USER MANUAL LIDIS - Jun 16, 2010
Contents
1. Terminate Lock hole Lock hole Lock hole Correct handle position Incorrect handle position Incorrect handle position gt gt we KZ d Lif 2 67 Pi Move the external guidance over the skin with the handle oriented in the same direction as the nail shadow Computer display shows the movements of the external guidance When the cross of the external guidance is in close range of the green square which indicates the distal hole axis of inserted nail adjust the inclination of external guidance so that all squares are aligned and the red lines turn green Lidis Version 1 1 3 6 Start interlocking process GUIDING A IDIS Red lines indicate 27 1mm incorrect position 1 D R C ted bi Terminate es Lock hole Return to welcome screen Press to lock hole 25 Lidis Version 1 1 3 6 Start interlocking process Green lines indicate correct position Hl gt 42 E H ted b Terminate 22 Lock hole Return to welcome screen Press to lock hole Exampl2. gt DJ ekliptik LIMB TRANSMITTER RELATION It is very important how you place the transmitter according to the limb In the calibration procedure define the orientation of the probes to the transmitter Examples below will show you how to properly place the transmitter over the limb Keep in mind the field of accuracy not shown below described in section above page 10 Correct placement of the transmitter Green axis of the leg and green axis of the transmitter correlates and so do the red axes The height of the transmitter is also correct 13 40 cm from the probe inserted in the leg 18 Si ekliptik Incorrect placement of the transmitter The transmitter is turned in the wrong direction The axes do not correlate 19 ekliptik The transmitter is too high TOO HIGH The transmitter does not lie in the prescribed distance from the probe inserted in the leg 20 ekliptik Before you insert the nail into the patient you have to insert the inner probe into the channel of the nail to the most distal hole and place the marker in front of the jig entrance 21 iS ekliptik Start with the surgical procedure Once the nail has been inserted into the bone use a metal wire to clear the spongiosis that could block the inner probe from the nail channel Insert the inner probe in the channel of the jig used for drilling the proximal holes Push the inner probe forward along the
3. GUIDING STAR Prior to the operation cover the cart including the computer unit the navigational system the extension arm and the power supply unit with a set of sterile sheets for x ray machines min size 225 x 90 cm If the sterile sheets are too short you can cover the navigational unit separately with an adhesive waterproof sterile compress LIDIS module If the LIDIS module is to used then the following LIDIS parts have to be sterilized with plasma before use in the operating theater e 2 LIDIS inner probes nr 14 1 as a Spare e 2 LIDIS external guidance 1 as a Spare 3 Preamplifiers 1 as a spare The following LIDIS parts have to be sterilized with either plasma or another sterilization method before use in the operating room 2 Calibration tools 1 as a spare Place all the accessories that have to be sterilized in appropriate box Pay special attention to the inner probe It must be completely stretched out Place external guidance and internal probe with the cable rolled into a coil when sterilizing Place all the accessories in a plasma chamber and start the sterilization cycle After the sterilization update your documents with the number of times each probe has been used each probe can be used for a maximum of 15 surgical operations 32 Warnings There are some problems with the navigation system Is it connected properly and switched on The system is warming up Please wait
4. ekliptik Ekliptik d o o Teslova 30 1000 Ljubljana Slovenia T 386 1 477 66 31 F 386 1 477 66 32 W www ekliptik si USER MANUAL GUIDING STAR LIDIS D gt ekliptik Contents GUIDING TAR Grats uneven seen cas sven aunts 4 ADIS MO Ul iai ii a i i iii ii i i E S ia 6 V OAS EA iii ii i ii i i 7 Start with the surgical procedure i ana ii a ei i sis 22 SUCEMZACION iii ai i ii Sai i ii a i pi ii iki ia a S 32 Instructions for SUEHIZAU ON pi i ini i ii iii i i i i i i i 32 GUJLID ING SPARK 32 LDS TO iai iii a i i i i i y a 32 WY QUIN S es os paai Rada Dad a a a o a a a S d a a 33 TOCHMCA CAC A E E 34 CERTIFICATE OF CONFORMITY L mainainnssiasianiassi nasi ainiai i se reel ai is 37 No CE 223 0009 O72 sakinius ai ini io ai ii as 37 iS ekliptik Picture 1 GUIDING STAR Parts GUIDING STAR Parts description 1 2 9 10 Computer unit with integrated display and touch screen Navigational unit Power supply unit Cart with wheels Extension arm Transmitter Power cable Computer button on off Navigational unit power and USB con
5. 6 Start interlocking process onnected probes C Terminate 99 Lock hole Return to welcome screen Press to lock hole Correct inclination red lines on the edges of a square are coloured green When the handle is in the correct inclination move the handle toward the green square in the middle of the display which indicates axis of distal hole of the nail The targeting cross of external guidance has to cover over the green square in the middle of the computer display When the external guidance is in the right position the squares of the external guidance turn green Lidis Version 1 1 3 6 Start interlocking process te P Connected probes Terminate 00A Lock hole Return to welcome screen Press to lock hole Example of correct handle position during the surgery 28 iS ekliptik Make a small incision under the same angle as the external guidance Enter the incision with the external guidance heading towards the bone Insert the appropriate driller into the drilling hole of the external guidance On the bone fine tune the external guidance external guidance square has to be green Drill through the bone 29 iS ekliptik After few mm of drilling into the bone remove the inner probe and continue d
6. Keep the calibration still Turn the inner probe for 180 degrees Keep the probes between 13 cm and 40 cm from the transmitter One or more probes are not connected properly Information in the probe d is corrupted Report this error to the hardware The Probe d usage has expired Return the probe to the hardware vendor 2 r The Probe in port d has only d usage s left There is interference from the environment 33 Technical data Storage and Operating Specifications Storage conditions 0 C to 60 C with 20 to 90 humidity non condensing Operating conditions 15 C to 35 C Computer unit e Power supply 100 240V 47 63Hz 80W e Display 17 colour active matrix LCD 5 wire resistive touch screen e Resolution 1280 x 1024 pixels e Processor Intel Mobile Pentium M 1 6GHz with 1 MB 2nd level cache memory Hard disk drive 20GB e System memory 512MB DDR RAM e Audio Internal speaker amplified mono 8 ohm Speaker Out 1 8 mini phone Line in and Microphone in 1 8 mini phone e Ports 2 USB Type A receptacles USB 2 0 compliant 1 DVI I digital analog video output 1 Serial RS 232 9 pin micro miniature D LAN 10 100 BaseT Ethernet RJ 45 1 Compact Flash memory socket Type I 1 PCMCIA CardBus Slot Type I or Type II e Warranty one year limited warranty Power supply unit e Power 100 240V 50 60Hz 100Wmax e Fuses F1 F4 T4 0AL 250V e Operating temperature 15
7. as shown on the computer screen Place the calibration accessory under the transmitter about 20 cm between 13 and 40cm from the transmitter as shown on the computer screen Field of accuracy The greatest accuracy of the calibration and the procedure itself is achieved if the probes are placed between 13 and 40 cm from the transmitter and they must lie in the lower left quadrant as shown in the sketch below fai Ld Sy TESTS OT T M Field of accuracy 10 O ekliptik Working area EA i EE s a WORKING AREA For the best results the work and the calibration shown above must be done inside the field of accuracy Once outside the field results are not as good as they should be 11 ekliptik Orientation of the calibration stand Correct position Incorrect position The orientation of the calibration stand on the sketch above is important The calibration stand has a small pin on one side marked green above On the other side rotated for 1805 horizontally there is no pin The pin must be turned towards you not away from you When the calibration stand is in the correct position you can insert the internal guidance in the calibration stand and proceed as instructed below 12 iS ekliptik Press the Calibrate button on the computer screen Follow the steps from to D on the computer screen INFO Calibrate step A Keep
8. channel until the marker of the probe impacts the jig Insertion of the inner probe femur example 22 5 ekliptik Insertion of the inner probe tibia example Rotate the inner probe until it locks in the distal hole of the nail In the left upper corner there is a number that indicates the distance between the top of the external guidance and middle of the distal hole in mm In most cases you have to double this number to get the screw length In a few seconds a shadow will appear on the screen as shown on the picture bellow Shadow indicates the position of inserted inner probe and nail The green and black dot will also appear on the screen as shown on the picture bellow Ci ted bi Terminate a OOO Lock hole t Press to lock hole The black dot represents the handle direction The green dot represents the fine tuning of the handle angle Numbers on the left side of the green dot indicate degrees of the handle angle The black dot should be positioned in accordance to the position of the nail shadow by pressing the screen Incorrect position of the black dot Correct position of the black dot 23 gt ekliptik Lidis Version 1 1 3 6 Start interlocking process onnected probes a C
9. probes under the transmitter as shown on the picture below Keep them still for a moment Calibrate A INFO Calibrate step B Take off the aiming probe and place it on the calibration stand as shown on the picture below Keep all probes still for a moment m m Calibrate B 13 iS ekliptik INFO Calibrate step C Take off the aiming probe and place it on calibration stand from the left side as shown on the picture below Keep them still for a moment Calibrate C INFO Calibrate step D Take off the aiming probe and place it on the calibration stand from the right side as shown on the picture below Keep them still for a moment Calibrate D 14 ekliptik INFO Calibrate step E Keep the D position of the calibration Turn the aiming probe 905 down so the handle of the aiming probe is turned down step 1 in a sketch below Then turn the calibration stand for 90 from vertical to horizontal position step 2 in a sketch below the orientation of the calibration stand and the transmitter remains the same Keep all probes still for a moment Step 1 Step 2 15 ekliptik Calibrate E INFO Calibrate step F Take off the aiming probe and place it on calibration stand as shown on the picture below Keep them still for a moment Calibrate F 16 iS ekliptik When the calibration has been completed successfully go to the next phase 17
10. C to 35 C Navigational unit e Power supply from 85 to 265V 47 63Hz 60 VA e Fuses A fuse drawer is located on the rear panel next to the AC power inlet Both power entry conductors are protected by size 5 x 20 mm fuses 1 0 250 T Time Lag SLO BLO 34 Operating temperature 15 C to 35 C e Warm up System meets accuracy specifications after 5 mins Transmitter 3 75 9 6cm cube with 10 3 05m cable Sensors e Sensor max OD 1 3mm e Sensor max length 6 7mm e Cable max OD 0 6mm e Cable length 2 5 meters e USP class 6 epoxy sensor housing e USP 6 polyester protective wrap bare sensor only e Maximum temperature of exposure 150 degrees C e Sensor assembly and cable materials are plasma EtO gamma and cold sterilant tolerant e Semiconductor devices in the connector are not gamma shielded and may be damaged or erased if exposed to gamma radiation e Connectors are not sealed and must not be subjected to immersion in liquids of any type e Do not subject cable to an axial pull greater than 200 grams e Additional materials for vinyl sensor assemblies Tygon tubing USP 6 USP class 6 epoxy tip PVC shrink tubing on cable at connector end e Connector housing is PEEK material e Static accuracy 1 4mm RMS position 0 5 degree RMS orientation e Translation range 20 cm minimum to 71 cm maximum in X 30 cm in Y and Z in the forward positive X hemisphere only e Update rate 7 1 to 90 m
11. easurements per second Default measurement rate 68 3 Hz The system is calibrated at 68 3 Hz 35 Preamplifiers Module max OD minus threaded cap 23 5mm e Module max length including sensor connector 163mm e Module length excluding sensor connector 144mm e Cable max OD 5mm e Cable length 3 meters NOTE Current pre amplifiers are designed with consumer grade materials and construction Specifically they are designed to be resistant only to plasma sterilization method Immersion in liquids will render them inoperable Software e Operating system Windows XP SP2 e Application LIDIS TOCOS BATTIATO software version 1 1 1 1 or newer e Security LIDIS TOCOS BATTIATO runs in a limited account 36 CERTIFICATE OF CONFORMITY No CE 223 0009 07 2 The product complies with the essential reguiments of the following directives 93 42 EEC Medical Device Directive MDD Annex IV Classification of the device Class IIb Active surgically invasive device for transient use Verification Report No T223 VER 014 07 37
12. es Switch off Press to switch off the system Do not touch the screen again until the GuidingStar LIDIS enters into the gt ACTIVE mode Connect two preamplifiers to any of the 4 sockets on the front of the navigational unit 4 2 3 4 wi Sensors E cin Push the preamplifiers connectors into the sockets on the front of the navigation unit until they click Gently insert each probe s connector internal probe and external guidance probe into the preamplifier s socket until it touches the bottom of the socket Gently rotate the probe s connector until you can push it further into the socket Push the probe s connector to the end of the socket until it clicks ekliptik When the probes are connected and the GuidingStar LIDIS is ACTIVE press the GuidingStar LIDIS button to go into the Calibration mode Welcome Version 1 1 1 6 Welcome GUIDING STAR LIDIS L 2 Start LIDIS Start interlocking process Connected probes Switch off Press to switch off the system Lidis Version 1 1 1 6 Start interlocking process GUIDING af IDIS Connected probes Terminate Calibrate Return to welcome screen Press here to calibrate ekliptik Insert the external guidance into the calibration accessory and lock it into the position Insert the inner probe into the calibration accessory and lock it into the position
13. es of the handle inclination adjustments Lidis Version 1 1 3 6 Start interlocking process onnected probes 9 Terminate 99 Lock hole Return to welcome screen Press to lock hole Incorrect inclination change handle inclination toward right 26 Lidis Version 1 1 3 6 Start interlocking process ted prob Terminate Lock hole Return to welcome screen Press to lock hole Incorrect inclination change handle inclination toward left Lidis Version 1 1 3 6 Start interlocking process onnected probes y Terminate 00O Lock hole Return to welcome screen Press to lock hole Lidis Version 1 1 3 6 Start interlocking process onnected probes Terminate 66 Lock hole Return to welcome screen Press to lock hole Incorrect inclination change handle inclination toward up 27 iS ekliptik Lidis Version 1 1 3
14. i Terminate 00O Lock hole Return to welcome screen Press to lock hole Incorrect position of the black dot Lidis Version 1 1 3 6 Start interlocking process onnected probes Ci Terminate 00O Lock hole Return to welcome screen Press to lock hole Lidis Version 1 1 3 6 Start interlocking process 22 3mm 1 1 Er I L Terminate Return to welcome screen Lidis Start interlocking process Version 1 1 3 6 1 Lock hole Press to lock hole IMPORTANT Also the handle has to be oriented in the direction of the nail shadow on the screen Fine tune the handle angle as shown on the picture bellow When the dot is green the handle angle is in the correct position With the respect of the position the colour of the dot is changing green correct angle position yellow red incorrect angle position The position of the handle is important for the accuracy of the procedure 24 gt amp gt ekliptik Lidis Lidis Lidis Start interlocking process Start interlocking process Start interlocking process
15. nection Navigational unit 4 socket 11 Transmitter cable connected to the navigational unit 12 13 14 Power unit on off button Wheel with brake Computer unit power and USB connection iS ekliptik icture 2 LIDIS module parts LIDIS Module Parts description 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 Inner probe Leaf springs with elliptical caps Clamping sleeve Slider marker Holder Inner probe connector Inner probe connector cable External probe External probe connector External probe connector cable External guidance Calibration accessory Preamplifier connector Preamplifier cable Preamplifier socket SN Cy ekliptik Before you start The LIDIS module has to be sterilized Don t sterilize with autoclava Use cold sterilization plasma Eto The navigational unit and the computer unit must be switched off The Guiding Star LIDIS has to be placed on the proper position for the surgical procedure and connected to the power Switch on the power unit with the button located on the front panel Switch on the navigational unit with the button located on the back of the navigational unit Press the power button on the front of the computer to switch on the computer ekliptik On the computer screen the Welcome lt mode appears Welcome Version 1 1 1 6 Welcome en Connected prob
16. rilling When the drilling has successfully finished repeat the procedure described above for the second hole OPTIONAL On the right bottom of the computer display there is a button the lock hole When pressing the lock hole button the system memorizes the position of the distal hole in the nail After the system has memorized the distal hole position you can remove the inner probe This button can only be used in special cases when neither the patient nor the nail is being moved after pressing the lock hole button When the drilling was successful for the second hole too you can turn of the LIDID module by pressing the Terminate button To switch off the system press the Switch off button in the left corner of the display 30 5 ekliptik To switch off the navigational unit you have to press the Switch off button located on the back of the navigational unit 31 Sterilization Instructions for sterilization All the probes and preamplifier have to be sterilized with plasma before they can be used in the operating room Other accessories can be sterilized using other sterilization method Do not use autoclave sterilization for probes and preamplifiers Always sterilize more probes tools and preamplifiers than needed directly this will allow the surgeon to carry on using the system in the event that one of the sterilized accessories comes in contact with a non sterile object or person or reaches its usage limit
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