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1. 2 1A Power Consumption 50 W max 24 W typical 14 pin Position Sensor cable permanently connected to the Host USB Converter various lengths max 30 m screened USB cable A B male double shielded 5m Positioning Laser The positioning laser is a Class 2 laser with a wavelength of 635 nm and a maximum output of 1mW The Polaris Spectra System containing a positioning laser conforms to the following standards ANSI Z136 1 2000 IEC 60825 1 2001 FDA CDRH 21 CFR 1040 10 and 1040 11 except for deviations pursuant to Laser Notice No 50 dated July 26 2001 Power Adapter Output Cable Cable AC Line Cord permanently connected to the power adapter plug in jack connector Power Adapter Power Cable medical grade AC line cord Electromagnetic Immunity Standards IEC 61000 4 2 6 kV in contact 8 kV in air EC 61000 4 4 2 kV for the power lines 1 kV for the I O lines EC 61000 4 5 1 kV differential X2 kV common IEC 61000 4 11 lt 5 U for 0 5 cycle 40 U for 5 cycles 70 U for 25 cycles lt 5 U for 5 sec IEC 61000 4 8 3 A m IEC 61000 4 6 3 V IEC 61000 4 3 3 V m 41 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 5 1 2 iMac Computer Technical Specifications Hardware summary Computer model iMAC CPU type Intel Core 2 Duo CPU number 1 CPU speed 2 GHz Memory 1 GB RAM Power supply
2. In case of a fault follow the on screen instructions Contact technical service 4 1 A keyboard problem occurs 5 NAVIGATION Check the cable that connects the keyboard to the main unit 5 1 The footswitch does not transmit the signal to the system Check the connection to the iMac computer Disconnect and reconnect the footswitch cable 1 Then check manually via the keyboard 5 2 The system turns off unexpectedly Check the power cable 5 3 The main unit does not see the camera 5 3 1 The camera is off Check the connection cables 5 3 2 The camera is on but the main unit cannot communicate with it Check that there is not too much natural light in the room Check the integrity 2 of the cameras and that there are no scratches and marks on the POLARIS SPECTRA Position Sensor Check that there are no light sources shining directly on the camera Check the camera position Check the USB connection between the Host USB Converter and the iMAC 32 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 Clean the passive markers Check proper assembly of the passive markers Check that the field of view of the camera is 5 3 3 One or more reference array are not unobstructed visible to the camera Check the camera position Check the integrity of the reference arrays Remove from the field of view of the camera all the reference arrays not currently in use 1 n some rooms for constructio
3. Voltage 100 240V AC Rate 50 60 Hz Monitor data Monitor type 20 LCD Resolution 1680 x 1050 pixels DVD burner data SuperDrive 8x CD burner RW DVD burner R DL RW Certifications and conformity CE 0984 ICES 003 Class B FCC ID BCGA1115 IC 579C A1115 5 1 3 Acquisition Device Support Tripod Technical Specifications Made up of MA299 stem ball joint MA486 Minimum height 117 2 cm Maximum height 281 2 cm Load at maximum extension at 10 inclination 2 7 kg Weight 5 2 kg Maximum clearance on ground 75 cm Panoramic rotation 360 Lateral inclination 90 90 Stem diameter 35 30 25 mm 42 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 5 1 4 REOMED 600 Isolation Transformer Input voltage 115V 230 V 50 60 Hz Output voltage 230 V 50 60 Hz on 6 sockets EN60320 Current 2 6 A Power 600 VA Equipped with input fuse F126 30A T F2 3 15A T 5x20 Case protection IP 20 Protection class I The REOMED 600 complies with the Low Voltage Directive 73 23 EEC 43 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 6 APPENDIX EQUIPMENT SYMBOLS SYMBOL MEANING LOCATION iMac computer Polaris Spectra Position Sensor Attention Caution Host ice AN Consult acompanying Polaris Spectra power adapter documents REOMED 600 3 pedal footswitch Lli Refer to accompanying documentation iMac
4. on the body of the iMac system or on the keyboard It is advisable to insert the keyboard and the footswitch in a transparent plastic bag large enough to cover as much cable as possible Close the bag around the cable using some adhesive tape 26 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 3 4 3 REOMED 600 isolation transformer wiring Connect the X end of the iMAC power cable in one of the sockets C in figure 17 of the REOMED 600 isolation transformer likewise insert the power cable of the Polaris Spectra in another of these sockets DJ gt Peron ETS Figure 17 REOMED 600 wiring Check that the switch A in figure 17 is set to OFF O and insert the remaining power cable into the input socket of the isolation transformer B in figure 17 and into the mains power outlet Y Connect the REOMED 600 isolation transformer to an electric system in compliance with the national regulations regarding electrical safety in the operating theater In case of doubt refer to qualified technical staff Check that the input voltage agrees with the local mains voltage reading the number you can see through the slot of the fuse holder on the transformer s rear D in figure 17 230 for 220V mains voltage 115 for 110V mains voltage If the voltages disagree refer to the qualified technical staff When replacing input fuses only use the same type supplied with the unit See sec
5. Error LED goes off replace the Position Sensor otherwise check or replace the Power Adapter or the Host USB Converter Voltage is out of range Check the power cables Off Off 35 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 4 2 AUDIO CODES The Position Sensor is able to emit audio tones which provide an audible indication of the system status When the power is initially applied to the system or the system is reset the Position Sensor emits two beeps indicating proper operation If a fault condition occurs the system will emit two beeps every three seconds In this case please contact Medacta for technical service 4 3 CLEANING AND MAINTENANCE 4 4 CLEANING As the iMNS system cannot be sterilized never place it in a sterile field for any reason whatsoever Before proceeding with the cleaning operations check that the iMNS system is off and all the cables have been disconnected To clean the iMNS Navigation System use soft and clean cloth moistened with 70 isopropyl alcohol solution or specific products such as KENDALL CURITY Alcohol Preps or Sani Cloth wipes Additional care must be taken when cleaning the Position Sensor see following paragraph Do not immerse any part of iMNS system in water and do not let water or other liquids penetrate the system in any way Do not sterilize the iMNS system or any of its parts in an autoclave Do not use spray detergents on or near the iMNS
6. MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 5 TECHNICAL SPECIFICATIONS CONFORMITY CLASSIFICATIONS ELECTROMAGNETIC COMPATIBILITY 5 1 TECHNICAL DATA AND CONFORMITY In the following table the operating environmental conditions of the iMNS System are reported Specification Value Atmospheric Pressure TO kPa to 106 kPa Relative Humidity 3096 to 7596 non condensing Temperature 10 C to 30 C The iMNS Medacta Navigation System has been tested and declared complying with the Standard CEI EN 60601 1 and amendments A1 A11 A12 and A2 together with the Standard EN 60601 1 1 The iMNS Medacta Navigation System has been tested and declared complying with the Standard EN 60601 1 2 2 edition Ref 75 41 029 rev 00 dedacta This label is located on the back doin m of iMAC computer base and shows the expiring date of Data di esecuzione del test Deticclaniin ie detent electrical safety test validity Testdurchf hrungsdatum The frequency of the test is fixed Fecha de ejecuci n de la prueba in at least 2 years Utilizzare entro utiliser avant Verfallsdatum Utilizar antes de Firma Signature Unterschrif Firma 39 MEDACTA iMNS Instrumentation and Hardware 5 1 1 Polaris Spectra Technical Specification THE NDI PASSIVE POLARIS SPECTRA SYSTEM has been tested and declared complying with IEC 60601 1 2 Sec Ed 2001 Medical Electrical Equipment Collateral Standard Elec
7. compatibility requirements indicated in the standards EN 60601 1 2 2 ed radio communication devices including portable ones may interfere with the iMNS system reducing its accuracy MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 1 3 STRUCTURE AND OPERATION The iMNS system is made up of the following devices e Ti e N Orr e Acquisition system 1 NDI PASSIVE POLARIS SPECTRA SYSTEM composed of 2 infrared cameras Position Sensor equipped with IR LEDs to track the reference arrays e Information processing and display system 2 The data are processed and displayed using an Apple iMac computer running navigation software developed internally by MEDACTA e Interface devices 3 and 4 The iMNS system is controlled by means of the following devices keyboard 3 pedal footswitch and mouse optional e Manual Reusable Instruments The system works with reusable instruments supplied in trays MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 ASA Schailtechnik GmbH 0 32457 Porta Westfalica Technical specifications of the 3 pedal footswitch Type Type F 3 Ut Ut U1 F can be found on the label located on the bottom of Aa No 096 0704 the unit max 25V AC max 25 mA max 125 mW IP X8 CEA 1 4 TRAINING Y The system shall be used exclusively by suitably trained personnel Studying this manual is an integral part of the training process S
8. system Spray detergents might penetrate the system and damage the circuits Do not use solutions containing chlorinated solvents aromatic solvents paint thinners naphta acetone ammonia benzene xylene Do not use hard pointed or abrasive objects to clean the iMNS Navigation System 36 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 4 4 1 Polaris Spectra System cleaning Before cleaning the lenses of the Position Sensor remove any possible trace of dust using compressed air or preferably nitrogen or a brush made for cleaning photographic lenses Gently wipe the surface in one direction only by pulling the brush across the surface To disinfect the lenses and the remainder of the Position Sensor disinfectant wipes containing 70 isopropanol for example KENDALL CURITY Alcohol Preps can be used For actual cleaning use a commercial lens cleaning solution formulated for multi coated lenses for example AR66 and a clean knitted microfibre optical cleaning cloth for example Hitecloth Do not use paper towels on the lenses as this might scratch them NEVER use water soap detergents or other liquids on the lenses When you clean the remainder of the Position Sensor take care not to wipe debris from the Position Sensor case onto the illuminator filters or lenses Avoid prolonged contact between the wipes and the Position Sensor Dirt blood or damp on the markers may hamper their recog
9. 0 Spectra in use Item ID Serial QAAE UE UA LAE Number and manufacturing date MFG DATE June 2006 are reported on a label located on MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 2 2 IMAC COMPUTER Slot loading optical disk drive Power indicator light 48 Volume controls S USB Media eject key ports j Apple keyboard Mouse Figure 3 Frontal view of iMAC Computer MEDACTA has chosen to use the integrated Apple iMac computer for data processing and display This compact and highly reliable system reduces wiring complexity and space required in the operating theater It also allows setting up the iMNS system with a few simple operations On the base of the iMAC computer support is located a Adedacta label indicating the manufacturer Mai D name and the machine serial Strada Regina CH 6874 Castel San Pietro number 41 91 696 60 60 www medacta ch i4ANS XXXX Ref 75 41 019rev2 12 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 ICI Mini DVI port Ventilation opening lt gt Ethernet port 10 100 1000Base T fet Audio line in port e Headphone out Power port optical audio in out port 7 e 09s Power button Y USB 20 ports Q FireWire 400 ports 2 Security slot Figure 4 Rear view of iMAC Computer 13 The machine must be properly grounded in order to operate under safety conditions Do no
10. 0H 16US rev 02 The system is supposed to function under a 115 V voltage This label is positioned on the back of the Reomed isolation transformer FACTORY SETTING 2 4 INSTRUMENTS For information related to the navigation instruments software instructions for use Refer to the Recommendations for the Decontamination and Sterilization of Medacta International SA Reusable Orthopaedic Devices available from the company s website www medacta com or by calling 1 800 901 7836 1 16 Before every surgery make sure that the instruments have been properly sterilized and that they are in such conditions as to adequately perform their function Before sterilizing the reference arrays remove the markers from the supports THE MARKERS ARE FOR SINGLE USE ONLY do not re sterilize them do not re use them Re sterilizing or re using the markers may deteriorate the reflecting properties and the system may not be able to recognize the reference array The user is responsible to follow the directions for properly handling the components Always have the instrumentation for non navigated surgeries sterilized and ready as a back up to any navigated surgical procedure refer to the MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 3 INSTALLATION AND START To facilitate transport and at the same time guarantee adequate protection the Medacta iMNS navigation system is
11. ARKERS ON THE REFERENCE ARRAYS ccessceeseeneeceeeeeceaeeeeeeeeeeceeaeesteaeeestanees 20 3 3 ASSEMBLING THE SUPPORT TRIPOD cesscceeesecceeseececesseeeceseeceeeeaaeeceaeecesaceecesaeeseaaecessaeeeseaaeeseeeaees 21 3 4 INSTALLING AND TURNING ON THE SYSTEM 0 eecccessscceceeseceseececeeeaeeceeaaeeceseeeeeesaeeeeesaeeeseeeeseaeeseeaeeees 23 3 4 1 Polaris Spectra acquisition system wiring eeesss sesenta nen ener 23 34 2 iMAC Computer WIFIBS oed eee E oa ne E etum c E eto 26 3 4 3 REOMED 600 isolation transformer WINO 5i edat dd eio EXE ANE A AEA a RUN EASES 27 3 4 4 Turning on the iMNS us aset etie ra RR e STR RR AER RS REN pd 29 3 5 STARTING AND USING THE NAVIGATION SOFTWARE cccesecceeeeeceeseeeeecesneeeeesaeeeeteaeeeseeeeeeseaeeeeeeeees 31 peli zi elei lj E m M 32 A I POLARIS SPECTRA al EDS Nassau see etd ad enda Gash cea nasa Ordo atis catene s Aet P 35 AD AUDIO CODES sc eter ee ERE RUE BB s Um EM e Uu RENE 36 4 3 CLEANING AND MAINTENANCE 000 ccecceeseceeeencceceeceecesaceeeeeaeeeeseceesneaeesesacesenaeeeseaaeeseeaaeeeeeeaeeeseeaeeeeenee 36 quA ACbEANING eene onte tenete niente deii 36 4 4 1 Polaris Spectra System cleaning eere tede a aen eroe ex INE FETA ERRAT Fe reu NR 37 4 5 IMNS SYSTEM MAINTENANCE AND REPAIR rettet ttt nid 38 TECHNICAL SPECIFICATIONS CONFORMITY CLASSIFICATIONS ELECTROMAGNETIC COMPATIBILITY 39 5 1 TECHNICAL DATA AN
12. Aesact i AANS International MEDACTA NAVIGATION SYSTEM INSTRUMENTATION AND HARDWARE Ref 33 22 1000US Ref 99 30H 16US rev 02 Last update May 2010 USER MANUAL MEDACTA iMNS Instrumentation and Hardware CAUTION Federal law USA restricts this device to sale by or on the order of physician Copyright 2008 Medacta International SA All Rights Reserved All other product or service names are the property of their respective owners Distributed by MEDACTA USA Inc 4725 Calle Quetzal Unit B Camarillo CA 93012 9101 1 800 901 7836 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 TABLE OF CONTENTS 1 GENERAL DESCRIPTION M esnie 4 1 1 INTENDED USE 1 i m e eo erre eene erreur n ra ea A OLEE EEE 1 2 COMPLICATIONS 1 3 STRUCTURE AND OPERATION 1 4 TRAINING eee HARDWARE AND INSTRUMENTS 2 1 POLARIS SPECTRA ACQUISITION SYSTEM 52 5 RM aan uar ebbe Med rd 9 2 2 IMAC CONTRE Roue usc it RR DON roba TO cives eiit iati AE T vitia Fro ei es ded 12 2 3 REOMED 600 ISOLATION TRANSFORMER ccesccesceceseeesceceseecseeeceseceeceecaeeseatcnseeseaeeseeseaeeseaeesateneaees 15 2 4 INSTRUMENTS INSTALLATION AND START eee eene a ne eo ana go eene Yea eoe ee a rev k ava neveu Reo aeg echa Gee e e ves ous re Yee a Een aon 17 3 1 WIRING DIAGRAM in cscs 5rd io fh cs deter irr oh take Sa e la AE ee FU vea a P SANG oi dade ies PASE freres 18 3 2 ASSEMBLING THE M
13. D CONFORMITY cc ceeeeecceeeeeeeeseeaeeecesceeeseaaeeceaaeeceaceeesaeeeeeaeeessaeesteaeeeeetaees 39 5 1 1 Polaris Spectra Technical Specification i iiie er do tte etn a EE aii detec 40 5 1 2 iMac Computer Technical Specifications eese sees essen eene ennn netta enata hase rana sona 42 5 1 3 X Acquisition Device Support Tripod Technical Specifications eese 42 5 1 4 REOMED 600 Isolation Edo lel o 1a tt E 43 APPENDIX EQUIPMENT SYMBOLS 0 cccsescecaccessteccasessscenctsosedconssconstscstscsostecedacesdsenncenseadaensrecostessys 44 APPENDIX ACRONYMS AND ABBREVIATIONS ccccsesssecccessececccssceeccesececccesseesesessseceesseeesonense 45 1 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 BEFORE USING THE MEDACTA iMNS NAVIGATION SYSTEM CAREFULLY READ THROUGH THE MANUALS PROVIDED WITH THE SYSTEM AND THE OPERATING TECHNIQUES RELATED TO THE SURGERY TO BE PERFORMED THE USER IS RESPONSIBLE FOR ANY DAMAGE OR MALFUNCTION CAUSED BY IMPROPER USE OF THE iMNS SYSTEM OR OF ANY OF ITS COMPONENTS The information contained in this manual and the product to which it refers may be modified by MEDACTA without giving prior notice thereof The trademarks and product names quoted in this manual belong to the respective owners MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 1 GENERAL DESCRIPTION 1 1 INTENDED USE The iM
14. IS DEVICE CAN NOT BE USED AS A PERSONAL COMPUTER OR FOR ANY PURPOSE OTHER THAN NAVIGATION WITH THE SOFTWARE PROVIDED BY MEDACTA Mini DVI Ethernet 10 100 1000Base T Audio line in Headphone out and FireWire 400 ports are NOT used by the navigation system In particular Ethernet port is NOT FOR PHONE CONNECTION 14 This label is positioned above the Ethernet port on the back of the iMAC computer NOT FOR PHONE CONNECTION es MEDACTA iMNS Instrumentation and Hardware 2 3 REOMED 600 ISOLATION TRANSFORMER The iMac system is connected to the mains through the REOMED 600 isolation transformer equipped with a protection against short circuits and overloads and a current limiter The transformer is equipped with a power switch and EMC line filter 3 115V ACTORY SETTI f Figure 5 REOMED 600 Y Electrical device operating at potentially hazardous or lethal voltages the maintenance operations must be carried out by qualified personnel Pull the plug from the mains socket before any installation or maintenance operations Before using the unit check that the mains voltage is compatible with that of the device see 83 4 3 Do not use the device in the presence of flammable or hazardous substances To prevent the risk of electric shocks protect the transformers and cables used against moisture MEDACTA iMNS Instrumentation and Hardware ref 99 3
15. NS Medacta Navigation System is intended to be used to support surgeon during specific orthopaedic surgical procedures by providing information on bone resections instrument and implant positioning The iMNS Medacta Navigation System provides computer assistance to the surgeon based on anatomical landmarks and other specific data obtained intra operatively that is utilized to place surgical instruments Examples of surgical procedures include but are not limited to Total knee replacement Minimally invasive total knee replacement The MEDACTA iMNS system does not provide information of diagnostic nature Use the iMNS system only with the equipment specifically supplied or approved by MEDACTA The iMNS navigation system must be cleaned and disinfected immediately after use by qualified personnel see 85 1 Cleaning Clean and disinfect the instruments supplied in trays to be used with the iMNS navigation system before sterilization following the Recommendations for the Decontamination and Sterilization of Medacta International SA Reusable Orthopaedic Devices available from the company s website www medacta com or by calling 1 800 901 7836 1 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 The iMNS system shall not be used to perform surgeries other than the ones indicated in the surgical techniques described in this manual Do not use the iMNS sys
16. SB Universal Serial Bus 45
17. cle marked Hospital Only or Hospital Grade Please take into account the following warning label applied on the mains power supply unit AN GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN THE EQUIPMENT IS CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED HOSPITAL ONLY OR HOSPITAL GRADE MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 3 2 ASSEMBLING THE MARKERS ON THE REFERENCE ARRAYS 2 Figure 8 Reference arrays Before each surgery apply the sterile markers on each reference array The markers are pressure fitted on the 20 special supports Only use markers supplied by MEDACTA Using different markers from those supplied by MEDACTA may result in a loss of accuracy Make sure that the markers are firmly inserted and at the end of their stroke on the pin In addition to the markers the discs shown in the figure 8 must be assembled on the pointer and the G shaped reference array They are indispensable for accurate acquisition Do not proceed with navigation if the discs have not been fitted STERILE MARKERS ARE FOR SINGLE USE ONLY Do not re sterilize them Do not re use them Re sterilizing or re using the markers may deteriorate the reflecting properties and the system may not be able to recognize the reference array MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 3 3 ASSEMBLING THE SUPPORT TRIPOD Open the cases by lif
18. computer Polaris Spectra Position Sensor A D Laser warning Consult accompanying documents Polaris Spectra Position Sensor ON power connection to the mains supply Polaris Spectra Position Sensor Host USB converter REOMED 600 OFF power disconnection from the mains supply REOMED 600 Status see user manual Polaris Spectra Position Sensor Error see user manual Polaris Spectra Position Sensor Host USB converter Laser Activation button Polaris Spectra Position Sensor Connection Port Polaris Spectra Position Sensor ml9 co Recycle where possible or return to manufacturer Polaris Spectra Position Sensor Host USB converter Polaris Spectra power adapter REOMED 600 Direct Current DC Host USB converter Polaris Spectra power adapter Alternating Current AC iMac computer Polaris Spectra power adapter USB port USB plug iMNS identification plate Host USB converter 3 pedal footswitch ON OFF button iMac computer RG i Indoor use only Polaris Spectra power adapter 44 7 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 APPENDIX ACRONYMS AND ABBREVIATIONS AC Alternating Current CD Compact Disc DC Direct Current DVD Digital Versatile Disc EMC Electromagnetic Compatibility IR Infra Red LED Light Emitting Diode RAM Random Access Memory U
19. ef 99 30H 16US rev 02 Never disconnect the power cable or the 14 pin cable when the amber light error LED on the front of the Position Sensor figure 18 is on Check that the system is off before disconnecting any of these cables It is advisable to wait 20 minutes from the turning on the system before proceeding with the acquisitions The device requires a warm up and thermal stabilization period before being able to operate with maximum accuracy During warm up the Power LED of the Position Sensor flashes once this LED is steady the system is ready to use To prevent damaging the cables do not to bend them excessively The power supply unit must be located outside the patient vicinity under ALL operating conditions Do not obstruct the normal flow of air around the Position Sensor e g draping or bagging it Doing so will affect the Position Sensor s operational environment possibly beyond its recommended thresholds It is the responsibility of the system integrator and or the end user to ensure that the system is appropriately configured for the operating conditions these steps have been completed the acquisition system is connected and powered Finally start the iMAC Computer using the power button I Power Button 30 Figure 19 iMAC Computer MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 3 5 STARTING AND USING THE NAVIGATION SOFTWARE For the instructions on t
20. he startup and use of the software refer to the enclosed software manuals Y THE iMAC COMPUTER PROVIDED WITH THE iMNS SYSTEM HAS UNDERGONE HARDWARE AND SOFTWARE MODIFICATIONS TO OPTIMIZE PERFORMANCE OF THE NAVIGATION PROGRAM AS A RESULT IT IS NO LONGER POSSIBLE TO USE iMAC AS A PERSONAL COMPUTER OR FOR OTHER APPLICATIONS DIFFERENT FROM NAVIGATION WITH THE SOFTWARE SUPPLIED BY MEDACTA Some applications has the possibility to jump form one screen to another by mean of dedicated shortcuts This label summarizing the available shortcuts is optionally available positioned in front of the iMAC computer Verify available shortcuts for the e N S software in use by pressing F5 E MEDACTA NAVIGATION SYSTEM Save a snapshot 5 List of shortcuts Navigation settings Camera positioning Confidence test I Tl j TY TI T T o O9 M OD Pre surgery analysis B q N I ack to current step ref 99 30 99 rev 01 31 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 4 TROUBLESHOOTING PROBLEM DESCRIPTION TROUBLESHOOTING 1 INSTALLATION 1 1 Problem in assembling the camera support tripod 2 SETUP 2 1 Turning on 2 1 1 The system does not turn on 2 1 2 The camera does not turn on 3 STARTING THE SYSTEM Follow the assembly instructions Check the power cable Check the power cables 3 1 A fault occurs 4 LOGIN
21. hould any part of the manual not be clear refer to the specialized MEDACTA staff for help MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 2 HARDWARE AND INSTRUMENTS 2 1 POLARIS SPECTRA ACQUISITION SYSTEM The acquisition system NDI PASSIVE POLARIS SPECTRA SYSTEM consists of a pair of cameras Position Sensor capable of emitting and receiving infrared rays reflected by special reflectors passive markers positioned on reference arrays Figure 1 Figure 1 Reference arrays During the surgeries different reference arrays are used Their position is identified and represented by the system in real time Thanks to the binocular vision of the Position Sensor a triangulation process of the acquired images can be performed Figure 2 identifying the position of each marker with a tolerance of 0 5 mm When all 3 markers positioned on the reference array are visible to the Position Sensor the system is able to reconstruct and represent the position and precise orientation of the body If some of the markers are not visible the system blocks the confirmation of the acquisition until the reference array is again fully visible and recognized Figure 2 Image Acquisition MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 1 10 The acquisition system is made up of very sensitive precision instruments Protect it against bumps and dropping in order not to jeopardize it
22. ifferent components Make sure that this operation is carried out in such a way as to minimize the space used in the operating theatre and the risk of accidental detachment of the connectors during surgery Should one of the connectors accidentally slip out of its seat check the integrity of the cable and the connector Make sure to reinsert the connector in the correct socket and check device functioning In some cases the system will have to be restarted 3 4 1 Polaris Spectra acquisition system wiring To provide power supply to the Polaris Spectra acquisition system follow the steps below 23 dn j I LaserLabel Serial Number Mount 14 pin connector Label socket 44 pin connector t1 Host USB Converter 7 ENDI Figure 13 Polaris Spectra Acquisition System MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 Insert the 14 pin connector of the Host USB Converter in the corresponding socket on the rear of the Position Sensor Figure 13 As shown in figure 14 connect the A end of the USB cable to the sockets amp and the power adapter cable of the power supply unit to the special socket of the Host USB Converter power supply unit Figure 14 Host USB Converter wiring Insert the Y end of the power cable in the Polaris Spectra power supply unit ITEM ID 8700336 001 05 TOC uisus saint 7 BORRAR buain Information Item ID Model and Serial cable N
23. n reasons an electrostatic charge may build up on the footswitch which interferes with the proper operation of the device The presence of scratches or marks on the body of the POLARIS SPECTRA system may be an indication that it has not been handled with the due care In this case suspend use of the navigator and contact the Technical Service to have the functions checked and recalibrated if necessary For questions or service requests contact Medacta customer support www medacta ch info medacta ch 1 800 901 7836 or the sales representative in your country Before contacting Technical Service make sure that the following information is available e System serial number located on the identification plate see below e Installed software version e Possibly reference to the component for which assistance is being requested e Any error message that has appeared and a description of the problem 33 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 The identification plate is located on the top of the Reomed isolation transformer Adedacta International Medacta International Strada Regina CH 6874 Castel San Pietro Switzerland Model Name iMNS Medacta Navigation System Part Number REF XX XX XXXXXX Input Rating 115 230V 50 60Hz 600VA Serial Number Mfg Date Ce 0546 CAUTION Federal law USA restricts this dlevice to sale distribution and use by or on the
24. nition by the acquisition system In this case clean them by gently dabbing them with a soft and dry cloth If any traces of blood have dried remove them with a wet cloth and then dry the markers Should this not be sufficient replace the dirty markers 37 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 4 5 IMNS SYSTEM MAINTENANCE AND REPAIR The iMNS navigation system must undergo maintenance and be checked at least every 24 months Regular maintenance will ensure full functionality of the system Y THE REPAIR MAINTENANCE AND CHECKING OPERATIONS SHALL BE CARRIED OUT EXCLUSIVELY BY SPECIFICALLY TRAINED PERSONNEL AUTHORIZED BY MEDACTA To ship the MEDACTA iMNS system use the original containers with all the protective wrappings to prevent damaging the system Do not transport or store the system outside the recommended storage temperature range this may cause the system to go out of calibration In the following table the transportation and storage environmental conditions are summarized Specification Value Atmospheric Pressure TO kPa to 106 kPa Relative Humidity 10 to 90 non condensing Temperature 10 C to 50 C This label reminding the storing condition is positioned on the top of the Reomed isolation transfomer Ref 75 41 028 rev 00 d keep dry conservare in luogo asciutto conserver au sec trocken halten 38 mantener en lugar seco
25. order of a physician Ref 75 31 066rev5 Serial Number Manufacturing Date 34 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 4 1 POLARIS SPECTRA LEDS The power status and error LEDs on the Position Sensor indicate the status of this component as described in the following table Figure 18 l 1 Power Led Status Led Error Led Meaning and Action Required green green amber The power LED will stop flashing and light steady Flashing Any state Any state green when system is ready for use Solid Solid Off The Position Sensor is ready for use no faults Solid Solid Flashing Minor recoverable fault Solid or off off Solid Major recoverable fault Solid off Solid Non recoverable fault Return the Position Sensor for service Voltage is out of range off off Off Check the Position Sensor Host USB Converter or cables On the Host USB Converter there are two LEDs Figure 18 the Power LED green light and the Error LED amber light They show the status of this component as described below l L Power Led Error Led Meaning and Action Required green amber Solid Off The Host USB Converter works no faults There s a fault Unplug the cable of the power supply unit from the special socket of the Host USB Converter Wait approx 10 seconds and then Solid Solid plug it in again If the Error LED is still on disconnect the Position Sensor If the
26. s precision and proper operation Always position the POLARIS SPECTRA system on a stable support Before use inspect the system and make sure that it is intact and clean Should this not be the case the measuring accuracy would be jeopardized The following label is located on the top of the position sensor A FRAGILE Ti THIS DEVICE IS HIGHLY SENSITIVE TO MECHANICAL SHOCKS BUMPS AND FALLS CAN ADVERSELY AFFECT MEASUREMENT ACCURACY IN THIS CASE PLEASE DO NOT USE THE MEDACTA NAVIGATION SYSTEM AND CONTACT YOUR LOCAL REPRESENTATIVE T Do not use transparent materials glass Plexiglas or any other materials to protect or shield the POLARIS SPECTRA system during the acquisitions Even transparent materials or clear plastic in the line of sight of the cameras may degrade system performance The machine must be properly grounded in order to operate safely Do not bypass the grounding using three to two prong adapters The POLARIS SPECTRA system is not designed to perform absolute measurements Use of the system to carry out absolute measurements may produce inaccurate results The manufacturer recommends using a reference instrument whenever possible to assure that there are no measuring inaccuracies due to environmental or time causes 11 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 Do not connect or disconnect the camera system when the power supply unit is live as this migh
27. supplied in two rigid cases with appropriately shaped foam rubber linings One case contains the Polaris Spectra Position Sensor c the support tripod a and the REOMED 600 isolation transformer b Figure 6 First iMNS transport case The other case contains the iMac system e complete with keyboard d 3 pedal footswitch h USB and power cables g Host UBS Converter and feeder of the Polaris Spectra system f Figure 7 Second iMNS transport case 17 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 Do not use cables or accessories other than those listed Y in this manual The use of other cables or accessories may result in increased emission and or decreased immunity of the Polaris Spectra System and may lead to personal injury 3 1 WIRING DIAGRAM MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 Electrical plugs and their sockets differ by country in shape size and type of connectors Make sure that the supplied mains power connector A matches your local socket Do not connect any other electrical devices than those shown to the outlets of the REOMED isolation transformer Mains power connector supplied with iMNS for the US market is displayed in the picture on the right 19 In order to achieve an appropriate grounding reliability the equipment must be connected to an equivalent recepta
28. t bypass the grounding using three to two prong adapters To prevent risks of overheating do not obstruct the ventilation opening on the rear of the device Do not insert any object in the ventilation opening on the rear of the device As the iMac system cannot be sterilized never place it in a sterile field for any reason whatsoever Before proceeding with the cleaning operations check that the system is off and that all the cables have been disconnected MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 Do not turn off the system by pressing the power button To turn off the system exit the navigation software Do not sterilize the iMac system or any of its parts in an autoclave Never disconnect the power cable when the system is on Do not immerse the system in water Do not let water or other liquids penetrate the system in any way To clean the outside of the computer use a soft and clean cloth Do not spray any liquid directly onto the computer Refer to 8 5 1 for cleaning instructions IMPORTANT NOTICE The iMAC computer provided with the iMNS can not be used for any urpose other than navigation with the software rovided b MEDACTA Please carefully take in account the label located on the back of the iMAC computer and reported here BOTH HARDWARE AND SOFTWARE COMPONENTS OF THIS SYSTEM HAVE BEEN DEVELOPED AND ASSEMBLED IN ORDER TO CONSITUTE A MEDICAL DEVICE TH
29. t damage the system Never disconnect the power cables or the 14 pin cable of the Position Sensor when the amber light on the front of the Position Sensor is on Make sure that the system has been turned off before disconnecting any of these cables Do not look directly into the Class 2 laser emitting aperture Take precautions to ensure that patients do not look directly into it Direct viewing of the laser diode emission may cause eye damage The follwing label is located in the back of the unit Please read it carefully LASER RADIATION Emitted from Aperture DO NOT STARE INTO BEAM CLASS 2 LASER PRODUCT max output 1mW wavelength 635 nm IEC 60825 1 2001 ANSI 2136 1 2000 Complies with 21 CFR1040 10 and 1040 11 except for deviations pursuant to Laser Notice No 50 dated July 26 2001 Use of laser controls or adjustments or performance of laser related procedures other than those specified herein may result in hazardous radiation exposure ITEM ID 8700439 001 MODEL Polaris Spectra Position Sensor PCE T JH NCRA IC 053A MCA the back of the unit This Ou ion oorr qi ex edi fart M stia FCO Bes Dpormi on uu nini end ta the 1olio ung haa osnan ana DLP Oeo Das nor esus Natu incentornncos and 121 4 CO Meret Z2 OG ny UTC ono 6 PoO9 WO indauoeg interrer ence Tot oy oue unde sire d acer Au CE Wtan gh mc 103 yid Or Vwrari co C Can acia V7 105 Information about the Polaris SERIAL No PT 0001
30. tem in the presence of sources or reflectors of intense infrared radiation as under these conditions the acquisition system is unable to work properly Additionally avoid exposing the acquisition system to direct daylight In case of knee operations adequate mobility of the corresponding hip joint is an essential requirement for the effective use of the iMNS system It is essential to always bear in mind all the warnings related to the surgery to be performed MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 1 2 COMPLICATIONS If the MEDACTA iMNS system is improperly used the following complications may arise including but not limited to e Infection e Incorrect implant positioning e Failed recovery of the articular functionality Refer to the respective package insert of the implants for a comprehensive list of complications and information regarding the implants VY Like all electrical devices the MEDACTA iMNS 5 navigation system may be subject to malfunctioning due to improper use or to technical reasons It is however always possible to complete the surgery with the aid of the standard equipment which must necessarily be available in the operating theater Do not use the iMNS system in the presence of flammable materials such as anaesthetics solvents detergents and gases Although the iMNS Navigation System has been tested and declared fully satisfying the electromagnetic
31. ting the tabs of the closing mechanism and turning them anticlockwise figure 9 Figure 9 Case locking system Take the support tripod out of the case slide the locking device P in Figure 10 to release the opening and open the tripod legs wide apart Releasing the locking device P secure the legs in open position Fig 10 b ensuring that they are firmly in place Figure 10 Tripod base 21 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 Position the ball joint G in figure 11 of the Polaris Spectra system on the tripod stem and turning the fastening knob M securely tighten the locking device to prevent the joint from slipping from the stem Figure 12 Adjusting tripod height 22 Figure 11 Position Sensor on the Tripod Extend the tripod by sliding out the telescopic rods Once the desired height has been reached securely tighten the locking devices by turning the fastening knobs figure 12 Make sure that the structure is stable Knocking or dropping the Polaris Spectra system may cause irreparable damage During acquisition even small system vibrations may lead to inaccurate and unreliable results Stability of the system will be enhanced if the locking latches on the castors are depressed MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 3 4 INSTALLING AND TURNING ON THE SYSTEM System installation requires wiring of d
32. tion 6 1 4 for the fuse 27 specifications MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 Detailed technical specifications of the REOMED 600 can be found on the label located on one side of the unit MEDICAL ISOLATING TRANSFORMER Article No BV65B5167Axx Supply voltage 115V 230V Frequency 50 60 Hz Power input 600 VA Fuse F1 F2 716 30 13 15A 5x20 Rated output voltage 230V by 6 Outputs Rated output current 2 60 A Case protection IP 20 Protection class l C MADE IN GERMANY 28 MEDIZINISCHER TRENNTRANSFORMATOR Artikel Nr BV65B5167A xx Eingangsspannung 115V 230V Frequenz 50160 Hz Leistungsaufnahme 600 VA Sicherung F1 F2 T6 30 T3 15A 5x20 Ausgangsspannung 230V an 6 Ausg ngen Ausgangsstrom 2 60A Schutzart IP 20 Schutzklasse l C C MADE IN GERMANY A X MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 3 4 4 Turning on the iMNS Turn on the REOMED 600 isolation transformer by setting the switch A in figure 17 to ON I Check that the LED on the power supply unit and the green Power LED I on the Host USB Converter become on and the Power LED I on the front of the camera starts flashing figure 18 Error LED Power LED Laser Aperture Laser Activation Button Figure 18 LEDS on Polaris Spectra System When the power LED stops flashing you can hear two beeps 29 1 When MEDACTA iMNS Instrumentation and Hardware r
33. tromagnetic compatibility Requirements and tests The POLARIS SPECTRA system has been tested for electrical safety and risk of fire No other physiological effects have been evaluated The ambient operating temperature range of the Polaris Spectra System is dependent upon the physical location of the Host USB Converter If the Host USB Converter is located where it may get in touch with the patient the operating ambient temperature ranges from 10 C to 309 C Otherwise if the Host USB Converter is placed outside this patient vicinity the operating ambient temperature range permitted for the system is 10 C to 40 C Although the POLARIS SPECTRA system can operate in a wide temperature range 10 C 30 C all the performances specified including accuracy are based on characterization and calibration performed at 20 C All the NDI acquisition systems are designed for use of specific NDI components only Do not use the POLARIS SPECTRA system in radioactive environments The system has not been tested nor approved for use in radioactive environments Position Sensor Maximum Update Rate 60 Hz Input Voltage 18 32 VDC Power Consumption 13 5 W Host USB Converter Input Voltage 24 VDC Output Voltage 26 VDC Power Consumption lt 2 W MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 Power Adapter Input Voltage 100 VAC to 240 VAC 50 60 Hz Output Voltage 24 VDC
34. umber are reported on a label located on SERIAL No U1 00642 the back of the USB Converter MEL LETT ELTE MFG OATE K As 24 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 Figure 15 Polaris Spectra Power Supply Unit wiring APS ADVANCED POWER SOLUTIONS MODEL APS49ES 24021 LF Detailed information about the power supply are Power Supply tor Medical Use r x AC INPUT DC OUTPUT displayed on the label located on the unit 100 240V 24y 2 1A 1 0A 50 60Hz INDOOR USE OY Puer ADVANCED SYSTEMS CO LTD TPHLZARPVATLAXMK L oov TEL 825 734 3080 MADE IN CHINA 25 MEDACTA iMNS Instrumentation and Hardware ref 99 30H 16US rev 02 3 4 2 iMAC Computer wiring As shown in the figure below connect the Host USB Converter to the iMAC system inserting the B end of the USB cable in one of the three socket amp on the rear of the iMAC screen i Sas e 1gJ00DD i I Figure 16 iMAC Computer wiring Connect the keyboard to anotherone of the USB ports amp If a wireless keyboard optional is available switch on the keyboard with the switch located on the lower face of the device Check that the green LED comes on Connect the footswitch to one of the USB ports amp on the body of the iMac system or to one of the USB ports locate on the keyboard using the special adapter if necessary Connect the mouse optional to one of the USB ports

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