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`407 of patient line 305p and waste line 305w, respectively, extending from second side
`
`392 of frame 39. Although ends 406, 407 are shown extending upward from tray 39a,
`
`as they would within shielding assembly 200, it should be appreciated that the tubing
`
`lines of circuit 300 are preferably flexible and would drop down under their own
`
`5
`
`weight rather than extending upward, as shown, if not supported. Referring back to
`
`Figure ID, in conjunction with Figure 3C, it can be seen that the aforementioned
`
`fittings are provided for coupling subassembly 390 into circuit 300: first fitting 311
`
`couples the section of eluant line 302 to filter 37; second fitting 312 couples eluant line
`
`304 to an inlet port of generator 21; third fitting 313, which may incorporate a check
`
`10
`
`valve, couples eluate line 305 to an outlet port of generator 21; fourth fitting 314
`
`couples waste line 305w to waste bottle 23; and fifth fitting 315 couples patient line
`
`305p to an extension thereof, which extends outside shell 13 (designated by the dotted
`
`line). Each of the fittings 311, 312, 313, 314, 315 may be of the Luer type, may be a
`
`type suitable for relatively high pressure applications, or may be any other suitable
`
`15
`
`type that is known to those skilled in the art.
`
`As previously mentioned, when generator 21 is replaced, it is typically
`
`desirable to also replace those portions of circuit 300 which are shielded behind lid
`
`223 and doors 227, 225, and, in those instances wherein system 10 is moved to a new
`
`site each day, these portions may be replaced daily. Thus, according to the illustrated
`
`20
`
`embodiment, these portions are conveniently held together by frame 39, as
`
`subassembly 390, in order to facilitate relatively speedy removal and replacement,
`
`while assuring a proper assembly orientation, via registration with features formed in
`
`sidewall 205 (Figure 3A), for example: registration of divergence valve 35WP with
`
`valve actuator receptacle 253, registration of tubing line ends 403 and 404A with
`
`25
`
`passageways 251 b and 251 g, respectively, registration of tubing line ends 4048 and
`
`405 with passageways 215i and 2150, respectively, and registration of tubing line ends
`
`406 and 407 with passageway 207.
`
`With further reference to Figure 38, other portions of tubing circuit 300 are
`
`shown. Figure 38 illustrates eluant tubing line 301 extending from reservoir 15,
`
`30
`
`outside of shell 13 (Figure IA), to syringe pump 33, which is mounted to an actuating
`
`platform 433. According to the illustrated embodiment, platform 433 is actuated by
`
`another servomotor (not shown) of system 10, which is controlled by the controller
`
`and computer 17 of system 10, to cause a plunger of pump 33 to move, per arrow I, so
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`as to draw in eluant, from reservoir 15, through tubing line 301, and then to cause the
`
`plunger to move in the opposite direction so as to pump the eluant, through tubing line
`
`302, to either generator 21 or to by-pass line 303. Although the illustrated
`
`embodiment includes syringe pump 33, other suitable pumps, known to those skilled
`
`5
`
`in the art, may be substituted for pump 33, in order to draw eluant from reservoir 15
`
`and to pump the eluant throughout circuit 300. Although not shown, it should be
`
`appreciated that divergence valve 35BG is fitted into another valve actuating
`
`receptacle mounted within shell 13 and coupled to yet another servomotor (not shown)
`
`of system 10.
`
`10
`
`Figure 3B further illustrates a filter holder 317 that is mounted alongside an
`
`interior surface of shell 13 to hold filter 3 7 (Figure ID) of tubing line 302. Filter
`
`holder 3 I 7, like frame 39 for subassembly 390, may be formed from a thermoformed
`
`plastic sheet; holder 3I 7 may have a clam-shell structure to enclose filter 37 in an
`
`interior space, yet allow tubing line 302, on either side of filter 37, to extend out from
`
`I5
`
`the interior space, in between opposing sides of the clam-shell structure. Holder 3I 7 is
`
`shown including an appendage 307 for hanging holder 3 I 7 from a structure (not
`
`shown) inside shell I3.
`
`Turning now to Figures 4-9C details concerning computer-facilitated operation
`
`of system I 0 will be described, according to some embodiments of the present
`
`20
`
`invention. As previously mentioned, and with reference back to Figure IA, computer
`
`I 7 of system I 0 includes monitor I 72, which, preferably, not only displays indications
`
`of system operation to inform a user of system I 0, but is also configured as a touch
`
`screen to receive input from the user. It should be understood that computer I 7 is
`
`coupled to the controller of system 10, which may be mounted within the interior
`
`25
`
`space surrounded by shell 13. Although Figure IA shows computer 17 mounted to
`
`post 142 of system I 0, for direct hardwiring to the controller of system 10, according
`
`to some alternate embodiments, computer I 7 is coupled to the controller via a flexible
`
`lead that allows computer I 7 to be positioned somewhat remotely from those portions
`
`of system IO, from which radioactive radiation may emanate; or, according to some
`
`30
`
`other embodiments, computer I 7 is wirelessly coupled, for example, via two-way
`
`telemetry, to the controller of system 10, for even greater flexibility in positioning
`
`computer 17, so that the operation of system I 0 may be monitored and controlled
`
`remotely, away from radioactive radiation.
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`According to some preferred embodiments, computer 17 is pre-programmed to
`
`guide the user, via monitor 172, through procedures necessary to maintain system 10,
`
`to perform quality control tests on system 10, and to operate system 10 for patient
`
`infusions, as well as to interact with the user, via the touch-screen capability of
`
`5
`
`monitor 172, according to preferred embodiments, in order to track volumes of eluant
`
`and eluate contained within system 10, to track a time from completion of each elution
`
`performed by system 10, to calculate one or more system parameters for the quality
`
`control tests, and to perform various data operations. Computer 17 may also be pre(cid:173)
`
`programmed to interact with the controller of system 10 in order to keep a running
`
`10
`
`tally or count of elutions per unit time, for a given generator employed by the system,
`
`and may further categorize each of the counted elutions, for example, as being
`
`generated either as a sample, for quality control testing, or as a dose, for patient
`
`injection. The elution count and categorization, along with measurements made on
`
`each sample or dose, for example, activity level, volume, flow rate, etc ... , may be
`
`15
`
`maintained in a stored record on computer 17. All or a portion of this stored
`
`information can be compiled in a report, to be printed locally, and/or to be
`
`electronically transferred to a remote location, for example, via an internet connection
`
`to technical support personnel, suppliers, service providers, etc ... , as previously
`
`described. Computer 17 may further interact with the user and/or a reader of encoded
`
`20
`
`information, for example, a bar code reader or a radiofrequency identification (RFID)
`
`tag reader, to store and organize product information collected from a product
`
`labels/tags, thereby facilitating inventory control, and/or confirming that the proper
`
`components, for example, of the tubing circuit, and/or accessories, and/or solutions are
`
`being used in the system.
`
`25
`
`It should be understood that screen shots shown in Figures 4-9C are exemplary
`
`in nature and are presented to provide an outline of some methods of the present
`
`invention in which computer 17 facilitates the aforementioned procedures, without
`
`limiting the scope of the invention to any particular computer interface format.
`
`Computer 17 may also include a pre-programmed user manual, which may be viewed
`
`30
`
`on monitor 172, either independent of system operation or in conjunction with system
`
`operation, for example, via pop-up help screens. Although the English language is
`
`employed in the screen shots of Figures 4-9C, it should be understood that, according
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`to some embodiments, computer 17 is pre-programmed to provide guidance in
`
`multiple languages.
`
`Figure 4 is a screen shot of a main menu 470, which is presented by computer
`
`17 on monitor 172, according to some embodiments. Main menu 470 includes a
`
`5
`
`listing of each computer-facilitated operation that may be selected by the user, once
`
`the user has logged on. According to some multi-lingual embodiments, computer 17
`
`presents a list of languages from which the user may select, prior to presenting main
`
`menu 470.
`
`Figure 5A is a schematic showing a series of screen shots which includes a log
`
`10
`
`in screen 570. According to some embodiments, when the user touch-selects the data
`
`entry fields of screen 570 or 571, or of any of the other screens presented herein,
`
`below, a virtual keyboard is displayed for touch-select data entry into the selected data
`
`entry field; alternately, computer 17 may be augmented with another type of device for
`
`user data entry, examples of which include, without limitation, a peripheral keyboard
`
`15
`
`device, a storage medium (i.e. disk) reader, a scanner, a bar code reader (or other
`
`reader of encoded information), a hand control (i.e. mouse, joy stick, etc ... ).
`
`Although not shown, according to some embodiments, screen 570 may further include
`
`another data entry field in which the user is required to enter a license key related to
`
`the generator employed by system 10 in order to enable operation of system 1 O; the
`
`20
`
`key may be time sensitive, related to generator contract terms. Of course any number
`
`of log in requirements may be employed, according to various embodiments, and may
`
`be presented on multiple sequentially appearing screens rather than on a single log in
`
`screen.
`
`After the user enters the appropriate information into data entry fields of log in
`
`25
`
`screen 570, computer 17 presents a request for the user to confirm the volume of
`
`eluant that is within reservoir 15 (e.g. saline in saline bag), via a screen 571, and then
`
`brings up main menu 470. If the user determines that the volume of eluant/saline is
`
`insufficient, the user selects a menu item 573, to replace the saline bag. If system 10
`
`includes an encoded information reader, such as a bar code or RFID tag reader,
`
`30
`
`confirmation that the selected reservoir is proper, i.e. contains the proper saline
`
`solution, may be carried out by computer 17, prior to connecting the reservoir into
`
`circuit 300, by processing information read from a label/tag attached to the reservoir.
`
`Alternatively, or in addition, tubing line 301 of circuit 300 may be provided with a
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`connector which only mates with the proper type of reservoir 15. According to some
`
`embodiments, system 10 may further include an osmolarity or charge detector, which
`
`is locatedjust downstream ofreservoir 15 and is linked to computer 17, so that an
`
`error message may be presented on monitor 172 stating that the wrong osmolarity or
`
`5
`
`charge is detected in the eluant supplied by reservoir, indicating an improper solution.
`
`One example of a charge detector that may be employed by system 10 is the Sci Con TM
`
`Conductivity Sensor (available from SciLog, Inc. of Middleton, WI).
`
`Once the reservoir/saline bag is successfully replaced, computer 17 prompts the
`
`user to enter a quantity of saline contained by the new saline bag, via a screen 574.
`
`10
`
`Alternately, if system 10 includes the aforementioned reader, and the saline bag
`
`includes a tag by which volume information is provided, the reader may automatically
`
`transfer the quantity information to computer 17. Thus, computer 1 7 uses either the
`
`confirmed eluant/saline volume, via screen 571, or the newly entered eluant/saline
`
`volume as a baseline from which to track depletion of reservoir volume, via activations
`
`15
`
`of pump 33, in the operation of system 10. With reference to Figure 5B, during the
`
`operation of system 10, when computer 17 detects that the eluant reservoir/saline bag
`
`has been depleted to a predetermined volume threshold, computer 17 warns the user,
`
`via a screen 577. If the user has disregarded screen 577 and continues to deplete the
`
`saline bag, computer 17 detects when the saline bag is empty and provides indication
`
`20
`
`of the same to the user, via a screen 578. To replenish the reservoir/saline bag, the
`
`user may either refill the reservoir/bag or replace the empty reservoir/bag with a full
`
`reservoir/bag. According to some embodiments, system 10 automatically precludes
`
`any further operation of the system until the reservoir is replenished. It should be
`
`noted that, as previously mentioned, system 10 can include a fluid level sensor coupled
`
`25
`
`to the eluant reservoir in order to detect when the level of saline drops below a certain
`
`level.
`
`In addition to tracking the volume of eluant in reservoir 15, computer 17 also
`
`tracks a volume of the eluate which is discharged from generator 21 into waste bottle
`
`23. With reference to Figure 5C, an item 583 is provided in main menu 470, to be
`
`30
`
`selected by the user when the user empties waste bottle 23. When the user selects item
`
`583, computer 17 presents a screen 584, by which the user may effectively command
`
`computer 17 to set a waste bottle level indicator to zero, once the user has emptied
`
`waste bottle 23. Typically, the user, when powering up system 10 for operation, each
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`day, will either empty waste bottle 23, or confirm that waste bottle 23 was emptied at
`
`the end of operation the previous day, and utilize screen 584 to set the waste bottle
`
`level indicator to zero. Thus, computer 17, can track the filling of waste bottle 23 via
`
`monitoring of the operation of pump 33 and divergence valve 35WP, and provide an
`
`5
`
`indication to the user when waste bottle 23 needs to be emptied, for example, via
`
`presentation of screen 584, in order to warn the user that, unless emptied, the waste
`
`bottle will overflow. According to some embodiments, system 10 automatically
`
`precludes any further operation of the system until the waste bottle is emptied.
`
`According to some alternative embodiments, a fluid level sensor may be coupled to
`
`10
`
`waste bottle, for example, as mentioned above in conjunction with Figure ID, in order
`
`to automatically detect when waste bottle is filled to a predetermined level and to
`
`provide, via computer 17, an indication to the user that waste bottle 23 needs to be
`
`emptied and/or to automatically preclude operation of system 10 until the waste bottle
`
`is emptied.
`
`15
`
`In addition to the above maintenance steps related to eluant and eluate volumes
`
`of system 10, the user of system 10 will typically perform quality control tests each
`
`day, prior to any patient infusions. With reference to Figure 6, according to preferred
`
`methods, prior to performing the quality control tests (outlined in conjunction with
`
`Figures 7A-C and 8A-B), the user may select an item 675 from main menu 470, in
`
`20
`
`order to direct system 10 to wash the column of generator 21. During the generator
`
`column wash, which is performed by pumping a predetermined volume of eluant, for
`
`example, approximately 50 milliliters, through generator 21 and into waste bottle 23,
`
`computer 17 provides an indication, via a screen 676, that the wash is in progress.
`
`Also, during the generator column wash, the system may provide a signal to indicate
`
`25
`
`that eluate it being diverted to waste bottle 23, for example, light projector 100 (Figure
`
`1 C) may project a flashing light signal, as previously described.
`
`Figure 6 further illustrates a screen 677, which is presented by computer 17
`
`upon completion of the column wash, and which provides an indication of a time lapse
`
`since the completion of the wash, in terms of a time countdown, until a subsequent
`
`30
`
`elution process may be effectively carried out. While screen 6 77 is displayed, system
`
`10 may be refilling, from reservoir 15, pump 33, which has a capacity of
`
`approximately 55 milliliters, according to some embodiments. According to some
`
`preferred embodiments of the present invention, computer 17 starts a timer once any
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`elution process is completed and informs the user of the time lapse, either in terms of
`
`the time countdown (screen 677), or in terms of a time from completion of the elution,
`
`for example, as will be described in conjunction with Figure 7B. According to an
`
`exemplary embodiment, wherein generator 21 is the CardioGen-82® that yields a
`
`5
`
`saline solution ofRubidium-82, produced by the decay of Strontium-82, via the
`
`elution, a time required between two effective elution processes is approximately 10
`
`minutes.
`
`Once the appropriate amount of time has lapsed, after the elution process of
`
`generator column wash, a first quality control test may be perfom1ed. With reference
`
`10
`
`to Figure 7A, the user may select, from main menu 470, an item 773A, which directs
`
`computer 17 to begin a sequence for breakthrough testing. According to some
`
`embodiments, in conjunction with the selection of item 773A, the user attaches a
`
`needle to an end of patient line 305p and inserts the needle into to a test vial, for the
`
`collection of an eluate sample therefrom, and, according to Figure 7 A, computer 17
`
`15
`
`presents a screen 774, which instructs the user to insert the test vial into a vial shield,
`
`which may be held in recess 101 of shell 13 (Figure 1 C).
`
`Figure 7A further illustrates a subsequent screen 775, by which computer 17
`
`receives input, from the user, for system 10 to start the breakthrough elution, followed
`
`by a screen 776, which provides both an indication that the elution is in progress and
`
`20
`
`an option for the user to abort the elution. As previously described, the system may
`
`provide a signal to indicate that elution is in progress, for example, light projector 100
`
`(Figure IC) may project a flashing light signal during that portion of the elution
`
`process when eluate is diverted from generator 21 through waste line 305w and into
`
`waste bottle 23, and then a steady light signal during that portion of the elution process
`
`25
`
`when the eluate is diverted from generator 21 through patient line 305p and into the
`
`test vial, for example, once activity detector 25 detects a dose rate of approximately
`
`1.0 mCi/sec in the eluate discharged from generator 21. Another type of light signal,
`
`for example, the more rapidly flashing light, as previously described, may be projected
`
`when a peak bolus of radioactivity is detected in the eluate.
`
`30
`
`Upon completion of the elution process for breakthrough testing, computer 17
`
`presents a screen 777, shown in Figure 7B, which, like screen 677, provides an
`
`indication of a time lapse since the completion of the elution, but now in terms of a
`
`time since completion of the breakthrough elution process. When the user transfers
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`the vial containing the sample of eluate into a dose calibrator, to measure the activity
`
`of the sample, the user may make a note of the time lapse indicated on screen 777.
`
`With further reference to Figure 7B, once the user has received the activity measure
`
`from the dose calibrator, the user proceeds to a screen 778, which includes data entry
`
`5
`
`fields for the activity measure and the time between that at which the dose calibrator
`
`measured the activity of the sample and that at which the elution was completed. The
`
`user may enter the data via the touch-screen interface of monitor 172, or via any of the
`
`other aforementioned devices for user data entry. According to some alternate
`
`embodiments, computer 17 may receive the data, electronically, from the dose
`
`10
`
`calibrator, either via wireless communication or a cable connection.
`
`After the data is entered by the user, computer 1 7 presents screen 779, from
`
`which the user moves back to main menu 470 to perform a system calibration, for
`
`example, as will be described in conjunction with Figures 8A-B, although the
`
`breakthrough testing is not completed. With reference back to Figure 7A, an item
`
`15
`
`773B is shown, somewhat faded, in main menu 470; item 773B may only be
`
`effectively selected following the completion of steps for item 773A, so as to perform
`
`a second stage of breakthrough testing. In the second stage, the breakthrough of the
`
`sample of eluate collected in the test vial for the breakthrough testing is measured, at a
`
`time of approximately 60 minutes from the completion of the elution that produced the
`
`20
`
`sample. With reference to Figure 7C, after the user has selected item 773B from main
`
`menu 470, in order to direct computer 17 to provide breakthrough test results, a screen
`
`781 is displayed. Screen 781 includes, for reference, the values previously entered by
`
`the user in screen 778, along with another pair of data entry fields into which the user
`
`is instructed to enter the breakthrough reading of the sample at 60 minutes and the
`
`25
`
`background radiation reading, respectively. After the user enters this remaining
`
`information, as described above, computer 17 may calculate and then display, on a
`
`screen 782, the breakthrough test results. According to the illustrated embodiment,
`
`computer 17 also displays on screen 782 pre-programmed allowable limits for the
`
`results, so that the user may verify that the breakthrough test results are in compliance
`
`30
`
`with acceptable limits, before moving on to a patient infusion. According to some
`
`embodiments, system 10 will not allow an infusion if the results exceed the acceptable
`
`limits, and may present a screen explaining that the results are outside the acceptable
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`limits; the screen may further direct the user to contact the generator supplier, for
`
`example, to order a replacement generator.
`
`With reference to Figure SA, during the aforementioned 60 minute time period,
`
`while waiting to complete the breakthrough testing, the user may perform calibration
`
`5
`
`by selecting item 873 from main menu 470. Upon selection of item 873, computer 17
`
`presents a screen 874, which instructs the user to insert a new test vial into an elution
`
`vial shield. In addition to placing the vial in the shield, the user, preferably, replaces
`
`patient line 305p with a new patient line, and then attaches a needle to the end of the
`
`new patient line for insertion into the test vial, in order to collect an eluate sample
`
`10
`
`therefrom. After performing these steps, the user may move to screen 875, wherein a
`
`plurality of data entry fields are presented; all or some of the fields may be filled in
`
`with pre-programmed default parameters, which the user has an option to change, if
`
`necessary. Once the user confirms entry of desired parameters for the calibration, the
`
`user may enter a command, via interaction with a subsequent screen 876, to start the
`
`15
`
`calibration elution.
`
`With reference to Figure SB, after computer 17 starts the elution process, a
`
`screen 87 informs the user that the calibration elution is in progress and provides an
`
`option to abort the elution. As previously described, the system may provide an
`
`indication that elution is in progress, for example, light projector 100 (Figure 1 C) may
`
`20
`
`project a flashing light signal during that portion of the elution process when eluate is
`
`diverted from generator 21 through waste line 305w and into waste bottle 23, and then
`
`a steady light signal during that portion of the elution process when activity detector
`
`25 has detected that a prescribed dose rate threshold is reached, for example, 1.0
`
`mCi/sec, and the eluate is being diverted from generator 21, through the new patient
`
`25
`
`line, and into the test vial. Another type of light signal, for example, the more rapidly
`
`flashing light, as previously described, may be projected when a peak bolus of
`
`radioactivity is detected in the eluate. Upon completion of the elution process for
`
`calibration, computer 17 presents a screen 878, which provides an indication of a time
`
`lapse since the completion of the elution, in terms of a time since completion of the
`
`30
`
`calibration elution process. When the user transfers the vial containing the sample of
`
`eluate into the dose calibrator, to measure the activity of the sample, the user may
`
`make a note of the time lapse indicated on screen 878. With further reference to
`
`Figure 8B, once the user has received the activity measure from the dose calibrator, the
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`user proceeds to a screen 879, which includes data entry fields for the activity measure
`
`and the time, with respect to the completion of elution, at which the dose calibrator
`
`measured the activity of the sample. Once the data is input by the user, as described
`
`above, computer calculates a calibration coefficient, or ratio, and presents the ratio on
`
`5
`
`a screen 880. According to Figure 8B, screen 880 further provides an indication of a
`
`desirable range for the calibration ratio and presents an option for the user to reject the
`
`calculated ratio, in which case, the user may instruct computer 17 to recalculate the
`
`ratio.
`
`As previously mentioned, some alternate embodiments of the present invention
`
`10
`
`include an on board dose calibrator so that the entire sequence of sample collection
`
`and calculation steps, which are described above, in conjunction with Figures 6-8B, for
`
`the quality control procedures, may be automated. This automated alternative
`
`preferably includes screen shots, similar to some of those described above, which
`
`provide a user of the system with information at various stages over the course of the
`
`15
`
`automated procedure and that provide the user with opportunities to modify, override
`
`and/or abort one or more steps in the procedure. Regardless of the embodiment (i.e.
`
`whether system 10 employs an on board dose calibrator or not), computer 17 may
`
`further collect all quality control test parameters and results into a stored record and/or
`
`compile a report including all or some of the parameters and results for local print out
`
`20
`
`and/or electronic transfer to a remote location.
`
`With reference to Figure 9A, upon completion of the above-described quality
`
`control tests, the user may select an item 971, from main menu 470, in order to direct
`
`system 10 to begin a procedure for the generation and automatic infusion of a
`
`radiopharmaceutical into a patient. As previously described, system 10 infuses the
`
`25
`
`patient with the radiopharmaceutical so that nuclear diagnostic imaging equipment, for
`
`example, a PET scanner, can create images of an organ of the patient, which absorbs
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`the radiopharmaceutical, via detection of radioactive radiation therefrom. According
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`to Figure 9A, upon selection of item 971, computer 17 presents a screen 972 which
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`includes a data entry field for a patient identification number. This identification
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`30
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`number that is entered by the user is retained by computer 17, in conjunction with the
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`pertinent system parameters associated with the patient's infusion. After the user
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`enters the patient identification number, computer 17 directs, per a screen 973, the user
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`to attach a new patient line and to purge the patient line of air. A subsequent screen
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`974 presented by computer 17 includes data entry fields by which the user may
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`establish parameters for the automatic infusion; all or some of the fields may be filled
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`in with pre-programmed default parameters, which the user has an option to change, if
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`necessary.
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`5
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`With reference to Figure 9B, if pump 33 does not contain enough eluant/saline
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`for the patient infusion, computer 1 7 will present a warning, via a screen 901, which
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`includes an option for the user to direct the refilling of pump 33, via a subsequent
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`screen 902. Once pump 33 has been filled, computer 17 presents an indication to the
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`user, via a screen 903. According to some embodiments, if the user does not re-fill
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`10
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`pump 33, yet attempts to proceed with an infusion, system 10 will preclude the
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`infusion and present another screen, that communicates to the user that no infusion is
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`possible, if the pump is not refilled, and asking the user to refill the pump, as in screen
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`901. When pump 33 contains a sufficient volume of eluant for the patient infusion,
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`computer 17 presents a screen 975, which is shown in Figure 9C, and allows the user
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`15
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`to enter a command for system 10 to start the patient infusion. During the infusion,
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`computer 17 provides the user with an indication that the infusion is in process and
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`with a option for the user to abort the infusion, via a screen 976. As previously
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`described, the system may provide an indication that an elution is in progress, for
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`example, light projector 100 (Figure 1 C) may project a flashing light signal during that
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`20
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`portion of the elution process when eluate is diverted from generator 21 through waste
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`line 305w and into waste bottle 23, and then a steady light signal during that portion of
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`the elution process when activity detector 25 has detected that a prescribed dose rate
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`threshold is reached, for example, 1.0 mCi/sec, and the eluate is being diverted from
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`generator 21, through the new patient line for infusion into the patient. Another type
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`25
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`of light signal, for example, the more rapidly flashing light, previously described, may
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`be projected when a peak bolus of radioactivity is detected in the eluate. At the
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`completion of the infusion, a screen 977 is displayed by computer 17 to inform the
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`user of the completion of the infusion and a time since the completion. Computer 17
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`also displays a summary of the infusion, per screen 978.
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`30
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`With further reference to Figure 9C, screen 976 shows an exemplary activity
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`profile (activity - mCi/ sec, on y-axis, versus time - sec, on x-axis) for the
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`infusion/injected dose (designated between the two vertical lines). Those skilled in the
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`art will appreciate that the shape of this profile depends upon the infusion flow rate,
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`for a given volume of the dose, which flow rate is controlled, for example, by the
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`speed at which pump 33 drives flow through the patient line, and upon the amount of
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`Strontium-82 remaining in the generator. In the absence of flow rate control, activity
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`profiles may change over the life of the generator. Furthermore, the peak bolus of
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`5
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`radioactivity, particularly for injected doses from a relatively new generator, may
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`exceed a saturation level of the imaging equipment, i.e. PET scanner. According to
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`some preferred methods of the present invention, in order to maintain relatively
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`consistent, and desirable/effective, activity profiles for patient injections, over the life
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`of the generator, the operating speed of pump 33 may be varied (both over the course
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`10
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`of a single injection and from injection to injection), according to feedback from
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`activity detector 25. Such a method may be implemented via incorporation of another
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`quality control test in which pump 33 is operated to drive flow through the generator at
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`a constant rate, in order to collect, into computer, a plurality of activity measurements
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`from activity detector 25; the plurality of measurements comprise a characteristic, or
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`15
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`baseline activity profile from which the computer 17 may calculate an appropriate
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`flow rate profile to control a speed of pump 33, in order to achieve the
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`desirable/effective activity profile. In general, at the start of generator life, when
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`Strontium-82 is plentiful, the pump is controlled to drive infusion flow at relatively
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`lower rates, and, then, toward the end of generator life, when much of the Strontium-
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`20
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`82 has been depleted, the pump is controlled to drive infusion flow at relatively higher
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`rates. As was described