Date of Issue: February - 2015 PATENT NUMBERS US 8,058,632, Rev. 23 US 7,504,646, US 7,394,074, US 8,216,181, US 8,216,184 PATENT PENDING Rx Only (USA) CardioGen-82 ® (Rubidium Rb 82 Generator) INFUSION SYSTEM USER GUIDE Manufactured by: RbM Services, Inc. For: Bracco Diagnostics Inc. 259 Prospect Plains Road Monroe Township, NJ 08831 USA 1-800-447-6883 EU Manufacturer: Bracco Diagnostics Inc. 259 Prospect Plains Road Monroe Township, NJ 08831 USA 1-800-447-6883 1-609-514-2200 Authorized Representative Bracco UK Ltd Wooburn Green Bucks, HP10 0HH United Kingdom +44 (0) 1628 851500 9300003-00
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Date of Issue: February - 2015 PATENT NUMBERS US 8,058,632,
Rev. 23 US 7,504,646, US 7,394,074,
US 8,216,181, US 8,216,184
PATENT PENDING
Rx Only (USA)
CardioGen-82®
(Rubidium Rb 82 Generator)
INFUSION SYSTEM USER GUIDE
Manufactured by:
RbM Services, Inc.
For:
Bracco Diagnostics Inc.
259 Prospect Plains Road
Monroe Township, NJ 08831 USA
1-800-447-6883
EU Manufacturer:
Bracco Diagnostics Inc.
259 Prospect Plains Road
Monroe Township, NJ 08831 USA
1-800-447-6883
1-609-514-2200
Authorized Representative
Bracco UK Ltd
Wooburn Green
Bucks, HP10 0HH
United Kingdom
+44 (0) 1628 851500
9300003-00
Date of Issue: February - 2015 Page 2 of 88
CardioGen-82 (Rubidium Rb 82 Generator) Infusion System
Limited Warranty
Bracco Diagnostics Inc. (“BRACCO DIAGNOSTICS”) warrants the CardioGen-82
Infusion System (the “Infusion System”) against any defects in materials and
workmanship for a period of one year from the date of installation. BRACCO
DIAGNOSTICS’ 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,
subject to the following exceptions: (i) misuse, (ii) abuse, or (iii) alteration (without
BRACCO DIAGNOSTICS’ express written consent).
Any part or component of the CardioGen-82 Infusion System that is judged to be
defective by BRACCO DIAGNOSTICS in material or workmanship during the warranty
period will be repaired or replaced by BRACCO DIAGNOSTICS 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 BRACCO DIAGNOSTICS in its sole judgment.
Application for a warranty remedy must be made to BRACCO DIAGNOSTICS within
(30) days of the apparent malfunction.
EXCEPT AS EXPRESSLY PROVIDED HEREIN, BRACCO DIAGNOSTICS MAKES
NO ADDITIONAL WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH
RESPECT TO THE INFUSION SYSTEM, INCLUDING, BUT NOT LIMITED TO,
ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR USE OR PURPOSE.
BRACCO DIAGNOSTICS 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, LOSS ARISING FROM A DEFECT IN DESIGN, MATERIAL AND/OR
MANUFACTURE OR WORKMANSHIP, OR ARISING OUT 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 BRACCO
DIAGNOSTICS SHALL HAVE BEEN ADVISED TO THE POSSIBILITY OF SUCH
DAMAGES.
The CardioGen-82 Infusion System should only be serviced by personnel authorized by
BRACCO DIAGNOSTICS. Any service performed by other than BRACCO
DIAGNOSTICS-authorized personnel will void this warranty.
For product complaints or questions regarding the operation and service of the system,
please contact your assigned Bracco Representative.
Date of Issue: February - 2015 Page 3 of 88
TABLE OF CONTENTS
I. SAFETY SUMMARY & GENERAL PRECAUTIONS 6
II. DAILY QUALITY CONTROL 14
III. ELECTROMAGNETIC/ELECTROSTATIC INTERFERENCE 16
IV. LABELS AND SYMBOLS 20
1. INTRODUCTION 23
2. GENERAL DESCRIPTION 23 2.1 CARDIOGEN-82 INFUSION SYSTEM – SYSTEM OVERVIEW 23 2.2 CARDIOGEN-82 INFUSION SYSTEM - DISPOSABLES OVERVIEW 23 2.3 AUTOMATIC INFUSION MODE - OVERVIEW 27
CARDIOGEN-82 INFUSION SYSTEM-CALIBRATION DATA SHEET 61
6. TROUBLESHOOTING GUIDE 65
7. CONTACT INFORMATION 88
8. CARDIOGEN-82® INFUSION SYSTEM SUPPLIES 88
Date of Issue: February - 2015 Page 5 of 88
LIST OF FIGURES
Figure 2. 1 CardioGen-82 Infusion System Diagram 25 Figure 2. 2 CardioGen-82 Infusion System Photograph 25 Figure 2. 3 CardioGen-82 Infusion System Fluid-System Diagram 26
Figure 4.1 Image of the Display/Control Panel 34
Figure 4.2 a Purge Generator to Waste 39
Figure 4.2 b Purge Generator to Patient Administration Set 39
Figure 4.3 a Activity Build Up Cycle 40
Figure 4.3 b Patient Infusion Cycle 41
Figure 4.3 c Infusion Ending Cycle 42
Figure 4.4 Sample of Infusion Report Printout 44
Figure 5.1 Tubing Diagram 56
Figure 5.2 SR-82 / SR-85 Testing Worksheet 62
Figure 5.3 Rb-82 Infusion System Calibration Log Sheet 63
Date of Issue: February - 2015 Page 6 of 88
I. SAFETY SUMMARY & GENERAL PRECAUTIONS
BEFORE OPERATING THE CARDIOGEN-82 INFUSION SYSTEM:
READ THE ENTIRE SAFETY SUMMARY & GENERAL PRECAUTIONS
SECTION
CONSULT THE CARDIOGEN-82 (RUBIDIUM-82 GENERATOR),
PACKAGE INSERT, FOR PROPER DOSAGE AND ADMINISTRATION
The CardioGen-82 Infusion System MUST only be eluted with 0.9% additive-free
sodium chloride for injection, USP (saline).
Do not use any other type of solution with the system.
BEFORE DAILY USE, OPERATORS MUST ENSURE:
ALL SYSTEM CONNECTIONS ARE IN PLACE, SECURE, AND FUNCTIONAL.
PROPER GROUNDING AND ISOLATION STANDARDS ARE MAINTAINED.
OPERATIONAL AND CALIBRATION CHECKS ARE PERFORMED DAILY
PRIOR TO USE OF THE SYSTEM/PATIENT STUDIES.
READ BELOW FOR INFORMATION CONSISTENT WITH CARDIOGEN-82
PACKAGE INSERT
PLEASE SEE CARDIOGEN-82 (RUBIDIUM RB 82 GENERATOR) FULL
PRESCRIBING INFORMATION FOR ADDITIONAL DETAILS
IMPORTANT SAFETY INFORMATION
WARNING: UNINTENDED STRONTIUM-82 (Sr-82) AND STRONTIUM-85 (Sr-85)
RADIATION EXPOSURE
Unintended radiation exposure occurs when the levels of Sr-82 or Sr-85 in the rubidium Rb 82
chloride injection exceed specified limits
Perform generator eluate tests:
1) Record each generator eluate volume, including waste and test volumes, and
keep a record of the cumulative eluate volume.
2) Determine Rb-82, Sr-82, Sr-85 in the generator eluate:
Once a day, prior to any drug administrations, and
At additional daily tests after detection of an Alert Limit. Alert Limits are:
o 14 L for the generator’s cumulative eluate volume, or
o An eluate Sr-82 level of 0.002 μCi/ mCi Rb-82, or
o An eluate Sr-85 level of 0.02 Sr-85 μCi/ mCi Rb-82.
o Perform the additional daily tests at time points determined by the day’s elution
volume; tests are performed every 750 mL.
3) Stop use of a generator at an Expiration Limit of:
o 17 L for the generator’s cumulative eluate volume, or
o 42 days post generator calibration date, or
o An eluate Sr-82 level of 0.01 μCi /mCi Rb-82, or
o An eluate Sr-85 level of 0.1 μCi /mCi Rb-82
Date of Issue: February - 2015 Page 7 of 88
Intended Use
The CardioGen-82 Infusion System is intended to be used in a healthcare facility to deliver the
radiopharmaceutical eluate rubidium-82 chloride to a patient in a controlled manner.
Principles of Operation
A. Type of protection against electric shock:
Class 1
B. Degree of protection against electric shock:
Type B applied part
C. Methods of sterilization or disinfection: Disposable parts used, no sterilized parts
D. Equipment not suitable for use in the presence of flammable mixtures
E. Mode of operation: Continuous
Date of Issue: February - 2015 Page 8 of 88
Electrical Safety
To reduce the risk of ELECTRICAL SHOCK, do not move or operate this system without
all the appropriate doors and panels in place.
HAZARDOUS VOLTAGE exists within the CardioGen-82 Infusion System. To avoid
shock, only trained, qualified service personnel should service the system. Always disconnect
the system from line power before attempting to perform any maintenance. Never touch any
pins on connectors or cables that have become disconnected from a live system.
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.
Connections to the patient are PHYSICALLY ISOLATED from all CardioGen-82 Infusion
System power sources. Follow standard health care facility procedures to ensure that there is
no degradation of system electrical performance.
This system is equipped with a three-conductor 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 ensure a reliable ground. Use only a power cord that is
in good condition.
To avoid fire hazard, use a FUSE of the correct type, voltage rating, and current rating as
specified:
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.
F1, Power chassis assembly (rear panel), ¼ x 1 ¼ T2, 5AL250V~ (2.5A, 250V~ time
delay)
F2, Power chassis assembly, ¼ x 1 ¼ T1, 5AL250V~ (1.5A, 250V~ time delay)
Refer all service to authorized personnel.
To prevent equipment damage, ACCESSORY EQUIPMENT connected to the
CardioGen-82 Infusion System must be certified to the respective IEC standard (i.e., UL/IEC
60601-1 for medical equipment). Any person who connects equipment to the input or output
signal part configures a medical system and is, therefore, responsible that the system complies
with the requirements of the system standard UL/IEC 60601-1. For questions regarding the
operation and service of the system, please contact your assigned Bracco Representative.
Date of Issue: February - 2015 Page 9 of 88
Explosion Hazard
Do not use the CardioGen-82 Infusion System in the presence of flammable anesthetics or
other flammable substances in combination with air, oxygen-enriched environments, or
nitrous oxide.
Cleaning & Maintenance
Before performing any cleaning operations, turn off the system and unplug the power cord. The
system should only be cleaned with an alcohol-dampened cloth. Be very careful when wiping
the Mylar windows that cover the seven segments LED displays, so as not to puncture them.
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.
To ensure all safety features are maintained to system specifications and that your
CardioGen-82 Infusion system is in optimal working condition, annual preventative
maintenance is recommended. A preventive maintenance program is available through Bracco
Diagnostics Inc. Refer all service to authorized personnel.
Training
In accordance with the CardioGen-82 (Rubidium Rb 82 Generator) handling instructions, all
authorized CardioGen-82 users must be certified in product safety and trained on quality
control procedures.
Aseptic Techniques
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.
Each user is responsible for maintaining the generator and associated tubing in aseptic
condition. The user must strictly observe aseptic technique following all internal facility
procedures and guidelines.
Air Embolism
An air embolism can cause patient injury or death. Operator vigilance and care, combined
with a set procedure, are essential to avoid injecting air and causing an air embolism:
Before patient infusions, visually inspect tubing for air bubbles.
Before patient infusions, purge air from the patient administration set.
Do not connect the patient until after the purge.
Date of Issue: February - 2015 Page 10 of 88
Radiation Safety
The CardioGen-82 Generator supplied by Bracco Diagnostics Inc. for use with the
CardioGen-82 Infusion System, emits radiation. All applicable radiation safety regulations
should be followed by the user. Inadvertent radiation exposure has been documented with the
misuse of the CardioGen-82 Generator due to Strontium-82/Strontium-85 breakthrough.
When working with any radioactive material, care should be taken to minimize radiation
exposure to the patient, consistent with proper patient management and following ALARA
(As low as reasonably achievable) principles. Additionally, care should be taken to minimize
the radiation exposure to attending personnel.
To limit the exposure of personnel, the CardioGen-82 Generator must be installed in the lead
shield provided in the CardioGen-82 Infusion System as a radiation safety precaution.
Gloves should be worn when handling any of the generator, generator tubing, or waste
components.
All components that may contain residual radioactivity must be stored and disposed of in
accordance with the facility’s radioactive materials license.
Radiopharmaceuticals should be used only by physicians who are qualified through training
and experience in the safe use and handling of radionuclides and whose experience and
training have been approved by the appropriate government agency authorized to license the
use of radionuclides.
If assistance is needed for the proper disposal of this product (including accessories and
components), please contact Bracco Diagnostics Inc.
Date of Issue: February - 2015 Page 11 of 88
Date of Issue: February - 2015 Page 12 of 88
Generator and Disposable Components
Only use and install the CardioGen-82 Generator into the CardioGen-82 Infusion System.
Only use and install the CardioGen-82 compatible sterile tubing set provided by Bracco
Diagnostics Inc. with each generator into the CardioGen-82 Infusion system.
Verify installation is correct before using.
Do not use any sterile tubing sets after the expiration date shown on the labeling.
Do not use sterile tubing sets if the package is opened or damaged.
The Patient Administration Set is single use only. Re-use carries increased risk of cross-
contamination.
For locations where the CardioGen-82 generator and the CardioGen-82 Infusion System
remain in one location (i.e., hospital, physician’s office, or imaging center): the tubing set
connected to the generator and the Infusion System must remain in place until a new generator
is installed. New tubing sets are provided by Bracco Diagnostics Inc. with each new
generator.
Due to the short half-life of CardioGen-82 (Rubidium-82, 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.
Used sterile tubing sets are biohazardous waste and should be handled in accordance with
institutional procedures and disposed of in accordance with local and national laws.
Please contact Bracco Diagnostics Inc. for ordering additional CardioGen-82 Accessory
supplies.
Date of Issue: February - 2015 Page 13 of 88
Transportation and Storage
The system should not be stacked with other equipment.
Do not attempt to lift this cart. The system is very heavy.
To avoid personal injury, do not move or operate this system without all appropriate lids and
panels in place.
Ensure that the power cord is placed in a manner that it does not get run over. The power cord
can be detached from the system. Reattach the power cord, if necessary, and/or ensure the
power cord is fully engaged in the power entrance module when arriving at the final
destination.
The saline bag hanger can be removed by pulling straight up if removal is necessary for height
clearance during movement. Reinsert when at final destination.
See the information under Generator and Disposable Components for specific details on
transportation requirements regarding the generator and disposable components.
Contact Bracco Diagnostics Inc. for additional instructions about your specific transportation
situation.
Date of Issue: February - 2015 Page 14 of 88
II. DAILY QUALITY CONTROL
Consistent with the CardioGen-82 Generator instructions for use, all quality control procedures
must be performed and recorded each day before patient studies are performed. These procedures
include:
1. Daily generator column wash
2. QUALITY CONTROL TESTING REQUIREMENTS AND EXPIRY LIMITS
PLEASE SEE CARDIOGEN-82 (RUBIDIUM RB 82 GENERATOR) FULL
PRESCRIBING INFORMATION FOR ADDITIONAL DETAILS
IMPORTANT SAFETY INFORMATION
WARNING: UNINTENDED STRONTIUM-82 (Sr-82) AND STRONTIUM-85 (Sr-85)
RADIATION EXPOSURE
Unintended radiation exposure occurs when the levels of Sr-82 or Sr-85 in the rubidium Rb 82
chloride injection exceed specified limits
Perform generator eluate tests:
1) Record each generator eluate volume, including waste and test volumes, and
keep a record of the cumulative eluate volume.
2) Determine Rb-82, Sr-82, Sr-85 in the generator eluate:
Once a day, prior to any drug administrations, and
At additional daily tests after detection of an Alert Limit. Alert Limits are:
o 14 L for the generator’s cumulative eluate volume, or
o An eluate Sr-82 level of 0.002 μCi/ mCi Rb-82, or
o An eluate Sr-85 level of 0.02 Sr-85 μCi/ mCi Rb-82.
o Perform the additional daily tests at time points determined by the day’s elution
volume; tests are performed every 750 mL.
3) Stop use of a generator at an Expiration Limit of:
o 17 L for the generator’s cumulative eluate volume, or
o 42 days post generator calibration date, or
o An eluate Sr-82 level of 0.01 μCi /mCi Rb-82, or
o An eluate Sr-85 level of 0.1 μCi /mCi Rb-82
Date of Issue: February - 2015 Page 15 of 88
3. Daily calibration test
Results must be within the specified limits:
Initial calibration of a new generator should be within 0.95 and 1.05.
Daily calibration should be within 0.90 and 1.10.
If calibration exceeds limits, calculate a new calibration factor. Repeat calibration procedure
until the ratio is within the specified limits.
THE CARDIOGEN-82 INFUSION SYSTEM MUST ONLY BE ELUTED WITH 0.9%
ADDITIVE-FREE SODIUM CHLORIDE FOR INJECTION, USP (SALINE).
Do not use any other type of solution with the system.
Date of Issue: February - 2015 Page 16 of 88
III. ELECTROMAGNETIC/ELECTROSTATIC INTERFERENCE
The CardioGen-82 Infusion system may fail to operate appropriately if exposed to high electromagnetic
fields (which may be generated by sources such as radio transmitters and cellular phones), or to high levels
of electrostatic discharge.
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 and 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 emissions and decreased
immunity of this system. Portable and mobile communications equipment can and may affect Medical
Electrical Equipment.
Guidance and manufacturer’s declaration –electromagnetic emissions
The CardioGen-82 Infusion System is intended for use in the electromagnetic environment specified below. The customer or the user of the CardioGen-82 Infusion System should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11
Group 1
The CardioGen-82 Infusion System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class A
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations / flicker emissions IEC 61000-3-3
Complies
The CardioGen-82 Infusion System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies power used for domestic purposes.
Date of Issue: February - 2015 Page 17 of 88
Guidance and manufacturer’s declaration –electromagnetic immunity
The CardioGen-82 Infusion System is intended for use in the electromagnetic environment specified below. The customer or the user of the CardioGen-82 Infusion System should ensure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment –
guidance
Electrostatic discharge (ESD) IEC 61000-4-2
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/burst IEC 61000-4-4
±2 kV for power supply lines ±1 kV for input/output lines
±2 kV for power supply lines ±1 kV for input/output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
±1 kV differential mode ±2 kV common mode
±1 kV differential mode ±2 kV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec
<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment. If the user of the [EQUIPMENT or SYSTEM] requires continued operation during power mains interruptions, it is recommended that the [EQUIPMENT or SYSTEM] be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
3 A / m 3 A / m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Date of Issue: February - 2015 Page 18 of 88
Guidance and manufacturer’s declaration –electromagnetic immunity
The CardioGen-82 Infusion System is intended for use in the electromagnetic environment specified below. The customer or the user of the CardioGen-82 Infusion System should assure that it is used in such an environment.
Portable and mobile RF communications equipment should be used no closer to any part of the [EQUIPMENT or SYSTEM], including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Pd
3
5,3
Pd
3
5,3 80 MHz to 800 MHz
Pd
3
7 800 MHz to 2,5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey
a, should be less than the
compliance level in each frequency range. b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CardioGen-82 Infusion System is used exceeds the applicable RF compliance level above, the CardioGen-82 Infusion System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the CardioGen-82 Infusion System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Date of Issue: February - 2015 Page 19 of 88
Recommended separation distances
between portable and mobile RF communications equipment and the CardioGen-82 Infusion System
The CardioGen-82 Infusion System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CardioGen-82 Infusion System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CardioGen-82 Infusion System as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
Pd
3
5,3 Pd
3
5,3 Pd
3
7
0,01 0.12 0.12 0.23
0,1 0.37 0.37 0.74
1 2.17 2.17 2.33
10 3.69 3.69 7.37
100 11.66 11.66 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Date of Issue: February - 2015 Page 20 of 88
IV. LABELS AND SYMBOLS
Symbol Definition Symbol Definition
Nameplate/Serial
Number
Type and Rating of Fusing
Manufacturer
Symbol
Operating Temperature
Type B Applied
Part
Attention: Consult
Accompanying Documents
100/120/220/240V~, 50/60Hz, 6.3A
Operating Supply
Voltage and
Frequency (Hz)
XXYYZZZ Serial number.
Read User Manual
Before Operation
Alternating current.
Protective earth
ground
Consult instructions for
use
Date of
manufacture Catalog number
Date of Issue: February - 2015 Page 21 of 88
Symbol Definition Symbol Definition
CAUTION: Federal
law (USA) restricts
this device to sale,
distribution, and use
by, or on the order of,
a physician
With respect to electric
shock, fire, mechanical,
and other specified
hazards, only in
accordance with UL
60601-1 and CAN/CSA
C22.2 No. 601.1 medical
equipment
Dangerous voltage
Explosion hazard
European
representative Contact for service
Single Use Only
Sterile
This product should
be recycled and not
disposed of as
general waste
(subject to WEEE
annex IV resp. EN
50419).
In accordance with
European Union
WEEE Directive
2002/96/EC, Bracco
UK will be fully
responsible for the
coordination,
logistics, and costs
of the WEEE
process
Pyrogen Free /
Non-Pyrogenic
Do not use if package
is damaged
Radioactive Hazard:
WASTE SHIELD
Date of Issue: February - 2015 Page 22 of 88
Radioactive Hazard:
GENERATOR
SHIELD
Radioactive Hazard:
VALVE SHIELD
Radioactive Hazard:
TUBING SHIELD
Date of Issue: February - 2015 Page 23 of 88
1. INTRODUCTION
The CardioGen-82 Infusion System is a complete system for the generation and
delivery of Rubidium-82 (Rb-82) from a CardioGen-82 Generator to a patient for
cardiovascular nuclear medicine procedures. Rb-82 is a short half-life (75 seconds)
positron emitter, highly extracted by the myocardium and is a potassium analogue.
For these reasons, Rb-82 is very useful for myocardial perfusion studies. The Rb-82
obtained from the CardioGen-82 Infusion System is eluted in sterile normal saline
(0.9% additive-free sodium chloride injection, USP) for direct injection into a
patient.
2. GENERAL DESCRIPTION
2.1 CardioGen-82 Infusion System – 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 CardioGen-82 Infusion System delivers Rb-82 chloride by pumping saline (0.9%
additive-free sodium chloride injection, USP) (which acts as an eluant) through a
CardioGen-82 Generator to produce the Rb-82 chloride eluate. A diagram of the
fluid system for the CardioGen-82 Infusion System is shown in Figure 2.3. Note that
the CardioGen-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. The positron detector cannot detect the
presence of Sr-85 (which does not emit positrons), and cannot distinguish between
Sr-82 and Rb-82, in eluate. The system is illustrated in Figure 2.1.
In addition to the syringe pump, the CardioGen-82 Generator, and the positron
detector, the fluid system contains a divergence valve for directing fluid flow in the
CardioGen-82 Infusion System. This divergence valve (see Figure 2.3) 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 CardioGen-82 Generator
reaches levels sufficient for patient injection, this valve directs the Rb-82 eluate to
the patient administration set.
2.2 CardioGen-82 Infusion System - Disposables Overview
The CardioGen-82 sterile disposable tubing set consists of two (2) primary
components: (1) the generator tubing set and (2) the patient administration set which
is replaced for each patient.
Date of Issue: February - 2015 Page 24 of 88
The CardioGen-82 Accessory Package connects the saline bag to the patient
administration set. It consists of tubing, a syringe piston, a high pressure syringe,
filters, valves, and various other fittings necessary to achieve the eluate and bypass
fluid pathways.
The patient administration set connects the generator tubing set to the delivery site
which typically consists of another tubing set, not provided with the CardioGen-82
Infusion System, which provides access to the patient’s vascular system.
THE PATIENT ADMINISTRATION SET IS SINGLE USE ONLY. Re-use
carries increased risk of cross-contamination.
The CardioGen-82 sterile disposable tubing set is Ethylene Oxide (EO) sterilized and
is provided sterile to the user.
CardioGen-82 elution vials are also provided.
Product Description Catalog # Usability
CardioGen-82 Patient Administration Set,
X25 001506 Single-Use Only
CardioGen-82 Accessory Package, X1 001510
Multi-Use
(Must be replaced when
the generator is replaced)
CardioGen-82 Elution Vials, X25 001530 Single-Use Only
CardioGen-82 Elution System:
Accessory Package, X1
Patient Administration Line, X25
Elution Vials, 2 X25
001536
Refer to above for usability of
specific components of the Elution
system
CardioGen-82 Waste Bottle, 2X500ml 001520
Multi-Use
CardioGen-82 Vented Cap for Waste Bottle,
X12 001511
Multi-Use
(Must be replaced when
the generator is replaced)
Date of Issue: February - 2015 Page 25 of 88
Figure 2. 1 CardioGen-82 Infusion System Diagram
Figure 2. 2 CardioGen-82 Infusion System Photograph
Date of Issue: February - 2015 Page 26 of 88
Figure 2. 3 CardioGen-82 Infusion System Fluid-System Diagram
Date of Issue: February - 2015 Page 27 of 88
2.3 Automatic Infusion Mode - Overview
The CardioGen-82 Infusion System provides an AUTOMATIC INFUSION mode for
automatic delivery of Rb-82 chloride to a patient. Additionally, the system provides
two purge modes, PURGE-GENERATOR-TO-WASTE and PURGE-
GENERATOR-TO-PATIENT, for system setup and maintenance. The two purge
modes are used to purge air out of the system tubing following the installation of a
CardioGen-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.
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 in mCi and a flow rate of 50 mL/min in accordance with the CardioGen-82
package insert. (NOTE: The term “dose” or “patient dose” is used throughout to refer
to the activity (mCi) of Rb-82 delivered or to be delivered to a patient.)
Additionally, the operator selects a patient volume (mL) and elution volume (mL),
which are used as backup limits to ensure patient safety. 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 (0.9% additive-free sodium chloride
injection, USP) 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 administration set and both the patient dose (mCi) and patient volume
(mL) 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.
Date of Issue: February - 2015 Page 28 of 88
3. SYSTEM SPECIFICATIONS
OPERATING
MODES
AUTOMATIC INFUSION
PURGE-GENERATOR-TO-WASTE
PURGE-GENERATOR-TO-PATIENT
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
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.
Flow Rate 20, 35, 50, 65, and 80 mL/min
(50 mL/min must be used for the CardioGen-82 Generator)
chloride injection, USP) is pumped through the generator and is routed to the waste
bottle by the automatic flow-control valve. In the PURGE-GENERATOR-TO-
PATIENT mode, saline (0.9% additive-free sodium chloride injection, USP) is also
pumped through the generator, but is routed to the patient administration set instead
of the waste bottle. The PURGE-GENERATOR-TO-PATIENT mode SHOULD
NOT be used to purge the infusion system into a patient. Instead this mode is used
to clear the patient administration set 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 (0.9% additive-free sodium chloride injection, USP)
solution through the CardioGen-82 Infusion System during the purge operation. The
PURGE-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 mode by selecting
PURGE-GENERATOR-TO-PATIENT 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 (0.9% additive-free sodium chloride injection, USP)
solution through the CardioGen-82 Infusion System during the purge operation. The
PURGE-GENERATOR-TO-PATIENT operation is summarized in Figure 4.2(b)
which includes an illustration of the Display/Control mode display.
Date of Issue: February - 2015 Page 39 of 88
Purge switch is depressed continuously during purge operation
Generator eluate is purged into waste bottle.
Figure 4.2 a Purge Generator to Waste
Purge switch is depressed continuously during purge operation
Generator eluate is purged into the patient administration set.
Figure 4.2 b Purge Generator to Patient Administration Set
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4.7 Automatic Infusion Mode
SUMMARY OF THE AUTOMATIC INFUSION OPERATION
Figure 4.3 a Activity Build Up Cycle
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Figure 4.3 b Patient Infusion Cycle
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Figure 4.3 c Infusion Ending Cycle
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4.7.1 Description The AUTOMATIC INFUSION mode is the normal infusion system mode for delivering a
set dose of Rb-82 (mCi) to the patient, a set patient volume limit (mL), or a set total elution volume limit (mL), whichever comes first. 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 (0.9% additive-free sodium chloride injection, USP) 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 by the detector) exceeds the preset dose rate threshold (selected by the DOSE RATE THRESHOLD switch), the radioactive eluate from the generator is directed to the patient administration set. At this time, both the patient dose (mCi) and the patient volume (mL) are measured and displayed on the PATIENT DOSE and PATIENT VOLUME displays.
The radioactive eluate continues to be infused into the patient administration set until either the patient dose limit (mCi), patient volume limit (mL), or elution volume limit (mL) is reached. These limits are selected by controls on the Display/Control Panel. With a new generator, for the first patient infusion, the patient volume limit may reasonably be set at 30 mL, and the elution volume limit at 40 mL, as is seen at the top of the sample infusion report printout on the next page (Figure 4.4). The patient volume limit and the elution volume limit for each succeeding patient infusion may reasonably be set using as a guide the actual infused patient volume and elution volume, as reported in the infusion report printout, from the previous patient infusion.
Once one of the preset infusion limits is reached, the saline pump is stopped and the
INJECT START/STOP switch stops glowing red to indicate the conclusion of the infusion. At this time, the generator outlet is directed back to the waste bottle and the system printer begins printing out a report of the infusion. The infusion report includes setup parameters, measured infusion data, and a history of activity (mCi) passing the detector port and the patient port in one-second time intervals. The printout data is also sent out the RS-232C port for access by a remote computer.
Note that reaching any of three independent parameter limits (the patient dose limit (mCi),
the patient volume limit (mL), or the elution volume limit (mL)) will stop an infusion. The AUTOMATIC INFUSION mode is summarized in Figure 4.3. Note that the Figure
shows the Display/Control Panel mode display for the activity buildup cycle, the patient infusion cycle, and the infusion end cycle. Additionally, each cycle is described briefly in the Figure.
Date of Issue: February - 2015 Page 44 of 88 Page 44 of 88
4.7.2 Report Printout At the end of an infusion operation, a complete report of the
Rb-82 infusion is printed on the system printer and this same
data is echoed out the RS-232C serial data port. The RS-
232C port can be connected to the facility’s computer for
analysis or storage of Rb-82 infusion data.
A sample automatic infusion printout is shown in Figure 4.4.
Note that the first entry of the report contains status
information. A normal infusion is indicated by the statement
"INFUSION TERMINATED NORMALLY." If the
infusion is unable to start or is interrupted in process, the
detected error condition(s) is (are) printed out. Infusion
error conditions are described in detail in the Section 6 of
this manual.
The next entries in the infusion report are the set-points
selected by the operator for the infusion. Elution volume,
patient volume, patient dose, and dose rate threshold set-
points are listed in the report. Additionally, the selected
flow rate and the selected calibration factor are listed.
The next entry in the infusion report is actual measured
infusion data. The actual elution volume, patient volume,
and patient dose are listed. Additionally, the activity present
at the end of infusion is listed. This activity is the activity
that would be present in an infusion collection bottle at the
end of an infusion. It is this activity value that is used for
calibrations since on-going decay of the collected eluate is
considered. Note that patient dose is the direct sum of
activity leaving the patient port and does not consider on-
going decay of the collected eluate. Finally, the activity
present between detector and waste valve and the activity
present between waste valve and patient are listed along
with the corresponding saline (0.9% additive-free sodium
chloride injection, USP) volumes. This data is informational
only and requires no user action as the infusion system
automatically considers the effects of radioactivity stored in
the tubing lines.
Finally, the infusion report contains an activity profile listing
in one-second intervals. Both the activity measured at the
detector and the activity calculated at the patient port are
displayed for each one-second interval. This data should be
interpreted as the amount of activity passing the detector and
patient port in successive one-second time intervals. Note
that the transit-time delay between the detector and the
patient port can be readily observed in the sample infusion
report. NOTE: THE POSITRON DETECTOR DOES NOT
DETECT THE PRESENCE OF STRONTIUM ISOTOPES
(Sr-82 and/or Sr-85) IN THE ELUATE.
Figure 4.4 Sample of Infusion Report Printout
INFUSION TERMINATED NORMALLY
SET-POINT VALUES:
Elution Volume = 40 mL
Patient Volume = 30 mL
Patient Dose = 50.0 mCi
Dose Rate Threshold. = 1.0 mCi/sec
Flow Rate = 50 mL/min
Calibration Factor = 926
ACTUAL INFUSION DATA:
Elution Volume = 26 mL
Patient Volume = 19 mL
Patient Dose = 50.1 mCi
Infused Activity Present
At End Of Infusion = 45.4 mCi
Activity Present Between
Detector and Waste Valve = 0.674 mCi
in Volume of 0.592 mL
Activity Present Between
Waste Valve and Patient = 3.23 mCi
in Volume of 2.75 mL
ACTIVITY PROFILE Time sec
Detector mCi/sec
Patient mCi/sec
1 0.000 0.000
2 0.000 0.000
3 0.000 0.000
4 0.000 0.000
5 0.000 0.000
6 0.000 0.000
7 0.003 0.000
8 0.056 0.000
9 0.377 0.000
10 1.149 0.000
11 1.937 0.016
12 3.026 0.422
13 3.558 1.191
14 3.648 1.996
15 3.624 3.023
16 3.652 3.487
17 3.650 3.548
18 3.564 3.528
19 3.385 3.558
20 3.134 3.549
21 2.848 3.457
22 2.556 3.270
23 2.277 3.024
24 2.023 2.743
25 1.797 2.462
26 1.611 2.188
27 1.450 1.946
28 1.314 1.729
29 1.204 1.552
30 1.103 1.398
31 1.020 1.268
32 0.578 0.709
Date of Issue: February - 2015 Page 45 of 88 Page 45 of 88
5. OPERATING PROCEDURE
5.1 General Notes
The sterility of each component must be preserved. Be sure to wear protective gloves.
Aseptic techniques must be strictly observed in all handling. Do not remove any luer
lock protective caps until instructed to do so. Additionally, do not allow any
unprotected luer lock fittings to make contact with anything other than its mating luer
lock fitting.
As system pressure can approach 100 PSI, it is important that luer lock fittings be
connected tightly without stripping or otherwise damaging the fittings. Improper luer
lock connections will result in saline (0.9% additive-free sodium chloride injection,
USP) leaks that may be difficult to find and correct.
5.2 CardioGen-82 Generator and Sterile Components
The CardioGen-82 Infusion System sterile disposable tubing set consists of two (2)
primary components: (1) the outlet generator assembly extension tubing which is for
use on multiple patients and is replaced with each generator, and (2) the patient
administration set which is replaced for each patient.
The generator tubing set connects the saline (0.9% additive-free sodium chloride
injection, USP) bag to the patient administration set. It consists of tubing, a syringe
piston, a high pressure syringe, filters, valves and various other fittings necessary to
achieve the eluate and bypass fluid pathways.
The patient administration set connects the generator tubing set to the delivery site
which typically consists of another tubing set, not provided with the CardioGen-82
System, which provides access to the patient’s vascular system.
The CardioGen-82 Infusion System sterile disposable tubing set is Ethylene Oxide
(EO) sterilized, and is provided sterile to the user.
Product Description Catalog # Usability
CardioGen-82 Patient
Administration Set 001506 Single-Use
CardioGen-82 Accessory Package,
X1 001510 Multiple Use
Compare the CardioGen-82 Accessory Package sterile disposable tray
label's parts list, list 001510, with the actual components in the tray. If not
correct, contact BDI Nuclear Medicine Customer Service at 1-800-447-6883.
Date of Issue: February - 2015 Page 46 of 88 Page 46 of 88
5.3 CardioGen-82 Infusion System Preparation
Remove the syringe pump cover by loosening the three mounting thumb screws and
carefully lifting the cover off the pump assembly. Activate the CardioGen-82
Infusion System by depressing the power switch and moving the mode switch to the
Purge Generator to Waste position.
Raise the lid of the hinged valve shield cover to expose the inside of the valve shield
assembly. Visually make sure there are no used disposables present in the system. If
any of the used disposables are present they must be disposed of to prevent possible
confusion with the new set-up. Close the valve cover.
Move the syringe pump to its upper end of the travel position by continuously
depressing the purge switch while the system is in the Purge Generator to Waste
mode. The pump will automatically stop when it reaches the upper end of the travel
position. The LED pump limit light will come on.
NOTE: The contents of the Accessory Pack are packaged in 3 plastic pouches, labeled
Package 1, Package 2, and Package 3. Only open and install the components in the
sequence in which they are packaged, before opening the next subsequent package in the
10. Determine if Sr-82 level in the eluate exceeds an Alert or Expiration Limit by
dividing the µCi of Sr-82 by the mCi of Rb-82 at EOE. (See below for further
instructions based on the Sr-82 level.)
Example:
0.47 µCi Sr-82 = 0.0094 µCi Sr-82/mCi Rb-82
50 mCi Rb-82
(test result is above Alert limit of 0.002 µCi Sr-82/mCi Rb-82; additional daily eluate
testing must be performed)
11. Determine if Sr-85 level in the eluate exceeds an Alert or Expiration Limit by
multiplying the result obtained in step 10 by the Sr-85/Sr-82 ratio (R), either as
calculated in step 7 above, or as provided in the data sheet supplied with the
generator.
Example:
0.0094 x 1.48 = 0.014 µCi Sr-85/mCi Rb-82
(test result is below the Alert limit of 0.02 µCi Sr-85/mCi Rb-82; result is within
specification for once daily testing)
Stop use of the CardioGen-82 generator once any one of the following Expiration
Limits is reached.
A total elution volume of 17 L has passed through the generator column, or
42 days post calibration date, or
An eluate Sr-82 level of 0.01 μCi /mCi Rb-82, or
An eluate Sr-85 level of 0.1 μCi /mCi Rb-82.
Date of Issue: February - 2015 Page 61 of 88 Page 61 of 88
CardioGen-82 INFUSION SYSTEM-CALIBRATION DATA SHEET
Infusion System Control Panel Settings Mode Switch: Automatic infusion Elution Volume: 99 mL Patient Volume: 20-50 mL
Patient Dose: Calibration activities must be performed with the SAME
LEVEL OF ACTIVITY (mCi Rb-82) that will be used for
patient doses. Dose Rate: 1 mCi/sec. Flow Rate: 50 mL/min. 1. Date of Calibration or Calibration Verification: ______________________ 2. Initial Generator Sr-82 Potency on calibration date: _______________mCi 3. Generator Sr-82 Potency on present date: ______________________mCi 4. Present Calibration Factor: _____________________________________ 5. Measured Rb-82 Activity from dose calibrator (corrected for decay):
___________________mCi 6. Printed Rb-82 Activity Present at the end of infusion: _______________mCi 7. Ratio of Measured Rb-82 Activity and Printed Rb-82: Measured Rb-82 Activity Printed Rb-82 Activity = Ratio 8. Is the difference between Measured Rb-82 Activity and Printed Rb-82:
+/-5% (Ratio=0.95 to 1.05) for initial calibration (generator installation) or +-/10% (Ratio=0.9 to 1.1) daily calibration? ____________________ (If no, unit requires recalibration).
9. Calculated New Calibration Factor (if needed): ______________________ Measured Rb-82 Activity at End of New Initial Infusion ___________________ Cal. = Cal. ________x __________________________ Factor Factor Printed Rb-82 Activity Present at
End of Infusion ______________ .
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Figure 5.2 SR-82 / SR-85 Testing Worksheet
Date of Issue: February - 2015 Page 63 of 88
Figure 5.3 Rb-82 Infusion System Calibration Log Sheet
Date of Issue: February - 2015 Page 64 of 88
Date of Issue: February - 2015 Page 65 of 88
6. TROUBLESHOOTING GUIDE
The table below describes possible purge and infusion error conditions that are
displayed on the Control/Display panel. These errors are also listed in the infusion
report printout. Suggested corrective action is provided in the table for each error
condition.
For product complaints or questions regarding the operation and service of the
system, please contact your assigned Bracco Representative.
This device has been tested for protection against electro-magnetic interference
according to IEC 60601-1-2. However, the proximity of other devices that give off
electro-magnetic radiation, such as X-ray machines, can interfere with the operation
of this system.
Date of Issue: February - 2015 Page 66 of 88
CardioGen-82®
(Rubidium Rb 82 Generator) Operator’s Manual Trouble Shooting Guide Index
Errors / Illustrations Page
Infusion System Diagram 67
Automatic Infusion Errors 68
Elution Volume (Illustration) 69
Patient Volume (Illustration) 70
Patient Dose (Illustration) 71
Pump Limit (Illustration) 72-73
Thumbwheel (Illustration) 74-75
Automatic Infusion and Purge Errors 76
Valve Failure (Illustration) 77-78
Valve Shield Open (Illustration) 79-80
High Pressure Errors 81
High Pressure Errors (Illustration) 82-83
Infusion Calibration Issues 84-85
Thumb Screws (Illustration) 86-87
Date of Issue: February - 2015 Page 67 of 88
CardioGen-82 Infusion System Diagram
Date of Issue: February - 2015 Page 68 of 88
Automatic Infusion Errors
Error Condition
Potential Root
Cause Indicative Signs of Error Suggested Action Illustration
Elution Volume
Elution Volume Set-
Point = 0
Print out will read "INFUSION NOT STARTED INFUSION PARAMETER ERROR Elution Vol. setpt. =
0"
Select non-zero infusion set points
See "Elution Volume" pg.
69
Patient Volume
Patient Volume Set-
Point = 0
Print out will read "INFUSION NOT STARTED INFUSION PARAMETER ERROR Pt. Vol. setpt. = 0"
Select non-zero infusion set points
See "Patient Volume" pg.
70
Patient Dose Patient Dose Set-Point =
0
Print out will read "INFUSION NOT STARTED INFUSION PARAMETER ERROR Pt.Dose setpt. = 0"
Select non-zero infusion set points
See "Patient Dose" pg. 71
Pump Limit
Pump At Extreme Forward
Limit Position
With Minimal Saline in Syringe
Print out will read "INFUSION UNABLE TO START Pump at Limit POS" and yellow pump limit light is
illuminated Refill syringe pump
See "Pump Limit" pg. 72-
73
Thumbwheel Oxidation on thumbwheel connections
Elution Volume, Patient Volume, Patient Dose, and/or Dose Rate on control panel will not match up with the
tape print out.
Cycle through a full range of numbers to clear
contacts of oxidation. Perform two elutions, one at a 35 ml and one at 50 ml for the parameter with
the issue, i.e. elution volume, and compare to
tape print out for accuracy. Contact Clinical
Applications Specialist (CAS).
See “Thumbwheel”
pg. 74-75
Date of Issue: February - 2015 Page 69 of 88
Elution Volume Print Out
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Patient Volume Print Out
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Patient Dose Print Out
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Pump Limit Control Panel
NOTE: Pump limit light will be illuminated when the syringe is full or nearly empty. When the system is set up correctly for an infusion, the pump limit light will be illuminated. This error will occur when there is not enough saline in the syringe to complete an infusion.
Date of Issue: February - 2015 Page 73 of 88
gggg
Pump Limit Print Out
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Thumbwheel Error Control Panel
NOTE: In this example the Patient Volume Limit is set for 35 mL but the printout on the next page shows 15 mL is the set point value and what the system actually eluted at patient volume
Date of Issue: February - 2015 Page 75 of 88
Thumbwheel Error Print Out
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Automatic Infusion and Purge Errors
Error Condition
Potential Root Cause
Indicative Signs of Error Suggested Action Illustration
Valve Failure Tight Divergence Valve or Loss of
Mechanism
Print out will read "INFUSION UNABLE TO START Valve Error" and Valve Failure light on
the control panel display is illuminated
Remove divergence valve and gently rotate lever-arm on tubing set before placing back in original position. If this process fails, contact
CAS.
See "Valve Failure" pg. 77-78
Valve Shield Open
Valve Shield Open Print out will read "INFUSION UNABLE TO
START Pt. Valve Shield Open"
Close the valve shield for all purge and
infusion operations. Make sure the inlet and patient port are properly inserted into the tubing
channel and not preventing the shield from completely
closing.
See "Valve Shield Open" pg. 79-80
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Valve Failure Control Panel
Date of Issue: February - 2015 Page 78 of 88
Valve Failure Print Out
Date of Issue: February - 2015 Page 79 of 88
Valve Shield Open
NOTE: This error is activated even if valve shield is slightly open and not depressing the red switch button.
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Valve Shield Open Print Out
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High Pressure Errors
Error Condition
Potential Root Cause
Indicative Signs of Error Suggested Action Illustration
High Pressure
Restricted tubing
Print out will read "INFUSION ABORTED BY ERROR High Pressure Error" and Red High Pressure light on the control panel display is illuminated.
Ensure all tubing is free of kinks and is not pinched in the system
See "High Pressure" pg.
82-83
High Pressure
Inadequate patient IV access
See Reference 6
Print out will read "INFUSION ABORTED BY ERROR High Pressure Error" and Red High Pressure light on the control panel display is illuminated.
Make sure gauge of needle is equal to or greater than 20 gauge.
Make sure stopcock or tubing clip is not locked. Position IV, check for flow in catheter.
Make sure patient’s arm is not bent in such a way as to restrict flow.
See "High Pressure" pg.
82-83
High Pressure
Faulty tubing, filter, or other
accessory pack or PAS component
Print out will read "INFUSION ABORTED BY ERROR High Pressure Error" and Red High Pressure light on the control panel display is illuminated.
Replace accessories as deemed necessary. The CAS or Field Service Engineer will decide if
customer should bypass the generator
See "High Pressure" pg.
82-83
High Pressure
Vent needle not fully pierced
through the elution test vial
septum during testing
Print out will read "INFUSION ABORTED BY ERROR High Pressure Error" and Red High Pressure light on the control panel display is illuminated.
Make sure proper positioning of vent needle and the patient administration set (PAS) needles are
inserted fully into elution test vial septum
See "High Pressure" pg.
82-83
High Pressure
Waste bottle cap filter failure or
clogging
Print out will read "INFUSION ABORTED BY ERROR High Pressure Error" and Red High Pressure light on the control panel display is illuminated.
Replace waste bottle cap NOTE: New waste bottle cap should be installed
with each new generator
See "High Pressure" pg.
82-83
High Pressure
Improper flow rate setting
(80ml/min instead of 50ml/min)
Print out will read "INFUSION ABORTED BY ERROR High Pressure Error" and Red High Pressure light on the control panel display is illuminated.
Flow rate setting should always be set to 50ml/min in accordance with Prescribing
Information (PI)
See "High Pressure" pg.
82-83
High Pressure
Generator column failure/blockage
Print out will read "INFUSION ABORTED BY ERROR High Pressure Error" and Red High Pressure light on the control panel display is illuminated.
Run through all other troubleshooting potential causes before bypassing generator. NOTE:
Customers must contact CAS prior to bypassing the generator.
See "High Pressure" pg.
82-83
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High Pressure Control Panel
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High Pressure Print Out
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Infusion System Calibration Issues NOTE: Normal calibration QC may take several infusions before being within acceptable limits when a new generator is installed.
Error Condition
Potential Root Cause
Indicative Signs of Error Suggested Action Illustration
Infusion System Calibration
Issues
Pump syringe is not secure to pump
syringe tower (chatter)
Multiple attempts to calibrate the system and/or large swings in the calibration factor
Ensure all four (4) thumb screws are secure See "Thumb
Screws" pg. 86 & 87
Infusion System Calibration
Issues System Leak
Multiple attempts to calibrate the system and/or large swings in the calibration factor
Lower than normal calibration factor: observed leak on the inlet side of the
generator Higher than normal calibration factor: observed leak on the outlet side of the
generator
Infusion System Calibration
Issues
Timing inconsistency in
dose assay
Multiple attempts to calibrate the system and/or large swings in the calibration factor
Make sure assays are performed consistently at 3 min. 45 sec. by all end-
users. Ensure the timer is started immediately at the end of infusion (when the light goes
out).
Infusion System Calibration
Issues
Incorrect channel selected on dose calibrator when assaying Rb-82
eluate for CardioGen-82 QC
Multiple attempts to calibrate the system and/or large swings in the calibration factor
Determine if the dose calibrator has an Rb-82 pre-set channel: Program dose
calibrator for Rb-82 as recommended by the manufacturer, Biodex: Atomlab 100 =
8.8 ; Atomlab 400/500 = 8.7, Capintec: 504 Check user manual for setting specifics,
The facility must have a dose calibrator capable of reading microcuries (uCi) out to
2 decimal places
Date of Issue: February - 2015 Page 85 of 88
Infusion System Calibration Issues Continued NOTE: Normal calibration QC may take several infusions before being within acceptable limits when a new generator is installed.
Error Condition
Potential Root Cause Indicative Signs of
Error Suggested Action Illustration
Infusion System Calibration
Issues
Dose calibrator non-linearity: Assaying the dose at 2min 30sec on a Capintec dose calibrator when the
dose is between 12-15mCi
Multiple attempts to calibrate the system and/or
large swings in the calibration factor
Measure assays consistently at 3 min 45 sec
Infusion System Calibration
Issues Equipment power surge
Multiple attempts to calibrate the system and/or
large swings in the calibration factor
Equipment power surge can effect dose accuracy of dose calibrator and infusion system
Notify CAS.
Infusion System Calibration
Issues
High background in hot lab when assaying Rb-82 elution vials for QC
Multiple attempts to calibrate the system and/or
large swings in the calibration factor
Reduce background to a minimum. Always make sure
background is subtracted when performing level testing
Infusion System Calibration
Issues
Possible control panel toggle switch setting contact issues: Oxidation of contacts, especially when the
infusion system is not used for an extended period of time
Multiple attempts to calibrate the system and/or
large swings in the calibration factor
After observing differences between the Infusion System Print-out Set Point Values and actual Control Panel Setting
values, notify CAS.
Infusion System Calibration
Issues
A site unknowingly tries to be within +/- 5% threshold for daily calibration, instead of the +/- 10% threshold
Multiple attempts to calibrate the system and/or
large swings in the calibration factor
Instruct the user that they only have to achieve +/- 5%
threshold on day one and +/-10% thereafter
Date of Issue: February - 2015 Page 86 of 88
Thumb Screws
Date of Issue: February - 2015 Page 87 of 88
Thumb Screws
Date of Issue: February - 2015 Page 88 of 88
7. CONTACT INFORMATION
Bracco Diagnostics Inc. 259 Prospect Plains Road, Monroe Township, NJ 08831 USA
1-609-514-2200
1-800-631-5245
Bracco Nuclear Medicine Customer Service 1-800-447-6883
Option 1
Technical Support
Service, Parts, and Technical Support; Bracco Professional