A sample automatic infusion printout is shown in Figure 4.4. Note that the
`first entry of the report contains status information. A normal infusion is
`indicated by the statement "INFUSION TERMINATED NORMALLY." If the
`infusion is unable to start or is interrupted in process, the detected error
`condition(s) is (are) printed out. Infusion error conditions are described in
`detail in the Section 6 of this manual.
`
`The next entries in the infusion report are the set-points selected by the
`operator for the infusion. Elution volume, patient volume, patient dose, and
`dose-rate threshold set-points are listed in the report. Additionally, the
`selected flow rate and the selected calibration factor are listed.
`
`The next entry in the infusion report is actual measured infusion data. The
`actual elution volume, patient volume, and patient dose are listed.
`Additionally, the activity present at end of infusion is listed. This activity is
`the activity that would be present in an infusion collection bottle at the end of
`an infusion. It is this activity value that is used for calibrations since on-going
`decay of the collected eluate is considered. Note that patient dose is the
`direct sum of activity leaving the patient port and does not consider on-going
`decay of the collected eluate. Finally, the activity present between detector
`and waste valve and the activity present between waste valve and patient
`are listed along with the corresponding saline volumes. This data is
`informational only and requires no user action as the infusion system
`automatically considers the effects of radioactivity stored in the tubing lines.
`
`Finally, the infusion report contains an activity profile listing in one-second
`intervals. Both the activity measured at the detector and the activity
`calculated at the patient port are displayed for each one-second interval.
`This data should be interpreted as the amount of activity passing the
`detector and patient port in successive one-second time intervals. Note that
`the transit-time delay between the detector and the patient port can be
`readily observed in the sample infusion report.
`
`19
`
`BRACCOITC00011042
`
`

`

`• The infusion
`operation is started
`by
`depressing the
`inject/sta rt/stop
`switch.
`
`• The saline pump is
`started.
`
`• Low-Level activity is
`directed to the
`waste bottle.
`
`• The running elution
`volume (volume
`through the
`generator) is
`displayed on the
`elution volume
`display.
`
`SALINE
`SUPPLY
`
`GENERATOR DETECTOR
`
`DIVERGENCE
`VALVE
`
`0
`
`op-
`PATIENT LINE
`
`° PUMP LIMIT
`
`HIGH PRESSURE
`
`VALVE FAILURE
`
`SYRINGE
`PUMP
`
`WASTE
`
`(A) Activity Build Up Cycle
`
`Figure 4.3.a Summary of the AUTOMATIC INFUSION Operation
`
`20
`
`BRACCOITC00011043
`
`

`

`SALINE
`SUPPLY
`
`\\/
`
`DIVERGENCE
`VALVE
`
`GENERATOR— DETECTOR
`
`PATIENT LINE
`
`z W
`
`ASTE
`
`o PUMP LIMIT
`
`°HIGH PRESSURE
`
`°VALVE FAILURE
`
`SYRINGE
`PUMP
`
`• Activity is directed
`to the patient line
`once the measured
`infusion dose rate
`exceeds the
`selected dose rate
`threshold.
`
`• The running patient
`volume is dispayed
`on the patient
`volume display.
`
`' The running patient
`dose is displayed
`on the patient
`volume display.
`
`•The running elution
`volume continues
`to be displayed in
`the elution volume
`display.
`
`(B) Patient Infusion Cycle
`
`Figure 4.3.b Summary of the AUTOMATIC INFUSION Operation (continued)
`
`21
`
`BRACCOITC00011044
`
`

`

`• The saline pump
`stops when the
`patient-dose limit is
`reached. The
`elution-volume and
`patient volume
`limits serve as
`backup limits.
`
`• The total elution
`volume, patient
`volume and patient
`dose is stored on
`the displays.
`
`• The generator
`activity is directed
`to the waste bottle
`and patient line is
`diconnected form
`the generator.
`
`• The printor begins
`to print out a
`report of the
`infusion.
`
`SALINE
`SUPPLY
`
`DIVERGENCE
`VALVE
`
`GENERATO
`
`DETECTOR
`
`PATIENT LINE
`
`0 PUMP LIMIT
`
`III
`SYRINGE
`PUMP
`
`°HIGH PRESSURE
`
`0 VALVE FAILURE
`
`WASTE
`
`(C) Infusion Ending Cycle
`
`Figure 4.3.c Summary of the AUTOMATIC INFUSION Operation (continued)
`
`22
`
`BRACCOITC00011045
`
`

`

`INFUSION TERMINATED NORMALLY
`
`SET-POINT VALUES:
`
`Elution Vol. = 40 ml
`Patient Vol. = 30 ml
`Patient Dose = 50.0 mCi
`Dose Rate Thld. = 1.0 mCi/sec
`Flow Rate = 50 ml/min
`Cal. Factor = 926
`
`ACTUAL INFUSION DATA:
`
`Elution Vol. = 26 ml
`Patient Vol. = 19 ml
`Patient Dose = 50.1 mCi
`
`Infused Activity Present
`At End Of Infusion = 45.4 mCi
`
`Activity Present Between
`Det. and Waste Valve - 0.674 mCi
`in Volume of 0.592 ml
`
`Activity Present Between
`Waste Valve and Pat. = 3.23 mCi
`in Volume of 2.75 ml
`
`4.4 Sample of Infusion Report Printout
`
`23
`
`BRACCOITC00011046
`
`

`

`ACTIVITY PROFILE
`
`Time
`sec
`
`Detector Patient
`mCi/sec mCi/sec
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`29
`30
`31
`32
`
`0.000
`0.000
`0.000
`0.000
`0.000
`0.000
`0.003
`0.056
`0.377
`1.149
`1.937
`3.026
`3.558
`3.648
`3.624
`3.652
`3.650
`3.564
`3.385
`3.134
`2.848
`2.556
`2.277
`2.023
`1.797
`1.611
`1.450
`1.314
`1.204
`1.103
`1.020
`0.578
`
`0.000
`0.000
`0.000
`0.000
`0.000
`0.000
`0.000
`0.000
`0.000
`0.000
`0.016
`0.422
`1.191
`1.996
`3.023
`3.487
`3.548
`3.528
`3.558
`3.549
`3.457
`3.270
`3.024
`2.743
`2.462
`2.188
`1.946
`1.729
`1.552
`1.398
`1.268
`0.709
`
`4.4 Sample of Infusion Report Printout (Cont'd.)
`
`24
`
`BRACCOITC00011047
`
`

`

`5.0
`
`OPERATING PROCEDURE
`
`5.1 General Notes
`
`The sterility of each component must be preserved, be sure to wear
`protective gloves. Aseptic techniques must be strictly observed in all
`handling. Do not remove any luer-lock protective caps until instructed to
`do so. Additionally, do not allow any unprotected luer-lock fittings to make
`contact with anything other than its mating luer-lock fitting.
`
`As system pressure can approach 100 PSI it is important that luer-lock
`fittings be connected tightly without stripping or otherwise damaging the
`fittings. Improper luer-lock connections will result in saline leaks that may
`be difficult to find and correct.
`
`5.2 Rb-82 Generator and Sterile Components
`
`Compare the Rb-82 Generator sterile disposable tray label's parts list, list
`015100, with the actual components in the tray. If not correct, contact BDI
`Nuclear Medicine Customer Service at 1-800-447-6883.
`
`5.3 Rb-82 Infusion System Preparation
`
`Remove the syringe pump cover by loosening the three mounting thumb
`screws and carefully lifting the cover off the pump assembly. Activate the
`Rb-82 Infusion System by depressing the power switch and moving the
`mode switch to the Purge Generator to Waste position.
`
`Raise the lid of the hinged valve shield cover to expose the inside of the
`valve shield assembly. Visually make sure there are no used disposables
`present in the system. If any of the used disposables are present they
`must be disposed of to prevent possible confusion with the new set-up.
`Close the valve cover.
`
`Move the syringe pump to its upper end of the travel position by
`continuously depressing the purge switch while the system is in the
`Purge Generator to Waste mode. The pump will automatically stop
`when it reaches the upper end of the travel position. The LED pump limit
`light will come on.
`
`5.4 Installation of the Syringe Pump Components
`
`5.4.1 Pump Syringe Installation (Pump Syringe Package #1)
`
`Loosen the 4 thumb screws; upper and lower on the pump syringe
`carriage. Install the 140 mL pump syringe with its luer-lock fitting facing
`
`25
`
`BRACCOITC00011048
`
`

`

`upward into its carriage in the pump assembly. Be sure to rotate the
`syringe so that the graduations face toward the operator. Tighten the
`upper and lower thumbscrews to secure both the syringe body and
`plunger into the carriage. Do not remove the protective cap on this
`syringe until directed to do so.
`
`5.4.2 Pressure Sensor Syringe Installation (Inlet Assembly Package #2)
`
`Install the 10 cc pressure sensor syringe by placing it with the luer-lock
`fitting facing upward into the carriage in the pump assembly. This is done
`by tilting the syringe into place with the plunger contacting the bottom of
`the carriage followed by pushing the top of the syringe back until it's
`locked in place. Be sure to rotate the syringe so the graduations face
`toward the operator. Do not remove the protective cap on the syringe until
`directed to do so.
`
`5.4.3 Pump Cover Installation
`
`Re-install the pump cover by carefully sliding it over the top of the pump
`assembly with the pump syringe and pressure sensor syringe protruding
`through the pump cover. Be sure the protective caps on the syringes
`protect the syringe luer-lock fittings from contacting the pump cover.
`Verify that the pump cover is fully seated on the pump assembly.
`
`5.5 Generator Inlet Assembly Package
`
`Remove the tubing assembly from its package and connect the check
`valve to the pump syringe. Tighten the luer-lock fittings but be careful not
`to damage the pump syringe connection.
`
`5.5.1 Pressure Sensor Line Installation
`
`Connect the shortest line of the inlet tubing assembly to the 10 mL sensor
`syringe. Tighten the syringe to the luer-lock connection, but be careful not
`to damage.
`
`5.5.2 Generator Inlet Line Installation
`
`Open the Valve shield. Take the longest line of the generator inlet tubing
`assembly and insert it down through the tubing shield so that it appears in
`the generator shield. Remove the generator shield lead lid and retrieve
`the free end of the generator inlet line. Approximately three to six inches
`of this line will now be in the generator shield with the luer-lock fitting and
`the cap on. Place the saline supply hook assembly back onto the pump
`assembly.
`
`26
`
`BRACCOITC00011049
`
`

`

`5.5.3 Generator Inlet Line Sterilizing Filter Installation
`
`Take the filter from the generator inlet assembly package and connect
`the female luer-lock fitting of the Generator Inlet Sterilizing Filter to the
`male luer-lock fitting on the free end of the generator inlet line that is now
`located in the generator shield. Make sure that the luer-lock fitting on the
`other end of this filter remains in place until directed to do otherwise.
`
`5.6 Generator Outlet Assembly (Package #3)
`
`5.6.1 Divergence Valve Installation
`
`If it is not already open, raise the lid on the valve shield assembly located
`on the top of the Rb-82 Infusion System Cart and remove the valve
`retainer. Note: The lid cannot be raised if the Rb-82 Infusion System is
`unpowered or if the system detects activity within this shield. Take the
`divergence valve, (the white valve with the three arrows and the off sign)
`and orient it with the handle facing down toward the bottom of the Rb-82
`Infusion System Cart. Note: The shortest line of this connection will be
`facing towards the left end of the infusion system cart as you are looking
`at it. Finally, without changing the orientation of the valve, rotate the valve
`handle so that the valve can be dropped into its actuation carriage, to
`prevent it from being moved, with the "valve" arm fitting into the groove of
`the actuation carriage.
`
`5.6.2 Generator Outlet Line Installation
`
`Take the line with the red cap end and feed it through the hole in the
`valve shield assembly. Verify that the end of this line has entered the
`generator shield. There should now be two lines in the generator shield;
`the generator inlet line with its associated filter and the generator outlet
`line. Secure the end of the generator outlet line (located in the valve
`shield assembly) by inserting into the tubing slot near the detector and
`route the line past the detector; secure with detector cover.
`
`5.6.3 Generator Waste Line Installation
`
`Take the line from the outlet tubing assembly with the clear end and feed
`it down the opening of the valve shield assembly. There should now be
`three sets of tubing in the generator shield.
`
`27
`
`BRACCOITC00011050
`
`

`

`5.6.4 Generator Waste Line To Waste Shield
`
`Take the line in the generator shield with the clear cap and feed it through
`the hole inside the generator into the waste shield. Tape the tubing in the
`generator shield so that the generator will not crimp the tubing.
`
`5.6.5 Waste Bottle Preparation and Sterilizing Filter Installation
`
`From the outlet assembly package take the short line with the filter on the
`end and connect it to the waste line inside the waste bottle shield. Once
`this connection has been made, take the waste bottle and connect the
`waste line to the top of the bottle make sure you remove the cover from
`the needle under the bottle cap cover. Verify that the waste bottle
`connections are correct. Carefully lower the waste bottle into the waste
`shield and route the extra waste line tubing to prevent any kinking or
`obstruction in the tubing. Place the lid on top of the waste shield.
`
`The waste bottle should be emptied every morning prior to system
`use or at the end of system usage.
`
`5.7 Patient Line Installation
`
`Remove a patient line from its protective wrapping. Connect the female
`side of the luer-lock fitting, to the line on top of the infusion cart system
`which comes out the left side of the valve. This patient line contains its
`own sterilizing filter. This is the only part of the system that you must
`change as a new patient is being imaged. Make sure that the valve
`retainer is now over the valve and close the lid.
`
`5.8 Saline Supply Installation
`
`5.8.1 Installation of the Saline Supply
`
`Take the remaining free tubing of the generator inlet line, which was the
`first kit you hooked up, pinch off valve and then carefully insert the spike
`into your bottle or bag of preservative-free, normal saline. Make sure the
`spike is fully inserted. Hang the saline supply on the saline supply hook
`located on top of the pump assembly.
`
`28
`
`BRACCOITC00011051
`
`

`

`5.9 Rb-82 Generator Installation
`
`5.9.1 Installation Preparation
`
`Look inside the generator shield, and verify that there are two lines
`available for connection:
`
`• Generator inlet line and its attached filter with a male
`luer lock fitting.
`• Generator outlet line with a female luer-lock fitting
`
`Make sure the waste line that passes through the generator shield
`chamber is against the wall of the generator shield so that it does not
`interfere with the generator installation.
`
`5.9.2 Rb-82 Generator Installation
`
`Remove the generator from its shipping container, and unclip the outlet
`and inlet tubing, carefully lower it into the generator shield. Make sure
`that the generator does not interfere with the waste line that passes
`through the generator shield. Connect the inlet line on the generator
`(marked "inlet," and has a female luer-lock fitting on it) to the remaining
`fitting on the generator sterilizing filter and has a male luer-lock fitting on
`it. Connect the outlet line of the generator (marked outlet and has a male
`luer-lock fitting on it) to the remaining line in the generator shield which
`has a red cap on it. Carefully lower the generator shield lid making sure
`that none of the lines are restricted.
`
`5.10 Purge Operation
`
`5.10.1 Syringe Filling
`
`Position the syringe pump to its limit if not already there, by continuously
`depressing the PURGE switch (in the PURGE GENERATOR TO WASTE
`mode) until the pump automatically stops. Open the saline supply pinch
`valve and depress the REFILL switch once. The syringe pump should
`begin drawing in saline and a stream of air bubbles should appear in the
`saline supply bottle. The refill operation can be stopped at any time by
`depressing the REFILL switch a second time. Otherwise, the pump will
`continue refilling until it reaches its refill limit and automatically stops.
`Unless problems are encountered, allow the pump to refill until it
`automatically stops on its refill limit.
`
`29
`
`BRACCOITC00011052
`
`

`

`5.10.2 Waste Line Purging
`
`With the MODE switch in the PURGE GENERATOR TO WASTE position
`continually depress the PURGE switch to pump saline through the
`generator and into the waste bottle. A volume of 50 mL of saline should
`be sufficient to guarantee purging the waste lines of air. Note: The purge
`volume can be checked by observing the markings on the pump syringe.
`Lift the waste bottle shield cover and look for any signs of leakage.
`Correct any leaking connections before continuing to use the Rb-82
`infusion system.
`
`Note: It is recommended that leak testing be carried out by wipe test and
`radiation detection survey.
`
`5.10.3 Pressure Sensor Line
`
`Pinch off the saline bag valve, disconnect the pressure sensor line from
`the pressure sensor syringe and place it in a beaker. Depress the purge
`switch until liquid flows into the beaker. Reconnect the pressure sensor
`line to the pressure sensor syringe. Now unpinch the saline valve.
`
`5.10.4 Patient Line Purging
`
`Place the MODE switch in the PURGE GENERATOR TO PATIENT
`position. Connect the patient line to a shielded 50 mL vial and insert a
`venting needle. Continuously depress the PURGE switch until all the air
`has been expelled from the patient line into the vial. A volume of 20 mL
`should be sufficient to purge the patient line. The purge volume can be
`determined by observing the pump syringe markings.
`
`Lift the generator shield cover and look for any signs of leakage. Correct
`any leaking connections before continuing to use the Rb-82 Infusion
`System.
`
`Note: It is recommended that leak testing be carried out by wipe test and
`radiation detection survey.
`
`5.10.5 Volumetric Flow Rate Verification
`
`This is performed with the installation of a new generator.
`Set the controls on the Display/Control Panel as follows:
`
`• Mode Switch
`=
`• Elution Volume Limit =
`• Patient Volume Limit =
`
`Automatic Infusion
`99 mL
`50 mL
`
`30
`
`BRACCOITC00011053
`
`

`

`=
`• Patient Dose Limit
`• Dose Rate Threshold =
`• Flow Rate
`=
`
`99 mCi
`1.0 mCi/sec.
`50 mL/min.
`
`Check for a 50 mL/min. flow rate using a stop watch.
`
`5.11 Patient Administration
`
`PATIENT ADMINISTRATION MAY BE PERFORMED ONLY AFTER
`SUCCESSFUL COMPLETION OF DAILY CALIBRATION, SR-82/85
`BREAKTHROUGH PROCEDURES, AND FIRST WASH (ELUTION)
`DISPOSAL USING SAME SETTINGS AS SEEN ON SR-82/85
`BREAKTHROUGH SHEET PAGE.
`
`IN THE EVENT OF A POWER-FAILURE OR THE SYSTEM IS
`INADVERTENTLY SHUT DOWN, CALIBRATION SHOULD BE
`RECONFIRMED.
`
`5.11.1 Replace the patient administration set for each new patient.
`
`5.11.2 Purge all air out of the patient administration set and verify that all
`air is purged from the system. Refer to Installation Instructions, section
`5.10.4.
`
`5.11.3 Set the controls on the Display/Control panel as prescribed by the
`administering physician.
`
`5.11.4 Verify that the syringe pump has been filled with saline. The
`syringe pump volume must at least equal the selected elution volume-set
`point plus 20 mL. This volume will cover the 15 mL nominal dead volume
`in the syringe.
`
`5.11.5 Verify that the system printer is on and that approximately 1 inch
`of paper extends out of the printer. If the RS-232C port is being used for
`infusion data acquisition, the system printer can be turned off. Infusion
`report data is transmitted out the RS-232C port whether the system
`printer is powered or not.
`
`5.11.6 Attach the Rb-82 infusion system patient line to the patients
`intravenous line.
`
`5.11.7 Make sure that at least 10 minutes has elapsed following any
`purge or infusion operation. Start the infusion by depressing the INJECT
`START/STOP switch.
`
`NOTE: The infusion can be terminated at any time by depressing the
`INJECT START/STOP switch a second time.
`
`31
`
`BRACCOITC00011054
`
`

`

`The running elution volume, patient volume, patient dose and dose rate
`will be registered on the control/display panel. Once the infusion
`operation is completed the INJECT START/STOP switch will stop glowing
`red and the infusion report data will be printed on the system printer and
`echoed out the RS-232C port.
`
`5.11.8 Unless manually interrupted, the infusion will terminate when the
`number of mCi preset on the PATIENT DOSE LIMIT switch has been
`reached. As a safety precaution, the infusion will also terminate if the
`preset ELUTION VOLUME LIMIT or PATIENT VOLUME LIMIT are
`reached.
`
`NOTE: THE SR-82/RB-82 GENERATOR ELUATE IS RADIOACTIVE
`AND SHOULD BE HANDLED WITH PROPER RADIATION
`SAFETY PRECAUTIONS.
`
`NOTE: WAIT AT LEAST 10 MINUTES AFTER ANY PURGE OR
`INFUSION OPERATION BEFORE LIFTING THE GENERATOR
`SHIELD COVER, WASTE BOTTLE SHIELD COVER OR THE
`HINGED VALVE-SHIELD COVER. THIS WILL ALLOW ANY
`RB-82 ELUATE TO DECAY TO A SAFE LEVEL.
`
`NOTE: THE HINGED VALVE-SHIELD COVER AUTOMATICALLY
`LOCKS IN THE CLOSED POSITION DURING ANY PURGE OR
`INFUSION OPERATION. THE COVER REMAINS LOCKED
`UNTIL THE DETECTED RADIOACTIVITY DECAYS TO A
`SAFE LEVEL. NO PURGE OR INFUSION OPERATION CAN
`BE STARTED UNLESS THE COVER IS CLOSED.
`ADDITIONALLY, THE COVER CANNOT BE RAISED UNLESS
`THE RB-82 INFUSION SYSTEM IS POWERED.
`
`NOTE: ALWAYS WEAR GLOVES BEFORE TOUCHING ANY OF THE
`TUBING, SYRINGE PUMP, VALVE OR COLLECTION BOTTLE
`SYSTEM COMPONENTS.
`
`32
`
`BRACCOITC00011055
`
`

`

`co L L000011033VIE1
`
`FEMALE LUER LOCK
`
`CD
`
`MALE LUER LOCK
`
`(PACKAGE 3)
`FILTER SET
`WASTE LINE
`
`(PACKAGE D
`IOML
`SYRINGE
`
`UMP
`
`A
`
`WASTE BOTTLE
`
`, r
`
`SHIELD
`TUBING
`
`GENERATOR
`
`Rb-82
`
`INLET
`
`çi
`
`04
`
`(RED DOT)
`OUTLET
`
`SHEILD
`GENREATOR
`
`(PACKAGE 2)
`INLET FILTER
`GENERATOR
`
`(CUSTOMER PROVIDED)
`
`SALINE SUPPLY
`
`ASSEMBLY
`PUMP
`
`(PACKAGE 2)
`ASSEMBLY
`TUBING
`INLET
`GENERATOR
`
`(PACKAGE 2)
`IOML
`SYRINGE,
`SENSOR
`PRESSURE
`
`DETECTOR
`
`SHIELD
`VALVE
`
`PACKAGE 3)
`ASSEMBLY
`TUBING
`OUTLET
`GENERATOR
`
`(PACKAGE 4)
`SET
`ADMINISTRATION
`PATIENT
`
`weibuci buqni
`
`

`

`CardioGen-82 Generator
`Sr-82/85 Breakthrough Worksheet
`
`Date
`
`Infusion System Control Panel Settings
`
`Mode Switch:
`Elution Volume:
`Patient Volume:
`Patient Dose:
`Dose Rate:
`Flow Rate:
`
`Dose Calibrator Setting
`
`Automatic Infusion
`99 mL
`50 mL
`99 mCi
`1 mCi/sec.
`50 mL/min.
`
`Figure 5.1 Tubing Diagram
`
`504 (Capintec only) or
`Co-60 setting then divide reading obtained by 0.548
`
`1.
`
`Elute 50 mL of eluate into 50 mL vial using Infusion System Control Panel
`Settings as above. Note exact time at end of elution (EOE).
`
`Time when elution ended
`
`2. Set dose calibrator as above. Setting used:
`
`3. Measure Rb-82 activity in dose calibrator. Note exact time (minutes/seconds)
`when measurement is made.
`
`Rb-82 activity
`Time of measurement
`
`(mCi).
`
`4. Decay correct Rb-82 measurement to time when elution ended (EOE).
`
`(Note: If time between end of elution and measurement is allowed to be 150
`seconds (2.5 minutes), multiply dose calibrator reading by a factor of 4).
`
`Decay correction factor
`Rb-82 activity at EOE (mCi)
`
`5. Using same vial, let sample stand for 60 minutes to allow for complete decay
`of Rb-82.
`
`34
`
`BRACCOITC00011057
`
`

`

`6. Measure sample in dose calibrator.
`
`7. Calculate amount of Sr-82 in sample using the following equation:
`
`Sr-82 = dose calibrator reading (pCi)
`divisor (from sheet supplied with Generator)
`
`Example:
`
`Sr-82 = 0.5 =.216
`2.3
`
`Sr-82 = .216 µCi
`
`8. Determine Sr-82 Breakthrough by dividing tiCi of Sr-82 by the mCi of Rb-82
`at EOE
`
`Example:
`
`.216µCi Sr-82 = .004 µCi Sr-82/mCi Rb-82
`50 mCi Rb-82
`
`Allowable Limit = .02 liCi Sr-82/mCi Rb-82
`
`9. Determine Sr-85 Breakthrough by multiplying the result obtained in step 8 by
`the Sr-85/Sr-82 ratio from the data sheet supplied with the generator.
`
`Example:
`
`.004x 1.48 =.00592
`
`Allowable Limit = 0.2 pCi Sr-85/mCi Rb-82
`
`35
`
`BRACCOITC00011058
`
`

`

`Rb-82 INFUSION SYSTEM-CALIBRATION DATA SHEET
`
`Infusion System Control Panel Settings
`
`Mode Switch:
`Elution Volume:
`Patient Volume:
`Patient Dose:
`Dose Rate:
`Flow Rate:
`
`Automatic infusion
`99 mL
`50 mL
`60 mCi
`1 mCi/sec.
`50 mL/min.
`
`1. Date of Calibration or Calibration Verification:
`
`2. Initial Generator Sr-82 Potency on calibration date:
`
`3. Generator Sr-82 Potency on present date:
`
`4. Present Calibration Factor:
`
`mCi
`
`mCi
`
`5. Measured Rb-82 Activity from dose calibrator (corrected for decay):
` mCi
`
`6. Printed Rb-82 Activity Present at the end of infusion:
`
`mCi
`
`7. Ratio of Measured Rb-82 Activity and Printed Rb-82:
`
`Measured Rb-82 Activity
`Printed Rb-82 Activity =
`
`Ratio
`
`8. Is the difference between Measured Rb-82 Activity and Printed Rb-82 .95 -
`1.1?
` (If no, unit requires recalibration).
`
`9. Calculated New Calibration Factor (if needed):
`
`New
`
`Initial
`
`Measured Rb-82 Activity at End of
`Infusion
`
`Cal.
`Factor
`
`=
`
`Cal.
`Factor
`
`x
`Printed Rb-82 Activity Present at
`End of Infusion
`
`10. Is new Calibration factor within 5% of old Calibration factor?
`
` (If no, repeat calibration).
`
`36
`
`BRACCOITC00011059
`
`

`

`operation manual.
`** Calibration should be performed to 15% (Ratio=0.95 to 1.05). Daily calibration checks should be within ±10% (Ratio=0.9 to 1.1). See Section 5.2 of the
`* Use the dose calibrator reading directly if an RB-82 calibration setting is used or divide the reading by 0.548 if a Co-60 Calibration setting is used.
`
`Figure 5.2 Rb-82 Infusion System Calibration Log Sheet
`
`090 1.1-000011033VIE1
`
`FOS
`
`EGS
`
`N/A
`
`853
`
`Initials
`Operator
`
`Factor
`Calib.
`New
`
`J
`
`553
`
`1000
`
`Printer)
`Rb-82
`(from
`Factor
`Calib.
`
`I
`
`Ye:
`
`No
`
`1.10
`.90 to
`G =
`±10%?
`Calib.
`
`H "
`
`Yes
`
`No
`
`1.05
`.95 to
`G =
`t5%?
`Calib.
`
`CALIBRATION SHOULD ALWAYS BE DONE AT THE DESIRED PATIENT DOSE SETTINGS. THE FIRST ELUTION OF THE DAY MUST BE DISCARDED
`
`AND NOT USED FOR CALIBRATION. REFER TO SECTION 5.2 OF TI IE OPERATION MANUAL FOR INSTRUCTIONS.
`
`',d1
`
`, .. s. 7
`
`:“ 2
`
`13. 8'
`
`13.8
`
`.853
`
`57 7
`
`d3 8
`
`2:30
`
`12 2
`
`122
`
`(E/F)
`
`E to F
`Ratio
`
`G
`
`(mCi)
`Infusion
`End of
`Activity
`Printed
`
`F
`
`(mCi)
`Factor)
`
`(C x Decay
`Corrected
`Dose, Decay
`
`E
`
`(min:sec)
`
`Time
`Decay
`I )ose
`
`D
`
`(mCi)
`
`(B/0.548)
`(B/1) or
`
`Dose
`
`Corrected
`
`C*
`
`Calibrator
`From Dose
`
`(mCi)
`
`Reading
`Dose
`
`B
`
`8:12 AM
`
`Example: 9128/85
`
`8:00 AM
`
`Example: 9/28/85
`
`(Date & Time)
`
`Calibration Infusion
`
`A
`
`0 Sec
`45 Sec
`30 Sec
`15 Sec
`0 Sec
`
`5 Min
`3 Min
`2 Min
`1 Min
`0 Min
`
`Factor
`
`Measured 'rime
`
`Decay Factor Table
`
`3. Date
`
`mCi/sec
`
`2. Initial Gen. Potency
`
`1. Generator Lot Number
`
`nil/min
`
`mCi
`
`1.0
`
`50
`
`3. Patient Dose Threshold
`
`2. Flow Rate
`
`1. Patient Dose
`
`GENERATOR DATA
`
`INFUSION SYSTEM SETTINGS
`
`Rb-82 Infusion System Calibration Log Sheet
`
`Site Name
`
`K
`
`16
`
`1
`
`2
`
`4
`
`8
`
`

`

`Initials
`Operator
`
`L
`
`u Ci/mCi?
`
`<0.02
`Rb-82
`Sr-82 to
`Ratio
`
`K
`
`(u. Ci/mCi)
`
`(j.i Ci)
`
`I/E
`Rb-82
`Sr-82 to
`Ratio
`
`J
`
`G/H
`through
`Break-
`Sr-82
`
`I
`
`Data
`Gen.
`From
`Divisor
`through
`Break-
`
`H
`
`Corrected
`through
`Break-
`0'
`TRUCTIONS.
`
`(u Ci)
`F/0.548
`F/1 or
`
`(µ Ci)
`Calibrator
`from Dose
`Reading
`through
`Break-
`
`F
`
`(mCi)
`Factor)
`
`(C x Decay
`Corrected
`Decay
`Rb-82,
`
`E
`
`(min:sec)
`
`(mCi)
`
`(mCi)
`
`Time
`Decay
`Rb-82
`
`D
`
`(B/0.548)
`(B/1) or
`Rb-82
`
`Corrected
`
`C'
`
`Calibrator
`From Dose
`Reading
`Rb-82
`
`B
`
`THE FIRST ELUTION OF THE DAY MUST BE DISCARDED AND NOT USED FOR BREAKTHOUGH MEASUREMENT. REFER TO SECTION 5.3 OF THE
`
`I
`
`2
`
`4
`
`8
`
`Factor
`
`45 Sec
`30 Sec
`15 Sec
`0 Sec
`
`3 Min
`2 Min
`1 Min
`0 Min
`Measured Time
`
`Decay Factor Table
`
`3. Date
`2. Initial Gen. Potency
`1. Generator Lot Number
`
`ml
`ml
`nil
`
`GENERATOR DATA
`
`mCi/sec
`50
`50
`99
`mCi
`INFUSION SYSTEM SETTINGS
`
`1.0
`
`99
`
`5. Patient Dose Threshold
`4. Flow Rate
`3. Patient Volume
`2. Elution Volume
`1. Patient Dose
`
`Sr-82 Breakthrough Log Sheet
`CARDIOGEN® Rb-82 Generator
`
`Site Name
`
`* Use the dose calibrator reading directly if an RB-82 calibration setting is used or divide the reading by 0.548 if a Co-60 Calibration setting is used.
`
`Figure 5.3 CARDIOGENO-82 GENERATOR SR-82 Breakthrough Log Sheet
`
`1.901. 1.000011000VIE1
`
`W1.0
`
`Yes
`
`0.0026
`
`0.124
`
`6.43
`
`0.8
`
`0.8
`
`48.4
`
`2:30
`
`12.1
`
`12.1
`
`9:00 AM
`
`Example: 9/28/85
`
`(Date & Time)
`
`Breakthrough Infusion
`
`A
`
`

`

`6. TROUBLESHOOTING GUIDE
`
`The table below describes possible purge and infusion error conditions that
`are displayed on the Control/Display panel. These errors are also listed in
`the infusion report printout. Suggested corrective action is provided in the
`table for each error condition.
`
`This device has been tested for protection against electro-magnetic
`interference according to IEC 60601-1-2. However, the proximity of other
`devices that give off electro-magnetic radiation, such as X-ray machines, can
`interfere with the operation of this system.
`
`TROUBLESHOOTING TABLE
`
`Error Condition Suggested Action
`
`Automatic Infusion Errors (listed in infusion report printout)
`
`"Elution Vol. Setpt. = 0"
`"Patient Vol. Setpt. = 0"
`"Patient Dose Setpt. = 0"
`
`Select non-zero infusion set-points
`Select non-zero infusion set-points
`Select non-zero infusion set-points
`
`"Valve Shield Open"
`"Pump At Limit Position"
`"High Pressure Error"
`"Valve Error"
`
`Close the valve shield
`Refill syringe pump
`Look for possible tubing constriction
`Notify Bracco Diagnostics Inc.
`
`Automatic Infusion and Purge Errors (displayed on Control/Display panel)
`
`PUMP LIMIT
`
`HIGH PRESSURE
`VALVE ERROR
`Valve Shield Open
`(not displayed)
`
`Refill the syringe pump, if necessary.
`Note that this display is also active
`if the pump is on the refill limit.
`Look for possible tubing constriction
`Notify Bracco Diagnostics Inc.
`Close the valve shield for all purge and
`infusion operations
`
`39
`
`BRACCOITC00011062
`
`

`

`SYSTEM DIARY
`
`Date:
`Problem:
`
`Action Taken:
`
`Date:
`Problem:
`
`Action Taken:
`
`Date:
`Problem:
`
`Action Taken:
`
`Date:
`Problem:
`
`Action Taken:
`
`40
`
`BRACCOITC00011063
`
`

`

`Date:
`Problem:
`
`Action Taken:
`
`Date:
`Problem:
`
`Action Taken:
`
`Date:
`Problem:
`
`Action Taken:
`
`Date:
`Problem:
`
`Action Taken:
`
`Date:
`Problem:
`
`Action Taken:
`
`41
`
`BRACCOITC00011064
`
`