DIAGNOSTICS
`
`RB-82 INFUSION SYSTEM
`USER'S GUIDE
`
`Manufactured By:
`
`RbM Services, LLC
`101C Valley Court
`Oak Ridge, Tennessee 37830
`For
`Bracco Diagnostics Inc.
`107 College Road East
`Princeton, NJ 08540
`
`RbM Part Number 9300003-00
`July 20, 2004
`Rev 07
`
`BRACCOITC00011016
`
`JUBILANT EXHIBIT 1021
`Jubilant v. Bracco, IPR2018-01449
`
`

`

`Rb-82 Infusion System
`
`Warranty
`
`Bracco Diagnostics Inc. (BDI) warrants the Rb-82 Infusion System
`against any defects in materials or workmanship for a period of one
`year from the date of installation. BDI's warranty covers all parts,
`repair labor and its associated expenses for failures of the infusion
`system to perform to its specifications during the warranty period.
`
`The Rb-82 Infusion System should only be serviced by authorized
`BDI- personnel. Any service by other than BDI-authorized personnel
`will void this warranty.
`
`ii
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`BRACCOITC00011017
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`

`

`SAFETY SUMMARY
`
`The "!" mark inside of a triangle as labeled on the Rb-82 Infusion System, as well as the
`label showing "a person looking at a book" is meant to reference the user to this User's
`Manual in order that the individual will understand the complete operation of the system
`and understand all safety precautions.
`
`Radiation Safety
`
`The Rb-82 Generator supplied by Bracco Diagnostics, Inc for use with the Rb-82
`Infusion System emits radiation. All applicable radiation safety regulations should
`be followed by the user.
`
`DANGER: EXPLOSION HAZARD. DO NOT USE IN THE PRESENCE OF
`FLAMMABLE ANAESTHETICS.
`
`CAUTION!
`
`To reduce the risk of electrical shock, do not remove. Refer servicing to qualified
`service personnel. Refer to Bracco Diagnostics, Inc. for servicing.
`
`Power Source
`
`This system can be set for 100/120/220/240V- operation via the power entry
`module. For 230V- operation use the 240V- setting. To change this setting,
`ensure that the system is unplugged from its power source, and use a small flat
`screwdriver to remove the fuse drawer of the power entry module. Remove the
`small voltage selector card and rotate the card until the desired voltage is shown.
`Then replace the card and fuse drawer. Only use the fuse type and rating as
`indicated on the system label located near the power entry module. System
`power is 2.5A. The protective ground connection via the grounding conductor in
`the power cord is essential for safe operation.
`
`Grounding the System
`
`This system is equipped with a three-conductor ac power cord marked "Hospital
`Grade." The power cord must be plugged into an approved three-contact
`electrical outlet marked "Hospital Only" or "Hospital Grade" to assure a reliable
`ground. Use only a power cord that is in good condition.
`
`iii
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`BRACCOITC00011018
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`

`Do not operate this system in an explosive atmosphere, such as, flammable
`gases or fumes.
`
`The type B symbol refers to the fact that all applied parts of this system are
`categorized as Type B with regard to electrical shock per IEC 60601 Safety
`Standards for Medical Electrical Equipment.
`
`Do Not Remove Covers or Panels
`
`To avoid personal injury, do not remove or operate this system without all
`appropriate covers and panels in place. Refer all service to authorized
`personnel.
`
`Fusing
`
`To avoid fire hazard, use a fuse of the correct type, voltage rating and current
`rating as specified.
`
`The following fuses and values are used in the system:
`
`Power entry module: Use only the fuse type and rating as indicated on the
`system label located near the power entry module. Internal fuses should
`only be replaced by qualified personnel.
`
`Fl, Power chassis assembly (rear panel), 1/4 x 1 1/4 T2, 5AL250V- (2.5A,
`250V- time delay
`F2, Power chassis assembly, 1/4 x 1 1/4 Ti, 5AL250V- (1.5A, 250V- time
`delay
`
`Safety Compliance
`
`The Cardiogen-82® Infusion System (Rubidium Rb 82 Generator) is compliant
`with IEC60601 and UL60601 Safety for Electronic Medical Equipment.
`
`Service and Parts
`
`Because of the danger of introducing additional hazards and personal injury, do
`not install substitute parts or perform any unauthorized modifications to the
`system. Refer to Bracco Diagnostics Inc. for all service and repairs to ensure
`that all safety features are maintained.
`
`iv
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`BRACCOITC00011019
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`

`

`Preventive Maintenance
`
`To ensure all safety features are maintained to system specifications, the system
`should have annual preventive maintenance service.
`
`A preventive maintenance program is available through Bracco Diagnostics Inc.
`
`V
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`BRACCOITC00011020
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`

`

`TABLE OF CONTENTS
`
`Section
`
`1.0
`
`INTRODUCTION
`
`Paae
`
` 1
`
` 1
` 1
` 4
`
` 5
` 5
` 6
`
`GENERAL DESCRIPTION
`2.1 Rb-82 Infusion System Overview
`2.2 Automatic Infusion Mode Overview
`
`GENERAL INFORMATION
`3.1 General Precautions
`3.2 System Specifications
`
`2.0
`
`3.0
`
`4.0
`
` 9
`SYSTEM OPERATION
`4.1 Introduction 9
`4.2 The Display/Control Panel
` 9
`4.2.1 POWER ON Switch
` 10
`4.2.2 POWER OFF/ABORT Switch
` 10
`4.2.3 MODE Switch
` 10
`4.2.4 MODE Display
` 10
`4.2.5
` 12
`INJECT Start/Stop Switch
`4.2.6 PURGE Switch
` 12
`4.2.7
`REFILL Switch
` 12
`4.2.8 FLOW RATE Switch
` 12
`4.2.9
`ELUTION VOLUME Display and Limit Switch 12
`4.2.10 PATIENT VOLUME Display and Limit Switch 13
`4.2.11 PATIENT DOSE Display and Limit Switch
` 13
`4.2.12 DOSE RATE Display and Threshold Switch
` 13
`4.2.13 PUMP LIMIT Indicator Light
` 13
`4.2.14 HIGH PRESSURE Indicator Light
` 13
`4.2.15 VALVE FAILURE Indicator Light
` 14
`4.2.16 AC MAIN Indicator Light
`14
`4.3 The CALIBRATION FACTOR Switch
` 14
`4.4 System Activation
` 15
`4.5 Pump Refill Operation 15
`4.6 Purge Modes
` 15
`4.7 Automatic Infusion Mode
` 16
`4.7.1
`Description
` 16
`4.7.2
`Report Printout
` 17
`
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`Section
`
`5.0
`
`TABLE OF CONTENTS
`(Continued)
`
`Page
`
`OPERATING PROCEDURES
`25
`25
`5.1
`General Notes
`25
`5.2
`Rb-82 Generator and Sterile Components
`5.3
`Rb-82 Infusion System Preparation 25
`Installation of the Syringe Pump Components
`5.4
`25
`5.5
`Generator Inlet Assembly Package
`26
`5.6
`Generator Outlet Assembly
`(Package #3)
`Patient Line Installation
`Saline Supply Installation
`Rb-82 Generator Installation
`Purge Operation
`Patient Administration
`
`5.7
`5.8
`5.9
`5.10
`5.11
`
`27
`28
`28
`29
`29
`31
`
`CardioGen-82 Generator Sr-82/85
`Breakthrough Worksheet
`Rb-82 Infusion System Calibration
`Data Sheet
`
`6.0
`
`TROUBLESHOOTING GUIDE
`
`SYSTEM DIARY
`
`34
`
`36
`
`39
`
`40
`
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`BRACCOITC00011022
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`

`LIST OF FIGURES
`
`Figure
`
`Paae
`
`2.1
`
`Rb-82 Infusion System Illustration 2
`
`2.2
`
`Rb-82 Infusion System Fluid-System Diagram 3
`
`4.1
`
`Illustration Of The Display/Control Panel
`
`11
`
`4.2
`
`Summary Of The Purge Operations 17
`
`4.3
`
`Summary Of The Automatic Infusion Operation 20
`
`4.4
`
`Sample Infusion Report Printout 24
`
`5.1
`
`Tubing Diagram
`
`33
`
`5.2
`
`Rb-82 Infusion System Calibration Log Sheet 37
`
`5.3
`
`CARDIOGEN®-82 Generator Sr-82 Breakthrough
`Log Sheet
`
`38
`
`viii
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`BRACCOITC00011023
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`

`1. INTRODUCTION
`
`The Rb-82 Infusion System is a complete system for the generation and
`delivery of Rb-82 from a CardioGen®-82 generator (Sr-82/Rb-82 generator)
`to a patient for cardiovascular nuclear medicine procedures. Rb-82 is a
`short-half-life (75 seconds) positron emitter and is a potassium biochemical
`analogue. For these reasons, Rb-82 is very useful for myocardial perfusion
`studies. The Rb-82 obtained from the Rb-82 Infusion System is eluted in
`sterile normal saline for direct injection into a patient.
`
`Rb-82, with its 75-second half-life, offers some distinct advantages over
`radionuclides with longer half lives. The patient dose received for a given
`activity of Rb-82 is lower than the patient dose received from other, longer
`half-life positron emitters. Additionally, the rapid decay of Rb-82 (as well as
`the reduced patient exposure) permits multiple patient studies to be
`performed over a relatively short period of time.
`
`2. GENERAL DESCRIPTION
`
`2.1 Rb-82 Infusion System Overview
`
`The Rb-82 Infusion System is a mobile, self-contained cart complete with a
`shield for a CardioGen®-82 generator, a waste bottle shield, a saline syringe
`pump, sterile tubing and valve components, a positron detector, and all of
`the support electronics necessary to administer controlled levels of Rb-82
`activity to a patient. The system is illustrated in Figure 2.1.
`
`The Rb-82 Infusion System delivers Rb-82 by pumping saline (which acts as
`an eluant) through a Sr-82/Rb-82 generator to produce the Rb-82 eluate. A
`diagram of the fluid system for the Rb-82 Infusion System is shown in Figure
`2.2. Note that the Rb-82 generator eluate is assayed by a positron (beta)
`probe which consists of a plastic scintillator and a photomultiplier tube. This
`detector and its associated electronics are designed to reject the normally-
`occurring 511-keV gamma rays associated with positron annihilations while
`detecting the interaction of positrons in the detector's thin scintillator.
`
`In addition to the syringe pump, the Sr-82/Rb-82 generator, and the positron
`detector, the fluid system contains a divergence valve for directing fluid flow
`in the Rb-82 Infusion System. This divergence valve (see Figure 2.2) is used
`to direct the low-level Rb-82 activity that initially leaves the Sr-82/Rb-82
`generator to a shielded waste bottle. Once the Rb-82 activity leaving the Sr-
`82/Rb-82 generator reaches levels sufficient for patient injection, this valve
`directs the Rb-82 eluate to the patient.
`
`1
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`BRACCOITC00011024
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`

`YRINGE
`PUMP
`
`PRINTER
`
`[761.9]
`30.00
`
`DETECTOR AND
`VALVE SHIELD
`
`\
`
`[914.3]
`36.0
`
`762A2]
`30.0
`
`CONTROL
`PANEL
`
`[898.44]
`35.37
`
`[577.85]
`22.75
`
`Figure 2.1 Rb-82 Infusion System Illustration
`
`2
`
`BRACCOITC00011025
`
`

`

`FILTER
`
`STERILIZATION
`
`LINE
`PATIENT
`
`VALVE
`
`DIVERGENCE
`
`DETECTOR
`
`/
`
`FILTER
`
`STERILIZING
`
`(BETA)
`GENERATOR POSITRON
`
`Rb-82
`
`VALVE
`CHECK
`
`SUPPLY
`SALINE
`
`/
`
`/// /
`z///
`
`
`
`
`/ BOTTLE
`WASTE
`
`PUMP
`
`SYRINGE
`
`SHIELD
`
`GENERATOR
`
`TRANSDUCER
`
`PRESSURE
`
`Figure 2.2 Rb-82 Infusion System Fluid-System Diagram
`
`9O I- L000au000ve
`
`

`

`The Rb-82 Infusion System provides an AUTOMATIC INFUSION mode for
`automatic delivery of Rb-82 to a patient. Additionally, the system provides
`two purge modes, PURGE-GENERATOR-TO-WASTE and PURGE-
`GENERATOR-TO-PATIENT-LINE, for system setup and maintenance. The
`two purge modes are used to purge air out of the system tubing following the
`installation of a Sr-82/Rb-82 generator and the associated sterile tubing-
`component set. Detailed descriptions for all three operating modes are
`included in Section 4, and an overview of the AUTOMATIC INFUSION mode
`is contained in the following section.
`
`2.2 Automatic Infusion Mode Overview
`
`The AUTOMATIC INFUSION Mode is used for delivering a pre-selected
`quantity of Rb-82 eluate into the patient for myocardial perfusion studies.
`
`To perform an automatic infusion operation, the operator selects the desired
`patient dose (the word dose is used to reflect common usage although the
`correct word is activity) in mCi and a flow rate of 50 ml/min in accordance
`with the CardioGen®-82 (Sr-82/Rb-82) package insert. Additionally, the
`operator selects a patient volume (ml) and an elution volume (ml) which are
`used as backup limits in the event of a detector failure. Note that patient
`volume is the volume administered to a patient, and elution volume is the
`total volume pumped through the generator during an infusion. Finally, the
`operator sets the dose-rate threshold, to 1.0 mCi/sec, which controls when
`the system will direct eluate (which initially is routed to the waste bottle) to
`the patient.
`
`Once an automatic infusion is started, saline is pumped through the
`generator and the resulting eluate is routed to the waste bottle until its dose
`rate (mCi/sec) exceeds the pre-selected dose-rate threshold. It typically
`takes 10 to 18 seconds before eluate leaving the generator becomes
`sufficiently concentrated to reach the required dose-rate threshold of 1.0
`mCi/sec. Once the dose-rate threshold is exceeded, the Rb-82 eluate is
`directed to the patient line and both the patient dose and patient volume are
`measured and displayed. The infusion continues and stops on whichever
`limit is reached first: patient dose, patient volume, or elution volume. As
`mentioned, the normal stopping limit is the patient dose.
`
`Once the infusion is complete, the pump stops and the generator eluate is
`directed back to the waste bottle to vent any residual generator pressure. At
`this time, a complete report of the Rb-82 infusion is printed on the system
`printer and this same data is echoed out a RS-232C serial data port. The
`RS-232C port can be connected to the customer's computer for analysis or
`storage of Rb-82 infusion data.
`
`4
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`BRACCOITC00011027
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`

`3. GENERAL INFORMATION
`
`3.1 General Precautions
`
`• Use the Rb-82 Infusion System only with a CardioGen®-82 generator
`(Sr-82/Rb-82 generator) and the sterile tubing set provided with the
`generator.
`
`• For locations where the generator and infusion system remain in
`one location (i.e., hospital, physician office, or imaging center):
`The tubing set connected to the generator and the infusion system
`is to remain in place until a new generator is installed. A new
`tubing set will be provided with each new generator.
`
`For locations where the generator and infusion system are
`transported from one location to a different location or Daily Use
`Customers (i.e., generator and infusion system are used and
`stored at a facility for one or more consecutive days and the
`following day the generator and infusion system are used by a
`different facility), the tubing set connected to the generator and the
`infusion system must be replaced. Prior to transporting the
`generator and infusion system to a different location, all tubing
`must be removed and discarded in accord with approved radiation
`safety and waste disposal procedures. Under no circumstances
`should the tubing used at one facility be used at a different facility.
`New tubing sets are available from Bracco Diagnostics, Inc., or the
`provider of the Daily Use program.
`
`•
`
`Since the eluate obtained from the Sr-82/Rb-82 generator may be
`intended for intravenous administration to a human patient, aseptic
`technique must be strictly observed in all handling of the eluate and
`tubing set. In addition, care should be taken to ensure that the Rb-82
`Infusion System is purged of air prior to each patient infusion.
`
`• As in the use of any radioactive material, care should be taken to
`minimize radiation exposure to the patient consistent with proper patient
`management. Additionally, care should be taken to minimize the
`radiation exposure to attending personnel.
`
`• Radiopharmaceuticals should be used only by physicians who are
`qualified by training and experience in the safe use and handling of
`radionuclides.
`
`• To limit the exposure of personnel, the CardioGen®-82 generator (Sr-
`82/Rb-82 generator) must be installed in the lead shield provided in the
`Rb-82 Infusion System as a radiation safety precaution.
`
`5
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`BRACCOITC00011028
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`

`• Due to the short half-life of Rb-82, a time period of 10 minutes is
`sufficient to permit Rb-82 to decay before handling Rb-82 eluate.
`Hospital personnel should wait at least 10 minutes before handling Rb-
`82 eluate. Gloves should be worn when handling any of the generator,
`tubing, or waste bottle components.
`
`• All components that may contain residual radioactivity must be stored
`and disposed of in accordance with the facility's radioactive materials
`license.
`
`• Turn the power off the system and disconnect the power cord prior to
`cleaning the system. The system may be cleaned by using a cloth
`which has been dampened with alcohol. Do not use liquid cleaners on
`or near the power entry module or the display control panel.
`
`3.2 System Specifications
`
`OPERATING MODES:
`
`AUTOMATIC INFUSION
`PURGE-GENERATOR-TO-WASTE
`PURGE-GENERATOR-TO-PATIENT-LINE
`
`AUTOMATIC INFUSION MODE:
`
`Preset Elution Volume:
`
`0-99 ml in 1 ml increments
`
`Preset Patient Volume:
`
`0-99 ml in 1 ml increments
`
`Preset Patient Dose:
`
`0-99 mCi in 1 mCi increments
`
`Preset Dose Rate Threshold:
`
`Flow Rate:
`
`Rb-82 Delivery Accuracy:
`
`Generator Activity
`
`>40 mCi:
`20 - 40 mCi:
`10 - 20 mCi:
`5- 10 mCi:
`
`0.0 - 9.9 mCi/sec in 0.1 mCi/sec
`increments. The proper preset
`dose rate threshold for Rb-82 is
`1.0 mCi/sec.
`
`20, 35, 50, 65, and 80 ml/min
`(Flow rate for Rb-82 = 50 ml/min)
`
`(Generator Sr-82 Activity 30-120
`mCi, Flow Rate 50 ml/min)
`
`Accuracy
`
`+/- 10%
`+/- 10%
`+/- 15%
`+/- 20%
`
`Patient Volume Delivery Accuracy: +/- 2 ml
`
`6
`
`BRACCOITC00011029
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`

`Automatic Infusion Report: The system printer prepares a detailed
`report following every automatic infusion.
`This report lists all system settings,
`measured
`infusion
`volumes and
`activities, and a history (in one-second
`intervals) of activity seen at the detector
`and patient port. Additionally, any error
`conditions are listed if an automatic
`infusion is unable to start or is terminated
`due to an error condition. Data identical
`to the system printout is provided on the
`RS-232C port.
`
`SPECIAL SYSTEM MONITORING FUNCTIONS:
`
`System pressure:
`
`Valve operation:
`
`Pump limit:
`
`Valve shield:
`
`Monitoring function
`
`90 psig (+/- 5 psig) pressure limit sensor
`is provided along with a second,
`redundant pressure limit of 100 psig (+/-
`10 psig) provided by the syringe pump.
`
`Valve position is continuously monitored.
`Additionally, the valve must transition
`between waste and patient positions in
`less than 2 seconds or an error will be
`detected.
`
`Syringe pump limits, both refill (nom. 128
`ml) and pump limits (nom. 15 ml) are
`monitored.
`
`The valve shield is monitored to detect if
`it is open. Additionally, the valve shield
`remains locked for any purge or infusion
`operation and does not unlock until the
`detector measures a count rate less than
`50 cps.
`
`Automatic infusion operations will not
`start if operation shield-open error is
`detected. Automatic infusion operations
`are terminated (if in progress) for all of
`the preceding conditions.
`Purge-generator-to-waste and purge-
`generator-to-patient-line operations will
`not start and will be terminated if in
`progress if a high-pressure error, valve
`
`7
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`BRACCOITC00011030
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`

`error, pump limit, or shield-open error is
`detected.
`
`SYRINGE PUMP CAPACITY:
`
`Mechanically limited to -130m1 full
`capacity.
`
`RS-232C PORT CHARACTERISTICS:
`
`Description: The RS-232C port echoes out infusion report printout
`data for access by a remote computer. Although this
`port has a receive line, the Rb-82 Infusion System does
`not recognize incoming data.
`
`RS-232C Port Interface Details:
`
`Signal DB25P Connector Pin
`
`TX (transmit data)
`RX (receive data)
`GND (signal ground)
`
`(pin 2)
`(pin 3) This signal is not used.
`(pin 7)
`
`Data Format Baud Rate
`
`2400 bit/sec
`
`1 Start bit
`1 Stop bit
`8 Data bits
`No Parity
`
`SYSTEM POWER REQUIREMENTS:
`System power is 2.5A max. This system can be set for
`100/120/220/240V- operation via the power entry module. To
`change this setting, ensure that the system is unplugged from its
`power source, and use a small flat screwdriver to remove the fuse
`drawer of the power entry module. Remove the small voltage
`selector card and rotate the card until the desired voltage is shown.
`Then replace the card and fuse drawer. Use only the fuse type and
`rating as indicated on the system label located near the power entry
`module.
`
`System Weight:
`
`650 lbs.
`
`System Size:
`
`See Fig. 2.1 on page 2
`
`Shipping Weight:
`
`875 lbs.
`
`Shipping Size:
`
`48"H x 31"W x 41"L
`
`8
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`BRACCOITC00011031
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`

`ENVIRONMENTAL CONDITIONS FOR OPERATION, TRANSPORTING
`AND STORAGE OF SYSTEM:
`The system should be operated in a normal office environment,
`but can be safely operated, stored, and transported between
`temperatures of 40°F (4.4°C) - 110°F (43.3°C). This is primarily due
`to characteristics of the detector. Although no known problems have
`been encountered with storage and transport of the system below or
`above these temperatures, it would be best not to subject it to
`extreme high or low temperatures beyond this point for an extended
`period. Avoid condensing humidity conditions.
`
`CLEANING:
`Before performing any cleaning operations, turn off the system
`and unplug the power cord. The System Display Control Panel
`should only be cleaned with an alcohol-dampened cloth. Be very
`careful when wiping the mylar windows that cover the seven
`segment LED displays, so as not to puncture them. The top and
`sides of the system can be cleaned with normal household cleaners
`applied with a damp cloth. Use a sample test area on the plastic top
`of the system to verify the cleaner will not stain the plastic. The
`interior of the system should only be cleaned by trained and
`qualified radiation and safety personnel. Observe all safety
`precautions noted in this manual.
`
`4.0 SYSTEM OPERATION
`
`4.1 Introduction
`
`This section of the Rb-82 Infusion System manual describes the
`display/control panel features and operating modes of the infusion system.
`The user, however, must refer to the specific operating procedures contained
`in Section 5 of this manual and to medical protocols for the CardioGen®-82
`(Sr-82/Rb-82 generator) when performing system preparations, calibrations,
`breakthrough measurements, and infusions.
`
`4.2 The Display/Control Panel
`
`All displays and controls for the Rb-82 Infusion System, except for the
`CALIBRATION FACTOR switch, are located on the Display/Control Panel
`which is illustrated in Figure 4.1. This Figure should be referred to during the
`following discussion of the Display/Control Panel features.
`
`9
`
`BRACCOITC00011032
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`

`4.2.1 POWER ON Switch
`
`This momentary-contact, push-button-indicator switch is used to apply power
`to the infusion system. When the system is powered, this switch glows
`green. If AC power to the infusion system is interrupted, it is necessary to
`depress this switch to repower the system. When the system is turned off by
`the Power Off Abort switch, the system can only be turned back on by
`rotating the Power Off Abort switch clock-wise, until the Power Off Abort
`switch "resets" by popping up. If this Power Off Abort switch is not "reset,"
`the Start switch is rendered disabled.
`
`4.2.2 POWER OFF/ABORT Switch
`
`Depressing this switch turns off the system. Please note that this switch does
`not turn off AC power to the system, and as long as the system's power cord
`is plugged into a live AC electrical outlet, there will be AC power to the
`system as indicated by the lighted AC Main LED indicator on the Display
`Control Panel. This switch also works as an emergency cutoff to stop the
`system in case of emergencies. In order to turn the system back on, the
`switch must be rotated clock-wise, until the switch "resets" by popping up. If
`this Power Off Abort switch is not "reset" the Start switch is rendered
`disabled.
`
`4.2.3 MODE Switch
`
`This rotary switch is used to select the operating mode of the infusion
`system. The modes available are
`
`AUTOMATIC INFUSION,
`PURGE-GENERATOR-TO-WASTE, and
`PURGE-GENERATOR-TO-PATIENT-LINE.
`
`4.2.4 MODE Display
`
`The mode display is an illuminated flow diagram showing the routing of
`saline in the infusion system. The mode display shows the saline flow path
`for all operating modes of the infusion system.
`
`10
`
`BRACCOITC00011033
`
`

`

`eq4t CARDIOGEN-82® INFUSION SYSTEM
`
`ELUTION
`VOLUME
`
`PATIENT
`VOLUME
`
`(Rubidium Rb 82 Generator)
`PATIENT
`
`1_1
`
`ml
`
`II I
`LI 1_1
`
`ml
`
`UMIT
`
`5 0
`
`POWER OFF
`
`DOSE
`
`1-1
`1_1
`
`1-1
`1_1
`
`mCi
`
`DOSE
`RATE
`
`Lc 1_1
`
`n
`
`mCils
`
`SALINE
`SUPPLY
`
`START/STOP
`
`INJECT
`
`VALVE
`
`PATIENT
`
`TO
`
`• PUMP LIMIT
`O HIGH PRESSURE
`SYRINGE 0 VALVE FAILURE
`
`PUMP
`
`'Al WASTE
`
`LIMIT
`
`THRESHOLD
`
`PURGE
`
`6€
`
`EMPTY
`WASTE
`BOTTLE
`DAILY
`
`0A
`
`C MAIN
`
`PURGE GENERATOR
`
`TO WASTE
`
`65
`
`80
`
`AUTOMATIC
`INFUSION
`
`i
`
`PURGE
`GENERATOR
`TO PATIENT
`
`REFILL
`
`MODE.
`
`Illustration of the Display/Control Panel
`
`BRACCOITC00011034
`
`

`

`4.2.5 INJECT START/STOP Switch
`
`This momentary-contact, indicator-push-button switch is used to start an
`automatic infusion. This switch glows red during an infusion and is
`extinguished once the infusion pumping operation is complete. This switch
`may be depressed during an infusion to stop the infusion.
`
`4.2.6 PURGE Switch
`
`This momentary-contact, push-button switch is used to purge the infusion
`system in the PURGE-GENERATOR-TO-WASTE or PURGE-GENERATOR-
`TO-PATIENT-LINE mode. It is necessary to continuously depress this
`switch during a purge operation.
`
`4.2.7 REFILL Switch
`
`This momentary-contact, push-button switch is used to refill the saline pump.
`To start a refill operation, depress the REFILL switch once. The pump will
`begin refilling and will stop when either the pump limit is reached or the
`operator depresses the REFILL switch a second time.
`
`4.2.8 FLOW RATE Switch
`
`This rotary switch is used to select the saline-pump flow rate used during
`infusion and purge operations. The available flow rates are
`
`20 ml/min,
`35 ml/min,
`50 ml/min, (50 ml/min must be used for the CardioGen0-82,
`Sr-82/Rb-82 generator)
`
`65 ml/min, and
`80 ml/min.
`
`4.2.9 ELUTION VOLUME Display and Limit Switch
`
`This display and limit switch combination is used to display the total
`generator elution volume during an infusion operation and to set the elution
`volume limit for the infusion. Note that the ELUTION VOLUME display
`provides a running display of generator elution volume during an infusion and
`holds the total elution volume after the infusion operation is completed. Both
`the ELUTION VOLUME display and limit switch operate over the range of 0-
`99 ml.
`
`12
`
`BRACCOITC00011035
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`

`

`4.2.10 PATIENT VOLUME Display and Limit Switch
`
`This display and limit switch combination is used to display the patient elution
`volume during an infusion operation and to set the patient volume limit for
`the infusion. Note that the PATIENT VOLUME display provides a running
`display of patient elution volume during an infusion and holds the total
`patient elution volume after the infusion operation is completed. Both the
`PATIENT VOLUME display and limit switch operate over the range of 0-99
`ml.
`
`4.2.11 PATIENT DOSE Display and Limit Switch
`
`This display and limit switch is used to display the patient dose during an
`infusion operation and to set the patient dose limit for the infusion. Note that
`the PATIENT DOSE display provides a running display of patient dose
`during an infusion and holds the total patient dose after the infusion
`operation is completed. Both the PATIENT DOSE display and limit switch
`operate over the range of 0-99 mCi.
`
`4.2.12 DOSE RATE Display and Threshold Switch
`
`This display and threshold switch combination is used to display the infusion-
`system dose rate during an infusion operation and to set the dose-rate
`threshold for the infusion. Both the DOSE RATE display and threshold
`switch operate over the range of 0.0-9.9 mCi/sec, where mCi/sec represents
`the amount of activity produced by the infusion system in a one-second time
`interval. For Rb-82 the proper setting is 1.0 mCi/sec.
`
`4.2.13 PUMP LIMIT Indicator Light
`
`This light glows yellow whenever the saline pump is at either the refill limit
`(pump fully extended) or at the pump limit (pump fully contracted). No
`infusion or purge operation can be started with the pump at the pump limit
`position. Additionally, if the pump reaches the pump limit position during an
`infusion or purge operation, that operation will be terminated automatically.
`
`4.2.14 HIGH PRESSURE Indicator Light
`
`This light glows red whenever the generator inlet pressure exceeds the
`preset high-pressure threshold. Infusion and purge operations cannot be
`started if there is a high-pressure error. Additionally, if a high-pressure error
`occurs during an infusion or purge operation, that operation will be
`terminated automatically.
`
`13
`
`BRACCOITC00011036
`
`

`

`4.2.15 VALVE FAILURE Indicator Light
`
`This light glows red whenever the system has detected a valve error. The
`system detects valve positioning errors by measuring the time required for
`the valve to move from one position to the next position. Additionally, the
`system continuously tests the valve to ensure that it is in the correct position.
`Infusion and purge operations cannot be started if there is a valve error.
`Additionally, if a valve error occurs during an infusion or purge operation, that
`operation will be terminated automatically.
`
`4.2.16 AC MAIN Indicator Light
`
`This light glows green as long as the system's power cord is plugged into a
`live AC electrical outlet. This light indicates there is live AC power inside the
`system, even though the system is not "powered on."
`
`4.3 The CALIBRATION FACTOR Switch
`
`The CALIBRATION FACTOR switch contains a four-digit number which
`controls the calibration of Rb-82 delivery. This switch is adjusted only during
`calibration and is located away from the Display/Control panel to prevent
`accidental changing of its setting. The CALIBRATION FACTOR switch is
`located on the processing-electronics chassis front panel.
`
`The CALIBRATION FACTOR switch is set by depressing the small buttons
`associated with each digit using a pointed object such as a writing pen.
`
`14
`
`BRACCOITC00011037
`
`

`

`4.4 System Activation
`
`Depressing the POWER ON switch activates the infusion system and causes
`this switch to glow green indicating that the infusion system is powered.
`Note that the POWER ON switch is used in a power latching-relay system to
`prevent the infusion system from restarting following an AC power failure. If
`AC power to the infusion system is interrupted, or if the POWER
`OFF/ABORT switch is depressed, it is necessary to depress the POWER ON
`switch again to reactivate the infusion system.
`
`Depressing the POWER OFF/ABORT switch shuts the infusion system off.
`This switch allows the operator to easily shut the system off during normal
`shutdown or in the event a problem is experienced.
`
`4.5 Pump Refill Operation
`
`The saline pump must be filled with saline solution before the Rb-82 Infusion
`System can be purged of air, or before an infusion can be performed. In
`order to refill the saline pump, the REFILL switch is depressed once and the
`pump will begin refilling. The refill operation can be stopped by the operator
`by depressing the REFILL switch a second time or by letting the pump reach
`its refill limit. It is, of course, important to ensure that the saline supply valve
`is open to permit the pump to accept saline from the saline supply.
`
`4.6 Purge Modes
`
`The Rb-82 Infusion System must be purged of air before an infusion can be
`performed. There are two purge modes used for purging the system:
`PURGE-GENERATOR-TO-WASTE, and
`PU AGE-GENERATOR-TO-
`PATIENT-LINE. In the PURGE-GENERATOR-TO-WASTE mode, saline is
`pumped through the generator and is routed to the waste bottle by the
`automatic flow-control valve. In the PURGE-GENERATOR-TO-PATIENT-
`LINE mode, saline is also pumped through the generator, but is routed to the
`patient line instead of the waste bottle. The PURGE-GENERATOR-TO-
`PATIENT-LINE mode should not be used to purge the infusion system into a
`patient. Instead this mode is used to clear the patient line using a collection
`bottle to collect the purged eluate.
`
`The operator activates the PURGE-GENERATOR-TO-WASTE mode by
`selecting PURGE-GENERATOR-TO-WASTE on the MODE switch and by
`continuously depressing the PURGE switch. The mode display on the
`Display/Control panel will show the routing of the saline solution through the
`Rb-82 Infusion System during the purge operation.
`The PURGE-
`
`15
`
`BRACCOITC00011038
`
`

`

`GENERATOR-TO-WASTE operation is summarized in Figure 4.2(a) which
`includes an illustration of the Display/Control mode display.
`
`The operator activates the PURGE-GENERATOR-TO-PATIENT-LINE mode
`by selecting PURGE-GENERATOR-TO-PATIENT-LINE on the MODE switch
`and by continuously depressing the PURGE switch. The mode display on
`the Display/Control panel will show the routing of the saline solution through
`the Rb-82 Infusion System during the purge operation. The PURGE-
`GENERATOR-TO-PATIENT-LINE operation is summarized in Figure 4.2(b)
`which includes an illustration of the Display/Control mode display.
`
`4.7 Automatic Infusion Mode
`
`4.7.1 Description
`
`The AUTOMATIC INFUSION mode is the normal infusion system mode for
`delivering a fixed dose of Rb-82 eluate to the patient. The operator initiates
`an automatic infusion by selecting AUTOMATIC INFUSION on the MODE
`switch and then depressing the INJECT START/STOP push-button switch.
`The infusion system then begins pumping saline through the generator at the
`flow rate selected by the FLOW RATE switch and the running generator
`elution volume is displayed on the ELUTION VOLUME display. The
`radioactive saline eluate from the generator is first directed to the waste
`bottle.
`
`However, once the measured infusion dose rate (mCi/sec of infused activity
`as measured at the detector) exceeds the preset dose rate threshold
`(selected by the DOSE RATE THRESHOLD switch), the radioactive saline
`eluate from the generator is directed to the patient line. At this time, both the
`patient dose and the patient volume are measured and displayed on the
`P