BRACCO
`
`LIFE FROM INSIDE
`CardioGen-82°
`INFUSION SYSTEM USER'S GUIDE
`
`Manufactured By:
`
`RbM Services, LLC
`
`For
`ACIST Medical Systems, Inc.
`A Bracco Company
`7905 Fuller Road
`Eden Prairie, MN 55344
`
`REP
`\ EC
`Medical Product Service GmbH
`Borngasse 20
`35619 Braunfels
`Germany
`011 49 6442 962073 (PHONE)
`01 1 49 6442 962074 (FAX)
`RbM Part Number 9300003-00
`July 3, 2007 - ECN 07-0703
`Rev 11
`
`O
`
`A 17 EXHIBIT
`
`-
`
`Date
`
`Rptr
`
`BRACCOITCOOO11254
`
`JUBILANT EXHIBIT 1037
`Jubliant v. Bracco, IPR2018-01449
`
`

`

`CardioGen-82 Infusion System
`Limited Warranty
`
`the CardioGen-82 Infusion
`("ACIST") warrants
`ACIST Medical Systems,
`Inc.
`System (the "Infusion System") against any defects iri materials and workmanship
`for a period of one year from the date of installation. ACIST's warranty covers all
`labor and its associated expenses for failures of
`the Irifusion System
`parts,
`repair
`to perform to its specifications during the warranty period, subject
`to the following
`exceptions:
`(iii) alteration (without ACIST's express
`rrlisuse,
`(ii) abuse,
`or
`(i)
`written consent).
`
`is judged to be defective by
`the Infusion System that
`Any part or component of
`ACIST in material or workmanship during the warranty period will be repaired or
`replaced by ACIST at
`its sole option and its expense. Remedies available under
`this warranty are limited to repair or replacement of malfunctioning parts, system
`replacement, or refund of
`the purchase price with the specific remedy subject to
`election by ACIST in its sole judgment.
`
`Application for a warranty remedy must be made to ACIST within (30) days of the
`apparent malfunction.
`
`EXCEPT
`PROVIDED HEREIN, ACIST MAKES NO
`EXPRESSLY
`AS
`ADDITIONAL WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH
`RESPECT TO THE INFUSION SYSTEM,
`INCLUDING, BUT NOT LIMITED TO,
`ANY IMPLIED WARRANTIES OF MERCHANTABILITYAND FITNESS FOR A
`PARTICULAR USE OR PURPOSE.
`
`ACIST SHALL UNDER NO CIRCUMSTANCES BE LIABLE FOR SPECIAL,
`INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES OF ANY.
`NATURE, WHATSOEVER,
`INCLUDING BUT NOT LIMITED TO, COMMERCIAL
`LOSS FROM ANY CAUSE, BUSINESS INTERRUPTION OF ANY NATURE,
`LOSS OF PROFITS OR REVENUE, REAL OR PERCEIVED LOSS OF USE,
`ARISlNG FROM A DEFECT
`IN DESIGN, MATERIAL AND/OR
`LOSS
`MANUFACTURE
`ARISING OUT
`OR WORKMANSHIP,
`OR
`OF
`THE
`PURCHASER'S FAILURE TO COMPLY WITH ALL OR ANY OF THE
`PROVISIONS OF THE INFUSION SYSTEM MANUAL AND/OR THE FAILURE
`OF THE INFUSION SYSTEM TO PERFORM AS SPECIFIED, EVEN IF ACIST
`SHALL HAVE BEEN ADVISED TO THE POSSIBILITYOF SUCH DAMAGES.
`
`The Infusion System should only be serviced by personnel authorized by ACIST.
`Any service other than ACIST-authorizedpersormel will void this warranty.
`Fpr product complaints or questions regarding the operation and service of
`system, please contact your assiglied Bracco Representative.
`
`the
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`ISRACCOITCOOO11255
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`SAFETY SUMMARY
`
`The "!" mark inside of a
`as well
`triangle as labeled on the CardioGen-82 Infusion System,
`to reference the user
`a book" is meant
`as the label showing "a person looking at
`to this
`the individual will understand the complete operation of the
`User's Manual
`in order that
`system and understand all safety precautions.
`
`Radiation Safety
`
`The CardioGen-82 Generator supplied by Bracco Diagnostics, Inc for use with
`the CardioGen-82 Infusion System emits radiation. AII 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
`Inc. User Manual for
`service personnel. Refer to ACIST Medical Systems,
`servicing.
`
`Power Source
`
`for 100/120/220/240V~ operation via the power entry
`This system can be set
`module. For 230V~ operation use the 240V~ setting. To change this setting,
`the system is unplugged from its power source, and use a small
`flat
`ensure that
`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
`is 2.5A. The protective ground connection via the grounding conductor in
`power
`the power cord is essential for safe operation.
`
`Grounding the System
`
`This system is equipped with a three-conductorac 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
`is in good condition.
`ground. Use only a power cord that
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`BRACCOlTCOOO11256
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`The "Hospital Grade" detachable 10 foot power cord, supplied with this system,
`is recommended. The use of a cable other than the cable
`P/N 4040010-00,
`specified may result
`in increased emissions and decreased immunity of
`the
`CardioGen-82 Infusion System.
`
`Do not operate this system in an explosive atmosphere, such as,
`fumes.
`gases or
`
`flammable
`
`refers to the fact that all applied parts of
`The type B symbol
`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
`
`injury, do not remove or operate this system without all
`To avoid personal
`appropriate covers and panels in place. Refer all service to authorized
`personnel.
`
`Fusinq
`
`To avoid fire hazard, use a fuse of
`rating as specified.
`
`the correct
`
`type, voltage rating and current
`
`The following fuses and values are used in the system:
`
`Power entry module: Use only the fuse type and rating as indicated on the
`located near the power entry module. Internal fuses should
`system label
`only be replaced by qualified personnet
`
`1 ¼ T2, 5AL250V~ (2.5A,
`F1, Power chassis assembly (rear panel), ¼ x
`250V~ time delay
`1 ¼ T1, 5AL250V~ (1.5A, 250V~ time
`F2, Power chassis assembly, ¼ x
`delay
`
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`BRACCOITCOOO11257
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`EMC Compliance
`
`The CardioGen-82 Infusion System is compliant with EN/IEC 60601-1-2 Medical
`electrical equipment- Part 1-2: General requirements for safety - Collateral
`standard: Electromagnetic compatibility- Requirements arid tests. Medical
`Electrical Equipment needs special precautions regarding EMC and needs to be
`installed and put into service according to the EMC information provided in this
`manual. CardioGen-82 Infusion System should be observed for normal operation
`when used with other electronic equipment. The Use of cables other than those
`specified may result
`in increased emissioris artd decreased immunity of this
`system. Portable and niobile communications equipment can and may affect
`Medical Electrical Equipnient.
`
`Guidance and manufacturer'sdeclaration -electromagnetic emissions
`The CardioGen-82Infusion System is intended for use in the electromagnetic environmentspecified
`the CardioGen-82Infusion System should assure
`below. The customer
`that
`it
`is used in
`the user of
`of
`such an environment.
`Emissions test
`
`Compliance
`
`RF emissions
`CISPR 11
`
`RF emissions
`CISPR 11
`Harmonic emissions
`IEC 61000-3-2
`
`Voltage fluctuations /
`flicker emissions
`IEC 61000-3-3
`
`Group 1
`
`Class A
`
`Class A
`
`Complies
`
`Electromagnetic environment - guidance
`The CardioGen-82 Infusion System uses RF energy
`only for its internal function. Therefore, its RF
`are very low and are not likely to cause any
`emissions
`interference in nearby electronic equipment.
`
`The CardioGen-82 Infusion System is suitable for use
`in all establishments other than doniestic and those
`directly connected to the public low-voltage power
`supply network that supplies
`used for domestic
`purposes.
`
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`BRACCOITCOOO11258
`
`

`

`Guidance and manufacturer's declaration ---electromagneticimmunity
`
`intended for use in the electromagnetic environment
`The CardioGen-82 Infusion System is
`specified below. The customer or
`the CardioGen-82 Infusion System should
`the user of
`assure that
`is used in such an environment.
`
`it
`
`immunity test
`
`IEC 60601 test
`
`level
`
`Compliance level
`
`Electrostatic
`discharge (ESD)
`
`IEC 61000-4-2
`
`±6
`
`±8
`
`kV contact
`
`kV air
`
`±6
`
`kV contact
`
`±8 kV air
`
`Electromagnetic environment
`- guidance
`
`Floors should be wood, concrete
`or ceramic tile.
`floors are
`If
`covered with synthetic material,
`the relative humidity should be
`least 30 %.
`at
`
`na
`
`t
`
`n
`
`i
`
`IEC 61000-44
`
`Surge
`
`IEC 61000-4-5
`
`Voltage dips,
`short
`interruptions and
`voltage variations
`on power supply
`input
`lines lEC
`61000-4-11
`
`±2 kV for power supply
`
`lines
`
`±2 kV for power supply
`
`lines
`
`±1
`
`kV for
`
`input/output
`
`lines
`
`±1
`
`kV forinput/output
`
`lines
`
`Mains power quality should be
`commercial
`that
`a typical
`or
`of
`hospital environment.
`
`±1
`
`kV differential mode
`
`±1
`
`kV differential mode
`
`±2 kV common mode
`
`±2 kV common mode
`
`<5 % Ur
`(>95% dip in Ur)
`for 0,5 cycle
`
`40 % Ur
`(60 % dip in Ur)
`for
`5 cycles
`
`70 % Ur
`(30 % dip in Ur)
`for 25 cycles
`
`<5% Ur
`(>95 % dip in Ur)
`for
`5 sec
`
`<5% Ur
`(>95% dip in Ur)
`for 0,5 cycle
`
`40 % Ur
`(60 % dip in UT)
`for
`5 cycles
`
`70 % Ur
`(30 % dip in Ur)
`for 25 cycles
`
`<5% Ur
`(>95 % dip in Ur)
`for
`5 sec
`
`Mains power quality should be
`of atypical commercial or
`that
`hospital environment.
`
`Mains power quality should be
`of atypical commercial or
`that
`hospital environment.
`the user
`If
`the [EQUIPMENT or SYSTEM)
`of
`requires continued operation
`during power mains
`interruptions,
`recommended
`it
`is
`the [EQUIPMENTor
`that
`SYSTEM)
`be powered from an
`uninterruptible power supply
`battery.
`
`or
`
`a
`
`Power frequency
`a/g6n0et
`c4field
`IEC
`61000-4-8
`
`3 A / m
`
`3 A / m
`
`NOTE Ur
`
`is
`
`the a.c.
`
`rr ains voltage prior
`
`to application of
`
`the test
`
`level.
`
`Power frequency magnetic fields
`should be at
`levels characteristic
`location in
`typical
`typical
`of
`commercial
`or hospital
`environment.
`
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`
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`BRA CCOITCOOO11259
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`O
`
`O
`
`O
`
`it
`
`Immunity test
`
`IEC 60601 test
`
`level
`
`Electrornagnetic environment - guidance
`
`Guidance and manufacturer's declaration -electromagnetic immunity
`The CardioGen-82 Infusion System la intended for use in the electromagnetic environment
`specified below. The customer or
`the CardioGen-82 Infusion System should
`the user of
`it used in such an environment.
`assure that
`Compliance level
`
`Portable and mobile RF communications equipment should
`be used no closer to.any
`part
`the [EQUIPMENTor SYSTEM],
`of
`includirig cables,
`than the recömmended separation
`distance calculated from the equation applicable to the
`frequency of
`the transmitter.
`
`Recommended separation
`
`distance
`
`Conducted RF
`IEC 61000-4-6
`
`3 Vrms
`150 kHz to 80 MHz
`
`8 Vrms
`150 kHz to 80 MHz
`
`Radiated RF
`IEC 61000-4-3
`
`3 V/m
`80 MHz to 2,5 GHz
`
`3 Vlm
`80 MHz to 2,5 GHz
`
`d =
`
`d =
`
`Ñ
`Ñ 80 MHz to 800 MHz
`d = Ñ 800 MHz to 2,5 GHz
`
`3
`
`3
`
`3
`
`the maximum output power rating of
`where P is
`the
`transmitter
`(W) according to the transmitter
`in watts
`manufacturer and d
`the recommended separation
`is
`distarice in meters (m).
`
`Field strengths from fixed RF transmitters,
`as deter-mined
`ashould be less than the
`by an electromagnetic site survey
`compliance level
`in each frequency range.
`
`Interference may occúr in
`with the following symbol:
`
`the vicinity
`
`of equipment marked
`
`NOTE 1 At80 MHz od 800 MHz,
`NOTE 2 These guidelines may not apply
`from structures, objects and people.
`
`the higher
`
`requency range applie1.
`all situations. Electromagnetic propagation is affected
`
`in
`
`by absorption and reflection
`
`a
`
`b
`
`telephones and land mobile radios,
`such as base stations for radio (cellular/cordless)
`Field strengths from fixed transmitters,
`radio, AM and FM radio broadcast arid TV broadcast cannot be predicted theoretically with accuracy. To assess the
`amateur
`electromagnetic environment due to
`an electromagnetic site survey should be considered.
`fixed RF trarismitters,
`the
`If
`measured field strength in
`the location in which the CardioGen-82 Infusion System is used exceeds the applicable RF
`If abnormal
`System should be observed to verify normal operation.
`the CardioGen-82 infusion
`compliance level above,
`re-orienting or relocating the CardioGen-82
`performance is observed, additional measures may be necessary, such as
`Infusion System.
`
`Over
`
`the frequency range 150 kHz to 80 MHz,
`
`field strengths should be less than 3V/m.
`
`vii
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`BRACCOITCOOO11260
`
`

`

`Recommended separation distances
`between portable and mobile RF communications equipment and the CardioGen-82 Infusion
`System
`
`in which radiated RF disturbances are
`intended for use in an electromagnetic erwironment
`The CardioGen-82 infusion System is
`interference by
`the CardioGen-82 Infusion System can help prevent electromagnetic
`controlled. The customer or
`the user of
`maintaining a minimum distance between portable and mobile RF communications equipment
`(transmitters) and the CardioGen-82
`the communications equipment.
`the maximum output power of
`Infusion System as recðmmended below, according to
`
`Rated maximum output power of
`transmitter
`
`w
`
`0,01
`
`0,1
`
`1
`
`10
`
`Separation distance according
`m
`
`to frequency
`
`of transmitter
`
`150 kHz to 80 MHz
`d=
`
`Ñ
`
`3
`
`0.12
`
`0.37
`
`2.17
`
`3.69
`
`80 MHz to 800 MHz
`d=
`
`Ñ
`
`3
`
`0.12
`
`0.37
`
`2.17
`
`3.69
`
`800 MHz to 2,5 GHz
`
`d= Ñ
`
`3
`
`0.23
`
`0.74
`
`2.33
`
`7.37
`
`23.33
`11.66
`100
`the recommended separation distance d in meters (m) can be
`a maximum ou:put power not
`For transmitters rated at
`listed above,
`the maximum output power rating of
`the transmitter, where P is
`estimated using the equation applicable to the frequency of
`the
`(W) according to the transmitter manufacturer.
`transmitter
`in watts
`the separation distance for the higher frequency range applies.
`NOTE 1 At 80 MHz and 800 MHz,
`NOTE 2 These guideÏines may not apply
`all situations. Electromagnetic propagation is affected
`structures, objects and people.
`
`11.66
`
`in
`
`by absorption and reflection from
`
`Safety Compliance
`
`The ÖardioGen-82 Infusion System is compliant with ENllEC 60601-1-2 Medical
`electrical equipment- Part 1-2:General requirements for safety --- Collateral
`standard: Electromagnetic compatibility- Requirements and tests.
`
`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 ACIST Medical Systems,
`Inc. User Manual for all service and
`repairs to ensure that all safety features are maintained.
`
`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 Diagnostic, Inc.
`
`V111
`
`BRACCOITCOOO11261
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`

`Section
`
`.0
`
`1
`
`2.0
`
`3.0
`
`4.0
`
`O
`
`TABLE OF CONTENTS
`
`I NTRODUCT I ON ..........................................................................
`
`Page
`
`1
`
`GENER A LDESCR I PT I Q N............................................................1
`CardioGen-82 Infusion System Overview.............................
`2.1
`Automatic Infusion Mode Overview ...................................,
`2.2
`
`1
`
`4
`
`GENERAL INFONMATIOld ...........................................................
`General Precautions.............................................................
`3.1
`System Specifications ..........................................................
`3.2
`
`5
`5
`6
`
`9
`9
`
`SYSTEM OPERATION .................................................................
`Introduction ..........................................................................
`4.1
`The Display/Control Panel....................................................10
`4.2
`POWER ON Switch ...............................................
`4.2.1
`10
`4.2.2
`POWER OFF/ABORT Switch ................................
`10
`4.2.3
`MO DE Switch .........................................................
`10
`4.2.4
`MODE Display .......................................................
`10
`4.2.5
`INJECT Start/Stop Switch ......................................
`12
`PURGE Switch.......................................................12
`4.2.6
`4.2.7
`REFILL Switch .......................................................
`12
`4.2.8
`FLOW RATE Switch ..............................................
`12
`ELUTION VOLUME Display and Limit Switch ........
`4.2.9
`12
`PATIENT VOLUME Display and Limit Switch,.......
`4.2.10
`13
`PATIENT DQSE Display and Limit Switch .............
`4.2.11
`13
`DOSE RATE Display and Threshold Switch...........
`4.2.12
`13
`PUMP LIMIT Indicator Light...................................
`4.2.13
`13
`HIGH PRESSURE Indicator Light..........................
`4.2.14
`13
`VALVE FAILURE indicator Light............................
`4.2.15
`14
`AC MAIN Indicator Light
`4.2.16
`14
`The CALIBRATION FACTOR Switch ...................................
`14
`System Activation.................................................................
`15
`Pump Refill Operation ..........................................................
`15
`Purge Modes........................................................................
`15
`Autoniatic Infusion Mode......................................................16
`Description............................................................. 16
`4.7.1
`Report Printout....................................................... 17
`4.7.2
`
`4.3
`4.4
`4.5
`4.6
`4.7
`
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`BRACCOlTCOOO11262
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`Section
`
`5.0
`
`6.0
`
`TABLE OF CONTENTS
`(Continued)
`
`Page
`
`OPERATING PROCEDURES....................................................... 25
`General Notes........................................................25
`5.1
`CardioGen-82 Gerierator and Sterile Components
`25
`5.2
`CardioGen-82 Infusion System Preparation...........
`25
`5.3
`the Syringe Pump Components .......
`Installation of
`5.4
`25
`Generator inlet Assembly Package........................
`26
`5.5
`Generator Outlet Assembly
`5.6
`(Package #3)..................................................
`27
`.......
`Patient Line Installation ..........................................
`28
`Saline Supply installation .......................................
`28
`CardioGen-82 Generator Installation .....................
`29
`Purge Operation..................................................... 29
`Patient Admin istration ............................................
`31
`
`5.7
`5.8
`5.9
`5.10
`5.11
`
`CardioGen-82 Generator Sr-82/85
`Breakthrough Worksheet....................................... 34
`CardioGen-82 Infusion System Calibration
`Data Sheet.............................................................36
`TROUBLESHOOTING GUIDE......................................................39
`
`CONTACT INFORMATION........................................................... 40
`
`SYST EMDIARY ...........................................................................
`
`41
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`

`LIST OF FIGURES
`
`Fiqure
`
`2.1
`
`2.2
`
`4.1
`
`4.2
`
`4.3
`
`4.4
`
`5.1
`
`5.2
`
`5.3
`
`Page
`CardioGen-82 Infusion System Illustration .............................................2
`
`CardioGen-82 Infusion System Fluid-System Diagram...........................3
`
`Illustration Of The Display/Control Panel..........................
`
`......................11
`
`Summary Of The Purge Operations............................,...........................18
`Summary Of The Automatic Infusion Operation..................................20
`
`Sample Infusion Report Printout .....................................
`
`.......................23
`
`Tubing Diagram ...................................................
`
`..................................33
`
`CardioGen-82 Infusion System Calibration Log Sheet............................37
`
`CardioGen-82 Generator Sr-82 Breakthrough.........................................38
`Log Sheet
`
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`BRACCOITCOOO11264
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`

`1.
`
`INTRODUCTION
`
`The CardioGen-82 Infusion System is a complete system for the generation
`from a CardioGen-82 Generator to a
`and delivery of Rubidium-82 (Rb-82)
`patient for cardiovascular nuclear medicine procedures. Rb-82 is
`a short-
`a potassium biochemical
`emitter and is
`half-life (75 seconds) positron
`for myocardial perfusion
`analogue. For these reasons, Rb-82 is very useful
`The Rb-82 obtained from the CardioGen-82 Infusion System is
`studies.
`eluted in sterile normal saline for direct injection into a patient.
`
`Rb-82, with its 75-second half-life, offers some distinct advantages over
`The patient dose received for a given
`radionuclides with longer half
`lives.
`than the patient dose received from other,
`longer
`activity of Rb-82 is
`lower
`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 CardioGen-82 Infusion System Overview
`
`The CardioGen-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 CardioGen-82 Infusion System delivers Rb-82 by pumping saline (which
`acts as an eluant) through a CardioGen-82 Generator to produce the Rb-82
`eluate. A diagram of the fluid system for the CardioGen-82 Infusion System
`the CardioGen-82 Generator eluate is
`is shown in Figure 2.2.
`Note that
`assayed by a positron (beta) probe which consists of a plastic scintillator and
`This detector and its associated electronics are
`a photomultiplier
`tube.
`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.
`
`the CardioGen-82 Generator, and the
`In addition to
`pump,
`the syringe
`the fluid system contains a divergence valve for directing
`positron detector,
`fluid flow in the CardioGen-82 Infusion System.
`This divergence valve (see
`the low-level Rb-82 activity that
`initially leaves
`Figure 2.2)
`is used to direct
`the Sr-82/Rb-82 generator
`a shielded waste bottle.
`Once the Rb-82
`to
`activity leaving the CardioGen-82 Generator
`levels sufficient
`reaches
`for
`patient injection, this valve directs the Rb-82 eluate to the patient.
`
`1
`
`BRACCOITCOOO11265
`
`

`

`O
`
`DETECTOR AND
`VALVE SHIELD
`
`[914.3
`36.0
`
`762.42
`30.0
`
`CONTROL
`PANEL
`
`YURNGE
`
`PRINTER
`
`30.00
`
`898.44
`35.37
`
`577.85]
`22.75
`
`Figure 2.1 CardioGen-82 Infusion System Illustration
`
`2
`
`BRACCOlTCOOO11266
`
`

`

`O
`
`O
`
`O
`
`O OOO
`
`LINE
`PATIENT
`
`I
`
`DIVERGENCE
`
`VALVE
`
`DETECTOR
`
`POSITRON
`
`(BETA)
`
`GENERATOR
`
`Rb-82
`
`STERILIZING
`
`FILTER
`
`VALVE
`CHECK
`
`i
`
`SUPPLY
`SALINE
`
`5.
`
`o
`
`Q
`
`.
`
`o
`
`STERILlZATION
`
`FILTER
`
`BOTTLE
`WASTE
`
`PUMP
`SYRINGE
`
`U
`
`GENERATOR
`//pyyyyy/
`
`SHIELD
`
`TRANSDUCER
`PRESSURE
`
`

`

`O
`
`O
`
`The CardioGen-82 Infusion Systern provides an AUTOMATIC INFUSION
`mode for automatic delivery of Rb-82 to a patient. Additionally,
`the system
`provides
`PURGE-GENERATOR-TO-WASTE
`two
`purge modes,
`and
`PURGE-GENERATOR-TO-PATIENT-LINE, for
`system
`and
`setup
`maintenance. The two purge modes are used to purge air out of
`the sÿstem
`tubing following the installation of
`a CardioGen-82 Generator and the
`assóðiated sterile tubing-cornponentset. Detailed descriptions for all
`three
`operating modes
`included in Section
`and an overview of
`the
`are
`4,
`AUTOMATIC INFUSION mode is contained in the following section.
`
`2.2 AutomaticInfusion 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
`in mCi and a flow rate of 50 ml/min in accordance
`correct word is activity)
`with the CardioGen-82 package insert. AdditionalÍy,
`the operator selects a
`patient volume (ml) and 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 patierit, and elution volume is
`the total volume pumped
`through the generator during an infusion. Finally, the operator sets the dose-
`rate threshold,
`1.0 mCilsec, which controls when the system will direct
`to
`eluate (which initially is routed to the waste bottle) to the patient.
`
`is pumped through - the
`an automatic infusion is
`saline
`Once
`started,
`generator and the resulting eluate is
`routed to the waste bottle until
`its dose
`exceeds the pre-selected dose-rate threshold.
`typically
`rate (mCilsec)
`It
`before eluate leaving the generator becomes
`takes
`seconds
`10
`18
`to
`sufficiently concentrated to
`reach the required dose-rate threshold of 1.0
`Once the dose-rate threshold is exceeded,
`the Rb-82 eluate is
`mCilsec.
`directed to the patient line and both the patient dose and patient volume are
`measured and dispÏayed. The Ïnfusion continues and stops on whichever
`reached first: patient dose, patÌent volume, or elution volume.
`limit
`As
`is
`mentioned, the normal stopping limit
`is the patient dose.
`
`Once the infusion is complete,
`the pump stops and the generator eiuate is
`directed back to the waste bottle to vent any residual generator pressure.
`At
`the Rb-82 infusion is printed on the system
`a complete report of
`this time,
`printer and this same data is echoed out a RS-232C serial data port. The
`computer for analysis or
`RS-2320 port can be connected to the customer's
`storage of Rb-82 infusion data.
`
`4
`
`BRACCOITCOOO11268
`
`

`

`3.
`
`GENERAL INFORMATION
`
`3.1 General Precautions
`
`(cid:127)
`
`(cid:127)
`
`(cid:127)
`
`(cid:127)
`
`(cid:127)
`
`(cid:127)
`
`Use the CardioGen-82 Infusion System only with a CardioGen-82
`Generator and the sterile tubing set provided with the generator.
`locations where the generator and infusion system remain in
`For
`one location (i.e., hospital, physician office, or
`imaging center):
`The tubing set connected to the generator and the infusion system
`installed. A new
`to remain in place until a new generator is
`is
`tubing set will be providedwith each new generator.
`locations where the generator and
`infusion system are
`For
`transported from one location to a different
`location or Daily Use
`Customers (i.e., generator and
`infusion system are used and
`facility for one or more consecutive days and the
`stored at
`a
`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.
`to transporting the
`Prior
`generator and infusion system to a different location, all
`tubing
`must be removed and discarded in accord with approvedradiation
`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 availablefrom Bracco Diagnostic, Inc., or the
`provider of
`the Daily Use program.
`
`Since the eluate obtained from the CardioGen-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.
`taken to ensure that
`In addition, care should
`the
`be
`CardioGen-82 Infusion System is purged of air prior
`to each patient
`infusion.
`
`of any radioactive material, care should be
`the use
`taken to
`As
`in
`minimize radiation exposure to the patient consistent with proper patient
`management.
`Additionally, care should
`taken to minimize
`the
`be
`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.
`
`the exposure of personnel,
`the CardioGen-82 Generator must
`To limit
`be installed in the lead shield provided in
`the CardioGen-82 Infusion
`System as a radiation safety precaution.
`
`5
`
`BRACCOITCOOO11269
`
`

`

`(cid:127)
`
`(cid:127)
`
`(cid:127)
`
`the short half-life of Rb-82,
`Oue to
`10 minutes
`time period of
`is
`a
`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 niay contain residual radioactivity must be stored
`in accordance with the fability's radioactive rnaterials
`and disposed of
`license.
`
`the system and disconnect
`the power cord prior
`Turn the power off
`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
`
`ÖPERATING MODES:
`
`AUTOMATIC INFLISION
`PURGE-GENERATOR-TO-WASTE
`PURGE-GENERATOR-TO-PATIENT-Lil\lE
`
`AUTOMATIC INFUSION MÖDE:
`
`O
`
`Preset Elution Volume:
`
`0-99 ml
`
`in 1 ml
`
`increments
`
`Preset Patient Volume:
`
`0-99 mi
`
`in 1 ml
`
`increments
`
`Preset Patient Dose:
`
`0-99 mÖi
`
`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 mÖilsec in 0.1 mCilsec
`irtcrements. The proper preset
`dose rate threshold for Rb-82 is
`1.0 mCilsec.
`
`20, 35, 50, 65, and 80 ml/min
`(Flow rate for Rb-82 = 50 ml/min)
`
`(Generator Sr-82 Activity 30-120
`mOi, Flow Rate 50 mIlmin)
`
`Accuracy
`+/- 10%
`+/- 10%
`+/- 15%
`+/- 20%
`
`Þatient Volume Delivery Accuracy: +|- 2 ml
`
`6
`
`BRACCOITCOOO11270
`
`

`

`Automatic Infusion Report:
`
`The system printer prepares a detailed
`following every autornatic infusion.
`report
`This
`report
`system settings,
`lists
`all
`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
`automatic
`listed
`are
`an
`if
`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 MONITORINGFUNCTIONS:
`
`System pressure:
`
`Valve operation:
`
`Pump limit:
`
`Valve shield:
`
`Monitoring function
`
`5 psig) pressure limit sensor
`90 psig (+/-
`provided
`with
`along
`second,
`is
`a
`redundant pressure limit of 100 psig (+/-
`10 psig) provided by the syringe pump.
`
`Valve position is continuouslymonitored.
`the valve must
`transition
`Additionally,
`between waste and patient positions in
`than 2 seconds
`or an error will be
`less
`detected.
`
`Syringe pump limits, both refill
`and pump limits (nom.
`ml)
`monitored.
`
`(nom. 128
`are
`15 ml)
`
`The valve shield is monitored to detect if
`the valve shield
`is open. Additionally,
`it
`infusion
`remains locked for any purge or
`operation and does not unlock until
`the
`detector measures a count
`rate less
`than
`50 cps.
`
`infusion operations will not
`Automatic
`if operation shield-open error
`start
`is
`detected. Automatic infusion operations
`are terininated (if
`in progress)
`for all of
`the preceding conditions.
`Purge-generator-to-waste
`purge-
`and
`generator-to-patient-line
`operations will
`terminated if
`riot start and will
`be
`in
`a high-pressure error, valve
`progress
`if
`error, puttip limit, or shield-open error
`is
`detected.
`
`7
`
`BRACCOITCOOO11271
`
`

`

`O
`
`SYRINGE PUMP CAPACITY:
`
`Mechanically
`capacity.
`
`limited
`
`to
`
`~130ml
`
`full
`
`RS-232C PORT CHARACTERISTICS:
`
`Description:
`
`infusion report printout
`The RS-232C port echoes out
`Although this
`data for access
`remote computer.
`by a
`the CardioGen-82 Infusion
`port has
`receive
`line,
`a
`System does not recognize incoming data.
`
`RS-232C Port Interface Details:
`
`be attached to
`interface cable to
`The recommended RS-232
`the
`CardioGen-82 Irifusion System should be a shielded type cable less
`If an RS-232 cable is attached to the
`than or equal
`long.
`to 10 feet
`CardioGen-82 Infusion System that exueeds the 10 foot
`length,
`the
`system should be observed to verify normal operation as well as other
`the CardioGen-82 Infusion
`electronic equipment
`the vÏcinity of
`in
`If abnormal operation is observed, it may be necessary to re-
`System.
`orient the RS-232 cable to the CardioGen-82 Infusion System.
`
`Signal
`
`DB2 P Connector Pin
`
`TX (transmit data)
`RX (receive data)
`GND (signal ground)
`
`(pin 2)
`(pin 3) This signal
`(pin 7)
`
`is not used.
`
`Data Format
`
`Baud Rate
`
`2400 bit/sec
`
`1 Start bit
`1 Stop bit
`8 Data bits
`No Parity
`
`SYSTEM POWER REÓUIRElvlENTS:
`System powet
`2.6A max.
`for
`system can
`This
`set
`be
`is
`100/120/220/240V~ operation via the power
`To
`entry module.
`the system is unplugged from its
`change this setting, ensure that
`flat screwdriver to remove the fuse
`power source, and use a srnall
`the power entry module. Remove
`the small voltage
`drawer
`of
`the desired voltage is shown.
`selector card and rotate the card until
`Then replace the card and fuse drawer. Use only the fuse type and
`rating as indicated on the system label
`located near the power eritry
`inodule.
`System Weight:
`
`650 lbs.
`
`System Size:
`
`See Fig. 2.1 on page 2
`
`8
`
`BRACCQITCOOO11272
`
`

`

`Shipping Weight:
`
`875 lbs.
`
`Shipping Size:
`
`48"H x 31"W x 41"L
`
`ENVIRONMENTAL CONDITIONS FOR OPERATION, TRANSPORTING
`AND STORAGE OF SYSTEM:
`The system should be operated in a normal office erivironrrient, but
`operated,
`transported
`between
`safely
`can
`and
`stored,
`be
`temperatures of 40°F (4.4°C)
`- 110