USER MANUAL TOCOS
Contents
1. ekliptik Ekliptik d 0 0 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 TOCOS ekliptik Contents GUIDING e i a S Ga e sven NEM 4 TOCOS MOGUIC sivakis ee a a a i i i ny a 6 EO V OAS EA L iii rasa dia i iii ii i S i i i a een i a S a m i se 6 Start with tne surgical procedure Ls simsai asies iai a ii a i i is 10 e gem S 14 Instructions for SUCHIZAU ON cen en in ny ay 14 GUJLID ING SPARK eee e ee e eee eee wee eee ve e ere ere 15 TOCOS INO yyl ma 15 WY QUIN S e e cen e ua e uni o md e m a dn a e a a mare ii 15 TOCHMCA CAC a nara rn e e vena lay 17 CERTIFICATE OF CONFORMITY vine pe al rn sa ama 19 gi ekliptik Picture 1 GUIDING STAR Parts GUIDING STAR Parts description Computer unit with integrated display and touch screen 1 Navigational unit 2 Power supply unit 3 Cart with wheels 4 Extension arm 5 Transmitter 6 Power cable 7 Computer button on off 8 Navigational unit power and USB connection 9 Navigational unit 4 socket 10 Transmitter cable connected to the navigational unit 11 Power unit on off button 12 Wheel with brake 13 Computer unit power and USB connection 14 iS ekliptik Picture 2 TOCOS module parts TOCOS Module Parts description e Aiming probe 31 e Aiming probe connector 31 a e Plastic tube 32 e Reduction probe 33 e2. Sensor for reduction probe 34 e Sensor connector 34 a e Preamplifier cable 35 e Preamplifier connector 35 a e Preamplifier socket 35 b Before you start The TOCOS 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 K ekliptik The Guiding Star TOCOS 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 switches on the computer ekliptik On the computer screen the Welcome mode appears Welcome Version 1 1 1 6 Welcome GUIDING STAR Switch off Press to switch off the system E ekipi Push the preamplifiers connectors into the sockets on the front of the navigation unit until they click Gently insert the each probe s connector reduction probe and aiming 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 Do not touch the screen again until the GuidingStar TOCOS enters into the ACTIVE mode When the p
3. 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 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 A 250V T Time Lag SLO BLO e Operating temperature 15 C to 35 C e Warm up System meets accuracy specifications after 5 mins 17 Transmitter e 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 materia
4. for inserting the intramedullary nail 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 14 OP Z ekliptik 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 TOCOS module If the TOCOS module is to used then the following TOCOS parts have to be sterilized with plasma before use in the operating theater e 2 reduction probes 1 asa Spare e 2 aiming probes 1 as a Spare e 3 Preamplifiers 1 as a spare Place all the accessories that have to be sterilized in appropriate box Pay special attention to the reduction and aiming probes cables and connectors they have to be rolled into a coil when sterilizing The ai
5. ls 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 measurements per second Default measurement rate 68 3 Hz The system is calibrated at 68 3 Hz Preamplifiers e Module max OD minus threaded cap 23 5mm e Module max length including sensor connector 163mm 18 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 CERTIFICATE OF CONFORMITY No CE 223 0009 07_3 The product complies with the essential requiments 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 19
6. ming probe must be completely stretched out 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 Warnings a eg e There are some problems with the navigation system Is it connected properly and switched on The system is warming up Please wait 15 Keep the calibration stand still Keep the probes between 13cm and 40cm from the transmitter One or more probes are not connected properly Information in probe d is corrupted Report this error to the hardware Probe d usage has expired Return the probe to the hardware vendor Probe in port d has only od usage s left There is interference from the environment 16 Technical data Storage and Operating Specifications e Storage conditions 0 C to 60 C with 20 to 90 humidity non condensing e 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
7. proximal bone part Mark that position and make the incision for inserting the reduction probe 11 iS ekliptik Push the reduction probe towards the bone and press it on to the bone With free hand push the bone from the opposite site A Tocos Version 1 1 1 2 GUIDING STAR TOCOS The system is showing the aiming probe relative to the distal fragment medullary channel axis 28 30 mm M 30 32 mm T EE 32 34 mm MAT AEA 34 36 mm r C ted be Terminate e ns Return to welcome screen 250m 51 260m 50 On the computer monitor check the position of the reduction probe the sguares with perpendicular green lines with regard to aiming probe small green sguares surrounded with yellow sguare 12 iS ekliptik Move the reduction probe to overlap the squares on the computer monitor A Tocos Version 1 1 1 6 GUIDING STAR T The system is showing the aiming probe relative to the distal fragment medullary channel axis KE EK ANA 22 24 mm Z i RK 24 26 mm Z ZAK K K 6 28 mm Terminate 2 Connected probes Return to welcome screen 13 WS ekliptik When the squares are overlap push the aiming probe forward into the medullar channel of the distal fragment After you done the reduction pull out the aiming probe from the plastic tube Insert the guiding wire into the plastic tube and continue with standard surgical procedure
8. robes are connected and the GuidingStar TOCOS is ACTIVE press the button GuidingStar TOCOS to go into the TOCOS program Welcome Version 1 1 1 6 Welcome m MU GUIDING STAR TOCOS Start TOCOS NI gt Start reduction process Connected probes anc 0050 Press to switch off the system Module TOCOS don t have to be calibrated Before you start to use TOCOS probes you have to choose the predefine bone diameter on the left and right side of the computer monitor Tocos Version 1 1 1 2 The system is showing the aiming probe relative to the distal fragment medullary channel axis GUIDING STAR TOCOS O Zcm Connected probes Terminate O 2 a Return to welcome screen 256m 5 1 250m 5 0 ekliptik Start with the surgical procedure Insert the aiming probe into the plastic tube Once the entering point in the bone is defined insert the aiming probe with plastic tube into the medullar channel Push the aiming probe forward along the medullar channel until you reach the fracture edge 10 iS ekliptik Move the reduction probe over the skin In the left lower corner the numbers indicate the distance from aiming probe cap and the beginning of reduction probe Move the reduction probe over the distal fragment but no more than 3cm to 5 cm from fracture end of
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