C-Trak® Galaxy
Contents
1. Perform System Test Main Menu Setup Select Probe Select Isotope Set Time Zone Set Language Main Menu EXPERIENCE amp EXPERTISE 2 4 9 Select Probe Screen The Select Probe Screen Figure 14 can be reached from the SYSTEM TEST Screen or the SETUP Screen Select Probe allows users with multiple probes to select which C Trak gamma probe to use Users can create new probe entries by selecting NEW or choose a different probe with SELECT All probe information can be edited using the EDIT option To edit an existing probe profile select the probe to be edited and press Edit Both creating a new probe entry and editing an existing one will bring up the Edit Create Probe Screen shown in Figure 15 below When finished touch the select button in the lower left corner of the screen This will navigate back to the System Test or Setup Screens Adding a New Probe or Editing Existing Probe Information To create a new entry select the Probe Type from the drop down menu Then select Name or Serial to generate an on screen keyboard and type in the new information Press OK to save the probe data Multiple probe entries may be saved retrieved on the Galaxy system along with the calibration data for each Pressing the OK button saves the changes and returns to the Select Probe Screen above Care Wise Medical Products C Irak Galaxy System Calibration Probe Te st User Probe2. Gamma Probe System Care Wise Medical Products C Trak Galaxy System C Trak Galaxy www southernscientific co uk 1 0 Introduction 3 1 1 C Trak Analyzer and Probe Introduction 3 1 2 C Trak Getting Started Guide 3 1 3 C Trak Quick Reference for Surgical Use 4 2 0 Getting acquainted with the C Trak System 5 2 1 Front Panel 5 2 2 Bottom Panel 6 2 3 Right Panel 6 2 4 Accessing the Display Screens Sections 1 14 7 16 3 0 Calibration Guidelines 17 3 1 Isotope Check Source Sections 1 2 17 3 2 Check Source Holder Use 17 3 3 Performing Calibration Systems Test 17 4 0 Pre Surgery Set Up 18 4 1 Before Power Is Turned On 18 4 2 Background Test 18 5 0 Sterile Practicies Cleaning and Disinfecting 18 5 1 Use of Sheath 18 5 2 Disinfecting 18 5 3 Decontamination 18 19 5 4 Sterilization 19 6 0 Safety Considerations 20 6 1 Error Messages 20 6 2 Power Supply Requirements 20 6 3 Disassembly 20 6 4 Radioactive Concerns 20 6 5 Use of Electrosurgical Devices 20 6 6 Use of Accessory Equipment 20 6 7 Probe Handling Guidelines 20 7 0 Technical Specifications 21 7 1 Power Probe Overload Cutoff 21 7 2 LCD Display 21 7 3 Probe Cable Connector 21 7 4 Size 21 7 5 Weight 21 7 6 Finish 21 7 7 Mode of Operation 21 7 8 Serial Numbers 21 7 9 Environmental Limits 21 7 10 Label Legibility 21 2 www southernscientific co uk 8 0 Use of Optional Accessories 8 1 C Trak Galaxy System Cart 8 2 Printer 8 3
3. 1040 East Brandon Blvd Brandon FL 33511 5509 USA E mail solutions lablogic com Tel 1 813 626 6848 Fax 1 813 620 3708 Web www lablogic com A S LabLogic Company
4. 2 3 None The user can exit from the Take Timed Counts Screen by pressing 4 the Exit button If the user chooses to exit while a count is being taken counting is interrupted and no data are saved If the user exits after the count is completed but before the 3 second automatic return to the Counts Screen the data from the current timed count are saved NOTE ID information entered on the View Timed Counts Screen will be displayed above the timed counts list Time Remaining 7 Figure 7 Take Timed Counts Screen 2 4 3 View Timed Counts Screen On the View Timed Counts Screen Figure 8 a user can see View Timed Counts the results of any timed counts that have been taken edit ID information for the data and print the results E Date Jul 08 2015 14 23 J Patient 123 Sample oe Duration CPS Percent Viewing Timed Counts Each time a user presses the Take Timed Counts button on the Number 1 None None None Nane None Location Type Time l4 23 11 14 23 28 14 23 43 Counts 5611 5559 7604 361 555 360 Primary 0 3 Hone F Ex Wiwo l None 14 23 58 5 0 ar Count Screen described in 2 4 1 and the user does not interrupt the collection of timed count data by pressing the Exit button described in 2 4 2 data are retained about the amount of radiation collected during that timed count Data about timed counts are retained on the View Timed Counts Screen until the syst
5. Screen described in 2 4 1 System Test Screen described in 2 4 7 and Setup Screen described in 2 4 8 and also allows the user to turn off the C Trak Galaxy System s power using the Shutdown button described in 2 4 13 Care Wiese Medieasal Pradicte k Probe Name Demo Probe Type OmniPr Isotope Cobalt 57 Count Time 1 guelch Disabled Range 0 1000 Figure 9 Change Count Time Screen gt Increase Default Range Counts Per Second Figure 10 Big Counts Screen Care Wise Medical Products Main Menu C Trak Galaxy System Probe Demo Probe sotope Cobalt 57 Figure 11 Main Menu Screen C Trak Galaxy Gamma Probe System 2 4 7 System Test Screen On the System Test Screen Figure 12 reached from the Main Menu Figure 11 a user can calibrate and test all functionality of the Galaxy system When a user presses the PERFORM SYSTEM TEST the Galaxy system will both calibrate and test the system IT IS ESSENTIAL THAT THE CORRECT PROBE BE SELECTED FOR THIS PROCESS If the wrong probe is selected the system test data will be inaccurate because they will pertain to the wrong probe The probe must be inserted into a fresh within 2 years for Co57 within 5 years for Na22 check source to perform the test The C Trak Galaxy system creates a database and stores calibration data for each probe used For a first time calibration or to change to a different probe
6. 30 The following may result in increased emissions or decreased immunity of the Care Wise CW4000 Galaxy System The use of accessories cables or other components other than those specified provided or sold by Care Wise see Product Parts List in Appendix F Unauthorized replacement parts or additional e Main power should be that of a typical commercial or hospital environment e Power frequency magnetic fields should be at levels of a typical location in a typical commercial or hospital environment components internal to the Galaxy System e The C Trak CW4000 is intended for use in an electromagnetic environment in which radiated RF Radio Frequency disturbances are controlled e Interference may occur in the vicinity of equipment marked with the symbol e The use of portable or mobile RF communications equipment within close proximity to the Galaxy System or other nearby Medical Electrical Equipment Recommended separation distance e d 1 2VP 150 kHz to 80 MHz e d 1 2VP 80 MHz to 800 MHz e d 2 3VP 800 MHz to 2 5 GHz 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 e The use either adjacent to or stacked with other equipment unless previously verified that such use does not affect performance C Trak Galaxy Gamma Probe System Appendix E Proof of Cleaning S
7. Set Time Zone Screen C Trak Galaxy Gamma Probe System 2 4 12 Set Language Screen Care Wise Medical Products The Set Language Screen Figure 20 reached from the SETUP C Trak Galaxy System SCREEN Figure 13 allows the user to select the appropriate Set Language language for their locale e tina Ceska republika Deutsch Deutschland English United States espanol Espa a francais France italiano Italia a Figure 20 Set Language Screen 2 4 13 Shutdown Screen EA The Shutdown Screen Figure 21 is located on the Main Menu Main Menu described in 2 4 6 and allows the user to turn off the Galaxy System Care Wise Medical Products C Trak Exit from C Trak Surgical Guidance E ia Probe Der isotope Cobalt 57 Shutdewn Figure 21 Shutdown Screen 2 4 14 User Guide Screen 7 Galaxy User Guide l oe Introduction a ET a S Ph Gen tanh Adam den de en ee The User Guide Screen Figure 22 allows the user to gain information Qk aference Sits convey an increas cr Secrewse in radiation detection atosing the arjocn bo localize raciolabeted Ussu for about the system provides a copy of the manual for help and shows Smm Tre mutans is emt of the Ctra Celery toxhacese an Ss Sacer supers eater he Darter gauss Cana DERA ember et ces oe eee contact information for Care Wise TERS C Ta probes hore aaa phere ieee ern Eann Pet nean MAy aa detection of radiation trom Pome Pg shes o
8. Trak Galaxy standard systems a b C With OmniProbe standard device and standard Technetium collimator With OmniProbe EL device With OmniProbe PET device 2 C Trak Galaxy bundled systems a b G d With OmniProbe standard device standard Technetium and Lechner Collimator With OmniProbe standard device standard Technetium collimator and OmniProbe EL device With OmniProbe standard device standard Technetium collimator and OmniProbe PET device To add any additional items use the product code and discount its list price by 10 3 Component Parts d C Trak OmniProbe Standard device with snap on Technetium Collimator Angled Standard device with snap on Technetium Collimator Straight Indium handle shield and Indium collimator EL device straight EL device 20 EL device 90 PET device C Trak Analyzer Galaxy Automatic Refurbished Dual Refurbished Available in US only 4 Accessories a To Pp ans C Trak OmniProbe collimators Standard Lechner 5mm opening Galaxy Printer Galaxy Power Cable Power Supply Brick Power Adaptor International by country Galaxy Stand Galaxy Quick Release Bracket C Trak OmniProbe Probe Cable Check Source Cobalt 57 5uCi Cobalt 57 10uCi Sodium Na 22 5uCi Analyzer and Probe Carrying Case Galaxy System Automatic Analyzer System Dual Analyzer System C Trak OmniProbe EL device Carrying Case C Tr
9. oume f ne oe f cae Figure 14 Select Probe Screen Care Wise Medical Products E C Trak Galaxy System Name JiDemo Probe 12345678 x Figure 15 Edit Create Probe Screen C Trak Galaxy Gamma Probe System 2 4 10 Select Isotope Screen The Select Isotope Screen Refer to Figure 16 allows the user to quickly choose from a list of commonly used isotopes based on the type of probe currently selected 1 Clinical Isotope Pressing this button brings up the Count Screen preset to detect the most commonly used clinical isotope associated with the type of probe selected The default settings for OmniProbe and OmniProbe EL devices the clinical isotope is TcC99m For OmniProbe PET devices the clinical isotope is 18F FDG 2 Calibration Isotope Pressing this button brings up the Count Screen preset to detect the calibration isotope associated with the type of probe selected The default calibration isotope for the OmniProbe and OmniProbe EL devices is Co57 For OmniProbe PET devices the calibration isotope is Na22 It is not necessary to select a calibration isotope before performing a System Test as the C Trak Galaxy System will automatically select the appropriate calibration isotope for the selected probe 3 User Isotope This button brings up the Count Screen preset to detect the secondary isotope assigned by the user By default it will display User Isotope and be grayed out
10. point 9 3 psia Ethylene oxide concentration 725 25 mg L Gas exposure time full cycle 2 hours Aeration time full cycle 12 hours Aeration temperature 51 59 C NOTE Sterilization methods other than those described above could damage the probe and cable void the warranty and could result in injury to the operator or patient CABLE AND PROBE SHOULD BE COVERED BY A STERILE DRAPE WHEN USED IN SURGERY The probe cable may be used in a sterile field after a sterile drape is placed over the sterilized probe and cable Sterile drapes are available from medical supply companies that will allow use with a trocar sheath or cannula Suggested installation sequence of a sterile probe into a sterile drape is as follows 1 A professional in the sterile field i e scrub nurse holds the sterile OmniProbe device and the sterile drape 2 A professional outside the sterile field i e circulating nurse holds the cable 3 The scrub nurse inserts the probe into the drape and passes the rear end of the drape without pulling it out to its full length to the circulating nurse 4 The circulating nurse takes the rear end of the drape in one hand and the cable in the other hand reaches into the un extended drape with the cable and inserts the cable connector into the OmniProbe connector 5 The circulating nurse then pulls the drape up the cable to its full length and connects the cable to the analyzer IMPORTANT NOTE The Om
11. provided by Care Wise specifically for the C Trak Galaxy System to prevent the occurrence of shock fire or product damage 6 3 Disassembly Do not attempt to disassemble or otherwise service the probe analyzer unit or power supply There are no user serviceable parts DISASSEMBLY VOIDS THE WARRANTY AND TRANSFERS ALL CONTINGENT LIABILITY TO THE INDIVIDUAL AND INSTITUTION INVOLVED 6 4 Radioactive Concerns All radioactive isotopes and or material drapes liquids cleaning materials etc that come in contact with a radioisotope or item that is contaminated with a radioisotope must be handled as per your institution s radiation rules and regulations Consult with your Radiation Safety Officer for guidance concerning the use and disposal of radioactive material See Appendix G for disposal information provided by the manufacturer of the Care Wise provided Cobalt57 and or Sodium22 Check Source www southernscientific co uk 6 5 Use of Electrosurgical Devices Electrosurgical and other electrocautery devices can emit excess electromagnetic noise that may cause the C Trak analyzer to record false counts if these devices are used to cut or cauterize concurrent with the probe s use in surgical exploration 6 6 Use of Accessory Equipment Accessory equipment connected to the computer interfaces must be certified according to the respective IEC standards i e IEC 950 for data processing equipment and IEC 60601 1 3rd
12. saved set of timed counts by pressing the Load button Note that the first data set in the list of sets that can be loaded is always called Previous and corresponds to the latest automatically saved data set This allows a user to quickly restore a patient s data if the C Trak Galaxy system is mistakenly shut down NOTE If system is not shut down properly all current data will be lost Data are only written to the database at the time the system shuts down Printing Timed Count Data To print from the C Trak Galaxy system ensure that the printer cable is plugged into the USB port and the printer is turned on then press print on the screen www southernscientific co uk EXPERIENCE amp EXPERTISE 2 4 4 Change Count Time Screen On the Change Count Time Screen Figure 9 a user can set the duration of timed counts The default is 10 seconds The default can be restored quickly by pressing the Default button The duration for timed counts can range from 1 second to 999 seconds 2 4 5 Big Counts Screen On the Big Count Screen Figure 10 a user can receive enlarged numeric feedback about the amount of radiation the probe is detecting To show the Big Counts Screen press the button with the eye icon located in the top right corner of the Count Screen To exit from the Big Counts Screen press any area on the screen 2 4 6 Main Menu The Main Menu Figure 11 allows the user to navigate to the Count
13. select the probe to be used through the SELECT PROBE button as described in 2 4 9 When a system test is performed the C Trak Galaxy system compares the current performance of the selected probe with the saved results of previous performances to see if any undesirable changes have occurred A warning message will appear if there are any issues with the probe or analyzer See Appendix C for Error Messages 2 4 8 Setup Screen The Setup Screen Figure 13 allows the user to navigate to various screens used to set up or customize the C Trak Galaxy system Users can navigate from here to the Select Probe Select Isotope Set Time Zone Set Language and Main Menu Screens The Setup Screen also displays important information about the hardware firmware and software serial numbers and version numbers as well as information about the probe and isotope currently selected www southernscientific co uk System Status Source Cobalt 57 Probe Type OmniProbe Selected Probe Demo Probe System Test Details Coarse Gain 2 Fine Gain 140 Peak Channel 120 Total Counts 5508 Last Calibration Jul 08 2015 14 29 Figure 12 System Test Screen Care Wise Medical Products C Trak Galaxy System Hardware Serial Number 0096 Firmware Version US Software Version 1 1 0 81 Date Jul 08 2015 14 30 Frobe Wane Dermo Probe Probe Type OmniPrabe Isotope Cobalt 5 7 Figure 13 Setup Screen System Test Select Probe
14. special collimators can be made available by special order Call Care Wise on 1 813 626 6848 US amp Canada 44 1273 497600 Europe amp Worldwide for information and advice as needed www southernscientific co uk 8 4 Indium Shield Assembly The Indium shield assembly is an extra layer of shielding that allows the C Trak OmniProbe to be used with the higher energy radioisotope In111 It is a two part tungsten sheath that covers the existing probe It does not alter the basic operation of the OmniProbe nor does it require any special safety considerations To install the shield 1 Disconnect cable from the OmniProbe and remove the collimator mounted on the probe 2 Start from the cable connector end of the probe and with the protuberance end of the shield facing the probe and the protuberance on top slide the shield over the probe shaft 3 Do not insert the probe all the way into the shield leave about 1 mm between the end of the shield and nose bend 4 Line up the small hole in the Indium collimator so that it is facing away from the probe bend and is on top when holding the probe shaft horizontal with the nose bend facing down 5 Slide the Indium collimator onto the probe nose You may need to wiggle it in place Line up the hole in the collimator with the shield protuberance and push together 6 After re attaching the cable the probe is now ready for use Make sure you set the Isotope Settings t
15. subsequent count rates Thus an area that has lt 100 cps would register as Ocps an area with 500 cps would register as 400 cps etc 4 8 5 Increase Range 7 Enable Squelch and Disable Squelch Coums Per Second Dynamic Squelch allows the user to find a source of discrete _ E radiation uptake a hot spot and simultaneously auto range i B y Change f sea oT E to optimize detection of that hot spot and other sites of Time ec meni similar activity while also removing background radiation To use Dynamic Squelch find a source of radiation uptake Figure 6 Change Count with Histogram other than the injection site and adjust the probe until the counts detected are as high as possible Then press the ENABLE SQUELCH BUTTON to activate the Dynamic Squelch Upon doing so the RANGE CONTROLLERS will be disabled and the system will automatically find range settings appropriate for the amount of radiation being detected The Galaxy System will then automatically remove 50 of the background radiation 8 Main Menu Button Pressing this button directs the user to the MAIN MENU Figure 11 described in 2 4 6 9 Big Counts Button Pressing this button directs the user to the BIG COUNTS SCREEN Figure 10 described in 2 4 5 10 User Guide Button Pressing this button directs the user to the help section USER GUIDE SCREEN Figure 21 E Care Wite Medical Products described in 2 4 13 C Trak Galaxy Syst
16. the collimator and sterilizing it separately alongside the OmniProbe device Refer to section 5 4 for additional sterilization guidelines 5 3 Decontamination The probe could be contaminated with radioactive isotope if the instrument indicates an increase in background counts in the NORMAL OPERATING MODE with no radioisotope near the probe The system can be tested for radioisotope contamination by doing a background test described in section 4 2 If the probe is found to be contaminated use the following procedure to remove radioactive contamination Also confer with your nuclear medicine or biomedical engineering departments as applicable To decontaminate the Probe Remove the sterile drape from the probe the background should return to normal To decontaminate the System 1 If after removing the sterile drape from the probe the system still indicates a high background shut down the system EXPERIENCE amp EXPERTISE 2 Use a disposable pan vessel etc to contain the liquid required to complete the cleaning process The liquid disposal wipes and any other material that will contact the liquids used in the decontamination process must be assumed to be radioactive These materials and liquids must be handled and disposed of as per your institution s license agreements with state and federal regulatory agencies Consult with your radiation safety officer for guidance 3 Use a commercially available dec
17. unusable until the user assigns an isotope to this shortcut button by pressing the LIBRARY button and selecting an isotope from the list Press ASSIGN to save the isotope as the User Isotope Press SELECT to bring up the Count Screen preset to detect the selected User Isotope 4 Isotope Library Pressing this button brings up the ISOTOPE LIBRARY a list of commonly used isotopes described in 2 4 10 1 5 Main Menu Pressing this button allows the user to navigate to the MAIN MENU described in 2 4 6 2 4 10 1 Isotope Library Screen The Isotope Library Figure 17 comes pre installed with commonly used isotopes Users can freely create edit and delete their own isotope entries The isotopes that come pre installed shown in red on the Isotope Library Screen cannot be edited or deleted To create a new isotope entry press NEW To edit or delete an existing user created isotope entry select the entry then press EDIT or DELETE respectively To select an isotope highlight the entry and press SELECT The isotope chosen will become the active isotope To assign an isotope to the USER ISOTOPE button select the entry from the list and press ASSIGN Assigning a user isotope allows the user to quickly select a commonly used isotope without having to navigate to the full isotope library www southernscientific co uk B Isotope Care Wise Medical Products C Trak Galaxy System Technetium 99m L Cobalt 57
18. B Connectors These are ONLY for use with Care Wise approved peripherals e g Care Wise approved accessory printer Section 8 2 Attaching any devices not explicitly approved by Care Wise including keyboards mice other printers etc can lead to loss of functionality and system damage DO NOT PLUG ANY UNAPPROVED DEVICES INTO THE C TRAK GALAXY SYSTEM 2 USB Connectors 1 Power Cable Connection Figure 2 Bottom Panel of C Trak Galaxy System 2 3 Right panel Figure 3 Probe Connector The analyzer connection is a MHV style high voltage connector for all Care Wise probes NOTE This is not a BNC connector Reminder The OmniProbe is a Type B Applied Part Figure 3 Right Panel of C Trak Galaxy System www southernscientific co uk EXPERIENCE amp EXPERTISE 2 4 Accessing the screens The C Trak Galaxy is a touchscreen system To change screens or input data select the desired field by touching the corresponding button with your finger The screen will respond to bare or gloved fingers or other stylus and solid instruments Please use caution when using anything other than your finger The screen can be damaged You may wish to use a clear plastic screen protector product Note Grayed out buttons indicate options that are unavailable based on current settings Note There may be differences in the screen on your analyzer from those presented here due to revis
19. Edition for medical equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 Anyone who connects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible that the system complies with the requirements of IEC 60601 1 If in doubt consult your technical services department or your local regulatory representative 6 7 Probe Handling Guidelines Treat the probe as you would any expensive delicate surgical instrument The probe is not a solid bar of metal Inside are two crystals and a photomultiplier tube If the probe is dropped or hit sharply against something hard it can break PLEASE HANDLE THE PROBE CAREFULLY DO NOT PLACE C TRAK PROBES ON OR NEAR A MAGNETIC INSTRUMENT PAD OR MAT The magnetic field can permanently degrade probe components and diminish performance CAUTION The C Trak system is not intended for use in the presence of flammable anesthetics or other explosive gases There is a risk of explosion if the Galaxy System is used in the presence of flammable gases EXPERIENCE amp EXPERTISE 7 0 Technical Specifications 7 1 Power Probe Overload Cutoff The Galaxy CW4000 system is classified by the U S Code of Federal Regulations as a Class I device In Europe and Canada the Galaxy system is classified as a Class Ila device Power is provided to the Galaxy CW4000 system via a Hospital Grade extern
20. IRSE mwe MCA Serial Humber 0096 Firmware Version 05 Software Version 1 1 0 81 Probe Demo Probe Isatepe Cobalt 57 Figure 16 Select Isotope Screen 1 Clinical 2 Calibration 3 User Isotope 4 Isotope 5 Main Menu Care Wise Medical Products C Trak Galaxy System Threshold Window Figure 17 Isotope Library Screen EXPERIENCE amp EXPERTISE 2 4 10 2 Edit Create Isotope Screen e Care Wise Medical Products To create or edit an isotope entry from the Isotope Library Screen C Trak Galaxy System Section 2 4 10 1 selecting NEW will bring up the Edit Create Isotope Screen Figure 18 The user can enter the isotope s full name as well as a shortcut name threshold setting window Jz135 setting and primary photopeak using the on screen keyboard _ Threshold Window A30 Peak GS Cancel Figure 18 Edit Create Isotope Screen 2 4 11 Set Time Zone Screen Care Wise Medical Products The Set Time Zone Screen Figure 19 reached from the C Trak Galaxy System SETUP SCREEN Figure 13 allows the user to select the appropriate time zone Set Time Zone UTC Casablanca UTC Coordinated Universal Time UTC Dublin Edinburgh Lisbon Londo UTC Monrovia Reykjavik UTC 01 00 Amsterdam Berlin Bern R UTC 01 00 Belgrade Bratislava Budar UTC 01 00 Brussels Copenhagen Ma UTC 01 00 Sarajevo Skopje Warsaw i 4 gt o Figure 19
21. Lechner Collimator 8 4 Indium Shield Assembly 9 0 International Symbols Appendix A Warranty Receiving Examination Returns and Repairs Appendix B Troubleshooting FAQ Appendix C Error Messages Appendix D EMC Precautions Appendix E Proof of Cleaning Statement Appendix F Care Wise Products List Instructions for Detaching C Trak Cable Appendix G Manufacturer s Radioactive Material Exempt Quantity Statement Probe Handling Information Care Wise contact information Europe United Kingdom and Rest of World Southern Scientific Ltd Scientific House The Henfield Business Park Shoreham Road Henfield West Sussex BN5 9SL United Kingdom Tel 44 0 1273 497600 Fax 44 0 1273 497626 Web www southernscientific co uk United States Care Wise c o LabLogic Systems Inc 1040 East Brandon Boulevard Brandon Florida 33511 5509 USA Tel US 813 626 6848 Fax US 813 620 3708 Web www carewise com 30 EXPERIENCE amp EXPERTISE 1 0 Introduction 1 1 C Trak Analyzer and Probe Introduction The C Trak Galaxy system has been designed to detect and quantify the nuclear radiation from gamma emitting isotopes ranging in energy emissions between 27 600 keV A clear display of numeric quantities and an audible signal convey an increase or decrease in radiation detection allowing the surgeon to localize radiolabeled tissue for excision The system is comprised of the C Trak Ga
22. S SCREEN Details are in 2 4 2 Range 0 100 5 View Timed Counts Button Pressing this button allows the user to view any data for timed counts already taken Details are in 2 4 3 6 Change Count Time Button Pressing this button allows the user to change the duration of timed counts ge Details are in 2 4 4 5 2 8 pri 7 Enable Squelch and Disable Squelch Pressing Enable es cea Squelch will activate the squelch feature When squelch 7 lt 2 E a is active this button displays Disable Squelch and Bae r Ta Dik pressing it will deactivate the squelch feature e Soe Time Figure 5 Count Screen with Analog Meter la C Trak Galaxy Gamma Probe System There are two different types of squelch available in the C Trak l Care Wise Medical Praduete Galaxy System Standard Squelch and Dynamic Squelch 2 Standard Squelch is available if the probe type selected is C Trak Galaxy System OmniProbe EL or OmniProbe PET Dynamic Squelch eee is available for the OmniProbe Std amp Straight Reda a eae e Isotope Cobalt 57 Count Time 10 Squalck Disabled Standard Squelch allows the user to select an area of Range 0 1000 background radiation and then remove the amount of radiation detected in that area from all radiation detection counts E g if the Standard Squelch is activated while the probe is detecting 100 counts per second then 100 counts would be removed from all
23. a sterile disposable sleeve such as those commonly used with ultrasound probes or laparoscopic cameras CAREFULLY FEED PROBE AND CABLE INTO SHEATH DO NOT DROP PROBE INTO SHEATH AS THIS PLACES STRESS ON THE CABLE CONNECTIONS Tip After the probe is inserted into the end or tip of the sheath some practitioners place the sheathed tip of the probe into one finger of a surgical glove and then tie the glove around the body of the probe for further protection and definition of its shape and position within the sheath 5 2 Disinfecting The system should be turned off before cleaning or disinfecting The components of the C Trak Galaxy system the analyzer probe and cables may be cleaned and surface disinfected when necessary by wiping down their surfaces with either alcohol wipes with 70 isopropyl alcohol or with a lint free cloth moistened with 70 isopropyl alcohol DO NOT IMMERSE THE ANALYZER CONTROL UNIT OR CABLE CONNECTORS IN LIQUIDS DO NOT AUTOCLAVE THE GAMMA PROBE Steam or dry heat sterilization will damage the gamma probe and cable void the warranty and could result in injury to the operator or patient www southernscientific co uk IMPORTANT NOTE The OmniProbe s collimator MUST be removed when cleaning or sterilizing Both the inside and outside surfaces must be cleaned and or sterilized Care Wise recommends using a bottle brush for cleaning inside the collimator For sterilization Care Wise recommends removal of
24. ada 44 1273 497600 Europe amp Worldwide for information and advice as needed C Trak Galaxy Gamma Probe System Appendix C Error Messages Connection Error Figure 23 A Connection Error will appear if the probe or cable is disconnected from the analyzer Reconnect the probe and select YES to continue High Voltage Error Figure 24 This error will appear if the system detects a short circuit in the probe or cable Check the probe and cable for damage and select YES to continue if there is no visible damage If this error continues to appear the probe may be damaged Contact Care Wise on 1 813 626 6848 US amp Canada 44 1273 497600 Europe amp Worldwide for assistance Error Messages Not Enough Radiation Detected Error Figure 25 This error will appear if the probe does not detect enough radiation to complete the System Test Section 2 4 7 Ensure that the probe is fully inside the check source holder and that the source disc is less than two years old Reattempt System Test If this error continues to appear when performing a System Test the probe may be damaged Contact Care Wise on 1 813 626 6848 US amp Canada 44 1273 497600 Europe amp Worldwide for assistance www southernscientific co uk Care Wise Medical Products Main Menu em Test Care Wise Medical Products C Trak Galaxy System Decrease Increase gt Range Range Change Enable Count S
25. ak OmniProbe standard device Carrying Case Product Code GDBS GSLS GSPT GSCS GSES OSSP OPB OPS OPSC SEL AEL NEL OPT CW4000 CW3000 R CW2200R OPTC OPCI GP GPC GPS GPA GS GSQR CSC5 CSC10 Coo CCCG CCC1 CCCA CCL1 CCS1 C Trak Galaxy Gamma Probe System Appendix F continued C Trak Systems and Components m Check Source Holder C Trak OmniProbe Standard C Trak OmniProbe EL devices C Trak OmniProbe PET Probe Holster Printer Cable Repeater Cable for Automatic Analyzer System PATO a Galaxy Cart 5 Service Contracts Remote Repeater Unit with cable for Automatic Analyzer System Product Code CSH CSH CSHL CSHP PH PRC RRU RRC GC ONE Year Maintenance Contract includes annual preventive maintenance calibration and certification return shipping charges 20 discount on parts and labor one Check Source free loaners on a System will cost 10 of the total current list price of the system to be covered All complete systems include carrying case check source and check source holder unless quoted otherwise Prices are F 0 B Factory All products are covered by a two 2 year warranty unless otherwise specified Contact Care Wise or your local Care Wise representative for current pricing information Appendix G Radioactive Material Exempt Quantities Per U S NRC amp State Regulations This radioactive material conforms to the c
26. al Limits 10 400C 50 F to 104 F 10 400C 50 F to 104 F 30 75 non condensing Operational Temperature Storage Temperature Operation Relative Humidity Storage Relative Humidity 30 75 non condensing 700 hPa to 1060 hPa less than 2000 meters 6000 ft Atmospheric Pressure Operational Altitude 7 10 Label Legibility In normal use the operator of the CW4000 views the product from the front facing the computer screen usually at a distance no greater than nine 9 feet The ID Serial Number Label is on the rear of the product and is intended to be viewed in a normal room lighting environment 500 lux or greater by a person with a visual acuity corrected if necessary of 20 20 at a distance of approximately 12 18 inches a normal reading distance Aside from the serial number the information included on this label is also available in the printed User s Guide included with each product and the on screen User s Guide C Trak Galaxy Gamma Probe System 8 0 Use of Optional Accessories 8 1 C Trak Galaxy System Cart To ensure that all system components are neatly and securely stored Care Wise offers a sturdy wheeled C Trak Galaxy System Cart The analyzer is attached to the cart using a quick release bracket A cushioned drawer will store the probes check sources and holders The lower basket may be used to hold additional surgical supplies 8 2 Printer Care Wise offers an optional printer fo
27. al power supply included with the purchased system e External Universal AC input 100 240 vac 47 63 hz 100 watts DC out 12 V maximum 8 33A e For U S applications the AC mains plug is Hospital Grade NEMA 5 15P HG e Contact Care Wise or your Care Wise distributor to supply or replace the proper AC mains plug cable for your application or governmental country requirements e The guidelines set forth by your recognized National Certification Body NCB may require additional certification If required contact Care Wise or your Care Wise distributor for assistance CAUTION Use only a power supply provided by Care Wise specifically for the C Trak Galaxy System to prevent the occurrence of shock fire or product damage Bias voltage supplied to the probe is generated by a stable high voltage supply embedded within the C Trak Galaxy system This voltage is set at 900 vdc and is always less than 10 HA Any current exceeding this threshold will immediately turn OFF this voltage The system can only be turned back ON via direct user interaction as directed by the displayed error message Unauthorized attempts to repair the probe cable or the C Trak Galaxy computer system can result in a minor electrical shock Neither the external power supply nor the power supply inside the computer are serviceable by the user CAUTION Use only the hospital grade power supply and power cord provided by Care Wise The use of any other powe
28. ation in an operating room environment as long as flammable anesthetic gases are not used and the system is not physically abused The C Trak Galaxy CW4000 System is CE C 0843 certified and is fully compliant with FDA 21 CFR Part 820 MDD 93 42 EEC and CMDR SOR 98 282 requirements Slide computer monitor quick release bracket over stand bracket until the tab locks into place 1 2 C Trak Getting Started Guide 1 Attach the Monitor to the Stand Place the stand on a flat stable surface Slide computer onto stand carefully until the Quick Release bracket on the back of the computer locks into the bracket on the stand Alternatively if using an accessory cart slide computer onto the bracket mounted on the cart 2 Connect the Care Wise provided Power Cord Check that the power supply cables are free of any nicks cuts exposed wires or other damage Connect the power supply to the computer and to an AC outlet Turn on the power supply with the switch on the back of the power supply An indicator light on top of the power supply should glow 3 Connect the Probe Check that probe cable is free of any nicks cuts exposed wires or damaged connectors Connect the probe to the monitor and then turn the power on using the power button on the front of the monitor Reminder The OmniProbe is a Type B Applied Part The C Trak Galaxy system takes a few minutes to start up boot completely Once
29. ce disc is its birth date at which time the radioactivity was at the strength listed on the disc For information on obtaining a check source contact Care Wise or your representative Check Source for C Trak OmniProbe and OmniProbe EL A 5uCi Cobalt 57 Co 57 check source should be used to calibrate the system if an OmniProbe is in use or a 10uCi Cobalt 57 check source for the OmniProbe EL The characteristics of Cobalt 57 are e Primary photo peak energy 122 keV e Half life time it takes for activity to decay by one half 271 days 9 months The Co 57 check source Product Code CSC for the 5 uCi CSC 10 for the 10 uCi should be replaced every 18 months Check Source for C Trak OmniProbe PET A Sodium 22 Na 22 check source should be used to calibrate the system if an OmniProbe PET is in use The characteristics of Sodium 22 are e Primary photo peak energy 511 keV e Half life time it takes for activity to decay by one half 951 days 2 6 years The 5 uCi Na 22 check source Product Code CSS should be replaced every 5 years See Appendix G for information on handling and disposal provided by the manufacturer of the Care Wise supplied Check Source 3 2 Check Source Holder Use A Source Holder is used for calibrating C Trak systems Unscrew the two pieces of the source holder and place the source inside with the label facing the foam padding Screw together When performing a System Test Secti
30. ds There are three user editable fields in the View Timed Counts Screen ID Location and Type The user can edit the ID field by pressing within the white area and using the popup keyboard enter any defining ID to correspond with this data set To set Location and Type select an entry to display a pop up menu Select the appropriate option from the menu For Location the options include In Vivo Left and Right Ex Vivo Left and Right and Background Left and Right For Type the options include Sentinel Primary Tumor and Other The Primary option in the Type field should be selected for the sentinel node with the highest amount of radioactivity in a given set of timed count data The C Trak Galaxy system will automatically calculate the percentage of the Primary s activity for all other timed counts and display these percentages in the Percent Primary field Note that only one timed count can be set as Primary if another timed count is set to Primary the count previously labeled Primary will be relabeled Other Figure 8 View Timed Counts Screen Saving Timed Count Data The C Trak Galaxy system will automatically save the data for all current timed counts every time a new timed count is completed as well as every time a field i e ID Location and Type is edited The user can also manually save a data set by pressing the Save button The user can restore a previously
31. dwide with any inquiry Q www southernscientific co uk EXPERIENCE amp EXPERTISE 2 0 Getting acquainted with the C Trak System 2 1 Front Panel Figure 1 1 Display Screens Depending on the specific screen selected displays the data on radiation detected by the system the specific configuration of the system when in use or the information needed to calibrate or reconfigure the system as desired 2 Brightness Controls Adjust the brightness of the system s display screen 3 Power Switch Turns the system on To shut down the system navigate to the Main Menu and select Shutdown 4 Volume Controls Adjust the system volume B Care Wise Medical Products C Trak Galaxy System Probe Type Calbratian Freba lnptepe Cobalt 57 Count Timm 10 seconde apiece mst be Range O 109 Docrease 1 4 r g Increase Range Range CUMS per aecenel e Enable Saguweleh C Trak Galaxy Figure 1 Front Panel of C Trak Galaxy System C Trak Galaxy Gamma Probe System 2 0 Getting acquainted with the C Trak System continued 2 2 Bottom Panel Figure 2 1 Power DC In Connection e External Universal AC input 100 240 vac 47 63 Hz 100 watts DC out 12 V e For U S applications the AC mains plug is Hospital Grade NEMA 5 15P HG e Contact Care Wise or your Care Wise distributor to supply or replace the proper AC mains plug cable for your application 2 US
32. early subscription Please contact Care Wise for further information EXPERIENCE amp EXPERTISE Appendix B Troubleshooting The meter moves but there is no sound 1 The volume may be turned down To adjust the volume on the system press the volume buttons located on the front panel The range selected does not detect the radioisotope present Lower the Range using the Range Selections Connection error or no counts or sound 1 Check that probe connector is turned and locked in place If not re connect select YES on error message and try again Check that analyzer has the proper probe and isotope selected for use If not select proper probe and isotope and try again Check that you get counts with a known source of radiation i e A valid Check Source held against nose of probe If yes then problem may be with radiopharmaceutical administration or distribution If no the probe may be damaged Call Care Wise for assistance Erratic counts or intermittent counts 1 There may be electrical interference Remove offending sources of interference There may be magnetic interference Do not use the gamma probe near a magnetic pad or mat The probe could be contaminated with radioactivity Follow the instructions in Section 5 3 to decontaminate the probe The probe could be damaged Call Care Wise for assistance Any other questions or concerns Call Care Wise on 1 813 626 6848 US amp Can
33. ed All radioactive material should be securely stored when not in use These exempt quantity products may be disposed of in regular waste providing all radiation symbols have been removed or defaced When disposing of liquid exempt quantities it is recommended that they be flushed into the public sewer system diluted with large volumes of water Manufactured and Distributed by SPECTRUM TECHNIQUES 106 Union Valley Road Oak Ridge Tennessee 37830 USA Tel 865 482 9937 Fax 865 483 0473 Web www spectrumtechniques com EXPERIENCE amp EXPERTISE Important Information Probe Handling Treat the probe as you would any expensive delicate instrument Inside the probe are crystals and a glass photomultiplier tube If the probe is dropped or hit against something hard it can break PLEASE HANDLE CAREFULLY Figure 27 Detaching the C Trak Cable 1 Grasp cable connector by release sleeve 2 Gently pull release sleeve away from probe as shown below Cable will release Figure 26 Overview of Probe and Cable Release Sleeve C Trak Galaxy Gamma Probe System CARE WISE 2 Europe amp Worldwide Southern Scientific Limited Scientific House The Henfield Business Park Shoreham Road Henfield BN5 9SL UK E mail info southernscientific co uk Tel 44 0 1273 497600 Fax 44 0 1273 497626 Web www southernscientific co uk USA amp Canada C o LabLogic Systems Inc East Pointe Park
34. em 11 Surgical Information Window This area of the screen displays information about the current surgical procedure rr New raha including which probe and isotope are in use what count time duration is selected whether the squelch is active or not and what detection range is selected Note When the isotope selected for use is Technetium a toggle button will appear allowing the user to switch to a Tc Wide setting when radiation uptake is low Some directionality will be sacrificed in order to achieve a greater level of sensitivity Pressing the toggle button again Goes 3 2 1 9 aa returns to standard Tc settings Range Peg OT Figure 4 Duplicated from page 7 Count Screen with Wedge Meter and Tc Narrow Wide Toggle Button f fA x SA ED www southernscientific co uk Aa EXPERIENCE amp EXPERTISE 2 4 2 Take Timed Counts Screen On the Take Timed Counts Screen Figure 7 a user can collect information about how much radiation is detected over time In the lower corner is a countdown timer which starts with the duration of the timed count selected in 2 4 4 the default Sample Location Time Duration Tal CPS duration is 10 seconds Three seconds after the countdown is None complete the user will be returned to the Counts Screen in 2 4 1 naos pct sia 14 23 43 5604 0 None 14 73 48 2057 oO Take Timed Count Date Jul 08 2015 14 23 Percent Primary 14 23 11 3611 0
35. em is shut down or until the user presses the Clear button in the lower left corner and confirms the choice in the dialog box that appears Arranging Timed Count Fields There are 7 fields on the View Timed Counts Screen which the user can rearrange by touching the field name and sliding to the left or right Location Type Timestamp Duration Total Counts Counts per Second and Percent Primary There is one field which cannot be rearranged and always remains on the left side of the screen this field has no field title and is used to track the serialized number of the timed count Thus the first timed count taken will have a number 1 the second timed count taken will have a number 2 etc Figure 8 View Timed Counts Screen C Trak Galaxy Gamma Probe System 2 4 3 View Timed Counts Screen Continued 2 View Timed Counts Locking Timed Count Fields oo W Patient 123 Date Jul 08 2015 14 23 The user can lock the changeable fields by pressing the lock icon in ae 5s Sampl Total P t the upper left corner When the image of the padlock is open as Number Location Type Time Duration counts Primary in Figure 8 the fields can be rearranged When the image of the l None None 1423 11 10 5611 None Mare 14 23 28 10 5559 padlock is closed the fields are locked in place 2 3 None None L4 23 43 10 5604 F Ex Wiwo l None 14 73 58 10 5 70 Editing Timed Count Fiel
36. f interest along wth greatly reduced detection of radiet Technical The ana Ne ee ee pha CGR IONER 301 Caster nad Scoctixarions ee peeuenant of MENDAS MEI us TANAN es Tepe Paus 431 i ut Cinta Sones 144 rrr ad Poses Electrical Safety pyrr er ga mpa Gctuction of Comptes sxettened About Us The C Trak Gelaxy Sytten meets UL SIEC 60601 1 macical safety t ond certifkation requirements Rs electrica curent erma pele ringa laene pes the Coreen Gola Da bas eee Cetas garay Be be Getigrd totem ct tha high vitage te excess L pA or of ony short clout is The system hes for sate coerstion in an ocerating as long as flammable anesthetic ges we Aot used and the gyfer Ie aot phyekelly abused canons is a touchscreen system To change screens ed pat a Select the desired fjeld by touching ja panee reei gtd ee lebe da a age ee coe g may wish to use a cheer plastic screen Scraen protecter gei ay raia SLE Moke Grayed out buttons indicete cotions that ore unavailable based on current settings Mote There may de ditteresces in the screen on your analyzer trom those presented here due to revisions to the Syste soltmare over time Copyrigh 2010 12 Case Wise Medical Products Figure 22 User Guide Screen www southernscientific co uk EXPERIENCE amp EXPERTISE 3 0 Calibration Guidelines 3 1 Isotope Check Source The Galaxy System is designed to warn the user when the check source is getting low The date stamped on the Check Sour
37. ions to the system software over time 2 4 1 Count Screen Care Wise Medical Products The first screen to appear when the system starts up is the Count lt C Trak Galaxy System Screen which displays feedback about the amount of radiation the probe detects Figure 4 The features of this screen are described below Refer to Figure 4 and the numeric reference for details 1 Rate Meter Display e There are three versions of the RATE METER DISPLAY The default shown in Figure 4 uses a wedge shaped indicator to show the amount of radiation detected The other two versions of the RATE METER DISPLAY are an analog indicator and a histogram of counts per second over time These are shown in Figures 5 and 6 respectively e NOTE To change the version of meter being used touch any free space or touch on the meter itself 2 Counts per Second Display This numerical display indicates the number of photons detected by the gamma probe per second 3 Range Controllers The DECREASE RANGE and INCREASE Figure 4 Count Screen with Wedge Meter RANGE controllers are used to adjust the range of counts per second displayed Ranges of 0 100 0 1 000 Care Wise Medical Products 0 10 000 and 0 100 000 are available e C Trak Galaxy System 4 Take Timed Count Button Pressing this button begins a RL es timed count for the current duration While timed counts seaport eae are underway they are viewed on the TAKE TIMED DEDA COUNT
38. laxy touchscreen analyzer and one or more of the OmniProbe family of probes The OmniProbe and OmniProbe EL are capable of detecting gamma ray energies up to 364 keV The OmniProbe PET is capable of detecting gamma ray energies up to 600 keV The analyzer is designed for operation with Care Wise designed gamma probes C Trak probes have special collimation and shielding that allow highly directional detection of radiation from sites of interest along with greatly reduced detection of background radiation The analyzer is designed to operate the probe display the data from the detected radiation and display and control the system s operating parameters The result is optimum performance in measuring gamma radiation from the photopeak of isotopes such as Technetium 99m Tc99m Indium 111 In111 Iodine 125 1125 and Fluorine 18 18F FDG while minimizing detection of Compton scattered radiation The C Trak Galaxy system meets IEC 60601 1 3rd Edition medical safety testing and certification requirements Its comprehensive shielding of high voltage sites within the instrument eliminates the possibility of significant electrical current leakage to patient or user under normal operating conditions The C Trak Galaxy system has excellent electrical safety the system is designed to turn off the high voltage if the current exceeds 10 uA or if any short circuit is detected The system has been designed and manufactured for safe oper
39. niProbe s collimator MUST be removed when cleaning or sterilizing Both the inside and outside surfaces must be cleaned and or sterilized For cleaning Care Wise recommends using a bottle brush for cleaning inside the collimator For sterilization Care Wise recommends removal of the collimator and sterilizing it separately alongside of the OmniProbe device NOTE If OmniProbe EL is to be used in open surgery without being passed through a trocar trocar sleeve or cannula then the same sterile practices used with C Trak OmniProbe devices involving a sterile drape covering probe and cable may be used With use of the sterile sheath probe sterilization will not be required C Trak Galaxy Gamma Probe System 6 0 Safety Considerations 6 1 Error Messages Appendix C describes the various error messages that may appear if the C Trak Galaxy System detects any malfunction In the event of an error message select YES to continue use of the Galaxy System If the message continues to appear call Care Wise for guidance 6 2 Power Supply Requirements The power supply included with the C Trak Galaxy system is rated for 100 V 240 V AC Do not attempt to use the Galaxy system with any voltage below 100V or above 240 V The power supply included with the Galaxy system transforms the incoming AC current and provides the system with 12 V DC current at a maximum of 8 33 A CAUTION Use only a power supply and power cord
40. o the proper selection described in section 2 4 10 C Trak Galaxy System with printer and cart so a BEENA EXPERIENCE amp EXPERTISE 9 0 International Symbols AA Information Consult Accompanying Documents 4 Temperature Limits C User s Guide 10 oy Humidity Limits Equipment not suitable for use in the presence oe adie of a flammable mixture with air or with oxygen or nitrous oxide Atmospheric Pressure hPa ile Medical General Medical Equipment as to as electrical shock fire and mechanical hazards only in US accordance with UL 60601 1 2003 CAN CSA C22 2 w Man Reading Book Consult Accompanying Documentation for Mandatory Information No 601 1 2005 ANSI AAMI ES60601 1 2005 CAN CSA C22 2 No 60601 1 2008 lt 48ZK gt Conformity with the MDD has been confirmed and 0843 approved by the Notified Body UL International UK Ltd Registration Number 0843 Degree of protection against electric shock Type B Applied Part OmniProbe Family of Probes Protective Earth Ground Protection against Electric Shock Class 1 Equipment Manufacturer s Site Southern Scientific o Product is shipped in a non sterile state C Trak Galaxy Gamma Probe System Appendix A Warranty Care Wise warrants all new analyzers probes and related products addressed in this User Guide to be free of defects due to workmanship materials and design for a period of twenty fo
41. on 2 4 7 insert the nose of the probe into the holder all the way so that it touches the source disk When System Test is complete remove the probe from the source holder Note If using the OmniProbe the collimator may sometimes pull off and stay in the holder Unscrew the base and push the collimator with your finger or other soft object If using a C Trak OmniProbe have the standard Tc collimator on the probe for calibration This allows it to fit properly into the Source Holder If a sterile drape sleeve is on the probe it must be removed before placing probe in the Source Holder The check source may be stored in the Source Holder unless your institutional policies specify otherwise 3 3 Performing Calibration The C Trak system should be calibrated occasionally to ensure optimal sensitivity Performing a System Test in essence performs a calibration The System Test described in section 2 4 7 will compare the test results from the current calibration to data stored from previous tests of the same probe A System Test will ensure that all components are functioning properly Care Wise recommends that a System Test be performed each time it is first used on any given day C Trak Galaxy Gamma Probe System 4 0 Pre surgery Set Up 4 1 Before Power Is Turned On Connect probe to Right Panel probe connector Figure 7 Check probe cable for any significant nicks cuts exposed wires or damaged connecto
42. onditions and limitations specified for radioactive material in e 49CFR173 421 e 10CFR30 e 10CFR30 71 Schedule B Exempt Quantities e BS 5288 C11111 The radioactive material contained in the package is an exempt quantity from USNRC and or Agreement State licensing requirements The radiation exposure rate at any point on the external surface of this package does not exceed 0 5 milli rem hour No other hazard labeling and shippers declaration are required or authorized Radioactive Material Not for Human Use Introduction Into Foods Beverages Cosmetics Drugs or Medicinals or Into Products Manufactured for Commercial Distribution is Prohibited Exempt Quantities Should Not be Combined The quantity of radioactive material contained in these products is extremely small and present no known radiation hazard However www southernscientific co uk it is always good practice to minimize exposure by following the basic principles of time distance and shielding Solid sealed exempt quantity sources require no special handling but when working with liquid sources gloves and laboratory coats are recommended Eating drinking and smoking should be prohibited in areas where radioactive material is used or stored Use of radioactive material should be supervised by a responsible person and in authorized areas Exempt quantity products should be used only as intended and in accordance with instructions provid
43. ontaminating product to clean the probe Rinse the probe several times with distilled water Make certain that the connector within the distal end of the probe handle is absolutely dry before inserting the cable connector into the probe handle Never immerse the connector ends of the probe cable in liquid 4 Dry the probe thoroughly with a disposable wipe It is extremely unlikely that the probe cable will become contaminated however if it does the same practice can be followed as with the probe 5 Turn on the C Trak Galaxy System If the system is still indicating a high background turn the system off and repeat the steps above If the system still indicates a high background contact nuclear medicine or biomedical engineering for evaluation The probe may have been damaged 5 4 Sterilization The probe with cable removed can be sterilized using one of the following methods 1 A Full Cycle of the STERRAD 100S Sterilizer From Advanced Sterilization Products a Johnson amp Johnson Co Division of Ethicon Inc Irvine CA USA 2 Ethylene Oxide Sterilization validated by Nelson Laboratories Inc Salt Lake City UT USA Preconditioning Parameters Temperature 544 2 C Relative humidity 70 5 Vacuum set point 1 3 psia Steam partial pressure 2 18 psia Preconditioning set point 2 8 psia Preconditioning time 1 hour Sterilization Parameters Temperature 54 2 C Relative humidity 70 5 Pressure set
44. ptake of clinical interest before making the first incision 7 In sentinel node procedures always remain conscious of the location of the injection site in order to differentiate between very high levels of radiation coming from the injection site and radiation coming from the desired tissue e g sentinel lymph node itself It can be helpful to mark the patient s skin to show the boundary of the very high level radiation coming from tissue immediately surrounding the injection site 8 Move the probe slowly and avoid jerky movements With experience the user will develop a feel for the appropriate speed 9 Detected count rates drop with the square of the distance from tissue being viewed Stay very close to the tissue plane While performing the initial survey be careful not to push the probe into the skin while moving it as this will also move the skin relative to the lymphatics 10 When the tissue of interest has been excised take a 10 second count for the ex vivo specimen s and for the cavity background This will establish whether all significantly radioactive tissue has been removed The 5uCi Co 57 check source should be replaced every 18 24 months Na 22 check source should be replaced every 5 years Check sources may be purchased through Care Wise or your Care Wise distributor See Product List Appendix F for Product Codes Call Care Wise on 1 813 626 6848 US amp Canada 44 1273 497600 Europe amp Worl
45. queich Time q Figure 24 High Voltage Error Message Syste Source Cobalt 5 Probe Type Om Selected Probe d System Test ct Probe System Coarse Gain 2 Fine Gain 21 System Test Peak Channel 1 Total Counts Energy Resolutio Last Calibration Main Menu Figure 25 Not Enough Radiation Detected Error Message EXPERIENCE amp EXPERTISE Appendix D EMC Precautions Electromagnetic environment guidance Special precautions regarding EMC Electromagnetic e The C Trak CW4000 uses RF Radio Frequency energy Compatibility and the Care Wise C Trak Galaxy System only for its internal function Therefore its RF emissions The C Trak Galaxy System conforms to IEC 60601 1 2 standards oy ou ae honey egret aly Menten eer in nearby electronic equipment for electromagnetic compatibility However the Galaxy System a requires special precautions regarding EMC and needs to be e The C Trak CW4000 is suitable for use in all establishments installed and put in service according to the EMC information other than domestic and those directly connected to the provided in this User Guide The customer user of the C Trak public low voltage power supply network that supplies CW4000 should assure that it is used in such an environment buildings used for domestic purposes e Use on floors that are wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least
46. r hardcopy output of results Printer software is preloaded in the C Trak Galaxy System Attach the printer cable to any of the four USB ports on the bottom panel of the analyzer unit See Figure 2 Use only Care Wise approved accessories in the USB ports See Section 2 2 The printer is powered from the AC mains and is supplied with a standard US style AC plug set Contact Care Wise or your Care Wise distributor to supply or replace the proper AC mains plug cable for your application or governmental country requirements Printer supplies ink cartridges are available from your local computer printer supply outlet the printer manufacturer or from Care Wise 8 3 Lechner Collimator Care Wise provides a standard technetium collimator on the OmniProbe with a 39 angled nose and a 270 aperture The accessory Lechner collimator is designed with a 30 angled nose and a 200 aperture The Lechner collimator is designed for conditions of high background radiation levels Using the specialized Lechner collimator can be a major advantage in certain types of clinical cases The removable collimators add additional directionality but decrease sensitivity due to the narrower aperture When a collimator is used it must be firmly attached to the probe to avoid injury to the operator or patient To attach keep the nose aperture open to prevent air pressure that impedes installation and click the slide on collimator firmly in place Other
47. r supply or power cord may cause harm to the user damage the equipment and void the warranty Contact Care Wise for repair or replacement parts Automatic shutoff is a safety feature of the C Trak Galaxy system Ten micro amperes 10 uA is the international standard for the maximum allowable leakage current from a medical device operating off of an external power source that contacts a patient s body during use If current greater than 10 A were to flow to the probe the C Trak Galaxy system would immediately shut off all current to the probe to prevent any risk to patient or surgeon A warning dialog would then appear on screen instructing the user how to proceed safely 7 2 LCD Display The 17 LCD Resistive Touch display is integral to the C Trak Galaxy CW4000 System The screen is sensitive to finger pressure and does not require a stylus Resolution is 1280 x 1024 7 3 Probe Connector Series MHV coaxial connector for ALL probes CAUTION This is NOT a BNC style connector 7 4 Size 420 mm W x 360 mm H x 80 mm D 7 5 Weight Approximately 7 kg 15 4 lbs 7 6 Finish Anti bacterial coated plastic 7 7 Mode of Operation Continuous operation 7 8 Serial Numbers The serial number of the analyzer is located on the back of the unit on the Product Label The serial number for the probe is engraved on the side of the probe at the base of the probe body near the cable connection 7 9 Environment
48. rs 4 2 Background Test A background test will determine if the equipment or the environment is contaminated with radioactive material The background test should be conducted inside the operating room immediately prior to probe use and the results logged to establish the baseline or normal amount of radioactivity present 1 Make sure the isotope that will be used in the surgery is selected 2 Remove or shield all known sources of radioactivity from area Point the probe up and away from all known sources 3 Perform one or more 10 second counts with probe pointed straight up Log the results 4 If the results are elevated from the last log entry decontaminate the probe in accordance with guidelines in section 5 3 If results are still elevated the environment may be contaminated and the appropriate hospital personnel should be informed CAUTION If the instrument indicates a high background when no radioisotope is present the sterile disposable drape may be contaminated If such is the case removing the sterile drape from the probe should reduce the background to a normal reading if no radioisotope is present Continued indication of radioisotope after the sterile drape has been removed may indicate that the probe body has been contaminated See section 5 3 Decontamination 5 0 Sterile Practices Cleaning and Disinfecting 5 1 Use of Sheath All probes in the C Trak family of probes are operated while sheathed in
49. tatement Must be included with any C Trak Device System return RMA Number Date Purchase Order Number Serial Number s and Reason s for return S N 1 REASON 1 S N 2 REASON 2 S N 3 REASON 3 S N 4 REASON 4 S N 5 REASON 5 This Proof of Cleaning Statement is a safety requirement Its purpose is to ensure that the item s being returned for evaluation repair maintenance pose no biological threat to any personnel that may be exposed to said product A thorough cleaning with 70 denatured alcohol or an enzymatic detergent such as Klenzyme Manu Klenz or similar product will suffice If you are returning an OmniProbe device with a collimator the collimator must be removed and cleaned thoroughly inside and outside along with the probe body No residue is to remain on the probe or collimator surfaces Improperly cleaned product may be returned to the customer at their expense or incur a 150 cleaning charge If there are questions on how to properly clean the equipment please refer to your Product Manual or call Care Wise for instructions I attest that the above cleaning procedure has been completed and that the item s being returned is are not contaminated and pose s no biohazard threat to personnel Signature Date Title www southernscientific co uk EXPERIENCE amp EXPERTISE Appendix F Care Wise Product List C Trak Systems and Components 1 C
50. the system displays the Count Screen described in section 2 4 1 it is ready for use NOTE To verify or reset the clock time if the system has been relocated press Main Menu then Setup then Select Time Zone to choose the time zone for your area Care Wise Medical Products C Trak Galaxy System C Trak Galaxy Assembly of the C Trak Galaxy System C Trak Galaxy Gamma Probe System 1 3 C Trak Quick Reference for Surgical Use 7 Care Wise Medical Products 1 Ensure that the Galaxy Analyzer is securely attached to C Trak Galaxy System es the stand Check that the power cable and probe cable are free of any nicks cuts exposed wires or damaged ee lpolepe Techmelium 99m connectors Ensure that the power box is on Connect Count Time 1 guelch Hsabled probe and then turn the Galaxy power on Range 0 1000 as in steps 1 3 above 2 Ensure that a The probe connected to the analyzer is the probe listed on the Count Screen Fig 4 b The Isotope shown on the Count Screen C Trak Galaxy Count Screen is the isotope that will be used 3 Set RANGE at desired setting based on the expected level of activity A range of 0 100 is often preferred for the initial survey Figure 1 4 Check VOLUME setting to ensure a comfortable level Figure 1 5 Take background test Section 4 2 to ensure probe is free of contamination 6 Use the probe to locate the area of greatest radiation u
51. thorized proper and responsive repair rework and remanufacture of the C Trak Products Care Wise and only Care Wise has a full understanding of the manufacture operation and performance of the C Trak Products Full working knowledge and understanding including tolerances specifications performance requirements and product history of each of the specific machined molded and assembled components and subassemblies of the C Trak Products are known only to Care Wise and are proprietary to Care Wise Care Wise will support the repair and maintenance of the Galaxy product for four years after purchase of the system Care Wise will endeavor to satisfactorily repair these systems after this period but cannot guarantee the availability of components or manufacturer support Due to the nature of computer manufacturers their product support history and in keeping with state of the art design upgrades the stated useful life of this product is four years Any unauthorized servicing disassembly or attempted repair or rebuilding of a C Trak Product by the customer owning the Product or a third party voids the warranty of the entire C Trak System Please see the Product Warranty Service Contracts Care Wise offers Service Contracts that further assure the proper upkeep and performance of the C Trak products The Service Contract includes a discount on repair charges free loaners and one PM Preventive Maintenance per y
52. ufacturer All equipment being returned for repair or evaluation whether under warranty or not must receive return authorization from Care Wise or your local international distributor prior to shipment and be assigned an RMA number The C Trak instrument must be returned in the original shipping container box or in a container that will adequately protect the product Do NOT ship in just the carrying case All shipments should include documentation containing customer name shipping address telephone number and any other necessary information Please call if there are any questions regarding the packing material and cartons A Purchase Order signifying customer authorization must be provided before repair or rework is performed www southernscientific co uk Equipment being returned for any reason MUST be clean and disinfected A completed copy of the Care Wise Proof of Cleaning Statement Appendix E must be signed and accompany any returned product Items returned without this form as well as any items deemed to be contaminated may be returned at the expense of the party returning the equipment or be assessed a charge of 150 for cleaning disinfecting by Care Wise Repair of C Trak Products Statement New and or manufacturer refurbished C Trak Products are only available for sale directly from Care Wise or one of the Care Wise licensed distributors or sales representatives Care Wise is also the sole source for au
53. ur months from date of delivery Refurbished products are warranted for one year Repaired product is warranted for ninety days Damage resulting from misuse by the owner or its agent s will be the sole responsibility of the owner and is not covered under warranty In the event of instrument failure the owner must notify Care Wise for repair or replacement Liability of this warranty is limited to the purchase price of the instrument Electrical safety must be periodically checked at the hospital in which this device is used in accordance with the Joint Commission standards and procedures User servicing or disassembly of any portion of this system voids the warranty The individual performing unauthorized disassembly and the owner of the system assume sole liability for damage to the system and any consequential damages Receiving Condition Examination Owner is responsible for inspecting the shipping carton for visible damage when it is delivered by the carrier If damage to the shipping carton is visible the carrier should be notified immediately that the carton was received in damaged condition If damage to the equipment is visible save the shipping container and the packing material and request an immediate inspection by the carrier Care Wise is not responsible for any damage that occurs during shipment Please contact our office if we can be of assistance in resolving a damage claim with the carrier Return of Goods to Man
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