1 Contents Chapter 1 Introduction
Contents
1. Odyssey 30 B User s Manual Symbols CHAPTER 1 Introduction The following table lists the symbols used on the laser system and within this Manual The placement of the labels are diagrammed in Chapter 3 Additional symbols used on the touch screen interface are described in Chapter 6 A Refer to Manual for additional instructions or warnings Y Non AP equipment RZ Alternating current O Key switch OFF isolation transformer may be energized AI Remote interlock A WARNING Dangerous voltage Type BF medical equipment MAINS ON isolation transformer energized O Standby state Optical fiber applicator A WARNING Visible and invisible laser radiation STOP 3 Emergency Stop O MAINS OFF no power to entire laser system O Ready state PA Foot switch laser activation device 7 8 CHAPTER 1 Introduction Holmium Laser Theory of Operation The Odyssey is a pulsed holmium YAG laser emitting laser radiation at 2100 nm The holmium wavelength is highly absorbed by water making it superior for tissue ablation with minimal lateral thermal damage In the case of laser lithotripsy laser energy vaporizes water in the calculus causing it to crumble into smaller particles that pass easily through the urinary tract A laser an acronym for Light Amplification by Stimulated Emission of Radiation produces a highly concentrated beam of light of a given wavelength In contrast2. error Call for service Call for service Call for service 57 Cooling water flow rate error Odyssey 30 B User s Manual Error 56 has occurred Water pump failure Cooling system leaking Water flow rate sensor failure Call for service Call for service Call for service Call for service CHAPTER 7 61 Maintenance Troubleshooting Problems Without Error Codes e Laser returns to Standby without giving an Error Code re enter ready Call for service if this issue continues e Reconnect Fiber if a delivery system is in place before the laser is powered ON the touch screen will indicate that the fiber must be reconnected Simply remove the fiber from the aperture then reconnect it to the laser system e System boots to Pass Code screen if the foot switch is depressed when the laser powers ON it will enter service mode and request the pass code To exit disengage or disconnect the footswitch and restart the laser If the system continues to enter service mode call for service e Touch Screen Failure shut down the laser system wait several seconds before restarting Call for service if the problem persists The MAINS Switch will not stay ON verify that the Emergency Stop button is not depressed If the laser still will not power ON call for service e Laser system will not power ON verify that the laser is plugged in If the laser is plugged in and will not power ON call a technician to veri
3. 2010 Holmium Laser Safety Glasses HLA 2020 Holmium Laser Safety Goggles HLF S273 CNV 273 um single use laser fiber with flat tip HLF S365 CNV 365 um single use laser fiber with flat tip HLF S550 CNV 550 um single use laser fiber with flat tip HLF S940 CNV 940 um single use laser fiber with flat tip HLF M273 CNV 273 um multi use laser fiber with flat tip HLF M365 CNV 365 um multi use laser fiber with flat tip HLF M550 CNV 550 um multi use laser fiber with flat tip HLF M940 CNV 940 um multi use laser fiber with flat tip Registering Your Laser System Please be sure to register your laser system with your local distributor Please include the serial number of your laser system when contacting them By registering your laser system you will be notified of product safety bulletins and updates to the software and documentation 16 CHAPTER 2 Installation Transportation and Storage Conditions In transit the laser system must be packaged to protect the enclosures from damage such as in the original shipping crate Ifthe original shipping crate is not used for transportation the system must be secured to prevent damage The handles can be used to tie the system to a secure surface the enclosure should NOT be used for this purpose The enclosures should not be subjected to excessive force shock or vibration If shock or vibration are suspected the laser alignment should be inspected by a trained technician If any water remains in the cool
4. distal end from the operating plane 4 Increase the repetition rate This setting may be set as high as possible while maintaining visibility of the target The repetition rate governs the rate of energy delivery In general higher repetition rates mean shorter operating times when using the dusting method 5 The laser system automatically calculates the average power by multiplying the pulse energy with the repetition rate Keep in mind that certain combinations of pulse energy and repetition rate are not possible Please consult the power matrix listed in this chapter for available power settings 52 CHAPTER 6 Operation Treatment Set the laser system to Ready state by pressing the Ready button located on the control panel The green Ready light will be lit After two seconds the display will indicate that the Laser is in Ready Carefully position the fiber optic probe at or near the intended surgical site Adjust the aiming beam intensity by using the UP DOWN arrows on the touch screen display Aim and steady the distal end of the fiber at the surgical target Depress the foot switch when laser energy is desired The Joules counter adds the amount of energy delivered Adjust power as necessary Return the laser system to Standby state by pressing the Standby button The laser system automatically returns to Standby state when changing any power parameter Shut down Sequence 1 Note the clinical parameters and Joule c
5. in Standby exceeded state until error disappears or lower output power Cooling system Call for service component failure 12 Foot switch stuck foot An object is causing the Check foot switch for switch in down position foot switch to remain in obstruction while attempting to the down position place system in Ready state Foot switch failure Replace foot switch 14 Top Panel Interlock Top panel signal connector Call for service disengaged is not properly connected Top Panel Connector is Call for service damaged 15 Optical deck interlock Optical deck covers are not Call for service error properly seated or optical deck interlock failure 58 CHAPTER 7 Maintenance Code 16 Description Delivery system not connected Probable Cause An appropriate delivery system is not in place Fiber is faulty or heavily damaged Solution Verify that the delivery system uses a Convergent compatible connector Replace fiber Verify that the connector is screwed down finger tight 17 Remote interlock open Remote connector missing An external device caused the remote interlock circuit to disable the laser system Verify that the remote connector located on the back panel is seated securely Re engage the remote interlock with the external source 18 Foot switch not connected An appropriate foot switch is not in place The foot switch connector is damaged Verify that the
6. is proportional to the pulse energy and inversely proportional to the square of the beam diameter For example switching from a 400 um micron core fiber 0 4 mm to a 200 um micron core fiber 0 2 mm results in an energy density that is four times greater than before The selection of appropriate power parameters is dependent on the procedure the selection of delivery system and the specific conditions of the patient Before using the laser system on a patient the user should have attended a training course on the specific procedure and have consulted fellow physicians on the latest clinical techniques indications and contraindications ulse energy J energy density J cm TERE st ee beam diameter um Unique Features of the Odyssey 30 B e Controlled Delivery Microprocessor controlled delivery insures precise power delivery and pulse to pulse uniformity e Ease of Use Touch screen user interface reduces the number and type of controls to a bare minimum A status line at the bottom of the screen alerts the user in the event of a safety hazard or system error Motorized blast shield facilitates blast shield changes without removing any access panels e 273 um Fiber Capable Specially designed optics and mounts allow laser energy to be delivered into a straight 273 um core fiber without the need for expensive tapered fibers e Variable Pulse Duration Allows the user to easily change the mode of laser delivery and shif
7. manual carefully The performance of procedures controls or adjustments other than those specified herein may result in hazardous radiation exposure Optical Hazards All persons in the operating room must wear appropriate safety eyewear while the laser is in operation Appropriate eyewear includes safety spectacles and goggles with an Optical Density of 4 or greater The working beam is invisible and can cause irreparable eye damage Only direct the optical fiber at the intended surgical site e Eye damage can occur not just by direct viewing of the working beam but also through scattered laser radiation when reflected off smooth surfaces such as operating room walls floors and other surgical equipment e Do not look directly at the distal end of the optical fiber or into the laser aperture Odyssey 30 B User s Manual CHAPTER 3 Safety 25 Electrical Hazards A e Only a qualified service technician may remove the enclosure covers Removing the enclosures exposes personnel to potential electrical hazards There are no user serviceable parts within the laser system e Donottouch areas marked HIGH VOLTAGE These and surrounding components in the laser system contain charge voltages of up to 1000 VDC e Donotoperate the laser system or the UPS if the procedure room floor is flooded Delivery System Related Hazards The use of incorrect or broken fibers may result in injury to the user or the patient due to inadverte
8. system is unique in that it enables the user to easily alternate between two pulse widths thus offering a variety of ablative effects 350 us higher peak power optimal for ablation but may cause stone migration 700 us lower peak power optimal for coagulation also minimizes stone migration Selection of the pulse width depends on the given procedure When operating on soft tissue 700 us will provide more thermal effect and cause less bleeding than 350 us For Lithotripsy there are two main methodologies e Break up the stone and extract the particulates with a basket or grasper To achieve this use the 350 us pulse width with a high energy level J and low repitition rate Hz The repeated extraction of larger particulates may cause more trauma to surrounding tissue e Dust the stone and allow small particulates to void or irrigate easily during the procedure To achieve this use a low energy level J and a high repitition rate Hz To select the optimal power parameters for a given target 1 Selectthe pulse width based on expected migration and or desired affect 2 Set the parameters to 5 Hz 0 6 J 3 Lase fora few seconds to observe the particulate size Adjust Energy for desired affect higher energy will produce large coarse particulates while lower energy will produce finer particulates Note that the fluence or energy density is the operating parameter and depends on the chosen fiber type and distance of the
9. that the laser system is in Ready state no system errors are present and the touch screen is displaying the user power settings screen Depressing the foot switch will activate the laser When switching from Standby state to Ready state there is a two second delay to allow time for laser operator to give adequate notice to operating room personnel e Capacitor charge indicator icon located on the lower right corner of the touch screen display indicates whether the main capacitor bank has no charge is half charged or is fully charged e Audible emission warning alerts operating room personnel that the laser is firing Visible emission indicator blinking amber LED indicates that the laser is firing The audible and visible emission indicators operate simultaneously Status readout located on the lower left corner of the touch screen display alerts the user of any internal system errors The error codes are referenced in Chapter 7 In the event of a system error the laser system will immediately return to Standby state and the Status readout will display a corresponding error code Labeling The Odyssey contains all appropriate labels to satisfy U S Food and Drug Administration FDA Underwriter s Laboratory UL European Union CE and Canadian Standards Assocation CSA medical laser device labeling requirements Odyssey 30 B User s Manual CHAPTER 3 27 Safety Visible emission indicator blinks when laser is o
10. white light such as sunlight is composed of light throughout the electromagnetic spectrum from ultraviolet UV through visible light i e the rainbow to infrared IR Laser energy is generated by converting electrical energy to light energy using a flash lamp The flash lamp energy is then used to excite the lasing medium in this case a holmium YAG laser rod The laser energy is amplified in the laser resonator cavity and a small portion of the energy is allowed to leak out This becomes the working laser beam The Odyssey isa flash lamp High Reflector Mirror Output Coupler Mirror pumped solid state laser Working Beam 2100n mhe fiashlamp Re Holmium YAG Laser Rod electrical energy to optical e u energy and the resonator Pd Es zr mirrors amplify the optical energy p Odyssey 30 B User s Manual CHAPTER 1 9 Introduction Laser Power Parameters Lasers are useful in medical applications because of selective absorption of their energy by tissue Since a laser emits light energy at a distinct wavelength a laser wavelength is chosen that best matches the desired absorption characteristics for the target tissue In general holmium lasers 2100 nm are better at ablating tissue than Nd YAG lasers 1064 nm because the holmium wavelength is readily absorbed by water which constitutes a major portion of tissue However the Nd YAG wavelength transmits easily through water making it more suitable f
11. 6 20 3 10 Hz 4 0 5 0 6 0 7 0 8 0 9 0 10 0 11 0 12 0 13 0 14 0 15 0 16 0 17 0 18 0 19 0 20 0 21 0 22 0 23 0 24 0 25 0 26 0 27 0 28 0 29 0 30 0 12Hz 4 8 6 0 7 2 8 4 9 6 10 8 12 0 132 14 4 15 6 16 8 18 0 19 2 20 4 21 6 22 8 24 0 252 26 4 15 Hz 6 0 7 5 9 0 10 5 12 0 13 5 15 0 16 5 18 0 19 5 21 0 22 5 CHAPTER 6 Operation 20 Hz 8 0 47 48 CHAPTER 6 Operation 700 us pulse width power in W 5Hz 7Hz 10 Hz 12 Hz 15 Hz 0 4 J 2 0 2 8 4 0 4 8 6 0 0 5 J 2 5 3 5 5 0 6 0 7 5 0 6 J 3 0 4 2 6 0 7 2 9 0 0 7 J 35 4 9 7 0 8 4 10 5 0 8 J 4 0 5 6 8 0 9 6 12 0 0 9 J 4 5 6 3 9 0 10 8 13 5 1 0 J 5 0 7 0 10 0 12 0 15 0 1 2J 6 0 8 4 12 0 14 4 1 3J 6 5 9 1 13 0 15 6 14J 7 0 9 8 14 0 16 8 1 5 J 7 5 10 5 15 0 18 0 1 6J 8 0 11 2 16 0 1 7 J 8 5 11 9 17 0 1 8 J 9 0 12 6 18 0 1 9J 9 5 133 19 0 2 0J 10 0 14 0 20 0 2 1J 10 5 14 7 21 0 2 2 11 0 15 4 22 0 or 100 V 10 W using a 273 um core fiber and 20 W using a 365 um core fiber Full power is achievable using 230 V or 200 V with a 550 uim or larger core fiber 15 and 20 Hz are not achievable using a 273 um core fiber N For 30 Watt systems the software limits the output power to 15 W using 115 V Odyssey 30 B User s Manual CHAPTER6 49 Operation Preparation 1 Make sure that all persons in the operating room have appropriate laser safety eyewear s
12. Contents Chapter 1 algo DUCE OM PPP CO O00ONU O rin Introduction 6 How to Use This Manual 6 Symbols 7 Holmium Laser Theory of Operation 8 Laser Power Parameters 9 Energy Density 10 Unique Features of the Odyssey 30 B 10 System Specifications 11 Chapter 2 Installation ree ene ier eor o ree e E Rd tae Vides RR ee Nee rs 13 Installation 14 Unpacking the Laser System 14 Component Checklist 14 Optional Accessories 15 Registering Your Laser System 15 Transportation and Storage Conditions 16 Electrical Requirements 16 Ambient Operating Conditions 17 Space Requirements 18 Initial System Power ON 18 Verifying Alignment and Calibration 19 Uninterruptable Power Supply 21 Chapter 3 cci n I 23 Introduction 24 Optical Hazards 24 Electrial Hazards 25 Delivery System Related Hazards 25 Other Hazards 25 Safety Indicators 26 Labeling 26 Table of Contents Chapter 4 Fiber OP th Sii ii Introduction Care and Handling Blast Shields Choosing the Ideal Delivery System Chapter 5 MMC atei Physician Training General Information and Precautions Urology Chapter 6 Operation alal Introduction Navigating the User Interface User Power Settings Screen Status Icons User Options Screen Power Matrices Preparation Procedure Environment Start up Sequence Adjusting the Screen Contrast Setting Power Parameters Treatment Shut down Sequence Resetting the Emergency Stop Ch
13. G Er YAG and CO wavelength lasers The physician should attend training courses and seminars at medical conferences related to holmium laser procedures At these conferences there are a number of courses on laser therapy which discuss the latest surgical techniques precautions indications and contraindications The physician should attend hands on workshops offered at medical conferences or available in your local area The physician should attend didactic courses that include both seminar and laboratory sessions Where possible the physician should visit other physicians who are performing similar or related laser therapy to observe cases and discuss different aspects of the procedures Odyssey 30 B User s Manual CHAPTER 5 37 Indications General Information and Precautions Indications The Odyssey laser system and accessories are intended solely for use by properly trained and qualified physicians The laser system is indicated for use in urology The use of the laser system for an application is at the physician s discretion except in cases where contraindicated Warnings Unexpected or uncontrolled tissue damage can sometimes occur due to excessive power application Use only the lowest pulse energy settings required to achieve the desired tissue effects Extreme caution should be employed until the biological interaction of the laser energy with tissue is fully understood by the physician As with conventional endo
14. Start up Sequence 1 Turn ON the key switch The key switch is located on the back panel 2 The laser system powers ON and the touch screen displays the welcome screen After 2 seconds the power setting screen appears 3 Open the laser aperture door by lifting the handle 4 Connect the fiber delivery system into the fiber optic port located on the front panel Make sure that the connector is screwed down finger tight but do NOT overtighten the fiber connector The touch screen displays a fiber icon corresponding to the fiber core size Ifa fiber delivery system is connected when the laser is initially turned ON the status displays RECONNECT FIBER Remove and reconnect the fiber The Status display will change to STANDBY 5 Adjust the screen contrast as necessary See Adjusting the Screen Contrast below The aiming beam can be turned on in Standby state by pressing the aiming beam UP arrow button In Ready state the aiming beam will turn on automatically unless it has been manually set in the OFF position Adjusting the Screen Contrast 1 From the power setting screen touch the options button 2 If the screen is too bright touch the DOWN arrow until the contrast is optimum If the screen is too dark touch the UP arrow until the contrast is optimum 3 Touch the back button to return to the power setting screen Odyssey 30 B User s Manual CHAPTER6 51 Operation Setting Power Parameters The Odyssey laser
15. apter 7 MET AA aaa ai Preventive Maintenance Other Regular Maintenance Troubleshooting Error Codes Troubleshooting Problems Without Error Codes Blast Shield Maintenance Inspecting the Blast Shield Power Calibration Odyssey 30 B User s Manual Table of Contents Chapter 8 CUSTOMER Service oia dana 65 Customer Service and Warranty 66 O 1999 2008 Xintec Corporation dba Convergent Laser Technologies All rights reserved Odyssey 30 B User s Manual Cook Urological Document No U_Ody30_EN_CE_REV1 No part of this manual may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical recording or otherwise without the prior written permission of Cook Urological Inc The content of this manual is furnished for informational use only and is subject to change without notice Odyssey 30 IO Connector and OptiLite are trademarks of Convergent Laser Technologies and Xintec Corporation This product is protected by US Patent 4 950 268 5 269 778 5 689 520 other patents pending Manufactured by Cook Urological Inc Cook OB GYN 1100 West Morgan Street Spencer IN 47460 USA Cook Ireland LTD O Halloran Road Printed in U S A C National Technology Park January 2008 0088 Limerick Ireland Odyssey 30 B User s Manual 1 Introduction CHAPTER 1 Introduction Introduction The Odyssey surgical laser system and accessories are designed for use in the treatme
16. assemblies are fragile While smaller fibers are more flexible all sizes are prone to fracture Do not bend fibers to a diameter of 5 inches 12 7cm or less Do not apply excessive pressure Use of broken fibers may cause injury to the system or the patient Ensure the integrity of the delivery system prior to use Using the aiming beam or an HLA 2300 Fiber Inspection Microscope check for any light escaping along the length of the fiber or for unusual dimness from the distal end The connector end of the fiber assembly is also fragile and must be kept clean Any dust dirt oil or scratches on the connector can cause costly damage to the laser Never touch the connector surface with bare hands Do not use a fiber if the connector may be soiled or damaged Always replace the connector cap when the fiber is not connected to the laser system The distal end is sharp and will damage articulating endoscopes if not threaded through carefully Extend the distal end of the fiber through the working channel of the endoscope only when the endoscope is straight If the endoscope must be articulated to visualize the calculus straighten it to extend the distal end of the fiber through Then articulate the endoscope to bring the calculus back into view Blast Shields Each Odyssey Laser is equiped with a disk of six blast shields which protect the output lens from flash back debris Normally each blast shield should last over 100 cases but they can be
17. call for service 12 230 V systems only Repeat steps 7 9 amp 11 for 350 us 10 Hz 3 0 J 30 W 13 Follow instructions in Chapter 6 to shut down the laser system If you receive an under power warning message the most likely cause is that the N resonator mirrors are slightly out of alignment The laser will continue to operate normally Call for service at next opportunity Uninterruptable Power Supply UPS Consult the UPS users manual for information on safe installation Ensure that the UPS is safely installed prior to use with the laser system 22 CHAPTER 2 Installation This page intentionally left blank Odyssey 30 B User s Manual Safety 24 gt p CHAPTER 3 Safety Introduction This chapter contains important safety information related to the use of the laser system All operating room personnel should familiarize themselves with the contents of this chapter before operating or assisting in the operation of the laser system All efforts have been made to minimize hazardous conditions during system design However since the laser system is high power equipment it is impossible to eliminate all potential hazards that may result in user and patient injury The Odyssey is classified as a Class IV laser system by the National Center for Devices and Radiological Health CDRH Class IV represents the highest class of laser devices Laser energy should only be applied to the intended treatment area Read this
18. e and fume extraction must be considered Laser plume may contain viable tissue particulates Odyssey 30 B User s Manual CHAPTER 5 39 Indications Urology Indications Incision excision coagulation ablation therapeutic thermal or photodisruption of all tissue and treatment of tumors and stones in the genitourinary tract and specifically for the fragmentation of upper and lower tract urinary calculi including cystine calcium oxalate monohydrate and calcium oxalate dihydrate stones Warnings Extreme caution should be used until the physician is completely familiar with the biological interactions of laser with various tissue types Do not operate the laser if the operating plane is not visible either by direct sight or via an endoscope Steady the distal end of the fiber at the intended treatment target before depressing the foot switch Tissue perforation can occur if excessive laser energy is applied whether through excessive pulse energy or extended laser application dwell time Because fiber tips are sharp perforation may occur by mechanical means poking When risk of air embolism is present such as cutting vaporizing organs with large vascular structures always use fluid cooling Screen tumors that are in close proximity to known arteries or veins by pretreatment workups to precisely locate the tumors The risk of combustion perforation and laser induced hemorrhage any of which can cause patient death mu
19. e width Laser timer error Turn OFF laser system error and restart after 30 seconds if error persists call for service 42 Main power supply Power supply or capacitor Turn OFF laser system charge error bank failure and restart after 30 seconds if error persists call for service 44 Safety shutter error Safety shutter stuck in Call for service incorrect position Safety shutter sensor error Call for service 60 CHAPTER 7 Maintenance Code Description 46 Laser flash lamp simmer error Probable Cause Low line supply voltage condition Flash lamp failure Solution Verify that the supply voltage meets the performance specifications in Chapter 2 Turn OFF laser system and restart after 30 seconds if error persists call for service 50 Foot switch error Foot switch in short circuit situation or foot switch failure Replace foot switch 52 Computer error At least one microcontroler has stopped responding Turn OFF laser system and restart after 30 seconas if error persists call for service 53 External watchdog error External watchdog microcontroler failed to communicate with the main computer Turn OFF laser system and restart after 30 seconds if error persists call for service 56 Laser cavity water pressure error Preventive maintenance procedure needed Water pressure across laser cavity is out of range Cavity pressure sensor
20. eam brightness control v A defaults to OFF in Standby state and defaults to ON in Ready state adjustable in 10 step increments lowest step is OFF touch UP to turn ON beam while in Standby mode PULSE WIDTH Pulse width pulse duration control toggle between 350 us and 700 us Odyssey 30 B User s Manual AVG POWER REP RATE ENERGY STATUS Standby o N c COUNTER O Status Icons Input line voltage indicator Delivery system indicator CHAPTER6 45 Operation Energy control increase or decrease pulse energy in 0 1 J increments Repetition rate control increase or decrease the pulse repetition rate Average power display average power calculated by multiplying rep rate pulse frequency with pulse energy Status display under normal conditions displays the operating state of the system STANDBY or READY under error state displays the error identification number Joule counter displays the total amount of energy delivered reset button sets the counter back to zero User options screen button jump to user options screen ug 115V line input also used for 100 V S 230 V line input also used for 200 V Z no delivery system connected CB 273 um fiber assembly connected da 365 um fiber assembly connected 550 um fiber assembly connected Go 940 um fiber assembly connected 46 CHAPTER 6 Operation Capacitor charge indicator capacitor voltage between 0 a
21. easily damaged by using dirty scratched or inapropriate delivery systems Continued use of a soiled blast shield will damage the output lens Odyssey 30 B User s Manual CHAPTER4 33 Fiber Optics Damaged fibers can be both a cause and a symptom of a soiled blast shield If a fiber is suspected to be damaged after use with the laser rotate the blast shield disk see Chapter 7 and alert a technician that a blast shield may be soiled Choosing the Ideal Delivery System Cook OptiLite delivery systems come with 273 365 550 or 940 um core diameters Larger cores will provide more power but are less flexible Users are encouraged to select the largest core feasable considering the flexibility needed to reach the target and the size of the endoscope s working channel 34 CHAPTER 4 Fiber Optics This page intentionally left blank Odyssey 30 B User s Manual 5 Indications 35 36 CHAPTER 5 Indications Physician Training Physician training should include all of the following areas which are often performed chronologically in the order listed below 1 The physician should thoroughly review published literature related to the holmium laser procedures These include literature pertaining to general laser biology and specific treatment techniques for a particular disease entity The physician should also review similar modalities in related specialties and similar indications using other types of lasers such as Nd YA
22. ee Chapter 3 2 Verify that the power cord is plugged into to a suitable electrical outlet For additional details please review the installation procedures in Chapter 2 3 Verify that the MAINS switch located on the back panel is in the ON I position 4 Verify that the foot switch is properly connected The foot switch connector is located on the back panel 5 Verify that the remote connector is attached The remote connector is located on the back panel above the foot switch connector In case of an emergency hit the emergency stop button located on the top panel When the button is engaged all electrical power to the laser system will be cut AN immediately Remember to release the emergency stop button before attempting to restart the laser system Procedure Environment Operating room should be well ventilated and air conditioned Ambient temperature should be between 18 22 C 65 72 F variance in temperature may affect laser output e To reduce potential operating hazard the laser system should be positioned at least 1 meter 3 ft from the patient e Because the laser is not designed to be sterilized it should be kept outside the sterile operating field Extend the sterilized delivery system into the operating area for use e The UPS used with the laser is also non sterile and should not enter the sterile operating field e Donot contact the laser or UPS and patient simultaneously 50 CHAPTER6 Operation
23. en displays the user power settings screen 10 Lift the laser aperture door and insert the 600 um test fiber into laser aperture Do not overtighten the delivery system connector The connector only needs to be finger tight for proper operation 11 After about 5 seconds the touch screen status displays STANDBY and an icon appears on screen indicating that a 600 um core fiber has been properly connected 12 Press the Ready button The green Ready LED is lit 13 The touch screen status displays Please Wait 14 Ifthe touch screen status displays READY after 2 seconds then the system is operating normally If not please consult the troubleshooting guide in Chapter 6 or call for service 15 Follow the instructions in the next section to verify the alignment and calibration Verifying Alignment and Calibration The laser system has been designed with many safeguards to prevent optical misalignment due to shipping and normal operation However it is important to verify the alignment and calibration of the laser system to ensure peak system performance 20 CHAPTER 2 Installation The following test requires a calibrated energy or power meter Please contact your distributor if you would like to know if your energy or power meter is compatible with the Odyssey The test below is intended for laser systems operating at 230 V nominal Skip step 12 if you are operating the laser system using a 115 V electrical outlet 1 Se
24. er meter to read the laser output at the distal end of the fiber 8 Touch the calibration button v 9 Referring to the power matrix in Chapter 6 step through each value and confirm output power The power setting should be within 10 10 If necessary adjust the output power by increasing or decreasing the power supply voltage After the correct voltage is set touch the save button to store the current value in static memory Do not set the power supply program voltage over 4 800 V 11 Return to the service menu and then to the user power settings screen 12 Step through each power setting and confirm output power Note any discrepancies and re calibrate specific data points as necessary 13 Verify the laser s ability to launch energy into a small core fiber 273 um Always verify every output power combination in user mode after calibration An incorrectly set data point may cause unexpected levels of output energy Odyssey 30 B User s Manual 8 Customer Service 65 66 CHAPTER 8 Customer Service Customer Service and Warranty Customer Service and warranty information for your Odyssey 30 Laser System are offered by a Cook representative or by an authorized distributor Please review the information provided by the distributor for details on customer service and warranties offered Odyssey 30 B User s Manual Notes 67 68 Notes
25. foot switch connector located on the back panel is seated securely Call for service 27 Blast shield error Blast shield motor or optical sensor error Blast Shield installed backwards Call for service Call for service 28 Laser output below minimun Laser resonator out of alignment or laser resonator mirror damaged Call for service 29 Laser output 10096 above set point System requires re calibration Error spike injected into high power electronics See Power Calibration in this chapter Turn OFF laser system and restart after 30 seconds Odyssey 30 B User s Manual CHAPTER 7 59 Maintenance Code Description Probable Cause Solution 30 Cooling fan failure Cooling fans operating Continue procedure below performance call for service at next opportunity 32 IGBT falure High power electronics Turn OFF laser system failure and restart after 30 seconds if error persists call for service 34 Main power supply Low line voltage condition Verify that the voltage overload causes power supply to meets the performance draw too much current specifications in Chapter 2 Component failure Call for service 35 Main power supply over Power supply cooling fan Call for service temperature failure 37 Laser timer repitition Laser timer error Turn OFF laser system rate errror and restart after 30 seconds if error persists call for service 38 Laser timer puls
26. fy that the supply power is sufficient If this problem persists call for service e Laser system damages fibers rotate the blast shield and connect a new undamaged fiber If the problem persists call for service 62 CHAPTER 7 Maintenance Blast Shield Maintenance The Odyssey is preinstalled with a blast shield to protect the output lens from flashback debris There are six blast shields per disk After one blast shield is soiled the next one can be activated simply by rotating the disk to the next position from the user power setting screen After the last blast shield is exhausted the blast shield disk will have to be replaced A new blast shield may be ordered by calling the manufacturer and requesting part number LP7105 Under normal operating conditions a blast shield should last for over 100 cases Typically a blast shield gets soiled for the following reasons e the delivery system connector face became soiled due to mishandling e the internal optical system became misaligned e aninappropriate delivery system was used Using another manufacturer s delivery system on the Odyssey may damage the laser system and will void the manufacturer s warranty Inspect the blast shield whenever you notice a drop in output power This can be noticed clinically it takes a higher energy setting to achieve the same clinical result or verified quantitatively using an appropriate energy or power meter The following procedures expose t
27. he biomedical engineer to high voltages Please Observe all safety precautions The following procedures should only be attempted by a qualified biomedical engineer or service technician Inspecting the Blast Shield 1 Enter service mode avoid entering the calibration screen 2 Turn ON the aiming beam without a fiber attached 3 Placea piece of paper approximately 1 2 feet 30 60cm in front of the open laser aperture and inspect the interference pattern of the aiming beam 4 Aclean blast shield will have a very homogenous interference pattern Odyssey 30 B User s Manual CHAPTER 7 Maintenance 5 A soiled blast shield will have defects that look like pebbles thrown into calm water 6 Defects near the periphery do not indicate a soiled fiber A fractured blast shield could give a false clean interference pattern since the optic is no longer present If the blast shield was suspected to have damage but appears very clean it may be fractured For this reason this procedure does not replace regular preventive maintenance Once a soiled blast shield is discovered inspect any recently used fibers for burnt connector faces Reusing a fiber with a damaged connector will systematically destroy blast shields Power Calibration As the laser system ages the efficiency of certain components may decrease Power calibration should be verified as part of the preventive maintenance program Only authorized service personnel may cal
28. ibrate the laser system The calibration procedures permit access to service mode functions which if used improperly may damage the laser system During calibration the ambient conditions and cooling water temperature must be within the tolerated ranges e the ambient temperature should be between 18 22 C 65 72 F e cooling water temperature must not exceed 29 C 84 F Always conduct the calibration in a restricted access room with laser safety signs posted at all entrances Wear appropriate safety eye wear at all times during power calibration 1 Pluglaser system into a 230 V electrical outlet Power calibration can only be conducted using a 230 V line input Re configure the transformer if necessary 2 Turn the MAINS switch ON I 3 Simultaneously turn ON the key switch and depress the foot switch This will allow you to gain access to the software s service mode functions 63 A A A 64 CHAPTER 7 Maintenance 4 When prompted for the pass code enter in the pass code supplied with your laser system and touch the button The pass code is issued to the registered owner of the laser system Please contact customer service if you have forgotten or misplaced your pass code Each laser system has a unique pass code 5 If the pass code is entered correctly the service menu will be displayed on the touch screen 6 Inserta new 550 um core fiber into the fiber optic port 7 Setup a compatible energy or pow
29. ing system the laser must not be subjected to freezing temperatures Storage and transit temperature must not exceed 43 C 110 F Storage humidity should not exceed 95 If the laser is stored in a high humidity location it must be allowed sufficient time to reach equilibrium when introduced to a cool operating environment Failure to do this may result in damage to the optics from condensation Electrical Requirements The Odyssey is equipped with a worldwide tappable isolation transformer which can be configured to suit your line voltage conditions The laser system will perform optimally if it has its own dedicated stable electrical supply line Measure the alternating current AC line voltage with and without load to verify that the electrical supply line is stable Please contact customer service to request the technical bulletin on reconfiguring the transformer DANGER High Voltage Only a qualified service technician or biomedical engineer can reconfigure the isolation transformer A mistapped transformer may cause serious harm to the technician and or damage the laser system Nominal Outlet Voltage 115 V 230 V Voltage Range 103 127 V 207 253 V Current Rating 15A 15A Maximum Output Power 15W 30W Odyssey 30 B User s Manual CHAPTER 2 17 Installation The maximum output power is dependent on the line voltage When the input voltage is 115 V the software limits the output power to 15 W At 230 V the laser system i
30. l is removed A A CAUTION Mains 115 230V 50 60 Hz 15A Manually configured See Chapter 2 for electrical requirements MAINS switch MAINS appliance inlet 30 CHAPTER 3 Safety The following labels are found inside the laser system Only a certified technician is authorized to remove the enclosures e This explanatory label is located on the cover of the optical platform and on the resonator chamber When these interlocked covers are removed hazardous laser radiation may be emitted from the laser head into the operating room e Access to this panel is restricted to authorized service personnel e This label indicates dangerous voltage Systems bearing this label must be accessed with caution e These systems include the AC Distribution System and the High Voltage Capacitor Bank e This label indicates a ground connection e Low Voltage Power Supply and the AC Inlet MAINS are connected to the chassis Odyssey 30 B User s Manual 4 Fiber Optics 32 CHAPTER 4 Fiber Optics Introduction Your Odyssey Laser System is designed for use with Cook OptiLite optical fibers exclusively The use of any alternative delivery system may result in user or patient injury or damage to the laser system and will void the warranty see Chapter 8 The delivery system affects the patient the user and the laser system and therefore must be treated with care Care and Handling All optical fiber
31. med Ifa surgical probe is used in contact mode with the tissue the localized heating may cause the distal end of the fiber to deform Please consult the specific sections of this chapter for additional clinical information The most up to date clinical indications can be collected through the sources listed in the Physician Training section of this chapter Usage Recommendations The holmium laser wavelength is strongly absorbed by water and is generally considered as an effective tool for tissue ablation with minimal lateral thermal damage When the surgical probe is used in non contact mode the working beam is diverging at approximately 25 The energy density decreases as the distal tip moves further from the target tissue see Chapter 1 Approximately 2 3096 of the working beam may be lost to backscatter of which a portion may be absorbed by non targeted peripheral tissue When using the surgical probe in contact mode place the distal tip in contact with tissue before activating the laser Discontinue power delivery as the fiber tip is being disengaged from the tissue to minimize the adhesion of tissue to the fiber tip When selecting power parameters always select the lowest power parameters to achieve the desired tissue effect Start with the lowest reasonable setting and gradually increase power if necessary See Chapter 6 for power selection methodology When using the laser within a non aqueous environment a method of plum
32. nd 50 no icon capacitor voltage between 50 and 400 V capacitor voltage between 400 and 600 V capacitor voltage between 600 and 1000 V User Options Screen System information INFO system serial number Serial No 29020 000 software version number Version No date of manufacuture V2 19 0 Manufactured January 2008 Coolant temperature display COOLANT TEMP displays the cooling water temperature in degrees Fahrenheit and Celsius SCREEN CONTRAST OMO BLAST SHIELD Blast Shield control 3 e advance or reverse blast shield disk position between 5 positions 1 through 6 Unless the Blast Shield is inadvertantly rotated forward only a trained service technician should rotate the disk in reverse Return button return to the user power settings screen Screen contrast adjustment increase or decrease the touch screen contrast Odyssey 30 B User s Manual Power Matrices Bolded numbers are for use in calibration 350 us pulse width power in W 0 4 J 0 5 J 0 6 J 0 7 J 0 8 J 0 9 J 1 0 J 1 1J 1 2J 1 3 14 1 5 J 1 6 J 1 7 J 1 8 J 1 9 2 0 J 2 1 J 2 2J 2 3 J 2 4 J 2 5 J 2 6 J 2 7 J 2 8 J 2 9 J 3 0J 5 Hz 2 0 2 5 3 0 35 4 0 4 5 5 0 5 5 6 0 6 5 7 0 7 5 8 0 8 5 9 0 9 5 10 0 10 5 11 0 11 5 12 0 12 5 13 0 13 5 14 0 14 5 7Hz 2 8 3 5 4 2 4 9 5 6 6 3 7 0 7 7 8 4 9 1 9 8 10 5 11 2 11 9 12 6 13 3 14 0 14 7 15 4 16 1 16 8 17 5 18 2 18 9 19
33. nspect and replace water filter if necessary e inspect and replace blast shield if necessary e clean optics e verify optical alignment and resonator tune e verify power calibration e inspect and replace air filter if necessary Only an authorized service technician may conduct the preventive maintenance procedures Other Regular Maintenance Users and technicians are encouraged to maintain the appearance of the laser and UPS by regularly cleaning the external surfaces with alcohol or a damp cloth Consult the UPS user manual for any needed preventive maintenance Failure to maintain the UPS may cause damage to the laser system Odyssey 30 B User s Manual Troubleshooting Error Codes Code 03 Description WARNING Optical deck interlock override Probable Cause Optical deck interlock override switch engaged CHAPTER 7 57 Maintenance Solution Call for service 07 WARNING Energy Laser resonator out Continue Procedure output 20 below set of alignment or laser call for service at next point resonator mirror damaged opportunity 08 WARNING Energy System requires Continue procedure output 20 above set re calibration call for service at next point opportunity 11 Cooling water over Ambient operating room Place system in Standby temperature above temperature has exceeded state until error 38 C 100 F 24C 74 F disappears or lower ambient temperature Laser operating duty cycle Place system
34. nt laser exposure e The use of incorrect damaged or soiled fibers may result in damage to the laser system blast shield and output lens and to the endoscope in use e Check fibers regularly for damage See Chapter 4 for more information Other Hazards e RISK OF FIRE Do not direct the distal end of the fiber on flammable materials such as surgical drapes RISK OF EXPLOSION Do not operate the laser system in the presence of flammable substances including flammable anesthetics e Electromagnetic Interference There is a risk of interference when the laser is used in conjunction with other electronic devices Use of an Uninterrupted Power Source UPS is required to comply with IEC 60601 1 1 Specifically regulations require the use of the Smart UPS 3000 made by APC or a unit which has the same funtionality and appropriate medical certifications and approvals e Unauthorized Use The laser system is designed to be used and serviced by trained individuals To protect against damages from unauthorized use remove the key from the key switch and make it available only to qualified technicians and operators 26 CHAPTER 3 Safety Safety Indicators Standby yellow LED located on the Standby button on the control panel indicates that the laser system is in Standby state Depressing the foot switch will NOT activate the laser e Laser Ready indicator green LED located on the Ready button on the control panel indicates
35. nt of soft tissue disease and urinary stones The laser system emits a concentrated beam of invisible radiation that may cause injury to the user or patient if improperly used Prior to operating the laser system the user and operating room personnel should be familiar with laser safety and the proper use of the laser system and its accessories The user should carefully read and understand the contents of this Manual and accompanying documentation before using the laser to treat a patient How to Use This Manual Chapter 1 Introduction introduces the Odyssey laser system and its theory of operation Chapter 2 Installation outlines the procedure for site preparation and installation of the laser system Chapter 3 Safety provides information on regulatory compliance and the safe use of the laser system Chapter 4 Fiber Optics explains the delivery system and provides information for care and handling of fibers Chapter 5 Indications provides the physician with precautions indications and contraindications related to the intended use of the laser system Chapter 6 Operation describes laser system controls and indicator signals This chapter also outlines standard operating procedures Chapter 7 Maintenance provides maintenance procedures and a troubleshooting guide Chapter 8 Customer Service contains contact information for ordering accessories obtaining warranty repair or general service requests
36. or coagulation and for generating thermal effects The erbium laser 2940 nm is superior at ablation but the lack of commercially available fiber optics makes it unsuitable for endoscopic procedures A laser s water absorption characteristics coupled with the mode of laser delivery governs its clinical efficacy I Pulse Peak Power W Pulse Duration us Power gt gt Water Absorbtion Coefficient log 10 Pulse Energy J 1064 2100 2940 Laser Wavelength nm Though laser wavelength is the primary governing factor in tissue interaction the mode of laser delivery or power parameter determines its clinical effectiveness For pulsed lasers like the Odyssey the mode of laser delivery depends on the pulse peak power energy density pulse duration and repetition rate Most pulsed laser systems are rated by their highest attainable average power Average power P measured in Watts is calculated by multiplying the pulse energy E measured in Joule per pulse with the repetition rate f measured in pulses per second or Hz For example the Odyssey 30 is capable of delivering 3 0 J pulse at 10 Hz making it a 30 Watt laser system Note that useful laser power should be measured at the operating plane and not out of the laser resonator cavity 10 CHAPTER 1 Introduction Energy Density Energy density is one of the most important laser operating parameters for safe and effective laser surgery Energy density
37. ount as necessary Disconnect and dispose of the delivery system Close the laser aperture door by sliding the handle down Turn the key switch to the OFF position Remove the key from the key switch and store in safe place to protect against unauthorized use of the laser Turn OFF the MAINS switch Unplug the power cord from the wall outlet Cover the laser system with the dust cover and store in a safe dry area Odyssey 30 B User s Manual CHAPTER6 53 Operation Resetting the Emergency Stop 1 Verify that the MAINS switch is in the OFF position 2 Verify that the key switch is in the OFF position 3 Twist counterclockwise to release the emergency stop button 4 Turn ON the MAINS switch 5 Turn ON the key switch The laser system will not power ON unless the latching emergency stop button is in the UP released position 54 CHAPTER6 Operation This page intentionally left blank Odyssey 30 B User s Manual 7 Maintenance 55 56 CHAPTER 7 Maintenance Preventive Maintenance The Odyssey has been designed to operate trouble free for thousands of procedures To maintain peak performance the laser system should undergo a preventive maintenance procedure every six to twelve months depending on usage The procedure should also be repeated if the laser system has not been used for over two months The preventive maintenance procedures are as follows e inspect and replace cooling water if necessary e i
38. perating Laser ready indicator laser ready to fire when green LED is lit Oreaoy Ready button C STAND BY set laser system in Ready state Standby button sets laser system in Standby state LASER APERTURE laser aperture laser radiation is emitted from this aperture laser aperture door UP open position laser aperture door lever g fiber optic laser aperture door DOWN connector port closed position Odyssey 30 B Front View 28 CHAPTER 3 Safety STOP Emergency Stop hit the emergency stop to cut all electrical power to the laser system located on the lower right side door Odyssey 30 B Top View Odyssey 30 B User s Manual Key switch we A ds n INTERLOCK og CO FOOT SWITCH Model No Odyssey 30 Serial No 29020 0001 Manufactured August 1999 X vee time U CONVERGENT LASERTECHNOLOGIES E 1660 South Loop Rd Alameda CA 94502 e Made in the U S A CF C a DANGER Risk of explosion if used in the presence of flammable anesthetics Type BF Equipment This equipment is designed to provide an adequate degree of protection against electric shock particularly regarding allowable leakage currents and reliability of the protective earth connection Odyssey 30 B Back View CHAPTER 3 29 Safety top panel lock Access to dangerous voltages if top pane
39. s capable of delivering full power Ambient Operating Conditions The laser system should be used in a well ventilated air conditioned operating room The procedure room temperature should be kept between 18 22 C 65 72 F for optimum system performance In general Holmium lasers are very sensitive to temperature so the output can vary by up to 1596 depending on the room temperature The laser system is factory calibrated at 21 C 70 F When the laser system reaches above 38 C 100 F the safety circuits will prevent the laser system from operating The touch screen status readout will display 11 System Overheat The laser system overheats for the following reasons e the ambient operating room temperature is above 24 C 74 F the laser system has been running at high power for an extended period of time greater than 20 minutes or e theinputline voltage is lower than normal causing the cooling fans or water pump to under perform 18 CHAPTER 2 Installation Space Requirements The laser system requires adequate space to reduce potential operating hazards and allow for proper air ventilation The cooling system contains two radial fans located at the bottom of the laser system Cooling air is drawn from the bottom of the unit and exhausted through the vents located on the right left and back sides of the laser system There should be a clearance of at least 1 meter 3 ft on each side of the system to allo
40. scopic and laparoscopic treatment the possibility of adverse reactions such as chills fever edema and hemorrhage may occur following treatment In extreme cases death may occur either due to procedural complications concurrent illness or laser application Precautions Use caution with patients who have had difficulty with previous endoscopic or laparoscopic procedures The laser should be used only on a tissue target that is fully observable either by direct sight or through an endoscope Vaporization or excision of anatomical structures in proximity to known critical structures such as large arteries veins bowel ureter bladder etc should be performed carefully to avoid damage to such structures Electrocautery should be easily accessible in the event that a bleeding artery or vein needs to be cauterized The flammability of methane gas must be considered when treating in the perianal area Clinical Parameters The holmium laser wavelength 2100 nm has been shown to be a safe and effective tool for ablation excision and coagulation of a variety of soft tissues as demonstrated by numerous clinical studies and pre clinical experience The depth of laser incision is dependent on the power parameters see Chapter 1 38 CHAPTER 5 Indications The rate of incision is dependent on the pulse frequency or repetition rate Optimum incision of tissue is accomplished by balancing the depth and rate of the incision being for
41. sist for as long as 48 hours e Fever amp Leukocytosis lmmediately after laser therapy the patient may experience fever and leukocytosis which are commonly associated with tissue destruction These conditions are generally resolved without treatment Tissue cultures are indicated to exclude the possibility of infection e Bleeding Patients may experience bleeding at the surgical site or from erosion of a tumor during or after laser therapy Post treatment blood studies such as hematocrit levels may be necessary e Sepsis Laser ablated tissue may become infected after therapy If a question of sepsis exists a culture should be taken and other appropriate evaluations made e Perforation Perforation can occur as a result of excessive exposure to laser radiation Perforation can also occur from tumor erosion or as a result of endoscopic or cystoscopic procedures To clinically diagnose perforation patients must be monitored postoperatively through physical signs hematocrit and radiography Odyssey 30 B User s Manual CHAPTER 5 41 Indications e Gas Over distention amp Pneumothorax Patients may experience gastrointestinal distension or pneumothorax during or after therapy Contraindications The use of the holmium laser is contraindicated for patients e who are inappropriate candidates for laser surgery e who are intolerant of anesthesia 42 CHAPTER 5 Indications This page intentionally left blank Odysse
42. st be fully explained to the patient prior to surgery Endoscopic treatment may result in adverse reactions such as fever chills sepsis edema and hemorrhage In extreme cases death may occur due to procedural complications concurrent illness or the application of laser radiation Precautions Use caution when treating patients who have had difficulty with previous endoscopic procedures When radiotherapy and laser therapy are used concurrently extra precautions should be taken including conducting more stringent postoperative 40 CHAPTER 5 Indications monitoring Patients who have undergone radiotherapy present a greater risk of perforation and tissue erosion e Cook Medical has no clinical information or experience concerning the use of the Odyssey on pregnant women or nursing mothers e Patients who have experienced discomfort during previous laser treatment may require analgesics Complications amp Risks e The following complications can cause patient death Non thermal Perforation aspiration induced hemorrhage allergic reaction to medication hypertension arrhythmia pain gas over distention pneumothorax and infection Thermal Acute Induced hemorrhage ulceration perforation edema pain fever leukocytosis and chills Thermal Chronic Delay in healing perforation delayed hemorrhage and sepsis e Pain Short lived pain may occur immediately following endoscopic laser therapy and may per
43. t between ablative or coagulative tissue effects e Safety A safety monitor continuously monitors every subsystem and automatically sets the laser system to Standby state in the event a potential hazard is detected Odyssey 30 B User s Manual System Specifications CHAPTER 1 11 Introduction Model Odyssey 30 Laser Type Pulsed CTH YAG holmium YAG Laser Wavelength 2100 nm Maximum Output Power 30W Pulse Peak Power 1 14 to 7 1 KW Pulse Duration 350 or 700 us Pulse Energy 0 4 to 3 0J Repetition Rate 5 to 20 Hz Beam Divergence 25 cone angle Laser Output Gaussian Nominal Ocular Hazard Distance 5 64in 14 33cm Visible Aiming Beam Variable intensity 3 mW green 532 nm Laser Activation Foot switch Cooling System Self contained water to air Physical Dimensions SOM n xi PUR W3 id any 40 H x 16 W x 33 D Weight 90 Kg 200 Ib Electrical Requirements 115 230 V 50 60Hz Regulatory Compliance US CFR 1040 10 1040 11 Safety Compliance UL CSA 2601 EN 60601 1 1 EN 60825 1 EN 60601 2 22 EN 60601 1 2 EMC 130 W average power achievable with 230 V input and 550 um core fiber See Chapter 2 for more complete electrical requirements 12 CHAPTER 1 Introduction This page intentionally left blank Odyssey 30 B User s Manual 2 Installation 14 CHAPTER 2 Installation Installation The Odyssey laser system and any uninterrup
44. table power supply UPS used in conjunction with the laser system should be installed in a way that optimizes its usability Unpacking the Laser System Your Odyssey laser system is shipped from the factory in a wooden crate to protect the laser system from damage during shipping Before uncrating inspect the crate for damage If there is evidence of damage save all packing materials and notify the shipping company by filing an insurance claim report After the laser system has been unpacked please store the shipping crate and packing materials in a safe location in case the laser system has to be transported in the future Component Checklist The Odyssey laser system is delivered with the following components or accessories Please take inventory of the below items and ensure that there are no missing items Odyssey 30 B laser system e User s manual e Product performance certificate e Dust cover e Detachable power cord with NEMA L6 30P plug for 230 VAC or NEMA L5 15P for 115 VAC e Detachable foot switch e Remote interlock connector attached to laser system e 2 operation keys 600 um core test fiber assembly with flat tip Odyssey 30 B User s Manual CHAPTER 2 15 Installation Optional Accessories The following list includes the most common accessories used with the Odyssey Please refer to Cook s product catalog for additional information and pricing HLA 2000 Holmium Laser Radiation Warning Sign HLA
45. tup laser system for lasing 2 Verify that the 600 um test fiber has clean surfaces on both the connector and distal ends 3 Insert the 600 um test fiber into the laser aperture 4 Wear appropriate safety eyewear See Chapter 3 A While the laser is in operation all personnel in the operating room must wear appropriate laser eyewear The working beam is invisible and can cause irreparable eye damage Do not stare into the beam even through laser eyewear 5 Setup energy power meter probe in front of and parallel to the distal face of the test fiber Be careful not to place the fiber tip too close to the probe as the energy density may damage the probe s sensitive surface Do not place the distal tip of the fiber too close to the Measuring probe as the high energy P Pare density may destroy the Fiber Distal End fi WAS probe sensitive coatings 3 6 cm 6 Set the power parameters to 350 us 7 Hz 0 5 J 3 5 W 7 Press the Ready button and wait 2 seconds 8 Depress the foot switch for 5 10 seconds until you get a stable reading on your energy power meter 9 fthe power reading is not within 1096 of the displayed power the laser system is either misaligned or out of tune Please call for service Odyssey 30 B User s Manual CHAPTER 2 21 Installation 10 Repeat steps 7 9 for 350 us 10 Hz 1 5 J 15 W 11 Inspect connector end of fiber for burn marks If there is a burn mark the laser system is out of tune Please
46. w for proper airflow Allow about 1 meter on all sides of the laser to allow for adequate ventilation Top View To reduce potential operating hazard the laser system should be positioned at least 1 meter 3 ft from the patient The procedure room should be in a controlled access area If necessary install the remote interlock switch to prevent inadvertent laser exposure to unsuspecting personnel entering the operating room A laser danger sign must be posted on each operating room access door Please consult your Laser Safety Officer for applicable laser safety procedures Initial System Power ON Review the previous sections in this chapter and verify that all site installation requirements have been met The laser system should only be operated in a restricted access area Post a laser danger sign on each access door 1 Plug the detachable power cord into the laser system Odyssey 30 B User s Manual CHAPTER 2 19 Installation 2 Verify that the MAINS switch is in the OFF O position 3 Verify that the key switch is in the OFF O position 4 Plug the outlet end of power cord to a suitable electrical outlet 5 Verify that the remote connector is secured 6 Plug the detachable foot switch into the connector on the back panel 7 Raisethe fiber mast to the upright position 8 Turn ON I MAINS switch 9 Turn ON I the key switch The yellow Standby LED is lit After 5 seconds the touch scre
47. y 30 B User s Manual 6 Operation 44 CHAPTER 6 Operation Introduction The Odyssey laser system user interface is feature rich and intuitive The touch screen display allows you to precisely control your laser parameters The laser system is intended for use only by physicians trained in the therapeutic use of holmium lasers Before operating the laser the user should be familiar with the safety precautions noted in Chapter 3 and the clinical indications noted in Chapter 5 In addition all operating room personnel should be trained in laser safety touch screen interface All user controls are Odyssey accessible through the control panel and ue BM mo touch screen interface BER BATE ENERGY T Hal 0 7 1 r PULSE WIDTH a IO 350 lE r COUNTER 9 G 00000 fe Md ready indicator ESTATUS Standby button u 2018 O smwosv reaoy Ready button Navigating the User Interface The user mode touch screen interface is separated into two screens user power settings screen and user options screen All necessary operating controls are located on the user power settings screen To prevent inadvertent laser exposure the laser system can only lase when the touch screen is displaying the user power settings screen and the laser Ready indicator is ON lit green User Power Settings Screen AIMING BEAM Visible aiming b
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