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1. 10 A Model 5000E AC1009 5 mm x 20mm 5A Table 4 1 Fuse overview M Y Warning Only replace CoolWave Control Unit fuses with Urologix supplied components Part 250023 001 Rev J 99 of 182 Section 4 Equipment Maintenance 3 Replace the fuse holder caps 4 2 4 Cleaning Cooling System Vent 1 By hand carefully remove the upper front control unit cover by grasping and carefully pulling the cover straight back 2 Next remove the lower front control unit panel in the manner exposing the cooling system vent at the lower portion of the control unit 3 Using a vacuum carefully remove any dust and lint from the front of the cooling system vent 4 The cooling system vent should be cleaned or inspected periodically to ensure the cooling vent is not blocked and to ensure the control unit has proper airflow to the control unit cooling unit Figure 4 2 5 Replace the control unit upper and lower front covers in reverse order installing the bottom cover then the top by pushing them back into place onto the control unit frame 5 Warning Never remove control unit panels or perform cleaning or maintenance while the control unit is ON or plug into a wall outlet 4 3 Maintaining the printer Printer maintenance consists of refilling the printer with paper replacing an ink tank printing the nozzle check pattern and cleaning the print head Refer to the instructions below as well as the technical manual that comes wit
2. ACTION STEPS Press the Resume button or the Reset button to continue Resume treatment after the pain level has reduced Call Urologix Customer Service ERROR 22 RECTAL UNIT DISCONNECTED POSSIBLE CAUSES 1 Rectal unit has become disconnected ACTION STEPS Reattach the rectal unit to the patient connection cable housing ERROR 23 URETHRA SIGNAL WEAK POSSIBLE CAUSES 1 Loose microwave catheter fiber connectors 2 Microwave catheter may be defective 3 Patient cable may be defective ACTION STEPS Reattach connector Replace the microwave catheter Call Urologix Customer Service ERROR 50 MAXIMUM TREATMENT TIME EXCEEDED POSSIBLE CAUSES 1 Treatment timer has exceeded 60 minutes Part 250023 001 Rev J ACTION STEPS Press the Pause End button to begin cooldown 113 of 182 Section 5 Appendix A ERROR 51 MAXIMUM MWG TIME EXCEEDED POSSIBLE CAUSES 1 100 minutes have elapsed since completing calibration ACTION STEPS Press the Pause End button to begin cooldown ERROR 52 WARNING URETHRA TEMP gt 41 C POSSIBLE CAUSES 1 Urethra temperature is too high ERROR 54 WARNING POSSIBLE CAUSES 1 Rectal temperature is too high ACTION STEPS Reduce microwave power to maintain urethra temperature below 41 C RECTAL TEMP gt 42 C ACTION STEPS Reduce microwave power to lower the rectal temperature to less than 42 C ERROR 59 WA
3. C as measured by the Coolant Bag sensor If the coolant pump is turned OFF this reading will gradually approach room temperature e Rectal Displays the warmest of the 5 rectal temperatures in C Part 250023 001 Rev J 63 of 182 Section 3 Treatment Instructions e Urethra Displays the urethra temperature in C e Status Highlights status as pause treatment OFF ramp system preparing for treatment treat treatment ON or cool cooldown ON e Progress Displays treatment time minutes seconds elapsed treatment time minutes seconds remaining and energy kilojoules Treatment time elapsed also referred to as the treatment timer is defined by the following algorithms Targis CTC Advance CTC Advance Short amp Standard Short Standard amp Long e Urethra gt 35 C with e Urethra 35 C with e Urethra 35 C with Urethra Coolant Urethra Coolant Urethra Coolant difference gt 23 C difference gt 20 C difference gt 20 C e OR MW Power 50 W e OR MW Power 50 W e OR MW Power gt 65 W e OR RTU241 C e OR RTU2 gt 41 C e OR RTU241 C Table 3 4 Treatment Timer algorithms Treatment time remaining is calculated by subtracting the current elapsed treatment time from the treatment time setting You can tell from the time remaining when the CoolWave Control Unit will enter cooldown 2 View treatment details at the left side of the Urologix BPH treatment screen
4. Control Unit will automatically fill in the microwave catheter serial number and rectal unit serial number data fields with simulated information Start with step 4 above 58 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 3 3 3 Treatment Checklist screen Microwave OFF pushbutton Figure 3 22 Treatment Checklist screen and Microwave Off pushbutton 1 Read the Treatment Checklist screen for information about the treatment Figure 3 22 Prior to continuing this treatment verify that all of these steps are complete 2 Follow the instructions on the Treatment Checklist screen to go to the next screen Or press the Back button to return to the previous screen g Note When you press the Microwave Off pushbutton on the CoolWave Control Unit the system will confirm that the Microwave Off pushbutton functions properly Demonstration mode When in demonstration mode you will not press the Microwave Off pushbutton Instead press the Microwave Off button on the Treatment Checklist screen Figure 3 23 Part 250023 001 Rev J 59 of 182 Section 3 Treatment Instructions water and mounted in the Control Unit 5 2 The Microwave Catheter is properly positioned in the patient AS VERIFIED BY ULTRASOUND with the urine port and coolant tubing flushed with 4 to a 5cc of sterile water A 3 The Rectal Unit is properly positioned in the patient 4 The disposable products are properly connected Be to
5. Treatment Catheter SN 98765432 10ABCDE Treatment Time 2 min 34 sec Elapsed Time 6 min 58 sec Total Energy TSAK Figure 5 1 Treatment Restart Available Verify the information the screen is correct e Shutdown Time indicates when the control unit stopped working e User Name the user that had been logged in at the time of shutdown e Treatment Catheter SN the serial number on the RFID tag of the catheter that was connected at the time of shutdown e Treatment Time the amount of time the patient has received treatment at the time of shutdown e Elapsed Time the total amount of time after calibration completed at the time of shutdown This includes the initial ramp treatment and cooldown phases of treatment e Total Energy the amount of microwave energy applied during the treatment at the time of shutdown If the above information is not correct or you wish to discontinue treatment press the Exit button confirm your selection by hitting Exit again to advance to the Welcome login screen If the above information is correct press the Cool button to begin the 5 minute cooldown and prepare to recalibrate with the current catheter and RFID tags The control unit will begin pumping coolant at 37 C for a minimum of 5 minutes before the Calibrate button becomes active Figure 5 2 Part 250023 001 Rev J 121 of 182 5 Section 5 Appendix A Ezllorecs Cooling Timer Temperature 20 0 C psi High Coolant
6. a Press the Chart button View the microwave power coolant temperature rectal temperature and urethra temperature for this treatment in a scrolling strip chart format Figure 3 28 The colors of each trace on the chart correspond to the color of the item in the Status Panel The white vertical line indicates the current values and the end of the chart Press the left and right arrows to scroll left and right through the chart The Zoom button allows you to view this information in a 10 minute view a 30 minute view or a 60 minute view 64 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 End of chart te i Urethra liga Z Setting hose Trace g 40 0 c M ae ne Time 23 30 E Pause End Standard _ Advanced Left arrow Right arrow Zoom button Figure 3 28 Chart pane b Press the Event button View the treatment event log events errors and warnings Figure 3 29 Press the up and down arrows to scroll through the log You can also view the current error or warning listed in priority order errors first in the Current Error or Warning window To reset current errors and warnings press the Reset button If the system does not return to the treatment and an error remains refer to Section 5 1 Troubleshooting guide for further information For additional information about system errors refer to Section 3 6 System errors Part 250023 001 Rev J 65 of 182 Section 3 Treatment Instructio
7. median lobe Only physicians who have been thoroughly trained on the operation of the Targis System CoolWave Control Unit and the Cooled ThermoTherapy treatment should deliver the Cooled ThermoTherapy treatment Attention by a qualified physician is required during the use of the Targis System The Control Unit display must be monitored and controlled during the course of the treatment to make sure that the urethral and rectal temperatures are within prescribed treatment parameters 148 of 182 Part 250023 001 Rev J Appendix B Section 6 Indications for Cooled ThermoTherapy The Targis System CoolWave Control Unit is a non surgical device intended to relieve symptoms and obstruction associated with BPH and is intended for men with prostatic urethra lengths of gt 2 5 cm There are several Microwave Catheter options Microwave Catheter Prostatic Time of Treatment Urethra Length Targis Microwave Catheter 2 5 3 5 cm 28 5 to 60 minutes Targis Microwave Catheter 3 0 5 0 cm 28 5 to 60 minutes CTC Advance Microwave Catheter 2 5 3 5 cm 28 5 minutes CTC Advance Microwave Catheter 3 0 5 0 cm 28 5 minutes CTC Advance Microwave Catheter 4 5 cm 28 5 minutes Contraindications for Cooled ThermoTherapy e Patients with a prostatic urethra length of lt 2 5 cm as measured from the bladder neck to the verumontanum as indicated in the table above for the specific Microwave Catheter e Patients with urin
8. 0 70 345 8570 Fax 31 0 70 346 7299 CE CoolWave User Manual Part 250023 001 Rev J February 2012 2012 Urologix Inc All rights reserved Printed in the USA 182 of 182 Part 250023 001 Rev J
9. 102 3 RTU Plus Reusable Handle 97 173 of 182 Section 7 Touchscreen 98 Clean button 82 Clear button 70 83 Clear print queue 70 83 Clinic supplied equipment 17 Clinical protocol 81 Component See also the Individual component Control Unit 9 Coolant Bag 16 Microwave catheter 15 Patient connection cable 9 Patient connection cable housing 9 Rectal unit 16 Connector Coolant Bag 16 Fiber optic 9 Microwave antenna 9 14 105 Rectal unit 9 Temperature sensor 14 Contents button 43 Contraindications 149 Control Panel 63 Advanced mode Control Panel 56 72 93 Manual mode Control Panel 74 94 Standard mode Control Panel 56 71 Control Unit 8 14 21 45 Automatic treatment mode 49 92 94 94 Calibration process 49 61 Clean 97 Coolant system 12 Cooled ThermoTherapy Treatment 40 49 Daily maintenance 98 Data file 48 69 81 Demonstration mode 40 41 42 48 52 58 59 60 80 Description overview 8 14 Emergency 14 Equal potential ground cable 19 Equipment connections 20 Equipment testing 21 Equipment warranty 99 Features 9 Fuses 99 100 99 100 Headphone jack 14 Housing 8 97 Install 18 Keyboard 10 39 105 Maintenance 22 98 99 Manual treatment mode 74 76 81 94 95 Microwave catheter and rectal unit connection picture 36 Microwave Off button 59 Microwave Off pushbutton 14 59 Models 105 Move 103 4 ON 45 ON OFF power switch 11 Operating conditions 10
10. 92 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 3 7 1 1 Ramp e Monitor the patient for discomfort and adjust the ramp rate 1f necessary from the advanced mode on the Control Panel e Adjust the microwave catheter and coolant setting temperatures as desired However Urologix recommends using the default microwave catheter and default coolant setting temperatures 3 7 1 2 Treatment The treatment timer counts up the amount of time elapsed when the criteria defined in Table 3 4 Section 3 3 5 Urologix BPH Treatment screen are met If the rectal unit temperature is nearing 41 C the CoolWave Control Unit automatically increases the temperature of the coolant but not the displayed setting temperature to compensate Adjust the treatment time to select when the automatic treatment mode automatically stops microwave power oe The treatment timer runs when the following conditions occur Targis CTC Advance CTC Advance Short amp Standard Short Standard amp Long e Urethra gt 35 C with e Urethra 35 C with e Urethra 35 C with Urethra Coolant Urethra Coolant Urethra Coolant difference gt 23 C difference gt 20 C difference gt 20 C e OR MW Power 50 W e OR MW Power 50 W e OR MW Power gt 65 W e OR RTU241 C e OR RTU 241 C e OR RTU 241 C Monitor the patient for discomfort and adjust the following settings if necessary e Decrease the u
11. Accents Blue Handle Grey Accents White Catheter Green Handle White Catheter White Handle Serial Number Tag Color Section 2 Serial Number Prefix y Note The serial number label is attached to the cable of the microwave catheter near the connection to the patient cable w Caution The microwave antenna on the distal end of the microwave catheter may break if you bend it Do not grab the microwave catheter or squeeze it in the area of the antenna or the shaft The optical fiber located in the flexible shaft may be broken 1f it is clamped Open the package containing the microwave catheter Figure 2 7 Test the location balloon by filling it with 10 cc of sterile water and examining it for leaks Part 250023 001 Rev J 29 of 182 Section 2 Treatment Session Setup to N Balloon inflation port Microwave antenna A Cooling connector XY amp Shaft channel i A j yd s Coude tip i A TPA ay A A Sy TAA A a a AN he ge sa eae SS Ea Wom i sen EN aN RN _ maa a i fy Ta SA N borne e AS se MA Ma RN F muen kA Ea J N re rR ve saint b F ee w Pa gm m SE uen 3 i 7 aP F a a e RR Location balloon Temperature sensor Urine drainage port connector Serial number label Figure 2 7 CTC Advance Microwave Catheter a Note For this user manual the representative microwave catheter is the CTC Advance Microwave Catheter Lubricate the
12. temperature sensor pressure sensor and peristaltic pump mechanism Coolant pump See peristaltic pump mechanism Coolant set point The temperature at which the cooling system is set to regulate the temperature of the water circulating through the microwave catheter The actual water temperature may be different from this value during the time that the system chills or warms the water Once the water reaches the coolant set point value the coolant temperature is maintained within a small tolerance of this value Coolant system The coolant system consists of a chill plate temperature and pressure sensors a peristaltic pump mechanism and a coolant bag Coolant temperature The actual measured temperature of the water circulating through the microwave catheter This temperature is measured at the sensor block just before the water leaves the Control Unit Cooldown The time in a treatment when the microwave power is OFF the coolant pump is running and the cooldown 5 minute timer appears Cooled ThermoTherapy Treatment A medical treatment that uses microwave energy to destroy the prostatic tissue that constricts the urethra while preserving urethral function and tissue Part 250023 001 Rev J 131 of 182 Section 5 Appendix A Cooling channel The tiny passageways adjacent to the antenna within the microwave catheter that transport chilled sterile water throughout the catheter to maintain a urethral temperature Cooling
13. 0 37 0 37 0 37 0 Distal Proximal Serial Number 0123456A4AAAAAB Temp High Temp Low Disconnect Temperature 36 7 C Temp High UU UUUIVUUTUU Urethra Signal Level 50 0 Temp Low Serial Number 9876543210ABCDE j i Pump Reset MW Power Off ese Close Figure 3 53 Example of a Debug screen 5 Press the Back button to return to the Options Menu screen 3 6 System errors This section contains information on system errors general halt errors calibration errors and treatment errors Error messages can appear on the System Error screen the System Calibration screen the Event pane and the Detail pane e Note If you receive an error message on the System Calibration screen the System Error screen or while on the Urologix BPH Treatment screen pressing the Help button provides you with information about the displayed error message 3 6 1 General halt errors If the CoolWave Control Unit discovers a significant hardware problem you will hear a single beep and an error message will appear on the System Error screen Figure 3 54 in the Detail pane or in the Event pane You cannot continue using the CoolWave Control Unit The Reset button Event and Detail panes and System Error screen and the Resume Treatment button Cooldown pane will appear grayed out Review the following conditions and actions Microwave power will turn OFF if there is a treatment in progress The error message will be saved to the eve
14. 169 Disposable balloon See Rectal balloon Edema 79 Emergency Control Unit 14 Enter Manual Mode dialog box 75 Equal potential ground cable 19 Part 250023 001 Rev J Section 7 Equipment 5 6 7 8 16 104 Clinic supplied 17 Component testing 21 Connections 20 Electromagnetic energy 7 Maintenance 22 98 99 Safety concerns 21 Safety symbols 5 Type BF 127 Urologix supplied 17 Equipment overview 8 Equipment warranty 99 Error 42 62 65 66 92 Calibration 30 89 90 91 General halt 89 90 System 65 66 89 90 107 See also System error Treatment 89 92 Error icon 62 Error message See also System error Calibration 91 General halt 90 Treatment 92 Event button 65 Event log 69 Calibration error 90 General halt error 89 Print 69 Treatment 65 66 Event pane 65 66 89 Events button 69 Fiber optic Connector 9 Temperature sensor 14 Finger pad 15 Flash drive See USB flash drive Frequently Asked Patient Questions 159 Full Name data field 47 81 Fuse 99 100 Catalog number 99 Holder cap 100 Overview 99 Types 99 General halt error 89 90 General halt error message 90 Glossary button 43 Go To Cooldown button 76 Handle key hole 33 Headphone jack 14 Help button 42 Help feature 41 42 43 Help window 42 43 Holder Cable holder 9 11 104 Microwave catheter Holder 35 Microwave catheter Holder 17 Microwave catheter Holder 129 Tubing holder 28 Housing 175 of 1
15. 250023 001 Rev J 139 of 182 Section 5 Appendix A Guidance and manufacturer s declaration Electromagnetic Immunity The Targis System with CoolWave Control Unit is intended for use in the electromagnetic environment specified below The customer or the user of the Targis System with CoolWave Control Unit should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Targis System with CoolWave Control Unit including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter ADEE tree ty E separation distance IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m d 1 2 P 80MEz to IEC 61000 4 3 80MHz to 2 5 GHz 800 MHz d 2 3VP g00MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol lo Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not
16. 3 Microwave catheter may be defective ACTION STEPS Reattach fiber connector Clean both ends of connection with alcohol wipe or swab Allow microwave catheter temperature to drop lt 41 C Replace the microwave catheter ERROR 18 URETHRA TEMP LOW POSSIBLE CAUSES 1 Loose microwave catheter fiber connectors 2 Microwave catheter may be defective ACTION STEPS Reattach connector Replace the microwave catheter ERROR 19 CATHETER EFFICIENCY LOW POSSIBLE CAUSES 1 Cable may not be connected properly 2 Microwave catheter may not be inserted properly Urine drainage line not purged 4 Defective microwave catheter SS 112 of 182 ACTION STEPS Reattach connector Rotate the Microwave Antenna Connector nut 4 full turns with your fingers until snug to ensure a proper connection Check that the microwave catheter is inserted properly Purge urine drainage line Replace the microwave catheter and recalibrate Part 250023 001 Rev J Appendix A Section 5 ERROR 20 PUMP LATCH OPEN POSSIBLE CAUSES 1 Coolant pump clamp latch is open 2 Lift lever has failed ACTION STEPS Close the latch Open and close lift lever and listen for 2 clicks ERROR 21 USER PRESSED MICROWAVE OFF POSSIBLE CAUSES 1 User accidentally pressed the Microwave Off pushbutton 2 Patient was experiencing pain 3 Microwave indicator was illuminated when it should not have been
17. 3 3 5 3 Using manual mode When the manual treatment mode is active the interval timer will appear on the Status Panel This timer indicates the amount of time elapsed since you last adjusted microwave power and can be used to help you in timing a manual treatment Refer to Section 3 7 2 Manual treatment mode for further information on using the manual treatment mode a Note If you do not have access to the manual treatment mode you will not see this option on the Control Panel Control Panel Coolant ae Setting 7 2 Pump On Off Ramp Rate A FA Gon Fast Manual N j Figure 3 38 Manual mode 74 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 1 Select Yes or No when the Enter Manual Mode dialog box appears Proceed to step 2 if entering the manual treatment mode selecting No returns you to the Urologix BPH Treatment screen 2 Adjust the power setting pump ON OFF coolant setting and ramp rate from the Control Panel Figure 3 38 if desired a Press the Power Setting button Press the up and down arrows to adjust the microwave power setting from 0 0 W to 60 0 W for a Targis and CTC Advance Short Microwave Catheters and from 0 0 W to 75 0 W for a CTC Advance Standard or Long Microwave Catheters in 1 W increments Figure 3 39 Press the Close button when done b Press the Pump On Off button Press the up and down arrows to turn the coolant pump ON or OFF In additi
18. 3 41 and then the Resume button Figure 3 40 to resume the treatment c End the cooldown Press the Cooldown End button to end the cooldown Figure 3 41 A dialog box appears to confirm that you want to end the cooldown and therefore end this treatment Part 250023 001 Rev J 71 of 182 Section 3 Treatment Instructions 3 3 5 5 Ending a treatment l Monitor the cooldown 5 minute timer Figure 3 33 This timer shows the time remaining until the end of cooldown which also indicates how much time has passed since the microwave power was turned OFF with the coolant pump still running Select one of the following options in cooldown remain in cooldown for the full 5 minutes 10 minutes or 15 minutes reset the 5 minute cooldown timer or end the cooldown Notes e tis recommended that the cooldown phase last 5 minutes prior to exiting the treatment e Once you exit cooldown the treatment is done and cannot be resumed a Remain in cooldown Cooldown ends after 5 minutes and the Treatment Cooldown End window appears Figure 3 41 If you need to reset the 5 minute cooldown timer proceed to step 2b Or you can return to the Urologix BPH Treatment screen Status Panel status at pause Press the Resume Treatment button Figure 3 41 Finally you can exit the treatment Press the Exit button Figure 3 41 A dialog box appears to confirm that you want to exit and therefore end this treatment b Reset the tim
19. 39 3 1 System Navigation nd Screen QVETVICOW vasiwsicssaiwecstencdunntasti ove csutiessuseisaduesiiscan sit N a 39 3 2 CoolWave Control Unit setup asc ceecscneyoiced Sea castvoscecacecons a6 cadseseattdnsonsiadia ctor doe SicdsoestsdesiopGtindieacatcsedes 45 3 3 Cooled Thermo lherapys V TTEN ior i aaa E TEE E EE E a dataas Sictietks 49 SA POSEDE faa E E a n E e a a a a susdeeee 78 PS COMMON OIE OP ONS a case tectaacacda as iaica toe kauaeecauanaeate Dee aoe se area anata Renee neiwauaiess 80 LO STOIC I Oly eae E TE A EEA A T O EAE E O TOO AE 89 Se TNO E EE A E E A E E pa snoadash ete eoeaee eee 92 Part 250023 001 Rev J 3 of 182 4 Egdupm nt VIATITCIAN CE sinna a eea ra eeoa aE aanas a inae 97 4 C leonine ANC egu NEN ti E EAE A 97 4 2 Maintaining the CoolWave Control Unit c c ccccccccscccscsssssssssssesesesssesesesesvevsvacscsesesvscsvavavacaeneseseees 98 Aa Manainn he PTU CT Sar ea a E E E EA O ated das E O O 100 4 4 Moving the CoolWave Control Uniit cccccccccccccsssssssessssssesvevsvsvsescsvevscseseusescscsvavscsensesesvavavacacneseseees 104 4 5 Storing the CoolWave Control Unit ccccccccccccccecscsssssssvsssescssssscseevsvscsvevssscsessesvsvsvacsesessesvsvavacseseess 104 4 6 Shipping the CoolWave Control Uniit c cccccccscscsssssssssesessssssscsescvscsvsvevscsesessescsvavacscsesesesvavacacsees 104 4 7 CoolWave Control Unit specifications ccccccccscsessssssssssssssssrevscsessevavevacsesevsesssvavavacsenseavavav
20. 89 System Error screen 89 90 92 System Settings screen 85 89 Treatment Checklist screen 59 60 Urologix BPH Treatment screen 62 89 User Settings screen 81 82 Screen name 41 Screen overview 41 See also Treatment screen flowchart Sensor Channel See Temperature sensor channel Module 16 Pressure 12 13 Temperature 90 Temperature 12 13 14 15 Serial number Microwave catheter 54 58 Rectal unit 54 58 Service Control Unit 21 Service agreement 99 Service port 9 Set point Coolant temperature 49 Microwave catheter temperature 49 Ramp rate 49 Sheath 16 Ship Control Unit 104 Storage conditions 105 Sight gauge See Internal coolant level indicator Single use balloon See Rectal balloon Software version 41 Speaker volume 87 Specifications Coolant system 105 Coolant temperature 105 Microwave power output 105 Rectal temperature 105 Urethra temperature 105 User interface 105 Standard button 70 76 Standard mode 71 72 Standard mode Control Panel 56 71 Status Panel 63 74 Store Control Unit 104 Symbols 5 126 28 System button 80 System Calibration screen 49 60 62 89 System critical error See System error System error 65 66 89 90 107 Detected by software 119 Part 250023 001 Rev J Index Section 7 Error 001 Rectal Temp High 107 Targis Microwave catheter Error 002 Rectal Temp Low 108 Default coolant setting 58 73 Error 003 Coolant Press High 108 Default coolant set
21. A catheter holder was used to maintain the microwave catheter and RTU in the proper position and these units were connected to the Targis CoolWave Control Unit After the calibration process was satisfactorily completed the treatment started when the treatment parameters were met and was completed after___ minutes After a 5 minute cool down period the microwave catheter and the RTU were removed and a fr Foley catheter was inserted into the patient s bladder and retained A drainage bag was attached Complete instructions on catheter care and follow up appointments were given to the patient Please see the chart notes for detail Physician s signature Date Cooled ThermoTherapy is available by prescription only This therapy is not for everyone Talk to your physician to see if Cooled ThermoTherapy is right for you Most medical treatments may have side effects Possible side effects for Cooled ThermoTherapy include blood in urine clots in urine painful or difficult urination thickened bladder muscle rectal irritation temporary inability to control urination brief inability to achieve or maintain an erection and the inability to discharge semen in orgasm thus should be considered by men who wish to have further offspring A small risk of urethral stricture may result requiring further intervention Patients may experience discomfort during the treatment that may require the use of analgesics or sedatives Patients may be catheterize
22. C Room ventilation system should provide 8 10 air changes per hour for natural odor removal 20cm clearance around the base of the CoolWave Control Unit e Please refer to the Section 2 of this User Manual for additional information Required Supplies and Equipment Ultrasound Equipment with Transrectal or Transabdominal Probe Recommended Supplies and Equipment Standard Urological Supplies Straight catheter 14 16 French Foley catheter 16 18 French Anesthetic lubricating jelly Urojet Anestecon or lidocaine jelly Local bladder anesthetic of choice e g 50 cc of 1 or 2 lidocaine without epinephrine Water soluble lubricating gel e g KY 200 cc sterile water for Coolant Bag and Microwave Catheter balloons 60 cc catheter tip syringe e g Toomey syringe 60 cc luer lok syringe 10cc luer lok syringe x2 Catheter plug Urine drainage bag Permanent marker or tape Sterile gloves Non sterile gloves Penile clamp Specimen cup Urinal or graduate Ice or ice pack 154 of 182 Part 250023 001 Rev J Appendix B Section 6 Targis System CoolWave Control Unit Patient Comfort Kit including Microwave Catheter Holder and Knee Cushions Procedure Kit including Sterile Microwave Catheter and Rectal Thermosensing Unit RTU Coolant Bag Pretreatment and Treatment Preparation The Facility Environment A comfortable and restful atmosphere he
23. C with e Urethra gt 35 C with Urethra Coolant Urethra Coolant Urethra Coolant difference gt 23 C difference gt 20 C difference gt 20 C e OR MW Power 50 W e OR MW Power 50 W e OR MW Power gt 65 W e OR RTU2 gt 41 C e OR RTU2 gt 41 C e OR RTU2 gt 41 C Table 3 3 Treatment Timer algorithms a Urethra setting Press the up and down arrows to adjust the urethra setting temperature in 0 5 C increments The default urethra setting temperature for the Targis Microwave Catheter and the CTC Advance Microwave Catheter are 40 C b Coolant setting Press the up and down arrows to adjust the coolant setting temperature in 0 5 C increments The following table includes the default coolant setting temperature for the Targis Microwave Catheter and the CTC Advance Microwave Catheter DEFAULT COOLANT SETTING TEMPERATURE Microwave Catheter Microwave Catheter The coolant temperature will ramp to its coolant setting temperature during a treatment c Ramp rate Press the up and down arrows to select the ramp rate slow medium fast approximately 12 8 4 minutes respectively 7 Press the OK button to save the new treatment parameter s Or press the Cancel button to return to the original treatment parameters for that protocol 8 Press the Next button to go to the next screen Or press the Back button to return to the previous screen Demonstration mode The CoolWave
24. Error screen only e Run the CoolWave Control Unit for 5 minutes to cool the patient s urethra before removing the microwave catheter if applicable e Contact Urologix Customer Service at 1 888 229 0772 for assistance a Note If one of these messages appears refer to Section 5 1 Troubleshooting guide for further information 3 7 Treatment modes After completing the calibration process the CoolWave Control Unit will enter the automatic treatment mode The other treatment mode available from the Urologix BPH Treatment screen is the manual treatment mode This section provides background information on both of these treatment modes However for specific information on using the CoolWave Control Unit begin with Section 3 3 Cooled ThermoTherapy Treatment 3 7 1 Automatic treatment mode In automatic treatment mode the CoolWave Control Unit automatically ramps the urethra and coolant temperatures to their settings based on the selected ramp rate In addition a CoolWave Control Unit operating in automatic treatment mode will adjust the coolant temperature to respond to rectal and urethra temperatures and will discontinue microwave power when the treatment timer has elapsed therefore automatically beginning cooldown The automatic treatment mode consists of 3 parts ramp treatment and cooldown a Note If an error occurs during automatic treatment mode the CoolWave Control Unit will turn OFF microwave power
25. Evidence of bacterial prostatitis Bladder neck contracture Renal impairment Urinary sphincter abnormalities Coagulation disorders e For patients with active implanted devices located greater than 2 6 inches 6 5 cm from the prostatic urethra it is recommended that non cardiac devices be turned OFF during the treatment with the Targis System if possible e g active implanted devices used in the treatment of pain or incontinence to lessen the likelihood of adverse interaction caused by electromagnetic interference If possible active implanted devices that must remain ON should be programmed to the bipolar configuration Implanted cardioverter defibrillators should be set to monitor only mode during therapy Regardless of whether active implanted devices gt 2 6 inches 6 5 cm from the prostatic urethra can be turned OFF the patient should be monitored during the Cooled ThermoTherapy treatment for possible interactions In the unlikely event of an active implanted device programming change the device should be interrogated following the treatment with the Targis System e All components of the Targis System must be used in a manner consistent with the instructions set forth in their respective Instructions for Use insert and the Targis System CoolWave Control Unit User Manual Failure to do so may result in insufficient treatment or increased risk 150 of 182 Part 250023 001 Rev J Appendix B Section 6 of injury or in
26. Lockable wheels Keep the CoolWave Control Unit from moving by locking the front wheels Figure 1 7 Wheel lock tabs ar M ia TS N i ere 5 a4 ie 7 Se t mo ae he si es a E oI Bay Figure 1 7 Wheel lock tabs To lock the wheels use your foot to press down on the wheel lock tabs To unlock the wheels press on the back part of the wheel lock tabs Coolant System The Coolant System consists of a chill plate temperature and pressure sensors a peristaltic pump mechanism and a coolant bag Figure 1 8 12 of 182 Part 250023 001 Rev J System Description Section 1 Coolant bag fits over chill plate Pump tubing clamp Temperature sensor Pressure Pump mechanism sensor Mounting pin 3 pins Figure 1 8 Coolant System features Chill plate The chill plate located behind the coolant door Figure 1 8 is equipped with mounting pins to hold the coolant bag securely against the chill plate surface Temperature and pressure sensors These sensors located on the CoolWave Control Unit monitor the coolant temperature and the coolant pressure Figure 1 8 Peristaltic pump mechanism The peristaltic pump mechanism Figure 1 8 circulates the coolant Coolant bag The coolant bag Figure 1 8 serves as the reservoir for the coolant Main power indicator and microwave power indicator The main power indicator Figure 1 9 located under the touchscreen monitor is a green LED that illumi
27. Pressure 5 5 psi Ambient Joong psi Low Latch Maximum 37 0 2G 1 2 3 4 5 Rectal 37 0 37 0 37 0 37 0 37 0 Distal Proximal Serial Number 0123456AAAAAAAB Temp High Temp Low Disconnect Temperature 34 8 C Signal Level 50 0 Temp High UU UUUJUUU Temp Low Serial Number 9876543210ABCDE Figure 5 2 Treatment Restart Cooling This screen Figure 5 2 will display the current values for the coolant rectal and urethra sensors as well as current warnings and errors Any active error will be marked with a red light To reset warnings and errors press the Reset button For additional information about system errors refer to Section 3 6 System Errors Wn ote You may need to review this information if an error occurs and does not resolve At this point contact Urologix Customer Service 1 888 229 0772 to help you resolve any remaining errors 122 of 182 Part 250023 001 Rev J Appendix A Section 5 Cooling Timer Pre Number 0123456AAAAAAAB E Fe ee Va 50 0 O No Errors Rt Figure 5 3 Treatment Restart Cooling Calibrate After the Cooling Timer has reached 5 minutes press Calibrate button to continue to the Treatment Checklist screen and begin calibration Wrote The same catheter RFID tag must be connected In the event of a catheter RFID tag error the following message will appear Figure 5 4 ame as befo Figure 5 4 RFID Tag Error Part 250023 001 R
28. Replace button to return to the Protocol Screen using the currently attached catheter ERROR 426 MULTIPLE CATHETER RFIDS POSSIBLE CAUSES ACTION STEPS 1 More than microwave catheter near Remove the extra microwave catheters the patient connection cable housing from the area around the patient cable ERROR 427 MULTIPLE RECTAL RFIDS POSSIBLE CAUSES ACTION STEPS 1 More than 1 rectal unit near the patient Remove the extra rectal units from the connection cable housing area around the patient cable ERROR 428 NO CATHETER RFID SENSED POSSIBLE CAUSES ACTION STEPS 1 The microwave catheter RFID tag has Replace the same microwave catheter so been removed from the patient that the CoolWave Control Unit can connection cable housing area access the RFID tag 2 The microwave catheter RFID tag is Adjust the orientation of the tag label on not in range the microwave catheter so that it can be read Part 250023 001 Rev J 117 of 182 Section 5 Appendix A ERROR 429 NO RECTAL RFID SENSED POSSIBLE CAUSES ACTION STEPS 1 The rectal unit RFID tag has been Replace the same rectal unit so that the removed from the patient connection CoolWave Control Unit can access the cable housing area RFID tag 2 The rectal unit tag is not in range Adjust the orientation of the tag label on the rectal unit so that it can be read ERROR 431 MANY RFIDS SENSED POSSIBLE CAUSES ACTION STEPS 1 More than 4 RFID tags are n
29. Rev J 9 of 182 Section 1 System Description Latch Touchscreen monitor Figure 1 3 Touchscreen monitor u Note Keep the touchscreen clean since debris water droplets or lidocaine jelly can affect its ability to register a touch Keyboard Enter patient data using the keyboard Figure 1 4 The keys are sealed to prevent damage from spillage onto the keyboard To access the keyboard lift the touchscreen monitor into an upright position Keyboard Figure 1 4 Keyboard 10 of 182 Part 250023 001 Rev J System Description Section 1 Printer 1 Print data from any treatment using the Canon color inkjet printer Figure 1 5 The printer drawer pulls out and holds the printer y Caution The CoolWave Control Unit can tip over if you press down on the open printer drawer with too much weight Do not press down on the open drawer with more than 20 kg 44 lbs Printer Figure 1 5 Printer ON OFF power switch Clil Instruction Manual Read the CoolWave Control Unit User Manual this document before turning ON and operating the system Turn the CoolWave Control Unit ON or OFF with this power switch Figure 1 6 located on the back of the CoolWave Control Unit When not in use place the power cord in the cable holder located on the back of the CoolWave Control Unit Part 250023 001 Rev J 11 of 182 Section 1 System Description ONOFF power switch Figure 1 6 ON OFF power switch
30. Setup Section 2 2 Treatment Session Setup 2 1 General safety precautions The CoolWave Control Unit is a medical device equipped with the ability to emit microwave radiation Therefore observe the following general safety precautions e The CoolWave Control Unit must only be installed and serviced by qualified service personnel e The CoolWave Control Unit may not be used for any purpose other than those for which it is designed and approved and then only in accordance with this manual The CoolWave Control Unit may be used only by authorized and properly trained personnel and the treating physician must be present throughout the duration of the Cooled ThermoTherapy treatment The CoolWave Control Unit display must be monitored and controlled during the course of a treatment session to make sure that the urethral and rectal temperatures are within prescribed treatment parameters The CoolWave Control Unit must never be left unattended when the machine is switched ON The CoolWave Control Unit is exclusively for use by physicians who have been trained The treating physician should be present at all times during treatment 2 2 Treatment session setup overview The treatment session requires several preparation steps Some of these steps may be done concurrently e Preparing the patient for treatment Positioning and preparing the CoolWave Control Unit Installing the coolant bag Inserting the microwave cat
31. Urethra setting Urethra temperature 8 14 15 64 66 Automatic treatment mode 92 Temperature range specifications 105 Urine Drainage bag 14 Drainage lumen 30 Drainage port 14 Urologix Customer Service 6 Urologix supplied equipment 17 Urologix BPH Treatment screen 62 89 USB flash drive 14 84 USB port 14 84 User interface specifications 105 User Login window 46 47 User name 41 47 Demonstration mode 48 User Name data field 47 User setting Allow Administrator Privileges 81 Allow Clinical Protocols 81 Allow Manual Control 81 Reset Password 82 User Settings screen 81 82 Users button 80 View button 83 Volume System setting speaker 87 Volume control 14 Warning 5 Warnings See Safety information Warranty 99 Wheel lock tab See Wheels Wheels 12 Window Create New User window 46 47 Current Error or Warning window 65 66 Data window 83 Help window 42 43 Notes Entry window 44 45 Password Setup window 84 Print window 69 Treatment Cooldown window 70 77 94 95 User Login window 46 47 Zoom button 64 Part 250023 001 Rev J Index Section 7 Part 250023 001 Rev J 181 of 182 Urologix Inc 14405 Twenty First Avenue North Minneapolis MN 55447 4640 763 475 1400 Phone 800 475 1403 Toll free 763 475 1443 Fax 888 229 0772 Toll free 24 hour customer service www urologix com Emergo Europe Molenstraat 15 REP 2513 BH The Hague The Netherlands Tel 31
32. Urologix Customer Service ERROR 317 LOW VOLTAGE STARTUP POSSIBLE CAUSES ACTION STEPS 1 Low voltage at start up Verify that an extension cord is not being used and check the circuit breaker for sufficient current capability 2 Hardware failsafe switch in wrong Call Urologix Customer Service position ERROR 422 INVALID RECTAL RFID POSSIBLE CAUSES ACTION STEPS 1 The rectal unit RFID tag is being read Replace the rectal unit with one that but it contains invalid data contains a valid RFID tag ERROR 423 DIFFERENT RECTAL RFID POSSIBLE CAUSES ACTION STEPS 1 The rectal unit RFID tag is different Reattach the original rectal unit and select from the one displayed on the Protocol the Retry button or select the Replace Screen button to return to the Protocol Screen using the currently attached rectal unit 116 of 182 Part 250023 001 Rev J Appendix A Section 5 ERROR 424 INVALID TAG POSSIBLE CAUSES ACTION STEPS 1 An RFID tag is being read but it Remove the connectors from both contains invalid data disposable devices and replace them individually Observe the rectal unit and microwave catheter serial number fields to determine which RFID tag is invalid ERROR 425 DIFFERENT CATHETER RFID POSSIBLE CAUSES ACTION STEPS 1 The catheter RFID tag is different from Reattach the original microwave catheter the one displayed on the Protocol and select the Retry button or select the Screen
33. Volume 87 Treatment report 83 System Settings screen 85 89 Case note 69 Target temperature See Set point Copy 84 Part 250023 001 Rev J 179 of 182 Section 7 Event log 69 Patient data 69 Print 69 84 Treatment chart 69 Treatment data 69 Treatment protocol 69 View 83 Treatment Restart 121 122 123 Treatment safety check 50 Treatment screen flowchart 125 Treatment screen overview See Treatment screen flowchart Treatment session 23 Treatment status Cool 64 Pause 64 Ramp 64 Treat 64 Treatment time 9 49 56 71 93 94 Advanced mode 73 Elapsed See Treatment timer Manual treatment mode 94 Remaining 64 Standard mode 71 Treatment Time button 71 Treatment timer 58 64 92 Algorithms 64 Troubleshooting See System error Tubing Balloon inflation 33 Clamp 26 Coolant 14 16 Extension 32 Holder 28 Semirigid 32 Type See Rating Ultrasound 6 Transabdominal 50 Universal Precautions for Contamination 78 Universal Serial Bus flash drive See USB flash drive Universal Serial Bus port See USB port Upper pump tubing clamp 27 Urethra 8 64 General halt error 89 Microwave catheter 14 Post treatment 79 Treatment error 92 Urethra setting 49 58 94 Advanced mode 73 Automatic treatment mode 93 180 of 182 index Patient comfort automatic treatment mode 93 Patient comfort manual treatment mode 95 Standard mode 71 Urethra Setting button 71 Urethra setting temperature See
34. at your local drug store 4 The catheter has a drainage bag attached to it It is important to ensure that the drainage bag is below the level of the bladder to prevent urine from going back up the tube and contaminating the bladder This reduces the possibility of urinary tract infection 5 Itis important to avoid any tension on the catheter Tension on the catheter can cause discomfort to tender tissues or dislodge the catheter from the bladder You may take a daily shower However avoid a bath until the catheter has been removed 7 Observe the catheter for any signs of infection Note and report any signs of swelling inflammation colored discharge or elevated temperatures to your physician D If you have ANY questions after your return home please do not hesitate to call Your physician clinician 1s Phone number After normal business hours call Cooled ThermoTherapy is available by prescription only This therapy is not for everyone Talk to your physician to see if Cooled ThermoTherapy is right for you Most medical treatments may have side effects Possible side effects for Cooled ThermoTherapy include blood in urine clots in urine painful or difficult urination thickened bladder muscle rectal irritation temporary inability to control urination brief inability to achieve or maintain an erection and the inability to discharge semen in orgasm thus should be considered by men who wish to have further offspring A s
35. determine whether its components are functioning properly 1 Rectal unit and temperature sensors are operating within 2 degrees of each other 2 Urethra temperature sensor is operational 3 Pressure in the microwave cooling system 1s normal and 4 Antenna is operational as verified by a frequency sweep Catheterization The placement of the microwave catheter or urine drainage catheter into the urethra 130 of 182 Part 250023 001 Rev J Appendix A Section 5 Chill plate One of the components of the CoolWave Control Unit coolant system that removes heat from the coolant bag Computer subsystem The CoolWave Control Unit contains a computer that allows the clinician to input patient identification data control the treatment and collect treatment data Control Panel The area of the Urologix BPH Treatment screen that allows you to adjust urethra temperature treatment time coolant temperature and ramp rate You can also pause or end a treatment Coolant Bag The coolant bag is comprised of 3 main subassemblies coolant bag coolant reservoir sensor module and tubing with connectors The coolant bag is a container that fits against the chill plate It is filled with sterile distilled water coolant that circulates through the microwave catheter during treatment to preserve urethral tissue Coolant door The large panel on the right side of the CoolWave Control Unit behind which is located the coolant bag chill plate
36. discomfort after the treatment On occasion some bloody discharge may be apparent from the penis You may have soreness in the lower abdomen and it may be uncomfortable to sit You may experience the need to urinate more frequently and with greater urgency These are all normal reactions to the treatment It is important to take care of yourself the next couple of days to facilitate a speedy recovery The following are some suggestions 1 Have someone drive you home after the treatment 2 Drink plenty of water 3 Do not engage in strenuous activity until the catheter is removed 4 You may take a shower Avoid a bath until your catheter has been removed 5 Take your medication as prescribed MEDICATIONS Take the following medications as directed e When taking pain medications you may experience dizziness or drowsiness Do not drink alcohol or drive when you are taking these medications e If you are given an antibiotic to prevent urinary tract infection it is important to finish all medications as directed See instructions for Care of Catheter COMPLICATIONS You should contact your physician at if you experience any of the following 1 Temperature above 101 5 taken by mouth Excessive urinary bleeding or bleeding from the penis Continuous bladder spasms Painful swollen and or inflated testicle s or scrotum Unable to void spontaneously or the indwelling catheter is not draining urine or is blocked Difficulty moving bow
37. into the inflation port located on the proximal end of the rectal unit Adjust air volume for patient comfort to no less than 80 cc Close the valve on the inflation port Re verify proper positioning of the rectal unit by observing that the orientation flag located on the balloon is facing away from the prostate and toward the patient s posterior K 7 Warning A minimum of 80 cc of air in the standard RTU rectal balloon is required to maintain contact between the temperature sensors and the rectal wall M Y Warning This visual reference should be made every 5 to 10 minutes throughout the treatment to verify the proper position of the rectal unit Failure to properly orient the rectal unit during treatment can result in patient injury e g fistula or scrotal burn 2 8 Inserting the RTU Plus Reusable Handle and Single Use Balloon Verify the patient has received an enema Open the package for the RTU Plus Reusable Handle or obtain a disinfected RTU Plus Handle from a previous treatment Figure 2 10 The RTU Plus Handle with the temperature sensors should not be used in more than 30 treatments Handle Key hole Side View Connector Temperature sensors Inflation tubing channel Cable Figure 2 10 RTU Plus Reusable Handle Open the package for a RTU Plus Disposable Balloon Figure 2 11 Semirigid Rectal ballon tubing Undeployed sheath Locating key Balloon inflation port Figure 2 11 RTU Plus Dispos
38. lamp flashes twice the printer prints the nozzle check pattern Inspect the nozzle check pattern printout Missing lines in the chart mean the print head for the black ink cartridge needs cleaning White stripes in the bar graph mean the print head for the color ink cartridge needs cleaning Refer to Section 4 3 4 Cleaning the Print Head for further information a Note If the nozzle check pattern does not print properly and the ink level is low replace the ink tank Refer to Section 4 3 2 Replacing an Ink Tank for further information 102 of 182 Part 250023 001 Rev J Equipment Maintenance Section 4 4 3 4 Cleaning the Print Head a Notes J Print and inspect the nozzle check pattern before cleaning the print head A print head cleaning uses up ink and should be performed only when needed e You can also clean the print head from the Printer Utilities screen Refer to Section 3 5 2 Printer Utilities screen for further information 1 Open the paper rest and press the Power button Figure 4 3 The power lamp next to the Power button will be green when the printer is ready Figure 4 3 2 Press and hold the Resume Cancel button Figure 4 3 on the printer When the power lamp flashes once the printer cleans the print head 4 3 5 Printer Replacement a Notes Printer replacement maybe necessary if an issue arises that cannot be addressed by the routine maintenance described above in Sections 4 3 1 4 3 4 e Contac
39. locates the microwave antenna within the bladder bladder neck Manual mode Though the CoolWave Control Unit begins a treatment based on the selected treatment protocol you can manually adjust the microwave power and coolant pump ON vs OFF during the treatment Messages Directions or reports that assist the clinician in monitoring a Cooled ThermoTherapy treatment Microwave antenna The component within the microwave catheter that generates heat energy to destroy prostate tissue Microwave Off pushbutton The red button located under the touchscreen on the CoolWave Control Unit that allows you to discontinue the delivery of microwave power immediately Microwave catheter A disposable catheter based device which is delivered sterile that is inserted into the urethra It includes a fiber optic temperature sensor to measure urethral temperature a microwave antenna and cable cooling channels and connectors a urine drainage port that connects to a standard urine drainage bag and a location balloon to position the catheter at the bladder neck Microwave catheter balloon See location balloon Microwave Catheter Holder The Microwave Catheter Holder is designed to hold the microwave catheter in position during treatment Microwave catheter serial number The serial number of the microwave catheter used in a treatment and required for the patient s data file MW An abbreviation for microwave Neurogenic bladder Dy
40. medication as needed to help relax e Arrange for transportation home after the treatment patient should not drive himself home Prior to the treatment and as instructed by the treating urologist facility staff should e Ensure that an enema has been administered recommended 1 to 2 hours prior to the treatment and that the patient had results e Give the patient pre medication such as relaxants analgesics antibiotics and anti inflammatories e Explain the treatment by reviewing the patient information in the Instructions for Use with the patient Part 250023 001 Rev J 155 of 182 Section 6 Appendix B Instruct patient to disrobe Administer routine skin preparation of the meatal area e g Betadine prep Catheterize the patient drain the bladder and instill urethral and bladder local anesthetic Assist patient into a supine position with a maximum head shoulder elevation of 20 Follow the treating urologist s recommendations for monitoring Managing Patient Expectations Keys to Success An appropriately trained staff member directly involved in patient care should be with the patient throughout the treatment Only physicians who have been thoroughly trained on the operation of the CoolWave Control Unit and the Cooled ThermoTherapy treatment should deliver the Cooled ThermoTherapy treatment Attention by a qualified physician is required during the use of the Targis System A patient who is informed of
41. microwave catheter Disconnect coolant luers from microwave catheter and flush microwave catheter coolant luers with sterile water Reconnect coolant bag luers to microwave catheter and restart treatment If error repeats replace microwave catheter ERROR 4 COOLANT PRESS LOW POSSIBLE CAUSES 1 Pressure is too low in the tubing 2 Coolant tubing between coolant bag and sensor module may be twisted Coolant bag may be defective 4 Microwave catheter may be defective oS 108 of 182 ACTION STEPS Check water level in the coolant bag Check that pump tubing clamp is properly fastened Verify tubing is not twisted Replace the coolant bag Replace the microwave catheter Part 250023 001 Rev J Appendix A Section 5 ERROR 5 URETHRA TEMP HIGH POSSIBLE CAUSES ACTION STEPS 1 Loose microwave catheter fiber Reattach fiber connector Clean both connector ends of connection with alcohol wipe or swab 2 Temperature in urethra gt 44 5 C Allow microwave catheter temperature to drop lt 41 C 3 Microwave catheter may be defective Replace the microwave catheter ERROR 6 URETHRA TEMP LOW POSSIBLE CAUSES ACTION STEPS 1 Loose microwave catheter fiber Reattach fiber connector Clean both connectors ends of connection with alcohol wipe or swab 2 Microwave catheter may be defective Replace the microwave catheter ERROR 7 CATHETER EFFICIENCY LOW POSSIBLE CAUSES ACTION STEPS 1 Cable
42. microwave catheter with a water based lubricant or local anesthetic Insert the microwave catheter into the patient s urethra until the location balloon is completely in the bladder Align the microwave catheter so that the urine drainage port is pointed toward the patient s posterior and the coolant tubing is in an anterior orientation M Y Warning Avoid excessive force when pulling back on the microwave catheter to seat the balloon at the bladder neck Excessive force could injure the patient or damage the catheter Inflate the location balloon with 10 cc of sterile water Pull back on the microwave catheter until mild resistance 1s felt Flush the urine drainage lumen with 4 5 cc of sterile water Insert a catheter plug to retain bladder anesthetic if used or attach a urine drainage bag a Note Failure to flush the urine drainage lumen may cause system calibration errors Position the microwave catheter properly by pulling on it until the balloon is seated in the bladder neck locating the microwave antenna within the preprostatic urethra Figure 2 8 Verify microwave catheter position with the ultrasound probe M Y Warning Proper position of the location balloon is essential to patient safety 30 of 182 Part 250023 001 Rev J Treatment Session Setup Section 2 Urethra Prostate gland Bladder Rectal unit Rectal unit orientation flag Figure 2 8 Inserted Microwave Catheter and Standard RTU If the
43. on how to change system settings handle system errors and work in demonstration mode Section 4 Equipment Maintenance presents information on post treatment cleaning procedures and storage instructions You will also find information on how to move and ship the CoolWave Control Unit Finally this section discusses how to maintain the equipment though some maintenance requires a Urologix trained service representative Section 5 Appendix A includes a troubleshooting guide a flowchart of the treatment screens a description of the symbols used in the manual and on the labels an overview of the Patient Comfort Kit and a glossary of terms used in CoolWave Control Unit literature Section 6 Appendix B includes a Course Description Analgesia Guidelines Frequently Asked Questions and Sample Practice Forms Section 7 Index 1 4 Precautions Only those physicians who have been thoroughly trained on the operation of the CoolWave Control Unit and the Cooled ThermoTherapy treatment should deliver the treatment The Cooled ThermoTherapy Treatment must not be initiated without assurance that the microwave catheter is properly positioned in the patient The correct positioning of the microwave catheter must always be checked by ultrasound imaging prior to commencing treatment Improper placement or orientation of the microwave catheter may lead to treatment failures or heating damage of non target tissues such as the bladder neck e
44. open the housing of the CoolWave Control Unit Part 250023 001 Rev J 151 of 182 Section 6 Appendix B Power Requirements Supply European Version 220 240V 10 8 A Single phase 50 or 60 Hz US Version 110 120V 10 15 A Single phase 50 or 60 Hz Connections Hospital Grade plug While the above summarizes the use of Targis System please refer to specific product labeling the Targis System CoolWave Control Unit User Manual and Instructions for Use For product performance related questions please contact Urologix at 800 475 1403 152 of 182 Part 250023 001 Rev J Appendix B Section 6 6 4 CoolWave System Software Review Section 3 Treatment Instructions of this User Manual with the Physician Part 250023 001 Rev J 153 of 182 Section 6 Appendix B 6 5 Performing a Cooled ThermoTherapy Treatment Implementation Guidelines Facility e Adequate space should be available for patient preparation and post treatment recovery e The treatment room should have adequate floor space to accommodate the e following CoolWave Control Unit Treatment table Ultrasound unit Working space for staff e Other treatment room requirements include A standard 110 volt electrical supply for the CoolWave Control Unit European Version 220 240V 10 8 A Single phase 50 or 60 Hz Ajr conditioning to maintain ambient room temperature between 59 F 15 C and 95 F 35
45. prescription only This therapy is not for everyone Talk to your physician to see if Cooled ThermoTherapy is right for you Most medical treatments may have side effects Possible side effects for Cooled ThermoTherapy include blood in urine clots in urine painful or difficult urination thickened bladder muscle rectal irritation temporary inability to control urination brief inability to achieve or maintain an erection and the inability to discharge semen in orgasm thus should be considered by men who wish to have further offspring A small risk of urethral stricture may result requiring further intervention Patients may experience discomfort during the treatment that may require the use of analgesics or sedatives Patients may be catheterized for a 2 to 5 day period following the treatment For more complete information about the benefits and risks associated with Cooled ThermoTherapy please refer to the Instructions for Use found on our website at www urologix com or call us at 1 800 475 1403 Data taken from the CTC Advance Instructions for Use 250348 Rev B 12 08 Part 250023 001 Rev J 165 of 182 Section 6 Appendix B Patient Instructions for a Cooled ThermoTherapy Treatment 1 Your treatment is scheduled for 2 Please arrive promptly by at the following address 3 The following guidelines are suggested for the day before and the day after treatment Reduce fluid intake the day before treatment but do not stop dri
46. temperatures that might indicate a sensor has moved from its previous position M y WARNINGS e The Cooled ThermoTherapy treatment must not be initiated without assurance that the microwave catheter is properly positioned in the patient The correct positioning of the catheter must always be checked by ultrasound imaging prior to commencing treatment Improper placement or orientation of the microwave catheter may lead to treatment failures or heating damage of nontarget tissues such as the bladder neck external sphincter or penile urethra e Do not underinflate or overinflate the microwave catheter balloon Underinflation can cause the microwave antenna to be misplaced in the prostate affecting the external sphincter or penile urethra Overinflation may result in balloon malfunction and possible improper positioning of the microwave antenna e The rectal unit must be positioned and inflated properly to ensure correct temperature sensing 2 of 182 Part 250023 001 Rev J Table of Contents Patient Salety SUMMIM ALY noirir r n eE E O E a N 2 L Systems Descriphon seseo enn a eea EEEa TENONO EESE E OETA ERNS 5 1d NON CE sorie Bh ceca N E eal E ha acs aus Aiea ae aide ote eu cca cuGna nari aha ita 3 1 2 SOL CLY SIND OLS And AON S aia a T a a a O Rides ccc sedan ueen se 5 1 3 User Marna OVET IEW sasiecus sei iatue E E saan aera ee reaua sei nano usaananeeaa ae ane ES 6 Te CCU ONT i aa ete a LNA ele A el tte ded eel aati dat tae A 6 1 5 In
47. the Microwave Catheter may lead to treatment failures or heating damage of non target tissues Part 250023 001 Rev J 149 of 182 Section 6 Appendix B such as the bladder neck external sphincter or penile urethra e The Cooled ThermoTherapy treatment must not be initiated until an enema has been given and the Rectal Thermosensing Unit RTU is properly placed into the patient s rectum and inflated e tis important that the patient not be over sedated Over sedation may compromise his ability to communicate pain e The safety and effectiveness of the Cooled ThermoTherapy treatment has not been established in patients with the following conditions Patients with clinical or histological evidence of prostatic cancer or bladder cancer Interest in preservation of future fertility Post void residual PVR gt 350mL Previous pelvic surgery Previous rectal surgery other than hemorrhoidectomy Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder sometimes referred to as a ball valve median lobe Active urinary tract infection Gross hematuria not due to BPH Prior prostatic surgery excluding balloon dilatation Coexisting illness or specified obstructive symptoms found to be caused by any of the following conditions Neurologic bladder disorders Bladder stones Prostate volume greater than 100 cc
48. the Control Unit rads ae tie Microwave Off button when in demonstration mode Microwave Off button Figure 3 23 Treatment Checklist screen Demonstration mode 3 3 4 System Calibration screen User Demo Version X XxXy 22Z i F E Frequency Calibration Figure 3 24 System Calibration screen 60 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 1 Wait while the Control Unit proceeds through a calibration process can take up to 7 minutes Figure 3 24 e Temperature stabilization Rectal unit calibration Urethra temperature calibration Pump calibration Frequency calibration As each item in the list completes calibration a checkmark appears in the box next to that item a Calibration completes successfully Proceed to Section 3 3 5 Urologix BPH Treatment screen if the Control Unit completes the calibration process and automatically goes to the Urologix BPH Treatment screen b Calibration does not complete successfully An error message appears on the System Calibration screen Proceed to step 2 c Calibration needs to stop due to user needs Press the Cancel button to stop the calibration process An error message appears on the System Calibration screen Proceed to step 2 2 Read the System Calibration screen Figure 3 25 and use the error message to resolve the problem In addition use one of the actions listed on the System Calibration screen to help you determ
49. to ensure patient safety Verify that the correct catheter has been read by the Control Unit using the instructions provided in step 3 3 Verify that the correct microwave catheter was read by the CoolWave Control Unit The microwave catheter serial number and the description provided on the Protocol CoolWave screen must match the microwave catheter selected and inserted in the patient The catheter can be verified using the information provided in Table 3 2 g Note The serial number label is attached to the cable of the microwave catheter near the connection to the patient cable Figure 3 18 a Note The control unit will display a warning indicator if the microwave catheter is expired Figure 3 19 98765432 10ABCDE Figure 3 19 Expired Catheter Warning screen Part 250023 001 Rev J 55 of 182 Section 3 Treatment Instructions Serial Prostatic Catheter Serial Microwave Catheter Number Urethral Color Number Catheter Picture Tag Length Scheme Color Prefix Blue Handle n o_o 2 5t03 5cm Black Accents CTC Advance E _ Standard 3 0 to 5 0 cm White Accents CTC Advance Blue Handle gt 4 5 cm Long Grey Accents White 2 5 to 3 5 cm Catheter Green Handle White rca d 3 0 to 5 0 cm Catheter tener White Handle Table 3 2 Microwave Catheter Identification 4 Select the desired treatment protocol in step 2 on the Protocol screen for your patient and then press the treatment protocol name Fi
50. tract The pathway in the urogenital system that urine travels as it is eliminated from the body It consists of the renal tubules and pelvis of the kidney the ureter the bladder and the urethra Urination Discharge of liquid waste from the body USB flash drive A Universal Serial Bus USB flash drive is a portable storage device that plugs into a computer USB port Verumontanum An elevation in the floor of the prostate gland where it joins the urethra and the entrance of the seminal ducts Part 250023 001 Rev J 137 of 182 5 Section 5 Appendix A 5 7 Electromagnetic Compatibility EMC Tables Guidance and manufacturer s declaration Electromagnetic Emissions The Targis System with CoolWave Control Unit is intended for use in the electromagnetic environment specified below The customer or the user of the Targis System with CoolWave Control Unit should assure that it is used in such an environment Electromagnetic Environment Guidance RF emissions Group 2 The Targis System with CoolWave Control CISPR 11 Unit must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions Class A The Targis System with CoolWave Control CSPR 11 Unit is suitable for use in all establishments other than domestic and may be used in domestic Harmonic emissions Class A establishments and those directly connected to the IEC 61000 3 2 public low
51. urethra to the rectal wall in cm as measured by ultrasound Prostate Specific Antigen ng mL Enter the prostate specific antigen level ng mL International Prostate Symptom Score Enter the international prostate symptom score or the AUA symptom score Qmax mL s Enter the maximum flow rate mL s Urethra Length cm Enter the prostatic urethra length PUL in cm as measured from the bladder neck to verumontanum by ultrasound The prostatic urethra length must be at least 2 5 cm This is a required field Prostate Volume mL Enter the prostate volume mL This is a required field Post Void Residuals mL Enter the postvoid residual volume mL 2 Press the Next button to go to the next screen Or press the Back button to return to the previous screen Part 250023 001 Rev J 51 of 182 Section 3 Treatment Instructions J Note If any Patient Information entry is invalid a dialog box will display Figure 3 15 and the text that is invalid is highlighted in yellow D Robinson 3412315 Figure 3 15 Patient Data Error Screen Demonstration mode Enter dummy text on the Patient Information screen Be sure to include information in the data fields marked with a bullet 52 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 3 3 2 Protocol screen Standard Protocol 40 0 C 15 0 C Medium Custom Protocol 1 Custom Protocol 2 Figure 3 16 Example of a Protocol screen g Note T
52. urinary sphincter and surrounding healthy tissues with continuous cooling Biophysics of Cooled ThermoTherapy e Microwaves comprise the 300 3000 MHz range of the electromagnetic spectrum The entire spectrum of electromagnetic waves e g X rays visible light infrared can interact with living matter but the mechanisms of interactions are not the same on the entire frequency range The interaction with microwaves results in the heating of biological tissue e As microwaves propagate through biological tissue they transfer energy to heat by the electromagnetic field oscillation of free charges of electrons and ions and by the polarization of small molecules primarily water e The resulting molecular kinetic energy raises the temperature of the tissue and causes heating The frequency of the microwave energy and the type of tissue targeted affect the depth of penetration A frequency of 915 MHz is used in the CoolWave Control Unit The water in treated tissues reduces the penetration of microwaves Therefore the penetration of microwaves is greater in low water content tissue adipose than in high water content tissue muscle Cooling of tissue surrounding the treatment zone during microwave thermotherapy can protect normal tissue e Tissue temperatures achieved in a microwave field depend on the energy delivered and thermal conduction and thermal convection e g tissue perfusion Cell necrosis only occurs when the cell temper
53. verify that all soil was removed If not repeat above steps 7 Rinse the rectal unit handle with deionized water to remove any excess residues left by the tap water Gently shake to remove excess water and to avoid splashing or casting of solution 8 Soak the rectal unit handle again do not soak or immerse the connector in CIDEX PLUS 28 Day Solution according to the manufacturer s instructions 9 After soaking rinse devices per manufacturer s instructions 10 Gently dry the rectal unit handle Store in dry ambient conditions between 59 F 95 F 15 C 35 C until the next use Always avoid bending the temperature sensor strip significantly 4 1 2 Cleaning the Control Unit There are no special clean up operations required after a Cooled ThermoTherapy Treatment for the CoolWave Control Unit The CoolWave Control Unit exterior should be cleaned periodically following these instructions e Clean the exterior surface of the CoolWave Control Unit with a soft lint free cloth dampened with warm water and a diluted detergent 10 dilution of bleach or a diluted nonabrasive nonstaining standard hospital disinfectant Use a lint free cloth dampened with warm water to rinse the surface of the unit e Do NOT use isopropyl alcohol IPA to wipe the exterior CoolWave Control Unit housing Using cleaning solvents such as IPA could result in damage to the CoolWave Control Unit 4 1 3 Cleaning the touchscreen The touchs
54. 01 Patient connection cable 8 9 14 63 104 Print queue Cable holder 9 11 104 Clear 70 83 Housing 8 9 14 Print window 69 Patient critical error See System error Printer 11 Patient data 69 Clean print head 82 102 3 Patient information Clear print queue 83 Age 51 Daily maintenance 98 Institution 51 Ink tank 101 International prostate symptom or AUA symptom Maintenance 100 103 score 51 Nozzle check pattern 82 102 Patient ID 51 Output slot cover 101 Patient name 51 Overview 101 Postvoid residual 51 Paper guide 101 Prostate specific antigen 51 Paper refill 101 Prostate volume 51 Paper rest 101 Qmax 51 Paper thickness lever 101 Quality of life 51 Power button 101 Urethra length 51 Power lamp 101 Patient Information screen 51 52 Print head cover 101 Patient Instructions 155 166 167 170 Print head nozzles 82 Patient post treatment 79 Printer drawer 11 Patient Screening Form 164 Printer utilities 82 83 Pause End button 76 Printer Utilities screen 82 83 102 103 Peristaltic pump See Peristaltic pump mechanism Resume Cancel button 101 Peristaltic pump mechanism 12 13 16 94 105 Printer button 80 Post Procedure Care 158 Procedure Kit 8 Power button printer 101 Prostate 8 13 15 79 Power connection See Power cord Protective sheath 33 Power cord Protocol Cable holder 11 Clinical 81 Daily maintenance 98 Custom 56 57 Types 20 Treatment 49 56 57 62 69 Power indicator P
55. 2 Section 3 Treatment Instructions b Print Turn the printer ON load paper into the printer and then press the Print button However if you pressed the Print button and paper was not in the printer the printer flashes 1 long green and 2 short orange lights Insert paper into the printer and press the Resume Cancel button on the printer Press the Print button again The printer prints the treatment report c Copy Insert a USB flash drive into the USB port Press the Copy button to copy a treatment report to the drive However if you pressed the Copy button before inserting the flash drive into the USB port a dialog box appears instructing you to insert the drive Insert the drive close the dialog box and press the Copy button again A dialog box appears to confirm that copying is in progress Note The output file is encrypted with the password ez4u2p To view the file contents you can use the free 7 zip utility from www 7 zip org The encryption method is also compatible with the WinZip utility 3 Press the Back button to return to the Options Menu screen 3 5 4 Password Setup window Set Password For jdoe ss Current Password EEEE New Password Mew Password Confirm CAPS LOCK IS ON alphanumeric characters and is case z sensitive Password may contain from 3 to 20 Cancel Figure 3 46 Password Setup window 1 Enter the following information in the Password Setup window Current Passw
56. 3 Describe patient selection pre and post treatment patient preparation and comfort management including analgesia options 4 Describe the system components and treatment protocols for the Targis System 5 Describe the safety precautions Faculty A Clinical Specialist and or Certified Master Trainer or Certified Trainer Instruction Materials Targis System CoolWave User Manual Instructions for Use and post test Part 250023 001 Rev J 143 of 182 Section 6 Appendix B Training Methods Didactic session Includes instruction on the principles of microwave thermotherapy patient selection and management office medication protocol description of Targis System components and treatment protocols for the CoolWave Control Unit Perform or observe a minimum of 2 patient treatments proctored by a Urologix Clinical Specialist Certified Master Trainer or Certified Trainer Evaluation Methods Written post test with a minimum score of 90 and signed Training Confirmation form Certificate of Training A Certificate of Training is issued to urologists and staff members who satisfactorily complete all of the aforementioned training requirements 144 of 182 Part 250023 001 Rev J Appendix B Section 6 6 2 Cooled ThermoTherapy Overview Cooled ThermoTherapy Overview Heat is the result of energy whose biologic effects depend on the intensity duration and means of application The majority of minimall
57. 4 66 74 75 76 89 90 92 93 94 95 126 Manual treatment mode 94 Microwave power indicator 13 Microwave power output specifications 105 176 of 182 Index Mode Advanced mode 72 74 Demonstration mode 40 41 42 48 52 58 59 60 80 Manual mode 74 76 Standard mode 71 72 Models Control Unit 105 Power requirement 19 Mounting hole 16 Mounting pin 13 Move Control Unit 103 4 Navigation 39 40 New user 46 47 New User button 46 Note 5 Notes button 43 Notes dialog box 43 44 Notes Entry window 44 45 Notes feature 41 44 Nozzle check pattern 82 83 ON OFF Power switch 11 12 45 Pump 75 Operating conditions 105 Options button 48 Options Menu screen 80 Orientation flag 15 Output slot cover 101 Pane Chart pane 65 Cooldown pane 89 92 Detail pane 66 67 89 Event pane 65 66 89 Panel Advanced mode Control Panel 56 72 93 Control Panel 63 Manual mode Control Panel 74 94 Standard mode Control Panel 56 71 Status Panel 63 74 Treatment parameter control panel 72 Paper Guide 101 Refill 101 Rest 101 Thickness lever 101 Parameters Treatment 8 9 49 50 62 70 Password 46 48 Demonstration mode 48 Password button 80 Password Confirm data field 47 Password data field 47 Password Setup window 84 Reset 81 82 Reset Password button 82 Setup 84 Patient button 83 Part 250023 001 Rev J Index Section 7 Patient Comfort Kit 35 129 Print head cover 1
58. 5 Patient connection cable 9 174 of 182 index Patient connection cable housing 9 Post treatment 78 Power cord types 20 Power indicators 13 Power requirement 19 Prepare for treatment 24 Printer 11 Safety check 22 Safety instructions 21 Screen 39 41 Service 21 Service agreement 99 Service port 9 14 Ship 104 Shipping storage conditions 105 Store 104 System error 89 92 107 See also System error System navigation 39 40 Touchscreen monitor 9 21 39 Treatment overview 66 USB port 14 84 Volume 14 87 Wheels 12 Control Unit options Data 83 Password 84 Printer 82 System setting 85 User setting 81 Coolant 9 13 16 28 49 93 Coolant bag 12 13 16 Coolant Bag 16 20 Connector 16 Coolant tubing 16 Coolant door 13 28 Coolant level See Internal coolant level indicator Coolant pump See Peristaltic pump mechanism Coolant setting 49 58 Advanced mode 73 Automatic treatment mode 93 Default temperature 49 Manual mode 75 Manual treatment mode 94 Patient comfort automatic treatment mode 93 Patient comfort manual treatment mode 95 Coolant Setting button 73 Coolant system 12 Specifications 105 Temperature sensor 12 13 Coolant temperature 9 16 49 63 64 66 94 Automatic treatment mode 92 Temperature range specifications 105 Coolant tubing Coolant Bag 16 Microwave catheter 14 Cooldown 64 76 78 Automatic treatment mode 93 94 Manual treatment mode 95 Pa
59. 6 of 182 Part 250023 001 Rev J Equipment Maintenance Section 4 4 Equipment Maintenance 4 1 Cleaning the equipment 4 1 1 Cleaning the RTU Plus Reusable Handle Post Treatment The following process will be used to clean and disinfect the RTU Plus Reusable Handle containing the temperature sensors for subsequent use The RTU rectal unit handle should not be used more than 30 times 1 Remove and discard the disposable rectal balloon if not already discarded 2 Tie a glove over the rectal unit cable connector to prevent it from being splashed or soaked 3 Rinse the rectal unit handle with warm running tap water until all visible gross debris is removed Avoid any water contact with the connector Gently shake to remove excess water and to avoid splashing or casting of solution 4 Place the rectal unit handle in a bath with water and enzymatic detergent e g ENZOL mixture diluted according to the manufacturer s instructions for 2 minutes Do not soak or immerse the connector After soaking 2 minutes clean the crevices with a soft bristle brush Pay special attention to the temperature sensor flex circuit bend points sensor handle junction and inflation tubing channel to avoid damage and to ensure adequate cleaning 5 Rinse the rectal unit handle for 2 minutes using warm tap water Gently shake to remove excess water and to avoid splashing or casting of solution 6 Inspect the rectal unit handle under standard lighting to
60. 82 Section 7 Control Unit 8 97 Patient connection cable 8 9 14 Hydrophobic vent 16 Implementation Guidelines 154 Indications 149 Inflation port See Balloon inflation port Inflation tubing channel 32 33 Informed Consent Form 165 Ink tank 101 Internal coolant level indicator Daily maintenance 98 Sight gauge 98 Interval timer 74 94 Key hole 32 Keyboard 10 39 105 General halt error 89 Treatment error 92 Knee cushion 35 129 Language System setting 86 Locating key 33 Location balloon 14 Locking lever 26 Log Out button 48 Login button 46 Login screen 41 45 46 48 Lower pump housing 27 Main Menu screen 48 Main power indicator 13 Maintenance 22 Daily 98 Periodic 99 Printer 100 103 Manual button 70 Manual mode 74 76 Manual mode Control Panel 74 94 Manual treatment mode 70 74 76 81 95 Microwave antenna 14 Microwave antenna cable See Antenna cable Microwave antenna connector 9 14 105 Microwave catheter 6 7 8 9 14 15 16 17 20 21 28 49 50 92 Connection to Control Unit picture 36 Default coolant setting 49 58 73 Identification 56 Microwave power 75 94 Microwave catheter coolant tubing 14 Microwave catheter Holder 17 35 37 129 Microwave catheter serial number 54 58 Microwave catheter temperature sensor 90 Microwave connector See Microwave antenna connector Microwave Off button 59 Microwave Off pushbutton 14 59 Microwave power 8 14 63 6
61. C1017 Canada United States Mexico Catalog Number AC1018 Switzerland Table 1 4 CoolWave Control Unit Power Cords Equipment connections The CoolWave Control Unit must not be connected to any device other than the microwave catheter rectal unit or coolant bag In addition the microwave catheter rectal unit and coolant bag must not be connected to any other device or outlet 20 of 182 Part 250023 001 Rev J System Description Section 1 Equipment testing Turn the CoolWave Control Unit ON and verify that the Login screen display appears Do not use the CoolWave Control Unit if there are any irregular sounds or vibrations present Prior to beginning a Cooled ThermoTherapy treatment verify that all components of the Procedure Kit microwave catheter RTU and coolant bag have arrived in a sealed condition 1 8 2 Use Environment Y Cautions Do not stack any objects on top of CoolWave Control Unit microwave catheter RTU or coolant bag e Do not place the CoolWave Control Unit near any electronic device or other equipment emitting electromagnetic waves The interference may compromise the operation of the equipment e Provide ventilation space of at least 20 cm clearance around the base of the CoolWave Control Unit for operation e Do not turn ON the CoolWave Control Unit with the touchscreen monitor lid closed The touchscreen will turn OFF and the lid may become warm to the touch e Oper
62. Coo l Wave Targis System CoolWave Control Unit UROLOGIX Part 250023 001 Rev J Patient Safety Summary This patient safety summary is an overview of the key patient safety information provided in the CoolWave Control Unit User Manual Please refer to the user manual to obtain all safety information pertaining to the use and operation of the CoolWave Control Unit e The treating physician should be present at all times during treatment e Perform an enema to 2 hours before treatment or per physician instructions An enema is mandatory e tis critical that throughout the patient s treatment the treating physician verify the correct position of the microwave catheter and the rectal unit Patient safety is at risk if the following simple and straightforward safety check procedures are not correctly observed SAFETY CHECKS 1 Throughout the duration of the treatment verify that the position mark on the catheter remains at a fixed distance from the penile meatus 2 Itis strongly recommended that at least every 5 10 minutes of the treatment the correct position of the location balloon and the rectal unit 1s checked 3 Always immediately check microwave catheter and rectal unit placement if the patient complains of any abnormal or sudden increase in pain Pause the treatment if the patient complains of serious pain 4 Observe the treatment parameters for sudden changes in readings especially decreases in
63. Microwave Power Range 0 W 75 W Accuracy 10 FCC Registration 0012913901 Table 4 2 CoolWave Control Unit specifications Part 250023 001 Rev J 105 of 182 Section 4 Equipment Maintenance 106 of 182 Part 250023 001 Rev J Appendix A Section 5 5 Appendix A 5 1 Troubleshooting guide Each system error has a unique number and may be followed by a single letter suffix that indicates where the error occurred For example 0OOx is a system error where 000 is the system error number and the x is the single letter suffix See the following table for the letter suffix definitions X WHERE THE SYSTEM ERROR OCCURRED blank during treatment a calibration temperature stabilization b calibration rectal sensor C calibration fiber optic sensor d calibration coolant pump e calibration frequency sweep p prior to treatment Below is a list of system errors in numerical order possible causes and the actions to take to resolve the error s If you still cannot resolve an error after using this troubleshooting guide please contact Urologix Customer Service at 1 888 229 0772 ERROR 1 RECTAL TEMP HIGH POSSIBLE CAUSES ACTION STEPS 1 Loose connector Reattach connector 2 Temperature in rectum has exceeded Allow rectal temperature to drop below 42 5 C 42 C 3 Enema not performed within 2 hours of Remove rectal unit and perform enema treatment 4 Air may not have been removed from R
64. OC Discharge Vital Signs Catheter Removal Return Appointment Discharge Medications Discharge Instructions Given by Nurse Signature MD Signature Cooled ThermoTherapy is available by prescription only This therapy is not for everyone Talk to your physician to see if Cooled ThermoTherapy is right for you Most medical treatments may have side effects Possible side effects for Cooled ThermoTherapy include blood in urine clots in urine painful or difficult urination thickened bladder muscle rectal irritation temporary inability to control urination brief inability to achieve or maintain an erection and the inability to discharge semen in orgasm thus should be considered by men who wish to have further offspring A small risk of urethral stricture may result requiring further intervention Patients may experience discomfort during the treatment that may require the use of analgesics or sedatives Patients may be catheterized for a 2 to 5 day period following the treatment For more complete information about the benefits and risks associated with Cooled ThermoTherapy please refer to the Instructions for Use found on our website at www urologix com or call us at 1 800 475 1403 Data taken from the CTC Advance Instructions for Use 250348 Rev B 12 08 168 of 182 Part 250023 001 Rev J Appendix B Section 6 Discharge Instructions Following Cooled ThermoTherapy Treatment GENERAL EXPECTATIONS Some men may experience
65. Options Menu screen 3 5 3 Data View Print Copy screen ser Aamin 11 Jul 2005 ab0123 08 Jul 2005 9876543210ABCDE 17 Jun 2005 98765432 10ABCDE Data window 17 Jun 2005 98765432 10ABCDE 16 May 2005 98765432 10ABCDE 12 May 2005 9876543210ABCDE 12 May 2005 98765432 10ABCDE 09 May 2005 9876543210ABCDE 05 May 2005 9876543210ABCDE 05 May 2005 98765432 10ABCDE 05 May 2005 tcl Figure 3 45 Data View Print Copy screen 1 Press the Date Patient or Catheter button to sort treatments by date recent date first by patient alphabetical by last name letter A first or by microwave catheter serial number lowest number first Figure 3 45 Unless you have administrative privileges you can only access those treatment files you created You cannot access treatment files created by other users 2 Select a treatment in the Data window by pressing on the date patient or microwave catheter serial number Then press the Remove Patient Info button optional before choosing an action view print or copy to remove a patient s name from the treatment report A check mark appears in the button a View Press the View button to view a treatment report that includes patient data treatment protocol data treatment data a treatment chart the event log and case notes Use the arrows to scroll through the summary Press the Close button to return to the Data View Print Copy screen Part 250023 001 Rev J 83 of 18
66. RNING CRUISE UNAVAILABLE POSSIBLE CAUSES 1 An error condition is active ACTION STEPS Resolve any indicated errors before turning on Automatic treatment mode ERROR 99 URETHRA TEMP PROBE ERROR POSSIBLE CAUSES 1 Loose microwave catheter fiber connectors 2 Microwave catheter may be defective ACTION STEPS Reattach connector Replace the microwave catheter ERROR 100 RECTAL UNIT CAL FAILURE POSSIBLE CAUSES 1 All 5 rectal sensors are not within required temperature range 114 of 182 ACTION STEPS Allow time for temperatures to stabilize and press the Retry button If unsuccessful replace the rectal unit Part 250023 001 Rev J Appendix A Section 5 2 Rectal unit not properly inserted or Ensure that the rectal unit is inserted and inflated inflated properly Then press the Retry button 3 Defective rectal unit Replace the rectal unit ERROR 101 URETHRA TEMP CAL FAIL POSSIBLE CAUSES ACTION STEPS 1 Fiber optic connector may be Disconnect and reconnect microwave improperly connected catheter fiber optic connector to patient connection cable housing 2 Fiber optic connector may be dirty Disconnect fiber optic connector inspect for foreign material and clean with isopropyl alcohol and swab 3 Microwave catheter may not be Ensure that the microwave catheter is properly inserted properly inserted in patient 4 Microwave catheter may be defective Replace the microwave cat
67. ThermoTherapy is right for you Most medical treatments may have side effects Possible side effects for Cooled ThermoTherapy include blood in urine clots in urine painful or difficult urination thickened bladder muscle rectal irritation temporary inability to control urination brief inability to achieve or maintain an erection and the inability to discharge semen in orgasm thus should be considered by men who wish to have further offspring A small risk of urethral stricture may result requiring further intervention Patients may experience discomfort during the treatment that may require the use of analgesics or sedatives Patients may be catheterized for a 2 to 5 day period following the treatment For more complete information about the benefits and risks associated with Cooled ThermoTherapy please refer to the Instructions for Use found on our website at www urologix com or call us at 1 800 475 1403 Data taken from the CTC Advance Instructions for Use 250348 Rev B 12 08 Part 250023 001 Rev J 167 of 182 Section 6 Appendix B Cooled ThermoTherapy Treatment Flow Sheet Name Date Physician Allergies Consent Signed Enema Routine Medications Cysto ____ IPSS ___ QMax _____ PSA ____ Prostate Size PUL Pre Treatment Vital Signs B P_ eee INTRA TREATMENT Time In Time Out Treatment Start Treatment End Catheter S N RTU Lot Treatment Time POST TREATMENT Post Therapy Catheter L
68. a microwave catheter This microwave catheter also minimizes patient discomfort and risk to the urethra by circulating cooling fluid In addition rectal wall damage is prevented by continuously monitoring rectal wall temperature readings throughout the treatment If during a treatment urethra or rectal temperatures exceed protocol treatment parameters the system will adjust microwave power to protect the urethra or rectal wall from overheating 1 6 Targis System CoolWave Control Unit equipment overview The Targis System is comprised of a CoolWave Control Unit model 5000 series a Procedure Kit comprised of a microwave catheter a rectal thermosensing unit and a coolant bag and accessories For this user manual the representative microwave catheter is the CTC Advance Microwave Catheter 1 6 1 CoolWave Control Unit Touchscreen monitor Indicators Microwave Off pushbutton volume control headphone jack USB port ON OFF power switch Coolant door Service Port Power cord Patient connection cable housing Patient connection cable Power cord and patient connection cable holder Figure 1 1 CoolWave Control Unit 8 of 182 Part 250023 001 Rev J System Description Section 1 The CoolWave Control Unit Figure 1 1 supplies microwave energy and coolant to the microwave catheter and collects temperature data from the microwave catheter and the rectal unit The CoolWave Control Unit also provides a way of en
69. able Balloon Insert the temperature sensor strip into the sensor channel of the disposable balloon as shown in Figure 2 12 Orient the sensors toward the outside of the balloon and do not bend the temperature 32 of 182 Part 250023 001 Rev J Treatment Session Setup Section 2 strip significantly The temperature sensor strip should extend to the distal end of the channel and the temperature sensor channel should be aligned with the top side of the handle Figure 2 12 Inserting the Temperature Sensor Strip Seat the balloon inflation tubing in the inflation tubing channel located in the base of the rectal unit handle The locating key should snap into place within the handle key hole if not reorient reassemble the device The proper positioning of the temperature sensor strip in the disposable balloon is assured by the locating key handle interaction Figure 2 13 Figure 2 13 Proper Positioning of the Temperature Sensor Strip Slide the protective sheath down from the balloon and pull it over the handle as shown in Figure 2 14 Part 250023 001 Rev J 33 of 182 Section 2 Treatment Session Setup Deployed sheath Serial number label Cable Temperature sensors Connector ar Semirigid tubing Z Extension tubing Rectal balloon Balloon inflation port Figure 2 14 Assembled RTU Plus with Deployed Sheath Attach a syringe to the inflation port and inflate the balloon with approximately 90 cc of air to
70. abs To unlock the wheels press on the back part of the wheel lock tabs Plug the CoolWave Control Unit electrical cord to a wall outlet The connection requires a fully tested hospital grade power outlet with adequate grounding and the power supply must meet the following specifications Control Unit Model SOOOE 220 240 V 10 4 25 A Europe Single phase 50 or 60 Hz Control Unit Model 5000A US 110 120 V 10 8 5 A Single phase 50 or 60 Hz K 7 Warning Do not move the CoolWave Control Unit while the electrical cord is connected to a power source Turn ON the CoolWave Control Unit and login to the system Refer to Section 3 2 CoolWave Control Unit setup for further information a Note Turn ON the CoolWave Control Unit at least 5 minutes before treatment begins to allow the system to warm up Enter patient and clinical information on the Patient Information screen Refer to Section 3 3 1 Patient Information screen for further information E Note For first time users it may be helpful to read Section 3 1 System Navigation and Screen Overview prior to entering patient and clinical information on the Patient Information screen 24 of 182 Part 250023 001 Rev J Treatment Session Setup Section 2 2 5 Installing the Coolant Bag Be Instruction Manual Read the CoolWave Control Unit User Manual this document before installing the coolant bag Open the package containing the coolant bag
71. afe and effective use of the Targis System CoolWave Control Unit for treating patients with BPH Training relevant to the urologists nurses and assistants is available and recommended Required Training e Receive and review the Targis System CoolWave Control Unit User Manual and Instructions for Use for the CoolWave Control Unit and components e Understand the information presented in the training session that covers the key elements of the Cooled ThermoTherapy treatment including indications contraindications warnings and precautions patient selection and assessment pre and post treatment parameters inherent risks of treatment system components and protocols and safety precautions e Perform and or observe a minimum of 2 patient treatments proctored by a Urologix Clinical Specialist Certified Master Trainer or Certified Trainer e Complete a post test achieve a minimum score of 90 and sign a Training Confirmation form confirming that all required instructional materials have been read and instruction and understanding of the key elements of Cooled ThermoTherapy have been achieved Program Objectives Upon completion of the program participants will be able to 1 Describe the mechanism of microwave thermotherapy 2 List the indications contraindications warnings and precautions and inherent risk of complications as stated in the Adverse Events and Complications sections in the Instructions for Use
72. after the treatment Your physician or nurse will provide you with instructions for catheter care 160 of 182 Part 250023 001 Rev J Appendix B Section 6 What are the risks or side effects There are few risks or side effects associated with the Cooled ThermoTherapy treatment Possible Cooled ThermoTherapy side effects include blood in urine clots in urine painful or difficult urination rectal irritation temporary inability to control urination brief inability to achieve or maintain an erection and the inability to discharge semen in orgasm Many patients experience post treatment catheterization for an average of 2 5 days The outcome of the treatment depends on your overall health as well as other factors Your physician or nurse will discuss all of your concerns before you receive the treatment How many patients have been treated with Cooled ThermoTherapy More than 225 000 patients have been successfully treated How much does the treatment cost and will my insurance cover it Your doctor s office staff will contact your insurance company to determine benefits Is Cooled ThermoTherapy cost effective Yes Cooled ThermoTherapy is more cost effective than surgery and a lifetime of drug therapy for BPH The long term use of drugs can cost thousands of dollars annually A TURP surgery requires hospitalization and anesthesia and up to six weeks of recovery Is Medicare Reimbursement available for Cooled ThermoThe
73. all aspects of the treatment should respond more favorably and with less anxiety when provided with these facts e Clear pre and post treatment instructions e Description of the Cooled ThermoTherapy transurethral microwave thermotherapy treatment the mechanics of the process e Explanation of what to expect during the treatment e g pressure in the bladder and penis heat sensation need to urinate bladder spasm e The length of the treatment 28 5 or 60 minutes e The risks associated with the treatment e g common side effects secondary reactions medications and methods Physicians should inform patients of an inherent risk of complications associated with the Cooled ThermoTherapy treatment refer to Adverse Events and Complications in the Instructions for Use Physicians should inform patients that a loss of ejaculation may occur as a result of the Cooled ThermoTherapy treatment which should be considered by men who may wish to have further offspring Physicians should inform patients that the volume of ejaculate may be decreased in some men who undergo the Cooled ThermoTherapy treatment Temporary acute urinary retention temporary incontinence minimal bleeding pain on urination and intercourse and urinary tract infection may be associated with the Cooled ThermoTherapy treatment The patient should be informed that a small risk of urethral stricture may result from the treatment requiring f
74. and remove the coolant bag Fill the coolant bag with 100 cc 5 cc of sterile water by injecting the water into the female luer fitting of the coolant bag with a syringe Figure 2 1 y Cautions Use only sterile water in the coolant bag Do not fill the coolant bag with saline solution Saline solution has electrical properties that can interfere with microwave energy from the microwave catheter during treatment Do not allow the coolant bag connectors to fall on the floor during installation e Note To prevent water from leaking out of the coolant bag once it has been filled temporarily connect the coolant bag connectors together Figure 2 1 Filling the Coolant Bag Open the coolant door on the right side of the CoolWave Control Unit by pulling the top of the door forward Position the coolant bag over the chill plate by aligning the top two mounting holes of the coolant bag with the top two mounting pins on the chill plate Gently position the coolant bag onto the pins Figure 2 2 Part 250023 001 Rev J 25 of 182 Section 2 Treatment Session Setup Figure 2 2 Positioning the Coolant Bag onto the Top Mounting Pins Position the bottom mounting hole of the coolant bag over the lower mounting pin below the chill plate to complete the process of installing the coolant bag Figure 2 3 Figure 2 3 Positioning the Coolant Bag onto the Lower Mounting Pin Route the coolant inlet tubing through the pump mechanism by pulli
75. aning the RTU Plus Reusable Handle Post Treatment for instruction on cleaning and disinfecting the RTU Plus Reusable Handle 78 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 8 Print the treatment report or copy it to a Universal Serial Bus USB flash drive Refer to Section 3 5 3 Data View Print Copy screen for further information Or if you do not wish to print the treatment report or copy it to a USB flash drive and no more treatments are scheduled for the day turn the Control Unit OFF by pressing the ON OFF power switch located on the back of the unit 0 Hang the patient connection cable on the cable holder located on the back of the Control Unit Cover the connectors at the end of the patient connection cable 9 Follow these instructions if there are no other treatments in the near future Disconnect the CoolWave Control Unit electrical cord from the wall outlet Roll the CoolWave Control Unit to a storage location 3 4 2 Patient Post treatment Instructions Due to edema from the thermal damage caused during treatment the patient s prostate may swell and obstruct the urethra for a short period of time For patient comfort the physician may recommend the following treatment 1 Instruct the patient in how to self perform Clean Intermittent Catheterization as needed at home If the patient fails a voiding trial after treatment the physician may place a Foley catheter in the urethra before discharging th
76. apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters and electromagnetic site survey should be considered If the measured field strength in the location in which the Targis System with CoolWave Control Unit is used exceeds the applicable RF compliance level above the Targis System with CoolWave Control Unit should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Targis System with CoolWave Control Unit Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Table 5 4 Electromagnetic Immunity continued 140 of 182 Part 250023 001 Rev J Appendix A Section 5 Recommended separation distance between portable and mobile RF communications equipment and the Targis System with CoolWave Control Unit The Targis System with CoolWave Control Unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Targis System with CoolWave Co
77. are comfortable How significant and long lasting is the improvement in my symptoms Cooled ThermoTherapy produces durable improvements in symptoms quality of life and flow rates to at least 5 years after treatment Data on file at Urologix Inc Drug cost per year for Flomax available at drugstore com Accessed January 7 2008 Miller Paul D et al Cooled ThermoTherapy for the Treatment of Benign Prostatic Hyperplasia Durability of Results Obtained with the Targis System Urology Vol 61 No 6 June 2003 162 of 182 Part 250023 001 Rev J Appendix B Section 6 6 7 Example Patient Documents These patient documents on the following pages are provided as examples to assist physicians and their staff on possible content for the purpose of aiding in their office processes and treatments This is not intended to constitute medical advice or is it meant to be exhaustive in acquiring patient information upon which to make medical decisions Rather it is a list of possible forms questions and information that physicians and office staff may use in managing patients throughout the treatment A physician must exercise his her own best judgment in gathering patient history consent patient instructions treatment protocol and or any follow up and discharge instructions Part 250023 001 Rev J 163 of 182 Section 6 Appendix B Cooled ThermoTherapy Patient Screening Form Patient Name Telephone Address City S
78. ary sphincter or any implant metallic or non metallic which is within 1 5 inches 38 mm of the prostatic urethra e Patients with urethral stricture unable to pass 22F urethroscope e Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome e g claudication of the buttocks or perineum Patients who have undergone pelvic radiation therapy Patients with implanted active devices including pacemakers or defibrillators within 2 6 inches 6 5 cm of the prostatic urethra Warnings for Cooled ThermoTherapy e The Cooled ThermoTherapy treatment has inherent risks of complications refer to Adverse Events and Complications The Targis System and components should not be used in any way other than the intended and indicated use and according to the Instructions for Use Precautions for Cooled ThermoTherapy e Only physicians who have been thoroughly trained on the operation of the CoolWave Control Unit and the Cooled ThermoTherapy treatment should deliver the Cooled ThermoTherapy treatment e Selection and Use of the appropriate catheter model is required to ensure patient safety e The Cooled ThermoTherapy treatment must not be initiated without assurance that the Microwave Catheter 1s properly positioned in the patient e The correct positioning of the Microwave Catheter must always be checked by ultrasound imaging prior to commencing treatment Improper placement or orientation of
79. ate the CoolWave Control Unit on a level surface e Operate the CoolWave Control Unit under these operating conditions An ambient temperature range of 10 C to 30 C A relative humidity range of 30 to 75 An atmospheric pressure range of 700 hPa to 1 060 hPa 1 9 Safety instructions M y Warning Do not open the housing of the CoolWave Control Unit Doing so risks receiving an electric shock Refer all CoolWave Control Unit servicing to qualified Urologix personnel M Y Warning This equipment is not intended for use in areas where there 1s a danger of explosion Do not use the CoolWave Control Unit in the presence of flammable substances UY Caution The CoolWave Control Unit must be operated by trained and authorized personnel You should read and understand the instructions in this manual before operating the system This manual does not claim to address all of the safety concerns associated with the use of this equipment You must establish appropriate safety and health practices prior to use Part 250023 001 Rev J 21 of 182 Section 1 System Description Perform the following CoolWave Control Unit safety checks at least once every 12 months e Cables and connectors for damage e Equipment for physical damage e Safety labels are readable Maintain a written record of these safety checks and service any equipment that does not meet these standards 22 of 182 Part 250023 001 Rev J Treatment Session
80. atic hyperplasia or BPH The treatment is delivered through a medical device that uses microwave energy to heat the diseased prostate gland areas in conjunction with a circulating cooling system that cools and protects the urethral tissue During this treatment a catheter like probe will be inserted into my urethra after application of an anesthetic jelly This probe contains the microwave generating applicator and the cooling system used to treat my prostate gland In addition a temperature sensitive probe will be inserted into my rectum to monitor the temperature during the treatment The treatment time will be approximately 30 minutes to one hour Pain medications may be given before during and or after treatment Anticipated Benefit I understand that the anticipated benefit of having a Cooled ThermoTherapy treatment is to relieve my bladder outflow obstruction and associated symptoms Risks Possible Complications I understand that the risks of this treatment to be decreased sexual function and or impotence temporary or permanent loss of ejaculation a consideration for men who may wish to have further offspring post treatment urinary retention which will require catheterization temporary or permanent incontinence urethral stricture I understand that I may have temporary pain and inflammation in the reproductive tract post treatment urethral discharge bleeding from the urethra penis urinary tract infection rectal discomfort I m
81. ature 38 4 C Urethra Signal Level 50 0 Serial Number 9876543210ABCDE Frequency Antenna Off Switch psi High psi Low Latch Temp High Temp Low Disconnect Temp High UUJUUUIUUUIUY Temp Low Detail Print Notes Help Remain 922 0 MHz Urethra Setting 40 0 C Treatment Time Standard Advanced Reset button Figure 3 30 Detail pane Power section Section 3 Power Off Switch The microwave off button indicator Coolant section The pump latch error indicator Rectal section 1 through 5 The individual rectal sensor readings Serial Number The serial number read from the RFID tag Note this field is blank if the RFID tag is not currently being read The highest reading of the five rectal sensors Temp High The high temperature error indicator The low temperature error indicator Disconnect The rectal sensor disconnect error indicator Part 250023 001 Rev J 67 of 182 Section 3 Treatment Instructions Urethra section The temperature read by the urethra sensor Signal Level A measure of the urethral sensor s optical loss Higher readings may indicate a dirty or damaged fiber optic connector Serial Number The serial number read from the RFID tag Note this field is blank if the RFID tag is not currently being read 3 View treatment data in a diagram format at the right side of the Urologix BPH Treatment screen Figure 3 31 Figure 3 31 Tr
82. atures exceed their thermal cytotoxic threshold The thermal cytotoxic threshold depends on thermal history 1 e time and temperature Bernardo NO Smith AD Transurethral microwave thermotherapy of the prostate for BPH C Urol 1999 1 6 146 of 182 Part 250023 001 Rev J Appendix B Section 6 Application of Energy to the Prostate e The thermal cytotoxic threshold for prostatic adenomatous tissue is believed to be about 50 C maintained for approximately 30 minutes As temperature increases above this level the required time decreases No irreversible thermal mediated injury can be demonstrated histologically in areas of the prostate where temperatures are below this threshold e Not all cells are affected within the treated area The thermal cytotoxic threshold varies with cell type While capillaries are thrombosed larger vessels can be preserved due to the blood flow cooling the vessel wall Consequently a full necrotic process does not necessarily occur e In most cases no prostatic urethral damage occurs because conductive cooling preserves the urethral mucosa The urethral cooling allows higher temperatures to be achieved and also minimizes discomfort during treatment Refer to the Instructions for Use for more information Bischof J et al Heat sensitivity of human prostatic tissue Implications for thermal therapy J Urol 2003 169 287 Part 250023 001 Rev J 147 of 182 Section 6 Appendix B 6 3 Cooled ThermoTh
83. ave catheter antenna connection or the coolant bag pressure during the calibration process Normally to correct the problem you can readjust the appropriate connector to the device Then press the Retry button to restart the calibration process Ultimately you should use the error message to resolve any error condition You can also refer to the actions listed on the System Calibration screen to help you determine what to do next 90 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 105e User canceled operation Replace Figure 3 55 Example of a System Calibration screen error message Notes e Ifa calibration error message appears refer to Section 5 1 Troubleshooting guide for further information e Before replacing a microwave catheter or rectal unit contact Urologix Customer Service at 1 888 229 0772 e Press the Help button Learn more about the error message and the appropriate response e Press the Retry button Proceed with CoolWave Control Unit calibration Refer to Section 3 3 5 Urologix BPH Treatment screen for further information e Press the Replace button Replace the microwave catheter or the rectal unit as needed Refer to Section 2 6 Inserting the Microwave Section 2 7 Inserting the Single Use Standard RTU or Section 2 8 Inserting the RTU Plus Reusable Handle and Single Use Balloon for further information The CoolWave Control Unit returns you to the Protocol scr
84. ay likely have to wear a catheter for a 2 to 5 day median 3 day period following the treatment Alternative to Treatment I understand there are alternative methods for the treatment of benign prostatic hyperplasia BPH These include 1 a procedure known as transurethral resection of the prostate TURP which involves surgical removal of part of the prostate 2 laser and vaporization therapy 3 transurethral needle ablation of the prostate TUNA using radio frequency waves 4 drug therapy with specific medications and 5 insertion of a urethral stent These therapies may or may not be considered advantageous alternatives based on my particular condition They may have risks and or complications that are greater or lesser in nature than the Urologix Cooled ThermoTherapy treatment My physician has discussed the alternatives with me and answered any questions I have about these alternative treatments Consent for Treatment My physician has discussed with me the contraindications and precautions along with the above information concerning this treatment I certify by my signature below that I have read or have had read to me and understand this Informed Consent form Any questions that I asked have been answered in a language that I understand I voluntarily consent to this treatment Signature of Patient Date Printed Name of Patient Signature of Physician Date Signature of Witness Date Cooled ThermoTherapy is available by
85. below 40 C 3 Coolant Bag may be defective Replace the Coolant Bag ERROR 12 COOLANT TEMP LOW POSSIBLE CAUSES ACTION STEPS 1 Coolant door open Close coolant door 2 Coolant bag may be defective Replace the coolant bag ERROR 13 RECTAL TEMP HIGH POSSIBLE CAUSES ACTION STEPS 1 Loose connector Reattach connector 2 Temperature in rectum has exceeded Allow rectal temperature to drop below 425 C 42 C 3 Enema not performed within 2 hours of Remove the rectal unit and perform treatment enema 4 Air may not have been removed from Remove air per Section 2 7 or 2 8 the original volume cc s in the rectal unit 110 of 182 Part 250023 001 Rev J Appendix A Section 5 5 Rectal unit may not be inserted Check that the rectal unit is properly properly positioned 6 Patient improperly positioned Reposition patient with head and shoulders elevated no higher than a 20 angle 7 Microwave catheter may not be Check that the microwave catheter is positioned properly properly positioned 8 Rectal unit may be defective Replace the rectal unit ERROR 14 RECTAL TEMP LOW POSSIBLE CAUSES ACTION STEPS 1 Loose connector Reattach connector Rectal unit temperature below 15 C Check that the rectal unit is inserted properly 2 Rectal unit expelled or not properly Reinsert the rectal unit or inflate the inflated rectal unit 3 Rectal unit may not be inserted Check that the rectal unit is pr
86. ber or clinic ID You can enter up to 20 alphanumeric characters institutions Enter the name of the hospital or clinic You can enter up to 20 alphanumeric characters Age Enter the patient s age Quality of Life Enter the quality of bfe index Prostate Specific Antigen igralk Enter the prostate specific antigen lawel ng Intemational Prostate Symptom Score Enter the international prostate Symptom score or the AUA sympion score Qmax mL s Enter the maximum flow rate mls Urethra Length om Enter the urethra length crm The urethra length must be at least 2 5 cm Prostate Volume mL Enter the prostate volume mL Fost Vold Residuals mL Enter the postvoid residual volume mL 2 Fress the Next button to go to the mest screen Or press the Back button to return to the previgus screen Down arrow Figure 3 6 Help Window 2 Press the up and down arrows to scroll through the Help window Or press the Back Forward Contents Glossary or Close buttons to move through the help feature e Press the Back button Move back through the help topics viewed recently e Press the Forward button Move forward through the help topics viewed recently e Press the Contents button View the CoolWave Control Unit User Manual table of contents e Press the Glossary button View the CoolWave Control Unit User Manual index glossary e Press the Close button Close the Help window 3 1 2 2 Notes 1 Press the Notes bu
87. cent rooms in the building including the rooms above and below the treatment room e Do not operate the Targis System near equipment that emits electromagnetic energy unless the effect on the Targis System has been evaluated and no degradation of performance was found e The national standard ANSI IEEE C95 1 1999 Edition Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields recommends a maximum stray field exposure level for whole body exposure of 3 mW cm2 as averaged for any six minute period The maximum radiated field at full power from the CoolWave Control Unit patient cable and Microwave Catheter at five centimeters is 2 1 mW cm2 Urologix recommends that the operator maintain a minimum distance to five centimeters from the patient cable and exposed portions of the Microwave Catheter during the treatment e Operate the CoolWave Control Unit and connected devices only in clinical environments where the electrical insulation is in accordance with international standard DIN VDE 0107 and the national standard ANSI NFPA 70 The equipment must be connected to a fully tested hospital grade power outlet with adequate grounding e The CoolWave Control Unit must be plugged into the appropriate voltage outlet e The electrical equipment inside the Targis System uses voltages which are capable of causing serious injury or death from electric shock To avoid this hazard operators must never
88. creen should be cleaned periodically following these instructions Part 250023 001 Rev J 97 of 182 Section 4 Equipment Maintenance e Clean the touchscreen with a soft lint free cloth dampened with a solution of 50 IPA and 50 warm water Or use 100 IPA instead of the IPA and water solution e Do NOT spray the cleaning solution directly on the screen The solution may seep inside the display or stain the bezel 4 2 Maintaining the CoolWave Control Unit If a product failure occurs the defective device must be returned to Urologix for evaluation and reimbursement 4 2 1 Daily Maintenance Before using the CoolWave Control Unit you should visually inspect system components for damage Refer to Section 1 8 1 Installation for a list of the system components requiring inspection e Wipe the exterior surface of the CoolWave Control Unit with a 10 solution of bleach or mild detergent Wipe the exterior surface of the unit with water to rinse e Keep the touchscreen clean If the screen needs cleaning refer to Section 4 1 3 Cleaning the touchscreen for further information e Check the printer paper If the printer needs a paper refill refer to Section 4 3 1 Refilling the printer with paper for further information e Check all cables and power connections Be certain that all cables are firmly attached and routed away from normal traffic paths e Check the sight gauge on the rear of the CoolWave Control Unit to ensure that
89. crements until the rectal unit is 41 5 C If the rectal unit temperature does not respond as quickly as needed decrease power by 3 W increments When the rectal unit temperature begins to decrease try to increase microwave power to achieve and maintain the microwave catheter at 40 C 1 C while maintaining rectal temperatures at or below 42 C After at least 28 minutes and 30 seconds of treatment end the treatment by pressing the Pause End button from the Control Panel and go to cooldown The Treatment Cooldown window will appear 3 7 2 3 Cooldown The cooldown 5 minute timer shows the time remaining until the end of cooldown which also indicates how much time has passed since the microwave power was turned OFF with the coolant pump still running You can add additional cooldown to by pressing the 10 minute or 15 minute button on the Cooldown window When the cooldown period ends the coolant pump will continue running with the cooldown timer at 00 00 Coolant will continue circulating until you end the treatment e Resume the treatment remain in cooldown or end the cooldown exit treatment if desired from the Treatment Cooldown window e Remain in cooldown press the 5 minute 10 minute or 15 minute button or end the cooldown exit treatment when the Treatment Cooldown End window appears It is recommended to remain in cooldown for at least 5 minutes Part 250023 001 Rev J 95 of 182 Section 3 Treatment Instructions 9
90. d be made every 5 to 10 minutes throughout the treatment to verify the proper position of the rectal unit Failure to properly orient the rectal unit during treatment can result in patient injury e g fistula or scrotal burn M 7 Warning A minimum of 70 cc of air in the RTU Plus rectal balloon is required to maintain contact between the temperature sensors and the rectal wall Inflate the rectal balloon by injecting 90 cc of air into the inflation port located on the proximal end of the rectal unit Adjust the air volume for patient comfort to 70 cc Remove the syringe The physician must confirm the proper positioning of the rectal unit prior to proceeding 34 of 182 Part 250023 001 Rev J Treatment Session Setup Section 2 a Note When using an RTU Plus Reusable Handle the Protocol screen will display the number of times the handle has been used and the number of remaining uses The RTU Plus Reusable Handle should not be used in excess of 30 times 2 9 Connecting the Microwave Catheter and Rectal Unit to the CoolWave Control Unit M Y Warning Excessive elevation of the patient torso may put additional pressure on the rectal unit resulting in increased patient discomfort and higher rectal temperatures If the rectal unit was placed in the rectum while the patient was on his side reposition the patient supine with head and shoulders at no greater than a 20 angle This position relieves pressure on the rectal unit and inc
91. d for a 2 to 5 day period following the treatment For more complete information about the benefits and risks associated with Cooled ThermoTherapy please refer to the Instructions for Use found on our website at www urologix com or call us at 1 800 475 1403 Data taken from the CTC Advance Instructions for Use 250348 Rev B 12 08 Part 250023 001 Rev J 171 of 182 Section 6 Appendix B 6 8 Urologix Return Material Instructions Urologix is committed to providing you with the best support and service for your Cooled ThermoTherapy system In order to ensure the greatest accuracy in tracking product performance we urge you to contact Field Service at any time before during or after treatment for assistance with any questions or issues that you may encounter Please call 1 888 229 0772 and request to speak to Field Service You may also request to speak to Urologix Customer Service at this telephone number to report a product issue or complaint obtain your RMA Returned Material Authorization number or to ask questions pertaining to a specific RMA or the RMA process Contents of Return Material Kit 1 UPS or FedEx Express Pad Pak and 1 Shipping Document Airbill 1 Floppy Disk 1 Biohazard bag with absorbent pad for un sterile product 1 Zip Top bag with bubble pack Requirements for RMA Number Issuance e If you receive an error code during the treatment please take a moment to document the error code number and messa
92. der neck Figure 1 12 The microwave antenna and temperature sensor are connected to the CoolWave Control Unit via the patient connection cable housing and patient connection cable To ensure that the microwave catheter is positioned properly within the urethra the location balloon is inflated to hold the catheter in place during treatment 14 of 182 Part 250023 001 Rev J System Description Section 1 Cooling Shaft channel Coude tip Location balloon Microwave antenna PORER x eren ee fs ad ia Temperature sensor Urine drainage port connector Serial number label Figure 1 12 Microwave Catheter The microwave catheter is used for Delivering microwave energy to the targeted prostatic tissue Monitoring the urethra temperature Cooling the urethra during treatment Draining urine during treatment 1 6 3 Rectal Thermosensing Unit RTU The CoolWave Control Unit requires the use of either the single use standard RTU or the RTU Plus with reusable handle and single use balloon The standard RTU and RTU Plus Figure 1 13 and Figure 1 14 both consist of an inflatable balloon with 5 temperature sensors These sensors monitor rectal temperature along the anterior rectal wall and send this information to the CoolWave Control Unit during a treatment After inserting one of the rectal units into the rectum inflating the rectal balloon with air holds the thermosensors in place against the anterior recta
93. down on the wheel lock tabs To unlock the wheels press on the back part of the wheel lock tab Several safeguards or cautions apply when moving the CoolWave Control Unit Protect the patient connection cable when moving the CoolWave Control Unit Although a cable holder is provided on the rear of the CoolWave Control Unit for the patient connection cable the cable is still susceptible to damage Do not pull on or stress the cable e Always handle the touchscreen with care e Maintain the CoolWave Control Unit in an upright position when it is in use or being stored e Avoid tipping the unit Since the CoolWave Control Unit is heavy it will be damaged if it were to tip over In addition personal injury could result Do not lift or elevate the CoolWave Control Unit 4 5 Storing the CoolWave Control Unit For short and long term storage handle the CoolWave Control Unit as you would other sensitive medical equipment Store the CoolWave Control Unit in a low moisture equipment storage area where it may be kept long term Keep the surfaces and components of the CoolWave Control Unit free of dust by covering the unit with plastic 4 6 Shipping the CoolWave Control Unit In the event that it becomes necessary to ship the CoolWave Control Unit contact Urologix Customer Service at 1 888 229 0772 For repeated transportation of the CoolWave Control Unit Urologix offers a Transport Kit which is the only FDA appro
94. e between the patient s legs not over the legs and use a towel to isolate the legs and keep them from moving e Then verify that the cable and handle are sufficiently isolated from the patient prior to beginning treatment 36 of 182 Part 250023 001 Rev J Treatment Session Setup Section 2 Place towels on legs Patient connection Treatment Catheter cable housing Holder Figure 2 16 Isolate the Antenna Cable and Catheter Handle Using the Microwave Catheter Holder Connect the rectal unit connector to the patient connection cable housing Figure 2 17 Rectal unit connector white marks must line up for connection Microwave Antenna Temperature Sensor Connector Connector fully tightened Figure 2 17 Patient Connection Cable Housing If not already completed attach a urine drainage bag to the urine drainage port of the microwave catheter Proceed to Section 3 Treatment Instructions for information on how to perform a Cooled ThermoTherapy Treatment Part 250023 001 Rev J 37 of 182 Section 2 Treatment Session Setup 38 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 3 Treatment Instructions 3 1 System Navigation and Screen Overview This section provides the information needed to navigate the CoolWave Control Unit as well as an overview of the screens including demonstration mode Please read this section prior to using the CoolWave Control Unit for the first time 3 1 1 Syste
95. e Urologix BPH Treatment screen to adjust treatment parameters urethra setting treatment time coolant setting and ramp rate during a Cooled ThermoTherapy Treatment in automatic treatment mode Analgesia The reduction of pain stimulus without the corresponding loss of consciousness Analgesic A medication that reduces or eliminates pain In BPH patients depending on the clinician s diagnosis there are several agents that might be considered for the reduction of pain Antibiotic A substance that is used to destroy or inhibit the growth of microorganisms Anti inflammatory A medication that is used to reduce inflammation which is often characterized by localized heat redness swelling and pain in the tissues Automatic treatment mode The CoolWave Control Unit begins a Cooled ThermoTherapy Treatment based on the selected treatment protocol and continues with that treatment until the end of cooldown without the need for adjusting any treatment parameters Benign Prostatic Hyperplasia BPH A nonmalignant but abnormal increase in the tissue of the prostate gland that sometimes results in constriction of the urethra BPH The acronym for Benign Prostatic Hyperplasia Cable holder Located on the back of the CoolWave Control Unit the cable holder provides a place to store the power cord and the patient connection cable and housing Calibration process A diagnostic test that the CoolWave Control Unit runs to
96. e at the desired temperature if the coolant door is not completely closed In addition a closed coolant door prevents damage to the coolant bag 2 6 Inserting the Microwave Catheter Drain the patient s bladder using only water soluble lubricant in the process Instill an anesthetic mixture of choice into the bladder Insert a water based anesthetic lubricant mixture of choice into the urethra and clamp the penis to contain the lubricant mixture within the urethra for 20 30 minutes M Y Warning Do not overinflate the microwave catheter balloon Overinflation may result in balloon malfunction and possible improper positioning of the microwave antenna Underinflation can cause the antenna to be misplaced in the prostate affecting the external sphincter M Y Warning Selection and use of the appropriate catheter model is required to assure patient safety Verify that the correct catheter has been inserted in the patient using the catheter identifiers provided in Table 2 1 Microwave Catheter Identification 28 of 182 Part 250023 001 Rev J Treatment Session Setup Prostatic Urethral Length Microwave Catheter CTC Advance 2 5 to 3 5 Short a CTC Advance 3 0 to 5 0 Standard ee CTC Advance gt 4 5 cm Long 2 5 to 3 5 cm 3 0 to 5 0 cm Targis Standard Table 2 1 Microwave Catheter Identification Catheter Color Scheme Catheter Picture Blue Handle Black Accents Blue Handle White
97. e patient The catheter may be removed within 24 to 60 hours or as the physician directs 2 Instruct the patient at discharge to take prophylactic oral antibiotics for 3 days 3 Provide the patient with sedatives pain relievers or anti inflammatory medication as necessary Part 250023 001 Rev J 79 of 182 Section 3 Treatment Instructions 3 5 Control Unit options The Options Menu screen lists the following CoolWave Control Unit options users printer data password and system Figure 3 42 These options allow you to access printer utilities copy a treatment file to a USB flash drive print a treatment report modify a password or adjust system settings And if you have administrative privileges you will also have access to user settings If you do not have administrative privileges you will not see the Users button on the Options Menu screen Demonstration mode When in demonstration mode you will not have access to user settings Therefore you will not see the Users button on the Options Menu screen Coo l Wave Figure 3 42 Options Menu screen 1 Press the Users button to view the User Settings screen Refer to Section 3 5 1 User Settings screen for further information 2 Press the Printer button to view the Printer Utilities screen Refer to Section 3 5 2 Printer Utilities screen for further information 3 Press the Data button to view the Data View Print Copy screen Refer to Section 3 5 3 Data V
98. e printer the printer flashes 1 long green and 2 short orange lights Insert paper into the printer and press the Resume Cancel button on the printer The CoolWave Control Unit automatically returns to the Urologix BPH Treatment screen while the event log prints Part 250023 001 Rev J 69 of 182 Section 3 Treatment Instructions c Clear Print Queue Press the Clear button to clear the print queue The CoolWave Control Unit automatically returns to the Urologix BPH Treatment screen while the print queue clears 5 Select one of the following options to view and adjust treatment parameters a Press the Standard button on the Control Panel View the controls for the urethra temperature and the treatment time Refer to Section 3 3 5 1 Using standard mode for further information b Press the Advanced button on the Control Panel View the controls for the urethra temperature treatment time coolant temperature and ramp rate Refer to Section 3 3 5 2 Using advanced mode for further information c Press the Manual button on the Control Panel View the controls for microwave power coolant pump ON OFF coolant temperature and ramp rate Refer to Section 3 3 5 3 Using manual mode for further information Note If you do not have access to the manual treatment mode you will not see this option on the Control Panel 6 Press the Pause End button on the Control Panel to pause a treatment or end a treatment early before the
99. e taking Cooled ThermoTherapy is available by prescription only This therapy is not for everyone Talk to your physician to see if Cooled ThermoTherapy is right for you Most medical treatments may have side effects Possible side effects for Cooled ThermoTherapy include blood in urine clots in urine painful or difficult urination thickened bladder muscle rectal irritation temporary inability to control urination brief inability to achieve or maintain an erection and the inability to discharge semen in orgasm thus should be considered by men who wish to have further offspring A small risk of urethral stricture may result requiring further intervention Patients may experience discomfort during the treatment that may require the use of analgesics or sedatives Patients may be catheterized for a 2 to 5 day period following the treatment For more complete information about the benefits and risks associated with Cooled ThermoTherapy please refer to the Instructions for Use found on our website at www urologix com or call us at 1 800 475 1403 Data taken from the CTC Advance Instructions for Use 250348 Rev B 12 08 164 of 182 Part 250023 001 Rev J Appendix B Section 6 Informed Consent Form for Cooled ThermoTherapy Treatment Description of Treatment Cooled ThermoTherapy or transurethral microwave thermotherapy TUMT is a non surgical treatment for benign enlargement of the prostate gland also known as benign prost
100. ear the Remove other microwave catheters and patient connection cable housing rectal units from the patient connection cable housing area CONTROL UNIT DOES NOT RECOGNIZE SERIAL NUMBER POSSIBLE CAUSES ACTION STEPS 1 RFID Tag not in Antenna Field Verify that serial tag is adjacent to Connection cable housing connector and rotated such that it touches the flat portion of the Patient Cable Connector 2 REID field being affected by If Patient cable Connector is setting on a surrounding metallic surfaces metallic surface raise it off the surface by setting it on a nonmetallic spacer such as a towel 118 of 182 Part 250023 001 Rev J Section 5 ERROR AND ERROR NAME DETECTED BY SOFTWARE Appendix A 309 Synthesizer Unlocked 311 File Open Error 312 Urethra Temp Comm Fail 313 MW Comm Failure 314 Parameter Error 315 Watchdog Timeout 316 Disk Free Error 322 File CRC Failure 375 MW Software Low 376 MW Software High 377 MW Software Mid 378 MW Software Reverse 379 MW Software Forward 398 Memory Free Error 399 Urethra Temp Setup Error 418 Urethra Temp Failure 430 RFID Comm Failure 432 RFID Update failure RTU 433 RFID Update failure Catheter 442 File Missing 443 Msg Queue Filling Warning 444 Memory Free Warning 445 Disk Free Warning 451 Software Watchdog Test Failure 452 Msg Queue Overflow 453 Process Status Error 456 Resource Mgr Read Error 457 Mutex Unlock Error 458 Mutex Lock Error 459 Mutex Init Error 460 Ti
101. eatment diagram 4 Press the Print button located in the upper right corner of the Urolo gix BPH Treatment screen Then select one of the following print options Print Treatment Report Print Event Log and Clear Print Queue Figure 3 32 Or press the Close button to return to the Urologix BPH Treatment screen 68 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 Figure 3 32 Print window e Note Refer to Section 4 3 Maintaining the printer Figure 4 3 for a printer overview a Print Treatment Report Press the Remove Patient Info button optional to remove a patient s name from a treatment report A check mark appears in the button Turn the printer ON load paper if needed into the printer and press the Report button However if you pressed the Report button and paper was not in the printer the printer flashes 1 long green and 2 short orange lights Insert paper into the printer and press the Resume Cancel button on the printer The CoolWave Control Unit automatically returns to the Urologix BPH Treatment screen while the treatment report prints The report includes the following information e Patient data Treatment protocol data Treatment data Treatment chart Event log Case notes b Print Event Log Turn the printer ON load paper if needed into the printer and press the Events button to print the event log However if you pressed the Events button and paper was not in th
102. edication may be required for a comfortable Cooled ThermoTherapy treatment It appears that the treatment is best tolerated by patients who have been given an NSAID and or an oral anxiolytic or analgesic ONE HOUR PRIOR TO BEGINNING THE TREATMENT or as the specific drug label requires for maximum effect during treatment e An anticholinergic or antispasmodic may also be given to relieve bladder spasms and additional analgesics may be administered if warranted by the patient s individual tolerance Post Treatment Medications e A short course of an oral NSAID is beneficial in many cases unless contraindicated Other options may include a 5 day minimum cycle of antibiotics and or alpha blockers for 6 8 weeks a Note All medication decisions are the prerogative of the treating urologist Part 250023 001 Rev J 157 of 182 Section 6 Appendix B Post Treatment Care e The patient may experience several days of prostatic discomfort and increased irritative symptoms following the Cooled ThermoTherapy treatment Overall post treatment side effects vary in duration and intensity At pre and post treatment it is important to explain to the patient that there is a possibility his symptoms may transiently worsen after treatment and that it may take up to several weeks before noticing significant improvement A Foley catheter for 2 5 days or longer for some patients may be used following the treatment to reduce the incidence of urinary ret
103. een Refer to Section 3 3 2 Protocol screen for further information e Press the Cancel button Exit this treatment and return to the Main Menu screen Refer to Section 3 2 3 Main Menu Screen for further information e Press the Debug button Display the Debug panel which can be used to determine which system component is reporting an error condition Refer to Section 5 1 Troubleshooting guide for further information At this point contact Urologix Customer Service 1 888 229 0772 to help you resolve any remaining errors Part 250023 001 Rev J 91 of 182 Section 3 Treatment Instructions 3 6 3 Treatment errors If an error occurs during the treatment you will hear a single beep and an error message will appear on the System Error screen in the Event pane or in the Detail pane Some errors will not allow you to continue using the CoolWave Control Unit The Reset button Event and Detail panes and System Error screen and the Resume Treatment button Cooldown pane will appear grayed out However some errors can be corrected You will notice that the Reset button is not grayed out Use the error message in the Event pane to correct the error Then press the Reset button to resume treatment Review the following conditions and actions e Microwave power will turn OFF if there is a treatment in progress e The error message will be saved to the event log e The keyboard will no longer function applies to errors on the System
104. els a Always call your physician before going to the emergency room If your doctor suggests that you go to the emergency room or other facility for catheterization for inability to urinate be sure to tell the facility personnel to use a Coud pronounced coo day tipped catheter If you cannot reach your physician and need immediate attention go to the hospital emergency room for treatment Date Time Location Cooled ThermoTherapy is available by prescription only This therapy is not for everyone Talk to your physician to see if Cooled ThermoTherapy is right for you Most medical treatments may have side effects Possible side effects for Cooled ThermoTherapy include blood in urine clots in urine painful or difficult urination thickened bladder muscle rectal irritation temporary inability to control urination brief inability to achieve or maintain an erection and the inability to discharge semen in orgasm thus should be considered by men who wish to have further offspring A small risk of urethral stricture may result requiring further intervention Patients may experience discomfort during the treatment that may require the use of analgesics or sedatives Patients may be catheterized for a 2 to 5 day period following the treatment For more complete information about the benefits and risks associated with Cooled ThermoTherapy please refer to the Instructions for Use found on our website at www urologix com or call us a
105. em Description Section 1 1 Systems Description 1 1 Notice The information contained in this manual is subject to change This manual does not necessarily address all safety concerns associated with the Urologix CoolWave Control Unit The CoolWave Control Unit is intended for use only by qualified medical personnel Federal USA law restricts this device to sale by or on the order of a physician trained and or experienced in the use of this device as outlined in the required training program Medical equipment however sophisticated should never be a substitute for the human care attention and critical judgment that only trained healthcare professionals can provide 1 2 Safety symbols and definitions The following safety symbols are used throughout this manual Familiarize yourself with each symbol and its meaning before using this equipment You can find additional symbols associated with the CoolWave Control Unit in Section 5 4 Description of symbols SAFETY SYMBOL DEFINITION A note indicates important information that helps you operate the CoolWave Control Unit or use the disposable devices Note A caution contains instructions that must be followed to avoid a possible malfunction of or damage to the equipment or its connected devices Do not proceed beyond a caution sign until the indicated conditions are fully understood and met A warning contains important information about possible danger to you or the pat
106. emove air per Section 2 7 or 2 8 the original volume cc s in the rectal unit 5 Rectal unit may not be inserted Check that the rectal unit is properly properly positioned 6 Patient improperly positioned Reposition patient with head and shoulders elevated no higher than a 20 angle 7 Microwave catheter may not be Check that the microwave catheter is positioned properly properly positioned 8 Rectal unit may be defective Replace rectal unit Part 250023 001 Rev J 107 of 182 Section 5 Appendix A ERROR 2 RECTAL TEMP LOW POSSIBLE CAUSES 1 Loose connector 2 Rectal unit temperature below 31 C 3 Rectal unit expelled or not properly inflated 4 Rectal unit may not be inserted properly 5 Rectal unit may be defective ACTION STEPS Reattach connector Check that the rectal unit is inserted properly Reinsert the rectal unit or inflate the rectal unit Check that the rectal unit is properly positioned Replace the rectal unit ERROR 3 COOLANT PRESS HIGH POSSIBLE CAUSES 1 Pressure too high in tubing 2 Coolant bag may be defective 3 Microwave catheter may be defective ACTION STEPS Check that the pump tubing clamp is properly fastened and that the tubing is not kinked Disconnect coolant luers from the microwave catheter temporarily connect coolant luers to each other and then restart treatment If error repeats replace coolant bag Otherwise check the
107. ent patient record 3 Check the correct positioning of the rectal unit at least every 5 to 10 minutes to ensure the rectal unit has not moved 4 Always immediately check microwave catheter and rectal unit placement if the patient complains of any abnormal or sudden increase in pain Pause the treatment if the patient complains of serious pain 5 Observe the treatment parameters for sudden changes in readings especially decreases in temperatures that might indicate a sensor has moved from its previous position Table 3 1 Safety Checks During Treatment 50 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 3 3 1 Patient Information screen Robinson Figure 3 14 Patient Information Screen 1 Enter patient information Figure 3 14 Data fields marked with a bullet require information before proceeding with the treatment Patient Name Enter up to 20 alphabetic characters for the first name 1 alphabetic character for the middle initial and up to 30 alphabetic characters for the last name Patient ID Enter the patient s hospital medical record number or clinic ID You can enter up to 20 alphanumeric characters Institution Enter the name of the hospital or clinic You can enter up to 20 alphanumeric characters Age yrs Enter the patient s age in years This is a required field Quality of Life Score Enter the quality of life index Urethra to Rectal Distance cm Enter the distance from the patient s
108. ention and the associated pain and discomfort resulting from the treatment e The patient may also experience a few side effects from the treatment and may notice some or none of the following Soreness in the lower abdomen Urgency to urinate even after the catheter is removed Frequent urination Bladder spasms Small amounts of blood in the urine Aching and or discomfort in the prostate area e Failure to void upon Microwave Catheter removal does not mean treatment failure e Prior to discharge home the patient and urologist should discuss patient expectations and the patient should be given 1 instructions to maintain an adequate fluid intake 2 prescriptions for an NSAID an antibiotic and antispasmodic 3 Foley catheter care instructions 4 a follow up appointment and 5 instructions similar to the following The patient should be told to contact the physician if he e Develops a high fever with temperature above 101 5 F e Notices a painful swollen and or inflamed testicle s or scrotum e Js unable to void spontaneously or the indwelling catheter is not draining urine and is blocked e Has difficulty moving his bowels e Has excessive urinary bleeding or bleeding from the penis e Has continuous bladder spasms For a complete description of System Components refer to Section 1 System Description 158 of 182 Part 250023 001 Rev J Appendix B Section 6 6 6 Frequently Asked Patient Quest
109. er Press the Resume Treatment button Figure 3 41 and then the Resume button Figure 3 40 to reset the 5 minute cooldown timer c End the cooldown Press the Cooldown End button to end the cooldown Figure 3 41 A dialog box appears to confirm that you want to end the cooldown and therefore end this treatment 3 4 Post treatment This section includes the steps to follow after completing a treatment what to do with the CoolWave Control Unit and associated devices and instructions for the patient post treatment 3 4 1 CoolWave Control Unit UY Caution Verify that the disposable components are removed intact l Disconnect the coolant bag from the microwave catheter To prevent water from draining out of the coolant bag and onto the floor connect the coolant bag connectors to each other Disconnect the microwave catheter from the CoolWave Control Unit Remove all water from the microwave catheter location balloon and withdraw the catheter from the patient Disconnect the rectal unit from the patient connection cable Remove all air from the rectal unit and withdraw the device from the patient If desired pull the sheath of the RTU Plus up over the balloon to contain contaminants Remove the coolant bag from the CoolWave Control Unit Dispose of the single use microwave catheter single use rectal unit or component and the coolant bag in accordance with Universal Precautions for Contamination Refer to Section 4 1 1 Cle
110. erapy Treatment Patient Selection Proper patient selection and education including setting realistic expectations for the treatment and its outcomes are essential for successful Cooled ThermoTherapy or transurethral microwave thermotherapy TUMT treatment in the office setting Patient Assessment Pretreatment patient assessment may include e International Prostate Symptom Score IPSS also known as American Urological Association Symptom Score Quality of Life QOL score Medical history including medications Physical exam including digital rectal exam DRE Urinalysis Blood analysis specifically PSA BUN creatinine and glucose consider INR if patient 1s anticoagulated Uroflowmetry e Post void residual PVR e Cystoscopy to rule out enlarged obstructing median lobe protruding into the bladder and to measure prostatic urethral length e Transrectal ultrasound to assess prostate volume e Appropriate evaluation to identify conditions that can mimic LUTS secondary to Benign Prostatic Hyperplasia BPH such as UTI Parkinson s Disease bladder or prostate cancer Urologists must establish to their satisfaction that e Prostate lengths are measured accurately from the verumontanum to the bladder neck The patient has BPH symptom score uroflowmetry quality of life Treatment is clinically indicated No active infection is present The median lobe is not protruding into the bladder a ball valve
111. ev J 123 of 182 Section 5 Appendix A Upon completion of Calibration the Treatment screen will appear Resume previous treatment until the desired treatment time is achieved 124 of 182 Part 250023 001 Rev J Appendix A Section 5 5 3 Treatment screen flowchart gt LOGIN SCREEN LOGOUT LOGIN MAIN MENU N A N J BACK TREATMENT C Y PATIENT INFORMATION BACK NEXT PROTOCOL SELECTION A BACK NEXT TREATMENT CHECKLIST C REPLACE MICROWAVE lt RETRY CANCEL gt OFF ba E S a D CALIBRATION CALIBRATION PROCESS ERROR ERROR y Ng d J AUTOMATIC C gt AUTOMATIC TREATMENT EXIT Figure 5 5 Treatment screen flowchart Part 250023 001 Rev J 125 of 182 Section 5 5 4 Description of symbols Appendix A There are a number of symbols associated with the Targis System CoolWave Control Unit Microwave Catheter RTU and Coolant Bag Some of these symbols appear in Section 1 of this manual Other symbols Urologix adopted from the international community to assist you in understanding Urologix labeling U lt W O rr O j DAOL 126 of 182 DESCRIPTION Alternating current Catalog Number Batch Code Lot Number Serial Number Do not re use Equal potential ground Fuse type and value Internal reser
112. fection to the patient e Use of the Targis System results in the deposition of microwave energy within the patient s prostate and in adjacent regions of the body Some animal studies in the literature suggest that there may be as yet unknown health effects from exposure to microwave radiation including an increased incidence of tumors Although it is not possible to extrapolate these studies to humans they suggest that unnecessary microwave radiation exposure should be avoided e At least 20 cm of ventilation clearance must be provided around the base of the CoolWave Control Unit e The Targis System emits a small amount of electromagnetic energy during a treatment Urologix recommends that all electronic medical devices be kept at a minimum distance of 1 0 meter from the Targis System when performing a treatment However a 1 0 meter separation of electronic medical equipment from the Targis System does not guarantee that operation of other devices will not be impacted The effect of this electromagnetic energy on all equipment cannot be predicted due to age and quality of maintenance The performance of each piece of equipment operated near the Targis System during a treatment must be evaluated for degradation e Since microwave energy can travel though walls ceilings and floors to affect other devices it is important to understand that the meter safety distance applies not only to the treatment room but also to all adja
113. ge as this will assist us in determining cause of error e Please have detailed information of the pre testing treatment and the errors that have occurred during the treatment Any and all information will be helpful e Keep all tags and boxes of product to assist in obtaining product information e g serial and lot number catheter size and type e Call Urologix Customer Service at 1 888 229 0772 to report the product issue or complaint Please follow the steps below for Return Materials Please ship defective product within 3 days of reporting the incident If you are unable to do so please communicate this with Customer Service at the time of your initial phone call Follow the 3 steps below to SEAL COPY and SHIP the RMA 1 SEAL Place the defective component s into the Biohazard bag and place the sealed Biohazard bag into the Zip Top bag Seal the Zip Top bag Please note that defective product from different patient treatments cannot be placed together in the same RMA kit and will need to be issued a unique RMA number 2 COPY Please refer to section 3 5 3 in this User Manual If you do not have a USB Flash Drive please contact Customer Service to receive one 3 SHIP Place the sealed Zip Top bag and the disk with the treatment file information into the Express Pad Pak Complete the shipping document Place the shipping document on top of the Express Pad Pak and record the RMA assigned Contact the courier UPS or FedEx at the
114. gure 3 16 Protocols can vary depending on the microwave catheter in use and user preference The description next to each protocol defines first the urethra temperature second the coolant temperature and third the ramp rate all treatment times default to 28 minutes and 30 seconds though that time can be modified from the standard mode or advanced mode CoolWave Control Panel on the Urologix BPH Treatment screen In addition a custom protocol is user defined and can be modified To modify a custom protocol proceed to step 5 Otherwise proceed to step 8 to continue with the treatment 5 Select a custom protocol if you have not done so already by pressing on the treatment protocol name Then press the Modify button Figure 3 20 56 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 98765432 10ABCDE 0123456AAAAAAAB Standard Protocol 40 0 C 15 0 C Medium Custom Protocol 1 Custom Protocol 2 40 0 C 15 0 C Fast Figure 3 20 Example of Protocol screen modify 6 Adjust the urethra setting coolant setting and ramp rate Figure 3 21 as desired 38 0 C 16 0 C Ramp Rate Figure 3 21 Example of treatment protocol modify Part 250023 001 Rev J 57 of 182 Section 3 Treatment Instructions Bisa The treatment timer runs when the following conditions occur Targis CTC Advance CTC Advance Short amp Standard Short Standard amp Long e Urethra 35 C with e Urethra 35
115. h your Canon color inkjet printer Paper guide Paper rest Resume Cancel button Power button Power lamp Print head cover Paper thickness lever Output slot cover Figure 4 3 Printer overview 100 of 182 Part 250023 001 Rev J Equipment Maintenance Section 4 4 3 1 Refilling the printer with paper y Notes e Do not load more than 10 sheets of paper in the output slot cover e Avoid touching a printed sheet until the ink dries Make sure the paper is flat and not curled at the edges Open the paper rest and output slot cover Figure 4 3 Slide the paper thickness lever Figure 4 3 to the right position Insert the paper into the sheet feeder while aligning it against the right side of the feeder Position the paper guide Figure 4 3 against the left side of the paper ae ae cae 4 3 2 Replacing an Ink Tank a Notes e Replace an empty ink tank immediately Printing with an empty ink tank may cause problems with the printer e Check the model number on the new ink tank to make sure you are using the correct one e Be careful not to stain your clothing or other items while replacing an ink tank e Dispose of an empty ink tank according to local laws and regulations regarding disposal of consumables e Use an ink tank within the first 6 months after it 1s installed e Do not remove an ink tank leave it out in the open and then place that ink tank back into the printer The ink in the ink tank will have dr
116. he RTU Plus Reusable Handle should not be used in excess of 30 times The control unit will display the number of times the RTU Plus Reusable Handle has been used on the Protocol screen Figure 3 16 Part 250023 001 Rev J 53 of 182 Section 3 Treatment Instructions If the size of microwave catheter and the urethra length do not meet our requirements a dialog box will display Figure 3 17 The user will not be able to proceed through Treatment Protocol until the PUL and catheter are compatible Warning The Catheter Treatment Length is greater than the Prostatic Urethra Length Please verify that the catheter is appropriate for the patient before proceeding Close J Figure 3 17 Warning Screen for Catheter Size Error 1 Connect the microwave catheter and the rectal unit to the Patient Connection Cable Housing if you have not done so already refer to Section 2 9 Connecting the Microwave Catheter and Rectal Unit to the CoolWave Control Unit 2 Verify that the CoolWave Control Unit automatically inserted the microwave catheter and rectal unit serial numbers in the appropriate data fields in step 1 on the Protocol screen Figure 3 16 a b c 54 of 182 If both serial numbers appear in the data fields proceed to step 3 If both serial numbers appear in the data fields but the microwave catheter serial number indicates that a used catheter is connected to the system a caution symbol appears To
117. he Targis Microwave Catheter and the CTC Advance Microwave Catheter are 40 C e Ramp rate The ramp rate reflects the speed at which the microwave catheter and coolant temperatures change from their current values to their set point target values Then once you reach the System Calibration screen the calibration process begins After the calibration process completes the CoolWave Control Unit enters the automatic treatment mode To learn more about the automatic treatment mode and the manual treatment mode please refer to Section 3 7 Treatment modes for further information Otherwise proceed to Section 3 3 1 Patient Information screen to begin the Cooled ThermoTherapy treatment Part 250023 001 Rev J 49 of 182 Section 3 Treatment Instructions SAFETY CHECKS DURING TREATMENT IMPORTANT It is critical that throughout the patient s treatment the treating physician verify the correct position of the microwave catheter and the RTU Patient safety is at risk if the following simple and straightforward procedures are not correctly observed 1 Throughout the duration of the treatment verify that the position mark on the catheter remains at a fixed distance from the penile meatus 2 Itis strongly recommended that at least every 5 10 minutes of the treatment the correct position of the location balloon in the bladder be checked by transabdominal ultrasound Document the action by placing the ultrasound in the perman
118. heter 5 Patient cable may be defective Call Urologix Customer Service ERROR 103 MW CALIBRATION FAILURE POSSIBLE CAUSES ACTION STEPS 1 Antenna connector may be improperly Reattach the connector being careful not connected to cross thread it Rotate the Microwave Antenna Connector nut 4 full turns with your fingers until snug to ensure a proper connection 2 The urine drainage lumen may contain Purge the urine drainage lumen with fluid air 3 Microwave catheter may be defective Replace the microwave catheter ERROR 105 USER CANCELED OPERATION POSSIBLE CAUSES ACTION STEPS 1 Calibration stopped by user Address reason for stopping calibration and resume calibration sequence ERROR 198 INVALID CATHETER TYPE DETECTED POSSIBLE CAUSES ACTION STEPS 1 Microwave catheter type in RFID does Replace the microwave catheter not match Part 250023 001 Rev J 115 of 182 Section 5 Appendix A ERROR 199 URETHRA TEMP CROSS CHECK POSSIBLE CAUSES ACTION STEPS 1 Internal voltage fluctuation relating to Press the Retry button if available fiber optic sensor ERROR 300 CONTROL UNIT TEMP TOO HIGH POSSIBLE CAUSES ACTION STEPS 1 CoolWave Control Unit vents are Remove any item that may be blocking blocked on the sides or back of the the vents machine 2 CoolWave Control Unit internal Allow the CoolWave Control Unit to temperature gt 60 C continue pumping coolant through the catheter Call
119. heter Inserting the single use standard RTU or inserting the RTU Plus with reusable handle and single use balloon e Connecting the microwave catheter and RTU to the CoolWave Control Unit 2 3 Preparing the Patient for Treatment Ensure the patient has received adequate information about the treatment and post treatment expectations and has provided informed consent Part 250023 001 Rev J 23 of 182 Section 2 Treatment Session Setup Perform an enema to 2 hours before treatment or per physician instructions An enema is mandatory Administer pre treatment medications such as local anesthetics antibiotics non steroidal anti inflammatory agents analgesics or anti anxiety medications generally given hour prior to the start of microwave power delivery It is important that the patient not be over sedated This may compromise his ability to communicate pain a Note Medications such as anti inflammatory agents may be given to the patient at the discretion of the physician based on the patient s physical and mental well being 2 4 Positioning and preparing the CoolWave Control Unit Position the CoolWave Control Unit on a level surface and close enough to the patient so that the patient connection cable connects easily to the microwave catheter and the RTU Lock the front wheels of the CoolWave Control Unit to prevent it from accidentally moving To lock the wheels use your foot to press down on the wheel lock t
120. ied out and may cause the printer to malfunction 1 Open the paper rest and press the Power button Figure 4 3 The power lamp next to the Power button will be green when the printer is ready Figure 4 3 2 Open the print head cover Figure 4 3 3 Push the tab on the old ink tank and remove the tank 4 Remove the new ink tank from its package and remove the orange protective cap Notes e Do not replace the orange protective cap after removing it from the new ink tank e Do not touch the open ink port after removing the orange protective cap 5 Insert the new ink tank with it slightly slanted into the ink tank slot Figure 4 4 Part 250023 001 Rev J 101 of 182 Section 4 Equipment Maintenance 6 T ee d o a N Sap Sy s Figure 4 4 Insert the new ink tank Push down on the PUSH symbol on the ink tank until it clicks into place Close the print head cover The print head will move to the right 4 3 3 Printing the nozzle check pattern 7 Note You can also print the nozzle check pattern from the Printer Utilities screen Refer to Section 3 5 2 Printer Utilities screen for further information l 2 3 4 Open the paper rest and press the Power button Figure 4 3 The power lamp next to the Power button will be green when the printer is ready Figure 4 3 Load paper into the printer Press and hold the Resume Cancel button Figure 4 3 on the printer When the power
121. ient Do not proceed beyond a warning sign until the indicated conditions are fully understood and met The instruction manual symbol is displayed on the product when it is necessary for you to refer to the CoolWave Control Unit User Manual Instruction Manual this document Table 1 1 Safety Symbols and Definitions Part 250023 001 Rev J 5 of 182 Section 1 System Description 1 3 User Manual Overview This manual combines technical reference material as well as information on how to use the CoolWave Control Unit a Notes e For information regarding the contents of this manual please call Urologix Customer Service at 1 888 229 0772 e Read this manual before operating the CoolWave Control Unit Section 1 System Description provides an overview of the CoolWave Control Unit equipment This section also provides important notes about using the CoolWave Control Unit including information on installation use environment equipment connections equipment testing and safety instructions Section 2 Treatment Session Setup describes how to prepare the patient prepare the CoolWave Control Unit install the coolant bag and insert the microwave catheter and the RTU rectal unit Section 3 Treatment Instructions provides instruction on how to use the CoolWave Control Unit from logging into the CoolWave Control Unit to beginning and ending a Cooled ThermoTherapy treatment You will also find information
122. iew Print Copy screen for further information 4 Press the Password button to view the Password Setup window Refer to Section 3 5 4 Password Setup window for further information 5 Press the System button to view System Settings screen Refer to Section 3 5 5 System Settings screen for further information 6 Press the Back button to return to the Main Menu screen Refer to Section 3 2 3 Main Menu Screen for further information 80 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 3 5 1 User Settings screen Admin Demo default Craminster OOOO Figure 3 43 User Settings screen 1 Select a user from the menu on the right side of the screen and press on the user name Figure 3 43 That person s name appears in the Full Name data field on the bottom of the screen 2 Press the Modify button g Note The Modify button toggles between the Modify button and the Apply button 3 Select the user setting s you want to change Allow Clinical Protocols Allow Administrator Privileges Allow Manual Control or Reset Password Then press the associated button a Press the Allow Clinical Protocols button Provide or remove access to the clinical protocols for the selected user If the button has a checkmark remove access by pressing on the button If the button does not have a checkmark provide access by pressing on the button Proceed to step 4 a Note Clinical protocols are not available unless provided b
123. ine drainage bag As needed Sterile gloves As needed Anesthetic lubricating jelly e g Urojet or lidocaine jelly 50 cc Local bladder anesthetic of choice e g 50 cc of 1 or 2 lidocaine without epinephrine As needed Water soluble lubricating gel e g K Y Jelly 1 60 cc luer lock syringe 1 60 cc catheter tip syringe e g Toomey syringe 2 10 cc luer lock syringe 200 cc Sterile water for coolant bag and catheter balloons 1 Ultrasound system 1 Catheter plug As needed Permanent marker or tape As needed Nonsterile gloves Penile clamp Specimen cup 1 Urinal or graduate As needed Ice or ice pack Table 1 3 Clinic provided equipment 17 of 182 Section 1 System Description 1 8 CoolWave Control Unit Installation and Use Environment 1 8 1 Installation M 7 Warning DO NOT USE components that have evidence of a compromised package or damage Before unpacking the CoolWave Control Unit inspect the shipping crate for signs of damage Remove the CoolWave Control Unit from the shipping crate and retain the shipping crate to return the CoolWave Control Unit for service if needed Then prior to using the CoolWave Control Unit visually inspect the following components for damage e CoolWave Control Unit for obvious damage e Pump latch and coolant door to see that they are operating correctly e Patient connection cable patient connection cable housing and connectors for kinks cuts d
124. ine what to do next 105e User canceled operation Figure 3 25 System Calibration Screen Error Message y Notes e Ifa calibration error message appears refer to Section 5 1 Troubleshooting guide for further information Part 250023 001 Rev J 61 of 182 Section 3 Treatment Instructions e Before replacing a microwave catheter or rectal unit contact Urologix Customer Service at 1 888 229 0772 a Press the Help button Learn more about the error message and the appropriate response b Press the Retry button Attempt the calibration process again c Press the Replace button Replace the microwave catheter or the rectal unit as needed Refer to Section 2 6 Inserting the Microwave Section 2 7 Inserting the Single Use Standard RTU or Section 2 8 Inserting the RTU Plus Reusable Handle and Single Use Balloon for further information The CoolWave Control Unit returns you to the Protocol screen Refer to Section 3 3 2 Protocol screen for further information d Press the Cancel button Exit this treatment and return to the Main Menu screen e Press the Debug button Display a panel of information to help in troubleshooting See Section 5 1 Troubleshooting guide for further information At this point contact Urologix Customer Service 1 888 229 0772 to help you resolve any remaining errors 3 3 Urologix BPH Treatment screen The Urologix BPH Treatment screen allows you to monitor patient progre
125. ions What is a prostate gland The prostate gland located just below the bladder is about the size and shape of a walnut Its primary function is to produce semen the fluid that carries sperm The prostate surrounds the urethra the tube that carries urine from the bladder What is BPH BPH is Benign Prostatic Hyperplasia also known as enlarged prostate It is a non cancerous condition in which the prostate cells increase in number as a normal part of aging What are the symptoms of enlarged prostate The symptoms of enlarged prostate are Frequent and urgent need to urinate both day and night Difficulty starting urination Weak urine flow Urine flow that stops and starts Feeling of being unable to completely empty your bladder Urinary incontinence Interference with sexual activity Urinary tract infections How does Cooled ThermoTherapy work The treatment uses a Microwave Catheter that your doctor inserts into your urethra This Microwave Catheter contains an antenna that delivers heat to the enlarged prostate tissue and destroys it At the same time cool water circulates through the Microwave Catheter to protect the surrounding tissues from the heat generated by the microwave energy How do I know if the treatment is right for me If your physician has diagnosed you with BPH or an enlarged prostate you may qualify for the Cooled ThermoTherapy treatment Your physician will complete an exam to determine if the treatment i
126. irt contamination or obvious damage e Microwave catheter for kinks cuts or obvious damage e Rectal unit for kinks cuts or obvious damage e Coolant Bag for kinks cuts or obvious damage 18 of 182 Part 250023 001 Rev J System Description Section 1 Operate the CoolWave Control Unit and its connected devices only in clinical environments where it can be connected to a fully tested hospital grade power outlet with adequate grounding Power requirements CoolWave Control Unit 220 240 V 10 4 25 A Model 5000E Europe Single phase 50 or 60 Hz CoolWave Control Unit 110 120 V 10 8 5 A Model 5000A US Single phase 50 or 60 Hz If required an equal potential ground cable should be connected to the CoolWave Control Unit Figure 1 16 and the appropriate ground Fuse holder caps Equal potential ground I Power cord inlet ay Power cord holder Figure 1 16 CoolWave Control Unit Rear Part 250023 001 Rev J 19 of 182 Section 1 System Description CoolWave Control Unit Power Cords Urologix provides the following power cords for use with the CoolWave Control Unit 1 END VIEW POWER CORD CATALOG NUMBER Catalog Number AC1011 France Austria Germany Norway Belgium Sweden Netherlands Finland Catalog Number AC1012 Australia New Zealand Catalog Number AC1013 United Kingdom Ireland Catalog Number AC1014 Denmark Catalog Number AC1015 Italy Catalog Number A
127. ith an instrument called a resectoscope Treatment parameters CoolWave Control Unit values such as the microwave catheter and the rectal temperatures that the clinician monitors during treatment Treatment protocol The step by step plan the clinician follows when treating the patient s prostate condition Or the set of treatment parameters clinicians choose to treat a patient s prostate condition 136 of 182 Part 250023 001 Rev J Appendix A Section 5 Treatment session A treatment session begins when the patient enters the clinic and ends when the treatment is over and he is discharged Treatment timer The mechanism in the CoolWave Control Unit that advances increments of seconds and minutes at therapeutic temperature TRUS An acronym for transrectal ultrasound TUIP An acronym for transurethral incision of the prostate TURP An acronym for the transurethral resection of the prostate Universal Precautions Guidelines A standard set of safeguards that apply to patients undergoing treatment For example the CoolWave Control Unit should not be moved while the electrical cord is connected to a power source Urethra set point The urethra temperature the Control Unit maintains during a treatment The system increases or decreases microwave power until it reaches the urethra set point Urethra temperature The temperature at the tip of the microwave catheter in the center of the treatment region Urinary
128. l e The microwave catheter reaches 40 C 1 C or e The rectal unit gt 41 5 C or e Microwave power reaches 60 W for a Targis or CTC Advance Short Microwave Catheters or 75 W or CTC Advance Standard amp Long Microwave Catheters e The patient is experiencing discomfort 94 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 3 7 2 2 Treatment Throughout the treatment carefully monitor the patient s comfort level and the microwave catheter and rectal unit temperatures Wrote The treatment timer runs when the following conditions occur Targis CTC Advance CTC Advance Short amp Standard Short Standard amp Long e Urethra gt 35 C with e Urethra 35 C with e Urethra gt 35 C with Urethra Coolant Urethra Coolant Urethra Coolant difference gt 23 C difference gt 20 C difference gt 20 C e OR MW Power 50 W e OR MW Power gt 50 W e OR MW Power gt 65 W e OR RTU gt 41 C e OR RTU gt 41 C e OR RTU gt 41 C Maintain the optimum microwave catheter temperature of 40 C 1 C Monitor the patient for discomfort and adjust the following settings if necessary e Decrease the urethra setting temperature by decreasing the microwave power from the manual mode on the Control Panel e Increase the coolant setting temperature from the manual mode on the Control Panel Decrease microwave power if the rectal unit exceeds 42 C in 1 W per minute in
129. l wall nearest the prostate Temperature sensors Connector Finger pad Rectal balloon Orientation flag Extension tubing Balloon inflation port Figure 1 13 Single use standard RTU Part 250023 001 Rev J 15 of 182 Section 1 System Description Deployed sheath Serial number label Cable Temperature sensors Handle Urologic Connector ore Semirigid tubing Extension tubing SI Rectal balloon Balloon inflation port Figure 1 14 Assembled RTU Plus with the reusable handle and single use balloon 1 6 4 Coolant Bag The single use coolant bag includes a coolant bag inlet and outlet tubing connectors and a sensor module Figure 1 15 The sensor module allows the CoolWave Control Unit to monitor coolant temperature and pressure in order to maintain coolant temperatures within acceptable limits and to ensure that the coolant circulates properly The coolant bag also includes 2 small holes on the top and 1 hole on the bottom for mounting the bag on the chill plate and a hydrophobic vent to release air but not coolant from inside the bag Coolant bag Hydrophobic vent Mounting hole l S ater L Cre Coolant inlet and outlet tubing Connectors Coolant inlet tubing Sensor module Figure 1 15 Coolant Bag The function of the coolant bag is to provide a reservoir for the coolant that circulates through the microwave catheter during a treatment The coolant circulates
130. ldown button 76 Help button 42 Log Out button 48 Login button 46 Manual button 70 Microwave Off button 59 Microwave Off pushbutton 14 59 New User button 46 Notes button 43 Part 250023 001 Rev J Section 7 Options button 48 Password button 80 Patient button 83 Pause End button 76 Power button printer 101 Power Setting button 75 94 Print button 68 84 Printer button 80 Pump On Off button 75 Ramp Rate button 73 Remove Patient Info button 69 Replace button 62 Report button 69 Reset button 65 66 89 90 92 93 Reset Password button 82 Resume button 76 77 78 Resume Treatment button 77 78 89 92 Resume Cancel button printer 101 Retry button 62 Standard button 70 76 System button 80 Treatment button 48 Treatment Time button 71 Urethra Setting button 71 Users button 80 View button 83 Zoom button 64 Cable Antenna cable 14 36 Cable holder 9 11 104 Daily maintenance 98 Equal potential ground cable 19 Patient connection cable 8 9 14 63 104 Rectal unit cable 35 Safety check 22 Calibration error 30 89 90 91 Calibration error message 91 Calibration process 49 61 Case notes 69 Catheter See Microwave catheter Catheter button 83 Catheter plug 30 Caution 5 Caution icon 62 Cautions See Safety information Chart button 64 Chart pane 65 Check button 82 Chill plate 12 13 16 Clamp 26 Classification See Rating Clean Control Unit 97 Print head 82 83
131. llowing printer utilities Print Nozzle Check Pattern Perform Head Cleaning or Clear Print Queue Figure 3 44 a b 82 of 182 Print Nozzle Check Pattern Determine 1f the ink is ejecting properly from the print head nozzles A fuzzy printout means the print head needs cleaning Turn the printer ON load paper into the printer and press the Check button However if you pressed the Check button and paper was not in the printer the printer flashes 1 long green and 2 short orange lights Insert paper into the printer and press the Resume Cancel button on the printer The printer prints a nozzle check pattern Note You can also print the nozzle check pattern from the printer Refer to Section 4 3 3 Printing the nozzle check pattern for further information Perform Head Cleaning A fuzzy printout means the print head needs cleaning Clean the print head Press the Clean button The printer cleans the print head Part 250023 001 Rev J Treatment Instructions Section 3 g Notes Print and inspect the nozzle check pattern before cleaning the print head A print head cleaning uses up ink and should be performed only when needed e You can also clean the print head from the printer Refer to Section 4 3 4 Cleaning the Print Head for further information c Clear Print Queue Clear all print jobs from the printer memory Press the Clear button The printer clears the print queue 2 Press the Back button to return to the
132. lps to minimize patient stress and anxiety during the treatment and promotes a positive clinical outcome Prior to the patient s arrival e Set up the ultrasound system e Assemble and set up the treatment field with all necessary equipment medications and supplies Please refer to the Targis System CoolWave Control Unit User Manual or Instructions for Use for proper system assembly e Prepare patient discharge supplies e g medications Foley Catheter with instructions e Provide a restful atmosphere with a quiet room comfortable treatment bed use the Knee Cushions dimmed lighting if possible and a minimal number of medical personnel During the treatment e Offer the patient diversions such as conversation music TV or video Pretreatment Patient Instructions The following guidelines are suggested for the day before and the day of treatment Avoid alcohol coffee and other caffeinated beverages 48 hours prior to the treatment The night before treatment eat a light meal The day of treatment eat a light breakfast such as toast juice or milk Continue taking all routine prescription medications Administer a self enema such as a Fleet enema 1 2 hours prior to the treatment An enema cleanses the rectum and Is essential for accurate rectal temperature measurement during the treatment e Plan to arrive about 60 minutes before the treatment This will allow enough time to prepare for the treatment including pretreatment
133. lumen See cooling channel CTC Advance Microwave Catheter A type of microwave catheter Data field An area on the touchscreen where you can enter information Demonstration mode Demonstration mode simulates a Cooled ThermoTherapy Treatment and allows you to work with the CoolWave System as though you were performing a treatment on a patient Dialog box A dialog box appears on the touchscreen and provides additional information or instruction during a treatment Ejaculation The discharge of semen through the penis during sexual excitement Exclusion criteria A list of conditions that may bar a prospective patient from participating in a BPH clinical trial Frequency sweep An internal diagnostic test the CoolWave Control Unit performs to determine the functional status of the microwave antenna once it is placed inside the patient Gross hematuria A profuse quantity of blood in the urine Help feature Provides information on error messages and topics within the CoolWave System Hospital or clinic ID The patient s medical record number Impotence The inability to achieve an erection Incontinence The inability to control urination 132 of 182 Part 250023 001 Rev J Appendix A Section 5 Interval timer The mechanism in the CoolWave Control Unit that displays the time at which the last power adjustment occurred Location balloon The inflatable portion of the microwave catheter found near the tip that
134. m Navigation The CoolWave Control Unit includes a touchscreen monitor This touchscreen monitor makes it easy to move around in the CoolWave Control Unit Simply use your finger to gently press on the buttons on the screen You will hear a tick sound when you press a button You may also notice that a pressed button looks flat on the screen while a nonpressed button looks more 3 dimensional Figure 3 1 Printer Pressed button mae Nonpressed button Password Figure 3 1 Pressed and Nonpressed Buttons Some screens require entering information into a data field Figure 3 2 Touch the screen in the desired data field and when the cursor appears in that data field use the keyboard to enter the requested information e Note You only need to touch the data field once with your finger to activate the operation of that field a Figure 3 2 Data Field When you are done entering information touch the screen in the desired data field or use the TAB key or the TAB and SHIFT keys to move from one data field to the next data field Part 250023 001 Rev J 39 of 182 Section 3 Treatment Instructions Press the TAB key to move the cursor ahead to the next data field TAB KEY Se a ae F were AE SHIFT KEY TAB KEY Press and hold the SHIFT key while pressing the TAB key to move the cursor back to the previous data field In addition you will encounter dialog boxes as you u
135. mall risk of urethral stricture may result requiring further intervention Patients may experience discomfort during the treatment that may require the use of analgesics or sedatives Patients may be catheterized for a 2 to 5 day period following the treatment For more complete information about the benefits and risks associated with Cooled ThermoTherapy please refer to the Instructions for Use found on our website at www urologix com or call us at 1 800 475 1403 Data taken from the CTC Advance Instructions for Use 250348 Rev B 12 08 170 of 182 Part 250023 001 Rev J Appendix B Section 6 Cooled ThermoTherapy Treatment Note Patient Date of Service Pre Treatment Diagnosis BPH with obstructive symptoms Treatment Cooled ThermoTherapy Urethra length was CM Physician The patient has been advised of the risks of and benefits of this treatment and an informed consent has been obtained from the patient Treatment The patient was given appropriate pre treatment medication as described in the chart notes The patient was on the procedure table in the supine position The Microwave Catheter was then introduced into the bladder and the retention balloon was filled with 10 ml of sterile water The Rectal Thermosensing Unit RTU was introduced into the rectum with the sensor strip in the anterior position and the retention balloon was filled with 70cc of air Proper catheter balloon orientation was confirmed via ultrasound
136. may not be connected properly Rotate the Microwave Antenna Connector nut 4 full turns with your fingers until snug to ensure a proper connection 2 Urine drainage line not purged Purge urine drainage line 3 Microwave catheter may not be Check that the microwave catheter is inserted properly inserted properly 4 Defective microwave catheter Replace the microwave catheter and recalibrate ERROR 8 CONTROL UNIT TEMP HIGH POSSIBLE CAUSES ACTION STEPS 1 CoolWave Control Unit vents Remove any item blocking vents blocked 2 Treatment room too warm Observe CoolWave Control Unit operating temperature requirements Part 250023 001 Rev J 109 of 182 Section 5 Appendix A ERROR 9 CONTROL UNIT TEMP LOW POSSIBLE CAUSES ACTION STEPS 1 CoolWave Control Unit stored in a Observe CoolWave Control Unit cold environment prior to treatment operating temperature requirements and wait until the system has reached room temperature before beginning treatment ERROR 10 MW FLANGE TEMP HIGH POSSIBLE CAUSES ACTION STEPS 1 CoolWave Control Unit vents Remove any item blocking vents blocked 2 Treatment room too warm Observe CoolWave Control Unit operating temperature requirements ERROR 11 COOLANT TEMP HIGH POSSIBLE CAUSES ACTION STEPS 1 Coolant door open Close coolant door 2 Coolant temperature gt 40 C Reduce coolant set point to the proper temperature and wait for coolant to drop
137. mer Multiple Ticks Missed 461 Data Corruption Error 462 Msg Queue Receive 463 Msg Queue Send Error 464 Msg Queue Destroy Error 465 Msg Queue Open Error Part 250023 001 Rev J 466 467 468 469 470 471 472 473 501 502 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 529 530 531 532 533 534 535 536 Msg Queue Open Error Msg Queue Not Open Msg Queue Already Open Msg Queue Create Error Process Internal Error Process Start Error Condvar Wait Error Error Reading Safety Data Coolant Regulation Aborted Urethra Regulation Aborted Data Write Error Data Read Error Mutex Set Error Mutex Clear Error Write Error Read Error Seek Error Language File Open Error Language Internal Error Language String Overflow Language Array Overflow Language Array Underflow Language Mgr Not Open Language Mgr Init Error Data Manager Not Open Data Manager Initialization File Length Error File Size Error Device Not Open Device Already Open Device Open Error Process Spawn Error Scan Data Error Ini File Range Error Ini File Label Error Ini Section Error 119 of 182 Section 5 POSSIBLE CAUSES 1 Detected in the software Appendix A ACTION STEPS Allow coolant system to run for 5 minutes on the System Error screen Reboot the CoolWave Control Unit by pressing the shutdown button and turning it OFF after the okay to shutdown message is displayed Wait until the fan
138. microwave catheter position is not acceptable it may have to be rotated or reinserted Push the catheter through the urethra until the tip and the location balloon is completely in the bladder Rotate the microwave catheter and then pull back until you feel mild resistance Figure 2 8 Verify the microwave catheter position with ultrasound prior to proceeding with rectal unit insertion 2 7 Inserting the Single Use Standard RTU Verify the patient has received an enema Open the package and remove the rectal unit Figure 2 9 Temperature sensors Handle Connector Finger pad Rectal balloon Orientation flag Extension tubing Balloon inflation port Figure 2 9 Standard RTU Deflate the rectal balloon completely by attaching a 60 cc syringe to the inflation port and withdrawing air The balloon should be deflated with the temperature sensors midline Lubricate the rectal balloon with a water based lubricant e g K Y Jelly and insert the balloon into the rectum with the index finger Inserting the balloon can be done with the patient on his side or supine with knees bent The temperature sensors must be oriented toward the prostate The orientation flag must be pointing toward the patient s posterior K 7 Warning The rectal unit must be positioned properly to ensure correct temperature sensing Part 250023 001 Rev J 31 of 182 Section 2 Treatment Session Setup Inflate the rectal balloon by injecting 120 cc of air
139. mosensing unit RTU A device with temperature sensors that monitors the patient s rectal temperatures when the device is positioned correctly within the rectum along the rectal prostatic wall It is connected to the patient connection cable via the patient connection cable housing of the CoolWave Control Unit Rectal unit serial number The serial number of a rectal unit Rectum The terminal portion of the intestine continuation of the sigmoid colon that ends in the anus Retrograde ejaculation Sometimes called dry climax this event refers to the discharge of semen backwards into the bladder The condition may result from surgery that cuts the muscle that blocks the entrance to the bladder 5 RFID An acronym for radio frequency identification RTU A single use rectal unit and an acronym for what was previously referred to as the Rectal Thermal Unit RTU Plus The rectal unit with a reusable handle and single use balloon Standard mode Select standard mode from the Control Panel on the Urologix BPH Treatment screen to adjust treatment parameters urethra setting and treatment time during a Cooled ThermoTherapy treatment in automatic treatment mode Part 250023 001 Rev J 135 of 182 Section 5 Appendix A Startup routine The CoolWave Control Unit internal checking procedure which runs each time the system is turned ON Status Panel Treatment data at the top of the Urologix BPH Treatmen
140. mp Probe Error 114 Touchscreen Error 100 Rectal Unit Cal Failure 114 Clean 98 Error 101 Urethra Temp Cal Fail 115 Daily maintenance 98 Error 103 MW Calibration Failure 115 Monitor 9 21 39 Error 105 User Canceled Operation 115 Transabdominal ultrasound 50 Error 198 Invalid Catheter Type Detected 115 Transport Kit 17 104 Error 199 Urethra Temp Cross check 116 Treatment button 48 Error 300 Control Unit Temp Too High 116 Treatment chart 69 Error 317 Low Voltage Startup 116 Treatment Checklist screen 59 60 Error 422 Invalid Rectal RFID 116 Treatment Cooldown window 70 77 94 95 Error 423 Different Rectal RFID 116 Treatment data 63 68 69 Error 424 Invalid Tag 117 Treatment diagram 68 Error 425 Different Catheter RFID 117 Treatment error 89 92 Error 426 Multiple Catheter RFIDs 117 Treatment error message 92 Error 427 Multiple Rectal RFIDs 117 Treatment event log 65 66 Error 428 No Catheter RFID Sensed 117 Treatment Flow Sheet 168 Error 429 No Rectal RFID Sensed 118 Treatment mode 92 Error 431 Many RFIDs Sensed 118 Automatic treatment mode 49 71 73 92 94 94 Hardware failure 120 Manual treatment mode 70 74 76 81 95 System Error screen 89 90 92 Treatment Note 171 System navigation 39 40 Treatment overview 66 System setting Treatment parameter control panel 72 Date 85 Treatment parameters 8 9 49 50 62 70 Language 86 Treatment protocol 49 56 57 62 69 Time 86 Treatment protocol list 55
141. n Na 2 Coolant Bag e amma ame ae Treatment cathefer S5 Rectal unit orientation flag Patient connection cable housing Figure 2 15 Connected Microwave Catheter and Rectal Unit Connect the male luer fitting of the microwave catheter coolant tubing to the female luer fitting of the coolant bag tubing Then flush the female luer fitting of the microwave catheter coolant tubing with 4 5 cc of sterile water and connect the microwave catheter to the coolant bag This will preinflate the microwave catheter cooling channel a Note Place the Patient Connection Cable Housing unit on a non metal surface This will ensure the RFID field is not weakened K 7 Warning Do not touch the antenna cable or the catheter handle while microwave power is ON Touching the cable or the handle while microwave power is ON can cause burns as the CTC Advance antenna cable may reach up to 69 7 C and the Targis antenna cable may reach 82 1 C at room temperature To prevent burns during treatment isolate the antenna cable and the catheter handle away from the patient s legs To reduce the risk of burns isolate the antenna cable Figure 2 15 and the catheter handle away from the patient s legs e Using the microwave catheter holder from the Patient Comfort Kit to secure the microwave catheter antenna cable handle location Figure 2 16 e Ifthe microwave catheter holder is not available place the antenna cable and handl
142. n Name Notes Feature User Name aie i Version Help Feature Date and Time Robinson Figure 3 4 Screen Overview Demonstration mode A yellow bar at the top of the screen with the text Demonstration Mode signals that you are in demonstration mode Figure 3 5 Part 250023 001 Rev J 41 of 182 Section 3 Treatment Instructions Temperatures C and Power Watts vs Time Minutes Urethra Setting Pause End P mo mS d Standard Advanced Figure 3 5 Example of a Treatment Screen in Demonstration Mode 3 1 2 1 Help e Note If you receive an error message on the System Calibration screen the System Error screen or while on the Urologix BPH Treatment screen press the Help button to view information about the displayed error message 1 Press the Help button The Help window Figure 3 6 appears containing the appropriate help information based on your location in the CoolWave Control Unit System software 42 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 Up arrow Figure 1 Patient Information screen lL Enter patient information Figure 1 Data fields marked with a bullet require information before proceeding with the treatment Patient Name Enter up to 20 alphabetic characters for the first name 1 ilphabetic character for the middle intial and up to 30 alphabetic characters for the last mame Patient ID Enter the patient s hospital medical record num
143. n the accuracy limits of the CoolWave Control Unit Preprostatic urethra The proximal portion of the prostatic urethra It runs through the prostate beginning just distal to the bladder neck and ending just proximal to the verumontanum Pressure sensor The small metal disk that fits against the diaphragm of the sensor module on the lower right front side of the CoolWave Control Unit Its function is to detect changes in pressure within the tubing of the microwave catheter and signal potential coolant leaks Procedure Kit The Procedure Kit contains 1 disposable microwave catheter disposable rectal unit and 1 coolant bag Prostate gland A partly muscular partly glandular organ that surrounds the neck of the bladder and the urethra It secretes an alkaline viscose fluid that provides maintenance and activation of sperm at ejaculation 134 of 182 Part 250023 001 Rev J Appendix A Section 5 Prostatic median lobe The middle rounded mass of 3 rounded masses of tissue that develop adjacent to the urethra in the hyperplastic prostate Prostatism Disease of the prostate gland Pump mechanism See peristaltic pump mechanism Pump tubing clamp The fastening arm just above the peristaltic pump mechanism that locks the coolant inlet tubing in place as it is routed out of the Control Unit console to the microwave catheter Rectal temperature The temperature reported by the warmest of the 5 sensors in the rectal unit Rectal ther
144. nates when the CoolWave Control Unit is ON The microwave power indicator Figure 1 9 also located under the monitor 1s an amber LED that illuminates when the CoolWave Control Unit delivers microwave power to the prostate So ae ae a E Ti ae Eri Wain power indicator Wicrowave power indicator green LED amber LED Figure 1 9 Power indicators Part 250023 001 Rev J 13 of 182 Section 1 System Description Microwave Off pushbutton If there is an emergency press the red Microwave Off pushbutton Figure 1 10 located under the touchscreen monitor and right of the green LED to immediately turn the microwave power OFF Microwave OFF udiitidtion Figure 1 10 Microwave Off pushbutton Other Volume control headphone jack USB ports The CoolWave Control Unit includes a volume control a headphone jack and two USB Universal Serial Bus ports Figure 1 11 all located under the touchscreen monitor Either of the USB ports can accommodate a single USB flash drive and or a wired USB mouse USES ports Volume control Headphone jack Figure 1 11 Volume Control Headphone jack USB Ports 1 6 2 Microwave Catheter The single use microwave catheter includes a fiber optic temperature sensor to measure urethra temperature a microwave antenna and cable cooling channels and connectors a urine drainage port that connects to a standard urine drainage bag and a location balloon to position the catheter at the blad
145. ng out the locking lever located on the upper pump tubing clamp and lifting the tubing clamp up Figure 2 4 Lay the coolant inlet tubing across the center of the pump mechanism When the coolant bag 1s mounted correctly on the chill plate the inlet tubing and sensor module are aligned with the pump mechanism Figure 2 4 26 of 182 Part 250023 001 Rev J Treatment Session Setup Section 2 Locking lever Upper pump Coolant bag tubing clamp Pump tubing notch Coolant inlet tubing Sensor module Lower pump housing Figure 2 4 Coolant System with Pump Mechanism Open Place the coolant inlet tubing under the upper pump tubing clamp and across the rotor of the pump mechanism Figure 2 4 Note Ensure that the coolant inlet tubing is not twisted Align the sensor module with the locating pins to the right of the pump mechanism Figure 2 5 Figure 2 5 Positioning the Sensor Module Ensure the coolant inlet tubing is properly seated in the notch of the lower pump housing Then firmly push down on the upper pump tubing clamp until it snaps into position Figure 2 6 Part 250023 001 Rev J 27 of 182 Section 2 Treatment Session Setup Figure 2 6 Coolant System with Pump Closed Insert the coolant inlet and outlet tubing into the tubing holder This will prevent the tubing from being pinched by the coolant door Close the coolant door completely Note The coolant delivered to the microwave catheter may not b
146. nking fluids altogether Avoid alcohol coffee and other caffeinated beverages 48 hours prior to the treatment The night before treatment eat a light meal The day of treatment eat a light breakfast such as toast juice or milk Continue taking all routine prescription medications Administer a self enema such as a Fleets enema 1 3 hours prior to the treatment An enema cleanses the lower bowel to aid in rectal temperature measurement and helps to maximize comfort during the treatment e Plan to arrive about 60 minutes before the treatment or as instructed by the office This will allow enough time to prepare for the treatment including pre treatment medication as needed to help relax e Arrange for transportation home after the treatment e Allow approximately 2 3 hours for completion of the treatment e If you have questions or for any reason you will be unable to make this appointment please call Clinician Physician s Name Clinician Physician s Phone Number Cooled ThermoTherapy is available by prescription only This therapy is not for everyone Talk to your physician to see if Cooled ThermoTherapy is right for you Most medical treatments may have side effects Possible side effects for Cooled ThermoTherapy include blood in urine clots in urine painful or difficult urination thickened bladder muscle rectal irritation temporary inability to control urination brief inability to achieve or maintain an e
147. ns Reset button Current Error Or Warning 0 No Errors Event Log 02 14 46 AM 831a Calibration Started 02 15 22 AM 105c User canceled operation 02 16 02 AM 832 Calibration Complete Urethra Setting Treatment ime i Pause End T C Standard Advanced Up arrow Down arrow Figure 3 29 Event pane c Press the Detail button View a detailed overview of the microwave power coolant temperature rectal temperature and urethra temperature for this treatment Figure 3 30 This overview also highlights current warnings and errors An active error 1s marked with a red light To reset warnings and errors press the Reset button For additional information about system errors refer to Section 3 6 System errors a Note The Detail button provides a detailed overview of the CoolWave Control Unit and its settings A typical treatment does not require access to this overview However you may need to view this information if an error occurs and does not resolve At this point contact Urologix Customer Service 1 888 229 0772 to help you resolve any remaining errors 66 of 182 Part 250023 001 Rev J Treatment Instructions Ais Nees Coolant aii 37 0 W Reflected Power 1 1W Reflected Percent 3 0 Temperature 19 926 Coolant Pressure 5 0 psi Ambient 30 0 Maximum ais S 1 2 3 4 5 Rectal 37 3 8 37 3 8 37 3 B 37 3 8 37 3 Distal Proximal Serial Number 0123456AAAAAAAB Temper
148. nt log The keyboard will no longer function Run the CoolWave Control Unit for 5 minutes to cool the patient s urethra before removing the microwave catheter if applicable Part 250023 001 Rev J 89 of 182 Section 3 Treatment Instructions e Contact Urologix Customer Service at 1 888 229 0772 for assistance 305a MW Interface Figure 3 54 Example of a System Error screen error message 3 6 2 Calibration errors If an error occurs during the Control Unit calibration process you will hear a single beep and an error message will appear on the System Error screen or the System Calibration screen Review the following conditions e Microwave power will turn OFF if there is a calibration in progress e The error message will be saved to the event log First determine if the error message is on the System Error screen Figure 3 54 or the System Calibration screen Figure 3 55 Error messages on the System Error screen indicate a system or patient critical error You cannot continue using the CoolWave Control Unit The Reset button will appear grayed out Contact Urologix Customer Service at 1 888 229 0772 for assistance However if the error message appears on the System Calibration screen you will need to correct the problem In most cases an error message appears because the CoolWave Control Unit failed to read or detect the microwave catheter temperature sensor the rectal unit temperature sensors the microw
149. nt time And in manual treatment mode the CoolWave Control Unit will continue to deliver microwave power until the physician ends the treatment The manual treatment mode consists of 3 parts ramp treatment and cooldown a Notes e If you do not have access to the manual treatment mode you will not see this option on the Control Panel e When the automatic treatment mode is turned ON from the manual treatment mode the CoolWave Control Unit will ensure that the treatment time is increased to have at least 2 minutes of treatment remaining unless doing so exceeds the treatment time setting temperature The CoolWave Control Unit will also return to the previous urethra setting temperature 3 7 2 1 Ramp 1 Verify that the coolant temperature is at the default setting and wait until the measured coolant temperature has reached lt the default setting 4 C before applying microwave power 2 Use the Power Setting button to apply 20 W of microwave power Wait 2 minutes Use the interval timer as a guide for timing additional power adjustments 3 Continue to increase microwave power by 5 W at 2 minute intervals until e The microwave catheter gt 35 C the treatment timer will begin automatically since the conditions for it to run should have been met or e The rectal unit reaches 40 C or e The patient is experiencing discomfort 4 Increase microwave power by W per minute once 1 of the 3 conditions in step 3 are met unti
150. ntrol Unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Targis System with CoolWave Control Unit as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 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 the 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 Table 5 5 Recommended Separation Distances Part 250023 001 Rev J 141 of 182 Section 5 Appendix A 142 of 182 Part 250023 001 Rev J Appendix B Section 6 6 Appendix B 6 1 Training Course Course Description Cooled ThermoTherapy or transurethral microwave thermotherapy TUMT is a non surgical treatment for benign prostatic hyperplasia BPH Urologists require specific training in the s
151. o give you medication at the start of the treatment You will also be positioned on the treatment table to make you feel relaxed and comfortable How long does the treatment take The treatment takes between 28 5 and 60 minutes excluding time of arrival preparation time and departure from the office Will I need someone to drive me home Yes you will How long will it take for me to recover and return to normal activity You will be able to go home shortly after the treatment You may have a urinary drainage catheter for 2 5 days post treatment which should not preclude you from returning to normal activities Most patients do not require bed rest after treatment however recovery time to return to your normal activities varies from patient to patient You should notice results within 6 12 weeks Will I have pain after the treatment You may be uncomfortable 2 5 days at least after treatment You may feel sore in your lower abdomen and it may be uncomfortable to sit down Some blood may be discharged from your penis which is normal It is important to take the medications your doctor prescribes after the treatment Will I need a urinary catheter after the treatment The tissue surrounding the urethra will be irritated and swollen after the treatment so you may go home with a urinary catheter in place The catheter will drain urine from your bladder while the swelling and inflammation recede The catheter may be in place for 2 5 days
152. on if microwave power was ON when turning the pump OFF microwave power will automatically turn OFF as well Press the Close button when done c Press the Coolant Setting button Press the up and down arrows to adjust the coolant setting temperature in 0 5 C increments The following table includes the default coolant setting temperature for the Targis Microwave Catheter and the CTC Advance Microwave Catheter DEFAULT COOLANT SETTING TEMPERATURE 8 C fo Catheter CTC Advance 15 C Microwave Catheters The coolant temperature will ramp to its coolant setting temperature during a treatment Press the Close button when done d Press the Ramp Rate button Press the up and down arrows to select the ramp rate slow medium fast Press the Close button when done Part 250023 001 Rev J 75 of 182 Section 3 Treatment Instructions Power Setting 40 0 W 0 0 75 0 W Close Figure 3 39 Example of a treatment parameter control panel 3 Exit manual treatment mode by pressing the Standard button or the Advanced button from the 3 Control Panel The Control Unit will return to the automatic treatment mode 3 3 5 4 Pausing a treatment or ending a treatment early 1 Press the Pause End button from the Control Panel to pause the treatment and turn OFF microwave power 2 Press the Resume button to resume treatment Figure 3 40 To end treatment and go to cooldown proceed to step 3 Press To Res
153. operly properly positioned 4 Rectal unit may be defective Replace the rectal unit ERROR 15 COOLANT PRESS HIGH POSSIBLE CAUSES ACTION STEPS 1 Pressure too high in tubing Check that pump tubing clamp is properly fastened and that the tubing is not kinked 2 Coolant bag may be defective Disconnect coolant luers from microwave catheter temporarily connect the coolant luers to each other and then restart treatment If error repeats replace coolant bag Otherwise check the microwave catheter 3 Microwave catheter may be defective Disconnect coolant luers from the microwave catheter and flush microwave catheter coolant luers with sterile water Reconnect coolant bag luers to the microwave catheter and restart treatment If error repeats replace the microwave catheter Part 250023 001 Rev J 111 of 182 Section 5 Appendix A ERROR 16 COOLANT PRESS LOW POSSIBLE CAUSES 1 Pressure is too low in the tubing 2 Coolant tubing between coolant bag and sensor module may be twisted Coolant bag may be defective 4 Microwave catheter may be defective oS ACTION STEPS Check water level in the coolant bag Check that the pump tubing clamp is properly fastened Verify tubing is not twisted Replace the coolant bag Replace the microwave catheter ERROR 17 URETHRA TEMP HIGH POSSIBLE CAUSES 1 Loose microwave catheter fiber connector 2 Temperature in urethra gt 44 5 C
154. ord New Password and New Password Confirm Figure 3 46 Your password which is case sensitive may contain from 3 to 20 alphanumeric characters 2 Press the OK button to complete password setup Or press the Cancel button to leave the Password Setup window without changing the password 84 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 3 5 5 System Settings screen Modify Button Debug Button Figure 3 47 Example of a System Settings screen 1 Select the system setting to change Date Time Language or Volume Then press the associated button Figure 3 47 2 Press the Modify button Figure 3 47 Refer to one of the following instructions based on the selected system setting i Note The Modify button toggles between the Modify button and the Apply button a Date Change the day month and year by pressing on the up and down arrows Figure 3 48 Proceed to step 3 Part 250023 001 Rev J 85 of 182 Section 3 Treatment Instructions ersion 1 53E2 6 Figure 3 48 System Settings screen date b Time Change the hours minutes and AM PM by pressing on the up and down arrows Figure 3 49 Proceed to step 3 version 1 53E2 6 Figure 3 49 System Settings screen time c Language Change the language by pressing on the desired language Figure 3 50 Proceed to step 3 86 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 Volume Figure 3 50 Sy
155. ox 76 Resume Cancel button printer 101 Retry button 62 Return Material Instructions 172 RMA Returned Material Authorization number 172 RTU See Rectal unit RTU RTU Plus 15 16 53 RTU Plus Disposable Balloon 32 RTU Plus Reusable Handle 32 Safety check Control Unit 22 Treatment 50 Safety information See also Precautions Caution Electromagnetic interference 21 Microwave antenna 29 Open printer drawer 11 Remove components intact 78 Stacking objects 21 Warning Verify position of microwave catheter and rectal unit 35 Warning Air minimum in RTU Plus rectal balloon 34 Air minimum in standard RTU rectal balloon 32 Compromised component package 18 Excessive elevation 35 Excessive force on microwave catheter 30 Explosion 21 Location balloon position 30 Power source 24 Rectal unit position 31 34 Verify proper rectal unit position 32 34 Warning Power source 45 Warning Urologix supplied fuses 99 Warning Urologix supplied fuses 100 Safety instructions Control Unit 21 Safety precautions CoolWave System 23 Safety symbols See also Symbols Caution 5 Instruction manual 5 Note 5 Warning 5 Screen See also Touchscreen monitor Data View Print Copy screen 83 84 178 of 182 Index Login screen 41 45 46 48 Main Menu screen 48 Options Menu screen 80 Patient Information screen 51 52 Printer Utilities screen 82 83 102 103 Protocol screen 53 58 System Calibration screen 49 60 62
156. power switch to the I position The CoolWave Control Unit turns ON and proceeds with its startup routine The Login screen appears Part 250023 001 Rev J 45 of 182 Section 3 Treatment Instructions 3 2 2 Login screen Figure 3 9 Login Screen a Note You can turn OFF the CoolWave Control Unit at this point during system startup without losing any stored data by pressing the Shutdown button u Note Entering an invalid password returns you to the Login screen 1 Press the Login button Figure 3 9 The User Login window appears Figure 3 10 Figure 3 10 User Login Window 2 Determine 1f you are a new user or a current user If you are a new user proceed to step 3 If you are a current user proceed to step 10 3 Press the New User button The Create New User window appears Figure 3 11 46 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 4 Enter your full name in the Full Name data field Figure 3 11 Create New User Window 5 Enter a user name in the User Name data field Your user name which is case sensitive may contain from 3 to 20 alphanumeric characters 6 Enter a password in the Password data field Your password which is case sensitive may contain from 3 to 20 alphanumeric characters 7 Re enter your password in the Password Confirm data field 8 Press the OK button to return to the Login screen Your user name and password are saved Proceed to step 9 Or pres
157. rapy Yes Medicare reimburses for the Cooled ThermoTherapy Treatments Most private insurance carriers also cover the treatment Who do I call with questions Call your urologist or a designated nurse and or assistant Who will do the treatment Your physician will insert the Microwave Catheter into your urethra and will be in attendance during the treatment A nurse or clinician may also assist What will I do if I have problems after the treatment Your physician or nurse will discuss with you what to expect after the treatment If you think you have a problem after the treatment contact your physician as soon as possible You may also be instructed to go to your local emergency room for treatment Does Cooled ThermoTherapy make drugs and surgery obsolete No drugs and surgery are still options Your physician will make a recommendation based on your specific needs Part 250023 001 Rev J 161 of 182 Section 6 Appendix B Will I have to miss work You may have a urinary drainage catheter for 2 5 days post treatment which should not preclude you from returning to work Most patients do not require bed rest after treatment however recovery time to return to your normal activities varies from patient to patient The majority of men return to work in less than one week How soon can I have sex Once you return home and the urinary drainage catheter has been removed if needed you can resume intercourse as soon as you
158. reases patient comfort Pull gently on the microwave catheter to reseat the location balloon at the bladder neck in case it moved during rectal unit insertion If ultrasound was not used to verify microwave catheter position prior to rectal unit insertion use ultrasound at this point to verify proper microwave catheter position Position the rectal unit cable underneath the microwave catheter holder Secure the microwave catheter into the microwave catheter holder with the cooling lines in the anterior position once the microwave catheter position is acceptable If desired position the patient s legs on the knee cushions that come with the Patient Comfort Kit Refer to Section 5 5 Patient Comfort Kit to view the accessories in the kit Make a mark with a permanent marker or tape on the microwave catheter at the meatus Use this mark as a visual reference to confirm proper microwave catheter position K n Warning This visual reference on the Microwave catheter and RTU should be checked every 5 10 minutes throughout the treatment to verify proper position Secure the microwave catheter fiber optic and microwave connectors to the patient connection cable housing Figure 2 15 Note Rotate the Microwave Antenna Connector nut 4 full turns with your fingers until snug to ensure a proper connection Part 250023 001 Rev J 35 of 182 Section 2 Treatment Session Setup Antenna cable Prostate gland Urethra kanaa
159. rection and the inability to discharge semen in orgasm thus should be considered by men who wish to have further offspring A small risk of urethral stricture may result requiring further intervention Patients may experience discomfort during the treatment that may require the use of analgesics or sedatives Patients may be catheterized for a 2 to 5 day period following the treatment For more complete information about the benefits and risks associated with Cooled ThermoTherapy please refer to the Instructions for Use found on our website at www urologix com or call us at 1 800 475 1403 Data taken from the CTC Advance Instructions for Use 250348 Rev B 12 08 166 of 182 Part 250023 001 Rev J Appendix B Section 6 Patient Instructions for Medication Management It is important that you follow your doctor s medication instructions as closely as possible This is necessary for your health and speedy recovery Your physician has ordered the following medication Name of medication This medication is used for Take it at the following times Dose Take the medication until The medication is known to have the following side effects If you have ANY questions after you return home please do not hesitate to call Your physician clinician is Phone number After normal business hours call Cooled ThermoTherapy is available by prescription only This therapy is not for everyone Talk to your physician to see if Cooled
160. ress the Treatment Time button Press the up and down arrows to adjust the treatment time in 30 second increments Figure 3 35 Press the Close button when done g Note In automatic treatment mode the treatment time is limited to 28 minutes and 30 seconds for the CTC Advance Microwave Catheter or from 28 minutes and 30 seconds to 60 minutes for the Targis Microwave Catheter Part 250023 001 Rev J 71 of 182 Section 3 Treatment Instructions Figure 3 35 Example of a Treatment Parameter Control Panel 3 3 3 5 2 Using advanced mode Mad z Urethra VS eal Coolant Setting a Setting 15 0 C _ Treatment Ramp Rate Time _ Medium Control Panel Pause End Figure 3 36 Advanced mode 72 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 Adjust the urethra setting treatment time coolant setting and ramp rate from the Control Panel Figure 3 36 if desired a Note The treatment timer runs when the following conditions occur Targis CTC Advance CTC Advance Short amp Standard Short Standard amp Long e Urethra gt 35 C with e Urethra 35 C with e Urethra gt 35 C with Urethra Coolant Urethra Coolant Urethra Coolant difference gt 23 C difference gt 20 C difference gt 20 C e OR MW Power 50 W e OR MW Power gt 50 W e OR MW Power gt 65 W e OR RTU2 gt 41 C e OR RTU 241 C e OR RTU 241 C Press the Urethra Setting bu
161. rethra setting temperature from the standard mode or the advanced mode on the Control Panel e Increase the coolant setting temperature from the advanced mode on the Control Panel Read all error messages and respond accordingly If possible clear the error message by pressing the Reset button After the message clears the Control Unit resumes the treatment in the automatic treatment mode After the treatment time expires cooldown will automatically start and the Treatment Cooldown window will appear 3 7 1 3 Cooldown The cooldown 5 minute timer shows the time remaining until the end of cooldown which also indicates how much time has passed since the microwave power was turned OFF with the coolant pump still running When the 5 minute cooldown period ends the coolant pump will continue running with the cooldown timer at 00 00 Coolant will continue circulating until you end the treatment Part 250023 001 Rev J 93 of 182 Section 3 Treatment Instructions e Resume the treatment remain in cooldown or end the cooldown exit treatment if desired from the Treatment Cooldown window e Remain in cooldown reset the 5 minute cooldown timer or end the cooldown exit treatment when the Treatment Cooldown End window appears 3 7 2 Manual treatment mode In manual treatment mode you can adjust the microwave power the coolant pump status ON vs OFF the coolant setting and the ramp rate the physician defines the treatme
162. rotocol screen 53 58 Main power 13 Pump See Peristaltic pump mechanism Microwave power 13 Pump mechanism See Peristaltic pump mechanism Power lamp 101 Pump ON OFF Power ON Manual mode 75 Control Unit 45 Manual treatment mode 94 Power requirement 19 Pump On Off button 75 Power setting Pump tubing notch 27 Manual mode 75 Ramp rate 49 58 Power Setting button 75 94 Advanced mode 73 Power switch 11 45 Automatic treatment mode 92 93 Precautions See also Safety information Manual mode 75 CoolWave System 8 Manual treatment mode 94 General safety 23 Patient comfort automatic treatment mode 93 Preprocedure medications 24 Ramp Rate button 73 Pressure sensor 12 13 Rating 105 Pretreatment and Treatment Preparation 155 Rectal balloon 15 Print Rectal temperature 8 15 63 64 66 95 Event log 69 Temperature range specifications 105 Nozzle check pattern 82 102 Rectal unit RTU 8 9 15 16 17 20 21 50 62 91 93 Treatment report 69 84 94 95 127 Print button 68 84 Cable 35 Print head 82 102 Connection to Control Unit picture 36 Clean 82 83 102 3 Connector 9 Nozzles 82 Serial number 54 58 Part 250023 001 Rev J 177 of 182 Section 7 Temperature sensor 15 90 Remove Patient Info button 69 Replace button 62 Report button 69 Reset button 65 66 89 90 92 93 Reset Password button 82 Resume button 76 77 78 Resume Treatment button 77 78 89 92 Resume Treatment dialog b
163. rt 250023 001 Rev J Index Cooldown 5 minute timer 78 93 95 Cooldown End button 77 Cooldown pane 89 92 Cooled ThermoTherapy Procedure 6 Cooled ThermoTherapy Procedure Kit See Procedure Kit Cooled ThermoTherapy Treatment 40 49 Cooling channel 14 Cooling lumen See Cooling channel CoolWave Control Unit See Control Unit CoolWave System 6 Demonstration mode 40 Equipment overview 8 Specifications 105 CoolWave System component Coolant Bag 16 Microwave catheter 15 Patient connection cable 8 9 Patient connection cable housing 8 9 Rectal unit 16 CoolWave System dialog box See Dialog box CoolWave System help feature See Help feature Copy button 84 Copy treatment report 84 Create New User window 46 47 Current Error or Warning window 65 66 Current user 46 Custom protocol 56 57 Customer Service See Urologix Customer Service Daily maintenance 98 Data button 80 Data field 39 40 Full Name data field 47 81 Password Confirm data field 47 Password data field 47 User Name data field 47 Data file 48 69 81 Data View Print Copy screen 83 84 Data window 83 Date Current 41 System setting 85 Date button 83 Debug Panel 88 Default coolant setting temperature 49 58 73 Demonstration mode 40 41 42 48 52 58 59 60 80 Detail button 66 Detail pane 66 67 89 Dialog box 40 Enter Manual Mode dialog box 75 Notes dialog box 43 44 Resume Treatment dialog box 76 Discharge Instructions 168
164. s to earth lt 5 Ur gt 95 dip in Ur for 0 5 cycle lt 40 Ur gt 60 dip in Ur for 5 cycles lt 70 Ur gt 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 s 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 Ur gt 95 dip in Ur for 0 5 cycle lt 40 Ur gt 60 dip in Ur for 5 cycles lt 70 Ur gt 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 s Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Targis System with CoolWave Control Unit requires continued operation during power mains interruptions it 1s recommended that the Targis System with CoolWave Control Unit be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris an A C mains voltage prior to application of the test level Table 5 3 Electromagnetic Immunity Part
165. s right for you As a patient why should I choose Cooled ThermoTherapy It is a convenient simple safe and effective treatment Cooled ThermoTherapy is a non surgical office procedure that requires only one visit for a full treatment This durable and proven therapy is often a better alternative to a lifetime of drug therapy and is less invasive than surgery Where is the treatment performed The treatment may be performed in your physician s office or in the outpatient treatment room of a hospital Part 250023 001 Rev J 159 of 182 Section 6 Appendix B Are there any pre existing conditions that would exclude me from this treatment Yes as with any treatment it is not for everyone There is a small list of contraindications that could exclude you from treatment However the person best able to assess this is your urologist What should I expect Pre During Post treatment After completion of your initial visit work up if the doctor decides you are a candidate for Cooled ThermoTherapy the doctor will go over and give you a complete list of instructions Am I awake during the treatment Yes The treatment does not require anesthesia so you can watch television read or listen to music during the treatment Will I have any pain during the treatment Some patients experience discomfort during the treatment The clinic staff will try to make the treatment as comfortable as possible for you Your physician may decide t
166. s stop and then turn the unit ON again If the error occurred during treatment use the Treatment Restart feature see section 5 2 to continue the treatment Note The error may repeat again Call Urologix Customer Service to report the error ERROR AND ERROR NAME HARDWARE FAILURES 301 Coolant Hotside Low 302 Coolant Coldside Low 303 Hardware Failsafe Malfunction 304 HW Sensor Address Error 305 MW Interface 306 Internal Sensor 307 MW Hardware 308 Rectal Sensor Interface POSSIBLE CAUSES 1 Nonresolvable hardware failure 120 of 182 319 HWES Disconnected 320 MW Supply 321 Quad Power Supply Error 387 Coolant Coldside High 388 Coolant Hotside High 389 Control Unit Temp Too Low 449 HW Control Register Error ACTION STEPS Will probably need a field service visit to resolve the problem Allow coolant system to run for 5 minutes on the System Error screen and call Urologix Customer Service Note If the coolant pump is not running manually irrigate Part 250023 001 Rev J Appendix A Section 5 5 2 Treatment Restart The purpose of the treatment restart function is to allow the user to continue a previously running treatment without having to swap the catheter should the control unit need to be restarted The Treatment Restart Available screen Figure 5 1 will automatically appear if the control unit is restarted within 30 minutes of a shutdown Shutdown Time 12 14 56 PM User Name jdoe
167. s the Cancel button to exit without creating a new user name and password 9 Press the Login button Figure 3 9 The User Login window appears Figure 3 12 MYUSERNAME a 5 Figure 3 12 User Login Window 10 Enter your user name which is case sensitive in the User Name data field Part 250023 001 Rev J 47 of 182 Section 3 Treatment Instructions 11 Enter your password which is case sensitive in the Password data field 12 Press the OK button to go to the Main Menu screen Or press the Cancel button to return to the Login screen Demonstration mode To enter demonstration mode type the following word as the user name and the password Demo The capitalization of the letter D in Demo is required 3 2 3 Main Menu Screen After logging into the CoolWave Control Unit your user name and the software version appears at the top of the Main Menu screen Figure 3 13 anes bean Software inti Coo I Wave Figure 3 13 Main Menu Screen e Note Turning OFF the Control Unit at this point during system startup will cause a loss of stored data If necessary to shut down at this point press Log Out and then Shutdown 1 Press the Treatment button to proceed with a treatment Refer to Section 3 3 Cooled ThermoTherapy Treatment for further information 2 Press the Options button to view CoolWave Control Unit system options Refer to Section 3 5 Control Unit options for further information 3 Press
168. se the CoolWave Control Unit A dialog box provides additional information or instruction Figure 3 3 When a dialog box appears on the screen read the information or follow the instructions before continuing with the Cooled ThermoTherapy Treatment Press To Resume Treatment Phase Press To Begin Cooldown Phase Go To Cooldown Figure 3 3 Example of a CoolWave Control Unit Dialog Box Demonstration mode If you are training on the CoolWave Control Unit you will be in demonstration mode Demonstration mode simulates a Cooled ThermoTherapy Treatment and allows you to work with the CoolWave Control Unit as though you were performing a treatment on a patient Follow the instructions in Section 3 Treatment Instructions and look for additional information regarding demonstration mode under the heading Demonstration mode 40 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 3 1 2 Screen Overview The following information appears on all of the CoolWave Control Unit screens except for the Login screen date time screen name user name and software version Each screen except for the Login screen also contains access to the CoolWave Control Unit help feature which contains the CoolWave Control Unit User Manual In addition on the treatment screens you will find a Notes button This button provides access to the notes feature where you can enter patient or treatment information Figure 3 4 Scree
169. sed areas while simultaneously cooling and protecting the pain sensitive urethral tissue This method of circulating cooling fluid through the Microwave Catheter minimizes patient discomfort and risk of thermal damage to the urethra The cooling of the urethra provides an analgesic effect during treatment while maintaining the urethral temperature at less than 45 C This effect allows the treatment to be performed on an ambulatory basis without the need for general anesthesia Continuous energy delivery allows for a durable and consistent treatment for many men with symptomatic and or obstructive BPH The preservation of urethral integrity is a unique feature of Cooled ThermoTherapy that defines it as a minimally invasive treatment and limits morbidity Part 250023 001 Rev J 145 of 182 Section 6 Appendix B Principles of Operation e Cooled ThermoTherapy is a process that delivers microwave energy to the prostatic adenoma and minimizes the effect on surrounding structures It combines the principles of Microwave radiative inductive heating delivered through the urethra Water conductive cooling e The biologic effects of applying thermal energy to the prostate depend on the intensity duration and means of application The goal of Cooled ThermoTherapy is to heat tissue within the prostate to therapeutic levels 50 C within the adenomous tissue during a single treatment 28 5 minutes to one hour while preserving the external
170. seneees 105 S RCI A ene a a a aaa a aE 107 5 1 Troublesho onno omde iat E toas aaa asta axed tide waa ana esd aad ea ean ead 107 32 FPEO NEEC FAIL R T a T 21 5 3 TPEGUNETE SCLC OWENA eico a nadaaaekeh wasn meaner seas uaaaataaciehaam men sweiaaw 125 34A Descrip hon OF SVINDOIS arco aii E E EAN O OA OE A a 126 S Panen COM OF E Ueroa a a A a O ne eac eeu 129 SO MOMOSSOTY er N a aaa a idenaln Rate tera 130 5 7 Electromagnetic Compatibility EMC Tables cccccccccccsssnsseececccccccnnsssccesccccsscnnseseseccccsecnaasessees 138 GO A PPC in Bossies oeae orea aere ARET a aaa a E a EEES 143 6 1 Tramin COUS C seas sain cence tea latiat ond sone E E OAA 143 6 2 Cooled Thermo Therapy Overview ico Badcactesttton Uae Mino Mate oe O han Seen 145 6 3 Cooled Thermo Therapy Treatment ivvcccareaisisch Aiinietavisissiveaandantebaeiiswrdobeveesietiteatawi wea htaawn 148 6 4 CoolWave System Software cccccccsssssssessssssesssvsvsvscsssvevscscsevsesvsvevavacsesessesvsvavavacsenssesvevavasseseeseseass 153 6 5 Performing a Cooled ThermoTherapy Treatment ccccccccsseccccccccccccccaneesssccceeeeaaaesssesecsseaaaneseeees 154 66 Frequently Asked Patient QUeCSIIONS srencscistieissicnni deen eee E a T d 159 OF Example Patient DOCUMEnIS orieiririi niit E eNO A E ERT EE E VOEO 163 6 8 Urologix Return Material Instructions eccccccccccccccscsssssesssssvsvsssscusesssvscuevssevsctevsvasscevsvavaceesvavsces 172 E deS a 173 4 of 182 Part 250023 001 Rev J Syst
171. sfunctional urinary bladder caused by a lesion of the nervous system Notes feature A place to enter a patient s treatment information during a treatment Part 250023 001 Rev J 133 of 182 Section 5 Appendix A Obstructive bladder neck syndrome An impairment of the outlet area of the bladder caused by prostate tissue constricting the urethra Orientation flag The vertical guide on the rectal unit approximately 1 in height that serves the clinician in correctly positioning the rectal balloon Patient Comfort Kit A CoolWave Control Unit accessory which includes 2 knee cushions and Microwave Catheter Holder It provides comfort for the patient and holds the catheter in position for the duration of treatment Patient connection cable An extension cable that connects the patient connection cable housing to the CoolWave Control Unit Patient connection cable housing The patient connection cable housing contains connectors for the rectal unit fiber optic connector and microwave connector Perineum An anatomical landmark between the scrotum and the anus Peristaltic pump mechanism The small wheel like motorized drive behind the coolant door of the CoolWave Control Unit that uses peristaltic action to propel coolant through the coolant inlet tubing to the microwave catheter and beyond Also referred to as the coolant pump Power set point Represents the actual microwave power output exactly equal to the power setting withi
172. ss during the treatment If you need to make any adjustments to the treatment parameters make those adjustments from this screen Otherwise treatment proceeds automatically based on the selected treatment protocol If a caution or error occurs during treatment a caution icon or error icon appears in the blue bar at the top of the screen Figure 3 26 If there is an emergency press the red Microwave Off pushbutton Figure 3 27 located under the touchscreen monitor and right of the green LED to immediately turn the microwave power OFF 62 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 Microwave Power On Blue Bar Screen Header Power 7 i 26 0 W Status g TENA C and TR Watts vs Time Minutes panel Time Tae 6 7 8 9 1 fa 10 Minutes ch rece TMS aS fh amp bp 30 Minutes Pause End _ 60 Minutes j 3 jp since cE oe Bete bale jas 2 Chart Detail Standard Advanced Control panel Figure 3 26 Urologix BPH Treatment screen Microwave OFF pushbutton Figure 3 27 Microwave Off Pushbutton 1 View treatment data in the Status Panel at the top of the Urologix BPH Treatment screen Figure 3 26 e Power Displays microwave power in watts measured at the patient connection cable When power is gt 1 W an animated microwave power ON graphic appears and the amber LED located to the right of the red Microwave Off pushbutton lights e Coolant Displays coolant temperature in
173. stem Settings screen language d Volume Change the speaker volume by pressing on the bar and sliding it left softer or right louder Figure 3 51 Proceed to step 3 Figure 3 51 System Settings screen volume 3 Press the Apply button to save the new system setting s Figure 3 52 Part 250023 001 Rev J 87 of 182 Section 3 Treatment Instructions Apply Button Figure 3 52 Example of a System Settings screen apply 4 Press the Debug button to display the Debug Panel This panel provides a method to display current measurements of the control unit and disposable components Figure 3 53 The Debug Panel also highlights current errors An active error is marked with a red light To reset warnings and errors press the Reset button To close the Debug Panel press the Close button For additional information about system errors refer to Section 3 6 System Errors You may need to view this information if an error occurs and does not resolve At this point contact Urologix Customer Service 1 888 229 0772 to help you resolve any remaining errors 88 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 Error 0 No Errors Power 3 0 W Frequency 915 0 MHz Reflected Power 0 1 W Antenna Reflected Percent 3 0 Off Switch psi High A psi Low i Be Temperature AEs Coolant Pressure 5 5 psi Language Latch guag Ambient 30 076 Maximum 37 0 C 1 2 3 4 5 37 0 37
174. t 1 800 475 1403 Data taken from the CTC Advance Instructions for Use 250348 Rev B 12 08 Part 250023 001 Rev J 169 of 182 Section 6 Appendix B Cooled Thermotherapy Patient Instructions for Care of Catheter Some swelling of the urinary tract tissue is normal following Cooled ThermoTherapy treatment The swelling may cause some difficulty in urination To prevent this problem a urinary drainage catheter may be inserted prior to your return home The catheter will drain the urine from your bladder while your urinary tract heals The following information will help you manage the care of the catheter during recovery period 1 A catheter is a urinary drainage tube that allows the drainage of urine from the bladder The tube has a small balloon on one end that is inflated with sterile water This balloon keeps the catheter in and prevents the tube from sliding out of the bladder 2 The catheter will remain in place for days 3 Itis important to clean the catheter the area of the tube where it enters your penis daily e First wash your hands before caring for your catheter e Use aclean wash cloth and soap to clean the catheter and the penis e You may wish to use a special cleaning liquid such as Betadine soap that can be purchased at your local pharmacy e Always clean by wiping away from the tip of the penis e Apply an antibiotic ointment to the tip of the penis after cleaning Antibiotic ointment can be purchased
175. t screen microwave power coolant temperature rectal temperature urethra temperature treatment status and treatment progress Targis Microwave catheter A type of microwave catheter Temperature sensor A device within the microwave catheter that monitors the urethral temperature of the patient or a device within the rectal unit that monitors the rectal temperature of the patient Testes The male reproductive glands that reside in the scrotum and produce spermatozoa Interstitial cells in the testes secrete a hormone an androgen that aids the growth and development of the prostate gland Touchscreen monitor The 15 diagonal color display with a touch sensitive glass covering A gloved or ungloved finger can activate the touchscreen a pen or stylus will not Transport Kit The only FDA approved method other than the original shipping crate for transporting a CoolWave Control Unit It includes a trolley and electrical safety tester Transrectal ultrasound TRUS Procedure where a clinician inserts a probe into the rectum to obtain an image of the prostate This image appears on the display to assist the clinician in placing a biopsy needle Transurethral incision TUIP A surgical procedure that widens the urethra by making small cuts in the prostate and the bladder neck where the bladder and urethra join Transurethral resection TURP A surgical procedure that involves the removal of tissue from the interior of the prostate w
176. t the Urologix field service department to obtain the appropriate Canon color inkjet replacement printer 1 With the control unit main power off and the control unit unplugged open the printer access drawer Figure 4 3 2 Remove the printer by carefully separating the printer from the Velcro coins that are attached to the printer and printer drawer 3 Carefully disconnect the printer power connector and serial connector at the printer 4 Install the replacement printer by attaching the appropriate Velcro coins and connecting the power and serial cable connections and installing the printer in place onto the printer drawer 5 If not already installed install the new printer ink cartridges refer to Section 4 3 2 g Notes e Ifthe user is uncomfortable performing the printer replacement or any other printer maintenance tasks described it is highly recommended that the Urologix field service department is contacted to provide guided assistance Part 250023 001 Rev J 103 of 182 Section 4 Equipment Maintenance 4 4 Moving the CoolWave Control Unit When moving the CoolWave Control Unit grip the handle at the top of the unit This handle is designed to allow one person to push or pull the unit with little effort The wheels of the unit pivot to assist you when turning the unit in a new direction The front wheels have an individual lock you can use when the unit is stationary To lock the wheels use your foot to press
177. tate Zip Insurance Referring Physician Name PRE SCREENING QUESTIONS TO DETERMINE ELIGIBILITY Questions 1 6 must be NO Yes No Don t we kow Patients with a prostatic urethra lt 2 5 cm in length as measured from the bladder neck to the verumontanum E D Patients with urinary sphincter or any implant metallic or non metallic which is within 1 5 38 mm of the prostatic urethra Patients with urethral stricture unable to pass 22 F urethroscope Pf Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome i e claudication of the buttocks or perineum Patients who have undergone pelvic radiation therapy Patients with implanted active devices including pacemakers or Pp ff defibrillators within 2 6 6 5 cm of the prostatic urethra If the patient answers No to the patient pre screening questions schedule a screening visit Your appointment is scheduled for Date Time Location Physician At this visit we will e Answer additional questions you may have about the Cooled ThermoTherapy treatment e Review and sign a patient consent form optional per hospital and or office policy e Obtain medical history information e Perform tests to determine your current medical condition Please come to the appointment with a full bladder medical records that pertain to any condition you are now being treated for and a list of medications and the dosage that you ar
178. telephone number found on the shipping document to arrange a time day to have the package picked up or you can personally drop it off at a local shipping site Note The data contained in the associated treatment file is essential for conducting a thorough analysis of the product performance issue 172 of 182 Part 250023 001 Rev J index 7 Index Access Administrative privileges 81 Demonstration mode 40 48 Administrative privileges 80 81 83 Advanced button 70 76 Advanced mode 72 74 Advanced mode Control Panel 56 72 93 Algorithms Treatment timer 64 Allow Administrator Privileges button 81 Allow Clinical Protocols button 81 Allow Manual Control button 81 Analgesia Guidelines 6 157 Antenna Microwave 14 Antenna cable 14 36 Automatic treatment mode 49 71 73 92 94 94 Balloon Inflation tubing 33 Microwave catheter 14 Rectal 15 Balloon inflation port Microwave catheter 14 Rectal unit 15 Benign Prostatic Hyperplasia 8 BPH See Benign Prostatic Hyperplasia Button 39 Advanced button 70 76 Allow Administrator Privileges button 81 Allow Clinical Protocols button 81 Allow Manual Control button 81 Catheter button 83 Chart button 64 Check button 82 Clean button 82 Clear button 70 83 Contents button 43 Coolant Setting button 73 Cooldown End button 77 Copy button 84 Data button 80 Date button 83 Detail button 66 Event button 65 Events button 69 Glossary button 43 Go To Coo
179. tering patient data controlling treatment parameters e g ramp rate coolant temperature and treatment time and monitoring rectal and urethra temperatures The CoolWave Control Unit includes these features e Patient connection cable and patient connection cable housing Touchscreen monitor Keyboard Printer ON OFF power switch Lockable wheels Coolant system Main power indicator and microwave power indicator Microwave Off pushbutton Other Volume control headphone jack USB ports al Note The service port is reserved for use by Urologix service personnel only Patient Connection Cable and Patient Connection Cable Housing Data from the microwave catheter and the rectal unit enters the CoolWave Control Unit via the patient connection cable and patient connection cable housing Figure 1 2 R Microwave connector e P T Fiber optic connector Rectal unit connector l Figure 1 2 Patient Connection Cable Housing The patient connection cable housing contains connectors for the rectal unit fiber optic connector and microwave antenna connector When not in use place the patient connection cable and housing in the cable holder located on the back of the CoolWave Control Unit Touchscreen monitor View a treatment using the touchscreen monitor Figure 1 3 and when necessary adjust treatment parameters The monitor can be tilted for improved viewing To open the monitor operate the latch and lift Part 250023 001
180. the Log Out button to return to the Login screen Refer to Section 3 2 2 Login screen for further information 48 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 3 3 Cooled ThermoTherapy Treatment This section of the user manual steps you through a Cooled ThermoTherapy Treatment for Benign Prostatic Hyperplasia BPH using the CoolWave Control Unit As you proceed through the various treatment screens described in this section beginning with the Patient Information screen you will be entering data and selecting treatment protocols You may also be modifying the following treatment parameters e Treatment time The treatment time reflects the length of time for a Cooled ThermoTherapy Treatment The default treatment time is 28 minutes and 30 seconds e Coolant setting The coolant setting reflects the set point target temperature at which the coolant flows through the microwave catheter The following table includes the default coolant setting temperature for the Targis Microwave Catheter and the CTC Advance Microwave Catheter DEFAULT COOLANT SETTING TEMPERATURE Targis Microwave Catheter 8 C CTC Advance Microwave Catheter 15 C The coolant temperature will ramp to its coolant setting temperature during a treatment e Urethra setting The urethra setting reflects the set point target temperature of the microwave catheter The default urethra setting temperatures for t
181. the internal coolant level is within the white open section of the correct level indicator Figure 4 1 Correct level indicator ne UDA Tor st Ave North 55447 T WHICH IS EFFECT SANCE DE FFETS JEVICE T N CAUTION ks of Urologix Inc l 234 004 5 300 099 Figure 4 1 Internal coolant level indicator 98 of 182 Part 250023 001 Rev J Equipment Maintenance Section 4 4 2 2 Periodic maintenance Equipment service and yearly preventive maintenance must be performed by a Urologix trained and authorized service representative Contact Urologix Customer Service 1 888 229 0772 if more than 12 months have passed since the last preventive maintenance Refer to Additional Terms and Conditions Exhibit A packaged with the CoolWave Control Unit for equipment warranty information Please note An extended service agreement is available through Urologix Contact your Urologix sales representative for further information Any other type of service or maintenance arrangement will void all warranties and claims 4 2 3 Replacing the fuses 1 Use a flat screwdriver to remove the fuse holder caps Figure 4 2 Fuse holder caps ye Equal potential ground L Power cord inlet Power cord holder Figure 4 2 Control Unit rear cover 2 Replace the defective fuses with the appropriate Urologix fuses listed below CONTROL UNIT FUSE CATALOG MODEL NUMBER FUSE TYPE RATING Model 5000A AC1008 1 1 4 x 1 4
182. through the coolant bag via the peristaltic pump mechanism The coolant inlet tubing runs across the pump mechanism which pushes the coolant through the inlet tubing the sensor module the coolant bag and the outlet tubing Coolant continuously circulates through the microwave catheter connected to the coolant outlet tubing and returns to the coolant bag via the coolant inlet tubing The coolant bag resides against the chill plate which chills the circulating coolant 1 7 Required equipment The following equipment including an ultrasound system is needed to successfully treat patients with the CoolWave Control Unit 16 of 182 Part 250023 001 Rev J System Description Section 1 1 7 1 Equipment provided by Urologix Urologix provides the following equipment Part 250023 001 Rev J QUANTITY EQUIPMENT MATERIAL 1 CoolWave Control Unit 1 CoolWave Control Unit User Manual this document 1 Kit containing either Targis or CTC Advance Microwave Catheter e 1 microwave catheter e 1 Rectal Thermosensing Unit standard RTU or RTU Plus e 1 coolant bag 1 Patient Comfort Kit 2 knee cushions and a microwave catheter holder 1 Transport Kit optional trolley and electrical safety tester Table 1 2 Urologix provided equipment 1 7 2 Equipment provided by the Clinic The clinic typically provides the following equipment QUANTITY EQUIPMENT MATERIAL 1 Foley catheter 16 18 French 1 Straight catheter 14 16 French 1 Ur
183. ting 49 Error 004 Coolant Press Low 108 Default urethra setting 49 Error 005 Urethra Temp High 109 Identification 56 Error 006 Urethra Temp Low 109 Microwave power 75 94 Error 007 Catheter Efficiency Low 109 Treatment time 71 73 Error 008 Control Unit Temp High 109 Temperature Error 009 Control Unit Temp low 110 Coolant 9 16 49 63 64 66 92 94 Error 010 MW Flange Temp High 110 Rectal 8 15 63 64 66 95 Error 011 Coolant Temp High 110 Urethra 8 14 15 64 66 92 Error 012 Coolant Temp Low 110 Temperature range specifications Error 013 Rectal Temp High 110 Coolant 105 Error 014 Rectal Temp Low 111 Rectal 105 Error 015 Coolant Press High 111 Urethra 105 Error 016 Coolant Press Low 112 Temperature sensor Error 017 Urethra Temp High 112 Channel 33 Error 018 Urethra Temp Low 112 Connector 14 Error 019 Catheter Efficiency Low 112 Coolant system 12 13 Error 020 Pump Latch Open 113 Fiber optic 14 Error 021 User Pressed Microwave OFF 113 Microwave catheter 90 Error 022 Rectal Unit Disconnected 113 Rectal unit 15 90 Error 023 Urethra Signal Weak 113 Strip 32 Error 050 Maximum Treatment Time Exceeded 113 Time Error 051 Maximum MWG Time Exceeded 114 Current 41 Error 052 Warning Urethra Temp gt 41 C 114 System setting 86 Error 054 Warning Timer Rectal Temp gt 42 C 114 Cooldown 5 minute 78 93 95 Error 059 Warning Interval 74 94 Cruise Unavailable 114 Treatment 58 64 92 Error 099 Urethra Te
184. treatment time expires Refer to Section 3 3 5 4 Pausing a treatment or ending a treatment early for further information 7 Continue with the treatment until the treatment time ends and the Treatment Cooldown window Figure 3 33 appears Treatment is now complete Refer to Section 3 3 5 5 Ending a treatment for further information Resume Cooldown Treatment End Figure 3 33 Treatment Cooldown window 70 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 3 3 5 1 Using standard mode Treatment et Control Panel Time a Figure 3 34 Standard mode Adjust the urethra setting and treatment time from the Control Panel Figure 3 34 if desired g Note The treatment timer runs when the following conditions occur Targis CTC Advance CTC Advance e Urethra gt 35 C with e Urethra 35 C with e Urethra 35 C with Urethra Coolant Urethra Coolant Urethra Coolant difference gt 23 C difference gt 20 C difference 20 C e OR MW Power 50 W e OR MW Power 50 W e OR MW Power gt 65 W e OR RTU2 41 C e OR RTU241 C e OR RTU241 C Table 3 5 Treatment Timer algorithms Press the Urethra Setting button Press the up and down arrows to adjust the urethra setting temperature in 0 5 C increments The default urethra setting temperature for the Targis Microwave Catheter and the CTC Advance Microwave Catheter is 40 C Press the Close button when done P
185. troduction to the CoolWave Control Uniit c ccccccccccccccssssssscssssssesscssssssscsssssssesesssvsssvsesessssssseseens S 1 6 Targis System CoolWave Control Unit equipment OVErVieW ccccccsssssesesessssssstsesesessesesceeseseees S LP AREGUIT CO egu PINCH caries eee cases theta parse Raia ce Naar WSR RS 16 1 8 CoolWave Control Unit Installation and Use Environment c ccccccccscscscsssssesesssssssessssvseseesesssscnees 18 1 9 SV INSITUC ON S EE E E N E ENTENT 21 2 Treatment Session SCD s sccsecscvdsctecaniassedinddetussecuvexsceasecospedesusasausenssndeceuceniecssuseeictucsacedeussvtactecs 23 2 1 Generals al A YPE AUN OMS aeeie e E E E E E O 23 22 Ireatment SESSION SCLUD OVETVIEW orres ran eas eae es ee E 23 23 Preparing the Patient for TVCQUINCI nrinn se r RR 23 2 4 Positioning and preparing the CoolWave Control Unit v ccccccccccscscsssssssesesesssvsssessesesvevscscsssctenseseees 24 23 Installing the COOIGH BOG rirani ie n i teasiuila aus meaedubateat O N N 23 2 6 Inserting the Microwave Catheter vsisedscasaxisessebdcosassstuseeineiiergetend duadess doeapeseasusdvadancadade desapbsersecactaseass 28 27 dnserung the Sincle Use Standard R Ussi n an AE asec ae Oa eae a 31 2 8 Inserting the RTU Plus Reusable Handle and Single Use Balloon cccccccccccccccceceeeeeeeneeeeeeneeees 32 2 9 Connecting the Microwave Catheter and Rectal Unit to the CoolWave Control Unit 0 35 3 Treatment Mstructhions issia aa ara EE SEa
186. tton Press the up and down arrows to adjust the urethra setting temperature in 0 5 C increments The default urethra setting temperature for the Targis Microwave Catheter and the CTC Advance Microwave Catheter is 40 C Press the Close button when done Press the Treatment Time button Press the up and down arrows to adjust the treatment time in 30 second increments Figure 3 37 Press the Close button when done y Note In automatic treatment mode the treatment time is limited to 28 minutes and 30 seconds for the CTC Advance Microwave Catheter and from 28 minutes and 30 seconds to 60 minutes for the Targis Microwave Catheter Press the Coolant Setting button Press the up and down arrows to adjust the coolant setting temperature in 0 5 C increments The following table includes the default coolant setting temperature for the Targis Microwave Catheter and CTC Advance Microwave Catheter DEFAULT COOLANT SETTING TEMPERATURE Microwave Catheter Microwave Catheter The coolant temperature will ramp to its coolant setting temperature during a treatment Press the Close button when done Press the Ramp Rate button Press the up and down arrows to select the ramp rate slow medium fast Press the Close button when done Part 250023 001 Rev J 73 of 182 Section 3 Treatment Instructions Treatment Time 28 30 28 30 28 30 mmissi Figure 3 37 Example of a treatment parameter control panel
187. tton The Notes dialog box appears Figure 3 7 Part 250023 001 Rev J 43 of 182 Section 3 Treatment Instructions Figure 3 7 Notes Dialog Box 2 Enter your initials in the data field You can use from 1 to 3 alphanumeric characters 3 Press the OK button and proceed to step 4 Or press the Cancel button to exit the notes feature 4 Enter patient treatment information in the Notes Entry window Figure 3 8 Each time you access the notes feature throughout a treatment you will see a date and time stamp the elapsed time and your initials The elapsed time indicates the time since system calibration started when you are on the System Calibration screen Or when on the Urologix BPH Treatment screen the elapsed time indicates the time since the treatment started If you have not started system calibration or a treatment then the elapsed time will be 00 00 44 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 02 13 19 AM 00 00 Elapsed dem Figure 3 8 Notes Entry Window 5 Press the Close button when finished 3 2 CoolWave Control Unit setup M Y Warning Do not move the CoolWave Control Unit while the electrical cord is connected to a power source a Note Turn ON the Control Unit at least 5 minutes before the treatment begins to allow the system to warm up 3 2 1 Turn ON the Control Unit Press the ON OFF power switch located on the back of the unit see Figure 1 6 ON OFF
188. ume Treatment Phase Press To Begin Cooldown Phase Go To Cooldown Figure 3 40 Resume Treatment dialog box 3 Press the Go To Cooldown button Figure 3 40 The cooldown 5 minute timer appears Figure 3 41 This timer shows the time remaining until the end of cooldown which also indicates how much time has passed since the microwave power was turned OFF with the coolant pump still running 76 of 182 Part 250023 001 Rev J Treatment Instructions Section 3 Resume Cooldown Treatment End Figure 3 41 Treatment Cooldown window 4 Select one of the following options in cooldown remain in cooldown for the full 5 minutes 10 minutes 15 minutes resume the treatment or end the cooldown Begin the cooldown at 5 minutes You may add additional cooldown time by pressing one of the grey buttons You can exit at any time but it is recommended to pump coolant for at least 5 minutes g Notes e Itis recommended that the cooldown phase last 5 minutes prior to exiting the treatment e Once you exit cooldown the treatment is done and cannot be resumed a Remain in cooldown Cooldown ends after 5 minutes and the Treatment Cooldown End window appears Figure 3 41 If you need to resume treatment proceed to step 4b Or you can exit the treatment Press the Exit button A dialog box appears to confirm that you want to exit and therefore end this treatment b Resume the treatment Press the Resume Treatment button Figure
189. urther intervention refer to Adverse Events and Complications in the Instructions for Use Patients may likely be catheterized for a 2 to 5 day median 3 day period or longer following the Cooled ThermoTherapy treatment Patients may be prescribed anti inflammatory and antibiotic medications for a period following the treatment Patients should be informed that they may experience discomfort during the treatment that may require the use of analgesics or sedatives to deliver an effective treatment 156 of 182 Part 250023 001 Rev J Appendix B Section 6 Analgesia Guidelines Anesthesia is NOT required for patients undergoing a Cooled ThermoTherapy treatment t is important that the patient not be over sedated This may compromise his ability to communicate pain or other experiences Pretreatment Medications e Many urologists choose to treat patients with a non steroidal anti inflammatory drug for 2 5 days and to start the patient on antibiotic one day pretreatment and continuing post treatment as required e Ifa patient is not on alpha blockers prior to treatment many physicians will start him on alpha blockers approximately one week prior to treatment continuing post treatment for 6 8 weeks Treatment Medications e tis suggested that topical lidocaine jelly and or a bladder cocktail be instilled into the urethra and allowed to dwell for 20 30 minutes before the Microwave Catheter is inserted e Additional m
190. use a new microwave catheter refer to Section 2 6 Inserting the Microwave Catheter for further information Once a new microwave catheter is in place the CoolWave Control Unit automatically reads the new serial number Proceed to step 3 If both serial numbers appear in the data fields but the rectal unit serial number indicates that the rectal unit has exceeded its maximum number of uses a caution symbol appears To use a new rectal unit refer to Section 2 7 Inserting the Single Use Standard RTU or Section 2 8 Inserting the RTU Plus Reusable Handle and Single Use Balloon for further information Once a new rectal unit is in place the CoolWave Control Unit automatically reads the new serial number Proceed to step 3 Part 250023 001 Rev J Treatment Instructions Section 3 d If one or both serial numbers do not appear in the data fields then the treatment protocol list appears blank Readjust the connectors tags and serial number labels Figure 3 18 until the serial number s appear in the data field s Proceed to step 3 Wy ote Placing the patient cable housing on a metal surface can reduce the RFID tag reading range of the antenna within the patient cable housing Placing a folded disposable bed pad between the patient cable housing and the metal surface may resolve the issue Figure 3 18 Readjust connectors tags and serial number labels K W warning Selection and use of the appropriate catheter model is required
191. ve Control Unit User Manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at the users own expense The Urologix CoolWave Control Unit emits a small amount of electromagnetic energy during a treatment Urologix recommends that all electronic medical devices be kept at a minimum distance of 1 0 meter from the CoolWave Control Unit when performing a treatment However a l meter separation of electronic medical equipment from the CoolWave Control Unit does not guarantee that operation of other devices will not be impacted The effect of this electromagnetic energy on all equipment cannot be predicted due to age and quality of maintenance The performance of each piece of equipment operated near the CoolWave Control Unit during a treatment must be evaluated for degradation For more detailed EMC requirements refer to Section 5 7 Electromagnetic Compatibility EMC Tables in the Appendix Since microwave energy can travel through walls ceilings and floors to affect other devices it is important to understand that the 1 meter safety distance applies not only to the treatment room but also to all adjacent rooms in the building including the rooms above and below the treatment room Do not operate the CoolWave Control Unit near equipment that emits electromagnetic energ
192. ved method for transporting the CoolWave Control Unit 104 of 182 Part 250023 001 Rev J Equipment Maintenance Section 4 4 7 CoolWave Control Unit specifications CoolWave 5000E Europe Control Unit Models 5000A US Power Requirements SOOOE 220 240 V 10 4 25 A Single phase 50 or 60 Hz 5000A 110 120 V 10 8 5 A Single phase 50 or 60 Hz Microwave Output Power 0 W 75 W output from the microwave antenna connector on the patient cable continuous duty Frequency 902 MHz to 928 MHz Coolant Circulation Chill Element Thermoelectric System Capacity 100 W element Configuration Disposable Coolant Bag Bag Dimensions Approximately 15 2 cm x 17 8 cm Bag Capacity Approximately 100 mL Pump Peristaltic pump User Interface Display Color liquid crystal display or LCD Input Touchscreen Keyboard Silicone rubber keyboard Operating Conditions Temperature 10 C to 30 C Humidity 30 to 75 relative humidity Atmospheric Pressure 700 hPa to 1 060 hPa Shipping Storage Temperature 20 C to 70 C Conditions Humidity 10 to 95 relative humidity Atmospheric Pressure 700 hPa to 1 060 hPa Class Type IEC 60601 1 Class I Type BF with defibrillation protection Measurements Range Rectal Sensor Range 1 C 50 C Accuracy 1 C from and Accuracy 35 C to 45 C and 2 C outside this range Urethra Sensor Range 27 C 47 C Accuracy 1 C Coolant Temperature Range 25 C 75 C Accuracy 3 C
193. verify that no leaks are present Remove all air to ensure that the balloon is completely deflated Then remove the syringe before proceeding to step 8 Lubricate the balloon area with a water based lubricant e g K Y Jelly K 7 Warning The rectal unit must be positioned properly to ensure correct temperature sensing Insert the balloon slowly into the rectum using the semirigid tubing to guide placement This can be done by initially grasping the sensor support tubing in the middle of the balloon area and slowly introducing the balloon into the rectum Then move the guiding hand back to the handle Slowly advance the balloon while grasping the handle until the entire balloon is inserted Inserting the balloon can be done with the patient on his side or supine with knees bent Note The rectal temperature sensors must be oriented toward the prostate The RTU Plus Reusable Handle is labeled anterior and posterior to help with placement Verify rectal unit orientation by confirming that the inflation tubing channel in the rectal unit handle Figure 2 10 is facing towards the patient s posterior Therefore with the patient supine the handle base would be against the treatment table surface with the Urologix logo visible on both sides of the handle This orientation ensures that the temperature sensors of the RTU Plus are pointed towards the patient s anterior rectal wall nearest the prostate M Y Warning This visual reference shoul
194. voir level Nonionizing radiation microwave power Part 250023 001 Rev J Appendix A Section 5 SYMBOL DESCRIPTION Operate on a level surface Rectal unit Consult Instructions for Use ie tH Caution Stop microwave energy Type BF equipment with defibrillation protection STERILE Sterilized Using Ethylene Oxide Use By Date Temperature Limitation Do Not Resterilize Recyclable Package S s00 gt Part 250023 001 Rev J 127 of 182 Section 5 Appendix A SYMBOL DESCRIPTION 20 cm Keep objects 20 cm from vents Do not place heavy objects on drawer on Caution cold surface Do Not Use if Package is Damaged Caution Federal U S A law restricts this device to sale by or on the order of a K ONLY physician trained and or experienced in the use of this device as outlined in the required training program a Note U Caution M Warning m Date of Manufacture onal Manufacturer REP Authorized Representative in the European Community Table 5 1 Description of symbols 128 of 182 Part 250023 001 Rev J Appendix A Section 5 5 5 Patient Comfort Kit Treatment catheter goes in top slot Treatment Catheter Holder Rectal unit cable goes in bottom groove Figure 5 6 Microwave catheter Holder Figure 5 7 Knee cushions Part 250023 001 Rev J 129 of 182 Section 5 Appendix A 5 6 Glossary Advanced mode Select advanced mode from the Control Panel on th
195. voltage power supply network that supplies building used for domestic proposes VON ove COmpMES provided that the following warning is heeded flicker emissions IEC 61000 3 3 Warning This equipment is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the Targis System with CoolWave Control Unit or shielding the location Table 5 2 Electromagnetic Emissions 138 of 182 Part 250023 001 Rev J Appendix A Section 5 Guidance and manufacturer s declaration Electromagnetic Immunity The Targis System with CoolWave Control Unit is intended for use in the electromagnetic environment specified below The customer or the user of the Targis System with CoolWave Control Unit should assure that it is used in such an environment IEC 60601 test level Compliance level Electromagnetic Environment Guidance Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line
196. xternal sphincter or penile urethra 6 of 182 Part 250023 001 Rev J System Description Section 1 All components of the CoolWave Control Unit must be used in a manner consistent with the instructions set forth in their respective instructions for use insert and the CoolWave Control Unit User Manual this document Failure to do so may result in insufficient treatment or increased risk of injury or infection to the patient Note Use of the CoolWave Control Unit results in the deposition of microwave energy in the patient s prostate and in adjacent regions of the body Some animal studies in the literature suggest that there may be as yet unknown health effects from exposure to microwave radiation including an increased incidence of tumors Although it is not possible to extrapolate these studies to humans they suggest that unnecessary microwave radiation exposure should be avoided At least 20 cm of ventilation clearance must be provided around the base of the CoolWave Control Unit u Note This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to part 15 of the Federal Communication Commission FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the CoolWa
197. y unless the effect on the CoolWave Control Unit has been evaluated and no degradation of performance was found The national standard ANSI IEEE C95 1 1999 Edition Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields recommends a maximum stray field exposure level for whole body exposure of 3 mW cm as averaged for any 6 minute period The maximum radiated field at full power from the CoolWave Control Unit patient cable and microwave catheter at 5 centimeters is 2 1 mW cm Urologix recommends that the operator maintain a minimum distance of 5 centimeters from the patient cable and exposed portions of the microwave catheter during the treatment Part 250023 001 Rev J 7 of 182 Section 1 System Description Operate the CoolWave Control Unit and connected devices only when connected to a fully tested hospital grade power outlet with adequate grounding The CoolWave Control Unit must be plugged into the appropriate voltage outlet The electrical equipment inside the CoolWave Control Unit uses voltages capable of causing serious injury or death from electric shock To avoid this hazard never open the housing of the CoolWave Control Unit 1 5 Introduction to the CoolWave Control Unit The CoolWave Control Unit treats Benign Prostatic Hyperplasia BPH by applying microwave power to the prostate This microwave power when applied to the prostate heats the diseased tissue via
198. y Urologix for a Urologix sponsored clinical study b Press the Allow Administrator Privileges button Provide or remove administrator access allows access to User Settings screen and all CoolWave Control Unit data files for the selected user there is at least 1 site administrator per hospital or clinic If the button has a checkmark remove access by pressing on the button If the button does not have a checkmark provide access by pressing on the button Proceed to step 4 c Press the Allow Manual Control button Provide or remove access to the manual treatment mode for the selected user If the button has a checkmark remove access by pressing on the button If the button does not have a checkmark provide access by pressing on the button Proceed to step 4 Part 250023 001 Rev J 81 of 182 Section 3 Treatment Instructions d Press the Reset Password button Activate or deactivate the password reset function for the selected user If the button does not have a checkmark reset the user s password to password by pressing on this button If the button does have a checkmark the password reset function is already active Proceed to step 4 4 Press the Apply button 5 Press the Back button to return to the Options Menu screen 3 5 2 Printer Utilities screen Figure 3 44 Printer Utilities screen e Note Refer to Section 4 3 Maintaining the printer Figure 4 3 for a printer overview 1 Select one of the fo
199. y invasive non surgical modalities that have emerged during the last decade apply thermal energy to the prostate by either the rectal or urethral route using a variety of heat applicators such as laser devices high intensity focused ultrasound HIFU or transurethral radiofrequency Currently a drawback of these options is the necessity for general anesthesia or a higher level of analgesia The use of microwave as a heat source has been investigated extensively Pioneer microwave research efforts in the early 1980s were focused on the use of hyperthermia by applying microwave heat rectally or urethrally It became apparent that hyperthermia target temperatures of less than 45 C were not effective and higher temperatures were required This led to the development of microwave thermotherapy that was designed to apply microwave energy deep within the lateral prostatic lobes and to simultaneously cool the urethral mucosa Cooled ThermoTherapy or transurethral microwave thermotherapy TUMT is a non surgical minimally invasive treatment for benign prostatic hyperplasia BPH The goal of the Cooled ThermoTherapy treatment is to improve patient symptoms and voiding function by thermoablation of the adenomous prostatic tissue while maintaining lower temperatures in non target tissue A Cooled ThermoTherapy treatment treats BPH by applying microwave energy to the prostate via its transurethral Microwave Catheter that precisely heats disea

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