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Targis® System CoolWave® Control Unit

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1. CoolWave Treatment Log Out Options Figure 3 13 Main Menu Screen y Note Turning OFF the Control Unit at this point during system startup does not cause a loss of stored data 1 Press the Treatment button to proceed with a treatment Refer to Section 3 3 Cooled ThermoTherapy for further information 2 Press the Options button to view CoolWave Control Unit system options Refer to Section 3 5 CoolWave Control Unit options for further information 3 Press the Log Out button to return to the Login screen Refer to Section 3 2 2 Login screen for further information 3 3 Cooled ThermoTherapy Procedure This section of the user manual steps you through a Cooled ThermoTherapy Procedure 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 Procedure 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 Coole
2. 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 catheter 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 3 3 5 Urologix BPH Treatment screen The Urologix BPH Treatment screen allows you to monitor patient progress during the procedure 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 23 If there is an emergency press the red Microwave Off pushbutton Figure 3 24 located under the touchscreen monitor and right of the green LED to immediately turn the microwave power OFF Microwave Power On Blue Bar Screen Header Status panel Control panel Figure 3 23 Urologix BPH Treatment screen
3. Prior to beginning a Cooled ThermoTherapy procedure 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 LL Cautions J 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 Operate 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 is a danger of explosion Do not use the CoolWave Control Unit in the presence of flammable substances u Caution
4. 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 130 of 143 Part Number 250023 001 Rev G Appendix Section 5 5 6 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 CISPR 11 RF emissions CSPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 The Targis System with CoolWave Control Unit must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected The Targis System with CoolWave Control Unit is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies building used for domestic proposes provided that the following warning is heeded Warning This equipment is intended for us
5. ceecccceeesessssnneceeeeeeeeeeeeeeeseseseseessneeeeeeeeeeeeeeeseeeeeeeeegs 85 Figure 3 47 System Settings screen date nicnn tata ela e inca a a aN 86 Figure 3 40 DYSE Stings SChC CM IMS i 86 Figure 3 49 System Settings screen lanouace enonsa A ae eee 87 Figure 3 50 System Settings screen Vol m orris a a EE 87 Figure 3 51 Example of a System Settings screen apply ccccccccccceseseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeey 88 Figure 3 52 Example of a System Error screen error MeCSSAQC cceesccccccccseeceeeeceesseeeesntaeeeeeeeeeeeeeeeeeseeees 89 Figure 3 53 Example of a System Calibration screen error message 0 ee eeecccceceessseeeeeessntneceeeeeeeeeeeseseees 90 Figure 4 1 Interial COOlaMtIEVel INGICAION isc esatediuss cdtasiddarrasitiod tataied ec cdaveasnendasevessaic sues toi epidatenseenddiaveesaay 97 Picure 4 7 Control Unit rear Covers sacsans cactus NS 98 Pa US PEME OVE OW erst ee area bes artis es cleat eas weed open gute ose aaah a ua ead dares aga cacti ead ees 99 Figure 4 4 nseri de Mew Mik Alken sceatenacinesa td cohiacieiandesadatiataninesuubl a SS 100 Figure dsl Preatnem bSCTeCM NOW MALU esee e aE aE riaan a ee aaa eE n 118 Furco 2 Microwave catheter Holde ierecrerorieiiirsi in a n T a A a 122 Piode 92 Fe ATIC 6 CUS INI OIG aonne E E E EE 122 6 of 143 Part Number 250023 001 Rev G List of Tables Table Jol Safety Symbols and Dernitions esipreestri 9 Fable 1 2 Urologie provided e
6. 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 16 until the serial number s appear in the data field s Proceed to step 3 Figure 3 16 Readjust connectors tags and serial number labels M ay Warning Selection and use of the appropriate catheter model is required to assure 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 u Note The serial number label is attached to the cable of the microwave catheter near the connection to the patient cable See Figure 3 16 Part Number 250023 001 Rev G 57 of 143 Section 3 Treatment Instructions Prostatic Catheter Serial Serial Microwave Urethral Color Number Number Catheter Length Scheme Tag Color Prefix CTC Advance 2 5 to 3 5 Blue Handle Short cm Black Accents races OF 3 0t05 0 Blue Handle Cooled ThermoCath cm White Accents Standard CTC Advance or Blue Handle Cooled ThermoCath gt 4 5 cm Grey Accents Long Targis 2 5 to 3 5
7. 91 Event button 66 Event log 69 Calibration error 89 General halt error 88 Print 69 Treatment 66 67 Event pane 66 67 88 Events button 69 Fiber optic Connector 13 Temperature sensor 18 Finger pad 19 Flash drive See USB flash drive Full Name data field 51 81 Fuse 97 98 Catalog number 98 Holder cap 98 Overview 98 Types 98 General halt error 88 89 General halt error message 89 Glossary button 47 Go To Cooldown button 77 Handle key hole 37 Headphone jack 17 18 Help button 46 Help feature 45 46 47 Help window 46 47 137 of 143 Section 5 Holder Cable holder 13 15 101 Microwave catheter Holder 39 Microwave catheter Holder 20 Microwave catheter Holder 122 Tubing holder 32 Housing Control Unit 12 96 Patient connection cable 12 13 18 Hydrophobic vent 20 Inflation port See Balloon inflation port Inflation tubing channel 36 37 Ink tank 99 100 Internal coolant level indicator Daily maintenance 96 Sight gauge 97 Interval timer 74 93 Key hole 36 Keyboard 14 43 103 Calibration error 89 General halt error 88 Treatment error 91 Knee cushion 39 122 Language System setting 86 Locating key 37 Location balloon 18 Locking lever 30 Log Out button 53 Login button 50 Login screen 45 49 50 52 Lower pump housing 31 Main Menu screen 52 53 Main power indicator 17 Maintenance 25 Daily 96 Periodic 97 Printer 98 101 Manual button 70 Manual
8. Pane Chart pane 66 Cooldown pane 88 91 Detail pane 67 68 88 Event pane 66 67 88 Panel Advanced mode Control Panel 58 72 92 Control Panel 65 Manual mode Control Panel 75 93 Standard mode Control Panel 58 71 Status Panel 65 74 Treatment parameter control panel 72 Paper Guide 99 Refill 99 Rest 99 Thickness lever 99 Parameters Treatment 12 13 53 55 64 70 Password 50 52 Demonstration mode 52 Password button 80 Password Confirm data field 51 Password data field 51 Part Number 250023 001 Rev G Appendix Password Setup window 84 Reset 81 82 Reset Password button 82 Setup 84 Patient button 83 Patient Comfort Kit 39 122 Patient connection cable 12 13 18 65 101 Cable holder 13 15 101 Housing 12 13 18 Patient critical error See System error Patient data 69 Patient information Age 55 Institution 55 International prostate symptom or AUA symptom score 55 Patient ID 55 Patient name 55 Postvoid residual 55 Prostate specific antigen 55 Prostate volume 55 Qmax 55 Quality of life 55 Urethra length 55 Patient Information screen 55 56 Patient post treatment 79 Pause End button 76 Peristaltic pump See Peristaltic pump mechanism Peristaltic pump mechanism 16 20 93 103 Power button printer 99 Power connection See Power cord Power cord Cable holder 15 Daily maintenance 96 Types 23 Power indicator Main power 17 Microwave power 17 Power lamp 99
9. Power ON Control Unit 49 Power requirement 22 Power setting Manual mode 75 Power Setting button 75 93 Power switch 15 49 Precautions See also Safety information CoolWave System 12 General safety 27 Preprocedure medications 28 Pressure sensor 16 Print Event log 69 Nozzle check pattern 82 100 101 Treatment report 69 84 Print button 68 84 Print head 82 100 Clean 82 83 101 Part Number 250023 001 Rev G Section 5 Nozzles 82 Print head cover 99 Print queue Clear 70 83 Print window 69 Printer 15 Clean print head 82 101 Clear print queue 83 Daily maintenance 96 Ink tank 99 100 Maintenance 98 101 Nozzle check pattern 82 100 101 Output slot cover 99 Overview 99 Paper guide 99 Paper refill 99 Paper rest 99 Paper thickness lever 99 Power button 99 Power lamp 99 Print head cover 99 Print head nozzles 82 Printer drawer 14 15 Printer utilities 82 83 Printer Utilities screen 82 83 100 101 Resume Cancel button 99 Printer button 80 Procedure Kit 12 Prostate 12 17 19 79 Protective sheath 38 Protocol Clinical 81 Custom 58 59 Treatment 53 58 59 64 69 Protocol screen 56 60 Pump See Peristaltic pump mechanism Pump mechanism See Peristaltic pump mechanism Pump ON OFF Manual mode 75 Manual treatment mode 93 Pump On Off button 75 Pump tubing notch 31 Ramp rate 54 60 Advanced mode 74 Automatic treatment mode 91 92 Manual mode 76 Manual tr
10. Standard Short Urethra Coolant Urethra Coolant Urethra Coolant difference 2 23 C difference 2 20 C difference 20 C OR MW Power 2 50 W OR MW Power 2 50 W e OR MW Power 2 65 W OR RTU 2 41 C e OR RTU2 41 C e OR RTU2 41 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 temperatures for the Targis Microwave Catheter and the Cooled ThermoCath Microwave Catheter and the CTC Advance Microwave Catheter are 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 Press the Close button when done a Note In automatic treatment mode the treatment time 1s limited to 28 minutes and 30 seconds for the Cooled ThermoCath Microwave catheter and from 28 minutes and 30 seconds to 60 minutes for the Targis Microwave catheter Part Number 250023 001 Rev G 71 of 143 Section 3 Treatment Instructions Figure 3 32 Example of a treatment parameter control panel 3 3 5 2 Using advanced mode Control Panel Figure 3 33 Advanced mode 72 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 Adjust the urethra setting treatment time coolant setting and ramp rate from the Control Panel Figure 3 33 if desired e Note The treatment timer runs whe
11. 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 24 of 143 Part Number 250023 001 Rev G System Description Section 1 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 Part Number 250023 001 Rev G 25 of 143 Section 1 System Description 26 of 143 Part Number 250023 001 Rev G Treatment Session 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 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 physi
12. 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 Itis recommended that a glove be tied 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 or most 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 typically 1 oz ENZOL per gallon of water 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 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 solutio
13. 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 3 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 My damage to the equipment or its connected devices Do not proceed beyond a caution sign Caution until the indicated conditions are fully understood and met A warning contains important information about possible danger to you or the patient Do not proceed beyond a warning sign until the indicated conditions are fully understood and met The instruction
14. 17 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 18 Urethra Temp Low Possible Causes Action Steps 1 Loose microwave catheter fiber Reattach connector connectors 2 Microwave catheter may be defective Replace the microwave catheter Error 19 Catheter Efficiency Low Possible Causes Action Steps 1 Cable may not be connected properly Reattach connector 2 Microwave catheter may not be Check that the microwave catheter is inserted properly inserted properly 3 Urine drainage line not purged Purge urine drainage line 4 Defective microwave catheter Replace the microwave catheter and recalibrate Error 20 Pump Latch Open Possible Causes Action Steps 1 Coolant pump clamp latch is open Close the latch 2 Lift lever has failed Open and close lift lever and listen for 2 clicks 110 of 143 Part Number 250023 001 Rev G Appendix Section 5 Error 21 User Pressed Microwave Off Possible Causes Action Steps 1 User accidentally pressed the Press the Resume button or the Reset Microwave Off pushbutton button to continue 2 Patient was experiencing pain Resume treatment after the pain level
15. 4 1 Fuse overview F Y Warning Only replace CoolWave Control Unit fuses with Urologix supplied components 3 Replace the fuse holder caps 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 with your Canon color inkjet printer 98 of 143 Part Number 250023 001 Rev G Equipment Maintenance Section 4 Paper guide Paper rest Resume Cancel button Power button Power lamp Print head cover Paper thickness lever De ee Output slot cover Figure 4 3 Printer overview 4 3 1 Refilling the printer with paper a 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 a a 4 3 2 Replacing an Ink Tank a Notes 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 a
16. 5 C or e Microwave power reaches 60 W for a Targis or CTC Advance Short Microwave Catheters or 75 W for a Cooled ThermoCath or CTC Advance Standard amp Long Microwave Catheters e The patient is experiencing discomfort Part Number 250023 001 Rev G 93 of 143 Section 3 Treatment Instructions 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 CTC Advance Cooled ThermoCath Standard amp Long Urethra 2 35 C with Urethra 2 35 C with Urethra 2 35 C with Targis CTC Advance Short amp Standard Short Urethra Coolant Urethra Coolant Urethra Coolant difference 2 23 C difference 2 20 C difference 20 C OR MW Power 2 50 W OR MW Power 2 50 W OR MW Power 2 65 W OR RTU 2 41 C OR RTU 2 41 C OR RTU 2 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 increments until the rectal unit is 41 5 C If the rectal unit temperature does no
17. 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 procedure 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 Part Number 250023 001 Rev G 11 of 143 Section 1 System Description 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 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 a
18. 64 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 Microwave Off pushbutton Figure 3 24 Microwave Off Pushbutton 1 View treatment data in the Status Panel at the top of the Urologix BPH Treatment screen Figure 3 23 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 Coolant Displays coolant temperature in C as measured by the Coolant Bag sensor If the coolant pump is turned OFF this reading will gradually approach room temperature Rectal Displays the warmest of the 5 rectal temperatures in C Urethra Displays the urethra temperature in C Status Highlights status as pause treatment OFF ramp system preparing for treatment treat treatment ON or cool cooldown ON 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 CTC Advance Cooled ThermoCath Standard amp Long Urethra 2 35 C with Urethra 2 35 C with Urethra 2 35 C with Targis CTC Advance Short amp Standard Short Urethra Coolant Urethra Coolant Urethra Coolant difference 2 23 C difference 2 20 C difference 20 C OR MW Po
19. Coolant system Main power indicator and microwave power indicator Microwave Off pushbutton Other Volume control headphone jack USB ports i 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 Cool Wave Control Unit via the patient connection cable and patient connection cable housing Figure 1 2 Microwave connector ow GE T Fiber optic connector Rectal unit connector 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 Number 250023 001 Rev G 13 of 143 Section 1 System Description Latch Touchscreen monitor Figure 1 3 Touchscreen monitor 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 F
20. Ee OTe TNE eee 71 Figure 3 32 Example of a treatment parameter control panel cc cc cccccccccccceceeeesseseeeessnnneeeeeeeeeeeeeeeeeeeeeeees 12 Figure ACV ANCCE Mode narena a a be velassauendabhiad esanteabeiaypiesesessauendaueiad ecanteataiaypesseln 72 Figure 3 34 Example of a treatment parameter control panel sosssooosseseeeeessssssssssssssrrrrrreeessssssssssssssrern 74 Pieire o 9 Manua Od lt aremegap erate eetreere ne ae meer Nec ent ne at wren Nec ea a a wemneln N 75 Figure 3 36 Example of a treatment parameter control pannel ccc ccc cccccccccceeceeeeseeseeesssnneeeeeeeeeeeeeeeeeeseeeees 76 igure 3 37 Resume Treatmenldialoo DOK casio duce totes oan ol reed bet ed ou ta kadeveada dante OR 76 Ficure 5 38 Treatment Coldo wi window sciscsecsst ena cctee aia ieee ness aa Beane cds Ta Fieure 3 39 Treatment Cooldown End Widow vwatacrecsess vat erst a a tours N 77 Figure 3 40 Treatment Cooldown End Window 0 cccccceseesessssnneeeeeeeeeeeeeeeesssseseeessssseeeeeeeeeeeeesseeeseeeees 78 Figure 5 41 Options Mont Scree Miesies a aeaaea aea e aa a aeea vesenecialleapeuseadapeiodteaad 80 Pieire o A2 User Se MNES Ser Cekas N A 81 Figure 5 43 Paner OSS SCE Ms tyaceei nets N a E AO RLE NE 82 Figure 3 44 Data View Print Copy Sere iieninneinn n sdavenesacevecsendueiereieeeaescads 83 Figure 5 45 Password SeUUp WINGO onesna a T E ATE Aaiatetuec ants 84 Figure 3 46 Example of a System Settings SCrCCN
21. Extension tubing Finger pad Rectal balloon Orientation flag Balloon inflation port Figure 2 9 Standard RTU 3 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 4 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 F W Warning The rectal unit must be positioned properly to ensure correct temperature sensing Part Number 250023 001 Rev G 35 of 143 Section 2 Treatment Session Setup 5 Inflate the rectal balloon by injecting 120 cc of air 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 6 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 M ay 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 ay Warning This visual reference s
22. Figure 3 21 62 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 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 22 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 determine what to do next 105c User canceled operation Figure 3 22 System Calibration Screen Error Message Notes e Ifa calibration error message appears refer to Section 5 1 Troubleshooting guide for further information Part Number 250023 001 Rev G 63 of 143 Section 3 Treatment Instructions e Before replacing a microwave catheter or rectal unit contact Urologix Customer Service at 1 888 229 0772
23. 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 35 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 Cooled ThermoCath and CTC Advance Standard and Long Microwave Catheters in 1 W increments 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 addition 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 Cooled ThermoCath Microwave Catheter Default coolant setting temperature Targis Microwave 8 C Catheter CTC Advance and 15 C Cooled ThermoCath Microwave Catheters Part Number 250023 001 Rev G 75 of 143 Section 3 Treatment Instructions 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 sel
24. White Catheter Short cm Green Handle Targis 3 0 to 5 0 White Catheter Standard cm White Handle Table 3 2 Microwave catheter identification NOTE A dark blue handle is Cooled ThermoCath the light blue is the CTC Advance 4 Select the desired treatment protocol in step 2 on the Protocol screen for your patient and then press the treatment protocol name Figure 3 15 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 Cool Wave 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 4 Otherwise proceed to step 7 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 17 58 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 98765432 10ABCDE Modify button Standard Protocol 40 0 C 15 0 C Medium 38 0 C 16 0 C Custom Protocol 1 Fast Custom Protocol 2 40 0 C 15 0 C Fast Figure 3 17 Example of Protocol screen modify 6 Adjust the urethra setting coolant set
25. cup i Urinal or graduate As needed Ice or ice pack Table 1 3 Clinic provided equipment 1 8 CoolWave Control Unit Installation and Use Environment 1 8 1 Installation K 2 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 Part Number 250023 001 Rev G CoolWave Control Unit for obvious damage Pump latch and coolant door to see that they are operating correctly Patient connection cable patient connection cable housing and connectors for kinks cuts dirt contamination or obvious damage Microwave catheter for kinks cuts or obvious damage Rectal unit for kinks cuts or obvious damage Coolant Bag for kinks cuts or obvious damage 21 of 143 Section 1 System Description Operate the Cool Wave 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
26. deliver microwave power until the physician ends the treatment The manual treatment mode consists of 3 parts ramp treatment and cooldown 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 l 2y 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 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 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 Increase microwave power by W per minute once 1 of the 3 conditions in step 3 are met until e The microwave catheter reaches 40 C 1 C or e The rectal unit gt 41
27. feature Copy button 84 Copy treatment report 84 Create New User window 51 Current Error or Warning window 66 67 Current user 51 Custom protocol 58 59 Customer Service See Urologix Customer Service Daily maintenance 96 Data button 80 Data field 43 44 Full Name data field 51 81 Password Confirm data field 51 Password data field 51 User Name data field 51 Data file 53 69 81 Data View Print Copy screen 83 84 Data window 83 Date Current 45 System setting 85 Date button 83 Default coolant setting temperature 54 60 73 Demonstration mode 44 45 46 52 56 60 61 62 80 Detail button 67 Detail pane 67 68 88 Dialog box 44 Enter Manual Mode dialog box 75 Part Number 250023 001 Rev G Section 5 Notes dialog box 47 48 Resume Treatment dialog box 76 Disposable balloon See Rectal balloon Edema 79 Emergency Control Unit 17 Enter Manual Mode dialog box 75 Equal potential ground cable 22 Equipment 9 10 11 12 20 102 Clinic supplied 20 Component testing 23 Connections 23 Electromagnetic energy 11 Maintenance 25 96 97 Safety concerns 24 Safety symbols 9 Type BF 120 Urologix supplied 20 Equipment overview 12 Equipment warranty 97 Error 46 64 66 67 91 Calibration 34 88 89 90 General halt 88 89 System 66 67 88 89 105 See also System error Treatment 88 91 Error icon 64 Error message See also System error Calibration 90 General halt 89 Treatment
28. has reduced 3 Microwave indicator was illuminated Call Urologix Customer Service when it should not have been Error 22 Rectal Unit Disconnected Possible Causes Action Steps 1 Rectal unit has become disconnected Reattach the rectal unit to the patient connection cable housing Error 23 Urethra Signal Weak Possible Causes Action Steps 1 Loose microwave catheter fiber Reattach connector connectors 2 Microwave catheter may be defective Replace the microwave catheter 3 Patient cable may be defective Call Urologix Customer Service Error 50 Maximum Treatment Time Exceeded Possible Causes Action Steps 1 Treatment timer has exceeded 60 Press the Pause End button to begin minutes cooldown Error 51 Maximum MWG Time Exceeded Possible Causes Action Steps 1 100 minutes have elapsed since Press the Pause End button to begin completing calibration cooldown Part Number 250023 001 Rev G 111 of 143 Section 5 Appendix Error 52 Warning Urethra Temp gt 41 C Possible Causes Action Steps 1 Urethra temperature is too high Reduce microwave power to maintain urethra temperature below 41 C Error 99 Urethra Temp Probe Error Possible Causes Action Steps 1 Loose microwave catheter fiber Reattach connector connectors 2 Microwave catheter may be defective Replace the microwave catheter Error 100 Rectal Unit Cal Failure Possible Causes Action Steps 1 All 5 rectal sensors are not
29. immediately turn the microwave power OFF Microwave Off pushbutton 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 Part Number 250023 001 Rev G 17 of 143 Section 1 System Description Volume control USB ports y 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 bladder 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 Luers Balloon inflation port Microwave antenna A Shaft Cooling a A 4 k a ni a N EN channel Coude tip au pan x n i T Location balloon Temperature sensor Urine drainage port con
30. manual symbol is displayed on the product when it is necessary for you to refer to the CoolWave Control Unit User Manual this document Table 1 1 Safety Symbols and Definitions 9 of 143 Part Number 250023 001 Rev G 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 u 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 procedure You will also find information on how to change system settings handle system errors and work in demonstration mode Section 4 Equipment Maintenance presents information on post treatmen
31. 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 4 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 Number 250023 001 Rev G 33 of 143 Section 2 Treatment Session Setup Cooling Microwave antenna Shafi channel Coude tip J pee editor Location balloon Temperature sensor rne drainage port connector Serial number label Figure 2 7 CTC Advance Microwave Catheter g Note For this user manual the representative microwave catheter is the CTC Advance Microwave Catheter 5 Lubricate the microwave catheter with a water based lubricant or local anesthetic 6 Insert the microwave catheter into the patient s urethra until the location balloon 1s 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 7 Inflate the location balloon with 10 cc of sterile water Pull back on the microwave catheter until mild resistance 1s felt 8 F
32. microwave catheter from the CoolWave Control Unit 3 Remove all water from the microwave catheter location balloon and withdraw the catheter from the patient 4 Disconnect the rectal unit from the patient connection cable 5 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 6 Remove the coolant bag from the CoolWave Control Unit 7 Dispose ofthe 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 Cleaning the RTU Plus Reusable Handle Post Treatment for instruction on cleaning and disinfecting the RTU Plus Reusable Handle 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
33. 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 Part Number 250023 001 Rev G 19 of 143 Section 1 System Description Coolant ba paS Mounting hole 3 pl lt lt papan Coolant inlet and outlet tubing Hydrophobic vent p 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 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 nee
34. 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 4 Patient Comfort Kit to view the accessories in the kit Part Number 250023 001 Rev G 39 of 143 Section 2 Treatment Session Setup 4 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 M Y Warning This visual reference should be checked every 5 10 minutes throughout the treatment to verify the proper position of the microwave catheter and of the rectal unit 5 Secure the microwave catheter fiber optic and microwave connectors to the patient connection cable housing Figure 2 15 Antenna cable Prostate gland a Urethra Ne Bladder i Se ee m h ji Treatment catheter Coolant Bag sy N Rectal unit Sana Ane Rectal unit W ae F orientation flag Patient connection 7 cable housing Figure 2 15 Connected Microwave Catheter and Rectal Unit 6 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
35. the coolant bag This will preinflate the microwave catheter cooling channel M Y 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 To prevent burns during treatment isolate the antenna cable and the catheter handle away from the patient s legs 7 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 handle 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 40 of 143 Part Number 250023 001 Rev G 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 8 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 j 5 connector Teatment catheter fiber optic connector port Figu
36. the wall outlet Roll the CoolWave Control Unit to a storage location 3 4 2 Patient 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 the 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 Number 250023 001 Rev G 79 of 143 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 41 These options allow you to access printer utilities copy a treatment report 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 demonstratio
37. vs OFF during the treatment Messages Directions or reports that assist the clinician in monitoring a Cooled ThermoTherapy procedure Microwave antenna The CoolWave Control Unit 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 devise which is delivered sterile that 1s 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 Dysfunctional urinary bladder caused by a lesion of the nervous system Notes feature A place to enter a patient s treatment information during a treatment Obstructive bladder neck syndrome An impairment of the outle
38. within Allow time for temperatures to stabilize required temperature range and press the Retry button If unsuccessful replace the rectal unit 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 1s properly inserted properly inserted in patient 4 Microwave catheter may be defective Replace the microwave catheter 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 112 of 143 Part Number 250023 001 Rev G Appendix Section 5 2 The urine drainage lumen may contain Purge the urine drainage lumen with fluid alr 3 Microwave catheter may be defective Replace the microwave catheter Error 105 User canceled operation Possible Causes Action Steps 1 Calib
39. 12 65 General halt error 88 Microwave catheter 18 Post treatment 79 Treatment error 91 Urethra setting 54 60 93 Advanced mode 73 Automatic treatment mode 92 Patient comfort automatic treatment mode 92 Patient comfort manual treatment mode 94 Standard mode 71 Urethra Setting button 71 Urethra setting temperature See Urethra setting 142 of 143 Appendix Urethra temperature 12 18 65 66 67 Automatic treatment mode 91 Temperature range specifications 103 Urine Drainage bag 18 Drainage lumen 34 Drainage port 18 Urologix Customer Service 10 Urologix supplied equipment 20 Urologix BPH Treatment screen 64 88 USB flash drive 17 84 USB port 17 84 User interface specifications 103 User Login window 50 52 User name 45 51 Demonstration mode 52 User Name data field 51 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 17 Warning 9 Warnings See Safety information Warranty 97 Wheel lock tab See Wheels Wheels 16 Window Create New User window 51 Current Error or Warning window 66 67 Data window 83 Help window 46 47 Notes Entry window 48 49 Password Setup window 84 Print window 69 Treatment Cooldown window 70 77 93 94 Treatment Cooldown End window 77 User Login window 50 52 Zoom bu
40. 15 Error 429 No Rectal RFID Sensed 115 Error 431 Many RFIDs Sensed 115 Error 5 Urethra Temp High 107 Error 50 Maximum Treatment Time Exceeded 111 Error 51 Maximum MWG Time Exceeded 111 Error 52 Warning Urethra Temp gt 41 C 112 Error 6 Urethra Temp Low 107 Error 7 Catheter Efficiency Low 107 Error 8 Control Unit Temp High 107 Error 99 Urethra Temp Probe Error 112 Hardware failure 117 System Error screen 88 89 91 System navigation 43 44 System setting Date 85 Language 86 Time 86 Volume 87 System Settings screen 85 88 Target temperature See Set point Targis Microwave catheter Default coolant setting 60 73 Default coolant setting 54 Default urethra setting 54 Identification 58 Microwave power 75 93 Treatment time 71 73 Temperature Part Number 250023 001 Rev G Section 5 Coolant 13 19 54 65 66 67 91 93 Rectal 12 19 65 66 67 94 Urethra 12 18 65 66 67 91 Temperature range specifications Coolant 103 Rectal 103 Urethra 103 Temperature sensor Channel 37 Connector 18 Coolant system 16 Fiber optic 18 Microwave catheter 89 Rectal unit 19 89 Strip 37 Time Current 45 System setting 86 Timer Cooldown 5 minute 77 78 92 94 Interval 74 93 Treatment 59 65 91 Touchscreen Clean 96 Daily maintenance 96 Monitor 13 24 43 Transabdominal ultrasound 54 Transport Kit 20 102 Treatment button 53 Treatment chart 69 Treatment Checklist screen 61 62 T
41. 3 001 Rev G Equipment Maintenance Correct level indicator ne USA TOT 3t Ave North 55447 T WHICH IS EFFECT SANCE DE FFETS JEVICE T AN CAUTION 4 ol Unotogix Ine 234 004 5 300 099 Figure 4 1 Internal coolant level indicator 4 2 2 Periodic maintenance Section 4 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 Part Number 250023 001 Rev G 97 of 143 Section 4 Equipment Maintenance il le E Fuse holder caps OR Equal potential ground 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 Model Fuse Catalog Number Fuse Type Rating Model 5000A AC1008 1 1 4 x 1 4 10A Model 5000E AC1009 5 mm x 20mm 5A Table
42. 3 1 System Navieatonvand SCEN Overview moroak ennn e E a 43 3 2 Cool Wave Control UNIT SED aerario a TA N A 49 3 3 Cooled Thermo Therapy Procedure seren ii E Neate dda idee eae te 53 De SOSUCU CATING INU a a Sonata Do ctuast A ede uote eb sonata a a a 79 3 5 Control Unit OPTIONS vernie inteneo statue cbutedungosadeasobetedendosesbpeubeteGrnaoaudossereteiensusesapeutosedeeusiets 80 3 6 DV SUCH CLOTS ieseana ANON 88 Ded AS AUIS TOC SS tie sheet sess heaters che Ata els oats ccc vented ads nares ee neat ea seen ae aden a sneaeee es 9 4 Fduipment Wa ICC aIh CC asseris neern ea E E ENN 95 4 1 Cleamne These QUI Mieti ecr 55 i annn ne N EEE AET E 95 4 2 Maintaining the CoolWave Control Unit 00 cecccsssseeeececcceeeeeeeeeeeaaaeseseesseeeeeeeeeeeeeees 96 4 3 Ni aim tain OTS PEALE esnin a T aut esac ete eieee eee seo meee 98 a4 Moving the CoolWave Control UMit ssiri nieri TTE cubated aaa 101 4 5 Storing the CoolWave RC nor Umit eroana A E O A 102 4 6 Shipping the CoolWave Control Unit cccscssessseseeceeceeeeeeeeeseeaaaaeeeeseseseeeeeeeeeeeeees 102 4 7 CoolWave Control Unit specifications ccccccceescecccccccceccassseeeccccceeeeaesseeeeeeceeeeeeaaeeeees 103 5 FX DDC e o EENE E EE E 105 5 1 TTOUDIES HO OUM 8 OU OG siasi e E ET E T 105 Ded MRS ATMS NIE SCRC CIT LO Wy CAL Gere E E acce in eds 118 5 3 DESCTIPION OT y 181610 cae ene r er ee Meee Nee eet eNO e E eet ee eens ee 119 SA SPAT tit COMIN Kifo deena ec teeexanni ane ease abod
43. 9 Device Not Open 530 Device Already Open 531 Device Open Error 532 Process Spawn Error 533 Scan Data Error 534 Ini File Range Error 535 Ini File Label Error 536 Ini Section Error Action Steps Allow coolant system to run for 5 minutes on the System Error screen Reboot the CoolWave Control Unit by turning it OFF Wait until the fans stop and then turn the unit ON again If the error Part Number 250023 001 Rev G Appendix Section 5 Error and Error Name detected by software occurred during treatment wait 15 minutes before restarting treatment Note The error may repeat again Call Urologix Customer Service to report the Crror 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 Possible Causes 1 Nonresolvable hardware failure Part Number 250023 001 Rev G 308 319 320 387 388 389 449 Rectal Sensor Interface HWES Disconnected MW Supply Coolant Coldside High Coolant Hotside High Control Unit Temp Too Low 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 117 of 143 Section 5 Appendix 5 2 Tre
44. DOILS and Ce MMILIONS ee e E es wee ee awe 9 1 3 S er aa MANTI KOVE IVIC W Meee eae ee nO nee NTE een eT ve aT serene ne ree 10 tA Precautions RMON eee MOe aa CHEN Te eeaPT MT OPE OTT MONT NUT SNe TOPLAS eT CRT NT AO Ste erer nt 10 1 5 Introduction to the CoolWave Control Unit 0 0 cccccsssssssssseeeeececceeeeeeeseeeeaaeseeeeeeseeees 12 1 6 Targis System CoolWave Control Unit equipment overview cccsseesssssssessseeeees 12 7 Reg ired cquiDMEn Ser Pe ee ere ere nt rT E A 20 1 8 CoolWave Control Unit Installation and Use Environment cccccccceeeeeeeeeeeeeeees 21 1 9 SALLY SUCOS neer a a kn Manes enaukeiuy ewe 24 2 Treatment Session SED wron an T E O NRA 21 2 Generalsarely Precaution S irn a a S 2 2 Treatment session SetUp OVETVIEW sxc dasesaddivstad n E E ES E A 2 2 3 Preparing th Patient tor Treatment russiine rE E EA EES Zi 2 4 Positioning and preparing the CoolWave Control Unit eeeeesssseessesssssssssseseeeees 28 2 5 Instat ine the COO SAG ona E E T EE Mask 29 20 ANSEPIMG TNE ANICLOWAY catheter 5 c22 sss ticsatitivantasenvedsbesnwieidedvsaadibivansasenvedtbesawleieebesaatiarecietes 32 27 lnserine the Sinele Use Standard RITU ereer a T E 35 2 8 Inserting the RTU Plus Reusable Handle and Single Use Balloon eeeeeeeeeeees 36 2 9 Connecting the Microwave Catheter and Rectal Unit to the CoolWave Control Unitt 39 3 Treatment ASt OCOS esma sinkcenveeadsinaatueeseserelemeeeneaetares 43
45. 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 a Fuse holder caps Equal potential ground Power cord inlet Power cord holder Figure 1 16 CoolWave Control Unit Rear 22 of 143 Part Number 250023 001 Rev G System Description Section 1 CoolWave Control Unit Power Cords Urologix provides the following power cords for use with the CoolWave Control Unit 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 AC1017 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 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 Part Number 250023 001 Rev G 23 of 143 Section 1 System Description
46. Targis System CoolWave Control Unit User Manual UROLOGIX 1 of 143 Part Number 250023 001 Rev G Table Of Contents Patient Safety Summary 1 System Description 2 Treatment Session Setup 3 Treatment Instructions 4 Equipment Maintenance 5 Appendix Troubleshooting Guide Glossary Treatment Timer Algorithm 2 of 143 Part Number 250023 001 Rev G 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 1 to 2 hours before treatment or per physician instructions An enema 1s mandatory e Itis 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 c
47. atheter 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 15 a If both serial numbers appear in the data fields proceed to step 3 b 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 use a new microwave catheter refer to Section 2 6 Inserting the microwave catheter for further information Once a new microwave catheter 1s 1n place the CoolWave Control Unit automatically reads the new serial number Proceed to step 3 56 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 c 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
48. ation mode 44 45 46 52 56 60 61 62 80 Description overview 12 18 Emergency 17 Equal potential ground cable 22 Equipment connections 23 Equipment testing 23 Equipment warranty 97 Features 13 Fuses 97 98 Headphone jack 17 Housing 12 96 Install 21 Keyboard 14 43 103 Maintenance 25 96 97 Manual treatment mode 74 76 81 93 94 Microwave catheter and rectal unit connection picture 40 Microwave Off button 61 Microwave Off pushbutton 17 61 Models 103 Move 101 ON 49 ON OFF power switch 15 136 of 143 Appendix Operating conditions 103 Patient connection cable 13 Patient connection cable housing 13 Post treatment 79 Power cord types 23 Power indicators 17 Power requirement 22 Prepare for treatment 28 Printer 15 Safety check 25 Safety instructions 24 Screen 43 45 Service 24 Service agreement 97 Service port 13 17 Ship 102 Shipping storage conditions 103 Store 102 System error 88 91 105 See also System error System navigation 43 44 Touchscreen monitor 13 24 43 Treatment overview 67 USB port 17 84 Volume 17 87 Wheels 16 Control Unit options Data 83 Password 84 Printer 82 System setting 85 User setting 81 Coolant 13 16 19 20 32 53 92 Coolant bag 16 19 20 Coolant Bag 19 20 23 Connector 19 Coolant tubing 19 Coolant door 16 32 Coolant level See Internal coolant level indicator Coolant pump See Peristaltic pump mechanism Coola
49. atment screen flowchart gt LOGIN SCREEN a A LOGOUT ioon a N MAIN MENU A N d BACK ren N PATIENT INFORMATION BACK NEXT PROTOCOL SELECTION BACK NEXT TREATMENT CHECKLIST C J REPLACE MICROWAVE lt RETRY CANCEL gt OFF y r gt r CALIBRATION x CALIBRATION PROCESS ERROR ERROR Ne d o d ison a N AUTOMATIC TREATMENT Ne d p J Figure 5 1 Treatment screen flowchart 118 of 143 Part Number 250023 001 Rev G Appendix 5 3 Description of symbols Section 5 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 Symbol gt 4O BEES YU A Part Number 250023 001 Rev G Description Alternating current Catalog Number Batch Code Lot Number Serial Number Do not re use Equal potential ground Fuse type and value Internal reservoir level Nonionizing radiation microwave power Operate on a level surface 119 of 143 Section 5 120 of 143 Symbol RTU gt Appendix Description Rectal unit Consult Instructions for Use Caution Stop microwav
50. cal 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 w 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 l 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 tabs 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 Powerrequremenis ooo Control Unit Model 5000E 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 F Y Warning Do not move the CoolWave Control Unit while the electrical cord is connected to a power so
51. cian must be present throughout the duration of the Cooled ThermoTherapy procedure The Cool Wave 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 1 Preparing the patient for treatment Positioning and preparing the CoolWave Control Unit Installing the coolant bag Inserting the microwave catheter Inserting the single use standard RTU or inserting the RTU Plus with reusable handle and single use balloon 6 Connecting the microwave catheter and RTU to the CoolWave Control Unit ie ae a 2 3 Preparing the Patient for Treatment 1 Ensure the patient has received adequate information about the treatment and post treatment expectations and has provided informed consent Part Number 250023 001 Rev G 27 of 143 Section 2 Treatment Session Setup 2 Perform an enema to 2 hours before treatment or per physician instructions 3 An enema is mandatory Administer pre procedure medications such as lo
52. ction 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 1s 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 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 U 106 of 143 Action Steps Check water level in the coolant bag Check that pump tubing clamp 1s properly fastened Verify tubing is not twisted Replace the coolant bag Replace the microwave catheter Part Number 250023 001 Rev G Appendix Section 5 Error 5 Uret
53. d ThermoCath Microwave Catheter and the CTC Advance Microwave Catheter Part Number 250023 001 Rev G 53 of 143 Section 3 Treatment Instructions Default coolant setting temperature Targis Microwave Catheter CTC Advance and Cooled ThermoCath Microwave Catheter 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 the Targis Microwave Catheter the Cooled ThermoCath 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 procedure 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 th
54. d i PMen osi0 sy 224 tsiis ieaiai a ea a ATE Aa A A 20 Table 1a C linie provided equipment sosise pais naa e e a A ome 21 Table 1 4 Coolw ave Control Unit Power CordSessieereieisian i nna e T ae 23 Table 2i Microwave Catheter Ident iG Atl OM si soz vaste ca ate a T A A T cases tare nates 33 Fable 3 12 Satety Checks D rme Treatment eron O E ese 55 Table 342s Microwave Catheter 1G CmlLINCallOM rratua ae nie 58 Table 3 3 Treatment Timer al Or thins nesreddin iinei iiai inie een ia E e a iaa a aia Weekes 60 Table s4 Treatment Tiner alg ori NNS six 252sss055 ceisqacsdoaptssaysateccad dapeaiaesercadie tigated ees ae 65 Table 3 5 Meatment Tmerr alo orit hins errena RS 71 Wables4 ela PUSS Oy Ch EN soskaassi wi acaseeauns hacetvaas aaa E A E A on eaaeiene ean 98 Table 4 2 CoolWave Control Unit specifications auccse scence aceite ee 103 Mable 522 BleCtromacnetic EMISSIONS vs ci6s es tiarptb esha esetcheia sn E haa aes oessheaencnaavetoesseaeseass 131 Table S Electroma cme tic annuity 5 oes s eae a pea eed ee asm E 132 Table 5 4 Electromagnetic Immunity continued cccccseeesseseseseseeeeeeeeeeseeeeeeseeseeseeseeeeeseeeeeeeeeeeees 133 Table 5 5 Recommended Separation Distance 65 accccereeoieoacasterp ered des ad es 134 Part Number 250023 001 Rev G 7 of 143 8 of 143 Part Number 250023 001 Rev G Section 1 System Description 1 Systems Description 1 1 Notice The information contained in this manual is subject to change
55. ded to successfully treat patients with the CoolWave Control Unit 1 7 1 Equipment provided by Urologix Urologix provides the following equipment Quantity Equipment Material l CoolWave Control Unit l CoolWave Control Unit User Manual this document l Kit containing either Targis Cooled ThermoCath or CTC Advance Microwave Catheter e microwave catheter e Rectal thermal unit standard RTU or RTU Plus e coolant bag l Patient Comfort Kit 2 knee cushions and a Microwave Catheter Holder l 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 20 of 143 Part Number 250023 001 Rev G System Description Section 1 Quantity Equipment Material l Foley catheter 16 18 French l Straight catheter 14 16 French i Urine drainage bag As needed Sterile gloves As needed Anesthetic lubricating jelly 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 l 60 cc luer lock syringe l 60 cc catheter tip syringe i e Toomey syringe 2 10 cc luer lock syringe 200 cc Sterile water for coolant bag and catheter balloons i Ultrasound system i Catheter plug As needed Permanent marker or tape As needed Nonsterile gloves l Penile clamp l Specimen
56. djust 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 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 Printer 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 12 of 143 Part Number 250023 001 Rev G 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 entering 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
57. dle 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 Enter the patient s age Quality of Life Enter the quality of life index 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 urethra length cm The urethra length must be at least 2 5 cm Prostate Volume mL Enter the prostate volume mL Part Number 250023 001 Rev G 55 of 143 Section 3 Treatment Instructions e 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 Demonstration mode Enter dummy text on the Patient Information screen Be sure to include information in the data fields marked with a bullet 3 3 2 Protocol screen Standard Protocol 15 0 C Medium Custom Protocol 1 15 0 C Slow Custom Protocol 2 15 0 C Fast Figure 3 15 Example of a Protocol Screen u Note The RTU Plus Reusable Handle should not be used in excess of 30 times 1 Connect the microwave c
58. e 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 permanent 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 54 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 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 3 3 1 Patient Information screen 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 mid
59. e 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 Part Number 250023 001 Rev G 131 of 143 Section 5 Appendix 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 Compliance level 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 IEC 60601 test level 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 5s 6 kV contact 8 kV air 2 kV for power supply lines 1
60. e 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 Number 250023 001 Rev G 83 of 143 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 3 Press the Back button to return to the Options Menu screen 3 5 4 Password Setup window F
61. e energy Type BF equipment with defibrillation protection Sterilized Using Ethylene Oxide Use By Date Temperature Limitation Do Not Resterilize Recyclable Package Keep objects 20 cm from vents Do not place heavy objects on drawer Part Number 250023 001 Rev G Appendix Section 5 Symbol Description 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 K F Warning m Date of Manufacture onal Manufacturer REP Authorized Representative in the European Community Table 5 1 Description of symbols Part Number 250023 001 Rev G 121 of 143 Section 5 Appendix 5 4 Patient Comfort Kit Treatment catheter goes in top slot Treatment Catheter Holder Rectal unit cable goes in bottom groove Figure 5 2 Microwave catheter Holder Figure 5 3 Knee cushions 122 of 143 Part Number 250023 001 Rev G Appendix Section 5 5 5 Glossary Advanced mode Select advanced mode from the Control Panel on the 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 conscious
62. e 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 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 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 e Do not lift or elevate the CoolWave Control Unit Part Number 250023 001 Rev G 101 of 143 Section 4 Equipment Maintenance 4 5 Stor
63. ear E A 22 Figure 2 ls Fine ihe COO lan DAG ana n a a a 29 Figure 2 2 Positioning the Coolant Bag onto the Top Mounting PIns cccccccccccccccccecceceeeeeeeeeeeeeeeeeeeeees 30 Figure 2 3 Positioning the Coolant Bag onto the Lower Mounting Pin cccceceeesesssteceeeeeeeeeeeeeeeeseeeens 30 Figure 2 4 Coolant System with Pump Mechanism Open ccccsssssscccceceeeceeceeessseeeeessssnneeeeeeeeeeeeeeeeeseeeees 31 Picure 2 5 Positioning the Sensor Modulosssir rare A ato aaene us resonates 31 Figure 2 6 Coolant System with Pump Closed serrassnenann e Ea 32 Figure 2 7 CTC Advance Microwave Catheter ocssuciospiiaie iii nals E A O E an 34 Figure 2 8 Inserted Microwave Catheter and Standard RTU ccccssssccccccceceeeceeeeseseeeennneeeeeeeeeeeeeeeeseeeeees 35 Fiene 2 Sandard RTU a a n a ner rent eae ee ete ene 35 Fisure 24 0 RTO Pus Reusable Handlers A A A OA TOA 36 Figure 2211 RTU Plus Disposable Balloon icant e T A a7 Figure 2 12 Inserting the Temperature Sensor Sp ciciaiecevscossesesisiaiav eres ad econeeadsiarpenveiesseuendabsiadecooeedeiapesselda 37 Figure 2 13 Proper Positioning of the Temperature Sensor Strip ccccccccccccccceeeesseessnsneeeeeeeeeeeeeeeeeseeeeeesees 38 Figure 2 14 Assembled RTU Plus with Deployed Sheath ccc ccccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeey 38 Figure 2 15 Connected Microwave Catheter and Rectal Unit ccccccccccccccceceesssseeeesnsnnnceeeeeeeeeeee
64. eatment mode 93 Patient comfort automatic treatment mode 92 Ramp Rate button 74 Rating 103 Rectal balloon 19 Rectal temperature 12 19 65 66 67 94 Temperature range specifications 103 Rectal unit RTU 12 13 19 20 23 24 54 64 90 92 93 94 120 Cable 39 Connection to Control Unit picture 40 Connector 13 139 of 143 Section 5 Serial number 56 60 Temperature sensor 19 89 Remove Patient Info button 69 Replace button 64 Report button 69 Reset button 66 67 88 89 91 92 Reset Password button 82 Resume button 76 78 Resume Treatment button 78 88 91 Resume Treatment dialog box 76 Resume Cancel button printer 99 Retry button 64 RTU See Rectal unit RTU RTU Plus 19 56 RTU Plus Disposable Balloon 36 RTU Plus Reusable Handle 36 Safety check Control Unit 25 Treatment 54 Safety information See also Precautions Caution Electromagnetic interference 24 Microwave antenna 33 Open printer drawer 15 Remove components intact 79 Stacking objects 24 Warning Verify position of microwave catheter and rectal unit 40 Warning Air minimum in RTU Plus rectal balloon 39 Air minimum in standard RTU rectal balloon 36 Compromised component package 21 Excessive elevation 39 Excessive force on microwave catheter 34 Explosion 24 Location balloon position 34 Power source 28 Rectal unit position 35 38 Verify proper rectal unit position 36 39 Warning Power source 49 Warning Correc
65. ect the ramp rate slow medium fast Press the Close button when done Power Setting 47 0 W 0 0 75 0 Wi Figure 3 36 Example of a treatment parameter control panel 3 Exit manual treatment mode by pressing the Standard button or the Advanced button from the 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 37 To end treatment and go to cooldown proceed to step 3 Resume Press To Resume Treatment Phase Press To Begin Cooldown Phase Go To Cooldown a E Figure 3 37 Resume Treatment dialog box 76 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 3 Press the Go To Cooldown button Figure 3 37 The cooldown 5 minute timer appears Figure 3 38 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 Resume Treatment Cooldown End Figure 3 38 Treatment Cooldown window 4 Select one of the following options in cooldown remain in cooldown for the full 5 minutes resume the treatment or end the cooldown Notes e Itis recommended that the cooldown phase last 5 minutes prior to exiting the treatm
66. ection 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 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 power switch to the I position The CoolWave Control Unit turns ON and proceeds with its startup routine The Login screen appears Part Number 250023 001 Rev G 49 of 143 Section 3 Treatment Instructions 3 2 2 Login screen Figure 3 9 Login Screen Notes e You can turn OFF the CoolWave Control Unit at this point during system startup without losing any stored data 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 50 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 Figure 3 10 User Login Window 2 Determine if 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 Press the New User button The Create New User window appears Figure 3 11 4 Enter your full name in the Full Name data field U Figure 3 11 Create New Use
67. ed Refer to Section 2 6 Inserting the microwave catheter 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 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 90 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 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 Cool Wave 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 Error screen only e Run the CoolWave Cont
68. ed information a Note You only need to touch the data field once with your finger to activate the operation of that field 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 Number 250023 001 Rev G 43 of 143 Section 3 Treatment Instructions Press the TAB key to move the cursor ahead to the next data field Press and hold the SHIFT key while pressing the TAB key to move the cursor back to the previous data field SHIFT KEY TAB KEY In addition you will encounter dialog boxes as you use 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 demon
69. eeeseeseeeees 40 Figure 2 16 Isolate the Antenna Cable and Catheter Handle Using the Microwave Catheter Holder 4 Ficure 2 1 7 Patient Connection Cable Hous ine cnie A A te eda 4 Pigure o 1 Pressed and NOM Pressed Buttons ccaad sasst riers ecotiegs th seus ousectasaiyeue O aN a 43 AOU eS 2c MUA 1 IG tesoant stearate ance cat E AEE E TEE E A A O nashean A E EE E T 43 Figure 3 3 Example of a CoolWave Control Unit Dialog BOX ssssssssssssseeesessssssssssssssssrrrreessssssssssssrrrreeee 44 Peuren ASC IOV CLV WY aah satrs serait cas a a duu a A 45 Figure 3 5 Example of a Treatment Screen in Demonstration Mode ceceeceeeeeeeeseseneceeeeeeeeeeeeeeeeeseeeees 46 PUM S520 x ICI WTI Wisi pececinsc 30a Saccaiostyae a a 47 Peura e NOtes I1alOe BOX ocena a T a S haute Ninian un tp getaiattueclaies 48 Figure 328 Notes Entry W 1d OW sse se lt scesasssasnsauscnsnatacseam tecandesaicassstusenanaaedeaesdeesadesansgaaysde denaeaddedanmacsmansmuncads 49 Fiene 529s LOSIS eas tera sn ceasing ass eas E SN 50 Pa Ure 51 0 Sem IO Oil VV 1G Wieaaicaria a cand ole yaaa T N 51 Figure 3 11 Create New User Window suicticeteiesee ie iain tae emanates eemns 51 Part Number 250023 001 Rev G 5 of 143 Figure 3212 User Login Wind Ow sree ccsaersossasssnoctnaniadeseannae canaevantgaausbectnahiadeseansdadsnausanisaagsbectnaniaidionmsadmansaniaad 52 S Woah osmosed Reema site Me o ree ener en eee ete e Re ror mene regret a repent tiem oe m
70. en ara tiat tenes ammnanncmeeeabedeearaman tenesaueiaacs 122 J E T eee E PE E E EA E re E T RN ee ar ee 123 4 of 143 Part Number 250023 001 Rev G 5 6 Electromagnetic Compatibility EMC Tables 000 0 ccccccscssssseeessseeeeeeeeeeeeeeeeeeeeeeaaaas 131 Se MIE e a E EA E E EO E Cn Ere rn 135 List of Figures Figure 1a COOL W ave Conto Um ess E A 12 Figt re l 2 Patient Connection Cable HOnsin 8 rsss erneta a aeaa E E E a a aa a 13 Figure 12 gt Tonchi ei MONON eenn A 14 Pcie I A k Cy DOAL G ra satnada sans cue mnetratag tacais esata nluaatiecucatratapesiauashae vane seadea cues ateons en eameeacteneas 14 PIU T3 Pnie pee atspscsecteias lal at E T E 15 Feme o ON OFF POWT S Wate essea ss E aint rans E A eget aiatuecl an 15 Figure Is Wheel loek tabean a EE 16 Figure 126 Coolant system eae S e a a a R MAE atod canal 16 Fieore T O POwerindical OnStar a ETN E E OE TO 17 Figure 1 10 Microwave Off pushbutton vecsaciendicatiolericas a E N 17 Figure 1 11 Volume Control Headphone jack USB Ports nsnseeseosoooenseeeeeeessssssssssssseesereeeesssssssssssssesenn 18 Fiewe 1212 Mic rowaye Catete a o E EEEE AE EE EEEE O EE E E OEE EE ES 18 Figure Tle Si eS eS Catan RTU sesin R Maxesa Cults ae sw envehian insu ieee 19 Figure 1 14 Assembled RTU Plus with the reusable handle and single use balloon ecccceceeeeee 19 igure 115 COONS E E nani T N E S A Bandanas aloes roe A L E TE EAT bon meet on E 20 Feared Cool Wave Control Unit R
71. ency sweep Catheterization The placement of the microwave catheter or urine drainage catheter into the urethra Chill plate One of the components of the Cool Wave Control Unit coolant system that removes heat from the coolant bag Part Number 250023 001 Rev G 123 of 143 Section 5 Appendix 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 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 tempera
72. ent 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 39 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 Resume Treatment Figure 3 39 Treatment Cooldown End window Part Number 250023 001 Rev G 77 of 143 Section 3 Treatment Instructions b Resume the treatment Press the Resume Treatment button Figure 3 38 and then the Resume button Figure 3 37 to resume the treatment c End the cooldown Press the Cooldown End button to end the cooldown Figure 3 38 A dialog box appears to confirm that you want to end the cooldown and therefore end this treatment 3 3 5 5 Ending a treatment l Monitor the cooldown 5 minute timer Figure 3 30 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 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
73. er 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 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 Timer 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 Possible Causes 1 Detected in the software 116 of 143 466 Msg Queue Open Error 467 Msg Queue Not Open 468 Msg Queue Already Open 469 Msg Queue Create Error 470 Process Internal Error 471 Process Start Error 472 Condvar Wait Error 473 Error Reading Safety Data 510 Data Write Error 511 Data Read Error 512 Mutex Set Error 513 Mutex Clear Error 514 Write Error 515 Read Error 516 Seek Error 517 Language File Open Error 518 Language Internal Error 519 Language String Overflow 520 Language Array Overflow 521 Language Array Underflow 322 Language Mgr Not Open 523 Language Mer Init Error 524 Data Manager Not Open 323 Data Manager Initialization 526 File Length Error 527 File Size Error 52
74. er interface 103 Standard button 70 76 Standard mode 71 72 Standard mode Control Panel 58 71 Status Panel 65 74 Store Control Unit 102 Symbols 9 119 21 System button 80 System Calibration screen 54 62 64 88 System critical error See System error System error 66 67 88 89 105 Detected by software 116 Error 1 Rectal Temp High 105 Part Number 250023 001 Rev G Appendix Error 100 Rectal Unit Cal Failure 112 Error 101 Urethra Temp Cal Fail 112 Error 103 MW Calibration Failure 112 Error 105 User Canceled Operation 113 Error 11 Coolant Temp High 108 Error 12 Coolant Temp Low 108 Error 13 Rectal Temp High 108 Error 14 Rectal Temp Low 109 Error 15 Coolant Press High 109 Error 16 Coolant Press Low 109 Error 17 Urethra Temp High 110 Error 18 Urethra Temp Low 110 Error 19 Catheter Efficiency Low 110 Error 198 Invalid Catheter Type Detected 113 Error 199 Urethra Temp Cross check 113 Error 2 Rectal Temp Low 106 Error 20 Pump Latch Open 110 Error 21 User Pressed Microwave OFF 111 Error 22 Rectal Unit Disconnected 111 Error 23 Urethra Signal Weak 111 Error 3 Coolant Press High 106 Error 300 Control Unit Temp Too High 113 Error 317 Low Voltage Startup 113 Error 4 Coolant Press Low 106 Error 423 Different Rectal RFID 114 Error 424 Invalid Tag 114 Error 425 Different Catheter RFID 114 Error 426 Multiple Catheter RFIDs 115 Error 427 Multiple Rectal RFIDs 115 Error 428 No Catheter RFID Sensed 1
75. ermoTherapy 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 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 locates the microwave antenna within the bladder bladder neck Part Number 250023 001 Rev G 125 of 143 Section 5 Appendix 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
76. erumontanum 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 disposable microwave catheter 1 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 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 Part Number 250023 001 Rev G 127 of 143 Section 5 Appendix Rectal temperature The temperature reported by the warmest of the 5 sensors in the rectal unit Rectal thermosensing unit RTU A device with temperature sensors that monitors the patient s rectal temperatures when the device 1s positioned correctly within the rectum along the rectal prostatic wall It is connected to the patient con
77. ete ee iene aren nr re htt a man cere en 53 Fisura 321 4 Patient IN Onna ON SCEE Pea A OA 55 Figure 3 15 Example of a Protocol SCreen ics nate O aR 56 Figure 3 16 Readjust connectors tags and serial number labels 00 0 0 cecccecceseeeeeesenneeeeeeeeeeeeeeeeeeeeeeees 57 Figure 3 17 Example of Protocol screen MOdIfY cceccceceeseesesnneeeeeeeeeeeeeeceeeeseeeeeeesssseeeeeeeeeeeeeseeeeeeeeees 59 Figure 3 18 Example of treatment protocol modify ee eecceeessssccceeeeeeeeeeeeeeesseeeeeessnsneeeeeeeeeeeeeeeeeeseeeees 59 Figure 3 19 Treatment Checklist screen and Microwave Off pushbutton cccsssssscccccceeeeeeeeeeseeeeensenees 61 Figure 3 20 Treatment Checklist screen Demonstration mode ec ccccccccceeesseeeeeeesnnseeeeeeeeeeeeeeeseeeeeeeas 62 Picure 542 SystemC albration Schemas his sass a a aatensaa ohueiaaneaa utente 62 Figure 3 22 System Calibration Screen Error Message oi ciscost ssevtsousecscaeinensiteentieenes E 63 Fige o2 Urologi BPE Treatment Sree Mm renas a dnote Geseinessaatutienauinen 64 Figure 5 24 Microwave Oi PUSHOUUOR sisse erei na ea a aa ae 65 TA E ESA OE a EE E E E S T E ON A A E IE E 66 Peme 3 2 oE Ven PINE er E E A E E E TE E T E 67 Peire 942 Detal PaE sA 68 Feur D 26 Ireament dieran E E E E N 68 Figure 329 Print WIndOW ctcssssia seaman aE a e aE E A 69 Figure 3 30 Treatment Cooldown Wind Ow sasscasisis todssdaancvaincodcanyseieesvied aaaea a a N 70 Feuer 00 0 8 e a eran
78. g Dimensions Approximately 15 2 cm x 17 8 cm Bag Capacity Approximately 100 mL Pump Peristaltic pump Display Color liquid crystal display or LCD Input Touchscreen Keyboard Silicone rubber keyboard Temperature 10 C to 30 C Humidity 30 to 75 relative humidity Atmospheric Pressure 700 hPa to 1 060 hPa Temperature 20 C to 70 C Humidity 10 to 95 relative humidity Atmospheric Pressure 700 hPa to 1 060 hPa IEC 60601 1 Class I Type BF with defibrillation protection Rectal Sensor Range 1 C 50 C Accuracy 1 C from 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 Microwave Power Range 0 W 75 W Accuracy 10 0012913901 Table 4 2 CoolWave Control Unit specifications Part Number 250023 001 Rev G 103 of 143 Section 4 Equipment Maintenance 104 of 143 Part Number 250023 001 Rev G Appendix Section 5 5 Appendix 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 000x 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 se
79. heck 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 temperatures that might indicate a sensor has moved from its previous position M 2 Warnings e The Cooled ThermoTherapy Procedure must not be initiated without assurance that the microwave catheter 1s 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 procedure 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 Part Number 250023 001 Rev G 3 of 143 Table of Contents Patent Sale ly SUMMA y 15255 ccsee tact atin sie tea set a etecoakaztacnssasiasieee 3 l SSeS e O E a sence anna eos ounces 9 1 1 INO UCC assim e e e hands 9 1 2 Daley SVM
80. hould 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 1 Verify the patient has received an enema 2 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 Ld S UU HS W HES Key hole Side View Connector emperature sensors Serial number label t AL gt F Leja Inflation tubing channel Cable Figure 2 10 RTU Plus Reusable Handle 3 Open the package for a RTU Plus Disposable Balloon Figure 2 11 36 of 143 Part Number 250023 001 Rev G Treatment Session Setup Section 2 Semirigid Rectal ballon tubing Undeployed sheath Locating key Balloon inflation port Figure 2 11 RTU Plus Disposable Balloon 4 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 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 ha
81. hra Temp High Possible Causes 1 Loose microwave catheter fiber connector 2 Temperature in urethra gt 44 5 C 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 6 Urethra Temp Low Possible Causes 1 Loose microwave catheter fiber connectors 2 Microwave catheter may be defective Action Steps Reattach fiber connector Clean both ends of connection with alcohol wipe or swab Replace the microwave catheter Error 7 Catheter Efficiency Low Possible Causes 1 Cable may not be connected properly 2 Urine drainage line not purged 3 Microwave catheter may not be inserted properly 4 Defective microwave catheter Action Steps Reattach connector Purge urine drainage line Check that the microwave catheter 1s inserted properly Replace the microwave catheter and recalibrate Error 8 Control Unit Temp High Possible Causes 1 CoolWave Control Unit vents blocked 2 Treatment room too warm Part Number 250023 001 Rev G Action Steps Remove any item blocking vents Observe CoolWave Control Unit operating temperature requirements 107 of 143 Section 5 Appendix Error 11 Coolant Temp High Possible Causes Action Steps 1 Coolant door open Close coolant door 2 Coolan
82. ic energy during a procedure 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 1 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 Cool Wave Control Unit during a procedure must be evaluated for degradation For more detailed EMC requirements refer to Section 5 6 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 energy 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
83. ications 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 Gai D P d 1 24P F2 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 134 of 143 Part Number 250023 001 Rev G Appendix 5 7 Index Access Administrative privileges 8 1 Demonstration mode 44 52 Administrative privileges 80 81 83 Advanced button 70 76 Advanced mode 72 74 Advanced mode Control Panel 58 72 92 Algorithms Treatment timer 65 Allow Administrator Privileges button 81 Allow Clinical Protocols button 81 Allow Manual Control button 81 Antenna Microwave 18 Antenna cable 18 40 Automatic treatment mode 54 71 73 91 93 93 Balloon Inflation tubing 37 Microwave catheter 18 Rectal 19 Balloon inflation port Microwave catheter 18 Rectal unit 19 Benign P
84. ies 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 Load paper into the printer 3 Press and hold the Resume Cancel button Figure 4 3 on the printer When the power lamp flashes twice the printer prints the nozzle check pattern 4 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 100 of 143 Part Number 250023 001 Rev G Equipment Maintenance Section 4 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 4 3 4 Cleaning the Print Head a 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 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 th
85. igure 1 4 Keyboard 14 of 143 Part Number 250023 001 Rev G System Description Section 1 Printer Print data from any treatment using the Canon color inkjet printer Figure 1 5 The printer drawer pulls out and holds the printer 7 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 Ba 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 ON OFF power switch Figure 1 6 ON OFF power switch Part Number 250023 001 Rev G 15 of 143 Section 1 System Description Lockable wheels Keep the CoolWave Control Unit from moving by locking the front wheels Figure 1 7 Wheel lock tabs 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 teas bag fits ove
86. igure 3 45 Password Setup window 1 Enter the following information in the Password Setup window Current Password New Password and New Password Confirm Figure 3 45 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 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 3 5 5 System Settings screen System settings buttons Modify button Figure 3 46 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 46 2 Press the Modify button Figure 3 46 Refer to one of the following instructions based on the selected system setting a 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 47 Proceed to step 3 Part Number 250023 001 Rev G 85 of 143 Section 3 Treatment Instructions Figure 3 47 System Settings screen date b Time Change the hours minutes and AM PM by pressing on the up and down arrows Figure 3 48 Proceed to step 3 Minutes Language Figure 3 48 System Settings screen time c Language Change the language by pressing on the desired language Figure 3 49 Proceed
87. in cooldown Cooldown ends after 5 minutes and the Treatment Cooldown End window appears Figure 3 40 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 40 Finally you can exit the treatment Press the Exit button Figure 3 40 A dialog box appears to confirm that you want to exit and therefore end this treatment Resume Treatment Figure 3 40 Treatment Cooldown End window b Reset the timer Press the Resume Treatment button Figure 3 38 and then the Resume button Figure 3 37 to reset the 5 minute cooldown timer c End the cooldown Press the Cooldown End button to end the cooldown Figure 3 38 A dialog box appears to confirm that you want to end the cooldown and therefore end this treatment 78 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 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 7 Caution Verify that the disposable components are removed intact 1 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 2 Disconnect the
88. ing 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 approved method for transporting the CoolWave Control Unit 102 of 143 Part Number 250023 001 Rev G Equipment Maintenance CoolWave Control Unit Models Power Requirements Microwave Output Coolant Circulation System User Interface Operating Conditions Shipping Storage Conditions Class Type Measurements Range and Accuracy FCC Registration Section 4 4 7 CoolWave Control Unit specifications SOOOE Europe 5000A US 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 Power 0 W 75 W output from the microwave antenna connector on the patient cable continuous duty Frequency 902 MHz to 928 MHz Chill Element Thermoelectric Capacity 100 W element Configuration Disposable Coolant Bag Ba
89. inuing this treatment verify that all of these steps are complete 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 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 20 Part Number 250023 001 Rev G Section 3 61 of 143 Section 3 Treatment Instructions Demonstration Mode gt tl 5 eee erst phe 1 The Coolant Bag is filled with sterile distill water and mounted in the Control Unit 2 The Microwave Catheter is properly positioned f in the patient AS VERIFIED BY ULTRASOUND with _ the urine port and coolant tubing flushed with 4to 5cc of sterile water 3 The Rectal Unit is properly positioned in the patient fi i 4 _ 4 The disposable products are properly connected to the Control Unit Ua Hun ad th TAN Microwave Off button when in demonstration mode Pi ss the Microwave Off pushbutton to coni Microwave off Microwave Off button Figure 3 20 Treatment Checklist screen Demonstration mode 3 3 4 System Calibration screen Frequency Calibration Figure 3 21 System Calibration screen 1 Wait while the Control Unit proceeds through a calibration process can take up to 7 minutes
90. ions 3 7 1 1 Ramp e Monitor the patient for discomfort and adjust the ramp rate if 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 Wroc The treatment timer runs when the following conditions occur CTC Advance Cooled ThermoCath Standard amp Long Urethra 2 35 C with Urethra 2 35 C with Urethra 2 35 C with Targis CTC Advance Short amp Standard Short Urethra Coolant Urethra Coolant Urethra Coolant difference 2 23 C difference 2 20 C difference 20 C OR MW Power 2 50 W OR MW Power 2 50 W OR MW Power 2 65 W OR RTU 2 41 C OR RTU 2 41 C OR RTU 2 41 C Monitor the patient for discomfort and adjust the following settings if necessary e Decrease the urethra setting temperature from the standard mode or the advanced mode on the Con
91. 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 5s Electromagnetic Environment Guidance 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 Uy is an A C mains voltage prior to application of the test level 132 of 143 Table 5 3 Electromagnetic Immunity Part Number 250023 001 Rev G Appendix Section 5 Guidance and manufacturer s declaration Electromagnetic Immunity The Targis System with CoolWave Control Unit is intended for use in the electromagnetic environmen
92. l Unit System software 46 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 Up arrow Figure 1 Patient Information screen L Enter patient information Figure 1 Data fields marked with a bullet requare information before proceeding with the treatment Patient Name Enter up to 20 alphabetic characters for the first name 1 alphabetic character for the middle intial 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 Enter the patient s age Quality of Life Enter the quality of ie index Prostate Specific Antigen ngl k Enter the prostate specific antigen lavel ngiml intermatonal Prostate Syrptom Score Enter the international prostate SYMpiOm score or the AUA symptom score Qmax mL s Enter the maximum flow rate miss Urethra Length om Enter the urethra length cm The urethra length must be at least 2 5 cm Prostate Volume mL Enter the prostate volume mL Post Void Residuals mL Enter the postvoid residual volume mL 2 Press the Next button to go to the mest screen Or press the Back button to return to the previous sergen Down arrow Figure 3 6 Help Window 2 Press the up and down arrows to scroll through the Help window Or press the Back Fo
93. lush 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 u Note Failure to flush the urine drainage lumen may cause system calibration errors 9 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 34 of 143 Part Number 250023 001 Rev G Treatment Session Setup Section 2 Urethra Prostate gland Bladder Fai pae Treatment catheter g e N Dr Pd F Rectal unit Rectal unit orientation flag Figure 2 8 Inserted Microwave Catheter and Standard RTU 10 If the 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 1 Verify the patient has received an enema 2 Open the package and remove the rectal unit Figure 2 9 Temperature sensors Handle Cable Connector
94. microwave catheter RFID tag has been removed from the patient connection cable housing area 2 The microwave catheter RFID tag is not in range ERROR 429 No Rectal RFID Sensed Possible Causes Action Steps 1 The rectal unit RFID tag has been removed from the patient connection cable housing area 2 The rectal unit tag is not in range Replace the same rectal unit so that the CoolWave Control Unit can access the RFID tag 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 near the patient connection cable housing Remove other microwave catheters and 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 1s adjacent to Part Number 250023 001 Rev G 115 of 143 Section 5 Connection cable housing 2 RFID field being affected by surrounding metallic surfaces Appendix connector and rotated such that it touches the flat portion of the Patient Cable Connector If Patient cable Connector is setting on a metallic surface raise it off the surface by setting it on a nonmetallic spacer such as a towel Error and Error Name detected by software 309 Synthesizer Unlocked 311 File Open Error 312 Urethra Temp Comm Fail 313 MW Comm Failure 314 Paramet
95. mode 74 76 Manual mode Control Panel 75 93 Manual treatment mode 70 74 76 81 93 94 Microwave antenna 18 Microwave antenna cable See Antenna cable Microwave antenna connector 13 18 103 Microwave catheter 10 11 12 13 18 20 23 24 32 54 91 See also Targis Microwave catheter See also Cooled ThermoCath Microwave catheter Connection to Control Unit picture 40 Identification 58 Microwave catheter coolant tubing 18 Microwave catheter Holder 20 39 41 122 Microwave catheter serial number 56 60 Microwave catheter temperature sensor 89 Microwave connector See Microwave antenna connector Microwave Off button 61 Microwave Off pushbutton 17 61 138 of 143 Appendix Microwave power 12 17 65 66 67 74 75 76 77 88 89 91 92 93 94 119 Manual treatment mode 93 Microwave power indicator 17 Microwave power output specifications 103 Mode Advanced mode 72 74 Demonstration mode 44 45 46 52 56 60 61 62 80 Manual mode 74 76 Standard mode 71 72 Models Control Unit 103 Power requirement 22 Mounting hole 19 Mounting pin 16 Move Control Unit 101 Navigation 43 44 New user 51 52 New User button 51 Note 9 Notes button 47 Notes dialog box 47 48 Notes Entry window 48 49 Notes feature 45 48 Nozzle check pattern 82 83 ON OFF Power switch 15 49 Pump 75 Operating conditions 103 Options button 53 Options Menu screen 80 Orientation flag 19 Output slot cover 99
96. n 8 Soak the rectal unit handle again do not soak or immerse the connector in CIDEX PLUS according to the manufacturer s instructions for high level disinfection typically 20 minutes at 20 C 25 C 9 After soaking rinse devices per manufacturer s instructions typically 3 separate 1 minute soaks in copious volumes of deionized water 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 Part Number 250023 001 Rev G 95 of 143 Section 4 Equipment Maintenance 4 1 3 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 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 Cleaning the touchscreen The touchscreen should be cleaned periodically following these inst
97. n mode you will not have access to user settings Therefore you will not see the Users button on the Options Menu screen Cool lWave Data Password System Figure 3 41 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 View 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 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 3 5 1 User Settings screen Admin Demo default Allow Manual Control Figure 3 42 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 42 That person s name appears in the Full Name data field on the bottom of the screen 2 Press the Modify button y Note The Modify button t
98. n the following conditions occur CTC Advance Cooled ThermoCath Standard amp Long Urethra 2 35 C with Urethra 35 C with Urethra 2 35 C with Targis CTC Advance Short amp Standard Short Urethra Coolant Urethra Coolant Urethra Coolant difference 2 23 C difference 2 20 C difference 20 C OR MW Power 250 W OR MW Power 2 50 W OR MW Power 2 65 W OR RTU 2 41 C OR RTU 2 41 OR RTU 2 41 C 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 temperatures for the Targis Microwave Catheter and the Cooled ThermoCath Microwave Catheter and the CTC Advance Microwave Catheter are 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 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 Cooled ThermoCath Microwave Catheter and CTC Advance Microwave Catheter from 28 minutes and 30 seconds or 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 the Cooled ThermoCath Microwave Catheter a
99. nd CTC Advance Microwave Catheter Default coolant setting temperature Targis Microwave Catheter CTC Advance and Cooled ThermoCath Microwave Catheter Part Number 250023 001 Rev G 73 of 143 Section 3 Treatment Instructions 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 Treatment Time 28 30 28 30 28 30 mmiss Figure 3 34 Example of a treatment parameter control panel 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 7 Note If you do not have access to the manual treatment mode you will not see this option on the Control Panel 74 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 Control Panel ae a ry Ad Selection il A vanced Manual i E Standard Figure 3 35 Manual mode 1 Select Yes or No when the Enter Manual Mode dialog box appears Proceed to step 2 if entering the manual treatment mode selecting
100. ndle Figure 2 12 Inserting the Temperature Sensor Strip 5 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 Part Number 250023 001 Rev G 37 of 143 Section 2 Treatment Session Setup Figure 2 13 Proper Positioning of the Temperature Sensor Strip 6 Slide the protective sheath down from the balloon and pull it over the handle as shown in Figure 2 14 Deployed sheath Serial number label Cable Te mperature sensors Connector Semirigid tubing 7 Extension tubing FE Rectal balloon Balloon inflation port Figure 2 14 Assembled RTU Plus with Deployed Sheath 7 Attach a syringe to the inflation port and inflate the balloon with approximately 90 cc of air to 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 8 Lubricate the balloon area with a water based lubricant e g K Y Jelly F Y Warning The rectal unit must be positioned properly to ensure correct temperature sensing 9 Insert the balloon slowly into the rectum using the semirigid tubing to guide placement This can be done by initiall
101. nection 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 RFID An acronym for radio frequency identification RTD An acronym for Resistive Thermal Device 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 procedure in automatic treatment mode 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 Treatment 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 tha
102. nector f 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 18 of 143 Part Number 250023 001 Rev G System Description Section 1 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 rectal wall nearest the prostate Temperature sensors Handle Cable Connector Balloon inflation port Figure 1 13 Single use standard RTU Deployed sheath Serial number label Cable Temperature sensors Handle Connector 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
103. ness 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 1s 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 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 is normal and 4 Antenna is operational as verified by a frequ
104. nsor 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 Remove 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 Number 250023 001 Rev G 105 of 143 Section 5 Appendix 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 A
105. nsors and the rectal wall 11 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 12 The physician must confirm the proper positioning of the rectal unit prior to proceeding 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 ay Warning Excessive elevation of the patient torso may put additional pressure on the rectal unit resulting in increased patient discomfort and higher rectal temperatures 1 Ifthe 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 increases patient comfort 2 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 3 Position the rectal unit cable underneath the microwave catheter holder Secure
106. nt setting 53 60 Advanced mode 73 Automatic treatment mode 92 Default temperature 53 Manual mode 75 Manual treatment mode 93 Patient comfort automatic treatment mode 92 Patient comfort manual treatment mode 94 Coolant Setting button 73 Coolant system 16 Specifications 103 Temperature sensor 16 Coolant temperature 13 19 54 65 66 67 93 Automatic treatment mode 91 Temperature range specifications 103 Coolant tubing Coolant Bag 19 Microwave catheter 18 Cooldown 65 76 79 Part Number 250023 001 Rev G Appendix Automatic treatment mode 92 93 Manual treatment mode 94 Cooldown 5 minute timer 77 78 92 94 Cooldown End button 78 Cooldown pane 88 91 Cooled ThermoCath Microwave catheter 12 See also Microwave catheter Default coolant setting 54 60 73 Default urethra setting 54 Identification 58 Microwave power 75 93 Treatment time 73 Treatment time 71 Cooled ThermoTherapy Procedure 10 Cooled ThermoTherapy Procedure Kit See Procedure Kit Cooled ThermoTherapy Treatment 44 53 Cooling channel 18 Cooling lumen See Cooling channel CoolWave Control Unit See Control Unit CoolWave System 10 Demonstration mode 44 Equipment overview 12 Specifications 103 CoolWave System component Coolant Bag 20 Microwave catheter 18 Patient connection cable 12 13 Patient connection cable housing 12 13 Rectal unit 19 CoolWave System dialog box See Dialog box CoolWave System help feature See Help
107. oggles 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 b 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 P Note Clinical protocols are not available unless provided by Urologix for a Urologix sponsored clinical study 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 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 Number 250023 001 Rev G 81 of 143 Section 3 Treatment Instructions d Press the Rese
108. olant bag once it has been filled temporarily connect the coolant bag connectors together E Figure 2 1 Filling the coolant bag 3 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 Number 250023 001 Rev G 29 of 143 Section 2 Treatment Session Setup Figure 2 2 Positioning the Coolant Bag onto the Top Mounting Pins 4 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 5 Route the coolant inlet tubing through the pump mechanism by pulling out the locking lever located on the upper pump tubing clamp and lifting the tubing clamp up Figure 2 4 6 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 30 of 143 Part Number 250023 001 Rev G Treatment Session Setup Section 2 Upper pump Locking een tubing clamp Coolant bag Pump tubing notch Coolant inlet tubing eee Pe Lo
109. on 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 15 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 pump tubing clamp is properly fastened and that the tubing 1s not kinked 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 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 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 U Part Number 250023 001 Rev G 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 109 of 143 Section 5 Appendix Error
110. otential ground cable 22 Patient connection cable 12 13 18 65 101 Rectal unit cable 39 Safety check 25 Calibration error 34 88 89 90 Calibration error message 90 Calibration process 54 62 Case notes 69 Catheter See Microwave catheter See also Cooled ThermoCath Microwave catheter See also Targis Microwave catheter Catheter button 83 Catheter plug 34 Caution 9 Caution icon 64 Cautions See Safety information Chart button 66 Chart pane 66 Check button 82 Chill plate 16 19 20 Clamp 30 Classification See Rating Clean 135 of 143 Section 5 Control Unit 96 Print head 82 83 101 RTU Plus Reusable Handle 95 Touchscreen 96 Clean button 82 Clear button 70 83 Clear print queue 70 83 Clinic supplied equipment 20 Clinical protocol 81 Component See also the Individual component Control Unit 13 Coolant Bag 20 Microwave catheter 18 Patient connection cable 13 Patient connection cable housing 13 Rectal unit 19 Connector Coolant Bag 19 Fiber optic 13 Microwave antenna 13 18 103 Rectal unit 13 Temperature sensor 18 Contents button 47 Control Panel 65 Advanced mode Control Panel 58 72 92 Manual mode Control Panel 75 93 Standard mode Control Panel 58 71 Control Unit 12 18 24 49 Automatic treatment mode 54 91 93 93 Calibration process 54 62 Clean 96 Coolant system 16 Cooled ThermoTherapy Treatment 44 53 Daily maintenance 96 Data file 53 69 81 Demonstr
111. r chill plate a Pump tubing clamp CHIIL I t PLATE emperature sensor i E a 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 16 of 143 Part Number 250023 001 Rev G System Description Section 1 Main power indicator and microwave power indicator The main power indicator Figure 1 9 located under the touchscreen monitor is a green LED that illuminates when the CoolWave Control Unit is ON The microwave power indicator Figure 1 9 also located under the monitor is an amber LED that illuminates when the CoolWave Control Unit delivers microwave power to the prostate Main power indicator Microwave power indicator green LED amber LED Figure 1 9 Power indicators 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
112. r 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 Part Number 250023 001 Rev G 51 of 143 Section 3 Treatment Instructions 8 Press the OK button to return to the Login screen Your user name and password are saved Proceed to step 9 Or press 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 Figure 3 12 User Login Window 10 Enter your user name which is case sensitive in the User Name data field 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 1s 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 52 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 User Name Software version
113. r 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 Part Number 250023 001 Rev G 133 of 143 Section 5 Appendix 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 Control 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 commun
114. ration 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 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 Urologix Customer Service ERROR 317 Low Voltage Startup Possible Causes Action Steps 1 Low voltage at start up Verify that an extension cord 1s not being used and check the circuit breaker for sufficient current capability 2 Hardware failsafe switch in wrong Call Urologix Customer Service position Part Number 250023 001 Rev G 113 of 143 Section 5 Appendix ERROR 423 Different Rectal RFID Possible Causes 1 The rectal unit RFID tag is different from the one displayed on the Protocol Screen Action Steps Reattach the original rectal unit and select the Retry button or select the Replace button to return to the Protocol Screen using the cur
115. re 2 17 Patient Connection Cable Housing 9 Ifnot already completed attach a urine drainage bag to the urine drainage port of the microwave catheter Part Number 250023 001 Rev G 41 of 143 Section 2 Treatment Session Setup 10 Proceed to Section 3 Treatment Instructions for information on how to perform a Cooled ThermoTherapy Treatment 42 of 143 Part Number 250023 001 Rev G 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 System 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 Pressed button Nonpressed button 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 request
116. re 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 dried 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 Part Number 250023 001 Rev G 99 of 143 Section 4 Equipment Maintenance 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 a 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 Figure 4 4 Insert the new ink tank 6 Push down on the PUSH symbol on the ink tank until it clicks into place 7 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 Utilit
117. reatment 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 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 Part Number 250023 001 Rev G 129 of 143 Section 5 Appendix 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 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
118. reatment Cooldown window 70 77 93 94 Treatment Cooldown End window 77 Treatment data 65 68 69 Treatment diagram 68 Treatment error 88 91 Treatment error message 91 Treatment event log 66 67 Treatment mode 91 Automatic treatment mode 54 71 73 91 93 93 Manual treatment mode 70 74 76 81 93 94 Treatment overview 67 Treatment parameter control panel 72 Treatment parameters 12 13 53 55 64 70 Treatment protocol 53 58 59 64 69 Treatment protocol list 57 Treatment report 83 Case note 69 Copy 84 Event log 69 Patient data 69 Print 69 84 Treatment chart 69 Treatment data 69 Treatment protocol 69 View 83 Treatment safety check 54 Treatment screen flowchart 118 141 of 143 Section 5 Treatment screen overview See Treatment screen flowchart Treatment session 27 Treatment status Cool 65 Pause 65 Ramp 65 Treat 65 Treatment time 13 53 58 71 92 93 Advanced mode 73 Elapsed See Treatment timer Manual treatment mode 93 Remaining 65 Standard mode 71 Treatment Time button 71 Treatment timer 59 65 91 Algorithms 65 Troubleshooting See System error Tubing Balloon inflation 37 Clamp 30 Coolant 18 19 Extension 37 Holder 32 Semirigid 37 Type See Rating Ultrasound 10 Transabdominal 54 Universal Precautions for Contamination 79 Universal Serial Bus flash drive See USB flash drive Universal Serial Bus port See USB port Upper pump tubing clamp 31 Urethra
119. rently attached rectal unit ERROR 424 Invalid Tag Possible Causes 1 An RFID tag is being read but it contains invalid data Action Steps Remove the connectors from both disposable devices and replace them individually Observe the rectal unit and microwave catheter serial number fields to determine which RFID tag 1s invalid ERROR 425 Different Catheter RFID Possible Causes 1 The catheter RFID tag is different from the one displayed on the Protocol Screen 114 of 143 Action Steps Reattach the original microwave catheter and select the Retry button or select the Replace button to return to the Protocol Screen using the currently attached catheter Part Number 250023 001 Rev G Appendix Section 5 ERROR 426 Multiple Catheter RFIDs Possible Causes Action Steps 1 More than 1 microwave catheter near the patient connection cable housing Remove the extra microwave catheters from the area around the patient cable ERROR 427 Multiple Rectal RFIDs Possible Causes 1 More than 1 rectal unit near the patient connection cable housing Action Steps Remove the extra rectal units from the area around the patient cable ERROR 428 No Catheter RFID Sensed Possible Causes Action Steps Replace the same microwave catheter so that the CoolWave Control Unit can access the RFID tag Adjust the orientation of the tag label on the microwave catheter so that it can be read 1 The
120. 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 Number 250023 001 Rev G Treatment Instructions Event Log 02 14 46 AM 831a Calibration Started 02 15 22 AM 105c User canceled operation 02 16 02 AM 832 Calibration Complete Up arrow Figure 3 26 Event pane Section 3 Reset button Urethra Setting yb E tee Amn a 40 0 C ap r m wwe Bi Treatment a5 ime wear rae f A 28 30 Pause End Advanced 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 27 This overview also highlights current warnings and errors An active error is marked with a blue light To reset warnings and errors press the Reset button For additional information about system errors refer to Section 3 6 System errors 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 1f an error occurs and does not resolve At this point contact Urologix Customer Service 1 888 229 0772 to help you resolve any remaining e
121. rol 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 u 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 1s 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 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 Note If an error occurs during automatic treatment mode the CoolWave Control Unit will turn OFF microwave power Part Number 250023 001 Rev G 91 of 143 Section 3 Treatment Instruct
122. rostatic Hyperplasia 12 BPH See Benign Prostatic Hyperplasia Button 43 Advanced button 70 76 Allow Administrator Privileges button 81 Allow Clinical Protocols button 81 Allow Manual Control button 81 Catheter button 83 Chart button 66 Check button 82 Clean button 82 Clear button 70 83 Contents button 47 Coolant Setting button 73 Cooldown End button 78 Copy button 84 Data button 80 Date button 83 Detail button 67 Event button 66 Events button 69 Glossary button 47 Go To Cooldown button 77 Help button 46 Log Out button 53 Login button 50 Manual button 70 Microwave Off button 61 Microwave Off pushbutton 17 61 New User button 51 Notes button 47 Part Number 250023 001 Rev G Section 5 Options button 53 Password button 80 Patient button 83 Pause End button 76 Power button printer 99 Power Setting button 75 93 Print button 68 84 Printer button 80 Pump On Off button 75 Ramp Rate button 74 Remove Patient Info button 69 Replace button 64 Report button 69 Reset button 66 67 88 89 91 92 Reset Password button 82 Resume button 76 78 Resume Treatment button 78 88 91 Resume Cancel button printer 99 Retry button 64 Standard button 70 76 System button 80 Treatment button 53 Treatment Time button 71 Urethra Setting button 71 Users button 80 View button 83 Zoom button 66 Cable Antenna cable 18 40 Cable holder 13 15 101 Daily maintenance 96 Equal p
123. rror 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 event 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 e Contact Urologix Customer Service at 1 888 229 0772 for assistance 88 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 534p Ini File Range Error Figure 3 52 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 e The keyboard will no longer function First determine if the error message 1s on the System Error screen or the System Calibration screen Figure 3 53 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 mes
124. rrors Part Number 250023 001 Rev G 67 of 143 Section 3 Treatment Instructions i I tone As aS sed Remain _ 00 00 28 30 8 8 kj _ WS i jesja Nea oe s a Distal Proximal Sea PE i 3 Disconnect i Urethra 0123456AAAAAAAB Ai i Setting i 40 0 C 38 4 C ai answer gs ey Treatment 50 0 3 Templ Time 9876543210ABCDE Reset button Figure 3 27 Detail pane 3 View treatment data in a diagram format at the right side of the Urologix BPH Treatment screen Figure 3 28 Figure 3 28 Treatment diagram 4 Press the Print button located in the upper right corner of the Urologix BPH Treatment screen Then select one of the following print options Print Treatment Report Print Event Log and Clear Print Queue Figure 3 29 Or press the Close button to return to the Urologix BPH Treatment screen 68 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 b Figure 3 29 Print window Note Refer to Section 4 3 Maintaining the printer Figure 4 3 for a printer overview 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 sho
125. rt 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 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 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 event log prints Part Number 250023 001 Rev G 69 of 143 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
126. ructions 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 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 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 Keep the touchscreen clean If the screen needs cleaning refer to Section 4 1 3 Cleaning the touchscreen for further information 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 Check all cables and power connections Be certain that all cables are firmly attached and routed away from normal traffic paths Check the sight gauge on the rear of the CoolWave Control Unit to ensure that the internal coolant level 1s within the white open section of the correct level indicator Figure 4 1 96 of 143 Part Number 25002
127. rward 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 button The Notes dialog box appears Figure 3 7 Part Number 250023 001 Rev G 47 of 143 Section 3 Treatment Instructions Figure 3 7 Notes Dialog Box 2 Enter your initials in the data field You can use from 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 48 of 143 Part Number 250023 001 Rev G Treatment Instructions S
128. sage appears on the System Calibration screen you will need to correct the problem In most cases an error message appears because the Cool Wave Control Unit failed to read or detect the microwave catheter temperature sensor the rectal unit temperature sensors the microwave 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 Part Number 250023 001 Rev G 89 of 143 Section 3 Treatment Instructions 105c User canceled operation Figure 3 53 Example of a System Calibration screen error message Notes e fa 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 need
129. sk of injury or infection to the patient 10 of 143 Part Number 250023 001 Rev G System Description Section 1 u 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 1n 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 a 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 instruction 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 his own expense The Urologix CoolWave Control Unit emits a small amount of electromagnet
130. stration mode under the heading Demonstration mode 44 of 143 Part Number 250023 001 Rev G 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 Date User ivan ee Screen Name aa Version Notes feature Help Time feature 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 Part Number 250023 001 Rev G 45 of 143 Section 3 Treatment Instructions Figure 3 5 Example of a Treatment Screen in Demonstration Mode 3 1 2 1 Help 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 Contro
131. t 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 43 Printer Utilities screen Note Refer to Section 4 3 Maintaining the printer Figure 4 3 for a printer overview 1 Select one of the following printer utilities Print Nozzle Check Pattern Perform Head Cleaning or Clear Print Queue Figure 3 43 a Print Nozzle Check Pattern Determine if 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 g 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 b Perform Head Cleaning A fuzzy printout means the print head needs cleaning Clean the print head Press the Clean b
132. t 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 126 of 143 Part Number 250023 001 Rev G Appendix Section 5 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 within 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 v
133. t 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 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 1 4 Precautions Only those physicians who have been thoroughly trained on the operation of the CoolWave Control Unit and the Cooled ThermoTherapy Procedure should deliver the treatment The Cooled ThermoTherapy Procedure must not be initiated without assurance that the microwave catheter 1s 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 procedure failures or heating damage of non target tissues such as the bladder neck external sphincter or penile urethra 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 Cool Wave Control Unit User Manual this document Failure to do so may result in insufficient treatment or increased ri
134. t microwave catheter 57 Warning Urologix supplied fuses 98 Safety instructions Control Unit 24 Safety precautions CoolWave System 27 Safety symbols See also Symbols Caution 9 Instruction manual 9 Note 9 Warning 9 Screen See also Touchscreen monitor Data View Print Copy screen 83 84 Login screen 45 49 50 52 140 of 143 Appendix Main Menu screen 52 53 Options Menu screen 80 Patient Information screen 55 56 Printer Utilities screen 82 83 100 101 Protocol screen 56 60 System Calibration screen 54 62 64 88 System Error screen 88 89 91 System Settings screen 85 88 Treatment Checklist screen 61 62 Urologix BPH Treatment screen 64 88 User Settings screen 81 82 Screen name 45 Screen overview 45 See also Treatment screen flowchart Sensor Channel See Temperature sensor channel Module 19 20 Pressure 16 Temperature 89 Temperature 16 18 19 Serial number Microwave catheter 56 60 Rectal unit 56 60 Service Control Unit 24 Service agreement 97 Service port 13 Set point Coolant temperature 53 Microwave catheter temperature 54 Ramp rate 54 Sheath 19 Ship Control Unit 102 Storage conditions 103 Sight gauge See Internal coolant level indicator Single use balloon See Rectal balloon Software version 45 Speaker volume 87 Specifications Coolant system 103 Coolant temperature 103 Microwave power output 103 Rectal temperature 103 Urethra temperature 103 Us
135. t monitors the urethral temperature of the patient or a device within the rectal unit that monitors the rectal temperature of the patient 128 of 143 Part Number 250023 001 Rev G Appendix Section 5 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 with an instrument called a resectoscope Treatment parameters Cool Wave Control Unit values such as the microwave catheter and the rectal temperatures that the clinician monitors during t
136. t 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 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 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 94 of 143 Part Number 250023 001 Rev G 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 can be used to clean and disinfect the RTU Plus Reusable Handle containing the temperature sensors for subsequent use
137. t 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 BERE calculated from the a to the frequency of the transmitter separation distance ERE alle ee IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 1 JP 80MHz to IEC 61000 4 3 SOMHz to 2 5 GHz i MHz d 2 3VP 800MHzto 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 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 amateu
138. t temperature gt 40 C Reduce coolant set point to the proper temperature and wait for coolant to drop 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 42 5 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 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 108 of 143 Part Number 250023 001 Rev G Appendix Section 5 Error 14 Rectal Temp Low Possible Causes 1 Loose connector Rectal unit temperature below 15 C 2 Rectal unit expelled or not properly inflated 3 Rectal unit may not be inserted properly 4 Rectal unit may be defective Acti
139. tain 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 32 of 143 Part Number 250023 001 Rev G Treatment Session Setup Section 2 Prostatic Catheter Serial Serial Microwave Urethral Color Number Number Catheter Length Scheme Tag Color Prefix CTC Advance 2 5 to 3 5 Blue Handle Black TH Short cm Black Accents CTC Advance or Cooled ThermoCath oe Blue Handle White TC cm White Accents Standard CTC Advance or Blue Handle Cooled ThermoCath Grey TF Grey Accents Long Targis 2 5 to 3 5 White Catheter Targis 3 0 to 5 0 White Catheter Table 2 1 Microwave Catheter Identification NOTE A dark blue handle is Cooled ThermoCath the light blue is the CTC Advance y Note The serial number label is attached to the cable of the microwave catheter near the connection to the patient cable 7 Caution The microwave antenna on the distal end of the microwave catheter
140. ting and ramp rate Figure 3 18 as desired ex Xs Ps 2 gt Custom Protocol 17 Urethra Setting Coolant Setting 38 0 C 16 0 C 20 0 41 0 C Vv 5 0 40 0 C v Ramp Rate Figure 3 18 Example of treatment protocol modify Wrote The treatment timer runs when the following conditions occur Part Number 250023 001 Rev G 59 of 143 Section 3 Treatment Instructions 7 CTC Advance Targis CTC Advance Cooled ThermoCath Short amp Standard Short Standard amp Long Urethra 2 35 C with Urethra 2 35 C with Urethra 2 35 C with Urethra Coolant Urethra Coolant Urethra Coolant difference 2 23 C difference 2 20 C difference 20 C e OR MW Power 250 W e OR MW Power 2 50 W OR MW Power 2 65 W fe OR RTU2 41 C OR RTU 2 41 C OR RTU 2 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 temperatures for the Targis Microwave Catheter and the Cooled ThermoCath 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 the Cooled ThermoCath Microwave Catheter and the CTC Advance Microwave Catheter Targis Microwa
141. to step 3 86 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 Language Figure 3 49 System Settings screen language d Volume Change the speaker volume by pressing on the bar and sliding it left softer or right louder Figure 3 50 Proceed to step 3 Figure 3 50 System Settings screen volume 3 Press the Apply button to save the new system setting s Figure 3 51 Part Number 250023 001 Rev G 87 of 143 Section 3 Treatment Instructions Figure 3 51 Example of a System Settings screen apply 4 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 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 52 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 E
142. 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 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 30 appears Treatment is now complete Refer to Section 3 3 5 5 Ending a treatment for further information Resume Treatment Cooldown End Figure 3 30 Treatment Cooldown window 70 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 3 3 5 1 Using standard mode Control Panel Figure 3 31 Standard mode Adjust the urethra setting and treatment time from the Control Panel Figure 3 31 if desired u Note The treatment timer runs when the following conditions occur CTC Advance Cooled ThermoCath Standard amp Long Urethra 2 35 C with e Urethra 2 35 C with e Urethra 2 35 C with Targis CTC Advance Short amp
143. trol 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 92 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 e Resume the treatment remain in cooldown or end the cooldown exit treatment 1f 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 treatment time And in manual treatment mode the CoolWave Control Unit will continue to
144. tton 66 Part Number 250023 001 Rev G Appendix Section 5 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 0 70 345 8570 Fax 31 0 70 346 7299 CE CoolWave User Manual Part 250023 001 Rev G Jun 2010 2010 Urologix Inc All rights reserved Printed in the USA Part Number 250023 001 Rev G 143 of 143
145. ture 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 ThermoCath Microwave catheter A type of microwave catheter Cooled ThermoTherapy Treatment A medical procedure that uses microwave energy to destroy the prostatic tissue that constricts the urethra while preserving urethral function and tissue 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 124 of 143 Part Number 250023 001 Rev G Appendix Section 5 Cooling 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 Th
146. urce 4 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 J Enter patient and clinical information on the Patient Information screen Refer to Section 3 3 1 Patient Information screen for further information a Note For first time users 1t 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 28 of 143 Part Number 250023 001 Rev G Treatment Session Setup Section 2 2 5 Installing the Coolant Bag Li Instruction Manual Read the CoolWave Control Unit User Manual this document before installing the Coolant Bag 1 Open the package containing the coolant bag and remove the coolant bag 2 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 W Cautions e 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 a Note To prevent water from leaking out of the co
147. utton The printer cleans the print head 82 of 143 Part Number 250023 001 Rev G Treatment Instructions Section 3 u Notes e 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 Options Menu screen 3 5 3 Data View Print Copy screen 06 Jul 2005 987654327 10ABCDE 17 Jun 2005 98765432 LOABCDE Data window 17 Jun 2005 98765432 1OABCDE 16 May 2005 9876543 1OABCDE 12 May 2005 90765432 LOABCDE 12 May 2005 98765432 10ABCDE 09 May 2005 98765432 10ABCDE 05 May 2005 9876543210ABCDE 05 May 2005 98765432 10ABCDE 05 May 2005 Figure 3 44 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 44 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 microwav
148. ve Catheter CTC Advance and Cooled ThermoCath 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 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 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 60 of 143 Part Number 250023 001 Rev G Treatment Instructions 3 3 3 Treatment Checklist screen 2 Note When you press the Microwave Off pushbutton on the CoolWave Control Unit the system will 2 The Microwave Catheter is properly po inthe patient AS VERIFIED BY ULTRASOUND w f urine port and coolant tubing flushed wia oa of sterile water ete Rectal Unit is properly positioned in i peaa iss A 4 The disposable products are propery g conr to the Control Unit Figure 3 19 Treatment Checklist screen and Microwave Off pushbutton Read the Treatment Checklist screen for information about the treatment Figure 3 19 Prior to cont
149. wer 2 50 W OR MW Power 2 50 W OR MW Power 2 65 W OR RTU 2 41 C e OR RTU2 41 C OR RTU 2 41 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 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 25 The colors of each trace on the chart correspond to the color of the item Part Number 250023 001 Rev G 65 of 143 Section 3 Treatment Instructions b 66 of 143 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 End of chart Trace Left arrow Right arrow Zoom button Figure 3 25 Chart pane Press the Event button View the treatment event log events errors and warnings Figure 3 26 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
150. wer pump housing Figure 2 4 Coolant System with Pump Mechanism Open 7 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 8 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 9 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 Number 250023 001 Rev G 31 of 143 Section 2 Treatment Session Setup Locking lever 3 Sensor block B Tubing holder Figure 2 6 Coolant System with Pump Closed 10 Insert the coolant inlet and outlet tubing into the tubing holder This will prevent the tubing from being pinched by the coolant door 11 Close the coolant door completely a Note The coolant delivered to the microwave catheter may not be 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 1 Drain the patient s bladder using only water soluble lubricant in the process 2 Instill an anesthetic mixture of choice into the bladder 3 Insert a water based anesthetic lubricant mixture of choice into the urethra and clamp the penis to con
151. y 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 a 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 38 of 143 Part Number 250023 001 Rev G Treatment Session Setup Section 2 10 Verify rectal unit orientation by confirming that the inflation tubing channel in the rectal unit handle Figure 2 10 1s 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 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 M ay Warning A minimum of 70 cc of air in the RTU Plus rectal balloon 1s required to maintain contact between the temperature se

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