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Targis® System Targis Control Unit

1. MW POWER IS OFF Coolant Pressure Low 4 MW POWER IS OFF MDS Temp High 5 MW POWER IS OFF MDS Temp Low 6 MW POWER IS OFF MDS Efficiency Low 7 MW POWER IS OFF Control Unit Temp High 8 MW POWER IS OFF Control Unit Temp Low 9 84 of 112 Possible Causes 1 Pressure is too low in the tubing 2 Coolant Bag may be defective 3 MDS may be defective 4 Coolant tubing between coolant bag and sensor module may be twisted 5 Microwave power and pump are off 1 Loose MDS fiber connector 2 Temperature in urethra gt 44 5 C 3 MDS may be defective 1 Loose MDS fiber connector 2 MDS temperature is lt 5 C 3 MDS may be defective 1 Cable may not be connected properly 2 MDS may not be inserted properly 3 Defective MDS 4 Urine drainage line not purged 1 Control Unit vents blocked 2 Control Unit internal temperature gt 55 C 3 System not operating properly 1 Control Unit internal temperature broken Troubleshooting Action Steps 1a Check water level in the Coolant Bag 1b Reattach pump tubing clamp 1c Check that pump tubing clamp is properly fastened 2 Replace Coolant Bag 3 Replace the MDS 4 Verify tubing is not twisted 5 Manually irrigate and contact Urologix Customer Service Resume microwave power 1a Reattach fiber connector 1b Clean both ends of connection with alcohol wipe or swab 2a Allow MDS temperature t
2. rt Terperuture sensor connector k EHO aiaa Location balloon inflation port Sho tt Cooling balloon Coude tip EEN Location bal logn Urine drainoge Figure 1 10 MDS Features The MDS also includes A urine drainage port that connects to a standard drainage bag Luer connectors that attach to the Coolant Bag W caution The microwave antenna on the distal end of the MDS may break if you bend it Do not grab the MDS and squeeze it in the area of the antenna or the shaft The optical fiber located in the flexible MDS shaft may be broken it is clamped 16 RTU RTU Plus The RTU RTU Plus figures 1 10a and I 10b contain sensors that monitor rectal temperature and send this information to the Control Unit during treatment Once the clinician inserts the RTU RTU Plus into the rectum he or she inflates the RTU balloon with air to hold the thermosensors in place against the prostatic wall of the rectum Temperature sensors Handle _ Pott Peteestee tio ete esse esse Te Pi es alas Extension tubing Finger pad Rectal balloon Orientation flag 5 Balloon inflation port Figure 1 10a RTU Features With the single Use RTU the Orientation Flag allows the clinician to verify that the RTU sensors are facing the anterior wall of the rectum The flag must be pointed toward the patient s posterior Part Number 250209 001 Rev G 7 10 19 of 112 Section 1 System Description DEPLOYED
3. 10A Model 4000E AC1009 5S mm x 20mm 5A 3 Replace the Fuse Holders Mil Y Warning Only replace Targis Control Unit fuses with Urologix supplied components Part Number 250209 001 Rev G 7 10 79 of 112 Section 4 Equipment Maintenance 4 6 Targis Control Unit Power Cords Urologix provides the following power cords to be used with the Targis 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 80 of 112 Part Number 250209 001 Rev G 7 10 Equipment Maintenance Section 4 4 7 Targis Control Unit Specifications Targis Control Unit Models Power Requirements Microwave Output Coolant Circulation System User Interface Operating Conditions Class Type Measurements Range and Accuracy Part Number 250209 001 Rev G 7 10 4000E Europe 4000A US 4000E 220 240 V 10 4 25 A Single phase 50 or 60 Hz 4000A 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 el
4. 2 kV line s to earth lt 5 Ur gt 95 dip in Ur for 0 5 cycle lt 40 Ur gt 60 dip in Ur for 5 cycles lt 70 Ur gt 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 s Compliance 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 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 Control Unit requires continued operation during power mains interruptions it is recommended that the Targis 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 Part Number 250209
5. 3 4 4 2 Section Treatment A minimum of 28 5 minutes of treatment will begin at this point Throughout the treatment carefully monitor patient discomfort levels and the MDS and RTU temperatures e Maintain the optimum MDS temperature of 40 0 1 C e Should the RTU exceed 42 0 C decrease power in 1 watt per minute increments until RTU 1s 41 5 C If the RTU temperature does not respond as quickly as needed decrease power by 3 watt increments as needed When RTU temperature begins to decrease try to increase power to achieve and maintain MDS at 40 1 C while maintaining rectal temperature at or below 42 0 C e After at least 28 5 minutes of treatment maximum of 60 minutes for a Targis MDS 28 5 minutes for a Cooled Thermocath and CTC Advance MDS select TX END YES The Cool Controls panel will be displayed 3 4 4 3 Section Cooldown e During this section the user may choose to print the treatment listing e Continue pumping coolant until the Cooldown timer has reached 5 minutes e The Hi Lo HI beep tones will sound to remind the user that the time has expired e Select COOL END YES and press the spacebar to exit treatment and prepare for the next patient 3 5 Terminate Treatment 1 After you press the spacebar on the EXIT COOLDOWN panel the OPTIONS MENU will be displayed 62 of 112 Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 2 Disconnect the coolant Ba
6. TOTAL ENERGY 21 4 KJ MAX MDS 40 3 C MAX RTU 37 8 C TREATMENT TIME 28 30 RTU LOT ROO123 RTU USE n a TREATMENT DATA POWER COOLANT MDS WATTS TEMP C TEMP C Figure 3 21 Treatment Printout 3 7 3 Format Diskette in Floppy Drive If required you may format a new diskette before copying a patient data file 1 Place a diskette in the Control Unit floppy disk drive Use the TAB key to select FORMAT DISKETTE function on the Options Screen figure 3 17 and press the ENTER key 2 The Confirm Format Disk Pop up Screen will be displayed figure 3 22 Press the TAB key to select YES and press the ENTER key to format the diskette Press the TAB key to select NO and press the ENTER key to cancel the format operation Part Number 250209 001 Rev G 7 10 67 of 112 Treatment Instructions ai sear i feeae ack Section 3 up Screen k Pop IS Confirm Format Di 3 22 igure F k Pop up Screen figure 3 23 will YES the Formatting Dis ith firmed w ing is con After formatt 3 display the formatting status a FEES S is pane pane Se a ce ae E ne ay ey te eh ifs E jiii Disk Pop up Screen ing Formatt Figure 3 23 it 2 S T Re Oo gt ro ON O S 5 a N m oO D gt z S g A oO amp qs _ F 5 s SN O B O ron t 2 F g S O 5 a 3 o O a A 5 om DO iD ee uo OQ O
7. 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 14 The RTU Plus Handle with the temperature sensors should not be used in more than 30 treatments Handle LJ SM _ _ _S E He rou hale side View BS Connector Key hole Serial number label J mperature sensors n mm Inflation tubing channel Cable Figure 2 14 RTU Plus Reusable Handle 3 Open the package for a RTU Plus Disposable Balloon 4 Inflate balloon to approximately 70 cc to verify no leaks are present Remove air before proceeding to step 5 Semirigid Rectal ballon tubing Undeployed sheath Locating key Ei hh ienn ii hh dianadh ii ee i dbania dh ii Extension tubing Temperature sensor channel Balloon inflation port Figure 2 15 RTU Plus Disposable Balloon 5 Insert the temperature sensor strip with the sensors oriented so that they will be toward the outside of the balloon into the temperature sensor channel entrance of the Disposable Balloon as shown in figure 2 16 being careful not to bend the temperature strip significantly Ensure that the temperature sensor strip is extended to the distal end of the temperature sensor channel and the temperature sensor channel is aligned with the top of the handle Part Number 250209 001 Rev G 7 10 39 of 112 Section 2 Treatment Setup Figure
8. Do Sa l ON Sco 2s g n gt J gt gt D Os S Se i Oe a g oO D ay Fe ta lt 7 st m a cr ings Screen System Sett 3 24 Figure Part Number 250209 001 Rev G 7 10 68 of 112 Treatment Instructions Section 3 3 7 4 1 Set Control Unit Time and Date 1 Ifthe Control Unit time or date are incorrect they can be changed Press the TAB key to Set system Time on the System Settings Screen figure 3 24 and press the ENTER key At this point the Set Date and Time Pop up screen figure 3 25 will be displayed 2 Check the date and time displayed If the time is incorrect press the TAB key to CHANGE TIME and press the ENTER key This will display the Set Time Pop up Screen figure 3 26 CHANGE DATI CHANGI THI Figure 3 25 Set Date and Time Pop up Screen Figure 3 26 Set Time Pop up Screen 3 TAB to the HOURS and correct the setting by pressing the ENTER key Each time the ENTER key is pressed the value will increase by 1 4 Next TAB to MINUTES and follow the same steps as setting the hours 5 After the time is set correctly TAB to the OK and press the ENTER key This will return the display to the Set Date and Time Pop up Screen figure 3 25 6 To set the date TAB to the CHANGE DATE on the Set date and Time Pop up screen figure 3 25 and press the ENTER key This will display the Set Date Pop up Screen figure 3 27 CHANGE WATE a j Figure 3 27 Set Date Pop up Sc
9. Figure 2 18 Connected MDS and RTU Note The single use RTU is pictured above Wrote Failure to fill the urine drainage lumen may cause system calibration errors 9 Connect the rectal unit connector to the patient connection cable housing Figure 2 19 42 of 112 Part Number 250209 001 Rev G 7 10 Treatment Setup Section 2 ATU CONNECTOR WHITE MARKS MUST LINE UP FOR CONNECTION ICROWAVE CONNECTOR fe bite bee EEEE EEEE series a ERE hs MDS FIBER OPTIC CONNECTOR PORT Figure 2 19 Patient Connection Cable Part Number 250209 001 Rev G 7 10 43 of 112 Treatment Instructions Section 3 3 1 Treatment Settings Screen This screen displays the initial settings for treatment The settings can be changed later during treatment if desired Figure 3 1 Treatment Settings Screen 3 1 1 Treatment Time The initial length of time that the user is planning for treatment This value can be set from 28 5 minutes to 60 0 minutes in 0 5 minute increments for the Targis MDS or 28 5 minutes for the Cooled Thermocath MDS or CTC Advance MDS This value can be changed during treatment and only determines when Cruise will automatically end It has no effect on the Manual Control panel 3 1 2 Coolant Start This is the initial starting value of the Coolant Ramp Coolant will ramp from this value to the target value Default Start and Target values are defined in table below Default Start
10. i EA i maan OLIMP TUBING CLAMP TEMPERATURE Lo SENSOR fi E E PRESSURE MOUNTING MECHANISM SENSOR PIN 3 PINS Figure 1 9 Coolant System Features 1 4 12 Temperature and Pressure Sensors Temperature and pressure sensors located on the Control Unit monitor the coolant temperature and the coolant pressure figure 1 9 This monitoring ensures that the coolant temperature 1s maintained at acceptable limits and that the coolant circulates properly 1 4 13 Pump Mechanism Coolant is circulated by the pump mechanism figure 1 9 The inlet coolant tubing runs across a peristaltic pump which pushes the coolant through the tubing and MDS and back into the Coolant Bag 1 5 Microwave Catheter MDS The single use MDS contains all of the features shown in Figure 1 10 The CTC Advance MDS is depicted in Figure 1 10 for reference The MDS 1s used for Delivering microwave energy to the targeted prostatic tissue Monitoring the urethra temperature Cooling the urethra during treatment Draining urine during treatment The microwave antenna and temperature sensor are connected to the Control Unit via the patient connection cable To ensure that the MDS is positioned properly within the urethra the clinician inflates the location balloon in the bladder to hold the MDS in place during treatment 18 of 112 Part Number 250209 001 Rev G 7 10 System Description Section 1 Luers Hicrowove ontenna connector
11. 001 Rev G 7 10 Table 5 2 Electromagnetic Immunity 109 of 112 Section 5 Troubleshooting Guidance and manufacturer s declaration Electromagnetic Immunit The Targis Control Unit is intended for use in the electromagnetic environment specified below The customer or the user of the Targis Control Unit should assure that it is used in such an environment Immunity Test IEC 60601 Test Compliance Electromagnetic Level Level Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Targis Control Unit including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter e a separation distance IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3V m d 12VP 80MHz IEC 61000 4 3 80MHz to 2 5 GHz to 800 MHz d IIP 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol O Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic prop
12. 18 Figure 1 10 MDS Features 19 Figure 1 10a RTU Features 19 Figure 1 10b Assembled RTU Plus Features 20 Figure 1 11 Coolant Bag Features 20 Figure 1 12 Targis Control Unit Rear Cover 23 Section 2 Figure 2 1 Startup Display Screen 27 Figure 2 2 Main Menu Screen 28 Figure 2 3 Patient Data Display Screen 29 Figure 2 4 Clinical Data Screen 30 Figure 2 5 Filling the Coolant Bag 31 Figure 2 6 Positioning the Coolant Bag on the Top Mounting Pins 32 Figure 2 7 Positioning the Coolant Bag onto the Lower Mounting Pin 32 Figure 2 8 Coolant System with Pump Mechanism Open 33 Figure 2 9 Positioning the Sensor Module 34 Figure 2 10 Coolant System with Pump Closed 34 Figure 2 lla Targis MDS 36 Figure 2 11b CTC Advance MDS 36 Part Number 250209 001 Rev G 7 10 7 of 112 Figure 2 12 Figure 2 13 Figure 2 14 Figure 2 15 Figure 2 16 Figure 2 17 Figure 2 18 Figure 2 19 Section 3 Figure 3 1 Figure 3 2 Figure 3 3 Figure 3 4 Figure 3 5 Figure 3 6 Figure 3 7 Figure 3 8 Figure 3 9 Figure 3 10 Figure 3 11 Figure 3 12 Figure 3 13 Figure 3 14 Figure 3 15 Figure 3 16 Figure 3 17 Figure 3 18 Figure 3 19 Figure 3 20 Figure 3 21 Figure 3 22 Figure 3 23 Figure 3 24 Figure 3 25 Figure 3 26 Figure 3 27 Figure 3 28 Figure 3 29 Figure 3 30 Figure 3 31 Figure 3 32 Section 4 Inserted MDS and Single Use RTU 37 Standard RTU 38 RTU Plus Reusa
13. Check pump tubing clamp to ensure it s properly fastened 2 Replace Coolant Bag 3 Replace MDS 4 Verify tubing is not twisted 5 Manually irrigate and contact Urologix Customer Service Resume microwave power Part Number 250209 001 Rev G 7 10 Troubleshooting Problem Message Possible Causes 17 MW POWER IS OFF 1 Loose connector MDS Temp High 17 2 Temperature in the urethra gt 47 C 3 MDS may be defective 18 MW POWER IS OFF 1 Loose connector MDS Temp Low 18 2 MDS is lt 5 C 3 MDS may be defective 19 MW POWER IS OFF 1 Cable may not be MDS Efficiency Low connected properly 19 2 MDS may not be inserted properly 3 MDS may be defective 4 Urine drainage line not purged 20 MW POWER amp PUMP 1 Coolant pump clamp latch ARE OFF is open or lift lever has failed Pump Latch Open 20 Part Number 250209 001 Rev G 7 10 Section 5 Action Steps 1a Reattach fiber connector 1b Clean both ends of connection with alcohol wipe or swab 2a Allow MDS temperature to drop lt 41 C 2b Restart system at 5 watts below previous microwave power setting 3 Replace the MDS Resume microwave power 1 Reattach connector 2 Restart system at a previous microwave power setting 3 Replace MDS Resume microwave power 1 Reattach the connector 2 Check that MDS is inserted properly 3 Replace the MDS and recalibrate Re enter patient information 4 Purge urine
14. Connectors Sensor module Coolant inlet tubing Figure 1 5 Coolant Bag 1 2 5 Accessories Several accessories accompany the Targis System They are Targis System Targis Control Unit User Manual Control Unit Dust Cover 14 of 112 Part Number 250209 001 Rev G 7 10 System Description Section 1 Patient Comfort Kit containing 2 Knee Cushions and the MDS Holder An optional Transport Kit containing a Trolley Protective Cover and Electrical Safety Tester 1 3 Introduction to the Targis System Equipment This section further describes the Targis System equipment Control Unit Microwave Catheter MDS Rectal Thermosensing Unit RTU Coolant Bag 1 4 Targis Control Unit The Targis Control Unit houses several components that apply microwave power monitor temperatures and maintain coolant circulation during the Cooled Thermotherapy Procedure In addition the Control Unit displays procedure information to the user The Control Unit includes these features figure 1 6 Therapy Monitor Microwave Power Indicator Display Screen Printer Main Power Indicator Keyboard Patient SB y Connection Keyboard eee a ii Cable Drawer ee Te Floppy Disk Drive Coolant Door On Off Switch Figure 1 6 Targis Control Unit Part Number 250209 001 Rev G 7 10 15 of 112 Section 1 System Description 1 4 1 Patient Connection Cable and Connector Housing Data from the Targis MDS and the RTU RTU Plus enter the
15. Control Unit and call Urologix Customer Service 4 Check that the RTU is properly positioned 5 Reinsert RTU or inflate RTU 1a Disconnect and reconnect MDS optical fiber connector on patient connection cable 1b Press REPEAT soft key 1c If 1b does not solve problem disconnect optical fiber connector and clean with isopropyl alcohol and swab 1d Reconnect MDS optical fiber connector on patient connector cable and press REPEAT soft key 1e If this doesn t work go to Step 3 below 2 Ensure that MDS is properly inserted in patient 3a Replace MDS 3b Press REPEAT soft key 3c Enter new MDS serial 3d Press NEXT soft key 3e Record on Device Return Form that new MDS has been installed 4 Turn off Control Unit Call Urologix Customer Service Part Number 250209 001 Rev G 7 10 Troubleshooting Problem Message 102 Calibration halted by the Coolant Pump 102 103 Calibration halted by the MDS antenna 103 Possible Causes 1 Disposable Coolant Bag did not reach proper pressure during air purge 2 Coolant Bag not filled with water 3 Coolant Bag not installed properly 4 Coolant Bag not connected to MDS 5 Coolant Bag leaking 6 MDS may be obstructed 1 Check all previous 100 101 102 error causes first 2 Antenna connector may be improperly connected 3 Ensure that the urine drainage lumen has been purged 4 MDS may be defective Part Number 2502
16. Control Unit via the Patient Connection Cable figure 1 6 and 1 7 MICROWAVE CONNECTOR CONNECTOR WINS ABEROPTIC Figure 1 7 Patient Connection Cable The Patient Connection Cable contains connectors for the RTU RTU Plus fiber optic and microwave connectors 1 4 2 Treatment Monitor The monitor houses the display and soft keys figure 1 8 It can be tilted or swiveled for improved viewing ates TREATMENT MICROWAVE DISPLAY MONITOR POWER SCREEN S l P INDICATOR ip MAIN POWER F INDICATOR Figure 1 8 Treatment Monitor Features 16 of 112 Part Number 250209 001 Rev G 7 10 System Description Section 1 1 4 3 Display Screen The display screen figure 1 8 allows you to monitor the treatment session and when necessary enter patient data adjust the coolant temperature adjust the microwave power and turn the coolant pump on or off 1 4 4 Soft Keys Soft keys figure 1 8 provide you with the ability to operate the Targis Control Unit They allow you to toggle through software screens and adjust settings 1 4 5 Keyboard Stored within the Targis Control Unit body the keyboard figure 1 6 allows you to enter and store patient data The keys are sealed to prevent internal damage from spillage onto the keyboard To access the keyboard grasp the sides of the keyboard door and pull the keyboard towards you 1 4 6 Floppy Disk Drive You can store patient data on a floppy disk by using the floppy disk drive figur
17. Default Target Targis o CTC Advance and Cooled ThermoCath 20 C Microwave Catheters Part Number 250209 001 Rev G 7 10 45 of 112 Section 3 Treatment Instructions 3 1 3 Coolant Temp This is the current measured value of the surface of the chill plate Wait until this value has reached the Coolant Start temperature above before beginning calibration 3 1 4 Cruise Ramp ON OFF This will determine if the system will begin to ramp MW Power using Cruise I or begin in manual mode 3 1 5 Ramp Rate SLOW MED FAST The Ramp Rate controls how rapidly the MDS and Coolant temperatures are changed from their initial values to their final target set points The MDS temperature ramp is active in Cruise mode only The Coolant ramp is active in Manual mode as well The initial rate is selected here and can be adjusted throughout treatment In treatment the user can also select HOLD which will maintain MDS and Coolant at their present value 3 1 6 Navigating the Menu To move ahead between fields press the TAB key on the Control Unit Keyboard To move the cursor ahead to the next data field Hold down the SHIFT key and press the TAB key simultaneously to move back to the previous field SHIFT KEY TAB KEY Press the NEXT soft key and display the Treatment Checklist Screen figure 3 2 46 of 112 Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 3 2 Begin Calibration and Self Test Cycle Treatmen
18. G 7 10 Treatment Instructions Section 3 Disk Eject Button meia Disk Indicator Light Figure 3 18 Floppy Disk Drive 3 7 1 Copy File to Diskette You may copy a patient data file to a diskette 1 44 MB DOS formatted 3 5 inch using the following instructions Place the diskette into the floppy disk drive located at the right side of the keyboard drawer figure 3 18 2 Make certain Copy File to Diskette function box is highlighted If it is not press the TAB key until it is highlighted 3 Press the ENTER key The Select File Pop up Screen will appear cee pee ES ane Ea era fe a 5 eh eh ee RE ene inet Figure 3 19 Select File Pop up screen Part Number 250209 001 Rev G 7 10 65 of 112 Section 3 Treatment Instructions 4 Using the TAB key highlight the FILES box Use the down and up fT cursor arrows to highlight the file to be copied Press the ENTER key to select and copy the file Note some keyboards may require the use of the Q key to operate the cursors Wrote If a treatment has just been completed it will be automatically selected and will skip to the Confirm Operation Pop up Screen 5 Pressing the ENTER key to copy the file will display the Confirm Operation Pop up Screen figure 3 20 with the file name to be copied Press the TAB key to select YES and press the ENTER key to copy the file Press the TAB key to select NO and press the ENTER key to discontinue the copy fun
19. Power and switch to the Cool Controls panel CRUISE If the user presses the OFF soft key the MANUAL CONTROLS panel will be displayed using the current values for MW Power Part Number 250209 001 Rev G 7 10 55 of 112 Section 3 Treatment Instructions 3 4 2 2 Control Panel MANUAL CONTROLS This is the control panel displayed when operating in Manual Control Figure 3 12 Manual Control Screen PWR SET the current value of MW Power COOL SET the target Coolant temperature set point RAMP RATE the rate at which Coolant temperature will approach COOL SET PUMP If the user presses the OFF soft key a message will appear to confirm turning the pump off When confirmed the pump will turn off If MW Power was ON it will be automatically turned OFF also CRUISE If the user presses the ON soft key the CRUISE CONTROLS panel will be displayed using the current value of MDS temperature as the new MDS set point TX END If the user presses the YES soft key the system will display a confirmation message If confirmed the system will stop MW Power and display the Cool Control panel a Note The MW Power must be at least 10 watts and MDS must be gt 25 C before Cruise is allowed to engage 56 of 112 Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 w Note When Cruise is turned on the software will ensure that the TX TIME is increased to have at least 2 minutes of treatment remaini
20. USA 112 of 112 Part Number 250209 001 Rev G 7 10
21. acceptable it may have to be rotated or reinserted Push the MDS through the urethra until the MDS balloon is completely in the bladder Rotate the MDS and then pull back until you feel mild resistance Figure 2 2 Verify the position of the MDS with ultrasound 12 If using a Cooled Thermocath MDS or CTC Advance MDS flush the cooling system with 3 5 cc of sterile water and connect luers together amp i Urethra ae gland Bladder S HE arse Treatment catheter Rectal unit Rectal unit orientation flag Figure 2 12 Inserted MDS and Single Use RTU Mil Warning Insulate the antenna cable away from the patient s legs The cable can become hot to the touch during extended treatment at high power levels Ml YW 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 2 10 Preparing and Inserting the Single Use Standard RTU Note The Single Use RTU pictured below 1 Verify the patient has received an enema 2 Open and remove the RTU from the sealed packaging Part Number 250209 001 Rev G 7 10 37 of 112 Section 2 Treatment Setup Tem perature sensors Handle Cable Connector Orientation flag Extension tubing E PERE ail Rectal balloon oct p Balloon inflation port Figure 2 13 Standard RTU 3 Deflate the RTU balloon completely by attaching a syr
22. adjacent to the rubber Soft Key pushbuttons used to control the treatment Each icon has a text descriptor directly below it to clarify the function of the soft key Figure 3 5 Soft Icon Keys 50 of 112 The 4 soft key icons are as follows figure 3 5 MW OFF This is the top soft key and will disable MW Power immediately whenever it is pressed This generates an error message therefore it 1s preferred that other controls are used for managing patient comfort UP ON YES This is the second soft key from the top It is used to modify the current selected control value Its function changes depending on the highlighted parameter DOWN OFF NO This is the third soft key from the top It is also used to modify the current selected control value Its function changes depending on the highlighted parameter NEXT this is the bottom soft key and is used to navigate the highlighted options It can be pressed at any time without changing any treatment parameters Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 3 4 1 2 Status Panel The Status Panel displays the current values of important treatment parameters STATUS MDS MDS C PUR W RIU C COOL C 39 5 MEXA Figure 3 6 Status Panel These are e PWR W This displays the current MW Power output in watts measured at the Patient Cable e MDSC This displays the current MDS sensor temperature in degrees C e RTUC This display
23. all of the safety concerns associated with the use of this equipment The user must establish appropriate safety and health practices prior to use Perform the following Control Unit safety checks at least once every 12 months Check all cables and connectors for damage Check equipment for physical damage Ensure that safety labels are readable Maintain a written record of these safety checks Any equipment that does not meet these standards should be serviced 24 of 112 Part Number 250209 001 Rev G 7 10 Treatment Setup Section 2 Safety Precautions General Safety The Targis System is a medical device equipped with the ability to emit microwave radiation therefore the user must ensure the following general safety precautions are observed The Targis System must only be installed and serviced by qualified service personnel The Targis System 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 Targis System may be used only by authorized and properly trained personnel and the treating physician must be present throughout the duration of the Cooled ThermoTherapy procedure The Targis 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 Targis Control Unit must never be left unattended when the machine i
24. temperature RTU temperature Coolant temperature and MW Power as a function of time The colors of each trace correspond to the color of the item in the Status Panel a0 MINUTE VIEW cio HMHIH DIY3 Figure 3 9 60 minute view Part Number 250209 001 Rev G 7 10 53 of 112 Section 3 Treatment Instructions 3 4 1 6 Treatment Timers Below the 10 minute graph are two timers The timer on the left is always the Treatment Timer labeled TX TIMER The timer to the right will be one of the following REMAIN INTERVAL or COOLDOWN depending upon the current active control panel TX TIMER 55 REMAIN 27 35 Figure 3 10 Treatment Timers TX TIMER This records the actual Treatment Time in minutes and seconds as defined by the following algorithm Targis CTC Advance CTC Advance Short amp Standard Short Cooled ThermoCath ee Standard amp Long Urethra 2 35 C with Urethra 2 35 C with e Urethra 2 35 C with 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 OR RTU 2 41 C e OR RTU 2 4 C REMAIN When the Cruise Panel is active this timer will be displayed It indicates the Treatment Time remaining calculated by subtracting the current value of the TX TIMER from the value of the TX TIME input by the user It can be used to tell at a glan
25. tubing ARE OFF 2 Coolant Bag may be Coolant Pressure High defective 3 3 MDS may be defective Part Number 250209 001 Rev G 7 10 Section 5 Action Steps 1 Reattach connectors 2a Allow rectal temperature to drop below 42 C 2b Restart system at 5 watts below previous microwave power setting 3 Replace RTU 4 Remove air per section 2 10 or 2 11 5 Remove RTU and perform enema 6 Check that the RTU is properly positioned 7 Reposition patient with head and shoulders elevated no higher than a 20 angle 8 Check that the MDS is properly positioned Resume microwave power 1 Reattach connectors 2a Check that RTU is inserted properly 2b Restart system at previous microwave power setting 3 Replace RTU 4 Reinsert RTU or inflate RTU 5 Check that RTU is properly positioned Resume microwave power 1a Check water level in the Coolant Bag 1b Check for tubing kink 1c Check that pump tubing clamp is properly fastened 2 Turn pump off verify pump is off Disconnect coolant luers from MDS and connect coolant luers to each other then restart pump If error repeats replace coolant bag 3 Turn off pump verify pump is off Disconnect coolant luers from MDS and flush MDS coolant luers with sterile water Reconnect coolant bag luers to MDS and restart pump If error repeats replace MDS Resume microwave power 83 of 112 Section 5 Problem Problem Message
26. 09 001 Rev G 7 10 Section 5 Action Steps 1 Press REPEAT 2 Check water level in Coolant Bag to ensure that it is filled with 100 cc of sterile water Press REPEAT 3 Ensure that Coolant Bag and sensor module assembly are properly installed on Control Unit Press REPEAT 4a To ensure Coolant Bag is properly connected to MDS press REPEAT 4b If none of the above steps resolves the error replace the Coolant Bag fill with water and press REPEAT Record on Device Return Form that new Coolant Bag has been installed and return to Urologix 5 Replace Coolant Bag Fill with 100cc sterile water and press REPEAT Record on Device Return Form that new Coolant Bag has been installed and return to Urologix 6a Replace MDS and press REPLACE 6b Enter new MDS serial Press NEXT to start calibration cycle Record on Device Return Form that new MDS has been installed and return to Urologix 1 Check possible causes in error categories 100 101 102 and follow action steps 2a Reattach the connector 2b Press REPEAT 3 Purge urine drainage lumen 4a Replace MDS if device fails to calibrate 4b Press REPLACE 4c Enter new MDS serial Press NEXT 4d Record on Device Return Form that new MDS was installed and return to Urologix 91 of 112 Section 5 Troubleshooting Problem Message Possible Causes Action Steps 104 MW OFF button has 1 MW OFF soft key pressed 1 If key pressed accident
27. 10 Contents Patient Safety Summary 3 User Manual Overview 4 Notice 9 Safety Symbols and Definitions 9 Precautions 10 1 13 Introduction to the Targis System 11 Targis System Equipment Overview 11 Targis Control Unit 12 Microwave Catheter 13 Rectal Thermosensing Unit RTU RTU Plus 13 Coolant Bag 14 Accessories 14 Introduction to the Targis System Equipment 15 Targis Control Unit 15 Patient Connection Cable and Connector Housing 16 Treatment Monitor 16 Display Screen 17 Soft Keys 17 Keyboard 17 Floppy Disk Drive 17 Printer 17 On Off switch 17 Lockable wheels 17 Coolant System 17 Chill Plate 18 Temperature and Pressure Sensors 18 Pump Mechanism 18 Microwave Catheter MDS 18 RTU RTU Plus 19 Coolant Bag 20 Required Equipment 21 Equipment Provided by Urologix 21 Equipment Provided by the User 21 Control Unit Installation and Use Environment 22 Equipment Cleaning 23 Equipment Connections 23 Equipment Testing 23 Safety Instructions 23 Safety Precautions 25 Targis Treatment Setup Introduction 26 Prepare the Patient 26 Prepare and Position the Targis Control Unit 26 Power Requirements 27 Turn on the Targis Control Unit 27 Enter Patient Data 28 Enter Clinical Data 30 Prepare the Coolant Bag 31 Insert the Microwave Catheter 35 Preparing and Inserting the Single Use Standar
28. 2 16 Inserting the Temperature Sensor Strip 6 Seat the balloon inflation tubing in the inflation tubing channel in the base of the RTU Plus handle The locating key should snap into place within the handle key hole if not re orient 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 17 Figure 2 17 Proper Positioning of the Temperature Sensor Strip 7 Once the handle and balloon are integrated the protective sheath must be slid down from the balloon and pulled over the handle 8 Lubricate the balloon area with a water based lubricant e g K Y Jelly 9 If necessary deflate the RTU Plus balloon completely by attaching a syringe to the inflation port and withdrawing air 10 Slowly insert the balloon into the rectum using the semi rigid inflation tubing to guide placement This can be done with the guiding hand initially over the distal balloon area 40 of 112 Part Number 250209 001 Rev G 7 10 Treatment Setup Section 2 Advance the RTU Plus slowly The guiding hand can be moved more and more proximally as the RTU Plus is properly inserted into the rectum The rectal temperature sensors must be oriented toward the prostate M 2 Warning The rectal unit must be positioned properly to ensure correct temperature sensing 11 The RTU Plus orientation should be verified by inserting a finger and assuring prope
29. 50209 001 Rev G 7 10 105 of 112 Section 5 Troubleshooting Self Test Cycle The Targis Control Unit s internal checking procedure which runs each time the system is turned on Soft Keys Four vertically positioned keys next to the Targis Control Unit display screen that allow the clinician to control the procedure session Targis Microwave Catheter A type of Microwave Catheter Temperature Sensor A device within the Microwave Catheter that monitors the urethral temperature of the patient or a device within the rectal unit that monitors the rectal temperature of the patient Testes The male reproductive glands that reside in the scrotum and produce spermatozoa Interstitial cells in the testes secrete a hormone an androgen that aids the growth and development of the prostate gland Transport Kit The only FDA approved method other than the original shipping crate for transporting a Targis 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 Also used to determine prostate size Transurethral Incision of the Prostate 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 of the Prostate TU
30. 8 MW OFF Soft Key The MW OFF soft key appears on all screens Press the MW OFF soft key 1f The microwave power indicator is illuminated when microwave power has not been intentionally applied The patient reports pain and there is no apparent reason 70 of 112 Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 The Control Unit will respond by discontinuing microwave power and turning off the microwave power indicator light Coolant will continue to circulate if it is on During screens when microwave power could be applied to the patient Calibration Progress Coolant Adjust Microwave Power Adjust Pump On Off Confirm Pump Off End Treatment and Confirm End Treatment there will be a screen response when the soft key is pressed See section 5 Troubleshooting Guide error numbers 21 and 104 for the action steps to be taken Turn off the Control Unit and call Urologix customer Service at 1 888 229 0772 3 9 Targis System Errors 3 9 1 Calibration Errors Errors during the Targis System calibration are displayed on the Calibration Halted Screen figure 3 30 If any disposable needs to be replaced press the REPLACE soft key and enter the new serial or lot number on the Patient Data Display Screen Resume calibration by pressing the NEXT soft key twice to return to the Calibration Progress Screen or press REPEAT to retry the halted calibration step or press MAIN to return to the Main Menu Screen Wrote If you press the M
31. AIN soft key you must reenter all the information in the Patient Data Display screen Figure 3 30 Calibration Halted Screen El Warning If one of these messages appears refer to Section 5 Troubleshooting Guide in this Manual for more information Part Number 250209 001 Rev G 7 10 71 of 112 Section 3 Treatment Instructions In most cases error messages will appear on the display screen because the Control Unit failed to read or detect the MDS temperature sensor RTU temperature sensors MDS antenna connection or Coolant Bag pressure during the calibration cycle Normally to correct the problem you can readjust the appropriate connector to the component and then press the REPEAT soft key to restart the cycle 3 9 2 Treatment Errors If an error occurs during the treatment session read the message in the ERROR WARNING Panel and follow those instructions See Section 5 Troubleshooting Guide for other possible causes and action steps to be taken if an error is present Errors will set the microwave power to zero and in some cases turn off the MDS coolant pump al Warning If one of these messages appears refer to Section 5 Troubleshooting Guide in this Manual for more information After correcting the cause of the error select RESUME TX YES This will clear the error and allow the treatment to resume Figure 3 31 Treatment Error Message Panel 3 9 3 System Halt Errors If the Control Unit dis
32. Catheter during the procedure Operate the Targis Control Unit and connected devices only when connected to a fully tested hospital grade power outlet with adequate grounding The Targis Control Unit must be plugged into the appropriate voltage outlet The electrical equipment inside the Targis Control Unit uses voltages capable of causing serious injury or death from electric shock To avoid this hazard never open the housing of the Targis Control Unit 1 1 Introduction to the Targis System The Targis Control Unit treats Benign Prostatic Hyperplasia BPH by applying microwave power to the prostate and continuously heating the diseased tissue via the Microwave Catheter It also minimizes patient discomfort and risk to the urethra by circulating cooling fluid through the Microwave Catheter Rectal wall damage is prevented by preferential targeted heating of the prostate with the Targis Microwave Catheters Qualified medical personnel are able to continually monitor the Microwave Catheter and rectal temperatures If these temperatures indicate that a protocol parameter may be exceeded the operator can adjust the microwave power to protect the urethra or rectal wall from overheating 1 2 Targis System Equipment Overview The products to be described in this manual comprise the Targis System which includes the Control Unit Procedure Kit comprised of a Microwave Catheter a Rectal Thermosensing Unit and a Coolant Bag and accessories The Targ
33. ICATION 313 34 ILLEGAL RETURN VALUE 314 1 12 4 2345 WATCHDOG TIMEOUT 315 346 HARD DRIVE FULL 316 347 HWFS FAILSAFE DISABLED 317 MW SOFTWARE 318 319 HWFS DISCONNECTED 319 MW SUPPLY 320 RAM PARITY 321 PROGRAM INTEGRITY 322 94 of 112 Possible Causes 1 Control Unit hard drive failed 1 MDS temperature electronics failed 1 Microwave generator failed 1 Control Unit software failed 1 Control Unit software failed 1 Control Unit hard drive full 1 Hardware failsafe disabled 2 Low voltage at start up 3 Power loss or surge 4 Extension cord used 1 Microwave generator failed 2 Low voltage at start up 3 Power loss or surge 4 Extension cord used 1 Control Unit electronics failed 1 Microwave generator power supply failed 1 RAM parity check failed 1 CRC failed Troubleshooting Action steps 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 4 Do not continue to use the Control Unit Call Uro
34. KLIST PROGRESS CLINICAL DATA SCREEN SCREEN SCREEN SCREEN CRUISE RAMP ON CRUISE ON PANEL CRUISE CRUISE OFF CONTROLS RESUME TX CONFIRM END TX Part Number 250209 001 Rev G 7 10 Troubleshooting 5 3 Description of Symbols Section 5 There are a number of symbols associated with the Targis System Targis 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 Part Number 250209 001 Rev G 7 10 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 Rectal unit 97 of 112 Section 5 Troubleshooting Symbol Description Consult Instructions for Use Caution Stop microwave 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 98 of 112 Part Number 250209 001 Rev G 7 10 Troubleshooting Symbol Part Number 250209 001 Rev G 7 10 Section 5 Description Caution cold surface Do Not Use if Package is Damage
35. OFF Coolant Pressure High 15 86 of 112 1 Loose connector 2 RTU temperature lt 15 C 3 RTU may not be inserted in the rectum 4 RTU may be defective 5 RTU expelled or not properly inflated 6 RTU may not be inserted properly 1 Pressure in tubing is too high 2 Coolant Bag may be defective 3 MDS may be defective 1 Pressure is too low in the tubing 2 Coolant Bag may be defective 3 MDS may be defective 4 Coolant tubing between coolant bag and sensor module may be twisted 5 Microwave power and pump are off Troubleshooting Action Steps 1 Reattach connector 2 Restart system at previous microwave power setting 3 Check that RTU is inserted properly 4 Replace RTU 5 Reinsert RTU or inflate RTU 6 Check that RTU is properly positioned Resume microwave power 1a Check water level in Coolant Bag 1b Check for tubing kink 1c Check that pump tubing clamp is properly fastened 2 Turn pump off verify pump is off Disconnect coolant luers from MDS and connect coolant luers to each other then restart pump If error repeats replace coolant bag 3 Turn off pump verify pump is off Disconnect coolant luers from MDS and flush MDS coolant luers with sterile water Reconnect coolant bag luers to MDS and restart pump If error repeats replace MDS Resume microwave power 1a Check water level in Coolant Bag 1b Check for tubing kink 1c
36. RP A surgical procedure that involves the removal of tissue from the interior of the prostate with an instrument called a resectoscope Treatment Monitor The housing that sits on top of the Targis Control Unit including the display screen that allows the clinician to view information related to a patient s prostate treatment Treatment Parameters Targis System values such as the Microwave Catheter and the rectal temperatures that the clinician monitors during treatment Treatment Protocol The step by step plan the clinician follows when treating the patient s prostate condition Or the set of treatment parameters clinicians choose to treat a patient s prostate condition 106 of 112 Part Number 250209 001 Rev G 7 10 Troubleshooting Section 5 Treatment Session A treatment session begins when the patient enters the clinic and ends when the treatment is over and he is discharged Treatment Timer The mechanism in the Targis Control Unit that advances increments of seconds and minutes at therapeutic temperature TRUS An acronym for transrectal ultrasound TUIP An acronym for transurethral incision of the prostate TURP An acronym for the transurethral resection of the prostate Universal Precautions Guidelines A standard set of safeguards that apply to patients undergoing treatment For example the Targis Control Unit should not be moved while the electrical cord is connected to a power source Urethra Set Point T
37. SHEATH RECTAL BALLOON SERIAL MUMECR LABEL a HANDLE CONNECTER BALLIN INFLATION FIET Figure 1 10b Assembled RTU Plus Features In the reusable RTU Plus the proper orientation is achieved by placing the side of the handle labeled Anterior face up As such when the patient is positioned on his back the handle base would be resting on the table and the Urologix Logo would be visible on both sides of the handle This assures that the temperature sensors of the RTU Plus are pointed towards the patients prostate anterior 1 7 Coolant Bag The single use Coolant Bag includes a bag for chilled water inlet and outlet tubing a sensor module and connectors figure 1 11 The function of the bag is to provide a reservoir for coolant that is circulated through the MDS during treatment The Coolant Bag includes these functional components Small holes on the top and bottom of the Coolant Bag allow it to be mounted on the chill plate A hydrophobic vent releases air but not coolant from inside the bag A sensor module allows coolant temperature and pressure to be monitored by the Control Unit The sterile water circulates through the coolant inlet tubing sensor module and outlet tubing which connects to the MDS Water continues to circulate through the MDS and returns to the Coolant Bag via the Coolant Bag inlet tubing The Coolant Bag resides against the chill plate which removes heat from the circulating sterile wa
38. Targis System Targis Control Unit User Manual UROLOGIX 1 of 112 Part Number 250209 001 Rev G 7 10 2 of 112 Part Number 250209 001 Rev G 7 10 Patient Safety Summary This patient safety summary is an overview of the key patient safety information provided in the Targis Control Unit User Manual Please refer to the user manual to obtain all safety information pertaining to the use and operation of the Targis 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 is 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 check microwave catheter and rectal unit placement if the patient complains of any abnormal or sudden increase in pain Pause the treatment if the patient complains of serious pain 4 Observe the treatment parameters for su
39. afety concerns associated with the Urologix Targis Control Unit The user must establish appropriate safety and health practices The Targis Control Unit is intended for use only by qualified medical personnel Federal U S A 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 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 Targis Control Unit in Section 5 3 Description of Symbols Safety Symbol Instruction Manual 9 of 112 Definition A note indicates important information that helps you operate the Targis Control Unit or use the disposable devices A caution contains instructions that must be followed to avoid a possible malfunction of or damage to the equipment or its connected devices Do not proceed beyond a caution sign until the indicated conditions are fully understood and met A warning contains important information about possible danger to you or the patient Do not proceed beyond a warning sign until the indicated conditions are fully understoo
40. agation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters and electromagnetic site survey should be considered Ifthe measured field strength in the location in which the Targis Control Unit is used exceeds the applicable RF compliance level above the Targis 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 Control Unit Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Table 5 3 Electromagnetic Immunity continued 110 of 112 Part Number 250209 001 Rev G 7 10 Troubleshooting Section 5 Recommended separation distance between portable and mobile RF communications equipment and the Targis Control Unit The Targis 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 Control Unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Targis C
41. ally been actuated 104 accidentally restart calibration sequence 2 Microwave indicator 2 Press MAIN soft key and turn illuminated when it should not off Control Unit Call Urologix have been Customer Service User pressed the 1 CANCEL soft key 1 If key pressed accidentally Cancel soft key 105 accidentally pressed restart calibration sequence 2 Calibration stopped by 2 Address reason for stopping user calibration and resume calibration sequence Invalid time 201 1 Time is not in a valid 1 Enter time in a valid format 201 format Invalid date 202 1 Date is not in a valid 1 Enter date in a valid format format Disk write error 203 Disk write error 203 error 203 1 1 Floppy disk is corrupt 1 Floppy disk is corrupt is corrupt 1 1 Use a new floppy disk a new 1 Use a new floppy disk disk Track formatting error 1 Floppy disk is corrupt 1 Use a new floppy disk 204 Insufficient disk space 1 Floppy disk is full 1 Copy to a new floppy disk 205 206 Couldn t create target 1 Floppy disk is write 1 Remove the write protect tab file 206 protected and retry 2 Floppy disk is corrupt 2 If error reoccurs use a new floppy disk 207 I O error during copy 1 Floppy disk is not in drive 1 Place floppy disk in drive 207 Paper empty 208 1 Printer is out of paper 1 Load paper into the printer 209 Printer time out 209 1 Printer has malfunctioned 1 Do not continu
42. ated This may compromise his ability to communicate pain 2 3 Prepare and Position the Targis Control Unit 1 Position the Targis Control Unit close enough to the patient so that the patient connection cable is able to reach the MDS and RTU RTU Plus easily The Control Unit should be placed on a level surface 2 Lock the front wheels to ensure the Control Unit does not move inadvertently To lock the wheels use your foot to press down on the front part of the wheel lock tabs To unlock the wheels press on the back part of the wheel lock tabs 3 Plug the Control Unit electrical cord to a wall outlet The power supply must have these specifications 26 of 112 Part Number 250209 001 Rev G 7 10 Treatment Setup Section 2 2 4 Power Requirements Europe version 220 240 V 10 4 25 A Single phase 50 or 60 Hz US version 110 120 V 10 8 5 A Single phase 50 or 60 Hz Connections Hospital grade plug M YW Warning Do not move the Control Unit while the electrical cord is connected to a power SOUrce 2 5 Turn on the Targis Control Unit 1 Turn on the Targis Control Unit by pressing the ON OFF switch located on the right side of the unit to the position The Control Unit then proceeds with its startup routine Verify that the Startup display Screen figure 2 1 is displayed on the monitor Press MW OFF to complete the Control Unit diagnostic tests Figure 2 1 Startup Display Screen y Note Tur
43. atic Catheter Serial Serial Microwave Catheter Urethral Color Number Number Length Scheme Tag Color Prefix CTC Advance Blue Handle CTC Advance or Cooled ThermoCath 3 0 to 5 0 cm Blue Handle White TC 2 Seandacd White Accents CTC Advance or Cooled Blue Handle Gr TF ThermoCath Grey Accents a Long Targis White Catheter Targis White Catheter NOTE A dark blue handle is Cooled ThermoCath the light blue is the CTC Advance M W 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 1 Drain patient s bladder 2 Inject anesthetic mixture of choice into bladder 3 Inject anesthetic lubricant mixture of choice into the urethra and clamp penis to contain within the urethra for 20 30 minutes 4 Open the package containing the Microwave Catheter 5 Test the locating balloon by filling it with 10 cc of sterile water examining it for leaks and then draining 6 Lubricate the Microwave Catheter tip and shaft with a water based lubricant or local anesthetic Part Number 250209 001 Rev G 7 10 35 of 112 Section 2 Treatment Setup Conde tip N Locetlon belleon Lorct lon inflaton part Figure 2 11a Targis MDS Microwave notenna connector iM Terp eroture sensor ee WH Aa i A E ES a s Location bal loon Location balloon inflation port Sho tt Cooling ball
44. ble Handle 39 RTU Plus Disposable Balloon 39 Inserting the Temperature Sensor Strip 40 Proper Positioning of the Temperature Sensor Strip 40 Connected MDS and RTU 42 Patient connection Cable 43 Treatment Setting Screen 45 Treatment Checklist Screen 47 Calibration Progress Screen 48 Treatment Screen 50 Soft Icon Keys 50 Status Panel 51 Control Panels 52 10 Minute View 53 60 Minute View 53 Treatment Timers 54 Cruise Control Screen 55 Manual Control Screen 56 Cool Control Screen 57 Message Panel 58 Error Warning Panel 58 Exit Cooldown Panel 59 Options Screen 64 Floppy Disk Drive 65 Select File Pop up Screen 65 Confirm Operation Pop up Screen 66 Treatment Printout 67 Confirm Format Disk Pop up Screen 68 Formatting Disk Pop up Screen 68 Systems Setting Screen 68 Set Date and Time Pop up Screen 69 Set Time Pop up Screen 69 Set Date Pop up Screen 69 Select Language Screen 70 Options Error Pop up Screen 70 Calibration Halted Screen 71 Treatment Error Message Panel 72 System Halt Screen 73 Figure 4 1 Internal Coolant Level Indicator 77 Figure 4 2 Loading Paper in the Printer 78 Figure 4 3 Targis Control Unit Rear Cover 79 8 of 112 Part Number 250209 001 Rev G 7 10 Section 1 Notice System Description The information contained in this manual is subject to change This manual does not purport to address all s
45. blem disconnect optical fiber connector and clean with isopropyl alcohol and swab 1d Reconnect MDS optical fiber connector on patient connector cable and press REPEAT soft key 1e If this doesn t work go to Step 2 below 2a Replace MDS 2b Press REPEAT soft key 2c Enter new MDS serial 2d Press NEXT soft key 2e Record on Device Return Form that new MDS has been installed 3 Turn off Control Unit Call Urologix Customer Service Part Number 250209 001 Rev G 7 10 Troubleshootinc Problem Message 5O CAUTION Treatment Time gt 60 min 50 51 CAUTION MW Duration gt 100 min 51 5 CAUTION MDS Temp gt 41 C 52 53 CAUTION Run Coolant 5 min 53 54 CAUTION Cruise unavailable 54 D5 REMINDER Interval Elapsed 55 DG CAUTION RTU Temp gt 42 C 56 Possible Causes 1 TREATMENT timer has exceeded 60 minutes 1 One hundred minutes have elapsed since completing calibration 1 MDS temperature gt 41 C 1 Five minutes have not elapsed since microwave power was discontinued 1 Cruise Control is unable to be engaged 1 Two minutes have elapsed since the last time MW power was adjusted 1 RTU temperature has exceeded 42 C Part Number 250209 001 Rev G 7 10 Section 5 Action Steps 1 Press MW END to discontinue microwave power Wait 5 minutes and QUIT Treatment 1 Press MW END to discontinue microwave power Wait 5 minutes and QUIT Treatment 1 Red
46. ce when the Cruise will automatically discontinue and enter the Cooldown mode INTERVAL When the Manual Panel is active this timer will be displayed It indicates the amount of time elapsed since the user last adjusted MW Power It can be used to assist the user in timing a manual protocol COOLDOWN When the Cool Panel is active this timer will be displayed It indicates the amount of time spent since the MW Power was turned off and only counts time spent with the coolant pump running 3 4 2 Control Panel Operation Each Control Panel displays a list of the current control item settings 54 of 112 Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 These settings can be adjusted by pressing the NEXT soft key until the item to be changed 1s selected the background of the control is black Once an item has been selected it can be adjusted by pressing either of the two middle soft keys These middle soft keys are labeled to correspond to the item selected For example they will change from ON OFF to UP DOWN to YES NO 3 4 2 1 Control Panel CRUISE CONTROLS This panel is active when Cruise is engaged Figure 3 11 Cruise Control Screen MDS SET the target MDS temperature set point for the Cruise ramp COOL SET the target Coolant temperature set point for the Cruise ramp RAMP RATE the rate at which Cruise will approach MDS SET and COOL SET TX TIME the time when Cruise will automatically stop MW
47. covers a significant problem it automatically shuts itself down If this occurs the System Halt Screen figure 3 32 will be displayed 72 of 112 Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 Figure 3 32 System Halt Screen If this message appears do the following Save Error Message printout Do not continue the treatment Run the Control Unit for 5 minutes to cool the patient s urethra Power down the Control Unit Call Urologix Customer Service at 1 888 229 0772 with error printout available Part Number 250209 001 Rev G 7 10 73 of 112 Equipment Maintenance Section 4 4 1 Post Treatment Cleaning Procedures The following process can be used to clean and disinfect the RTU Plus Handle containing the temperature sensors for subsequent use The RTU Plus handle should not be used more than 30 times Remove and discard the disposable rectal balloon if not already discarded It is 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 4 Place the RTU Plus 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 immer
48. ction Figure 3 20 Confirm Operation Pop up Screen 6 To remove the diskette press the DISK EJECT button figure 3 18 Label the diskette with the name of the copied file 3 7 2 Print a File 1 Make certain the PRINT A FILE function box is highlighted If it is not press the TAB key until it is highlighted 2 Press the ENTER key The Select File Pop up Screen will appear figure 3 19 3 Using the TAB key highlight the DIRS FILES box Use the and up 7 cursor arrows to highlight the file to be copied Press the ENTER key to select and copy the file Note some keyboards may require the use of the Q key to operate the cursors 4 Pressing the ENTER key to print the file will display the Confirm Operation Pop up Screen figure 3 20 with the file name to be printed Press the TAB key to select YES and press the ENTER key to print the file Press the TAB key to NO and press the ENTER key to discontinue the print function 5 The Control Unit reads from the hard disk and prints the data in the format shown figure 3 21 66 of 112 Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 UROLOGIA Inc PATIENT DATA NAME John Jones ID 0123456789 MDS S N RTU LOT ROO123 DATE 25 AUG 2000 TIME 02 29 02 PM CLINICAL DATA PHYSICIAN Dr My Namehere INSTITUTION IPSS OMAX QOL PSA URETHRA LENGTH PROSTATE VOLUME PVR DOB TREATMENT SUMMARY MAX POWER 42 8 W
49. d Caution Federal U S A 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 Note Caution Warning Date of Manufacture Manufacturer Authorized Representative in the European Community 99 of 112 Section 5 Troubleshooting 5 4 Glossary Analgesia The reduction of pain stimulus without the corresponding loss of consciousness Analgesic A medication that reduces or eliminates pain In BPH patients depending on the clinician s diagnosis there are several agents that might be considered for the reduction of pain Antibiotic A substance that is used to destroy or inhibit the growth of microorganisms Anti inflammatory A medication that is used to reduce inflammation which 1s often characterized by localized heat redness swelling and pain in the tissues ASCII Format A unique computer code associated with a particular function and key on the keyboard of the Targis Control Unit 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 Calibration Process A diagnostic test that the Targis Control Unit runs to determine whether its components are functioning properly 1 Rectal unit and temperature sensors are operating within 2 C of each
50. d RTU 37 Part Number 250209 001 Rev G 7 10 5 of 112 2 11 Preparing and Inserting the RTU Plus with Reusable Handle 39 2 12 Connect the MDS and RTU to the Control Unit 41 3 1 Treatment Settings Screen 45 3 1 1 Treatment Time 45 3 1 2 Coolant Start 45 3 1 3 Coolant Temp 46 3 1 4 Cruise Ramp 46 3 1 5 Ramp Rate 46 322 Begin Calibration and Self Test Cycle 47 3 3 Calibration Progress Screen 48 3 4 Treatment Procedure 49 3 4 1 Treatment Screen Description 49 3 4 1 1 Soft Key Icons 50 3 4 1 2 Status Panel 51 3 4 1 3 Control Panel 52 3 4 1 4 10 Minute Graph 53 3 4 1 5 60 Minute Graph 53 3 4 1 6 Treatment Timers 54 3 4 2 Control Panel Operation 54 3 4 2 1 Control Panel CRUISE CONTROL 55 3 4 2 2 Control Panel MANUAL CONTROL 56 3 4 2 3 Control Panel COOL CONTROLS 57 3 4 2 4 Control Panel MESSAGE 58 3 4 2 5 Control Panel ERROR WARNING 59 3 4 2 6 Control Panel EXIT COOLDOWN 59 3 4 3 Automatic Treatment Cruise II 60 3 4 3 1 Section Ramp 60 3 4 3 2 Section Treatment 61 3 4 3 3 Section If an Error Warning occurs read the message and respond according 61 3 4 3 4 Section Cooldown 61 3 4 4 Manual Treatment Express Protocol 61 3 4 4 1 Section Ramp 61 3 4 4 2 Section Treatment 62 3 4 4 3 Section Cooldown 62 3 5 Terminate Treatment 63 3 6 Post Procedure Treatment Options 64 3 7 Options 64 3 7 1 Copy File to Diskette 65 3 7 2 Prin
51. d and met The instruction manual symbol is displayed on the product when it is necessary for you to refer to the Targis Control Unit User Manual this document Part Number 250209 001 Rev G 7 10 Section 1 System Description Precautions Only those physicians who have been thoroughly trained on the operation of the Targis System and the Cooled ThermoTherapy Procedure should deliver the treatment The Cooled ThermoTherapy Procedure must not be initiated without assurance that the Microwave Catheter is properly positioned in the patient The correct positioning of the Microwave Catheter must always be checked by ultrasound imaging prior to commencing treatment Improper placement or orientation of the microwave catheter may lead to procedure failures or heating damage of non target tissues such as the bladder neck external sphincter or penile urethra All components of the Targis Control Unit must be used in a manner consistent with the instructions set forth in their respective Instructions for Use insert and the Targis Control Unit User Manual this document Failure to do so may result in insufficient treatment or increased risk of injury or infection to the patient F Note Use of the Targis 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 micro
52. dden changes in readings especially decreases in temperatures that might indicate a sensor has moved from its previous position M 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 non target tissues such as the bladder neck external sphincter or penile urethra e Do not under inflate or over inflate the microwave catheter balloon Under inflation can cause the microwave antenna to be misplaced 1n the prostate affecting the external sphincter or penile urethra Over inflation 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 250209 001 Rev G 7 10 3 of 112 User Manual Overview This manual combines technical reference material as well as user information on how to use the Targis Control Unit The sections include these topics y Notes For information regarding the contents of this manual please call Urologix Customer Service at 1 888 229 0772 Read this manual before operating the Targis Control Unit and keep the manual in the holder on the unit f
53. defined in section 3 4 1 6 are met 60 of 112 Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 e Ifthe RTU temperature is nearing 41 C the Status Panel title will change to STATUS RTU In this case Cruise will automatically increase the temperature of the coolant but not the displayed set point to compensate e Adjust the TX TIME to select when Cruise will automatically stop MW Power e After TX TIME has expired the Cruise will sound the Hi Lo H1 beep tones and enter the Cooldown section 3 4 3 3 If an Error Warning occurs read the message and respond accordingly Clear the message by selecting RESUME TX YES When the message is cleared the Manual Controls panel will be active Re engage Cruise by the following procedure e Adjust PWR SET to gt 10 watts preferably to a value 5 watts below the value when the error occurred NOTE check the TX graph for a display of MW Power history e Allow the MDS temperature to stabilize for approximately 30 seconds before engaging Cruise Engage Cruise by selecting CRUISE ON Cruise is now running using the current value of the MDS sensor as the set point Adjust the MDS set point to the desired value Cruise will ramp the MDS to the new set point at the rate defined by the RAMP RATE setting 3 4 3 4 Section Cooldown During this section the user may choose to print the treatment listing Continue pumping coolant until th
54. drainage line Resume microwave power 1a Close the latch 1b Restart the system at the previous microwave power setting 1c Open and close lift lever and listen for two clicks 87 of 112 y moon nee 5 Problem Problem Message MW POWER IS OFF User pressed MW OFF 21 MW POWER IS OFF RTU Disconnected 22 MW POWER IS OFF MDS signal weak 23 88 of 112 Possible Causes 1 User accidentally pressed the soft key 2 Patient was experiencing pain 3 Microwave indicator was illuminated when it should not have been 1 RTU has become disconnected from the patient cable 1 Fiber optic connector may be improperly connected or contaminated 2 MDS may be defective 3 Fiber optic cable may be broken Troubleshooting Action Steps 1 If the key was pressed accidentally restart the system at the previous microwave power setting 2 Restart system and input microwave power to an acceptable setting lower than previous setting 3 Press NEXT soft key to advance to the End Treatment Screen Press QUIT soft key confirm with YES and turn off Control Unit Call Urologix Customer Service 1a Reattach the connectors 1b Restart the system at previous microwave power setting 1c If system fails again call Urologix Customer Service 1a Disconnect and reconnect MDS optical fiber connector on patient connection cable 1b Press REPEAT soft key 1c If 1b does not solve pro
55. e 1 6 This drive is designed to copy data to 1 44 MB 3 5 inch DOS formatted floppy disks 1 4 7 Printer You can print the data from any treatment using the printer The printer 1s a 4 inch thermal printer and uses paper provided by Urologix 1 4 8 On Off switch Turn the Targis Control Unit on or off with this switch figure 1 6 1 4 9 Lockable wheels The Targis Control Unit can be made stationary by locking the front wheels figure 1 6 To lock the wheels use your foot to press down on the front part of the wheel lock tab To unlock the wheels press on the back part of the wheel lock tab Manual Read the Targis System Targis Control Unit User Manual before turning on and operating the system 1 4 10 Coolant System The coolant system consists of these components chill plate temperature and pressure sensors peristaltic pump mechanism coolant door and Coolant Bag figure 1 9 Part Number 250209 001 Rev G 7 10 17 of 112 Section 1 System Description 1 4 11 Chill Plate The chill plate is located behind the coolant door on the front of the Targis Control Unit figure 1 9 The chill plate is equipped with mounting pins that hold the Coolant Bag securely against the chill plate surface As coolant returns from the MDS outlet tubing it circulates through the Coolant Bag and transfers heat to the chill plate which in turn chills the fluid and re circulates it through the MDS FIISOVER CHILL PLATE
56. e Cooldown timer has reached 5 minutes The Hi Lo H1 beep tones will sound to remind the user that the time has expired Select COOL END YES and press the spacebar to exit treatment and prepare for the next patient 3 4 4 Manual Treatment Express Protocol In this mode the user can adjust MW Power and Coolant manually Maintain MDS and RTU temperatures within the appropriate limits for the prescribed time 3 4 4 1 Section Ramp Verify that coolant set point is at the default value and wait until the measured coolant temperature has reached lt the default value 4 C before applying MW Power Step 1 Begin applying MW Power by adjusting the PWR SET to 20 watts e Wait 2 minutes Use the Interval Timer as a guide for timing PWR SET adjustments Step 2 Continue to increase PWR SET by 5 watts at 2 minute intervals until e MDS gt 35 C TX TIMER will begin automatically since the conditions for it to run should have been met e OR RTU reaches 40 C Part Number 250209 001 Rev G 7 10 61 of 112 Section 3 Treatment Instructions e OR Patient comfort level is exceeded Step 3 When one of the above parameters is reached increase power by 1 watt per minute until e MDS reaches 40 0 1 C e OR RTU gt 41 5 C e OR MW Power reaches 60 watts for a Targis or CTC Advance Short MDS or 75 watts for a Cooled Thermocath or CTC Advance Standard or Long MDS e OR Patient comfort level is exceeded
57. e to use the Control Unit Call Urologix Customer Service Print head up 210 1 Printer head is up 1 Close the printer head 24141 Source file not found 1 Control Unit cannot find 1 Do not continue to use the 211 the selected file Control Unit Call Urologix Customer Service 212 Invalid drive specified 1 Do not continue to use the 212 hee re Control Unit Call Urologix l Customer Service 216 Program will proceed 1 Language Disk was not 1 Reload language with English files loaded 2 Call Urologix Customer Language 216 2 Hard drive failure Service 92 of 112 Part Number 250209 001 Rev G 7 10 Troubleshooting Problem Message Possible Causes 1 Control Unit vents are COLDSIDE PELTIER 303 HARDWARE FAILSAFE MALFUNCTION 303 AMBIENT 300 HOTSIDE PELTIER 301 302 REGISTER SENSOR ADDRESS 304 MW MODULE INTERFACE 305 INTERNAL SENSOR INTERFACE 306 HARD DRIVE FAILURE 310 blocked on the sides or back of the machine 2 Control Unit internal temperature gt 60 C 1 Peltier temperature sensor failed 2 Peltier hot side temperature reached upper temperature limit 1 Peltier temperature sensor has failed 2 Peltier element has reached low temperature limit 1 Control Unit electronics have failed 1 Control Unit electronics have failed 1 Microwave amplifier or Control Unit electronics have failed 1 Control Unit electronics have
58. een Using cleaning solvents such as IPA could result in damage to the Control Unit 1 11 Equipment Connections The Targis Control Unit must not be connected to any device other than the MDS RTU or Coolant Bag The MDS RTU and Coolant Bag must not be connected to any other device or outlet 1 12 Equipment Testing Turn on the unit and verify that the initial screen display has appeared Do not use the Control Unit if there are any irregular sounds or vibrations present Prior to beginning a Cooled ThermoTherapy procedure verify that all components of the Procedure Kit MDS RTU and Coolant Bag have arrived in a sealed condition 1 13 Safety Instructions Pi Y Warning Do not open the housing of the Targis Control Unit Doing so risks receiving an electric shock M Y Warning This equipment is not intended for use in areas where there is a danger of explosion Part Number 250209 001 Rev G 7 10 23 of 112 Section 1 System Description 7 Caution The Targis Control Unit must be operated by trained and authorized personnel You should read and understand the instructions in this manual before operating the system Do not open the housing of the Targis Control Unit An electrical shock hazard exists 1f the housing of the control Unit is opened Refer all Control Unit servicing to qualified Urologix personnel Do not use the Control Unit in the presence of flammable substances This manual does not claim to address
59. ement Configuration Disposable Coolant Bag Bag Dimensions Approximately 15 2 cm x 17 8 cm Bag Capacity Approximately 100 mL Pump Peristaltic pump Display Color LCD Input Soft keys menus Keyboard Silicone rubber keyboard Temperature 10 C to 30 C Humidity 30 to 75 relative humidity Atmospheric Pressure 700 hPa to 1 060 hPa IEC 60601 1 Class I Type BF with defibrillation protection RTU Range 1 C to 50 C Accuracy 1 C from 35 C to 45 C and 2 C outside this range MDS Range 27 C to 47 C Accuracy 1 C MDS Coolant Temperature Range 25 C to 75 C Accuracy 3 C Microwave Power Range 0 W 75 W Accuracy 10 81 of 112 Section 4 Equipment Maintenance 82 of 112 Part Number 250209 001 Rev G 7 10 Troubleshooting 5 1 Troubleshooting Guide Problem Problem Message Possible Causes MW POWER IS OFF 1 Loose connector RTU Temp High 1 2 Temperature in rectum has exceeded 42 5 C 3 RTU may be defective 4 Air may not have been removed from the original volume cc s in the RTU 5 Enema not performed within 2 hours of treatment 6 RTU may not be inserted properly 7 Patient inaccurately positioned 8 MDS may not be positioned properly MW POWER IS OFF 1 Loose connector RTU Temp Low 2 2 RTU temperature below 31 C 3 RTU may be defective 4 RTU expelled or not properly inflated 5 RTU may not be inserted properly MW POWER amp PUMP 1 Pressure too high in
60. essure 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 Coolant Down The coolant down button soft key allows the user to decrease the coolant set point by 1 C Coolant Up The coolant up button soft key allows the user to increase the coolant set point by 1 C 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 Procedure 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 urethra temperature Cooling Lumen See cooling channel Computer Subsystem The Targis Control Unit contains a computer that allows the clinician to input patient identification data control the treatment session and collect treatment data Part Number 250209 001 Rev G 7 10 101 of 112 Section 5 Troubleshooting CTC Advance Microwave Catheter A type of Microwave Catheter Display Screen The thermo
61. failed 1 Microwave amplifier has failed 2 Power ramped too quickly 1 Control Unit electronics have failed 1 Microwave amplifier has failed 1 Control Unit drive has failed Part Number 250209 001 Rev G 7 10 Section 5 Action Steps 1 Remove any item that may be blocking the vents 2a Restart system at previous microwave power setting 2b Allow coolant system to run for five minutes in the halted screen and call Urologix Customer Service 1 amp 2 Allow coolant system to run for five minutes in the halted screen and call Urologix Customer Service 1 amp 2 Allow coolant system to run for five minutes in the halted screen and call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 amp 2 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 93 of 112 Section 5 Problem Message FILE OPEN 311 LX COMMUNICATION 312 343 MW COMMUN
62. g Unit for kinks cuts or obvious damage Coolant Bag for kinks cuts or obvious damage 76 of 112 Part Number 250209 001 Rev G 7 10 Equipment Maintenance Section 4 Daily Maintenance 1 Wipe the exterior surface of the Control Unit with a 10 solution of bleach or mild detergent Wipe with water to rinse 2 Check the printer paper and refill is necessary see Printer Maintenance Section 4 4 Check all cables and power connections Be certain that all cables are firmly attached and routed away from normal traffic paths 4 Check the sight gauge on the left side of the Control Unit to ensure that the internal coolant level is within the white open section of the correct level indicator Figure 4 1 FLUID LEVEL a CORRECT LEVEL INDICATOR he Figure 4 1 Internal Coolant Level Indicator Periodic Maintenance Preventive maintenance should be performed each year by a Urologix trained and authorized service representative Contact Urologix Customer Service if more than 12 months have passed since the last preventive maintenance Service and maintenance of equipment must be performed only by trained and authorized personnel from Urologix or its distributors Any other type of service and maintenance arrangement will void all warranties and claims 4 4 Printer Maintenance Printer maintenance consists of changing paper when needed and cleaning the printer periodically 4 4 1 Changing Paper in the Printer You can orde
63. g from the MDS Be careful to keep the Coolant Bag inlet and outlet tubing above the handle of the Control Unit This will prevent water from draining out of the Coolant Bag onto the floor Alternatively you could connect the Coolant Bag connectors to each other 3 Disconnect the MDS from the Control Unit 4 Remove all water from the location balloon and withdraw the MDS from the patient 5 Remove all air from the RTU and withdraw the device from the patient W caution Verify that the disposable components are removed intact 6 Disconnect the RTU from the Control Unit patient connection cable Turn the grey portion of the connector for ease of disconnection 7 Remove the Coolant Bag from the Control Unit 8 Dispose of the Single Use MDS Single Use RTU or component and Coolant Bag in accordance with Universal Precautions for contamination Refer to section 4 1 for instruction on cleaning and disinfecting the reusable RTU Plus handle 9 Print the treatment data or copy it to a floppy disk 10 If you do not wish to copy the patient file to a floppy disk or print out the information turn off the Control Unit by pressing the ON OFF switch located on the right side of the unit o Hang the patient connection cable on the holder located on the Control Unit 11 Cover the connectors at the end of the patient cable 12 If no additional procedures are to be performed disconnect the electrical cord of the unit fr
64. gnetic energy on all equipment cannot be predicted due to age and quality of maintenance The performance of each piece of equipment operated near the Targis Control Unit during a procedure must be evaluated for degradation For more detailed EMC requirements refer to Section 5 5 Electromagnetic Compatibility EMC Tables in the Appendix 10 of 112 Part Number 250209 001 Rev G 7 10 System Description Section 1 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 Targis Control Unit near equipment that emits electromagnetic energy unless the effect on the Targis Control Unit has been evaluated and no degradation of performance was found The national standard ANSI IEEE C95 1 1999 Edition Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields recommends a maximum stray field exposure level for whole body exposure of 3 mW cm as averaged for any 6 minute period The maximum radiated field at full power from the Targis 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
65. he 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 Targis Control Unit Preprostatic Urethra The proximal portion of the prostatic urethra It runs through the prostate beginning just distal to the bladder neck and ending just proximal to the verumontanum Pressure Sensor The small polyurethane disk that fits against the diaphragm of the sensor module on the lower right front side of the Targis Control Unit Its function 1s 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 disposable Rectal Thermosensing 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 104 of 112 Part Number 250209 001 Rev G 7 10 Troubleshooting Section 5 Prostatic Median Lobe The middle rounded mass of 3 rounded masses of tissue that develop adjacent to the urethra in the hyperplastic prostate Prostatism Disease of the prostate gland Pump Mechanism The small wheel like motorized drive behind the coolant door of the Targis Control Unit that uses peristaltic action to propel coolant th
66. he RTU 5 Enema not performed within 2 hours of treatment 6 RTU may not be inserted properly 7 Patient inaccurately positioned 8 MDS may not be positioned properly Part Number 250209 001 Rev G 7 10 Section 5 Action Steps 1 Remove any item blocking vents 2a Restart system at the previous microwave power setting 2b If system fails again call Urologix Customer Service Resume microwave power 1a Check water level in the Coolant Bag 1b Check for tubing kink 1c Check that pump tubing clamp is properly fastened 2 Replace the Coolant Bag 3 Close coolant door Resume microwave power 1 Check water level in the Coolant Bag 1b Check for tubing kink 1c Check that pump tubing clamp is properly fastened 2 Replace the Coolant Bag 3 Close coolant door Resume microwave power 1 Reattach connector 2a Allow RTU temperature to drop below 42 C 2b Restart system at 5 watts below previous microwave power setting 3 Replace RTU 4 Remove Air per section 2 10 or 2 11 5 Remove RTU and perform enema 6 Check that the RTU is properly positioned 7 Reposition patient with head and shoulders elevated no higher than a 20 angle 8 Check that the MDS is properly positioned Resume microwave power 85 of 112 Section 5 Problem Problem Message Possible Causes MW POWER IS OFF RTU Temp Low 14 MW POWER IS OFF a Pressure Low MW POWER amp PUMP ARE
67. he 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 Urination Discharge of liquid waste from the body Verumontanum An elevation in the floor of the prostate gland where it joins the urethra and the entrance of the seminal ducts Part Number 250209 001 Rev G 7 10 107 of 112 Section 5 Troubleshooting Electromagnetic Compatibility EMC Tables 5 5 Electromagnetic Compatibility EMC Tables Guidance and manufacturer s declaration Electromagnetic Emissions The Targis Control Unit is intended for use in the electromagnetic environment specified below The customer or the user of the Targis Control Unit should assure that it is used in such an environment Electromagnetic Environment Guidance RF emissions Group 2 The Targis Control Unit must emit CISPR 11 electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions Class A The Targis Control Unit is suitable for use in CSPR 11 all establishments other than domestic and may be used in domes
68. ial number printed on the MDS Enter the Single Use RTU lot number on the packaging label or the RTU Plus Handle serial number located on the device Enter the treating physician name Displays Control Unit date in the format dd mmm yyyy date can be changed using the OPTIONS functions on Main Menu Screen figure 2 2 Displays Control Unit time in the format hh mm ss time can be changed using the OPTIONS functions on Main Menu Screen figure 2 2 To move ahead between fields press the TAB key on the Control Unit keyboard L gt Part Number 250209 001 Rev G 7 10 29 of 112 Section 2 Treatment Setup To move cursor ahead to the next entry field SHIFT KEY TAB KEY Hold down the SHIFT and press TAB simultaneously to move back to the previous field If you press the ENTER key the data will be entered but the cursor will not move between fields Once all of the patient and procedure data are entered each data field must contain an entry before you can proceed press the NEXT soft key figure 2 3 on the monitor to advance the Clinical Data Screen figure 2 4 2 7 Enter Clinical Data Figure 2 4 Clinical Data Screen This screen is used to enter patient clinical data It 1s optional and only for the convenience of the user Institution name of the hospital or clinic IPSS International Prostate Symptom Score Qmax maximum flow rate QOL Quality Of Life index PSA Prosta
69. inge to the inflation port and withdrawing air The RTU should be deflated with the temperature sensors centered 4 Lubricate the RTU balloon and insert into the rectum with the index finger aligned under the temperature sensors which should be oriented toward the prostate The orientation flag must be pointing toward the patient s posterior M W Warning The rectal unit must be positioned properly to ensure correct temperature sensing 5 Inflate the rectal balloon by injecting 120 cc of air into the inflation port located on the proximal end of the RTU Adjust air volume to a minimum of 80 cc for patient comfort Close RTU valve 6 Verify proper positioning of the RTU by observing that the orientation flag located on the RTU The orientation flag should be facing away from the prostate toward the patient s posterior M YW 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 E WARNING THIS VISUAL REFERENCE SHOULD BE MADE EVERY 5 TO 10 MINUTES THROUGHOUT THE TREATMENT TO VERIFY THE PROPER POSITION OF THE RECTAL THERMOSENSING UNIT FAILURE TO PROPERLY ORIENT THE RTU DURING TREATMENT CAN RESULT IN PATIENT INJURY E G FISTULA OR SCROTAL BURN 38 of 112 Part Number 250209 001 Rev G 7 10 Treatment Setup Section 2 2 11 Preparing and Inserting the reusable RTU Plus Handle Follow these steps to prepare the reusable RTU
70. is Control Unit requires the use of either the single use RTU or the RTU Plus with reusable handle and single use balloon The standard RTU and RTU Plus both consist of an inflatable balloon with 5 temperature sensors that is placed in the rectum to monitor rectal temperature along the anterior rectal wall during treatment The RTU figure 1 3 is a single use device The RTU Plus figure 1 4 employs a reusable handle that is coupled with a single use balloon Part Number 250209 001 Rev G 7 10 13 of 112 Section 1 System Description Temperature sensors Handle Cable Connector Finger pad Rectal balloon Orientation flag Extension tubing Balloon inflation port Figure 1 3 Single Use Rectal Thermosensing Unit RTU DEPLOYED SHEATH RECTAL BALLOON SERIAL MUMECR LABEL EN TEMP SENSORS HANDLE CONNECTER EXTENSION TUBING BALLIN INFLATION FIRT Figure 1 4 Assembled RTU Plus with reusable handle and single use balloon 1 2 4 Coolant Bag The single use Coolant Bag figure 1 5 serves as the reservoir for the sterile water and during treatment is placed in the Control Unit on the chill plate Tubing from the Coolant Bag is connected to the MDS The sterile water is chilled and circulated through the MDS by the Control Unit to protect the urethra from the heat generated by the MDS Coolant bas Mounting hole 3 pl lt lt DASE Coolant inlet and outlet tubing Hydrophobic vent _
71. is System equipment overview is as follows Part Number 250209 001 Rev G 7 10 11 of 112 Section 1 System Description 1 2 1 Targis Control Unit The Targis Control Unit provides the user with interface for entering patient data controlling treatment parameters for microwave power coolant temperature and time and monitoring rectal and Microwave Catheter temperatures figure 1 1 Figure 1 1 Targis Control Unit The Control Unit supplies microwave energy and coolant to the Microwave Catheter and collects temperature data from the Microwave Catheter and the Rectal Thermosensing Unit 12 of 112 Part Number 250209 001 Rev G 7 10 System Description Section 1 1 2 2 Microwave Catheter The Targis Microwave Catheter MDS the Cooled ThermoCath MDS and the CTC Advance MDS contain a microwave antenna and cable a distal balloon to position the device at the bladder neck optical fiber temperature sensor to measure urethral temperatures a urine drainage port and lumens to circulate sterile water to cool the urethra figure 1 2 The CTC Advance MDS is shown in Figure 1 2 for reference Hicrowove tenna connector Sho tt TA FR R Tenperoture sensor NS Lool ing balloon Coude tip connectar X NY x a se T a oer H y Locotion bol loon inflation port lii Location bal laon eriol lobe lirine drainage Figure 1 2 CTC Advance Microwave Catheter 1 2 3 Rectal Thermosensing Unit RTU RTU Plus The Targ
72. le housing and connectors for kinks cuts dirt contamination or obvious damage The recommended environment for use includes Providing ventilation space of at least 20 cm clearance around the base of the Control Unit for operation Operating the Control Unit on a level surface 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 The equipment must be connected to a fully tested hospital grade power outlet with adequate grounding Power requirements European version 220 240 V 10 4 25 A Single phase 50 or 60 Hz U S version 110 120 V 10 8 5 A Single phase 50 or 60 Hz If required an equal potential ground cable should be connected to the Control Unit figure 1 12 and the appropriate ground 22 of 112 Part Number 250209 001 Rev G 7 10 System Description Section 1 Equal Polential Figure 1 12 Targis Control Unit Rear Cover 1 10 Equipment Cleaning Follow these instructions to clean the Control Unit exterior Clean the exterior surface of the Control Unit using a lint free cloth dampened with warm water and a 10 solution of mild detergent or a diluted non abrasive non staining standard hospital disinfectant Use a lint free cloth dampened with warm water to wipe the surface of the unit Do NOT use isopropyl alcohol IPA to wipe the exterior Control Unit housing or the display scr
73. lever tubing clamp i Coolant bag Pump tubing notch Coolant inlet tubing f Sensor module Lower pump housing Figure 2 8 Coolant System with Pump Mechanism Open 7 Place the Coolant Bag pump tubing inlet tubing of the Coolant Bag under the upper pump tubing clamp and across the rotor of the pump mechanism Figure 2 8 8 Align the Coolant Bag sensor module with the locating pins to the right of the pump mechanism Figure 2 9 9 Push down the pump tubing clamp until it snaps into position figure 2 10 Part Number 250209 001 Rev G 7 10 33 of 112 Section 2 Treatment Setup Figure 2 9 Positioning the Sensor Module 10 Ensure the coolant inlet tubing is properly seated into the notch of the lower pump housing clamp Locking lever Sensor block BEE Tubing holder Figure 2 10 Coolant System with Pump Closed 11 Insert the coolant inlet and outlet tubing into the tubing holder next to the ON OFF switch This will prevent the tubing from being pinched by the coolant door 12 Close the coolant door completely 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 34 of 112 Part Number 250209 001 Rev G 7 10 Treatment Setup Section 2 2 9 Insert the Microwave Catheter Select the appropriate catheter model as per table Prost
74. ll end the treatment 3 4 2 5 Control Panel ERROR WARNING This panel is displayed to indicate an error or warning ERROR WARRING RESUME 1X FO TX END HO Figure 3 15 Error Warning Panel e RESUME TX Pressing YES will return to the previous panel e END TX pressing YES will exit the treatment mode and enter Cooldown 58 of 112 Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 3 4 2 6 Control Panel EXIT COOLDOWN This panel is displayed to indicate the user has selected COOL END EXIT COOLDOWN RESUME COOL E Figure 3 16 Exit Cooldown Panel e RESUME COOL Pressing YES will return to the previous panel e SPACEBAR press the spacebar on the keyboard to exit treatment Note After confirming this message with the spacebar it is not possible to re enter treatment without recalibration Part Number 250209 001 Rev G 7 10 59 of 112 Section 3 Treatment Instructions 3 4 3 Automatic Treatment Cruise IT In this mode the Control Unit will automatically ramp the MDS temperature to the MDS set point and the Coolant temperature to the coolant set point value of 8 C for the Targis MDS and 15 C for the Cooled ThermoCath MDS and the CTC Advance MDS These target values of MDS Set point and Coolant Set point can be changed at any time The initial ramp rate is chosen on the Treatment Settings screen a Note If an error occurs during Cruise the system will t
75. logix Customer Service 1 4 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service Part Number 250209 001 Rev G 7 10 Troubleshootince Problem Message ENGLISH LANGUAGE FILE 323 MDS WARMUP ERROR 324 MDS HEATER FAILURE 325 MDS FAILURE 326 Possible Causes 1 A problem was found with the English language file 1 MDS temperature electronics failed 1 MDS temperature electronics failed 1 MDS temperature electronics failed Part Number 250209 001 Rev G 7 10 Section 5 Action Steps 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 1 Do not continue to use the Control Unit Call Urologix Customer Service 95 of 112 Section 5 5 2 Targis Treatment Screens r Startup Display Screen MW OFF MAIN MENU PATIENT DATA SCREEN SCREEN NEXT OPTIONS OPTIONS SCREEN SPACEBAR 96 of 112 Troubleshooting TREATMENT TREATMENT CALIBRATION SETTINGS CHEC
76. logix for evaluation and reimbursement The Control Unit exterior should be cleaned periodically following these instructions Clean the exterior surface of the Control Unit with a soft lint free cloth dampened with warm water and a diluted detergent 10 dilution of bleach or a diluted nonabrasive non staining 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 Control Unit or display screen Using cleaning solvents such as IPA could result in damage to the Control Unit Part Number 250209 001 Rev G 7 10 75 of 112 Section 4 Equipment Maintenance Storage Instructions For short and long term storage handle the Targis Control Unit as you would other sensitive medical equipment Store the Control Unit in a low moisture equipment storage area where it may be kept long term Keep the surfaces and components of the Control Unit free of dust by covering the unit with its cover or plastic 4 2 Equipment Moving Instructions When moving the Targis Control Unit grip the handle at the top of the unit This handle is designed for moving and one person should be able to push or pull the unit with little effort The wheels of the unit pivot to assist you when you wish to turn 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 d
77. n ON the Control Unit at least 5 minutes before treatment begins to allow the system to warm up Part Number 250209 001 Rev G 7 10 2 of 112 Section 2 Treatment Setup 2 After the Control Unit has been operating for at least 5 minutes press the MW OFF soft key to verify its operation and advance to the Main Menu Screen figure 2 2 UROL LOGIX ion amp 10b Figure 2 2 Main Menu Screen 2 6 Enter Patient Data 1 Pull the keyboard drawer out on the top front panel of the unit You will use the keyboard to enter patient data 2 Press the NEXT soft key figure 2 2 on the monitor to advance to the Patient Data Display Screen figure 2 3 28 of 112 Part Number 250209 001 Rev G 7 10 Treatment Setup Section 2 HAME gt John Doe ID gt 33445123 MDS TYPE gt lt Targis 3 8 5 0 Blue tag 6 v MDS SH gt abi23456 RIU SH LDT gt 2123456 PHYSICIAN NAME Dr Ronald Obvious 25 FEB 2089 02 44 21 PM Figure 2 3 Patient Data Display Screen 3 Enter patient data using the keyboard as prompted on this screen and using the following format guidelines Name ID MDS Type MDS S N RTU SN Lot Physician Name Date Time Enter the patient s name up to 25 alphabetic characters Enter the patient s hospital medical record number or clinic ID You can enter up to 15 alphanumeric characters Press up down arrow to change type Enter the MDS ser
78. ng The current MDS temperature will become the set points 3 4 2 3 Control Panel COOL CONTROLS This is the control panel displayed during the Cooldown after treatment Figure 3 13 Cool Control Panel a Note Make sure that the Cooldown timer has reached 5 minutes prior to exiting treatment y Note The keyboard must be accessed and the space bar pressed in order to completely exit a treatment e PRINT Press YES to print a listing of the treatment e COOL SET the target Coolant temperature set point e PUMP Ifthe user presses the OFF soft key a message will appear to confirm turning the pump off When confirmed the pump will turn off e RESUME TX Ifthe user presses YES the Manual Controls panel will be displayed and the treatment can resume e COOL END Ifthe user presses YES a confirmation message will appear If the user selects YES again to confirm Cooldown will stop and the treatment is ended and cannot be resumed Part Number 250209 001 Rev G 7 10 57 of 112 Section 3 Treatment Instructions 3 4 2 4 Control Panel MESSAGE During treatment messages are displayed with a message panel MESSAGE Confirm TAa EH HD at a 2 m de a a to resume therapy Select Tm END to begin Cooldown RESUME IX HU TX ERD Figure 3 14 Message Panel e RESUME TX Pressing YES will return to the previous panel pressing NO will have no effect e TX END Pressing YES wi
79. nt door on the front of the 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 6 Figure 2 6 Positioning the Coolant Bag onto the Top Mounting Pins 4 Complete the process of installing the Coolant Bag by positioning the bottom mounting hole over the lower mounting pin below the chill plate Figure 2 7 Figure 2 7 Positioning the Coolant Bag onto the Lower Mounting Pin 7 Caution Do not allow the Coolant Bag connectors to fall on the floor during installation 5 Route the Coolant Bag 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 Lay the pump tubing of the Coolant Bag across the center of the pump mechanism Figure 2 8 32 of 112 Part Number 250209 001 Rev G 7 10 Treatment Setup Section 2 z Note To prevent damage from occurring to the Coolant Bag never leave the coolant door in the open position Note Ensure inlet tubing is properly seated in the notch of the lower pump housing Ensure that the coolant tubing is not twisted 6 When the Coolant Bag is mounted correctly on the chill plate the Coolant Bag inlet tubing and sensor module are aligned with the pump mechanism Figure 2 8 Upper pump Locking
80. o drop lt 41 C 2b Restart system at 5 watts below previous microwave power setting 3 Replace the MDS Resume microwave power 1a Reattach connector 1b Clean both ends of connection with alcohol wipe or swab 2 Restart system at a previous microwave power setting 3 Replace MDS Resume microwave power 1 Reattach connector 2 Check that MDS is inserted properly 3 Replace MDS and recalibrate Re enter patient information 4 Purge urine drainage line Resume microwave power 1 Remove any item blocking vents 2 Restart system at the previous microwave power setting 3 If system fails again call Urologix Customer Service Resume microwave power 1 Call Urologix Customer Service Part Number 250209 001 Rev G 7 10 Troubleshooting Problem Message MW POWER IS OFF Amplifier Temp High 10 MW POWER IS OFF Coolant Temp High 11 MW POWER IS OFF Coolant Temp Low 12 MW POWER IS OFF RTU Temp High 13 Possible Causes 1 Control Unit vents are blocked 2 Microwave amplifier temperature is greater than the allowed value 1 Coolant temperature gt 40 C 2 Coolant Bag may be defective 3 Coolant door open 1 Coolant temperature is too low 2 Coolant Bag may be defective 3 Coolant door open 1 Loose connector 2 Temperature in the rectum gt 42 C 3 RTU may be defective 4 Air may not have been removed from the original volume in t
81. om the wall outlet and roll the Control Unit to a storage location until the next procedure Replace Control Unit cover 3 6 Post Procedure Treatment Options Due to edema from thermal damage caused by the treatment to the prostate tissue the prostate may swell and obstruct the urethra for a short period of time For patient comfort the physician may e Place a Foley Catheter before discharging the patient The catheter may be removed within 2 to 5 days or as the physician directs e Instruct the patient at discharge to take prophylactic oral antibiotics for 3 to 5 days e Provide the patient with sedatives pain relievers or anti inflammatory medication as necessary Part Number 250209 001 Rev G 7 10 63 of 112 Section 3 Treatment Instructions 3 7 Options The Options Screen figure 3 17 will be displayed after exiting a treatment or by pressing the OPTIONS soft key on the Main Screen The Options Screen menu allows the following functions Copy a patient data file to a floppy diskette Print a patient data file on the Control Unit printer Format a diskette to prepare it for copying patient data Adjust system settings Select the desired function by pressing the TAB key on the Control Unit keyboard A border highlighting the selected function will move between functions as the TAB key is pressed After selecting the desired function press the ENTER key on the keyboard to activate the function 64 of 112 Part Number 250209 001 Rev
82. ontrol Unit as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m output power of transmitter 150 kHz to 80 80 MHz to 800 MHz 800 MHz to 2 5 GHz 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 4 Recommended Separation Distances Part Number 250209 001 Rev G 7 10 111 of 112 Section 5 Troubleshooting 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 2513 BH The Hague The Netherlands Tel 31 0 70 345 8570 Fax 31 0 70 346 7299 CE Targis System Targis Control Unit User Manual Part 250209 001 Rev G Jul 2010 2010 Urologix Inc All rights reserved Printed in the
83. oon Coude tip Seriol Tobel Urine drainage Figure 2 11b CTC Advance MDS 7 Insert the MDS into the patient s urethra until the location balloon is completely in the bladder Align the MDS so that the urine drainage port is pointed toward the patient s posterior and the coolant tubing is in an anterior orientation ii al Warning Do not overinflate the Microwave Catheter balloon Over inflation may result in balloon malfunction and possible improper positioning of the microwave antenna Under inflation can cause the antenna to be misplaced in the prostate affecting the external sphincter 7 Caution The microwave antenna on the distal end of the Microwave Catheter may break if you bend it Do not grab the Microwave Catheter or squeeze it in the area of the antenna or the shaft The optical fiber located in the flexible shaft may be broken if it is clamped 8 Inflate the location balloon with 10 cc of sterile water Pull back on the MDS until you feel mild resistance 9 Flush the urine drainage lumen with 4 cc of sterile water Attach a urine drainage bag or catheter plug 36 of 112 Part Number 250209 001 Rev G 7 10 Treatment Setup Section 2 10 Position the MDS properly by pulling on it until the balloon is seated in the bladder neck locating the microwave antenna within the preprostatic urethra Figure 2 12 Verify MDS position with the ultrasound probe 11 If the MDS position is not
84. ooting Section 5 MDS An acronym for Microwave Delivery System also refers to the Microwave Catheter MDS Temp The temperature at the tip of the Targis Microwave Catheter in the center of the treatment region Messages Directions or reports that assist the clinician in monitoring a Cooled ThermoTherapy procedure Microwave Antenna The Targis System component within the Microwave Catheter that generates heat energy to destroy prostate tissue 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 Microwave Delivery System Microwave Catheter MDS A disposable catheter based device which 1s 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 Power Down The microwave power down button soft key on the Control Unit monitor that decreases the power set point by one watt Microwave Power Off The microwave power off button on the Control Unit monitor that allows you to discontinue
85. or reference Section 1 System Description outlines Targis system components equipment subsystems provides important notes about usage describes the Targis Control Unit and the Targis Procedure Kit including the Microwave Catheter Rectal Thermosensing Unit Coolant Bag and accessories presents information on installation environment sterilization and cleaning procedures connections testing and safety instructions Section 2 Treatment Setup describes how to set up the Control Unit enter patient data prepare the patient prepare the coolant bag and insert the Microwave Catheter and the RTU rectal unit Section 3 Treatment Instructions discusses Targis System calibrations how to adjust the coolant temperature and microwave power how to begin and end treatment and how to copy and print treatment data The section ends with post treatment options Section 4 Equipment Maintenance presents information on post treatment cleaning procedures and storage instructions describes correct moving and shipping methods and cautions describes normal maintenance procedures that can be performed by the user organization This chapter also itemizes equipment that is serviceable only by a Urolog1x trained service representative Section 5 Troubleshooting includes the Targis System specifications a Troubleshooting Guide Targis Treatment Screens Description of Symbols List of Figures and a Glossary 4 of 112 Part Number 250209 001 Rev G 7
86. 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 frequency sweep Catheterization The placement of the Microwave Catheter or urine drainage catheter into the urethra Chill Plate One of the components of the Targis Control Unit Coolant System that removes heat from the Coolant Bag 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 1s filled with sterile distilled water coolant that circulates through the Microwave Catheter during treatment to preserve urethral tissue 100 of 112 Part Number 250209 001 Rev G 7 10 Troubleshooting Section 5 Coolant Door The large front panel of the Targis Control Unit behind which is located the Coolant System Coolant Pump See peristaltic pump mechanism Coolant Set Point The temperature at which the cooling system is set to regulate the temperature of the water circulating through the Microwave Catheter The actual water temperature may be different from this value during the time that the system chills or warms the water Once the water reaches the coolant set point value the coolant temperature is maintained within a small tolerance of this value Coolant System The Coolant System consists of a chill plate temperature and pr
87. own on the front part of the wheel lock tabs To unlock the wheels press on the back part of the wheel lock tab Observing Proper Safeguards Several safeguards or cautions apply when you need to move the Control Unit They are as follows Protect the patient connection cable when you move the system Although a storage hook is provided on the handle for the patient connection housing the cable is still susceptible to damage Maintain the system in an upright position when it is in use or being stored Avoid tipping the unit Since the system is heavy it will be damaged if it were to tip over In addition personal injury could result Do not lift or elevate the Control Unit Equipment Shipping Instructions In the event that it becomes necessary to ship the Targis Control Unit contact Urologix Customer Service at 1 888 229 0772 For repeated transportation of the Targis Control Unit Urologix offers a Targis Transportable Kit which is the only FDA approved method for transporting the Targis System 4 3 Operator Inspection Before using the Targis system operators should visually inspect the following components for damage Examine Control Unit for obvious damage Pump latch and coolant door to see that they are operating correctly Patient connection cable cable connection housing and connectors for kinks cuts dirt contamination or obvious damage Microwave Catheter for kinks cuts or obvious damage Rectal Thermosensin
88. plastic viewing surface of the Targis Control Unit that allows the clinician to view information related to a patient s prostate 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 Floppy Disk A portable 3 5 inch storage medium where the patient s files are stored It is inserted in the floppy disk drive on the right side of the Targis Control Unit keyboard Floppy Disk Drive The computer device that reads and writes information on the patient s floppy portable disk The floppy disk drive is located on the right side of the Targis Control Unit keyboard Frequency Sweep An internal diagnostic test the 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 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 Targis 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 102 of 112 Part Number 250209 001 Rev G 7 10 Troublesh
89. plete appearing on the screen after each step The calibration process requires up to 7 minutes to complete Part Number 250209 001 Rev G 7 10 47 of 112 Section 3 Treatment Instructions 3 3 Calibration Progress Screen Figure 3 3 Calibration Process Screen The Calibration Progress screen displays the completion status of each item listed After a successful calibration the Treatment Screen will be displayed To cancel calibration press the CANCEL soft key The Calibration Halted Screen will be displayed If the Control Unit does not calibrate the Calibration Halted Screen will be displayed Use the error message displayed and refer to Section 5 Troubleshooting Guide to resolve the problem El Warning If a calibration error message appears see Section 5 Troubleshooting Guide in this manual for more information 48 of 112 Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 3 4 Treatment Procedure After completing Calibration the Targis system will enter one of the two treatment modes depending upon the user selection on the Treatment Settings screen These modes are Cruise Control or Manual Control Safety Checks During Treatment Important It is critical that throughout the patient s treatment the treating physician verify the correct position of the Microwave Catheter and the RTU Patient safety is at risk if the following simple and straight forward procedures are not correctl
90. r alignment The side of the RTU Plus labeled Anterior will be facing up when properly positioned 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 THERMOSENSING UNIT FAILURE TO PROPERLY ORIENT THE RTU DURING TREATMENT CAN RESULT IN PATIENT INJURY E G FISTULA OR SCROTAL BURN Pi Warning A minimum of 70 cc of air in the RTU Plus rectal balloon is required to maintain contact between the temperature sensors and the rectal wall 12 Inflate the rectal balloon by injecting 90 cc of air into the inflation port located on the proximal end of the RTU Adjust the air volume to a minimum of 70 cc for patient comfort 13 The physician must confirm the proper positioning of the RTU Plus prior to proceeding y Note When a reusable RTU Plus is being used the Treatment checklist screen will display the number of times the handle has been used and the number of remaining uses The reusable RTU Plus should not be used in excess of 30 times 2 12 Connect the MDS and RTU to the Control Unit 7 Note To relieve pressure on the RTU and increase patient comfort position patient so that he is reclining on his back with head and shoulders elevated no higher than a 20 angle M YW Warning Excessive elevation of the patient s torso may put additional pressure on the rectal unit resulting in increased patient discomfort and higher rectal tempera
91. r replacement paper for the printer from Urologix Follow these steps to replace the paper 1 Press down on printer door to release the latch and lift the door open Part Number 250209 001 Rev G 7 10 1 of 112 Section 4 Equipment Maintenance 2 Remove the old roll from the paper well 3 Place the paper roll in the paper well Note Thermal paper must roll out from the bottom of the paper roll 4 Cut the end of the new paper square 5 Push the paper into the printer The printer will feed the paper using its automatic feed After the printer feeds the paper advance approximately 3 inches of paper out the top of the printer using the Paper Feed Button figure 4 2 6 Feed the paper through the paper slot in the printer door 7 Close and latch the printer door PRINTER DOOR Ma a NY PAPER WELL PAPER FEED BUTTON Figure 4 2 Loading Paper in Printer 4 4 2 Printer Cleaning Printer cleaning must be performed by trained service personnel using the instructions in the Targis Control Unit Service Manual 4 5 Fuse Replacement 1 Using a flat screwdriver remove the fuse holder caps figure 4 3 78 of 112 Part Number 250209 001 Rev G 7 10 Equipment Maintenance Section 4 Equal Potential Figure 4 3 Targis Control Unit Rear Cover 2 Replace the defective fuses with the appropriate Urologix fuses listed below Control Unit Model Fuse Catalog Number Fuse Type Ratinc Model 4000A AC1008 1 1 4 x 1 4
92. reen 7 TAB to DAY and press the ENTER key Each time the ENTER key is pressed the day will increase by 1 8 TAB to the MONTH and press ENTER to cycle through the months 9 TAB to the YEAR and press ENTER to increase the year Each time the ENTER key is pressed the year will increase by 1 until 2020 and then it will start over at 1990 10 TAB to OK and press ENTER to exit This will return you to the Set Date and Time Pop up Screen figure 3 25 Part Number 250209 001 Rev G 7 10 69 of 112 Section 3 Treatment Instructions 11 Tab to the OK on the Set Date and Time Pop up screen and press ENTER to return to the Options Menu Screen figure 3 17 3 7 4 2 Select a Language The Targis System user software 1s only available in English Lanuage F Figure 3 28 Language Screen 3 7 5 Options Errors If an options error occurs the Options Error Pop up Screen figure 3 28 will be displayed If this screen is displayed refer to Section 5 Troubleshooting Guide action steps to correct the error Figure 3 29 Options Error Pop up Screen 3
93. rough the inlet tubing to the Microwave Catheter and beyond This is part of the coolant system Pump Tubing Clamp The fastening arm just above the peristaltic pump mechanism that locks the coolant inlet tubing in place as it is routed out of the Control Unit console to the Microwave Catheter Rectal Temperature The temperature reported by the warmest of the 5 sensors in the rectal unit Rectal Thermosensing Unit RTU Rectal Unit 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 connection cable via the patient connection cable housing of the Targis Control 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 RTD An acronym for Resistive Temperature Detector RTU A single use rectal unit and an acronym for what was previously referred to as the Rectal Thermosensing Unit RTU Plus The rectal unit with a reusable handle and single use balloon RTU Serial Number The serial number of the Rectal Thermosensing Unit used in a treatment and required for the patient s data file Part Number 2
94. s switched ON The Targis System is exclusively for use by physicians who have been trained The treating physician should be present at all times during treatment Part Number 250209 001 Rev G 7 10 25 of 112 Section 2 Treatment Setup 2 1 Targis Treatment Setup Introduction The Cooled ThermoTherapy procedure requires several preparation steps Some of these steps may be done concurrently 1 Prepare the patient for treatment 2 Setup the Control Unit 3 Enter the patient data 4 Prepare the Coolant Bag 5 Insert the Microwave Catheter 6 Insert the single use standard RTU or insert the RTU Plus with reusable handle and single use balloon 7 Connect the Microwave Catheter and RTU RTU Plus to the Control Unit 8 Access the Treatment Checklist Screen y 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 2 Prepare the Patient To prepare the patient for treatment follow these steps 1 Ensure the patient has received adequate information about the treatment and post treatment expectations and has provided informed consent 2 Perform an enema 1 to 2 hours before treatment or per physician instructions 3 Administer pre operative medications at this time such as local anesthetics antibiotics non steroidal anti inflammatory agents It is important that the patient not be over sed
95. s the current RTU sensor temperature in degrees C e COOL C This displays the current Coolant sensor temperature in degrees C as measured by the Coolant Bag sensor block If the coolant pump is turned off this reading will gradually approach room temperature Part Number 250209 001 Rev G 7 10 51 of 112 Section 3 3 4 1 3 Control Panels CRUISE CONTROLS MDS SET COUL SET RAMP RATE TX TIME 4H B Treatment Instructions MANUAL CONTROLS COOL CONTROLS PUR SET d8 PRINT NO COOL SEI COOL SET CRUISE TX EXD NO COOL ERD Figure 3 7 Control Panels The Control Panel displays the current value of treatment parameters and allows the user to modify them The Control Panel contains a list of treatment parameters on the right and text description on the left with the exception of the Message and Error Warning Control Panels Control Panel types Cruise Controls Manual Controls Cool Controls Message and Error Warning 52 of 112 Part Number 250209 001 Rev G 7 10 Treatment Instructions Section 3 3 4 1 4 10 Minute Graph This is a scrolling strip chart displaying MDS temperature RTU temperature Coolant temperature and MW Power as a function of time The colors of each trace correspond to the color of the item in the Status Panel DEGREES C amp WATTS 918 AHS 10 MINUTE VIEW 2 MIN DIWS Figure 3 8 10 minute view 3 4 1 5 60 Minute Graph This is a scrolling strip chart displaying MDS
96. se 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 solution 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 RTU Plus 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 NO There are no special clean up operations required after a Cooled ThermoTherapy Treatment for the Control Unit If a product failure occurs the defective device must be returned to Uro
97. t Checklist Screen EER Prior to pressing NEXT ensure that 1 The Coolant Bag is filled with sterile distilled water and mounted in the Targis Control Unit 2 The WDS is properly positioned in the patient AS VERIFIED BY ULTRASOUND with urine port flushed 3 The RIU is properly positioned in the patient The disposable products are properly connected to the Targis Control Unit ATTENTION RTU 2123456 has been used 4 times It is approved for use another 26 times Figure 3 2 Treatment Checklist Screen Please note that when a reusable RTU is being used the Treatment Checklist screen will display the number of times is has been used and the number of remaining uses The reusable RTU Plus should not be used in excess of thirty 30 times Figure 3 2 displays the Treatment Checklist screen when used with a reusable RTU The Treatment Checklist screen contains a list of items that must be verified prior to pressing the NEXT soft key 1 Review the Treatment Checklist Screen to ensure that all steps have been taken figure 3 2 If you need to change any patient or product data press the BACK soft key on the Treatment Checklist Screen to return to the previous screen 2 Press the NEXT soft key on the Treatment Checklist Screen to begin calibration As the calibration sequence proceeds the indicator will change to blue Progress through each calibration step is shown by the vertical bar figure 3 3 and by the word com
98. t to File 66 3 7 3 Format Diskette in Floppy Drive 67 3 7 4 Adjust System Settings 68 3 7 4 1 Set Control Unit Time and Date 69 3 7 4 2 Select a Language 70 3 7 5 Option Errors 70 3 8 MW OFF Soft Key 70 3 9 Targis System Errors 71 3 9 1 Calibration Errors 71 3 9 2 Treatment Errors 72 3 9 3 System Halt Errors 72 4 1 Post Treatment Cleaning Procedures 75 Storage Instructions 76 6 of 112 Part Number 250209 001 Rev G 7 10 4 2 Equipment Moving Instructions 76 Observing Proper Safeguards 76 Equipment Shipping Instructions 76 4 3 Operator Inspection 77 Daily Maintenance 77 Periodic Maintenance 77 4 4 Printer Maintenance 77 4 4 1 Changing Paper in Printer 77 4 4 2 Printer Cleaning 78 4 5 Fuse Replacement 78 4 6 Targis Control Unit Power Cords 80 4 7 Targis Control Unit Specifications 81 5 1 Troubleshooting Guide 83 5 2 Targis Treatment Screens 98 5 3 Description of Symbols 97 5 4 Glossary 100 5 5 Electromagnetic Compatibility EMC Tables 108 List of Figures Section 1 Figure 1 1 Targis Control Unit 12 Figure 1 2 CTC Advance Microwave Catheter 13 Figure 1 3 Single Use Rectal Thermosensing Unit RTU 14 Figure 1 4 Assembled RTU Plus 14 Figure 1 5 Coolant Bag 14 Figure 1 6 Targis Control Unit 15 Figure 1 7 Patient Connection Cable 16 Figure 1 8 Treatment Monitor Features 16 Figure 1 9 Coolant System Features
99. te Specific Antigen level 30 of 112 Part Number 250209 001 Rev G 7 10 Treatment Setup Section 2 Urethra Length Prostatic Urethra Length from the bladder neck to the verumontanum measured in centimeters Prostate Volume volume in grams PVR post void residual volume ml DOB Date of Birth Press the NEXT soft key figure 2 4 on the monitor to advance to the Treatment Settings Screen 2 8 Prepare the Coolant Bag Follow these steps to prepare the Coolant Bag pH Instruction Manual Read the Targis Control Unit User Manual before installing the Coolant Bag 1 Open the package containing the Coolant Bag and remove the Coolant Bag 2 Fill the Coolant Bag with sterile water 100 cc 5 cc by injecting the water into the luer fitting of the Coolant Bag with a syringe Figure 2 5 Once Coolant Bag has been filled temporarily connect the luer fittings to each other to prevent leakage W caution 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 Figure 2 5 Filling the Coolant Bag Wrote To prevent water from leaking out of the Coolant Bag hold the Coolant Bag connectors above the Coolant Bag or loosely temporarily connect them together Part Number 250209 001 Rev G 7 10 31 of 112 Section 2 Treatment Setup 3 Open the coola
100. ter Hydrophobic Vent _ Mounting Pins 3 places ail _ Coolant Inlet Tubing we J Coolant Flow pe ee Sensor Module Connectors N Coolant Bag Coolant Outlet Tubing Coolant Inlet and Outlet Tubing Figure 1 11 Coolant Bag Features 20 of 112 Part Number 250209 001 Rev G 7 10 System Description Section 1 W caution 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 MDS during treatment 1 8 Required Equipment The following equipment is needed to successfully treat patients with the Targis System 1 8 1 Equipment Provided by Urologix The following equipment is provided by Urologix Quantit l 1 Equipment Material Targis Control Unit Procedure Kit containing e 1 Microwave Catheter either Targis Cooled ThermoCath or CTC Advance e 1 Rectal Thermosensing Unit standard RTU or RTU Plus e 1 Coolant Bag Patient Comfort Kit 2 knee cushions and a Microwave Catheter Holder 1 8 2 Equipment Provided by the User The following equipment is typically provided by the user Quantit l l l As needed As needed 50 cc As needed l l 2 200 cc l l As needed As needed l l l As needed Equipment Material Foley catheter 16 18 French Straight catheter 14 16 French Urine drainage bag Sterile gloves Anesthetic lubricating jell
101. the delivery of the microwave power immediately Microwave Power Up The microwave power up button soft key on the Control Unit monitor that increase the power set point by one watt MW An abbreviation for microwave Neurogenic Bladder Dysfunctional urinary bladder caused by a lesion of the nervous system Part Number 250209 001 Rev G 7 10 103 of 112 Section 5 Troubleshooting Obstructive Bladder Neck Syndrome An impairment of the outlet area of the bladder caused by prostate tissue constricting the urethra Orientation Flag The vertical guide on the disposable rectal unit approximately 1 in height that serves the clinician in correctly positioning the rectal balloon Patient Comfort Kit A Targis Control Unit accessory which includes 2 knee cushions and Microwave Catheter Holder It provides comfort for the patient and holds the catheter in position for the duration of treatment Patient Connection Cable An extension cable that connects the patient connection cable housing to the Targis 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 Targis Control Unit that uses peristaltic action to propel coolant through the coolant inlet tubing to t
102. tic establishments and Harmonic emissions Class A those directly connected to the public low IEC 61000 3 2 voltage power supply network that supplies Voltage fluctuations Complies pulls used 208 eomesitc Pave ren Pae provided that the following warning is flicker emissions IEC 61000 3 3 ERA Warning This equipment is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the Targis Control Unit or shielding the location Table 5 1 Electromagnetic Emissions 108 of 112 Part Number 250209 001 Rev G 7 10 Troubleshooting Section 5 Guidance and manufacturer s declaration Electromagnetic Immunit The Targis Control Unit is intended for use in the electromagnetic environment specified below The customer or the user of the Targis Control Unit should assure that it is used in such an environment 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
103. tures 1 If necessary reposition the patient on his back with his head and shoulders at less than a 20 angle Part Number 250209 001 Rev G 7 10 41 of 112 Section 2 Treatment Setup 2 Gently pull on the MDS to reseat the location balloon at the bladder neck in case it moved during RTU 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 Secure the Microwave Catheter into the Microwave Catheter holder with the cooling lines in the anterior position 4 Mark position on MDS at penis meatus with marker W caution THIS VISUAL REFERENCE SHOULS BE CHECKED EVERY 5 TO 10 MINUTES THROUGHOUT THE TREATMENT TO VERIFY THE PROPER POSITION OF THE MICROWAVE CATHETER AND THE RECTAL THERMOSENSING UNIT 5 Secure the Microwave Catheter fiber optic and microwave connectors to the patient connection cable housing figure 2 18 6 Connect the coolant tubing connectors of the MDS to the coolant bag connectors 7 Attach a urine drainage bag to the urine drainage port of the MDS 8 Insulate the antenna cable away from the patient s legs The cable can become hot to the touch during extended treatment at high power levels micnowave_ DELIVERY SYSTEM RECTAL THERMO SENSING UNIT ATU j ATU ORIENTATION FLAG bS PATIENT CONNECTION CABLE HOUSING j
104. uce microwave power until the MDS temperature is between 39 C and 41 C 1a Wait 5 minutes with the microwave power at zero 1b Press YES to confirm 1a The current MDS temperature needs to be between 35 C and 40 C 1b MW power needs to be 210 watts 1 Increase MW power per protocol 1 Drop the MW power to lower the RTU temperature less than 42 C 89 of 112 Section 5 101 Problem Message Possible Causes 100 Calibration halted by the 1 Temperature RTU 100 positioned 5 RTU expelled or not properly inflated Calibration halted by the MDS sensor 101 contaminated inserted broken 90 of 112 measurements in the RTU are not being received by the Targis Control Unit 2 RTU may be lt 31 C 3 RTU may be defective 4 RTU may not be properly 1 Fiber optic connector may be improperly connected or 2 MDS may not be properly 3 MDS may be defective 4 Fiber optic cable may be Troubleshooting Action Steps 1a Disconnect and reconnect RTU connector on patient cable 1b Press REPEAT soft key If this doesn t correct problem replace RTU as in Step 3 below 2a Ensure RTU is properly inserted in patient 2b Press REPEAT soft key 3a Replace the RTU 3b Press REPLACE soft key 3c Enter new RTU number 3d Press NEXT soft key to restart calibration cycle 3e Record on Device Return Form that RTU has been replaced if applicable 3f Turn off
105. urn off MW Power and revert to Manual Control The default set point values depend upon the MDS being used and are defined in the table below Default MDS Set Point Default Coolant Set Targis 40 C Microwave Catheter CTC Advance and Cooled ThermoCath 40 C 15 C Microwave Catheter What will the Cruise II software do for me e It will ramp the MDS temperature and Coolant temperature to the desired set points e It will adjust the coolant set point to respond to RTU temperatures e It will discontinue the MW Power when the TX TIME has elapsed and will automatically begin Cooldown The entire treatment can be described in three sections Ramp Treatment Cooldown 3 4 3 1 Section Ramp e The ramp will begin automatically when calibration has completed e MW Power will be applied automatically according to the individual patient s urethral temperature response Cruise will ramp the MDS and Coolant temperatures to their set point values according to the Ramp Rate selection e Monitor the patient for discomfort and adjust the Ramp Rate if necessary The Ramp Rate can be reduced to HOLD allowing the patient to get used to the current level of MW Power before continuing e Adjust the MDS and Coolant set points as desired It is recommended to use the default MDS and Coolant set points 3 4 3 2 Section Treatment e The TX TIMER will count up the amount of time elapsed when the criteria
106. wave 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 Targis Control Unit 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 1f 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 Targis Control Unit emits a small amount of electromagnetic energy during a procedure Urologix recommends that all electronic medical devices be kept at a minimum distance of 1 0 meter from the Targis Control Unit when performing a treatment However a 1 meter separation of electronic medical equipment from the Targis Control Unit does not guarantee that operation of other devices will not be impacted The effect of this electroma
107. y e g Urojet or lidocaine jelly Local bladder anesthetic of choice e g 50 cc of 1 or 2 lidocaine without epinephrine Water soluble lubricating gel e g K Y Jelly 60 cc luer lock syringe 60 cc catheter tip syringe e g Toomey syringe 10 cc luer lock syringe Sterile water for coolant bag and catheter balloons Ultrasound system Catheter plug Permanent marker or tape Nonsterile gloves Penile clamp Specimen cup Urinal or graduate Ice or ice pack Part Number 250209 001 Rev G 7 10 21 of 112 Section 1 System Description 1 9 Control Unit Installation and Use Environment Before unpacking the Targis Control Unit inspect the shipping crate for signs of damage il Warning DO NOT USE components that have evidence of a compromised package or damage W caution Do not stack any objects on top of Targis Control Unit Microwave Catheter RTU or Coolant Bag u Caution Do not place the Control Unit near any electronic device or other equipment emitting electromagnetic waves The interference may compromise the operation of the equipment Remove the Targis Control Unit from the shipping crate and inspect the device for damage that may have occurred during shipment Retain the shipping material should the Control Unit need to be returned for service Visually check e Targis Control Unit for obvious damage e Pump latch and coolant door to see that they are operating correctly e Patient connection cable patient connection cab
108. y 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 It is 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 Check the correct positioning of the rectal unit at least every 5 to 10 minutes to ensure the rectal unit has not moved 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 reports serious pain Observe the treatment parameters for sudden changes in readings especially decreases in temperatures that might indicate a sensor has moved from its previous position 3 4 1 Treatment Screen Description The Treatment Screen has several panels used to display temperatures graphing trends and for selecting and modifying controls y Note The user can switch between Cruise and Manual modes at any time during treatment Part Number 250209 001 Rev G 7 10 49 of 112 Section 3 Treatment Instructions ede de Gis dea fede deed fete fede e AN ANT A Figure 3 4 Treatment Screen 3 4 1 1 Soft Key Icons These are the round button images aligned vertically along the right side of the screen They are positioned

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Targis® System Targis Control Unit