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Invasix BodyTite™ Service Manual DO600463F

0344

Page 5 of 52

Rev. Page Description

Date

Release to service

07/04/2009

Typo changes in assembly instructions

20/05/2009

Adding of RF calibration and Testing

14/10/2009

Update to cover the upgrade to TiteFX
hand piece

11/07/2011

all

Update according to DEKRA reviewer
question TDR04/Q11 in report 3900465-
TDR04-R0

16/10/2011

30,31 Updated Error codes

23/01/2012

Содержание BodyTite

Страница 1: ...Invasix BodyTite Service Manual DO600463F 0344 Page 1 of 52 BodyTite TiteFx Service Manual DO600463F ...

Страница 2: ...8 THE PATIENT 8 TREATING ATTENDANT 8 CAUTIONS 9 ELECTRICAL AND MECHANICAL SAFETY 9 FIRE HAZARDS 10 SAFETY FEATURES OF THE SYSTEM 10 ACTIVE ACCESSORIES 11 LABELS 11 EQUIPMENT CLASSIFICATION 12 SECTION 3 SYSTEM INSTALLATION 14 ELECTRICAL REQUIREMENTS 14 ENVIRONMENTAL REQUIREMENTS 14 EQUIPMENT LIST 14 INSTALLATION 15 System parts View 15 MOVING THE SYSTEM 17 DISPOSAL OF SYSTEM 17 SECTION 4 DESCRIPTIO...

Страница 3: ...RROR MESSAGES 30 SECTION 8 TROUBLESHOOTING 32 SECTION 9 ASSEMBLY INSTRUCTIONS 34 Front Cover disassembling 34 Front Cover assembling 34 AC Card Disassembling 36 AC Card Assembling 36 Power Supply Disassembling 37 Power Supply Assembling 37 RF Card Disassembling 38 RF Card Assembling 38 Fan Assembly Disassembling 40 Fan Assembly Assembling 40 Controller Card Disassembling 42 Top Assy Disassembling ...

Страница 4: ...over disassembling Error Bookmark not defined 2 RF Card Disassembling Error Bookmark not defined 3 Controller Card Disassembling Error Bookmark not defined 4 Top Assy Disassembling Error Bookmark not defined 5 RF Card Assembling Error Bookmark not defined 6 Controller Card Assembling Error Bookmark not defined 7 Connector Bracket Assembling Error Bookmark not defined ...

Страница 5: ...7 04 2009 B Typo changes in assembly instructions 20 05 2009 C Adding of RF calibration and Testing 14 10 2009 D Update to cover the upgrade to TiteFX hand piece 11 07 2011 E all Update according to DEKRA reviewer question TDR04 Q11 in report 3900465 TDR04 R0 16 10 2011 F 30 31 Updated Error codes 23 01 2012 ...

Страница 6: ... operate the System RF electrosurgical devices can cause injury if used improperly High voltage is present inside the System Always be aware of the possible dangers and take proper safeguards as described in the manual The System must be serviced only by Invasix Ltd qualified personnel System Overview The BodyTite platform is intended multiple applications and support different hand pieces employi...

Страница 7: ...WARNING This information is extremely important Explanation of the Symbols used on the System Symbol Description Attention Consult Accompanying Document CSA marking 212603 CSA master contract number CE marking Do not discard in trash Electronic equipment should be disposed of in an appropriate manner Fuse Type BF applied part HF Isolated Patient Circuit This equipment intentionally supplies non io...

Страница 8: ... safety for both treating attendant and patient Read this chapter to be familiar with all its safety requirements and operating procedures prior to System operation RF devices can cause injury if used improperly High voltage is present inside the System Always be aware of the possible dangers and take proper safeguards as described in the manual The Patient Well trained staff assures patient safet...

Страница 9: ... the covers creates a safety hazard Keep hands away from the applicator during the System start up Perform maintenance procedures when the System is shut down and disconnected from power The System is grounded through the grounding conductor in the power cable This protective grounding is essential for safe operation Provide as much distance as possible between system and other electronic equipmen...

Страница 10: ...tures of the System The System incorporates the following safety features All personnel operating the System should be familiar with these features The power electronics can not be activated unless the applicator has been connected to the System An audible tone indicates energy activation During activation the System performs a self test of the hardware Hardware is tested every 1 ms to ensure prop...

Страница 11: ...ed Improper connection may result in arcs and sparks accessory malfunction or unintended surgical effect Do not wrap the hand piece cords around metal objects It may induce current that could lead to chocks fire or injury to the patient or surgical personal Do not connect wet accessories to the System Hand piece are single use only Don t try to sterilize and reuse the hand piece Labels ...

Страница 12: ...igure 2 Hand Piece Label Equipment Classification The following is a list of the different equipment used and their classifications Electric shock protection Class I Type BF Protection against ingress of liquids Ordinary equipment Not suitable for use in presence of flammable substance ...

Страница 13: ...Invasix BodyTite Service Manual DO600463F 0344 Page 13 of 52 System is classified as a IIb device defined by the Medical Device Directive 93 42 EEC for CE marking ...

Страница 14: ...ntinued protection against fire replace the fuse only with one of the same type and rating Proper grounding is essential for safe operation Environmental Requirements Corrosive materials can damage electronic parts therefore the System should operate in a non corrosive atmosphere For optimal operation of the System maintain room temperature between 20º 27ºC 68º 79ºF and relative humidity of less t...

Страница 15: ...Invasix BodyTite Service Manual DO600463F 0344 Page 15 of 52 Installation System parts View Figure 3 Front view Main Display On Off switch TiteFx Connector Operating Keys ...

Страница 16: ...Invasix BodyTite Service Manual DO600463F 0344 Page 16 of 52 Figure 4 Back View Software Plug Power Inlet Foot Switch connection Fan ...

Страница 17: ...hin the facility Turn the System off Disconnect the Power Cord Put Footswitch with cable to the pocket located on the back panel of the system Release the wheel brakes Slowly push or pull the System using the handle Lift the System to the vehicle and lay it carefully on its side handles Never lift pull or push the System using the operating panel Always use the handles when moving the System Dispo...

Страница 18: ...trol Panel is located on the upper side of the System The Operator Control Panel consists of On Off switch four function keys an information screen and hand piece connector Figure 3 2 Power On Off switch Power switch turns system on and off On Off switch TiteFx Connector Operating Buttons Main Display BodyTite and Fractora connector ...

Страница 19: ...connected to the platform Functional keys Control panel comprises four functional keys Functional keys perform function according to information shown on the LCD screen above the each key LCD screen LCD screen shows information about machine status treatment parameter and titles of functional keys LCD treatment Scroll Key Increase Key Decrease Key OK Key ...

Страница 20: ... of 52 Treatment Screens Figure 4 2 Splash screen The Self Test screen appears after the Power switch is turned on Software is loaded from the plug and self test of the system modules is performed After the end of the self test the Treatment screen appears ...

Страница 21: ... temperature which is adjustable from 35o C up to 44o C Pulse Width This indicator shows the time period during which RF energy is delivered which is adjustable from 1sec to 5ses 2nd RF level Deliver short pulses of 2nd frequency RF energy which is adjustable from level 0 to 5 Total Energy This indicator shows the total energy delivered from the beginning of the treatment Volume This function allo...

Страница 22: ... of energy is not allowed in Standby mode In Ready mode the system is waiting for a signal from the footswitch to activate the energy Any attempt to change the treatment settings switches the system to Standby mode When the signal from the footswitch is indicated the system switches to Active mode Any attempt to change the treatment settings switches the system to Standby mode ...

Страница 23: ...ameter Down sign This sign indicates a functional key allowing to decrease selected treatment parameter Mode sign This sign indicates a functional key allowing changing System Mode or accept selection It will toggle system from Standby mode to Ready mode or vice versa Pressing 2 central functional keys simultaneously will present measured information on the top of treatment screen The presented in...

Страница 24: ...nnector Figure 4 4 Headpiece Handle Hand piece handle is made from metal and has ergonomic design for easy treatment with high visibility of the treated area Vacuum chamber Applied to the skin surface and shape the skin for optimal heating RF electrodes Located in the vacuum chamber and delivers RF energy to the treated tissue Screen Shows measured temperature ...

Страница 25: ...0344 Page 25 of 52 Cable Has a length of 250cm 100 Connector It is connected to the control panel of the system The connector has individual IDs to recognize each handpiece and its usage history Hand pieces in cradle are shown in picture below ...

Страница 26: ...perature range allow one hour for the to reach room temperature before use Transport and Storage Ambient Temperature Range Relative Humidity Atmospheric Pressure 20 65 C 35 131 F 0 to 80 non condensing 500 hPa to 1060 hPa Dimensions System Handpiece cable 36cm W x 36cm D x 100cm H 250 cm 14 2 W x 14 2 D x 40 H 100 Weight System Applicator 15 Kg 1 Kg 33 lbs 2 2 lbs Output Parameters Output Configur...

Страница 27: ...Invasix BodyTite Service Manual DO600463F 0344 Page 27 of 52 ...

Страница 28: ...n Splash screen and progress bar appears System goes into treatment screen and it is in Standby mode Software version is displayed Connected Hand piece type is allowed in hand piece menu 3 Set treatment parameters using Up and Down keys 4 Press OK key to switch into the READY mode 5 After the system is ready to use Ready Mode Step on footswitch to start treatment Troubleshooting If cavity is not s...

Страница 29: ...vice exterior Clean exterior of the BodyTite system with soft cloth Disinfect the exterior parts of the device with hospital grade disinfector if it is required Do not use alcohol or spill any liquids on any part of the system it is not sealed to liquids Clean the fan grids located on the rear panel using vacuum cleaner at least once a month ...

Страница 30: ... well connected Software Loading Error Checksum 0xNNNNNNNN The software plug is present but an integrity error was detected If the checksum is 0 the reason is a non programmed software plug but from the user point of view it is an invalid one Reason The software plug is corrupted rare because it is tested during manufacturing Software Start Error The software plug is present but for any reason the...

Страница 31: ...n The BodyTite HP has made more than 150KJ or FaceTite HP has made more than 50KJ H005 System Memory Fault The software failed to read system parameters Reason The system parameters RF calibration are corrupted It may appear in a system that was never calibrated corruption after calibration was never faced H006 Low Temperature Message is displayed on screen if the temperature does not rise by ºC d...

Страница 32: ...roller card 4 No Software plug Replace Software plug Replace Controller card 5 SW Memory Fault Check Sum Verify that the memory plug is tight Turn the System on If massage reappears replace memory plug 6 Fan Fault Display is OK Verify that the fan is not blocked by an external object If the fan is blocked remove the object Check DC power connection to controller Check fan wiring Replace Fan 7 Hand...

Страница 33: ...ce Hand piece Recalibrate RF card Replace RF card Check wiring from RF card to Hand piece connector 14 Key does not respond Replace LCD adaptor card 15 Footswitch does not respond Replace footswitch Check controller to footswitch wiring Replace Controller card 16 Hand piece LCD is blank Replace hand piece 17 2nd RF is not produced Replace hand piece 17 No Vacuum Replace hand piece ...

Страница 34: ...e cover from its place gently do not remove it all the way the grounding wire must be disconnected from the bottom part of the cover before it is removed all the way Front Cover assembling Lay down the system on its back side on soft material Attach the GND quick disconnect connection to its place on the front cover Align the fingers to the openings in the cabinet and insert the fingers into the o...

Страница 35: ...Invasix BodyTite Service Manual DO600463F 0344 Page 35 of 52 Figure 5 Front cover removal Figure 6 Front cover assembly 2 x Screws Fingers GND Connection ...

Страница 36: ...pen the 4 screws attaching the AC card to the cabinet Remove the card from the cabinet AC Card Assembling Position the AC filter card on the four standoffs Tighten the card with the four screws Insert the two connectors into the AC card From power inlet From On off switch Figure 7 AC Card removal Assembly 4 x Screws From Power entry Connectors AC Filter card Connector to On Off Switch ...

Страница 37: ...upply to the cabinet Remove the power supply from cabinet Power Supply Assembling Position the power supply on its standoffs and attach it to the frame using the four screws Insert the 20 pin Molex connector to the power supply Insert the AC power connector into the power supply Insert the GND quick disconnection to the GND terminal on the power supply located to the right of the AC power connecto...

Страница 38: ...w Remove the 3 connectors from the RF card Open the remaining three screws Remove the RF card from the RF shielding box RF Card Assembling Position the RF on its standoffs and attach it to the frame using the four screws Do not forget to attach the ring terminal coming from the RF control signals harness to the upper right screw Connect the three connectors back to the RF card Align the RF box cov...

Страница 39: ...anual DO600463F 0344 Page 39 of 52 Figure 9 RF card box cover Figure 10 RF card removal RF box cover 11 x Screws RF Card RF Card RF out Connector RF Card Ring Terminal RF Card Control Signals Connector RF Card DC power Connector ...

Страница 40: ...he fan Assy to the cabinet Remove the DC power connection wiring harness including the fan from the cabinet Fan Assembly Assembling Align the fan Assy to the four screws going out from the honey comb and push it all the way so it touches the honey comb Make sure the fan wings are facing the front of the system and the wires going out from the fan are facing the upper part of the RF shielding box T...

Страница 41: ...Service Manual DO600463F 0344 Page 41 of 52 Figure 11 DC power Fan Assy wiring harness DC power in to controller card connector DC power out to RF Controller Fan 4 x Nuts and washers DC Power connection Fan Assy wiring ...

Страница 42: ...ntroller card attached on the back side of the system Remove the five screws attaching the card to the cabinet Remove the card from the cabinet Controller Card Assembling Align the controller card to its standoffs Attach the card to the cabinet using the five screws Connect the connectors to the card Connect back the software plug at the back side of the system After replacing the Controller card ...

Страница 43: ...3 of 52 Figure 12 Controller card Assembly AC openning to On Off switch Gromet Key pad flat cabel openning Controller to H P I2 C not in use Controller to Key Pad harness Controller to LCD harness EH600567x Hand piece wiring opening TiteFX Comm and power ...

Страница 44: ...from the LCD adaptor Remove the connector bracket from the Top Assy by removing the 2 brackets holding it in place Pull up the Top Assy and let the two flat cables go through their opening Top Assy Assembling Position the top Assy to the top panel and tilt it so the connector bracket can be attached to it using the two holding brackets use four screws to attach it Connect the two flat cables to th...

Страница 45: ... 52 Figure 13 Top Assy Figure 14 Top Assy Connector bracket LCD Ferrite Cable Connection Key Pad Cable connection LCD Adaptor Connector Bracket 2 screws Connector Bracket 2 screws LCD Ferrite Cable Connection Key Pad Cable connection Screws holding top panel ...

Страница 46: ...rd Remove the tie wraps attaching the speaker harness to the cabinet Remove the four screws attaching the speaker to the cabinet right side wall Remove the speaker from the cabinet Speaker Assembling Align the speaker to its standoffs Attach the speaker to the cabinet using four screws Connect the speaker connector to the controller card Figure 15 Speaker Speaker Connection Speaker Controller ...

Страница 47: ...Invasix BodyTite Service Manual DO600463F 0344 Page 47 of 52 Figure 16 Speaker Speaker Screws x 4 Tie wraps ...

Страница 48: ... trigger to Channel A o Set trigger type to positive edge Normal o Set trigger level to 20V RF 75W upon RF card type Press and hold the footswitch Measure the Vrms level on the scope Press the scroll key to move to V1 rms Adjust the reading on the display as close as possible to the reading on the scope by using the up or down keys Calculate the I1 rms as follow I1 rms V rms 200 Press the scroll k...

Страница 49: ...low I2 rms V rms 200 Press the scroll key to move to I2 rms Adjust the reading on the display as close as possible to the calculated value on using the up or down keys Release the footswitch After the RF initial calibration is done and footswitch is released the screen will proceed to the RF calibration screen To start RF calibration press shortly on the footswitch and release The RF calibration i...

Страница 50: ...hat the Power display is in range of 15 of the Setup Power Change Setup Power to 40W energy and press the footswitch observe that the Power display is in range of 10 of the Setup Power Change Setup Power to 75W energy and press the footswitch observe that the Power display is in range of 10 of the Setup Power Press the OK key to finish the test a TEST COMPLETE screen appears Write down all paramet...

Страница 51: ...m Block Diagram Figure 17 BodyTite Block diagram LCD LCD Adaptor card Interface Card RF Card Power Supply AC Card Power Entry Fan Rework Speaker BodyTite Connection Key Switch FootSwitch Flash Memory BodyTite Block Diagram BodyTite Hand Piece TiteFx Connection Tite Fx Hand Piece ...

Страница 52: ...Invasix BodyTite Service Manual DO600463F 0344 Page 52 of 52 Section 12 System Wiring Figure 18 System wiring diagram ...

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