Connected to Stephen S 5 LimbLogic Vacuum Systems Protected by one 3 om patent or more patents For details see www owwco c 15 Click Usage on the left side of the screen to see a summary of the usage history of the LimbLogic System during the selected time fram
11. to d 2 3VP 800 MHzto 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters rn Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each freguency range Interference may occur in the vicinity of equipment marked with the following symbol Co NOTET At 80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic 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 5 V rn od
12. with the requirements for a General User Licence GUL FCC AND IC COMPLIANCE INFORMATION Note This equipment contains FCC ID XDULEAO S2 IC 8456A LEAS2 Contient le module d mission IC 8456A LEAS2 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 Guidance and Manufacturer s Declaration Electromagnetic Emissions LimbL ogic 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 from this device comply with the recommendations of the ICNIRP s Guide domestic purposes Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Emissions test Electromagnetic environment guidance RF emissions Group 2 LimbLogic must emit electromagnetic energy in CISPR Tl order to perform its intended function Nearby electronic equipment may be affected HF ernissions Class B LimbLogic is suitable for use in all establishments CISPR Tl including domestic establishments and those di Harmonic ernissiorns Class Uk rectly connected to the public low voltage power IEC 61000 3 2 supply network that supplies buildings use
13. 2015 The Ohio Willow Wood Company All rights reserved imbLogic Vacuum Systems Protected by one or more patents For details see www owwco com patent As the settings are applied the progress is displayed on the screen LimbLogic amp Communicator Getting Started Pair Fob Guides Apply Settings to LimbLogic Fob Your fob will be paired with Vacuum System serial number 000000126 Please remove the battery from the LimbLogic fob and click the Battery Removed button when complete Note Directions on removing the fob battery can be found in the LimbLogic Prosthetist Instructions Insert the battery into the battery clip on the fob circuit board as shown in the LimbLogic Prosthetist Instructions but do not reassemble the fob yet After you see the lights on the back of the fob circuit board begin to flash in a circular pattern click the Apply Settings button Do not click the Apply Settings button until you see the lights flash in a circular pattern on the fob Applying settings DE Cg ConnectedtoJaneDoe PIT O S Copyright amp 2013 2015 The Ohio Willow Wood Company All rights reserved LimbLogic amp Vacuum Systems Protected by one or more patents For details see www owwco com patent 9 Once the fob has been successfully paired with the system you will see the message shown on the screen below At this point you may reassemble the fob as described in the LimbLogic Prosthetist Instructions 10 When you
14. LimbLogic Communicator t User s Guide All LimbLogic components have passed safety testing for use as medical devices Radio enabled devices 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 Electrical equipment can interact Do not operate the LimbLogic Communicator or pump while they are stacked upon or in close proximity to other electrical equipment without monitoring performance Doing so may result in equipment malfunction or failure This product is designed to work with WillowWood products specifically designed for its use 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 Refer to product manuals to verify compatibility There are no field serviceable parts inside the Communicator Opening the Communicator may result in serious injury compromise performance and or compliance and will void the warranty Unauthorized changes or modifications to the Communicator may impair its function resulting in serious injury prevent its compliance with relevant standards and will void the warranty Do not use the Communicator n
15. NT Pia SET POINT 16 2 RESTING RANGE At MOVING RANGE 43 USER MAXIMUM 20 gt On the left side of the screen in the Vacuum Settings pane the following values are displayed numerically and are also displayed graphically in an analog style needle dial RESTING SETTINGS MOVING SETTINGS The current vacuum level in the socket is displayed in the black Vacuum field under the dial and is also indicated by the tip of the orange needle on the dial The current User Maximum is displayed in the User Maximum field and is indicated in brown on the dial Values for Vacuum Set Point and Vacuum Range are displayed as follows Adaptive Mode Enabled When Adaptive Mode is enabled refer to page 20 the Moving Settings control vacuum activation when the user is in motion and the Resting Settings control vacuum activation when the user is at rest For Standard Moving Mode the current Vacuum Range is displayed in the Moving Range field and is also highlighted in blue on the dial The current Vacuum Set Point is displayed in the Set Point field and is the number at the upper end of the blue range on the dial Note if Adaptive Mode is enabled when communication between the Communicator and the pump is shut down the patient will only have access to the Adaptive Mode until the next time the pump is configured by a Communicator For Resting the current Vacuum Range is displayed in the Resting Range field and is also highlighted in
16. are done click the Back to Setup button in the lower right corner of the screen LimbLogic Communicator Getting Started Pair Fob Guides Apply Settings to LimbLogic Fob Your fob will be paired with Vacuum System serial number 000000126 Please remove the battery from the LimbLogic fob and click the Battery Removed button when complete Note Directions on removing the fob battery can be ua found n the LimbLogic Prosthetist Instructions Battery Removed The LimbLogic Fob settings have been successfully changed You can now reassemble the Fob e S hi AN 2 LimbLoaic V s Copyright 2013 2015 The Ohio Willow Wood Company All rights reserved A PARI imbLogic Vacuum Systems Protected by one or more patents For details see www owwco com patent 19 ADAPTIVE VACUUM In Adaptive Mode the system switches between a higher and a lower vacuum level range depending on whether the patient is moving or resting Because the pump activates less frequently at the lower vacuum level the patient may find Adaptive Mode helpful in quiet environments or during periods of prolonged inactivity The higher Moving and lower Resting vacuum settings can be adjusted as described on pages 8 9 There is a 5 minute delay before the system switches from the Moving vacuum level to the Resting vacuum level so that the vacuum level will not drop to the lower setting every time the user takes a brief break from activity
17. before the vacuum setting switches from Resting to Moving Activity Capture Moving 35 za PO Resting Enable k Adaptive Vacuum E i N pr a p Green line has been adjusted to a lower threshold x kr 0 1 2 5 4 5 6 7 8 9 Slider bar A nien eH o 2o o MELIUS There is no correct value for the threshold simply adjust it to a level at which the patient wants the vacuum to activate If you set the threshold at a level that is not recommended the threshold line will turn from green to yellow Note before the patient can be configured to use the Adaptive Vacuum function you must click the Enable Adaptive Vacuum button on the left side of the screen If you click the Disable Adaptive Vacuum button on this screen it will not be possible to configure the pump for Adaptive Vacuum until it is enabled again After you ve enabled Adaptive Vacuum click the Next button to go to the Vacuum Settings screen because the vacuum settings are reset after Adaptive Vacuum is enabled Adjust the Moving and Resting settings as shown in the Vacuum Settings chapter Once Adaptive is enabled it is then possible to select between Adaptive and Standard modes in the Vacuum Settings screen The patient will not be able to use Adaptive Mode unless it is enabled in the Adaptive Vacuum screen and selected in the Vacuum Settings screen 2 ASSISTANT The Assistant function is currently only available for transfemoral patients
18. button at the bottom of the screen and enter the new orientation Once the orientation has been set up for a transfemoral prosthesis the system will be ready to begin capturing data Mid Peaking Ratio START OQ The information is displayed on screen as follows A The vacuum pressure waveforrn Smooth shapes like you see here without any peaks at the top or the bot tom of the waveform tend to indicate intimate fit However intimate fit can be caused by excessive vacuum or firmly pulling a patient into an ill fitting socket f xav v Xx 0x 22 Peaks on the top of the waveform such as those shown here often indicate motion during swing phase Increased vacuum may address these conditions A JN f AN Zs PA FL NE ALE A Peaks on the bottom like the ones you see here can indicate motion during stance phase Additional vacuum mavy not be appropriate in these cases B Each step is indicated by a dot on this graph The axes are labeled Late Peaking Ratio and Mid Peaking Ratio these ratios are measure ments that help classify the steps according to whether they are likely to have experienced significant motion The dots inside the target in the center of the graph indicate steps with few indications of motion C This display indicates the total number of steps the number of steps in which indications of susti 2 motion were detected and the percentage of the total step
19. d for lines for Limiting Exposure to Time Varying Electric and Magnetic Fields 1 Hz 100 kHz Health Physics 99 6 818 836 2010 2E Guidance and Manufacturer s Declaration Electromagnetic Immunity LimbLogic is intended for use in the electromagnetic environment specified below The custorner or the user of the LimbLogic should assure it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic environment test test level level guidance Electrostatic 6 kV 224 Floors should be wood concrete or discharge contact contact ceramic tile If floors are covered with ESD tokar aside synthetic material the relative humidity IEC 61000 4 2 should be at least 30 Electrical fast 2kV for 2kV on transient burst power power IEC 61000 4 4 supply supply lines lines 1kV on 1kVon Input input output lines output lines Mains power quality should be that of a typical commercial or hospital environment Surge 1kV 1kV Mains power quality should be that of a IEC 61000 4 5 differential differential typical commercial or hospital mode mode environment T 2 KV Tod common common mode mode Voltage dips S odes S6 tT Mains power quality should be that of a short typical commercial or hospital environ gt 95 96 dip 2595 96 dip in Uy for in UT for O 5 cycle O 5 cycle 40 UT 40 UT 6096 dip 6096 dip in Uy for in UT for 5 cycles 5 cycles 70 UJ ment If the u
20. e The pie chart indicates the percentage of time that the system spent in the various operating modes Leak Mode Charging Adaptive Moving Adaptive Resting Active and Standby he text below the pie chart describes the total usage time along with the number of uses A use is a powering up of the vacuum pump after it was powered off LimbLogic Communicator Getting Started Vacuum Settings Seal Quality Pair Fob Adaptive Vacuum Assistant Guides START DATE END DATE March March 24 2015 12 02 PM acid Toae titen Statistics Summary for March 24 2015 12 02 PM ballely USAGE SUMMARY i The Usage Summary pie chart nrovides a summary of the MlLeak Mode 0 usage historv zi 39 the Limr The pi E Charging 13 ED Refer tothisarea qt i Adaptive Moving 1 in of the screen for d E Adaptive Resting 4 st MActive 24 N descriptions of the Standby 59 patient Usage statistics Total Usage Time 27 hours 44 minutes 2 Uses Cg Connected to kjojioj 22 LimbLogic V S Copyright amp 2013 2015 The Ohio Willow Wood Company All rights reserved WO OQNC acuum Systems Protected by one or more patents For details see www owwco com patent ar r A high percentage of time in Leak Mode may indicate that the patient is unaware of a leak in the system 14 SEAL QUALITY DIAGNOSTICS To run a diagnostic test on the quality of the seal while the user is sta
21. e s LimbLogic device is at firmware revision 0 43 27 REGULATORY INFORMATION Return this product to the factory for proper disposal Essential performance The LimbLobic Communicator performs no essential performance Acceptable temperature range for long term storage Acceptable humidity range for long term storage 47 Acceptable pressure range for long term storage o9 1060 hPA Consult instructions for use Your device is designed for submersion in fresh water for up to 8 hours at a depth of up to 5 rneters Adjacent to Manufacturers name and address This product complies with applicable standards for sale and use in EC countries This device operates on up to 7 volts of AC and DC current Type BF applied part On Off button Push Push style This product contains an RF transmitter This device enclosure is manufactured with an acetal polymer This product is compliant for sale in Australia and New Zealand Year of manufacture 28 C C This product complies with EN 60601 1 2 2007 IEC 60601 1 6 2010 IEC 60601 1 2 ED 3 0 ana IEC 60601I E2005 CORR I 2006 CORR 2 2007 IEC 60601 1 Classifications A Degree of protection against electrical shock Type B Applied Part In addition to the above compliances this device complies with EN55022 1998 A1 2000 A2 2003 Class B ITE emissions requirements and all requirements for Low Interference Potential Devices LIPD and compliance
22. e statistics have been retrieved you will see a message on the screen saying Usage statistics download complete LimbLogic Communicator usage Seal Quality Pair Fob Adaptive Vacuum Assistant Updates Guides a Click arrows Click arrows START DATE END DATE until desired until desired Start Date End Date appears in March 24 2015 12 12 PM Q O a March 25 2015 8 50 AM eae in the field the field Summary from March 24 2015 12 12 PM to March 25 2015 8 50 AM Status J Charging Jf Leaks Vv Battery Vv Seal Quality Jf Relative Limb Motion Seal i After selecting the Start and End Dates Battery Jf lelick on the statistic you wish to view p Usage CS o i 14 LimbLogic vacuum Systems S ariile rg de eer Dates when data has been saved will be displayed in the Start Date and End Date lists Select a starting point for the summary by clicking on the arrows on either side of the Start Date field Select an end date for the summary by clicking on the arrows on either side of the End Date field The Status section in the middle of the screen indicates the status during the selected time frame of five key aspects of the system Charging Leaks Battery Seal Quality and Relative Limb Motion A green check mark indicates normal operation an orange exclamation point indicates that an issue has been detected Hover over the symbol with the cursor for further information Note the Status sec
23. ear water The Communicator is not waterproof Use of the Communicator near water may result in serious injury compromise performance and or compliance and will void the warranty gt gt gt gt gt 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 Copyright 2015 2015 The Ohio Willow Wood Company All rights reserved Protected by one or more patents For details see www willowwoodco com education and resources patents 2 TABLE OF CONTENTS jauces AO IN T d 4 x LEFT PIE p e E Qmm n 4 LACIE me aioe ROCII RN ta 5 EE E EAS a cin i alte m 6 Register New 3majees C NETERRRRRRERCP
24. ed to reflect the new settings You may also adjust the Set Point Range and User Maximum by clicking and dragging the indicators on the dial Click and drag the indicator labeled LSP to adjust the size of the Range Click and drag the indicator labeled USP to move the entire Range up or down Click and drag the red indicator to adjust the User Maximum There is no need to press a save button to lock in your changes The Communicator automatically saves all of the changes that you make to the settings The Mode pane allows you to change the current operating mode of the device If the device is currently in Standard Mode the Change to Standard button will be grayed out If the device is currently in Adaptive Mode refer to page Q 20 the Change to Adaptive button will be grayed out CHANGE TO ADAPTIVE If the device is currently in Standby Mode the Change to Standby button will be grayed out CHANGE TO To switch the device to a different mode click the abia associated button If you select Change to Adaptive before you have configured this function for the patient you will orompted to complete the setup process The Leak button indicates that a leak has been detected in the system The Speaker pane allows you to change the volume of the SPEAKER 6596 beeper inside the vacuum pump The beeper activates whenever the LimbLogic pump is turned on or off has a setting updated by the Communicator has a low bat
25. en turn the pump back on Note it is recommended that you close other applications while running the Communicator GETTING STARTED he Getting Started screen shown below is presented when you start the program Displayed on this screen are icons representing all of the LimbLogic devices that have been discovered in range of the Communicator and are turned on or plugged in to the charger There are two types of these icons A device that has already been registered with the Communicator is represented with an icon that includes the serial number and patient identifier that you entered for that device A device that has not yet been registered is represented with the icon that is labeled New Vacuum System Detected Register New LimbLogic LimbLogic Communicator Getting Started Pair Fob Guides LimbLogic Vacuum Systems o9 New Vacuum Vacuum System X System Detected d Serial 735366655 pice This device is in range of the Communicator nbl ogicil John Smith is turned on or plugged in to the charger and has been registered This icon indicates that at least one device is in range of the Communicator and is turned on or plugged in to the charger but has not yet been registered Total number of devices found in range that Status Bar are turned on or plugged in to the charger NN EE ee om 1 LimbLogic Vacuum Systems po n Copyright amp 2013 2015 The Ohio Willow W
26. ic Device Unilateral Bilateral Patient Identifier Unilateral or Bilateral Cancel Register Your LimbLogic Device 734856460 Register to New Patient Serial Number Patient Identifier The LimbLogic device with serial number 734856460 will be registered to new patient Jane Doe OK Cancel Cancel Note the software stores and displays data that you have entered that may include patient information associated with a LimbLogic Vacuum System If you choose to enter patient information in the software it is your responsibility to ensure that any and all requirements under the Health Insurance Portability and Accountability Act HIPAA are met If you choose to enter patient information Willow wood recommends using an Identifier other than a patient s name or other personally identifiable information After a pump is registered any items that require additional setup or configuration will be indicated by an icon on the associated tab VACUUM SETTINGS After you have successfully registered a new device or after you have selected an existing device from the Getting Started screen the Vacuum Settings screen appears Getting Started Vacuum Settings Vacuum amp Prosthetist Settings VACUUM SETTINGS MODE SPEAKER 100 CHANGE TO MOVE LSP STANDARD 9 M ADAPTIVE CUNS CHANGE TO STANDBY os oe di ou Y VACUUM o BATTERY 98 RESTING SET POI
27. ip on the fob circuit board Cwith the positive side which is usually marked with a plus sign facing up as shown in the LimbLogic Prosthetist Instructions but do not reassemble the fob yet After you see the lights on the back of the fob circuit board begin to flash ina circular pattern click the Apply Settings button Do not click the Apply Settings button until you see the lights flash in a circular pattern on the fob LimbLogic Communicator Getting Started Vacuum Settings Usage Seal Quality Pair Fob Adaptive Vacuum Assistant Updates Guides Apply Settings to LimbLogic Fob Your fob will be paired with Vacuum System serial number 000000126 Please remove the battery from the LimbLogic fob and click the Battery Removed button when complete Note Directions on removing the fob battery can be found in the LimbLogic Prosthetist Instructions Battery Removed Insert the battery into the battery clip on the fob circuit board as shown in the LimbLogic Prosthetist Instructions but do not reassemble the fob yet After you see the lights on the back of the fob circuit board begin to flash in a circular pattern click the Apply Settings button Do not click the Apply Settings button until you see the lights flash in a circular pattern on the fob A Do not click the lt n Apply Settings button until you see the lights flash ina Apply Settings circular pattern on the fob D DEEE BRE DUST 1 LimbLoaic V S Copyright 2013
28. is while the Communicator is currently connected to a system click the Communicator icon in the lower left corner of the screen The About LimbLogic window will appear in the middle of whatever screen you are currently using To access the About LimbLogic window when you are on the Getting Started screen before you have connected to a specific unit begin by clicking on the desired unit to highlight it in grey Then click the Communicator icon in the lower left corner of the screen 26 imbLogic Communicator Getting Started Vacuum Settings Vacuum amp Prosthetist Settings Usage Seal Quality Pair Fob Adaptive Vacuum Assistant Updates Guides RESTING SET POINT RESTING RANGE sm VACUUM SETTINGS SPEAKER 100 REST LimbLogic AdverseConditions 015 2 1 8 LimbLogic adverse conditions support gt SRE lt gt RESTING SETTINGS LSP 8 4 i Copyright 2013 2015 The Ohio Willow Wood Company All rights reserved Protected by one or more patents For details see About LimbLogic LimbLogic Communicator WWww owwco com patent patent Name Version Description 4 LimbLogic Bootloading 2015 2 LimbLogic bootloading support LimbLogic Communicator 2015 2 1 8 LimbLogic Communicator LimbLogic Communicator 2015 2 LimbLogic Communicator LimbLogic Communicator Data 2015 21 8 LimbLogic Communicator data access components LimbLogic Communicator Framework 20152 LimbLogic amp
29. nding walking and sitting click the Seal Quality tab at the top of the screen The Seal Quality Diagnostic provides an indication of how well the prosthesis is sealed and provides estimates of how frequently the vacuum pump is likely to activate at the current Vacuum Set Point The flexing of the socket and seal in certain positions or activities can result in additional leaks Checking the Seal Quality in different positions can verify that the system can accommodate Activities of Daily Living Click Start and follow the directions shown on the screen As each of the three tests proceeds a graph will develop on the screen along with a countdown of the amount of time remaining in the test When each test is complete an assessment of the quality of the seal will be displayed on the right side of the screen along with a table display ing the numerical results Note the patient will need to break the seal to lower the vacuum level prior to the start of each test Getting Started Vacuum Settings Seal Quality Diagnostics 22 Standing Seal Quality 214 20 SONIDO SOTO GEL O5 33 B S 8 gu omo d ci Un m om Gone gm am gn aa gn ad not Ban a Good TA 00D QD ab db OG Q ap 00H D oD W O O oOx 000 Walking Seal Quality Seal Quality Rating Estimated Cycle Time Pressure Loss Rate Time s Performing seal quality diagnostics 1 minute 35 seconds remaining SET POINT RANGE Copyright
30. nfiguration Bilateral Serial 000000126 Unilateral Drag your Limblogic8 Vacuum System here Jane Doe EE CI za 1 LimbLoaic V S Copyright amp 2013 2015 The Ohio Willow Wood Company All rights reserved imbLogic Vacuum Systems Protected by one or more patents For details see www owwco com patent 5 The next screen asks you to remove the battery from the fob Note directions on removing the fob battery can be found in the LimbLogic Prosthetist Instructions Refer to page 25 of this guide for information on accessing the LimbLogic Prosthetist Instructions When you are done click the Battery Removed button on the screen LimbLogic Communicator Getting Started Vacuum Settings Usage Seal Quality Pair Fob Adaptive Vacuum Assistant Updates Guides Apply Settings to LimbLogic Fob Your fob will be paired with Vacuum System serial number 000000126 Please remove the battery from the LimbLogic fob and click the Battery Removed button when complete Note Directions on removing the fob battery can be Step 1 A P found in the LimbLogic Prosthetist Instructions Battery Removed CI NI EREI 1 LimbLogic V S Copyright 2013 2015 The Ohio Willow Wood Company All rights reserved imbLogic Vacuum Systems Protected by one or more patents For details see www owwco com patent B 18 Next you will be asked to reinstall the fob battery Insert the battery into the bat tery cl
31. ood Company All rights reserved Protected by one or more patents For details see www owwco com patent To view the data for a particular device double click on the icon associated with that device For assistance in finding a particular device when numerous icons are displayed enter the patient identifier or serial number in the Search field Until the Communicator has established a connection with the device the status bar at the bottom of the screen will indicate that it is Searching Searching time depends upon the number of Bluetooth enabled devices within range of the Communicator Recognition of new devices typically happens within 30 seconds but may take up to 2 minutes Once communication has been established the status will change to say that it is connected to the device If the Communicator is unable to connect make sure that the pump is turned on or olugged in to the charger REGISTER NEW LIMBLOGIC To begin using the Communicator with a new device that you are providing for a patient double click on the icon that is labeled New Vacuum System Detected Register New LimbLogic The Register Your LimbLogic Device window appears Enter the Serial Number of the device and a Patient Identifier for the user Select whether the patient is Unilateral or Bilateral Click Register when you are done A message confirming the serial number and patient identifier will appear Click OK to proceed Register Your LimbLog
32. ote regarding the ability of the system to maintain vacuum There are many potential pathways for air pressure to travel to the socket and decrease the vacuum pressure Three primary factors influence the quality of the pressure seal in the socket 1 the size or area of the pathways 2 the pressure difference from atmosphere to the inside of the socket and 3 the residual volume or space between the limb and the socket walls PAIR FOB WITH VACUUM SYSTEM In the event that a fob must be replaced click on the Pair Fob tab at the top of the screen to link the new fob to the pump as follows 1 Click on the icon for the pump to be paired with the new fob Drag the icon into the window on the bottom half of the screen If the fob is to be paired with two pumps for a bilateral user be sure to click the Bilateral button When you are asked if you would like to continue click Yes LimbLogic Communicator Getting Started Vacuum Settings Usage Seal Quality Pair Fob Adaptive Vacuum Assistant Updates Guides Choose LimbLogic Vacuum System Drag a LimbLogic Vacuum System into the Configure Fob section to associate it with a LimbLogic fob Search O CL ld Serial 000000126 4 Unilateral jane Dos Continue to Pair Fob with Vacuum System x Your fob will be paired with Vacuum System serial number 000000126 Would you like to continue Configure LimbLogic Fob Yes o Choose your LimbLogic Fob co
33. s in which indications of motion were detected STEPS with Motion 0 PERCENT Motion 0 The data provided by the Communicator can assist in the evaluation of the amount of movement between the liner and the socket of a transfemoral LimbLogic user Vacuum level settings leading to gait with few indications of motion are usually sufficient for reliable suspension Settings leading to frequent indications of motion generally correspond with higher amounts of socket motion However the Communicator cannot replace the abilities of a clinical professional Traditional methods of evaluating suspension should always be used for final determinations LIMBLOGIC UPDATES If a firmware update is available for the pump that is currently connected to the Communicator or if a software update is available for the Communicator the 3 icon will be displayed on the Updates tab Before beginning an update charge the pump to at least 50 then unplug the pump from the charger Make sure that the prosthesis is within a few feet of the Communicator until the update is complete Pay attention to any warnings that are displayed for the updates Click on the updates you wish to apply then click the Apply Update button LimbLogic Communicator ee Getting Started Vacuum Settings Usage Seal Quality Pair Fob Adaptive Vacuum Assist nt Updates o Gi des You may choose to update your LimbLogic Communicator Software or LimbLogic Vacuum System from
34. ser of the LimbLogic requires continued operation during mains interruptions it is recommended that the LimbLogic be powered from an un interruptible power supply or a battery interruptions and voltage variations on power supply input lines IEC 61000 4 11 70 UT 30 dip in UT for 25 cycles 30 dip in UT for 25 cycles lt 5 UT lt 5 UT gt 95 96 dip gt 95 96 dip in UT for in UT for 5 sec 5 sec Power 5 A m 5 A m Power frequency magnetic fields should frequency be at levels characteristic of a typical 50 60 Hz ou in a typical commercial or magnetic field ospital environment IEC 61000 4 8 NOTE Ur is the a c mains voltage prior to application of the test level SO 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 environment guidance test test level Level Portable and mobile RF communications equipment should be used no closer to any part of the LimbLogic including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vms 5V d 1 2 VP IEC 61000 4 6 150 kHz to Radiated RF 3 V m a 1 2VP 80 MHz to 800 MHz IEC 61000 4 2 80 MHz
35. tery or is in Leak Mode These beeps may be delayed until the pump is done with its current task Click and drag the slider to the desired beeper volume level The amount of charge left in the device s battery is displayed in the Battery pane Four vertical bars inside the battery symbol indicate a fully charged battery The bars disappear as the battery is discharged Hold the mouse cursor over the battery icon to see additional information about the status of the battery BATTERY 9796 1 Your LimbLogic vacuum system is not charging and has a battery level of 97 3 940 V If the battery is currently being charged the black in the battery icon will appear from left to right in an animation instead of appearing as solid black USAGE STATISTICS To view information about a patient s usage of the selected device between two visits click on the Usage tab at the top of the screen Click the Get Latest Statistics button to initiate the download of usage statistics from the device LimbLogic8 Communicator Getting Started Vacuum Settings Seal Quality Pair Fob Adaptive Vacuum Assistant Updates START DATE END DATE 4 March 21 2015 5 45 PM Statistics Summary for March 21 2015 5 45 PM Note usage below may contain information from initial assembly and may not reflect actual patient usage Status Jf Charging Sf Leaks lt S Battery f Seal Quality JS Relative Limb Motion Seal Battery Usage Once th
36. the choices below Please select the update you want to apply and then click the Apply Update button to begin the software update Recommended Software 1 Features Update v0 46 Features Update v0 46 This update provides a variety of new features including Adaptive Vacuum and the Assistant This update will erase all current usage data on the vacuum system being upgraded Please download usage data prior to updating the vacuum Apply Update Co ee 1 LimbLoaic V S Copyright 2013 2015 The Ohio Willow Wood Company All rights reserved imbLogic Vacuum Systems Protected by one or more patents For details see www owwco com patent SOFTWARE UPDATES Software updates for the Communicator will be automatically downloaded to the computer on which the Communicator is installed assuming the computer is connected to the internet After an update has been downloaded the 3 icon will appear on the Updates tab Click Yes to install the update If you click No you may install the update later by clicking on the Updates tab described above If the computer is not connected to the internet please call or use another computer that is connected to the internet to check the WillowWood website for notices of Communicator software updates 24 GUIDES Clicking the Guides tab at the top of the screen allows you to access various instructions related the LimbLogic System The default guide that appears is this manual
37. the screen for descriptions of the Average Seal A Quality statistics li patient o so n Marginal N A rating of Poor means that the system is activating frequently z o CI ea 2 LimbLogic V S Copyright amp 2013 2015 The Ohio Willow Wood Company All rights reserved Note regarding the ability of the system to maintain vacuum There are many potential pathways for air to leak into the socket and decrease the vacuum pressure Three primary factors influence the quality of the pressure seal in the socket 1 the size or area of the pathways 2 the pressure difference from atmosphere to the inside of the socket and 3 the residual volume or space between the limb and the socket walls 12 Click Battery on the left side of the screen to view the Charging History graph which shows the length in hours of each charging session during the selected time frame An empty maroon circle indicates a completed full charge cycle A full charge at the end of each day of use is recommended in order to maintain operation throughout the next day A filled in maroon circle indicates that the pump was disconnected frorn the charger before a full charge could be achieved Peaks in the charging plot with open tops indicate very long charge times To see how the charge ended click and drag the indicator in the lower left hand corner of the plot If the graph indicates frequent short charges during the day
38. thetic 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 Nationality Any Mentally competent to operate system as judged by prosthetist PERFORMANCE CHARACTERISTICS Capabilities 2 year warranted service life Norrnal use Temperature T5 7C LOS C Humidity 15 to 93 non condensing Altitude 1250 to 10000 feet 380 to 3000 meters Pressure 1060 to 700 hPA Transportation and storage Temperature 25 Cto T O C Humidity 15 to 93 non condensing Altitude 1250 to 20000 feet 380 to 6000 meters Pressure 1060 to 470 hPA Restrictions LimbLogic Communicator must not be exposed to liquids PHYSICAL MEASUREMENTS Weight ema Do WillowlVood 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 C Keizersgracht 62 64 1015 CS Amsterdam The Netherlands Ec REP PN 23507 F 5 JUN 2015
39. tion is is only available when Adaptive Vacuum and Assistant have been set up for transfemoral systems Click Seal Battery or Usage on the left side of the screen to view statistics associated with these options Refer to the following three pages for details n Select Seal on the left side of the screen to view historical information on how frequently and how long the vacuum pump activated and operated The Average Seal Quality provides an indication of whether the current seal is likely to be sufficient to allow the system to run a full day on a single charge A rating of Good indicates that the system was well sealed so during normal use it should last for a full day s use on a full charge A rating of Marginal indicates that the system is likely to provide a full day of operation but is activating more than might be expected A rating of Poor means that the system is activating frequently The Good Marginal and Poor ratings are historical and may not indicate future performance LimbLogic Communicator Getting Started Vacuum Settings Seal Quality Pair Fob Adaptive Vacuum Assistant Updates Guides START DATE END DATE e March March 21 2015 5 47 PM 40 mee March 22 2015 7 08 AM Summary from March 21 2015 5 47 PM to March 22 2015 7 08 AM AVERAGE SEAL QUALITY Prosthetic sockets leak at different rates The Average Seal Quality rating n hether the system could m ay Refer to this area of
40. trace has not dropped visibly during the test and the system reports motion this was likely the case The Estimated Cycle Time which estimates how often the pump will activate to maintain vacuum is measured in minutes between pump activations Estimated Cycle Time provides a general estimation only it does not take into account every factor that could affect the length of time between pump activations The Pressure Loss Rate which is the rate at which the system is losing vacuum is measured in units of vacuum per 10 minute period This measurement does not directly correlate to seal quality Two sockets with the same leakage but different volumes will have different Pressure Loss Rates However on a given socket changes in the Pressure Loss Rate indicate a corresponding change in leakage and can be very useful for pinpointing the location of a leak For example if a system exhibits a high Pressure Loss Rate and you suspect that the leak is occurring at the sealing sleeve you could replace the sealing sleeve and run the Seal Quality Diagnostic again A lower Pressure Loss Rate would be a good indication that the source of the leak has been isolated For fast leaks the change in slope of the graph can be seen as sudden changes in the slope of the leak rate line This allows quick checks such as putting a finger over a hole to be made during troubleshooting For more information hover over the help icons in the table with your mouse N
41. uides each of which is described on the following pages WillowWood reserves the right to modify its products at any time The representations of the software included in this document are included as examples and may not reflect the current level of software that you are using Recommended Setup Windows Intel i5 or AMD A8 or Phenom II X3 at 2 0 GHz or faster USB port In order to access updates and additional features network and or Internet connectivity is highly recommended DirectX 11 or OpenGL 4 0 compatible video card Support for at least 1024 x 768 resolution and IGB memory minimum Use of vendor provided graphics drivers is highly recommended Use on a Mac or through Windows emulation is not supported Your LimbLogic Communicator software will perform well if installed on your existing OMEGA System computer LAUNCHING THE PROGRAM Insert the Communicator into a USB port on your PC Click on the LimbLogic Communicator icon on the desktop to launch the software Note if the icon is deleted or hidden from the desktop you may launch the software by clicking All Programs gt WillowWood gt LimbLogic Communicator Make sure that the Vacuum Pump is turned ON or plugged into the charger and the fob is turned OFF If the fob is currently on turn the fob off as follows wait approximately one minute for the fob to shut off Of turn the vacuum pump off which automatically turns the fob off th
42. wwco com Your LimbLogic Communicator is running version 1 2 1 3 1 0 software Jane Doe s LimbLogic device is at firmware revision 0 43 i rex 2 LimbLogic Vacuum Systems Copyright 2013 2015 The Ohio Willow Wood Company All rights reserved Protected bv one or more patents For details see www owwco com natent Under the orange text in the About LimbLogic window you will see the following 1 Details for contacting Technical Support 2 The manufacturing date of the Communicator 5 he name of the unit along with its firmware revision level About LimbLogic LimbLogic Communicator Copynght 2013 2015 The Ohio Willow Wood Company All rights reserved Protected by one or more patents For details see wWwWw owwco com patent Name Version Description LimbLogic AdverseConditions 2015 2 1 8 LimbLogic adverse conditions support LimbLogic Bootloading 2015 2 1 8 LimbLogic bootloading support LimbLogic Communicator 2015 2 1 8 LimbLogic Communicator LimbLogic Communicator 2015 2 1 8 LimbLogic Communicator LimbLogic Communicator Data 2015 2 1 8 LimbLogic Communicator data access components LimbLogic Communicator Framework 20152 1 8 LimbLogic Communicator software interface components 1 Se n LimbLogic Technical Support may be contacted by phone at 1 800 846 4930 ar by email at limblogicsupportibowwco com Your LimbLogic Communicator is running version 1 2 1 3 1 0 software Jane Do
Download Pdf Manuals
Related Search