C-Trak® Analyzer
Contents
1. 6 1 1 Select the RATEMETER MULTIPLIER range x1 x10 x100 or x1000 that provides a full scale range and that allows the ratemeter to read less than full scale during normal use A lit orange LED indicates the selected multiplier 6 1 2 Adjust the SPEAKER VOLUME to a comfortable audible level by depressing the UP or DOWN switches marked VOLUME 6 1 3 To change the counting period for timed counts go to HOME SCREEN and choose CHANGE COUNT TIME Increase or decrease the count time by pressing corresponding option Press EXIT to return to HOME SCREEN 6 1 4 The HOME SCREEN displays the isotope that the analyzer is configured for If it is necessary to change the isotope access MASTER CONTROL screen and SELECT ISOTOPE screen Make appropriate selection and SAVE 6 1 5 If Tc 99m is selected the user has a choice of two THRESHOLD and WINDOW settings Pressing CHANGE WINDOW will alternate between the settings for Tc 99m Std Window Threshold 130 keV Window 40 keV and Tc 99m Wide Window Threshold 110 keV Window 80 keV The Wide Window setting can be used to accept a greater number of scattered photons which increases detected radiation but reduces directionality somewhat The Wide Window setting will be most useful in situations where there is very little radiation e g target tissue has lt 25 CPS 6 2 Cautions CAUTION PROBE MUST NOT BE OPERATED IN SURGERY WITHOUT A STERILE DRAPE CAUTION Do not place C Tra2. 5 FOOTSWITCH External footswitch utilized to start the preset counting period Tools are not required to remove and replace the batteries 2 PHA OUT A BNC coaxial connector designed primarily for connection to an external pulse height analyzer PHA or multi channel analyzer 3 RS 232 PRINTER OUTPUT Optically isolated serial data utilizing a 9 pin sub d connector designed to operate external 6 PROBE HOLDER SOURCE DRAWER On earlier models only battery powered no AC line connections permitted printer internal battery pack in the printer capable of operating the receiver part of the optical isolation system Uses a 3 pin female Switchcraft SL173F connector BATTERY COMPARTMENT CONSULT ACCOMPANYING DOCUMENTS MADE IN THE USA FOR CARE WISE MEDICAL PRODUCTS Coe U S PATENT Mis 4 559 S47 5 038 201 5 196 016 5 148 000 5 170 055 5 246 005 MORGAN HILL CALIAORNIA USA OTHER PATENTS PENDING Figure 2 Rear Panel 2 3 Side Panel CONTROL WHEEL A dial on the right side of the analyzer that allows user to access CONTROL SCREENS for advanced functions The control wheel is also used to edit settings on certain CONTROL and FACTORY SCREENS e Rotating the Control Wheel clockwise increases the number being edited e Rotating the Control Wheel counter clockwise decreases the number being edited Figure 3 Side Panel C Trak Analyzer 2 4 Accessing
3. C Trak Analyzer Automatic Analyzer and Probe System e A e a gt if t 5 s a CARE WISE 2 www southernscientific co uk Warranty Receiving Condition Examination Return of Goods to Manufacturer 1 0 Introduction 1 1 C Trak Analyzer and Probe 1 2 Product Manual 2 0 Getting acquainted with the C Trak System 2 1 Front Panel 2 2 Rear Panel 2 3 Side Panel 2 4 Accessing the Display Screens 3 0 Calibration Checking 3 1 When To Do Calibration Check 3 2 Isotope Source 3 3 Performing Calibration Check 3 4 Source Holder Use 4 0 Performing Calibration 4 1 Different Probe or Source 4 2 Failed Calibration Check 4 3 Calibrating 5 0 Pre Surgery Set Up 5 1 Before Power is Turned On 5 2 Turning Power On 5 3 Battery Check 5 4 Isotope Settings 5 5 Background Test 6 0 Use During Surgery 6 1 System Adjustments Changes During Surgery 6 2 Cautions Use of Sterile Drapes Magnetic Drapes Contaminated Drapes 2 www southernscientific co uk 12 12 12 12 13 13 13 i 14 14 15 15 7 0 Sterile Practices Cleaning and Disinfecting 8 0 System Decontamination 8 1 Decontamination Steps 9 0 Safety Considerations 9 1 Current Overload 9 2 Power Supply Requirements 9 3 Accessory Colimator 9 4 Radioactive Concerns 9 5 Use of Electrosurgical Devices 10 0 Use of Optional Accessories 10 1 LED Repeater 10 2 Lechner Collimator 10 3 Blocking Plate 10 4 Indi
4. complete the cleaning process The liquid disposal wipes www southernscientific co uk e The analyzer control unit must not be sterilized or immersed Never immerse the connector ends of the cables for the probe the footswitch or printer in liquid Steam or dry heat sterilization will damage the detector probe and cable void the warranty and could result in injury to the operator or patient 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 8 1 4 Use a commercially available decontaminating product to clean the probe Rinse the probe several times with distilled water 8 1 5 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 being careful not to immerse the connector end of the cable in liquid 8 1 6 Turn on the C Trak system and wait until the system returns to the normal operating mode 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
5. 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 mpe T 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 Trak OmniProbe standard device Carrying Case www southernscientific co uk 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 EXPERIENCE amp EXPERTISE Appendix H continued C Trak Systems and Components Product Code m Check Source Holder C Trak OmniProbe CSH Standard CSH C Trak OmniProbe EL devices CSHL C Trak OmniProbe PET CSHP n Probe Holster PH o Printer Cable PRC p Remote Repeat
6. months from date of delivery Refurbished products are warranted for twelve 12 months and product repairs are warranted for ninety days Damage resulting from misuse by the owner or its agent s will be the sole responsibility of the owner In event of instrument failure the owner must notify Care Wise for repair or replacement Liability of this warranty is limited to the 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 Should the instrument be received in a damaged condition save the shipping container and the packing material and request an immediate inspection by the carrier Return of Goods to Manufacturer All equipment being returned for repair or evaluation whether under warranty or not must receive return authorization from Care Wise 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 Shi
7. As received from Care Wise Medical Products the system will be calibrated and will have a completed Bias Voltage Record form included General Tips e To change screens select fields save or enter data or to exit etc press your choice on the button above the corresponding screen option e To change settings numbers on the screen turn the Control Wheel while viewing screen Note There may be differences in the screen on your analyzer from those presented here due to revisions to the system firmware over time www southernscientific co uk Figure 4 Warm Up Screen This screen appears while the system the probe is warming up The countdown in the center of the screen will indicate when the system is ready for use Figure 5 Internal Diagnostic If a problem occurs in the system while doing calibration check or if the red overload indicator light goes on the screen you are using will be replaced by the Internal Diagnostic screen If one or more items are not ok but instead read Failed see Appendix C for corrective action Figure 6 Calibration Check This screen shows the system is ready for a calibration check EXPERIENCE amp EXPERTISE Figure 7 Home Screen Figure 10 Perfrom Calibration This is the primary screen seen in clinical use Can be manually accessed via the Master Control screen in order Radiation counts are displayed along with parameters to recalibrate t
8. is done with the OmniProbe and the MiniProbe e The check source holder with the OmniProbe EL holder insert should be used with the OmniProbe EL The OmniProbeEL holder insert should be fully inserted into the source holder Note 900 Omni EL uses a different Source Holder 3 2 Place the source holder with probe on a level surface so that the flat side of the holder rests on the surface as well as the handle of the probe Be sure the probe is pressed firmly against the check source during calibration Have someone assist if necessary 3 3 With probe and source positioned the Calibration Process and the System Check Process are carried out in the same way as with the OmniProbe and the MiniProbe Refer to Product Manual Para 4 0 Performing Calibration 3 4 When done slowly remove the probe from the holder to avoid allowing probe to strike any hard surface Check source may be stored in the holder C Trak Analyzer Appendix E continued 4 0 Sterile Practices Cleaning and Disinfecting CAUTION Probe must not be used in minimally invasive or Laparascopic surgery when inserted through a trocar sheath or cannula without first being cleaned and then sterilized with probe cable removed See Par 4 5 below if OmniProbe EL is to be used in open surgical procedures without being introduced through a trocar sheath or cannula 4 1 Cleaning External surfaces of OmniProbe EL Probe with
9. manufactured to be connected to an AC power line or any other type of external power supply The system has been designed and manufactured for safe operation in an operating room environment as long as flammable anesthetic gasses are not used 1 1 Product Manual Sections 2 0 Getting Acquainted and 3 0 Calibration Checking provide information to help you become familiar and comfortable with the system and the various screens and calibration check steps Section 4 0 presents the calibration procedure Section 5 0 outlines the pre surgery set up requirements and Section 6 0 the steps for actual use during surgery Sections 7 0 8 0 9 0 11 0 and 12 0 provide important cleaning safety and technical information Section 10 0 addresses the various accessories available for the C Trak system and how to use them If you don t find the answer there contact your responsible department or call Care Wise on 1 813 626 6848 USA amp Canada 44 1273 497600 Europe amp Worldwide C Trak Analyzer 2 0 Getting acquainted with the C Trak System 2 1 Front Panel 1 Main Power Turns the main battery power supply on and off A green LED is lighted when main power is on 2 Reserve Power Turns the reserve battery power supply on and off A green LED is lighted when reserve power is on 3 Display Screens Depending on the specific screen selected displays the data on radiation detected by the sys
10. mm between the end of the shield and nose bend 10 4 3 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 10 4 4 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 The probe is now ready for use EXPERIENCE amp EXPERTISE 11 0 Technical Specifications 11 1 Power Main power supply consists of 6 alkaline D cell long shelf life batteries contained in the analyzer Reserve power supply consists of 6 alkaline AA cell long shelf life batteries contained in the analyzer Both Main and Reserve batteries are accessible from the instrument s rear panel No tools are required to change the batteries All internal voltages are closely regulated to within 0 1 vdc Battery voltage will not affect instrument operation or accuracy until the battery voltage is reduced to below 6 9 vdc end of useful battery life Diagnostic circuits automatically monitor the voltage of both internal power supplies main and reserve If the voltage from the MAIN power supply decreases to less than 7 0 vdc a warning will begin to blink on the LCD display Also an audible tone will be heard every 10 15 seconds until the instrument is switched to the RESERVE power supply or the batteries a
11. old If using MiniProbe Collimator must be off The red probe overload light is on 1 PROBE FAULT FAILED will also be displayed on the Self Test screen 2 Turn power OFF wait a few seconds to allow system to reset Turn system ON If both FAILED and OVERLOAD LIGHT are no longer displayed proceed with use of system 3 If system still shows FAILED and or OVERLOAD LIGHT turn system off Disconnect probe Turn analyzer ON If the overload fault displays are not now activated the problem is likely a damaged probe or probe cable Before reconnecting probe to analyzer inspect surfaces and both ends of cable probe connections and probe connector on analyzer for damage If visible damage is present contact responsible hospital department or Care Wise 4 If no visible damage reconnect probe and turn system ON If overload fault displays do not recur proceed with use of system If they do recur turn system OFF and contact Care Wise I am getting counts for no reason 1 I get counts with analog meter on X1 and no source present Likely due to stray radiation or contaminated area Clean area and retest 2 I get counts when I shake the probe or wiggle probe cable Likely due to damaged probe or probe cable Call Care Wise 3 I m getting counts and the probe is not connected Call Care Wise Analyzer is making sounds Whoop Whoop Whoop five times 1 Five whoops is the low bat
12. probe may have been damaged EXPERIENCE amp EXPERTISE 9 0 Safety Considerations 9 1 Current Overload 9 4 Radioactive Concerns The current overload indicator signals excessive current flow to All radioactive isotopes and or material drapes liquids cleaning the probe If the current OVERLOAD indicator is on the system materials etc that comes in contact with a radioisotope or item will not operate until it is reset Before resetting the system that is contaminated with a radioisotope must be handled as per inspect all external wiring connectors etc for obvious damage your institution s radiation rules and regulations Consult with If no obvious defects are found refer to Section 11 5 and or your institution s Radiation Safety Officer for guidance concerning Appendix C for corrective action the use and disposal of radioactive material 9 2 Power Supply Requirements 9 5 Use of Electrosurgical Devices Electrosurgical and other electrocautery devices can emit 9 2 1 excess electromagnetic noise This noise may cause the The system is designed and manufactured to operate with D cell C Trak analyzer to record false counts if these devices as disposable alkaline batteries in the MAIN power supply and AA cell used to cut or cauterize concurrent with the probe s use disposable alkaline batteries in the RESERVE power supply in surgical exploration DANGER The C Trak system is not intended for use in the 9 2 2 presence of f
13. the Source Holder and store the Source Holder with Na 22 Source inside within the System Case The System Probe and Analyzer is now set up and ready for use 4 0 Cable and Probe must be covered by a sterile drape The Probe is operated while Probe and Cable are sheathed in a sterile disposable sleeve such as those commonly used with ultrasound probes or laparoscopic cameras as well as with the OmniProbes and MiniProbes e Carefully feed probe and cord into sheath e Donot drop probe into sheath as this places stress on the cord 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 They then tie the glove around the body of the probe for further protection and definition of the shape and position of the probe within the sheath EXPERIENCE amp EXPERTISE Appendix G Proof of Cleaning Statement 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 assure 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 denatur
14. 5 4 2 e Remove or shield all known sources of radioactivity Select isotope by following the prompts on the screen from area Point the probe up and away Save the selection and then exit the screen from all known sources e Perform one or more 10 second counts with 5 4 3 probe pointed straight up Log the results The EDIT ISOTOPE Figure 13 screen changes the Window e If the results are elevated from the last log entry or Threshold settings for a particular isotope decontaminate the probe in accordance with guidelines in manual If results are still elevated the environment may be contaminated and the appropriate hospital personnel should be informed e The screen is also entered from the MASTER CONTROL screen Select the particular value to be changed Threshold or Window and edit by following the prompts on the screen The control wheel changes or edits a selected value Once editing is done save the values and exit the screen 5 4 4 The USER ISOTOPE selection can be used to set up the system for an isotope other than Tc 99m In 111 or Co 57 e Note that the sum of the Window and Threshold settings can not be greater than 400 keV www southernscientific co uk 6 0 Use during Surgery EXPERIENCE amp EXPERTISE e Before beginning a procedure always check the HOME SCREEN to verify that no error messages are present e During usage the HOME SCREEN will be displayed 6 1 System Adjustments Changes During Surgery
15. back on The system should reset and the overload light will be off and FAILED replaced with OK e If all items are OK return to the screen you were previously using and continue e Ifthe problem is not corrected call Care Wise C Trak Analyzer Appendix D 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 www southernscientific co uk EXPERIENCE amp EXPERTISE Appendix E USE OF C Trak OmniProbe EL Probe 1 0 Selecting OmniProbe EL Probe e OmniProbe EL Probe EndoProbe is shown as ENDO on Analyzer LCD screens 1 1 Turn power on 1 2 Rotate Control Wheel on right side on Analyzer to bring up Master Control Screen 1 3 Use SELECT FIELD to select the SELECT PROBE screen and press START This brings up the SELECT PROBE Screen e Use SELECT FIELD to select the ENDO probe then press SAVE CHANGES e Press EXIT The Master Control Screen will appear 2 0 Select Isotope Threshold and Window Settings e If the clinical isotope to be use
16. cable removed must be properly cleaned prior to sterilization and post sterilization attachment of sterile drape that covers handle and cable NOTE Neither water nor any other liquid may be allowed to be present within the cable connector at the distal end base of the probe handle when cable is installed therein Liquid present within said connector may cause electrical short circuits rendering probe unusable connector must be completely dry during clinical use Said connector shall always be enclosed within the sterile drape covering handle and cable during clinical use If the STERIS sterilization process is used said connector must be completely dry before cable is re installed into probe The following products processes are recommended by Care Wise for the cleaning sterilization of our products 1 Prepare an enzymatic detergent Klenzyme according to manufacturer s recommendations 2 Using a clean absorbent cloth or sponge soaked with Klenzyme prepared following manufacturer s instructions thoroughly dampen and soak all external probe surfaces with cable removed except for the surfaces of the cable connector at the distal end base of the probe handle 3 After allowing the detergent Klenzyme to stay on probe surfaces for five minutes remove detergent using clean absorbent cloth soaked in clean tap water 4 Prepare a second cleaning detergent Manu Klenz according to the manufacturer s recomme
17. d is Tc 99m use of the Tc 99m Wide Window is recommended Threshold of 110 keV and Window of 80 keV If the surgeon elects to use these settings carry out the following steps 2 1 Start from the Master Control screen see 1 3 above 2 2 Use SELECT FIELD to select the SELECT ISOTOPE screen and press START This brings up the SELECT ISOTOPE screen 2 3 Use SELECT FIELD to select Tc 99m Wide Window and press SAVE CHANGES Press EXIT The Master Control screen will appear 2 4 Press EXIT the Home screen will appear The Analyzer is now set up to use the OmniProbeEL e For use with other isotopes please refer to Product Manual Para 5 4 Isotope Settings 3 0 Calibration The Analyzer must always be calibrated for use with the specific probe that is to be used with it With Firmware Version 2 08 or higher the Analyzer will retain calibration for a specific probe once performed and saved For Example the User may have the Analyzer calibrated for an OmniProbe and for an OmniProbe EL Once both calibration processes are carried out the Analyzer will retain them Selecting the probe to be used as described under 1 0 above will activate the correct Bias Voltage for that probe 3 1 With the ENDO selected the calibration process is essentially the same as that for an OmniProbe or a MiniProbe Refer to Product Manual e Aone inch diameter disc Cobalt 57 source is used to calibrate the OmniProbe EL as
18. e around the body of the probe for further protection and definition of the shape and position of the probe within the sheath e The system should be turned off before cleaning or disinfecting The components of the C Trak system may be cleaned and surface disinfected when necessary by wiping down their surfaces with either Alcohol Wipes with 70 percent isopropyl alcohol or with a lint free cloth moistened with 70 percent isopropyl alcohol This method is satisfactory for cleaning the surfaces of the analyzer control unit the detector probe and its cables the footswitch and cable assembly and the printer with its cable 8 0 System 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 Section 5 5 If the probe is found to be contaminated use the following procedure to remove radioactive contamination Also check with your nuclear medicine or biomedical engineering departments as applicable 8 1 Decontamination Steps 8 1 1 Remove the sterile cover from the probe the background should return to normal If the system still indicates a high background proceed to the next step 8 1 2 Turn the system off 8 1 3 Use a disposable pan vessel etc to contain the liquid required to
19. e party returning the equipment Once evaluated the customer must issue a hard copy purchase order for the total repair cost prior to commencement of the repairs No product will be returned without a purchase order EXPERIENCE amp EXPERTISE 1 0 Introduction 1 0 C Trak Analyzer and Probe The C Trak system has been designed to detect and quantify the nuclear radiation from gamma emitting isotopes The system is comprised of a probe and an automatic analyzer The probe or detector is capable of detecting gamma ray energies up to 364 keV The analyzer is designed for operation with scintillation detectors 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 battery powered 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 isotopes such as Technetium 99m and Indium 111 Comprehensive shielding of high voltage sites within the instrument and operation only from internal batteries eliminate the possibility of significant electrical current leakage to patient or user under normal operating conditions The C Trak system s electrical safety is greatly enhanced by the fact that the system is not designed or
20. ed 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 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
21. ed 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 C Trak Analyzer Appendix H Care Wise Product List C Trak Systems and Components 1 C 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 E 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
22. er Unit with cable for Automatic Analyzer System RRU q Repeater Cable for Automatic Analyzer System RRC r Galaxy Cart GC 5 Service Contracts 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 O B Factory All products are covered by a two 2 year warranty refurbished products are covered by a one 1 year warranty repaired products are warranted for 90 days Contact Care Wise on 1 813 626 6848 US amp Canada 44 1273 497600 Europe and Worldwide or your local Care Wise representative for current pricing information C Trak Analyzer Appendix I Index foe amon ma K inamaana 60 157 Pe feom ssw DA en o INTI E fees os 7 F frn a TI fe a e i rumsneansen oa e Jow o ie upne a ET o operans 100 18 omama a www southernscientific co uk Pr froin ts Pa rescatan aa acne f Fe PCT IE rector Sid sa ranting O am CTN FN o frans IC ceros as rones a roman f o e sesenta so is sec menos 0 a COTA A IC EXPERIENCE amp EXPERTISE C Trak Analyzer Europe amp Worldwide Southern Scientific Limit
23. esh D cells Also check the RESERVE battery level by pressing RES If they are less than 8 5 Volts replace them EXPERIENCE amp EXPERTISE Appendix C continued Screen INTERNAL DIAGNOSTIC During the initial system set up or during use an error could be identified by the system and the screen you are using replaced with the INTERNAL DIAGNOSTIC screen One or more FAILED messages may appear on the screen Only Date Time and Probe Fault can be corrected by the user If any other item displays FAILED call Care Wise SYSTEM FAILURE Contact Care Wise XXXXXX ok XXXXXX ok DATE TIME FAILED XXXXXX ok XXXXXX ok PROBE FAULT FAILED XXXXXX ok XXXXXX ok Corrective Action DATE TIME e Turn control wheel and bring up MASTER CONTROL screen Select FACTORY MENU and proceed to set date and time Save changes and exit e Turn the system off then back on Return to INTERNAL DIAGNOSTIC screen If the DATE TIME condition is OK continue as applicable e Ifthe FAILED message is still displayed contact Care Wise Corrective Action PROBE FAULT e Ifthe current at the probe connector is more than 10 u amps the power to the connector and the probe if installed will be turned off and the red overload light will be on e The INTERNAL DIAGNOSTIC screen will replace the screen in use and Probe Fault will display FAILED e Turn the power off Wait 10 seconds Turn power
24. etained by the system designated Mini and Omni on the screen You may have two OmniProbes by using the Mini values for your second Omni Be sure probe you are using is displayed Figure 14 Select Probe NOTE System must be recalibrated after restoring factory settings D gt START Figure 15 Factory Menu Allows you to set date and time and restore Factory Settings 10 www southernscientific co uk EXPERIENCE amp EXPERTISE 3 0 Calibration Checking 3 1 When To Do Calibration Check Your C Trak system needs to be calibrated to ensure optimal sensitivity Also if you are using a different probe or check source you will need to calibrate e Calibration check need only be done once a week and that would be prior to the first surgery of the week Routine calibration checks should be performed weekly to ensure optimal performance of your C Trak system If you use the system less than once a week check the calibration before using The calibration check is fully automated and once the system i e the probe is warmed up takes approximately 30 seconds 3 2 Isotope Source A Cobalt 57 Co 57 check source can be used to set up a system intended for use with either Indium 111 In 111 or Technetium 99m Tc 99m The characteristics of Cobalt 57 are Primary photo peak energy 122 keV Half life time it takes for activity to decay by one half 271 days e ACo 57 source comes as part of the C Trak sys
25. fic co uk 3 0 Calibration The Analyzer must always be calibrated for use with the specific probe that is to be used with it The Analyzer will only work with the OmniProbe PET Device PET Probe with Firmware Version 2 08 or higher It will retain calibration for a specific probe once performed and saved For Example the User may have the Analyzer calibrated for an OmniProbe and for a PET Probe Once both calibration processes are carried out the Analyzer will retain them Selecting the probe to be used as described under 1 0 above will activate the correct Bias Voltage for that probe 3 1 With FDG selected the calibration process is essentially the same as that for an OmniProbe or a MiniProbe Refer to Product Manual e A Sodium 22 Na 22 Source one inch diameter disc is used to calibrate a PET Probe The Na 22 annihilation radiation photon peak is at 511 keV the same energy as FDGs annihilation radiation photons 3 2 Place the Na 22 Source in the PET Source Holder label down larger inside probe diameter for a PET Probe Then place the PET Probe in the Source Holder as with the OmniProbe or MiniProbe flush against the Na 22 Source 3 3 With probe and source positioned the Calibration Process and the System Check Process are carried out in the same way as with the OmniProbe and the MiniProbe Refer to Product Manual Para 4 0 Performing Calibration 3 4 When done remove the Probe from
26. he analyzer with a probe Note however that if selected and cps or timed count data calibration checks are performed regularly the system is already confirmed to be in calibration Figure 8 Count time Screen Figure 11 Calibration This screen allows you to specify the duration of timed counts Displayed at conclusion of calibration process The default time is 10 seconds pay p PANE CHANGE Butto o Select OO Save Selection AN a ria INDOV Figure 12 Select Isotope Figure 9 Master Control Allows you to select an isotope for clinical use If neither Tc 99M Turning the control wheel on the side of the analyzer or In 111 is being used select USER ISOTOPE and customize allows access to the Master Control Screen setting as necessary in EDIT ISOTOPE screen C Trak Analyzer aN CHANGES Selects election CHANGES o Select election Figure 13 Edit Isotope Figure 16 Set Date and Time Allows you to change the values preset by the factory User custom Li values for an isotope not shown may also be entered CHANGES Select e Selection ct it Data or SA Figure 17 Restore Factory Settings Restores all system settings to factory default values Deletes calibration data all user defined isotope settings and returns Allows you to switch from one C Trak probe to another Bias Voltage to 700 V default value Calibration settings for two different probes are r
27. he same sterile practices used with C Trak OmniProbes involving a sterile drape covering probe and cable may be used with the C Trak OmniProbe EL See Para 7 0 p 23 Probe sterilization shall not then be required C Trak Analyzer Appendix F Use of C Trak OmniProbe PET Device CAUTION Handle the OmniProbe PET device by its body not the cable Handling by the cable will place undue stress on the cable connection and possibly render the device inoperative 1 0 Selecting OmniProbe PET Device PET Probe e PET Probe is shown as FDG on Analyzer LCD screens 1 1 Turn power on 1 2 Rotate Control Wheel on right side on Analyzer to bring up Master Control Screen 1 3 Use SELECT FIELD to select the SELECT PROBE screen and press START This brings up the SELECT PROBE Screen e Use SELECT FIELD to select the FDG PET Probe then press SAVE CHANGES e Press EXIT The Master Control Screen will appear 2 0 Select Isotope Threshold and Window Settings 2 1 Start from the Master Control screen see 1 3 above 2 2 Use SELECT FIELD to select the SELECT ISOTOPE screen and press START This brings up the SELECT ISOTOPE screen 2 3 Use SELECT FIELD to select FDG or Na 22 and press SAVE CHANGES Press EXIT The Master Control screen will appear 2 4 Press EXIT the Home screen will appear The Analyzer is now set up to use the PET Probe www southernscienti
28. ifferent probe or source is selected go to the CONTROL SCREEN and choose PERFORM CALIBRATION Press START and bring up the PERFORM CALIBRATION screen Figure 10 4 2 Failed Calibration Check If a routine calibration check fails the screen will display Calibration Check Failed Press CALIBRATE and bring up the PERFORM CALIBRATION screen Figure 10 4 3 Calibrating e DO NOT BYPASS WARM UP OF PROBE WHEN DOING A CALIBRATION 4 3 1 Place the probe in the source holder along with the check source See Section 3 3 for proper set up www southernscientific co uk 4 3 2 Press START The screen will display the calibration process that includes e Varying the Bias Voltage applied to the probe from 500 volts to 900 volts in 10 volt steps while searching for the highest observed count rate and then e Varying the voltage in one volt steps over a narrower range while again searching for the highest observed count rate 4 3 3 Once found the corresponding voltage becomes the selected and stored Bias Voltage for that probe A 20 second count is then taken and stored for future calibration checks 4 3 4 The screen will display SYSTEM IS CALIBRATED 4 3 5 Exit through the screens back to HOME SCREEN Remove the probe from the source holder and the system is ready for use 5 0 Pre surgery Set Up EXPERIENCE amp EXPERTISE 5 1 Before Power Is Turned On e Install or remove collimator from probe as requ
29. ired If an OmniProbe is being used the standard Technetium collimator is often installed for initial surveys If a MiniProbe Technetium probe or Indium probe is being used the accessory collimator may or may not be installed for initial surveys e Connect probe to front panel probe connector e Check probe cable for any significant nicks cuts or exposed wires e Verify that external accessories if used are connected properly on the rear panel 5 2 Turning Power On e Press MAIN power on the front panel to turn on analyzer 5 2 1 A five minute warm up period is desirable to stabilize the probe before use however you may bypass warm up If you bypass warm up the probe may be less sensitive for a few minutes 5 2 2 Normal operation is designed to utilize the main power supply The reserve power supply is only designed to provide temporary power if the main power supply fails during a critical operation and the batteries cannot be changed immediately Turning on either main or reserve power supply automatically turns the other supply off 5 2 3 The voltage of the power supply in use will be displayed on the screen e g 8 1 vdc Changing from main to reserve or the reverse during use will not affect instrument accuracy 5 2 4 Turning on the main power supply will automatically begin a diagnostic test cycle to determine if all internal components and voltages are within tolerance If the instrumen
30. ixed to an IV pole and moved to the most convenient and easily seen location 10 1 2 The repeater is provided with a ten foot cable that plugs into the Display receptacle on the rear panel 10 1 3 The small green lights on the faceplate when lit indicate whether it is displaying count rate in counts per second or is in the process of taking a timed count The small red light when lit indicates the batteries are low see below 10 1 4 The repeater should not be immersed or sterilized Cleaning can be done by wiping the surface with a disinfectant or alcohol wipe 10 1 5 To replace the batteries place the repeater face down on a flat surface unscrew the four screws and lift off the back Replace batteries uses six AA cell batteries Fit back carefully to front and tighten screws Do not over tighten e Partially tighten opposite corners and alternate tightening until screws are secured 10 2 Lechner Collimator The Lechner collimator is a special purpose collimator designed for certain conditions of high radiation levels from tissues of no clinical interest nonspecific uptake or background The collimating section of the nose of the collimator has a smaller inner diameter and greater depth than the Standard Technetium collimator The outer diameter however is the same as the Standard Technetium collimator By replacing the Standard collimator with the Lechner model the OmniProbe becomes more direc
31. k probe on or near a magnetic drape pad or mat The magnetic field can permanently degrade probe components and or performance CAUTION If the instrument indicates a high background when no radioisotope is present the sterile disposable drape may be contaminated 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 disposable drape has been removed may indicate the probe body has been contaminated See SYSTEM DECONTAMINATION C Trak Analyzer 7 0 Sterile Practices Cleaning and Disinfecting 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 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 The probe is operated while sheathed in a sterile disposable sleeve such as those commonly used with ultrasound probes or laparascopic cameras e CAREFULLY FEED PROBE AND CORD INTO SHEATH e DO NOT DROP PROBE INTO SHEATH AS THIS PLACES STRESS ON THE CORD 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 They then tie the glov
32. lammable anesthetics or other explosive gases There is a risk of explosion if the System is used in the Do not attempt to operate the instrument or printer with any presence of flammable anesthetics type of AC powered Battery Eliminator or to connect the instrument to an AC power line through any type device CAUTION Do not place C Trak probe on or near a magnetic Connecting the instrument to the AC power line will void instrument pad or mat The magnetic field can permanently the warranty and could result in serious damage to the degrade probe components and or performance patient operator and or instrument e Do not attempt to disassemble or otherwise service the probe or analyzer unit THERE ARE NO USER SERVICEABLE PARTS DISASSEMBLY VOIDS THE WARRANTY AND TRANSFERS ALL CONTINGENT LIABILITY TO THE INDIVIDUAL AND INSTITUTION INVOLVED 9 3 Accessory Collimator The accessory collimator when used must be firmly attached to the probe to avoid injury to the operator or patient When attaching it make sure the air hole in the side or nose depending on collimator is not covered The collimator will click firmly in place when installed properly C Trak Analyzer 10 0 Use of Optional Accessories 10 1 LED Repeater The repeater repeats the timed counts and count rates displayed by the analyzer HOME SCREEN and can be placed in full view of the user during surgery 10 1 1 The repeater can be easily aff
33. ll cycle 12 hours Il 39L NOTE Sterilization other than that described above could damage the probe and cable voids the warranty and could result in injury to the operator or patient Aeration temperature e Cable and probe handle must be covered by a sterile drape 4 3 The probe cable may be used in a sterile field after a sterile drape is placed over cable and secured in place on handle of the Sterilized probe An acceptable drape is Advanced Medical Designs Inc Marietta GA Universal Camera and Laser Drape With Semi opaque Closure 5 inches wide by 96 inches long AMD Part 04 CC216 or equivalent Drape requirements are e Open at the nose small opening as well as the rear end e Has either an elastic nose or a nose with tapes and or rubber bands e Is 5 6 inches wide and 96 inches long 4 4 Suggested installation sequence is as follows Appendix E continued EXPERIENCE amp EXPERTISE 4 4 1 A professional in the sterile field i e scrub nurse holds the sterile OmniProbe EL and the sterile drape 4 4 2 A professional outside the sterile field i e circulating nurse holds the cable 4 4 3 The scrub nurse inserts the probe handle into the small opening of the drape and passes the rear end of the drape without pulling it out to its full length to the circulating nurse 4 4 4 The circulating nurse takes the rear end of the drape in one hand and the cable in the o
34. ndations 5 Thoroughly clean all external probe surfaces except for said surfaces of the cable connector by a using a clean absorbent cloth or sponge soaked with Manu Klenz prepared following manufacturer s instructions and b using a hand held soft bristle brush wetted with Manu Klenz to brush surfaces in a back and forth motion 6 Remove Manu Klenz using clean absorbent cloth soaked in clean tap water Repeat as necessary 7 Probe with cable removed is now ready for sterilization NOTE Klenzyme and Manu Klenz are provided by STERIS Corp of Mentor Ohio USA www southernscientific co uk 4 2 Sterilization The probe with cable removed can be sterilized by the hospital using one of the following methods 1 A Full Cycle of the STERRAD 100S Sterilizer Equipment is available from Advanced Sterilization Products a Johnson amp Johnson company and a division of Ethicon Inc Irvine CA USA 2 Ethylene Oxide Sterilization as validated by Nelson Laboratories Inc Salt Lake City UT USA Preconditioning Parameters Temperature 54 t 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 t 2 C Relative humidity 70 5 Pressure set point 9 3 psia Ethylene oxide concentration 725 25 mg L Gas exposure time full cycle 2 hours Aeration time fu
35. od setting for the initial survey If the analog meter is pegged needle remaining at 30 or 0 when probe is scanning an area of interest change the range Change to a higher range x100 if pegged at 30 or a lower range x1 if pegged at O e Check VOLUME setting to ensure a comfortable level e Look at the HOME SCREEN are the correct isotope window and threshold selected e Use the probe to locate the area of greatest radiation uptake before making the first incision e n 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 e Move the probe slowly and avoid jerky movements With experience the user will develop a feel for the appropriate speed e 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 e Take a 10 second count for the ex vivo specimen s and for the cavity background This will establish whether all significantl
36. on does not work and the warning is still present contact nuclear medicine or biomedical engineering or Care Wise on 1 813 626 6848 US amp Canada 44 1273 497600 Europe amp Worldwide for evaluation This is a safety feature of the C Trak system Ten micro amps is the international standard for the maximum allowable leakage current from a medical device operating off of external power which contacts a patient s body during use 11 6 Rear Panel Connectors PHA out for pulse height analyzer BNC coaxial connector RS 232 printer output 9 pin SUB D female External LED Display 9 pin SUB D male Remote footswitch 3 pin female Switchcraft SL173F 11 7 Size 12 3 312 mm long x 10 254 mm deep x 7 178 mm high 11 8 Weight 10 lbs 4 5 kg including full battery complement without detector 11 9 Housing Aluminum with moisture resistant touch sensitive front panel 11 10 Finish Aluminum cover back panels and chassis with catalyzed polyurethane enamel coating front panel is laminated with silk screening beneath top polycarbonate layer 11 11 Environmental Temp 10 C 40 C Hum 30 75 C Trak Analyzer 11 0 Technical Specifications continued 11 12 Compliance 11 13 Serial Numbers CE mark certified The serial number of the analyzer is located on the back The serial number for the probe is located in the vicinity Meets requirements of US Food and Drug Administration of
37. ource holder drawer located on the back of the analyzer Take the check source and place it in the slot to the right end of the holder with the unlabeled side facing the probe Place the probe in the holder with the nose of the probe against the check source Use the velcro strap to secure the probe in place See Figures 18A and 18B for placement of the probe and source e The circular depression under the Velcro strap can be used to store the check source Figure 18 A Source Holder Drawer Later analyzers do not have the source drawer an external source holder is used Unscrew the two pieces of the source holder and place the source inside with the label facing the foam padding Screw together Insert the nose of the probe into the holder so that it bottoms out or touches the source Proceed with calibration steps When done remove the probe Note If using the OmniProbe the collimator may sometimes pull off and stay in the holder Unscrew the base and remove the collimator with your finger or other soft object e Check source may be stored in the holder Figure 18 B External Source Holder C Trak Analyzer 4 0 Performing Calibration The C Trak system will occasionally need to be calibrated to ensure optimal sensitivity The need will arise if e Adifferent probe is selected e Anew check source is to be used e The system fails a routine calibration check 4 1 Different Probe or Source If a d
38. p to Europe amp Worldwide 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 Q www southernscientific co uk 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 Council TJC 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 assumes sole liability for damage to the system and any consequential damages Care Wise is not responsible for any damage that occurs during shipment Please contact our office if we can be of assistance in resolving the damage claim with the carrier United States amp Canada 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 Your cooperation will expedite the return of your equipment Equipment being returned for any reason MUST be clean and disinfected A signed and completed copy of the Care Wise Proof of Cleaning Statement Appendix G must accompany any returned product Items returned without this form as well as any contaminated items will be returned at the expense of th
39. re replaced and the internal power supply voltages are above 7 0 vdc The same warning signals will be displayed if the RESERVE power supply decreases to less than 8 0 vdc A stable high voltage supply provides the bias voltage required for proper operation of the probe The bias voltage can be adjusted to meet each probe s requirements during calibration Probes require between 500 and 900 vdc bias voltage for proper operation 11 2 LCD Display 320 x 240 pixels monochrome type 5 125 130mm wide x 3 76mm high 11 3 Ratemeter FOUR RANGES Selectable from touch sensitive range multiplier buttons on the front panel Ranges are x1 0 30 CPS x10 0 300 CPS x100 0 3 000 CPS x1000 0 30 000 CPS RATEMETER DISPLAY A high torque taut band analog meter with a O 30 scale Scale length 4 22 107 mm Accuracy 2 of full scale RATEMETER LINEARITY 5 of full scale RATEMETER RESPONSE Automatically optimized for each range and does not require adjustment 11 4 Probe Connector Series MHV coaxial connector for ALL probes detectors 11 5 Probe Overload Indicator The red LED overload indicator will light and the bias voltage supplied to the probe will be reduced to near zero if the probe current exceeds 10 micro amps The INTERNAL DIAGNOSTIC screen Figure 5 will replace the screen in use and will display Probe Fault Failed See Appendix C for corrective action If corrective acti
40. rocedure see below 5 3 3 When the MAIN battery supply is too low the following occurs e The audible alarm is five sound signals in succession whoop whoop whoop whoop whoop repeating at regular intervals e The battery symbol at the lower left corner of the screen used during surgery will blink on and off and contain the word LOW rather than OK e You will not be able to turn the unit off without removing one or more batteries from the analyzer If this has occurred the unit will come back on when you install fresh batteries If it is not to be used at that time you should turn it off using the main battery switch C Trak Analyzer 5 4 Isotope Settings 5 5 Background Test The SELECT ISOTOPE screen Figure 12 is used to select the This test is used to determine if the equipment or the environment isotope that the C Trak system is to set up to detect is contaminated with radioactive material The background test should be conducted inside the operating room immediately 5 4 1 prior to probe use and logged to establish the baseline or normal amount of radioactivity present To enter screen turn the control wheel to bring up the MASTER CONTROL screen Figure 9 Follow the prompts e Use the same Threshold and Window settings for on the screen to bring up the SELECT ISOTOPE screen each Background Test taken The standard Tc 99m WINDOW settings Window 40 keV Threshold 130 keV are satisfactory
41. roperly positioned at the nose of the probe Try again to calibrate e If message is displayed again contact Care Wise for information on purchasing a fresh 5 0 uCi Co57 source www southernscientific co uk Screen CALIBRATION While performing a calibration the displayed word CALIBRATING is replaced with the following CALIBRATION FAILED Please Recalibrate If this recurs contact Care Wise Corrective Action Assure the probe is configured for calibration i e the standard collimator is installed if it is an OmniProbe or the collimator is removed if it is a MiniProbe Assure that the check source is properly positioned at the nose of the probe Try again to calibrate Observe the counts per second cps displayed during the first calibration run of voltages from 500 Volts to 900 Volts If the highest cps values are around or below 500 cps you may have a low calibration check source Contact your nuclear medicine department and try to obtain a source that is at least 1 0 Ci and try to calibrate with it If successful you may use the system If the system will not calibrate with a source of 1 0 uCi or more contact Care Wise Screen HOME SCREEN During the use of the system the OK in the battery symbol at the lower right corner of the HOME SCREEN and others may change to a flashing LOW LOW Corrective Action Replace batteries in the Main Battery supply with fr
42. t fails the DIAGNOSTIC TEST an error message identifying the failure s will appear and the user can acknowledge by choosing the appropriate response on the screen to repeat the test If the instrument fails the diagnostic tests again turn OFF the analyzer and contact nuclear medicine or biomedical engineering or Care Wise as applicable for evaluation 5 2 5 When the instrument successfully completes the DIAGNOSTIC cycle a message will appear on the screen indicating that the instrument has PASSED the DIAGNOSTIC TEST 5 3 Battery Check e Always check batteries before using system 5 3 1 The main battery supply is provided by six alkaline D cell batteries the reserve supply by six alkaline AA cell batteries The level of the main battery supply is displayed on the startup screen at the lower left corner by BATT The level of the reserve supply is shown by RES when the reserve supply is turned on Note The RES voltage displayed when the MAIN supply is on will be incorrect 5 3 2 Operating battery levels for the main supply must be above 6 9 volts for proper operation We recommend that fresh D cell batteries be installed if the main supply is at or below 7 5 volts The reserve supply should be at 8 4 volts or above Check it by turning on the RES supply and then turn it off It will provide enough power for 10 hours of normal use The reserve supply should be used only if the main supply becomes too low during a p
43. tem The five Ci co 57 check source should be replaced at least every 18 months For information on obtaining a check source contact Care Wise 3 3 Performing Calibration Check e DO NOT BYPASS WARM UP OF PROBE WHEN DOING CALIBRATION CHECK e Connect probe and turn on analyzer After turning on the analyzer a screen will be displayed that counts down from 5 minutes The probe will be warmed up when the clock reaches zero This ensures that your C Trak probe will have maximum sensitivity during the calibration check procedure and during any clinical procedures The next screen to be displayed is an internal diagnostic screen This is a self test that shows that all the circuitry of the analyzer is functioning properly Press EXIT to continue The screen should now display the following TO PERFORM A CALIBRATION CHECK PLACE PROBE IN SOURCE HOLDER AND PRESS START Place probe in holder and continue as directed by the screens e Ifa routine calibration check fails the screen will display CALIBRATION CHECK FAILED Proceed to Section 4 0 to calibrate Also see Appendix C Error Messages 3 4 Source Holder Use e If you are using a C Trak OmniProbe leave the standard Tc collimator on for calibration e If you are using a C Trak MiniProbe remove the collimator for calibration e Ifa sterile drape sleeve is on the probe it must be removed before placing probe in source holder Earlier analyzers have a s
44. tem the specific configuration of the system when in use or the information needed to reconfigure the system when desired 4 Ratemeter Multiplier Selection Button Allows selection of the multiplier i e x1 x10 x100 x1000 for the ratemeter range If x10 is selected the ratemeter range is from zero to 300 30 x 10 An orange LED identifies the selected multiplier Q ee m aa E Dit 5 Selection Buttons Located above LCD display they are used to select certain parameters and initiate certain processes depending on the screen selected 6 Volume Control Adjusts volume level of the audible tones that indicate the detected level of radioactivity bar graph on LCD display indicates approximate volume level 7 Probe Connector MHV style connector for all probes 8 Overload Indicator If the current at the probe connector is more than 10 u amps the red indicator light is lighted and the power to the connector and the probe if connected is turned off www southernscientific co uk Figure 1 Front Panel C Trak Automatic ASV ak EXPERIENCE amp EXPERTISE 2 2 Rear Panel 1 BATTERY ACCESS PANEL Provides access 4 LED REPEATER LED display of timed counts or counts per to the main and reserve batteries second by a small unit that can be positioned as preferred by the user e g hanging from an IV pole for a higher view or anywhere within the line of vision
45. tery alarm If batteries are low the LOW battery symbol should be displayed at the lower right corner of the HOME SCREEN 2 Check battery level If less than 7 0 Volts switch to RES If sound stops sound was low battery alarm 3 At first opportunity check both MAIN and RES batteries MAIN should be at least 7 5 Volts at start of case RES should be at least 8 5 Volts must have RES power button on to check RES Replace all low batteries 4 If Batteries less than 6 9 Volts unit may not shut off Open battery compartment and remove one D cell battery or one AA battery if RES on Unit will turn off 5 If battery alarm stays on with good fresh batteries Call Care Wise When should I perform QC CHECK termed CALIBRATION CHECK 1 If the system is used every day check before use once a week allowing time for tech support if needed 2 Ifthe system is used less often check before using allowing time for tech support if needed How do I get the sound louder Check out Figure 1 item 6 in the manual It shows the location of the Volume Control The bar on the right of the LCD screen represents the sound level The power won t turn off Replace the batteries with fresh ones On rare occasions when the battery voltage is lower than 7 0 volts the system will not allow you to turn itself off using the Power On Off button Removing a battery will turn the system off replacing it will turn i
46. the Screens The following steps will guide you through the various screen options It will take a minimum of 10 minutes to go through all the screens and then reset the analyzer Take enough time to become familiar and comfortable with all the controls 2 4 1 If you are just going to go through the screens get the analyzer and turn it on It is not necessary to have the probe connected or to have a check source 2 4 2 If you want to go through the calibration check and or calibration process you will need the analyzer probe and a check source Connect probe to analyzer then turn on analyzer Insert probe and source in source holder 2 4 3 The first screen to appear will be WARM UP the PROBE not the analyzer needs to be warmed up You can follow directions on screen and calibrate see Section 4 0 OR you can use the control wheel on the side to go directly to Control Screen and change to the various screens by following the screen options 2 4 4 Continue going through the screens Follow directions on how to select and save isotopes edit isotopes change count time etc 2 4 5 If the system is a newly purchased one from a Third Party and not calibrated or if you are not sure about the calibration status you should first follow the directions to RESTORE FACTORY SETTINGS Then proceed to SET UP and calibrate the system for the probe and clinical isotope you are using NOTE
47. the cable connection and Medical Device Directive of the European Union EN 60601 1 3rd Ed and 60601 1 2 certified www southernscientific co uk EXPERIENCE amp EXPERTISE 12 0 International Symbols 12 1 Front Panel 12 2 Rear Panel K Loudspeaker o Start Symbol High Voltage Information Consult Accompanying Documents User s Guide Printer Equipment not suitable for use in the presence of a flammable mixture with air or with oxygen or nitrous oxide Medical General Medical Equipment as to electrical shock fire and mechanical hazards only in accordance with UL 60601 1 2003 CAN CSA C22 2 No 601 1 2005 ANSI AAMI ES60601 1 2005 CAN CSA C22 2 No 60601 1 2008 lt 48ZK gt amp aop 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 C Trak Analyzer Appendix A C Trak Quick Reference for Surgical Use e Check that probe cable is free of any nicks cuts or exposed wires Connect probe then turn power on e Check calibration at least once a week if used weekly or before each surgical use if used less often e Take background test to ensure probe is free of contamination e Set Ratemeter at desired multiplier range x1 x10 x100 x1000 based on the expected level of activity e x10 is often a go
48. ther hand reaches into the unextended drape with the cable and inserts the cable connector into the OmniProbe EL connector 4 4 5 The scrub nurse closes the drape on the probe handle with the tape or rubber bands supplied with the drape 4 4 6 The circulating nurse pulls the drape up the cable to its full length connects the cable to the analyzer 4 5 The components of the C Trak system other than the OmniProbe EL may be cleaned and surface disinfected when necessary by wiping down their surfaces with either Alcohol Wipes with 70 percent isopropyl alcohol or with a lint free clothe moistened with 70 percent isopropyl alcohol This method is satisfactory for cleaning the surfaces of the analyzer control unit the detector probe other than OmniProbe EL and its cables the footswitch and cable assembly and the printer with its cable e The analyzer control unit must not be sterilized or immersed 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 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 4 6 NOTE If OmniProbe EL is to be used in Open Surgery without being passed through a trocar sheath or cannula then t
49. tional but less sensitive The overall outer diameter of the OmniProbe nose with either collimator installed is the same This can be a major advantage in certain types of clinical cases Other 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 10 3 Blocking Plate The C Trak blocking plate is a hand held Tungsten alloy plate Its dimensions are 3 x 3 1 2 x 1 8 thick The user can selectively block radiation from known areas of high radioactive uptake It is another tool like special collimators allowing the user to better cope with high radiation levels from tissues of no clinical interest nonspecific uptake or background 10 4 Indium Shield Assembly The Indium shield assembly converts the C Trak OmniProbe from a probe with shielding and collimation optimized for use with radioisotope Tc 99m to a probe optimized for use with the higher energy radioisotope In 111 10 4 1 To install the shield disconnect cable from the OmniProbe and remove the standard collimator already on the probe 10 4 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 e Do not insert the probe all the way into the shield leave about 1
50. tself back on If changing the batteries does not fix the problem call Care Wise C Trak Analyzer Appendix C Error Messages Screen CALIBRATION CHECK The following message may be displayed during calibration check CALIBRATION CHECK FAILED Corrective Action e Assure that the probe is configured for checking calibration i e the standard collimator is installed if it is an OmniProbe or the collimator is removed if it is a MiniProbe e Assure that calibration check source is properly positioned at the nose of the probe the same way it was positioned during system calibration Try again to check calibration e Ifthe system fails calibration check again turn the control wheel to bring up the MASTER CONTROL screen select PERFORM CALIBRATION and recalibrate the system Screen CALIBRATION The following message may be displayed when you exit at the completion of calibration SYSTEM IS CALIBRATED Your calibration source may need replacing soon e The system is calibrated and ready for use even if this message is displayed Exit the calibration screen and return to the home screen and continue as applicable e Assoonas possible perform the Corrective Action below Corrective Action e Assure that probe is configured for calibration i e the standard collimator is installed if it is an OmniProbe or the collimator is removed if it is a MiniProbe e Assure that the check source is p
51. um Shield Assembly 11 0 Technical Specifications 11 1 Power 11 2 LCD Display 11 3 Ratemeter 11 4 Probe Connector 11 5 Probe Overload Indicator 11 6 Rear Panel Connectors 11 7 Size 11 8 Weight 11 9 Housing 11 10 Finish 11 11 Environmental 11 12 Compliance 11 13 Serial Numbers 12 0 International Symbols 16 16 17 17 17 17 17 17 18 18 18 18 18 EXPERIENCE amp EXPERTISE Appendix A 22 Care Wise contact information Quick Reference for Surgical Use Europe amp Worldwide Southern Scientific Ltd Appendix B 23 Scientific House The Henfield Business Park Shoreham Road Henfield West Sussex Troubleshooting Q A BN5 9SL United Kingdom Tel 44 0 1273 497600 Appendix C 24 25 Fax 44 0 1273 497626 Error Messages Web www southernscientific co uk USA amp Canada Appendix D 26 Care Wise c o LabLogic Systems Inc 1040 East Brandon Boulevard Brandon Florida 33511 5509 USA Tel US 813 626 6848 Instructions for Detaching Probe Cable APPEASE 27 29 Fax US 813 620 3708 Use of OmniProbe EL Web www carewise com Appendix F 30 Use of Omniprobe PET Device Appendix G 31 Proof of Cleaning Statement Appendix H 32 33 Products List Appendix I 34 Index C Trak Analyzer Warranty Care Wise warrants new analyzers probes and related products addressed in this Product Manual to be free of defects due to workmanship materials and design for a period of twenty four 24
52. y radioactive tissue has been removed e Every 18 months replace the 5 uCi Co 57 source You may purchase a check source through Care Wise Part number CSC Call Care Wise on 1 813 626 6848 US amp Canada 44 1273 497600 Europe Worldwide with any inquiry www southernscientific co uk EXPERIENCE amp EXPERTISE Appendix B Troubleshooting Q amp A I push main power ON but nothing happens What s wrong 1 Check that the batteries are installed properly check the polarity amp contacts Try again 2 Replace the 6 each D batteries Try again 3 Still won t turn on Call Care Wise I m not getting counts 1 Check that cable connectors are turned and locked in place on the analyzer and pushed in and locked on the probe If not correct and try again 2 Check that analyzer has proper Window and Threshold settings for isotope in use If not correct and re try 3 Check that you get counts with Co 57 source held against nose of probe If yes then problem may be with radiopharmaceutical administration or distribution 4 Check calibration If OK try using again If not OK recalibrate If no counts during calibration process probe may be damaged Call Care Wise NOTE During calibration check or re calibration Nose of OmniProbe with Collimator installed must be centered on and flush against bare side of Co 57 Check Source Source must be less than two years
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