TRIVEX® System - LeMaitre Vascular, Inc
Contents
1. Light Source port two Footswitch cable connectors and a Resector Handpiece connector REAR PANEL Power ON OFF Rocker switch AC Power Detachable cord with a three pin hospital grade connector Power input circuit automatically detects AC power standard Fuses Two 6 3 amp 250 volt time delay fuses Littel Fuse Inc P N 021806 3HXP TRIVEX RESECTOR HANDPIECE REF 7210387 Handpiece with push button motor and window lock controls Length 11 Weight 8 5 oz Equipped with 10 foot 3 meter autoclavable replaceable resector handpiece cable TRIVEX SYSTEM FOOTSWITCH REF 7209791 Two supplied Dimensions 4 00 wide x 5 50 deep x 1 75 high Weight 7 5 07 ORDERING INFORMATION TRIVEX SYSTEM COMPONENTS REF DESCRIPTION 2141 VERSITIP ACMI Adaptor 7205180 Gemini Universal Light Guide 7209791 TRIVEX System Footswitch 7210351 TRIVEX System Illuminator 7210375 VERSITIP TRIVEX Adaptor 7210386 TRIVEX System Control Unit 7210387 TRIVEX System Resector Handpiece 7210414 TRIVEX System Cart 8005600 U S Power Cord 8013378 U K Power Cord 8013380 International Power Cord 1248 00 China Power Cord TRIVEX SYSTEM DISPOSABLES ACCESSORIES REF DESCRIPTION 7205683 Autoclavable Storage and Sterilization Tray 7209513 Illuminator Inflow Tubing 7209514 TRIVEX 4 5 mm Blade and Tubing 7209515 TRIVEX 5 5 mm Blade and Tubing 7210115 Replacement Lamp GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISS2. and washers from the handle using the 3 16 Allen wrench and then place the handle inside the Figure 2 Assemble Control Unit to Stand box section of the mast weldment Orient the handle so the threaded inserts align with the hole openings in the box section of the weldment Secure the handle with the two 1 4 20 x 5 8 socket head screws and washers 8 Fit the irrigation mast with handle onto the rear of the control unit and secure it with the four irrigation mast mounting bolts CAUTION Make sure the wheels on the TRIVEX System roller base are locked to prevent the system from rolling during setup and use TRIVEX SYSTEM CONTROL UNIT FRONT PANEL CONTROL UNIT FRONT PANEL 1 Tumescence Pump Door covers the tumescence pump hardware 2 Saline Pump Door covers the saline pump hardware 3 TRIVEX System Display contains the push buttons and displays for system operation FRONT PANEL CONNECTORS There are four connectors on the front panel 4 Fiber Optic Cable Connection Port self closing port designed to accept the TRIVEX Light Source Adaptor REF 7210375 CAUTION Use of any other light source port adaptor may cause reduced light emission from the fiber optic cable or damage internal components including the light source bulb 5 Two Footswitch Tubing Connection Ports accept tubing for the TRIVEX System footswitches 6 Resector Handpiece Cable Connection Port accepts the Resector Handpiece cable Figure
3. be wood concrete or ceramic tile and the relative kV air saWar humidity should be at least 30 IEC 61000 4 2 Electrical fast transient burst 2kV for power supply lines 2kV for power supply lines Mains power quality should be that of a typical commercial or IEC 61000 4 4 1kV for input output lines 1kV for input output lines hospital environment Surge 1kV differential mode 1kV differential mode Mains power quality should be that of a typical commercial or IEC 61000 4 5 oul eommonmade ov eommonmade hospital environment Voltage dips short interruptions and lt 95 dip in UT for 1 2 cycle lt 95 dip in UT for 1 2 cycle Mains power quality should be that of a typical commercial voltage variations on power supply 60 dip in UT for 5 cycles 60 dip in UT for 5 cycles or hospital environment If the user of the LeMaitre Vascular input lines TRIVEX System requires continued operation during power mains IEC 61000 4 11 30 dip in UT for 25 cycles 30 dip in UT for 25 cycles interruptions it is recommended that the LeMaitre Vascular gt 95 dip in UT for 5 sec gt 95 dip in UT for 5 sec TRIVEX System be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 The power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test le
4. has been removed Only personnel qualified to service electronic equipment should operate or troubleshoot an uncased power supply Dangerous voltages are present during leakage current testing DO NOT TOUCH the TRIVEX System while power is applied 4 HIGH VOLTAGE 1500 VAC is present during dielectric strength and Hi Pot testing Exercise extreme caution while operating the dielectric strength tester or the Hi Pot tester to prevent personal injury from electrical shock or damage to the equipment Ensure that only authorized personnel are in the test area during the tests To avoid fire hazard use only fuses of the correct type voltage rating and current rating The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system Consideration relating to the choice shall include e Use of the accessory in the patient vicinity e Evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 60601 Standard PRECAUTIONS U S Federal law restricts this device to sale by or on the order of a physician Prior to use examine the device s for possible damage to assure proper functioning H damaged do not use Verify that the resector handpiece and its cable are sterile Verify that the Illuminator Light Guide and adaptors are sterile Check to ensure that the resector s required for the pro
5. ro 7209513 Figure 6 Tubing Connections WARNINGS de 6 The Tumescence Pump should not be running while setting up the tubing Injuries to the operator s hands can occur Tube sets are provided STERILE and are for single use only Do not reuse Do not resterilize Prior to use inspect the product package for signs of damage or tampering Discard any opened and unused product Close the Tumescence Pump using the Tumescence Pump Handle Make sure the tubing forks do not pierce the tumescence solution tubing Connect the tubing to the Tumescence solution bag NOTE The Tumescence Solution tubing should only be connected to the TRIVEX System Illuminator 7 Close the Tumescence Pump Door RESECTOR HANDPIECE SALINE SUPPLY SETUP 1 2 3 d Hang the Saline solution bag from the right hand arm of the TRIVEX System irrigation mast Open the Saline Pump Door Move the Saline Pump Handle to the open position to allow loading of the tubing into the Saline Pump Insert the Saline solution tubing into the Saline Pump and snap the green tubing fittings into the corresponding green brackets Ensure that the tubing rests securely in the tubing forks CAUTION Use only TRIVEX System Resector Kit tube sets REF 72095 14 or 7209515 5 6 WARNING The Saline pump should not be running while setting up the tubing Injuries to the operator s hands can occur WARNING Tube sets are provided STERILE and are for single use only Do not r
6. the rear panel to the right of the three pronged electrical connector If the control unit fails to power up when properly connected to a 100 240 volt 10 AC power source check the fuses in the rear panel To replace the rear panel fuses WARNING To prevent electrical shock unplug the unit from the electrical outlet before attempting to replace the fuses Disconnect the unit from the power source Locate the fuse tray just to the right of the power cord Use a slotted screwdriver to press the tab on the side of the fuse holder in toward the center of the fuse tray Slide the fuse tray out Replace the fuses with 6 3 amp 250 volt time delay fuses A WARNING To avoid fire hazard use only fuses of the correct type voltage rating and current rating 6 Insert the tray into the holder until the tab click into place 7 Reapply power to the unit NOTE Blown fuses usually indicate a short circuit or a failed component Make sure components are properly interconnected If the problem persists contact LeMaitre Vascular Customer Service for troubleshooting assistance RETURNING THE TRIVEX SYSTEM CONTROL UNIT In the event of a System Error code or some other failure of the TRIVEX System Control Unit remove the unit from its stand and ship it back to LeMaitre Vascular in its original box 1 Unplug and remove the power cord from the TRIVEX System Control Unit 2 Remove the footswitch connectors fiber optic cable and adaptor resector hand
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8. 3 Control Unit Front Panel S LeMaitre UMA TRIVEX Too Figure 4 Control Unit Display CONSOLE CONTROLS AND FUNCTIONS Tumescence Pump ON OFF Button Turns the tumescence pump ON or OFF EN Tumescence Pump Flow LED Indicators Indicates the flow rate setting of the tumescence solution Tumescence Pump Flow Increase Decrease Buttons Increase or decrease the flow rate of the tumescence pump Each press of a button results in the flow rate increasing or decreasing by one level Lamp ON OFF Button Turns the lamp ON or OFF 11 Window Lock Control Holding down both Resector Speed Control increase decrease buttons simultaneously engages the Window Lock function Resector Speed Increase Decrease Buttons Increase or decrease resector speed by 100 rpm with each button press 13 Resector Speed Display rpm Displays the current speed of the resector incrementally in 100 rpm steps over a range of 100 rpm to 1500 rpm i Resector Mode Select Button The Resector Mode button is used to change the resector direction between Oscillate Forward and Reverse Resector Mode Indicators When the resector is in Oscillate mode a single arrow on each side of the Resector Mode Select button illuminates green lt gt When the resector is in Forward Mode both right side arrows illuminate green gt gt When the resector is in Reverse mode both left side arrows illuminate green lt lt Saline Pump Flow LED Indicators Indicates the flow rate setti
9. IONS Guidance and Manufacturer s Declaration Electromagnetic Emissions The LeMaitre Vascular TRIVEX System is intended for use in the electromagnetic environment specified below The customer or the user of the LeMaitre Vascular TRIVEX System should assure that it is used in such an environment Electromagnetic Environment Guidance RF emissions Group 1 The LeMaitre Vascular TRIVEX System uses RF energy only for its internal functions Therefore the CISPR 11 RF emissions are very low and are not likely to cause any interference in nearby electronic equip ment RF emissions Class A CISPR 11 The LeMaitre Vascular TRIVEX System is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies build ings used for domestic purposes e kee EE Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY Guidance and Manufacturer s Declaration Electromagnetic Immunity The LeMaitre Vascular TRIVEX System is intended for use in the electromagnetic environment specified below The customer or the user of the LeMaitre Vascular TRIVEX System should assure that it is used in such an environment IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic ESD Discharge 6kV contact 6kV contact Floors should
10. Kits can be used with the TRIVEX System Control Unit The resectors are intended for single use only Do not resterilize Do not lubricate resectors Discard the devices after use Make sure the wheels on the TRIVEX System roller base are locked to prevent the system from rolling during setup and use RESECTOR CONTROL There are two button controls on the Resector Handpiece Figure 8 Press and hold the Run button to start the resector The resector will run in the selected mode Forward Reverse or Oscillate until the button is released On startup the TRIVEX System will default to Oscillate mode The Resector Mode Select button indicator will glow green when a resector handpiece is connected For problem conditions with the Resector Handpiece the TRIVEX System will light the indicator bracketing the Resector Mode Select button There are three possible indicators a flashing orange light indicates a stalled motor or high current condition a steady orange light indicates the TRIVEX System cannot detect a Handpiece and a flashing green light indicates a problem with the Handpiece itself See TROUBLESHOOTING for additional information The Window Lock function determines the stop position of the inner resector relative to the Run Button i N A Window Lock Set Button Figure 8 Resector Handpiece Controls 11 opening in the outer resector Press and hold the Window Lock Set button to set the Window Lock The Window Lock wil
11. NIT 7210386 Dimensions 22 6 wide x 24 2 deep x 64 0 high Weight 80 lbs Power 100 120 200 240 VAC 50 60 Hz 350 VA Equipment Classification Protection against electrical shock class 1 with BF type applied part Protection against harmful ingress of water Ordinary equipment none provided Degree of safety of application in the presence of flammable anesthetics with mixture of air oxygen or nitrous oxide Not suitable FRONT PANEL Lamp ON OFF Button Turns the 50 Watt Metal Halide lamp On or Off and displays current lamp status Resector Speed Display 4 character digital display actual speed for installed resector Resector Mode Select Button Single momentary push button used to select the Resector Mode Resector Mode Display Two left facing arrows and two right facing arrows display resector mode Forward gt gt Reverse lt lt and Oscillate lt gt Resector Speed Buttons Two momentary push buttons for increasing and decreasing speed settings Resector Window Lock Display Pressing and holding both the Resector Speed Buttons at the same time sets the Resector Window Lock Tumescence Pump Flow Buttons Two momentary push buttons for increasing or decreasing Tumescence pump flow Saline Pump Flow Buttons Two momentary push buttons for increasing or decreasing Saline pump flow Pump ON OFF Buttons Two momentary push buttons for starting or stopping the Saline pump or the Tumescence pump Connectors
12. acturer s Declaration Electromagnetic Emissions 17 Guidance and Manufacturer s Declaration Electromagnetic Immunity 17 Guidance For Separation Distances 18 Warranties 19 Replacement Program 20 Repair Service Program 20 Symbol Legend 23 Figures 1 Component Identification 6 2 Assemble Control Unit To Cart 7 3 Control Unit Front Panel 7 4 Control Unit Display 8 5 Control Unit Rear Panel 9 6 Tubing Connections 10 7 Fiber Optic Cable Inspection 11 8 Resector Handpiece Controls 11 9 Fully Opened Resector Handpiece Suction Lever 12 10 Fully Closed Resector Handpiece Suction Lever 12 11 Lamp 14 DEVICE DESCRIPTION The TRIVEX System uses a metal halide arc lamp to provide intense white light via the TRIVEX System Illuminator for transillumination The illuminator connects with fiber optic cables to the TRIVEX System to provide transillumination during endoscopic resection of superficial varicosities of the lower extremities The TRIVEX System uses a pair of peristaltic pumps to provide irrigation and tumescence anesthesia for the Transilluminated Powered Phlebectomy procedure The left hand pump is dedicated to providing the tumescence anesthesia via the TRIVEX System Illuminator The right hand pump is dedicated to providing saline to the TRIVEX Resector Handpiece for resector tip irrigation INDICATIONS FOR USE The TRIVEX System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose v
13. ay LeMaitre VASCULAR TRIVEX System Operation Service Manual English TABLE OF CONTENTS PREFACE This manual contains information you need to operate and maintain the LeMaitre Vascular TRIVEX System It is essential that you read and understand all the information in this manual before using or maintaining the system TABLE OF CONTENTS Device Description Indications for Use Contraindications Warnings Precautions System Components Resector Handpiece Illuminator Unpacking the Components Assembling the Control Unit to Cart Assebling the Handle to Mast Control Unit Front Panel Console Controls and Functions Power Switch Fuse Panel Preoperative Setup Power Up Tumescence Supply Setup Resector Handpiece Saline Supply Setup Connecting the Resector Handpiece and Resector Connecting the Illuminator Operation Resector Control Resector Handpiece Suction Control Resector Handpiece Irrigation Control Resector Speed Cutting Window Lock Illuminator Irrigation Illuminator Control Cleaning And Sterilization Maintenance Electrical Interference Environmental Protection Preventative Maintenance Replacing The Lamp Fuses Oo OO CON NY sl sl DD DD Li HP A A A sch do do do do do do do do do do do do do do do do NO Mm Li Ps B HB Pp Ww Ww Ww W NJ NJ NJ KN gt gt gt O O O Service 14 Returning the Control Unit 15 Troubleshooting 15 Technical Specifications 16 Ordering Information 17 Guidance and Manuf
14. ay delivery For a Return Goods Authorization RGA number or for additional information on this program call Customer Service at 1 800 628 9470 in the U S or contact your LeMaitre Vascular representative Next day delivery is not offered in all countries REPAIR SERVICE PROGRAM For devices no longer under warranty repairs can be made by LeMaitre Vascular Non warranty repairs will be made at the list price of replacement parts plus labor We will provide an estimate of repair cost and time required for the repair before any work is completed Repair items should be carefully repackaged marked with the Return Goods Authorization RGA number and returned postpaid to the address provided by LeMaitre Vascular LeMaitre Vascular Customer Service or your local representative can provide shipping information 21 22 9A1Je u9sa1day ueadouny dn dem si 918 YIM a pueH 13116814 12045 311199 3 ed parjddy 49 add jo Jabueq uoleiped Juan JOVLIOA NOLLWIHISSYD gt Heubeuorpale Yims Lys aysem Je19u96 uonesyisse IN asn4 JaquunN 21195 Jogun Dateie bunewayy SNOYI NYA INJWdINOI BuIZIUOI UON 216601 40 216601 up VEER 10 J0N SN X207 MOPUIM 9432 ISO 2519194 SY DIE 41410410 1 DIE gt lt lt gt gt gt 101110 10 110 uepIsAyd e jo Japso ayy UO 10 q piemuo YouMs 004 aaldpuey dwey Deg pn LOH DNINYYM suen umog pue dp 104340 paads Pajas apow ysnd Up up ajesor a2 Aap SIY 519141591 ME 19410 pue e19pay H
15. cedure are available Verify that the Preoperative Setup has been successfully completed Only LeMaitre Vascular Disposable TRIVEX Resector Kits can be used with the TRIVEX System Resectors used with the TRIVEX System are for single use only Do not resterilize or lubricate the resectors Dispose of the resectors after use Use of reprocessed single use resectors may permanently damage impede performance or cause failure of your LeMaitre Vascular TRIVEX System Use of such products may render any warranties null and void Make sure the wheels on the TRIVEX System roller base are locked to prevent the system from rolling during setup and use As in conventional ambulatory phlebectomy procedures bruising hematoma and hemosiderin deposits have been observed in clinical studies utilizing the TRIVEX System Disconnect power cord before cleaning the unit Do not sterilize or immerse the TRIVEX System console in disinfectant To prevent moisture from entering the handpiece cable during sterilization ensure that the protective cap is screwed on completely Moisture can damage the cable or handpiece connectors Do not allow the rotating portion of any resector to touch any metallic object such as the illuminator Damage to both instruments is likely Damage to the resector can range from a slight distortion or dulling of the resector edge to actual fracture of the tip in vivo If such contact does occur inspect the tip If you find cracks fractures or
16. ck of the control unit Incorrect voltage can cause errors or malfunction and may permanently harm the equipment Handle the unit with care If the unit is dropped or damaged in any way it must be returned immediately for service Electrical safety testing should be performed by a biomedical engineer or other qualified person This equipment contains electronic printed circuit assemblies At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional related policy relating to obsolete electronic equipment This equipment is designed and tested to minimize interference with other electrical equipment However if interference occurs with other equipment it may be corrected by one or more of the following measures e Reorient or relocate this equipment the other equipment or both e Increase the separation between the pieces of equipment e Connect the pieces of equipment into different outlets or circuits Consult a biomedical engineer Equipment should be disposed of in accordance with local and or federal codes and requirements SYSTEM COMPONENTS The TRIVEX System consists of a variety of components The TRIVEX System control unit provides controls for the mode and speed of the TRIVEX Resector for activation and flow of the tumescence and saline pumps and for operation of the light source for the TRIVEX System Illuminator The console includes a display for resector s
17. dulling or if you have any other reason to suspect a resector is damaged replace it immediately Excessive leverage on the resector does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly Do not cool the resector handpiece by immersing it in cold water Do not operate the resector in the open air for an extended period Use only the TRIVEX Light Source Adaptor REF 7210375 with this system Use of any other light source port adaptor may cause reduced light emission from the fiber optic cable The power switch must be turned off and the power cord disconnected from the power source before attempting to replace the lamp Replace the lamp only with an appropriate LeMaitre Vascular lamp REF 7210115 as specified for the TRIVEX System Use of any other lamp will void the warranty Lamp may be very hot Use protective eyewear and gloves when handling lamp Do not leave the operating light cord without an Illuminator attached on the patient or surrounding materials The light cord tip may reach a high temperature due to the high intensity light This unit complies with IEC 60601 1 2 However the user must be aware that this does not necessarily ensure protection of the unit against interference from other devices Do not operate at line voltage other than those stipulated on the back of the unit Ensure that the available mains voltage matches the data listed on the label attached to the ba
18. e frequency of the transmitter where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people HARDWARE CONTROL UNIT AND MDU NEW If you purchased a new device then the following warranty applies Limited Product Warranty Limitation of Remedies LeMaitre Vascular Inc warrants that reasonable care has been used in the manufacture of this device Except as explicitly provided herein LEMAITRE VASCULAR AS USED IN THIS SECTION SUCH TERM INCLUDES LEMAITRE VASCULAR INC ITS AFFILIATES AND THEIR RESPECTIVE EMPLOYEES OFFICERS DIRECTORS MANAGERS AND AGENTS MAKES NO EXPRESS OR IMPLIED WARRANTIES WITH RESPECT TO THIS DEVICE WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND HEREBY DISCLAIMS THE SAME LeMaitre Vascular makes no representation regarding the suitability for any particular treatment in which this device is used which determination is the sole responsibility of the purchaser This warranty applies to the original buyer of this device only This limited warranty does not apply to the extent of any abuse or misuse of
19. e of the tip in vivo If such contact does occur inspect the tip If you find cracks fractures or dulling or if you have any other reason to suspect a resector is damaged replace it immediately CAUTION Excessive leverage on the resector does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly CUTTING Cutting takes place when the resector edge of the inner tube rotates across the resector s outer window The resector action alternately opens and closes the window to modulate the suction flow WINDOW LOCK With the Window Lock feature the resector handpiece can be set to stop the resector in a specific position The window can be fully opened or closed or somewhere in between depending on the technique requirement Pressing the Window Lock button on the resector handpiece or pressing the increase and decrease buttons on the console simultaneously will engage the Window Lock function CAUTION Do not operate the resector in the open air for an extended period as the lack of irrigation may cause the resector to overheat and seize TRIVEX SYSTEM ILLUMINATOR IRRIGATION Turn the Tumescence Pump on using the Tumescence Pump ON OFF Button The TRIVEX System defaults to a Tumescence Pump Flow setting level of four on Startup approximately 450 ml min The Tumescence Pump Flow can be increased or decreased by pressing the Flow Increase or Flow Decrease buttons located above and below the Tum
20. e resector action to verify that it is properly installed Set the window lock position as described in the Operation section of this manual 10 NOTE The default directional mode setting for the resector handpiece is Oscillate 7 Use the Resector Mode Select Button on the console to verify Forward and Reverse modes NOTE If the Resector Mode Select Button is flashing green or orange there is a problem with the resector handpiece See the Troubleshooting section 8 Connect the saline supply line from the Saline Pump to the inflow portal on the TRIVEX System resector 9 Connect the suction by sliding the suction tubing onto the outflow portal on the proximal end of the resector handpiece NOTE It is recommended that suction of 600 mm Hg be used for optimal resection performance CONNECTING THE ILLUMINATOR WARNING Do not hold the shutter open without a fiber optic cable in place Failure to observe this precaution may result in eye injury 1 Check the fiber optic cable for damage Cuts abrasions or tears in the silicone sheath covering the fiber optic cable will reduce overall light transmission 2 While aiming one end of the cable toward a bright light inspect the other end for damaged fibers e g black dots or dark areas Figure 7 Excessive numbers of broken fibers in the cable will result in reduced light transmission 3 Connect the TRIVEX System Illuminator to the instrument end of the fiber optic cable using the ACMI in
21. eins CONTRAINDICATIONS Use of the TRIVEX System is contraindicated in situations where ambulatory phlebectomy is contraindicated WARNINGS Please read this manual before using the TRIVEX System The brief operating instructions in this guide will make the system easier to use while the recommended service and maintenance procedures will ensure optimal performance and reliable use As with any surgical instrument there are important health and safety considerations These are listed below and reiterated within the text Prior to using the TRIVEX System it is essential that all components of the system be inspected for damage that can negatively impact the equipment performance The inspection should include all equipment to be used in surgery including the illuminator cables and accessories When removing the TRIVEX System and accessories from the shipping container inspect contents to ensure that all components from the Unpacking the Components section are available Contact your LeMaitre Vascular Representative if damage is noted Before using the TRIVEX System for the first time you should review all available product information Surgeons should become familiar with this surgical technique and the TRIVEX System You should be experienced in ambulatory phlebectomy surgery using powered instruments Healthy tissue can be injured by improper use of the TRIVEX System resector Use every available means to avoid such injury TRIVEX Re
22. escence Pump Flow Display The Tumescence Pump has five Flow settings The approximate flow rates for the pump fall between 300 ml per minute and 500 ml per minute NOTE The Tumescence Pump ON OFF Button glows orange when the pump is off and glows green when the pump is on Press and hold either footswitch to start the Tumescence Pump Release the footswitch to stop the pump NOTE The TRIVEX System starts up with the Tumescence pump OFF The Tumescence Pump must be started using the Tumescence Pump ON OFF button before the footswitches will work TRIVEX SYSTEM ILLUMINATOR CONTROL Turn the illuminator lamp on using the Lamp ON OFF Button When the TRIVEX System lamp is first turned on the button will flash green for 10 seconds while the system does a lamp check When the lamp is off the Button glows orange Each time the lamp is turned off it will enter a 30 second cool down cycle This 30 second cycle is in addition to the 10 second lamp check cycle As a result the lamp button can flash green for up to 40 seconds before switching to a steady green glow In the event that the lamp does not light after the self check cycles the lamp button will flash orange CLEANING AND STERILIZATION RESECTOR HANDPIECE Follow these steps after each procedure to sterilize the resector handpiece 1 Dispose of the resector and tube set used during the procedure following standard protocols for disposal of biohazardous waste CAUTION Resectors and tube sets
23. euse Do not resterilize Prior to use inspect the product package for signs of damage or tampering Discard any opened and unused product Close the Saline Pump using the Saline Pump Handle Make sure the tubing forks do not pierce the saline solution tubing Connect the tubing to the Saline solution bag NOTE The Saline Solution tubing should only be connected to the Resector Handpiece 1 Close the Saline Pump Door CONNECTING THE RESECTOR HANDPIECE AND RESECTOR CAUTION Make sure the wheels on the TRIVEX System roller base are locked to prevent the system from rolling during setup and use 1 2 Unscrew the protective cap from the connector end of the resector handpiece cable Connect the resector handpiece cable to the connection port on the front panel as follows Orient the handpiece cable connector by aligning the white double arrows on the connector with the white dot on the connection port The handpiece cable is fully engaged when the white arrows and the white dot are almost touching Make certain the handpiece cable is fully inserted into the connection port Press and hold the Run button on the resector handpiece to confirm operation The resector handpiece motor action can be observed by looking inside the distal end of the resector handpiece Remove the resector from the sterile package and insert the resector into the resector handpiece per the TRIVEX Resector Instructions for Use R2590 Press the Run button and observe th
24. formed only by LeMaitre Vascular service centers If service becomes necessary contact LeMaitre Vascular Customer Service prior to returning the device to request a Return Goods Authorization RGA number Items to be serviced should be carefully repackaged and returned LeMaitre Vascular Daily rentals are available as needed A replacement program is available contact your LeMaitre Vascular representative for details NOTE Product returned that is found to have been serviced by an unauthorized third party repair facility and or sterilized with a sterilization method other than one approved by LeMaitre Vascular will incur additional costs regardless of warranty status It is not necessary to include accessory items i e power cords etc when returning a device for service REPLACING THE LAMP 1 Pull knob on Lamp assembly drawer down and pull drawer out 2 Disconnect Lamp 3 Using provided screwdriver remove circuit boards as necessary and unlatch lamp 4 Replace Lamp 5 Latch brackets connect lamp and reinstall circuit boards as necessary CAUTION Replace the lamp only with an appropriate LeMaitre Vascular Replacement Lamp REF 7210115 as specified for the TRIVEX System Use of any other lamp will void the warranty CAUTION Lamp may be very hot Use protective eyewear gloves when handling the lamp Figure 11 Lamp TRIVEX SYSTEM FUSES The control unit is protected by dual 6 3 amp 250 volt time delay fuses mounted on
25. l rotate while the button is pressed Release the button when the Window Lock has reached the desired position NOTE The Resector Window Lock can also be set from the TRIVEX System control console unit console by pressing and holding the Resector Speed Increase and Decrease buttons simultaneously RESECTOR HANDPIECE SUCTION CONTROL The TRIVEX System uses standard hospital suction For optimal resection a suction pressure of 600 mm Hg is recommended Suction is connected to a portal on the proximal end of the resector handpiece and removes fluid and debris drawn through the resector window In addition to removing fluids the suction fluid cools and lubricates the motor drive A lever on the proximal end of the resector handpiece provides suction flow control The lever can be adjusted from fully opened to fully closed to provide immediate manual control of the suction rate 1 When lever is aligned with arrow indicator figure 9 the suction flow rate is maximized 2 When the lever is perpendicular to the arrow indicator figure 10 the suction flow rate is shut off Figure 9 Fully Opened Resector Handpiece Figure 10 Fully Closed Resector Handpiece Suction Lever Suction Lever RESECTOR HANDPIECE IRRIGATION CONTROL Turn the Saline Pump on using the Saline Pump ON OFF Button The TRIVEX System defaults to a Saline Pump Flow setting level of one on startup This is approximately 50 ml min The Saline Pump will only run while the Resector Hand
26. l unit 1 Disconnect the TRIVEX System from the electrical source 2 Wipe the console with a clean damp cloth and mild germicide or isopropyl alcohol CAUTION Do not sterilize or immerse the TRIVEX System console in disinfectant Wipe the footswitches and footswitch cables with a clean damp cloth The footswitches REF 7209791 are watertight per IPX8 FIBER OPTIC CABLE See the Fiber Optic Cable Instructions for Use R2603 for proper cleaning and sterilization procedures TRIVEX SYSTEM ILLUMINATOR See the TRIVEX System Illuminator Instructions for Use R2596 for proper cleaning and sterilization procedures MAINTENANCE ELECTRICAL INTERFERENCE CAUTION This equipment is designed and tested to minimize interference with other electrical equipment However if interference occurs with other equipment it may be corrected by one or more of the following measures Reorient or relocate this equipment the other equipment or both Increase the separation between the pieces of equipment Connect the pieces of equipment into different outlets or circuits Consult a biomedical engineer ENVIRONMENTAL PROTECTION CAUTION This equipment contains electronic printed circuit assemblies At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional related policy relating to obsolete electronic equipment PREVENTATIVE MAINTENANCE Recommended Electrical Safety Checks Three safety tes
27. lled Remove and inspect the resector Replace with a new resector if orange while handpiece Run button is held damaged down Run the handpiece without a resector If the handpiece is still Stalled use alternate handpiece and contact your LeMaitre Vascular representative Resector Mode Select button indicator light High current warning for resector handpiece Contact your LeMaitre Vascular representative is flashing orange after handpiece Run button is released Resector Handpiece will not run and Bad handpiece connector cable Check cable connections Make certain the handpiece cable is fully Resector Mode Select button indicator light inserted into the port on the front panel is green Resector Mode Select button indicator light Resector Handpiece not connected Connect a resector handpiece to the is steady orange TRIVEX System Resector Speed Display reads E 01 through System Error Note the error code and contact your Sak LeMaitre Vascular representative Tubing appears to be creeping through the Tubing forks not tight enough Tighten the tubing forks by one notch until tubing is secure or pump contact your LeMaitre Vascular representative for specific adjustment instructions No fluid flow from peristaltic pump Pump head is not latched Check black pump closing lever to be sure it is fully closed Pump rollers have seized Call Customer Service for return authorization TECHNICAL SPECIFICATIONS TRIVEX SYSTEM CONTROL U
28. ng of the Saline solution 17 Saline Pump Flow Increase Decrease Buttons Increase or decrease the flow rate of the Saline pump Each press of a button results in the flow rate increasing or decreasing by one level Saline Pump ON OFF Button Turns the Saline pump ON or OFF Status Indicators These indicators are located above and below the control buttons for the Tumescence Pump Lamp Resector Mode and Saline Pump They indicate the components status by illuminating steady green flashing green steady orange or flashing orange TA i PE L o 0 E E D u hd Wi e e D lo L E AAA EE Li 0 amp Figure 5 Control Unit Rear Panel POWER SWITCH The green rocker switch on the right side is the power ON OFF switch for the entire system O The switch is illuminated when the system is ON The three prong electrical connector allows connection of the system to any 100 to 240 volt AC 50 60 Hz source using the power cord supplied with the system The system power supply automatically detects the local power standard and adapts the system to that standard FUSE PANEL The control unit is protected by dual 6 3 amp 250 volt time delay fuses mounted on the rear panel to the right of the green power switch 2 NOTE If system is turned off for any reason wait at least 15 seconds before turning power back on PREOPERATIVE SETUP FOR USE IN A SURGICAL PROCEDURE A WARNING Work e
29. ng procedure avoid prolonged contact of the Illuminator tip to patient tissue or flammable materials The Illuminator tip may reach high temperatures due to high intensity light transmission DANGER Risk of explosion if used in the presence of flammable anesthetics When the light source is turned on do not look directly at the metal halide arc lamp without protective goggles To prevent electrical shock do not remove the TRIVEX System console cover There are no user serviceable components inside Dismantling the equipment will void the warranty Refer servicing to LeMaitre Vascular To prevent electrical shock connect the power cord to a properly wired grounding receptacle only To prevent electrical shock unplug the unit from the electrical outlet before attempting to replace the fuses Use extreme caution The high internal pressure of the lamp may cause an explosion regardless of whether the lamp is cold or hot Always wear protective clothing and a face mask when handling the lamp Hazardous high voltage and energy are present at the output and in the internal circuitry of this unit If this unit is configured as part of a system the entire system should be tested for compliance with IEC 60601 1 If the leakage current of the configured system exceeds the limits of IEC 60601 1 install an appropriately rated UL 60601 1 IEC 60601 1 approved isolation transformer and retest the system In some cases high voltage may persist after the power
30. nt Identification O OOOO Fluid Bag Holder Hooks x2 7 Saline Solution Bag Tumescence Solution Bag 9 Irrigation Mast D Control Unit Control Unit Display Connection Ports TRIVEX System Stand TRIVEX System Illuminator TRIVEX System Resector Handpiece Footswitch x2 UNPACKING THE COMPONENTS Carefully unpack and inspect all components shipped with your LeMaitre Vascular TRIVEX System If any parts are missing or damaged contact your LeMaitre Vascular representative Save the carton and packing materials in the event a component must be returned for repair ASSEMBLE CONTROL UNIT TO STAND 1 Place the stand with roller base on a smooth level surface with the rear panel facing you 2 Remove the 3 16 Allen wrench from the base of the irrigation mast Using the Allen wrench remove the four bolts securing the rear panel to the roller base 3 Align the base of the control unit with the top of the roller base and lower the control unit straight down onto the roller base figure 2 4 For each of the four drawer latches located in the interior of the roller base lift and engage the latch then turn the latch key one half turn clockwise Fold the latch key flat 5 Replace the rear panel and reinsert the four bolts ASSEMBLE HANDLE TO MAST 6 Remove the four irrigation mast mounting bolts from the rear of the control unit 7 Assemble the handle to the mast by removing the two 1 4 20 x 5 8 socket head screws
31. or failure to properly store this device by the purchaser or any third party Damage inflicted on this device by the user that renders it unsuitable for refurbishment may result in additional charges regardless of warranty status The sole remedy for a breach of this limited warranty shall be repair or replacement of this device at LeMaitre Vascular s sole option following the purchaser s return of the device to LeMaitre Vascular This warranty shall terminate on the date that is twelve months from the date of invoice for such device IN NO EVENT SHALL LEMAITRE VASCULAR BE LIABLE FOR ANY DIRECT INDIRECT CONSEQUENTIAL SPECIAL PUNITIVE OR EXEMPLARY DAMAGES IN NO EVENT WILL THE AGGREGATE LIABILITY OF LEMAITRE VASCULAR WITH RESPECT TO THIS DEVICE HOWEVER ARISING UNDER ANY THEORY OF LIABILITY WHETHER IN CONTRACT TORT STRICT LIABILITY OR OTHERWISE EXCEED ONE THOUSAND DOLLARS US 1 000 REGARDLESS OF WHETHER LEMAITRE VASCULAR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS AND NOTWITHSTANDING THE FAILURE OF THE ESSENTIAL PURPOSE OF ANY REMEDY THESE LIMITATIONS APPLY TO ANY THIRD PARTY CLAIMS A revision or issue date for these instructions is included on the back page of these Instructions for Use for the user s information If twenty four 24 months has elapsed between this date and product use the user should contact LeMaitre Vascular to see if additional product information is available HARDWARE REFURBISHED If you purchased a refu
32. p ON OFF button is lit steady orange Resector Mode is set to Oscillate lt gt The Resector Mode button will be lit steady orange if no Resector Handpiece is connected The button will be lit steady green if a Resector Handpiece is connected Resector Speed is set to 500 rpm Lamp is OFF Lamp ON OFF button is lit steady orange NOTE If the Resector Mode Select Button is flashing green or orange see TROUBLESHOOTING NOTE If the Lamp ON OFF Button is flashing orange see TROUBLESHOOTING TUMESCENCE SUPPLY SETUP 1 NOTE Fluid bags must only be hung on the bag holder hooks Hang only one WARNINGS This system is intended only for use with flexible fluid containers and fluid bags Glass containers or bottles may break and there is a risk of implosion Use of bags or containers not approved for this system or large and or lopsided loads may cause the device to tip over Hang the tumescence solution bag from the left hand arm of the TRIVEX System irrigation mast bag per hook Maximum allowable volume is 3 liters Open the Tumescence Pump Door Move the Tumescence Pump Handle to the open position to allow loading of the tubing into the Tumescence Pump Insert the tumescence solution tubing into the Tumescence Pump and snap the yellow tubing fittings into the corresponding yellow brackets Ensure that the tubing rests securely in the tubing forks d CAUTION Use only the TRIVEX System Illuminator Inflow Tube Set REF
33. peed and LED indicators for pump flow rate The four control buttons tumescence pump lamp resector mode and saline pump have lighted indicators above and below each push button These indicate the status of each component by illuminating steady green flashing green steady orange or flashing orange The front of the control unit has ports for connecting the illuminator two footswitches and resector handpiece The TRIVEX System stand provides a mobile base for the TRIVEX System control unit and an irrigation mast for the saline and tumescence solution irrigation bags The 50 watt metal halide arc lamp provides intense white light via the TRIVEX System Illuminator The TRIVEX Resector Handpiece drives the LeMaitre Vascular 4 5 mm TRIVEX Resector REF 7209514 and 5 5 mm TRIVEX Resector REF 7209515 and features push button controls for resector operation RESECTOR HANDPIECE The TRIVEX Resector Handpiece is a hand held motor drive that is electrically connected to the control unit via a 10 foot 3 meter cable The resector handpiece drives the disposable resectors The resector handpiece and its cable are autoclavable see CLEANING AND STERILIZATION TRIVEX SYSTEM ILLUMINATOR The TRIVEX System Illuminator REF 7210351 and is used to instill tumescence solution and to transilluminate the targeted varicosities Please see the TRIVEX System Illuminator Instructions for Use R2596 for additional information Figure 1 Compone
34. piece Run button is held down The Saline Pump Flow can be increased or decreased by pressing the Flow Increase or Flow Decrease buttons located above and below the Saline Pump Flow Display The Saline Pump has five Flow settings The approximate flow rates for the pump fall between 50 ml per minute and 175 ml per minute NOTE The Saline Pump ON OFF Button glows orange when the pump is off and glows green when the pump is on NOTE While operating the Resector Handpiece be sure that the saline pump is turned ON RESECTOR SPEED The resector speed display indicates the current speed of the resector in rpm When the TRIVEX System is turned on the system is set to a default resector speed of 500 rpm Use the increase and decrease push buttons below the console display to set the actual speed of the resector Pressing the increase and decrease buttons simultaneously will enable the Window Lock function Each press of a button will increase or decrease the speed of the resector by 100 rpm The Resector speed can be set to any 100 rpm increment between 100 rpm and 1500 rpm The Forward gt gt and Reverse lt lt arrows that bracket the Resector Mode Select button indicate the resector direction CAUTION Do not allow the rotating portion of the resector to touch any metallic object such as the illuminator Damage to both instruments is likely Damage to the resector can range from a slight distortion or dulling of the resector edge to actual fractur
35. piece cable and all tube sets 3 Using the 3 16 Allen wrench located at the base of the irrigation mast remove the four mounting bolts and detach the irrigation mast 4 Using the 3 16 Allen wrench remove the four bolts securing the rear panel to the roller base Remove the rear panel 5 Locate the four drawer latches on the upper interior of the roller base For each of the four drawer latches Lift the latch key and turn it one half turn counterclockwise Then lift and disengage the keeper 6 Lift the TRIVEX Control Unit straight up from the roller base 7 Repack the TRIVEX Control Unit in its original carton and ship back per instructions provided by LeMaitre Vascular TROUBLESHOOTING SERVICE INDICATIONS During system operation the TRIVEX System runs a concurrent diagnostic routine in the background checking inputs from the attached components When the system detects a condition that requires attention an orange or green indicator light is lit on the front panel In many cases the system will continue to operate normally but occasionally allowable resector speed will be reduced If the procedures below do not resolve the problem the unit should be referred to qualified personnel for service Possible Cause The TRIVEX System fails to come on when The unit is not connected to power Plug into a power outlet of suitable rating Ensure that both ends of the power switch is pressed power cord are properly connected Lamp assembl
36. rbished device then the following warranty applies Limited Product Warranty Limitation of Remedies LeMaitre Vascular Inc warrants that reasonable care has been used in the manufacture of this device Except as explicitly provided herein LEMAITRE VASCULAR AS USED IN THIS SECTION SUCH TERM INCLUDES LEMAITRE VASCULAR INC ITS AFFILIATES AND THEIR RESPECTIVE EMPLOYEES OFFICERS DIRECTORS MANAGERS AND AGENTS MAKES NO EXPRESS OR IMPLIED WARRANTIES WITH RESPECT TO THIS DEVICE WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND HEREBY DISCLAIMS THE SAME LeMaitre Vascular makes no representation regarding the suitability for 19 any particular treatment in which this device is used which determination is the sole responsibility of the purchaser This warranty applies to the original buyer of this refurbished device only This limited warranty does not apply to the extent of any abuse or misuse of or failure to properly store this device by the purchaser or any third party Damage inflicted on this device by the user that renders it unsuitable for refurbishment may result in additional charges regardless of warranty status The sole remedy for a breach of this limited warranty shall be repair or replacement of this device at LeMaitre Vascular s sole option following the purchaser s return of the device to LeMaitre Vascular This warranty
37. sector Kits are packaged as a set They must be used as supplied Do not interchange resector components Illuminator inflow tube sets and resector kits are provided STERILE and are for single use only Do not reuse Do not resterilize Prior to use inspect the product package for signs of damage or tampering Discard any opened and unused product Do not use after the expiration date Resterilization and or re use of the Illuminator Tube Sets or Resector Kits may cause mechanical damage to these products This may result in injury to the patient or user The TRIVEX System pumps should not be running while setting up the tubing Injuries to the operator s hands can occur Work exclusively with sterile substances sterile fluids and sterile accessories This system is intended only for use with flexible fluid containers and fluid bags Glass containers or bottles may break and there is a risk of implosion Use of bags or containers not approved for this system or large and or lopsided loads may cause the device to tip over If visualization is lost during any point in the procedure stop resetting immediately Excessive pressure of the TRIVEX resector against the vessel or prolonged activation of the TRIVEX resector in a stationary position may result in perforation of the resector through the limb surface Do not hold the light source shutter open without a fiber optic cable in place Failure to observe this precaution may result in eye injury Duri
38. shall terminate on the date that is three months from the date of invoice for such device IN NO EVENT SHALL LEMAITRE VASCULAR BE LIABLE FOR ANY DIRECT INDIRECT CONSEQUENTIAL SPECIAL PUNITIVE OR EXEMPLARY DAMAGES IN NO EVENT WILL THE AGGREGATE LIABILITY OF LEMAITRE VASCULAR WITH RESPECT TO THIS DEVICE HOWEVER ARISING UNDER ANY THEORY OF LIABILITY WHETHER IN CONTRACT TORT STRICT LIABILITY OR OTHERWISE EXCEED ONE THOUSAND DOLLARS US 1 000 REGARDLESS OF WHETHER LEMAITRE VASCULAR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS AND NOTWITHSTANDING THE FAILURE OF THE ESSENTIAL PURPOSE OF ANY REMEDY THESE LIMITATIONS APPLY TO ANY THIRD PARTY CLAIMS A revision or issue date for these instructions is included on the back page of these Instructions for Use for the user s information If twenty four 24 months has elapsed between this date and product use the user should contact LeMaitre Vascular to see if additional product information is available SERVICE REPLACEMENT UNITS WARRANTY The TRIVEX System replacement units are warranted to be free from defects in material and workmanship for 90 days from the date of original invoice unless otherwise provided by local law REPLACEMENT PROGRAM LeMaitre Vascular offers a Replacement Program for TRIVEX System Control Units to minimize downtime in your operating room With an active Replacement Agreement in place a replacement TRIVEX System Control Unit will be shipped within 48 hours via next d
39. strument end adaptor REF 2141 included with the TRIVEX System 4 Attach the TRIVEX Light Source adaptor REF 7210375 to the system end of the fiber optic cable Press the shutter button and insert the light source end of the fiber optic cable into the light source port To remove the cable press the shutter button and then withdraw the cable CAUTION Use only the TRIVEX Light Source adaptor REF 7210375 with this system Use of any other light source port adaptor may cause reduced light emission from the fiber optic cable and may cause damage to the system light bulb 5 Connect the Tumescence inflow tubing to the Illuminator 6 Connect the Tumescence Pump Footswitches to the Footswitch connectors NOTE The TRIVEX System starts up with the Tumescence pump OFF The Tumescence Pump must be turned on using the Tumescence Pump ON OFF button before the footswitches will work Figure 7 Fiber Optic Cable Inspection WARNING Possible explosion hazard if used in the presence of flammable anesthetics OPERATION CAUTIONS e Before using the TRIVEX System for the first time you should review all available product information Verify that the resector handpiece and its cable are sterile Verify that the illuminator and the light guide cable are sterile Check to ensure that the resector s required for the procedure are available Verify that the Preoperative Setup has been successfully completed Only LeMaitre Vascular Disposable TRIVEX Resector
40. tromagnetic site survey should be considered If the measured field strength in the location in which the LeMaitre Vascular TRIVEX System is used exceeds the applicable RF compliance level above the LeMaitre Vascular TRIVEX System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the LeMaitre Vascular TRIVEX System gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m GUIDANCE FOR SEPARATION DISTANCES Recommended separation distances between portable and mobile RF communications equipment and the LeMaitre Vascular TRIVEX System The LeMaitre Vascular TRIVEX System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the LeMaitre Vascular TRIVEX System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the LeMaitre Vascular TRIVEX System as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter M bide alae edad MECC T 80 MHz to 800 MHz 800 MHz to 2 5 GHz Transmitter W For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to th
41. ts are conducted on each unit during factory acceptance testing Dielectric Strength Test Ground Continuity Test Leakage Current Test LeMaitre Vascular recommends that these tests be performed regularly to assure continued compliance with applicable safety requirements These tests should be conducted in accordance with specifications IEC 60601 1 CAUTION Electrical safety testing should be performed by a biomedical engineer or other qualified person WARNING HIGH VOLTAGE is present during electrical safety testing Exercise extreme caution to prevent personal injury from electrical shock or damage to the equipment Ensure that only authorized personnel are in the test area during the tests Recommended Periodic Cleaning LeMaitre Vascular recommends periodic cleaning of the fan screens on the rear panel of the TRIVEX System control unit Use a soft brush to loosen and remove any dirt that may have collected on the fan screens CAUTION Excessive dirt buildup may reduce air flow from the fans and cause overheating SERVICE Appropriate servicing of the TRIVEX System involves field replacement of fuses the lamp damaged or worn handpiece cable fiber optic cable or damaged or worn power cord All other repairs should be performed by LeMaitre Vascular See ORDERING INFORMATION for a list of replacement parts SERVICE PHILOSOPHY There are no user serviceable components inside the TRIVEX System Control Unit Repairs and adjustments are to be per
42. used with the TRIVEX System are for single use only Do not resterilize Discard after use 2 Disconnect the resector handpiece cable from the front panel Do not disconnect the cable from the handpiece Screw the protective cap on to the connector end of the cable CAUTION To prevent moisture from entering the handpiece cable during sterilization ensures that the protective cap is screwed on completely Moisture can damage the cable or handpiece connectors 3 Set the suction lever to fully open by aligning the lever with the double arrows NOTE Use care not to lose the suction control lever O ring if the suction control lever is removed 4 Clean the unit thoroughly with soapy water The unit may be immersed 5 Clean the drain tube with a brush Rinse the unit thoroughly with water Do not use saline or solvents such as alcohol or acetone 6 Sterilize the handpiece using one of the following methods Steam pre vacuum wrapped at 270 F to 275 F 132 Cto 135 C for four minutes Steam gravity method wrapped at 270 F to 275 F 132 C to 135 C for ten minutes CAUTION Do not cool the resector handpiece by immersing it in cold water TRIVEX SYSTEM CONTROL UNIT AND FOOTSWITCHES The TRIVEX System control unit operates outside of the sterile field and does not require sterilization Sterilization and or disinfection procedures will damage the product and void the warranty Follow these steps after each procedure to clean the contro
43. vel Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of the LeMaitre Vascular TRIVEX System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 v p d 1 2 dipl 80 MHz to 800 MHz d 2 3 dipl 800 MHzto 2 5 GHz Where pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is Radiated RF 3 V m the recommended separation distance in meters m IEC 61000 4 3 80 MHz to 2 5 GHz Field strength from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol GY NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones land mobile radios amateur radios AM and FM radio broadcasts and TV broadcasts cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an elec
44. xclusively with sterile substances sterile fluids and sterile accessories There are five main steps for preparing the TRIVEX System for use in a surgical procedure 1 Power up turn the TRIVEX System on and check for faults 2 TRIVEX System Illuminator Tumescence supply setup prepare the Tumescence solution and tubing 3 Resector Handpiece saline supply setup prepare the saline irrigation and tubing 4 Resector Handpiece setup connect the Resector Handpiece and verify operation 5 Connect the TRIVEX System Illuminator and Tumescence Pump footswitches and verify operation POWER UP CAUTION Ensure that the available mains voltage matches the data listed on the label attached to the back of the control unit Incorrect voltage can cause errors or malfunction and may destroy the equipment WARNING To prevent electrical shock connect the power cord to a properly wired grounding receptacle only 1 Plug the unit power cord into the rear panel connector and a grounded AC power source The control unit power supply automatically detects the local power standard and adapts the system to that standard 2 Push the power switch on the rear panel to the ON 1 position 3 The TRIVEX System will start up with these defaults Tumescence pump flow set to level four which corresponds to approximately 450 ml min flow Tumescence pump is OFF and Pump ON OFF button is lit Steady orange Saline pump flow is set to level one Saline pump is OFF and pum
45. y drawer is not fully closed Check lamp drawer to be sure that it is fully seated into its housing Lamp ON OFF button indicator light is Lamp self test The lamp is running a self test Wait flashing green 10 40 seconds for self test to finish Lamp ON OFF button indicator light is Defective lamp Replace the lamp See Service Maintenance for instructions on flashing orange replacing the lamp The light output is low The light cable is not in the light source Reseat the fiber optic cable Check to see if the light source adaptor is in adaptor correctly the correct position Illuminator defective Replace the illuminator Defective lamp Replace the lamp module Wrong light source portal adaptor attached Use only the TRIVEX System Light to fiber optic cable Source adaptor REF 7210375 Resector Mode Select button indicator light Moisture in resector handpiece or resector Disconnect the cable from the control unit Check the cable connector is flashing green cable connectors for moisture If wet rinse the connector with distilled water and dry completely There is a problem with the resector If the flashing green persists the resector handpiece is damaged handpiece contact your LeMaitre Vascular representative No light from light guide Light guide adaptor latch did not catch Check light guide adaptor to ensure that it is fully seated into console Resector Mode Select button is flashing The resector handpiece motor has sta
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