`
`
`
`
`
`The touch screen uses intuitive color-coding: green indicates normal operation and red indicates an
`error, warning or that some intermediate step is needed. Blue indicates the user's menu selection and
`also indicates non-radioactive operation; the yellow radiation symbol indicates radioactive operation so
`the user knows when the unit is generating ionizing radiation.
`
`
`
`When the unit is in radioactive operation, users should move away from the unit
`to a distance that allows them to avoid unnecessary exposure, in accordance
`with ALARA principles.
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` LOADING PRINTING LABELS 5.3
`
`The system ships with one packet of labels for use
`with the RUBY Rubidium Elution System. Additional
`labels must be ordered from Jubilant DraxImage
`Inc.
`
`To load the labels, open the printer access door on
`the back of the system (see Fig. 16, Printer Access
`Door). The label should face out when it is unfolded
`up
`toward
`the printer
`(see Fig. 17, Label
`Orientation). Thread the leading edge of the label
`up through the opening (see Fig. 18, Label Feed).
`Make sure the edges of the label are parallel to the
`edges of
`the print mechanism. The
`labels
`automatically feed into the printer. Close the printer
`access door before proceeding.
`
`
`
`
`
`
`Figure 16, Printer Access Door
`
`Figure 17, Label Orientation
`
`Figure 18, Label Feed
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` CONFIGURING THE SYSTEM 5.4
`
`At installation, the system needs to be configured to the site's specification. The Jubilant DraxImage
`representative will configure the unit according to each site's needs by selecting Settings on the top
`row of the task bar. The admin level PIN may also access the Settings section that includes a choice of
`units, time zones, site-specific identification (name of clinic or hospital) and personal identification
`numbers (PINs) (see Fig. 19, Settings Control Panel Screen).
`
`These five settings must be defined:
`
`
`1. Manage PINs (The system's default PINs are User: 12345; Administrator: 11111)
`2. Constancy Standard Setup
`3. Site Setup
`4. Elution Setup
`5. USB Transfer File Setup (This should be performed prior to report transfer)
`
`After the settings have been modified, press Save Changes, and return to the main software page by
`pressing Home at the bottom of the screen.
`
`
`
`
` MANAGING PERSONAL IDENTIFICATION NUMBERS (PINS) 5.5
`
`The RUBY Rubidium Elution System has two permission categories: administrator (admin) and user.
`The admin level has authority to select important site parameters determined by the medical staff. The
`user level allows the nuclear medicine technologist to perform normal set-up procedures and use the
`RUBY Rubidium Elution System. To modify a PIN, the administrator clicks on the appropriate
`permission level, then enters and confirms the new PIN. The administrator may reset the admin level
`PIN, or the PIN of the user (see Fig. 20, Managing PINs Screen).
`
`
`Figure 19, Settings Control Panel Screen
`
`Figure 20, Managing PINs Screen
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`There is one admin PIN for all administrators and one user-specific PIN for all
`users. An admin level PIN must be entered to modify any setting.
`
`
`
`
`
` CONSTANCY STANDARD SETUP 5.6
`
`The RUBY Rubidium Elution System is equipped with an on-board dose calibrator. The daily quality
`assurance procedure recommended by the manufacturer and by regulatory bodies includes a daily
`constancy check of the dose calibrator. The check is performed by using a calibrated standard (for
`example, Cs-137) of long half-life and checking against it every day. The calibrated standard
`parameters must be entered in all the fields shown (see Fig. 21, Constancy Standard Setup Screen).
`
`
`
`
` SITE SETUP 5.7
`
`The RUBY Rubidium Elution System has a built-in report system. To customize reports and labels with
`site information, fill in all the fields on the screen (see Fig. 22, Site Setup Screen). The information
`entered here appears on all reports generated by the system (Daily Quality Control and Patient
`Infusion reports). The site setup information is also a part of a system setup.
`
`
`
`Changing the system time, time zone and/or date could adversely affect future elutions. These parameters
`are set at initial installation. The Admin level PIN is required to adjust the system time for the daylight saving
`time period.
`
`
`
`Press Save Changes to keep the changes. Then go to the Main Menu to select the next
`Settings screen or the Home screen. To restore default values, select Restore Defaults and
`Save Changes to reset the system to the factory assigned values.
`
`
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`Figure 21, Constancy Standard Setup Screen
`
`Figure 22, Site Setup Screen
`
`
`
`
`
` ELUTION SETUP 5.8
`
`The RUBY Rubidium Elution System has four configurable elution parameters: (see Fig. 23, Elution
`Setup Screen)
`
`
`1. Activity/Patient Weight Ratio determines the amount of activity to inject per kilogram or
`pound. This ratio is multiplied by the weight of the patient to determine the total activity for
`the procedure.
`2. Extra Flush to Patient sets the volume of saline that is injected after the total activity has
`reached the patient to lead the isotope to the heart. The default value is 5 mL. This volume
`is included in the 60 mL limit of total volume infused.
`3. Labels Printed per Elution allows the user to determine how many copies of each label
`need to be printed after each daily QC and patient infusion. The default value is 1.
`
`
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` Figure 23, Elution Setup Screen
`
`
`
`
`
` USB FILE TRANSFER SETUP 5.9
`
`After each Patient Infusion or Daily QC, data is saved on the system's hard drive and accessible
`through the USB Port (see Fig. 24, USB Port). Report data can be transferred using the USB key
`provided with the system, or saved by the report application, which can upload to a web-based
`application for storage on one dedicated personal computer that is synced with the elution system. To
`configure a report for USB transfer, follow the steps on USB File Transfer Setup screen (see Fig. 25,
`USB File Transfer Setup Screen).
`
`Only one computer can be configured to run the Reports Application for each RUBY Rubidium Elution
`System. This ensures secure handling of report data. Refer to the Report Application instructions for
`information on how to authenticate the USB key and use the Report Application.
`
`
`
`If a USB other than the formatted USB key is used, it will erase all information on that USB key.
`
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`Figure 24, USB Port
`
`
`
`
`
`
`
`Figure 25, USB File Transfer Setup Screen
`
`
`
`The RUBY Rubidium Elution System has a scenario mode that should be turned off
`during normal use of the system. This is disabled by a JDI representative during
`installation. This can also be performed by the administrator.
`
`
`
`
`
`
` SYSTEM SHUTDOWN 5.10
`
`To shutdown the RUBY Rubidium Elution System, select shutdown from the Home Screen. Select OK
`to continue with shutdown, or Cancel to cancel the shutdown. The RUBY Rubidium Elution System
`must be connected to a power outlet and the main on/off switch near the power cord at the back base
`of the system must be in the ON position to allow for continuous charge to the battery. For a complete
`shutdown, Press on the main on/off switch near the power cord at the back base of the system to the
`off position. Turn off the UPS by opening the printer access door and pressing the power button.
`
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`6. OPERATING THE SYSTEM
`
` DOSE CALIBRATOR QUALITY ASSURANCE 6.1
`
`The RUBY Rubidium Elution System comes with an integrated dose calibrator. This dose calibrator is
`fully controlled using the system's software. To access the quality assurance mode, press Dose
`Calibrator Quality Assurance on the second row of the task bar and enter the required password. The
`control screen is displayed (see Fig. 26, Dose Calibrator Quality Assurance Screen). To perform the
`required quality assurance tests, such as Linearity, Geometry and Accuracy, an independent control
`screen is included to enable the operation and/or configuration of the dose calibrator in conventional
`mode (Table 2, Dose Calibrator Quality Assurance & Required Frequency of Performance). JDI
`personnel will complete all four quality assurance tests upon installation of the elution system. Users
`are responsible for performing Constancy daily (integrated into Daily Quality Control); Linearity
`quarterly and Accuracy annually.
`
`Dose Calibrator Quality
`Assurance Test
`Constancy
`
`Required Frequency
`
`Upon Installation; Daily (integrated into Daily Quality Control procedure);
`following repair
`Upon installation; quarterly; following repair
`Linearity
`Upon installation; annually; following repair
`Accuracy
`Upon installation; following repair
`Geometry
`Table 2, Dose Calibrator Quality Assuarance & Required Frequency of Performance
`
`Required frequency of dose calibrator quality assurance tests may vary according to local
`regulations. Daily Dose Calibrator Constancy check is integrated into Daily Quality Control tab.
`
`
`
`
`
`
`
` PERFORMING READINGS ON THE DOSE CALIBRATOR 6.2
`
`To perform dose calibrator readings to complete quality assurance testing the user will follow the
`steps below on the Dose Calibrator Quality Assurance screen (see Fig. 26, Dose Calibrator Quality
`Assurance Screen).
`
`
`1. Click Stop Continuous Reading
`2. Enter the isotope to be assayed (for example: Cs-137 or TC-99) by entering the isotope
`into the box displayed on the screen labeled Isotope
`3. Click on Change Isotope
`4. Ensure that the dose calibrator chamber is empty and press Zero Background
`5. Insert radioactive sample to be assayed
`6. Press Perform Reading or press Start Continuous Reading to see the stabilization of the
`reading or to monitor the decay automatically
`7. When finished, select Home Screen on the touchscreen monitor to return the Home
`Screen
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`Figure 26, Dose Calibrator Quality Assurance Screen
`
`
`
`
`
` GENERATOR INSTALLATION & SETUP 6.3
`
`Generator Installation is performed by the user by accessing Generator Installation & Setup on the
`second row of the task bar. Press Generator Installation & Setup and enter your PIN (see Fig. 27,
`Generator Installation & Setup Screen). From there, six task screens detail each step required to safely
`remove an expired generator and accessories and install a new generator and accessories.
`
`Some safety precautions are necessary when working with the generator and its shipping container.
`Be sure to follow these steps:
` (cid:135) The generator is heavy; work slowly and deliberately when handling the shipping container.
`(cid:120) Ensure correct placement of the generator handle to the generator container before moving the
`generator.
`(cid:135) Lift and lower the generator slowly into the generator well to avoid damaging the lead shielding.
`
`
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`Figure 27, Generator Installation & Setup Screen
`
`
`
`
`
` REMOVAL OF EXPIRED COMPONENTS 6.4
`
`Before installing a new Generator, the expired Generator and RUBY Tubing Sets must be removed. An
`expired Generator still contains a significant quantity of radioactive strontium (Sr-82, Sr-85) and must
`be discarded or stored according to local procedures.
`
`To remove the expired Generator and consumables, perform the first two tasks identified in the left
`column on the screen: Remove Generator and Remove RUBY Tubing. Click Next after each task.
`When you select Next, the system considers those tasks to be complete.
`
`
`tubing components are radioactive. All
`The Generator and expired
`procedures for disposal of radioisotopes should be followed.
`
`
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` 6.5
`
`INSTALLING THE RUBY SET
`
`If any part of the RUBY SET becomes contaminated or damaged before or during installation, a new
`RUBY SET must be installed by the user.
`
`
`1. Obtain new RUBY SET and visually inspect packaging for damage.
`2. Remove from packaging. Do not remove the protective caps yet from any of the connectors
`at the end of each line.
`Insert plastic tube holder containing RUBY SET into place on the RUBY Rubidium Elution
`System (see Fig. 28, Tubing Holder).
`
`3.
`
`Figure 28, Tubing Holder
`
`Figure 29, Flow Regulator
`
`
`
`
`
`4. Set Flow Regulator to 250 mL/h (see Fig. 29, Flow Regulator).
`5. Clip Pressure Sensor into holder (#1 & #2 positions on the RUBY Rubidium Elution System)
`(see Fig. 30, Pressure Transducer).
`6. Plug in #3 connector (see Fig. 31, Pressure Sensor Connector).
`
`
`
`
`
`
`
`Figure 31, Pressure Sensor Connector
`
`
`
` Figure 30, Pressure Transducer
`
`Check expiry dates on all consumables prior to use
`
`
`7. Insert line #1 into pinch valve 2nd from the right (see Fig. 32, RUBY SET Installation
`Diagram, or the Installation Diagram on the RUBY Rubidium Elution System, section 9.5)
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`8. Insert line #2 into pinch valve furthest to the right.
`9. Insert waste section line into pinch valve with red circle around it.
`10. Insert patient section line into pinch valve with blue circle around it.
`11. Remove the protective cap and attach the Waste portion of tubing (next to the Red Trash
`Icon) to the Waste Bottle.
`12. Insert line section between #4 and #5 into groove of the PMT, ensuring PMT door may be
`closed properly after tube placement (See Fig. 33, Installation of PMT portion of RUBY
`SET).
`
`Be sure to properly connect Waste portion of RUBY SET to waste container with
`each RUBY SET installation and after each time the waste container is emptied. The
`waste container holds 1 L of fluid and must be emptied daily.
`
`
`
`PInch
`Valves
`
`Figure 32, RUBY SET installation diagram
`
`
`
`
`
`PMT
`
`Figure 33, Installation of PMT portion of RUBY SET
`
`
`
`
`
`
`
`32
`
`

`

`
`
`11. Using aseptic technique, open the sterilized package of RUBY CONNECTORS. Connect IN to
`the female RUBY CONNECTOR and OUT to the male RUBY CONNECTOR (see Fig. 34,
`Female RUBY CONNECTOR to IN, Fig. 35, Male RUBY CONNECTOR to OUT).
`12. Using aseptic technique, connect both RUBY CONNECTORS to each other to maintain sterility
`until Generator has been installed (see Fig. 36, Connect RUBY CONNECTORS attached to
`each other).
`
`
`
`
`
`
`
`Figure 34, Female RUBY CONNECTOR to
`IN
`
`
`
`Figure 35, Male RUBY CONNECTOR to
`OUT
`
`
`
`
`
`Figure 36, RUBY CONNECTORS attached
`
`
`
`Aseptic technique must be used when connecting the RUBY SET to the RUBY
`CONNECTORS. Do not use RUBY CONNECTORS if packaging is damaged.
`
`
`It is recommended to have a spare set of RUBY CONNECTORS and RUBY SET on site at all
`times.
`
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` 6.6
`
`INSTALLING THE NEW GENERATOR
`
`Using the Generator handle, install a new Generator by inserting it carefully into the Generator well
`(see Fig. 37, Installing the New Generator). Remove the Generator handle, then the cover. Using
`aseptic techniques, remove the metal caps on the Generator and connect both RUBY CONNECTORS
`to the quick connects on the Generator, mating a male to a female quick connect. Make sure the
`tubing lines are in the grooves of the Generator lead well and close the Generator well lid promptly to
`avoid unnecessary exposure. The Generator packing slip is shipped with the Generator in a plastic
`pouch inside of the shipping container. Retrieve the packing slip, and on the Generator Setup screen,
`step 5 under the Generator Installation and Setup (Fig. 38, Generator Setup Screen) enter the lot
`number, strontium ratio (Sr-85/Sr-82), calibration date and expiration date.
`
`
`
`
`Figure 37, Installing the New Generator
`
`
`
`
`
`Figure 38, Generator Setup Screen
`
`
`
`Save the Generator handle and cover with shipping container for use when removing
`the expired Generator and metal caps to recap the generator.
`
`The Generator and expired components are radioactive. All procedures for disposal of
`radioisotopes should be followed.
`
`
`
`
`
`The Generator is heavy. Use proper lifting technique whenever lifting or moving the
`Generator.
`
`It is very important that the Generator information be entered correctly.
`
`
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` 6.7
`
`INSTALLING THE 0.9% SODIUM CHLORIDE (ADDITIVE FREE) INJECTION, USP
`(SALINE SUPPLY) & RUBY SALINE LINE
`
`A 0.9% sodium chloride (additive free) injection USP saline bag, RUBY SALINE LINE and RUBY IV
`LINE must be installed by the user to perform the Setup Validation in Daily Quality Control tab on the
`touchscreen monitor.
`
`1. Visually inspect the RUBY SALINE LINE packaging for damage. Discard if damaged.
`2. Using aseptic techniques, remove protective cap from saline bag and spike saline bag with the
`spike end of the RUBY SALINE LINE.
`3. Ensure that the roller clamp is in the closed position on the RUBY SALINE LINE and hang the
`saline bag on the Saline hook.
`4. Insert the RUBY SALINE LINE into the RUBY Rubidium Elution System via the keyhole on the right
`hand side of the system (see Fig. 39, RUBY SALINE LINE keyhole).
`5. Open the pump by pulling lever and install the RUBY SALINE LINE into the pump (see Fig. 40,
`Installing RUBY SALINE LINE into Pump). Close the pump using the lever.
`6. Using aseptic techniques, remove the protective cap of the RUBY SALINE LINE at point A and
`connect to the A portion of the RUBY SET (see Fig. 41, Attaching RUBY SALINE LINE to RUBY
`SET).
`7. Open roller clamp on the RUBY SALINE LINE.
`8. On the touch screen, select Pre-set Saline Volume (500mL or 1000ml) or Customized Saline
`Volume. The 0.9% USP saline bag must contain more than 50mL.
`9. Change RUBY SALINE LINE with each new install of saline supply.
`
`
`
`
`
`
`
`
`
`
`
` Figure 39, RUBY SALINE LINE Keyhole
`
`
`
`Figure 40, Installing RUBY SALINE LINE into Pump
`
`
`
`Only 0.9% sodium chloride (additive free) injection, USP may be used with the Generator.
`
`
`
`Make sure no clips are pinching the tubes before moving to the next step.
`
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` 6.8
`
`INSTALLING THE RUBY IV LINE
`
`1. Visually inspect the RUBY IV LINE packaging for damage. Discard if damaged.
`2. Using aseptic techniques, remove cap from B end of RUBY IV LINE and connect to B end of RUBY
`SET (see Fig. 42, Installing RUBY IV LINE).
`3. A new RUBY IV LINE must be used for each patient.
`4. The patient end of the RUBY IV Line (yellow sticker with patient icon) is connected to the patient.
`5. Between Rubidium-82 Chloride injections (rest & stress) and if the RUBY IV LINE is disconnected
`from the patient, engage the clamp to close the line.
`6. After each patient, and at the end of the day, remove and discard used RUBY IV LINE from the
`RUBY SET and discard according to local procedures for potentially biohazardous materials.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Figure 41, Saline Line to RUBY SET Figure 42, Installing RUBY IV Line
`
`Remove and discard used RUBY IV LINE after each patient and at the end of day. Discard
`according to local procedures for potentially biohazardous materials.
`
`
`
`Engage the clamp to the closed position on the RUBY IV LINE if the line is detached from the patient
`and between infusions.
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`7. DAILY QUALITY CONTROL
`
`Daily Quality Control must be performed after Generator Installation and every day prior to patient use.
`Daily Quality Control must be successfully performed before the Patient Infusion tab is available on the
`RUBY Rubidium Elution System (see Fig. 43, Daily Quality Control Needed Screen). The Daily Quality
`Control is accessed through the second row of the task bar. Once a PIN is entered, the following steps
`are required:
`
`
`Figure 43, Daily Quality Control Needed Screen
`
`It is very important to perform a Daily Quality Control immediately after the installation
`of a new RUBY SET and/or Generator to confirm the correct performance of the
`system. RUBY tubing and Generator installation takes approx. 20 minutes to
`complete.
`
`
`
`If the RUBY SET needs to be replaced following the Generator and Tubing installation, leave the
`RUBY CONNECTORS attached the Generator, attach a new set of sterile caps (provided with each
`generator) to the RUBY CONNECTORS to maintain sterility of the Generator until new RUBY SET
`is installed.
`
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`
` EMPTY WASTE CONTAINER 7.1
`
`To empty the liquid waste bottle, open the shielded lid and disconnect the tube from the bottle and
`discard the solution according to local regulations. Reinstall the waste bottle; making sure the tube is
`correctly installed to avoid leaks into the well. Close the lid and press Next on the Empty Waste
`Screen (see Fig.44, Empty Waste Screen).
`
`
`
`
`
`Discard the waste solution according to local regulations and procedures for radioactive
`waste.
`
`Failure to empty the waste daily could cause the waste bottle (1L fluid limit) to overflow into the
`waste well. If this occurs, remove the liner and clean waste well per site-specific procedures.
`
`
`
`Figure 44, Empty Waste Screen
`
`
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` 7.2
`
`INSTALL SALINE SUPPLY
`
`Refer to INSTALLING THE 0.9% SODIUM CHLORIDE (ADDITIVE FREE) INJECTION, USP (SALINE
`SUPPLY) & RUBY SALINE IV LINE, section 6.7 (see Fig. 45, Install Saline Supply Screen).
`
`Figure 45, Install Saline Supply Screen
`
`
`
`Make sure no clips are pinching the tubes before moving to the next step.
`
`Only 0.9% Sodium Chloride (additive free), USP Saline may be used with the generator.
`
`Change RUBY SALINE LINE with each new saline supply, or at least daily, and perform Setup
`Verification.
`
`
`
`
`
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` SETUP VERIFICATION 7.3
`
`After the RUBY SET and Generator installation are complete, the software automatically displays the
`Setup Verification Screen (see Fig. 46, Setup Verification Screen) to check three components for
`normal operation:
`
`
`Pinch Valves: Each valve is activated by the system. Clicks will be heard as each valve is
`checked; this is normal. Check that all tubing remains correctly inserted into each pinch
`valve before proceeding. If an error occurs, contact Jubilant DraxImage Inc.
`
`Pump Flow Rate: Obtain the provided graduated cylinder. The system dispenses a test
`volume with continuous flow rate to calibrate the pump and verify that it is working correctly.
`Install a RUBY IV LINE (Installing RUBY IV LINE; refer to section 6.8), and a sterile 20G
`needle and place tip inside a graduated cylinder to collect the pumped volume, and then
`press Verify Pump. Enter the volume collected in the volume field (mL) on the screen. Press
`Confirm Volume. The % value obtained is normally close to 0. If the error % is >10% the
`user should repeat pump validation. If the volume entered is too far from the targeted
`value, an error is displayed. If an error occurs the user needs to repeat pump validation. If
`the error persists, contact Jubilant DraxImage.
`
`Pressure Transducer Range: Press Verify Pressure and wait for completion. After 10
`seconds the pump runs with increasing speed. If there is an error, the user should check
`that the pressure transducer is connected, verify proper installation of the RUBY tubing and
`repeat the process by pressing Validate Pressure transducer. If the error persists, contact
`Jubilant DraxImage.
`
`
`
`Figure 46, Setup Verification Screen
`
`
`
`The blue bar at the bottom of the screen indicates the progress of each procedure (see Fig. 46,
`Setup Verification Screen). On screen, a green check appears next to each step when each
`verification is complete.
`
`
`
`
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`
`1.
`
`2.
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`
`
`3.
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`If the supplied graduated cylinder is lost the replacement cylinder must be at least 30ml.
`
`
`
`
`
`
` DAILY DOSE CALIBRATOR CONSTANCY CHECK 7.4
`
`Verify the dose calibrator using a calibrated source. Note that before the first verification, the source
`must be entered in the system as the dedicated reference source (see Settings, see refer to Section
`5.4).
`
`To perform the verification:
`1. Make sure no exterior source is near the elution system to minimize background noise and
`ensure dose calibrator is empty (no radioactive sources).
`2. Press Zero Background on the Check Constancy Screen (see Fig. 47, Check Constancy
`Screen) and wait until the green check mark appears. This can take up to 90 seconds,
`depending on background noise.
`3.
`Insert the calibrated standard in the dose calibrator and wait until the reading stabilizes.
`4. Press Start. A screen should appear to indicate if the verification was successful (see Fig. 48,
`Check Constancy Screen (Successful). If an error occurs, check that the correct calibration
`standard is being used and repeat the constancy check.
`5. Remove the calibrated standard from the dose calibrator.
`
`
`
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`Figure 48, Check Constancy Screen (Successful)
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`Figure 47, Check Constancy Screen
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` FLUSH, CALIBRATION & BREAKTHROUGH 7.5
`
`The last step within the Daily Quality Control tab is preparing for the Flush, Calibration, and
`Breakthrough (see Fig. 49, Flush, Calibration, and Breakthrough Screen).
`
`The flush process pumps a precise amount of saline solution through the Generator to rinse off any
`impurities from the column or the lines. The solution is directed to the waste container and can be left
`there to decay in the shielded enclosure. After this procedure, the Generator needs time to fully
`recharge before beginning the calibration process. The user should verify that no leak occurred after
`the flush (during the Generator recharge) and stop the process if needed.
`
`As soon as the system stops directing saline through the Generator, the Generator recharge begins.
`The recharge progress is displayed in the upper right corner of the screen (see Fig. 50, Performing
`Daily Quality Control), The percentage value is the recharge percentage for Rubidium-82 in terms of
`half-life. The time value until recharge is displayed below that. A complete recharge takes ~15
`minutes. The time remaining is also displayed. Calibration does not begin unless a full recharge has
`been reached.
`
`The calibration process runs a measured amount (35mL) of saline through the Generator at a flow rate
`of 20 mL/min to deliver a calibrated sample. This calibrated sample is collected in a vial in the dose
`calibrator and measured to determine the activity. This activity will be used by the system to determine
`the activity available at this point in the life of the Generator and to measure the activity delivered in
`patient infusions.
`The breakthrough test uses the sample produced during the calibration process. This portion of the
`Daily Quality Control takes 30 minutes, during which the Rb-82 decays completely, and the system
`assays the calibration sample and measures the amount of strontium-82 and strontium-85 present in
`the sample. This information is saved in the calibration report (refer to section 8.1, Reports).
`
`Follow these steps before initiating Start for the Flush, Calibration and Breakthourgh.
`
`
`1. Obtain a 50 ml sealed glass vial (with rubber stopper)
`2. Aseptically install a RUBY IV LINE on the B needleless injection port of the RUBY SET
`3. Aseptically install a sterile needle (20G) on the end of the RUBY IV LINE and insert into rubber
`stopper of glass vial
`4. Insert a sterile vent needle (20G) into rubber stopper of glass vial
`5. Place the vial into dose calibrator dipper and lower into the dose calibrator chamber
`6. Press Start to begin the 50-minute procedure (see Fig. 49, Flush, Calibration, and
`Breakthrough Screen).
`
`
`The word Successful (in green) appears next to each item as it is completed. This information is
`saved in the Daily QC report. If an error occurs, a red 'X' appears and that process is aborted. If this
`occurs, the user needs to repeat this process before proceeding to the next step (see Fig. 50,
`Performing Daily Quality Control).
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`Figure 49, Flush, Calibration, and Breakthrough Screen
`
`
`Figure 50, Performing Daily Quality Control (Flush and Calibration
`are completed and the Breakthrough Check is in progress)
`
`The yellow progress bar indicates that a radioactive procedure is in progress and that radioactive
`solution is flowing through unshielded tubes. The user should remain at a safe distance from the
`elution system.
`
`
`
`When the breakthrough check is complete, a label with the daily QC values automatically prints as
`configured in the settings. The user can either press Reprint Labels or press Finish.
`
`When the user selects Finish, the Ready for Patient Infusion Screen appears (see Fig. 51, Ready for
`Patient Infusion Screen). This screen displays important information about the state of the elution
`system at a glance. The most important information displayed on this screen is:
`
`
`(cid:120) Breakthrough: Indicated as a percentage of the USP limit* (see Table 3), this field indicates the
`level of impurities calculated in the Daily Quality Control.
`(cid:120) Breakthrough History: The graph tracks the breakthrough levels for each day of use of the
`installed generator.
`(cid:120) Below the yellow line (<20% of USP limit*, see Table 3), the system can be used without any
`restriction on the number of infusions per Quality Control.
`(cid:120) An alert limit is reached when the reading is above the yellow line ((cid:149) 20%) and below
`the red line (<50% of the USP limit*, see Table 3). Alert limits may be triggered by the
`following:
`
`o 20 L of saline eluted through the Generator.
`o or an eluate Sr-82 level of (cid:149)0.004 μCi/mCi Rb-82. and (cid:148) 0.01 μCi/mCi Rb-82.
`o or an eluate Sr-85 level of (cid:149)0.04 μCi/mCi and (cid:148) 0.1 μCi/mCi Rb-82.
`
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`PASS
`< 20% of USP limits*
`(Green)
`
`Breakthrough level is low.
`
`ALERT
`(cid:149) 20% and <50% of USP limits*
`OR 20L volume limit
`(Yellow)
`
`Breakthrough level is increased.
`
`FAIL
`(cid:149) 50% of USP limits*
`OR 30L volume limit
`(Red)
`Breakthrough level is approaching the
`allowable limit.
`The Daily Quality Control (automated
`breakthrough test) does not allow a
`sufficient margin of safety to continue the
`elutions (scans).
`The use of the RUBY-FILL® Rubidium Rb
`Repeat an automated Daily Quality Control
`82 Generator must be discontinued
`after every 4 patients (8 scans) and record
`immediately.
`the results
`Contact Jubilant DraxImage:
`Contact Jubilant DraxImage:
`1-888-633-5343
`1-888-633-5343
`*USP limits: <0.02μCi of Sr-82/mCi of Rb-82; <0.2μCi of Sr-85/mCi of Rb-82
`Table 3: Strontium Breakthrough Results
`
`The Daily Quality Procedure (automated
`breakthrough test) is valid for a 24 hour
`period.
`
`The Daily Quality Procedure (automated
`breakthrough test) is valid for 4 patients only.
`
`Proceed with use
`
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`The system can be used with four (4) patients before a Quality Control procedure must be performed if
`the breakthrough reaches an alert limit. If the user repeats the flush, the system counts this as a patient
`infusion.
`
`
`(cid:120) (cid:149) 50% of the USP limit* (see Table 3), the system does not allow the user to perform a patient
`infusion.
`(cid:120) Refer to Table 3 below for instructions to follow on Strontium Breakthrough results.
`
`
`
`Remove and discard the calibration
`vial according to local procedures
`and regulations. Use a clean vial for
`each Daily Quality Control.
`
`After the initial Daily Quality Control
`following Generator
`installation,
`visually inspect the RUBY SET and
`all needleless injection ports for any
`leaks.
`
`Figure 51, Ready for Patient Infusion Screen
`
`
`
`
`
`Generator should not be used if any of the following are reached: (1) 50% of Sr-82/ Sr-85 USP limits,
`(2) 30 L volume limit or (3) Generator expiration date
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` PREPARING FOR PATIENT INFUSIONS 7.6
`
`Upon completion of Daily Quality Control, in preparation for Patient Infusions, close the front door and
`top panel of the RUBY Rubidium Elution System. The patient portion of the RUBY SET is placed
`outside of the RUBY Rubidium Elution System through the notch in the top panel for accessibility to
`change the RUBY IV LINE.
`
`An absorbency pad may be placed on top of the RUBY Rubidium Elution System to place the RUBY IV
`LINE and other materials in preparation for patient setup.
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`Do not use the top of the elution system as a work desk.
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`8. PATIENT INFUSIONS
`
`To access the patient infusion mode, press Patient Infusion on the second row of the task bar. Enter
`PIN and